中国中药杂志

2020, v.45(07) 1657-1663

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银杏内酯B纳米混悬剂的制备及其体外释放研究
Preparation and in vitro release of ginkgolide B nanosuspension

王镜;朱君君;申宝德;张婷;朱雅宁;袁海龙;
WANG Jing;ZHU Jun-jun;SHEN Bao-de;ZHANG Ting;ZHU Ya-ning;YUAN Hai-long;School of Pharmacy, Chengdu University of Traditional Chinese Medicine;Department of Pharmacy,Air Force Medical Center, PLA;

摘要(Abstract):

制备银杏内酯B纳米混悬剂(ginkgolide B nanosuspension, GB-NS),并考察其体外溶出行为。采用微型化介质研磨法制备GB-NS,以平均粒径(PS)和多分散指数(PDI)为评价指标,单因素试验法优化其处方,Box-Behnken效应面法优化其制备工艺;使用扫描电镜(SEM)和X射线衍射(XRD)考察其形态与结晶度;使用桨法考察其体外溶出度。以最优处方和工艺制备的GB-NS的PS为(180±7) nm,PDI为0.196±0.036;SEM显示GB-NS呈棒状或不规则的颗粒状,XRD显示GB-NS的结晶度较GB原料药明显减弱;体外溶出试验结果显示GB-NS在30 min内累积溶出度接近90%,显著优于GB原料药。结果表明介质研磨法能较好的应用于GB-NS的制备,且工艺简单、高效可行。GB原料药制备为GB-NS后溶出度显著提高。
To prepare ginkgolide B nanosuspension(GB-NS), and investigate its dissolution behaviors in vitro. The miniaturized media milling method was used to prepare nanosuspensions, with average particle size and polydispersity index as the evaluation indexes. The formulation and process of GB-NS were optimized by single factor experiment and Box-Behnken design-response surface method. The morphology was observed by scanning electron microscope(SEM), and thecrystallinity of GB-NS was investigated by X-rays diffraction(XRD). The paddle method was used to study the dissolution of GB-NS in vitro. The mean particle size of optimized GB-NS was(180±7) nm, with a polydispersity index of 0.196±0.036. SEM showed that GB-NS was rod-like or irregular granular. XRD showed that the crystallinity of GB-NS was significantly reduced compared with GB raw material. The cumulative dissolution rate of GB-NS reached 90% in 30 min, which was higher than that of GB raw material. The findings suggested that the miniaturized media milling method was simple, efficient and feasible to prepare GB-NS. And the dissolution rate of GB was significantly improved by nanosuspension technology.

关键词(KeyWords): 银杏内酯B;纳米混悬剂;介质研磨法;效应面法;累积溶出度
ginkgolide B;nanosuspension;media milling;response surface method;cumulative dissolution

Abstract:

Keywords:

基金项目(Foundation): 军队后勤科研重点项目(BKJ16J011);; 全军医学科技青年培育计划拔尖项目(17QNP028)

作者(Author): 王镜;朱君君;申宝德;张婷;朱雅宁;袁海龙;
WANG Jing;ZHU Jun-jun;SHEN Bao-de;ZHANG Ting;ZHU Ya-ning;YUAN Hai-long;School of Pharmacy, Chengdu University of Traditional Chinese Medicine;Department of Pharmacy,Air Force Medical Center, PLA;

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DOI: 10.19540/j.cnki.cjcmm.20200207.306

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