复方丹参片溶出行为比较研究

Comparative study on dissolution behavior of Fufang Danshen Pian

比较了不同厂家、不同批号的复方丹参片中7种指标性成分在4种溶出介质中的溶出行为,并采用多条溶出曲线对其进行评价。采用桨法进行溶出度试验,以pH 1.2的盐酸盐缓冲液、pH 4.0的醋酸盐缓冲液、纯水和pH 6.8的磷酸盐缓冲液为溶出介质,转速75 r·min^-1,HPLC测定各取样点7种指标成分含量,计算累积溶出率,绘制累积溶出曲线并对溶出模型进行拟合。不同厂家、不同批号的复方丹参片在不同溶出介质中的溶出行为及溶出曲线拟合方程均存在较大差异。不同厂家同一制剂在同一溶出介质下的溶出存在一定差异,同一厂家产品的不同指标成分在同一溶出介质中的溶出不同步;不同厂家、不同批号片剂在同一溶出介质中其溶出行为有差异且受pH影响较大,表明不同厂家、不同批号的复方丹参片质量存在较大差异。该研究为复方丹参片制备工艺改进及批次一致性评价提供了科学依据。

To compare the quality of Fufang Danshen Pian, the dissolution behaviors of 7 index components in Fufang Danshen Pian in different batches and from different manufacturers in 4 kinds of dissolution mediums, and evaluate by multiple dissolution curves. The dissolution test was carried out by the paddle method, with pH 1.2 hydrochloride buffer, pH 4.0 acetate buffer, distilled water and pH 6.8 phosphate buffer as dissolution medium. The rotation speed was 75 r·min^-1. The content of 7 index components at each sampling point was measured by HPLC. The accumulative dissolution rate was calculated, the cumulative dissolution curve was drawn, and the dissolution models were fitted. The dissolution behaviors and the dissolution curve fitting equations of Fufang Danshen Pian in different batches and from different manufacturers in different dissolution mediums were quite different. The dissolution of the same preparation from different manufactures was different in the same dissolution medium, and the dissolution of different index components from the same manufacturer was not synchronized in the same dissolution medium;the dissolution behaviors of Fufang Danshen Pian in different batches and from different manufacturers in the same dissolution medium were different and greatly affected by pH value, indicating differences in the quality of Fufang Danshen Pian in different batches and from different manufacturers. This study provides scientific basis for the improvement in preparation process and the evaluation of batch consistency of Fufang Danshen Pian.