Insulin aspart injection and preparation method thereof
A technology for insulin aspart and injection, which is used in pharmaceutical formulations, medical preparations containing active ingredients, and metabolic diseases, etc., can solve problems such as insulin resistance, and achieve improved insulin resistance, easy industrial production, and simple preparation technology. Effect
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[0019] Example 1 Preparation of insulin aspart injection
[0020] Insulin aspart 1.2mmol
[0021] α-Mannan peptide 0.03mmol
[0022] M-cresol 2500mg
[0023] Zinc chloride 28mg
[0024] Water for injection up to 1000mL
[0025] Preparation Process:
[0026] (1) Add α-mannan peptide to 750 mL of water for injection and stir to dissolve it, adjust the pH to 4.0-4.2 with 0.1 mol / L hydrochloric acid solution, add the prescription amount of insulin aspart and stir to dissolve it for use;
[0027] (2) Add zinc salt and m-cresol to the remaining amount of 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 drug solution to 4.0-4.2, 0.22μm filter membrane Filter sterilize, fill, and get insulin aspart injection.
Example Embodiment
[0029] Example 2 Preparation of insulin aspart injection
[0030] Insulin aspart 0.6mmol
[0031] α-Mannan peptide 0.03mmol
[0032] M-cresol 2500mg
[0033] Zinc chloride 28mg
[0034] Water for injection up to 1000mL
[0035] Preparation Process:
[0036] (1) Add α-mannan peptide to 700 mL of water for injection and stir to dissolve it, adjust the pH to 4.0-4.2 with a 0.1 mol / L hydrochloric acid solution, add the prescription amount of insulin aspart and stir to dissolve it for use;
[0037] (2) Add zinc salt and m-cresol to the remaining amount of 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 drug solution to 4.0-4.2, 0.22μm filter membrane Filter sterilize, fill, and get insulin aspart injection.
Example Embodiment
[0039] Example 3 Preparation of insulin aspart injection
[0040] Insulin aspart 0.3mmol
[0041] α-Mannan peptide 0.03mmol
[0042] M-cresol 2500mg
[0043] Zinc chloride 28mg
[0044] Water for injection up to 1000mL
[0045] Preparation Process:
[0046] (1) Add α-mannan peptide to 700 mL of water for injection and stir to dissolve it, adjust the pH to 4.0-4.2 with a 0.1 mol / L hydrochloric acid solution, add the prescription amount of insulin aspart and stir to dissolve it for use;
[0047] (2) Add zinc salt and m-cresol to the remaining amount of 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 drug solution to 4.0-4.2, 0.22μm filter membrane Filter sterilize, fill, and get insulin aspart injection.
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