巴基斯坦卡拉奇市不同品牌利奈唑胺600 mg片剂溶出度与崩解度比较研究

Uddin As
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引用次数: 1

摘要

溶出崩解试验(USP)广泛用于安全有效药物的测定以及药品的稳定性和质量。研究了产自巴基斯坦卡拉奇的利奈唑胺600 mg片剂的崩解、溶出度,并通过重量变化和硬度试验对其质量进行了评价。所有品牌的重量变化试验均在正常范围内,所有品牌的硬度也在正常范围内。崩解时间按规格执行,除C3品牌崩解时间为3.98 min外,其余片剂均在30 min内崩解,崩解时间较长。虽然各品牌的溶出率均较好,但与不同品牌相比,C1的释药百分率最好,即30分钟内药物100%溶出。溶出度试验是一种较为有效和经济的体外方法,可用于评价制剂的释放特性。结果表明,与其他品牌相比,C1和C2品牌具有更好的溶出度。虽然,C3和C4也被发现在限制范围内,即药物标签量的80%。
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Comparative Dissolution and Disintegration Study of Different Brands of Linezolid 600 mg Tablets Available in Karachi, Pakistan
The dissolution and disintegration tests (USP) are extensively useful for the determination of the safe and effective drugs as well as used for the stability and quality of the drug product. The purpose of the study was to observe the disintegration and dissolution profile (UV spectrophotometer), and estimation of the quality through weight variation and hardness test of different brands of Linezolid 600 mg tablets from Karachi, Pakistan. The weight variation test for all the brands was found to be under normal limits and the hardness of all the brands was also within normal limits. The tablet disintegration time was as per the specifications and all the tablets were disintegrated within 30 minutes except for brand C3, which disintegrates within 3.98 minutes and provided better disintegration time. Although, all the brands showed better dissolution rate, but the percent drug release of C1 was found to be the best, i.e. 100% drug was dissolved in 30 minutes in contrast to the different brands. Dissolution test is comparatively an efficient and cost effective in vitro approach that can be helpful in the assessment of the release attributes of formulation. It was found that brand C1 and C2 exhibited better dissolution profile as compared to other brands. Although, C3 and C4 were also found to be under the limits i.e. 80 % of the label amount of the drug.
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