Discussion of the Supervision Mode for the Quality of Traditional Chinese Medicine and Traditional Chinese Medicine Pieces in Traditional Chinese Medicine Preparations
- VernacularTitle: 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
- Author:
Nan OUYANG
1
Author Information
- Publication Type:Journal Article
- Keywords: Quality issue; Supervision mode; Traditional Chinese medicine; Traditional Chinese medicine piece; Traditional Chinese medicine preparation
- From: Chinese Pharmaceutical Journal 2018;53(3):239-244
- CountryChina
- Language:Chinese
- Abstract: 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.
