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

摘要:

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pH筛选适宜处方，并制备3种FGFC1粉针剂，通过外观、FGFC1含量、pH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，pH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。

Abstract:

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 FGFC1: 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.