Standardization system of industry decoction pieces based on whole process quality control concept

• Published in: Zhongguo zhongyao zazhi Vol. 43; no. 14; p. 2837
• Main Authors: Zhang, Shi-Chen, Sun, Yu, Dai, Jun-Dong, Wang, Yun, Pei, Wen-Xuan, Liu, Yang, Chen, Jian-Bo, Dong, Ling
• Format: Journal Article
• Language: Chinese
• Published: China 01.07.2018
• Subjects: Drugs, Chinese Herbal; Medicine, Chinese Traditional; Prescriptions; Quality Control; Reference Standards; standardization strategy in traditional Chinese medicine; whole-process quality control; GPP(good processing practice); industry decoction pieces
• ISSN: 1001-5302
• DOI: 10.19540/j.cnki.cjcmm.2018.0087

Traditional Chinese medicine (TCM) decoction pieces refer to prescription drugs that can be used in clinical or preparation production after processing medicinal herbs. TCM decoction pieces industries are inherited from the culture of TCM and are important because of their independent intellectual property rights. The Chinese Pharmacopoeia (Ch. P) 2010 edition stipulated that "All drugs taken are decoction pieces", which raised the drug status to statutory law for the first time and clearly specified that TCM decoction pieces should be applied to TCM prescription deployment and production of proprietary Chinese medicines. It also pointed out that "The specifications of the decoction pieces used in the preparation should comply with the requirements of the actual process of the corresponding formulation type". For a long time, both the processing methods and the specification grades of the clinically used pieces of Chinese medicine were based on the inheritance and supported by the classical theory and method