八味茵术颗粒剂中质量标准研究

Study on the quality standard of Bawei Yinshu Granule

目的:建立八味茵术颗粒的质量标准。方法:采用高效液相色谱法,inertSustain?C18(4.6 mm×250 mm,5μm,Japan)色谱柱,柱温30℃,进样量为5μL,流动相为水(A)-乙腈(B)梯度洗脱,流速为1 mL/min,在275 nm、340 nm处分别鉴别白术、茵陈。DAD全波长扫描(200~400 nm)同时监测6,7-二甲氧基香豆素、白术内酯Ⅲ、白术内酯Ⅰ的含量。结果:高效液相色谱鉴别专属性强。6,7-二甲氧基香豆素、白术内酯Ⅲ、白术内酯Ⅰ在0.1~100.0μg/mL之间线性结构较好(R2=1.0000),其精确性较高,加样回收满足具体的测量条件。结论:采用高效液相色谱法鉴别和同时测定6,7-二甲氧基香豆素、白术内酯Ⅲ、白术内酯Ⅰ的含量的方式便于实施,且数据准确度较高,对八味茵术颗粒剂质量的管理能够产生重要影响。

Objective: To establish the quality standard of Bawei Yinshu Granule(八味茵术颗粒剂). Methods: Using high performance liquid chromatography(HPLC) method and inertSustain ■C18(4.6 mm×250 mm, 5 μm, Japan) chromatographic column, column temperature 30 ℃, sample quantity is 5 μL, mobile phase for the water-and acetonitrile(B)(A) gradient elution, flow rate of 1 mL/min, atractylodes and wormwood was identified at 275 nm and 340 nm, respectively. DAD full-wavelength scanning(200 ~ 400 nm) simultaneously monitored the contents of 6, 7-dimethoxycoumarin, albumin Ⅲ and albumin Ⅰ. Results: High performance liquid chromatography had identification specificity. The linear structures of 6, 7-dimethoxy cumarin, leucolactone Ⅲ and leucolactone Ⅰ between 0.1--100.0 μg/mL were better(R2=1.0000), the accuracy was higher, and the sample recovery met the specific measurement conditions. Conclusion: HPLC method was used to identify and simultaneously determine the contents of 6, 7-dimethoxycoumarin, atractyl lactone Ⅲ and atractyl lactone Ⅰ, which was easy to implement and had high data accuracy, and had an important impact on the quality management of Bawei Yinshu Granule.