芦荟气雾剂的制备与质量控制

Preparation and quality standard of Aloe aerosol

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。

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.