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目的:考察阿莫西林和克拉维酸钾在4种介质中的稳定性及自制阿莫西林/克拉维酸钾片、市售品和原研制剂在不同介质中的溶出曲线,分析体外释放行为。方法:采用已知含量的原料溶解于不同溶出介质中,在不同的时间段测定其色谱峰面积,考察其稳定性。参考日本橙皮书中阿莫西林/克拉维酸钾片溶出曲线的测定方法,以不同溶出介质对阿莫西林/克拉维酸钾片进行溶出曲线考察。采用f_2因子进行比较分析。结果:克拉维酸在pH 1.2、pH4.0溶出介质中1 h分别降解90%和3%,在水、pH 6.8介质中8.h稳定;阿莫西林在pH 1.2溶出介质中1 h降解3%,在水、pH 4.0、pH 6.8溶出介质中8 h稳定。C厂样品与B厂样品在不同溶出介质中溶出曲线均与A厂(原研)产品相似;C厂样品与B厂样品在pH 1.2的盐酸溶液与pH4.0的醋酸缓冲溶液中前10 min的溶出速度较原研A药品快10%~20%。D厂样品、E厂样品在水介质下与原研样品不具有相似性。结论:克拉维酸溶液(pH 1.2)稳定性极差;国内有些厂家产品在4种溶出介质中的溶出曲线与原研产品不一致,质量存在差异。
OBJECTIVE: To investigate the stability of amoxicillin and potassium clavulanate in four media and the dissolution profile of amoxicillin / clavulanate tablets, commercial preparations and original preparations in different media, and to analyze the in vitro release behavior. Methods: Raw materials of known content were dissolved in different dissolution media, and the chromatographic peak areas were measured at different time intervals to investigate their stability. Reference to Japan Orange Book amoxicillin / clavulanate potassium tablets dissolution curve determination of dissolution medium with different dissolution of amoxicillin / clavulanate tablets dissolution curve. Using f_2 factor comparative analysis. Results: Clavulanic acid was degraded by 90% and 3% respectively in pH 1.2 and pH 4.0 dissolution media for 1 h, and stable in water and pH 6.8 for 8 h. Amoxicillin was degraded 1 h in pH 1.2 dissolution media %, Stable in water, pH 4.0, pH 6.8 dissolution medium for 8 h. The dissolution curves of Factory C and Factory B in different dissolution media are similar to those of Factory A (original research); Factory C and Factory B samples were incubated in hydrochloric acid solution of pH 1.2 and acetic acid buffer solution of pH 4.0 for 10 min Dissolution rate than the original research A drugs 10% to 20% faster. D factory samples, E factory samples in aqueous media and the original sample does not have similarities. CONCLUSION: The stability of clavulanic acid solution (pH 1.2) is very poor. The dissolution curves of some domestic manufacturers in four dissolution media are inconsistent with the original products, and the quality is different.