板蓝根口服液定性定量方法的研究

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)-epigoitrin and adenosine was determined by HPLC.The HPLC procedure was carried out using C₁₈ column with gradient 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 column 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 recovery rates. Conclusion: This method is simple,convenient,accurate and repeatable,which can be used for quality evaluation of liquid formulations containing Radix Isatidis.

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