Anti-dedication Of The Injection Preparation Process And Quality Standards

Kangjue injection is composed of fructus comi. fructus auraritii. radix cyathulae with effect of strenghening the superficial resistance and promoting circulation of vital energy and making smooth flow of qi. According to the requirement of preparing the category II drug of TCM in ? methods for examining and approving new drug ? I make a systematical research on the technology and quality standard of preparation of kangjue injection. 1. Using the theory of TCM as the guideline and combining with the achievement of modem chemical and pharmacological research. I elaborate the source of this formulation and the significance of developing this medicine, the general sit on companied with tracking the activity of artery strip the isolation of the contrast of uation of the research. 2. Isolation of active constituents of fructus aurantii and fructus corni is in way of c1 chromatography column and preparative column with medium pressure. 3. Orthogonal experiment design is utilized to select the best technological condition: the optimum technology of isolating and refining of fructus comi plus radix cyathulae, optimum technology of isolating and refining of fructus aurantii. 4. A lock of tests has been made to select the optimum condition of concentration and frying factor, preparative technology and suitable auxiliarant. 5. The medial experiment is completed to provide the preparation for pharmacological test before clinical. 6. Research of the quantity standard has been completed, standard of drug and preparation has been set up, The result show this method is simple and feasible and can guarantee the stability of this preparation.