醒脑通脉胶囊质量标准的提升  

Improvement of Quality Standard for Xingnao Tongmai Capsules

作　　者：覃翔[1,2] 韦世民 黄鸿敖[1,2] 韦胡丹 陈壮 Qin Xiang;Wei Shimin;Huang Hongao;Wei Hudan;Chen Zhuang(Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine,Nanning 530011,China;Guangxi Zhuang Yao Medicine Engineering Technology Research Center;Youjiang Medical College for Nationalities)

机构地区：[1]广西中医药大学附属瑞康医院,南宁530011 [2]广西壮瑶药工程技术研究中心 [3]广西右江民族医学院

出　　处：《中国药师》2022年第12期2223-2229,共7页China Pharmacist

基　　金：2021年广西中药壮瑶药院内制剂孵化基地项目[编号:桂中医药发(2021)7号];2022年广西中医药管理局自筹经费科研课题(编号:GXZYA20220110)。

摘　　要：目的:提升醒脑通脉胶囊的质量标准。方法:采用化学反应法鉴别冰片;薄层色谱法鉴别石菖蒲、地龙、胆南星;高效液相一测多评法测定三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1的含量,色谱柱为Shim-pack GIS C18柱(4.6 mm×250 mm, 5μm),流动相为乙腈(A)-水(B),梯度洗脱,流速为1.0 ml·min^(-1),柱温为25℃,检测波长为203 nm。以三七皂苷R1为内标参照物,建立其与人参皂苷Rg1、人参皂苷Rb1的相对校正因子,并计算含量;同时采用外标法测定醒脑通脉胶囊中3种皂苷的含量,将2种方法的测定结果进行对比,验证一测多评法(QAMS)的科学性及可行性。结果:冰片反应显色,阴性无干扰;石菖蒲、地龙、胆南星图谱清晰,阴性无干扰,重现性好;三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1分别在39.069~312.552μg·ml^(-1)(r=0.999 4)、160.899~1 287.192μg·ml^(-1)(r=0.999 7)、80.859~646.872μg·ml^(-1)(r=0.999 3)浓度范围内与峰面积线性关系良好,平均加样回收率(RSD)分别为103.55%(1.12%)、102.69%(1.25%)、102.45%(1.54%)(n=6);以三七皂苷R1为内标,人参皂苷Rg1、人参皂苷Rb1的相对校正因子分别为0.915 6、1.472 3,一测多评法的计算值与外标法测定值无明显差异。结论:该方法简便,专属性强,耐用性和重复性均较好,可用于醒脑通脉胶囊的质量控制。Objective: To improve the quality standard for Xingnao Tongmai capsules.Methods: Borneol was identified by chemical reaction method;Acori tatarinowii rhizoma, Pheretima and Arisaema cum bile were identified by thin layer chromatography;the contents of notoginsenoside R1, ginsenoside Rg1and ginsenoside Rb1were determined by HPLC-QAMS. The chromatographic column was Shim-pack GIS C18(4.6 mm×250 mm, 5 μm), the mobile phase was acetonitrile(A)-water(B) with gradient elution, the flow rate was 1.0 ml·min^(-1), the column temperature was 25℃, and the detection wavelength was 203 nm. Using notoginsenoside R1as the internal reference substance, the relative correlation factors of ginsenoside Rg1and ginsenoside Rb1were calculated, and the contents were calculated;at the same time, the contents of the three saponins in Xingnao Tongmai capsules were determined by using an external standard method, the results of the two methods were compared to verify the scientificalness and feasibility of QAMS.Results: Borneol developed chromogenic reaction without any negative interference;the spots of Acori tatarinowii rhizoma, Pheretima and Arisaema cum bile were clear with good reproducibility and without any negative interference;the solution concentrations of notoginsenoside R1, ginsenoside Rg1and ginsenoside Rb1showed good linear relationships with the peak areas within the range of(39.069-312.552) μg·ml^(-1)(r=0.999 4),(160.899-1 287.192) μg·ml^(-1)(r=0.999 7)and(80.859-646.872) μg·ml^(-1)(r=0.999 3), respectively. The average recovery(RSD) was 103.55%(1.12%), 102.69%(1.25%) and 102.45%(1.54%), respectively(n=6);using notoginsenoside R1as the internal reference substance, the relative correction factors of ginsenoside Rg1and ginsenoside Rb1were 0.9156 and 1.472 3, respectively. There was no significant difference between the calculated value of QAMS and the measured value of external standard method.Conclusion: The method is simple, specific, durable and reproducible, and can be used for the quality control of Xingnao T

关 键 词：醒脑通脉胶囊 质量标准 薄层色谱法 高效液相一测多评法 三七皂苷R1 人参皂苷RG1 人参皂苷RB1 

分 类 号：TQ460.72[医药卫生—药物分析学]