健脑益神丸质量标准研究  

Study on quality standard of Jiannao Yishen Pills

作　　者：刘珊[1] 苗立成[1] 牟立娜 孟繁颖 侯明月 田明 LIU Shan;MIAO Licheng;MU Lina;MENG Fanying;HOU Mingyue;TIAN Ming(Pharmaceutical Preparation Section,NO.211 Hospital of PLA,Heilongjiang Province,Harbin 150080,China;Pharmacy Teaching and Research Department,Heilongjiang University of Chinese Medicine,Heilongjiang Province,Harbin 150000,China)

机构地区：[1]解放军第二一一医院药剂科,黑龙江哈尔滨150080 [2]黑龙江省中医药大学药剂学教研室,黑龙江哈尔滨150000

出　　处：《中国医药导报》2019年第1期24-27,32,共5页China Medical Herald

基　　金：军队医疗制剂标准提高科研专项课题(14TG0637)

摘　　要：目的建立健脑益神丸的质量标准。方法对健脑益神丸中的炙甘草、葛根、酸枣仁、益智仁进行显微鉴别,对川芎、葛根采用薄层色谱法(TLC)进行定性鉴别,并采用高效液相色谱法测定健脑益神丸中葛根素的含量,色谱柱为美国Agilent Zorbax Extend-C_(18),柱温为室温,流动相为甲醇-水(25∶75),流速为1.0 mL/min,检测波长为250 nm,进样量10μL。结果该制剂的显微鉴别明显;TCL斑点清晰,阴性样品无干扰;葛根素在40～240μg/mL浓度范围内与峰面积呈良好的线性关系(r=0.999),平均回收率为99.98%,RSD为0.44%。结论该方法稳定、可行,且专属性高,可有效控制健脑益神丸的质量。Objective To establish the quality standard of Jiannao Yishen Pills. Methods Microscopic identification of Prepared Radix Glycyrrhizae, Pueraria lobata, Semen Zizyphi Spinosae and Alpinia oxyphylla in Jiannao Yishen Pills was carried out. Thin layer chromatography(TLC) was used for qualitative identification of Ligusticum Chuanxiong and Pueraria lobata. The content of Puerarin in Jiannao Yishen Pills was determined by high performance liquid chromatography. The column was Agilent Zorbax Extend-C18, the column temperature was room temperature, the mobile phase was methanol-water(25:75), the flow rate was 1.0 mL/min, the detection wavelength was 250 nm, and the injection volume was 10 μL. Results The microscopic identification of the preparation was obvious; the spots in TCL were clear,and the negative samples had no interference; puerarin showed a good linear relationship with the peak area in the concentration range of 40-240 g/mL(r = 0.999), with an average recovery of 99.98% and RSD of 0.44%. Conclusion The method is stable, feasible and specific. It can effectively control the quality of Jiannao Yishen Pills.

关 键 词：健脑益神丸 质量标准 显微鉴别 薄层色谱 葛根素 

分 类 号：R286.0[医药卫生—中药学]