尼日利亚江户州Okada市售品牌心得安片体外质量比较评价

Oluwatobi O Olakojo, Precious Okpara, Stephanie Ikebiagbo
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摘要

普萘洛尔是一种β受体阻滞剂,用于治疗心律失常和高血压等心血管疾病。开展这项研究是为了检查在尼日利亚埃多州冈田市零售药店销售的7个品牌盐酸心得安40mg片剂制剂的体外质量控制测试。测定了其鉴别、重量变化、脆度、硬度、崩解度、溶出度、含量测定等参数。按照英国药典(BP)标准对其进行了符合性评价。结果表明:片重为155.6±3.2mg ~ 348.2±2.0mg,硬度为1.03±0.17 ~ 10.70±0.90 kg/cm2,除1个品牌外,脆碎度< 1%,崩解时间为1.37±0.15 ~ 18.05±2.88 min,其中2个品牌为无包衣片,崩解时间为90.07±1.15 ~ 102±1.62%,其中1个品牌偏离规定限量。7个批次在30min内释放出80%以上的药物含量。相似因子分析表明,除PN-7外,所有品牌均可与PN-1在溶出度方面互换。研究表明,除tpn -6不符合大部分药典标准外,经检验的普萘洛尔样品均通过药典检验,质量满意。因此,不是所有的品牌都可以在临床实践中互换使用。
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Comparative In Vitro Quality Evaluation of Brands of Propranolol Tablet Marketed in Okada, Edo State, Nigeria.
Propranolol, a beta-blocker is used in the management of cardiovascular conditions such as irregular heart rate and high blood pressure.The study was carried out to examine the in vitro quality control tests for seven brands of propranolol hydrochloride 40mg tablet formulation, sold in retail pharmacies in Okada, EdoState, Nigeria. The parameters determined were identification, weight variation, friability, hardness, disintegration, dissolution rate, and assay of the tablets. The tablets were evaluated for conformity with British Pharmacopoeia (BP) standards. Results obtained showed tablet weight in the range of 155.6±3.2mg to 348.2±2.0mg, hardness ranged from 1.03±0.17to 10.70±0.90 kg/cm2, friability of < 1 % except for one brand, disintegration time of 1.37±0.15 to 18.05±2.88 min whereby two brands are uncoated tablets and assay of 90.07 ±1.15 to 102±1.62% with one brand deviating from the specified limit. The seven batches also released more than 80% of their drug content within 30min. Analysis of similarity factor revealed that all brands but PN-7 can be interchangeable with PN-1 in terms of dissolution profile. The study showed that propranolol samples examined passed all the Pharmacopoeial tests for satisfactory quality exceptPN-6 which did not comply with most of the Pharmacopoeial specifications. Thus, not all brands can be used interchangeably in clinical practice.
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