Preparation of Indomethacin Solid Dispersions by Kneading Method and Evaluation of Its  Dissolution

ZHANG Wei; ZHENG Xun; ZHANG Zhi-yun; LI Tong; WANG Li-hong; ZHOU Li-li

doi:10.13422/j.cnki.syfjx.2014200031

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Preparation of Indomethacin Solid Dispersions by Kneading Method and Evaluation of Its Dissolution

更新时间：2024-01-04

- Preparation of Indomethacin Solid Dispersions by Kneading Method and Evaluation of Its Dissolution
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 20, Issue 20, Pages: 31-34(2014)
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- DOI：10.13422/j.cnki.syfjx.2014200031
  CLC： R944;TQ460.6
- Published：2014
- 稿件说明：
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ZHANG Wei, ZHENG Xun, ZHANG Zhi-yun, et al. Preparation of Indomethacin Solid Dispersions by Kneading Method and Evaluation of Its Dissolution[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(20): 31-34.
DOI：

ZHANG Wei, ZHENG Xun, ZHANG Zhi-yun, et al. Preparation of Indomethacin Solid Dispersions by Kneading Method and Evaluation of Its Dissolution[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(20): 31-34. DOI： 10.13422/j.cnki.syfjx.2014200031.

摘要

目的：制备水难溶性药物固体分散体并初步考察其稳定性和片剂处方。方法：选择吲哚美辛为模型药物，采用捏合法制备固体分散体，通过单因素试验考察载体种类、捏合剂和捏合时间对固体分散体体外溶出效果的影响。利用粉末X射线衍射法对固体分散体进行表征，考察固体分散体在40 ℃，相对湿度（RH）75%条件下放置的稳定性，采用粉末直接压片法对固体分散体进行压片。结果：优选的制备工艺为以泊洛沙姆188为载体，乙醇-水（1：1）为捏合剂，捏合时间30 min；固体分散体体外溶出效果显著提高，Cmax为原料药的29倍；固体分散体在40 ℃，RH 75%条件下1个月内稳定；制备的固体分散体片外观光洁美观，各项参数均符合2010年版《中国药典》要求。结论：采用捏合法制备的吲哚美辛固体分散体溶出效果显著提高，稳定性好，易于粉末直接压片。

Abstract

Objective: To investigate influencing factors of kneading method for preparing solid dispersions of water-insoluble drugs by dissolution test under condition of supersaturation.Stability and formulation of solid dispersions were also studied preliminarily. Method: Indomethacin was selected as model drug

solid dispersions were prepared by kneading method

impacts of carrier types

kneading solvent and time on dissolution effects were investigated by single factor tests.Indomethacin solid dispersions were characterized by powder X-ray diffraction;stability test was performed under condition of 40 ℃ and relative humidity of 75% in an environmental test chamber;solid dispersions was formulated in a tablet dosage form by direct compression method. Result: Indomethacin solid dispersions were prepared with poloxamer 188 as a carrier

ethanol-water(1:1) as kneading solvent and kneading time of 30 minutes

which performed well in dissolution test and the maximum solution concentration was 29 times that of indomethacin material;solid dispersions was stable within one month under these test condition;these compressed solid dispersion tablets were bright and clean

whose parameters fitted the standard of 2010 edition of 〈Chinese Pharmacopoeia〉. Conclusion: Dissolution of solid dispersions can be enhanced to a great extent by kneading method

they can easily compress to tablets by direct compression method.

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