CN109200014B - A kind of triamcinolone acetonide acetate emulsifiable paste and preparation method thereof - Google Patents
A kind of triamcinolone acetonide acetate emulsifiable paste and preparation method thereof Download PDFInfo
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- CN109200014B CN109200014B CN201811089707.9A CN201811089707A CN109200014B CN 109200014 B CN109200014 B CN 109200014B CN 201811089707 A CN201811089707 A CN 201811089707A CN 109200014 B CN109200014 B CN 109200014B
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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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/17—Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/04—Antipruritics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
Abstract
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of triamcinolone acetonide acetate emulsifiable paste and preparation method thereof.The emulsifiable paste is made of active constituent and matrix, and the active constituent includes following raw material and its parts by weight: 0.4~1.2 part of triamcinolone acetonide acetate, 80~120 parts of urea, 0.5~1.2 part of citric acid and 6~12 parts of dimethyl sulfoxide；The matrix includes following raw material and its parts by weight: 35~62 parts of peregal A-20,120~180 parts of octadecyl alcolol, 630~750 parts of propylene glycol and 0.5~1.5 part of sodium alginate.The cream on skin permeability is strong, rapid-action, can be widely used for treatment inflammation, itch, anaphylaxis dermatosis etc., and stability is high, does not have irritation to intact skin, practical.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of triamcinolone acetonide acetate emulsifiable paste and preparation method thereof.
Background technique
Triamcinolone acetonide acetate is a kind of long-acting adrenal corticosteroids, and external application has significant anti-inflammatory, antiallergy
With antipruritic effect.The organic compound that urea is made of carbon, nitrogen and hydrogen is that mammal discharge is intracorporal containing nitrogen metabolism
Object, external application can dissolve colloid albumen, have antipruritic, antibacterial effect, moreover it is possible to increase protein aquation and drug percutaneous skin
Penetrability.Above two drug combination is often clinically treated into inflammation, itch, anaphylaxis dermatosis etc..
Chinese patent application CN100435801C disclose it is a kind of treat dermopathic external drug and preparation method thereof, should
Drug is mainly made of dexamethasone acetate, camphor, menthol, triamcinolone acetonide acetate, urea and acetylsalicylic acid, has and kills
The effect of bacterium, anti-inflammatory, antipruritic, detumescence, and drug release absorbent properties are good, and onset time is fast, drug effect play rapidly, stablize, energy
Good treatment is played to by diseases such as a variety of skin tineas such as fungus-caused psoriasis, the tinea manuum, tinea pedis and various dermatitis, eczemas
Effect, but the medicine stability is bad, and long-term place can generate the case where active constituent content declines, and drug effect is caused to drop
It is low.
Chinese patent application CN105853443A discloses a kind of triamcinolone acetonide acetate carbamide ointment and preparation method thereof, should
Ointment is by triamcinolone acetonide acetate, urea, thiocarbamide, natrium adetate, citric acid, DBPC 2,6 ditertiary butyl p cresol, stearic acid, Dan Shuan
Tristerin, triethanolamine, dimethyl sulfoxide, albolene, light liquid paraffin, glycerol, bacteriostatic agent, purified water group
At.Using the comprehensive function of stabilizer, the stability of triamcinolone acetonide acetate is enhanced, makes triamcinolone acetonide acetate carbamide ointment 2
In year, content does not decline, and keeps stablizing, but thiocarbamide, natrium adetate, dimethyl sulfoxide etc. all have one to skin in the ointment
Fixed irritation, long-time service may will affect function of human body.
Therefore, there is an urgent need to provide the triamcinolone acetonide acetate cream that a kind of stability is good, small to skin irritation, highly-safe
Cream and preparation method thereof.
Summary of the invention
The present invention is intended to provide the triamcinolone acetonide acetate emulsifiable paste that a kind of stability is good, small to skin irritation, highly-safe
And preparation method thereof.
In order to achieve the above object, the invention adopts the following technical scheme:
A kind of triamcinolone acetonide acetate emulsifiable paste, the emulsifiable paste are made of active constituent and matrix, the active constituent include with
Lower raw material and its parts by weight: 0.4~1.2 part of triamcinolone acetonide acetate, 80~120 parts of urea, 0.5~1.2 part of citric acid and two
6~12 parts of first sulfoxide；The matrix includes following raw material and its parts by weight: peregal A-2035~62 part, octadecyl alcolol 120~
180 parts, 630~750 parts of propylene glycol and 0.5~1.5 part of sodium alginate.
Further, the active constituent includes following raw material and its parts by weight: 0.5~1 part of triamcinolone acetonide acetate, urine
85~100 parts of element, 0.8~1 part of citric acid and 8~10 parts of dimethyl sulfoxide；The matrix includes following raw material and its parts by weight:
Peregal A-2040~50 part, 135~150 parts of octadecyl alcolol, 630~700 parts of propylene glycol and 0.5~1 part of sodium alginate.
Further, the active constituent includes following raw material and its parts by weight: 1 part of triamcinolone acetonide acetate, urea
100 parts, 1 part of citric acid and 10 parts of dimethyl sulfoxide；The matrix includes following raw material and its parts by weight: peregal A-2050
Part, 150 parts of octadecyl alcolol, 687 parts of propylene glycol and 1 part of sodium alginate.
Further, the emulsifiable paste preparation method the following steps are included:
S1, the urea of corresponding amount and propylene glycol are placed in heated aqueous cylinder, are heated to 80~85 DEG C, stirring and dissolving, mistake
Filter, obtains solution A；
S2, the dimethyl sulfoxide filtered through gauze by corresponding amount, are added the triamcinolone acetonide acetate, sodium alginate and Chinese holly of corresponding amount
Rafter acid, stirs to being completely dissolved, obtains solution B；
S3, the peregal A-20 and octadecyl alcolol of corresponding amount are placed in oily heat phase cylinder, are heated to 88~92 DEG C, stirred molten
Solution, is transferred in reaction cylinder, and step S1 acquired solution A is added, stirring while adding, adds 10~15min of stirring, and emulsification 18~
25min, controlled at 80~85 DEG C；After the completion of emulsification, it is cooled to 73~76 DEG C while stirring, step S2 acquired solution is added
Solution B continues to cool, stirring to it is solidifying to get.
In addition, the present invention also provides a kind of preparation methods of triamcinolone acetonide acetate emulsifiable paste, comprising the following steps:
I, the urea of corresponding amount and propylene glycol are placed in heated aqueous cylinder, are heated to 80~85 DEG C, stirring and dissolving, mistake
Filter, obtains solution A；
II, the dimethyl sulfoxide filtered through gauze by corresponding amount, are added the triamcinolone acetonide acetate, sodium alginate and Chinese holly of corresponding amount
Rafter acid, stirs to being completely dissolved, obtains solution B；
III, the peregal A-20 and octadecyl alcolol of corresponding amount are placed in oily heat phase cylinder, are heated to 88~92 DEG C, stirring
Dissolution, is transferred in reaction cylinder, and step I acquired solution A is added, stirring while adding, adds 10~15min of stirring, and emulsification 18~
25min, controlled at 80~85 DEG C；After the completion of emulsification, it is cooled to 73~76 DEG C while stirring, step II acquired solution is added
Solution B continues to cool, stirring to it is solidifying to get.
In the present invention, dimethyl sulfoxide facilitates drug and permeates to human body because it has extremely strong permeability to skin, but it is simultaneously
Also there is certain irritation to skin.Applicant's pleasantly surprised discovery in practice, sodium alginate, which is added, can significantly reduce acetic acid song
The irritation of An Naide cream on skin, the triamcinolone acetonide acetate cream that it can be seen from test example 1 prepared by the embodiment of the present invention 1
Cream is primary, multiple dosing is nonirritant to intact skin, has slight irritation to damaged skin, comparative example 1~2 is (respectively
Removing and replace sodium alginate with chitosan) the triamcinolone acetonide acetate emulsifiable paste of preparation is primary, multiple dosing is removing tested material 1h
Afterwards, there is slight irritation to intact skin, there is moderate irritation to damaged skin；In conjunction with test example 2, the present invention is implemented
The triamcinolone acetonide acetate of example 1 and the kojic acid Kenac Cream of comparative example 1 (removing sodium alginate) preparation accumulates transdermal penetration amount
There is no significant differences.As it can be seen that the addition of sodium alginate will not reduce the accumulation transdermal penetration amount of triamcinolone acetonide acetate, may be used also
To significantly reduce the irritation of triamcinolone acetonide acetate cream on skin.
In addition, citric acid, which is added, can accelerate cutin update, also have certain bactericidal effect, but it holds with acidity
Easily influence the stability of emulsifiable paste.Applicant is found surprisingly that sodium alginate, which is added, can significantly improve acetic acid Qu An in practice
How the stability of moral emulsifiable paste.The triamcinolone acetonide acetate emulsifiable paste that it can be seen from test example 3 prepared by the embodiment of the present invention 1~3 is being put
After setting 24 months, the content of effective component triamcinolone acetonide acetate and urea is held essentially constant, and stability is good, and comparative example 1~2
The triamcinolone acetonide acetate emulsifiable paste of (remove respectively and replace sodium alginate with chitosan) preparation is bent to the 24th month effective component acetic acid
The content of An Naide and urea significantly reduces 20~30%.
The invention has the following advantages that
(1) triamcinolone acetonide acetate cream on skin permeability prepared by the present invention is strong, rapid-action, and it is scorching to can be widely used for treatment
Disease, itch, anaphylaxis dermatosis etc., while the stability of cream is high, does not have irritation to intact skin, it is practical.
(2) triamcinolone acetonide acetate emulsifiable paste prepared by the present invention is guaranteeing triamcinolone acetonide acetate tool by the way that sodium alginate is added
While having higher accumulation transdermal penetration amount, significantly reduce that emulsifiable paste is primary, multiple dosing is to complete or damaged skin stimulation
Property, and the content of effective component triamcinolone acetonide acetate and urea can also be made to be held essentially constant after placing 24 months, surely
Qualitative height.
Specific embodiment
The specific embodiment of form by the following examples makees further specifically above content of the invention
It is bright.But the range that this should not be interpreted as to the above-mentioned theme of the present invention is only limitted to following embodiment.
Wherein, agents useful for same is common agents, can produce and sell enterprise's purchase in conventional reagent.
A kind of triamcinolone acetonide acetate emulsifiable paste of Examples 1 to 3
Triamcinolone acetonide acetate emulsifiable paste described in Examples 1 to 3 is made of 1 ingredient of table and parts by weight.
1 Examples 1 to 3 triamcinolone acetonide acetate emulsifiable paste ingredient of table and its parts by weight
| Ingredient | Embodiment 1 | Embodiment 2 | Embodiment 3 |
| Triamcinolone acetonide acetate | 1 | 1.2 | 0.5 |
| Urea | 100 | 85 | 90 |
| Citric acid | 1 | 0.8 | 0.5 |
| Dimethyl sulfoxide | 10 | 12 | 8 |
| Peregal A-20 | 50 | 60 | 40 |
| Octadecyl alcolol | 150 | 160 | 135 |
| Sodium alginate | 1 | 1.5 | 1 |
| Propylene glycol | 687 | 679.5 | 725 |
Preparation method:
S1, the urea of corresponding amount and propylene glycol are placed in heated aqueous cylinder, are heated to 83 DEG C, stirring and dissolving, filtering obtains
Solution A；
S2, the dimethyl sulfoxide filtered through gauze by corresponding amount, are added the triamcinolone acetonide acetate, sodium alginate and Chinese holly of corresponding amount
Rafter acid, stirs to being completely dissolved, obtains solution B；
S3, the peregal A-20 and octadecyl alcolol of corresponding amount are placed in oily heat phase cylinder, are heated to 90 DEG C, stirring and dissolving,
It is transferred in reaction cylinder, step S1 acquired solution A is added, it is stirring while adding, stirring 10min is added, 20min, control temperature are emulsified
Degree is 80~85 DEG C；After the completion of emulsification, it is cooled to 75 DEG C while stirring, step S2 acquired solution solution B is added, continues cooling drop
Temperature, stirring to it is solidifying to get.
A kind of triamcinolone acetonide acetate emulsifiable paste of comparative example 1
Difference from Example 1 is, comparative example 1 removes sodium alginate, increases propylene glycol to 688 parts, remaining parameter
And operation reference implementation example 1.
A kind of triamcinolone acetonide acetate emulsifiable paste of comparative example 2
Difference from Example 1 is that sodium alginate is replaced with chitosan by comparative example 2, remaining parameter and operation ginseng
Examine embodiment 1.
1 Skin Irritation Test of test example
1. test material: triamcinolone acetonide acetate emulsifiable paste prepared by embodiment 1 and comparative example 1~2.
2. subjects: albino guinea-pig, half male and half female, 300~400g.
Before administration for 24 hours, guinea pig back backbone diamond wool is sloughed, every side depilation area is 20cm2Left and right, removes because of unhairing
And the cavy of skin is scratched, the stimulation test object as intact skin；Unhairing disinfection skin is scratched with sterilizing needle point, seeing has
Oozing of blood is degree, the stimulation test object as damaged skin.
3. test method:
(1) skin irritation test of single administration: being divided into intact skin group and damaged skin group, is all made of itself androgynous left side
Right skin compares, and left side goes to hair-fields to be coated with triamcinolone acetonide acetate emulsifiable paste 1g, and right side goes to hair-fields to apply matrix as control, uses yarn
Cloth and immobilization with adhesive tape after administration for 24 hours, remove residual tested material with warm water, remove tested material 1,24,48, with the naked eye see in 72h
It examines, records situations such as whether there is or not erythema and oedema at coating, score by standards of grading and strength criterion judges stimulus intensity.
(2) skin irritation test of multiple dosing: test method and observation connect with reference to the skin irritation test of single administration
Be administered within continuous 1 week, be administered once daily, remain tested material with warm water removal, remove tested material 1,24,48, with the naked eye see in 72h
It examines, records situations such as whether there is or not erythema and oedema at coating, score by standards of grading and strength criterion judges stimulus intensity.
Irritative symptoms standards of grading and irritation strength judgment standard are referring to Tables 1 and 2.
1 irritative symptoms standards of grading of table
| Score | Erythema | Oedema |
| 0 | Without erythema | Without oedema |
| 1 | Erythema is visible reluctantly | Oedema is visible reluctantly |
| 2 | Moderate erythema | Obvious protuberance |
| 3 | Severe erythema | Cutaneous protuberance 1mm, is clearly outlined |
| 4 | Aubergine erythema simultaneously has eschar to be formed | Oedema protuberance about 1mm or more simultaneously has expansion |
2 irritation strength judgment standard of table
| Score value | Irritation intensity |
| 0~0.49 | It is nonirritant |
| 0.5~2.99 | Slight stimulation |
| 3.0~5.99 | Moderate irritation |
| 6.0~8.0 | Strong and stimulating |
4. test result: test result is referring to table 3 and table 4.
The scoring and irritation intensity of 3 single administration skin irritatin of table
The scoring and irritation intensity of 4 multiple dosing skin irritatin of table
By table 3 and table 4 as it can be seen that the triamcinolone acetonide acetate emulsifiable paste for preparing of the embodiment of the present invention 1 is primary, multiple dosing is to complete
No skin irritation has slight irritation to damaged skin.Comparative example 1~2 (is removed respectively and replaces seaweed with chitosan
Sour sodium) preparation triamcinolone acetonide acetate emulsifiable paste is primary, multiple dosing is after removing tested material 1h, have slightly to intact skin
Irritation has moderate irritation to damaged skin.
The test of 2 triamcinolone acetonide acetate emulsifiable paste Transdermal Absorption of test example
1. test material: triamcinolone acetonide acetate emulsifiable paste prepared by Examples 1 to 3 and comparative example 1~2.
2. subjects: isolated mouse skin (takes mouse, 8% Na is coated at abdomen same position2S solution, 3min
Afterwards, it is cleaned repeatedly with clear water to no Na2S residual, rear cervical dislocation is put to death for 24 hours, strips skin of abdomen, cleans remaining subcutaneous group
It knits and fat several times with normal saline flushing, is set with water repeated flushing to net and refrigerates spare, use in 1 week in physiological saline).
3. test method:
(1) Transdermal Absorption is tested: the isolated skin prepared being taken out from refrigerator, is soaked in physiological saline and solves
Freeze 1h, after blotting surface moisture with filter paper, takes the triamcinolone acetonide acetate emulsifiable paste of 0.5g Examples 1 to 3 and the preparation of comparative example 1~2
Apply the stratum corneum side in skin, the skin handled well be fixed between the supply chamber of diffusion cell and receiving chamber, stratum corneum side to
0.9% sodium chloride 15ml is added in acceptance pool as acceptable solution for supply chamber, empties bubble, magnetic stirring speed about 200r/min,
Bath temperature (37 ± 1) DEG C starts timing, takes out whole acceptable solutions from acceptance pool after 12h while opening magnetic stirring apparatus,
It is filtered with 0.45 μm of miillpore filter, with reference to " Chinese Pharmacopoeia " (version in 2015) second triamcinolone acetonide acetate emulsifiable paste assay side
Method measures Assaying of triamcinolone acetonide acetate, calculates it and accumulates transdermal penetration amount (μ g).
4. test result:
The accumulation transdermal penetration amount of 5 triamcinolone acetonide acetate of table
| Group | The accumulation transdermal penetration amount (μ g) of triamcinolone acetonide acetate |
| Embodiment 1 | 122.31±10.42 |
| Embodiment 2 | 123.83±11.51 |
| Embodiment 3 | 108.07±13.60 |
| Comparative example 1 | 126.87±11.92 |
| Comparative example 2 | 96.23±12.82** |
Note: compared with Example 1,*P < 0.05,**P<0.01。
By table 5 as it can be seen that the kojic acid Kenac Cream of the embodiment of the present invention 1 and comparative example 1 (removing sodium alginate) preparation
Triamcinolone acetonide acetate accumulation transdermal penetration amount be not present significant difference, it is seen then that the addition of sodium alginate can't reduce vinegar
The accumulation transdermal penetration amount of sour Triamcinolone acetonide.And comparative example 2 (replacing sodium alginate with chitosan) is compared with Example 1, acetic acid
The accumulation transdermal penetration measurer of Triamcinolone acetonide has significant difference.
3 study on the stability of test example
According to drug stability test in " Chinese Pharmacopoeia " 2015 editions annex requirement to Examples 1 to 3 and comparative example 1~
2 carry out study on the stability, are detected according to hygienic ministerial standard (WS1-282 (D-41) -88) Dichlorodiphenyl Acetate Triamcinolone acetonide and urea,
It is compared with labelled amount, triamcinolone acetonide acetate/urea labelled amount percentage (%) is expressed as, as a result referring to table 6.
6 study on the stability result of table
As shown in Table 6, the embodiment of the present invention 1~3 prepare triamcinolone acetonide acetate emulsifiable paste place 24 months after, effectively at
The content of triamcinolone acetonide acetate and urea is divided to be held essentially constant, stability is good.Triamcinolone acetonide acetate prepared by comparative example 1~2
Emulsifiable paste content of effective component triamcinolone acetonide acetate and urea since June begins to be greatly lowered, and reduces by the 24th month
20~30%, effective component significantly reduces.
The above-described embodiments merely illustrate the principles and effects of the present invention, and is not intended to limit the present invention.It is any ripe
The personage for knowing this technology all without departing from the spirit and scope of the present invention, carries out modifications and changes to above-described embodiment.Cause
This, institute is complete without departing from the spirit and technical ideas disclosed in the present invention by those of ordinary skill in the art such as
At all equivalent modifications or change, should be covered by the claims of the present invention.
Claims (5)
1. a kind of triamcinolone acetonide acetate emulsifiable paste, which is characterized in that the emulsifiable paste is made of active constituent and matrix, it is described activity at
Divide and is made of following raw material and its parts by weight: 0.4~1.2 part of triamcinolone acetonide acetate, 80~120 parts of urea, citric acid 0.5~
1.2 parts and 6~12 parts of dimethyl sulfoxide；The matrix is made of following raw material and its parts by weight: peregal A-20 35~62
Part, 120~180 parts of octadecyl alcolol, 630~750 parts of propylene glycol and 0.5~1.5 part of sodium alginate.
2. triamcinolone acetonide acetate emulsifiable paste according to claim 1, which is characterized in that the active constituent by following raw material and its
Parts by weight are made: 0.5~1 part of triamcinolone acetonide acetate, 85~100 parts of urea, 0.8~1 part of citric acid and dimethyl sulfoxide 8~10
Part；The matrix is made of following raw material and its parts by weight: 40~50 parts of peregal A-20,135~150 parts of octadecyl alcolol, third
630~700 parts and 0.5~1 part of sodium alginate of glycol.
3. triamcinolone acetonide acetate emulsifiable paste according to claim 2, which is characterized in that the active constituent by following raw material and its
Parts by weight are made: 1 part of triamcinolone acetonide acetate, 100 parts of urea, 1 part of citric acid and 10 parts of dimethyl sulfoxide；The matrix is by following
Raw material and its parts by weight are made: 50 parts of peregal A-20,150 parts of octadecyl alcolol, 687 parts of propylene glycol and 1 part of sodium alginate.
4. any triamcinolone acetonide acetate emulsifiable paste according to claim 1~3, which is characterized in that the preparation method of the emulsifiable paste
The following steps are included:
S1, the urea of corresponding amount and propylene glycol are placed in heated aqueous cylinder, are heated to 80~85 DEG C, stirring and dissolving, filtering obtains
Solution A；
S2, the dimethyl sulfoxide filtered through gauze by corresponding amount, are added the triamcinolone acetonide acetate, sodium alginate and citron of corresponding amount
Acid stirs to being completely dissolved, obtains solution B；
S3, the peregal A-20 and octadecyl alcolol of corresponding amount are placed in oily heat phase cylinder, are heated to 88~92 DEG C, stirring and dissolving,
It is transferred in reaction cylinder, step S1 acquired solution A is added, it is stirring while adding, add 10~15min of stirring, emulsification 18~
25min, controlled at 80~85 DEG C；After the completion of emulsification, it is cooled to 73~76 DEG C while stirring, step S2 acquired solution is added
Solution B continues to cool, stirring to it is solidifying to get.
5. a kind of preparation method of any triamcinolone acetonide acetate emulsifiable paste of Claims 1 to 4, which is characterized in that including following
Step:
I, the urea of corresponding amount and propylene glycol are placed in heated aqueous cylinder, are heated to 80~85 DEG C, stirring and dissolving, filtering obtains
Solution A；
II, the dimethyl sulfoxide filtered through gauze by corresponding amount, are added the triamcinolone acetonide acetate, sodium alginate and citron of corresponding amount
Acid stirs to being completely dissolved, obtains solution B；
III, the peregal A-20 and octadecyl alcolol of corresponding amount are placed in oily heat phase cylinder, are heated to 88~92 DEG C, stirring and dissolving,
It is transferred in reaction cylinder, step I acquired solution A is added, it is stirring while adding, 10~15min of stirring is added, 18~25min is emulsified,
Controlled at 80~85 DEG C；After the completion of emulsification, it is cooled to 73~76 DEG C while stirring, step II acquired solution solution B is added,
Continue to cool, stirring to it is solidifying to get.
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| US20040141925A1 (en) * | 1998-11-12 | 2004-07-22 | Elan Pharma International Ltd. | Novel triamcinolone compositions |
| CN101401783A (en) * | 2007-09-16 | 2009-04-08 | 杨喜鸿 | Percutaneous absorption agent containing Ailamode, preparation method and medical uses thereof |
| CN103127139B (en) * | 2011-11-30 | 2016-01-20 | 天津金耀集团有限公司 | Difluprednate topical external preparation |
| CN105853443B (en) * | 2016-04-01 | 2018-10-02 | 国药集团三益药业（芜湖）有限公司 | A kind of triamcinolone acetonide acetate carbamide ointment and preparation method thereof |
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