CN110051621A - A kind of compound dexamethasone acetate antiperspirant cream compositions and preparation method thereof - Google Patents
A kind of compound dexamethasone acetate antiperspirant cream compositions and preparation method thereof Download PDFInfo
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- CN110051621A CN110051621A CN201810046901.2A CN201810046901A CN110051621A CN 110051621 A CN110051621 A CN 110051621A CN 201810046901 A CN201810046901 A CN 201810046901A CN 110051621 A CN110051621 A CN 110051621A
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- dexamethasone acetate
- cream compositions
- antiperspirant cream
- compound dexamethasone
- compound
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- 229960003657 dexamethasone acetate Drugs 0.000 title claims abstract description 63
- -1 compound dexamethasone acetate Chemical class 0.000 title claims abstract description 55
- 239000000203 mixture Substances 0.000 title claims abstract description 43
- 239000006071 cream Substances 0.000 title claims abstract description 41
- 230000001166 anti-perspirative effect Effects 0.000 title claims abstract description 39
- 239000003213 antiperspirant Substances 0.000 title claims abstract description 39
- 238000002360 preparation method Methods 0.000 title claims abstract description 21
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 15
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims abstract description 12
- FPVRUILUEYSIMD-RPRRAYFGSA-N [(8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11-hydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] acetate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(OC(C)=O)[C@@]1(C)C[C@@H]2O FPVRUILUEYSIMD-RPRRAYFGSA-N 0.000 claims abstract description 11
- 239000011159 matrix material Substances 0.000 claims abstract description 10
- DSSYKIVIOFKYAU-XCBNKYQSSA-N (R)-camphor Chemical compound C1C[C@@]2(C)C(=O)C[C@@H]1C2(C)C DSSYKIVIOFKYAU-XCBNKYQSSA-N 0.000 claims abstract description 9
- 241000723346 Cinnamomum camphora Species 0.000 claims abstract description 9
- 229960000846 camphor Drugs 0.000 claims abstract description 9
- 229930008380 camphor Natural products 0.000 claims abstract description 9
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 claims abstract description 7
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims abstract description 7
- 229940041616 menthol Drugs 0.000 claims abstract description 7
- 239000003002 pH adjusting agent Substances 0.000 claims abstract description 7
- 239000012071 phase Substances 0.000 claims description 22
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 12
- 239000000498 cooling water Substances 0.000 claims description 12
- 239000007788 liquid Substances 0.000 claims description 10
- 239000002075 main ingredient Substances 0.000 claims description 10
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 9
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 9
- 229920002125 Sokalan® Polymers 0.000 claims description 9
- 229960001631 carbomer Drugs 0.000 claims description 9
- 230000005496 eutectics Effects 0.000 claims description 8
- 238000003756 stirring Methods 0.000 claims description 8
- 239000000126 substance Substances 0.000 claims description 8
- 230000001804 emulsifying effect Effects 0.000 claims description 7
- 239000008346 aqueous phase Substances 0.000 claims description 6
- 239000006210 lotion Substances 0.000 claims description 6
- RCEAADKTGXTDOA-UHFFFAOYSA-N OS(O)(=O)=O.CCCCCCCCCCCC[Na] Chemical compound OS(O)(=O)=O.CCCCCCCCCCCC[Na] RCEAADKTGXTDOA-UHFFFAOYSA-N 0.000 claims description 5
- 229940082500 cetostearyl alcohol Drugs 0.000 claims description 5
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 claims description 5
- 239000004094 surface-active agent Substances 0.000 claims description 5
- OULAJFUGPPVRBK-UHFFFAOYSA-N tetratriacontyl alcohol Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCO OULAJFUGPPVRBK-UHFFFAOYSA-N 0.000 claims description 5
- 229940099259 vaseline Drugs 0.000 claims description 5
- 238000010438 heat treatment Methods 0.000 claims description 4
- 238000002844 melting Methods 0.000 claims description 4
- 230000008018 melting Effects 0.000 claims description 4
- 229920000148 Polycarbophil calcium Polymers 0.000 claims description 3
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 claims description 3
- 229950005134 polycarbophil Drugs 0.000 claims description 3
- 125000004079 stearyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims description 3
- 235000021355 Stearic acid Nutrition 0.000 claims description 2
- 150000001875 compounds Chemical class 0.000 claims description 2
- 238000004090 dissolution Methods 0.000 claims description 2
- 229930195733 hydrocarbon Natural products 0.000 claims description 2
- 150000002430 hydrocarbons Chemical class 0.000 claims description 2
- 239000000463 material Substances 0.000 claims description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 2
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 2
- 239000012188 paraffin wax Substances 0.000 claims description 2
- 239000008117 stearic acid Substances 0.000 claims description 2
- 229960004274 stearic acid Drugs 0.000 claims description 2
- RZYKUPXRYIOEME-UHFFFAOYSA-N CCCCCCCCCCCC[S] Chemical compound CCCCCCCCCCCC[S] RZYKUPXRYIOEME-UHFFFAOYSA-N 0.000 claims 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- 235000006508 Nelumbo nucifera Nutrition 0.000 claims 1
- 240000002853 Nelumbo nucifera Species 0.000 claims 1
- 235000006510 Nelumbo pentapetala Nutrition 0.000 claims 1
- 210000004556 brain Anatomy 0.000 claims 1
- 229940056211 paraffin Drugs 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 230000007306 turnover Effects 0.000 claims 1
- 238000012360 testing method Methods 0.000 description 6
- WWYNJERNGUHSAO-XUDSTZEESA-N (+)-Norgestrel Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 WWYNJERNGUHSAO-XUDSTZEESA-N 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 2
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 2
- 241001269238 Data Species 0.000 description 2
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 2
- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 229960003957 dexamethasone Drugs 0.000 description 2
- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 description 2
- SNRUBQQJIBEYMU-UHFFFAOYSA-N dodecane Chemical compound CCCCCCCCCCCC SNRUBQQJIBEYMU-UHFFFAOYSA-N 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 description 2
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- GYCKQBWUSACYIF-UHFFFAOYSA-N o-hydroxybenzoic acid ethyl ester Natural products CCOC(=O)C1=CC=CC=C1O GYCKQBWUSACYIF-UHFFFAOYSA-N 0.000 description 2
- 239000008213 purified water Substances 0.000 description 2
- 230000008961 swelling Effects 0.000 description 2
- DCXXMTOCNZCJGO-UHFFFAOYSA-N tristearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCCCCCC)COC(=O)CCCCCCCCCCCCCCCCC DCXXMTOCNZCJGO-UHFFFAOYSA-N 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- 201000004624 Dermatitis Diseases 0.000 description 1
- 206010012442 Dermatitis contact Diseases 0.000 description 1
- 201000009053 Neurodermatitis Diseases 0.000 description 1
- 208000003251 Pruritus Diseases 0.000 description 1
- 206010039792 Seborrhoea Diseases 0.000 description 1
- 229940022663 acetate Drugs 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 239000002585 base Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 235000019636 bitter flavor Nutrition 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 208000010247 contact dermatitis Diseases 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 229960000935 dehydrated alcohol Drugs 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 229960004756 ethanol Drugs 0.000 description 1
- 235000019441 ethanol Nutrition 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000004519 grease Substances 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 239000007908 nanoemulsion Substances 0.000 description 1
- 230000009965 odorless effect Effects 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 208000008742 seborrheic dermatitis Diseases 0.000 description 1
- 208000017520 skin disease Diseases 0.000 description 1
- 229910052938 sodium sulfate Inorganic materials 0.000 description 1
- 235000011152 sodium sulphate Nutrition 0.000 description 1
- 239000004575 stone Substances 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
Classifications
-
- 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
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
-
- 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
- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- A61K31/125—Camphor; Nuclear substituted derivatives thereof
-
- 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
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- 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
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
- Cosmetics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The application discloses the component dexamethasone acetate 0.05%~0.1% that a kind of compound dexamethasone acetate antiperspirant cream compositions include following weight percentage；Camphor 0.5%~1.5%；Menthol 0.5%~1.5%；Emulsifiable paste matrix material 20%~40%；Dimethyl sulfoxide 0.5%~2.5%；PH adjusting agent 0.02%~0.08%；Surplus is water.Compound dexamethasone acetate antiperspirant cream compositions provided herein, stability are significantly improved compared with the prior art.Disclosed herein as well is a kind of preparation methods of compound dexamethasone acetate antiperspirant cream compositions.
Description
Technical field
The application belongs to pharmaceutical technology field, more specifically, this application involves a kind of compound dexamethasone acetate emulsifiable paste groups
Close object and preparation method thereof.
Background technique
Dexamethasone acetate, chemical name: 16 Alpha-Methyl -11 β, 17 α, -9 α of 21- trihydroxy-pregna-fluoride-Isosorbide-5-Nitrae-diene -3,
20- diketone 21- acetate.Compound dexamethasone acetate emulsifiable paste is a kind of externally used compound preparation, is clinically used for regional pruritus
The cutaneous diseases such as disease, neurodermatitis, contact dermatitis, seborrhea and chronic eczema.
Currently, dexamethasone acetate is prepared into various exterior-applied formulations both at home and abroad, such as compound dexamethasone acetate nano-emulsion
Cream, compound dexamethasone acetate gel, compound dexamethasone acetate emulsifiable paste etc., especially compound dexamethasone acetate emulsifiable paste is applied to
Market hours are more long, deep to be approved by the majority of consumers.
The main component of compound dexamethasone acetate emulsifiable paste is dexamethasone acetate, camphor, menthol.Dexamethasone acetate
It is cortex hormone of aadrenaline medicine.For white or crystallization or the crystalline powder of off-white color, odorless, mildly bitter flavor.It is readily soluble in acetone,
It is dissolved in methanol or dehydrated alcohol, slightly molten in ethyl alcohol or chloroform, the soluble,very slightly in ether is insoluble in water.
However, in acid, oxidation and illumination destroy according to compound dexamethasone acetate emulsifiable paste prepared by the prior art
Under the conditions of it is more stable, still, under high temperature and alkali failure condition, principal component degradation impurity dexamethasone content is significantly increased.By
This is as it can be seen that high temperature and alkaline environment can all promote transformation of the dexamethasone acetate to dexamethasone.
Therefore, in order to overcome the above-mentioned deficiency in the presence of the prior art, spy proposes the application.
Summary of the invention
The first purpose of the application is, provides a kind of compound dexamethasone acetate antiperspirant cream compositions.
To achieve the goals above, the application adopts the following technical scheme that
A kind of compound dexamethasone acetate antiperspirant cream compositions, which is characterized in that the compound dexamethasone acetate emulsifiable paste group
Close the component that object includes following weight percentage:
Preferably, the emulsifiable paste matrix material includes oil phase substance, surfactant and water.
Preferably, the oil phase substance is single bi-tristearin, cetostearyl alcohol, vaseline, stearic acid, liquid stone
One of cured, hexadecanol and octadecyl alcolol or more than one combinations.
Preferably, the surfactant is one of single bi-tristearin, lauryl sodium sulfate or a kind of
Combination of the above.
Preferably, the pH adjusting agent is one or both of carbomer, polycarbophil.
Preferably, the compound dexamethasone acetate antiperspirant cream compositions include the component of following weight percentage:
Preferably, the emulsifiable paste matrix material includes the component of following weight percentage:
Preferably, the compound dexamethasone acetate antiperspirant cream compositions include the component of following weight percentage:
The another object of the application is, provides a kind of preparation method of compound dexamethasone acetate antiperspirant cream compositions.
To achieve the goals above, the application adopts the following technical scheme that
A kind of preparation method of compound dexamethasone acetate antiperspirant cream compositions, which is characterized in that the preparation method includes
Following steps:
(1) carbomer of recipe quantity is added into water, is heated after being swollen it sufficiently, add the dodecane of recipe quantity
Base sodium sulphate and glycerol obtain aqueous phase solution to abundant dissolution；
(2) the emulsifiable paste matrix material of recipe quantity is heated, makes to melt completely, obtains oil-phase solution；
(3) by camphor, menthol melting, camphomenthol's eutectic liquids are obtained；；
(4) recipe quantity acetic acid recipe quantity dexamethasone acetate is dissolved in dimethyl sulfoxide, obtains main ingredient solution；
(5) step (2) resulting oil-phase solution is added to the emulsifying homogeneous pot of preheating, sucks step after starting stirring
(1) resulting aqueous phase solution；It opens cooling water and waits being cooled to 65~75 DEG C, it is resulting to sequentially add step (3) after starting homogenizer
Camphomenthol's eutectic liquids and the resulting main ingredient solution of step (4)；After homogeneous, open cooling water wait for lotion be cooled to 35~
45 DEG C, stopping is stirred up to the compound dexamethasone acetate antiperspirant cream compositions.
Preferably, the step (5) specifically includes:
Emulsifying homogeneous pot is preheated, and start vacuum to make vacuum pressure≤- 40KPa, sucking step (2) resulting oil mixes
Liquid sucks step (1) resulting aqueous phase solution after starting stirring, opens cooling water and waits being cooled to 65~75 DEG C, after starting homogenizer
Sequentially add rapid (3) the resulting camphomenthol's eutectic liquids of step-and the resulting main ingredient solution of step (4)；Homogeneous 8-15 minutes altogether,
Then after adjusting 15~30 revs/min of revolving speed, vacuum≤- 40KPA is opened, cooling water is opened and waits for that lotion is cooled to 35~45 DEG C, stop
It only stirs up to the compound dexamethasone acetate antiperspirant cream compositions.
Preferably, the heating in step (1), which refers to, is heated to 85 ± 5 DEG C；Heating in step (2), which refers to, is heated to 75~80
℃。
The beneficial effect that the application can generate includes:
1, compound dexamethasone acetate antiperspirant cream compositions provided herein, by changing each component type in the formula
And the proportion of content, and qs pH adjuster is added finished product can be adjusted to pH value 6-8, so that the related substance of finished product drops
Low, stability is significantly improved.
2, the preparation method of compound dexamethasone acetate antiperspirant cream compositions provided herein, during the preparation process, drop
When low main ingredient is added in emulsifying homogeneous pot content temperature, improve the stability of finished product.The preparation method of the application is led to
The temperature and adjustment product pH value when control main ingredient is added are crossed, the stability of product quality is improved.And when water phase is prepared
Appropriate amount pH adjusting agent is added in water phase, mixes rear required finished product pH range to reach final grease.And the preparation method
Simply, stability is good, is suitble to industrialized production.
Specific embodiment
The application is described in detail below with reference to embodiment, but the application is not limited to these embodiments.
Unless otherwise instructed, the raw material in embodiments herein is bought by commercial sources.
According to a kind of embodiment of the application, a kind of compound dexamethasone acetate antiperspirant cream compositions, including following component:
Dexamethasone acetate 0.05%~0.1%；
Camphor 0.5%~1.5%；
Menthol 0.5%~1.5%；
Emulsifiable paste matrix material 20%~40%；
Dimethyl sulfoxide 0.5%~2.5%；
PH adjusting agent 0.02%~0.08%；
Surplus is water.
Oil phase substance is single bi-tristearin, cetostearyl alcohol, vaseline, tristearin in the emulsifiable paste matrix material
The mixture of one or more of acid, paraffin hydrocarbons, hexadecanol and octadecyl alcolol.
Surfactant is one of single bi-tristearin, lauryl sodium sulfate in the emulsifiable paste matrix material
Or two kinds of mixture.
The pH adjusting agent is one or both of carbomer, polycarbophil mixture.
Embodiment 1
The present embodiment is related to the formula of compound dexamethasone acetate antiperspirant cream compositions, specific as shown in table 1:
1 compound dexamethasone acetate antiperspirant cream compositions formula table of table
Embodiment 2
The present embodiment is related to a kind of preparation method of compound dexamethasone acetate antiperspirant cream compositions.
A kind of preparation method of compound dexamethasone acetate antiperspirant cream compositions, which is characterized in that the method includes as follows
Step:
(1) purified water and carbomer is added according to formula 1,85 ± 5 DEG C, at addition is heated to after carbomer complete swelling
Side's amount lauryl sodium sulfate and glycerol make to dissolve to obtain water phase.
(2) recipe quantity list bi-tristearin, cetostearyl alcohol, vaseline and ethyl hydroxy benzoate is added to oily phase pot.Add
Heat makes to melt to obtain oily phase completely to 75~80 DEG C.
(3) camphor, menthol are stirred to grind repeatedly and makes melting.
(4) weighing recipe quantity dexamethasone acetate makes to be dissolved in dimethyl sulfoxide.
(5) emulsifying homogeneous pot is preheated, and start vacuum to make vacuum pressure≤- 40KPA, sucks oily phase, is inhaled after starting stirring
Enter water phase, opens cooling water and wait being cooled to 65~75 DEG C, camphomenthol's eutectic liquids are added after starting homogenizer, main ingredient solution, are total to
Homogeneous 10 minutes, after 15~30 revs/min of revolving speed of adjustment, open vacuum≤- 40KPA, open cooling water wait for lotion be cooled to 35~
45 DEG C, stopping is stirred up to the compound dexamethasone acetate antiperspirant cream compositions.
The testing result of prepared compound dexamethasone acetate antiperspirant cream compositions is as shown in table 2 below:
2 testing result table of table
| Detection project | Testing result | Check conclusion |
| Character | White emulsifiable paste has camphor specifically fragrant | Meet regulation |
| Content | 105.9% | Meet regulation |
Embodiment 3
The present embodiment is related to a kind of preparation method of compound dexamethasone acetate antiperspirant cream compositions.
A kind of preparation method of compound dexamethasone acetate antiperspirant cream compositions, which is characterized in that the method includes as follows
Step:
(1) purified water and carbomer is added according to formula 2,85 ± 5 DEG C, at addition is heated to after carbomer complete swelling
Side's amount lauryl sodium sulfate and glycerol make to dissolve to obtain water phase.
(2) recipe quantity list bi-tristearin, cetostearyl alcohol, vaseline and ethyl hydroxy benzoate is added to oily phase pot.Add
Heat makes to melt to obtain oily phase completely to 75~80 DEG C.
(3) camphor, menthol are stirred to grind repeatedly and makes melting.
(4) weighing recipe quantity dexamethasone acetate makes to be dissolved in dimethyl sulfoxide.
(5) emulsifying homogeneous pot is preheated, and start vacuum to make vacuum pressure≤- 40KPA, sucks oily phase, is inhaled after starting stirring
Enter water phase, opens cooling water and wait being cooled to 65~75 DEG C, camphomenthol's eutectic liquids are added after starting homogenizer, main ingredient solution, are total to
Homogeneous 10 minutes, after 15~30 revs/min of revolving speed of adjustment, open vacuum≤- 40KPA, open cooling water wait for lotion be cooled to 35~
45 DEG C, stopping is stirred up to the compound dexamethasone acetate antiperspirant cream compositions.
The testing result of prepared compound dexamethasone acetate antiperspirant cream compositions is as shown in table 3 below:
3 testing result table of table
Comparative example 1
According to the sample that preparation method in embodiment 2 prepares, after being packed using aluminum pipe, with Zhejiang Ovrette and China Resources
The compound dexamethasone acetate emulsifiable paste comparison of Sanjiu Pharmaceutical Co., Ltd's production, at 30 DEG C ± 2 DEG C of temperature, relative humidity
65% ± 5% carries out accelerated test 3 months, detects every quality index and has no significant change compared with 0 month, meets quality
Pertinent regulations in standard.Main result is shown in Table 4, table 5 and table 6:
Table 4 makes the stability data that sample accelerates 3 months by oneself
5 Zhejiang Ovrette sample of table accelerates 3 months stability datas
6 China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.'s product of table accelerates 3 months stability datas:
It can be seen that the compound dexamethasone acetate emulsifiable paste of the application and Zhejiang are difficult to understand from the experimental result of table 4, table 5 and table 6
Rett and China Resources medicine compound dexamethasone acetate emulsifiable paste sample folk prescription comparatively, product content variation less, but the application
The control of related substance more stringent, related the low of content of material, and change it is unobvious, therefore integrally than Ovrette side's product
The control of medicine is stringenter with China Resources three nine-day periods after the winter solstice, illustrates that the compound dexamethasone acetate stability of cream of the application of the application mentions
Gao Liao, to improve the safety of product clinical application.
The above is only several embodiments of the application, not does any type of limitation to the application, although this Shen
Please disclosed as above with preferred embodiment, however not to limit the application, any person skilled in the art is not taking off
In the range of technical scheme, a little variation or modification are made using the technology contents of the disclosure above and is equal to
Case study on implementation is imitated, is belonged in technical proposal scope.
Claims (10)
1. a kind of compound dexamethasone acetate antiperspirant cream compositions, which is characterized in that the compound dexamethasone acetate emulsifiable paste combination
Object includes the component of following weight percentage:
2. compound dexamethasone acetate antiperspirant cream compositions according to claim 1, which is characterized in that the emulsifiable paste matrix material
Material includes oil phase substance, surfactant and water.
3. compound dexamethasone acetate antiperspirant cream compositions according to claim 2, which is characterized in that the oil phase substance is
One of single bi-tristearin, cetostearyl alcohol, vaseline, stearic acid, paraffin hydrocarbons, hexadecanol and octadecyl alcolol or one
Kind combination of the above.
4. compound dexamethasone acetate antiperspirant cream compositions according to claim 2, which is characterized in that the surfactant
For one of single bi-tristearin, lauryl sodium sulfate or more than one combinations.
5. compound dexamethasone acetate antiperspirant cream compositions according to claim 1, which is characterized in that the pH adjusting agent is
One or both of carbomer, polycarbophil.
6. compound dexamethasone acetate antiperspirant cream compositions described in any one of -4 according to claim 1, which is characterized in that institute
State the component that emulsifiable paste matrix material includes following weight percentage:
7. compound dexamethasone acetate antiperspirant cream compositions according to claim 1, which is characterized in that the compound acetic acid
Sai meter Song antiperspirant cream compositions include the component of following weight percentage:
8. a kind of preparation method of the compound dexamethasone acetate antiperspirant cream compositions as described in any one of claim 1-7,
It is characterized in that, the preparation method includes the following steps:
(1) carbomer of recipe quantity is added into water, is heated after being swollen it sufficiently, add the dodecyl sulphur of recipe quantity
Sour sodium and glycerol obtain aqueous phase solution to abundant dissolution；
(2) the emulsifiable paste matrix material of recipe quantity is heated, makes to melt completely, obtains oil-phase solution；
(3) by camphor, menthol melting, camphomenthol's eutectic liquids are obtained；；
(4) recipe quantity acetic acid recipe quantity dexamethasone acetate is dissolved in dimethyl sulfoxide, obtains main ingredient solution；
(5) step (2) resulting oil-phase solution is added to the emulsifying homogeneous pot of preheating, sucks step (1) institute after starting stirring
The aqueous phase solution obtained；It opens cooling water and waits being cooled to 65~75 DEG C, it is thin to sequentially add step (3) resulting camphor after starting homogenizer
Lotus brain eutectic liquids and the resulting main ingredient solution of step (4)；After homogeneous, opens cooling water and waits for that lotion is cooled to 35~45 DEG C,
Stopping is stirred up to the compound dexamethasone acetate antiperspirant cream compositions.
9. the preparation method of compound dexamethasone acetate antiperspirant cream compositions according to claim 8, which is characterized in that described
Step (5) specifically includes:
Emulsifying homogeneous pot is preheated, and start vacuum to make vacuum pressure≤- 40KPa, sucks step (2) resulting oil-phase solution, open
Step (1) resulting aqueous phase solution is sucked after moving stirring, cooling water is opened and waits being cooled to 65~75 DEG C, is successively added after starting homogenizer
Enter rapid (3) the resulting camphomenthol's eutectic liquids of step-and the resulting main ingredient solution of step (4)；It homogeneous 8-15 minutes altogether, then adjusts
After 15~30 revs/min of turn over speed, vacuum≤- 40KPA is opened, cooling water is opened and waits for that lotion is cooled to 35~45 DEG C, stop stirring
Up to the compound dexamethasone acetate antiperspirant cream compositions.
10. the preparation method of compound dexamethasone acetate antiperspirant cream compositions according to claim 8, which is characterized in that step
Suddenly the heating in (1), which refers to, is heated to 85 ± 5 DEG C；Heating in step (2), which refers to, is heated to 75~80 DEG C.
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| CN113876782A (en) * | 2021-11-09 | 2022-01-04 | 广州医药研究总院有限公司 | Compound dexamethasone acetate emulsifiable paste and preparation method thereof |
| CN114504548A (en) * | 2020-11-16 | 2022-05-17 | 湖北舒邦药业有限公司 | Ointment and preparation method thereof |
| CN116036095A (en) * | 2022-09-30 | 2023-05-02 | 华润三九医药股份有限公司 | Preparation method of compound dexamethasone acetate emulsifiable paste |
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| CN114504548A (en) * | 2020-11-16 | 2022-05-17 | 湖北舒邦药业有限公司 | Ointment and preparation method thereof |
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| CN113876782A (en) * | 2021-11-09 | 2022-01-04 | 广州医药研究总院有限公司 | Compound dexamethasone acetate emulsifiable paste and preparation method thereof |
| CN116036095A (en) * | 2022-09-30 | 2023-05-02 | 华润三九医药股份有限公司 | Preparation method of compound dexamethasone acetate emulsifiable paste |
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