A kind of insulin aspart injection and preparation method thereof
A technology for insulin aspart and injection, which is applied in the fields of pharmaceutical formulations, medical preparations containing active ingredients, metabolic diseases, etc., and can solve problems such as insulin resistance, achieve improvement of insulin resistance, facilitate industrialized mass production, and simple preparation process Effect
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Embodiment 1
[0019] Example 1 Preparation of Insulin Aspart Injection
[0020] Insulin aspart 1.2mmol
[0021] α-mannan peptide 0.03mmol
[0022] m-cresol 2500mg
[0024] Add water for injection to 1000mL
[0025] Preparation Process:
[0026] (1) Add α-mannan peptide into 750mL water for injection and stir to dissolve, adjust the pH to 4.0-4.2 with 0.1mol / L hydrochloric acid solution, add the prescribed amount of insulin aspart and stir to dissolve, set aside;
[0027] (2) Add zinc salt and m-cresol to the remaining water for injection, stir to dissolve, and set aside;
[0028] (3) Add the solution prepared in step (1) to the solution prepared in step (2) under stirring conditions, mix well, add 0.1mol / L hydrochloric acid solution to adjust the pH value of the liquid to 4.0-4.2, 0.22μm filter membrane Sterilize by filtration and fill to obtain insulin aspart injection.
Embodiment 2
[0029] Example 2 Preparation of Insulin Aspart Injection
[0030] Insulin aspart 0.6mmol
[0031] α-mannan peptide 0.03mmol
[0032] m-cresol 2500mg
[0034] Add water for injection to 1000mL
[0035] Preparation Process:
[0036] (1) Add α-mannan peptide into 700mL water for injection and stir to dissolve, adjust the pH to 4.0-4.2 with 0.1mol / L hydrochloric acid solution, add the prescribed amount of insulin aspart and stir to dissolve, set aside;
[0037] (2) Add zinc salt and m-cresol to the remaining water for injection, stir to dissolve, and set aside;
[0038] (3) Add the solution prepared in step (1) to the solution prepared in step (2) under stirring conditions, mix well, add 0.1mol / L hydrochloric acid solution to adjust the pH value of the liquid to 4.0-4.2, 0.22μm filter membrane Sterilize by filtration and fill to obtain insulin aspart injection.
Embodiment 3
[0039] Example 3 Preparation of Insulin Aspart Injection
[0040] Insulin aspart 0.3mmol
[0041] α-mannan peptide 0.03mmol
[0042] m-cresol 2500mg
[0044] Add water for injection to 1000mL
[0045] Preparation Process:
[0046] (1) Add α-mannan peptide into 700mL water for injection and stir to dissolve, adjust the pH to 4.0-4.2 with 0.1mol / L hydrochloric acid solution, add the prescribed amount of insulin aspart and stir to dissolve, set aside;
[0047] (2) Add zinc salt and m-cresol to the remaining water for injection, stir to dissolve, and set aside;
[0048] (3) Add the solution prepared in step (1) to the solution prepared in step (2) under stirring conditions, mix well, add 0.1mol / L hydrochloric acid solution to adjust the pH value of the liquid to 4.0-4.2, 0.22μm filter membrane Sterilize by filtration and fill to obtain insulin aspart injection.
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