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Clotrimazole gel, and its prepn. method

A clotrimazole gel and clotrimazole technology, which can be applied in the directions of antifungal agents, pharmaceutical formulations, medical preparations with inactive ingredients, etc., can solve uneven drug release, reduce patient adaptability, and irreversible changes in cell membrane function. and other problems, to achieve the effect of reliable curative effect, improved drug curative effect, and increased exposure

Active Publication Date: 2007-01-31
北京科信聚润医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, there are also some problems in the gel dosage form. For example, in order to promote the osmotic absorption of the drug at the site of application, it is often necessary to use a penetration-promoting agent, such as azone
However, it has been reported that azone causes irreversible changes in the function of the cell membrane due to its chemical structure similar to the composition of the cell membrane.
The use of too much penetration enhancer can also lead to uneven drug release
In addition, for some drugs, when the drug concentration is too high, there is irritation to the local mucosa, which will greatly reduce the patient's adaptability

Method used

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  • Clotrimazole gel, and its prepn. method

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Experimental program
Comparison scheme
Effect test

preparation Embodiment

[0045] 1. pH value inspection:

[0046]Investigate carbomer and triethanolamine in different ratio situation and pH value, take pH value 6-7.5 as index, set

[0047] Meter test:

[0048]

[0049] Result analysis:

[0050] When the ratio of carbomer and triethanolamine is 1:1, the pH value meets the requirement.

[0051] 2 Viscosity inspection:

[0052] Investigate the viscosity of different amounts of carbomer and triethanolamine at 1:1.

[0053] Carbomer and Triple B

Alcohol amine dosage

clotrimazole

Glycerin

Ethylparaben

viscosity

3％

5％

10％

0.06％

very large difficult to prepare

2％

5％

10％

0.06％

larger

1％

5％

10％

0.06％

appropriate

0.8％

5％

10％

0.06％

smaller

0.6％

5％

10％

0.06％

small, liquid

0.4％

5％

10％

0.06％

very small, liquid

[0054] From th...

Embodiment 1

[0057] Clotrimazole 150g 5%

[0058] Glycerin 300g 10%

[0059] Cabham 934 12g 0.4%

[0060] Ethylparaben 1.5g 0.05%

[0061] Triethanolamine 15g 0.5%

[0062] Add distilled water to 3000g, appropriate amount to 100%

[0063] Process:

[0064] (1) Sterilize by boiling in distilled water, weigh 1.5 g of ethylparaben, dissolve in 2100 ml of hot water (80°C), let cool to 40°C, and set aside.

[0065] (2) Take another 12g of carbomer, sprinkle it into the above solution in batches, stir until evenly dispersed, let it stand for 2 hours, and set aside.

[0066] (3) Weigh 15 g of triethanolamine, dilute it with distilled water (420 ml) and slowly add it to the above solution; then add glycerin, stir until translucent and homogeneous, and obtain a blank gel.

[0067] (4) Weigh 150 g of clotrimazole fine powder, evenly disperse it in the blank gel, and stir until a uniform system is obtained.

[0068] (5) Dispense the gel into vaginal applicators to obtain the product.

Embodiment 2

[0070] Clotrimazole 150g 5%

[0071] Glycerin 300g 10%

[0072] Cabham 934 15g 0.5%

[0073] Ethylparaben 1.5g 0.05%

[0074] Triethanolamine 15g 0.5%

[0075] Add distilled water to 3000g, appropriate amount to 100%

[0076] Technology is with preferred embodiment 1

[0077] In summary, the gel formulation of the present invention is superior to conventional options in terms of stability, transdermal absorption, etc., and these effects are obviously not brought about by the drug or adjuvant itself, or the dosage form itself. Therefore, compared with the prior art, the technical solution of the present application is a creative effort. Therefore, the technical solution of the present application has an inventive step.

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Abstract

A mycosporin gel with high percutaneous absorptivity and stability and its preparing process are disclosed.

Description

technical field [0001] The invention relates to a clotrimazole gel preparation and a preparation method thereof. Background technique [0002] Clotrimazole (clotrimazole, clotrimazole) is the first broad-spectrum antifungal drug used clinically. Currently used in the local treatment of skin candida infection, such as tinea corporis, onychomycosis, athlete's foot, tinea versicolor, etc.; mucosal candida infection, such as lip, oropharynx, anus, vulva, and interdigital infection; vaginal candida infection Vaginitis, as well as tinea pedis, ear canal and vaginal mycosis. It is also effective for trichomonal vaginitis. It has slow metabolism in the body, low toxicity and good curative effect. [0003] In the 95th edition of Pharmacopoeia, the preparations of clotrimazole include suppository, tablet, oral film, ointment, solution; in the ministerial standard, the preparation of clotrimazole includes clotrimazole vaginal effervescent tablet (WS-1001- HD-0097)-2002), Clotrimazo...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/4164A61K47/32A61P31/10
Inventor 王锦刚蒋海松
Owner 北京科信聚润医药科技有限公司
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