清肺抑火片质量标准研究

›› 2017, Vol. 2 ›› Issue (2): 20-23.

清肺抑火片质量标准研究

（云南腾药制药股份有限公司研发部，云南腾冲679100）

收稿日期:2015-06-16 修回日期:2015-10-10 出版日期:2017-02-15 发布日期:2017-02-15
作者简介:邵维在，工程师，主要从事中药新产品研发、产品工艺优化、中药治疗标准研究.

Study on the Quality Standard of Qingfei Yihuo Tablet

（The Research and Development Department, Yunnan Tengyao Pharmaceutical Co., Ltd., Tengchong, Yunnan 679100, China）

Received:2015-06-16 Revised:2015-10-10 Online:2017-02-15 Published:2017-02-15

摘要/Abstract

摘要：

目的：修订提高清肺抑火片的质量标准。方法：采用显微鉴别法、薄层色谱（TLC）法对制剂中的大黄、桔梗、黄柏、苦参
进行定性鉴别；采用HPLC法对黄芩中的黄芩苷进行定量分析，色谱柱：Agilent TC-C1（8 250 mm × 4.6 mm，5 m）；流动相：甲醇-
0.4%磷酸溶液（53：47）；流速：0.6 mL/min；检测波长：280 nm；柱温：30 ℃。结果：在显微鉴别中检出草酸钙簇晶大，直径60~
140 μm（大黄）、菊糖扇形或类圆形（桔梗）；在TLC色谱中检出大黄、黄柏、苦参；黄芩苷进样量在0.025~4.000 μg/mL范围内线性
关系良好，r=0.999 8；平均加样回收率99.8%，RSD=0.34%（n=9）。结论：所建立的方法可靠、准确、专属性强，可控制该制剂的质量。

关键词: 清肺抑火片, 显微, 薄层色谱, 高效液相色谱, 黄芩苷

Abstract:

Objective: To develop a method for revising and improving the quality standards of the Qingfei Yihuo Tablet. Methods:
Microscopic identification and TLC method were adopted to identify the quality of the Dahuang, Jugeng, Huangbo and Kusheng in
preparation and analyzing the Huangqigan in Huangqi by the method of HPLC. The analysis was performed on an Agilent TC-C18
column with the mobile phase consisting of methanol（A）−0.4% phosphate acid（53：47）by gradient elution at a flow rate of 0.6
mL/min. The detection wavelength was set at 280 nm and the column temperature was 30 ℃. Results: Calcium oxalate crystal clusters
were checked out by the method of microscopic identification, the diameter of Dahuang was 60-140 microns and the shape of Jugeng
was inulin fan or quasi-circular. Additional, Dahuang, Huangbo and Kusheng were detected out by the methods of TLC and the HPLC
results showed that the linear ranges were 0.025-4.000 μg/mL（r=0.999 8）for Huangqigan. The average recoveries（n=9）were
99.8%, RSD=0.34%. Conclusion: The developed method is accurate, reproducible and specific and the quality of the preparation can
be controlled.

Key words: Qingfei Yihuo Tablet, microscopic identification, TLC, HPLC, Huangqigan

中图分类号:

R284.1

邵维在，段治尚，万德生，阙玉玲，周永斌. 清肺抑火片质量标准研究[J]. , 2017, 2(2): 20-23.

Shao Weizai, Duan Zhishang, Wan Desheng, Que Yuling, Zhou Yongbin. Study on the Quality Standard of Qingfei Yihuo Tablet[J]. , 2017, 2(2): 20-23.

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