摘要
目的:制备补骨脂乳膏并建立其质量标准。方法:加热回流法提取补骨脂中主要成分补骨脂素和异补骨脂素,浓缩至浸膏。取处方对应量的主药、乳化剂水相和油相制得乳膏剂,采用高效液相法测定乳膏中补骨脂素和异补骨脂素的含量,并考察制剂稳定性。结果:补骨脂素检测浓度在0.0145～0.3620μg范围内线性关系良好(r=0.9999),平均回收率为98.20%(RSD=1.79%,n=6);异补骨脂素检测浓度在0.0188～0.470μg范围内线性关系良好(r=0.9999),平均回收率为98.87%,RSD=1.58%,且制备的补骨脂乳膏均匀细腻,易于涂布,质量稳定。结论:补骨脂乳膏的处方及制备工艺合理,质量可控,值得推广,质量控制方法简便﹑准确﹑重现性好,适用于该制剂的质量控制。
Objective：To prepare Fructus Psoraleae Cream and establish its standard of quality control. Methods：Extracted psoralen and isopsoralen by using heating reflux method and condense to a certain volume. The oil phase and water phase were prepared according to prescription and merged to make Fructus Psoraleae Cream. The HPLC method was used to determined the content of psoralen and isopsoralen. Results：The linear range of psoralen was in the range of 0.014 5-0.362 0 μg（r=0.999 9） . The average recovery was 98.20% with a RSD of 1.79%（n=6） . The linear range of isopsoralen was in the range of 0.018 8-0.470 0 μg（r=0.999 9） . The average recovery was 98.87% with a RSD of 1.58%（n=6） . The prepared Cream was even,fine stable and easy to spread. Conclusion：The prescription and preparation of Fructus Psoraleae Cream are reasonable and controllable,worth popularizing. The method for determinetion is simple,accurate and reproducible,applicable to the quality control of the preparation.
出处
《中国医药导报》
CAS
2010年第16期71-73,共3页
China Medical Herald
关键词
补骨脂
乳膏
制备
质量控制
Fructus Psoraleae
Cream
Preparation
Quality control
