Study On Preparation Technology ,Quality Standard And Anti Alzheimer's Disease Effect Of Fibraurea Recisa Pierre Alkaloid Tablets

In this paper,comprehensive and systematic studies have been made on tablets of Fibraurea recisa Pierre alkaloid,including the extraction technology of Fibraurea recisa Pierre alkaloid,the preparation process,quality criterion and stability test of tablets,along with the pharmacological effects of the preparation on mice in Alzheimer's disease model,which all provided brand new research ideas for the development of new drugs for Alzheimer's disease.The study on the extraction process of total alkaloids from Fibraurea recisa Pierre relayed on fibrauretinin and jatrorrhizine being indicative components.By using the method of HPLC,indicated by total content of palmatine and jateorhizine in Fibraurea recisa Pierre,the optimum extraction conditions have been determined through CCD response surface methodology.The alkaloid obtained from Fibraurea recisa Pierre was mixed with appropriate accessories,then tableted directly in powder.We investigated the dosage and proportion of filling agents,the force of tableting,along with the amount of disintegrating agent and lubricant via single factor,in order to ascertain the best tablet preparation technics,the quality standard and stability of the tablets.The content of MDA,SOD,CAT,NO in blood and activity of AchE,ChAT,GSH-PX and P-Tau in cerebral homogenate of AD model mice,which were caused by the union of D-galactose and AlCl₃,were influenced by Fibraurea recisa Pierre alkaloid tablets.The method of ELISA has been involved in inspecting such effects.The optimum extraction conditions of the total alkaloid from Fibraurea recisa Pierre were ascertained as following:55%for ethanol volume fraction,10:1 for liquid-solid ratio and 3times for heating reflux extraction with 1.8h each.The optimum preparation conditions for the Fibraurea recisa Pierre alkaloid tablets includes 34%for the proportion of alkaloid in tablets;Pregelatini satum and MCCl were selected as filling agents with 40%of proportion within the tablets for the former and 20%for the latter;CMS-Na and L-HPC were chosen to be disintegrating agents with 3%of proportion within the tablets for the former and 2%for the latter,in addition,magnesium stearate has been used as lubricant with 0.8%of proportion within the tablets.After mixing the Fibraurea recisa Pierre alkaloid with appropriate accessories,tablet the mixture with the force of 8⁹kn.The substance of fibriuretinin and jatrorrhizine in Fibraurea recisa Pierre alkaloid tablets were identified by means of TLC,in which distinct yellow spots have been detected.The content of palmatine and jatrorrhizine in the tablets were inspected by method of HPLC,with above,the quality evaluation method of Fibraurea recisa Pierre alkaloid tablets have been established.Other tests for the tablets such as high temperature,high humidity,accelerating experiment and long-term inspection have been done as well,so as to explore the properties,TLC identification,hardness,fragility,disintegration time and effective components of the tablets.The result indicated that each of these items was within standard.In addition,the effective period of time for the tablets was ascertained as 1 year.The studies on AD model mice caused by union of D-galactose and AlCl₃ indicated following results:The tablets of Fibraurea recisa Pierre alkaloid has the function of increasing the spontaneous alternating response rate of Y labyrinth in mice while reducing the content of MDA and NO in the serum of mice;promoting the activity of SOD and CAT in serum while restraining the activity of AchE in brain,in addition,the tablets can also increase the activity of ChAT and GSP-PX,reduced the content P-Tau in brain,which means to improve memorizing and learing ability,resisting strength to oxidation and activity of neurotransmitter.In conclusion,this study has inspected the herba fibraureae recisae alkaloid tablets thoroughly with the expectation of providing a theoretical basis for the development of new drugs for Alzheimer's disease.