Studys On The Preparation And Quality Standards Of Chaihuguijiang Decoction Agent

Chai Hu Gui Jiang Tang decoction dose prescription is from "Treatise on the"in"sun identified abnormal pulse passes and Governance " chapter, and it is the classic prescription for symptoms of typhoid Shaoyang,the prescription both release the Shaoyang meridian and warm taiyin meridians,it is also has the effect of easing middle energizer. The prescription is still widespread used in modern clinical medicine, mainly for the treatment of chronic hepatitis, cholecystitis, chronic gastritis and other diseases,in which have the significant effects. The subject of Chai Hu Gui Jiang Tang has a comprehensive and systematic overview both in ancient and modern clinical application, we select the dosage forms of decoction by the technical requirements of Chinese medicine formulations of drugs, preparation process, quality standards and stability were studied.Researching in the preparation process, firstly,we have compared the traditional boiling process and modern extraction process, draw up the extraction line by the physical and chemical properties of bio-active ingredients, pharmacological and clinical applications of various ingredients of prescription.The main factors, we have researchd by the single-factor test and multi-factor orthogonal test by the appropriate assessment indicators, such as soak time, amount of water, extraction times and extraction time were studied to determine the best extraction conditions parameters; we investigated the atmospheric processes and vacuum concentration to the processe of the concentrating of the extract,then determined the appropriate concentration conditions; At last, we establish a scientific and rational line of the preparation process technology by the research of molding process of preparation, sterilization and pilot project.In the study of the Quality standards, we widely used modern science and technology, such as thin layer chromatography (TLC) was used on the distinguishment of Bupleurum, Scutellaria, ginger, licorice; high performance liquid chromatography (HPLC) was used to determine the content of the baicalin,which is the active ingredient of skullcap. we established agent standards of Chai Hu Gui Jiang Tang decoction,and accomplish the purposes of controling quality of product.In the test of preliminary stability, according to technical requirements of "Drug Registration ",we test the initial stability for 6 months. Respectively test the identification, determination, relative density, insoluble and other aspects of load difference, and the results showed that all the indexes stableof preparations at 0 month,1 month,2 months,3 months,6 months. The results showed that any indicator basicly stable,which is in line with quality standards and the "Chinese Pharmacopoeia"2010 edition under a decoction agent Provisions.