Study On Preparation Polytechnics, Qualitative Standard & Pharmacology Of Huangqidangseng Granule

Objective: to study on preparation polytechnics, qualitative standard and pharmacology of Huangqidangseng gramule for the further clinical development research.Methods: The preparation polytechnics were optimized by orthogonal test. Water, time and frequency of decoction was investigated with the content of astragalosideⅣand the yield of solid as evaluation index. The wind temperature of inlet and exhaust and the relative density of extract were optimized through moisture of the granule in the spray dryng process. In the particle formation, the proportion of mixed powder, sucrose and yellow rice wine was also imvestigated. meanwhile granulation difficult, granule distribution, granule solubility, and the dosage as systematic evaluation index.The content of astragalosideⅣof the main ingredient in astragalus as monarch drug in the prescription, was determined by high-performance liquid chromatography (HPLC) method. The quantitative method of quality control was practical. The TLC identification methods of asiabell and jujube were used in the qualitative quality control.In the deficient spleen model induced by reserpoid or Chinese traditional medicine rhubarb in mice, the effect and the action mechanism in interlcukin 2-(IL-2)-interferon-natural killer cell of the granule was identified. The improvement of defatigation was proved in the defatigation model in swimming mice. The intestinal propulsion rate of Chinese ink and the moisture content of intestinum crassum in normal mice were determined in thanks for the effect of transforming nutrients from foodstuff.Results: The optimized preparation polytechnies were 11-fold water of solvent and 2.5 hours of extraction time for the first time. 9-fold water of solvent and 1.5 hours of extraction time for the second time, and then 7-fold water of solvent and 1 hours of extraction time for the third time: 62℃of inlet wind, 155℃of exhaust wind, and 1.12g/mL of the relative density of extract in the spray dry:And the optimum formation with no more than 5% moisture content of extractive powder compared with sucrose in proportion as 15:0.5 and yellow rice wine in proportion as 15:2.The content determination by HPLC of astragalosideⅣwas the practical quantity-control method due to the regression cquation(IgA= 1.5471 IgW+4.6231, r=0.9996) in the excellent linear range of 1.656～4.968μg.mL-1,1.56% of accuracy RSD,1.73% of rcproducibility RSD, 2.56% of RSD and 101% of yield in recovery experiment, stable sample within 12h, and no negative interference. The TLC identification methods were profit for the qualitative quality control of asiabcll and jujube.The serious symptoms of deficient spleen in model mice were inhibited by the formalation, such as anorexia, dysentery, lassitude, aetiolation of skin and hair, hyperanacinesia in stomach intestine, peripheral nervous disorder, and so on. And in this system, the differences of body weight and liver index of experimental animals were significant (P<0.05 compared with the ones in model group. P<0.05 with the ones in normal group). The swimming duration and the mortality reduction in groups administrated with the granule were improved significantly. The activitics of interleukin 2, interferon and natural killer cell were dramatically increasing in the positive group and three administrated groups of the high, intermediate and low dosage. Meanwhile, the levels in groups of the high, intermediate dosage were adjacent to the one of negative group. The intestinal propulsion rate of Chinese ink and the moisture content of intestinum crassum in normal mice was increased significantly.