Optimization of Formulation of Erhuangsan Bletillae Rhizoma Gelatin Sustained Release Double-layer Membrane by Central Composite Design-response Surface Methodology

Yan-hong WANG; Liu YANG; Chao WANG; Feng GUAN; Feng-juan HAN

doi:10.13422/j.cnki.syfjx.20182406

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Optimization of Formulation of Erhuangsan Bletillae Rhizoma Gelatin Sustained Release Double-layer Membrane by Central Composite Design-response Surface Methodology

Pharmacy and Processing | 更新时间：2021-02-09

- Optimization of Formulation of Erhuangsan Bletillae Rhizoma Gelatin Sustained Release Double-layer Membrane by Central Composite Design-response Surface Methodology
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 25, Issue 4, Pages: 146-152(2019)
- 作者机构：
  
  1.黑龙江中医药大学　药学院，哈尔滨　 150040；
  2.黑龙江中医药大学　附属第一医院，哈尔滨　 150040
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20182406
  CLC： R22;R94;R28;C37;R736
- Received：25 May 2018，
  
  Published Online：27 September 2018，
  
  Published：20 February 2019
- 稿件说明：
移动端阅览
Yan-hong WANG, Liu YANG, Chao WANG, et al. Optimization of Formulation of Erhuangsan Bletillae Rhizoma Gelatin Sustained Release Double-layer Membrane by Central Composite Design-response Surface Methodology[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(4): 146-152.
DOI：

Yan-hong WANG, Liu YANG, Chao WANG, et al. Optimization of Formulation of Erhuangsan Bletillae Rhizoma Gelatin Sustained Release Double-layer Membrane by Central Composite Design-response Surface Methodology[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(4): 146-152. DOI： 10.13422/j.cnki.syfjx.20182406.

摘要

目的：

以白及胶为主要成膜材料，将临床有效经验方——儿黄散研制开发成阴道用缓释双层膜剂。

方法：

以羟丙基甲基纤维素(HPMC)和白及胶为黄连明矾药膜层的成膜材料，羧甲基纤维素钠(CMC-Na)和白及胶为儿茶药膜层的成膜材料，甘油为增塑剂，制备儿黄散白及胶缓释双层膜，以外观质量(浆液状态、成膜性、脱膜性、均匀性、黏连性、表面光滑度、柔软性)评分、黏附力和体外累积释放度为考察指标，采用星点设计-效应面法优化该膜剂的处方，并对最优处方进行验证。

结果：

儿茶药膜层最优处方组成为CMC-Na质量分数1.61%，白及胶质量分数3.81%，甘油用量8.49%；黄连明矾药膜层最优处方组成为HPMC质量分数1.15%，白及胶质量分数3.41%，甘油体积分数10.02%。

结论：

通过星点设计-效应面法优化的儿黄散白及胶缓释双层膜处方稳定可行，该制剂具有使用方便、药物滞留时间延长等特点，为中医药治疗宫颈癌提供一个可行的现代中药制剂，并为类似中药膜剂的研究积累实验数据。

Abstract

Objective:

With Bletillae Rhizoma gelatin as the main film-forming materials

Erhuangsan was developed into a sustained-release double-layer membrane for vagina.

Method:

Taking hydroxypropyl methyl cellulose(HPMC) and Bletillae Rhizoma gelatin as the film-forming materials of Coptidis Rhizoma-Alumen membrane layer

sodium carboxymethyl cellulose(CMC-Na) and Bletillae Rhizoma gelatin as the film-forming materials of Catechu membrane layer

glycerol as plasticizer

Erhuangsan Bletillae Rhizoma gelatin sustained release double-layer membrane was prepared.Central composite design-response surface methodology was used to optimize formulation of this preparation with appearance quality score

adhesion force and

in vitro

cumulative release as indexes.

Result:

Optimum formulation of Catechu membrane layer was 1.61% of CMC-Na

3.81% of Bletillae Rhizoma gelatin and 8.49% of glycerol; optimum formulation of Coptidis Rhizoma-Alumen membrane layer was 1.15% of HPMC

3.41% of Bletillae Rhizoma gelatin and 10.02% of glycerol.

Conclusion:

The optimized formulation is stable and feasible.Erhuangsan Bletillae Rhizoma gelatin sustained release double-layer membrane has characteristics of advanced dosage form and convenient use

providing a feasible modern Chinese medicine preparation for treatment of cervical cancer

and accumulating data for the research of Chinese medicine film agent.

关键词

Keywords

references

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