Study On Preparation And Quality Of Taurine Mineral Vitamin Chewable Tablets

Objective:The study adopt the taurin,VitaminB1,VitaminB2,Ca,Fe and Zn as functions of the Taurine mineral Vitamin chewable tablets to develop a safety,activity,controllable and stable product throngh preparation research,quality research,stability testing and the experiment of assisting memory improvement function.Through developing the cranial nervous tissue and perfecting the senior function and preventing the symptoms of the learning dysmnesy and the fail memory which is originated the short of Vitamin and mineral, the product is expected to improve the intelligence of the children.Methods:(1)To screen the excipientes through inspecting the feel by single-faceor.The compatibility of excipientes and APIs was studied based on physico chemical property.Through inspecting the feel,hardness,friability and disintegration,the prescription and the critical process were optimized and obtained by orthogonal test. (2)According to the requirement of building the criterion,the quality criterion of the Taurine mineral Vitamin chewable tablets was established. (3)Through analysising the character,identification, disaggregation,hardness and content. We carried out the accelerating testing and Long-time testing according to Chinese Pharmacopeia (Edition 2005).(4)The testing of assisting memory improvement function was carried out according to the requirement of《Technical Standards for Testing & Assessment of Health Food》.Results:(1)To select xylitol and cocoa as diluents and correctants, Danbaitang as sweeting agent,pvp as adhesive,pvpp as disintegrant,CPPs as absorbents of Ca,Fe&Zn.The process:To weigh the materials according to the prescription and throw into the high performance wet granulator,then add adhesives slowly after mixed 5min,and open the diffusion knife 20Hz-30Hz and the high-speed 3s-5s to shear and granulate.And drying the hygro-granula 15min-20min on the conditions of 55℃-65℃,frequency of waves of intake air 30Hz in the fluidizedbed boiling drying equipment.To tabletting on the condition of controlling pressure 30KN and the pressure-time 3ms.(2)To established the qualitative and quantitative methods about taurine, calcium, iron, zinc and vitamin B2, vitamin B1, the inspection items and the contents were tested as the methods,the results were in line with quality standards and the methodes were validated succeedly.(3)Through the affecting factors testing and accelerat testing of 6monthes and long-time testing of 24 monthes on the industrial products, there were no significantly changes on the prodects.(4)The animal tests on the memory of mouse to made clear that there were not significant in the mouse body weight after lavaged 30 days with three different doses.The Jumping stair and Water-maze experiments were positive in twice through metering the memory index.Conclusion:(1)Verify experiment made it known that the better prescription is reasonable, the program is practical, controlled. The prescription and process was available in industrialization. (2)The quality of the products can be controlled by the quality critervity.(3)the preparation is stable.(4)Animal tests showed that the products have the fuction of improving memory.