实施《中药饮片GMP认证检查项目》中遇到的问题及思考  

Some Thoughts on the Problems Encountered in the "Implementation of GMP Certification and Inspection Items of Chinese Herbal Pieces"

作　　者：刘兆龙[1] 田红林[1] 

机构地区：[1]新疆医科大学附属中医医院,新疆乌鲁木齐830000

出　　处：《中医药导报》2017年第6期8-11,共4页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：新疆维吾尔自治区科技计划项目(201333103);新疆医科大学科研创新基金项目(ZYY201311)

摘　　要：目的:对实施《中药饮片GMP认证检查项目》中遇到的问题,提出解决建议。方法:分析比较在实施《中药饮片GMP认证检查项目》《中国药典》(2015版)工作中遇到的实际问题和困难。结果:实施《中药饮片GMP认证检查项目》中存在中药材交易市场和流通领域缺乏有效监管、质量标准制定有缺陷、检测不能根治中药农药残留重金属超标、中药饮片室内炮制操作不符合实际情况也不利于劳动者保护、检验费用昂贵等问题。结论:应加强对中药材交易市场和流通领域监管、创新产业链发展思路、及时修改完善质量标准、通过环境保护综合治理根本性解决农药残留重金属超标、根据中药炮制特点适当合理调整法规、进行区域合作分工降低检验成本,这样才能有利于中药饮片炮制行业的传承、创新和发展。Objective： To put forward the solution to the problems encountered in the implementation of GMP certification and inspection items of Chinese herbal pieces. Methods： To compare and analyze the practical problems and difficulties encountered in the course of the work of the 2015 edition of Chinese Pharmacopoeia, which is implemented in the GMP certification and inspection items of Chinese herbal pieces. Results： the im- plementation of ＂Chinese herbal medicine GMP certification inspection project＂ in Chinese herbal medicine mar- ket circulation and the lack of effective supervision, quality standards, inspection defects can not cure the pesti- cide residue in Chinese herbal medicines, Chinese herbal medicine processing heavy metal exceed the standard indoor operation does not conform to the actual situation is not conducive to the protection of laborers, inspec- tion fees expensive problems. Conclusion： It is recommended to strengthen the Chinese herbal medicine market and circulation regulation, innovation of industry chain development ideas, timely revise and improve quality stan- dards, through the comprehensive management of environmental protection fundamental solution, according to the characteristics of heavy metal exceed the standard processing of traditional Chinese medicine appropriate reason- able adjustments and regulations, regional cooperation and division of labor to reduce the cost of testing of pesti- cide residues, so as to have the inheritance, innovation and development for Chinese herbal medicine production processing industry.

关 键 词：GMP 中药 饮片 炮制 

分 类 号：R19[医药卫生—卫生事业管理]