中文摘要：

目的：比较5厂家桂枝茯苓丸在4种溶出介质中的溶出曲线,利用多条溶出曲线评价桂枝茯苓丸的内在质量。方法：采用浆法进行溶出度试验,以蒸馏水、p H=1.2盐酸氯化钠溶液、p H=4.0醋酸盐缓冲液及p H=6.8磷酸盐缓冲液为溶出介质,转速100r/min,HPLC测定各取样点肉桂酸、芍药苷和丹皮酚含量,计算累积溶出率,绘制累积溶出曲线,f2比较各曲线溶出差异,并对溶出模型进行拟合。结果：不同厂家丸剂溶出相似性74.2%;介质p H不同,同一厂家同种成分的溶出差异也不同;同一厂家不同成分在同一介质中的溶出相似性仅为11.7%;不同厂家不同介质下各指标成分的溶出数据拟合结果一致,均以Weibull模型为最佳。结论：同一厂家丸剂不同成分在同一介质中的溶出基本不同步;不同厂家丸剂同一介质下体外溶出行为具有一定相似性,但仍存在差异,并受介质p H影响,提示不同厂家的桂枝茯苓丸质量存在差异,该研究为完善桂枝茯苓丸的制备工艺和质量评价提供了科学依据。

英文摘要：

Objective： To evaluate the internal quality of Guizhi Fuling Pill by comparing the dissolution curves of the pills from 5 different manufacturers in 4 kinds of dissolution mediums. Methods： The dissolution rate test was carried out based on stirring paddle method with the dissolution mediums as distilled water, hydrochloric acid sodium chloride solution（p H=1.2）, acetate buffer solution（p H=4.0） and phosphate buffer solution（p H=6.8）. The contents of cinnamic acid, paeoniflorin and paeonol in each sampling point were measured by using HPLC with rotation speed as 100r/min. The accumulative dissolution rate was calculated, the cumulative dissolution curve was drawn, the dissolution differences were compared based on the f2 similarity factors, and the dissolution models were fitted. Results： The similarity among pills form different manufacturers was 74.2%. The dissolution differences of pills from the same manufacturer in dissolution mediums with different p H values were different. The similarity of different components in pills from the same manufacturer in the same dissolution medium was only 11.7%. The fitting results of dissolution data of each component in pills from different manufacturers in different dissolution mediums were consistent, and the Weibull model was proved to be the best. Conclusion： The dissolution rate of different components in pills from the same manufacturer in the same dissolution medium is different. The dissolution of pills from different manufacturers in the same dissolution medium is similar, but there are still some differences caused by the p H value of dissolution mediums, which suggests that the quality of Guizhi Fuling Pills from different manufacturers is not the same. This study provides scientific basis for the improvement in preparation technology and quality evaluation of Guizhi Fuling Pills.