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目的考察硝苯地平缓释片中原料药与辅料的相容性,为更好地设计处方,控制和提高质量提供依据和信息。方法采用中国药典2015年版二部硝苯地平原料药项下有关物质检查方法,考察有关物质变化,作为不同辅料对硝苯地平缓释片光稳定性的影响指标。结果在光照条件下,硝苯地平易产生光降解杂质2,且微晶纤维素和硬脂酸镁会加速杂质2的产生。结论在满足相关制剂要求的条件下,建议尽量少加或不加微晶纤维素和硬脂酸镁。
Objective To investigate the compatibility of drug substance with excipients in nifedipine sustained-release tablets to provide basis and information for better design of prescription, control and quality improvement. Methods The relevant substances under the Chinese Pharmacopoeia 2015 Nifedipine API were examined to investigate the effects of different substances on the photostability of nifedipine sustained-release tablets. Results In the light conditions, nifedipine easily produce photodegradable impurities 2, and microcrystalline cellulose and magnesium stearate will accelerate the production of impurities 2. Conclusion It is suggested to add little or no microcrystalline cellulose and magnesium stearate to meet the requirements of the relevant preparations.