海洋候选药物FGFC1冻干粉针剂处方工艺研究

A study on the formulation of FGFC1 power injection

为了优化FGFC1粉针剂处方和制备工艺,选用不同的助溶剂、赋形剂,通过考察FGFC1粉针剂的溶解度、外观及p H筛选适宜处方,并制备3种FGFC1粉针剂,通过外观、FGFC1含量、p H作为考察指标考察FGFC1粉针剂的稳定性,优化制备工艺。发现当FGFC1∶枸橼酸钠∶甘露醇=1∶3∶10、-48℃冻干48 h制得的粉针剂外观性状良好、复溶时间为(15.33±1.53)s,p H为6.86±0.03,在葡萄糖注射液、甘露醇注射液中30℃水浴24 h含量无明显变化,表明FGFC1高温环境下稳定,还发现高湿和强光促进FGFC1粉针剂中FGFC1降解,低温条件下性质稳定。研究结果显示,FGFC1粉针剂处方合理,制备工艺可行。

To optimize the formulation and preparation technology of Fungi Fibrinolytic Compound 1 （FGFC1） powder injection by experiments, the appearance, drug content, water content, redissolving time and pH of the freeze-dried FGFC1 powder were investigated to determine the best formulation and preparation technology. When the formulation craft is FGFCI： Sodium citrate： mannitol = 1： 3： 10, -48 ℃ freeze-dried for 48 h, the appearance of the powder injection is well, the average redissolving time is （ 15.33 ± 1.53） s, pH =6. 86 -± 0. 03, concentration of FGFC1 has no obvious change in glucose injection and mannitol injection. This freeze-dried power is stable in high humidity conditions, and has a certain degree of degradation at high temperature and strong light environment, and drug properties are very stable under low temperature conditions. The FGFC1 freeze-dried power formulation is reasonable, and the preparation technology is feasible.