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Terbinafine hydrochloride cream and preparation method thereof

A technology for terbinafine hydrochloride and nafine cream, which is applied in ointment delivery, pharmaceutical formula, emulsion delivery, etc. It can solve the problems of high skin irritation, non-moisturizing cream, and unstable milk droplets, etc., and reach the skin Less irritating, moisturizing ointment, and the effect of mixing the main ingredients evenly

Active Publication Date: 2013-06-05
TIANSHENG PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Yet when carrying out prescription technology research to existing terbinafine hydrochloride emulsifiable paste, with reference to the prescription composition of commercially available product, dosage is screened, and the prescription that orthogonal test is optimized produces a batch of samples and carries out stability investigation, test result shows : If the pH of the sample is too low, it will be too acidic and too irritating to the skin
During the placement of the sample, the milk droplets formed by emulsification are unstable and the water is lost, resulting in a non-moisturizing paste, difficult to apply, slow absorption, and demulsification and stratification

Method used

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  • Terbinafine hydrochloride cream and preparation method thereof
  • Terbinafine hydrochloride cream and preparation method thereof
  • Terbinafine hydrochloride cream and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] A kind of terbinafine hydrochloride emulsifiable paste, the quality proportioning relation that its each material is formed is:

[0036] Terbinafine Hydrochloride 2g, Sodium Lauryl Sulfate 2g,

[0037] Propylene Glycol 20g, Glyceryl Monostearate 12g,

[0038] Stearyl alcohol 10g, white petrolatum 10g,

[0039] Ethylparaben 0.4g, light liquid paraffin 14g,

[0040] 130g of water;

[0041]Its preparation method, it is to carry out according to the steps described below: take 8g propylene glycol and terbinafine hydrochloride mix, 50 ℃ slightly heat to dissolve, set aside; Take another 2g propylene glycol and ethylparaben to mix, 50 ℃ slightly heat to dissolve , for subsequent use; take the remaining 10g propylene glycol, sodium lauryl sulfate, water, and the mixed solution of propylene glycol and ethylparaben, and mix them in a container to form an aqueous phase; in addition, add glyceryl monostearate , stearyl alcohol, white petrolatum and light liquid paraffin in a w...

Embodiment 2-4

[0076] Using the same preparation method as in Example 1, according to the material composition ratio described in the following table 6, prepare terbinafine hydrochloride emulsifiable paste containing terbinafine hydrochloride specification of about 1%. Terbinafine hydrochloride cream for comparison:

[0077] Table 6

[0078] Name of raw material

Example 2

Example 3

Example 4

Example 1

Terbinafine hydrochloride (g)

2

2

2

2

Sodium Lauryl Sulfate (g)

2

3

3

2

Propylene glycol (g)

20

20

20

20

water (g)

120

140

122

130

Glyceryl monostearate (g)

15

11

15

12

Octadecanol (g)

15

5

12

10

White petrolatum (g)

12

5

12

10

Light liquid paraffin (g)

14

14

14

14

Ethylparaben (g)

0.4

0.4

0.4

0.4

[0079] For the terbinafine hydrochloride emulsifiable paste o...

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PUM

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Abstract

The invention relates to a terbinafine hydrochloride cream. According to the invention, terbinafine hydrochloride with an effective amount is adopted as a main raw material, and the cream is prepared with the main raw material and pharmaceutically acceptable auxiliary materials of sodium dodecyl sulfate, propylene glycol, glycerol monostearate, octadecanol, white vaseline, light liquid paraffin, ethyl paraben, and water. The cream provided by the invention has the advantages of moisturizing cream body, good spreadability, convenient medication, low irritation to skins, good treatment effect, and stable quality.

Description

technical field [0001] The invention relates to a cream for treating superficial mycosis of the skin, in particular to a terbinafine hydrochloride cream and a preparation method thereof. Background technique [0002] Due to the wide application of antibiotics and the change of body immunity, there are more and more diseases caused by fungal infections. Since the first antifungal antibiotic amphotericin came out in 1955, the diagnosis of fungal diseases has become more and more perfect. The research and development of fungal drugs has also made great progress. At present, there are more than 80 kinds of antifungal drugs used clinically in the world. [0003] Among them, terbinafine hydrochloride is an allylamine derivative and has broad-spectrum antifungal activity. It mainly inhibits fungal squalene cyclooxygenase, causing ergosterol deficiency and interfering with cell membrane integrity, so that fungi stop growing and play an antibacterial role; at the same time, squalene...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/137A61K47/44A61P31/10A61P17/00
Inventor 刘群谈宗华李红刘明莉吴统选
Owner TIANSHENG PHARMA GROUP
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