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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)10 mmol/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Plu-ronic 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。
The freeze-dried structure and collapse phenomenon of the preparation were observed. The collapse temperature (Tc) of the system composed of sucrose, amino acids and / or Pluronic F68 was measured to study the influence factors of collapse temperature. (1) 2.5%, 5%, 7.5% sucrose solution; (2) 10 mmol / L sodium phosphate buffer solution respectively with 2.5%, 5%, 7.5% % Sucrose solution; (3) ternary system consisting of 5% sucrose and 0.15% amino acids (arginine, aspartic acid, glutamic acid or tyrosine); Solution, 0.15% amino acids and Plu-ronic F68 quaternary system. The results are as follows: (1) The Tc of sucrose solution increases with the increase of sucrose content; (2) the addition of low concentration of sodium phosphate does not cause Tc change (P> 0.05); (3) Tc increased by 7 ℃ (P <0.05). (4) Pluronic F68 decreased Tc and decreased tyrosine (6.0 ℃) (P> 0.05). The composition of the formulation determines the size of Tc, low concentrations of sodium phosphate buffer will not change Tc, tyrosine can make the system significantly increased Tc.