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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

Active Publication Date: 2013-06-05
CHONGQING Y S F PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] One of the technical problems to be solved by the present invention is to provide a kind of octreotide acetate freeze-dried powder injection for the technical problem of poor solubility existing in the existing octreotide acetate freeze-dried powder injection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Prepare the octreotide acetate freeze-dried powder injection for injection, 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 in ...

Embodiment 2

[0040] Prepare the octreotide acetate freeze-dried powder injection for injection, 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 in th...

Embodiment 3

[0053] Prepare the octreotide acetate freeze-dried powder injection for injection, 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 water 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 in the...

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Abstract

The invention discloses octreotide acetate freeze-dried powder injection, which takes octreotide acetate as an active ingredient, mannitol as a freeze-dried excipient and citric acid as a regulating agent, and is characterized in that the pH value of the octreotide acetate freeze-dried powder injection is 5.5 to 5.7. The octreotide acetate freeze-dried powder injection prepared by the method can dissolve quickly, and the solubility of the injection is high.

Description

technical field [0001] The invention relates to a drug freeze-dried powder injection and a preparation method thereof, in particular to a freeze-dried octreotide acetate powder injection for injection and a preparation method thereof. Background technique [0002] Bauer et al. synthesized a long-acting somatostatin in 1982, which is octreofide (octreofide), and its document code is SMS201-995, which was later introduced to the market by Sandoz Company under the trade name sandostatin. [0003] Octreotide acetate is a synthetic octapeptide derivative of somatostatin, in which 4 amino acids are arranged in the same way as natural endogenous somatostatin, and its pharmacological effects are the same as natural somatostatin. It has a variety of physiological activities, but its half-life is shorter Natural somatostatin was extended 30 times to 1.7 hours. It can inhibit the pathological hypersecretion of growth hormone, thyrotropin, gastrointestinal and pancreatic endocrine horm...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K38/08A61P1/04A61P1/18A61P5/06A61P35/00
Inventor 杨杰杨玉华甘建新
Owner CHONGQING Y S F PHARMA
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