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磷酸氯喹片的物理化学等效性

Physicochemical equivalence of chloroquine phosphate tablets.

作者信息

Bamiro O A, Odeniyi M A, Idowu O B, Jaiyeoba K T

机构信息

Dept. of Pharmaceutics and Pharmaceutics Technology, Olabisi Onabanjo University, Ago-Iwoye.

出版信息

Afr J Med Med Sci. 2004 Dec;33(4):371-5.

Abstract

Seven brands of chloroquine phosphate tablets sourced from different retail outlets in the South-West Nigerian market were analysed in order to determine their physicochemical equivalence. The assessment parameters included uniformity of weight, friability, crushing strength, disintegration and dissolution tests and chemical assay of the tablets. All the brands passed the British Pharmacopoeia tests for weight uniformity, disintegration time and dissolution rate. Two brands, C and E passed the minimum criterion for crushing strength, four brands passed the friability test and two brands exceeded the specified amount of active drug content for chloroquine tablets. Only one brand C out of the seven brands that were analysed passed all the BP quality specifications. Hence none of the seven brands analysed could said to be physically and chemically equivalent. This study highlights the need for constant market monitoring of new products in order to ascertain their quality.

摘要

对源自尼日利亚西南部市场不同零售渠道的七个品牌磷酸氯喹片进行了分析,以确定它们的物理化学等效性。评估参数包括重量均匀度、脆碎度、抗压强度、崩解和溶出度测试以及片剂的化学分析。所有品牌均通过了英国药典的重量均匀度、崩解时间和溶出率测试。两个品牌(C和E)通过了抗压强度的最低标准,四个品牌通过了脆碎度测试,两个品牌超过了氯喹片规定的活性药物含量。在分析的七个品牌中,只有一个品牌C通过了所有英国药典质量规格。因此,所分析的七个品牌中没有一个可以说是物理和化学等效的。这项研究强调了对新产品进行持续市场监测以确定其质量的必要性。

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