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机构地区:[1]沈阳医学院沈洲医院药剂科,辽宁沈阳110002 [2]沈阳医学院基础医学院化学教研室
出 处:《沈阳医学院学报》2012年第1期38-39,共2页Journal of Shenyang Medical College
摘 要:目的:参考国外吲哒帕胺片说明书的辅料种类优化出最佳处方及工艺参数。方法:以溶出度作为考察指标,对羟丙甲纤维素、乳糖、硬脂酸镁、微晶纤维素、聚乙烯吡咯烷酮等辅料的处方量进行对比试验,筛选出与进口吲达帕胺片溶出曲线相同的处方工艺。结果:最后确定的处方比例为羟丙甲纤维素1.7%、乳糖69.0%、硬脂酸镁0.7%、微晶纤维素17.2%,聚乙烯吡咯烷酮5.2%时,各项指标相对其它处方的各项指标最好。结论:以本处方工艺制备的吲达帕胺片剂,溶出度符合规定且与进口片剂溶出曲线相近,稳定性良好。Objective:To optimize the best prescription and technological parameter with the reference of foreign specification about auxiliary material of indapamide.Method:The dissolution rate was taken as investigational object,the contrast test was conducted on dose of hydroxypropyl methylcellulose,lactose,magnesium stearate,microcrystalline cellulose,polyvinylpyrrolidone,and so on to screen out the same dissolution curve as import indapamide.Result:The prescription was better than others,which is 1.7% of hydroxypropyl methylcellulose,69.0% of lactose,0.7% of magnesium stearate,17.2% of microcrystalline cellulose,5.2% of polyvinylpyrrolidone.Conclusion:The prescription screened out meet the criterion on dissolution rate,has a similar dissolution curve as import indapamide,and good stability.
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