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首页> 外文期刊>International Journal of Pharmacy and Pharmaceutical Sciences >IN VITRO EVALUATION OF DISSOLUTION PROFILE OF TWO COMMERCIALLY AVAILABLE FOLIC ACID PREPARATIONS
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IN VITRO EVALUATION OF DISSOLUTION PROFILE OF TWO COMMERCIALLY AVAILABLE FOLIC ACID PREPARATIONS

机译:两种市售叶酸制剂的溶解特性的体外评估

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摘要

Objectives: Folic acid is a water-soluble B vitamin that is naturally present in some foods such as dark green leafy vegetables and dairy products, added to others such as fortified breads, and available as a dietary supplement. In a study performed in the United States, out of nine multivitamin products, only three products met US Pharmacopeia (USP) standard for folic acid dissolution. The aim of this study is to evaluate the dissolution profile of folic acid supplements in the United Arab Emirates according to the USP standards. Methods : Two commercial brands were collected from the market that are commonly prescribed. Water and citrate buffer (pH 6.0) were used as dissolution media. Results : Both products passed the dissolution testing of releasing the required amount of drug substance (75%) within 60 minutes. Also, both products contain an over age of up to 150% of the labeled amount to ensure the availability of the claimed amount. Conclusion : The study indicates that dissolution test is well established, reproducible, reliable and valuable tool for characterizing a drug product at different stages in its lifecycle. The use of citrate buffer showed a significant change in the release of folic acid from the tablets. Keywords : In vitro equivalence, Folic acid, Dissolution, Overage, USP.
机译:目标:叶酸是一种水溶性B族维生素,它天然存在于某些食品中,例如深绿色的叶类蔬菜和乳制品,还可以添加到其他食品(例如强化面包)中,并且可以作为膳食补充剂使用。在美国进行的一项研究中,在九种复合维生素产品中,只有三种产品符合美国药典(USP)的叶酸溶解标准。这项研究的目的是根据USP标准评估阿拉伯联合酋长国的叶酸补充剂的溶出度。方法:从市场上收集两个通常规定的商业品牌。水和柠檬酸盐缓冲液(pH 6.0)用作溶解介质。结果:两种产品均通过了溶出度测试,在60分钟内释放了所需量的原料药(75%)。此外,两种产品的超过年龄的标签数量均高达150%,以确保所声明数量的可用性。结论:研究表明,溶出度测试是建立,表征可重复性,可靠和有价值的工具,可用于表征药物产品生命周期中的不同阶段。柠檬酸盐缓冲液的使用显示了叶酸从片剂中释放的显着变化。关键字:体外当量;叶酸;溶解;超量; USP。

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