复方酮康唑凝胶剂的研制方法研究

目的制备复方酮康唑凝胶并建立其质控方法。方法以卡波姆-940为凝胶基质,建立酸碱度、卫生学、含量测定等质控方法,并进行刺激性试验、高速离心试验、耐热耐寒试验和室温留样观察等。用高效液相色谱法,C18柱,甲醇-水(75∶25)为流动相,检测波长为240nm,流速1.0ml/min测定复方酮康唑凝胶中酮康唑的含量。结果该剂pH为6.5～7.0,卫生学检查符合规定,酮康唑在4.0～16.0μg/ml范围内,峰面积与浓度呈良好的线性关系(r=0.9999),平均回收率为99.51%,日内相对标准偏差(RSD)为0.86%,日间RSD为1.02%。结论复方酮康唑凝胶剂制备工艺简单,所得制剂质量可控,性质稳定,无刺激性,临床疗效可靠,可满足临床需要。

Preparation and quality control of compound ketoconazone gel and a clinical study on the effect of onychomycosis

Objective To prepare compound ketoconazone gel and estabilish its quality control methods and to observe A clinical study on the effect of onychomycosis.Methods Compound ketoconazone gel was prepared using Carbopol-940 as base material,and then evaluated by hygiene test,irritability test,centrifugal process,heat and cold proof test and stability test.HPLC method for determination of ketoconaloze was developed on a C18 colum,using methanol-water（75∶ 25,v∶ v）as mobile phase.UV-vis dection at 240nm,and the flow rate was 1.0ml/min.Results The pH value was 6.5~7.0,and it was up to the standard of hygienic test.The linear relationship between the concentration of drug and peak hight was found in the renge of 4.0~16.0μg/ml（r=0.9999）,the average recovery was 99.51%,RSD was 0.80%.Conclusion The preparing technique of compound ketoconazone gel is simple.The gel is stable and its quality can be easily controlled and the stability can be maintained and irritability had not been found,effect is reliable,The gel is a useful medicine for clinics.