摘要:In order to promote the standardization of drug selection in medical institutions ,enhance the level of pharmaceutical affairs management of medical institutions and promote the safe ,effective,economical and appropriate use of drugs in the treatment of diseases ,the Drug Selection Guideline for Medical Institutions (hereinafter refer to as the Guideline )is formulated. The development of the Guideline for medical institutions is following the latest definition of Institution of Medicine (IOM), National Academy of Sciences and based on the methodology of WHO handbook for guideline development. During the construction of the Guideline ,the research points of the Guideline are constructed on the basis of Delphi method ;a drug selection and evaluation system with 10 primary indicators and 30 secondary indicators as the core is also designed. The evaluation indexes can be divided into research indexes and policy indexes according to their attributes and main sources of evidence. The GRADE method is used to evaluate the quality of the evidence system for research indexes ,while the policy indexes are graded according to the Legislation Law of the People ’s Republic of China . On this basis ,the evaluation methods of those indexes are constructed by using evidence-based medicine method ,the recommendation is formed through expert consensus method ,and finally a standard guideline for drug selection in medical institutions is formed.
WANG Yujia,ZHANG Wan,WU Rui,HAN Liangfu,LI Yueming,FENG Yichong,HU Qizhi
Vol. 33, Issue 7, (2022)
摘要:OBJECTIVE To provide reference for the optimization of development policy of traditional Chinese medicine. METHODS ROSTCM text mining analysis software was adopted to screen the literature preliminarily ,the PMC policy index model was built ,and the results by PMC index and visual PMC surface were analyzed. RESULTS & CONCLUSIONS A total of 33 policies related to traditional Chinese medicine were included ,and 10 primary variables and 46 secondary variables were set. The average PMC index of 33 policies was 6.15,of which 2 were excellent policies and the rest were good policies. Among the primary variables ,the scores of policy openness ,policy evaluation and policy field were relatively high ,while the scores of release time ,policy level and policy type were low. The analysis of sink index and secondary variables showed that the macro planning of national policies was not specific enough in terms of policy objectives and contents ,with low score ,while the local policies were usually planned in detail. Generally speaking ,there is still much room for improvement in the policies related to the development of traditional Chinese medicine in terms of policy system construction ,government investment ,talent construction , financing supporting policies ,market access rules ,responsible subjects and legal guarantee.
关键词:traditional Chinese medicine;high-quality development;PMC index model
摘要:OBJECTIVE To study th e effects of drug circulation supervision on online drug retailing within different time span,and to provide reference for network drug circulation supervision. METHODS Based on the research hypothesis ,a scale was designed to verify the relationship between variables. Questionnaire was used for data collection. Structure equation modeling (SEM)was applied in verifying relationships between variables after exploratory factor analysis and confirmatory factor analysis , which aimed to test reliability and validity. RESULTS & CONCLUSIONS Result of SEM indicated that drug circulation supervision had a positive significant impact upon online drug retailing within different time spans ,but its intensity varied. Specifically,the influence intensity of drug circulation supervision on retail mode and online prescription decreased with the longer time span ;the influence intensity on the types of online drugs were relatively balanced within different time spans ;the intensity of the impact on the retail cost of online pharmacies increased with the longer time span. Results of further analysis suggested that there were also differences in the weights of observed variables in drug circulation supervision and the weight of information regulation was the lowest. Accordingly,it is suggested to strengthen industry linkage ,standardize retail methods ,coordinate digital supervision system ,strengthen online prescription management ,refine supervision methods ,implement classified supervision , buffer adverse effects and reduce enterprise costs.
关键词:drug circulation supervision;online drug retailing;time span;structure equation modeling
FAN Xingying,CHANG Yue,ZHOU Hanni,LI Duan,HUANG Mingcan
Vol. 33, Issue 7, (2022)
摘要:OBJECTIVE To in vestigate the existing problems about store construction and market operation and management of DTP (direct-to-patient)pharmacies in Guizhou province ,and to provide countermeasures and suggestions for the improvement and development of professional operation of DTP pharmacies in Guizhou province. METHODS According to the literature review , the questionnaire was designed. Then the field survey of 11 DTP pharmacies and questionnaire survey for the person in charge (or store managers ) in Guizhou province were conducted from April to May 2021. The questionnaire mainly included the basic information,online sales channel construction ,pharmaceutical logistics distribution ,pharmaceutical care ,vocational training , construction of pharmacy management system and application of drug management information system etc. ,in order to analyze the inadequacies of market operation and management of DTP pharmacies in Guizhou province and put forward suggestions. RESULTS Totally 11 questionnaires were delivered and 9 valid questionnaires were retrieved ,the effective response rate of questionnaires was 81.82% . The sample pharmacies were all from Guiyang ,most of them (77.78%)were established by local pharmaceutical enterprises in Guizhou province ,and only 22.22% of the sample pharmacies had opened online drug purchase channels. In terms of pharmaceutical care ,55.56% of the sample pharmacies provided basic testing and life style interventions respectively ,44.44% of the sample pharmacies provided adverse drug reaction monitoring ,and 33.33% of the sample pharmacies implemented health education presentations and chronic disease rehabilitation program respectively. In term of personnel training ,only 11.11% of the sample pharmacies implemented weekly business training ,and 66.67% of the sample pharmacies received innovative and academic pharmacy information training. The construction of DTP pharmacy management systems in Guizhou province was completed basically , but in terms of application of drug management information system , 22.22% of the sample pharmacies conducted drug application analysis and monitoring. CONCLUSIONS The development of DTP pharmacies in Guizhou province is still in initial stage currently. The convenience and accessibility of medicines for patients and the construction of online sales channel need to be improved ;the internet channel construction is slow ;an effective selection and evaluation mechanisms for pharmaceutical logistics enterprises need to be created ;pharmaceutical care ability and pharmacy service personnel training system need to be strengthened ;informatization management and industrial recognition of DTP pharmacies in Guizhou province need to be promoted. Therefore ,the enterprises , government, universities and associations should work together and strengthen the professionalization , informatization, institutionalization and standardization of DTP pharmacies in Guizhou province ,in order to provide patients with a convenient drug sales channels and high-quality personalized pharmaceutical care platforms eventually.
关键词:DTP pharmacy;pharmacy management;market operation and management;Pharmaceutical care;Guizhou
摘要:OBJECTIVE To investigate the allocation of antipsycho tics in regions with different economic levels in Shandong province,and to provide reference for strengthening the management of antipsychotics allocation and promoting the balance of regional allocation. METHODS The procurement information of the secondary and tertiary public medical institutions in Shandong province from 2016 to 2019 was collected from the Drug Centralized Bidding and Procurement Information Platform of Shandong Provincial Medical Institutions. The procurement varieties of antipsychotics ,allocation proportion and procurement cost per 10 000 people were analyzed in area with different economic levels in Shandong province. RESULTS From 2016 to 2019,there were 18 kinds of antipsychotics purchased by secondary and tertiary public medical institutions in Shandong province (9 kinds of first- and second-generation antipsychotics respectively ),and the average number of purchased varieties were 3.50-4.42. The average number of purchased varieties in undeveloped areas (3.59-4.48 kinds)were slightly higher than that in developed areas (3.41-4.36 kinds). In these four years ,average allocation proportion of antipsychotics was 17.19%,and most of them showed a fluctuating increase (the average annual increase ranged 4.64%-38.34%). The allocation proportion of second-generation antipsychotics was higher in developed areas than that in undeveloped areas. The purchasing cost per 10 000 people showed an upward trend of fluctuation , ranging from 2.45 to 7 440.20 yuan. Among the 18 antipsychotics procured from 2016 to 2019,61.11%,61.11%,83.33% and 72.22% of them were procured by developed areas with higher procurement costs per 10 000 people than by undeveloped areas. The total procurement cost of essential medicine per 10,000 people in developed areas (11 382.99-39 650.90 yuan)was also higher than that in undeveloped areas (8 353.15-30 561.77 yuan). CONCLUSIONS The allocation proportion of antipsychotics is low in Shandong province ,and the allocation proportion of second-generation antipsychotics in developed areas are higher than that in undeveloped areas.
PENG Hong,HUANG Pinzhe,SONG Yonggui,XU Huanhua,ZHOU Mingyue,ZHU Genhua,YANG Ming,AI Zhifu,SU Dan
Vol. 33, Issue 7, (2022)
摘要:OBJECTIVE To study the composition of chemical constituents of Sargassum fusiforme and its in vitro anti- neuroinflammatory activity ,and to provide reference for its development and utilization and the study of pharmacodynamic substances. METHODS UHPLC-QTOF-MS/MS analysis method and GC-MS/MS method were used to analyze the chemical constituents of S. fusiforme . The lipopolysaccharide (1 μg/mL)was adopted to establish the inflammatory model of neuromicroglia BV2. Using paroxetine (5 μg/mL)as positive control ,CCK-8 assay was used to detect the effects of the extracts of S. fusiforme (20,40,60,80,100 μg/mL)on the activity and morphology of neuromicroglia BV 2. The effects of the extracts of S. fusiforme (40,60,80 μg/mL)on the contents of tumor necrosis factor α(TNF-α)and interleukin- 6(IL-6)in cell supernatant were detected by ELISA. RESULTS A total of 103 non-volatile constituents were identified by UHPLC-QTOF-MS/MS ,and 60 volatile constituents were obtained by GC-MS/MS. The extracts of S. fusiforme (40,60,80 μ g/mL) could significantly reduce the abnormally increased activation of neuromicroglia BV 2 and the contents of TNF-α and IL-6 due to lipopolysaccharide (P<0.05 or P<0.01). CONCLUSIONS The study establish the full spectrum of chemical constituents of S. fusiforme ,and it is confirmed that fusiforme has certain in vitro anti-neuroinflammatory activity.
LI Honghong,Payman·Hermity,WANG Xinchun,HE Chenghui
Vol. 33, Issue 7, (2022)
摘要:OBJECTIVE To establish the method for t he content determination of 5 active components in Yixin badiran jibuya granules and their fingerprints. METHODS High performance liquid chromatography method was adopted to determine the contents of luteolin- 7-O-β-D-glucuronide(LG),apigenin-7-O-glucuronide(APG),rosmarinic acid (RA),diosmetin-7-O-β-D-glucuronide (DG)and tilianin (TL)in 10 batches(No. S 1-S10)of Yixin badiran jibuya granules. The fingerprints of 10 batches of Yixin badiran jibuya granules were drawn by Similarity Evaluation System of Chromatographic Fingerprint of Traditional Chinese Medicine(2004 A edition ),and similarity evaluation and cluster analysis were also performed. RESULTS The contents of LG , APG,RA,DG and TL in 10 batches of Yixin badiran jibuya granules were 0.279 5-0.449 9,0.082 4-0.135 3,0.184 8-0.472 1, 0.149 0-0.332 6,0.311 2-0.623 3 mg/g,respectively. A total of 13 common peaks were demarcated in the fingerprints and were identified as LG (peak 2)APG(peak 6),RA(peak 7),DG(peak 8),TL(peak 11). The similarity ranged from 0.598 to 0.990. The results of cluster analysis showed that S 6-S10 were clustered into one category and S 1-S5 were clustered into one category. CONCLUSIONS Established method for content determination and fingerprints can be used for the quality control for Yixin badiran jibuya granules.
摘要:OBJECTIVE To prep are folate-targeted miR- 221 antisense oligonucleotide (anti-miR-221)delivery system ,and to preliminarily evaluate its in vitro anti-cancer effect on hepatocellular carcinoma. METHODS Folate-targeted anti-miR- 221 liposomes(FRL)were prepared by thin-film dispersion method ;the particle size ,Zeta potential and encapsulation efficiency were determined. The delivery efficiency of folate-targeted anionic liposome in human hepatoma HepG 2 cells was determined by in vitro cellular uptake experiment using calcein as the model drug. Flow cytometry was used to detect the effects of FRL on the apoptosis and cell cycle of HepG 2 cells. RESULTS The particle size of prepared FRL was (172.70±3.76)nm,Zeta potential was (-1.16± 0.15)mV and encapsulation efficiency was (83.53±1.85)%. In vitro cellular uptake experiments showed that folate-targeted anionic liposome successfully delivered calcein to HepG 2 cells,and the delivery efficiency in targeted group was higher than that of non-targeted liposome group (P<0.01). Apoptosis experiment results showed that the apoptotic rate of HepG 2 cells treated with FRL was significantly higher than that of non-targeted liposome (P<0.01). In cell cycle experiment ,FRL could shorten the S phase fraction of HepG 2 cells and induced arrest in the G 0/G1 and G 2/M phases. CONCLUSIONS FRL can encapsulate anti-miR-221 well and deliver it to hepatocellular carcinoma HepG 2 cells successfully ,and has a good in vitro anti-hepatoma effect in inducing apoptosis and cell cycle regulation.
摘要:OBJECTIVE To investigate the effect of Compound danshen tablet s o n improving the blood lipid levels and the mechanism of protecting renal functions in hyperlipidemia model rats. METHODS Sixty male SD rats were divided into normal group,model group ,simvastatin combined with (2S)-N-[N-(3,5-difluorophenylacetyl)-L-alanyl]-2-phenylglycine tert butyl (DAPT)group and low-dose ,medium-dose and high-dose groups of Compound danshen tablets ,with 10 rats in each group. Rats in the normal group received routine diet. The other 5 groups were intraperitoneally injected with 75% yolk emulsion 10 mL/kg, fasting and drinking freely. After 16 h,they were fed high-fat diet for 4 weeks. Simvastatin combined with DAPT group was given simvastatin 0.002 g/kg and DAPT 0.012 g/kg at the same time of modeling. The low-dose ,medium-dose and high-dose groups of Compound danshen tablets were given Compound danshen tablets 0.25,0.5 and 1 g/kg respectively at the same time of modeling , the normal group and model group were given equal volume of distilled water ,once a day ,for 4 weeks. The serum levels of total cholesterol(TC),triglyceride(TG),creatinine(Cr)and urea nitrogen (BUN)in serum were detected by biochemical method ; kidney coefficient of rats was calculated ;histopathological changes of rat kidney were observed by HE staining ,and the renal injury was scored according to the degree of renal tubular injury and glomerular sclerosis in renal cortex ;expression levels of Notch signal receptor 1(Notch 1),Notch signal ligand 1(Jagged1)and hairy division associated enhancer 1(Hes1)in kidney were detected by immunohistochemistry ;mRNA expressions of Notch 1,Jagged1 and Hes 1 in renal tissue were detected by real-time fluorescence quantitative polymerase chain reaction. RESULTS Compared with normal group ,the serum levels of TG , TC,Cr and BUN were increased significantly in model group (P<0.05);renal coefficient increased significantly (P<0.05); pathological changes occurred in renal tissue ,and the scores of renal tubular injury and glomerular sclerosis increased significantly (P<0.05);protein and mRNA expressions of Notch1, Jagged1, Hes1 in renal tissue were increased significantly(P<0.05). Compared with model group ,serum levels of TG ,TC,Cr and BUN ,renal coefficient ,the scores of renal tubular injury and glomerular sclerosis ,protein and mRNA expression of Notch 1,Jagged1 and Hes 1 in renal tissue were all decreased in low-dose ,medium-dose and high-dose groups of Compound danshen tablets (P<0.05),and most indexes showed a dose-dependent trend ;the degree of renal lesions was reduced. CONCLUSIONS Compound danshen tablets possess obvious hypolipidemic effect ,and can protect the renal function of hyperlipidemia model rats by down-regulating Notch 1/Jagged1 signal pathway.
关键词:Compound danshen tablets;Hyperlipidemia;Renal function;Notch1/Jagged1 signal pathway;blood lipid
摘要:OBJECTIVE To study the quality difference of different specifications of Citri Grandis Exocarpium from different origins,and to provide reference for the orderly development of Citri Grandis Exocarpium industry. METHODS Different specifications [ Citrus grandis ‘Tomentos’young fruit ,Citrus grandis (L.)Osbeck young fruits ,exocarp] of 93 batches of Citri Grandis Exocarpium medicinal materials (decoction pieces )from different origins [ Citrus grandis ‘Tomentosa’or Citrus grandis (L.)Osbeck] were taken as samples. The contents of naringin and rhoifolin in samples were determined by HPLC. Through pheatmap parameters of R language ,heatmap was drawn for the contents of naringin and rhoifolin according to origins and specifications (young fruit and exocarp ). RESULTS Of 93 batches of samples ,the contents of naringin and rhoifolin were 16.52-214.64 and 1.03-10.96 mg/g,respectively. Among different specifications ,the contents of naringin and rhoifolin in the young fruit were the highest (their average contents were 108.96 and 6.30 mg/g respectively ). Heatmap analysis of R language content showed that the contents of naringin and rhoifolin in Citri Grandis Exocarpium from origin of C. grandis ‘Tomentosa’were generally higher than those from origin of C. grandis (L.)Osbeck. Of different specifications of Citri Grandis Exocarpium from origins,the contents of naringin and rhoifolin were higher in KTP young fruit relatively. CONCLUSIONS The quality of Citri Grandis Exocarpium from origin of C. grandis ‘Tomentosa’with the young fruit as specification is the best.
WANG Lu,WANG Lixia,WU Tingting,ZHAO Siqing,ZHENG Meiyu,LU Shengmin
Vol. 33, Issue 7, (2022)
摘要:OBJECTIVE To stu dy the effects of different processing me thods on the contents of the pharmacodynamic index components in Citrus aurantium and their antioxidant activity. METHODS According to the general principles of 2020 edition of Chinese Pharmacopoeia (volume Ⅳ) and the relevant processing methods in 2015 edition of Processing Specifications of Traditional Chinese Medicine in Zhejiang Province ,the samples of C. aurantium were prepared by steaming with water ,boiling with water ,stir-frying with vinegar ,stir-frying with wine ,stir-frying with bran ,processing with bran and processing with honey. The contents of moisture and ash in different products of C. aurantium were detected. The contents of naringin and neohesperidin in different products of C. aurantium were determined by high performance liquid chromatography. The antioxidant activity of different products was investigated by DPPH and ABTS + radical scavenging experiments and the total reducing power test. RESULTS The contents of moisture ,ash,naringin and neohesperidin were in line with the relevant requirements in 2015 edition of Processing Specifications of Traditional Chinese Medicine in Zhejiang Province . The content of naringin in descending order was as follow : unprocessed sample >sample processed with honey >sample processed with bran >sample boiled with water >sample stir-fried with vinegar>sample stir-fried with wine >sample stir-fried with bran >sample steamed with water. The content of neohesperidin in descending order was as follow :unprocessed sample >sample boiled with water >sample processed with bran >sample processed with honey >sample stir-fried with vinegar >sample steamed with water >sample stir-fried with wine >sample stir-fried with bran. The samples after boiling with water ,processing with bran ,and stir-fried with bran had better DPPH radicals scavenging ability (IC50 were 7.49,8.37 and 10.22 mg/mL,respectively). The samples after boiling with water ,steaming with water ,and processed with bran had better ABTS + radicals scavenging ability (IC50 were 1.76,2.03 and 2.72 mg/mL,respectively). In addition , compared with sample stir-fried with wine and processed with 发。E-mail:wanglu1286@163.com honey,unprocessed sample and other processed products of C.aurantium had bet ter total reducing ability. CONCLUSIONS After processing ,the contents of the main pharmacodynamic index components in C. aurantium have been reduced ,but they were also in line with the relevant requirements in 2015 edition of Processing Specifications of Traditional Chinese Medicine in Zhejiang Province . The antioxidant ability of some processed products has been enhanced.
JIN Xian,CHEN Jicong,XIN Yuying,XIAO Honghe,LI Yan,DENG Yan,YANG Jingxian
Vol. 33, Issue 7, (2022)
摘要:OBJECTIVE To study the neuroprotective effects of Shenzao jianna o oral liquid (SZJN)on Alzheimer ’s disease (AD)model mice and its mechanism. METHODS The mice were randomly divided into sham operation group ,model group , Donepezil hydrochloride tablet group (0.65 mg/kg),SZJN low-dose ,medium-dose and high-dose groups (0.3,1.5 and 7.5 g/kg, calculated by crude drug quantity ),with 12 mice in each group ,half male and half female. Each group was given relevant medicine(intragastric administration of water at constant volume in sham operation group and model group ),twice a day ,for consecutive 28 d. On the 15th day of administration ,intracerebroventricular injection of β-amyloid 1-42(Aβ1-42)combined with intraperitoneal injection of scopolamine hydrobromide were used to induce AD model. Morris water maze was used to detect the learning and memory ability of mice. HE staining and Nissl staining were used to evaluate the pathological changes of brain tissue in mice. The levels of MDA and SOD in brain tissue of mice were detected. The phosphorylation level of cyclic adenosine monophosphate response element binding protein (CREB) and expression of brain-derived neurotrophic factor (BDNF) in hippocampal tissues were detected by Western blot. RESULTS Compared with sham operation group ,the escape latency of the model group was significantly prolonged ,and the number of crossing the platform and the percentage of residence time in the target quadrant were significantly reduced (P<0.01). The level of SOD in brain tissue ,the phosphorylation level of CREB and the expression level of BDNF in hippocampus decreased significantly (P<0.01),while the level of MDA increased significantly (P< 0.01). In hippocampal CA 1 area and cortical tissue ,nerve cells showed significantly decreased number ,the disordered arrangement and large gap ;the shape of nucleus was irregular and deeply stained ,and Nissl body was blurred ,loosely arranged and the number decreased. Compared with model group ,the escape latency of mice in each dose group of SZJN was significantly shortened ,and the times of crossing the platform and the percentage of residence time in the target quadrant were significantly jing- increased(P<0.01). Above indexes of brain tissue in mice were reversed sig nificantly in SZJN high-dose group (P<0.01),and pathological damage of brain tiss ue was improved. CONCLUSIONS SZJN can significantly improve the learning and memory ability of AD model mice ,and alleviate the pathological injury and oxidative stress of brain tissue ,which may be related to the activation of CREB/BDNF signaling pathway.
摘要:OBJECTIVE To study the quality grade stand ard of the premature Forsythia suspensa . METHODS A total of 138 batches of premature F. suspensa were collected from the main producing areas of F. suspensa in China. According to 2020 edition of Chinese Pharmacopoeia ,the contents of impurities ,moisture,ethanol-soluble extract ,volatile oil ,forsythin and forsythoside A in the premature F. suspense were determined ,and the qualified samples were screened. AHP-PCA mixed weighting method was used to give comprehensive weight to the indicators (except for the limit of impurity ). The comprehensive score of the samples was calculated. The suggestions on the quality grade division of premature F. suspensa were put forward according to cluster analysis of K-mean value. RESULTS & CONCLUSIONS The contents of impurities ,moisture,ethanol-soluble extract ,volatile oil ,forsythin and forsythoside A in the premature F. suspense were 0-7.80%,1.60%-8.18%,13.13%-61.60%,0.21%-3.47%,0.02%-2.15% and 0.79%-14.04%,respectively;average contents of them were 1.24%,4.97%,34.88%,2.01%,0.42%,6.86%,respectively. Totally 47 batches of 138 batches were qualified in all indexes. It is suggested that the quality grade of the premature F. suspense can be divided into three grades :in first grade of F. suspense ,the contents of volatile oil ,forsythin,forsythoside A , ethanol-soluble extract and moisture were ≥2.40%,≥0.59%,≥8.34%,≥38.66% and ≤4.99%,respectively;in second grade of F. suspense ,the contents of above indicators were ≥2.26%,≥0.41%,≥7.47%,≥32.58% and ≤5.33%,respectively;in third grade of F. suspense ,the contents of above indicators were ≥2.15%,≥0.32%,≥4.60%,≥31.52% and≤7.23%,respectively.
摘要:OBJECTIVE To prepare cinnamaldehyde (CA) loaded liposomes bilayer-modified by bovine serum albumin (BSA)/chitosan (CTS)(BSA/CTS-Lip-CA) in order to improve the sustained-release effect and storage stability of the nanoparticles. METHODS Firstly,cinnamaldehyde loaded liposomes (Lip-CA)and blank liposomes (Lip-Blank)were prepared by thin film dispersion method. Then chitosan modified cinnamaldehyde loaded liposome (CTS-Lip-CA)and BSA/CTS-Lip-CA were obtained by electrostatic adsorption. Finally , the prepared liposomes were characterized , and their in vitro release characteristics and storage stability were investigated. RESULTS The particle size of BSA/CTS-Lip-CA was (177.8±4.0)nm and the Zeta potential was (-15.6±1.5)mV;they were in spherical shape ;FTIR analysis showed that the modification of BSA and CTS had no effect on the internal structure of liposomes. The results of in vitro drug release characteristics showed that the cumulative release of Lip-CA ,CTS-Lip-CA and BSA/CTS-Lip-CA within 10 hours were 82.9%,74.1% and 72.9% respectively. The results of storage stability showed that after 30 days of storage ,the particle sizes of Lip-CA ,CTS-Lip-CA and BSA/ CTS-Lip-CA were (134.2±2.1),(151.7±0.4),(164.8±1.5)nm;the retention rates of model drug CA were 65.4%,82.5% and 90.2% respectively. CONCLUSIONS BSA/CTS-Lip-CA is successfully prepared. It has a certain sustained-release effect and can improve the storage stability of the drug to a certain extent.
摘要:OBJECTIVE To study the components of ethyl acetate fraction in Qubai tablet ,and its pharmacodynamics on de melanocyte model ,and explore the material basis for anti-vitiligo effect of Qubai tablet. METHODS The ethyl acetate fraction of Qubai tablets was obtained by extraction ,and its components were analyzed by ultra performance liquid chromatography-mass spectrometry(UPLC-MS). Model control group ,vehicle control group and 8-methoxypsoralen(8-MOP)administration groups (10,50,100,150,200 μmol/L),ethyl acetate fraction administration groups of Qubai tablet (10,50,100,150,200 μg/mL) were set up in the experiment. By establishing the de melanocyte model ,the effects of ethyl acetate fraction of Qubai tablet on de melanocyte were studied from four aspects :cell number ,cell viability ,melanin formation and tyrosinase activity. RESULTS UPLC-MS component analysis preliminarily determined the structure of 64 compounds in the ethyl acetate fraction of Qubai tablet , of which 14 compounds were detected in positive and negative ion mode ;psoralen compounds accounted for the largest proportion , and the content of psoralen chromone chalcone was the highest in positive and negative ion mode. The results of pharmacodynamic study showed that the ethyl acetate fraction of Qubai tablet could increase the number of de melanocytes ,and significantly improve the cell proliferation rate ,the rate of promoting melanin formation and the rate of promoting tyrosinase activity in the process of melanin formation (P<0.01). CONCLUSIONS Psoralen compounds may be the material basis for the anti-vitiligo effect of ethyl acetate fraction of Qubai tablet ;good anti-vitiligo effect of ethyl acetate fraction of Qubai tablet may be related to the promotion of tyrosinase activity.
摘要:OBJECTIV E To optimize the s alt-processing technology of Rosa laevigata ,and to study high performance liquid chromatography(HPLC)fingerprints and chromaticity values of R. laevigata before and after salt-processing. METHODS The comprehensive scoring method was adopted to optimize the salt-processing technology of R. laevigata using appearance character , moisture and polysaccharide content as index. Fingerprints were established by HPLC method before and after salt-processing ,and chromaticity values (L*,a*,b*)of the powder before and after salt-processing were determined. The multivariate statistical analysis was carried out for raw product and salt-processing product of R. laevigata by using common peak areas and chromaticity values as index. RESULTS The optimal salt-processing technology of R. laevigata was to mix it with appropriate amount of salt water ,place them in the preheated frying wok at 140 ℃,fry them for 25 min,and rotate frying wok 20 times/min. Ten common peaks were calibrated by HPLC fingerprints before and after salt-processing ,and 3 components were identified ,such as gallic acid ,catechin and ellagic acid. The chromaticity values L*,b* and E* changed significantly after salt-processing. The multivariate statistical analysis method could distinguish raw products and salt-processing products into two categories ,in which peaks 1,5,6 and 10 and chromaticity values b* and E* were important characteristic factors. CONCLUSIONS The optimized salt-processing technology is stable and reliable ,and the established fingerprint has good repeatability and stability. Fingerprint and chromaticity values combined with multivariate statistical analysis can provide reference for the identification and quality analysis of R. laevigata before and after salt-processing.
摘要:OBJ ECTIVE To introduce adjusted limited dependent variable mixed model (ALDVMM)and study its application in mapping research ,so as to provide reference for pharmacoeconomic evaluation that needs to obtain health utility value through mapping. METHODS Using the method of literature research ,ALDVMM was introduced from the aspects of development background,model principle ,model determination and test ,model advantages and the current application of the model in empirical research. RESULTS & CONCLUSIONS ALDVMM is a mixed model developed by foreign scholars for the truncation and multimodality phenomenon of EuroQoL group ’s 5D(EQ-5D)at the health utility value 1. Compared with the traditional model,ALDVMM is feasible and has more advantages ,and can more effectively and flexibly capture the actual distribution of EQ-5D and deal with the boundary value problem ,which is helpful to obtain the health utility value more accurately and efficiently and carry out high-quality pharmacoeconomic evaluation.
摘要:OBJECTIVE To exc avate and evaluate the adverse reaction signals of 4 kinds of imported programmed cell death 1 (PD-1)and its ligand (PD-L1)inhibitors,and to guide rational drug use in clinic. METHODS OpenVigil 2.1 software was used to obtain the adverse event reports of four drugs as nivolumab ,pembrolizumab,atezolizumab and durvalumab from the first quarter of 2013 to the fourth quarter of 2020 in the US FDA adverse event reporting system. The reporting odds ratio and proportional reporting ratio were used for signal mining to evaluate new or potential adverse reaction signals. RESULTS A total of 46 840 reports of adverse events with PD- 1/PD-L1 inhibitors as the primary suspected drug were collected ,including 28 896 reports of nivolumab,13 298 reports of pembrolizumab ,3 398 reports of atezolizumab ,and 1 248 reports of durvalumab. From the general characteristics of these reports ,the gender distribution was more men than women ,and the age distribution was mainly in the range of 51-85 years old. The reporting year was mainly in the nearly 4-5 years,and the main reporting countries were the US and Japan,with“death”and“hospitalization or prolonged hospitalization ”as the main serious adverse events which were over 50% of the whole of 4 kinds of adverse events. A total of 1 597 adverse reaction signals were obtained ,involving 26 systems,focusing on “benign,malignant and unspecified neoplasms (cystic and polypoid tumor )”,“infections and infestations ”and“investigations”, etc. The analysis of the top 50 adverse reaction signals showed that the largest number of report was endocrine system disease ,the most frequency signal was “malignant neoplasm progression ”and the strongest adverse reaction signal was “radiation pneumonitis ”. And it was also found that 13 adverse reaction signals ,such as “radiation pneumonitis ”“cholangitis”“fulminant type 1 diabetes mellitus” “blood creatine phosphokinase increased ” “disseminated intravascular coagulation ”“cardiac failure ”and “cerebral infarction ”,etc.,were not reported in the drug instructions. CONCLUSIONS PD-1/PD-L1 inhibitors mediate a large number of adverse reaction signals,resulting in high safety risks in “benign,malignant and unspecified neoplasms (cystic and polypoid tumor )”,“infections and infestations ”and “investigations”,etc. The newly discovered 13 adverse reaction signals ,such as “radiation pneumonitis ”“cholangitis”“blood creatine phosphokinase increased ”“cardiac failure ”and“cerebral infarction ”are of great significance for guiding rational drug use in clinic.
摘要:OBJECTIVE To systematically evaluate the efficacy and safety of fondaparinux versus low molecular weight heparin(nadroparin,enoxaparin)in the treatment of non-ST-elevation acute coronary syndrome (NSTE-ACS). METHODS The computer searched PubMed ,Medline,Embase,EBSCO,CNKI,Wanfang medical network ,VIP Chinese Journal Full-text Database and relevant clinical trial registration network for the clinical retrospective cohort study (RCS)of fondaparinux (as trial group)and low molecular weight heparin (natroparin,enoxaparin)(as control group )in the treatment of NSTE-ACS. The retrieval time limit was from the establishment of the database to August 2021. Newcastle Ottawa scale (NOS)was used to evaluate the quality of literature. Outcome indicators included primary efficacy indicators (incidence of acute myocardial infarction and recurrent angina pectoris during hospitalization ),secondary efficacy indicators [revascularization of target vessels during 话:0835-2862024。E-mail:xiexingxing07@163.com hospitalization, prothrombin time (PT), activated partial thromboplastin time (APTT)],safety indicators (incidence of serious cardiovascular events ,severe bleeding ,slight bleeding and severe puncture site co mplications during hospitalization ),combined endpoint indicators (30 and 180 days combined endpoint). RevMan 5.3 software was used for Meta-analysis of each effect index. RESULTS Finally,17 RCS articles were included,involving 4 946 patients with NSTE-ACS ,including 2 507 in the trial group and 2 439 in the control group.The results of NOS literature quality evaluation showed that there were 8 high-quality studies ,accounting for 47.06% . The results of Meta-analysis showed that there was no significant difference in the incidence of acute myocardial infarction ,recurrent angina pectoris,revascularization of target vessels ,PT and serious cardiovascular events between 2 groups (P>0.05);there was significant difference in the APTT (MD=1.34,95%CI of 0.22-2.45,P<0.05),the incidence of severe bleeding (RR=0.47, 95%CI of 0.30-0.74,P<0.05),the incidence of slight bleeding (RR=0.48,95%CI of 0.32-0.71,P<0.05),the incidence of severe puncture site complications (RR=0.48,95%CI of 0.25-0.95,P<0.05),30 day combined endpoint (RR=0.57,95%CI of 0.46-0.72,P<0.05),180 days combined endpoint (RR=0.73,95%CI of 0.54-0.98,P<0.05). CONCLUSIONS Fondaparinux in the treatment of NSTE-ACS in China has the same efficacy as low molecular weight heparin (nadroparin,enoxaparin),and has more obvious advantages in drug safety such as bleeding ,severe puncture site complications.
摘要:OBJECTIVE To provide reference and ideas for optimizing the continuing education system of pharmacists in China. METHODS By introducing the continuing professional development (CPD)model of pharmacists in Japan ,the current situation and existing problems for continuing education of pharmacists in China were analyzed to puts forward some suggestions. RESULTS & CONCLUSIONS The continuing education system of CPD model for pharmacists in Japan included five continuous cycle processes :self-assessment,making plan ,implementing plan ,learning record and result evaluation. It emphasized the autonomy and sustainability of pharmacists ’learning and promoted the sustainable development of pharmacists ’career. The education and training of pharmacists in Japan were subject to the certification system ,and a diversified implementation organization composed of industry associations ,colleges and universities and commercial education institutions had been formed. After continuous reform ,Japan had established a relatively mature and perfect sustainable career development model for pharmacists. Our country can refer to the CPD model of Japanese pharmacists ,promote the legislation of pharmacists ,explore the unified management model (the unity of hospital pharmacists and licensed pharmacists ),explore the construction of pharmacists ’ continuing education certification mechanism ,carry out refined continuing education for pharmacists in different practice fields , improve the enthusiasm of industry associations ,and add practical content to pharmacists ’continuing education projects.
关键词:continuing professional development;Licensed pharmacist;Hospital pharmacist;Japan
TAO Xiaoqian,FU Huimin,QIAO Zitong,ZHANG Qiang,BAO Ziwei,CHENG Lan,ZHANG Chungang
Vol. 33, Issue 7, (2022)
摘要:Enteric-soluble soft capsule is a kind of new preparation that does not disintegrate in the stomach ,but releases rapidly in the intestinal tract to play a pharmacodynamic role. It has the unique advantages of improving drug stability ,reducing drug irritation ,delivering drugs directionally to the intestinal tract ,and prolonging drug action time. In this paper ,the decomposition and release mechanism ,application advantages ,classification of enteric-soluble coating materials and preparation methods of enteric-soluble soft capsule are sorted and summarized ,in order to provide reference for further development of this type of preparation.