从中药制剂生产用中药材及中药饮片质量问题谈监管模式

Discussion of the Supervision Mode for the Quality of Traditional Chinese Medicine and Traditional Chinese Medicine Pieces in Traditional Chinese Medicine Preparations

目的探讨我国中药制剂生产用中药材及中药饮片(药材及饮片)的质量监管模式,为科学有效地开展中药制剂生产用药材及饮片的质量监管提供建议。方法通过药材及饮片品质、加工、保存与中药制剂的质量关系,中药制剂生产环节执行药品生产质量管理规范(GMP)与中药制剂的质量关系,质量标准不完善与中药制剂的质量关系的研究分析,提出解决问题的措施和办法。结果与结论对中药制剂生产用药材及饮片的质量监管,应紧紧围绕保证中药制剂的质量这一核心,针对不同类别和特点的中药制剂采取不同的药材及饮片监管模式。同时还应该保证中药材来源、产地稳定;严格按照GMP组织生产;规范中药制剂生产企业对中药饮片的炮制;实行中药饮片生产备案制度;提升中药材及中药饮片质量标准;确保中药制剂质量安全、有效。

OBJECTIVE To discuss the supervision mode of traditional Chinese herbal medicines and traditional Chinese medicine pieces in the production of traditional Chinese medicine preparations, and provide advice for the scientific and effective supervision of traditional Chinese medicine preparations with Chinese herbal medicines and Chinese medicine pieces. METHODS Through the study of relationship between the quality, processing, preservation of medicinal herbs and the quality of preparations, the relationship between the implementation of Good Manufacture Practice （GMP） of traditional Chinese medicine preparations, and the relationship between imperfect quality standards and the quality of traditional Chinese medicine preparations, we put forward measures to solve the problems. RESULTS AND CONCLUSION In the supervision of Chinese herbal medicines and traditional Chinese medicine pieces during the production of traditional Chinese medicine preparations, we should be closely around the core to ensure the quality of traditional Chinese medicine preparations, and should take different supervision modes of herbs and pieces according to different types and characteristics of traditional Chinese medicine preparations. At the same time, we should ensure the stability of the sources and origins of Chinese herbal medicines and ensure that manufacturing comply with GMP. We should standardize the preparation process of Chinese herbal medicine pieces by the traditional Chinese medicine preparation enterprises and implementation of traditional Chinese medicine pieces production filing system. And the quality standard of Chinese medicinal herbs and Chinese prepared herbs should be improved, with the objective to ensure the safety and effectiveness of traditional Chinese medicine preparations.