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巴基斯坦卡拉奇市不同品牌多潘立酮片的评估与比较。

Evaluation and comparison of different brands of domperidone tablets available in Karachi, Pakistan.

作者信息

Khan Muhammad Qamar, Razvi Nighat, Anjum Fakhsheena, Ghazal Lubna, Siddiqui Saeed Ahmed, Shoaib Muhammad Harris

机构信息

Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.

Dow College of Pharmacy, Dow University of Health Sciences, Karachi, Pakistan.

出版信息

Pak J Pharm Sci. 2014 Jul;27(4):935-8.

PMID:25015463
Abstract

Domperidone is an anti-dopaminergic drug used for the treatment of nausea, vomiting and dyspepsia. It has also been used in Parkinson's disease. In this study, five different brands of Domeperidone tablets were selected from the local market for evaluation of their quality as the local market is occupied of many competitors for a single generic. The evaluation of Domperidone tablets was done using various pharmacopoeial and non-pharmacopoeial tests. All the test results fell within BP specified limits for all the selected brands i.e. the results for Brands A to E for weight variation, thickness and diameter were satisfactory and within limits. For Brands A to E, the results for hardness and friability were also satisfactory i.e. 4-10kg/cm2and 0.1-0.6% respectively. The results for Brands A to E for disintegration were 2-6 minutes; for dissolution and assay, the results were 89-92% and 95-99% respectively. The results of similarity factor (f2) also showed that all brands of Domperidone have comparative dissolution profiles.

摘要

多潘立酮是一种抗多巴胺能药物,用于治疗恶心、呕吐和消化不良。它也被用于帕金森病的治疗。在本研究中,从当地市场挑选了五个不同品牌的多潘立酮片,以评估其质量,因为当地市场上单一通用名药品有众多竞争对手。多潘立酮片的评估采用了各种药典和非药典测试方法。所有测试结果均在英国药典规定的所选所有品牌的限度内,即A至E品牌在重量差异、厚度和直径方面的结果令人满意且在限度内。对于A至E品牌,硬度和脆碎度的结果也令人满意,分别为4 - 10kg/cm²和0.1 - 0.6%。A至E品牌的崩解时间为2 - 6分钟;溶出度和含量测定结果分别为89 - 92%和95 - 99%。相似性因子(f2)的结果也表明,所有品牌的多潘立酮具有相似的溶出曲线。

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