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Compound triamcinolone acetonide acetate solution production technology

A technology of triamcinolone acetonide acetate and its production process, which is applied in the field of production process of compound triamcinolone acetonide acetate solution, can solve the problems of shortened validity period, decreased drug content, and failing to reach the labeled content, and achieves strong stability and solves the problem of main drug The effect of content reduction and stability assurance

Active Publication Date: 2011-05-11
SHANGHAI NEW ASIATIC PHARMA MINHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The corticosteroid triamcinolone acetonide acetate belongs to steroid hormone drugs. Judging from its chemical structural formula, it is very easy to be oxidized, and it also belongs to esters, which is prone to hydrolysis, resulting in a decrease in drug content, which cannot meet the requirements of the "Chinese Pharmacopoeia". The labeled content of the corresponding pharmaceutical preparations required, so the validity period of the drug is also shortened accordingly

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Add 85L of 1,2-propanediol, 50L of 85% ethanol, 4.0kg of salicylic acid, 3300ml of laurocapram, and 185g of triamcinolone acetonide into the batching pot in turn, and stir at a stirring speed of 50-60Hz for 2-3 hours until completely dissolved. Then add 25L 10% NaHCO 3 solution, adjust the pH to 6. With 85% ethanol, the liquid in the batching pot is settled to 185L, stops after stirring for 15 minutes, and feed liquid is filtered.

Embodiment 2

[0021] Add 90L of 1,2-propanediol, 60L of 85% ethanol, 3.8kg of salicylic acid, 3800ml of laurocaprolactone, and 190g of triamcinolone acetonide acetate into the batching pot in turn, stir until completely dissolved, then add 38g of glycine, and dissolve with 85% ethanol The liquid in the batching pot is fixed to 190L, and finally the feed liquid is filtered.

Embodiment 3

[0023] Add 75L of 1,2-propanediol, 55L of 85% ethanol, 3.8kg of salicylic acid, 3500ml of laurocaprolactone, and 185g of triamcinolone acetonide acetate into the batching pot in turn, stir until completely dissolved, then add 185g of vitamin C, and use 85% ethanol Set the volume of the liquid in the ingredient pot to 185L, and finally filter the feed liquid.

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Abstract

The invention provides a production technique of a compound triamcinolone acetonide acetate solution. The invention is characterized in that the stability of the solution of the invention is enhanced by regulating the PH value or adding various antioxidants. The compound triamcinolone acetonide acetate solution prepared by adopting the technique solves the problem that the content of the main medicine decreases in the validity period of the medicine preparation, so as to better treat allergic dermatitis, neurodermatitis and chronic eczema, etc. diseases.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a production process of compound triamcinolone acetonide acetate solution. Background technique [0002] Compound triamcinolone acetonide acetate solution is a compound preparation of triamcinolone acetonide acetate and salicylic acid, which belongs to adrenal cortex hormone drugs. The anti-inflammatory and anti-allergic effects of topical corticosteroid triamcinolone acetonide, in conjunction with the exfoliating effect of salicylic acid, enhance the curative effect on chronic pruritus and allergic skin diseases. [0003] The compound triamcinolone acetonide acetate solution currently on the market contains triamcinolone acetonide acetate, salicylic acid, laurocapram, propylene glycol and ethanol. Among them, laurocapram, as a transdermal absorption accelerator, improves the transdermal absorption rate of triamcinolone acetonide acetate and salicylic acid. However, d...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/60A61K47/22A61K47/18A61P17/04A61K31/58
Inventor 赵东明王佩芳陆丽红徐凤芳
Owner SHANGHAI NEW ASIATIC PHARMA MINHANG
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