Research on quality control method for Juhuang Oral Liquid / 中草药

ABSTRACT

Objective: To establish the quality control method for Juhuang Oral Liquid (JOL) based on the qualitative and quantitative analysis methods. Methods: TLC was used to identify Lycii Fructus and Polygonati Rhizoma in JOL. Phenol-sulfuric acid method was used for the detemination of total polysaccharide, HPLC was used to simultaneously determine the contents of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, coffeic acid, galuteolin, 3,4-dicaffeoylquinic acid, 3,5-dicaffeoylquinic acid, and 4,5-dicaffeoylquinic acid. The Odyssil C18 (250 mm × 4.6 mm, 5 μm) column was used. The mobile phase was acetonitrile-0.05% phosphoric acid solution in gradient elution, at the flow rate of 1.0 mL/min, the detection wavelength was set at 325 nm. Results: The identified characteristics of Lycii Fructus and Polygonati Rhizoma by TLC were distinct and the spots were clear, without interference and easy to recognize. When phenol-sulfuric acid method was used to determinate the total polysaccharide content, the regression equation was A=0.057 8 C + 0.032 5 (r=0.999 1, n=8). The linear with its absorbance in the range of 26.15-196.13 mg/mL, the average recoveries was 99.82%. The average content of the total polysaccharide in JOL from six batches is 157.74-166.49 mg/mL. When RP-HPLC was used to determine the eight chemical components, the compounds showed a good linearity(r ≥ 0.999 8) in the determination range. The average recoveries were between 99.18%-101.06% with RSDs between 0.79%-1.91%. The average content from the six batches showed neochlorogenic acid 102.9-142.6 μg/mL, chlorogenic acid 488.6-563.8 μg/mL, cryptochlorogenic acid 58.9-71.6 μg/mL, coffeic acid 240.7-326.1 μg/mL, galuteolin 228.6-302.7 μg/mL, 3,4-dicaffeoylquinic acid 398.0-485.4 μg/mL, 3,5-dicaffeoylquinic acid 184.1-203.1 μg/mL, and 4,5-dicaffeoylquinic acid 476.2-561.8 μg/mL. Conclusion: TLC identification method is simple. The determination method of total polysaccharide and chemical components is simple, accurate, and with a good repeatability. It can be used for the quality control of JOL.