酮洛芬凝胶的制备及质量控制

目的:制备酮洛芬凝胶并建立其质量控制方法。方法:以卡波姆-940、氮酮等为辅料制备凝胶;采用紫外分光光度法测定其中主药含量,并与不含氮酮凝胶比较其体外透皮速率。结果:所制凝胶涂展性好;酮洛芬检测浓度在4·016～12·048μg·mL-1范围内呈良好的线性关系(r=0·9991),平均回收率为99·7%(RSD=1·7%,n=9);含氮酮与不含氮酮凝胶6h累积渗透率分别为34·3%、4·8%。结论:该制剂制备工艺简单,质量稳定可控,体外透皮效果良好。

Preparation and Quality Control of Ketoprofen Gel

OBJECTIVE: To prepare ketoprofen gel and establish a method for its quality control. METHODS: Carbomer-940, azone and other excipient were used to prepare ketoprofen gel. Ketoprofen percutaneous absorption tests in vitro through rat skin were performed in two compartment diffusion cells, and the concentration of ketoprofen in gel was determined by means of ultraviolet spectrophotometry (UV). RESULTS: The standard curve of ketoprofen was linear in range of 4.016～12.048μg·mL-1(r=0.999 1). The average recovery was 99.7% (RSD=1.7%,n=9). The gel's cumulative penetration rates were respectively 34.3% and 4.8% for that with azone and that without azone. CONCLUSIONS: The preparation is simple in process technique, reliable and controllable in quality, and good in percutaneous absorption effect.