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1.
孙京林  余伯阳 《中国药学杂志》2021,55(23):1919-1922
目的 药品质量关系到每个人的身体健康和生命安全,2019年颁布的新修订的《中华人民共和国药品管理法》,确立了药品上市许可持有人制度,要求药品上市许可持有人建立质量体系,笔者旨在对行业建立质量管理体系提供参考。方法 作者结合相关文献的检索和分析,回顾了药品质量管理的发展历程,对药品质量管理体系的范围和内容等进行分析。结果与结论 上市许可持有人应围绕质量管理体系的范围、目标、设计和内容、管理职责、持续改进等方面开展工作,逐步建立并完善质量管理体系。  相似文献   

2.
隋振宇  陈兵 《中国药学杂志》2022,57(20):1776-1782
目的 为我国药品专利期限补偿制度的组织实施工作提供建议和参考。方法 通过梳理国际药品知识产权保护制度,对国际通行药品专利期限补偿制度中的美国模式和欧盟模式进行比较研究。结果 通过分析域外不同药品专利期限补偿制度模式下的补偿原则、实施流程和经验,总结了药品专利期限补偿制度的理论体系。结论 从我国建立药品专利期限补偿制度的意义、影响、后续的实施方式,以及实施过程中需要重点关注的问题等方面提供了具体建议。  相似文献   

3.
目的 开展对乙酰氨基酚片含量测定能力验证活动研究,了解和评价药品检测实验室的技术状况,提高药品检测实验室质控能力。方法 按国际标准ISO/IEC17043《合格评定能力验证的通用要求》进行,委托药品生产企业制备样品,经均匀性和稳定性试验合格后作为能力验证样品,随机分发给参加者,回收结果,采用Z比分数评价实验室能力。结果 全国共339家实验室参加本次能力验证,其中302家实验室结果评定为满意,满意率为89.1%;20家实验室结果评定为可疑,占比为5.9%;17家实验室结果评定为不满意,不满意率为5.0%。结论 绝大部分实验室具备紫外分光光度法(UV)分析对乙酰氨基酚片含量的能力;基本了解我国药品检测实验室的技术状况,药监系统实验室与药品企业质量控制实验室(QC)和第三方实验室相比,药监系统实验室能力较高。  相似文献   

4.
黄青  赵恂  黄敏文  袁耀佐  张玫 《中国药学杂志》2021,55(23):1923-1925
目的 进一步提高药品应急检验应对能力。方法 采用回顾性研究的方法,对江苏省食品药品监督检验研究院2019年亚硝胺类基因毒性杂质专项应急检验全过程工作进行梳理。结果 总结了专项应急检验中各环节的处置流程、管理特点和难点,提炼处置经验教训。结论 应急检验工作是对检验机构应急响应能力、技术实力的全面考验。需从事前、事中和事后制订系统的应对策略,构建完善的药品应急检验管理体系。  相似文献   

5.
邵华  吴鑫  陈浩  许译尹  张学丽 《中国药学杂志》2022,57(20):1771-1775
目的 评估国家药品集采目录江苏省中选药品与相应原研药说明书的差异,为药品生产企业和药品监督管理部门进一步提高一致性评价工作质量提供参考、为仿制药临床应用的安全合理性提供科学依据。方法 对国家药品集采目录江苏省中选药物的原研药和仿制药说明书全部项目进行一致性评价和风险评估,适应证与禁忌项采用SPSS和Medcalc进行统计分析。结果 仿制药与原研药说明书的适应证(P=0.782, ccc=0.93, 95%CI 0.89~0.95)与禁忌项(P=0.935, ccc=0.97, 95%CI 0.96~0.98)一致性较高,风险评估发现2组(2.25%)说明书内容差异可引起极度风险、高度风险9组(10.11%),GRADE循证证据佐证高度及以上风险的差异或成为患者用药安全的隐患。结论 药品监督管理部门应完善、落实仿制药说明书一致性评价的相关法律法规,保证临床安全用药。  相似文献   

6.
目的 分析美国药品即时审评制度实施方式,为我国药品注册审评制度改革提供参考。方法 通过文献与案例研究,全面分析美国食品和药物管理局药品即时审评制度的框架、实施流程和实施效果。结果 美国药品即时审评制度包括实时肿瘤学评估和评估支持两个项目,前者通过标准化数据分析过程和“预提交”、“预分析”步骤,后者通过标准化申报资料模板,加快审评速度。截止2019年底,已有27个项目通过该制度获批。结论 在我国药品审评制度改革不断深化过程中,建议加强政策顶层设计、探索多样化的加快审评方式、积极推进数据标准化,从而提高审评效率、加快具有临床价值的药品上市。  相似文献   

7.
目的 本研究旨在通过对新修订《药品质量抽查检验管理办法》的分析和探讨,提出可行的应对举措和建议,推动药品抽检管理模式的创新。方法 结合药品抽检工作中的实际问题,对《药品质量抽查检验管理办法》中检验和复验相关条款的要求进行分析和梳理,由内而外对检验机构强化内部质量管理,以及对外提升服务监管提出了明确要求,围绕全面质量管理(TQM)理论中“人机料法环测”5M1E 6大要素,以实验室质量管理为基础,对检验报告形成过程中的检验人员,检验样品、检验项目及检验时限等要素进行讨论。就如何做好新时期的药品检验工作提出建议和对策。结果与结论 药品质量抽查检验是上市后药品监管的重要手段之一,各级药品检验机构对内部要强化全面质量管理,确保检验结果准确可靠,同时要通过探索性研究等风险预警形式,对外实现技术支撑,服务监管的根本目的。有助于检验机构进一步健全质量管理体系,加强对检验人员,检验样品、检验项目及检验时限等要素的管理,确保检验结果准确可靠,为加强药品监管提供技术支持。  相似文献   

8.
目的 通过对我国药品注册行政受理的服务质量关键性维度进行梳理和评估,找到现存的实施困境进而提出相应的建议,以期对行政受理管理工作的改进有所启示。方法 利用文献研究梳理行政受理服务质量的评价维度,参考PZB的服务质量评价模型(SERVQUAL)评价表及Likert的“五点量表”形成问卷,进而对服务质量进行调研、分析。结果 响应性、透明性及可靠性对药品注册行政受理的服务质量影响权重较大,但其实际感知值均比原有期望值更低,且未能得到足够重视,体现在监管方实际感知值较行政相对人更高。结论 SERVQUAL评估模型适用于药品注册受理的服务质量评价,建议从明晰目标、简化流程、完善制度等3方面优化服务质量。  相似文献   

9.
目的 研究药品监管“四个最严”要求的提出、内涵及新时代落实相关要求应当统筹处理的问题。方法 结合新修订的《中华人民共和国药品管理法》相关规定,分别解析最严谨的标准、最严格的监管、最严厉的处罚和最严肃的问责的基本内涵和要求,分析新时代、新形势、新要求,提出应当高度关注的问题。结果与结论 “四个最严”揭示了药品监管的科学属性、现实路径、内在要求和保障机制。新时代落实“四个最严”要求,应当统筹好其与推动医药产业高质量发展的关系、与包容审慎监管的关系、与推进药品监管现代化的关系。  相似文献   

10.
目的 通过分析加速实验前后奥美拉唑肠溶胶囊释放曲线的变化,以考察药品包装材料的保护性。方法 对市售6家生产企业的奥美拉唑肠溶胶囊进行高温高湿条件下的加速试验,分别通过桨法和流通池法测定其释放曲线并进行相似因子评价和虚拟生物等效模拟分析。结果 加速试验对个别生产企业的奥美拉唑肠溶胶囊的释放存在影响。相比常规桨法溶出方法,流通池溶出方法更具区分力。释放曲线的评价分析结果表明,F企业的奥美拉唑肠溶胶囊试验后存在生物不等效风险。结论 市售奥美拉唑肠溶胶囊的包材保护性总体良好,但应用长时间后存在风险,提示药品包装材料有待改进。  相似文献   

11.
??OBJECTIVE To develop an UPLC method for simultaneous determination of seven components in Gardenia jasminoides, ie, gardoside, shanzhiside, deacetyl asperulosidic acid methyl ester, gardenoside (RG), genipin-1-??-D-gentiobioside, chlorogenic acid, and gardenoside to evaluate the quality of Gardenia jasminoides. METHODS ACQUITY UPLC HSS T3 column was used for the UPLC analysis. The mobile phase was acetonitrile-0.05% phosphoric acid solution. Gradient elution was conducted at a flow rate of 0.2 mL??min-1. The column temperature was maitained at 30 ?? and detection wavelength was set at 238 nm. A linear model was obtained through principal component analysis (PCA), and the scores of the principal components were used to evaluate the quality of Gardenia jasminoides Alba decoction pieces comprehensively. RESULTS The seven components could be well separated from each other with good specificity, precision,repeatability,linearity,recovery rate and stability.The 25 Gardenia jasminoides Ellis samples and two Gardenia jasminoides Ellis var.grandiflora Nakai samples conformed to the quality requirements in the chapter of gardoside, shanzhiside, deacetyl asperulosidic acid methyl ester, gardenoside(RG), genipin-1-??-D-gentiobioside, chlorogenic acid, gardenoside. As the comprehensive evaluation shown, the quality of wild Gardenia jasminoides samples from Jiangxi province was better; Gardenia jasminoides from inland provinces excelled those from coastal provinces; and Gardenia jasminoides across Jiangxi province were of stable and higher quality. CONCLUSION The method established in this study can effectively assay geniposide, gardoside, shanzhiside, deacetyl asperulosidic acid methyl ester, gardenoside and genipin gentiobioside in Gardenia jasminoides, thus it can be used for the quality control of Gardenia jasminoides.  相似文献   

12.
??OBJECTIVE To develop a comprehensive strategy integrateded with chemometrics METHODS for quality evaluation of Glechoma longituba(GL) from different geographical origins. METHODS The chemical differentiation of 22 batches of GL were performed by UPLC/QTOF-MSE coupled with UNIFITM software. To evaluate the quality of GL from different geographical origins, the principal component analysis (PCA) was developed to analyze the MSE data of 22 batches of GL. To find the markers, the orthogonal partial least squares discriminant analysis (OPLS-DA) was adopted to analyze the MSE data of 22 batches of GL. RESULTS A total of 31 compounds including 8 phenolic acids, 14 flavones, 7 terpenes, 1 organic acid and 1 coumarin were unambiguously or tentatively identified in the GL from Guangxi province. And 14 compounds were reported for the first time. Twenty-two batches of GL were well gathered and segregated into two different groups scattering in the score plot of PCA by MarkerLynx XS. The result of PCA showed that the chemical compositions of GL from Anhui province had obvious difference with those from other provinces. Based on the S-Plot from the score plot of OPLS-DA, the differential component of GL from Anhui province was tentatively identified as terpene. CONCLUSION The integrated strategy facilitates authentication of herbal medicines of different origins in a more efficient and more intelligent manner.  相似文献   

13.
为明确五味子优质药材产区空间分布,通过走访和实地调查,收集五味子药材样品和分布信息,基于五味子中4种木脂素类化学成分含量、生态环境因子和空间分布数据,利用GIS技术、最大信息熵模型、SPSS统计分析方法,进行五味子品质区划。结果显示五味子主要分布于辽宁的东北部、吉林的东部、黑龙江的东部。五味子醇甲含量较高的地区在吉林东南和辽宁的东北部,五味子甲素含量较高的地区在吉林中部和河北东北部地区,五味子乙素含量较高的地区在吉林地区,五味子酯甲含量较高的地区在吉林东南和辽宁的东北部地区。综合考虑五味子中4种成分含量高低,五味子优质药材集中分布在吉林东南和辽宁的东北部地区。  相似文献   

14.
目的对辽宁省进行了普查试点研究,旨在了解辽宁省地区野生中药资源蕴藏状况,并对新发现的新纪录种进行报道。方法依据全国第四次中药资源普查试点技术方案,通过对辽宁省15个市县野外样地调查,归纳总结各地区的资源蕴藏状况,对新发现的物种进行分类鉴定研究。结果共调查588个样地、2905个样方套,17430个样方的调查,共调查出1269种药用植物,31种新纪录植物。对辽宁省未报道的4种新纪录(其中臭菘Symplocarpus foetidus为辽宁省发现的新记录属,狭瓣孩儿参Pseudostellaria palibiniana、伏水碎米荠Cardamine prorepens、叶芽南芥Arabis gemmifera为3种新记录种)作首次报道。结论此次普查对辽宁省野生中药资源的保护与合理运用总结出了理论依据,新纪录的发现也为物种多样性提供了新资料。  相似文献   

15.
??OBJECTIVE To examine the influence of key monitoring drugs policy in Anhui province and Sichuan province on the change of adjuvant drugs for promoting its rational use and providing a basis for policy formulation. METHODS Based on the key monitoring drug libraries formed in the monitoring catalogs of all the provinces, combining with the key monitoring drug catalogs in Anhui province and Sichuan province, this study selected the characteristics of drug-typicality and data availability through the selection of adjuvant drug selection criteria. Eight drugs of Anhui province and 10 drug of Sichuan province were selected as research objects. The study extracted monthly data from 3 hospitals in Anhui province from November 2014 to September 2017 and quarterly data from 9 hospitals in Chengdu, Sichuan province in the first quarter of 2014 to the first quarter of 2017. Interrupted Time Series (ITS) model was used to analyze the changes of dosage and amount of sample drugs and reference drugs. RESULTS ??After the implementation of the key monitoring drugs policy in Anhui province in November 2015, the usage trend of adjuvant drugs changed from rising to declining, with a significant decrease in the dosage (??3=-0.035, P<0.001) and amount (??3=-0.025, P<0.05). ??The monitoring measures implemented by Anhui province in January 2016 had no significant difference on the decrease of the dosage of adjuvant drugs (??3=-0.010, P>0.1) and the amount of money (??3=-0.001, P>0.1). ??After the implementation of the key monitoring drugs policy in the first quarter of 2016 in Sichuan Province, the declining trend of the use of adjuvant drugs was widened with a decrease of the dosage (??3=-0.045, P<0.001) and the amount (??3=-0.037,P<0.001). CONCLUSION The implementation of key monitoring drugs policy in Anhui province and Sichuan province can effectively control the use of most adjuvant drugs, with a significantly decrease of the dosage and amount.  相似文献   

16.
??OBJECTIVE To discuss the drug therapy in a patient with in-stent restenosis, and explore the work forms of pharmacists in the department of cardiology. METHODS Two causes for in-stent restenosis were summarized by pharmacists, which the patient was noncompliance or poor quality of drugs. Then pharmacists gave feasible suggestions to improve drug therapy by searching literatures and consulting patients. RESULTS After regular administration of aspirin in our hospital, the symptoms improved and laboratory test showed poor. The outcome of follow-up in 5th month is normal. CONCLUSION Pharmacists identify adverse events and help physicians to make individual drug therapy to ensure patient safety, effectiveness and economy.  相似文献   

17.
文章从辽宁省中药生产企业入手,对国际化经营进行了分析,从品牌国际化、中药质量管理、中药市场竞争、知识产权保护等方面探讨国际化经营存在的问题,为提升辽宁省中药生产企业国际竞争力提供研究基础。  相似文献   

18.
??OBJECTIVE To identify the chemical components of bile acids from bear bile powder, the intermediate of bear bile powder and Tanreqing capsules by HPLC-MS/MS. METHODS All samples were extracted with 70% methanol(V/V), and an Ultimate XB C18 column (4.6 mm??250 mm, 5 ??m) was employed for separation with acetonitrile-0.1% formic acid as mobile phase in gradient elution. The MS spectrum was acquired in both positive and negative ion mode using ESI ion source. The chemical components were identified by the second mass spectrometric pyrolysis fragments, chromatographic peak retention time and fragmentation regularity summarized from the reference standards and the available literature. RESULTS A total of 33 compounds were successfully identified or tentatively predicted, and six chemical compounds including tauroursodeoxycholic acid, taurochenodeoxycholic acid, ursodeoxycholic acid, chenodeoxycholic acid, 7??-hydroxy-3-oxo-5??-cholanic acid and one unknown constituent were finally transferred to Tanreqing capsules through the intermediate of bear bile powder. Moreover, 21 new chemical compounds (major ingredients of free bile acids) were generated during the production process of the intermediate, and 19 components were also detected in Tanreqing capsules. CONCLUSION The investigation of the change of constituents in bear bile powder during Tanreqing capsules production provides a basis for the quality control and evaluation of Tanreqing capsules during production process.  相似文献   

19.
目的:对辽宁省五味子样品中无机元素含量进行分析,为五味子的栽培管理及质量评价提供参考。方法:采用ICP-MS电感耦合等离子体质谱仪测定,SPSS 14.0进行数据统计分析。结果:辽宁省14份五味子样品中5种重金属元素,铜、砷、镉、汞、铅含量及5种元素总含量均未超标;系统聚类分析表明,丹东地区栽培种五味子果实无机元素含量与与野生种较为相似;元素相关性分析表明,五味子果实中多种元素之间显著相关(P<0.05)。结论:该实验结果对辽宁省五味子地域性生态分布、质量评价等有重要的参考价值。  相似文献   

20.
??OBJECTIVE To provide reference for introducing new methods and technologies to the physical and chemical testing methods general chapters in Chinese Pharmacopoeia Volume ??. METHODS By reviewing the general chapters of drug physical and chemical testing methods (appendices)in the new editions of European, US, Japanese and British Pharmacopoeias, the harmonization results of the Pharmacopoeia Discussion Group (PDG)and the guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the authors summarized the overview and new, revised and harmonized texts of physical and chemical testing methods, and made a preliminary comparison with the related testing methods in Chinese Pharmacopoeia (2015 edition) Volume ??. RESULTS The new and revised text on the physical and chemical testing methods in the new editions of European, US, Japanese and British Pharmacopoeias are mainly concentrated in elements impurities, spectrometry and chemometrics. Chinese Pharmacopoeia can learn from the technology of identification tests, spectrometry and chromatography, impurities analysis and functionality-related characteristics of pharmaceutical excipients. CONCLUSION Chinese Pharmacopoeia should be based on the actual level of China's pharmaceutical industry, follow the principles of progressive and sustainable development, introducing new drug testing technologies and methods to strengthen the quality control of drugs and improve drug controllability.  相似文献   

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