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Methylprednisolone sodium succinate freeze-dried powder injection and preparation method thereof

A technology of methylprednisolone sodium succinate and freeze-dried powder injection, which is applied in the field of methylprednisolone sodium succinate composition, and can solve the problems of low production efficiency and freeze-drying time of more than 30 hours

Active Publication Date: 2012-11-28
天津金耀药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN200610076703.8 discloses a methylprednisolone sodium succinate freeze-dried composition and a preparation method thereof. We carry out 125mg / branch and 250mg / branch specifications according to the methylprednisolone sodium succinate freeze-dried composition formula disclosed in CN20061076703.8 When preparing the freeze-dried preparations, it was found that the freeze-drying time of each batch needs to be as long as more than 30 hours, and the production efficiency is very low

Method used

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  • Methylprednisolone sodium succinate freeze-dried powder injection and preparation method thereof
  • Methylprednisolone sodium succinate freeze-dried powder injection and preparation method thereof
  • Methylprednisolone sodium succinate freeze-dried powder injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019]

[0020] The preparation method is as follows:

[0021] 1. Weigh the prescription amount of NaHCO 3 , add 200ml of water for injection to dissolve, set aside.

[0022] 2. Weigh the prescription amount NaH 2 PO 4 ·H 2 O, add 200ml of water for injection to dissolve, set aside.

[0023] 3. Weigh the prescription amount Na 2 HPO 4 , add 200ml of water for injection to dissolve, set aside.

[0024] 4. Weigh the main drug of the prescribed amount, add 1200ml water for injection to stir into a suspension, and slowly add NaHCO under constant stirring 3 solution, heated to 40-50°C in a water bath and stirred, adding NaH 2 PO 4 ·H 2 O solution, followed by Na 2 HPO 4 Adjust the pH value of the solution, make up water for injection to 2000ml, keep warm in a water bath until the solution is clear, and circulate and filter the whole amount.

[0025] 5. Filter the medicinal solution with a 0.45 μm microporous membrane, and finally fine filter with a 0.22 μm microporo...

Embodiment 2

[0033]

[0034] The preparation method is as follows:

[0035] 1. Weigh the prescription amount of NaHCO 3 , add 200ml of water for injection to dissolve, set aside.

[0036] 2. Weigh the prescription amount NaH 2 PO 4 ·H 2 O, add 200ml of water for injection to dissolve, set aside.

[0037] 3. Weigh the prescription amount Na 2 HPO 4 , add 200ml of water for injection to dissolve, set aside.

[0038] 4. Weigh the main drug of the prescribed amount, add 1500ml water for injection to stir into a suspension, and slowly add NaHCO under continuous stirring 3 solution, heated to 40-50°C in a water bath and stirred, adding NaH 2 PO 4 ·H 2 O solution, followed by Na 2 HPO 4 Adjust the pH value of the solution, make up water for injection to 2500ml, keep warm in a water bath until the solution is clear, and circulate and filter the whole amount.

[0039]5. Filter the medicinal solution with a 0.45 μm microporous membrane, and finally fine filter with a 0.22 μm micropor...

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Abstract

The invention discloses a methylprednisolone sodium succinate freeze-dried powder injection and a preparation method thereof. The methylprednisolone sodium succinate freeze-dried powder injection is characterized by being prepared by dissolving 158.4-316.8mg of methylprednisolone, 28.1-56.2mg of NaHCO3, 1.6mg of Na2H2PO4.H2O and 17.4mg of Na2H2PO4 into water for injection to be 2-2.5ml; and filling and freeze-drying.

Description

Technical field: [0001] The invention relates to a methylprednisolone sodium succinate composition, in particular to methylprednisolone sodium succinate freeze-dried powder injection. Background technique: [0002] Methylprednisolone has anti-inflammatory, anti-allergic, anti-rheumatic, and immunosuppressive effects, and is widely used in the treatment of allergic and autoimmune inflammatory diseases, such as connective tissue diseases, active rheumatism, rheumatoid arthritis, erythema Lupus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia, etc., are also used in the comprehensive treatment of certain severe infections, poisoning, and malignant lymphoma. Since it is a poorly soluble organic compound, it can be prepared as a water-soluble salt, such as sodium succinate, for the convenience of preparing an injection. The existing methylprednisolone sodium succinate injection is a freeze-dried powder injection, which is divided into various dosag...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/573A61P29/00A61P37/06A61P37/08
Inventor 何光杰张宝文袁英赵曙光
Owner 天津金耀药业有限公司
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