滤膜吸附对复方甘草酸苷片溶出度的干扰试验

Interference Test of Filter Film Adsorption for Dissolution of Compound Glycyrrhizin Tablets

目的:考察滤膜对不同介质中复方甘草酸苷片溶出度的吸附情况,为其溶出试验的滤膜选择提供依据。方法:取复方甘草酸苷片,分别用水、pH 1.0盐酸、pH 4.5磷酸盐缓冲液、pH 6.8磷酸盐缓冲液4种介质,配制低、中、高3种浓度的供试品溶液,经不同滤膜过滤,用高效液相色谱法检测其溶出度并计算滤膜吸附率。结果:微孔滤膜对复方甘草酸苷片中甘草酸单铵盐吸附作用较大,在pH 1.0盐酸中吸附尤为明显;对甘氨酸、DL-蛋氨酸吸附作用较小;对低浓度供试品溶液的吸附作用大于高浓度供试品溶液。结论:滤膜吸附对4种介质中的溶出度测定有不同程度的干扰,在溶出试验前必须进行滤膜吸附试验,以选择合适的滤膜,排除干扰。

Objective： To investigate the membrane adsorption of compound glycyrrhizin tablets in dissolution test in different medium, so as to provide theoretical references for membrane filter choice. Methods： The test solution was prepared with compound glycyrrhizin tablets in four kinds of medium, including water, pH 1.0 hydrochloric acid, pH 4.5 phosphate buffer, and pH 6.8 phosphate buffer, in low, medium, and high concentration respectively. The test solution was filtered by different membrane, and then the dissolution was detected using HPLC method and membrane adsorption rate was calculated. Results： The adsorption of microporous membrane filter to Monoammonium Glycyrrhizinate in compound glycyrrhizin tablets was greater, especially in pH 1.0 hydrochloric acid; the adsorption of glycine and methionine was weaker; the adsorption of low concentration solution was greater than the high concentration solution. Conclusion： The membrane adsorption has different interference to dissolution test of four kinds of media, so that membrane adsorption test must be conducted before dissolution test so as to guarantee the suitable membrane filter.