20()-原人参二醇自微乳释药系统的处方优化和有效期预测

王冰; 浦益琼; 徐本亮; 张彤; 陶建生

doi:10.13422/j.cnki.syfjx.2016220001

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20()-原人参二醇自微乳释药系统的处方优化和有效期预测

药剂与炮制 | 更新时间：2024-01-04

- 20()-原人参二醇自微乳释药系统的处方优化和有效期预测
- Prescription Optimization and Expiration Term Prediction of 20 ()-Protopanaxadiol Self-microemulsion Drug Delivery System
- 中国实验方剂学杂志 2016年22卷第22期页码：1-6
- 作者机构：
- 作者简介：
- 基金信息：
  
  国家自然科学基金项目（81303233）
- DOI：10.13422/j.cnki.syfjx.2016220001
  中图分类号： R283.6
- 纸质出版日期：2016
- 稿件说明：
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王冰, 浦益琼, 徐本亮, 等. 20()-原人参二醇自微乳释药系统的处方优化和有效期预测[J]. 中国实验方剂学杂志, 2016,22(22):1-6.

WANG Bing, PU Yi-qiong, XU Ben-liang, et al. Prescription Optimization and Expiration Term Prediction of 20 ()-Protopanaxadiol Self-microemulsion Drug Delivery System[J]. Chinese journal of experimental traditional medical formulae, 2016, 22(22): 1-6.
王冰, 浦益琼, 徐本亮, 等. 20()-原人参二醇自微乳释药系统的处方优化和有效期预测[J]. 中国实验方剂学杂志, 2016,22(22):1-6. DOI： 10.13422/j.cnki.syfjx.2016220001.

WANG Bing, PU Yi-qiong, XU Ben-liang, et al. Prescription Optimization and Expiration Term Prediction of 20 ()-Protopanaxadiol Self-microemulsion Drug Delivery System[J]. Chinese journal of experimental traditional medical formulae, 2016, 22(22): 1-6. DOI： 10.13422/j.cnki.syfjx.2016220001.

摘要

目的：优化20（S）-原人参二醇自微乳释药系统处方并预测其有效期。方法：以油相中油酸质量分数、油相比例、乳化剂与助乳化剂比值为自变量，载药量，粒径，Zeta电位和优选10 min时药物溶出度为因变量，采用星点设计-效应面法优选20（S）-原人参二醇自微乳的处方组成；利用单因素试验优选制备工艺；通过Q10法在较高温度下进行加速试验，预测该制剂的有效期。结果：自微乳的最佳处方为油相中油酸质量分数84.09%，油相比例30%，乳化剂-助乳化剂（2.58：1）；载药量102.22 mg·g-1，粒径39.67 nm，Zeta电位-13.1 mV，10 min时药物溶出度75.01%。制备工艺参数为混合方式为磁力搅拌，混合速度400 r·min-1，混合时间30 min，混合温度45℃。Q10法预测自微乳的室温贮存有效期约1.51年。结论：优选的制剂处方合理、工艺可行、样品稳定性良好，可为20（S）-原人参二醇的新型制剂探索提供研究数据。

Abstract

Objective: To optimize prescription of 20 (S)-protopanaxadiol self-microemulsifying drug delivery system (PPD-SMEDDS) and predict its expiration term. Method: Ratio of oleic acid in oil phase

ratio of oil phase and ratio of emulsifier to co-emulsifier were selected as independent variables.Drug loading

particle size

Zeta-potential and dissolution of PPD in 10 min were set as dependent variables.Central composite design-response surface methodology was applied to optimize prescription of PPD-SMEDDS

and then its preparation technology was investigated by single factor tests.Q10 method was adopted to predict the expiration term by the accelerated test at high temperature. Result: Optimal prescription was as following

ratio of oleic acid in oil phase was 84.09%

ratio of oil phase was 30%

ratio of emulsifier to co-emulsifier was 2.58:1.Under these conditions

drug loading was 102.22 mg·g-1

the particle size was 39.67 nm

the Zeta potential was -13.1 mV

dissolution of PPD in 10 min was 75.01%.The process parameters were determined as:magnetic stirring

the mixing speed of 400 r·min-1

the mixing time of 30 min

the mixing temperature of 45℃.The expiration term at room temperature of PPD-SMEDDS was about 1.51 years by Q10 method. Conclusion: These optimized processes are stable and feasible with good stability of samples

which can provide some research data for the new preparations exploration of PPD.

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