[1]王 燕,李 威,韩品新,等.冻干技术在注射用盐酸吉西他滨脂质体中的应用[J].常州大学学报(自然科学版),2015,(01):66-70.[doi:10.3969/j.issn.2095-0411.2015.01.013]
　WANG Yan,LI Wei,HAN Pin-xin,et al.Application of Freeze-Drying Technology in GemcitabineHydrochloride Liposome for Injection[J].Journal of Changzhou University(Natural Science Edition),2015,(01):66-70.[doi:10.3969/j.issn.2095-0411.2015.01.013]
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冻干技术在注射用盐酸吉西他滨脂质体中的应用()
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常州大学学报(自然科学版)[ISSN:2095-0411/CN:32-1822/N]

卷:
期数:
2015年01期
页码:
66-70
栏目:
化学化工
出版日期:
2015-01-25

文章信息/Info

Title:
Application of Freeze-Drying Technology in Gemcitabine Hydrochloride Liposome for Injection
作者:
王 燕; 李 威; 韩品新; 舒 溢; 刘 霞
常州合规思远产品安全技术服务有限公司,江苏 常州 213022
Author(s):
WANG Yan;  LI Wei;  HAN Pin-xin;  SHU Yi;  LIU Xia
Changzhou Hegui Siyuan Products Safety Technology Service Co., Ltd., Changzhou 213022,China
关键词:
真空冷冻干燥;  冻干;  预冻;  真空度;  脂质体;  盐酸吉西他滨
Keywords:
vacuum freeze-drying;  freeze-drying;  pre-freeze;  vacuum;  liposome;  gemcitabine hydrochloride
分类号:
R914.2
DOI:
10.3969/j.issn.2095-0411.2015.01.013
文献标志码:
A
摘要:
为研究影响冻干过程的主要影响因素,考察冻干技术在注射用盐酸吉西他滨脂质体中的应用,以外观性状、水分、复溶、粒径、含量、有关物质为指标,对冻干工艺中参数进行优化。优化后的冻干工艺为:2.5%甘露醇为冻干保护剂; 快速预冻,温度为-50 ℃,时间为4 h; 真空度为15 Pa; 升华干燥的温度为-38 ℃,时间为25 h; 解析干燥的温度为30 ℃,时间为6 h。通过优化冻干工艺参数,所得的盐酸吉西他滨脂质体冻干制品外观平整、质地疏松,加水后分散均匀,含量及有关物质均符合规定,多次重复实验结果基本稳定。
Abstract:
To study the main influence factors in the freeze-drying, and the application of freeze-drying technology in Gemcitabine Hydrochloride liposome for injection was investigated,With the index of the appearance,moisture content,redissolving, particle size, content and related substances were optimizd in the proces of freeze-drying. The optimized process of the freeze-drying: using 2.5% mannitol as the cryoprotectant; quick-freeze, pre-freezing at -50 ℃ for 4 hours; Vacuum degree 15 Pa, Primary drying at -38 ℃ for 25 hours; Secondary drying at 30 ℃ for 6 hours. By the optimized factors of the process, the freeze-dried products of gemcitabine hydrochloride liposome looks smooth, loose texture, dispersed evenly after adding water, the content and related substances are in accordance with regulations and the experiment had better repeatability.

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备注/Memo

备注/Memo:
作者简介:王燕(1984-),女,江苏大丰人,工程师,主要从事脂质体技术、乳剂及纳米乳制备技术、冷冻及喷雾干燥技术研究。
更新日期/Last Update: 2015-01-25