Quality Problems and Supplementary Test Methods of Chinese Medicine Glue
LIN Yong-qiang1, LIN Lin1, JIAO Yang1, ZHOU Qian-qian1, WANG Bing1, CHENG Xian-long2, DAI Zhong2, MA Shuang-cheng2*
1. Key Laboratory for Quality Evaluation of Gelatin Products, National Medical Products Administration, Shandong Provincial Institute for Food and Drug Control, Jinan 250101,China; 2. National Institutes for Food and Drug Control, Beijing 100050, China
Abstract:OBJECTIVE To provide reference for the formulation of regulatory policies, revision and improvement of standards with the research and summary of Chinese medicine glues in recent years. METHODS The quality problems of Chinese medicine glues found in national drug sampling inspection since 2012 were summarized, and based on this, the screening of 41 Chinese medicine glues with large production batches and large market share was carried out, and relevant supplementary inspection methods were established. RESULTS AND CONCLUSION By summarizing the drug quality notices issued by the state and provincial and municipal drug administrations, from 2012 to 2015, it was found that the cowhide feeding in donkey-hide gelatin was serious. From 2015 to 2017, no cowhide feeding problems were found, but the feeding problems of mule and horse skins were extremely prominent. In view of the market problems, seven units completed the screening of 41 Chinese medicine glues, and established 15 supplementary inspection methods, which effectively strengthened the quality control and standardized the industrial order of Chinese medicine glues.
林永强, 林林, 焦阳, 周倩倩, 汪冰, 程显隆, 戴忠, 马双成. 胶类中药质量问题及补充检验方法研究[J]. 中国药学杂志, 2019, 54(17): 1448-1451.
LIN Yong-qiang, LIN Lin, JIAO Yang, ZHOU Qian-qian, WANG Bing, CHENG Xian-long, DAI Zhong, MA Shuang-cheng. Quality Problems and Supplementary Test Methods of Chinese Medicine Glue. Chinese Pharmaceutical Journal, 2019, 54(17): 1448-1451.
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