氨苯砜脂质体凝胶的制备及其质量控制

Preparation and Quality Control of Dapsone Liposomal Gel

目的:制备氨苯砜脂质体凝胶,并建立其质量控制方法。方法:以氨苯砜为主药,采用薄膜-超声法制备其脂质体,研和法制备其脂质体凝胶;采用紫外分光光度法测定其中主药的含量。结果:所制制剂为乳黄色半固体凝胶,鉴别符合2005年版《中国药典》中的相关规定;氨苯砜检测浓度的线性范围为1.02～6.12μg·mL-1,平均回收率为100.31%(RSD=0.83%)。结论:本制剂制备工艺简单可行,质量稳定可控。

OBJECTIVE： To prepare dapsone liposomal gel and establish its quality control method. METHODS： With dapsone used as principal agent, the liposome was prepared by film-ultrasound method and the liposomal gel was prepared by mixing method. The content of dapsone was determined by UV spectrophotometry. RESULTS： The preparation was canary semisolid gel and its quality was up to the standard stated in Chinese Pharmacopeia （2005 Edition） . The linear range of dapsone was 1.02-6.12μg·mL^-1 and the average recovery rate was 100.31% （RSD = 0.83%）.CONCLUSION ： The preparation technique for the gel is feasible and the quality of the gel is stable and controllable.