摘要
目的:制备倍他米松凝胶并建立其质量控制方法。方法:以正交试验筛选基质最佳配方,拟定制剂处方工艺,并采用紫外分光光度法测定其中主药的含量,同时通过离心、耐热、耐寒、长期试验考察制剂稳定性。结果:所制制剂为类白色半透明凝胶,鉴别项符合2005年版《中国药典》中的相关规定;倍他米松检测浓度的线性范围为6～36μg·mL-1(r=0.9999),平均回收率为98.88%(RSD=0.57%);稳定性试验结果均显示凝胶无分层现象。结论:本制剂制备工艺简单,质量稳定可控。
OBJECTIVE： To prepare betamethasone gel and establish its quality control method. METHODS： Orthogonal experiment was carried out to optimize the formula of the base material and design the formula technology of betamethasone gel. The content of betamethasone in the gel was determined by UV - spectrophotometry with its stability investigated through centrifugalization, thermostabilization, cold- resistance and longterm tests. RESULTS： The preparation was off- white semitransparent gel, with its property identification in line with the standard specified in Chinese Pharmacopeia （2005 edition）. The linear range of betamethasone was 6--36μg·mL-1（r = 0.999 9） and its average recovery rate was 98.88% （RSD = 0.57%） . The stability tests revealed no stratification of the gel. CONCLUSION： The preparation process is simple and the preparation is stable and controllable in quality.
出处
《中国药房》
CAS
CSCD
北大核心
2009年第34期2691-2693,共3页
China Pharmacy
关键词
倍他米松
凝胶
制备
质量控制
Betamethasone
Gel
Preparation
Quality control
