阿司匹林肠溶片质量研究与分析

发布时间：2018-03-05 02:15

本文选题：阿司匹林肠溶片　切入点：质量研究与分析　出处：《药物分析杂志》2015年12期 　论文类型：期刊论文

【摘要】：目的:研究阿司匹林肠溶片药物稳定性与患者用药情况、包装材料和处方中高价金属离子的相关性,并研究样品阿司匹林肠溶片与参比制剂释放曲线一致性,为企业提高产品质量提供改进方向。方法:以阿司匹林肠溶片含量、释放度和有关物质(中国药典2010年版二部阿司匹林肠溶片方法)为考察指标,开展Mg2+与阿司匹林稳定性、开瓶稳定性(100片·瓶~(-1))、包装材料与药品稳定性研究;释放曲线研究采用光纤药物释放度实时测定仪,测定各厂家阿司匹林肠溶片在5种释放介质中的实时释放曲线。结果:(1)阿司匹林与硬脂酸镁按不同处方比混合,随着放置时间的增加,游离水杨酸的含量增加,游离水杨酸增加速度与硬脂酸镁加入量呈正相关;(2)模拟患者使用方式,塑料瓶包装的产品(100片·瓶~(-1))每日开瓶3次,随时间增加,游离水杨酸含量呈上升趋势,p H 6.8缓冲溶液中释放度均呈下降趋势;(3)不同存放条件下,随时间增加,铝塑包装产品的含量、游离水杨酸和释放度均无显著性变化,塑料瓶包装产品的游离水杨酸和释放度均有显著性变化;(4)在p H 6.0的缓冲溶液中,参比制剂在60 min内能够完全释放,部分受试制剂在2 h内未完全释放,在分别以2010年版中国药典和日本橙皮书方法制备的2种p H 6.8的溶出介质中,参比制剂均能释放,部分受试制剂溶出行为表现出较大的差异。结论:阿司匹林肠溶片处方中应避免加入硬脂酸镁;考虑患者实际使用情况,为保证服药期间药品质量,建议减少每瓶包装量;铝塑包装产品稳定性明显优于塑料瓶包装产品,且不同塑料瓶包装产品稳定性有差异,建议生产企业选择优质包材;参比制剂在大部分肠道内均能够进行释放,并且受肠道内环境影响较小,部分企业阿司匹林肠溶片与参比制剂在释放度行为上存在差异,企业需重视处方工艺并做进一步研究,建议采用多条释放曲线评价阿司匹林肠溶片的质量。
[Abstract]:Objective: to study the relationship between drug stability of aspirin enteric-coated tablets and drug use, high valence metal ions in packaging materials and prescriptions, and to study the consistency of release curve between aspirin enteric-coated tablets and reference preparations. Methods: the contents, release and related substances of aspirin enteric-coated tablets (Chinese Pharmacopoeia, 2010) were used as the index to study the stability of Mg2 and aspirin. Open-bottle stability 100 tablets, packaging materials and drug stability study, release curve research using optical fiber drug release real-time measuring instrument, The real-time release curves of aspirin enteric-coated tablets in 5 kinds of release media were determined. Results the concentration of free salicylic acid increased with the increase of storage time, and the ratio of aspirin to magnesium stearate was mixed with different prescriptions. The increasing rate of free salicylic acid was positively correlated with the amount of magnesium stearate. The content of free salicylic acid in buffer solution of H6.8 showed a decreasing trend.) under different storage conditions, the content of free salicylic acid, free salicylic acid and release of aluminum-plastic packaging products did not change significantly with the increase of storage time. There were significant changes in free salicylic acid and release rate in plastic bottle packaging products. (4) in pH 6.0 buffer solution, the reference preparation could be completely released within 60 min, and some of the tested preparations could not be completely released within 2 h. In the dissolution media of two kinds of pH 6.8 prepared by the 2010 Chinese Pharmacopoeia and Japanese orange pericarp respectively, the reference preparation could be released. Conclusion: magnesium stearate should be avoided in the formulation of aspirin enteric-coated tablets. The stability of aluminum-plastic packaging products is obviously superior to that of plastic bottle packaging products, and the stability of different plastic bottle packaging products is different. Some enterprises have different release behavior between aspirin enteric-coated tablets and reference preparations. Enterprises should pay attention to prescription technology and do further research. It is suggested that multiple release curves be used to evaluate the quality of aspirin enteric-coated tablets.
【作者单位】：海南省药品检验所;
【基金】：2011年国家药品评价抽验项目(项目编号:60) 海南省社会发展科技专项资金项目(项目编号:SF201453)
【分类号】：R927

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