Sodium fusidate powder-injection pharmaceutical composition for injection and preparation method

A technology of sodium fusidate and its composition, which is applied in the field of medical technology and can solve the problems of reducing solvents, precipitation, turbidity, etc.

Active Publication Date: 2015-02-18
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] In addition, it is known that in clinical use, turbidity or precipitation will occur when the drug is mixed or encountered with sodium fusidate
The reasons may be: 1) Drugs with strong acidity, such as vitamin C, ligustrazine phosphate, etc., can cause fusidic acid to separate out from sodium fusidic acid due to lowering the pH of the solvent, forming turbidity or precipitation, so the choice of solvent It should be noted that if the pharmacopoeia stipulates that the pH range of glucose injection is 3.5-6.5, sodium fusidate is likely to precipitate in this pH range.
2) It may combine with fusidic acid to form a double salt with less solubility, which is easy to form turbidity or precipitation
[0017] It has been found that sodium fusidate prepared by existing methods is unsatisfactory in certain pharmaceutical properties, such as their chemical stability

Method used

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  • Sodium fusidate powder-injection pharmaceutical composition for injection and preparation method
  • Sodium fusidate powder-injection pharmaceutical composition for injection and preparation method
  • Sodium fusidate powder-injection pharmaceutical composition for injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0116] Embodiment 1: Preparation of sodium fusidate freeze-dried powder injection pharmaceutical composition

[0117] formula:

[0118] Sodium Fusidate 0.5g,

[0119] Glycine 0.2g,

[0120] Arginine 0.2g,

[0121] Add water for injection, appropriate amount, to 8ml.

[0122] Preparation method:

[0123] (a) Take the active ingredient of prescription quantity and neutral amino acid and basic amino acid, add appropriate amount of water for injection to dissolve, then add activated carbon, stir, filter and decarbonize;

[0124] (b) Add water for injection to the prescribed amount, stir evenly, measure the pH value of the solution and optionally measure the active ingredient content, and adjust the pH value to 8.0 to 8.5 with an acid-base regulator if necessary;

[0125] (c) Sterilize and filter the medicinal liquid, fill it in a vial, freeze-dry to remove water, and press the stopper to obtain the product.

[0126] Wherein the water for injection mentioned in the prescript...

Embodiment 2

[0127] Embodiment 2: Preparation of sodium fusidate freeze-dried powder injection pharmaceutical composition

[0128] formula:

[0129] Sodium Fusidate 0.5g,

[0130] Glycine 0.08g,

[0131] Arginine 0.165g,

[0132] Add water for injection, appropriate amount, to 4ml.

[0133] Preparation method:

[0134] (a) Take the active ingredient of prescription quantity and neutral amino acid and basic amino acid, add appropriate amount of water for injection to dissolve, then add activated carbon, stir, filter and decarbonize;

[0135] (b) Add water for injection to the prescribed amount, stir evenly, measure the pH value of the solution and optionally measure the active ingredient content, and adjust the pH value to 8.0 to 8.5 with an acid-base regulator if necessary;

[0136](c) Sterilize and filter the medicinal liquid, fill it in vials, freeze-dry (freeze-drying curve B) to remove water, and press stopper to obtain the product.

Embodiment 3

[0137] Embodiment 3: Preparation of sodium fusidate freeze-dried powder injection pharmaceutical composition

[0138] formula:

[0139] Sodium Fusidate 0.5g,

[0140] Glycine 0.2g,

[0141] Arginine 0.2g,

[0142] Mannitol 0.25g,

[0143] Add water for injection, appropriate amount, to 10ml.

[0144] Preparation method:

[0145] (a) Take the active ingredient and mannitol, neutral amino acid and basic amino acid of the prescribed amount, add appropriate amount of water for injection to dissolve, then add activated carbon, stir, filter and decarbonize;

[0146] (b) Add water for injection to the prescribed amount, stir evenly, measure the pH value of the solution and optionally measure the active ingredient content, and adjust the pH value to 8.0 to 8.5 with an acid-base regulator if necessary;

[0147] (c) Sterilize and filter the medicinal liquid, fill it in a vial, freeze-dry to remove water, and press the stopper to obtain the product.

[0148] Wherein the water fo...

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Abstract

The invention relates to a sodium fusidate powder-injection pharmaceutical composition for injection and a preparation method. Specifically, the invention belongs to the technical field of medicines, relates to a medicine which can be used for treating various infections such as osteomyelitis, sepsis, endocarditis, repeatedly infected cystic fibrosis, pneumonia, skin and soft tissue infections, surgical and traumatic infections and the like caused by various sensitive bacteria, especially staphylococcus, and particularly relates to a pharmaceutical composition such as a freeze-dried powder injection prepared by taking sodium fusidate as an active component. The invention also relates to a preparation method of the pharmaceutical composition. In an implementation scheme, the invention relates to a sodium fusidate powder-injection pharmaceutical composition for injection, which comprises sodium fusidate, a neutral amino acid and an alkaline amino acid. The pharmaceutical composition has excellent pharmaceutical properties.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a kind of medicine that can be used to treat various infections caused by various sensitive bacteria, especially staphylococcus, such as osteomyelitis, sepsis, endocarditis, cystic fibrosis, pneumonia, and recurrent infection. Drugs for skin and soft tissue infections, surgical and traumatic infections, etc., especially related to a pharmaceutical composition made of sodium fusidate as an active ingredient such as freeze-dried powder injection. The invention also relates to a preparation method of the pharmaceutical composition. Background technique [0002] Sodium Fusidate (Sodium Fusidate), its cultural name is: 16α-acetoxy-3β, 11β-dihydroxy-4β, 8β, 14α-trimethyl-18-nor-5β, 10α-cholesteric -(17Z)-17(20),24-diene-21-acid sodium, the English chemical name is: Sodium ent-(17Z)-16α-(acetyloxy)-3β,11β-dihydroxy-4β,8,14- trimethyl-18-nor-5β,10α-cholesta-17(20),24-dien-21-oate, molec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/56A61K47/18A61K47/22A61P31/04
Inventor 王敬江威方专吴国庆左伟赵东明
Owner CHENGDU TIANTAISHAN PHARMA
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