一般补益胶囊的体外生物制药研究

Feruza Maksudova, Zukhridin Mamatkulov, Nargiza Vakhidova, Davronbek Narzullaev
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引用次数: 0

摘要

现代药物质量的主要指标之一是生物制药指标,特别是固体剂型的“溶出度”试验,以及考虑到其治疗效果的增加和对生物体的副作用的减少,为创造新药和改进现有药物提供理论和实验依据。本文介绍了塔什干制药研究所对印度人参“溶出度”测试的研究结果。固体剂型中药物溶出率的测定是在“旋转筐”装置上进行的。采用《国家药典》第十四版(spxiv)中公认的“转篮法”研究所分析的胶囊剂型中活性物质的释放率。根据实验结果,选择体外法测定所分析胶囊生物利用度的条件如下:为了确定溶出度,连续使用两种溶出介质——0.1 M盐酸溶液(胶囊应在60分钟内不溶解)和pH为7.4的磷酸盐缓冲溶液(至少75%的活性物质应在45分钟内释放),介质体积为1000 ml,筐转速为100转/分,温度范围为37±10℃。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Biopharmaceutical study of general tonic capsules by in vitro method
One of the main indicators of the quality of modern drugs are biopharmaceutical indicators, in particular, the “Dissolution” test - for solid dosage forms, as well as theoretical and experimental justification for the creation of new drugs and improvement of existing ones, taking into account the increase in their therapeutic effect and the reduction of side effects on organism. The article presents the results of research on the development of the “Dissolution” test for Indian ginseng, conducted at the Tashkent Pharmaceutical Institute. Determination of the dissolution rate of drugs from solid dosage forms is carried out on the device “Rotating basket”. To study the release rate of active substances from the analyzed encapsulated dosage form, the generally accepted method “Rotating basket” included in the XIV edition of the State Pharmacopoeia (SP XIV) was used. Based on the results of the experiments, the following conditions for determining the bioavailability of the analyzed capsules by the in vitro method were selected: to determine the dissolution profile, two dissolution media are used in succession - a 0.1 M solution of hydrochloric acid (capsules should not dissolve within 60 minutes) and - a phosphate buffer solution with pH 7 ,4 (at least 75% of the active substances should be released within 45 minutes), the volume of the medium is 1000 ml, the rotation speed of the basket is 100 rpm, the temperature regime is 37±10 o C.
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