滑石粉中酸中可溶物对阿司匹林稳定性影响考察

Effect of acid-soluble substances in Talc on stability of aspirin

目的:通过滑石粉与阿司匹林的相容性考察,探索滑石粉中酸中可溶物对制剂质量的影响情况并初步探讨了影响机制。方法:通过阿司匹林与含有不同量酸中可溶物的滑石粉之间的相容性试验,考察滑石粉酸中可溶物含量与阿司匹林降解程度之间的相关性,并对酸中可溶物中对阿司匹林降解的影响因素进行考察。结果:滑石粉酸中可溶物在一定程度上加速了阿司匹林的降解。结论:滑石粉中的强碱弱酸盐或金属氧化物如碳酸钙、碳酸镁和氧化镁等酸中可溶物的水解,导致样品微环境的pH增加,影响对pH敏感活性药物成分的稳定性。

Objective:To study the compatibility of Talc and aspirin,to explore the influence of acid soluble substance of Talc on the quality of the preparation,and the influencing mechanism.Methods:Through the compatibility test between aspirin and Talc containing acid-soluble substances in a series of concentration gradient,the correlation between the content of soluble substances in the acid of talc and the content of impurities degraded by aspirin,and the influencing factors of aspirin degradation in acid soluble substances were investigated.Results:Acid-soluble substances in Talc accelerated the degradation of aspirin in a certain extent.Conclusion:Hydrolysis of strong base and weak acid salts or metal oxides such as calcium carbonate,magnesium carbonate and magnesium oxide in talc powder leads to pH increase in the sample microenvironment and affects the stability of pH sensitive active pharmaceutical ingredient.