| 银杏内酯B自微乳的处方优选及质量、安全性评价 |
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| 引用本文： | 杨鹏飞,丁兰萍,蔡晓蕾,鲁传华,陈卫东. 银杏内酯B自微乳的处方优选及质量、安全性评价[J]. 中国实验方剂学杂志, 2013, 19(12): 26-33 |
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| 作者姓名： | 杨鹏飞 丁兰萍 蔡晓蕾 鲁传华 陈卫东 |
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| 作者单位： | 1. 安徽中医学院药学院药代动力学研究室,合肥230038;安徽省中药制剂工程技术研究中心,合肥230038
2. 安徽中医学院药学院药代动力学研究室,合肥230038;安徽省中药研究与开发重点实验室,合肥230038 |
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| 摘 要： | 目的:优化银杏内酯B(GB)自微乳药物传递系统(SMEDDS)的处方,并初步评价其质量和安全性.方法:以微乳粒径、Zeta电位、药物平衡溶解度为指标,油相质量分数、混合表面活性剂比例、表面活性剂和助表面活性剂的比例为考察因素,采用伪三元相图结合星点设计-效应面法优选GB-SMEDDS的处方工艺.采用HPLC测定GB含量,并对自微乳的pH、形态学、粒径分布、Zeta电位、稳定性及部分安全性等进行评价.结果:最优处方为辛酸/癸酸三甘油脂、聚氧乙烯35蓖麻油、卵磷脂、乙醇质量比25.99∶39.47∶9.87∶24.67,载药量(24±1.4) g·L-1,粒径30 ～ 60 nm,GB-SMEDDS于1周内在常温、高温及低温状态下稳定性良好,通过溶血试验、血管刺激、急性毒性评价给药安全性良好.结论:星点设计-效应面法适用于GB-SMEDDS的处方优化,所建模型预测性良好,且GB自微乳制备工艺简单、性质稳定、质量易控.
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| 关 键 词： | 银杏内酯B 自微乳化给药系统 星点设计-效应面法 质量评价 |
| 收稿时间： | 2012-11-28 |
Optimization of Prescription and Evaluation of Quality and Security of Ginkgolide B Self-microemulsifying Drug Delivery System |
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| YANG Peng-fei,DING Lan-ping,CAI Xiao-lei,LU Chuan-hua and CHEN Wei-dong. Optimization of Prescription and Evaluation of Quality and Security of Ginkgolide B Self-microemulsifying Drug Delivery System[J]. China Journal of Experimental Traditional Medical Formulae, 2013, 19(12): 26-33 |
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| Authors: | YANG Peng-fei DING Lan-ping CAI Xiao-lei LU Chuan-hua CHEN Wei-dong |
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| Affiliation: | Pharmacokinetics Laboratory, College of Pharmacy, Anhui University of Traditional Chinese Medicine, Hefei 230038, China;Anhui Province Engineering Research Center of Chinese Materia Medica Preparations, Hefei 230038, China;Pharmacokinetics Laboratory, College of Pharmacy, Anhui University of Traditional Chinese Medicine, Hefei 230038, China;Anhui Province Engineering Research Center of Chinese Materia Medica Preparations, Hefei 230038, China;Pharmacokinetics Laboratory, College of Pharmacy, Anhui University of Traditional Chinese Medicine, Hefei 230038, China;Anhui Province Engineering Research Center of Chinese Materia Medica Preparations, Hefei 230038, China;Pharmacokinetics Laboratory, College of Pharmacy, Anhui University of Traditional Chinese Medicine, Hefei 230038, China;Anhui Province Key Laboratory of Research and Development of Chinese Materia Medica, Hefei 230038, China;Pharmacokinetics Laboratory, College of Pharmacy, Anhui University of Traditional Chinese Medicine, Hefei 230038, China;Anhui Province Key Laboratory of Research and Development of Chinese Materia Medica, Hefei 230038, China |
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| Abstract: | |
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| Keywords: | ginkgolide B self-microemulsifying drug delivery system central composite design-response surface method quality evaluation |
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