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市售磷酸氯喹抗疟药片的体外评估

In vitro evaluation of marketed antimalarial chloroquine phosphate tablets.

作者信息

Patel Amit K, Prajapati Bhupendra G, Moria Rubina S, Patel Chhaganbhai N

机构信息

Shri Sarvajanik Pharmacy College, Mehsana, India.

出版信息

J Vector Borne Dis. 2005 Dec;42(4):147-50.

Abstract

BACKGROUND & OBJECTIVES: The aim of the present study is to investigate the physicochemical equivalence of seven brands of tablets containing chloroquine phosphate, an antimalarial purchased from different retail pharmacy outlets.

METHODS

The quality and physicochemical equivalence of seven different brands of chloroquine phosphate tablets were assessed. The assessment included the evaluation of uniformity of weight, friability, crushing strength, disintegration and dissolution tests as well as chemical assay of the tablets.

RESULTS

All the seven brands of the tablets passed the British Pharmacopoeia (BP) standards for uniformity of weight, disintegration and crushing strength. One of seven brands failed the friability test. One of the brands did not comply with the standard assay of content of active ingredients. Dissolution test passes the pharmacopoeial standards for chloroquine phosphate tablets. There were no significant differences in the amounts of chloroquine phosphate released from the different brands.

INTERPRETATION & CONCLUSION: Out of the seven brands of anti-malarial chloroquine phosphate tablets only one brand fails to meet BP quality specifications which shows constant market monitoring of new products to ascertain their equivalency to pharmacopoeial standards.

摘要

背景与目的

本研究旨在调查从不同零售药店购买的七种含磷酸氯喹(一种抗疟药)片剂的物理化学等效性。

方法

评估了七种不同品牌磷酸氯喹片剂的质量和物理化学等效性。评估内容包括重量均匀度、脆碎度、抗压强度、崩解和溶出度测试以及片剂的化学分析。

结果

所有七个品牌的片剂均通过了英国药典(BP)关于重量均匀度、崩解和抗压强度的标准。七个品牌中的一个未通过脆碎度测试。其中一个品牌不符合活性成分含量的标准分析。溶出度测试通过了磷酸氯喹片剂的药典标准。不同品牌释放的磷酸氯喹量没有显著差异。

解读与结论

七种抗疟磷酸氯喹片剂品牌中只有一个品牌不符合BP质量规格,这表明对新产品进行持续的市场监测以确定其与药典标准的等效性。

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