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Preparation method for solution type triamcinolone acetonide acetate injection

A technology for triamcinolone acetonide acetate and injection, which is applied in the field of preparation of solution-type triamcinolone acetonide acetate injection, can solve the problems of easy generation of particulate matter in the storage process, complicated process, and no solution to the water solubility of the injection, and achieves easy absorption. , the production process is simple, the effect of local irritation is small

Active Publication Date: 2015-11-11
上海正大通用药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Therefore, the prior art does not solve the clinical problems such as low water solubility, complex process, easy generation of particulate matter in the storage process, and fibrosis of the injection.

Method used

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  • Preparation method for solution type triamcinolone acetonide acetate injection
  • Preparation method for solution type triamcinolone acetonide acetate injection
  • Preparation method for solution type triamcinolone acetonide acetate injection

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preparation example Construction

[0032] The present invention provides a kind of preparation method of the injection of solution type triamcinolone acetonide acetate, and described preparation method comprises:

[0033] 1) adding sulfobutyl ether-β-cyclodextrin and triamcinolone acetonide to the organic solvent, stirring and dissolving until clear, and evaporating the organic solvent;

[0034] 2) In the mixture obtained in step 1), add an aqueous solution of sodium hyaluronate, dissolve until clarified, then add dilution water, stir evenly, and prepare sulfobutyl ether-β-cyclodextrin inclusion compound after sterilization Injection.

[0035] The above method, wherein the molar ratio of triamcinolone acetonide acetate and sulfobutyl ether-β-cyclodextrin is 1:1~20, preferably 1:2~10; the ratio of triamcinolone acetonide acetate and water The weight ratio is 1:10-40, preferably 1:20-40, and the molar ratio of triamcinolone acetonide acetate to sodium hyaluronate is 1:1-10, preferably 1:1-5.

[0036] The above ...

Embodiment

[0054] Below in conjunction with specific embodiment, further illustrate the present invention. It should be understood that these examples are only used to illustrate the present invention and are not intended to limit the scope of the present invention. Those skilled in the art can make appropriate modifications and changes to the present invention, and these modifications and changes are all within the scope of the present invention.

[0055] For the experimental methods not indicating specific conditions in the following examples, conventional methods in the art can be used.

[0056] Percentages and parts are by weight unless otherwise indicated. Unless otherwise defined, all professional and scientific terms used herein have the same meanings as commonly understood by those skilled in the art. In addition, any methods and materials similar or equivalent to those described can be applied to the method of the present invention. The preferred implementation methods and ma...

Embodiment 1

[0059] The preparation of embodiment 1 solution type triamcinolone acetonide injection

[0060] Add 1mol of sulfobutyl ether-β-cyclodextrin and 1mol of triamcinolone acetonide acetate to 1L of 75%~100% ethanol, stir and dissolve until clear, and evaporate the organic solvent in a vacuum rotary evaporation; then add 2.5L of 4mol / L sodium hyaluronate aqueous solution, dissolved until clear, then add 2250ml sterilized water for injection, stir evenly, filter and sterilize to prepare an injection containing sulfobutyl ether-β-cyclodextrin inclusion compound.

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Abstract

The invention provides a preparation method for a solution type triamcinolone acetonide acetate injection. The preparation method comprises the following concrete steps: in the presence of an organic solvent, stirring triamcinolone acetonide acetate and sulfobutyl ether-beta-cyclodextrin until the obtained mixture is clear; then removing the organic solvent through evaporation; and adding an aqueous sodium hyaluronate solution, dilution water, etc. The preparation method for the solution type triamcinolone acetonide acetate injection is simple; the prepared injection has small local irritation in clinical application; and triamcinolone acetonide acetate can be easily absorbed especially when the injection is applied to intra-articular injection, and the problem of deposition of particles on the surface of periosteum caused by a suspension type triamcinolone acetonide acetate injection is avoided, so damage of the particles to the periosteum can be reduced.

Description

technical field [0001] The invention relates to a preparation process of a pharmaceutical preparation, in particular to a preparation method of a solution-type triamcinolone acetonide acetate injection. Background technique [0002] Triamcinolone acetonide is a long-acting glucocorticoid drug with strong and lasting anti-inflammatory and anti-allergic effects; it is suitable for various skin diseases, allergic rhinitis, arthralgia, bronchial asthma, frozen shoulder, tenosynovitis, slippery Meningitis, acute sprain, rheumatoid arthritis, etc.; because of its remarkable curative effect, the scope of clinical application continues to expand. Currently, the commercially available aqueous injections are triamcinolone acetonide acetate injection and triamcinolone acetonide injection, both of which have low water solubility and are suspension injections, using carboxymethylcellulose sodium as the suspending agent. When used, it is injected into the muscle, subcutaneous or joint ca...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/58A61P29/00A61P37/08A61P17/00A61P11/02A61P19/02A61P11/06A61P19/04
Inventor 徐若娴胡金山刘曲顾兆姝王军平
Owner 上海正大通用药业股份有限公司
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