健脾养胃颗粒质量标准研究

Establishment of Quality Standard for Jianpiyangwei Granules

目的建立健脾养胃颗粒的质量标准。方法采用薄层色谱(TLC)法鉴别制剂中的甘草、白术、党参,用高效液相色谱(HPLC)法同时测定厚朴酚与和厚朴酚的含量,色谱柱:Agilent Eclipse XDBC18柱(4.6mm×250mm,5μm);流动相:甲醇-水(65:35);流速:1.0mL·min-1;波长:294nm,柱温30℃。结果在TLC色谱中均能检出甘草、白术、党参;厚朴酚与和厚朴酚的线性范围分别为57.04～570.40ng(r=0.9997)和37.76～377.60ng(r=0.9995);平均回收率分别为97.0%(RSD为1.0%)和97.7%(RSD为1.9%)。结论所建鉴别方法专属性强,定量方法快速简单,快速,准确,可为健脾养胃颗粒的质量标准。

Objective To establish the quality standard for fianpiyangwei granules. Methods Glycyrrhetinic, Rhizoma Atractylodis Macrocephalae and Radix Codonpsis were identified by TLC. Contents of magnolol and honokiol were determinated by HPLC. The chromatographic column was an Agilent Eclipse XDB Cis （4.6 mm × 250 mm, 5 μm）, the mobile phase was methanol-water （65 ： 35）, the detection wavelength was 294 nm, with the flow rate at 1.0 mL · min^-1, and the column temperature at 30 ℃. Results Glycyrrhetinic, Rhizoma Atractylodis Macrocephalae and Radix Codonpsis could be detected by TLC. The linear ranges of magnolol and honokiol were from 57.04 to 570.40 ng （ r = 0. 999 7） and from 37.76 ng to 377.60 ng （ r = 0. 999 5 ）, respectively. The average recoveries of samples were 97. 7% （ RSD as 1.0 % ） and 97. 0 % （RSD as 1.9% ） , respectively. Conclusion The method is specific, simple, fast and accurate, which can be used for quality control of jianpiyangwei granules.