Tetramethylpyrazine Phosphate Lyophilized

In the preformulation research, UV spectrophotometry was developed for the studies of physicochemical properties and content. The method above is accurate, liable, the convenient and rapid, which all meet the requirement of measurement. The physicochemical properties of TMPP were investigated, which were connected closely with pharmaceutical formulation designs. The studies on solubility showed that the equilibrium solubility in distilled water, 0.1M HC1 aqueous solution, pH6.8 phosphate buffer and pH7.4 phosphate buffer were 5.873, 11.423, 7.581mg/ml and 6.581 mg/ml. Apparent oil / water partition coefficient in basic environment was 0.391. In addition, the chemical stability of solid TMMP was observed, the result of which indicated that TMMP is stable under the condition of exposuring to air, strong light , high humidity and high temperature(40℃,60℃).The freeze-dry powder injection technology research include the selection excipient of the skeleton excipients, the technology of the confecting liquid, the technic of freeze-dry and so on. The freeze-dry powder injection of TMPP with mannitol, glucose, lactose as skeleton excipients. And its content was detected by UV spectrophotometry. The optimum formula included TMPP 5mg, mannitol 5 mg, prepared for the solution of 2ml per ampoule to be lyophilized. The freeze-drying curve was obtained when the freeze-dry powder injection formula was produce in GMP workshop; Finally, the qualified TMPP freeze-dry powder injection is acquired after medium test. The quality evaluation system is researched,...