关键词: 甘草干姜汤, 临床疗效, 质量控制, 药效组分

Abstract: Gancao-Gangjiang-Tang(GGT) is a Traditional Chinese medicine(TCM) Prescription and is a representative prescription for recuperating depleted Yang in Treatise on Febrile Diseases. The TCM theory believes that the efficacy of medicinal herbs is decided by the multicompounds which consist of different kinds of chemical constituents with bioactivities,but not by a monomeric constituent. To determine 8 active compositions alignment in GGT so as to provide technology and ideas for the establishment of quality standard in accordance with its therapeutic effects,a new TCM(including single herb and prescription) quality control method is proposed. A high-performance liquid chromatography(HPLC) was established for the simultaneous determination of 8 compounds in GGT. The analysis was performed on a Hypersil Gold-C18 (4.6 mm×250 mm,5 μm) column at a flow rate of 0.6 mL/min. The mobile phase consisted of acetonitrile(A) and 0.1% H₃PO₄ aqueous(B) using a gradient elution of 5%-15%A at 0-5 min,15%-22%A at 5-10 min,22%-26%A at 10-15 min,26%-28%A at 15-30 min,28%-55%A at 30-32 min,55%-60%A at 32-35 min,60%-63%A at 35-40 min,and 63%-65%A at 40-45 min. The column temperature was holding on 30 ℃. The total contents of the 8 compounds in different GGT varied from 555.56 to 956.33 μg/mL,and the composition of them were also varied. The results showed that the dosage and compatibility of medicinal herbs have influenced the content of chemical compounds of TCM Prescription while the content of chemical compounds have act on clinical efficacy. Quality evaluation and active essence screening of TCM should be based on the TCM theory and clinical effectiveness. The method was applied to the simultaneous determination of eight compounds in GGT and was proven to be suitable for quality evaluation of GGT.

Key words: Gancao-Gangjiang-Tang, clinical effectiveness, TCM quality control, multicompounds