银黄注射液质量标准的改进
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[摘要] 目的：完善银黄注射液的质量标准。方法：采用高效液相色谱法同时测定绿原酸和黄芩苷的含量，色谱柱为Agilent-C18柱(150 mm×4.6 mm，5 μm)；流动相为甲醇-0.4%磷酸溶液(30∶60)；检测波长：绿原酸为327 nm,黄芩苷为276 nm；流速1.0 ml/min;进样量20 μl；柱温30℃。结果：绿原酸在0.010 83～0.108 30 mg/ml范围内线性关系良好(r=0.999 44)，平均回收率为100.24%，RSD为1.54%；黄芩苷在0.015 15～0.151 50 mg/ml范围内线性关系良好(r=0.999 99)，平均回收率为100.48%，RSD为0.79%。结论：本方法简便、快捷、结果准确，可用于银黄注射液的质量控制。
[关键词] 银黄注射液；高效液相色谱法；质量标准；绿原酸；黄芩苷
[中图分类号]R927 [文献标识码]B [文章编号]1673-7210(2009)02(b)-031-03
Improvement on quality standard for Yinhuang Injection
GE Yu-song1, YANG Jin-jing2, ZHOU Hui-qin1
(1.Jiangsu Province Yancheng Institute for Drug Control,Yancheng 224002,China;2.College of Pharmacy,Nanjing University of Chinese Traditional Medicine Institute,Nanjing 210046,China)
[Abstract] Objective: To improve the quality standard of Yinhuang Injection. Methods:HPLC was adopted for the determination of the chlorogenic acid and baicalin at the same time. Agilent-C18(150 mm×4.6 mm,5 μm) was used,the mobile phase was composedofmethanol-0.4% phosphoric acid(30∶60)with the flow rate of 1.0 ml/min,the detective wavelength was set at 327 nm for chlorogenic acid and 276 nm for baicalin,the column temperature was maintained at 30℃. Results: The linear range of chlorogenic acid was 0.010 83-0.108 30 mg/ml(r=0.999 44),the average recovery was 100.24% with RSD of 1.54%. The linear range of baicalin was 0.015 15-0.151 50 mg/ml(r=0.999 99),the average recovery was 100.48% with RSD of 0.97%. Conclusion: The method is simple,accurate,and can be used for the quality control of Yinhuang Injection.
[Key words] Yinhuang Injection; HPLC; Quality standard; Chlorogenic acid; Baicalin
银黄注射液具有清热、解毒、利咽的功效，用于风热犯肺而致发热、咳嗽、咽痛等症；上呼吸道感染、急性扁桃体炎、咽炎见上述症候者皆可用之。处方中金银花和黄芩为重要药材，其中绿原酸和黄芩苷的含量与药品质量密切相关。《卫生部药品标准》中药成方制剂第十九册[1]采用紫外分光光度法测定其含量。本文采用HPLC双波长法同时测定其中绿原酸和黄芩苷的含量，分析速度快、分离效率高、检测灵敏度高、重复性好、结果可靠，可作为本产品质量控制的方法。
1 仪器与试药
1.1 仪器
Aglient1200高效液相色谱仪,包括四元泵、柱温箱、紫外检测器、自动进样器、真空脱气机(美国惠普)；BP211D型电子天平，BT224S电子天平(德国Sartorius)；Cary100紫外分光光度计(美国Varian)。
1.2 试药
银黄注射液(四川升河制药有限公司，批号050655、060505、061203)；对照品：绿原酸(批号110753-200413)、黄芩苷(批号0821-200104) ......
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