板蓝根口服液定性定量方法的研究  

Study on qualitative and quantitative method of Banlangen oral solution analysis

作　　者：饶金华[1,2] 王京辉[1] 李东辉[2] 傅欣彤[1] 郭洪祝[1] 

机构地区：[1]北京市药品检验所,北京100035 [2]北京市海淀区药品检验所,北京100083

出　　处：《药物分析杂志》2013年第9期1593-1596,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立板蓝根口服液的定性定量方法。方法:采用TLC法,以板蓝根对照药材、精氨酸、L-脯氨酸和亮氨酸对照品为对照进行定性鉴别;采用HPLC法同时测定尿苷、鸟苷、(R,S)-告依春和腺苷4个核苷类成分的含量。HPLC条件:采用C18色谱柱,流动相A为甲醇,流动相B为水,梯度洗脱[0～3 min,A-B(3∶97);3～20 min,A-B(10∶90);20～40 min,A-B(70∶30);40～50 min,A-B(70∶30)],流速0.8 mL·min-1,检测波长254 nm,柱温为30℃。结果:薄层色谱斑点清晰,分离效果好,专属性强,阴性无干扰。4个核苷类成分含量测定经方法学验证,线性良好,制剂加样回收率(n=9)均符合含量测定要求。结论:该方法操作简便,重复性好,结果准确可靠,为含板蓝根制剂的质量评价提供了可靠的参考依据。Objective：To establish methods for qualitation and quantitation of Banlangen oral solution. Methods： Proline, arginine, leucine and Isatidis Radix were identified by TLC ; the content of uridine, guanosine, （ R, S） - epigoitfin and adenosine was determined by HPLC. The HPLC procedure was carried out using C18 column with gra- dient elution [ 0 - 3 min, A - B （ 3： 97 ） ; 3 - 20 min, A - B （ 10：90 ） ;20 - 40 min, A - B （ 70： 30 ） ; 40 - 50 min, A - B（70： 30） ] of methanol -water at a flow of 0.8 mL .min-1; the detection wavelength was 254 nm,and the col- umn temperature was 30℃. Results： The dots of TLC chromatogram was clear, separation degree was good, specific attribute was strong, and there was no interference from the negative control. The HPLC method for determination of uridine, guanosine, （ R, S） - epigoitrin and adenosine showed good linearity, precision, repeatability, stability and re- covery rates. Conclusion ：This method is simple, convenient, accurate and repeatable, which can be used for quality evaluation of liquid formulations containing Radix Isatidis.

关 键 词：薄层色谱 板蓝根 尿苷 鸟苷 （R  S）-告依春 腺苷 高效液相色谱法 中成药质量评价 

分 类 号：R917[医药卫生—药物分析学]