芦荟气雾剂的制备与质量控制

目的：制备芦荟气雾剂,建立其质量控制方法。方法：以喷射总量、稳定性等为指标,通过正交试验筛选芦荟气雾剂的处方。用等吸收点双波长分光光度法测定芦荟气雾剂中芦荟苷含量。结果：筛选得到优化处方为：芦荟50%、乙醇40%、甘油5%混合后,压入二甲醚用量25%。芦荟苷线性范围0.8×10-24.4×10-2mg/ml,回收率为98.3%101.5%,RSD为0.50%0.71%,芦荟大黄素对测定不影响。结论：所筛选的处方稳定可行。芦荟苷测定方法简便可靠,重现性好,对芦荟气雾剂质量控制提供方法。

Preparation and quality standard of Aloe aerosol

Objective：To prepare Aloe aerosol and establish its quality standard.Methods： According to the index of the total amount of spray and stability,orthogonal design was used to optimize the formulation.Dual-wavelength spectrophotometry was used to determine the content of Aloin in Aloe aerosol.Results： The optimized formulation was as following： after 50%Aloe,40%ethanol and 5% glycerol were mixted,press 25%DME to the mixture.Linear range of aloin was 0.8×10-2-4.4×10-2mg/ml.The recovery of aloin was 98.3%-101.5%,and RSD was 0.50%-0.71%.The method could eliminate the disturbance of aloe emodin.Conclusion： The formulation is repeatable and reliable;as a simple,accurate and well reproducible method of determination,it provides a feasible method to control the quality of Aloe aerosol.