阿替洛尔片原料与辅料相容性问题的探讨

目的：观察阿替洛尔片原料药与辅料的相容性,为更好地控制和提高质量提供依据和信息.方法：通过加速稳定性试验,应用《中国药典》2010年版二部阿替洛尔片有关物质检查方法,考察阿替洛尔片的有关物质变化,作为阿替洛尔片原辅料相容性的观察指标.结果：有新杂质产生,表明阿替洛尔原辅料发生了相容性反应.结论：阿替洛尔片的原辅料存在相容性问题,初步分析可能是由于阿替洛尔原料和辅料羧甲基淀粉钠中残留的一氯乙酸的相互作用有关,进而提示药品生产企业应关注上市后药品的原辅料相容性问题.

Discussion on Compatibility between Atenolol and Different Excipients

ABSTRACT Objective: To observe the compatibility of the raw material and accessories in atenolol tablets in order to provide the information for the quality control. Methods:According to the determination methods for the relative substances in atenolol tablets described in Chinese pharmacopoeia (the second part, 2010 edition), the changes of relative substances in the tablets were investigated by the accelerated stability test, which could evaluate the compatibility of the raw material and accessories. Results:There was a new impurity appeared during the test process, suggesting the reaction occurred between atenolol and sodium carboxymethyl starch. Conclusion:Incompatibility between the raw material and accessories in atenolol tablets is proven to exist, which is due to the interaction between atenolol and monochloroacetic acid residues in sodium carboxymethyl starch. The manufacturer should pay attention to the compatibility of the raw material and accessories after the initial public offer of the drug.