胆汁盐作为辅料对雷尼替丁、氨茶碱、苯巴比妥片溶出度的影响

M. Pocuca, J. Cvejić, S. Vukmirović, N. Stilinović, K. Kuhajda, S. Kevrešan, M. Mikov
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引用次数: 1

摘要

目的:考察胆盐、胆酸钠、12-酮胆酸钠和去氢胆酸钠作为辅料在雷尼替丁、氨茶碱和苯巴比妥片中的溶出度。方法:采用雷尼替丁、氨茶碱、苯巴比妥三种不同原料药配制四组片剂(不含胆盐的对照组和含不同胆盐的试验组)。测定溶出率。结果:三种原料药的溶出率在各研究组均较对照组显著提高。讨论:在溶出度增强的情况下,目前的结果是非常有利和令人鼓舞的,应该进一步调查,特别是根据生物制药分类系统(BCS)分类被分类为II类和IV类的原料药。结论:胆汁酸盐是一种很有前景的赋形剂,具有表面活性剂和润滑剂的作用。标题:胆汁盐作为雷尼替丁、氨茶碱和苯巴比妥片的辅料。
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Influence of Bile Salts as Excipients in Ranitidine, Aminophylline and Phenobarbital Tablets on Dissolution Rate
Aim: The aim of this study is to investigate the influence of bile salts, sodium cholate, sodium 12-ketocholate and sodium dehydrocholate, as excipients in ranitidine, aminophylline and phenobarbital tablets on dissolution rate. Methods: Four groups of tablets (control without bile salts and three investigational groups containing different bile salts) were prepared for three different drug substances: ranitidine, aminophylline and phenobarbital. Dissolution rate was measured. Results: Dissolution rate is increased significantly in all investigational groups comparing to the control group in all three drug substances. Discussion: Presented results are very favourable and encouraging in case of dissolution enhancing and should be further investigated, especially in drug substances that are classified in class II and IV as per Biopharmaceutical Classification System (BCS) classification. Conclusion: Bile acid salts are very promising excipients, proven to act as surfactants and as lubricants. Running title: Bile salts as excipients in ranitidine, aminophylline and phenobarbital tablets.
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