冻干制剂体系的多组分选择对崩塌温度的影响

J4 ›› 2012, Vol. 47 ›› Issue (7): 10-13.

冻干制剂体系的多组分选择对崩塌温度的影响

李小爽,韦宇平,王卿卿,李春龙,徐霞*

中国科学院过程工程研究所生化工程国家重点实验室, 北京 100190

收稿日期:2012-01-25 出版日期:2012-07-20 发布日期:2012-09-01
通讯作者: 徐霞(1969- ),女,研究员,博士生导师,主要从事生化剂型化及体外治疗技术研究.Email:xuxia@mail.ipe.ac.cn
作者简介:李小爽(1987- ),女,硕士研究生,主要从事生物大分子冷冻干燥研究.

Effects of multi-component selection on the collapse temperature in freeze-drying formulation

LI Xiao-shuang, WEI Yu-ping, WANG Qing-qing, LI Chun-long, XU Xia*

National Key Laboratory of Biochemical Engineering, Institute of Process Engineering,
Chinese Academy Of Sciences, Beijing 100190, China

Received:2012-01-25 Online:2012-07-20 Published:2012-09-01

摘要/Abstract

摘要：

观察制剂的冻干结构及崩塌现象,测定由蔗糖、氨基酸和(或)Pluronic F68混合所构成体系的崩塌温度(Tc),进而研究崩塌温度的影响因素。利用冻干显微镜观察蔗糖溶液,测定不同制剂的Tc: (1)2.5％、5％、7.5％的蔗糖溶液; (2)10mmol／L磷酸钠盐缓冲液分别与2.5％、5％、7.5％的蔗糖溶液构成的三元体系;(3)5％蔗糖与0.15％氨基酸(精氨酸、天冬氨酸、谷氨酸或酪氨酸)构成的三元体系; (4)5％蔗糖溶液、0.15％氨基酸与Pluronic F68构成的四元体系。得到了如下结果:(1)蔗糖溶液的Tc随蔗糖含量的增大而增大;(2)低浓度磷酸钠的加入不会引起Tc改变(P>0.05);(3)酪氨酸能使Tc升高7℃(P<0.05);(4)Pluronic F68会使体系的Tc降低,酪氨酸组降低最多(6.0℃)(P>0.05)。制剂的组成成分决定Tc的大小,低浓度的磷酸钠缓冲液不会改变Tc,酪氨酸能使体系的Tc显著升高。

关键词: 冷冻干燥;制剂;崩塌温度

Abstract:

Observe the appearance and the collapse of the freezedried products and measure the collapse temperatures (Tc) in the multiple component system containing sucrose, amino acid and／or Pluronic F68. Further determine the factors relating to Tc.The collapse of sucrose solution was observed using freezedrying microscope. Tc was measured for different freeze-drying formulations: (1) sucrose solutions at the concentration of 2.5％, 5％ and 7.5％.(2)Binary systems containing 2.5％, 5％ or 7.5％ sucrose and 10 mmol/L sodium phosphate buffer. (3)Ternary systems composed of 5％ sucrose and 0.15％ amino acid (Arg, Asp, Glu or Tyr). (4) Quaternary system containing 5％ sucrose, Pluronic F68 and 0.15％ amino acid. The results obtained as follows: (1) Tc of sucrose solution increased with the sucrose concentration; (2) Introduction of low concentration of sodium phosphate did not lead to change in Tc (P>0.05); (3) The presence of Tyr caused Tc increase by 7℃ (P<0.05); (4) Addition of Pluronic F68 resulted in a decrease in the Tc values, especially in the system with Tyr (6.0℃) (P>0.05). Tc is dependent on the composition of formulation. Introduction of low concentration of sodium phosphate does not lead to the change in Tc. The presence of Tyr results in significant increase in Tc.

Key words: freeze-drying; formulation; collapse temperature

李小爽,韦宇平,王卿卿,李春龙,徐霞*. 冻干制剂体系的多组分选择对崩塌温度的影响[J]. J4, 2012, 47(7): 10-13.

LI Xiao-shuang, WEI Yu-ping, WANG Qing-qing, LI Chun-long, XU Xia*. Effects of multi-component selection on the collapse temperature in freeze-drying formulation[J]. J4, 2012, 47(7): 10-13.

参考文献

多维度评价

Viewed

Full text

Abstract

Cited

Shared

Discussed