Studies On Development And Material Base Of Jiu Ganqing Capsule

Alcoholic fatty liver is a kind of the most familiar diffusible liver diseases. The excessive triglyeride stored in the liver cells is its mail pathologic change. In recent years,as the quantity of drinked liquor increased year after year, alcohol has become the primary damnous factor for liver lesion. As the technique of image check-up improved, the diagnosis rate of alcoholic fatty liver has been increased year by year with an increased tendency. Because the alcoholic fatty liver are susceptibler to developed fibrosis and hepatocirrhosis than the unalcoholic fatty liver, it is greater threat to people. A kind of drug named Jiu Ganqing Capsule (gained the clinical warrant from SFDA), which can be used to cure alcoholic fatty liver was develpoed. The material base of Jiu Ganqing Capsule was studied. The extraction technology and quality standard, which fits large-scale industrial production and can be used to control the quality of this drug preferably, were established.The active constituents of the medicine materials, such as Radix scutellariae, Radix paeoniae rubra and Radix et rhizoma glycyrrhizae, can be found on the foundation of the pharmacology study. According to the chemical property of the active constituents, the extraction modes of these three Chinese herbal medicines can be established by orthogonal design, the extraction methods such as acid extraction, macroporous resin method, amonia percolation method, organic solvent refinement were applied.The rude drugs and their preparation have been identified by thin layer chromatography, the content of baicalin, peoniflorin and glycyrrhizic acid in medicine materials and their preparation have been determined by high performance chromatography, and the dissolution rate of baicalin, peoniflorin and glycyrrhizic acid have been determined by high performance chromatography, so that we can control the quality of the medicine well.The rude drugs and their praeparatum stability meet the new medicine requirement by stability studies. At indoor temperature, their characters, discriminations, quantity difference, water content, disintegration time, contents and the hygiology index have no obvious variety.In the aspect of medicine compatibility study, firstly, according to condition of the clinical application, we build up the pharmacology model that can respond to the clinical curative effect, then combined different compositions that pharmacy provided, we sieved the active parts that correspond to the Chinese herbal medicine, consulted their dosage, and established several administration dosage, finally, we sieved out a best active quantity. Based on this foundation, according to the result of the Chinese medicine theories and pharmacology experiment, we sieved the best compatible proportion by orthogonal experiment, and build up the integrity, valid research method for searching for meterial base of Chinese herbal medicine.The acute toxicity test and the long-term toxicity test indicated that the drug has little adverse reaction. The general pharmacology test indicated that the HR, electrocardiogram, BR and extent were normal after administration by duodenum. After administration by id, the activity of the mice is normal, it has no synergistic action with pentobarbital sodium.Pharmacodynamics experiments indicated that the drug obviously degraded the content of Cholesterol,Triglycerides,glutamic pyruvic transaminase and Maleic Dialdehyde in the Alcoholic fatty liver of rats and mice treated with by oral administration, it also degraded the content of glutamic oxalacetic transaminase, r-GLU,alkaline phosphatase and increased the content of Albumin and Superoxide Dismutase in the Alcoholic fatty liver of rats, and remarkably reduced depressant effect of the mice'centra nerve. Treated with prophylactic by oral administration, it also obviously degraded the content of Cholesterol, Triglycerides, glutamic pyruvic transaminase, glutamic oxalacetic transaminase, Maleic Dialdehyde and Tunmor Necrosis Factor in Alcoholic fatty liver of rats, and increased the contents of Albumin and Superoxide Dismutase.Treated with baicalin by oral administration, the content of glutamic pyruvic transaminase and glutamic oxalacetic transaminase could be degraded in the Alcoholic fatty liver of rats, and it had evident protection for the rats and mice'Alcoholic fatty liver. The mechanism is that it can protect and stabilize hepatocyte membrane, degrade permeability of hepatocyte membrane, Tunmor Necrosis Factor and Maleic Dialdehyde's content, and stimulate Superoxide Dismutase and Glutathion peroxideas incerase, and decrease consumption of liver's Glutathion and the damage of free radical.Baicalin can protect osteoblast against oxidative stress caused by high-fluorine level. It also can prevent and cure the damage of free radical inducted by high fluoride. They are involved in degrading the contents of Maleic Dialdehyde in osteoblast, and elevating activity of Superoxide Dismutase and Glutathion peroxidease.Therefore, baicalin can resist the damage of free radical in vivo and vitro.In a word, all the above results provided the reliable theory foundation for the clinical test of drug.