氯沙坦钾缓释双层片的处方与评价

IF 0.4 Q4 PHARMACOLOGY & PHARMACY
T. Sandhya
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引用次数: 4

摘要

导读:心脏病是世界上非常常见的死亡原因。高血压是最常见的心脏病。氯沙坦治疗原发性高血压和充血性心力衰竭具有良好的临床疗效。单剂量氯沙坦可使血压降低维持6-8小时,因此需要在一天内重复用药以维持血压。因此,本研究的目的是研制氯沙坦钾缓释片,该缓释片的速释层在10 min内释放药物,速释层在一段时间内保持均匀的药物水平。材料和方法:本研究工作是为部分完成药学硕士学位而进行的。对其进行厚度、硬度、直径、重量变化、含量均匀性、脆性和体外释药研究。体外药物释放研究使用USP II型仪器(桨式法),在900 ml 0.1N HCl中以50 rpm的速度进行前2小时的溶出,然后用900 ml pH 6.8磷酸盐缓冲液替换,在37±0.5°C下进行剩余时间。结果:傅里叶变换红外和差示扫描量热分析结果表明,药物与其他赋形剂无物理化学相互作用。优化后的ME5在400C/75%RH条件下3个月的稳定性研究表明,其口感参数和释放度没有变化。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Formulation and Evaluation of Sustained Release Bilayer Tablets of Losartan Potassium
Introduction: Heart disease is very common cause of deaths in the world. Hypertension is the most prevalent form of heart disease. Losartan has wonderful clinical effectiveness in the treatment of essential hypertension and congestive heart failure. Single dose of losartan can maintain the lowering of blood pressure up to 6–8 h. Hence, repetitive medication is required in a day to maintain the blood pressure. Hence, the aim of this work is to formulation and evaluate of sustained release (SR) bilayer tablet of losartan potassium in which the immediate release layer will release the drug within 10 min and SR layer will maintain uniform drug levels over a sustained period of time. Materials and Methods: This research work is performed for the partial fulfillment of the degree of master of pharmacy. The tablets were evaluated to thickness, hardness, diameter, weight variation, drug content uniformity, friability, and in vitro drug release studies. In vitro drug release studies were performed using USP type II apparatus (paddle method) at 50 rpm in 900 ml of 0.1N HCl as dissolution medium for first 2 h and later replacing it with 900 ml pH 6.8 phosphate buffer solution for the remaining time period at 37±0.5°C. Results: The results of Fourier transform infrared and differential scanning calorimetry analysis showed that there was no physical and chemical interaction between drug and other excipients. The stability studies of optimized formulation ME5 at 400C/75%RH for 3 months did not show any variation in the tasted parameter and release.
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来源期刊
Asian Journal of  Pharmaceutics
Asian Journal of Pharmaceutics PHARMACOLOGY & PHARMACY-
自引率
0.00%
发文量
47
期刊介绍: Character of the publications: -Pharmaceutics and Pharmaceutical Technology -Formulation Design and Development -Drug Discovery and Development Interface -Manufacturing Science and Engineering -Pharmacokinetics, Pharmacodynamics, and Drug Metabolism -Clinical Pharmacology, General Medicine and Translational Research -Physical Pharmacy and Biopharmaceutics -Novel Drug delivery system -Biotechnology & Microbiological evaluations -Regulatory Sciences
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