不同厂家蒲地蓝消炎片溶出行为研究

Dissolution behaviors of Pudilan anti-inflammation tablets by different manufacturers

目的建立蒲地蓝消炎片溶出度测定方法,对不同企业产品的溶出行为进行研究,探索其内在质量差异,为本品的药效提供参考。方法采用超高效液相色谱法以外标法测定黄芩苷的溶出度,并采用相似因子法考察不同生产企业产品溶出曲线相似性。色谱柱为资生堂MGⅡC18(4.6 mm×100 mm,3μm),流动相为甲醇-水-磷酸(44∶56∶0.2,v/v/v),流速为1.0 mL·min^-1,检测波长为280 nm,柱温为30℃,进样量为10μL。采用桨法进行溶出,以pH=1.0盐酸溶液为溶出介质,转速为100r·min^-1,取样时间为90 min。结果本品在pH=1.0盐酸溶液具有较好的溶出行为,同一溶出介质批内批间溶出曲线相似,相似因子(f2)值均大于50,不同厂家蒲地蓝消炎片中黄芩苷的溶出曲线相似度较低,相似因子(f2)值均小于50。结论该溶出度测定方法操作简便、结果准确,不同厂家同一介质溶出曲线的区别体现了产品质量的差异性,本研究可对蒲地蓝消炎片药效评价提供参考。

Objective To determine the dissolution of Pudilan anti-inflammation tablets,study the dissolution behaviors of the tablets by different manufacturers,explore the difference in internal quality,and provide reference for the efficacy research of this product.Methods The dissolution rate of baicalin was determined by ultra-high performance liquid chromatography(UPLC),and the measure factor method was used to investigate the similarity of dissolution curves of tablets by different manufacturers.The column was Shiseido MGⅡC18(4.6 mm×100 mm,3μm),the mobile phase was methanol-water-phosphoric acid(44∶56∶0.2,v/v/v),the flow rate was 1.0 mL·min^-1,the detection wavelength was 280 nm,the column temperature was 30℃,and the injection volume was 10μL.The dissolution was carried out by the paddle method,the pH=1.0 hydrochloric acid solution was used as the dissolution medium at 100 r·min^-1,and the sampling time was 90 min.Results The product had good dissolution behaviors in pH 1.0 hydrochloric acid solution.The dissolution curve of the same batch in the same dissolution medium was similar,and the similar factor(f2)value was greater than 50.The dissolution curve of baicalin by different manufacturers of Pudilan anti-inflammation tablets was lower,and the f2 values were less than 50.Conclusion The dissolution method is simple and accurate.The difference in dissolution curve in the same medium from different manufacturers reflects the difference in product quality.This study can provide a reference for the evaluation of the efficacy of Pudilan anti-inflammation tablets.