尿囊素乳膏的质量控制

Quality Control of Allantoin Cream

目的建立尿囊素乳膏的质量控制方法。方法采用高效液相色谱法测定其中主药尿囊素的含量,建立pH值、微生物学、鉴别反应等质控方法。结果尿囊素在0.025～0.2 mg/ml浓度范围内呈良好的线性关系,r=0.999 9;平均回收率为100.7%(n=9,RSD=1.33%),pH值为6.0～7.0,微生物学检查符合规定,乳膏稳定无变化,无刺激性。结论本方法操作简便、快速准确,可用于尿囊素乳膏的质量控制。

Objective To establish a quality control method for allantoin cream.Methods The content of allantoin was determined by HPLC.Quality control methods include pH value,microbial limit test,identification.Results There was a good linearity in the range of 0.025-0.2 mg / ml（r = 0.999 9）.The average recovery was 100.7%（n = 9,RSD = 1.33%）.The pH of allantoin cream was 6.0 to 7.0 and the microbial limits were in conformity with requirements.The cream was stable without change and nonirritating.Conclusion The method is simple,quick,accurate and can be used for quality control of allantoin cream.