【摘要】 目的 完善抗病毒合剂的质量标准。方法 采用薄层色谱（TLC）法对制剂中的板蓝根、生地黄进行定性鉴别；采用化学鉴别法对制剂中的石膏进行定性鉴别；采用高效液相色谱（HPLC）法测定（R,S）-告依春和梓醇的含量，色谱柱为Shim-pack GIST C₁₈柱（250 mm×4.6 mm,5μm）,（R,S）-告依春和梓醇的流动相分别为甲醇-0.02%磷酸溶液（9∶91,V/V）和乙腈-0.05%磷酸溶液（0.5∶99.5,V/V），流速分别为1.0,0.8 mL/min，检测波长分别为240,205 nm，柱温分别为30,25℃，进样量分别为10,5μL。结果 板蓝根、生地黄的TLC图斑点清晰，且阴性对照无干扰。石膏的钙盐和硫酸盐鉴别均呈阳性。含量测定中，（R,S）-告依春和梓醇的质量浓度分别在1～20μg/mL、2～20μg/mL范围内与峰面积线性关系良好（R²=0.999 9,n=5）；精密度、稳定性、重复性试验结果的RSD均小于2.00%;（R,S）-告依春和梓醇的平均回收率分别为100.65%和97.93%,RSD分别为0.78%（n=9）和0.73%（n=6）。3批样品中，（R,S）-告依春和梓醇的含量分别为47.40～49.24μg/mL、52.84～54.64μg/mL。结论 所建立的方法操作简便、专属性强、重复性好、结果准确，可用于抗病毒合剂的质量控制。更多还原

【Abstract】 Objective To improve the quality standard of Kangbingdu Mixture.Methods Thin-layer chromatography（TLC）method was used to qualitatively identify Isatidis Radix and Rehmanniae Radix in the preparation. Chemical identification method was used to identify gypsum in the preparation. High-performance liquid chromatography（HPLC） method was used to the contents of（R,S）-epigoitrin and catalpol in the preparation. The chromatographic column was Shim-Pack GIST C₁₈column（250 mm × 4. 6 mm,5 μm）,the mobile phases for（R,S）-epigoitrin and catalpol were methanol-0. 02% phosphoric acid solution（9∶91,V/V）and acetonitrile-0. 05% phosphoric acid aqueous solution（0. 5∶99. 5,V/V）,with flow rates of 1. 0 mL/min and 0. 8 mL/min,detection wavelengths of 240 nm and 205 nm,column temperatures of 30 ℃ and 25 ℃,and injection volumes of 10 μL and 5 μL,respectively.Results The TLC chromatograms of Isatidis Radix and Rehmanniae Radix showed clear spots,and the negative control had no interference. The identification of calcium salts and sulfates in gypsum was positive. In the content determination,the linear ranges of（R,S）-epigoitrin and catalpol were 1-20 μg/mL and 2-20 μg/mL（R²= 0. 999 9,n = 5）,respectively. The RSDs of precision,stability,and repeatability test results were all lower than 2. 00%. The average recovery rates of（R,S）-epigoitrin and catalpol were 100. 65% and 97. 93%,with RSDs of 0. 78%（n = 9） and 0. 73%（n = 6）,respectively. In the three batches of samples,the contents of（R,S）-epigoitrin and catalpol were 47. 40-49. 24 μg/mL and52. 84-54. 64 μg/mL,respectively.Conclusion The established method is simple,specific,reproducible,and accurate,which can be used for the quality control of Kangbingdu Mixture.更多还原