关键词: 九味羌活制剂, 升麻素苷, 5-O-甲基维斯阿米醇苷, 甘草酸, 苍术素

Abstract:

Objective：To improve the current quality standards and strengthen the product quality control by developing UPLC method for simultaneously determining  prim-O-glucosylcimifugin, 4′-O-beta-glucopyranosyl-5-O-methylvisamminol, glycyrrhizic acid and atractylodin in 6 kinds of Jiuwei Qianghuo preparations. Methods：Waters Acquity UPLC HSS T3 column (100mm×2.1mm，1.8μm) was adopted with acetonitrile-0.1% phosphoric acid solution as the mobile phase for gradient elution. The flow rate was 0.35 mL·min^-1，the column temperature was 40℃ and the variable detection wavelength was used. The above 4 components were determined in 128 batches of samples from 18 enterprises and the results from different enterprises and dosage forms were analyzed. Results：The linear ranges of prim-O-glucosylcimifugin，4′-O-beta-glucopyranosyl-5-O-methylvisamminol, glycyrrhizic acid and atractylodin were 2.823-141.132, 3.515-175.737, 5.064-253.206, 8.096-404.789 μg·mL^-1(r＝0.999 9，for all )with the average recoveries (n＝6) of 103.7%(RSD ＝1.3%)，98.3%(RSD＝0.7%)，99.0%(RSD＝2.1%)，102.5%(RSD＝1.6%), respectively. The determination results showed significant differences among samples from different enterprises and dosage forms. For the integrity of chemical information of Jiuwei Qianghuo preparations, the best was water pills and the worst was granules. Conclusion：As an effective supplement to the current quality standards, the method is simple, rapid and reliable which can provide a quantitative basis for the objective comparison of the quality differences of samples from different enterprises and dosage forms.

Key words: Jiuwei Qianghuo preparations, Prim-O-glucosylcimifugin, 4′-O-beta-glucopyranosyl-5-O-methylvisamminol, Glycyrrhizic acid, Atractylodin