| YiMeiEr granule,which is made from Radix Acanthopanax Senticosus, Radix Polygoni Multiflori, Radix Polygalaei Tenuifoliae, Ganodennae Lucidi, Fructus Lycii Barbari and other four kinds of herbs, is a compound preparation for treating children's lower intelligence by benefttting kidney, reinforcing essence nourishing heart .exercising spleen, regulating the nerve cell and repressing the nerve cell apoptosis.The main research contents on YiMeiEr granule include technology of the preparation, quality standards, the stability of the pharmaceuticals and the effect of medicine. 1.Technology of the preparationDuring the research of the technology of preparation, we pay a point to choosing a suitable dosage on the foundation of guaranteeing the original valids and choosing a reasonable technology according to it's physics and chemistry character.First, because of it implies the volatile oil, we have a research on the volatile oil envoloping process:we used volatile oil utilization and packing ratio as evaluating indexes and investigated the optimum factors by orthogonal test. The optimum envoloping process was: β -CD : volatile oil(6 I 1), temperature is 40 ℃ ,stirring speed for 9 00r/min,stirring time is 2 hours.Second, taking the content of Isofraxidin and extracting ratio as evaluating indexes, the water-extraction process is decided: soaking the herbs with water for 1.5 hours and boiling 2 hours for 2 times,the amount of water used was 10 times of the herbs.The ethanol-precipitation optimum process is: regulating the density of the solution for 1.15, the concentration of ethanol is 70% and stationary for 24 hours.Third, We chose spray-drying method to desiccate this ointment ,air-inlet temperature at 120℃, the density of the solution for 1.10,solution-inlet speed for 6000mL/min and seprating speed is 6000r/min .Fourth, technology of the preparation is researched. 2.Study of quality standardDuring the quality research proceedings , we identified Radix Polygoni Multiflori, Radix Polygalaei Tenuifoliae, Canodermae Lucidi, Fructus Lycii Barbari by TCL (Thin Layer Chromatogragh ) method ,which is special and accurate The contents of Isofraxidin were determined by HPLC (High Performance Liquid Chromatograg) after the methodology was completed . The HPLC showed that theaverage recovery is up to standard and its precision, stability and reappearance were good. The experiment showed that the content of Isofraxidin should be more than 150 μ g in each bag( 10g).3.Study of primary stabilityFor the sake of inspecting primary stability of YiMeiEr granule, the room-temperature and accelerating test were carried into execution, from which the results showed every index marker was normal It indicated the quality of YiMeiEr granule was steady and controllable.4.Study of main PharmacodynamicalWe carried out main Pharmacodynamical experiment ,in which little rats were used We set up three groups which have different dosages of YiMeiEr granule,and compare their effect with positive medicine. The experiment shows that the preparation can improve children's lower intelligence .In a word, according to the above experiments, we made an acknowledge of the technology of preparation, quality standands, primary stability, pharmacodynamic and toxicity. We make sure YiMeiEr granule is useful to MR. We also assure that the drug not only would benefit our society and human being ,but also would have a good effect on the value of society and economy development. |
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