Anti Jue injection preparation process and quality standard
|School||Nanjing University of Traditional Chinese Medicine|
|Keywords||Anti - Jue injection Crafts Quality standards Zhishi Dogwood Active ingredients|
Anti- Jue injection from the the dogwood , citrus aurantium , Cyathula shamisen drug has centralizer solid off the effect of qi and blood circulation . For the treatment of shock . The second class drug development requirements for the approval of new pharmaceuticals medicine against the the Jue injection preparation process and quality standards system : 1 . Chinese medicine theory combined with modern chemistry , pharmacological research results , a comprehensive exposition of the sources of party legislation question the significance of its research profile . 2. Through activity of arterial strips follow - the separation of the active ingredients of the citrus aurantium , through C 18 pressure column chromatography and preparative column in the preparation of the dogwood control the separation . 3. Orthogonal Test conditions : dogwood and Cyathula extraction and refining process , citrus aurantium optimum extraction and refining process . 4. And concentrated by the choice of screening experiments , drying conditions, the molding process conditions and choice of suitable excipients , and the like. 5. Completion of the pilot production , molding formulations for preclinical pharmacological experiments . 6. Completed a study of quality standards , developed draft quality standards for herbs and preparations for the injection of two types of new drug resistant Jue , the method is simple and feasible , to ensure that the quality of the preparations is stable and controllable .