Box-Behnken响应面法优化穿心莲内酯自微乳的制备工艺
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篇名: Box-Behnken响应面法优化穿心莲内酯自微乳的制备工艺
TITLE:
摘要: 目的:优化穿心莲内酯自微乳的制备工艺。方法:以外观、滴入水相中颜色为指标筛选乳化剂、助乳化剂、油相种类;以伪三元相图筛选各基质的用量范围;以粒径、分散指数、平衡溶解度为考察指标,以综合评分为响应值,以乳化剂质量分数、助乳化剂质量分数、油相质量分数为响应因子,采用Box-Behnken响应面法优化穿心莲内酯自微乳的制备工艺。结果:优化的穿心莲内酯自微乳制备工艺以聚氧乙烯氢化蓖麻油为乳化剂,二乙二醇单乙基醚为助乳化剂,油酸聚乙二醇甘油酯为油相,三者质量比为40 ∶ 59 ∶ 10。在此工艺条件下制得的自微乳粒径为(38.15±1.56)nm、分散指数为0.12±0.01、平衡溶解度为(5.97±0.02)mg/mL,与预测值(39.72 nm、0.11、6.04 mg/mL)的相对误差分别为3.95%、3.54%、1.16%,实测值与预测值一致性良好。结论:优化所得穿心莲内酯自微乳制备工艺稳定、可行,适用于该制剂的制备。
ABSTRACT: OBJECTIVE: To optimize the preparation technology of Andrographolide self-microemulsion. METHODS: The types of emulsifier, co-emulsifer and oilphase were screened with appearance, color of them in water phase as indexes. The amount range of each matrix was screened by using pseudo-ternary phase diagram. The preparation technology of Andrographolide self-microemulsion was optimized by Box-Behnken response surface technology with particle size, dispersion index and equilibrium solubility as evaluation indexes, comprehensive score as response value, using mass fraction of emulsifier, mass fraction of co-emulsifier and mass fraction of oil phase as response factors. RESULTS: The optimal preparation technology of Andrographolide self-microemulsion included that polyoxyethylene hydrogen sesame oil as emulsifier, diethylene glycol mono ethyl ether as emulsifier, oleic acid polyethylene glycol glyceride as oil phase, with weight ratio of 40 ∶ 59 ∶ 10. Under the condition, particle size of obtained self-microemulsion was (38.15±1.56) nm, dispersion index was 0.12±0.01 and equilibrium solubility was (5.97±0.02) mg/mL, relative error of which to predicted value (39.72 nm, 0.11, 6.04 mg/mL) were 3.95%, 3.54%, 1.16%. The measured value was in good agreement with the predicted value. CONCLUSIONS: The optimal Andrographolide self- microemulsion is stable, feasible and suitable for the preparation of the self-microemulsion.
期刊: 2018年第29卷第24期
作者: 龙凯花,王春柳,李晔,张红,刘洋,孙婷婷,宗时宇
AUTHORS: LONG Kaihua,WANG Chunliu,LI Ye,ZHANG Hong,LIU Yang,SUN Tingting,ZONG Shiyu
关键字: 穿心莲内酯;自微乳;制备工艺;Box-Behnken响应面法;伪三元相图;粒径;分散指数;平衡溶解度
KEYWORDS: Andrographolide; Self-microemulsion; Preparation technology; Box-Behnken response surface methodology; Pseudo-ternary phase diagram; Particle size; Dispersion index; Equilibrium solubility
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