不同厂家利巴韦林片溶出曲线的测定

Determination of Dissolution Curve of Ribavirin Tablets from Different Manufacturers

目的:建立测定利巴韦林片溶出曲线测定方法,并比较不同厂家利巴韦林片溶出行为的一致性。方法:溶出试验采用《中国药典》四部通则0931第二法(桨法),以盐酸溶液(pH 1.2)为溶出介质,搅拌转速为50 rpm;检测方法采用高效液相色谱法,用磺化交联的苯乙烯–二乙烯基共聚物的氢型阳离子交换树脂为填充剂的色谱柱,以水(用稀硫酸调节pH值至2.5 ±0.1)为流动相;流速为1.0 mL/min,检测波长为207 nm。结果:同厂家不同批次之间的溶出曲线一致性较好,说明制剂工艺相对稳定。但是,不同厂家利巴韦林片溶出行为有明显差异,溶出曲线一致性不好,说明国内不同厂家生产的利巴韦林片处方、工艺不同,质量差异较大,有待提高。结论:试验结果显示本研究建立的试验方法可为利巴韦林片的溶出度测定提供实验基础和理论参考,可用于利巴韦林片的质量评价。

Objective: To establish a method for determining the dissolution curve of ribavirin tablets and compare the consistency of dissolution behavior of ribavirin tablets from different manufacturers. Methods: The second method (paddle method) of general rule 0931, Part IV of Chinese Pharmacopoeia was used for dissolution test, Hydrochloric acid solution (pH 1.2) was used as the dissolution medium, and the stirring speed was 50 rpm;the detection method was high performance liquid chromatography (HPLC). The column was filled with sulfonated cross linked styrene divinyl copolymer hydrogen cation exchange resin, and the mobile phase was water (adjust pH to 2.5 ±0.1 with dilute sulfuric acid). The flow rate was 1.0 ml/min, and the detection wavelength was 207 nm. Result: The dissolution curves of different batches from the same manufacturer were consistent, indicating that the preparation process was relatively stable. However, the dissolution behavior of ribavirin tablets from different manufacturers is obviously different, and the consistency of dissolution curve is not good, which indicates that the formulation and process of ribavirin tablets from different manufacturers in China are different, and the quality of ribavirin tablets is quite different, which needs to be improved. Conclusion: The results showed that the method established in this study can provide experimental basis and theoretical reference for the dissolution determination of ribavirin tablets, and can be used for the quality evaluation of ribavirin tablets.