葛根素微乳的质量评价

Quality Evaluation of Puerarin Microemulsion

目的:建立微乳的基本性能评价方法及葛根素微乳口服液中葛根素的含量测定方法。方法:采用反相高效液相色谱法,以甲醇∶水(30∶70)流动相,检测波长为250nm,测定该制剂中葛根素的含量,并对微乳的载药量、澄明度、稳定性进行评价。结果:线性范围3.87～20μg/ml,r=0.9998,平均回收率为97.28%,RSD为0.81%(n=3);载药量为20mg/ml,平均粒径为68nm。结论:该方法简单、快速、准确,葛根素微乳制剂质量稳定,重现性好。

Objective:To evaluate the primary property of microemulsion and establish an accurate method for determination of puerarin in the oral solution of puerarin microemulsion.Methods:The RP-HPLC method was employed.The mobile phase was CH3OH∶H2O(30∶70).The wavelength was 250 nm.The concentration, clarification and stability of microemulsion were evaluated.Results:The linear range was 3.87～20 μg/ml(r=0.999 8). The average recovery was (97.28)%, RSD was 0.81%(n=3). The concentration was 20 mg/ml. The mean droplet diameter was 68 nm.Conclusion:The method is simple, rapid, accurate. The microemulsion posseses good reproduction and stability.