复方胰岛素凝胶的研制及含量测定

Preparation and Content Determination of Compound Insulin Gel

目的：研制复方胰岛素凝胶并建立其含量测定方法。方法：以卡波姆为基质制备复方胰岛素凝胶；采用紫外分光光度法测定胰岛素含量，并考察其稳定性及对家兔皮肤的刺激性。结果：胰岛素检测浓度在10～150μg／ml范围内线性关系良好，线性方程为A=8．75120×10^-4C-0．00245（r=0．99976，n=3），平均加样回收率为100．46％，RSD=1．26％；所得凝胶在室温或4℃冰箱中存放稳定性好，对家兔皮肤未见刺激性发生。结论：该制剂制备工艺简单，稳定性好，检测方法快速、准确。

OBJECTIVE： To prepare compound insulin gel and to establish a method for its content determination. METHODS：With carbomer as veihele,the compound insulin gel was prepared;An ultraviolet spectrophotometry for the content determination of insulin in gel was established,and the stability and irritation on rabbit of compound insulin gel was observed. RESULTS：The calibration curve of insulin was linear in the concentration range of 10- 150μg/ml, A = 8.75 120 × 10^-4C--0.00 245 （r = 0.99 976, n = 3） .The average recovery rate was 100.46%, RSD = 1.26% ; The gel was good stability under room temperature and 4℃environment, no sensitiveness on rabbit was observed . CONCLUSIONS ： The technic of preparation was simple,and its stability was better,the method of content measured was rapid and accurate.