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Methylprednisolone sodium succinate lyophilized composition and its preparing method

A technology of methylprednisolone sodium succinate and methylprednisolone succinate, which is applied to the freeze-dried composition containing methylprednisolone sodium succinate and the preparation field thereof, can solve the problem of easy moisture absorption, high production cost, and inability to add pH Buffers, etc.

Active Publication Date: 2006-10-25
国药集团容生制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

When using the aseptic subpackage method to prepare methylprednisolone sodium succinate powder injection, because methylprednisolone sodium succinate is very easy to absorb moisture, the requirements for the production environment are very strict, and the production cost is relatively high.
At the same time, since the pH buffer agent cannot be added during aseptic subpackaging, it must be dissolved in a special solvent with a pH buffer agent when the solution is used clinically.

Method used

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  • Methylprednisolone sodium succinate lyophilized composition and its preparing method

Examples

Experimental program
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Embodiment 1

[0080] ①Preparation of liquid medicine: take the prescribed amount of alkaline drug excipients and dissolve them with water for injection, take the prescribed amount of pH buffer and dissolve them with water for injections, take the stabilizer and dissolve them with water for injections, accurately weigh the prescribed amount of methylprednisolone succinate, Make a paste with water for injection, slowly add alkaline solution, and stir while adding until methylprednisolone succinate is completely dissolved, then add pH buffer solution and stabilizer solution, and add water for injection to the full amount. Add medicinal charcoal, stir well, let it stand for about 20 minutes, decarburize by coarse filtration, and finely filter until the clarity of the liquid medicine is qualified. Take samples, measure and adjust the pH value of the medicinal solution to 7-8. Sterilize and filter with a Φ0.22 μm microporous membrane filter. Sampling and determination shows that the prope...

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PUM

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Abstract

The present invention provides a freeze-dried medicine composition containing methylprednisolone sodium succinate and its preparation method. Said medicine composition includes 1-3000 mg of methylprednisolone sodium succinate as main component and auxiliary component including 1-1000 mg of sodium hydrogen carbonate or other alkaline medicinal auxiliary material 1-500 mg of lactose or other stabilizing agent. 1-50 mg of sodium dihydrogen phosphate or acid component of other pH buffering agent, 1-500 mg of disodium hydrogen phosphate or alkaline component of other pH buffering agent and 1-50 ml of injection water.

Description

1. Technical field [0001] The invention relates to the field of pharmaceutical preparations. Specifically, the invention relates to a freeze-dried composition containing methylprednisolone succinate sodium and a preparation method thereof. 2. Background technology [0002] Methylprednisolone sodium succinate, the chemical name is sodium 11β, 17α, 21-trihydroxy-6α-methylpregna-1,4-diene-3,20-dione-21-succinate. The structural formula is as follows: [0003] [0004] Molecular formula: C 26 h 33 o 8 Na [0005] Molecular weight: 496.53 [0006] This product is a synthetic steroid for injection with strong anti-inflammatory effect. In addition to the pharmacological effects of glucocorticoids, compared with prednisolone, it has stronger anti-inflammatory effects and weaker water and sodium retention effects. This product has strong anti-inflammatory, immunosuppressive, anti-allergic, anti-shock and other pharmacological effects, and is especially suitable for use in c...

Claims

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Application Information

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IPC IPC(8): A61K31/573A61K9/19
Inventor 申桂英李小秀李大平崔凤云
Owner 国药集团容生制药有限公司
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