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香砂养胃口服微乳的处方优选及理化性质、稳定性考察.pdf

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香砂养胃口服微乳的处方优选及理化性质、稳定性考察 * # 张 婧 ,王木生,杨 明,廖正根 ,王 森(江西中医学院现代中药制剂教育部重点实验室,南昌市 330004) 中图分类号 R284.1;R283.62 文献标识码 A 文章编号 1001-0408(2011)27-2529-05 摘 要 目的:对香砂养胃口服微乳进行处方设计与评价。方法:采用Km 值滴定法绘制伪三元相图,以混合油相含量、聚氧乙烯 35蓖麻油(EL 35)含量、乙醇含量为考察因素,以制剂经热压灭菌前后平均粒径之比为指标,采用星点设计-效应面法优化处方;采 用染色法鉴别微乳类型;并考察制剂的理化性质与稳定性。结果:最优处方为混合油相占4.75%,EL 35占55.72%,乙醇占 25.01%,水提液占14.52%,糖精钠占0.01%;制备微乳为O/W 型微乳,pH 值为4.32±0.04,黏度为(10.1±0.32)mPa ·s ,电导率为 (12.33±0.91)μs ·cm- 1,折光率为1.3904±0.002,平均粒径为(14.0±0.11)nm ,乳滴呈球形,在高速离心、人工胃肠液中及长期留 样稳定性考察中无分层、絮凝。结论:香砂养胃口服微乳处方稳定、可靠。 关键词 微乳;香砂养胃;伪三元相图;星点设计-效应面优化法;性质考察 Optimization of the Formula of Xiangsha Yangwei Oral Microemulsion and Physiochemical Property and Stability of It ZHANG Jing ,WANG Mu-sheng ,YANG Ming ,LIAO Zheng-gen ,WANG Sen (Key Laboratory of Modern TC- M Preparation ,Ministry of Education ,Jiangxi College of TCM ,Nanchang 330004,China ) ABSTRACT OBJECTIVE :To design and evaluate the formula of Xiangsha yangwei oral microemulsion. METHODS :Pseu- do-ternary phase diagrams were constructed using Km titration ,The formula was optimized by central composite design-response sur- face methodology with amount of mixed oil phase ,EL35 and ethanol as factors and using ratio of mean particle size before and af- ter hot pressing sterilization as index. The prepared microemulsions were identified by staining method ,and the physiochemical property and stability of preparation were investigated. RESULTS :The optimized formula was made up of 4.75%mixed oil phase , 55.72% EL35,25.01% alcohol ,14.52% water extract ,and 0.01% sodium saccharin. Prepared microemulsion was O/W micro- emulsion. The relevant parameters of identified O/W microemulsion were as follows :pH 4.32±0.04,viscosity (10.1±0.32)mPa · s ,conductivity (12.33±0.91)μs ·cm- 1,refractive index 1.3904±0.002,mean particle size (14.0±0.11)nm. Spherical-shaped par- ticles were found under transmiss
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