止痒乳膏的质量标准研究  

Study on the quality standard of Antipruritic Cream

作　　者：池宁娟 杨志福[1] 潘静[1] 曹金一[1] 姚敏娜[1] 马宁[1] 文爱东[1] 

机构地区：[1]第四军医大学西京医院药剂科,西安710032

出　　处：《西北药学杂志》2015年第2期124-126,共3页Northwest Pharmaceutical Journal

基　　金：军队医疗机构制剂标准提高计划课题(编号:13ZJZ05-1)

摘　　要：目的建立止痒乳膏的质量标准。方法采用姜黄试纸法和TLC法分别对处方中硼砂和薄荷素油进行定性鉴别;采用HPLC法以甲醇-5mL·L^-1乙酸水溶液（40∶60）为流动相,在检测波长272nm处测定苯酚含量。结果定性鉴别的方法灵敏、专属性强。苯酚质量浓度在0.063 5~0.190 6mg·mL-1范围内线性关系良好（r=0.999 7,n=6）,平均加样回收率为101.0%,RSD=0.8%（n=9）,3批药品中苯酚的平均含量为2.48%。结论该法操作简便,结果准确,重复性好,可作为止痒乳膏的质量控制方法。Objective To establish the quality standard of Antipruritic Cream.Methods Turmeric paper method and TLC were used to identify borax and peppermint oil in Antipruritic Cream.Phenol was determined by HPLC with a mobile phase of methanol-5mL·L-1 acetic acid of（40∶60）.UV detection wavelength was set at 272 nm.Results The identification methods were distinct and highly specific.The linear range of phenol was in the range of 0.063 5-0.190 6mg·mL^-1（r=0.999 7,n=6）.The average recovery was 101.0% with RSD of 0.8%（n=9）,and the average content of phenol in Antipruritic Cream from three batches samples was 2.48%.Conclusion This method is simple,accurate and reproducible,and can be used for the quality control of Antipruritic Cream.

关 键 词：止痒乳膏 质量标准 硼砂 薄荷素油 苯酚 TLC法 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]