赖诺普利口服制剂治疗高血压的理化分析及质量评价

Ebiere Dode, Deghinmotei Alfred-Ugbenbo, Samuel J. Bunu, Akarhiunu Marcus
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摘要

背景:高血压(HT)是世界范围内死亡的主要原因之一,占所有死亡的13%。非洲的大多数心血管疾病暴发是由高血压引起的,尽管全球发现、认识、治疗和控制率很低。目的:分析不同品牌赖诺普利的理化参数及质量评价。方法:采购5个品牌的赖诺普利口服片(10mg),编号为LSP1、LSP2、LSP3、LSP4、LSP5。使用美国药典(USP)中列出的标准程序对所有品牌进行了不同的测试,包括重量均匀性、标准化、提取、滴定(水和非水)分析和质量测定。结果:各品牌赖诺普利均符合重量均匀性试验。LSP1符合水滴定分析的标准纯度范围(98.5%),而其他品牌的纯度接近但不符合规定的标准,纯度分别为82.2% (LSP2), 75.5% (LSP3), 87.1% (LSP4)和75.6% (LSP5)。对于非水滴定,LSP1和LSP2符合USP中列出的标准纯度百分比,分别为100.65% (LSP1)和97.55% (LSP2)。这些品牌的纯度分别为72.78% (LSP3)、88.26% (LSP4)和88.26% (lsp5)。结论:本研究方法具有快速、高效、经济、技术含量低、重复性好等优点,可用于患者常用固体剂型的质量评价和理化分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Physicochemical analysis and quality assessment of Lisinopril oral formulations used in the management of hypertension
Background: Hypertension (HT) is one of the primary causes of death worldwide, accounting for 13% of all deaths. Most cardiovascular disease (CVD) outbreaks in Africa are driven by hypertension, although global detection, awareness, treatment, and control rates are low. Aim: the study aimed to analyze the physicochemical parameters and quality assessment of different brands of Lisinopril. Method: Five (5) brands of Lisinopril oral tablets (10mg) were purchased and coded LSP1, LSP2, LSP3, LSP4, and LSP5. Different test including weight uniformity, standardizations, extraction, titrimetric (aqueous and non-aqueous) analysis, and quality determination of all the brands was conducted using standard procedures outlined in the United States Pharmacopoeia (USP). Result: All brands of Lisinopril used in the analysis conformed to the weight uniformity test. LSP1 conformed to the standard purity range in aqueous titrimetric analysis (98.5%), while the other brands had a close percentage but did not fall within the stated standard with a percentage purity of 82.2% (LSP2), 75.5% (LSP3), 87.1% (LSP4), and 75.6% (LSP5), respectively. For the non-aqueous titration, LSP 1 and LSP 2, conform to the standard percentage purity outlined in the USP, with 100.65% (LSP1), and 97.55% (LSP2). The brands had a percentage purity of 72.78% (LSP3), 88.26% (LSP4), and 88.26% (LSP 5), respectively. Conclusion: the method used in this study can be easily employed in the quality assessment and physicochemical analysis of solid dosage formulations commonly utilized by patients because it is rapid, efficient, cost-effective, less technical and reproducible.
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