山楂叶总黄酮固体自乳化颗粒的处方优化和评价

张建; 叶珍珍; 崔升淼

doi:10.13422/j.cnki.syfjx.2012.04.020

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山楂叶总黄酮固体自乳化颗粒的处方优化和评价

工艺与制剂 | 更新时间：2024-09-23

- 山楂叶总黄酮固体自乳化颗粒的处方优化和评价
- Optimization and Evaluation of Prescription for Hawthorn Leaves Flavonoids Solid Self-Emulsifying Granule
- 中国实验方剂学杂志 2012年18卷第4期页码：15-19
- 作者机构：
  
  广东药学院中药学院
- 作者简介：
- 基金信息：
  
  广东省科技计划项目（粤科社字[2011]106号）;广东省科技计划项目（2007B060401058）;广东省中医药局建设中医药强省科研项目（2008172）
- DOI：10.13422/j.cnki.syfjx.2012.04.020
  中图分类号： R283
- 纸质出版日期：2012
- 稿件说明：
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[1]张建,叶珍珍,崔升淼.山楂叶总黄酮固体自乳化颗粒的处方优化和评价[J].中国实验方剂学杂志,2012,18(04):15-19.

ZHANG Jian, YE Zhen-zhen, CUI Sheng-miao. Optimization and Evaluation of Prescription for Hawthorn Leaves Flavonoids Solid Self-Emulsifying Granule[J]. Chinese journal of experimental traditional medical formulae, 2012, 18(4): 15-19.
[1]张建,叶珍珍,崔升淼.山楂叶总黄酮固体自乳化颗粒的处方优化和评价[J].中国实验方剂学杂志,2012,18(04):15-19. DOI： 10.13422/j.cnki.syfjx.2012.04.020.

ZHANG Jian, YE Zhen-zhen, CUI Sheng-miao. Optimization and Evaluation of Prescription for Hawthorn Leaves Flavonoids Solid Self-Emulsifying Granule[J]. Chinese journal of experimental traditional medical formulae, 2012, 18(4): 15-19. DOI： 10.13422/j.cnki.syfjx.2012.04.020.

摘要

目的:制备山楂叶总黄酮固体自乳化颗粒

并对其进行质量评价。方法:通过溶解度考察、伪三元相图的绘制

以形成自乳化效果和自乳化时间为指标

选择最佳自乳化处方。通过对不同处方比例成型率、重分散性及体外溶出度进行综合考察

筛选山楂叶总黄酮固体自乳化颗粒的处方

并对其粒径、Zeta电位、DSC、X-衍射、溶出度进行考察。结果:优化的最佳处方为山楂叶总黄酮-聚山梨醇酯80-Transcutol P-蓖麻油-淀粉-乳糖-甘露醇的质量比为1∶1.5∶1.35∶0.15∶12∶2∶2

其分散后平均粒径（169.3±7.6）nm

30 min溶出度达89.5%。结论:山楂叶总黄酮固体自乳化颗粒制备简单

质量稳定

可以提高药物的溶出度。

Abstract

Objective:To prepare Hawthorn leaves flavonoids solid self-emulsifying granule（HLF-SSEG） and evaluate its quality.Method:With degree of emulsification and emulsifying time as indexes

self-emulsifying prescription was optimized by solubility experiment and ternary phase diagrams.Screened prescription of HLF-SSEG by comprehensive investigating forming ratio of different prescription proportion

re-dispersion and in vitro dissolution

and its particle size and zeta potential

DSC and X-diffraction scan and dissolution were examined.Result:Composition of optimized optimum formulation was as follows:Hawthorn leaves flavonoids-tween80-transcutol P-Castor oil-starch-lactose-mannitol 1∶1.5∶1.35∶0.15∶12∶2∶2

average particle size was（169.3±7.6） nm after dispersed

dissolution was 89.5% in 30 min.Conclusion:HLF-SSEG was easy to prepare and its quality was stable.The dissolution of HLF was dissolution improved by SSEG.

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