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基于近红外光谱法的复方阿胶口服液全质量控制体系构建及相关思考

[Construction of NIRS-based total quality control system for compound Ejiao oral liquid and relative thinking].

作者信息

Zhang Yan, Zhang Lu, Tian Shou-Sheng, Zhou Xiang-Shan, Li Wen-Long, Qu Hai-Bin

机构信息

Dong'e Ejiao Co., Ltd., Liaocheng 252201, China.

Pharmaceutical Informatics Institute, Zhejiang University, Hangzhou 310058, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2016 Oct;41(19):3574-3578. doi: 10.4268/cjcmm20161913.

Abstract

In this paper, near infrared spectroscopy (NIRS)-based total quality control system of compound Ejiao oral liquid is introduced briefly, including the quality control of raw traditional Chinese medicine (TCM) materials, monitoring and control of the extract and the alkaline precipitation technics, and also the inspection of finished products in both open bottle and non-opening modes. By analyzing and summing up the significance and difficulties, several important problems in the practical applications of NIRS technology are proposed, which will provide references for the similar studies of other TCM products.

摘要

本文简要介绍了基于近红外光谱(NIRS)的复方阿胶口服液全质量控制系统,包括对中药原料的质量控制、提取物及碱沉淀工艺的监测与控制,以及成品在开瓶和不开瓶模式下的检验。通过分析总结其意义与难点,提出了NIRS技术实际应用中的几个重要问题,可为其他中药产品的类似研究提供参考。

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