复方感冒灵片的溶出度测定方法研究及质量评价

Quality Evalution and Study of Dissolution Determination for Compound Ganmaoling Tablet

关键词:  复方感冒灵片  溶出度  溶出曲线  对乙酰氨基酚  咖啡因  马来酸氯苯那敏  高效液相色谱法  相似因子法

Key words:  compound ganmaoling tablet  dissolution  dissolution profile  paracetamol  caffein  chlorpheniramine maleate  HPLC  similarity factor method

摘要:

目的 探索复方感冒灵片的溶出度测定方法，研究不同企业复方感冒灵片的溶出度，评价其内在质量差异。方法 采用篮法进行溶出，以0.1 mol·L^-1盐酸溶液为溶出介质，转速为100 r·min^-1，取样时间为30 min。采用HPLC测定制剂中的对乙酰氨基酚、咖啡因和马来酸氯苯那敏的溶出度，进而采用相似因子法考察3家生产企业中3个批次产品溶出曲线的相似性。结果 由溶出曲线和相似因子法评价结果分析可见，3家生产企业3个批次的复方感冒灵片中对乙酰氨基酚和咖啡因的溶出曲线相似度较高，但马来酸氯苯那敏的累积溶出度存在一定的差异，相似度较低。结论 复方感冒灵片溶出度的差异可能对药物疗效造成一定的影响，国内该制剂的生产工艺和质控需要加强。同时，该制剂的现行质量标准尚未设置溶出度检查项目，亟待完善和提高。

Abstract:

OBJECTIVE To establish a method for the dissolution determination of compound ganmaoling tablet, and to evaluate the inherent quality differences of different batches of Compound Ganmaoling tablet from different domestic enterprises by researching its dissolution. METHODS The dissolution test was carried out with basket method, and using 0.1 mol·L^-1 hydrochloric acid solution as the dissolution medium, the rotation speed of 100 r·min^-1, and the sample dissolution time was 30 min. The dissolution test of paracetamol, caffeine and chlorphenamine maleate in preparations were performed on HPLC, then similarity factor method was adopted to detect the similarity of dissolution profiles of 3 batches of products from 3 domestic enterprises. RESULTS The dissolution profiles and similarity factor method evaluation results showed that the dissolution curve of paracetamol and caffeine in 3 batches of compound ganmaoling tablet from 3 domestic enterprises was relatively high;but the chlorphenamine maleate had certain difference, overall similarity was relatively low. CONCLUSION The difference of dissolution of compound ganmaoling tablet may affect the preparation's efficacy, the production process and quality control in domestic enterprises shall be managed strictly. Moreover, the current quality standard of this preparation has not been set up dissolution inspection item, which needs to be improved urgently.