采用差示扫描量热分析筛选与白障明无相互作用的辅料、片剂处方组成与工艺,改善了白障明的吸湿性。白障明片20min累积溶出度为98.84%±0.64%。白障明与白障明片用热重分析法分别测得热解活化能Ea为116±13kJ/mol与126±7kJ/mol,两者无显著性差异。在37℃、RH75%放置3个月,外观与含量等无变化。
Abstract
Differential scanning colorimetry(DSC) was used to screen out best excipientswhich do not interact with bendazac lysine(BZL).According to the preformulation studies,for-mulation composition and preparation of ordinary tablets have been designed. The humidificationof BZL was improved. The cumulative dissolution in 20min of the tablets was 98. 84%±0. 64%.Using thermogravimetry analysis(TGA ) method the activation energies of thermal degradationwere found to be 116±13(BZL) and 126±7(tablets)kJ/mol,respectively,which are not obviously different.On the other hand,the appearance and the content of the tablets had no change after three months of storage at 37℃ and 75% RH.
关键词
白障明 /
差示扫描量热分析 /
临界相对湿度 /
热重分析
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Key words
bendazac lysine /
differential scanning colorimetry /
critical relative humidity /
ther-mograviemetry analysis
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参考文献
1Silvestrini B,Catanese B, Lisciani R,et al.Studies on the mechanism of action of bendazac.Arzneimittelforsch,1970.50:252.
2Sivestrini B,Baiocchi L.Bendazac composition for treatment of cataract.UK Patent Application GB 2110532A.1983-06-22
3潘悌摘。DSC法研究盐酸氧烯洛尔、替马西渊与片剂赋形剂间的相容性[英].国外医学.药学分册,1990,17(6):373.
4金守礼.高分子材料热寿命快速评定方法的基础理论。工程塑料技术,1980,3:28
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脚注
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