CN110433135A - A kind of preparation method of Benzagel - Google Patents
A kind of preparation method of Benzagel Download PDFInfo
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- CN110433135A CN110433135A CN201910838191.1A CN201910838191A CN110433135A CN 110433135 A CN110433135 A CN 110433135A CN 201910838191 A CN201910838191 A CN 201910838191A CN 110433135 A CN110433135 A CN 110433135A
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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
- A61K31/327—Peroxy compounds, e.g. hydroperoxides, peroxides, peroxyacids
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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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- 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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Abstract
The present invention relates to technical field of medicine, a kind of a kind of preparation method of Benzagel: formulation ingredients ratio of Benzagel are as follows: main ingredient: benzoyl peroxide (pure meter) 5%, gel-type vehicle: Carbopol 0.60%~1.0%, wetting agent: propylene glycol 3%~5%, surfactant: PLURONICS F87 0.1%~0.3%, chelating agent: natrium adetate 0.1%, surfactant: docusate sodium 0.05%, suspending agent: colloidal silicon dioxide 0.02%~0.05%, adsorbent: acrylate copolymer (polytrap 6603) 1.5%~2.5%, moisturizer: glycerol 3%~5%, pH adjusting agent: sodium hydroxide 0.14% and solvent: purified water complements to 100%, the one kind The preparation method of Benzagel, carcinogenic solvent (benzene) is used in Acritamer 940 production process, also there is benzene residual in part in commodity Acritamer 940, and substitutes Acritamer 940 with Carbopol in the technical program, then without benzene in Carbopol, so improving Product Safety.
Description
Technical field
The present invention relates to technical field of medicine, specially a kind of preparation method of Benzagel.
Background technique
The Yuan Yan company of benza gel is Laboratoires Galderma, Yu Faguo on March 19th, 1986
Approval listing, trade name CUTACNYL, specification are 5% and 10%, and July in the same year lists 2.5% specification.At present in the U.S. without list
Side's listing, Japan's listing of approval in 2014, China have original to grind import kind.
Japan's in December, 2014 ratifies Maruho Co., the benza gel listing of Ltd company, and specification is
2.5%, 15g and 30g are that Japan uses Benzoyl Peroxide treatment acne vulgaris for the first time.But most of mistakes currently on the market
Carcinogenic solvent (benzene) is used in Acritamer 940 production process in Benzoyl Oxide prescription, makes also have portion in commodity Acritamer 940
Divide benzene residual, to reduce the safety of product.
Summary of the invention
(1) the technical issues of solving
In view of the deficiencies of the prior art, the present invention provides a kind of preparation methods of Benzagel, have raising
The advantages that Product Safety.
(2) technical solution
For the purpose for realizing above-mentioned raising Product Safety, the invention provides the following technical scheme: a kind of benzoyl peroxide
The preparation method of gel: a kind of formulation ingredients ratio of Benzagel are as follows: main ingredient: benzoyl peroxide (pure meter) 5%,
Gel-type vehicle: Carbopol 0.60%~1.0%, wetting agent: propylene glycol 3%~5%, surfactant: poloxamer
1880.1%~0.3%, chelating agent: natrium adetate 0.1%, surfactant: docusate sodium 0.05%, suspending agent: colloidal state
Silica 0.02%~0.05%, adsorbent: acrylate copolymer (polytrap 6603) 1.5%~2.5%, moisturizing
Agent: glycerol 3%~5%, pH adjusting agent: sodium hydroxide 0.14% and solvent: purified water complements to 100%.
A kind of preparation method of Benzagel, comprising the following steps:
S10, supplementary material is weighed by recipe quantity, it is spare；
S20, water phase preparation is carried out to part supplementary material；
S30, supplementary material progress gel in part is mutually prepared；
S40, activity mutually preparation is carried out to part supplementary material；
S50, the solution that three kinds of preparation methods prepare is followed the steps below into mixing:
Step 1: opening vacuum pump, control vacuum degree is -0.06MPa~-0.08MPa, and opening scraper plate speed of agitator is 40
Turn/min and homogeneous revolving speed be 1000~1500 turns/min, homogeneous stirs 20min；
Step 2: stopping stirring and homogeneous, prepared sodium hydrate aqueous solution is added into emulsion tank；
Step 3: opening scraper plate speed of agitator is 40 turns/min, control vacuum degree is -0.06MPa~-0.08MPa, stirring
20min；
After S60, intermediate products detection are qualified, discharging.Loading amount is set according to loading amount area requirement, loading amount debugging is qualified, examines
Weight scale rejects loading amount rejected product, can formally dispense.
Preferably, the step of prepared by the water phase are as follows:
Step 1: partial purification water is added into water phase tank, opens steam and be heated to 50 DEG C~60 DEG C, prescription is added
The docusate sodium and PLURONICS F87 of amount, opening stirring (revolving speed is 300~500 turns/min) makes to dissolve；
Step 2: the acrylate copolymer and colloidal silicon dioxide of recipe quantity are added into water phase tank, adjust stirring and turn
Speed to 500~1000 turns/min, stirring makes to soak；
Step 3: opening vacuum pump, material in water phase tank is transferred in emulsion tank, control vacuum degree is -0.06MPa
~-0.08MPa opens stirring (scraper plate speed of agitator is 40 turns/min), while opening cooling makes material be cooled to 30 DEG C or less.
Preferably, the step of gel is mutually prepared are as follows:
Step 1: into water phase tank be added partial purification water and recipe quantity glycerol, open stirring (revolving speed be 300 turns/
Min), open steam and be heated to 50 DEG C~60 DEG C, improve speed of agitator to 800 turns/min, be slowly added to the card of recipe quantity
Wave nurse 980 makes the fully dispersed swelling of carbomer (swelling time is about 30min~60min)；
Step 2: open vacuum pump, gel is mutually filtered into emulsion tank (40 mesh of sieve mesh number), control vacuum degree be-
0.06MPa~-0.08MPa opens stirring (scraper plate speed of agitator is 40 turns/min), while opening cooling makes material be cooled to 30
DEG C or less.
Preferably, the step of activity is mutually prepared are as follows:
Step 1: the natrium adetate of suitable purified water, recipe quantity is added into stainless steel barrel, it is stirred to dissolve；Again
The propylene glycol of recipe quantity is added, stirring makes to mix；
Step 2: the benzoyl peroxide of recipe quantity is added, stirring makes wetting uniformly, sample detection raw material granularity, according to grain
The following granularities of degree inspection result progress comply with standard or the non-compliant step operation of granularity.
Preferably, the raw material granularity inspection method are as follows: it takes sample appropriate, is placed on glass slide and applies straticulation, lamina plane
Product is equivalent to coverslip area, applies 3 altogether, according to granularity and determination of particle size distribution (Chinese Pharmacopoeia version general rule 0982 in 2015 the
One method) measurement, granularity control standard: 25 μm of particles below must not be less than 95%, and 100 μm or more of particle is not greater than 1%,
180 μm or more of particle must not be detected；
It when the bulk pharmaceutical chemicals granularity meets granularity control standard, transfers the material into emulsion tank, weighs surplus purifying
Water rinse container is simultaneously transferred in emulsion tank；
When the bulk pharmaceutical chemicals granularity does not meet granularity control standard, transfers the material into colloid mill and ground, opened
(2 DEG C~10 DEG C) control temperature of charge of chilled water are met the requirements of the standard at 60 DEG C hereinafter, being ground to granularity, transfer the material into cream
Change in tank, weighs surplus purified water rinse colloid mill and container and be transferred in emulsion tank.
(3) beneficial effect
Compared with prior art, the present invention provides a kind of preparation methods of Benzagel, have following beneficial
Effect:
1, a kind of preparation method of Benzagel, existing Benzagel product is on human skin
There is obvious feeling of grittiness when smearing, and pass through the absolutely not this feeling of grittiness of product that the technical program is produced, applies
Smear comfort more preferably.
2, a kind of preparation method of Benzagel uses carcinogenic solvent (benzene) in Acritamer 940 production process,
Also there is benzene residual in part in commodity Acritamer 940, and substitute Acritamer 940, carbomer with Carbopol in the technical program
Then without benzene in 980, so improving Product Safety.
3, a kind of preparation method of Benzagel, national medicine prison regulation: when product new recipe is declared, in prescription
Used auxiliary material has to be registered in national drug administration department, and production/agent of Acritamer 940 is reluctant on domestic market
Meaning carries out this registration work, and production/agent of Carbopol is then ready to register, that is to say, that domestic market card
Wave nurse 980 can be legal acquisition, and Acritamer 940 then temporarily it is not all right, so with Carbopol substitution Acritamer 940 be one
A good selection.
Specific embodiment
Below in conjunction with the embodiment of the present invention, technical solution in the embodiment of the present invention is clearly and completely retouched
It states, it is clear that described embodiments are only a part of the embodiments of the present invention, instead of all the embodiments.Based on the present invention
In embodiment, every other implementation obtained by those of ordinary skill in the art without making creative efforts
Example, shall fall within the protection scope of the present invention.
Embodiment one:
A kind of preparation method of Benzagel:
A kind of formulation ingredients ratio of Benzagel are as follows: main ingredient: benzoyl peroxide (pure meter) 5%, gel base
Matter: Carbopol 0.60%, wetting agent: propylene glycol 3%, surfactant: PLURONICS F87 0.1%, chelating agent: edetic acid(EDTA)
Disodium 0.1%, surfactant: docusate sodium 0.05%, suspending agent: colloidal silicon dioxide 0.02%, adsorbent: acrylate
Copolymer (polytrap 6603) 1.5%, moisturizer: glycerol 3%, pH adjusting agent: sodium hydroxide 0.14% and solvent: purifying
Water complements to 100%；
A kind of preparation method of Benzagel, comprising the following steps:
S10, supplementary material is weighed by recipe quantity, it is spare；
S20, water phase preparation is carried out to part supplementary material；
S30, supplementary material progress gel in part is mutually prepared；
S40, activity mutually preparation is carried out to part supplementary material；
S50, the solution that three kinds of preparation methods prepare is followed the steps below into mixing:
Step 1: opening vacuum pump, control vacuum degree is -0.06MPa~-0.08MPa, and opening scraper plate speed of agitator is 40
Turn/min and homogeneous revolving speed be 1000~1500 turns/min, homogeneous stirs 20min；
Step 2: stopping stirring and homogeneous, prepared sodium hydrate aqueous solution is added into emulsion tank；
Step 3: opening scraper plate speed of agitator is 40 turns/min, control vacuum degree is -0.06MPa~-0.08MPa, stirring
20min；
After S60, intermediate products detection are qualified, discharging.Loading amount is set according to loading amount area requirement, loading amount debugging is qualified, examines
Weight scale rejects loading amount rejected product, can formally dispense.
The step of prepared by water phase are as follows:
Step 1: partial purification water is added into water phase tank, opens steam and be heated to 50 DEG C~60 DEG C, prescription is added
The docusate sodium and PLURONICS F87 of amount, opening stirring (revolving speed is 300~500 turns/min) makes to dissolve；
Step 2: the acrylate copolymer and colloidal silicon dioxide of recipe quantity are added into water phase tank, adjust stirring and turn
Speed to 500~1000 turns/min, stirring makes to soak；
Step 3: opening vacuum pump, material in water phase tank is transferred in emulsion tank, control vacuum degree is -0.06MPa
~-0.08MPa opens stirring (scraper plate speed of agitator is 40 turns/min), while opening cooling makes material be cooled to 30 DEG C or less.
The step of gel is mutually prepared are as follows:
Step 1: into water phase tank be added partial purification water and recipe quantity glycerol, open stirring (revolving speed be 300 turns/
Min), open steam and be heated to 50 DEG C~60 DEG C, improve speed of agitator to 800 turns/min, be slowly added to the card of recipe quantity
Wave nurse 980 makes the fully dispersed swelling of carbomer (swelling time is about 30min~60min)；
Step 2: open vacuum pump, gel is mutually filtered into emulsion tank (40 mesh of sieve mesh number), control vacuum degree be-
0.06MPa~-0.08MPa opens stirring (scraper plate speed of agitator is 40 turns/min), while opening cooling makes material be cooled to 30
DEG C or less.
Active the step of mutually preparing are as follows:
Step 1: the natrium adetate of suitable purified water, recipe quantity is added into stainless steel barrel, it is stirred to dissolve；Again
The propylene glycol of recipe quantity is added, stirring makes to mix；
Step 2: the benzoyl peroxide of recipe quantity is added, stirring makes wetting uniformly, sample detection raw material granularity, according to grain
The following granularities of degree inspection result progress comply with standard or the non-compliant step operation of granularity.
Raw material granularity inspection method are as follows: take sample appropriate, be placed on glass slide and apply straticulation, thin layer area is equivalent to lid glass
Piece area applies 3 altogether, measures according to granularity and determination of particle size distribution (Chinese Pharmacopoeia 0,982 first method of version general rule in 2015), grain
Spend control standard: 25 μm of particles below must not be less than 95%, and 100 μm or more of particle is not greater than 1%, must not detect 180 μ
The particle of m or more transfers the material into emulsion tank when bulk pharmaceutical chemicals granularity meets granularity control standard, it is pure to weigh surplus
Change water rinse container and is transferred in emulsion tank；When bulk pharmaceutical chemicals granularity does not meet granularity control standard, glue is transferred the material into
It is ground in body mill, opens (2 DEG C~10 DEG C) control temperature of charge of chilled water and complied with standard at 60 DEG C hereinafter, being ground to granularity
It is required that transferring the material into emulsion tank, weighing surplus purified water rinse colloid mill and container and being transferred in emulsion tank.
A kind of Benzagel character according to made from above-mentioned formula and technique are as follows: this product is white uniformity butterfat sample
Gel, pH value: for 5.1~5.5 (four general rule 0631pH value measuring methods of Chinese Pharmacopoeia version in 2015).
Embodiment two:
A kind of preparation method of Benzagel:
A kind of formulation ingredients ratio of Benzagel are as follows: main ingredient: benzoyl peroxide (pure meter) 5%, gel base
Matter: Carbopol 0.80%%, wetting agent: propylene glycol 4%, surfactant: PLURONICS F87 0.2%, chelating agent: according to ground
Acid disodium 0.1%, surfactant: docusate sodium 0.05%, suspending agent: colloidal silicon dioxide 0.03%, adsorbent: acrylic acid
Ester copolymer (polytrap 6603) 2.0%, moisturizer: glycerol 4%, pH adjusting agent: sodium hydroxide 0.14% and solvent: pure
Change water and complements to 100%；
A kind of preparation method of Benzagel, comprising the following steps:
S10, supplementary material is weighed by recipe quantity, it is spare；
S20, water phase preparation is carried out to part supplementary material；
S30, supplementary material progress gel in part is mutually prepared；
S40, activity mutually preparation is carried out to part supplementary material；
S50, the solution that three kinds of preparation methods prepare is followed the steps below into mixing；
Step 1: opening vacuum pump, control vacuum degree is -0.06MPa~-0.08MPa, and opening scraper plate speed of agitator is 40
Turn/min and homogeneous revolving speed be 1000~1500 turns/min, homogeneous stirs 20min；
Step 2: stopping stirring and homogeneous, prepared sodium hydrate aqueous solution is added into emulsion tank；
Step 3: opening scraper plate speed of agitator is 40 turns/min, control vacuum degree is -0.06MPa~-0.08MPa, stirring
20min；
After S60, intermediate products detection are qualified, discharging.Loading amount is set according to loading amount area requirement, loading amount debugging is qualified, examines
Weight scale rejects loading amount rejected product, can formally dispense.
The step of prepared by water phase are as follows:
Step 1: partial purification water is added into water phase tank, opens steam and be heated to 50 DEG C~60 DEG C, prescription is added
The docusate sodium and PLURONICS F87 of amount, opening stirring (revolving speed is 300~500 turns/min) makes to dissolve；
Step 2: the acrylate copolymer and colloidal silicon dioxide of recipe quantity are added into water phase tank, adjust stirring and turn
Speed to 500~1000 turns/min, stirring makes to soak；
Step 3: opening vacuum pump, material in water phase tank is transferred in emulsion tank, control vacuum degree is -0.06MPa
~-0.08MPa opens stirring (scraper plate speed of agitator is 40 turns/min), while opening cooling makes material be cooled to 30 DEG C or less.
The step of gel is mutually prepared are as follows:
Step 1: into water phase tank be added partial purification water and recipe quantity glycerol, open stirring (revolving speed be 300 turns/
Min), open steam and be heated to 50 DEG C~60 DEG C, improve speed of agitator to 800 turns/min, be slowly added to the card of recipe quantity
Wave nurse 980 makes the fully dispersed swelling of carbomer (swelling time is about 30min~60min)；
Step 2: open vacuum pump, gel is mutually filtered into emulsion tank (40 mesh of sieve mesh number), control vacuum degree be-
0.06MPa~-0.08MPa opens stirring (scraper plate speed of agitator is 40 turns/min), while opening cooling makes material be cooled to 30
DEG C or less.
Active the step of mutually preparing are as follows:
Step 1: the natrium adetate of suitable purified water, recipe quantity is added into stainless steel barrel, it is stirred to dissolve；Again
The propylene glycol of recipe quantity is added, stirring makes to mix；
Step 2: the benzoyl peroxide of recipe quantity is added, stirring makes wetting uniformly, sample detection raw material granularity, according to grain
The following granularities of degree inspection result progress comply with standard or the non-compliant step operation of granularity.
Raw material granularity inspection method are as follows: take sample appropriate, be placed on glass slide and apply straticulation, thin layer area is equivalent to lid glass
Piece area applies 3 altogether, measures according to granularity and determination of particle size distribution (Chinese Pharmacopoeia 0,982 first method of version general rule in 2015), grain
Spend control standard: 25 μm of particles below must not be less than 95%, and 100 μm or more of particle is not greater than 1%, must not detect 180 μ
The particle of m or more transfers the material into emulsion tank when bulk pharmaceutical chemicals granularity meets granularity control standard, it is pure to weigh surplus
Change water rinse container and be transferred in emulsion tank, when bulk pharmaceutical chemicals granularity does not meet granularity control standard, transfers the material into glue
It is ground in body mill, opens (2 DEG C~10 DEG C) control temperature of charge of chilled water and complied with standard at 60 DEG C hereinafter, being ground to granularity
It is required that transferring the material into emulsion tank, weighing surplus purified water rinse colloid mill and container and being transferred in emulsion tank.
A kind of Benzagel character according to made from above-mentioned formula and technique are as follows: this product is white uniformity butterfat sample
Gel, pH value: for 5.1~5.5 (four general rule 0631pH value measuring methods of Chinese Pharmacopoeia version in 2015).
Embodiment three:
A kind of preparation method of Benzagel:
A kind of formulation ingredients ratio of Benzagel are as follows: main ingredient: benzoyl peroxide (pure meter) 5%, gel base
Matter: Carbopol 1.0%, wetting agent: propylene glycol 5%, surfactant: PLURONICS F87 0.3%, chelating agent: edetic acid(EDTA)
Disodium 0.1%, surfactant: docusate sodium 0.05%, suspending agent: colloidal silicon dioxide 0.05%, adsorbent: acrylate
Copolymer (polytrap 6603) 2.5%, moisturizer: glycerol 5%, pH adjusting agent: sodium hydroxide 0.14% and solvent: purifying
Water complements to 100%；
A kind of preparation method of Benzagel, comprising the following steps:
S10, supplementary material is weighed by recipe quantity, it is spare；
S20, water phase preparation is carried out to part supplementary material；
S30, supplementary material progress gel in part is mutually prepared；
S40, activity mutually preparation is carried out to part supplementary material；
S50, the solution that three kinds of preparation methods prepare is followed the steps below into mixing；
Step 1: opening vacuum pump, control vacuum degree is -0.06MPa~-0.08MPa, and opening scraper plate speed of agitator is 40
Turn/min and homogeneous revolving speed be 1000~1500 turns/min, homogeneous stirs 20min；
Step 2: stopping stirring and homogeneous, prepared sodium hydrate aqueous solution is added into emulsion tank；
Step 3: opening scraper plate speed of agitator is 40 turns/min, control vacuum degree is -0.06MPa~-0.08MPa, stirring
20min；
After S60, intermediate products detection are qualified, discharging.Loading amount is set according to loading amount area requirement, loading amount debugging is qualified, examines
Weight scale rejects loading amount rejected product, can formally dispense.
The step of prepared by water phase are as follows:
Step 1: partial purification water is added into water phase tank, opens steam and be heated to 50 DEG C~60 DEG C, prescription is added
The docusate sodium and PLURONICS F87 of amount, opening stirring (revolving speed is 300~500 turns/min) makes to dissolve；
Step 2: the acrylate copolymer and colloidal silicon dioxide of recipe quantity are added into water phase tank, adjust stirring and turn
Speed to 500~1000 turns/min, stirring makes to soak；
Step 3: opening vacuum pump, material in water phase tank is transferred in emulsion tank, control vacuum degree is -0.06MPa
~-0.08MPa opens stirring (scraper plate speed of agitator is 40 turns/min), while opening cooling makes material be cooled to 30 DEG C or less.
The step of gel is mutually prepared are as follows:
Step 1: into water phase tank be added partial purification water and recipe quantity glycerol, open stirring (revolving speed be 300 turns/
Min), open steam and be heated to 50 DEG C~60 DEG C, improve speed of agitator to 800 turns/min, be slowly added to the card of recipe quantity
Wave nurse 980 makes the fully dispersed swelling of carbomer (swelling time is about 30min~60min)；
Step 2: open vacuum pump, gel is mutually filtered into emulsion tank (40 mesh of sieve mesh number), control vacuum degree be-
0.06MPa~-0.08MPa opens stirring (scraper plate speed of agitator is 40 turns/min), while opening cooling makes material be cooled to 30
DEG C or less.
Active the step of mutually preparing are as follows:
Step 1: the natrium adetate of suitable purified water, recipe quantity is added into stainless steel barrel, it is stirred to dissolve；Again
The propylene glycol of recipe quantity is added, stirring makes to mix；
Step 2: the benzoyl peroxide of recipe quantity is added, stirring makes wetting uniformly, sample detection raw material granularity, according to grain
The following granularities of degree inspection result progress comply with standard or the non-compliant step operation of granularity.
Raw material granularity inspection method are as follows: take sample appropriate, be placed on glass slide and apply straticulation, thin layer area is equivalent to lid glass
Piece area applies 3 altogether, measures according to granularity and determination of particle size distribution (Chinese Pharmacopoeia 0,982 first method of version general rule in 2015), grain
Spend control standard: 25 μm of particles below must not be less than 95%, and 100 μm or more of particle is not greater than 1%, must not detect 180 μ
The particle of m or more transfers the material into emulsion tank when bulk pharmaceutical chemicals granularity meets granularity control standard, it is pure to weigh surplus
Change water rinse container and be transferred in emulsion tank, when bulk pharmaceutical chemicals granularity does not meet granularity control standard, transfers the material into glue
It is ground in body mill, opens (2 DEG C~10 DEG C) control temperature of charge of chilled water and complied with standard at 60 DEG C hereinafter, being ground to granularity
It is required that transferring the material into emulsion tank, weighing surplus purified water rinse colloid mill and container and being transferred in emulsion tank.
A kind of Benzagel character according to made from above-mentioned formula and technique are as follows: this product is white uniformity butterfat sample
Gel, pH value: for 5.1~5.5 (four general rule 0631pH value measuring methods of Chinese Pharmacopoeia version in 2015).
The sequencing of above embodiments is not only for ease of description, represent the advantages or disadvantages of the embodiments.
It although an embodiment of the present invention has been shown and described, for the ordinary skill in the art, can be with
A variety of variations, modification, replacement can be carried out to these embodiments without departing from the principles and spirit of the present invention by understanding
And modification, the scope of the present invention is defined by the appended.
Claims (6)
1. a kind of Benzagel, it is characterised in that: a kind of formulation ingredients ratio of Benzagel are as follows: main
Medicine: benzoyl peroxide (pure meter) 5%, gel-type vehicle: Carbopol 0.60%~1.0%, wetting agent: propylene glycol 3%~
5%, surfactant: PLURONICS F87 0.1%~0.3%, chelating agent: natrium adetate 0.1%, surfactant: more libraries
Ester sodium 0.05%, suspending agent: colloidal silicon dioxide 0.02%~0.05%, adsorbent: acrylate copolymer
(polytrap6603) 1.5%~2.5%, moisturizer: glycerol 3%~5%, pH adjusting agent: sodium hydroxide 0.14% and solvent:
Purified water complements to 100%.
2. a kind of preparation method of Benzagel, which comprises the following steps:
S10, supplementary material is weighed by recipe quantity, it is spare；
S20, water phase preparation is carried out to part supplementary material；
S30, supplementary material progress gel in part is mutually prepared；
S40, activity mutually preparation is carried out to part supplementary material；
S50, the solution that three kinds of preparation methods prepare is followed the steps below into mixing:
Step 1: open vacuum pump, control vacuum degree be -0.06MPa~-0.08MPa, open scraper plate speed of agitator for 40 turns/
Min and homogeneous revolving speed are 1000~1500 turns/min, and homogeneous stirs 20min；
Step 2: stopping stirring and homogeneous, prepared sodium hydrate aqueous solution is added into emulsion tank；
Step 3: opening scraper plate speed of agitator is 40 turns/min, control vacuum degree is -0.06MPa~-0.08MPa, stirring
20min；
After S60, intermediate products detection are qualified, discharging；
Loading amount is set according to loading amount area requirement, loading amount debugging is qualified, check weighing scale rejects loading amount rejected product, can formally divide
Dress.
3. a kind of preparation method of Benzagel according to claim 2, it is characterised in that: the S20 water phase
The step of preparation are as follows:
Step 1: partial purification water is added into water phase tank, opens steam and be heated to 50 DEG C~60 DEG C, recipe quantity is added
Docusate sodium and PLURONICS F87, opening stirring (revolving speed is 300~500 turns/min) makes to dissolve；
Step 2: into water phase tank be added recipe quantity acrylate copolymer and colloidal silicon dioxide, adjust speed of agitator to
500~1000 turns/min, stirring makes to soak；
Step 3: open vacuum pump, material in water phase tank is transferred in emulsion tank, control vacuum degree for -0.06MPa~-
0.08MPa opens stirring (scraper plate speed of agitator is 40 turns/min), while opening cooling makes material be cooled to 30 DEG C or less.
4. a kind of preparation method of Benzagel according to claim 2, it is characterised in that: the S30 gel
The step of mutually preparing are as follows:
Step 1: the glycerol of partial purification water and recipe quantity is added into water phase tank, stirring (revolving speed is 300 turns/min) is opened,
It opens steam and is heated to 50 DEG C~60 DEG C, improve speed of agitator to 800 turns/min, be slowly added to the carbomer of recipe quantity
980, make the fully dispersed swelling of carbomer (swelling time is about 30min~60min)；
Step 2: open vacuum pump, gel is mutually filtered into emulsion tank (40 mesh of sieve mesh number), control vacuum degree be-
0.06MPa~-0.08MPa opens stirring (scraper plate speed of agitator is 40 turns/min), while opening cooling makes material be cooled to 30
DEG C or less.
5. a kind of preparation method of Benzagel according to claim 2, it is characterised in that: the S40 activity
The step of mutually preparing are as follows:
Step 1: the natrium adetate of suitable purified water, recipe quantity is added into stainless steel barrel, it is stirred to dissolve；It adds
The propylene glycol of recipe quantity, stirring make to mix；
Step 2: the benzoyl peroxide of recipe quantity is added, stirring makes wetting, and uniformly sample detection raw material granularity is examined according to granularity
The following granularities of the fruit that comes to an end progress comply with standard or the non-compliant step operation of granularity.
6. a kind of preparation method of Benzagel according to claim 5, it is characterised in that: the raw material granularity
Inspection method are as follows: it takes sample appropriate, is placed on glass slide and applies straticulation, thin layer area is equivalent to coverslip area, 3 are applied altogether,
It is measured according to granularity and determination of particle size distribution (Chinese Pharmacopoeia 0,982 first method of version general rule in 2015), granularity control standard: 25 μm
Particle below must not be less than 95%, and 100 μm or more of particle is not greater than 1%, must not detect 180 μm or more of particle；
It when the bulk pharmaceutical chemicals granularity meets granularity control standard, transfers the material into emulsion tank, weighs surplus purified water profit
It washes container and is transferred in emulsion tank；
When the bulk pharmaceutical chemicals granularity does not meet granularity control standard, transfers the material into colloid mill and ground, open freezing
(2 DEG C~10 DEG C) control temperature of charge of water are met the requirements of the standard at 60 DEG C hereinafter, being ground to granularity, transfer the material into emulsion tank
In, it weighs surplus purified water rinse colloid mill and container and is transferred in emulsion tank.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113577022A (en) * | 2021-05-18 | 2021-11-02 | 南京欣通瑞亿医药科技有限公司 | Dapsone compound suspension and preparation method and application thereof |
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| US20110045037A1 (en) * | 2007-11-30 | 2011-02-24 | Foamix Ltd. | Foam containing benzoyl peroxide |
| US20120064135A1 (en) * | 2010-09-15 | 2012-03-15 | Norac Pharma | Benzoyl Peroxide Composition, Methods for Making Same, and Pharmaceutical or Cosmetic Formulations Comprising Same, and Uses Thereof |
| CN105411999A (en) * | 2015-11-23 | 2016-03-23 | 安徽新和成皖南药业有限公司 | Preparation method for adapalene gel |
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| US20110045037A1 (en) * | 2007-11-30 | 2011-02-24 | Foamix Ltd. | Foam containing benzoyl peroxide |
| US20120064135A1 (en) * | 2010-09-15 | 2012-03-15 | Norac Pharma | Benzoyl Peroxide Composition, Methods for Making Same, and Pharmaceutical or Cosmetic Formulations Comprising Same, and Uses Thereof |
| CN105411999A (en) * | 2015-11-23 | 2016-03-23 | 安徽新和成皖南药业有限公司 | Preparation method for adapalene gel |
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