紫花地丁复方止痒凝剂的处方和制备工艺优选

Optimization of Prescription and Preparation Technology for Herba Violae Compound Anti-itching Gel

目的:考察紫花地丁复方止痒凝胶剂的处方和制备工艺。方法:采用L9(34)正交实验设计,考察凝胶基质种类、甘油用量、氢氧化钠用量3个因素对凝胶剂质量的影响,以凝胶剂的成型性、酸碱度为指标进行综合评价;采用HPLC法对复方止痒凝胶制剂的君药紫花地丁的主要成分秦皮乙素含量进行测定。结果:紫花地丁复方止痒凝胶的最佳处方包括:中药复方止痒浓缩液53.9g、卡波姆940 1.80g、蒸馏水35.9g、无水乙醇5.00g、氮酮1.50g、甘油5.40g、氢氧化钠0.432g,复方止痒凝胶中秦皮乙素平均含量为457.2μg·mL-1。结论:经验证试验,证明所优选的复方止痒凝胶剂制备工艺简单、重复性好、质量可控。

Objective： To investigate the prescription and preparation technology of herba violae com- pound anti-itching gel. Methods： The types of gel matrix, the dosage of glycerin and the dosage of sodium hydroxide were selected as three study factors which could influence the quality gel by L9 （34 ） orthogonal test. The formability of gels and pH value were taken as the indices for the comprehensive evaluation. HPLC was employed to determine the content of esculetin in the herba violae, which was the key medicine of herba violae compound anti-itching. Results.. The best prescription of herba violae compound anti-itching was in- eluded the concentrated herba violae compound anti-itching solution53.9g, carbomer 940 1.80g, distilled water 35.9g, absolute ethyl alcohol 5.00g, azone 1.50g, glycerinum 5.40 g, sodium hydroxide 0,432g. The average content of esculetin in the gel was 457.2tLg mL 1. Conclusion：The verification tests showed that the op- timized preparation technology of the anti-itching compound gel was simple, repeatable and controllable.