Zhang Shui-Han, Liang Xue-Juan, Liu Hao, Wan Dan, Koin Toda, Chen Lin, Zhou Rong-Rong, Huang Lu-Qi
Institute of Chinese Materia Medica, Hunan Academy of Chinese Medicine, Changsha 410013, China.
Technology Service Center of Survey and Monitoring of Chinese Medicinal Materials in Hunan Province, Changsha 410013, China; 3. Tsumura & Co., Tokyo 107-8521, Japan.
Zhongguo Zhong Yao Za Zhi. 2017 Sep;42(17):3275-3281. doi: 10.19540/j.cnki.cjcmm.20170614.001.
Based on the reviewing of development and disadvantages of Chinese medicine formula granules, the concept of standard decoction of traditional Chinese medicine was proposed in this study, and it was used as the standard mode of Chinese medicine formula granules to standardize the production process and quality standards of formula granules. The standard was unified according to the principles of "standardization of medicinal materials, standardization of process, intellectualization of production, standardization of quality, normalization of packaging, and informatization of storage"; and consistency evaluation was carried out by the analysis of chemical components, pharmacological activities and clinical efficacy of the standardized decoction and the traditional decoction, interpreting the scientific questions to ensure the stability and uniformity of Chinese medicine formula granule as well as the safety and effectiveness of its clinical application.
通过回顾中药配方颗粒的发展历程及存在的不足，本研究提出了中药标准汤剂的概念，并将其作为中药配方颗粒的标准模式，以规范配方颗粒的生产工艺和质量标准。按照“药材标准化、工艺规范化、生产智能化、质量标准化、包装规范化、储存信息化”的原则统一标准；通过对标准化汤剂与传统汤剂的化学成分、药理活性及临床疗效进行分析，开展一致性评价，阐释科学问题，以确保中药配方颗粒的稳定性和均匀性以及其临床应用的安全性和有效性。
Zotero 插件