Guo Jun-Lin, Shao Qing, Liu Lu-Ming, Qu Hai-Bin, DU Xin-Gang, Gong Xing-Chu
Graduate College, Tianjin University of Traditional Chinese Medicine Tianjin 300193, China.
Pharmaceutical Informatics Institute, College of Pharmaceutical Science, Zhejiang University Hangzhou 310058, China.
Zhongguo Zhong Yao Za Zhi. 2019 Jun;44(11):2260-2265. doi: 10.19540/j.cnki.cjcmm.20181221.001.
This study aims to develop the quality standards of Fructus Corni piece standard decoction. Morroniside and loganin were considered as index components. The content determination method of morroniside and loganin were developed. The fingerprint analysis method was also established. The standard decoctions of 15 batches of Fructus Corni pieces from Henan, Zhejiang, and Shaanxi were analyzed. The similarity values of fingerprint were all above 0.99. The transfer rates of morroniside were all higher than 100%. The quality evaluation indices of standard decoction were discussed. The transfer rate of an index component was not easy to be measured accurately and its concept was not rigorous. Therefore, index component yield was suggested as an evaluation index of standard decoction. Two methods for setting quality standards of standard decoctions, which were the ■ method and the ■ method, were compared. It was found that the standard range of ■ method was wider and more suitable for smaller sample size of standard decoction. The quality standards of Fructus Corni standard decoction were as follows, dry matter extraction ratio 37.48%-69.60%; morroniside yield 8.719-16.19 mg·g(-1) piece; loganin yield 4.342-8.064 mg·g(-1) piece.
本研究旨在制定山茱萸饮片标准汤剂的质量标准。以莫诺苷和马钱苷为指标成分。建立了莫诺苷和马钱苷的含量测定方法。同时建立了指纹图谱分析方法。对河南、浙江、陕西15批山茱萸饮片的标准汤剂进行了分析。指纹图谱相似度均在0.99以上。莫诺苷转移率均高于100%。对标准汤剂的质量评价指标进行了探讨。指标成分转移率不易准确测定且概念不严谨,因此建议以指标成分得率作为标准汤剂的评价指标。比较了制定标准汤剂质量标准的两种方法,即■法和■法。发现■法的标准范围更宽,更适合标准汤剂样本量较小的情况。山茱萸标准汤剂的质量标准如下:干物质提取率37.48%-69.60%;莫诺苷得率8.719-16.19mg·g-1饮片;马钱苷得率4.342-8.064mg·g-1饮片。