基于差式扫描量热法的阿魏酸哌嗪片原辅料相容性研究

Drug-excipients Compatibility of Piperazineferulate Tablets by DSC

目的:考察阿魏酸哌嗪片原辅料相容性,为提高其质量提供依据。方法:采用差示扫描量热法对阿魏酸哌嗪和相应辅料的相容性进行分析,测试条件:参比为铟,气氛为氮气,升温速度为10℃·min^(-1),升温范围为25℃~250℃。结果:阿魏酸哌嗪与淀粉、糊精、羧甲纤维素钠等辅料相容性较好,与乳糖、硬脂酸镁有配伍反应;硬脂酸相比于硬脂酸镁,与阿魏酸哌嗪有更好的相容性。结论:阿魏酸哌嗪片原辅料相容性存在配伍风险,避免使用乳糖、硬脂酸镁,建议优化产品处方,提高药品质量及其安全性。

Objective:To research the drug-excipients compatibility of piperazineferulate tablets,in order to help the improvement of drug quality.Methods:Drug-excipients compatibility of piperazineferulate tablets was analyzed by DSC(differential scanning calorimetry).The reference was indium,the atmosphere was nitrogen,the heating rate was 10℃·min^(-1),and the heating range was 25℃~250℃.Results:Piperazineferulate had good compatibility with starch,dextrin,sodium carboxymethylcellulose and other excipients.It was imcompatible with lactose and magnesium stearate.Compare with magnesium stearate,stearic acid had a better compatibility with piperazineferulate.Conclusion:Piperazineferulate tablets had compatibility risk.Try to avoid using lactose and magnesium stearate.It was suggested to optimize the formulation of piperazineferulate tablets to improve the drug safety.