孟加拉国不同品牌氯吡格雷片剂质量比较评价

Naimur Rehman
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摘要

本研究旨在评估孟加拉国市场上不同厂家氯吡格雷片的质量参数。氯吡格雷是一种有效的抗血小板和抗血栓药物。氯吡格雷已被批准并在全球上市,主要适应症是减少因中风、心肌梗死和心血管疾病引起的几种合并症患者的动脉粥样硬化事件。本研究的目的是对部分已上市氯吡格雷片剂的质量参数进行评价,并对其进行比较。为评价其质量,选择3种不同的市售氯吡格雷75mg片剂,进行体外溶出度、效价、崩解时间的测定。这些片剂的其他一般质量参数如重量变化、硬度、易碎性也根据既定的方案确定。所有品牌均符合美国药典的要求,并标明可接受的重量变化范围。所有品牌易损性均小于1%。崩解时间无显著差异,均在15分钟内崩解。在溶出情况下,所有品牌都表现出更好的溶出时间,因为它们在45分钟内释放超过75%的药物。一个品牌的硬度在40-60N范围内。效价限制在95- 105%之间。这三个品牌都符合这个规格。本研究表明,孟加拉国大多数市售氯吡格雷片保持质量并符合USP规范,这对于这种抗血小板药物更好的治疗活性至关重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparative Quality Evaluation of Different Brands of Clopidogrel Tablet Available in Bangladesh
This study aims to assess the quality parameters of Clopidogrel tablets from different manufacturers available in the Bangladeshi market. Clopidogrel is a potent antiplatelet and antithrombotic drug. Clopidogrel has been approved and marketed globally with the primary indication being to reduce atherosclerotic events in patients with several comorbid conditions due to stroke, myocardial infarction and cardiovascular disease. The aim and the objective of our present study are to evaluate the quality parameters of some marketed Clopidogrel tablet and to compare the parameters among them. To assess the quality, three different marketed Clopidogrel 75 mg tablet are selected and invitro dissolution test, potency, disintegration time are carried out. Other general quality parameters of these tablets like weight variation, hardness, friability are also determined according to established protocols. All the brands comply the requirements of United State Pharmacopoeia as they show acceptable weight variation range. Friability of all brands is less than 1%. No significant differences are found in disintegration time as they disintegrate within 15 minutes. In case of dissolution profile all brands show better dissolution time as they release more than 75% of drug in 45 minutes. The hardness of one brand is within the range 40-60N. The limitation of the potency must be within 95- 105%. All three brands meet this specification. This study suggests that most commercially available Clopidogrel tablets in Bangladesh maintain the quality and comply with the USP specifications which are essential for better therapeutic activity of this antiplatelet drug.
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