论文部分内容阅读
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246 nm。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0.109 6~0.328 8,0.103 2~0.309 6μg,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≥0.4 mg。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 the preparation process of hair gel and to establish its quality control method. Methods: According to the change of physical properties and appearance of gels, the type and amount of matrix and the amount of humectants were investigated by single factor test. Quality control methods such as TLC and content determination of gels were established. The content of psoralen Isoprenoid, isopsoralen, mobile phase acetonitrile-water (35:65), detection wavelength 246 nm. Results: The optimal prescription was 0.2% carbomer-941 and 4% glycerol. The linear range of psoralen and isopsoralen was 0.109 6 ~ 0.328 8,0.103 2 ~ 0.309 6μg, Rates were 99.87%, 100.94%, tentatively scheduled for the product containing psoralen per gram, the total mass of isopsoralen ≥ 0.4 mg. Conclusion: The gel preparation process is simple and feasible with good repeatability. The established quality control method is simple and reliable, and can be widely used in the industrial production of hair gel.