药典委员会章程

第一章总则第一条国务院药品监督管理部门依据《中华人民共和国药品管理法》第三十二条的规定组织设立药典委员会。药典委员会一般每五年换届一次。第二条药典委员会依据《中华人民共和国药品管理法》及有关法律法规的规定,负责国家药品标准的制定和修订。     

关于颁布执行《中华人民共和国药典》2000年版的通知

各省、自治区、直辖市药品监督管理部门:根据《中华人民共和国药品管理法》第二十三条的规定,现予颁布《中华人民共和国药典》2000年版(以下简称《中国药典》2000年版),并自2000年7月1日起执行。《中国药典》2000年版是国家为保证药品质量、保护人民用药安全有效而制定的法典;是执行《中华人民共和国药品管理法》、监督检验药品质量的技术法规;是我国药品生产、经营、使用和监督管理所必须遵循的法定依据;宣传、执行好《中国     

关于《中国药典》2010年版第二增补本有关增修订内容的说明

根据《药典委员会章程》和国家药品标准发展的要求,为适应药品研发、生产、检验、应用以及监督管理等方面的需要,国家药典委员会及时对国家药品标准进行增修订和订正,出版《中国药典》增补本。增补本与现行版《中国药典》具有同等的法定地位。     

医改与监管

2010版药典编制基本完成药品标准水平将提高 《中华人民共和国药典》是我国药品标准体系的核心,是药品研究、生产、经营、使用和监管的法定依据。记者近日从国家食品药品监管局获悉,2010年版《中华人民共和国药典》编制工作已基本完成,新版药典实施后,我国药品标准水平将进一步提高。     

2010年版《中华人民共和国药典》编制大纲

2010年版《中华人民共和国药典》(以下简称《中国药典》)编制大纲是以十七大精神为指导,根据《国家食品药品安全"十一五"规划》提出的奋斗目标和任务,按照《中华人民共和国药品管理法》和相关的法规进行制定。主要阐明2010年版《中国药典》编制的指导思想、基本原则、发展目标和主要任务,是2010年版《中国药典》及相关工作的重要依据。     

《中华人民共和国药典（2015年版）》（二部）中抗生素类药品部分的增、修订情况介绍

通过介绍《中华人民共和国药典（2015年版）》（二部）中抗生素类药品部分的增、修订情况,分析抗生素类药品质量标准的变化趋势。这不仅有益于《中华人民共和国药典（2015年版）》的实施,而且也明确了今后抗生素类药品质量标准的增、修订方向。     

在《中华人民共和国药典》2000年版实施宣传贯彻大会上的讲话

今天是2000年6月15日,距离正式实施跨世纪的2000年版《中国药典》还有15天,为了加强宣传贯彻的力度,扩大《中国药典》在社会上的广泛影响,以利于支持和推动我国药品监督管理的健康发展,在“以监督为中心,监、帮、促相结合”方针的指导下,使《中国药典》在强化药品标准工作,     

现行药品标准中存在的部分问题及建议

现行国家级药品标准有国家食品药品监督管理局颁布实施的《中华人民共和国药典》2005年版、《国家药品标准》、《国家中成药标准汇编》和单行、试行标准,还有卫生部颁布实施的《卫生部药品标准》。在执行使用过程中,发现存在许多不尽完善之处,总结如下,希望本文能引起有关部门的注意,起到一定的参考作用。     

国家食品药品监督管理局文件国食药监注[2005]234号关于颁布和执行《中国药典》2005年版有关事宜的通知

各省、自治区、直辖市食品药品监督管理局（药品监督管理局）：根据《药品管理法》及《药品管理法实施条例》的有关规定，现颁布《中华人民共和国药典》（以下简称《中国药典》）2005年版，于2005年7月1日起执行。     

市级药检所在执行药品标准中存在的问题分析及建议

药品标准是药品生产、经营、使用和监督管理部门必须共同遵守的法定技术依据,其具有很强的科学性和权威性。药品标准是各级药检所开展监督抽验的依据,没有药品标准,药检所就无法开展工作。我所现有药品标准有《中华人民共和国药典》历年版本;国家药品标准化学药品地方标准上升国家标准第一至十六册;国家中药成方制剂第一到二十册;国家局新药转正标准第一册到七十五册;卫生部药品标准（二部）第一至五册;卫生部药品标准二部第六册（生化药品第一分册,蒙药分册,藏药第一册及各类单行、试行标准等收载药品数万个品种。）从上述标准看,国家药品标准中存在药品标准种类繁多;同一药品多个质量标准并存;同名异方,同方异名,同品种标准不统一;     

Search for the optimal conditions for the distillation of the antibacterial agent glyciphon

Preparation of the high-boiling-point organophosphate antiblastoma agent glyciphon at maximal yield and purity was addressed at the experimental production stage by studying its vacuum distillation by mathematical modeling. The optimum conditions for performing this final stage of the technical process allowed the number of distillations to be decreased and the yield of pharmacological purity product to be increased by an average of 20%. __________ Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 41, No. 6, pp. 35–38, June, 2007.     

Retinoids for the treatment of psoriasis: outlook for the future

Despite the demonstrated clinical success of retinoid therapy in psoriasis, its mechanism of action has not been fully elucidated, and investigators are confronted with two paradoxes. Firstly, the binding of retinoids to nuclear retinoic acid receptors (RARs) does not match their therapeutic efficacy. Secondly, formation of retinoic acid is probably increased in the psoriatic lesions. Answering these questions should result in: (i) the better use of acitretin, an oral synthetic retinoid, and tazarotene, the first compound for topical use; (ii) the development of new retinoids with specific pharmacological profile such as subtype-selective retinoids including molecules with an 'antiretinoid' activity and dissociating antiproliferative retinoids; and (iii) the better characterization of non-genomic effects of retinoids.     

Emerging technologies for the identification of therapeutic targets for the management of pre-eclampsia

Pre-eclampsia is a common and serious complication of pregnancy characterised by hypertension and proteinuria. Genetic and environmental factors influence the occurrence and progression of the disease. Emerging experimental systems and increasingly specific analytical methods for the study of differences between normal and pre-eclamptic placentae are close to identifying specific indicators of disease, which may allow early diagnosis and intervention and reveal targets against which therapeutic agents can be developed.     

Novel alternative methods for the delivery of drugs for the treatment of asthma

Successful delivery of dry powder aerosols to the lung requires careful consideration of the powder production process, formulation and inhaler device. Newer production methods are emerging to prepare powders with desirable characteristics for inhalational administration. The conventional formulation approach of adding coarse lactose carriers to the drug to form binary powder systems to enhance powder flow and dispersion properties has been expanded to using finer carrier particles and hydrophobic materials, as well as ternary systems. Particle morphology and surface properties have also been explored to enhance powder performance. For the inhaler device, the new generation inhalers are designed to reduce or completely decouple the influence of air flow on the aerosol generation. Each of these determinants for powder aerosol delivery is reviewed with a strong focus on the patent literature that contains enormous information about the latest development in this field.     

老年人肾脏疾病的B超诊断研究

目的对老年人肾脏疾病采用B超进行观察分析,以提高老年人肾脏疾病的诊断正确率。方法选择我院60例患有肾脏疾病的老年人,根据年龄分为两组,采用B超对两组患者进行观察分析,并比较结果。结果第二组大部分患者肾脏形态不规则,包膜呈波浪状,尤以纵断面明显,可见多处凹凸不平,皮质内回声尚均匀,无明显占位效应。第二组肾脏的长径和宽径均较对照组缩小,差异有统计学意义(P<0.05),而厚径差异无统计学意义(P>0.05)。结论老年人的肾脏由于年龄增大可引起肾脏不规则,集合系统回声增强,局部的隆起,皮质相对变薄等现象。     

Emerging technologies for the identification of therapeutic targets for the management of pre-eclampsia

Pre-eclampsia is a common and serious complication of pregnancy characterised by hypertension and proteinuria. Genetic and environmental factors influence the occurrence and progression of the disease. Emerging experimental systems and increasingly specific analytical methods for the study of differences between normal and pre-eclamptic placentae are close to identifying specific indicators of disease, which may allow early diagnosis and intervention and reveal targets against which therapeutic agents can be developed.     

Collaborative study for the establishment of the second international standard for gramicidin

An international collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish the WHO second International Standard (IS) for gramicidin as the stocks of the 1st IS, established in 1964, were close to depletion. The candidate material did not show any sign of potency loss when kept at elevated temperatures of + 4 °C, + 20 °C, + 37 °C and + 45 °C for 3 months. Six laboratories from 5 countries as well as the EDQM laboratory participated in the collaborative study. Potencies of the candidate material were estimated by microbiological assays with sensitive micro-organisms. To ensure continuity between consecutive batches, the 1st IS for gramicidin was used as standard. Based on the results of the study, the 2nd IS for gramicidin was adopted at the meeting of the WHO Expert Committee on Biological Standardization (ECBS) in 2008 with an assigned potency of 1070 International Units per mg (IU/mg). The 2nd IS for gramicidin is available from the EDQM.     

Collaborative study for the establishment of the third international standard for nystatin

Due to the depletion in stocks of the World Health Organization (WHO) 2nd International Standard (IS) for nystatin, an international collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish a replacement batch. Seventeen laboratories participated in the collaborative study, performing the microbiological diffusion assay to estimate the potency of the candidate 3rd International Standard for nystatin. The 2nd International Standard for nystatin was used as a standard to ensure the continuity of the unitage. Follow-up accelerated degradation studies demonstrated that the IS is stable when at the customary storage temperature of - 20 °C. The 3rd IS for nystatin was adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2006 with an assigned potency of 5710 International Units per mg (IU/mg). The 3rd IS for nystatin is available from the EDQM.