A kind of preparation method of solution type triamcinolone acetonide 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 complex process, water solubility of the injection, easy generation of particulate matter during storage, and the like, and the production process is achieved. Simple, easy to absorb, less local irritation effect

Active Publication Date: 2018-08-31
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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  • A kind of preparation method of solution type triamcinolone acetonide injection
  • A kind of preparation method of solution type triamcinolone acetonide injection
  • A kind of preparation method of solution type triamcinolone acetonide injection

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preparation example Construction

[0032] The present invention provides a preparation method of solution-type triamcinolone acetonide acetate injection, the preparation method includes:

[0033] 1) Add sulfobutyl ether-β-cyclodextrin and triamcinolone acetonide acetate to the organic solvent, stir to dissolve until clear, and evaporate the organic solvent;

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

[0035] The method as described above, wherein the molar ratio of triamcinolone acetonide acetate and sulfobutyl ether-β-cyclodextrin is 1:1-20, preferably 1:2-10; 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 method as described above, wherein the organic solvent can be one or more of alcohols...

Embodiment

[0054] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not 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 within the scope of the present invention.

[0055] For the experimental methods without specific conditions in the following examples, conventional methods in the art can be used.

[0056] Unless otherwise stated, percentages and parts are calculated by weight. Unless otherwise defined, all professional and scientific terms used in the text have the same meaning as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to the content described can be applied to the method of the present invention. The preferred implementation methods and materia...

Embodiment 1

[0059] Example 1 Preparation of solution type triamcinolone acetonide acetate injection

[0060] Add 1 mol of sulfobutyl ether-β-cyclodextrin and 1 mol of triamcinolone acetonide acetate into 1L of 75%~100% ethanol, stir to dissolve until clear, vacuum rotary evaporate the organic solvent; then add 2.5L of Dissolve 4mol / L sodium hyaluronate aqueous solution until it is clear, then add 2250ml sterile water for injection, stir evenly, filter and sterilize to prepare 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 medical preparations, in particular to a preparation method of 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, slip Meningitis, acute sprains, rheumatoid arthritis, etc.; because of its remarkable curative effect, the scope of clinical application continues to expand. At present, the commercially available aqueous injections are triamcinolone acetonide acetate injection and triamcinolone acetonide injection, which have low water solubility and are both suspension injections, using sodium carboxymethyl cellulose as a suspending agent. When in use, it is injected into the muscle, subcutaneous or joint cavity; the process a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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