CAI Mingyuan,ZHANG Cuilian,ZHOU Liang,YAN Qing,ZUO Wei
Vol. 33, Issue 5, (2022)
摘要:OBJECTIVE To investigate the situation of pharmaceutical pr eparations in medical institutions (hereinafter refer to hospital preparations ),and to promote the sustained and healthy development of hospital preparations. METHODS Under the organization of National Pharmacy Administration & Quality Control Center ,internet survey was adopted to statistically analyze the data of hospital preparations in 2019 that was completed and reported by the secondary general hospitals and above in provinces (cities,districts)and Xinjiang Production and Construction Corps. RESULTS Among the 4 639 hospitals,9.36% had drug approval numbers and 8.15% had preparation laboratories. The average ratio of the number of hospital preparations in production to the number of preparations approved was 0.72,and that of 41.52% hospital was concentrated in 1-0.9. Self-produced by hospital was the main production mode of hospital preparations ;the higher hospital level was ,the higher the proportion of self-production combined with commissioned processing ,while the lower the proportion of commissioned processing only. In hospitals with preparation approval numbers ,the proportion of owning TCM preparations was the highest (73.66%),followed by common chemical preparations (69.93%). From perspective of annual output value of hospital preparations ,tertiary hospitals were higher than secondary hospitals ,and private hospitals were higher than public hospitals ;it was related to the production mode ,varieties of hospital preparations and the establishment of the preparation laboratories. There was a trend that the development of hospital preparations in C entral China ,North China and South China was better than that in the Northeast China ,Northwest China and Southwest China. CONCLUSIONS At present ,hospital preparations in China are mainly made in medical institutions , com and the types are relatively limited. The regional developmentis unbalanced and the scale of hospital preparations is reduced.It is suggested that medical institutions should pay attention to the innovation of hospital preparations ,especially to deve lopment of characteristic preparations with definite curative effect ,so as to give full play to their role of “shortage make-up ”. Great importance also should be paid to the policy support of dispensing and the establishment of regional dispensing centers.
摘要:OBJ ECTIVE To provide policy referen ce for local marketing authorization holder (MAH)to implement their main responsibility of drug life cycle supervision and the Guiding Principles of Pharmacovigilance Inspection to be officially released. METHODS Taking 15 MAH in Shanghai who recently underwent pharmacovigilance inspection as the research objects ,the social network analysis was used to explore the logical relationship between MAHs ’enterprise attributes and inspection problems , summarize the problems found ,analyze the causes ,and put forward corresponding countermeasures. RESULTS & CONCLUSIONS The problems found in this pharmacovigilance inspection were mainly in aspects of organization ,personnel management ,quality management system ,report quality and so on. The reasons for these problems included light punishment ,which lead to the enterprise management ’s lack of attention to the pharmacovigilance system ,unclear problem handling and risk control mechanism , imperfect quality management system documents ,inadequate personnel training ,etc. MAH needs to pay more attention to pharmacovigilance,allocate corresponding human and resources ,constantly improve the pharmacovigilance quality management system,and improve the enforceability and effectiveness of the pharmacovigilance system. At the same time ,it is suggested that government departments should strengthen policy guidance , publicity and implementation , and combine with third-party institutional platforms such as industry associations to promote the smooth implementation of Good Validation Practice .
关键词:Good Validation Practice;MAH;Pharmacovigilance;Guiding Principles of Pharmacovigilance Inspection
HAN Bin,WU Jiayao,XIE Dong,YU Lu,ZHONG Weilong,DUAN Rong,LI Zhengxiang
Vol. 33, Issue 5, (2022)
摘要:OBJECTIVE To establish an evaluation syste m of clinical effec tiveness of Drug Selection Guideline for Medical Institutions,and to provide reference for drug selection in medical institution. METHODS Retrieved from relevant Chinese government websites ,PubMed,Embase,CBM and CNKI ,etc.,from the inception to Sept. 14th 2021,related contents of clinical effectiveness related to three secondary indicators ,such as “recommended level and strength of guideline ”“clinical pathway ”and “evidence and level of efficacy ”were extracted respectively ;evaluation system was construction for the clinical effectiveness. RESULTS A total of 5,4 and 17 policy documents or literatures were included according to “recommended level and strength of guideline”“clinical pathway ”and“evidence and level of efficacy ”,respectively.“The recommended level and strength of drug guideline”could reflect the clinical effectiveness of drugs ,and the evaluation content referred to the recommended level and strength of the selected drugs in the guidelines for corresponding indications. “Clinical pathway ”was the embodiment of drug effectiveness, and the evaluation content referred to the clinical path of whether the selected drugs were included in the corresponding indications. The evaluation contents of “evidence and level of efficacy ”were different between chemical medicine/ biological agent and Chinese patent medicine ;evidence and quality level of efficacy research for chemical medicine/biological agent referred to GRADE system ,while those for Chinese patent medicine referred to classic works or clinical experience inheritance. Therefore,the evaluation contents of this index system were the evidence and quality level of the efficacy research related to selected drugs. CONCLUSIONS The evaluation system of clinical effectiveness of drugs constructed from the perspective of drug selection in medical institutions can lay the foundation of evaluation system for the construction of Drug Selection Guideline for Medical Institutions ,and also provide reference for drug selection in medical institutions.
摘要:OBJECTIVE To separate and identif y the chemical constituen ts in 70% ethanol extract of Sabia parviflora ,and to preliminarily evaluate their in vitro antioxidant activity. METHODS The chemical constituents were separated and purified by silica gel,ODS reversed-phase silica gel ,Sephadex-LH20 column and preparative high performance liquid chromatography. The structures of the isolated compounds were identified by 1H-NMR,13C-NMR and ESI-MS. The in vitro antioxidant activities of the compounds were investigated by 2,2-diphenyl-1-picrylhydrazyl radical (DPPH·),2,2′-azino-bis(3-ethylbenzothiazoline-6- sulfonate)diammonium radical (ABST+)and hydroxyl radical (OH·). RESULTS A total of 9 compounds were isolated from the 70% ethanol extracts of S. parviflora . They were identified as rutin (1),diiononyl phthalate (2),dibutyl phthalate (3),vomifoliol (4),rhododendrol(5),quercetin-3-O-gentiobioside(6),narcissoside(7),kaempferol-3-O-rutinoside(8)and bonaroside (9). The in vitro antioxidant results showed that compound 1-9 showed certain in vitro antioxidant activity ,and the half scavenging concentrations of compound 1,6,7 and 8 to DPPH ·,ABST+,OH·were lower than 70 μg/mL. CONCLUSIONS Vomifoliol, rhododendrol and bonaroside are isolated from S. parviflora for the first time ,and rutin ,quercetin-3-O-gentiobioside,narcissoside and kaempferol- 3-O-rutinoside show good in vitro antioxidant activity.
LIU Zhiwen,XU Jiangyan,ZHANG Zhenqiang,ZHANG Xiaowei,GAO Gai,WANG Mengmeng,WANG Hui,LI Zhenzhen,XIE Zhishen
Vol. 33, Issue 5, (2022)
摘要:OBJECTIVE To study the effects of ginsenoside Rb 1(G-Rb1)on epithelial-mesenchymal transition (EMT)of renal tubular epithelial cells and its potential mechanism. METHODS The growth factor β1(TGF-β1)10 ng/mL was used to induce EMT of human renal tubular epithelial cells HK- 2. The morphological changes of HK- 2 cells were observed after treated with 10, 20,30 μmol/L G-Rb1 for 48 h. The transcriptional activities of biovector SBE in human embryonic kidney cell HEK 293 were determined after 24 h treatment with 1.0,2.5,5.0,10,20,30 μmol/L G-Rb1. Effects of above concentration of G-Rb 1 on the viability of HK- 2 cells were determined after 24 h of treatment. mRNA expressions of α-smooth muscle actin (α-SMA),collagen Ⅰ (COL-Ⅰ)and fibronectin (FN)in HK- 2 cells were detected after treated with 10,20,30 μmol/L G-Rb1 for 24 h. The expressions of α-SMA,Smad3,p-Smad3,COL-Ⅰ,FN and E-cadherin were detected after treated with 10,20,30 μmol/L G-Rb1 for 24 h. RESULTS G-Rb1 of 10-30 μmol/L significantly inhibited TGF-β1-induced EMT in HK- 2 cells and the increase of transcriptional activities of biovector SBE induced by TGF-β1(P<0.05),but had no effects on relative activities of HK- 2 cells(P>0.05). The protein and mRNA expressions of α-SMA,COL-Ⅰ and FN , the protein expressions of Smad 3 and p-Smad 3 were significantly up-regulated induced by TGF-β1(P<0.05),while the protein expression of E-cadherin was significantly down- regulated(P<0.05);G-Rb1 could effectively reverse aboveprotein or mRNA expressions. CONCLUSIONS G-Rb1 can protect renal tubular epithelial cells from EMT induced byxiezhishen TGF-β1 to a certain extent ,which may be related to inhibiting the activation of TGF-β1/Smad3 signaling pathway.
YANG Yang,LI Tianfa,WANG Jun,HUANG Shan,LING Xuebin
Vol. 33, Issue 5, (2022)
摘要:OBJECTIVE To explore the effects of acteoside on hypoxia/reoxygena tion(H/R)-induced cardiomyocyte damage by regulating Rho family GTPase 3(Rnd3)/nuclear factor κB(NF-κB)pathway. METHODS The H 9c2 cardiomyocyte were divided into control group (no administration ,no modeling ),H/R group (only modeling ),H/R+AS-L group ,H/R+AS-M group , H/R+AS-H group (10,30,90 μmol/L acteoside for above 3 groups firstly ,and then modeling ),H/R+pcDNA group [transfecting pcDNA (empty vector ) firstly,and then modeling] ,H/R + pcDNA-Rnd 3 group [overexpression of Rnd 3 by transfecting pcDNA-Rnd3(Rnd3 overexpression vector )firstly,and then modeling] ,H/R+AS-H+si-NC group [transfecting si-NC (negative control)firstly,and then giving 90 μmol/L acteoside and modeling],H/R+AS-H+si-Rnd3 group [inhibiting overexpression of Rnd 3 by transfecting si-Rnd 3 (Rnd3 small interfering RNA ) firstly,and then giving 90 μ mol/L acteoside and modeling]. After corresponding treatment ,the apoptotic rate ,release of lactate dehydrogenase (LDH),malondialdehyde(MDA)level,the activity of superoxide dismutase (SOD),the level of tumor necrosis factor α(TNF-α),interleukin 1β(IL-1β)and interleukin- 6(IL-6), mRNA and protein expression of Rnd 3 and NF-κB subunit p65(NF-κB p65),the expression of aspartate proteolytic enzyme 3 (Cleaved Caspase- 3)protein and Cleaved Caspase- 9 protein were detected. RESULTS Different concentrations of acteoside could reduce the apoptotic rate of H/R-induced H 9c2 cardiomyocyte,the protein expressions of Cleaved Caspase- 3 and Cleaved Caspase-9,mRNA and protein expressions of NF-κB p65,the levels of LDH release and MDA ,TNF-α,IL-1β and IL-6,while increase the activity of SOD and mRNA and protein expressions of Rnd 3(P<0.05),in a dose-dependent manner. Overexpression of Rnd 3 could decrease the apoptotic rate of H 9c2 cardiomyocyte,protein expressions of NF-κB p65,Cleaved Caspase- 3 and Cleaved Caspase- 9, the levels of LDH release , MDA, TNF-α,IL-1β and IL-6,while increase the protein expression of Rnd 3 and the activity of SOD (P<0.05). The inhibition overexpression of Rnd 3 could weaken the inhibitory effects of acteoside on H/R-induced apoptosis of H 9c2 cardiomyocyte, oxidative stress and inflammatory reaction (P<0.05). CONCLUSIONS Acteoside could regulate Rnd 3/NF-κ B pathway by promoting the expression of Rnd 3 and inhibiting the expression of NF-κB p65,inhibit cardiomyocyte apoptosis ,oxidative stress and inflammation reaction so as to relieve the H/R-induced cardiomyocyte damage.
摘要:OBJECTIVE To study the mechanism of curcumol inhibiting the pro liferation of breast cancer cells T 47D. METHODS MTT assay was used to detect the inhibitory effects of different doses of curcumol (0,6.25,12.5,25,50,100 μg/mL)on the proliferation of T 47D cells. After treated with curcumol (12.5,25,50,100 μg/mL),the morphology of T 47D cells was observed by inverted phase contrast microscope. The cell cycle and the levels of reactive oxygen species (ROS)were detected by flow cytometry. Quantitative real-time PCR (qRT-PCR)was used to detect the expressions of proliferating cell nuclear antigen (PCNA),cell cycle regular p 21 and cyclin-dependent kinase 2(CDK2)mRNA. Western blot assay was used to detect the protein expression of CDK 2,CDK6,Cyclin D ,PCNA,nucler transcription factor E 2-related factor (Nrf2)and Kelch-like ECH associated protein 1(Keap1). Breast cancer cells T 47D were divided into 2 groups,one group was given different doses of curcumol ,and another group was given curcumol 33 μg/mL for 6,12,24,48 h. After the optimal oxidation time and administration concentration were determined according to the results of the above two groups ,the blank control group ,N-acetylcysteine(NAC)group(ROS antioxidant NAC alone ),curcumol group (curcumol alone ),curcumol combined with NAC group (pretreatment with ROS antioxidant NAC ,and then adding into curcumol ). Cell cycle and fluorescence intensity of ROS were detected. RESULTS Curcumol could significantly increase the inhibitory rate of the proliferation of T 47D cells (P<0.05 or P<0.01),and showed a certain dose and time dependent trend. Curcumol blocked the , cycle in the G 1 phase and significantly increased the level of ROS (P<0.05 or P<0.01);ROS antioxidant NAC could significantly reverse above inductive effect of curcumol (P< 0.01). qRT-PCR showed that curcumol down-regulated the com expression of PCNA and CDK 2 mRNA and up-regulated the expression of p 21 mRNA(P<0.05 or P<0.01). Western blot assay showed that curcumol significantly down-regulated the edu.cn protein expression of Keap 1,Nrf2,CDK2,CDK6 and Cyclin D(P<0.05,P<0.01);ROS antioxidant NAC could reverse the down-regulation effects of curcumol on the expression of these proteins(P<0.05 or P<0.01). CONCLUSIONS Curcumol may induce oxidative stress and cell arrest in G 1 phase to inhibit the proliferation of T 47D cells.
关键词:curcumol;breast cancer cells T 47D;cell cycle arrest;Cell proliferation;Oxidative stress;Mechanism
摘要:OBJECTIVE To optimize the existing t hin layer chromatography (TLC)identification and content determination methods of Jizhi syrup. METHODS High performance thin-layer chromatography (HPTLC)was used to identify five medicinal materials in Jizhi syrup ,such as Ilex chinensis ,Houttuynia cordata ,Peucedanum praeruptorum ,Citrus aurantium ,Glycyrrhiza uralensis. High performance liquid chromatography (HPLC)was used to determine the contents of procatechuic acid ,ephedrine hydrochloride and naringin in Jizhi syrup. RESULTS HPTLC results showed that the identification spots of pedunculoside , praeruptorin A ,naringin,and liquiritin were clearly displayed ,and the retention factors were in the range of 0.2 to 0.8. After validation,the method had been proved to be strongly specific ,robust and repeatable. HPLC results showed that the linear ranges of protocatechuic acid ,ephedrine hydrochloride and naringin were 4.32-431.67,1.14-114.17 and 7.02-702.33 μg/mL(all r> 0.996),respectively. The average recoveries were 100.61%,100.40% and 99.22%,and RSDs were all less than 2.00%. RSDs of precision(n=6),stability(24 h,n=7)and repeatability (n=6)were all less than 2.00%. The average contents of the three components in 10 batches were 623.3,152.1,1 213.9 μg/mL(RSD<10.00%),respectively. CONCLUSIONS In this study , HPTLC method of one-plate multi-drug is established for the identification of Jizhi syrup. One sample pretreatment method and two TLC conditions are used to realize the rapid identification of five kinds of medicinal materials. An HPLC method is established to determine the content of Jizhi syrup ,which realizes the fast quantification of three active components in Jizhi syrup ,and can be used to optimize the identification and content determination items in the existing legal quality standards of Jizhi syrup.
LI Meng,YANG Ying,DENG Xiaoyan,ZHANG Jingke,WANG Shengchao,SUN Xiaoya,ZHENG Xiaoke,FENG Weisheng
Vol. 33, Issue 5, (2022)
摘要:OBJECTIVE To co mpare the difference of liposoluble constitue nts in different processed products of Huaizhong No.1 Rehmannia glutionsa (fresh R. glutionsa ,R. glutionsa and prepared R. glutionsa ),and to evaluate its in vitro antioxidant activity preliminarily. METHODS Liposoluble extracts were extracted from 3 processed products of R. glutionsa by Soxhlet extraction. Their constituents were analyzed by gas chromatography-mass spectrometry. The spectral library of NIST 98 system was used to automatically retrieve the mass spectrum information of components ,and the structures of compounds were identified in combination with relevant literature and by comparing with eight peak index and EPA/NIH library. Relative contents of the components were calculated by using peak area normalization method with Hewlett Packard software. The antioxidant activities of liposoluble constituents in 3 processed products of R. glutionsa were investigated by 1,1-diphenyl-2-picrylhydrazyl(DPPH)free radical scavenging. RESULTS A total of 79 liposoluble components were identified from different processed products of R. glutionsa,and 48,52 and 37 liposoluble compounds were identified from fresh R. glutionsa ,R. glutionsa and prepared R. glutionsa,respectively;their relative contents accounted for 92.69%,86.29%,92.89% of the total components respectively. Among them ,there were 20 liposoluble compounds totally ,and their relative contents accounted for 88.73%,80.89% and 85.87% of liposoluble components in each processed product respectively ;they were mainly composed of fatty acids such as methyl linoleate,methyl palmitate and methyl oleate. In addition ,there were 18 unique liposoluble components in fresh R. glutionsa , mostly terpenoids ;there were 17 and 6 unique liposoluble components in R. glutionsa and prepared R. glutionsa ,mostly alkanes. The results of antioxidant experiment showed that median scavenging concentrations of liposoluble components to DPPH limeng free radical were 0.756,0.660,0.758 mg/mL,respectively. CONCLUSIONS The common liposoluble components in different processed products of R. glutionsa are mostly acids;the unique liposoluble components in fresh R. glutionsa are mostly terpenoids ,and those of R. glutionsa and prepared R. glutionsa are mostly alkanes ;the liposoluble constituents possess in vitro antioxidant activities.
摘要:OBJECTIVE To compare t he diff erences of the fingerprint and in vitro antioxidant activity between decoction pieces of Polygonum cuspidatum by integrated technology of habitat processing and processing (short for IPDP )and traditional processing decoction pieces (short for TPDP ). METHODS Ten batches of IPDP and ten batches of TPDP were prepared by integrated technology and traditional technology ,respectively. HPLC method was used to establish and compare the fingerprints of IPDP and TPDP. The scavenging rates of DPPH free radical ,ABTS free radical ,superoxide free radical and hydroxyl free radical and reducing activity of Fe 3+ were detected for IPDP and TPDP. In vitro antioxidant activities were compared between IPDP and TPDP. RESULTS There were 11 common peaks in the fingerprints of IPDP and TPDP ,among which 17 came from IPDP and 13 came from TPDP. The peak heights of peak 6(polydatin)and peak 15(emodin-8-O-β-D-glucoside)in IPDP were significantly higher than those in the TPDP ,and the peak heights of peak 13(resveratrol),peak 17(emodin)and peak 19(physcion)in the TPDP were significantly higher than those in the IPDP. The results of in vitro antioxidant test showed that IPDP and TPDP had a certain scavenging capacity on DPPH free radical ,ABTS free radical ,superoxide free radical and hydroxyl free radicals ,and also had a certain reducing capacity on Fe 3+. CONCLUSIONS The integrated processing technology of P. cuspidatum has a good retention effect on the glycosides in P. cuspidatum ,and the in vitro antioxidant activity of IPDP is stronger than that of TPDP.
关键词:Polygonum cuspidatum;integrated technology of habitat processing and processing;Fingerprint;Antioxidant activity
WANG Jing,WANG Jie,Anaer,LI Tong,YANG Dongping,DAI Jundong,DONG Ling
Vol. 33, Issue 5, (2022)
摘要:OBJECTI VE To establish the high performan ce liquid c hromatography(HPLC)fingerprint of carotenoid in Lycium barbarum,and to investigate the spectrum-effect relationship between its common peak and antioxidant activity. METHODS HPLC method was adopted. The fingerprints of carotenoid in 34 batches of L. barbarum from different producing areas were established by Similarity Evaluation System of TCM Fingerprint (2012 edition),and similarity evaluation and common peak identification were carried out. Taking scavenging rate of DPPH free radical as index ,in vitro antioxidant activity of carotenoid in L. barbarum was investigated. The spectrum-effect relationship between the common peaks of carotenoids in L. barbarum and antioxidant activity was analyzed by grey correlation method. RESULTS There were 4 common peaks in the fingerprints of carotenoids in 34 batches of L. barbarum ,and the similarity was not less than 0.903. Peak 1 was identified as zeaxanthin ,and peak 4 as zeaxanthin dipalmitate. The scavenging rates of them to DPPH free radical were 1.792%-3.160%. The common peaks of carotenoids in L. barbarum were positively correlated with scavenging rate of DPPH free radical ,and the correlation degree was greater than 0.6;the correlation degree of peak 2 and peak 4(zeaxanthin dipalmitate )with scavenging rate of DPPH free radical was greater than 0.8. According to the correlation degree ,the contribution of each common peak to scavenging rate of DPPH free radical was determined as peak 2> peak 4(zeaxanthin dipalmitate )>peak 1(zeaxanthin)>peak 3. CONCLUSIONS In this study ,HPLC fingerprint of carotenoid in L. barbarum is successfully established ,and two common peaks are identified. The chemical components represented by peak 2 and zeaxanthin palmitate may be the material basis of antioxidant activity of carotenoid in L. barbarum .
摘要:OBJECTIVE To establish a comprehensive and rapid m ethod for the a nalysis of chemical constituents as phthalides and organic acids in Angelica sinensis ,and to provide scientific reference for the quality evaluation and pharmacodynamic substance research of A. sinensis . METHODS The 70% ethanol extract of A. sinensis was analyzed by ultra high performance liquid chromatography-quadrupole-time of flight tandem mass spectrometry (UPLC-Q-TOF/MS). The determination was performed on ACQUITY UPLC BEH-C 18 column with mobile phase consisted of 0.1% formic acid solution- acetonitrile(gradient elution )at the flow rate of 0.3 mL/min. The column temperature was set at 30 ℃,and sample size was 2 µL. The ion source was an electrospray ion source ,using positive ion scanning mode ,and the mass scanning range was m/z 50-1 000. Capillary voltage was 4 000 V; atomizer pressure was 35 psi;cracking voltage was 135 V and the taper hole voltage was 65 V;the temperature of dry gas was 320 ℃;the flow of dry gas was 10 L/min and the flow of sheath gas was 11 L/min;collision energy were 20 and 40 V. Qualitative Analysis 10.0 software was used to obtain the retention time of compounds ,the accurate mass number of excimer ion peaks and secondary fragments. The compounds were analyzed by comparing with the mass spectra of the reference substance ,combined with relevant literature ,mass spectrometry cleavage law and database such as Chemspider ,MassBank,PubChem. RESULTS A total of 72 compounds were identified or deduced from A. sinensis ,including 55 phthalides,13 organic acids and 4 other constituents. CONCLUSIONS The established method is rapid and accurate for the identification of chemical constituents from A. sinensis ,such as organic acids and phthalides ,which provides an efficient and rapid analytical method for the comprehensive characterization of its chemical constituents.
摘要:OBJ ECTIVE To establish HPLC finger print of Leonurus japonicus granules,and to determine the contents of 4 index components such as leonurine hydrochloride ,ferulic acid ,rutin,hyperoside. METHODS The determination was performed on Inertsil TM ODS-3 column with mobile phase consisted of acetonitrile (A)-0.1% formic acid solution (B)in the form of gradient elution;the flow rate was 1.0 mL/min,the detection wavelength was 280 nm,the column temperature was 25 ℃,and the sample size was 5 µL. Similarity Evaluation System of Chromatogram Fingerprint of TCM (2012 edition)was used for establishing the HPLC fingerprints of 10 batches of L. japonicus granules and analyzing their similarities. By comparing with HPLC fingerprints of reference substance ,the common peaks were identified. SPSS 25.0 and SIMCA 13.0 software were used for cluster analysis and principal component analysis ;the above HPLC method was used for the content determination of 4 index components in L. japonicus granules such as leonurine hydrochloride ,ferulic acid ,rutin,hyperoside. RESULTS HPLC fingerprints of 10 batches of L. japonicus granules were established ,and 16 common peaks were matched ,and 4 peaks identified were leonurine hydrochloride (peak 6),ferulic acid (peak 13),rutin(peak 14),hyperoside(peak 16);the similarities of 10 batches of samples were all higher than 0.970. The 10 batches of samples could be divided into four categories by cluster analysis and principal component analysis;the classification results were consistent. The contents of leonurine hydrochloride ,ferulic acid ,rutin and hyperoside were 122.10-138.82 μ g/g,9.33-10.45 μ g/g,14.12-18.95 μ g/g,5.87-8.06 μ g/g,respectively. CONCLUSIONS Established HPLC fingerprint of L. japonicus granules and the method for the content determination of 4 index components are simple and easy to operate,and have high precision and good repeatability ,which provide reference for the quality evaluation of L. japonicus granules.
WANG Bingran,CHEN Jing,LI Xintong,JIANG Changpeng,ZHANG Miao,MA Qifeng,GAO Hongmei
Vol. 33, Issue 5, (2022)
摘要:OBJ ECTIVE To optimize th e p rocessing technology of Portulaca oleracea charcoal,and to investigate its improvement effect on the symptom of hemorrhoid model rats. METHODS The effects of roasting temperature ,dosage and roasting time on the processing technology of P. oleracea charcoal were investigated with Box-Behnken response surface methodology using comprehensive score of tannin content ,water-soluble extract content and appearance properties as the index. The optimal process parameters are selected and verified. The hemorrhoid model rats were treated with P. oleracea charcoal(0.8 g/mL)prepared by the optimal processing technology ,once a day ,for 11 days. After last medication ,the perianal pathological score of hemorrhoid model rats were performed ;serum levels of tumor necrosis factor α(TNF-α),interleukin 6(IL-6)and IL- 1β were detected. RESULTS The optimal processing technology of P. oleracea charcoal included roasting temperature of 200 ℃, dosage of 150 g and roasting time of 14 min. Results of validation test showed that the comprehensive score of P. oleracea charcoal was 92.57,and relative error of it with predicted value (96.59)was -4.13%. External use of P. oleracea charcoal 0.8 g/mL prepared by the optimal processing technology could significantly promote the wound healing of hemorrhoid model rats ,reduced the amount of exudate ,and decreased the levels of TNF-α,IL-6 and IL-β in serum. CONCLUSIONS The optimized processing technology of P. oleracea charcoal is feasible. P. oleracea charcoal prepared by the optimized processing technology has good curative effect on the symptom of hemorrhoid model rats.
摘要:OBJECTIVE To s tudy the improvement effects of sinapic acid on Aβ42-induced injury of PC 12 cells and the mechanism. METHODS PC12 cells were divided into five groups :control group ,model group ,sinapic acid group ,phosphoinositide- 3-kinase(PI3K)inhibitor group and extracellular signal-regulated kinase (ERK)inhibitor group. Each inhibitor group was added with LY 294002 and U 0126(10 μmol/L)for 1 h;except for control group ,other four groups were treated with 2 μmol/L Aβ42 for 24 h to replicate the Alzheimer ’s disease cell model ;except for control group and model group ,other three groups were added with 100 μmol/L sinapic acid respectively. After 24 hours of continuous culture ,survival rate of PC 12 cells was detected and the morphology of PC 12 cells was observed. The content of Aβ42,mRNA expression of cAMP response element binding protein (CREB),protein expression of cyclic adenosine monophosphate (cAMP),protein kinase A (PKA),CREB signaling pathway and phosphorylated CREB (p-CREB)were detected. RESULTS After treated with sinapic acid ,the survival rate of PC 12 cells,mRNA expression of CREB and protein expressions of cAMP ,PKA and p-CREB were increased significantly (P<0.05),while the content of Aβ42 was decreased significantly (P<0.05);cell morphology was significantly improved and synapses increased. After intervened with PI 3K and ERK inhibitors ,the survival rate of PC 12 cells,above mRNA and protein expressions were reversed significantly (P<0.05 or P<0.01);cell morphology was irregular ,the fragments increased ,and the synaptic connections decreased. CONCLUSIONS Sinapic acid can improve the survival rate of PC 12 cells injured by A β 42,improve cell (No.2021-KYYWF-0349) morphology and decrease the content of Aβ42,the mechanism of which may be associated with promoting the gene transcription of CREB , and activating cAMP/PKA/CREB signaling pathway.
WANG Xiaoyang,WU Jun,HUANGFU Longtao,LIU Hong,LI Xuemei,TANG Haifeng,ZHANG Yanhua
Vol. 33, Issue 5, (2022)
摘要:OBJECTIVE To study the triterpenoid saponins from Anemone rivularis var. flore-minore and their antitumor activities. METHODS The n-butanol extract of 70% ethanol extract from rhizome of the plant was separated. The triterpenoid saponins were separated and purified by normal silica gel column chromatography ,reversed phase ODS column chromatography , Sephadex LH- 20 gel column chromatography and semi-preparation high performance liquid chromatography. The structures of these saponins were identified by spectral analysis (NMR and MS )and physical and chemical properties. MTT assay was used to test the proliferation inhibitory activity of the compounds against five kinds of human tumor cells (HL-60 cells,A549 cells,HepG2 cells,HeLa cells and U 87MG cells ). The apoptosis inducing effect of compound 7 on U 87MG cells was evaluated by flow cytometric Annexin V-FITC/PI staining test. RESULTS:Sixteen triterpenoid saponins were obtained and identified as 3 β-O-β-D-xylopyranosyl-(1→2)-α-L-arabinopyranosyl-oleanolic acid-28-O-α-L-rhamnopyranosyl- (1→4) -β-D-glucopyranosyl-(1→6)-β-D-glucopyranoside(1),3β-O-L-arabinopyranosyl oleanolic acid- 28-O-β-D-glucopyranoside(2),saponin B (3), 163.com oleanolic acid- 3β-O-β-D-glucopyranosyl-(1→2)-α-L-arabino- pyranoside(4),HN-saponin F (5),clematoside S (6),prosapogenin CP 4(7),cussonside B (8),pulsatilla saponin C (9), clemastanoside D (10),3 β-O-β-D-glucopyranosyl-(1→2)-β-L-arabinopyranosyl-hederagenin-28-O-β-D-glucopyranoside(11), ciwujianoside C 3(12),ciwujianoside A 1(13),huzhangoside D (14),kalopanaxsaponin B (15)and hederacolchiside E (16). Compounds 3,4,6-9 displayed inhibitory activities on the proliferation of tumor cells to different extent ,and compound 7 had the strongest activity ;compound 7 induced the apoptosis of U 87MG cell so as to inhibit the proliferation of cancer cells in a time-dependent manner. CONCLUSIONS The obtained 16 saponins are all identified as oleanolane-type ,among which compound 1 is a new compound. The monodesmosidic saponins ,the sugar chain of which attached at C- 3 and a free carboxyl at C- 28, possess stronger antitumor activity than others.
关键词:Anemone rivularis var. flore-minore;triterpenoid saponin;Identification;antitumor activities;oleanane-type
LIU Tianyi,LIU Zhihong,LIU Jun,FENG Yuan,LI Hsingjung,SHI Ruizhi
Vol. 33, Issue 5, (2022)
摘要:OBJECTIVE To evaluate the budget impact on medical insurance fund upon the treatment of pulmonary arterial hypertension(PAH)included in the outpatient special and chronic disease management policy (hereinafter refer to as the Policy ), so as to provide reference for medical insurance reimbursement decision-making. METHODS Based on the perspective of medical insurance payer ,a budget impact model with 10 million people was built to calculate the budget impact on the medical insurance fund in the next three years (2021-2023)after PAH treatment included in the Policy. The measured cost mainly included the cost of medicine,outpatient registration ,examinations,hospitalizations,and death events. RESULTS A total of 34-36 patients with PAH per year were expected to use targeted therapy during 2021-2023. For cities with outpatient costs not covered by the pooling fund of basic medical insurance ,upon the treatment of PAH included the Policy ,the annual expenditure of the medical insurance fund increased by about 40 000 yuan,i.e. an increase of about 1 000 yuan per patient. For cities with outpatient costs covered by the pooling fund ,the annual expenditure of the medical insurance fund increased by about 80 000 yuan,which was equal to 2 000 yuan increase per patient. The increment of above cost decreased year by year. CONCLUSIONS The incremental expenditure of the medical insurance fund is controllable after the treatment of PAH included the Policy ;with the implementation of the Policy ,the incremental expenditure of the medical insurance fund will be reduced year by year.
WANG Feng,WANG Ying,LONG Bin,SHU Xiaolei,LI Cong,LI Xiaoyu
Vol. 33, Issue 5, (2022)
摘要:OBJECTIVE To observe the clinical efficacy and safety of albumin-bound paclitaxel combined with nedaplatin inductive chemotherapy followed by concurrent radiochemotherapy in the treatment of loco-regionally advanced nasopharyngeal carcinoma. METHODS The clinical data of 45 patients (observation group ) with loco-regionally advanced nasopharyngeal carcinoma(Ⅲ/Ⅳa stage )who received albumin-bound paclitaxel combined with nedaplatin inductive chemotherapy in our hospital from August 2017 to July 2018 were retrospectively analyzed. Propensity score was used to match 45 patients(control group )with loco-regionally advanced nasopharyngeal carcinoma who received docetaxel combined with cisplatin and fluorouracil inductive chemotherapy. After inductive chemotherapy ,both groups received intensity-modulated radiochemotherapy (IMRT);observation group was additionally given concurrent nedaplatin chemotherapy ,and control groups was given concurrent cisplatin chemotherapy. Clinical efficacy and the incidence of ADR were compared between 2 groups. RESULTS All patients completed treatment and 3-year follow-up. After inductive chemotherapy and 1,3 months after concurrent radiochemotherapy ,there was no statistical significance in short-term response between 2 groups(P>0.05). There was no significantly difference in 3-years local control rate and 3-years free from distant metastasis between 2 groups(P>0.05). The incidences of leucopenia (grade 3 or above )in the observation group were significantly lower than those in the control group ,and the incidence of peripheral neuropathy in observation group was higher than that in control group (P<0.05). The incidences of thrombocytopenia (grade 2 or above ),rash and vomiting (grade 2 or above )in the observation group were lower than those in the control group ,but the difference was not statistically significant (P>0.05). There was no significant difference in the incidence of other ADR between 2 groups(P>0.05). CONCLUSIONS Albumin-bound paclitaxel combined with nedaplatin inductive chemotherapy followed by concurrent chemoradiotherapy in the treatment of loco-regionally advanced nasopharyngeal carcinoma is effective and tolerable .
摘要:OBJECTIVE To reevaluate the system atic evaluation of g emcitabine combined with cisplatin in the treatment of advanced non-small cell lung cancer (NSCLC),in order to provide evidence-based evidence for the treatment of NSCLC. METHODS Retrieved from Wanfang database ,CNKI,VIP,PubMed,Embase,systematic evaluation of gemcitabine combined with cisplatin versus pemetrexed/vinorelbine combined with cisplatin in the treatment of advanced NSCLC was included from the inception to Dec. 2021. RevMan 5.3 system evaluation software was used for meta-analysis of various outcome indicators ; AMSTAR2 scale was used for methodological quality evaluation ,and GRADE tool was used for evidence quality evaluation. RESULTS A total of 9 literatures were included. Meta-analysis showed that the effective rate of gemcitabine combined with cisplatin was significantly lower than pemetrexed combined with cisplatin ,but was similar to vinorelbine combined with cisplatin. The 1-year survival rate of gemcitabine combined with cisplatin was equivalent to that of pemetrexed combined with cisplatin ,but was superior to vinorelbine combined with cisplatin. There was no significant difference in the incidence of nausea and vomiting between gemcitabine combined with cisplatin and pemetrexed/vinorelbine combined with cisplatin. Gemcitabine combined with cisplatin had a higher incidence of thrombocytopenia than pemetrexed/vinorelbine combined with cisplatin. The incidence of neutropenia and leukopenia in gemcitabine combined with cisplatin were higher than pemetrexed combined with cisplatin ,but were significantly lower than vinorelbine combined with cisplatin. The evaluation results of AMSTAR 2 scale showed that 6 systematic evaluation were of low quality in methodology and 3 were of very low quality. The results of the GRADE tool showed that 31% of the outcome indicators were of medium quality (14 items),27% were of low quality (12 items),and 42% were of very low quality(19 items). Research limitations and publication bias were the most frequently downgraded factors. CONCLUSIONS Gemcitabine combined with cisplatin has advantages over 154854280@qq.com vinorelbine combined with cisplatin in the efficacy and safety of ad vanced NSCLC ,especially in the 1-year survival rate ,the incidence of neutropenia and leucopenia. The efficacy and safety of gemcitabine combined with cisplatin are inferior to those of pemetrexed combined with cisplatin. However ,the methodological quality and evidence level of systematic evaluation are not high on the whole ,and the overall quality of research needs to be improved.
关键词:gemcitabine;pemetrexed;vinorelbine;Cisplatin;non-small cell lung cancer;reevaluation of systematic evaluation
摘要:OBJECTIVE To evalu ate the effects of perimenopausal one-day outpatient multidisciplinary model on the cognition of women to menopause hormone therapy (MHT). METHODS The perimenopausal one-day outpatient service opened by the Third Affiliated Hospital of Chongqing Medical University in 2017 was introduced ,which was participated by doctors ,pharmacists, nutritionists,music psychotherapists ,nurses and other multidisciplinary members to provide systematic ,all-round,humanistic and face-to-face group science popularization and education ,practical experience and Q&A for women in perimenopause or about to enter perimenopause (called“students”). The students who participated in one-day outpatient service in 2020 were selected as the survey object , and the questionnaire was CMEI2020KPYJ(ZAMM)00206] designed to analyze the understanding of perimenopausal syndrome,awareness rate of MHT ,willingness to use and concerns. RESULTS A total of 295 students completed the questionnaire. Compared with before participation , after participated in one-day outpatient service ,the cognition level of the students were all improved significantly ,including perimenopausal age (96.61% vs. 99.32%,P=0.037),the importance of perimenopausal health care knowledge (91.19% vs. 96.95%,P<0.001),whether the perimenopausal syndrome needs treatment (88.47% vs. 99.32%,P<0.001),willingness to use MHT (70.59% vs. 94.48% ,P<0.001),MHT treatment timing (60.50% vs. 95.17% ,P<0.001),reducing the risk of cardiovascular disease (51.68% vs. 96.55% ,P<0.001),delaying aging (69.75% vs. 97.59% ,P<0.001),preventing osteoporosis(65.13% vs. 97.59%),P<0.001);the medical staff were higher than the non-medical staff (P<0.05). Totally 90% of the students said they had gained knowledge about the prevention and treatment of common diseases ,nutrition and guidance, psychological regulation guidance hormone therapy related knowledges and exercise methods ;the proportion of the students who were willing to use MHT for 1 to 5 years(31.09% vs. 47.93%)increased significantly. The proportion of the students who concerned about the risk of thrombosis (60.24% vs. 36.81%),weight gain (59.64% vs. 14.84%)and life-long dependence (52.41% vs. 18.13%)was significantly reduced ,but that of the students who concerned about cancer risk was not diminished. From 2017 to 2020,the utilization rate of MHT was increased from 2.22% to 62.16% in non-medical staff among the students. CONCLUSIONS The multidisciplinary model of perimenopausal one-day outpatient service can improve the awareness of MHT among perimenopausal women ,eliminate misunderstandings ,and increase the utilization rate of MHT.
关键词:menopause hormone therapy;perimenopausal period;one-day outpatient service
摘要:Caspofungin is the firs t echinocandin antifungal drug approved for serious fungal infections caused by Candida or Aspergillus. Currently ,caspofungin has been recommended as the first-line treatment for invasive Candida and the second-line treatment for invasive Aspergillus,for its safety and tolerability. However ,there are still probability of pharmacokinetic variability and the risk of low exposure in different populations. Herein the population pharmacokinetics-pharmacodynamics studies of caspofungin in children and adults were reviewed. The results indicate that the body surface area was the main factor affecting the distribution and clearance of caspofungin in pediatric patients. In adults ,the two-compartment model fits the caspofungin behavior best in vivo with the primary covariates of body weight and albumin level. The efficacy of caspofungin might be related to pharmacokinetics-pharmacodynamics parameters ,such as the ratio of area under blood concentration time curve to minimum inhibitory concentration (AUC/MIC),the ratio of peak concentration to minimum effective concentration (cmax/MEC).