Zhong Wen, Chen Sha, Zhang Jun, Wang Yu-Sheng, Liu An
Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China.
Zhongguo Zhong Yao Za Zhi. 2016 Mar;41(6):1027-1032. doi: 10.4268/cjcmm20160609.
To investigate the effect of Chinese medicine raw materials and production technology on quality consistency of Chinese patent medicines with Gegen Qinlian decoction as an example, and establish a suitable method for the quality consistency control of Chinese patent medicines. The results showed that the effect of production technology on the quality consistency was generally not more than 5%, while the effect of raw materials was even more than 30%, indicating that the effect of raw materials was much greater than that of the production technology. In this study, blend technology was used to improve the quality consistency of raw materials. As a result, the difference between the product produced by raw materials and reference groups was less than 5%, thus increasing the quality consistence of finished products. The results showed that under the current circumstances, the main factor affecting the quality consistency of Chinese patent medicines was raw materials, so we shall pay more attention to the quality of Chinese medicine's raw materials. Finally, a blend technology can improve the quality consistency of Chinese patent medicines.
以葛根芩连汤为例，探讨中药原料及生产工艺对中成药质量一致性的影响，并建立适用于中成药质量一致性控制的方法。结果表明，生产工艺对质量一致性的影响一般不超过5%，而原料的影响甚至超过30%，表明原料的影响远大于生产工艺。本研究采用混合技术提高原料的质量一致性。结果显示，原料生产的产品与参照组之间的差异小于5%，从而提高了成品的质量一致性。结果表明，在当前情况下，影响中成药质量一致性的主要因素是原料，因此应更加关注中药原料的质量。最后，混合技术可提高中成药的质量一致性。
