| Objective: As an effective formula through years of clinical observation by Professor YANG Mu-xiang, Zhi-Gan-Tai capsule (composed by fresh astragalus root, parched white atractylodes rhizome, oriental wormwood, curcuma root, thorowax root, red tangerine peel, oriental waterplantain rhizome, red sage root, rhubarb, hawthorn fruit, immature bitter orange and fleece-flower root, etc) has the function of strengthening spleen, regulating liver and removing stasis and phlegm. And it has been proved significantly effective in treating hyperlipemia-fatty liver through years of clinical observation. For the purpose of summarizing its treating effect, we made random-comparison (double blind) clinical study with strict design. in order to further probe its action mechanism, we duplicated the hyperlipemia-fatty liver animal model with high-fat forage, At the same time,we interfered the animal with medicine. And we studied the action mechanism of this formula in regulating lipid metabolism and protecting liver function through observing its effect on TC, TG, HDL-C, LDL-C, AST and ALT; We also studied its action mechanism in resisting lipid peroxidation injury through observing its effect on MDA, SOD, CAT, GSH and GSH-Px; We studied the action mechanism of this formula in vasomotion state and blood flow through observing its effect on NO, ET-1, TXB2 and 6-Keto-PGF1α; In addition, we also studied its action mechanism in anti-apoptosis through observing its effect on apoptosis and relevant controlling gene bc1-2 and bax. Furthermore, we made observation with HE staining on effect of this formula on pathomorphology of liver tissue. Methods: Part I Clinical observation on treating hyperlipemia-fatty liver with Zhi-Gan-Tai capsuleThe study adopted multi-center clinical trial of three hospitals withstrictly designed random comparison (double-blind) method. We took Dong-Bao-Gan-Tai as control drug and selected 60 cases in both treatment group and control group respectively according to the strict standard of diagnosis and inclusion. And we made observation on the patients' pre-treatment and post-treatment changes in clinical symptoms, blood fat, ultrasonic image of liver, liver function and hemorheology after one treatment course (2 month).Part II Experimental study of action mechanism on treating hyperlipemia-fatty liver with Zhi-Gan-Tai capsuleExperiment 1Effect of Zhi-Gan-Tai capsule on lipid metabolism & pathomorphology of hyperlipemia-fatty liver rat60 healthy male SD rats were divided into 5 groups at random, namely, (1) normal control group (normal group for short): Saline was given; (2) Model control group (model group for short): Saline was given; (3) Low-intensity group of Zhi-Gan-Tai group (low-intensity group for short): 0.7g/kg was given per day; (4) High-intensity group of Zhi-Gan-Tai group (high-intensity group): 1.4g/kg was given per day; (5) Dong-Bao-Gan-Tai control group (control group for short): 0.9g/kg was given per day. Rats in each group were given stomach-perfusion once a day and every time the drug volume was calculated by 1ml/100g. Except for the ordinary forage in normal group, the rest of groups were all fed with high-fat forage. Meanwhile control drug or treatment drug was given in each treatment group and Saline was given to normal and model group, which lasted for 10 weeks of stomach-perfusion.Confirmed the formation of fatty liver,Then 12 hours after fasting of the last time, the rats were cut off from the head and the their blood were drawn out, the blood sample was made centrifugation with low temperature and the blood serum was isolated. Finally the contents of TC, TG, HDL-C, LDL-C and FFA were measured with enzyme method; the contents of AST and ALT were measure with Lai's method. And the animal's liver was sectioned and removed simultaneously, 1cm×1cm liver tissue was removed at 0.5cm from thebiggest lobe to the border, fixed with formaldehyde and embedded with common paraffin, sliced and made HE staining for morphological observation with phot...
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