乳剂型凝胶剂预混辅料的初步研制

发布时间：2019-01-25 19:15

【摘要】：该实验旨在研究乳剂型凝胶剂预混辅料。以最为常用、成本低廉和工艺简单等为标准筛选辅料和设计配方。采用星点设计-效应面法进行实验设计,以主观评分为指标,使用Design-Expert 8.0.6 Trial进行数据拟合与分析,绘制三维效应曲面图和二维等高线图。结果确定最佳范围为A(卡波姆940):0.05~0.065 g;B(蓖麻油):1.00~1.12 m L;C[聚氧乙烯脱水山梨醇单油酸酯(吐温-80)]:0.15 m L。选取最佳配方为卡波姆0.057 5 g,蓖麻油1.1 m L,吐温-80 0.15 m L。对制得的基质进行了初步稳定性评价和一些流变学特性如黏度、触变性的考察。并以此最佳配方为基质,分别以98%芦丁、98%盐酸小檗碱和98%盐酸小檗胺为主药制备乳剂型凝胶制剂,以0.9%生理盐水为接收液,1 h内3种制剂的透皮量均在1%以下。可见,该基质具有发展成为预混辅料的潜力。该配方制得的乳剂型凝胶基质具有较好外观,具有一定的稳定性、较好黏度和触变性,在1 h内无皮肤刺激性。
[Abstract]:The purpose of this experiment is to study the premixed excipient of emulsion gel. The most commonly used, low-cost and simple process for screening excipients and design formulations. The star design-effect surface method is used for experimental design. The subjective score is taken as the index, and Design-Expert 8.0.6 Trial is used for data fitting and analysis, and 3D effect surface map and two-dimensional contour map are drawn. The results showed that the optimum range was as follows: a (Carbomer 940): 0.05n 0.065 g / B (castor oil): 1.00 ~ 1.12 mL ~ (-1) C [polyoxyethylene dehydrated sorbitol monooleate (Tween-80)]: 0.15 mL. The optimum formula is Carbomer 0.057 g, castor oil 1.1 mL, Tween-80 0.15 mL. The initial stability evaluation and some rheological properties such as viscosity and thixotropy of the prepared matrix were investigated. The emulsion gel was prepared with 98% rutin, 98% berberine hydrochloride and 98% berbamine hydrochloride, and 0.9% normal saline was used as the receiving solution. The transdermal volume of the three preparations was less than 1% within 1 h. It can be seen that the matrix has the potential to develop into premixed excipients. The gel matrix prepared by this formula has good appearance, stability, good viscosity and thixotropy, and no skin irritation within 1 h.
【作者单位】：北京中医药大学中药学院;
【基金】：北京中医药大学研究生自主课题项目(2016-JYB-XS063)
【分类号】：R943

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