CN109260141A - A kind of Terbinafine hydrochloride emulsifiable paste - Google Patents
A kind of Terbinafine hydrochloride emulsifiable paste Download PDFInfo
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- CN109260141A CN109260141A CN201710578466.3A CN201710578466A CN109260141A CN 109260141 A CN109260141 A CN 109260141A CN 201710578466 A CN201710578466 A CN 201710578466A CN 109260141 A CN109260141 A CN 109260141A
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- stainless steel
- formula ratio
- steel mixer
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- terbinafine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Emergency Medicine (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention discloses a kind of Terbinafine hydrochloride emulsifiable paste and its preparation method, product of the present invention belongs to pharmaceutical field；Producing the raw material that the product uses has: terbinafine HCl 2%-3%, benzoic acid 5%-6%, azone 10%, polysorbate -80 0.5%, ethylene diamine tetra methylene phosphonic acid sodium 0.5%, atoleine 31%, distilled water 50%, technique is: the atoleine of formula ratio is sent into the first stainless steel mixer, temperature, which is increased to 78-80 DEG C, becomes molten condition, and the terbinafine HCl that formula ratio is added stirs 0.5-0.6 hours；The distilled water 50% of formula ratio is sent into the second stainless steel mixer, benzoic acid, azone, polysorbate -80, the ethylene diamine tetra methylene phosphonic acid sodium that formula ratio is added stir 0.3-0.4 hours；Material in first stainless steel mixer is poured into the second stainless steel mixer, is stirred 0.3-0.4 hours, stops stirring after being cooled to room temperature, is got product after sterilization.
Description
Technical field:
Product of the present invention belongs to pharmaceutical field more particularly to a kind of Terbinafine hydrochloride emulsifiable paste and its preparation method.
Background technique:
Terbinafine hydrochloride emulsifiable paste is bentoquatam class non-prescribed medicine drug common medicine, which is that a kind of broad-spectrum antifungal is living
Property Allylamines drug, can specifically interfere the early stage biosynthesis of mycosterol, the highly selective ergot shark for inhibiting fungi
Alkene Cycloxygenase makes ergot squalene epoxidaseization reaction in fungal cell membrane forming process be obstructed, to reach killing or inhibit true
The effect of bacterium, suitable for treating the tinea manuum caused by sensitive fungi, tinea pedis, jock itch, ringworm of the body, tinea versicolor and cutaneous Candida
Disease, when use, apply affected part and its surrounding in right amount.Product of the present invention is with terbinafine HCl, benzoic acid, azone, polysorbate-
80, ethylene diamine tetra methylene phosphonic acid sodium, triethanolamine, atoleine, water are raw material, by the method that blends at a certain temperature come
Terbinafine hydrochloride emulsifiable paste is produced, which has few simple process, all devices, easy temperature control system, convenient for batch life
Production, finished product are of good quality.
Summary of the invention:
Present invention mainly solves the problem of be to provide a kind of Terbinafine hydrochloride emulsifiable paste and its preparation method, produce product use
Raw material have: terbinafine HCl 2%-3%, benzoic acid 5%-6%, azone 10%, polysorbate -80 0.5%, ethylenediamine tetraacetic methene
Alendronate 0.5%, atoleine 31%, distilled water 50%.
The present invention can be achieved through the following technical solutions:
(1) atoleine of formula ratio is sent into the first stainless steel mixer, temperature, which is increased to 78-80 DEG C, becomes molten
State, the terbinafine HCl that formula ratio is added stir 0.5-0.6 hours.
(2) distilled water of formula ratio 50% is sent into the second stainless steel mixer, the benzoic acid of formula ratio is added, azone, gathers
Sorbierite -80, ethylene diamine tetra methylene phosphonic acid sodium stir 0.3-0.4 hours.
(3) material in the first stainless steel mixer is poured into the second stainless steel mixer, it is small is stirred 0.3-0.4
When, stop stirring after being cooled to room temperature, is got product after sterilization.
Preferably, the purity of the terbinafine HCl is 98%.
The beneficial effect of product of the present invention is: providing a kind of Terbinafine hydrochloride emulsifiable paste and its preparation method, the preparation side
Method simple process, all devices are few, easy temperature control system, are convenient for batch production, finished product of good quality；Suitable for treating sensitive fungi institute
The caused tinea manuum, tinea pedis, jock itch, ringworm of the body, tinea versicolor and cutaneous candidiasis, when use, apply affected part and its surrounding in right amount.
Specific embodiment:
Embodiment 1:
The atoleine that total amount is 31% will be accounted for and be sent into the first stainless steel mixer, temperature, which is increased to 78-80 DEG C, becomes molten
State, addition account for the terbinafine HCl that total amount is 2% and stir 0.5 hour；The distilled water 50% that total amount is 50% will be accounted for and be sent into second not
Become rusty steel mixer, is added and accounts for benzoic acid that total amount is 6%, account for azone that total amount is 10%, account for the polysorbate-that total amount is 0.5%
80, the ethylene diamine tetra methylene phosphonic acid sodium that total amount is 0.5% is accounted for stir 0.3 hour；Material in first stainless steel mixer is poured into
Second stainless steel mixer is stirred 0.3 hour, is stopped stirring after being cooled to room temperature, is got product after sterilization.
Embodiment 2:
The atoleine that total amount is 31% will be accounted for and be sent into the first stainless steel mixer, temperature, which is increased to 78-80 DEG C, becomes molten
State, addition account for the terbinafine HCl that total amount is 2.5% and stir 0.55 hour；The distilled water 50% that total amount is 50% will be accounted for and be sent into the
Two stainless steel mixers are added and account for benzoic acid that total amount is 5.5%, account for azone that total amount is 10%, account for the poly- mountain that total amount is 0.5%
Pears alcohol -80, account for total amount be 0.5% ethylene diamine tetra methylene phosphonic acid sodium stir 0.35 hour；By the object in the first stainless steel mixer
Material pours into the second stainless steel mixer, is stirred 0.35 hour, stops stirring after being cooled to room temperature, gets product after sterilization.
Embodiment 3:
The atoleine that total amount is 31% will be accounted for and be sent into the first stainless steel mixer, temperature, which is increased to 78-80 DEG C, becomes molten
State, addition account for the terbinafine HCl that total amount is 3% and stir 0.6 hour；The distilled water 50% that total amount is 50% will be accounted for and be sent into second not
Become rusty steel mixer, is added and accounts for benzoic acid that total amount is 5%, account for azone that total amount is 10%, account for the polysorbate-that total amount is 0.5%
80, the ethylene diamine tetra methylene phosphonic acid sodium that total amount is 0.5% is accounted for stir 0.4 hour；Material in first stainless steel mixer is poured into
Second stainless steel mixer is stirred 0.4 hour, is stopped stirring after being cooled to room temperature, is got product after sterilization.
Claims (2)
1. a kind of Terbinafine hydrochloride emulsifiable paste, producing the raw material that the product uses has: terbinafine HCl 2%-3%, benzoic acid 5%-
6%, azone 10%, polysorbate -80 0.5%, ethylene diamine tetra methylene phosphonic acid sodium 0.5%, atoleine 31%, distilled water 50%, it is special
Sign is:
(1) atoleine of formula ratio is sent into the first stainless steel mixer, temperature, which is increased to 78-80 DEG C, becomes molten
State, the terbinafine HCl that formula ratio is added stir 0.5-0.6 hours；
(2) distilled water of formula ratio 50% is sent into the second stainless steel mixer, the benzoic acid, azone, poly- sorb of formula ratio is added
Alcohol -80, ethylene diamine tetra methylene phosphonic acid sodium stir 0.3-0.4 hours；
(3) material in the first stainless steel mixer is poured into the second stainless steel mixer, be stirred 0.3-0.4 hours, dropped
Stop stirring after temperature to room temperature, is got product after sterilization.
2. a kind of Terbinafine hydrochloride emulsifiable paste according to claim 1, it is characterized in that: the terbinafine HCl is pure
Degree is 98%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710578466.3A CN109260141A (en) | 2017-07-17 | 2017-07-17 | A kind of Terbinafine hydrochloride emulsifiable paste |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710578466.3A CN109260141A (en) | 2017-07-17 | 2017-07-17 | A kind of Terbinafine hydrochloride emulsifiable paste |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109260141A true CN109260141A (en) | 2019-01-25 |
Family
ID=65147848
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710578466.3A Pending CN109260141A (en) | 2017-07-17 | 2017-07-17 | A kind of Terbinafine hydrochloride emulsifiable paste |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109260141A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112190552A (en) * | 2020-10-21 | 2021-01-08 | 上海桓华制药有限公司 | Terbinafine hydrochloride particles and application method thereof |
-
2017
- 2017-07-17 CN CN201710578466.3A patent/CN109260141A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112190552A (en) * | 2020-10-21 | 2021-01-08 | 上海桓华制药有限公司 | Terbinafine hydrochloride particles and application method thereof |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20190125 |
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| WD01 | Invention patent application deemed withdrawn after publication |