从历届药典委员会章程的演变谈药品标准管理制度的优化

药典委员会章程是药典委员会组织开展工作的基本准则,在药典委员会发展历程中逐步完善,构建了药典委员会工作的基本架构,理顺了药品标准工作机制,完善了药品标准工作制度,成为药品标准工作的重要制度性保障。本文以药典委员会章程修订为契机,结合药品标准工作实际情况,提出药品管理制度优化的建议,包括落实新版《中华人民共和国药品管理法》（以下简称《药品管理法》）的修订内容,积极探索药品标准复审制度以及深入思考《中国药典》的功能定位与作用。     

我国药典委员会制度及变革刍议

药典委员会作为专司药品标准制修订工作的专业技术机构，在未来应当有着更为合理的定位和组织架构、程序设计，并充分彰显其作为一种装置性的程序机制所应具有的功能。     

贯彻《药品管理法》做好药品标准工作

《中华人民共和国药品管理法》第二十三条规定“国务院卫生行政部门颁布的《中华人民共和国药典》和药品标准为国家药品标准”,“国务院卫生行政部门的药典委员会,负责组织国家药品标准的制订和修订”,从国家法律上明确药典会是负责组织制、修订药典和国家药品标准的专业机构,是属标准化工作范畴.为了做好药品标准工作,除根据卫生工作的方针政策外,还应遵循国家标准工作的方针、政策、原则,并须了解标准和标准化的含义、性质和作用等.     

关于国家药品标准管理与发展问题的若干思考--国家药典委员会周福成副秘书长在2004年全国药品注册工作会议上的发言摘要

国家药典委员会是依法从事国家药品标准制定和修订的技术监督机构,成立于1950年,目前是第八届药典委员会,其主要任务是承担组织编制2005年版中国药典及配套图书和国家药品标准制定与修订等工作任务.为使大家有所了解,本人结合会议精神和药品标准工作谈些尚不成熟的思考.     

卫生部药品标准及药典考察组赴英国和日本考察报告

根据1985年世界卫生组织(WHO)科技交流计划,我国卫生部于1986年5月11日至6月8日派出药品标准及药典考察组,赴英国和日本考察.考察内容是:了解药品标准及药典组织机构及人员情况;制订药品标准及药典程序和原则以及新药质量标准审批情况等,从中吸取经验,以促进我国药品标准及药典的编制工作,提高药品标准水平.与此同时建立与国外同行的联系和有关的技术情报交流.在考察过程中受到了两国的友好接待,收     

《欧洲药典》适用性认证组织机构介绍

目的 介绍《欧洲药典》适用性认证程序的工作职责和组织机构,为国内药品监管机构和原料药生产企业提供信息,促进我国原料药生产企业的国际化.方法 通过查阅调研欧盟相关药品法规和与欧洲药品健康管理局(EDQM)同行面对面的交流,详细了解《欧洲药典》适用性认证的工作内容、规章制度和组织机构.结果与结论 欧洲有专门的组织机构负责《欧洲药典》适用性认证程序,具有专门的认证步骤和要求,加强了药典的监管力度,进一步保证了原料药的质量、安全性和有效性.     

国外药品质量考察报告(中国卫生部药品标准及药典考察组赴英国和日本考察)

根据1985年世界卫生组织科技交流计划,中国卫生部于1986年5月11日至6月8日派出药品标准及药典考察组赴英国和日本考察。考察目的是:了解这些国家药品标准及药典组织机构及人员情况,制订药品标准及药典的程序及原则以及新药质量标准审批情况等,从中吸取有用的经验,以促进我国药品标准及药典的编制工作,提高药品标准水平,并通过考察,建立与国外同行的联系和有大的技术情报交流。考察组由卫生部江焕波副局长领队,组员有药典委员会秘书杨岱、天津药检所所长黄乔书、辽宁省卫生厅药政处处长何毅人。现刊出此次考察报告摘要。     

医院制剂影响微生物限度检查结果诸因素分析

药品微生物限度检查指以规定的方法和步骤来测定药品中染菌程度.我国从1972年开展此项工作至今近30年,其标准颁布实施已有20多年,<中国药典>1995年版收载微生物限度检查方法,但限度标准尚未载入药典.之后2000年版以剂型载入微生物限度标准,该标准正确有效地规范了药品生产检定和监督的程序,为国家药品监督部门的监督管理、药品检验工作提供了更可靠的依据.     

《中国药典》二部勘误原因剖析及降低勘误率的探讨

根据《中华人民共和国药品管理法》（主席令第45号）第三十二条的规定：药品必须符合国家药品标准。国务院药品监督管理部门颁布的《中华人民共和国药典》和药品标准为国家药品标准。国务院药品监督管理部门组织药典委员会,负责国家药品标准的制定和修订。《中华人民共和国药典》（简称《中国药典》）作为国家药品标准体系的核心,其权威性不容置疑。《中国药典》的勘误或订正事关药典的权威性,一定程度会影响到药典标准的可执行性,而可执行性是药典的最基本要求。因此,我们必须十分重视且应尽量降低药典的订正率。笔者结合2005年版和2010年版药典二部编制工作的实际体会,就两版药典二部勘误情况进行统计和原因分析,并探讨相应的解决措施。     

药品标准提高工作会议在成都召开

2012年4月10～11日,为阶段性总结2009～2011年药品标准提高工作及研究部署下一步工作安排,国家药典委员会组织召开药品标准提高工作会议,听取各任务承担单位2009～2011年标准提高的工作情况。国家局药品注册司及规划财务司的有关领导、国家药典委员会王立丰秘书长,以及国家药典委员会各业务处室负责人和相关人员出席会议。承担药品标准提高工作任务的各省级药检所、副省级城市药检所、口岸药检所等共42家单位的代表参加了会议。     

The Value of U.S. Pharmacopeial Standards: A Review of the Literature

While there are many standard-setting health care organizations, the United States Pharmacopeial Convention's (USP) role includes the creation of documentary and physical standards for therapeutics, including chemical drugs, excipients, and biologics. Despite the ubiquity of these standards, little work has been carried out to characterize and quantify their value. We reviewed the peer-reviewed and gray literature relevant to such evaluations. The review yielded 36 articles, focused variously on accreditation and other standards in health care, the broad impact of pharmacopeial standards and evaluations of specific USP standards. We did not find any study quantifying the impact of USP or other pharmacopeial standards, but many reports have been published that suggest the utility of USP standards to drug development, quality assurance, and public health. Frequently cited areas of impact include equitably advancing the analytical capabilities of manufacturers; enabling the creation of legally enforceable naming conventions; detecting mislabeled and substandard drugs in the marketplace, especially in the context of increased globalization of drug markets; and facilitating the harmonization of diverse international drug quality standards. Our insights provide opportunities for empiric assessments of the effects of USP standards on important outcomes including their promotion of efficient drug development, market competition, drug quality, and patient safety.     

Content uniformity testing: suitability of different approaches for marketed low dose tablets

Context: Content uniformity (CU) testing was developed and improved to control the effectiveness and safety of dosage units. Many modifications of compendial CU test have been introduced and several alternatives have been suggested.

Objectives: This study aims to evaluate the degree of suitability of current USP CU test for low dose tablets and to compare the performance of the current test with that of the former USP27-NF22 and other alternatives for different sample sizes.

Methods: All locally marketed risperidone (RSP) tablets were analyzed using newly developed and validated isocratic UPLC method. The CU results were statistically analyzed in groups with sample sizes comparable to the USP sampling plans.

Results: Seven out of eleven products failed the different requirements of the former and current USP <905>chapters as well as of several alternative CU tests with several substantial deviations.

Conclusion: The current USP <905> chapter was found to have some deficiencies that allowed such failed products to exist in the market. The dependence of compendial CU test on two-staged sampling plan and the use of arithmetic mean to calculate the reference and acceptance values were obvious shortcomings.     

中美英三国药典标准比色液的对比与测定

目的:对中美英三国药典标准比色液的配制方法及不同测定方法所得的颜色参数进行对比,为进口药品检验和进口药品质量标准复核时颜色质量标准的制订提供参考。方法:采用《中国药典》2005版附录收载的目视比较法、紫外分光光度法、色差计法进行测定。结果:中英药典标准比色液之间有相似之处,但与美国药典标准比色液差别较大。     

Variation in light transmission properties of amber oral syringes

Four brands of amber oral syringes were tested for compliance with compendial standards for light-resistant packaging. United States Pharmacopoeia (USP) specifications state that light-resistant packaging must not transmit more than 10% of incident light with wavelengths of 290-450 nm. The amount of light transmitted by samples of the barrels of 200 amber plastic oral syringes from each of four manufacturers was determined by spectrophotometry. Samples of both the printed and unprinted sides of the barrel were tested (after removal of all ink). The thickness of each syringe-barrel sample was measured, and the apparent density was determined. All of the Becton-Dickinson syringes tested met the USP standard for light transmittance, and none of the syringes from Baxa or Solopak met the compendial standards. Of the Burron syringes tested, 70 syringes met the standard, 83 did not meet the standard, and 47 could not be classified. The samples of the printed side of the syringe barrel had light transmission properties similar to those of the unprinted side with the exception of the syringes from Baxa, which had substantially higher apparent densities at all wavelengths for the printed side. Only one manufacturer's oral syringes consistently met the USP standard for light-resistant packaging. Further testing is needed to determine the clinical importance of these findings.     

USP认证对我国原料药企业的影响分析

目的为我国原料药出口企业提供一条更为适用的国际认证途径。方法采用比较分析方法,阐明USP认证不同于其他几种较为成熟的国际认证方式的特性。结果与结论USP作为一种新的认证方式,从适用范围、认证流程、认证速度、认证费用以及认证周期等方面更适合中国原料药企业的发展现状,对我国企业开拓国际市场意义重大。     

Dissolution of poorly water-soluble drugs in biphasic media using USP 4 and fiber optic system

A novel in-vitro dissolution system based on the principle of flow-through technique has been designed to evaluate the in-vitro release rate of poorly water-soluble compounds. The flow through apparatus (USP 4) has been coupled with the compendial dissolution apparatus (USP apparatus 2). A bi-phasic dissolution medium is used to achieve sink conditions. The dissolved drug is continuously removed from the aqueous phase into the organic phase of the dissolution medium, mimicking the process of absorption in the systemic circulation. The in vitro release profiles obtained from this dissolution model was able to distinguish the formulation changes of several poorly water-soluble drugs from their dosage forms. For AMG 517, the model drug, excellent rank order correlation has been obtained between the in-vitro release and the in-vivo absorption of the drug from several different dosage forms and their formulations. In addition, for several commercial formulations, the model successfully discriminated between the bioequivalent and non-bioequivalent formulations.     

The Development of USP Dissolution and Drug Release Standards

Dissolution tests have been in use in the pharmaceutical industry for over 20 years, and they are official in The United States Pharmacopeia since the early 1960s. The dissolution test, reviewed primarily as a quality control tool, replaced the use of disintegration tests which had been official in The United States Pharmacopeia since 1950. Refinements in the dissolution test equipment and methodology have occurred over the years in order to enhance its relevance. The Subcommittees of the USP Committee of Revision dealing with these issues have developed and refined compendial dissolution standards and policies for conventional solid-oral dosage forms and modified-release dosage forms.     

Evaluation of the ScanRDI(R) as a Rapid Alternative to the Pharmacopoeial Sterility Test Method: Comparison of the Limits of Detection

Two sterility test methods, the ScanRDI? rapid sterility test and the United States Pharmacopeia/European Pharmacopoeia/Japanese Pharmacopoeia (USP/EP/JP) compendial sterility test, were compared with respect to the limits of detection for the presence of viable microorganisms in aqueous solutions at low inoculation levels. The ScanRDI? system employs a combination of direct fluorescent labeling techniques and solid-phase laser scanning cytometry to rapidly enumerate viable microorganisms from aqueous samples, whereas the compendial sterility test is a qualitative, growth-based method that uses a visual assessment of turbidity to indicate microbial contamination. Eight microorganisms were evaluated, seven compendial microorganisms (Clostridium sporogenes, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus subtilis, Aspergillus niger, Candida albicans) and the Gram-positive anaerobe Propionibacterium acnes. The number of viable organisms was estimated using the ScanRDI? method and the conventional sterility test method using most probable number methodology. The mean difference between the methods was computed and 95% confidence intervals around the mean difference were estimated. The ScanRDI? method was found to be numerically superior and statistically non-inferior to the compendial (USP/EP/JP) sterility test with respect to the limits of detection for all organisms tested.     

美国药典的历史沿革和现状

本文对《美国药典》的出版历史、药典结构、收载品种特点以及以后的发展趋势等进行了较为详细的介绍。