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Method for improving stability of triamcinolone acetonide preparation

A technology of triamcinolone acetonide acetate and stability, which is used in pharmaceutical formulations, allergic diseases, organic active ingredients, etc., can solve the problems of not reaching the labeled content, reducing the drug content, shortening the validity period, etc., and achieving low production cost and dosage. Small, stable effect

Inactive Publication Date: 2017-05-31
TIANJIN JINHUI PHARMA
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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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Embodiment Construction

[0020] A method for improving the stability of triamcinolone acetonide preparations, comprising the following components: triamcinolone acetonide acetate, polyglycol 15-hydroxystearate, sodium carboxymethylcellulose, 2-propylene glycol, 5% ethanol, salicylic acid acid and water for injection, including 100g-150g triamcinolone acetonide acetate, 0.2g-0.5g polyglycol 15-hydroxystearate, 30g-50g sodium carboxymethylcellulose, 2g-5g salicylic acid, 70-100L2 -Propylene glycol, 40-60L 5% ethanol, the rest is water for injection, the pH value is 4-7;

[0021] The specific processing methods are as follows: (1) 100g-150g triamcinolone acetonide acetate, 0.2g-0.5g polyglycol 15-hydroxystearate, 30g-50g sodium carboxymethylcellulose, 70L-80L 2-propylene glycol, 2g- Add 5g of salicylic acid and water for injection into the batching pot, stir and dissolve until clear, and stir until completely dissolved;

[0022] (2) adding alkaline solution;

[0023] (3) adding sodium chloride;

[002...

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Abstract

The invention relates to a method for improving the stability of a triamcinolone acetonide preparation. The triamcinolone acetonide preparation is prepared from the following components: 100-150g of triamcinolone acetonide acetate, 0.2-0.5g of 15-hydroxyl stearic acid polyethylene glycol ester, 30-50g of sodium carboxymethyl cellulose, 2-5g of salicylic acid, 70-100L of 2-propylene glycol, 40-60L of 5% ethanol and the balance of water for injection; the pH value of the triamcinolone acetonide preparation is 4-7. Sodium chloride is added into a triamcinolone acetonide acetate solution, and the amount of the sodium chloride is selected to be limited, so that the problem that the content of the triamcinolone acetonide acetate is reduced in a standing process of a compound triamcinolone acetonide solution is solved; furthermore, the sodium chloride is cheap and less in consumption, so that the method is lower in production cost and suitable for industrial production and application; in addition, the sodium chloride does not affect the cleanliness of the active ingredients in the solution, and does not affect the safety and effectiveness of the solution.

Description

[0001] Technical field: [0002] The invention relates to the technical field of preparation methods of medicines, in particular to a method for improving the stability of triamcinolone acetonide preparations. [0003] Background technique: [0004] The compound triamcinolone acetonide acetate solution currently on the market contains triamcinolone acetonide acetate, salicylic acid, laurocapram, propylene glycol and ethanol. However, due to the influence of external environmental factors such as light, temperature, humidity, etc., the content of triamcinolone acetonide acetate often decreases significantly during the storage process, and it gradually decomposes and becomes invalid. Salicylic acid is a phenolic substance with phenolic hydroxyl groups in its molecular structure, which is easy to oxidize and deteriorate. The corticosteroid triamcinolone acetonide acetate belongs to steroid hormone drugs. Judging from its chemical structural formula, it is very easy to be oxidized...

Claims

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Application Information

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IPC IPC(8): A61K31/60A61K31/58A61K9/08A61K47/02A61K47/14A61K47/38A61P37/08A61P17/00A61P25/00
CPCA61K31/58A61K9/08A61K31/60A61K47/02A61K47/14A61K47/38
Inventor 程绍国蔡浩杰王学元
Owner TIANJIN JINHUI PHARMA
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