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芦荟气雾剂的制备与质量控制

     

摘要

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0.8×10-2~4.4×10-2ng/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×l0-2-4.4×l0-2mg/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.

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