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[药物浓度和混合工艺对低剂量华法林片剂混合物料含量均匀度的影响]

[Influence of drug concentration and blending technology on the content uniformity of mixture for low dose warfarin tablets].

作者信息

Elbl Jan, Muselík Jan, Franc Aleš, Mikušová Jana, Dolejší Zuzana, Vetchý David

出版信息

Ceska Slov Farm. 2016 Winter;65(6):211-215.

Abstract

Warfarin is a drug with narrow therapeutic index. Individualization of dose and thorough therapy monitoring is compensated by long time use in praxis and low therapy cost. Considering the low dose usually administered, critical parameter of solid dosage form is its uniformity of content. It has to not only meet the criteria set by pharmacopoeia, but to meet them on statisticall significant level also.This experimental study asseses impact of warfarin concentration and blending time after adition of lubricant on uniformity of content of mixtures and tablets made of them. It concludes, that concentration in 2-2,7% range is optimal and its increase or decrease has a negative effect on uniformity of content. It also confirms 5 minutes of blending after lubricant addition to be adequate, as employing longer blending times leads to mixture overblending.Key words: content uniformity warfarin blending time narrow therapeutic index.

摘要

华法林是一种治疗指数狭窄的药物。在实践中,通过长时间使用和较低的治疗成本来弥补剂量个体化和全面的治疗监测。考虑到通常使用的低剂量,固体剂型的关键参数是其含量均匀度。它不仅要符合药典规定的标准,还要在统计学显著水平上符合这些标准。本实验研究评估了添加润滑剂后华法林浓度和混合时间对混合物及其制成的片剂含量均匀度的影响。研究得出结论,2-2.7%范围内的浓度是最佳的,浓度的增加或降低都会对含量均匀度产生负面影响。研究还证实,添加润滑剂后混合5分钟就足够了,因为混合时间过长会导致混合物过度混合。关键词:含量均匀度;华法林;混合时间;治疗指数狭窄

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