摘要
目的：优选生发凝胶剂的制备工艺并建立其质量控制方法。方法：以凝胶剂的物理性状和外观变化为指标，通过单因素试验考察基质种类及用量、保湿剂用量；建立生发凝胶剂的TLC和含量测定等质控方法，采用HPLC测定补骨脂素、异补骨脂素含量，流动相乙腈-水（35：65），检测波长246nm。结果：最优处方为卡波姆-941用量0．2％，甘油用量4％；补骨脂素和异补骨脂素线性范围分别为0．1096～0．3288，0．1032～0．3096μg，平均加样回收率分别为99．87％，100．94％，暂定本品每克含补骨脂素、异补骨脂素总质量≥0．4mg。结论：该凝胶制备工艺简单可行，重复性较好；建立的质量控制方法简便可靠，可推广于生发凝胶的工业生产。
Objective： To optimize preparation process of germinal gels and establish its quality control methods. Method： Physical properties and appearance changes of gels were investigated as indicators for investigating type and amount of matrix （carbomer-94） and the amount of humectant （glycerin） by single factor tests; Quality control methods of germinal gels were established, such as TLC identification and content determination; HPLC was adopted to determine contents of psoralen and isopsoralen with mobile phase of acetonitrile-water （35： 65） and detection wavelength at 246 nm. Result： Optimum amounts of carbomer-941 and glycerin for germinal gels was 0.2% and 4% , respectively. Linear ranges of psoralen and isopsoralen were 0. 109 6-0. 328 8 and 0. 103 2-0. 309 6 μg with average recoveries of 99.87% and 100.94% , respectively. Total content of psoralen and isopsoralen should be ≥0. 4 mg in per gram of this product. Conclusion： This preparation process was simple, feasible and reproducible; established quality control method was convenient and reliable, which could extend to industrial production of germinal gels.
出处
《中国实验方剂学杂志》
CAS
北大核心
2014年第12期40-43,共4页
Chinese Journal of Experimental Traditional Medical Formulae
关键词
生发凝胶
处方工艺
质量控制
补骨脂素
异补骨脂素
闹羊花
生姜
补骨脂
germinal gels
prescription process
quality control
psoralen
isopsoralen
RhododendriMollis Fios
Zingiberis Rhizoma Recens
Psoraleae Fructus
