阴炎净凝胶的制备及其质量标准的研究

Studies on the preparation and quality standard of Yinyanjing gel

目的 建立阴炎净凝胶的制备工艺及其质量标准.方法 以羧甲基纤维素钠为凝胶剂的基质;采用薄层色谱法对阴炎净凝胶进行定性鉴别;用高效液相色谱法进行蛇床子素含量测定.结果 阴炎净凝胶为棕褐色黏稠凝胶,气芳香.经薄层色谱鉴定,其中含有蛇床子、黄柏、黄连及苦参.20100428、20100503、20100508批次的pH值分别为5.65、5.32、5.57,黏度分别为2 050、2 280、1 960 mPa＆#183;s,均未检测出细菌、霉菌、大肠杆菌、金黄色葡萄球菌、铜绿假单胞菌.以蛇床子素的峰面积对浓度进行线性回归,得回归方程：A =41 162C-43 030,r=0.9998,蛇床子素在6.5 ～ 104.0 mg/L范围内线性良好.5次精密度试验的峰面积分别为717 340、703 451、701 329、718 902、713 987、710 984,相对标准偏差为1.14％.0、3、6、9、12 h稳定性试验的峰面积分别为679 128、665 923、681 834、666 791、671 298,平均为672 912,相对标准偏差为1.14％.测得20100428、20100503、20100508批次的蛇床子素平均含量分别为29.0、29.2、28.8 mg/g.结论 阴炎净凝胶制备工艺简单,质量稳定,质控方法可行.

Objective To develop the preparation technology and quality standard of Yinyanjing gel.Methods With sodium carboxymethyl cellulose as gel base,the layer chromatography was employed to make qualitative identification of Yinyanjing gel; high performance liguid chromatograyhy was used to determine the content of osthole.Results Yinyanjing gel was a brown viscous gel with aromatic scent.It contains Cnidium,Treats,berberine and Sophora.The pH of 20100428,20100503,20100508 batch was 5.65,5.32,5.57,respectively.Viscosity of 20100428,20100503,20100508 was 2 050,2 280,1 960 mPa ＆#183; s,respectively.Bacteria,fungi,Escherichia coli,Staphylococcus aureus and Pseudomonas aeruginosa were not detected in 20100428,20100503,20100508.Regarding the peak area osthole concentration linear regression,the regression equation was：A =41 162C-43 030,r =0.999 8.Peak area of stability tests in 0,3,6,9,12 h was 679 128,665 923,681 834,666 791,671 298.Osthol average content of 20100428,20100503,20100508 batches was 29.0,29.2,28.8 mg/g.Conclusion The formulation preparation technology is simple,stable and feasible.