中药注射剂国家药品标准提高及进展情况分析

Analysis of the Improvement of National Drug Standard of Traditional Chinese Medicine Injection and Its Progression

目的:掌握并分析目前中药注射剂品种的基本信息、分布和使用、质量标准等情况,为进一步推进未完成标准提高的中药注射剂国家药品标准提高工作提供基础研究数据,为国家药品标准监督管理部门更科学合理地评价和保障中药注射剂的质量、安全、有效提供研究分析资料和技术支撑。方法:通过国家食品药品监督管理总局数据库、中国药学会数据库搜索查询中药注射剂基本信息,包括:文号状态、生产企业分布、品种产量及市场销售额、临床应用情况;通过国家药典委员会档案库查询确定这些品种的标准沿革及其现执行标准和标准内容,对已完成标准提高品种的原标准及现行标准进行检测项目的比对分析,对部分企业(10家)的品种(14个)标准提高有关情况进行调研,梳理出未完成标准提高品种的标准项目收载情况并对其标准水平进行初步评估。结果与结论:通过本课题研究,梳理出129个中药注射剂的文号、生产企业、规格、标准沿革并明确了最终执行标准。结合已完成标准提高的品种检测项目修订、提高后标准对产品质量的影响、未完成标准提高品种标准现状及标准提高等情况,提出了下一步标准提高工作的建议:一是分批提高、分步纳入标准正文的标准提高方案。建议综合临床疗效、适用范围、安全性及不良反应等情况,对中药注射剂未完成标准提高品种重新进行全面评估定位,制定出分类逐步提高的方案。二是应综合国家引导、强制实施、企业参与并负责、临床应用及反馈、上市后再评价再研究等多方面力量,进一步加强中药注射剂质量标准提高的逐步推进工作。

Objective： To grasp and analyze the basic information, distribution and use, and quality standard of the current varieties of traditional Chinese medicine （TCM） injections and to provide the basic research data for further improvement of the national drug standard of the TCM injection and to provide analysis data and technical support for more scientific and reasonable evaluation of the national drug standard supervision and management departments, so as to ensure the quality, safety and effectiveness of the TCM injection. Methods： The basic information of TCM injection, such as reference number status, distribution of manufacturing enterprises, variety production and market sales, as well as clinical application, were searched at National Food and Drug Administration （CFDA） database, Chinese Pharmaceutical Association （CPA） database. The standard evolution of these varieties and its current implementation of standard and the contents of the standard were determined by referring to the Chinese Pharmacopoeia Commission Archives. The testing items of the previous and the current improved standard were compared. The improvement of the standard of 14 varieties of 10 enterprises was analyzed to find out and evaluate items without improvement. Results and Conclusion： Reference number, manufacturing enterprises, specifications, as well as previous standards were analyzed and the current standard in use was determined. The suggestions for further improving the standard were put forward based on revision of the testing items of improved varieties, the impact of the improved varieties on the quality of the products, the status of unimproved varieties. Firstly, the standard could be improved in batches or step by step. The unimproved varieties were comprehensively evaluated to make a gradual improvement scheme based on clinical efficacy, scope of application, safety and adverse reactions, etc. Secondly, the gradual improvement of the standard of TCM injection should be strengthened by integrating national guidance, compulsory implementation, enterprise participation and responsibility, clinical application and feedback, evaluation and study after they are marketed.