香砂养胃口服微乳的处方优选及理化性质、稳定性考察.pdf

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