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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 solutions to the problems encountered in the implementation of “GMP certification check items of Chinese Herbal Medicine”. Methods: To analyze and compare the practical problems and difficulties encountered in the implementation of “Chinese Herbal Medicine Pieces GMP Certification Check Project” and “Chinese Pharmacopoeia” (2015 edition). Results: The implementation of “Chinese Herbal Medicine Pieces GMP certification inspection items” there is the lack of effective supervision of the Chinese medicine market and the circulation of the product quality standards are flawed, the test can not cure excessive levels of heavy metals in pesticide residues of Chinese medicine, Chinese medicine Pieces indoors operations do not conform to the actual situation nor Conducive to the protection of workers, testing costs and other issues. Conclusion: It is necessary to strengthen the supervision of traditional Chinese medicine market and the development of innovative industry chain, modify and improve quality standards in time, fundamentally solve the excessive heavy metal content of pesticide residues through comprehensive environmental protection management, properly adjust regulations according to the characteristics of Chinese medicine processing, Cooperative division of labor to reduce inspection costs, so as to be conducive to the inheritance, innovation and development of Chinese medicine Pieces processing industry.