摘要
目的 考察变更包衣辅料代替铝箔对人丹质量的影响.方法 以水分、溶散时限、挥发油变化情况为指标筛选优化包衣辅料种类和用量;以显微、薄层鉴别、含量测定、稳定性等为指标,对比人丹包衣辅料变更前后的质量.结果 人丹包衣辅料变更为:胭脂红、滑石粉及红氧化铁的混合物,用量为17.5 g/500 g干燥素丸;糊精为黏合剂,用量为40 g/500 g干燥素丸.变更前后各3批样品的各项指标及溶出情况基本一致.结论 变更辅料不会引起物质基础改变,避免了因服用含铝箔包衣的人丹可能引发的毒副反应,提高GMP管理和用药安全.
Abstract
Objective To investigate the effect of changing coating excipients of Rendan on its quality.Methods The types and amounts of coating excipients were selected and optimized based on indicators such as moisture content,dissolution time limit,and volatile oil content,and the quality of Rendan coating excipients before and after changes was compared using indicators such as microscopy,thin-layer chromatography identification,content determination,and stability.Results The coating excipients of Rendan were changed to a mixture of carmine red,talc powder,and red iron oxide,with a dosage of 17.5 g/500 g of dried pills.Dextrin was used as an adhesive,with a dosage of 40 g/500 g of dried pills.A quality comparison study was conducted on three batches of samples before and after the change,and it was found that all indexes and dissolution conditions were basically consistent.Conclusion Changing the excipients will not cause a change of the material basis,and using a mixture of carmine red,talc powder,and red iron oxide instead of aluminum foil as the coating excipients for Rendan can solve the potential toxic side effects caused by the use of aluminum foil coating,improving GMP management and medication safety.
维普
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