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Methylprednisolone sodium succinate freeze-dried powder injection

A technology of methylprednisolone sodium succinate and freeze-dried powder injection, which is applied in the field of freeze-dried powder injection containing methylprednisolone sodium succinate, which can solve the problems of low production efficiency, low pass rate, and increased insoluble particles

Active Publication Date: 2013-10-30
TIANJIN JINYAO GRP
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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. When we prepared the freeze-dried preparation according to the methylprednisolone sodium succinate freeze-dried composition formula disclosed in CN20061076703.8, It is found that the freeze-drying time of each batch of products is very long, and the production efficiency is very low
[0003] In addition, we also found that the methylprednisolone sodium succinate freeze-dried powder injection produced in the prior art, after reconstitution, found that the insoluble particles in the injection were significantly increased after testing, and the pass rate was low. The indicators are extremely important but easily overlooked. Excessive insoluble particles are likely to cause many potential hazards, such as thrombosis, granuloma, and similar pyrogen reactions. Since most insoluble particles cannot be metabolized by the human body, once they are infused into the body , the resulting risk will be with you for life, so reducing the insoluble particles of injections has become an important issue in injection preparations

Method used

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  • Methylprednisolone sodium succinate freeze-dried powder injection
  • Methylprednisolone sodium succinate freeze-dried powder injection
  • Methylprednisolone sodium succinate freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Preparation process

[0032] 1. Weigh the prescription amount of NaHCO 3 , add an appropriate amount of water for injection to dissolve, set aside.

[0033] 2. Weigh the prescription amount NaH 2 PO 4 ·H 2 O, add an appropriate amount of water for injection to dissolve, set aside.

[0034] 3. Weigh the prescription amount Na 2 HPO 4 , add an appropriate amount of water for injection to dissolve, set aside.

[0035] 4. Weigh the prescribed amount of lactose, add an appropriate amount of water for injection to dissolve, and set aside.

[0036] 5. Weigh the main drug of the prescribed amount, add 80% of the prescribed amount of water for injection and the prescribed amount of ethanol, stir to form 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, Na 2 HPO 4 Solution and lactose solution, make up the prescribed amount of water for injection, keep warm in a wat...

Embodiment 2

[0043] Preparation process is the same as embodiment 1

[0044] Freeze-drying process

[0045] 1) Pre-freeze, control the product temperature below -40°C, and keep it warm for 1 hour.

[0046] 2) Sublimation drying, turn on the vacuum pump, control the vacuum degree below 40pa, gradually raise the temperature to control the product temperature at -10°C to -8°C, keep it for 2 hours, then raise the temperature to -5°C, and keep it for 6 hours.

[0047] 4) Secondary drying, control the vacuum degree below 30pa, raise the temperature to make the product temperature rise to 33-36°C, then make the freeze-drying box reach the ultimate vacuum, and keep it warm for 2h.

[0048] 5) Release the vacuum, and cap to obtain the finished product.

Embodiment 3

[0050] 1. Weigh the prescription amount of NaHCO 3 , add an appropriate amount of water for injection to dissolve, set aside.

[0051] 2. Weigh the prescription amount NaH 2 PO 4 ·H 2 O, add an appropriate amount of water for injection to dissolve, set aside.

[0052] 3. Weigh the prescription amount Na 2 HPO 4 , add an appropriate amount of water for injection to dissolve, set aside.

[0053] 4. Weigh the main drug of the prescribed amount, add 80% of the prescribed amount of water for injection and the prescribed amount of ethanol, stir to form 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, Na 2 HPO 4 Solution, make up the prescription amount of water for injection, keep warm in a water bath until the solution is clear, and circulate and filter the whole amount. Filter the medicinal solution with a 0.45 μm microporous membrane, and finally fine filter with a 0....

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Abstract

The invention relates to a methylprednisolone sodium succinate freeze-dried powder injection. Every bottle of freeze-dried powder injection is prepared from 12-2550mg of methylprednisolone succinic acid, alkaline auxiliary material in which the sodium ion:succinic acid methylprednisolone mol ratio is 1:1, 0-200mg of excipient and pH value regulator. The powder injection is prepared by dissolving the components in the formula and carrying out freeze-drying. The invention is characterized in that the solvent is ethanol-containing water for injection, and the liquor prepared by dissolving the components in the formula in the solvent contains 5-10 vol% of ethanol.

Description

Technical field: [0001] The invention relates to a corticosteroid preparation, in particular to a freeze-dried powder injection containing methylprednisolone sodium succinate. 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 dosage specif...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/573A61K47/10A61P29/00A61P37/08A61P37/06
Inventor 孙亮陈松赵琳
Owner TIANJIN JINYAO GRP
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