Octreotide acetate freeze-dried powder injection for injection and preparation method thereof
A technology of octreotide acetate and freeze-dried powder injection, which can be used in freeze-dried delivery, medical preparations containing active ingredients, powder delivery, etc., can solve problems such as poor solubility, and achieve the effect of good solubility
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Embodiment 1
[0027] The octreotide acetate freeze-dried powder injection for injection is prepared, which consists of 0.1 g of octreotide acetate, 10 g of mannitol and 0.3 g of citric acid in 1000 bottles, with a moisture content of ≤3% and a pH value of 5.6.
[0028] The specific preparation method is as follows:
[0029] 1. Take 50ml of mannitol solution with a concentration of 20% by weight, add water to 900ml, add 300mg of citric acid, and stir to dissolve;
[0030] 2. Measure the pH value, if it is 5.6, if it is acidic, add 1N NaOH to adjust the pH to 5.6, then add octreotide 100mg to the above solution, stir to dissolve, add water for injection to 1000ml;
[0031] 3. After aseptically filtering the solution prepared in step 2 through a 0.22μ microporous membrane, fill it in a vial in a sterile room; the filling volume is 1ml / bottle;
[0032] 4. Put the vials into the tray, put them into the freeze-drying box from the upper plate to the lower plate in turn, put the temperature probe ...
Embodiment 2
[0040] The octreotide acetate freeze-dried powder injection for injection is prepared, which consists of 0.1 g of octreotide acetate, 10 g of mannitol and 0.3 g of citric acid in 1000 bottles, with a moisture content of ≤3% and a pH value of 5.5.
[0041]The specific preparation method is as follows:
[0042] 1. Take 50ml of mannitol solution with a concentration of 20% by weight, add water to 900ml, add 300mg of citric acid, and stir to dissolve;
[0043] 2. Measure the pH value, if it is 5.5, if it is acidic, add 1N NaOH to adjust the pH to 5.5, then add octreotide 100mg to the above solution, stir to dissolve, add water for injection to 1000ml;
[0044] 3. After aseptically filtering the solution prepared in step 2 through a 0.22μ microporous membrane, fill it in a vial in a sterile room; the filling volume is 1ml / bottle;
[0045] 4. Put the vials into the tray, put them into the freeze-drying box from the upper plate to the lower plate in turn, put the temperature probe i...
Embodiment 3
[0053] The octreotide acetate freeze-dried powder injection for injection is prepared, which consists of 0.1 g of octreotide acetate, 10 g of mannitol and 0.3 g of citric acid in 1000 bottles, with a moisture content of ≤3% and a pH value of 5.7.
[0054] The specific preparation method is as follows:
[0055] 1. Take 50ml of mannitol solution with a concentration of 20% by weight, add water to 900ml, add 300mg of citric acid, and stir to dissolve;
[0056] 2. Measure the pH value, if it is 5.7, if it is acidic, add 1N NaOH to adjust the pH to 5.7, then add octreotide 100mg to the above solution, stir to dissolve, add water for injection to 1000ml;
[0057] 3. After aseptically filtering the solution prepared in step 2 through a 0.22μ microporous membrane, fill it in a vial in a sterile room; the filling volume is 1ml / bottle;
[0058] 4. Put the vials into the tray, put them into the freeze-drying box from the upper plate to the lower plate in turn, put the temperature probe ...
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