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Methylprednisolone sodium succinate composition for injection

A technology of methylprednisolone sodium succinate and methylprednisolone succinate, which is applied in the field of medicine, can solve the problems of reducing visible precipitates, limited solubilization effect, and unproposed stability, so as to achieve drug safety and facilitate industrial production and preparation The effect of stable quality

Active Publication Date: 2016-12-07
HAINAN HERUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the technologies disclosed in Chinese patent CN201110244020, Chinese patent CN201110244017.8 and Chinese patent CN201110244018.2, it is found that the drug stability is better when lactose is not added, and the freeze-drying time is shorter, but no solution to optimize the stability is proposed.
Chinese patent CN201410350785.5 adds poloxamer 188 to the formula of methylprednisolone sodium succinate composition to dissolve the precipitate, which can reduce the visible precipitate, but the solubilization effect is limited, and the stability problem of the preparation cannot be fundamentally solved

Method used

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  • Methylprednisolone sodium succinate composition for injection
  • Methylprednisolone sodium succinate composition for injection
  • Methylprednisolone sodium succinate composition for injection

Examples

Experimental program
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Effect test

Embodiment 1-5

[0040] Preparation methods of Examples 1-5:

[0041] (1) Weigh the prescribed amount of sodium dihydrogen phosphate and disodium hydrogen phosphate, add 100ml of water for injection to make a buffer solution, boil it for 20 minutes, reduce to room temperature, and set aside;

[0042] (2) Weigh the prescribed amount of sodium bicarbonate, add 50ml of water for injection, stir to dissolve, boil for 20 minutes, reduce to room temperature, and set aside;

[0043] (3) Weigh the prescribed amount of glycine and hydroxypropyl-β-cyclodextrin (with a degree of substitution of 3 to 7), add 350ml of water for injection, stir to dissolve, boil for 20 minutes, reduce to room temperature, and set aside;

[0044] (4) Add the prescribed amount of methylprednisolone succinate (in terms of methylprednisolone) into 300ml water for injection, and stir into a paste;

[0045] (5) Slowly add the solution of step (2) to step (4), stirring while adding, until the methylprednisolone succinate is completely disso...

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Abstract

The invention discloses a methylprednisolone sodium succinate composition for injection. The methylprednisolone sodium succinate composition is an injection and is prepared from methylprednisolone, glycine, hydroxypropyl-beta-cyclodextrin, sodium bicarbonate, sodium dihydrogen phosphate, disodium hydrogen phosphate and water for injection. The mass ratio of the glycine to the methylprednisolone is 1:3 to 1:7 and is preferably 1:4 to 1:6. The methylprednisolone sodium succinate composition for injection is stable in quality and safe in use, no visible foreign matter precipitates, the anti-inflammatory treatment effect is improved, and a preparation method includes simple steps, the conditions are simple, and industrial production is promoted.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a methylprednisolone sodium succinate composition for injection. Background technique [0002] Methylprednisolone is a synthetic, halogen-free, intermediate-acting glucocorticoid drug. The drug can quickly reach a higher blood concentration in the body with less side effects, especially for critically ill patients. Methylprednisolone has powerful anti-inflammatory, immunosuppressive, anti-allergic, anti-shock and other pharmacological effects. It has a strong anti-inflammatory effect, which is 5 times that of hydrocortisone and 20% higher than prednisone. The drug's mineralocorticoid-like effects (such as sodium retention) are weak, only 1 / 200 of deoxycorticosterone, far less than prednisone and dexamethasone. Methylprednisolone is widely used clinically in respiratory diseases, endocrine disorders, rheumatic diseases, collagen diseases, blood diseases, skin diseases, al...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/18A61K47/40A61K31/573A61K31/198A61P11/00A61P5/00A61P29/00A61P7/00A61P17/00A61P37/08A61P25/00A61P35/00A61P1/00A61P37/06A61P43/00
Inventor 钟正明
Owner HAINAN HERUI PHARMA
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