Study On Acute Toxicity Of Senecio Cannabifolius Less Ⅰ,Ⅱ And Preparation Of Senecio Cannabifolius Less Ⅱ Immediate-release Pellet

Objective: This topic is national technology major special topics researching of innovation drug. This thesis included two parts :1.The acute toxicity research of two species monomer of Senecio cannabifolius Less, with Bliss statistics method measureing LD50 and 95% confidence interval; It could be provide theoretical basis for the prevention and treatment of asphyxiant pulmonary edema 2. The research and preparation of Senecio cannabifolius LessⅡimmediate-release pellet. A kind of immediate-release pellet was preparated, which could prevent asphyxiant pulmonary edema, through determining prescription component and technical study.Methods:1. The acute toxicity of Senecio cannabifolius LessⅠ,Ⅱmain was in accordance with the chemical drug acute toxicity research technology guidance principles (second draft) and new drug toxicology research guidance principles, selecting 4-5 dose groups, each group at least 10 mouse, the dose group spacing was 0.65-0.85, and then in accordance with the two ways to administer, observing the reaction situation of mouse and 7-14 days continuously, and recording the toxicity reaction and death distribution of mouse, timely autopsying death mouse.2. The preparation of Senecio cannabifolius LessⅡimmediate-release pellet was including two parts: (1)The analysis method in vitro and the basic nature of Senecio cannabifolius LessⅡ;(2)The galenical pharmacy research of Senecio cannabifolius LessⅡimmediate-release pellet. Firstly, the drug assay method in pellet, the drug assay method of dissolution rate and release in pellet was established by UV, and the fundamentality of Senecio cannabifolius LessⅡwas investigated.Then the research of pellet's galenical pharmacy: adopting extrusion round method to prepare Senecio cannabifolius LessⅡimmediate-release pellet, by release dose in vitro of immediate-release pellet as its quality evaluation standard, the prescription components and preparation technology of immediate-release pellet was determined by single factors investigation. The stability effect factors test indicated that Senecio cannabifolius LessⅡimmediate-release pellet relative stability in high temperature, high wet, so after packaging, the immediate-release pellet would easy to save and transport.Results:1. The acute toxicity test indicated that the LD50 of i.g. of Senecio cannabifolius Less I was 1562.61mg/kg and the LD50 of i.p. of Senecio cannabifolius Less I was 853.69mg/kg. The LD50 of i.g. of Senecio cannabifolius LessⅡwas3378.14mg/kg, the LD50 of i.v. of Senecio cannabifolius LessⅡwas 475.62mg/kg and the LD50 of i.p. of Senecio cannabifolius LessⅡwas 567.61mg/kg,2. The preparation composition were: 20% FHC-2, 60% MCC, 10% lactose, 10% CC-Na; and the preparation technology of Senecio cannabifolius LessⅡimmediate-release pellet were: Wetter was 60% ethanol, spheronization speed was 600rpm, spheronization time was 4min, extrude rotation speed was 30rpm, Mesh screen size was 1.0mm.Conclusion: The acute toxicity research of two species monomer of Senecio cannabifolius Less with the different routes of administration measureing LD50 and this experiment had already prepared the immediate-release pellet which releaseing dose was above 90% in 30 min.