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氨苯砜脂质体凝胶的制备及其质量控制
引用本文:闫军,;王晓东,;唐文照,;贾献慧. 氨苯砜脂质体凝胶的制备及其质量控制[J]. 中国药房, 2009, 0(25): 1969-1970
作者姓名:闫军,  王晓东,  唐文照,  贾献慧
作者单位:[1]济南市皮肤病防治院,山东省济南市250001; [2]山东省医学科学院药物研究所,山东省济南市250062
基金项目:济南青年科技明星计划(10109).
摘    要: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。

关 键 词:氨苯砜脂质体凝胶  紫外分光光度法  制备  质量控制

Preparation and Quality Control of Dapsone Liposomal Gel
Affiliation:YAN Jun, WANG Xiao-dong,TANG Wen-zhao, JIA Xian-hui(1.Ji'nan Hospital for Prevention and Treatment of Skin Disease, Ji'nan 250001,China;2.Institute of Materia Medica, Shandong Academy of Medical Sciences, Ji'nan 250062, China)
Abstract: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.
Keywords:Dapsone liposomal gel  Ultraviolet spectrophotometry  Preparation  Quality control
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