Omeprazole sodium for injection and preparation method thereof
A technology for omeprazole sodium and injection, which is applied in the field of medicine and can solve the problems of small effect and poor clarity
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Embodiment 1
[0040] Omeprazole sodium preparation for injection consists of the following formulations:
[0041] Omeprazole sodium (calculated as omeprazole) 40g
[0042] Disodium edetate 0.5g
[0043] Add sterile water for injection to 2000mL
[0044] Freeze-dried to make 1000 bottles
[0045] Preparation steps include:
[0046] 1) Add omeprazole sodium and edetate disodium into sterile water for injection, dissolve completely, add sterile water for injection to 2000mL, and prepare omeprazole sodium solution;
[0047] 2) Adjust the pH value of the solution obtained in step 1) to 11.10 with 0.5 mol / L sodium hydroxide, add activated carbon with a volume of 0.1% of the solution, and obtain the filtrate after fine filtration;
[0048] 3) The filtrate obtained in step 2) is divided into bottles and freeze-dried to obtain omeprazole sodium freeze-dried powder injection. The freeze-drying process is as follows:
[0049] Samples were pre-frozen at -45°C for 2 hours and samples were snap-fro...
Embodiment 2
[0052] Omeprazole sodium preparation for injection consists of the following formulations:
[0053] Omeprazole sodium (calculated as omeprazole) 40g
[0054] Disodium edetate 0.5g
[0055] Add sterile water for injection to 2000mL
[0056] Freeze-dried to make 1000 bottles
[0057] Preparation steps include:
[0058] 1) Add omeprazole sodium and edetate disodium into sterile water for injection, dissolve completely, add sterile water for injection to 2000mL, and prepare omeprazole sodium solution;
[0059] 2) Adjust the pH value of the solution obtained in step 1) to 10.60 with 0.5 mol / L sodium hydroxide, add activated carbon with a solution volume of 0.15%, and obtain the filtrate after fine filtration;
[0060] 3) The filtrate obtained in step 2) is divided into bottles and freeze-dried to obtain omeprazole sodium freeze-dried powder injection. The freeze-drying process is as follows:
[0061] Samples were pre-frozen at -45°C for 2.5 hours and samples were snap frozen ...
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