The Research On The Foundation Substance Of Adverse Reaction And Improvement In Quality Of Ganyanling Injection

OBJECTIVE:To illustrate the foundational substance of adverse reaction of Ganyanling Injection for guiding technical improvement, improving the quality standards roundly and providing a safe and efficient Chinese Medicine product in clinic.METHODS1. Vomiting reaction animal model has been estabelished for adverse reaction evaluation of Ganyanling Injection.2. Extract of Vietnamese Sophora Root was divided into alkaloid part, flavone part, saponin part and other parts with the column chromatographic techniques. Each part was then subjected to the adverse reaction test in order to determine the possible part(s) and components responsible for the adverse reaction. According to the polarity, acid and alkaline property of the parts, they werer further seperated and purified via chromatographic technique and their adverese reactions were evaluated with vomiting reaction animal models to identifiy the toxic part. At the same time, possible toxic chemical components were analyzed on the basis of TLC, column chromatography, HPLC-DAD, LC-MS-MS, and NMR techniches.3. A new product process for Ganyanling Injection was set up, which eliminated the identified toxic section using Column chromatographic techniques.4. The method of biological activity measurement of Ganyanling Injection was established by applying the acute liver injury model and the method of adverse reaction evaluation of Ganyanling Injection was established by applying the vomiting reaction animal model for the first time.Results1. The vomiting reaction animal model of Ganyanling Injection has been established. Dosage of vomiting reaction for pigeons is 1.0ml/Kg and for cat is 3.0ml/Kg.2. The major foundation substance of adverse reaction of Ganyanling Injection is determined to be alkaloid parts with weaker polarity and lower alkaline, which synergisticly caused vomiting response of pigeon cooperateing with the main alkaloids.3. A new product procerss of Ganyanling Injection, which eliminated the toxic section, was designed to improve the security and effectiveness dramatically.4. The methods of biological activity measurement and reverse reaction evaluation of Ganyanling Injection were created.ConclusionThe major foundation substance of adverse reaction of Ganyanling Injection was clarified by using bioassay guidance technology. The quality control system of the product was improved dramatically and at the same time a product technical barrier was formed.