柴胡纳米乳凝胶膏的制备工艺及质量评价

Preparation Process and Quality Evaluation of Bupleurum Nanoemulsion Gel Paste

目的:在前期研究出柴胡纳米乳的基础上,进一步制备成凝胶膏,并对其进行初步质量研究。方法:以综合感官评分为指标,对凝胶膏辅料进行筛选,确定凝胶膏的基本处方以及制备工艺,并通过单因素考察和正交实验确定最优处方。考察其性状、气味、赋形性和初黏力,并通过紫外分光光度法测定柴胡纳米乳凝胶膏中柴胡总皂苷的含量,高效液相色谱法测定柴胡纳米乳凝胶膏中柴胡皂苷d的含量。结果:所制成柴胡纳米乳的凝胶膏的最优处方为:NP-700 1.75 g,甘羟铝0.15 g,甘油25 g,柴胡纳米乳8 g,酒石酸0.2 g,PVPK90 0.5 g;柴胡纳米乳凝胶膏为淡黄色半透明凝胶膏,具有独特的柴胡挥发油辛香,无流淌现象,初黏力为15.081 g;紫外分光光度法测得柴胡纳米乳凝胶膏中柴胡总皂苷的含量为2.333 mg/g;高效液相色谱法测得柴胡纳米乳凝胶膏中柴胡皂苷d的含量为0.512 mg/g。结论:本实验研究柴胡纳米乳凝胶膏的制备工艺稳定可行,制备的柴胡纳米乳凝胶膏赋形性好,黏度大,安全性良好,以期丰富柴胡退热制剂的种类,为进一步开发中药凝胶膏提供实验依据。

Objective: On the basis of the previous study of bupleurum nanoemulsion, further preparation of gel paste, and its preliminary quality study. Methods: Taking the comprehensive sensory score as the index, the excipients of the gel paste were screened to determine the basic prescription and preparation process of the gel paste, and the optimal prescription was determined by single factor investigation and orthogonal experiment. The properties, odor, formability and initial viscosity were investigated. The content of total saikosaponin in bupleurum nanoemulsion gel paste was de-termined by ultraviolet spectrophotometry, and the content of saikosaponin d in bupleurum nanoemulsion gel paste was determined by high performance liquid chromatography. Results: The optimal formulation of the gel paste was as follows: NP-700 1.75 g, aluminum glycinate 0.15 g, glyc-erol 25 g, bupleurum nanoemulsion 8 g, tartaric acid 0.2 g, PVPK90 0.5 g;bupleuri Radix nanoemulsion gel paste is a light yellow translucent gel paste, which has a unique spicy volatile oil of Bupleuri Radix, no flow phenomenon, and the initial viscosity is 15.081 g;the content of sai-kosaponin in bupleurum nanoemulsion gel was 2.333 mg/g by UV spectrophotometry. The content of saikosaponin d in bupleurum nanoemulsion gel was 0.512 mg/g by high performance liquid chromatography. Conclusion: In this experiment, the preparation process of bupleurum nanoemul-sion gel ointment is stable and feasible. The prepared bupleurum nanoemulsion gel ointment has good shape, high viscosity and good safety, in order to enrich the types of bupleurum antipyretic preparations and provide experimental basis for further development of traditional Chinese medi-cine gel ointment.