米诺生发搽剂的质量标准研究  

Study on quality control of Minuo Hair Solution

作　　者：岩林苹[1] 白玲玲[1] 黄婧[1] 王婷[1] 苏华[1] 廖欣[1] 

机构地区：[1]南京军区南京总医院制剂科,江苏南京210002

出　　处：《药学实践杂志》2016年第4期343-347,共5页Journal of Pharmaceutical Practice

基　　金：全军医疗机构制剂标准提高科研专项课题重点项目(No.14ZJZ08)

摘　　要：目的完善米诺生发搽剂的质量标准,以保证产品质量。方法采用薄层色谱法、紫外-可见光谱法分别对制剂中的当归、赤芍、白鲜皮及米诺地尔进行定性鉴别;采用一阶导数光谱法对制剂中的米诺地尔进行含量测定。结果薄层色谱斑点清晰,在与对照品或对照药材相应的位置上显相同颜色的斑点,阴性对照无干扰;紫外-可见光谱鉴别中,米诺地尔在（230±3）、（262±3）、（286±3）nm波长处有最大吸收峰;一阶导数光谱法含量测定中,米诺地尔在6.2~18.6μg/ml（r=0.999 7）范围内线性关系良好;平均回收率为99.4%,RSD为0.22%。结论本方法操作简便,准确度高,重复性好,能全面、有效地控制该制剂的质量。Objective To improve the quality standard of Minuo Hair Solution and to ensure product quality.MethodsThin layer chromatography（TLC）and UV-visible spectroscopy（UV-Vis）method was used for the qualitative identification of Angelica sinensis,Paeoniae Radix Rubra,Dictamni Cortex and minoxidil respectively.The Quantitive determination of minoxidil was completed by first order derivative spectroscopy.Results The spots in TLC were clear without inference.And the same color spots appeared in the corresponding position of references and reference drugs.The UV-Vis spectral absorption of minoxidil were in（230±3）,（262±3）,（286±3）nm.The linear range of minoxidil was obtained between 6.2and 18.6μg/ml（r=0.999 7）.The average recovery was 99.4%（RSD=0.22%）.Conclusion The method is simple,accurate and reproducible,and can be effectively used to control the quality of Minuo Hair Solution.

关 键 词：米诺生发搽剂 米诺地尔 当归 赤芍 白鲜皮 质量标准 

分 类 号：R93[医药卫生—生药学]