文章摘要
徐蓓蕾,吴文惠,朱全刚,田虹,张若曦.海洋候选药物FGFC1冻干粉针剂处方工艺研究[J].上海海洋大学学报,2016,25(5):775-785.
XU Beilei,WU Wenhui,ZHU Quangang,TIAN Hong,ZHANG Ruoxi.A study on the formulation of FGFC1 power injection[J].Journal of Shanghai Ocean University,2016,25(5):775-785.
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
投稿时间:2016-03-24  修订日期:2016-05-06
DOI:10.12024/jsou.20160301706
中文关键词: FGFC1  粉针剂  稳定性  处方工艺
英文关键词: FGFC1  power injection  stability  formulation
基金项目:国家高技术研究发展计划(2011AA090701);国家自然科学基金(81341082,81502955);上海市创新行动计划(14431906000)
作者单位E-mail
徐蓓蕾 上海海洋大学 食品学院, 上海 201306
上海中医药大学附属岳阳中西医结合医院, 上海 200437 
 
吴文惠 上海海洋大学 食品学院, 上海 201306 whwu@shou.edu.cn 
朱全刚 上海中医药大学附属岳阳中西医结合医院, 上海 200437  
田虹 赤峰学院附属医院, 内蒙古 赤峰 024005  
张若曦 上海中医药大学附属岳阳中西医结合医院, 上海 200437  
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中文摘要:
      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。
英文摘要:
      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.
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