沙利度胺乳膏的制备与质量控制

Preparation and Quality Control of Thalidomide Cream

目的目的制备沙利度胺乳膏,建立质量控制方法。方法自乳化基质聚乙二醇-7硬脂酸酯制备沙利度胺乳膏。建立鉴别反应、粒度、微生物限度检查、含量测定等质量控制方法,采用高效液相色谱法测定沙利度胺的含量。考察其稳定性。结果沙利度胺乳膏粒度、微生物限度、含量均符合中国药典2015版的规定;沙利度胺在0.01~0.5 mg/m L浓度范围内呈良好的线性关系,r=0.999 97;平均回收率为100.83%（n=9,RSD=0.81%）;乳膏无刺激性,在12个月内稳定。结论制备该乳膏工艺简单,质量稳定可控,为沙利度胺乳膏的药效学研究提供基础。

OBJECTIVE To prepare thalidomide cream and to establish its quality control methods. METHODS Thalidomide cream was prepared using self-emulsoin-base Teofes 63 and the content of thalidomide was determined by HPLC. The quality control methods including differential response,granularity,microbial limit inspection,determination et al were established. RESULTS The granularity,microbial limit inspection and determination were in accordance with the Chinese Pharmacopoeia 2015 Edition; There was a good linearity in the range of 0.01-0.5 mg / m L（ r = 0.999 97）; The average recovery was 100.83%,with RSD = 0.81%; The cream was no stimulation and stable in 12 month. CONCLUSION The cream can be easily prepared. Its quality can be controlled and the stability can be maintained. It can provide a basis for pharmacodynamics study of thalidomide cream.