采用多条溶出曲线评价异烟肼片的质量

目的：研究国内外异烟肼片在4种溶出介质中的溶出曲线，以评价该制剂质量。方法：浆法，50 r·min^-1，分别在pH1.2盐酸溶液、pH4.5醋酸盐缓冲液、pH6.8磷酸盐缓冲液和水中测定溶出曲线，比较了各企业样品的溶出均一性，并用单点法或f₂因子法进行了比较分析。结果：美国山德士样品批内批间溶出均一性均较好，国内企业溶出均一性参差不齐。以山德士样品作为参比制剂，A、B、C、F、G企业样品在4种溶出介质中均与参比制剂溶出过程相似；D、E、H企业样品在部分介质中与参比制剂溶出过程相似。结论：国内部分厂家异烟肼片生产工艺不稳定，各企业产品质量存在差异，亟待提高。

Quality Evaluation of Isoniazid Tablets by Dissolution Profiles in Different Dissolution Mediums

Objective: To study the dissolution profiles of isoniazid tablets from domestic and overseas pharmaceutical manufactures in four dissolution mediums, so as to evaluate the drug quality. Methods: Paddle method was adopted at a rotated speed of 50 r·min^-1. The dissolution profiles were determined in pH1.2 hydrochloric acid solution, pH 4.5 acetate buffer solution, pH 6.8 phosphate buffer solutions and water, and the results were analyzed by the method of single point or f₂ factor. The dissolutionhomogeneity of isoniazid tablets was determined. Results: The dissolutionhomogeneity of samples from Sandoz manufactures was all good, and samples from domestic were uneven. The sample from Sandoz manufactures was taken as reference preparation. All dissolution profiles of isoniazid tablets from manufactures A, B, C, F, G were similar to the reference preparation. Among these samples from manufactures D, E, H, only some dissolution profiles were similar to the reference preparation. Conclusion: The formula and preparation process of isoniazid tablets of several manufacturers ware unstable. There are differences among the quality of domestic isoniazid tablets from different manufactures which need to be improved.