心宝丸中不同产地附子的毒效成分含量测定方法及质量评价  

Determination Method and Quality Evaluation of Toxic-effective Components in Xinbao Pills made of Aconite from Different Regions

作　　者：江秀山 林琼英 张秋裕 刘兵兵 蔡荣钦 Jiang Xiushan;Li Qiongying;Zhang Qiuyu;Liu Bingbing;Cai Rongqin(Guangdong Xinbao Pharm-Tech Co.,Ltd.,Guangzhou 510535,China)

机构地区：[1]广东心宝药业科技有限公司,广东广州510535

出　　处：《广东化工》2023年第20期164-168,共5页Guangdong Chemical Industry

基　　金：广东省重点领域研发计划项目—岒南中医药现代化(2020B111100004)。

摘　　要：目的:建立心宝丸中附子组分单酯型生物碱和双酯型生物碱毒效成分的含量测定方法,以对不同产地附子制备的心宝丸进行质量评价,优选附子产地。方法:采用HPLC法,使用Phenomenex Gemini C18色谱柱(250 mm×4.6 mm,5µm),以乙腈-四氢呋喃(25∶15)为流动相A,以0.03 mol/L磷酸二氢钾的0.1%磷酸溶液为流动相B,梯度洗脱,检测波长为232 nm;流速为1.0 mL/min;柱温为25℃。结果:乌头碱、次乌头碱、新乌头碱、苯甲酰新乌头原碱、苯甲酰乌头原碱和苯甲酰次乌头原碱分别在3.2500~25.9997µg/mL、3.0660~24.5280µg/mL、3.2397~25.9179µg/mL、3.7107~18.5083µg/mL、3.9164~19.5822µg/mL、3.8569~19.2845µg/mL范围内线性关系良好;平均回收率分别为99.4%、100.8%、100.6%、100.9%、100.4%和99.4%,RSD分别为1.4%、0.6%、0.6%、1.3%、1.3%和0.7%(n=9);4个不同产地附子制备得到的心宝丸成品中,四川江油制成的心宝丸中单酯型生物碱的含量最高,为0.103%。结论:建立的方法结果准确,专属性强,为心宝丸的质量评价和组方附子的产地选择提供依据。Objective:The method was established for determinating the content of monoester alkaloids and diester alkaloids of Aconite in Xinbao pills,in order to evaluate the quality of Xinbao pills made from aconite from different origins and select the best origin of aconite.Methods:HPLC method was used for the detection.The content were analyzed by Phenomenex Gemini C18(250 mm×4.6 nm,5µm),with the mobile phase A of acetonitrile-tetrahydrofuran(25∶15)and the mobile phase B of 0.03 mol·L^(-1)potassium dihydrogen phosphate in 0.1%phosphoric acid for gradient elution at a flow of 1.0 mL·min^(-1).The detection wavelength was at 232 nm and column temperature was 30℃.Results:Aconitine,Hypoconitine,Neoaconitine,Benzoyl Neoaconitine,Benzoyl Aconitine and Benzoyl Hypoconitine showed good linear relationship within the range of 3.2500~25.9997µg/mL,3.0660~24.5280µg/mL,3.2397~25.9179µg/mL,3.7107~18.5083µg/mL,3.9164~19.5822µg/mL and 3.8569~19.2845µg/mL;their average recovery rates were 99.4%,100.8%,100.6%,100.9%,100.4%and 99.4%,and the RSDs were 1.4%,0.6%,0.6%,1.3%,1.3%and 0.7%(n=9).Among the 4 different origins,the total content of monoester alkaloids of Xinbao Pills made from Aconite from Jiangyou City,Sichuan Province is highest at 0.103%.Conclusion The established method is accurate and highly specific,which can provide a basis for the quality evaluation of Xinbao Pills and the better selection of the origin of Aconite.

关 键 词：心宝丸 附子 单酯型生物碱 双酯型生物碱 产地 

分 类 号：TQ[化学工程]