Two lyophilized powder injections of methylprednisolone sodium succinate and preparation methods 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

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

In addition, when we prepared the freeze-dried preparation according to the methylprednisolone sodium succinate freeze-dried composition formula disclosed in CN20061076703.8, we found that the freeze-drying time of each batch needs to be as long as more than 40 hours, and the production efficiency is very low

Method used

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  • Two lyophilized powder injections of methylprednisolone sodium succinate and preparation methods thereof
  • Two lyophilized powder injections of methylprednisolone sodium succinate and preparation methods thereof
  • Two lyophilized powder injections of methylprednisolone sodium succinate and preparation methods thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1-1

[0019]

[0020]

[0021] The preparation method is as follows:

[0022] 1. Weigh the prescription amount of NaHCO 3 , add 100ml of water for injection to dissolve, set aside.

[0023] 2. Weigh the prescription amount NaH 2 PO 4 ·H 2 O, add 100ml water for injection to dissolve, set aside.

[0024] 3. Weigh the prescription amount Na 2 HPO 4 , add 100ml of water for injection to dissolve, set aside.

[0025] 4. Weigh the main drug of the prescribed amount, add 500ml water for injection to stir into a suspension, and slowly add NaHCO under continuous stirring 3 solution, heated to 70-80°C in a water bath and stirred, adding NaH 2 PO 4 ·H 2 O solution, then add Na 2 HPO 4 solution, add water for injection to 1000ml, keep warm in a water bath until the solution is clear, and circulate and filter the whole amount.

[0026] 5. Filter the medicinal solution with a 0.45 μm microporous membrane, and finally fine filter with a 0.22 μm microporous membrane.

[0027] 6...

Embodiment 1-2

[0034]

[0035] The preparation method is as follows:

[0036] 1. Weigh the prescription amount of NaHCO 3 , add 100ml of water for injection to dissolve, set aside.

[0037] 2. Weigh the prescription amount NaH 2 PO 4 ·H 2 O, add 100ml water for injection to dissolve, set aside.

[0038] 3. Weigh the prescription amount Na 2 HPO 4 , add 100ml of water for injection to dissolve, set aside.

[0039]4. Weigh the main drug of the prescribed amount, add 500ml water for injection to stir into a suspension, and slowly add NaHCO under continuous stirring 3 solution, heated to 70-80°C in a water bath and stirred, adding NaH 2 PO 4 ·H 2 O solution, then add Na 2 HPO 4 solution, add water for injection to 1000ml, keep warm in a water bath until the solution is clear, and circulate and filter the whole amount.

[0040] 5. Filter the medicinal solution with a 0.45 μm microporous membrane, and finally fine filter with a 0.22 μm microporous membrane.

[0041] 6. After the i...

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PUM

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Abstract

The invention relates to two lyophilized powder injections of methylprednisolone sodium succinate and preparation methods thereof. Each lyophilized powder injection of methylprednisolone sodium succinate is obtained by dissolving 25.35-50.69mg of methylprednisolone succinate, 4.98-8.97mg of NaHCO3, 1.60mg of NaH2PO4.H2O, and 17.4mg of Na2HPO4 in water for injection, adding water for injection until 1ml, filling, and lyophilizing.

Description

Technical field: [0001] The invention relates to a methylprednisolone sodium succinate composition, in particular to two methylprednisolone sodium succinate freeze-dried powder injections of different specifications. 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. Because it is a poorly soluble organic compound, it can be prepared as a water-soluble salt, such as sodium succinate, in order to facilitate the preparation of injections. Chinese patent CN200610076703.8 discloses methylprednisolone sodium succinate freeze-drie...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/573A61K47/02A61P29/00A61P37/06A61P37/08
Inventor 何光杰张宝文袁英蔡卓谋柏德昌左兰义
Owner 天津金耀药业有限公司
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