脑心络通丸的质量标准  

Study on the Quality Standard for Naoxin Luotong Pills

作　　者：陆崟[1] 王银娟[1] 黄鲁[1] 白汝 苏华[1] 任海祥[1] 

机构地区：[1]南京军区南京总医院制剂科,南京210002

出　　处：《中国药师》2016年第4期776-780,共5页China Pharmacist

基　　金：全军医疗机构制剂标准提高科研专项课题面上项目(编号:13ZJZ15-2)

摘　　要：目的:建立脑心络通丸的质量标准。方法:对方中的黄芪、僵蚕、全蝎采用显微鉴别;对桃仁、黄芪、白芍、大黄、牡丹皮和丹参采用TLC鉴别;采用HPLC法测定总阿魏酸的含量,色谱柱:Sapphire C_(18)柱(250 mm×4.6 mm,5μm),流动相:乙腈-0.1%磷酸(12∶88),检测波长:316 nm,柱温:35℃,流速:1.0 ml·min^(-1)。结果:黄芪、僵蚕、全蝎的显微特征明显,易察见;桃仁、黄芪、白芍、大黄、牡丹皮和丹参的TLC色谱图斑点清晰,专属性强;阿魏酸在5.1~81.6μg·ml^(-1)浓度范围内线性关系良好(r=0.999 9),平均回收率为103.30%,RSD为1.96%(n=9)。结论:所建立的标准可用于脑心络通丸的质量控制。Objective： To establish the quality standard for Naoxin Luotong pills. Methods： Astragali radix,bombyx batryticatus and scorpio were identified under a microscope. Peach kernel,astragali radix,paeoniae radix alba,rheum,paeonia suffruticosa and salvia miltiorrhiza were identified by TLC. The content of total ferulic acid was determined by HPLC with a Sapphire C_（18）column（ 250mm×4.6 mm,5 μm）. The mobile phase was acetonitrile-0.1% phosphoric acid（ 12 ∶88） and the detection wavelength was 316 nm. The column temperature was 35℃ and the flow rate was 1.0 ml·min^（-1）. Results： The microscopic characteristics of astragali radix,bombyx batryticatus and scorpio were obvious to be observed easily. The TLC spots of peach kernel,astragali radix,paeoniae radix alba,rheum,paeonia suffruticosa and salvia miltiorrhiza were clear and specific. Ferulic acid had a good linear relationship within the range of 5.1-81.6 μg·ml^（-1）（ r= 0.999 9）,and the average recovery was 103.30% with RSD of 1.96%（ n = 9）. Conclusion： The standard can be used for the quality control of Naoxin Luotong pills.

关 键 词：脑心络通丸 质量标准 显微鉴别 薄层色谱法 高效液相色谱法 总阿魏酸 

分 类 号：TQ460.72[医药卫生—药物分析学]