消炎抗菌胶囊与消炎抗菌片的黄芩苷体外溶出性比较研究

目的探讨消炎抗菌胶囊中黄芩苷的体外溶出度及溶出动力学。方法分别采用桨法和转篮法，以消炎抗菌片为参比制剂，用 HPLC法测定消炎抗菌胶囊在pH 1.0、2.8、4.5、6.8溶液及水5种不同溶出介质中黄芩苷的累积溶出度，并分别用零级释放模型、单指数模型、对数正态分布模型及威布尔分布函数进行溶出动力学模拟。结果消炎抗菌胶囊中黄芩苷的溶出受pH 值影响较大，在 pH 6.8时溶出较完全，溶出过程以对数正态分布模型拟合最佳。与消炎抗菌片比较，消炎抗菌胶囊体外溶出速率较快，且能达到的最大溶出百分率。结论消炎抗菌胶囊中黄芩苷在 pH 6.8时体外溶出动力学符合对数正态分布模型，溶出比较完全。

Comparative Study on Baicalin Dissolution Rates in Vitro of Xiaoyankangjun Capsules and Xiaoyankangjun Tablets

Objective To determine the in vitro dissolution rate of baicalin in Xiaoyankangjun capsules .Methods A reversed-phase HPLC method was developed to determine the in vitro dissolution rate of baicalin.Xiaoyankangjun capsules was compared with Xiaoyankangjun tablets in the dissolution medium in the dissolution medium when the pH values were 1.0 ,2.8 ,4.5 ,6.8 and water by paddle method and rolling basket method.Zero-class model ,single-index model ,logarithm normal school model ,and Weibull distributing model were used to imitate the dissolution curve.Results The dissolution rate of Xiaoyankangjun capsules was affected greatly by the pH and dissolve com-pletely when the pH was 6.8.The dissolution rate in vitro imitation in logarithm normal school model was the best.Xiaoyankangjun capsules had the faster dissolution speed and the higher dissolution rate in vitro than Xiaoy-ankangjun tablets.Conclusion The in vitro dissolution rate of baicalin in Xiaoyankangjun capsules conforms to logarithm normal school model w hen the pH of the dissolution medium is 6.8.