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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。
In order to optimize the formulation and preparation of FGFC1 powder injection, different cosolvents and excipients were selected to investigate the solubility, appearance and p H of FGFC1 powder, and three kinds of FGFC1 powder injection were prepared. The appearance, FGFC1 content, p H as an indicator to examine the stability of FGFC1 injections and optimize the preparation process. The results showed that when FGFC1: sodium citrate: mannitol = 1: 3: 10 and freeze-dried at -48 ℃ for 48 h, the obtained powder had good appearance property, the refolding time was (15.33 ± 1.53) s, p H was 6.86 ± 0.03. There was no significant change in the contents of glucose and mannitol in 30 ℃ water bath for 24 h, indicating that FGFC1 was stable under high temperature. It was also found that FGFC1 degraded in FGFC1 injections under high humidity and high light, and was stable under low temperature. The results show that FGFC1 powder injection prescription is reasonable, the preparation process is feasible.