Comparative quality evaluation of paracetamol tablet marketed in Somali region of Ethiopia

S. Sahle, A. Ayane, N. Wabe
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引用次数: 23

Abstract

The safety and efficacy of a pharmaceutical dosage form can be guaranteed when its quality is reliable. The efficacy of pharmaceutical dosage forms generally depends on their formulation properties, and manufacturing methods, hence it is likely that the quality of dosage form may vary. The aim was to evaluate the quality of paracetamol tablet marketed in Somali region of Ethiopia. The study was exclusively experimental that used BP, USP and other standard books to check the in vitro quality of Paracetamol tablet using different analytical techniques and procedure. Test for weight variation, friability, disintegration time, identification test and assay were conducted. All of the brands under the study were within the specification for weight variation test. But from the contraband brands, two for friability, one for disintegration and all for percentage content paracetamol failed to satisfy the requirement though all of the products contain the wright active ingredients. The research has showed that the quality of contraband tablets were below the standard in contrast to the legal paracetamol tablet which is hazardous to the community. The regulatory body must work to stop illegal smuggling of medications .
在埃塞俄比亚索马里地区销售的扑热息痛片的质量比较评价
药品剂型的质量可靠,才能保证其安全性和有效性。药物剂型的功效通常取决于其制剂性质和制造方法,因此剂型的质量可能会有所不同。目的是评价在埃塞俄比亚索马里地区销售的扑热息痛片的质量。本研究采用BP、USP等标准,采用不同的分析技术和程序对扑热息痛片的体外质量进行了检验。进行了重量变化、脆度、崩解时间、鉴定试验和含量测定。所有参与研究的品牌均在重量变异试验的规格范围内。但从违禁品牌来看,易碎性两个、崩解性一个、百分含量都不符合要求,虽然所有产品都含有正确的有效成分。研究显示,与对社会有害的合法扑热息痛药片相比,走私药片的质量低于标准。监管机构必须努力制止药物的非法走私。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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