肤康涂膜剂质量控制标准研究

Study on Quality Standard of Fukang Film Former

目的 :建立肤康涂膜剂的质量控制标准。方法 :运用反相高效液相色谱法测定其中水杨酸和酮康唑的含量 ,微生物法测定其中氯霉素的含量。结果 :水杨酸和酮康唑在0 5～2 5mg/ml浓度范围呈良好线性关系 (r=0 9999) ,方法回收率分别为99 9 %、100 7 % ,相对标准差分别为0 68 % (n=5)、0 84 % (n=5) ;氯霉素含量测定方法回收率为99 8 % ,相对标准差为0 46 % (n=6)。结论 :本文制订的质量标准可以控制肤康涂膜剂的质量。

OBJECTIVE:To set up the quality standard for Fukang film former.METHODS:The contents of salicylic acid and ketoconazole were determined by RP-HPLC and the content of chloramphenicol by microbiological assay.RESULTS:The linear range of salicylic acid was0.5～2.5mg/mlr=0.9999,the recovery was99.9%,RSD=0.68%n=5,the linear range of ketoconazole was0.5～2.5mg/mlr=0.9999,the recovery was100.7%,RSD=0.84%n=5,while the recovery of chloramphenicol was99.8%,RSD=0.46%n=6.CONCLUSION:The quality standard established can be used to control the quality of Fukang film former.