最新刊期
卷 33 ， 期 6 ， 2022
- 摘要：In order to improve the management level of medicine list of medical institutions in China ，and help medical institutions build a medicine list of medical institutions with reasonable drug use structure ，standardized adjustment procedures ， convenient operation and application and scientific evaluation methods ，so as to meet the needs of clinical rational drug use to the greatest extent ，with the support of the Pharmaceutical Care Professional Committee of the Chinese Pharmaceutical Association ， China-Japan Friendship Hospital and the First Affiliated Hospital of University of Science and Technology of China （Anhui Provincial Hospital ）jointly initiate and complete Guideline for the Evaluation of Medicine List in Chinese Medical Institutions jointly with a number of medical institutions. In strict accordance with the methodological requirements of World Health Organization standard guidelines ，based on the Delphi method ，the guideline formulation working group has constructed the quality evaluation index system and quantitative scoring table of medicine list management in medical institutions from the 5 dimensions of organization and management ，structure，adjustment，application and e valuation of the list. It is used to help medical institutions evaluate the quality of their medicine list management ，so asto play a positive role in the fine management of medicine list in medical institutions.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To provide the suggestions for improving t he enthusiasm of the public to report adverse drug reactions （ADRs），promoting pharmaceutical manufacturers to improve the smoothness of ADR reporting channels by the public and the enthusiasm of assuming the main responsibility for drug safety ，and to provide reference for the performance of drug safety supervision by regulatory departments in China. METHODS Taking 180 pharmaceutical manufacturers that had entered the top 1 000 in the world as the objects ，the questionnaire was prepared to investigate the smoothness of ADR reporting channels through 4 channels：contact number ，e-mail，official website and new media （including Wechat and microblog ） of enterprise . The questionnaire involved the establishment of public reporting channels ，the records and the feedback of enterprises. The existing problems were analyzed and suggestions were put forward. RESULTS & CONCLUSIONS More than 70％ of pharmaceutical manufacturers in China had established the channels for reporting ADR by the public ，which were mainly regular channels such as contact numbers and e-mail ，and each channel had the phenomenon that ADR information couldn ’t be reported. More than 60％ of the public channels established by manufactures lacked inquiry and supplement for the miss ing part of th e reported information ； only 24 pharmaceutical manufacturers provided feedback on ADR information ，and the feedback contents were monotonous. gywf2021-11It is suggested that pharmaceutical manufacturers should pay more attention to ADR monitoring among the public ，consider increasing multiple reporting channels while ensuring the smoothness of channels ，strengthen the training of employee ’s information collection ability to improve the quality of information ，timely feed back the ADR information reported by the public ， and increase the feedback content concerned by the public.关键词：public reports;reports of adverse drug reaction;pharmaceutical manufacturer;reporting channal;smoothness
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发布时间：2022-06-21 - 摘要：OBJECTIV E To in vestigate the situation ，achievements and proble ms of consistency evaluation policy of generic medicines in China. METHODS The descriptive analysis was performed after collecting and sorting out the information of generic medicine passing consistency evaluation （GMPCE） published on the official website of the National Medical Products Administration. The basic information ，the distribution and changes of GMPCE were analyzed statistically in National Essential Medicine List （hereinafter refer to as “essential medicine list ”），Medicine List for National Basic Medical Insurance ，Industrial Injury Insurance and Maternity Insurance （hereinafter refer to as “medical insurance list ”）and the result of the successful selection of centralized medicine procurement organized by the state （hereinafter refer to as “centralized procurement list ”）. RESULTS From 2017 to 2021，415 chemical generic drugs had passed consistency evaluation in China ，including 309 varieties，1 822 specifications， 6 dosage forms ，and 17 pharmacological mechanisms ，basically belonging to 30 provinces，and 492 drug manufacturers （except 12 products had not been found the manufacturers ）；the proportion of GMPCE in essential medicine list increased from 0.96％ in 2012 edition to 25.40％ in 2018 edition；that of GMPCE in medical insurance list increased f rom 2.13％ in 2017 edition to 11.68％ in 2021 edition；in the first 5 batches of centralized procurement list，GMPCE accounted for 81.65％，and the maximum price drop after entering the list was 97.52％. CONCLUSIONS The policy linkage has been achieved with the continual increase of the number of GMPCE and their total amount in three lists in China. The accessibility and affordability of related medicines have been improved with the apparent decrease of the price of those medicines. H owever，total number of GMPCE is a little small，with the higher repetition rate of variety and the low proportion in the three lists ；the guarantee measures of those medicine supply need to be strengthened.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To investigate t he attitude of endocrinology physicians to clinical conversion and substitution of insulin drugs ，and to provide basis for improving the centralized procurement program of insulin. METHODS The proportion of convertible and substitutable insulin recognized by endocrinology physicians was investigated by questionnaire from 4 dimensions： intergenerational level ，bargaining group level ，common name level and brand/specification level. The subjects were endocrinology physicians in the third grade class A general hospitals in Nanchang. RESULTS A total of 89 questionnaires were successfully distributed，accounting for 80.2％ of the on-the-job endocrinology physicians （111 in total ）in the third grade class A general hospitals in Nanchang. Eighty-nine questionnaires were collected ，one of which was invalid ，and the effective rate was 98.9％. At the intergenerational level ，93.2％ of endocrinology physicians preferred insulin analogues. At the bargaining group level ，the weighted average of the convertible ratio between group 3 and group 4 approved by physicians was 63.9％. At the levels of common name and brand/specification ，the weighted averages of convertible proportion of each group were more than 70％. CONCLUSIONS The method of insulin grouping in Wuhan is reasonable which can complete clinical conversion and substitution of insulin in the group safely. It is suggested to cancel long-acting human insulin group. The weighted average of the proportion of convertible and substitutable drugs in the group is high. It is suggested to increase the agreed purchase volume of insulin and conduct“volume price linked ”negotiations. When the surveyed physicians choose the initial treatment scheme of insulin ，they pay more attention to the factors such as efficacy and safety ，so the replacement of insulin should be based on the clinical efficacy and drug safety.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To establis h the fingerprint of Cynanchum auriculatum，to conduct its chemical pattern recognition analysis，and to determine the contents of four components at the same time. METHODS High performance liquid chromatography （HPLC）method was adopted. The determination was performed on ACE UExcel C 18 column with mobile phase consisted of acetonitrile-0.1％ phosphoric acid solution （gradient elution ）at the flow rate of 1.2 mL/min. The determination wavelength was set at 210 nm，and the column temperature was 40 ℃. The sample size wa s 10 μL. Taking qingyang shengenin as the reference ，HPLC fingerprints of 16 batches of C. auriculatum medicinal materials were drawn and similarity was evaluated by using the Similarity Evaluation of Chromatographic Fingerprints of Traditional Chinese Medicine （2012 edition）， and the common peaks were determined. SPSS 26.0 software andSIMCA 14.0 software were used for cluster analysis ，principal component analysis and orthogonal partial least squares- discriminant analysis. The differential components affecting the quality of C. auriculatum were screened by taking the value of variable importance in projection （VIP）greater than 1 as the standard ；same HPLC method was used to determine the contents of syringic acid ，acyl asclepiadelenin ，baishouwubenzophenone and qingyang shengenin. RESULTS There were 29 common peaks in 16 batches of C. auriculatum ，with a similarity of 0.723-0.998. Four common peaks were identified ，namely syringic acid （peak 7），acyl asclepiadoidin （peak 9），baishouwubenzophenone（peak 13）and qingyang shengenin（peak 15）. The results of cluster analysis showed that 16 batches of C. auriculatum could be clustered into three categories ，among which S 1 were grouped into one category，S3 were grouped into one c ategory，S2，and S 4-S16 were grouped into one category. The results of principal component analysis showed that the cumulative variance contribution rate of the five principal components was 88.706％，and the classification results were consistent with the results of cluster analysis. The results of orthogonal partial least squares-discriminant analysis showed that the common peaks （from large to small ）with VIP value greater than 1 were peak 20，peak 10，peak 25，peak 12， peak 15（qingyangshengenin），peak 21，peak 14，peak 16，peak 26，peak 22 and peak 17. The linear ranges of syringic acid，acyl asclepterin，baishouwubenzophenone and qingyangshengenin were 0.715 3-45.778 0，2.379 4-152.281 0，0.642 0- 41.085 0，14.541 6- 930.662 0 µg/mL respectively （all R 2＞0.999）. The quantitative limits were 0.357 7，0.475 9，0.642 0 and 2.423 6 μg/mL；the detective limits were 0.146 0，0.164 1，0.248 8 and 0.833 3 μg/mL，respectively. RSDs of precision ，repeatability and stability （24 h）tests were less than 3％；the average recoveries were 99.11％（RSD＝2.00％，n＝9），98.54％（RSD＝2.21％，n＝9）， 96.33％（RSD＝2.54％，n＝9）and 95.96％（RSD＝2.93％，n＝9）；the contents were 17.12-147.80，95.23-583.10（S8 below the quantitative limit ），16.91-210.88 and 211.68-3 587.15（S1 below the quantitative limit ）μg/g，respectively. CONCLUSIONS Established HPLC fingerprint and the method of content determination are stable ，reliable，accurate and reproducible. Combined with analysis of chemical pattern recognition ，it can be used for the quality control of C. auriculatum .
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发布时间：2022-06-21 - 摘要：OBJECTIVE To establis h the method for the simultaneous determination of six iridoids （loganic acid ，loganin， sweroside，dipsanoside B ，dipsanoside A ，sylvestroside Ⅰ）and one triterpene saponin （asperosaponin Ⅵ）in Dipsacus asper . METHODS High performance liquid chromatography （HPLC） method was adopted. The determination was performed on Symmetry® C18 column with mobile phase consisted of acetonitrile- 0.1％ phosphoric acid solution （gradient elution ）at the flow rate of 1.0 mL/min. The detection wavelengths were set at 212 nm（asperosaponin Ⅵ）and 237 nm（dipsanoside B ，dipsanoside A ， sweroside，loganic acid ，sylvestroside Ⅰ，loganin）. The column temperature was set at 30 ℃，and sample size was 20 μL. RESULTS The linear range of loganic acid ， loganin， sweroside， sylvestroside Ⅰ ， dipsanoside B ， dipsanoside A and asperosaponin Ⅵ were 399.24-931.56，50.30-150.90，48.24-168.84，27.00-70.20，12.93-38.80，40.64-121.92，42.08-147.28 µg/mL （all r＞0.999 0）. RSDs of precision ，reproducibility and stability tests （24 h）were all less than 2％. Average recoveries were 104.43％（RSD＝0.63％，n＝6），101.74％（RSD＝1.11％，n＝6），100.76％（RSD＝1.06％，n＝6），98.00％（RSD＝1.58％，n＝6）， 99.03％（RSD＝2.31％，n＝6），102.93％（RSD＝2.26％，n＝6），102.31％（RSD＝1.00％，n＝6），respectively，The contents were 142.5-280.6，5.5-49.0，28.0-112.9，7.2-35.8，4.4-16.9，17.2-79.3，0.8-54.5 mg/g，respectively. CONCLUSIONS Established method is accurate and reliable ，and can be used for the content determination of 7 components in D. asper .关键词：Dipsacus asper;Content determination;high performance liquid chromatography;triterpene saponins;iridoids
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发布时间：2022-06-21 - 摘要：OBJECTIVE To inv estigate the in vitro inhibitory effects of acteoside on cytochrome P 450（CYP）enzymes in liver microsomes of rats. METHODS Using probe substrates method ，acteoside（0.1，0.3，1，3，10，30 μmol/L）was incubated with probe substrates phenacetin ，mephentoin，diclofenac，coumarin，dextromethorphan and testosterone （substrates of CYP 1A2， CYP2C19，CYP2C9，CYP2A6，CYP2D6 and CYP 3A4 enzymes，respectively）in liver microsomes of rats. Another blank control group and positive inhibitor group [ α-naphthoflavone，ticlopidine，sulfabendazole，pilocarpine，quinidine and ketoconazole （inhibitors of CYP 1A2，CYP2C19，CYP2C9，CYP2A6，CYP2D6 and CYP 3A4 enzymes，respectively）] were set up. Using indapamide as the internal standard ， the contents of corresponding metabolites （acetaminophen， 4-hydroxymephenytoin， 4-hydroxydiclofenac，7-hydroxycoumarin，dextran，6 β-hydroxytestosterone） were detected by ultra high performance liquid chromatography-tandem mass spectrometry . The IC 50 values were calculated by GraphPad v 8.0 software. By computer molecular docking technology ，acteoside and positive inhibitors were molecularly docked with the CYP enzyme ，and the binding mode and strength of the two molecules were analyzed. RESULTS The IC 50 values of acteoside to CYP 1A2 and CYP 2A6 enzymes were more than 30 μmol/L，and those of acteoside to CYP 2D6，CYP2C19，CYP2C9 and CYP 3A4 enzymes were 24.87，21.52，12.56 and 7.55 μmol/L，respectively. The hydrogen bond and hydrophobic force could form between acteoside and CYP 3A4 enzyme，and the hydrogen bond and electrostatic interaction could form between ketoconazole and CYP 3A4 enzyme. The binding free energy of acteoside and ketoconazole to CYP 3A4 enzyme were － 10.2 and － 12.4 kcal/mol （1 kcal/mol＝4.19 kJ），respectively. CONCLUSIONS Acteoside shows moderate inhibitory effect on CYP 3A4 enzyme in liver microsomes of rats ，and its affinity is equivalent to that of positive inhibitor ；the compound shows weak inhibitory effect on other 5 CYP enzymes.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the sp ectrum-effect relationship of anti-gastric ulcer effect of Shaoyao gancao decoction. METHODS Eleven batches of Shaoyao gancao decoction were prepared ；gastric ulcer model was established by anhydrous ethanol modeling method. Using Weikangling as positive control ，the effects of Shaoyao gancao decoction on the contents of defensive factors [nitric oxide （NO），epidermal growth factor （EGF），superoxide dismutase （SOD）] and attack factor [malondialdehyde （MDA）] in gastric tissue of model rats were investigated. HPLC fingerprints of 11 batches of Shaoyao gancao decoction were established and similarity evaluation was performed with Similarity Evaluation System of Traditional Chinese Medicine Chromatographic Fingerprint （2004A edition ）； common peaks were identified by comparing with mixed control. The spectrum-effect relationship of Shaoyao gancao decoction against gastric ulcer was analyzed based on the grey correlation analysis. RESULTS Eleven batches of Shaoyao ganyao decoction could significantly decrease the content of MDA in gastric tissue ，while increased the contents of NO ，EGF and SOD in gastric ulcer model rats （P＜0.01），and had a certain inhibitory effect on the gastric ulcer. There were 23 common peaks in chromatograms of 11 batches of samples ，and the similarity with the control fingerprint was not less than 0.9. By comparing with mixed control ，7 common peaks were identified ，namely gallic acid （peak 5），albiflorin（peak 9），paeoniflorin（peak 10），liquiritin（peak 12），isoliquiritin apioside （peak 14），isoliquiritoside（peak 15）， glycyrrhizic acid （peak 22）. The average correlation degree of 7 identified common peaks and pharmacodynamic indexes were greater than 0.6，of which peak 22（glycyrrhizic acid ），peak 10（paeoniflorin）and peak 12（liquiritin）had the largest correlation ， and their values were 0.807，0.772 and 0.770 respectively. RESULTS The anti-gastric ulcer effect of Shaoyao gancao decoction is the result of the synergistic effect of multiple components ，among which glycyrrhizic acid ，paeoniflorin and liquiritin may be the main pharmacodynamic components.关键词：Shaoyao gancao decoction;anti-gastric ulcer;Spectrum-effect relationship;grey correlation analy sis
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study th e pharmacodynamics and pha rmacokinetics of Qinglian ningxin capsule in rats with ischemic arrhythmia. METHODS Totally 30 male SD rats were randomly divided into blank control group ，model control group ， Qinglian ningxin capsule group （4.00 g/kg），Artemisia annua group（1.43 g/kg），Coptis chinensis group（0.42 g/kg），with 6 rats in each group. Administration groups were given relevant medicine intragastrically ；model control group and blank control group were given normal saline intragastrically ，once a day ，for consecutive 7 days. After last medication ，except for blank control group，other groups were given Posterior pituitary injection via tail vein （1 u/kg） to induce ischemic arrhythmia model. electrocardiogram changes of rats in each group were recorded. Another 36 rats were randomly divided into Qinglian ningxin capsule model group and Qinglian ningxin capsule control group （4.00 g/kg），A. annua model group and A. annua control group （1.43 g/kg），C. chinensis model group and C. chinensis control group （0.42 g/kg）. After the rats in each model group were injected with Posterior pituitary injection （1 u/kg）via tail vein ，administration groups were given relevant drugs intragastrically ， and control groups were given constant volume of normal saline intragastrically. Blood was taken from the orbit at different time points（0，0.25，0.75，1，2，4，6，8，12 and 24 h）. The concentrations of berberine hydrochloride and artemisinin in plasma were determined by HPLC ，and the pharmacokinetic parameters were calculated by WinNonlin 7.0 software. RESULTS Compared with the model control groups ，Qinglian ningxin capsule could significantly improve the heart rate slowing of rats and redu ced the prolongation of PR interval and QT interval significantly ，and the effects were generally better than those of A. annua group and C. chinensis group（P＜0.05）. Compared with A. annua control group and C. chinensis control group ，cmax，AUC0－t and AUC 0－∞ of berberine hydrochloride and artemisinin were increased significantly in Qinglian ningxin capsule control group，while CL was decreased significantly ；t1/2z of artemisinin was prolonged significantly （P＜0.05）. Compared with Qinglian ningxin capsule control group ，cmax（except artemisinin ），AUC0－t，AUC0－∞，MRT0－t and MRT 0－∞（except artemisinin ）of berberine hydrochloride and artemisinin were increased significantly in Qinglian ningxin capsule model group ，while CL was decreased significantly（P＜0.05）. CONCLUSIONS Qinglian ningxin capsule could significantly improve ischemic arrhythmia better than A. annua and C. chinensis ，and can improve the absorption of berberine hydrochloride and artemisinin in model rats and slow down their elimination.
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发布时间：2022-06-21 - 摘要：OBJE CTIVE To establish a method for quality evaluation of Xin ’an capsule by combining fingerprint ， multi-component quantitative analysis and chemical pattern recognition analysis. METHODS High performance liquid chromatography（HPLC）combined with Similarity Evaluation System of TCM Chromatogram Fingerprint （2012 edition）were used to establish the fingerprints of 24 batches of Xin ’an capsules and evaluate the similarity. The common peaks were determined. The contents of glucosylvitexin ，rhamnosylvitexin，vitexin，hyperoside and isoquercetin in Xin ’an capsules were determined by the same HPLC method. Taking the common peak area of fingerprint as the variable ，MetaboAnalyst 5.0 tool was used to draw the cluster analysis （CA）heat map. SIMCA 14.1 software was used to perform principle component analysis （PCA）and partial least squares-discriminant analysis （PLS-DA）. RESULTS Twelve common peaks were identified with the similarity greater than 0.97. Six common peaks were identified as chlorogenic acid ，glucosylvitexin，rhamnosylvitexin，vitexin，hyperoside and isoquercetin.The linear range of glucosylvitexin ，rhamnosylvitexin，vitexin， hyperoside and isoquercetin were 2.36-151.35，9.15-585.20， 1.20-76.50， 0.68-43.20， 0.44-27.90 µg/mL（all r＞0.999）.RSDs of precision ，repeatability and stability （24 h）tests were 163.com all less than 2.00％ . The average recoveries were 95.80％（RSD＝0.96％ ，n＝6），102.10％ （RSD＝0.93％ ，n＝6）， 103.26％（RSD＝1.28％，n＝6），103.89％（RSD＝0.73％，n＝6） and 102.09％（RSD＝1.79％，n＝6），respectively. The contents of the five components were 0.988 8-1.559 1，4.336 6-11.220 1， 0.065 1-0.830 5，0.043 8-0.692 5 and 0.023 2-0.427 2 mg/grain，respectively. The results of CA and PCA showed that 24 batches of samples could be divided into three categories ，i.e. S 1-S15，S16-S18 and S 19-S24. PLS-DA showed that variable importance in projection values of the corresponding component of peak 6 and glucosylvitexin （peak 7），rhamnosylvitexin（peak 8），hyperoside （peak 10） and isoquercetin （peak 11） were greater than 1. CONCLUSIONS The established HPLC fingerprint and multi-component quantitative method are simple and feasible. Combined with chemical pattern recognition analysis ，it can be used for the quality control of Xin ’an capsules. Glucosylvitexin ，rhamnosylvitexin and other components may be differentital markers affecting the quality of each batch of samples.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To optimize the extraction technology of volatile components from Wuyao decoction. METHODS On the basis of single factor investigation ，the extraction technology of volatile components from Wuyao decoction was optimized and validated by Box-Behnken design-response surface technology using the contents of bomyl acetate ，cyperotundone，α-cyperone， ligustilide and dehydrocostuslactone ， extraction rate of volatile oil as indexes ， with extraction time ， soaking time and liquid-material ratio as factors. On this basis ，the extraction state of the decoction was quantified. RESULTS The optimal extraction technology was as followed ：the ratio of liquid -material was 13∶1（mL/g），soaking time was 0.5 h，and the extraction time was 6 h in the boiling state. The comprehensive scores of the three validation experiments were 0.948 7，0.948 4 and 0.948 6 respectively （RSD＝0.02％，n＝3），and the deviation from the predicted value （0.947 9）was no more than 1％. The boiling state of the decoction in 180 ℃ oil bath was taken as the sudden boiling state. CONCLUSIONS The optimized extraction technology is stable and feasible.关键词：Wuyao decoction;Volatile components;Extraction technology;Box-Behnken design-response surface technology
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发布时间：2022-06-21 - 摘要：OBJECT IVE To provide reference for the improvement of the quality standard for Niushanggui capsules. METHODS Based on the previous quality standard ，thin-layer chromatography （TLC）identification methods were established for Angelicae dahurica and Anemarrhenae asphodeloides . High performance liquid chromatography （HPLC）method was established to determine the contents of 5 components simultaneously ，such as mangiferin ，prim-O-glucosylcimifugin，naringin，neohesperidin and 5-O-methylvisammioside. The limits were confirmed. RESULTS TLC chromatogram of Niushanggui capsules showed the same color spots in the same position as the corresponding （mixed）substance control or reference medicinal material of A. dahuricae and A. asphodeloides ，while the negative samples had no interference. The linear range of mangiferin ，prim-O-glucosylcimifugin， naringin，neohesperidin and 5-O-methylvisammioside were 7.98-127.63，6.74-107.84，53.06-848.96，39.31-628.90，13.54-216.62 μg/mL，respectively（all r＝0.999 9）. RSDs of precision ，stability（24 h）and repeatability tests were all no more than 1.20％（n＝ 6）. The average recoveries were 95.00％，105.16％，97.16％，101.00％ and 104.97％（RSD≤1.50％，n＝6）. In 4 batches of samples，the average contents of the above 5 components were 0.842，0.696，6.951，5.755 and 1.106 mg/g respectively ；the limits of A. asphodeloides ，Saposhnikovia divaricata and Citrus aurantium were based on the contents of mangiferin ，the total content of prim-O-glucosylcimmifugin and 5-O-methylvisammioside，naringin and neohesperidin ，which would not be less than 0.42，0.90 and 6.36 mg/grain，respectively. CONCLUSIONS TLC identification methods of A. dahurica and A. asphodeloides and the content determination methods of 5 components as mangiferin in Niushanggui capsules are established in this study ，and the limits of A. asphodeloides ，S. divaricata and C. aurantium are confirmed.关键词：Niushanggui c apsules;Identification;Content determination;improvement of quality standard
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发布时间：2022-06-21 - 摘要：OBJEC TIVE To optimize the simultaneous extraction technology of dietary fiber （DF）and flavonoids from the peel of Prunus armeniaca . METHODS The content of DF was calculated with enzyme-gravimetric method ，and the content of flavonoids was determined by ultraviolet spectrophotometry. The orthogonal design and single factor test were used to optimize the extraction technology ，with the factors of liquid-solid ratio ，pH，papain concentration ，α-amylase concentration ，temperature of enzymatic hydrolysis and time of enzymatic hydrolysis as factors ，using the contents of DF and flavonoids as indexes. RESULTS The optimal extraction technology included the solid-liquid ratio of 1 ∶ 10（g/mL），pH5，0.5％ papain and 0.5％ α-amylase， enzymatic hydrolysis at 50 ℃ for 1 h. After three times of validation ，the average content of DF was 0.801 g/g（RSD＝1.95％）， and the average content of flavonoids was 2.135 mg/g（RSD＝2.44％）. The average comprehensive score was 0.988（RSD＝ 0.81％）. CONCLUSIONS The optimal extraction technology is stable and feasible.关键词：the peel of Prunus armeniaca;dietary fiber;Flavonoids;orthogonal design;simultaneous extracxtion;technology
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发布时间：2022-06-21 - 摘要：OBJECTIVE To compar e the volatile components of Cuscuta chinensis and its processed products ，and to conduct principal component analysis （PCA）. METHODS The volatile components of C. chinensis ，C. chinensis stir-frying with saltwater ， C. chinensis stir-frying with wine were identified by headspace solid phase microextraction combined with gas chromatography- mass spectrometry. The relative percentage of each component was calculated by area normalization method. The PCA was conducted by using SPSS 21.0 software. RESULTS A total of 117 compounds were identified from C. chinensis ，C. chinensis stir-frying with saltwater and C. chinensis stir-frying with wine ，of which 68 compounds were identified from C. chinensis （relative percentage of 92.41％），such as phytone ，2-methoxy-3-（2-propenl）phenol，n-pentadecane，β-caryophyllene. Sixty compounds （relative percentage of 89.41％） were identified from C. chinensis stir-frying with saltwater ，such as maltol ，2，3-dihydro- benzofuran，4-vinyl-2-methoxyphenol. Fifty-eight compounds （relative percentage of 87.02％）were identified from C. chinensis stir-frying with wine ，such as phenylethanol ，β-caryophyllene，macrocarehe D. There were 24 common components in the three ， and relative percentage of them were 38.56％，30.61％，33.07％，respectively. After processing ，there were 49 new components ， such as furfural ，n-hexanoic acid ，caryophyllene oxide. The results of PCA showed that the cumulative contribution rate of the former two principal components was 100％ ；comprehensive score of volatile components of C. chinensis was the highest ， followed by C. chinensis stir-frying with wine and C. chinensis stir-frying with saltwater. CONCLUSIONS The quality of volatile components in C. chinensis is good ；the volatile components in processed products are more than those in C. chinensis .
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发布时间：2022-06-21 - 摘要：OBJECTIVE To investigate the efficacy and safety of Shenxiang suhe pill in the adjuvant treatment of triple vessel lesion of coronary artery. METHODS From February 2019 to February 2021，146 patients with unstable angina pectoris and triple vessel lesion of coronary artery （chest discomfort of hanning xinmai type ）admitted to Harrison International Peace Hospital were divided into observation group and control group according to random number table ，with 73 cases in each group. Control group was given Isosorbide dinitrate tablets+Aspirin enteric-coated tablets+Clopidogrel bisulfate tablets+Atorvastatin calcium tablets+ Bisoprolol fumarate tablets for western medicine treatment. Observation group was additionally given Shenxiang suhe pill 0.7 g/time orally after meal ，twice a day ，on the basis of control group. After 2 courses of treatment （3 weeks as a course of treatment ，with an interval of 1 week for each course of treatment ），curative effect and symptoms of angina pectoris [frequency and duration of angina pectoris ，walking distance of 6-min walking test （6MWT）]，TCM syndrome score ，cardiac markers [neutrophil to lymphocyte ratio （NLR）and the contents of endothelin-1（ET-1），nitric oxide （NO），soluble suppression of tumorigenicity 2 （sST2），angiotensin Ⅱ（Ang-Ⅱ）] and quality of life [Seattle angina questionnaire （SAQ），36-item short form health survey （SF-36）] before and after treatment were compared between the two groups. Adverse drug reactions （ADR）during treatment and major adverse cardiovascular events （MACE）during follow-up were recorded. RESULTS The total response rate of the observation group was 86.30％，significantly higher than 71.23％ of the control group （P＜0.05）. Before treatment ，there was no statistical difference in the above indexes between 2 groups（P＞0.05）. After treatment ，the frequency and duration of angina pectoris ，TCM syndrome score ，NLR and the contents of sST 2，ET-1 and Ang- Ⅱ in the two groups decreased or shortened significantly ，while the walking distance of 6MWT，NO content ，scores of each dimension in SAQ and SF- 36 increased significantly ；and the above indexes in observation group were significantly better than those in control group （P＜0.05）. There was no significant difference in the inciden ce of ADR between the two groups （P＞0.05）； however，the incidence of MACE in observation group was significantly lower than that in control group （P＜0.05）. CONCLUSIONS In the treatment of adjuvant treatment of triple vessel lesion of coronary artery ，Shenxiang suhe pill can improve the symptoms of angina pectoris and vascular endothelial function ，reduce the incidence of MACE ，improve the quality of life ，and has good safety.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To analyze the adverse drug reaction （ADR）signals of ado-trastuzumab emtansine and brentuximab vedotin，so as to provide reference for clinical medication safety. METHODS Using the FDA adverse drug event reporting system （FAERS）database and OpenVigil 2.1 data platform ，the ADR of the two drugs were collected from being approved by FDA to the Sep. 30th，2021. The ADR signals were detected by frequency method and sorted according to the occurrence frequency and signal strength respectively. RESULTS & CONCLUSIONS A total of 2 319 and 3 178 ADR reports related to ado-trastuzumab emtansine and brentuximab vedotin were collected ，215 and 329 ADR signals were detected respectively. According to the occurrence frequency，the most frequent ADR s of the two drugs were thrombocytopenia （109 cases）and febrile neutropenia （198 cases）， separately，which were consistent with the drug instructions. According to the signal strength ，the spider nevus of ado-trastuzumab emtansine（report odds ratio of 451.46）and the noninfectious endocarditis of brentuximab vedotin （report odds ratio of 304.35） ranked first ，both of which were not reported in the drug instructions. It is suggested that attention should be paid not only to the most common ADR s of blood and lymphatic system caused by both drugs ，but also to the ADRs not reported in the drug instructions such as spider nevus of ado-trastuzumab emtansine and noninfective endocarditis of brentuximab vedotin.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To sy stematically evaluate the relations hip between immune-related adverse events （irAEs） and efficacy of immune checkpoint inhibitors （ICIs） in the treatment of non-small cell lung cancer （NSCLC），and to provide evidence-based reference for clinical application of ICIs and safety evaluation. METHODS PubMed，Embase，Cochrane Library ， Web of Science ，CNKI，Wanfang database ，VIP and CBM were searched to collect prospective or retrospective cohort studies on the correlation between irAEs and efficacy of ICIs in the treatment of NSCLC. The retrieval time was from the inception to June 30th，2021. After literature screening and data extraction ，Newcastle-Ottawa scale was used to evaluate the quality of included literatures. Meta-analysis and publication bias analysis were performed by using RevMan 5.3 software；Stata 15.0 software was used for sensitivity analysis. RESULTS A total of 7 957 patients were included in 31 studies. Meta-analysis showed that the objective response rate （ORR）[RR＝2.34，95％CI（1.98，2.76），P＜0.000 01]，progression-free survival （PFS）[HR＝0.49，95％CI （0.44，0.55），P＜0.000 01] and overall survival （OS）[HR＝0.45，95％CI（0.39，0.53），P＜0.000 01] of irAEs group as well as ORR[RR＝1.88，95％CI（1.57，2.25），P＜0.000 01]，PFS [HR ＝0.59，95％CI（0.50，0.69），P＜0.000 01] and OS [HR ＝0.58，95％CI （0.48，0.70），P＜0.000 01] of this group at 6th week were all significantly higher or longer than non irAEs group. According to organ specificity ，severity and quantity of irAEs，subgroup analysis showed that skin ，gastrointestinal and endocrine system ，mild irAEs（grade 1-2）and one or more than 2 kinds of irAEs were significantly correlated with the improvement of PFS and OS （P＜ 0.05），while liver and lung ，severe irAEs（≥ grade 3）were not significantly correlated with the improvement of PFS and com OS （P＞0.05）. Sensitivity analysis results showed that the results of the above-mentione d meta-analysis were relatively robust. The results of publication bias showed that there was may be some possibility of publication bias in this study. CONCLUSIONS For NSCLC patients treated with ICIS ，the occurrence of irAEs may be related to their good prognosis. The irAEs may be a predictor of the efficacy of ICIs.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To explore and establis h a general pharmacist system suitable for China ’s national conditions ，and to improve the rational use of drugs in primary medical institutions . METHODS Under the leadership of Tianhe District Health Bureau of Guangzhou ，relying on the regional pharmaceutical specialty alliance ，general pharmacist system of medical consortium was established ，and the general pharmacist was responsible for the overall planning of pharmaceutical care in the medical consortium. The joint management office of pharmaceutical care was established ，and the training of the pharmacists in the medical consortium was organized. A regional audit center was established to realize the prescription review of 13 community health service centers in the medical consortium. “Internet plus ”home pharmaceutical care was carried out ，and science popularization education was provided for communities ，schools，enterprises and institutions. RESULTS After systematic training and assessment ，three pharmacist teams had been successfully established in the medical consortium to provide prescription review ，science popularization and education and family pharmacist services for community residents ；the regional audit center successfully intercepted 17.17％ of unreasonable prescriptions ，reducing the amount of unreasonable drug use by a total of 6.56 million yuan. After the intervention of prescription review system ，the qualified rate of outpatient prescriptions in community health service centers was ≥95％，and the qualified rate increased by an average of 6％. The department of pharmaceutical science popularization and education held 35 science popularization and free clinic activities ，of which 71.20％ of the residents believed that the activities had improved their understanding of drugs. In addition ，111 cases patients serviced by home pharmaceutical care were carried out successfully by pharmacist team ，and the patients ’acceptance of pharmacist intervention was 91.89％ . CONCLUSIONS Under the new medical reform ，it is feasible to implement a regional general pharmacist system within the medical consortium ， which improves the pharmaceutical administration and pharmaceuticalcare capabilities of m edical institutions in the medical consortium，as well as the level of rational drug use ，and reduces the me dical burden.
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发布时间：2022-06-21 - 摘要：The re gulators of renin-angiotensin system （RAS） include renin inhibitors ，angiotensin converting enzyme inhibitors，angiotensin Ⅱ receptor blockers ，angiotensin Ⅱ receptor agonists and angiotensin 1-7. This paper summarizes and analyzes the adjuvant effects of RAS regulators on antitumor drugs by searching the literature published from January 1992 to June 2021. The regulators of RAS can reduce the cardiotoxicity ，hematological toxicity and peripheral neurotoxicity of antitumor drugs ， and has renal protective effect ；the regulators of RAS combined with other chemotherapy drugs show favorable effects on promoting chemotherapeutic drugs delivery ，improving anti-angiogenesis and bypass activation of targeted drugs ，enhancing tumor immune response of immune checkpoint inhibitors ，so as to improve therapeutic efficacy of antitumor drugs. The combination of RAS regulators with antitumor drugs is expected to reduce the side effects of antitumor drugs ，enhance its efficacy and improve the prognosis of patients.关键词：renin-angiotensin system;regulator;malignant tumor;targeted treatment;chemotherapy;immunotherapy
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发布时间：2022-06-21 - 摘要：Zixue san is a preparation in Chinese Pharmacopoeia ，and is a commonly used representative formula in Liangkai formulation. In the previous editions of Chinese Pharmacopoeia ，for the item of the formulation and preparation method of Zixue san，“mirabilite”“mirabilite（prepare）”“Xuanming powder ”and other different descriptions have been repeatedly modified and amended；the methods of preparation of mirabilite in the processing specifications of different provinces and cities are also different，causing effects in actual production. Therefore ，the author has researched the historical evolution of Zixue ，the formulation and preparation method of Zixue san in the previous editions of Chinese P harmacopoeia，and has expounded the change process of mirabilite，mirabilite（prepare），Xuanming powder in the item of formulation and preparation method of Zixue san. In addition ，the author compares Chinese Pharmacopoeia with the processing methods of mirabilite in the national and provincial processing specifications ，in order to provide a basis for the processing of mirabilite in the formulation of Zixue san.关键词：Zixue san;mirabilite;processing method;pharmacopoeia
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发布时间：2022-06-21
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