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Mometasone furoate gelatin and preparation method thereof

A technology of mometasone furoate and gel, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problems of fast growth and product quality risks, and achieve growth Stability, good application feeling, and stable drug effect

Inactive Publication Date: 2019-04-12
华润三九(南昌)药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the 24-month inspection of related substances in mometasone furoate gel, it was found that the largest single impurity was close to 0.2%, and the total impurity increased by 2.5-4 times to close to 1.0%. The growth rate was relatively fast, and the product had quality risks

Method used

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  • Mometasone furoate gelatin and preparation method thereof
  • Mometasone furoate gelatin and preparation method thereof
  • Mometasone furoate gelatin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1: mometasone furoate gel, is characterized in that: be made of the raw and auxiliary materials of following weight ratio: mometasone furoate 1.0g, carbomer 10.0g, triethanolamine 5.0g, medicinal ethanol 50.0g , glycerin 150.0g, ethylparaben 1.0g, add purified water to a total weight of 1000g;

[0032] The preparation method of mometasone furoate gel is as follows: (1) Weigh the prescribed amount of carbomer and disperse it in 600g of purified water, fully swell for 3 hours; add glycerin and stir evenly; dilute with triethanolamine and the remaining amount of purified water, and stir (2) Mix mometasone furoate and ethylparaben in medicinal ethanol, stir to dissolve and heat to 55°C, Add it into the matrix under stirring, and continue to stir to obtain a milky white translucent gel, which is packaged.

Embodiment 2

[0033] Embodiment 2: mometasone furoate gel, is characterized in that: be made of the raw and auxiliary materials of following weight ratio: mometasone furoate 1.0g, carbomer 10.0g, triethanolamine 4.5g, medicinal ethanol 50.0g , glycerin 150.0g, ethylparaben 1.2g, add purified water to a total weight of 1000g;

[0034]The preparation method of mometasone furoate gel is as follows: (1) Weigh the prescribed amount of carbomer and disperse it in 600g of purified water, and fully swell for 3.5 hours; add glycerin and stir evenly; Add to the carbomer solution under stirring, and stir while adding to obtain a transparent gel matrix; (2) Mix mometasone furoate and ethyl paraben in medicinal ethanol, stir to dissolve and heat to 60°C, Add it into the matrix under stirring, and continue to stir to obtain a milky white translucent gel, which is packaged.

Embodiment 3

[0035] Embodiment 3: mometasone furoate gel, is characterized in that: be made of the raw and auxiliary materials of following weight ratio: mometasone furoate 1.0g, carbomer 10.0g, triethanolamine 4.0g, medicinal ethanol 50.0g , glycerin 150.0g, ethylparaben 1.5g, adding purified water to a total weight of 1000g, all the other with embodiment 1.

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PUM

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Abstract

The invention provides a preparation method of mometasone furoate gelatin. The mometasone furoate gelatin is prepared from the following raw materials and auxiliary materials in proportion by weight of 1.0g of mometasone furoate, 8.0-10.0g of carbomer, 4.0-6.0g of triethanolamine, 50.0g of medical ethanol, 150.0g of glycerine, and 0-1.5g of ethylparaben, and purified water is added until the totalweight is 1000g, wherein the pH value of the mometasone furoate gelatin is 5.5-6.5, and the mass ratio of the triethanolamine to the carbomer is 0.40-0.55; single unknown impurities of the mometasonefuroate gelatin do not exceed 0.2%; the total impurities are not greater than 1.0%, and the mometasone furoate gelatin is stable under the high-temperature illumination condition. Besides, radix angelicae pubescentis, herba selaginellae, Chinese arborvitae twigs and leaves, hedyotis diffusa, a pharmaceutic adjuvant, azone and rice milk, which are added, have favorable treatment effect on treatment of foot fracture.

Description

technical field [0001] The present invention relates to the technical field of a kind of external preparation medicine, especially a kind of external use gel preparation medicine containing mometasone furoate, because this gel adopts the matrix combination of carbomer and triethanolamine, carbomer is used as the gel matrix , Triethanolamine as a pH regulator, glycerin as a humectant, has better moisturizing properties and penetration absorption effect, can effectively absorb through tissues without hindering the normal function of the skin, especially suitable for seborrheic skin diseases. Background technique [0002] Mometasone furoate is a synthetic topical glucocorticoid with strong anti-inflammatory effects and low inhibition of adrenal cortex function. Mometasone furoate gel has the effect of reducing inflammation and itching, suitable for skin diseases that are effective to glucocorticoids such as dermatitis (contact dermatitis, seborrheic dermatitis, atopic dermatiti...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/58A61K36/748A61K47/32A61K47/18A61K47/14A61K47/10A61P17/02
CPCA61K9/0014A61K9/06A61K31/58A61K36/11A61K36/14A61K36/232A61K36/748A61K47/10A61K47/14A61K47/18A61K47/32A61K2236/15A61K2236/331A61K2236/333A61K2236/37A61K2236/39A61K2236/53A61K2236/55A61P17/02A61K2300/00
Inventor 徐玉琴梅璇潘忠平王志敏叶帮伟
Owner 华润三九(南昌)药业有限公司
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