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马来酸依那普利片新制剂的设计与评价

Design and evaluation of a new formulation of enalapril maleate tablet.

作者信息

Bibi Rehana, Naqvi Baqir Shyum, Shoaib Muhammad Harris, Rahim Najia

机构信息

Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi-75270, Pakistan.

出版信息

Pak J Pharm Sci. 2011 Apr;24(2):211-5.

Abstract

Enalapril maleate, one of the Angiotensin converting enzyme (ACE) inhibitor is effective in the treatment of hypertension. Enalapril maleate is selected for the present study. The aim of this study was to develop a new formulation of Enalapril maleate tablet and its comparative evaluation with other formulations of Enalapril maleate tablet that are listed in the local index of registered pharmaceutical products. To accomplish this task, a new formulation of Enalapril maleate tablet has been developed by direct compression method. All formulation tablets with 5mg potency were selected and the new formulation tablets were also developed with 5mg potency. For new formulation as well as for six available formulations of Enalapril maleate tablets, various pharmaceutical parameters namely weight variation, thickness, hardness test; friability test, disintegration test, dissolution test and pharmaceutical assay were performed in accordance with United States Pharmacopeias (USP). The results of all the above tests were within the specified limits as mentioned in USP, whereas hardness test results for two formulations were deviated from the specified limits. It is concluded that direct compression can be used as an alternate method for the manufacture of Enalapril maleate tablet.

摘要

马来酸依那普利是一种血管紧张素转换酶(ACE)抑制剂,对治疗高血压有效。本研究选用马来酸依那普利。本研究的目的是开发一种马来酸依那普利片的新剂型,并与当地注册药品索引中列出的其他马来酸依那普利片剂型进行对比评估。为完成此任务,采用直接压片法开发了一种马来酸依那普利片的新剂型。所有选定的片剂效力均为5mg,新剂型片剂的效力也为5mg。对于新剂型以及六种市售的马来酸依那普利片剂型,按照美国药典(USP)进行了各种药学参数的检测,即重量差异、厚度、硬度测试、脆碎度测试、崩解测试、溶出度测试和药物含量测定。上述所有测试结果均在USP规定的限度内,不过有两种剂型的硬度测试结果偏离了规定限度。得出的结论是,直接压片法可作为制备马来酸依那普利片剂型的替代方法。

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