Study On Solid Self-emulsifying Preparation Of Vitamin K2

Objective: Vitamin K2 has the function of treating and preventing osteoporosis,preventing liver cirrhosis from developing into liver cancer,and has certain development value.In this paper,we proposed a thermodynamically stable self-emulsifying drug delivery system with vitamin K2 as the model drug to improve drug solubility and dissolution.Methods: Based on previous literature research,a method for the determination of vitamin K2 was established according to the 2015 edition of Chinese pharmacopoeia.Through the solubility test of the model drug in each auxiliary material,the oil phase,surfactant and cosurfactant were screened out,Blank ternary phase diagram was be drawed under the condition of 37?.Furthermore,by means of star-point design-effect surface method,particle size,potential and dispersion coefficient were used as the indexes to optimize the prescription,and the proportion of each component in the optimal blank liquid self-emulsification prescription was determined.By measuring the solubility of vitamin K2 in the blank liquid self-emulsifying system and the emulsifying rate and appearance of the drug loading self-emulsifying system after water emulsification,the optimal proportion of vitamin K2 API in the liquid self-emulsifying system was determined.Vitamin K2 solid self-emulsifying preparation was obtained by taking self-emulsifying auxiliary material and microcrystalline cellulose as carrier,adopting spray drying method,and taking dissolution,powder fluidity and appearance as quality evaluation indexes of solid self-emulsifying preparation.Results: The method of measuring the content of vitamin K2 in vitamin K2 self-emulsifying preparation is stable and reliable.The best blank liquid self-emulsifying prescription group is ethyl oleate 40%,polyoxyethylene 40%,hydrogenated castor oil 40.5%,glycerin 19.5%,vitamin The ratio of K2 API and liquid self-emulsifying system is 1: 2,and the ratio of drug-loading self-emulsifying system and microcrystalline cellulose is 1: 4.Conclusion: Vitamin K2 self-emulsifying preparation with simple process and stable properties was successfully prepared,and its physical and chemical properties were good.