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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。
OBJECTIVE: To compare the dissolution curves of Guizhi Fuling pill (5) in four dissolution media and to evaluate the intrinsic quality of Guizhi Fuling pill by using multiple dissolution curves. Methods: The dissolution test was carried out by the slurry method. The distilled water, pH = 1.2 sodium chloride hydrochloride solution, p H = 4.0 acetate buffer solution and p H = 6.8 phosphate buffer solution were used as the dissolution medium at 100r / min, The contents of cinnamic acid, paeoniflorin and paeonol were determined by HPLC. The cumulative dissolution rate was calculated. The cumulative dissolution curve was plotted. The difference of each curve dissolution was compared by f2, and the dissolution model was fitted. Results: Dissolution similarity of 74.2% of pills from different manufacturers was different. The difference of p H was different among different manufacturers. The dissolution of the same components of the same manufacturer was also different. The dissolution similarity of different components of the same manufacturer in the same medium was only 11.7% The results of the fitting of the dissolution index of the indicator components are the same, all based on the Weibull model. Conclusion: Dissolution of different components of the same pill in the same medium is not synchronous. Dissolution behavior of different pills in the same medium is similar to each other, but there are still some differences. The effect of media p H suggests that the different manufacturers’ There are differences in the quality of the pills, the study provides a scientific basis for improving the preparation technology and quality evaluation of Guizhi Fuling pill.