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Medical product containing solution-type triamcinolone acetonide acetate

A technology of triamcinolone acetonide acetate and solution type, which is applied in the direction of medical preparations containing active ingredients, medical preparations of non-active ingredients, pharmaceutical formulas, etc., which can solve the complex process and the problem of water solubility of triamcinolone acetonide acetate injection. And other problems, to achieve the effect of simple production process, reduce periosteum damage, and local irritation

Active Publication Date: 2015-10-14
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 during storage, and fibrosis in triamcinolone acetonide acetate injection.

Method used

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Examples

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Embodiment

[0065] 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.

[0066] For the experimental methods not indicating specific conditions in the following examples, conventional methods in the art can be used.

[0067] 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

[0070] Example 1 Preparation of Solution Triamcinolone Acetate Injection

[0071] The prescription composition of the solution type triamcinolone acetonide acetate injection is composed of 1 mol of triamcinolone acetonide acetate, 1 mol of sulfobutyl ether-β-cyclodextrin, 10 mol parts by weight of sodium hyaluronate and 4750 ml of water for injection.

[0072] 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 sterile water for injection, stir evenly, adjust the pH to 5.5, filter and sterilize to prepare sulfobutyl ether-β-cyclodextrin inclusion compound Injection.

Embodiment 2

[0073] Example 2 Preparation of Solution Triamcinolone Acetate Injection

[0074] The prescription composition of the solution-type triamcinolone acetonide acetate injection is composed of 1 mol triamcinolone acetonide acetate, 20 mol sulfobutyl ether-β-cyclodextrin, 1 mol weight part of sodium hyaluronate and 19040 ml of water for injection.

[0075] Add 20mol of sulfobutyl ether-β-cyclodextrin and 1mol of triamcinolone acetonide to 20L of 75%~100% acetonitrile, stir and dissolve until clear, and evaporate the organic solvent in a vacuum; then add 10L of 0.1 mol / L aqueous solution of sodium hyaluronate, dissolved until clear, then add 9040ml sterilized water for injection, stir evenly, and adjust the pH to 4.5. After filtering and sterilizing, an injection solution containing sulfobutyl ether-β-cyclodextrin inclusion compound is prepared.

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Abstract

The invention provides a medical product containing solution-type triamcinolone acetonide acetate. The medical product contains triamcinolone acetonide acetate, sulfobutyl ether-beta-cyclodextrin and sodium hyaluronate. The medical product containing solution-type triamcinolone acetonide acetate is small in local irritation in clinic use, especially when the medical product is applied to intra-articular injection, the product is easy to absorb, the particle deposition on the surface of the periosteum existing in the suspension type triamcinolone acetonide acetate medical product is avoided, and the periosteum injury caused by particle deposition is reduced.

Description

technical field [0001] The invention relates to medical products, in particular to a medical product containing solution-type triamcinolone acetonide acetate. 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 cavity; its process and product quality proble...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/06A61K31/58A61K47/48A61K47/36A61P19/02
Inventor 俞庆臻魏东任寅顾兆姝王军平
Owner 上海正大通用药业股份有限公司
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