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Luliconazole external spray medicinal composition and preparation method thereof

A technology of luliconazole and its composition, which is applied in the field of luliconazole topical spray pharmaceutical composition and its preparation, can solve the problems not given, and achieve the effects of improving compliance, reducing the content of amide impurities, and making the preparation process simple and easy

Active Publication Date: 2018-04-03
SICHUAN HAISCO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it does not give other special technical information that is different from the prior art of luliconazole preparations

Method used

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  • Luliconazole external spray medicinal composition and preparation method thereof
  • Luliconazole external spray medicinal composition and preparation method thereof
  • Luliconazole external spray medicinal composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The preparation of embodiment 1 luliconazole topical spray

[0049] prescription:

[0050]

[0051] Preparation:

[0052] (1) Weigh each raw and auxiliary material according to the prescription quantity;

[0053] (2) First add about 80% absolute ethanol to the liquid mixing tank, turn on the agitator, add propyl gallate, phosphoric acid, medium-chain fatty acid triglycerides and polyethylene glycol 300 in turn, and then add the remaining about 20 % absolute ethanol to 1000mL, stir evenly;

[0054] (3) Add luliconazole, stir and dissolve;

[0055] (4) Filter the medicinal liquid with a 3 μm polypropylene filter element;

[0056] (5) Fill 100 bottles at 10mL / bottle, and crimp to get the finished product.

Embodiment 2

[0057] Embodiment 2 Preparation of luliconazole topical spray

[0058] prescription:

[0059]

[0060] Preparation:

[0061] (1) Weigh each raw and auxiliary material according to the prescription quantity;

[0062] (2) First add about 80% absolute ethanol to the liquid mixing tank, turn on the agitator, add dibutyl hydroxytoluene, phosphoric acid, medium-chain fatty acid triglycerides and polyethylene glycol 400 in sequence, and then add the remaining about 20% absolute ethanol to 1000mL, stir well;

[0063] (3) Add luliconazole, stir and dissolve;

[0064] (4) Filter the medicinal liquid with a 3 μm polypropylene filter element;

[0065] (5) Fill 100 bottles at 10mL / bottle, and crimp to get the finished product.

Embodiment 3

[0066] Embodiment 3 Preparation of luliconazole topical spray

[0067] prescription:

[0068]

[0069]

[0070] Preparation:

[0071] (1) Weigh each raw and auxiliary material according to the prescription quantity;

[0072] (2) First add about 80% absolute ethanol to the liquid preparation tank, turn on the agitator, add racemic α-tocopherol, phosphoric acid, medium-chain fatty acid triglycerides and polyethylene glycol 400 in sequence, and then add the remaining About 20% absolute ethanol to 1000mL, stir well;

[0073] (3) Add luliconazole, stir and dissolve;

[0074] (4) Filter the medicinal liquid with a 3 μm polypropylene filter element;

[0075] (5) Fill 100 bottles at 10mL / bottle, and crimp to get the finished product.

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PUM

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Abstract

The invention provides a luliconazole external spray medicinal composition and a preparation method of the luliconazole external spray medicinal composition. The composition contains luliconazole, medium-chain fatty acid glyceride, polyethylene glycol, a stabilizer, phosphoric acid and absolute ethyl alcohol. The composition provided by the invention has the advantages that the auxiliary materialsare simple, a preparation process is simple, convenient and feasible, combustible and explosive methyl ethyl ketone serving as a stabilizer is not needed, the prepared composition is good in stability, and the content of amide impurity of luliconazole can be controlled within a very small range, so that the quality of the product is remarkably improved.

Description

technical field [0001] The invention relates to a luliconazole topical spray pharmaceutical composition and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Fungal dermatoses are the result of fungal infections of skin tissue sites. Fungal infection sites can be distributed on the skin of the whole body, the highest incidence is the stratum corneum, and its typical representative diseases are ringworm, candida infection and vitiligo. According to the survey, patients with skin fungal infection accounted for about 13% of outpatients in dermatology department, including 88.0% of ringworm patients, 8.5% of candida infection patients and 3.4% of vitiligo patients, and 64.0% of ringworm patients were athlete's foot . [0003] Ringworm is a refractory skin disease, including tinea pedis, tinea corporis, jock itch, etc. The course of the disease is slow, and the recurrence rate is high after healing. The inflammation is obv...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/4178A61K47/22A61K47/14A61K47/10A61P31/10A61P17/00
CPCA61K47/10A61K47/14A61K47/22A61K9/0014A61K9/12A61K31/4178Y02A50/30
Inventor 蒋涛蒋德军
Owner SICHUAN HAISCO PHARMA CO LTD
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