A kind of 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: 2019-09-03
HAINAN HERUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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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  • A kind of methylprednisolone sodium succinate composition for injection
  • A kind of methylprednisolone sodium succinate composition for injection
  • A kind of methylprednisolone sodium succinate composition for injection

Examples

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Embodiment 1-5

[0040] The preparation method of embodiment 1-5:

[0041] (1) Take by weighing sodium dihydrogen phosphate and disodium hydrogen phosphate of prescription quantity, add 100ml water for injection, make buffer solution, boil 20min, drop to room temperature, standby;

[0042] (2) Take by weighing the sodium bicarbonate of recipe quantity, add 50ml water for injection, stir and dissolve, boil 20min, be down to room temperature, standby;

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

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

[0045] (5) Slowly add the step (2) solution into the step (4), and stir while adding, until the methylprednisolone succinate is completely dissolved;

[0046] (6) Add the s...

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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 medicines, in particular 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, and has less side effects, especially for critically ill patients. Methylprednisolone has powerful anti-inflammatory, immunosuppressive, anti-allergic, anti-shock and other pharmacological effects, and its anti-inflammatory effect is strong, which is equivalent to 5 times that of hydrocortisone and 20% higher than that of prednisone. The drug's mineralocorticoid-like effects (such as sodium retention) are weak, only 1 / 200 of that of deoxycorticosterone, far less than that of prednisone and dexamethasone. Methylprednisolone is widely used clinically in respiratory diseases, endocrine disorders, rheumatic diseases, collagen diseas...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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