中兽药平胃散质量标准提升研究  

Improvement of the quality standard of Chinese veterinary medicine Pingwei powder

作　　者：王坤丽 汤宇心 刘朋亚 刘素梅 汤法银[1] WANG Kunli;TANG Yuxin;LIU Pengya;LIU Sumei;TANG Fayin(Henan University of Animal Husbandry and Economy,Zhengzhou Henan 450046,China;Henan Institute of Veterinary Drug Feed Supervision,Zhengzhou Henan 450008,China)

机构地区：[1]河南牧业经济学院,河南郑州450046 [2]河南省兽药饲料监察所,河南郑州450008

出　　处：《中兽医医药杂志》2023年第3期69-72,F0003,共5页Journal of Traditional Chinese Veterinary Medicine

基　　金：河南省科技攻关项目(212102110093);河南牧业经济学院博士科研专项(24030126)。

摘　　要：平胃散收载于2020年版《中国兽药典》二部,为燥湿健脾、和胃利水的代表方,但现行兽药典所载质量标准不完善。本研究通过查阅文献,增加平胃散主要活性部位即总挥发油含量测定项目,并初步确定每100 g制剂总挥发油含量均不低于0.60 mL含量限度标准;增加HPLC法测定苍术素含量项目,采用ODS柱,甲醇-水(79∶21)流动相,1.0 mL/min流速,340 nm检测波长,理论塔板数以苍术素峰计算应不低于6000。该方法简单、可靠,易于操作,重现性好,初步确定平胃散中含苍术以苍术素计,每克不低于0.11%。研究表明,增加项目完善了现行质量标准,可有效评价该制剂优劣,并为其衍化方提供参考和借鉴。Pingwei powder is one classical prescription,collected in the second part of the Chinese Veterinary Pharmacopoeia(2020).It is effective for dampening the spleen and benefiting the stomach.But the current quality control standards are unable to meet the development.In order to optimize the quality control standards,the method of volatile oil was used to determine the content of total volatile oil,and the total volatile oil content of every 100.00 g preparation was preliminarily determined to be not less than 0.60 mL.HPLC was used to determine the content of atractylon,ODS column,methanol-water(79∶21)mobile phase,flow rate of 1.0 mL/min,detection wavelength of 340 nm,theoretical number of plates,atractylon peak calculation should not be less than 6000.The results showed that the method was simple,reliable,and easy to operate and reproducible.It was preliminarily determined that the content of atractylon in Pingwei powder was not less than 0.11%per gram,calculated as atractylon.In this study,the addition of projects improved the current quality standards,which could effectively evaluate the advantages and disadvantages of the preparation and provide reference for its evolution formula.

关 键 词：平胃散 质量标准 HPLC 苍术素 总挥发油 

分 类 号：S853.7[农业科学—临床兽医学]