六味地黄丸(水蜜丸)的质量评价  

Quality evaluation of Liuwei Dihuang Pill

作　　者：胡建平[1] 韩丽娜[2] 李正翔[1] 

机构地区：[1]天津医科大学总医院,天津300052 [2]天津中医学院

出　　处：《中成药》2006年第9期1293-1297,共5页Chinese Traditional Patent Medicine

摘　　要：目的：通过对不同生产厂家的六味地黄丸（水蜜丸）中丹皮酚含量和溶出度的测定，评价其内在质量。方法：建立六味地黄丸（水蜜丸）中丹皮酚的HPLC的含量测定方法和体外溶出度测定方法。流动相为甲醇-水（70：30），检测波长274nm，进样量20μL，流速1．0mL／min体外的接受溶媒为30％乙醇-0．1mol／L盐酸溶液。结果：该方法在1．4～140μg范围内线性关系良好，平均加样回收率97．38％，RSD=1．44％（n=6）；天津产溶出度测定T50=156．77，Td=256．55，M=0．734，北京产溶出度测定T50=110．66，Td=197．19，M=0．583。结论：该测定方法能够满足六味地黄丸（水蜜丸）中丹皮酚含量和溶出度的测定，方法简便，精密度高。实验表明各药厂间的溶出度无显著差异；同一药厂不同批次间存在显著差异。AIM ： To compare the quality of Liuwei Dihuang Pill among the pharmaceutical companies by determining the content and the dissolution of paeonol of Liuwei Dihuang Pill. METHODS： A method of determining paeonol and the dissolution from Liuwei Dihuang Pill was establishod. HPLC was used with methanol-water （70 ： 30） as a mobile phase and detection wavelength was at 274 nm. The flow rate was 1.0 mL/min, injection volume was 20 μL. The percentage of dissolution was determined in the 30% methanol-0.1 mol/1 HCL solution. RESULTS： A good linearity was over the weight range of 1.4 μg-140μg, the average recovery was 97.38%, the RSD for reproducibility was 1.44% （ n = 6）. The parameter of Tianjin＇ s production was T50 = 156.77, Td = 256.55, M = 0. 734 and the parameter of Beijing＇ s production was T50 = 110.66, Td = 197.19, M = 0.583. CONCLUSION： The method is simple, and can be used to determine the content and the percentage of dissolution of paeonol in Liuwei Dihuang Pill. The experiment indicates that the percentage of dissolution has no obvious distinction in products from different manufactures; but has obvious distinction in the batches of same manufacture.

关 键 词：六味地黄丸 丹皮酚 HPLC 溶出度 

分 类 号：R927.2[医药卫生—药学]