最新刊期
卷 33 ， 期 18 ， 2022
- 摘要：OBJECTIVETo provide empirical evidence for relevant decision makers in China to formulate and improve policies related to children’s medicine use.METHODSBased on the purchase data （Jul. 2016-Jun. 2019） of 18 tertiary children’s hospitals， the availability of medicines included in the 7th edition of WHO Model List of Essential Medicines for Children （WHO EMLc） and their influential factors were investigated according to standard medicine investigation method recommended by the WHO and Health Action International.RESULTSA totally 189 active ingredients listed in the 7th edition of WHO EMLc were available at 18 tertiary children’s hospitals in China， which referred to 229 medicines. The availability of Budesonide inhalation suspension， oral rehydration salt， Immunoglobulin for injection and Water for injection was 100%. In each quarter from Jul. 2016 to Jun. 2019， the availability of more than half of the medicines exceeded 50%， and the availability of the medicines remained basically stable in each quarter. The overall availability of cardiovascular system medicines and blood system medicines was the highest， while that of antiparasitic medicines and dermatology medicines was lower. There were 28 medicines （12.2%） that were not approved for use in children in China， the use of which were off-label. The medicines which had been approved for children and which were included in national essential medicine list had a significantly higher availability （P＜0.05）.CONCLUSIONSThe availability of essential medicines for children is generally better at tertiary children’s hospitals in China. But the use of some essential medicines in children are off-label. In order to ensure the safety and the availability of essential medicines for children， it is suggested to introduce China’s essential medicines list for children， to promote clinical trials in children for commonly used medicines， and to updete the drug manual in time.关键词：availability;tertiary children’s hospital;standard medicine investigation
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发布时间：2023-02-22 - 摘要：OBJECTIVETo establish the method for monitoring the dynamic changes of odor components in Cornus officinalis during processing.METHODSThe decoction pieces of C. officinalis with different processing time were prepared by the wine steaming method. The dynamic changes of odor components were obtained by using ultra-fast gas electronic nose； odor components were identified by comparing with AroChemBase database； the dynamic changes of odor compounds were analyzed in combination with peak area， and the chemical pattern recognition analysis were carried out.RESULTSA total of 12 common peaks of odor components were identified in the fingerprints of raw C. officinalis， and 21 in the fingerprints of decoction pieces of C. officinalis. Eight odor components with the high proportion of peak area during processing were ethanol， isopropyl alcohol， 2-methylpropylaldehyde， ethyl acetate， 2-methylbutanal， isoamyl alcohol， 2-hexanol and furfural， among which， the peak areas of ethanol， isoamyl alcohol and 2-hexanol showed a trend of first increasing and then decreasing； at 24 h of processing， their peak areas were still higher than those of raw products. The peak areas of ethyl acetate， 2-methylbutanal and furfural nearly increased with the increase of processing time. Variable importance in projection of above eight odor components were all greater than 1.CONCLUSIONSThe method is established for monitoring the dynamic changes of odor components of C. officinalis during processing. Eight odor components such as ethanol can be used as monitoring indicators of C. officinalis dring processing.关键词：ultra-fast gas phase electronic nose;odor;processing;wine steaming method;dynamic monitoring
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发布时间：2023-02-22 - 摘要：OBJECTIVETo separate and identify the flavone C-glycosides from the leaves of Dendrobium officinale， and to evaluate their in vitro inhibitory activities to α-glucosidase.METHODSThe flavone C-glycosides from the leaves of D. officinale were separated and purified by macroporous adsorption resin and preparative high-performance liquid chromatography. The structure of obtained compound was elucidated and identified by spectroscopic methods， such as ultraviolet spectrum， nuclear magnetic resonance， high-resolution electrospray ionization mass spectrometry， etc. The in vitro inhibitory activities of flavone C-glycosides and positive control （acarbose） to α-glucosidase were investigated.RESULTSFive apigenin-6，8-di-C-glycosides were isolated and purified from the leaves of D. officinale， and identified as apigenin-6-C-α-L-rhamnosyl-8-C-β-D-quinovoside（1）， schaftoside （2），isoschaftoside（3），isoviolanthin（4） and violanthin（5）. Half inhibitory concentration of compound 1-5 and acarbose inhibiting α-glucosidase were （1.79±1.27），（2.05±0.72），（1.93±0.67），（1.09±0.46），（1.36±0.58），（18.69±1.24） μmol/L， respectively.CONCLUSIONSFive apigenin-6，8-di-C-glycosides with α-glucosidase inhibitory activity are isolated from the leaves of D. officinale， of which compound 1 is a new compound and compound 2 is isolated from this plant for the first time.关键词：the leaves of Dendrobium officinale;flavone C-glycoside;apigenin-6-C-α-L-rhamnosyl-8-C-β-D-quinovoside;α-gulcosidase
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the effects of Achyranthis bidentatae-Cynanchum otophyllum as core couplet medicinals of Zhengan xifeng decoction on oxidative stress of cerebral tissue in Parkinson’s disease （PD） mice with syndrome of hyperactivity of liver-Yang.METHODSC57BL/6 mice were randomly divided into normal control group， model group， Zhengan xifeng decoction group， A. bidntatae group，C. otophyllum group and couplet medicinals of A. bidentatae-C. otophyllum group， with 10 mice in each group. PD model of hyperactivity of liver-Yang was established by intragastric administration of Aconitum carmichaelii decoction（4 g/kg） and intraperitoneal injection of 1-methyl-4-phenyl-1，2，3，6-tetrahydropyridine （25 mg/kg）.The behavioral changes and ultrastructure of substantia nigra neurons in mice were observed. The expressions of tyrosine hydroxylase （TH） positive neurons in substantia nigra were detected.The expressions of total antioxidant capacity （T-AOC），superoxide dismutase （SOD） and malondialdehyde （MDA） in substantia nigra as well as mRNA and protein expressions of nuclear factor-erythroid 2-related factor 2 （Nrf2）， thioredoxin reductase 1 （Trxr1）， thioredoxin interacting protein （Txnip） were also determined.RESULTSCompared with model group， PD behavior and ultrastructure of substantia nigra neurons were all improved in administration groups.The expressions of TH positive neurons， T-AOC （except for C.otophyllum group） and SOD （except for C.otophyllum group）， mRNA relative expression and protein expression levels of Nrf2 and Trxr1 were all increased significantly； the expression of MDA （except for C.otophyllum group） and mRNA relative expression and protein expression levels of Txnip were all decreased significantly （P＜0.05）. Intervention effect of couplet medicinals of A. bidentatae-C. otophyllum group was better than that of A.bidntatae group and C. otophyllum group （P＜0.05）， and the effect was similar to that of Zhengan xifeng decoction group （P＞0.05）.CONCLUSIONSThe couplet medicinals of A. bidentatae-C. otophyllum can inhibit the level of oxidative stress in the cerebral tissue of PD mice with hyperactivity of liver-Yang by targeting Nrf2， and play a protective role on the brain neurons. Its effect is better than that of A.bidntatae and C.otophyllum， and it plays the same role as that of the formula in tonifying the kidney， softening the liver and suppressing the Yang.关键词：hyperactivity of liver-Yang;Achyranthis bidentatae;Cynanchum otophyllum;couplet medicinals;Zhengan xifeng decoction;oxidative stress;mice
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发布时间：2023-02-22 - 摘要：OBJECTIVETo optimite the purification technology of total triterpenoid extracts from Inonotus obliquus， and to investigate the anti-tumor activity of its purified products.METHODSUsing inotodiol as control， the method was established for the content determination of total triterpenoid in I. obliquus. The type of macroporous adsorption resin， sample volume， sample concentration， sample flow rate， eluent volume， eluent dosage and elution flow rate were selected by single factor experiments. The purification technology of the crude extract was determined and verified. The effects of total triterpenoid purified from I. obliquus on the proliferation， migration and apoptosis of human cervical cancer HeLa cells were detected by cell proliferation test， migration test， flow cytometry and AO/EB kit.RESULTSThe best purification technology of total triterpenoid crude extracts from I. obliquus was as follows： AB-8 macroporous adsorption resin was used； mass concentration of the sample solution was 2.0 mg/mL； sample volume was 140 mL， and the flow rate was 1.0 mL/min； the impurity was removed with 50% ethanol 40 mL， then eluted with 95% ethanol 160 mL， at the elution flow rate of 3.0 mL/min. After purification， mass concentration of total triterpenoid from I. obliquus increased from 34.36% to 73.39%. The total triterpenoid of I. obliquus could inhibit the proliferation of HeLa cells， and the 50% inhibitory concentration was 184.20 μg/mL. Compared with control group， the purified products could significantly inhibit the migration and promote the apoptosis of HeLa cells（P＜0.05 or P＜0.01）.CONCLUSIONSThe purification technology of total triterpenoids extracts from I. obliquus is successfully optimited. The purified product could inhibit the proliferation and migration of HeLa cells and induce their apoptosis.关键词：purifi-cation;cell proliferation;cell migration;cell apoptosis
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发布时间：2023-02-22 - 摘要：OBJECTIVETo study the pharmacokinetic characters of Baihe-zhimu decoction （BZD） and its single herbs.METHODSA liquid chromatography-tandem mass spectrometry method was developed to simultaneously determine the blood concentrations of 7 effective components （neomangiferin， mangiferin， regaloside A， regaloside Ⅰ， timosaponin BⅡ， timosaponin E and timosaponin AⅢ） in rats after oral administration of BZD extract， single herb extract of Lilium brownii and Anemarrhena asphodeloides. The pharmacokinetic parameters were calculated.RESULTSThe linear range of 7 effective components as neomangiferin were 1-1 000， 1-1 000， 0.1-100， 0.4-400， 1-1 000， 0.1-100 and 0.5-500 ng/mL （all r＞0.998）， respectively. The accuracy of the method ranged from 87.50% to 115.00%， and the RSDs of intra-day and inter-day precision were 0.62%-14.35%. RSDs of matrix factor were 2.68%-14.03%， and deviation of stability were within ±15%. Compared with L. brownii and A. asphodeloides， AUC0－24 h，AUC0－∞ and cmax of 7 effective components in BZD were increased significantly （P＜0.05）， while CLz/F of 6 effective components （except timosaponin BⅡ） decreased significantly （P＜0.05）.CONCLUSIONSBZD can increase the absorption of effective ingredients in rats，slow down their elimination and prolong their retention time，indicating pharmacokinetic behaviors of effective components in BZD possess more advantages over those of single herbs.关键词：Baihe-zhimu decoction;pharmacokinetics
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发布时间：2023-02-22 - 摘要：OBJECTIVETo establish the method for simultaneous determination of 11 components as narirutin in Biantong capsules， to conduct chemical pattern recognition analysis and to screen differential markers affecting their quality.METHODSHPLC method was adopted. The separation was carried out on Venusil XBP C18 column with mobile phase consisted of acetonitrile-0.1％ phosphoric acid solution with gradient elution at flow rate of 1.0 mL/min. The sample size was 10 µL， and column temperature was set at 30 ℃. The detection wavelengths were set at 283， 330， 520， 220 nm， respectively. Using verbascoside as an internal standard， the contents were determined by quantitative analysis of mult-components by single marker （QAMS）， and the results were compared with those of external standard method. Cluster analysis， principle component analysis and orthogonal partial least squares-discriminant analysis were performed with SPSS 26.0 and SIMCA 14.1 software. The differential markers affecting the quality of Biantong capsules were screened using the variable importance in projection （VIP） value greater than 1 as the standard.RESULTSThe contents of narirutin， naringin， neohesperidin， echinacoside， tubuloside A， isoacteoside， cyanidin-3-O-glucoside， cyanidin-3-O-rutoside， atractylolide Ⅲand atractylolide Ⅰ were 0.739-1.265， 1.134-2.158， 1.407-2.359， 1.368-2.502， 0.304-0.522， 0.257-0.521， 0.423-0.727， 0.375-0.733， 0.130-0.283 and 0.062-0.166 mg/g， respectively. The relative average deviation of them from the external standard method was less than 2％. The results of cluster analysis showed that 15 batches of samples could be grouped into three categories， S1-S7 as a category， S8-S10 as a category， and S11-S15 as a category， which was consistent with the classification results of principal component analysis. The results of orthogonal partial least squares-discriminant analysis showed that the VIP values of cyanidin-3-O-rutoside， atractylolide Ⅲ， naringin， neohesperidin， echinacoside and verbascoside were all greater than 1.CONCLUSIONSThe method for simultaneous determination of 11 components in Biantong capsules， including narirutin， is successfully established. Combined with chemical pattern recognition analysis， it can be used for the quality control of Biantong capsules. Six components such as cyanidin-3-O-rutoside may be the differential markers that affect the quality of Biantong capsules.关键词：HPLC;QAMS;chemical pattern recognition;quality evaluation;differential markers
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发布时间：2023-02-22 - 摘要：OBJECTIVETo study the intervention effects and mechanism of Compound yu’e nasal drops on ovalbumin induced allergic rhinitis in rats.METHODSThe allergic rhinitis model of rat was induced with ovalbumin. Model rats were randomly divided into model group， triamcinolone acetonide group （positive control， 0.026 mg/kg）， Compound yu’e nasal drops high-dose， medium-dose and low-dose groups （134.4、67.2、33.6 mg/kg）， 12 rats in each group. Another blank control group was set. Except for blank control group， the corresponding drugs were given by nasal drip twice a day for 14 days. One hour after last administration， the nasal symptom scores of rats were recorded； the levels of serum immunoglobulin E （IgE）， interleukin-2 （IL-2）， IL-13 and tumor necrosis factor-α （TNF-α）were measured by enzyme-linked immunosorbent assay. The changes of nasal mucosa in rat were observed by HE staining. The expressions of TNF-α， IL-2 and IL-13 in nasal mucosa were detected by Western blot.RESULTSCompared with blank control group， nasal symptom score and the levels of serum IgE， IL-2， IL-13， TNF-α in model group were increased significantly （P＜0.01）； obvious pathological injury was found in nasal mucosa， and the expressions of TNF-α， IL-2 and IL-13 protein were increased significantly （P＜0.01）. Compared with model group， Compound yu’e nasal drops significantly reduced the nasal symptom score， the levels of serum IgE， IL-2， IL-13， TNF-α to different extents， improved pathological injury of nasal mucosa and significantly inhibited the expressions of TNF-α， IL-2 and IL-13 protein（P＜0.05 or P＜0.01）.CONCLUSIONSCompound yu’e nasal drops play significant effects against allergic rhinitis in rats by regulating the balance of type 1 helper T cells/type 2 helper T cells， balancing and inhibiting the secretion of inflammatory cytokines.关键词：allergic rhinitis;type 1 helper T cells/type 2 helper T cells balance
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发布时间：2023-02-22 - 摘要：OBJECTIVETo evaluate the quality of Xihuang pills， and to screen the differential markers affecting its quality.METHODSUsing muskone as internal reference， the content of α-pinene and other 4 components were determined by quantitative analysis of multi-components by single marker （QAMS）， and compared with the results of external standard method. The fingerprints of 13 batches of Xihuang pills were established by gas chromatography （GC） method. Cluster analysis （CA） and orthogonal partial least squares discriminant analysis （OPLS-DA） were performed by SPSS 25.0 software and SIMCA 14.1 software. The variable importance projection （VIP） value greater than 1 was used as the standard to screen differential markers affecting the quality of the samples.RESULTSThe contents of α-pinene， octyl acetate and β-elemene measured by QAMS were 0-0.628 4， 0.378 0-2.679 4 and 0.320 9-0.815 4 mg/g， respectively. The contents of α-pinene， octyl acetate， β-elemene and musk ketone measured by external standard method were 0.001 5-0.627 1， 0.378 0-2.594 7， 0.329 2-0.837 0 and 0.385 7-0.806 0 mg/g， respectively. The relative error of the content determination results of the two methods was less than 4%. There were 26 common peaks in 13 batches of Xihuang pills， and 3 common peaks， such as octyl acetate， β-elemene and musk ketone， were identified； their similarities were 0.912-0.946. 13 batches of samples could be divided into two categories （S1-S2， S6-S10， S13 were clustered into one category and S3-S5， S11-S12 were clustered into one category）. VIP values of peak 7， 11， 10， 17 and 16 were all greater than 1.CONCLUSIONSThe content of 4 components such as α-pinene in Xihuang pills combined with GC fingerprint and chemical pattern recognition analysis can be used to evaluate the quality of Xihuang pills. The components corresponding to 5 common peaks such as peak 7 may be differential markers affecting the quality of the samples.关键词：QAMS;content determination;GC fingerprint;chemical pattern recognition analysis
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发布时间：2023-02-22 - 摘要：OBJECTIVETo study the protective effect and mechanism of Shiyifang medicinal wine （SYF） on knee osteoarthritis （KOA） of rabbit induced by papain.METHODSThirty-five rabbits were randomly divided into blank group， model group， positive group （Diclofenac diethylamine emulsion 200 mg/kg）， SYF high-dose group （386 mg/kg） and SYF low-dose group （97 mg/kg）， with 7 rabbits in each group （all had 4 males and 3 females）. Except for the blank group， the other groups’ rabbits were injected 0.5 mL papain mixture （containing 2% papain and 0.03 mol/L L-cysteine） into the right knee cavity on day 1， 4 and 7， to replicate KOA model. Blank group was given constant volume of normal saline. From the 15th day， drugs were applied to right hind knee joints of rabbits in each group， twice a day for 20 days. At the same time， the diameter of right knee joints of rabbits was measured by vernier calipers at day 0， 8， 14 and 35 to calculate swelling degree. After the experiment， the levels of IL-1β， TNF-α and PGE2 in synovial tissue were determined by enzyme-linked immunosorbent assay. Hematoxylin-eosin （HE） staining was used to prepare the sections of synovial tissue， and the pathological changes were observed. The relative mRNA expressions of TLR4， MyD88 and NF-кB p65 in the TLR4/MyD88/NF-кB signaling pathway were detected by real-time quantitative polymerase chain reaction.The relative protein expressions of TLR4， MyD88， NF-кB p65 and p-NF-кB p65 were detect by Western blot.RESULTSCompared with blank group， the degree of knee swelling could be increased in model group， the pathological damage of synovial tissue was more serious， and the levels of IL-1β， TNF-α and PGE2 were increased significantly in synovial tissue （P＜0.05）. The relative expression levels of TLR4， MyD88， NF-кB p65 mRNAs and TLR4， MyD88， p-NF-кB p65 proteins were significantly increased （P＜0.05）. Compared with model group， swelling degree of right hind knee and the pathological injury degree of synovial tissue were significantly improved in each treatment group， while the levels of IL-1β， TNF-α and PGE2 in synovial tissue were significantly decreased （P＜0.05）. The relative mRNA expressions of TLR4， MyD88 and NF-кB p65 and relative protein expressions of TLR4， MyD88 （except for SYF low-dose group）and p-NF-кB p65 were all significantly decreased （P＜0.05）.CONCLUSIONSSYF shows protective effect on KOA induced by papain， the mechanism of which is associated with decreasing the levels of IL-1β， TNF-α and PGE2 and down-regulating TLR4/MyD88/NF-кB signaling pathway.关键词：knee osteoarthritis;inflammatory factor;TLR4/MyD88/NF-кB signaling pathway
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发布时间：2023-02-22 - 摘要：OBJECTIVETo establish quantitative analysis of multi-components by single marker（QAMS） method to simultaneously detect the contents of cinnamic acid，cinnamaldehyde，plantamajoside，verbascoside，isoacteoside，calceolarioside B，psoralen，isopsoralen，neobavaisoflavone and bavachin in Gushen dingchuan pill，and to perform quality evaluation of Gushen dingchuan pill by combining with chemical pattern recognition.METHODSHigh-performance liquid chromatography was adopted. Using psoralen as internal standard，the relative correction factors of the other 9 components were established，and the contents of each component were calculated and compared with those determined by external standard method.Cluster analysis，principal component analysis and partial least squares discrimination analysis were performed by the results of QAMS method， and the qualities of 15 batches of Gushen dingchuan pills were evaluated.RESULTSThe above 10 components showed a good linear relationship in their respective ranges（r＞0.999 0）. RSDs of precision，repeatability，stability and recovery tests were all lower than 2.00%. There was no significant difference between QAMS method and external standard method （P＞0.05）. The results of cluster analysis and principal component analysi showed that 15 batches of Gushen dingchuan pills could be clustered into 3 categories. The results of partial least squares discrimination analysis showed that psoralen，verbascoside，cinnamaldehyde and isopsoralen were the main potential markers affecting the quality of Gushen dingchuan pills.CONCLUSIONSEstablished QAMS method for quantitative control of multi index components and chemical pattern recognition can be used for the quality evaluation of Gushen dingchuan pills.关键词：multi-index component;QAMS method;chemical pattern recognition analysis
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发布时间：2023-02-22 - 摘要：OBJECTIVETo prepare AngelicaCinnamomum （Angelica sinensis-Cinnamomum cassia） selfmicroemulsion drug delivery system （ACSMEDDS）， and to optimize its formulation and characterize its preparation.METHODSUsing Angelica Cinnamomum mixed volatile oil as oil phase and model drug， on the basis of selecting emulsifier and co-emulsifier and the optimization of their mass ratio range， the formulation was optimized with central composite designresponse surface methodology using the ratio of oil phase （AngelicaCinnamomum mixed volatile oil）， mass ratio of emulsifier and co-emulsifier as factors， the comprehensive score of volatile oil content， particle size and emulsifying time as index. Morphology， particle size， drug loading， entrapped efficiency and stability of optimized ACSMEDDS were characterized.RESULTSThe optimum formulation of ACSMEDDS contained the ratio of oil phase was 30%， and the mass ratio of emulsifier （EL40） and co-emulsifier （ethanol） was 9∶1. Results of validation tests showed that the average particle size of ACSMEDDS was （148.33±1.53） nm， and emulsifying time was （18.44±0.11） s. The comprehensive score was 0.68， relative deviation of which from the predicted value （0.70） was 2.86%. ACSMEDDS prepared by optimal formulation was faint yellow， uniform and transparent liquid， and spherical particals with translucent edge were observed under transmission electron microscope. Calculated by ligustilide and cinnamaldehyde， the drug loading was （7.58±0.03） and （4.17±0.01） mg/g， and entrapped efficiency was （93.25±0.01）% and （88.89±0.02）%，respectively. No stratification or precipitation occurred after centrifugation at the speed of 10 000 r/min or placing within 7 days at 4 and 25 ℃. The contents of ligustilide and cinnamaldehyde were stable. Its particle size had no significant change after 50， 100 and 200 times dilution by purified water. CONCLUTIONS ACSMEDDS is prepared successfully and its formulation is optimized. The stability of the preparation is good.关键词：unification of drugs and excipients;AngelicaCinnamomum selfmicroemulsion drug delivery system;Formulation optimization;central composite designresponse surface methodology
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发布时间：2023-02-22 - 摘要：OBJECTIVETo establish a method for simultaneous determination of 5 saponins in Huoxue zhitong capsules/tablets and to confirm the illegal addition of Panax ginseng， Panax quiquefolium and stems and leaves of Panax notoginseng.METHODSUltra-high performance liquid chromatography tandem mass spectrometry was used. The Agilent RRHD Eclipse Plus C18 column was used with mobile phase of water （containing 0.1% formic acid）-acetonitrile for gradient elution at a flow rate of 0.35 mL/min. The column temperature was 35 ℃ and the sample size was 2 μL. Using electrospray ionization source， negative ion scanning was carried out in multi-reaction monitoring mode.RESULTSThe linear ranges of notoginsenoside R1， ginsenoside Rb1， ginsenoside Rg1， ginsenoside Rd， ginsenoside Re， ginsenoside Rf（an unique ingredient of P. ginseng）， ginsenoside Rb3（an unique ingredient of stems and leaves of P. notoginseng） and pseudo-ginsenoside F11（an unique ingredient of P. quiquefolium） were 9.99- 1 499.50， 9.99-1 499.50， 10.01-1 500.80， 9.99-1 499.10， 10.00-1 500.20， 9.99-1 499.50， 10.01-1 500.80， 9.99-1 499.00 ng/mL （R 2＞0.997）； the detection limits and the quantitative limits were not higher than 2.64 and 8.06 ng/mL， respectively. RSDs of precision， repeatability and stability （24 h） tests were all less than 6%. The average recoveries of saponins in capsules and tablets were 98.72%-102.40% and 95.18%-106.47%， respectively （all RSDs＜5%， n＝6）. In 18 batches of Huoxue zhitong capsules， the contents of ginsenoside Re， ginsenoside Rd， ginsenoside Rg1， notoginsenoside R1 and ginsenoside Rb1 were 291.79-426.89， 427.71-677.49， 2 294.28-3 371.43， 571.22-848.19 and 1 841.33-2 959.12 μg/g， respectively； the contents of ginsenoside Rb3 were no more than 45.02 μg/g. In 22 batches of Huoxue zhitong tablets， the contents of above indicators of P. notoginseng were 44.11-393.83， 80.48-549.55， 393.36-3 548.57， 79.83-872.60， and 288.64-2 912.66 μg/g， respectively； the contents of ginsenoside Rb3 were no more than 44.79 μg/g. Ginsenoside Rf and pseudo-ginsenoside F11 were not detected in the two preparations.CONCLUSIONSThe method can be used to determine the contents of saponins in Huoxue zhitong preparations. No illegal addition of P. ginseng and P. quiquefolium are found in 40 batches of preparations， but the input of P. notoginseng in some batches of tablet samples is less.关键词：Huoxue zhitong tablets;saponins;Panax notoginseng;Panax ginseng;Panax quiquefolium;stems and leaves extract of Panax notoginseng;illegal addition;ultra-high performance liquid chromatography tandem mass spectrometry
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发布时间：2023-02-22 - 摘要：OBJECTIVETo establish the fingerprints of Xanthoceras sorbifolia and determine the contents of flavonoids.METHODSHPLC was adopted. Using epigallocatechin as reference， the fingerprints of 11 batches （No. S1-S11） of X. sorbifolia were drawn with Similarity Evaluation System of Chromatographic Fingerprints of TCM （2004A edition）. The similarity evaluation was conducted， the common peaks were also confirmed. Cluster analysis （CA） and principal component analysis （PCA） were also performed. Epigallocatechin was selected as internal reference， and quantitative analysis of multi-components by single marker （QAMS） was used to determine the contents of gallocatechin， catechin， epicatechin， dihydromyricetin， taxifolin and myricetin in 16 batches （No. S1-S16） of X. sorbifolia. The results were compared with the results of one point external standard method and standard curve method.RESULTSThere were 15 common peaks in 11 batches of X. sorbifolia， and the similarity of them were 0.910-1.000. A total of 7 common peaks were identified， i.e. galliccatechin （peak 1）， epigallocatechin （peak 2）， catechin （peak 3）， epicatechin （peak 5）， dihydromyricetin （peak 6）， taxifolin （peak 14） and myricetin （peak 15）. The results of CA showed that S5-S7 and S9 were clustered into one category， S8 and S11 were clustered into one category， S10 were clustered into one category， S1-S4 were clustered into one category. The results of PCA showed that accumulative variance contribution rate of 3 principal components was 99.24%； S5-S7 were clustered into one category， S8-S11 were clustered into one category， S3 and S4 were clustered into one category， S1 and S2 were clustered into one category. With the exception of myricetin and a partial batches （S12， S14-S16） of catechin， the RSDs measured by the three methods for galliccatechin， catechin （remaining batches）， epicatechin， dihydromyricetin and taxifolin in 16 batches of X. sorbifolia were less than 4% （n＝3）.CONCLUSIONSThe established HPLC fingerprint and the method for content determination can be used for the quality control of X. sorbifolia. QAMS method can be used for the content determination of galliccatechin， epicatechin， dihydromyricetin and taxifolin.关键词：Xanthoceras sorbifolia;Flavonoids;finger-print;quantitative analysis of multi-components by single marker;HPLC
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发布时间：2023-02-22 - 摘要：OBJECTIVETo evaluate the cost-effectiveness of tislelizumab in the second-line treatment of advanced or metastatic esophageal squamous cell carcinoma （ESCC） in China.METHODSA three-state Markov model was constructed to assess the cost-effectiveness of tislelizumab versus chemotherapy in the second-line treatment of advanced or metastatic ESCC and programmed death receptor 1 （PD-L1） positive patients. The cycle length of the model was 1 month， and the time horizon of the model was set as 10 years. The discount rate of cost and utility was 5%. One-way sensitivity analysis， probability sensitivity analysis and scenario analysis were used to verify the robustness of the base-case analysis results.RESULTSThe results of the base-case analysis showed that compared with chemotherapy， the incremental cost-effectiveness ratio （ICER） of tislelizumab in the second-line treatment of advanced or metastatic ESCC and PD-L1-positive patients were 26 864.01 yuan/QALY and 37 510.07 yuan/QALY， respectively， which was much lower than 1 time per capita gross domestic product （GDP） in 2021 （80 976 yuan）. Results of scenario analysis showed that the ICER was less than 1 times per capita GDP， regardless of the chemotherapy regimens （paclitaxel， docetaxel or irinotecan） used. With the extension of the simulation time limit， the ICER of tirelizumab regimen gradually decreased， and the reduction rate gradually decreased， but they were all less than 1 time China’s per capita GDP in 2021. The results of the one-way sensitivity analysis showed that the 3 parameters with the most significant impact on the ICER were progression-free survival of tislelizumab group， price of tislelizumab， and the proportion of patients receiving follow-up treatment in the tislelizumab group. The results of the probability sensitivity analysis showed that the probability of tislelizumab with cost-effectiveness in the treatment of advanced or metastatic ESCC patients and PD-L1-positive patients were 99.09% and 99.94%， respectively， when using 3 times per capita GDP as the willingness-to-pay threshold.CONCLUSIONSTislelizumab has economic advantages over chemotherapy alone in the second-line treatment of advanced or metastatic ESCC patients.关键词：advanced or metastatic esophageal squamous cell carcinoma;cost-utility analysis;Markov model
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发布时间：2023-02-22 - 摘要：OBJECTIVETo establish a method for the determination of plasma protein binding rate of imatinib and its metabolite （N-desmethyl imatinib） and apply it to patients with gastrointestinal stromal tumor （GIST）.METHODSUsing imatinib-d8 as the internal standard， after being deproteinized methanol， the sample was determined by equilibrium dialysis combined with liquid chromatography-tandem mass spectrometry. The free concentrations of imatinib and its metabolites in plasma of GIST patients were detected by the same method.RESULTSThe protein binding rates of imatinib with albumin， α1-acid glycoprotein and globulin at 120 ng/mL and 4 000 ng/mL were （92.5±1.0）% and （91.7±0.4）%， （56.6±2.0）% and （62.6±2.6）%， （56.3±3.1）% and （68.0±8.6）%， respectively. The protein binding rates of N-desmethyl imatinib with albumin， α1-acid glycoprotein and globulin at 60 ng/mL and 2 000 ng/mL were （90.6±3.5）% and （91.3±1.5）%， （54.1±5.1）% and （63.7±1.3）%， （56.2±7.6）% and （67.5±7.3）%， respectively. Compared with the low concentration group of imatinib （120 ng/mL） and its metabolite （60 ng/mL）， the plasma protein binding rate of high concentration of imatinib （4 000 ng/mL） and its metabolite （2 000 ng/mL） with α1-acid glycoprotein and globulin was significantly increased （P＜0.05）， but there was no signifi-cant difference with albumin （P＞0.05）. In blank plasma， the protein binding rates of imatinib （4 000 ng/mL） at high concentration and its meta-bolites （2 000 ng/mL） were significantly lower than those of low （120， 60 ng/mL） and medium （750， 375 ng/mL） concentration （P＜0.01）. Average protein binding rates of imatinib and its metabolite in plasma of GIST patients were （99.0±0.3）% and（99.2±0.3）%， respectively； the correlation coefficients between the concentrations of imatinib and its metabolites and the protein binding rates were －0.298 5 and －3.332 3， respectively （all P＜0.05）.CONCLUSIONSThe method for determining the plasma protein binding rates of imatinib and its metabolites is successfully established. The plasma protein binding rates of imatinib and its metabolites in patients with GIST are negatively correlated with drug concentration.关键词：N-desmethyl imatinib;equilibrium dialysis;liquid chromatography-tandem mass spectrometry;plasma protein binding rate
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发布时间：2023-02-22 - 摘要：OBJECTIVETo establish and validate a population pharmacokinetic model of docetaxel in malignant tumor patients.METHODSThe clinical data of malignant tumor patients treated with chemotherapy regimen containing docetaxel in our hospital from June 2019 to December 2021 were retrospectively collected. According to the results of blood concentration detection， based on the three-compartment model the nonlinear mixed effect model （NONMEM） was used； covariates （age， weight， height， body surface area， Karnofsky performance scale， total protein， albumin， total bilirubin， aspartate aminotransferase， alanine aminotransferase and serum creatinine） affecting clearance （CL） were screened by “forward inclusion and backward exclusion”； the population pharmacokinetic model of docetaxel was established. The model was tested for goodness-of-fit diagnosis and internal validation by Bootstrap.RESULTSA total of 264 measured blood concentrations of 132 patients with malignant tumors during chemotherapy were included. The covariates that had significant effect on CL of docetaxel were serum creatinine and total bilirubin （P＜0.01）. The results of Bootstrap analysis （parameter median values and 95% confidence intervals） were close to predict results of the established model； the final model estimated that the population typical value of docetaxel CL was 37.82 L/h.CONCLUSIONSThe population pharmacokinetic model of docetaxel in malignant tumor patients is established successfully， which can be used for the formulation and optimization of clinical individualized regimen.关键词：blood concentration;population pharmacokinetic model;malignant tumor
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发布时间：2023-02-22 - 摘要：OBJECTIVETo evaluate the postprandial bioequivalence of two kinds of Diacerein capsules in healthy volunteers with oral administration.METHODSA total of 24 adult healthy subjects were included and randomly divided into two groups， with 12 subjects in each group. A randomized， open， double-cycle cross-over trial design was adopted. Both groups took 50 mg of the test preparation （domestic Diacerein capsules） or the reference preparation （Ambridine®） respectively at 30 min after eating the standard meal in the morning of the first day of each cycle of the trial. The cleaning period was one week. Blood samples were collected at different time points before and after taking the medicine and the protein was precipitated with methanol for sample pretreatment. The concentration of active metabolite rhein was determined by LC-MS/MS using emodin as internal standard. The pharmacokinetic parameters were calculated with DAS 3.2.9 software， and the bioequivalence of test and reference preparation were evaluated.RESULTSAfter the subjects took the test preparation and the reference preparation after meal， the main pharmacokinetic parameters of rhein were as follows： cmax were （3 517±1 121） and （3 225±755） ng/mL； AUC0－24 h were （25 764±6 134） and （24 316±5 856） ng·h/mL； AUC0－∞ were（26 679±6 409） and （25 170±6 415） ng·h/mL； tmax were 3.50（0.67，12.00） and 4.00（1.50，7.00）h； t1/2 were （4.26±1.12） and （4.19±1.05） h， respectively. The 90% confidence intervals of the geometric mean ratios of cmax， AUC0－24 h and AUC0－∞ were 100.8%-113.9%， 103.1%-109.4% and 103.2%-109.9%， respectively.CONCLUSIONSThe test preparation and reference preparation are bioequivalent in the postprandial state of healthy subjects.关键词：domestic generic drug;postprandial bioequivalence
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发布时间：2023-02-22 - 摘要：OBJECTIVETo systematically review the efficacy and safety of kidney-tonifying Chinese patent medicine combined with phosphodiesterase type 5 （PDE5） inhibitors in the treatment of erectile dysfunction （ED）， and to provide evidence-based reference for clinical medication.METHODSRetrieved from PubMed， Embase， Cochrane Library， Web of Science， VIP， China Biomedical Literature Database， CNKI and Wanfang database， randomized controlled trials （RCTs） of kidney-tonifying Chinese patent medicine combined with PDE5 inhibitors （trial group） versus PDE5 inhibitors or kidney-tonifying Chinese patent medicine alone （control group） were collected. The search period was from the establishment of the database to February 15， 2022. After literature screening and data extraction， the risk of bias assessment tool recommended in Cochrane System Reviewer’s Handbook 6.1.0 was used to evaluate the quality of the included literature； Stata 16.0 software was used for network meta-analysis； and the funnel plot was used for publication bias analysis.RESULTSA total of 23 RCTs were included， with a total of 2 417 patients， involving 8 kinds of Chinese patent medicines， including Congrong yishen granule， Canrong zhutian capsule， Compound xuanju capsule， Huanshao capsule， Shanhaidan granule， Shengjing capsule， Shisanwei ziyin zhuangyang capsule， Shugan yiyang capsule. The results of network meta-analysis showed that in terms of total effective rate， Compound xuanju capsule combined with PDE5 inhibitor， Shengjing capsule combined with PDE5 inhibitor， Shugan yiyang capsule combined with PDE5 inhibitor had higher total effective rate； in terms of international index of erectile function 5， the scores of Compound xuanju capsule combined with PDE5 inhibitor， Congrong yishen granule combined with PDE5 inhibitor， and Canrong zhutian capsule combined with PDE5 inhibitor were higher； in terms of safety， the incidence of adverse drug reactions caused by Huanshao capsule， Shanhaidan granule and Shugan yiyang capsule were lower.CONCLUSIONSKidney-tonifying Chinese patent medicine combined with PDE5 inhibitor can improve the erectile function of ED patients and reduce the occurrence of adverse drug reactions. In terms of efficacy and safety， Compound xuanju capsule combined with PDE5 inhibitor is the best.关键词：kidney-tonifying Chinese patent medicine;phosphodiesterase type 5 inhibitor;meta-analysis;efficacy;safety
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发布时间：2023-02-22 - 摘要：OBJECTIVETo provide ideas for pharmaceutical care of Mycobacterium abscess infection.METHODSThe diagnosis and treatment plan， about a patient with M. abscess infection after resection of intervertebral neurilemmoma participated by clinical pharmacists， was analyzed. According to the results of bacterial culture and drug sensitivity test of wound secretion， the clinical pharmacist timely dealed with the adverse drug reactions during the treatment. For the tinnitus caused by the patient taking amikacin （0.4 g， intravenous drip， q12 h）， it was suggested to stop amikacin and replace it with linezolid； however， the patient suffered from knee pain after taking linezolid. The clinical pharmacist once again suggested stopping linezolid， continuing to use amikacin， and adjusting the dose to 0.8 g， intravenous drip， q24 h； at the same time， the patients were given medication guidance and ordered to have regular follow-up after discharge.RESULTSThe physicians adopted the suggestions of clinical pharmacists， and the patient did not suffer from tinnitus， knee pain and other discomfort， and the liver and kidney functions were normal.CONCLUSIONSClinical pharmacists timely assist clinicians to adjust the medication plan， which improves the effectiveness and safety of patients’ medication.关键词：Clinical pharmacist;Mycobacterium abscess;skin;soft tissue;Infection;ADR;Pharmaceutical care
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发布时间：2023-02-22 - 摘要：OBJECTIVEFrom the perspective of licensed pharmacist， provide reference for improving the risk management ability of electronic prescription circulation in the internet hospitals.METHODSThe methods of literature review and comparative analysis were used to interpret the risk factor of electronic prescription circulation， stakeholders’ responsibilities and the situation of prescription reviewed by pharmacists. The responsibilities of pharmacists in internet hospitals， brick and mortar stores and third-party drug platforms were analyzed specifically to propose the institutional arrangements for the licensed pharmacist’s provision in the risk management of electronic prescription circulation. RESULTS &CONCLUSIONSThrough the establishment of internet hospital pharmacovigilance system， the preparation of double-reviewing specification for licensed pharmacists， and the remote reviewing of the chief licensed pharmacist system， the licensed pharmacists’ responsibilities should be promoted to fulfill the risk management of electronic prescription circulation in the internet hospital.关键词：risk management;licensed pharmacist;pharmacist’s responsibility;internet hospital
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发布时间：2023-02-22 - 摘要：Cyclosporine A is widely used in organ transplantation and autoimmune diseases. Due to the obvious differences in metabolism between individuals， the dosage should be adjusted according to the patient’s blood concentration during clinical use. But the blood concentration does not reflect accurately its clinical prognosis. This article focuses on the four laboratory examination indexes following aspects： the cyclosporine A concentration of peripheral blood mononuclear cells， calcineurin activity， T cell function and metabolite concentration of cyclosporine A. The relationship between them and the pharmacokinetics of cyclosporine and clinical prognosis were reviewed. It’s found that the above indicators have a certain predictive effect on the clinical prognosis of patients receiving cyclosporine A， which can make up for the insufficiency of blood drug concentration monitoring， and the clinical practicability needs to be further improved.关键词：therapeutic drug monitoring;clinical efficacy;safety;laboratory examination index
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发布时间：2023-02-22 - 摘要：In recent years， biomimetic nanodelivery system based on cell membrane coating has developed rapidly and shows better biocompatibility and efficacy than traditional nanodelivery systems in a variety of diseases. Macrophages， as members of the immune system， are closely related to the occurrence and development of a variety of diseases. Macrophages are derived from monocytes and can be polarized into M1 and M2 types after corresponding stimulation： M1 macrophages involved in the proinflammatory reaction and M2 macrophages involved in the inflammatory reaction. This paper reviews the application status of biomimetic nanoparticles coated with macrophage membrane in disease targeted therapy in recent years. Biomimetic nanoparticles coated with macrophage membrane has shown its high targeting and low immunogenicity in the treatment of malignant tumors （breast cancer， colorectal cancer， melanoma， glioma）， Alzheimer’s disease， liver ischemia-reperfusion injury， atherosclerosis and so on. However， the research of Biomimetic nanoparticles coated with macrophage membrane currently focuses on anti-tumor research and is still in the laboratory research stage.关键词：nanoparticles coated with cell membrane;biomimetic delivery system;targeted therapy
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发布时间：2023-02-22 - 摘要：Tianwang buxin dan （TWBXD）， as a classic prescription for treating insomnia， in forms of tablet， drop pill， patch and others， has been widely used in clinical practice. Its compound prescription and single ingredient can play a calming and tranquilizing role by regulating neurotransmitters， inhibiting oxidative stress reaction and the expression of inflammatory factors. Based on the theory of traditional Chinese medicine and combined with modern pharmacological research， this paper reviews single ingredient and active components of TWBXD， calming and tranquilizing role of related couplet medicinals. The results showed that the single ingredients such as Rehmannia glutinosa， the seeds of Zizyphus jujube， the seeds of Platycladus orientalis， Angelica sinensis， Schisandra chinensis， Poria cocos and their effective components as well as related couplet medicinals of Z. jujube could improve the insomnia symptoms in different degrees. Except that the mechanism of the seeds of P. orientalis has not been studied， other ingredients mainly act on nervous-endocrine-immune system. They can play the sedative and hypnotic effects by regulating neurotransmitters， inflammatory factors and oxidation.关键词：insomnia;theoretical basis of traditional Chinese medicine;couplet medicinals;pharmacological effect
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发布时间：2023-02-22 - 摘要：Ulcerative colitis （UC） is a chronic inflammatory bowel disease caused by multiple factors， and its etiology and pathogenesis remain unclear. Tofacitinib， a small molecule rapidly absorbed by oral administration， treats UC primarily by inhibiting Janus kinase （JAK）. Tofacitinib has been approved by the FDA and the European Medicines Agency for the treatment of moderate to severe UC. Many clinical studies on tofacitinib in the treatment of UC have been carried out abroad， but there is no relevant report on its use in UC in China. This paper summarizes the relevant research advances of tofacitinib in the treatment of UC from its mechanism， clinical application and safety. The results show that tefatinib mainly treats UC by inhibiting the expression of JAK and proinflammatory factors, regulating the overexpressed signaling transducers and activators of transcription, and repairing the intestinal mucosal barrier. Tofacitinib has good clinical efficacy， but safety studies have shown that the risks of herpes zoster and thrombosis should not be ignored， and the drug should be used with caution in pregnant， children， adolescents， and elderly patients. The efficacy and safety of tofacitinib in Chinese population should be further studied in the future， since it has not been used in UC patients in China.关键词：ulcerative colitis;mechanism;clinical research
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发布时间：2023-02-22
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