| 响应面法优化祛风止痛膏基质组方及其皮肤安全性试验 |
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| 引用本文： | 田昊,包海鹰,图力古尔.响应面法优化祛风止痛膏基质组方及其皮肤安全性试验[J].中国实验方剂学杂志,2015,21(23):1-6. |
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| 作者姓名： | 田昊 包海鹰 图力古尔 |
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| 作者单位： | 吉林农业大学中药材学院, 食药用菌教育部工程研究中心, 长春 130118,吉林农业大学中药材学院, 食药用菌教育部工程研究中心, 长春 130118,吉林农业大学中药材学院, 食药用菌教育部工程研究中心, 长春 130118 |
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| 基金项目： | 国家自然科学基金项目(31270088);长江学者和创新团队发展计划项目(IRT1134) |
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| 摘 要： | 目的:改良传统祛风止痛膏的基质处方并考察其皮肤安全性,为提高该制剂的患者依从性提供参考。方法:以外观、涂抹性、黏稠度、离心稳定性和p H为评价指标,筛选祛风止痛软膏的基质组成,采用响应面法对该制剂的油相水相比、甘油、聚氧乙烯-2(21)硬脂醇醚(72/721乳化剂)和硬脂酸添加量进行优化,改良后的剂型进行皮肤刺激性、皮肤过敏性及皮肤急性毒性试验。结果:改良祛风止痛膏软膏的基质组成配比为甘油添加量16.5 g,72/721乳化剂添加量25.5 g,硬脂酸添加量26 g,油相-水相(1∶7.8)。经皮肤刺激性试验、过敏性试验、皮肤急性毒性试验证明祛风止痛膏软膏无刺激性、过敏性及皮肤毒性。结论:改良后的祛风止痛膏软膏制备工艺优良,制剂性能稳定,外用安全无毒。
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| 关 键 词： | 安全性 基质配方 祛风止痛膏 软膏剂 皮肤刺激性试验 皮肤过敏性试验 |
| 收稿时间： | 2015/5/20 0:00:00 |
Optimization of Matrix Formulation of Qufeng Zhitong Ointments by Response Surface Methodology and Its Skin Safety Test |
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| TIAN Hao,BAO Hai-ying and BAU Tolgor.Optimization of Matrix Formulation of Qufeng Zhitong Ointments by Response Surface Methodology and Its Skin Safety Test[J].China Journal of Experimental Traditional Medical Formulae,2015,21(23):1-6. |
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| Authors: | TIAN Hao BAO Hai-ying and BAU Tolgor |
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| Institution: | Engineering Reseach Center of Edible and Medicinal Fungi, Ministry of Education, College of Chinese Medicinal Materials, Jilin Agriculture University, Changchun 130118, China,Engineering Reseach Center of Edible and Medicinal Fungi, Ministry of Education, College of Chinese Medicinal Materials, Jilin Agriculture University, Changchun 130118, China and Engineering Reseach Center of Edible and Medicinal Fungi, Ministry of Education, College of Chinese Medicinal Materials, Jilin Agriculture University, Changchun 130118, China |
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| Abstract: | Objective: To improve matrix composition of Qufeng Zhitong ointments and check its skin safety. Method: Taking appearance,ductility,viscosity,pH value and centrifugal stability as comprehensive evaluation index,response surface methodology was employed to optimize matrix formulation with ratio of oil phase to water phase,amounts of stearic acid,glycerin and 72/721 emulsifier as factors.Then its skin irritation,skin allergy and acute skin toxicity was investigated. Result: The best matrix formulation of Qufeng Zhitong was as followings:glycerin of 16.5 g,72/721 emulsifier of 25.5 g,stearic acid of 26 g,oil phase-water phase (1:7.8).The ointments showed no skin irritation,allergy and toxicity. Conclusion: After being improved,Qufeng Zhitong ointments has good preparation,stable performance and no-toxic for external use. |
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| Keywords: | safety matrix formulation Qufeng Zhitong ointments ointments skin irritation test skin allergy test |
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