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Liranaftate cream preparation method

A technology of liranaphthate cream and liranaphthate, which is applied in the field of medicine, can solve the problems affecting the efficacy and stability of the medicine, and the particle size does not meet the regulations, and achieve the effect of small side effects, good stability and definite curative effect

Active Publication Date: 2009-05-06
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because the preparation of this product is easy to aggregate into bundles during the placement process, the particle size does not meet the requirements, which affects its efficacy and stability

Method used

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  • Liranaftate cream preparation method
  • Liranaftate cream preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] Embodiment 1 Preparation prescription (every 10000g)

[0087] Liranaftate 200g

[0088] Cetyl Alcohol 350g

[0089] Octadecanol 350g

[0090] Tween 80 500g

[0091] Glycerin 700g

[0092] Light liquid paraffin 800g

[0093] Glyceryl Stearate 400g

[0094] Methylparaben 10g

[0095] Ethylparaben 10g

[0096] 2,6-di-tert-butyl-p-cresol 20g

[0097] Preparation:

[0098] ① Airflow ultrafine grinding of liranaphtate, control particle size below 100 μm, set aside.

[0099] ②Preparation of oil phase: weigh cetyl alcohol, stearyl alcohol, light liquid paraffin, glyceryl stearate, methylparaben, ethylparaben, 2,6-di-tert-butyl p-paraffin Place cresol in an oil phase pot, heat to 70-80°C to melt into a uniform liquid, add liranaphthyl ester, stir at a low speed of 20-30 rpm to dissolve, keep warm at 70-80°C for later use.

[0100] ③Preparation of the water phase: Weigh the prescribed amount of Tween 80, glycerin and purified water into the water phase pot, heat to 70-...

Embodiment 2

[0102] Embodiment 2 preparation prescription (every 10000g)

[0103] Liranaftate 200g

[0104] Cetyl Alcohol 1600g

[0105] Octadecanol 1600g

[0106] Tween 80 800g

[0107] Glycerin 800g

[0108] Methylparaben 10g

[0109] 2,6-di-tert-butyl-p-cresol 20g

[0110] Purified water 4970g

[0111] Preparation:

[0112] ① Airflow ultrafine grinding of liranaphtate, control particle size below 100 μm, set aside.

[0113] ②Preparation of the oil phase: Weigh the prescribed amount of cetyl alcohol, stearyl alcohol, methylparaben, and 2,6-di-tert-butyl-p-cresol into the oil phase pot, heat to 70-80°C, Make it melt into a uniform liquid, add liranaphthyl ester, stir at a low speed of 20-30 rpm to dissolve, keep warm at 70-80°C for later use.

[0114] Other steps are the same as in Example 1 to obtain liranaftate emulsifiable cream of the present invention.

Embodiment 3

[0115] Embodiment 3 preparation prescription (every 10000g)

[0116] Liranaftate 200g

[0117] Cetyl Alcohol 800g

[0118] Octadecanol 800g

[0119] Tween 80 500g

[0120] Glycerin 1500g

[0121] Glyceryl Stearate 500g

[0122] Methylparaben 10g

[0123] 2,6-di-tert-butyl-p-cresol 20g

[0124] Purified water 6670g

[0125] Preparation:

[0126] ① Airflow ultrafine grinding of liranaphtate, control particle size below 100 μm, set aside.

[0127] ②Preparation of oil phase: Weigh cetyl alcohol, stearyl alcohol, glyceryl stearate, methyl paraben, 2,6-di-tert-butyl p-cresol in the oil phase pot and heat to 70-80°C to melt into a homogeneous liquid, add liranaphthate, stir at a low speed of 20-30 rpm to dissolve, and keep warm at 70-80°C for later use.

[0128] Other steps are the same as in Example 1 to obtain liranaftate emulsifiable cream of the present invention.

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Abstract

The invention provides a Liranaftate emulsifiable paste preparation method which takes the Liranaftate as material; a water phase formed by an emulsifier, a humectant and a water-soluble substrate and an oil phase formed by a grease substrate, an antiseptic and a chemical inhibitor are respectively heated to 70 and 80 DEG C; the active component Liranaftate is dissolved in the oil phase, then the water phase is slowly added into the oil phase while stirring, and the stirring is continuously carried out until the room temperature is reached, thus preparing the emulsifiable paste preparation of the invention. The preparation has the advantages of precise curative effect, small side effect and better stability; moreover, the granularity meets the regulation of a pharmacopoeia.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a stable and uniform liranaftate cream preparation. Background technique [0002] Liranaftate is a new type of thiourea antifungal drug, which can inhibit the synthesis of ergosterol, a component of fungal cells, inhibit the growth of fungal mycelium, split its cell wall, and damage the cell membrane. And the bacteria did not develop resistance to liranaftate. It was first developed and marketed in Japan. At present, liranaftate is mainly used in the treatment of tinea pedis, tinea corporis and tinea femoris. [0003] The raw material properties of liranaftate are mostly granular crystalline powders, which have low solubility in water and are observed as long needle-like crystals under a microscope, so they are generally prepared into creams for use. Since the preparation of this product is easy to aggregate into bundles during the placement process, the particle size does not meet the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K9/06A61K31/44A61P31/10
Inventor 刘江华陈国俊戚苏民
Owner YANGTZE RIVER PHARM GRP CO LTD
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