CN116602914A - Cream for dermatitis and production process and production equipment thereof - Google Patents
Cream for dermatitis and production process and production equipment thereof Download PDFInfo
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- CN116602914A CN116602914A CN202310815623.3A CN202310815623A CN116602914A CN 116602914 A CN116602914 A CN 116602914A CN 202310815623 A CN202310815623 A CN 202310815623A CN 116602914 A CN116602914 A CN 116602914A
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- cream
- dermatitis
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- 239000006071 cream Substances 0.000 title claims abstract description 45
- 201000004624 Dermatitis Diseases 0.000 title claims abstract description 33
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 32
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 claims abstract description 22
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 claims abstract description 22
- 238000000034 method Methods 0.000 claims abstract description 20
- KASDHRXLYQOAKZ-ZPSXYTITSA-N pimecrolimus Chemical compound C/C([C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@]2(O)O[C@@H]([C@H](C[C@H]2C)OC)[C@@H](OC)C[C@@H](C)C/C(C)=C/[C@H](C(C[C@H](O)[C@H]1C)=O)CC)=C\[C@@H]1CC[C@@H](Cl)[C@H](OC)C1 KASDHRXLYQOAKZ-ZPSXYTITSA-N 0.000 claims abstract description 16
- 229960005330 pimecrolimus Drugs 0.000 claims abstract description 16
- 239000003814 drug Substances 0.000 claims abstract description 15
- 230000008569 process Effects 0.000 claims abstract description 13
- ALSTYHKOOCGGFT-KTKRTIGZSA-N (9Z)-octadecen-1-ol Chemical compound CCCCCCCC\C=C/CCCCCCCCO ALSTYHKOOCGGFT-KTKRTIGZSA-N 0.000 claims abstract description 11
- 229960000541 cetyl alcohol Drugs 0.000 claims abstract description 11
- GOQYKNQRPGWPLP-UHFFFAOYSA-N n-heptadecyl alcohol Natural products CCCCCCCCCCCCCCCCCO GOQYKNQRPGWPLP-UHFFFAOYSA-N 0.000 claims abstract description 11
- 229940055577 oleyl alcohol Drugs 0.000 claims abstract description 11
- XMLQWXUVTXCDDL-UHFFFAOYSA-N oleyl alcohol Natural products CCCCCCC=CCCCCCCCCCCO XMLQWXUVTXCDDL-UHFFFAOYSA-N 0.000 claims abstract description 11
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 claims abstract description 11
- 239000000203 mixture Substances 0.000 claims abstract description 8
- 238000003756 stirring Methods 0.000 claims description 162
- 238000004945 emulsification Methods 0.000 claims description 53
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 45
- 239000012071 phase Substances 0.000 claims description 44
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 35
- 230000001804 emulsifying effect Effects 0.000 claims description 31
- 239000000463 material Substances 0.000 claims description 31
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims description 30
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 30
- 230000005540 biological transmission Effects 0.000 claims description 26
- 230000001105 regulatory effect Effects 0.000 claims description 25
- 238000002156 mixing Methods 0.000 claims description 22
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 20
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 20
- 239000008213 purified water Substances 0.000 claims description 20
- 239000013067 intermediate product Substances 0.000 claims description 19
- 239000002994 raw material Substances 0.000 claims description 19
- 238000001816 cooling Methods 0.000 claims description 15
- 239000006260 foam Substances 0.000 claims description 11
- 235000019445 benzyl alcohol Nutrition 0.000 claims description 10
- 229940075507 glyceryl monostearate Drugs 0.000 claims description 10
- 239000007788 liquid Substances 0.000 claims description 10
- 239000001788 mono and diglycerides of fatty acids Substances 0.000 claims description 10
- 229910001220 stainless steel Inorganic materials 0.000 claims description 10
- 239000010935 stainless steel Substances 0.000 claims description 10
- 238000005406 washing Methods 0.000 claims description 10
- 229960004543 anhydrous citric acid Drugs 0.000 claims description 7
- 230000035939 shock Effects 0.000 claims description 6
- 239000000725 suspension Substances 0.000 claims description 6
- 239000000839 emulsion Substances 0.000 claims description 5
- 238000011049 filling Methods 0.000 claims description 5
- 238000010438 heat treatment Methods 0.000 claims description 5
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 claims description 5
- 229940093625 propylene glycol monostearate Drugs 0.000 claims description 5
- 229940046303 sodium cetostearyl sulfate Drugs 0.000 claims description 5
- CLBALUNQCMWJSU-UHFFFAOYSA-L sodium;hexadecyl sulfate;octadecyl sulfate Chemical compound [Na+].CCCCCCCCCCCCCCCCOS([O-])(=O)=O.CCCCCCCCCCCCCCCCCCOS([O-])(=O)=O CLBALUNQCMWJSU-UHFFFAOYSA-L 0.000 claims description 5
- QGLITUFXHVRMGV-UHFFFAOYSA-M sodium;tetratriacontyl sulfate Chemical compound [Na+].CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCOS([O-])(=O)=O QGLITUFXHVRMGV-UHFFFAOYSA-M 0.000 claims description 5
- 229940012831 stearyl alcohol Drugs 0.000 claims description 5
- 239000000126 substance Substances 0.000 claims description 5
- 230000007306 turnover Effects 0.000 claims description 5
- 230000000007 visual effect Effects 0.000 claims description 5
- 238000010030 laminating Methods 0.000 claims description 4
- 239000008346 aqueous phase Substances 0.000 claims description 2
- 230000003028 elevating effect Effects 0.000 claims 1
- 238000009434 installation Methods 0.000 claims 1
- 230000003110 anti-inflammatory effect Effects 0.000 abstract description 6
- 230000002757 inflammatory effect Effects 0.000 abstract description 6
- 230000000694 effects Effects 0.000 abstract description 5
- 239000003862 glucocorticoid Substances 0.000 abstract description 5
- 208000003251 Pruritus Diseases 0.000 abstract description 4
- 230000007803 itching Effects 0.000 abstract description 4
- 102000004127 Cytokines Human genes 0.000 abstract description 3
- 108090000695 Cytokines Proteins 0.000 abstract description 3
- 206010040799 Skin atrophy Diseases 0.000 abstract description 3
- 206010040914 Skin reaction Diseases 0.000 abstract description 3
- 230000015572 biosynthetic process Effects 0.000 abstract description 3
- 239000005556 hormone Substances 0.000 abstract description 3
- 229940088597 hormone Drugs 0.000 abstract description 3
- 210000002865 immune cell Anatomy 0.000 abstract description 3
- 230000035483 skin reaction Effects 0.000 abstract description 3
- 231100000430 skin reaction Toxicity 0.000 abstract description 3
- 238000003786 synthesis reaction Methods 0.000 abstract description 3
- 230000007423 decrease Effects 0.000 abstract description 2
- 230000007774 longterm Effects 0.000 abstract description 2
- 239000003246 corticosteroid Substances 0.000 abstract 1
- 229960001334 corticosteroids Drugs 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 28
- 238000005520 cutting process Methods 0.000 description 7
- 238000005303 weighing Methods 0.000 description 5
- 238000013016 damping Methods 0.000 description 4
- 230000009471 action Effects 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 3
- 238000007789 sealing Methods 0.000 description 3
- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical compound [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 229960004106 citric acid Drugs 0.000 description 2
- 239000002674 ointment Substances 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- 229940037128 systemic glucocorticoids Drugs 0.000 description 2
- WQNHWIYLCRZRLR-UHFFFAOYSA-N 2-(3-hydroxy-2,5-dioxooxolan-3-yl)acetic acid Chemical compound OC(=O)CC1(O)CC(=O)OC1=O WQNHWIYLCRZRLR-UHFFFAOYSA-N 0.000 description 1
- 206010013786 Dry skin Diseases 0.000 description 1
- 208000010201 Exanthema Diseases 0.000 description 1
- 201000004681 Psoriasis Diseases 0.000 description 1
- 206010040880 Skin irritation Diseases 0.000 description 1
- 238000005054 agglomeration Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- BLFLLBZGZJTVJG-UHFFFAOYSA-N benzocaine Chemical compound CCOC(=O)C1=CC=C(N)C=C1 BLFLLBZGZJTVJG-UHFFFAOYSA-N 0.000 description 1
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 description 1
- 239000004327 boric acid Substances 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 230000037336 dry skin Effects 0.000 description 1
- 201000005884 exanthem Diseases 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 206010037844 rash Diseases 0.000 description 1
- 238000007790 scraping Methods 0.000 description 1
- 230000036556 skin irritation Effects 0.000 description 1
- 231100000475 skin irritation Toxicity 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- FUSNMLFNXJSCDI-UHFFFAOYSA-N tolnaftate Chemical compound C=1C=C2C=CC=CC2=CC=1OC(=S)N(C)C1=CC=CC(C)=C1 FUSNMLFNXJSCDI-UHFFFAOYSA-N 0.000 description 1
- 229960004880 tolnaftate Drugs 0.000 description 1
- 239000011787 zinc oxide Substances 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F33/00—Other mixers; Mixing plants; Combinations of mixers
- B01F33/70—Mixers specially adapted for working at sub- or super-atmospheric pressure, e.g. combined with de-foaming
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/04—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of ointments
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
-
- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
-
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
- B01F23/40—Mixing liquids with liquids; Emulsifying
- B01F23/41—Emulsifying
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F33/00—Other mixers; Mixing plants; Combinations of mixers
- B01F33/80—Mixing plants; Combinations of mixers
- B01F33/83—Mixing plants specially adapted for mixing in combination with disintegrating operations
- B01F33/833—Devices with several tools rotating about different axis in the same receptacle
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
- B01F35/10—Maintenance of mixers
- B01F35/12—Maintenance of mixers using mechanical means
- B01F35/123—Maintenance of mixers using mechanical means using scrapers for cleaning mixers
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Mechanical Engineering (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
Abstract
The invention discloses a cream for dermatitis and a production process and production equipment thereof, belonging to the technical field of cream production. A cream for dermatitis and a production process and production equipment thereof comprise the following mixture of components in parts by weight: pimecrolimus 0.1-0.2g, oleyl alcohol 1.0-1.1g, medium chain triglyceride 1.5-1.6g, cetyl alcohol 0.4-0.5g, stearyl alcohol 0.4-0.5g. In order to solve the problems that although dermatitis emulsifiable paste can play a role in rapidly relieving itching in the using process, the glucocorticoid medicaments in the components of the dermatitis emulsifiable paste can cause dependence on patients, the long-term use can cause the decrease of the medicament effect and the dependence, the pimecrolimus can selectively inhibit the generation and the release of inflammatory cytokines, can block the synthesis of immune cell inflammatory factors, and shows stronger anti-inflammatory activity after the emulsifiable paste is locally used, wherein the anti-inflammatory activity is equivalent to that of the external emulsifiable paste of the glucocorticoid medicaments, and is different from the medicaments of the traditional corticosteroids, and the pimecrolimus does not cause skin atrophy and other hormone-related skin reactions.
Description
Technical Field
The invention relates to the technical field of cream production, in particular to a cream for dermatitis, a production process and production equipment thereof.
Background
Dermatitis is a generic term for common skin irritation. It has a variety of causes and manifestations, including itching, dry skin or rash. Dermatitis can also cause blistering, exudation, crusting, or flaking of the skin;
chinese patent publication No. CN115177583A discloses an ointment for psoriasis and its production process and equipment, wherein the ethyl p-aminobenzoate component in the ointment can reduce the irritation of the skin surface, and can relieve pain and itching on the skin surface under certain antibacterial and bactericidal capabilities, and the tolnaftate can be used together with boric acid solution and zinc oxide mixture to improve the curative effect.
In the above patent, although dermatitis cream can play a role in rapidly relieving itching in the use process, the glucocorticoid medicaments in the components of the dermatitis cream can cause dependence on patients, and the long-term use can cause the decline of the drug effect and also cause dependence; therefore, the existing requirements are not met, and a cream for dermatitis, a production process and production equipment thereof are provided.
Disclosure of Invention
The invention aims to provide a cream for dermatitis, a production process and production equipment thereof, pimecrolimus can selectively inhibit the generation and release of inflammatory cytokines, can block the synthesis of immune cell inflammatory factors, shows stronger anti-inflammatory activity after being locally used, has the anti-inflammatory activity which is equivalent to that of external cream of glucocorticoids, is different from the traditional corticoids, does not cause skin atrophy and other skin reactions related to hormones, and can solve the problems in the prior art.
In order to achieve the above purpose, the present invention provides the following technical solutions: a cream for dermatitis comprises the following mixture of components in parts by weight: pimecrolimus 0.1-0.2g, oleyl alcohol 1.0-1.1g, medium chain triglyceride 1.5-1.6g, cetyl alcohol 0.4-0.5g, stearyl alcohol 0.4-0.5g, glyceryl monostearate 0.2-0.3g, propylene glycol 0.5-0.6g, sodium cetostearyl sulfate 0.1-0.2g, anhydrous citric acid 0.005-0.006g, sodium hydroxide 0.002-0.003g, benzyl alcohol 0.1-0.2g, and purified water 5.5-5.7g.
A production process of a cream for dermatitis comprises the following steps:
step one: adding prescribed amounts of medium-chain triglyceride, oleyl alcohol, cetyl alcohol, stearyl alcohol, propylene glycol and glyceryl monostearate into a pretreatment pot B, starting stirring (900-960 rpm), adjusting the temperature of a jacket medium to heat the material to 70-80 ℃, and continuing stirring (900-960 rpm) for at least 30min until the visual solution is clear;
adding pimecrolimus raw material medicine into the pretreatment pot B, maintaining the material temperature, and stirring (900-960 rpm) for at least 2 hours until no insoluble matters are visible;
regulating the temperature of the jacket, and cooling the oil phase liquid medicine to 65-75 ℃ for standby;
step two: vacuum sucking 95% of purified water in the prescription amount in a vacuum emulsification mixer, and weighing 5% of purified water in the prescription amount to a stainless steel container for standby;
adding the benzyl alcohol, the anhydrous citric acid and the sodium hydroxide with the prescription amount into a vacuum emulsification mixer, and washing the benzyl alcohol and the sodium hydroxide container twice by weighing the purified water with the prescription amount of 5% for standby, wherein the washing liquid is added into the vacuum emulsification mixer;
heating the aqueous phase solution to 65-75 ℃, setting stirring speed (20.0-25.0 rpm), and stirring for at least 10min until the solution is clear visually;
step three: regulating the temperature of the oil phase and the water phase to ensure that the temperature difference of the oil phase and the water phase is not more than 2 ℃, regulating the vacuum of a vacuum emulsification stirrer to be between-0.04 and-0.07 MPa, setting stirring (20.0-25.0 rpm), passing the prepared oil phase solution through a filter provided with a stainless steel screen with 80 meshes, slowly adding the oil phase solution into the stirred water phase solution, and recovering normal pressure after mixing the two phases;
in the emulsification process, the temperature of a jacket medium is controlled, the temperature of the materials is kept at 65-75 ℃, the stirring speed (20.0-25.0 rpm) is set, and the materials are homogenized and emulsified for 10min at 3000.0+/-100.0 rpm; then stopping homogenizing, (20.0-25.0 rpm) stirring for 5min; maintaining stirring speed, homogenizing and emulsifying at 3000.0+ -100.0 rpm for 10min;
step four: setting stirring (10.0-15.0 rpm), regulating the temperature of a jacket medium, cooling the material to 53-57 ℃, setting vacuum to-0.02 to-0.06 MPa, maintaining stirring until the foam amount is stable, breaking vacuum to remove foam, repeatedly setting vacuum and breaking vacuum for 20min, or until the foam amount is not increased any more, and cooling to 45-50 ℃;
vacuum regulating the vacuum in the vacuum emulsifying stirrer to-0.02 to-0.06 Mpa, maintaining stirring (10.0-15.0 rpm), keeping the temperature of the intermediate product at 45-50 ℃, temporarily storing the intermediate product in the vacuum emulsifying stirrer for no more than 24 hours;
step five: pressurizing the vacuum emulsifying stirrer to 0.02-0.05 Mpa, opening a valve at the bottom discharge port, transferring the intermediate product to the next procedure for continuous filling through a clean turnover container, and temporarily storing the material to be filled in the vacuum emulsifying stirrer.
Preferably, in the second step, sodium cetylstearyl sulfate is added into the solution, the temperature of the material is maintained at 65-75 ℃, the stirring speed (20.0-25.0 rpm) is maintained, and the stirring is stopped for at least 30min until the solution is visually free of insoluble substances.
The utility model provides a production facility of cream for dermatitis, includes vacuum emulsification mixer, vacuum emulsification mixer includes platform frame, emulsification agitator tank and (mixing) shaft subassembly, the top of platform frame is provided with stirring platform, through lifting support connection between stirring platform and the platform frame, the inside one end of stirring platform is provided with the vacuum pump, and the inside other end of stirring platform is provided with driving motor, one side of driving motor is provided with the transmission case.
Preferably, the inside of lifting support is provided with flexible connecting rod, and one side in lifting support middle section is provided with the shock attenuation staple bolt, the shock attenuation staple bolt is connected with emulsifying agitator tank laminating, and the both sides of shock attenuation staple bolt all are provided with the lead screw hasp, the surface of platform frame is provided with spacing piece of supporting, emulsifying agitator tank's bottom is provided with the removal tray, and the removal tray passes through the draw-in groove with spacing piece of supporting and is connected.
Preferably, the top of emulsification agitator tank is provided with jar body closing cap, and jar body closing cap passes through flange joint with emulsification agitator tank, the inside of jar body closing cap is provided with the (mixing) shaft subassembly, and the surface of (mixing) shaft subassembly is provided with the protection shell cover, the (mixing) shaft subassembly includes transmission main shaft, first (mixing) shaft, second (mixing) shaft and scraper blade support axle, and transmission main shaft's top is provided with the reducing assembly, the reducing assembly passes through the driving pulley and rotates with the transmission case and be connected.
Preferably, the surface of transmission main shaft is provided with the gear, and the below of gear is provided with down the gear, the one end and the lower gear meshing rotation of second (mixing) shaft are connected, and the one end and the last gear meshing rotation of first (mixing) shaft are connected, the bottom of transmission main shaft is provided with and hangs the hanging scaffold, and first (mixing) shaft, second (mixing) shaft and scraper blade support axle all rotate with and be connected with hanging scaffold.
Preferably, the surface of first (mixing) shaft is provided with rotary-cut blade and vortex leaf, and the staggered mounting between rotary-cut blade and the vortex leaf, the scraper blade holds in the palm the axle and includes the scraper blade strut and hangs the link arm, and the scraper blade strut passes through the angle motor and hangs the link arm rotation and be connected, one side of scraper blade strut is provided with the inner wall scraper blade, and the inner wall scraper blade is connected with the emulsification agitator tank laminating.
Compared with the prior art, the invention has the beneficial effects that:
1. according to the invention, pimecrolimus can selectively inhibit the generation and release of inflammatory cytokines, can block the synthesis of immune cell inflammatory factors, and shows relatively strong anti-inflammatory activity after being locally used in cream, wherein the anti-inflammatory activity is equivalent to that of external cream of glucocorticoids, and is different from that of traditional corticoids, and pimecrolimus does not cause skin atrophy and other skin reactions related to hormones;
2. the stirring shaft assembly is formed by two groups of stirring shafts and one scraper supporting shaft, and in the emulsifying stirring process, the transmission main shaft is used for simultaneously driving the first stirring shaft and the second stirring shaft to stir raw materials, and the stirring effects achieved by the two groups of stirring shafts are different, so that the condition of uneven stirring of the raw materials can be avoided;
2. according to the invention, the transmission ratio of the upper gear and the lower gear is different, so that the rotation speeds achieved by the second stirring shaft and the first stirring shaft are different, the emulsion raw materials can be pulled back and forth by utilizing the differential speed, the agglomerated raw materials are prevented from being positioned in a gap dead angle area between the two stirring shafts, the rotary cutting blades and the turbulent flow blades are arranged on the outer surface of the first stirring shaft, the rotary cutting blades and the turbulent flow blades are arranged in a staggered manner, the cream is filtered by utilizing the self holes of the turbulent flow blades, the rotary cutting blades can crush the blocky structure in the cream, the cream is mixed into the cream again after the cream is intended, the contact area between the second stirring shaft and the cream is larger than that of the first stirring shaft, and the raw materials in the tank can be stirred and mixed rapidly through the second stirring shaft.
Drawings
FIG. 1 is an overall front view of the present invention;
FIG. 2 is a schematic view of the overall deployment structure of the present invention;
FIG. 3 is a schematic cross-sectional view of a stirring shaft assembly according to the present invention;
FIG. 4 is a schematic view of a stirring shaft assembly according to the present invention;
FIG. 5 is a schematic view of a first stirring shaft according to the present invention;
fig. 6 is a schematic view of a scraper supporting shaft structure according to the present invention.
In the figure: 1. a vacuum emulsification mixer; 2. a floor frame; 3. an emulsifying and stirring tank; 4. a stirring shaft assembly; 201. a lifting bracket; 202. a stirring platform; 203. a vacuum pump; 204. a driving motor; 205. a transmission case; 2011. damping anchor ear; 2012. a screw rod lock catch; 2013. limiting abutting blocks; 2021. a telescopic connecting rod; 301. moving the tray; 302. a can body cover; 401. a protective housing; 402. a first stirring shaft; 403. a second stirring shaft; 404. a scraper blade supporting shaft; 405. a transmission belt wheel; 406. hanging a hanging scaffold; 4021. a rotary cutting blade; 4022. turbulence leaves; 4041. a scraper blade bracket; 4042. an inner wall scraper; 4043. an angle motor; 4044. a suspension link arm; 4051. a deceleration assembly; 4052. a transmission main shaft; 4053. a top gear; 4054. and a lower gear.
Description of the embodiments
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Example 1: a cream for dermatitis comprises the following mixture of components in parts by weight: pimecrolimus 0.2g, oleyl alcohol 1.1g, medium chain triglyceride 1.6g, cetyl alcohol 0.5g, stearyl alcohol 0.5g, glyceryl monostearate 0.3g, propylene glycol 0.6g, sodium cetostearyl sulfate 0.2g, citric acid anhydride 0.006g, sodium hydroxide 0.003g, benzyl alcohol 0.4g, and purified water 5.5g.
A production process of a cream for dermatitis comprises the following steps:
step one: adding prescribed amounts of medium-chain triglyceride, oleyl alcohol, cetyl alcohol, stearyl alcohol, propylene glycol and glyceryl monostearate into a pretreatment pot B, starting stirring (960 rpm), adjusting the temperature of a jacket medium to heat the material to 75 ℃, and continuing stirring (960 rpm) for at least 30min until the visual solution is clear;
adding pimecrolimus raw material medicine into the pretreatment pot B, maintaining the material temperature, and stirring (960 rpm) for at least 2 hours until no insoluble matters are visible;
regulating the temperature of the jacket, and cooling the oil phase liquid medicine to 70 ℃ for standby;
step two: vacuum sucking 95% of purified water in the prescription amount in a vacuum emulsification mixer 1, and weighing 5% of purified water in the prescription amount to a stainless steel container for standby;
adding benzyl alcohol, anhydrous citric acid and sodium hydroxide with the prescribed amount into a vacuum emulsification mixer 1, washing benzyl alcohol and a sodium hydroxide container twice with purified water with the prescribed amount of 5% for later use, and adding the washing liquid into the vacuum emulsification mixer 1;
heating the aqueous solution to 70deg.C, setting stirring speed (25.0 rpm), and stirring for at least 10min until the solution is clear visually;
adding sodium cetylstearyl sulfate into the solution, maintaining the temperature of the material at 70deg.C, stirring at 25.0rpm, stirring for at least 30min until no insoluble substances are visible, and stopping stirring;
step three: regulating the temperature of the oil phase and the water phase to ensure that the temperature difference of the oil phase and the water phase is not more than 2 ℃, regulating the vacuum emulsifying mixer 1 to be under vacuum-0.05 MPa, setting stirring (25.0 rpm), passing the prepared oil phase solution through a filter provided with a stainless steel screen with 80 meshes, slowly adding the oil phase solution into the stirred water phase solution, mixing the two phases, and recovering normal pressure;
in the emulsification process, the temperature of a jacket medium is controlled, the temperature of the material is kept at 70 ℃, the stirring speed (25.0 rpm) is set, and the material is homogenized and emulsified for 10min at 3000.0+/-100.0 rpm; then stopping homogenizing, (25.0 rpm) stirring for 5min; maintaining stirring speed, homogenizing and emulsifying at 3000.0+ -100.0 rpm for 10min;
step four: setting stirring (15.0 rpm), regulating jacket medium temperature, cooling to 55deg.C, setting vacuum to-0.03 MPa, maintaining stirring until foam amount is stable, breaking vacuum, defoaming, repeating vacuum setting and breaking operation for 20min, or until foam amount is not increased, and cooling to 48deg.C;
vacuum regulating the vacuum emulsification mixer 1 to-0.03 Mpa, maintaining stirring (15.0 rpm), keeping the temperature of intermediate products at 48 ℃, temporarily storing the intermediate products in the vacuum emulsification mixer 1, and temporarily storing the intermediate products for no more than 24 hours;
step five: pressurizing the vacuum emulsifying stirrer 1 to 0.03Mpa, opening a bottom discharge port valve, transferring the intermediate product to the next procedure for continuous filling through a clean turnover container, and temporarily storing the material to be filled in the vacuum emulsifying stirrer 1.
Example 2: a cream for dermatitis comprises the following mixture of components in parts by weight: pimecrolimus 0.1g, oleyl alcohol 1.0g, medium chain triglyceride 1.6g, cetyl alcohol 0.4g, stearyl alcohol 0.4g, glyceryl monostearate 0.2g, propylene glycol 0.5g, sodium cetostearyl sulfate 0.2g, citric acid 0.005g, sodium hydroxide 0.002g, benzyl alcohol 0.1g, and purified water 5.5g.
A production process of a cream for dermatitis comprises the following steps:
step one: adding prescribed amounts of medium-chain triglyceride, oleyl alcohol, cetyl alcohol, stearyl alcohol, propylene glycol and glyceryl monostearate into a pretreatment pot B, starting stirring (960 rpm), adjusting the temperature of a jacket medium to heat the material to 75 ℃, and continuing stirring (960 rpm) for at least 30min until the visual solution is clear;
adding pimecrolimus raw material medicine into the pretreatment pot B, maintaining the material temperature, and stirring (960 rpm) for at least 2 hours until no insoluble matters are visible;
regulating the temperature of the jacket, and cooling the oil phase liquid medicine to 70 ℃ for standby;
step two: vacuum sucking 95% of purified water in the prescription amount in a vacuum emulsification mixer 1, and weighing 5% of purified water in the prescription amount to a stainless steel container for standby;
adding benzyl alcohol, anhydrous citric acid and sodium hydroxide with the prescribed amount into a vacuum emulsification mixer 1, and washing benzyl alcohol and a sodium hydroxide container twice with purified water with the prescribed amount of 2.5% for standby, wherein the washing liquid is added into the vacuum emulsification mixer 1;
heating the aqueous solution to 70deg.C, setting stirring speed (25.0 rpm), and stirring for at least 10min until the solution is clear visually;
adding sodium cetylstearyl sulfate into the solution, maintaining the temperature of the material at 70deg.C, stirring at 25.0rpm, stirring for at least 30min until no insoluble substances are visible, and stopping stirring;
step three: regulating the temperature of the oil phase and the water phase to ensure that the temperature difference of the oil phase and the water phase is not more than 2 ℃, regulating the vacuum emulsifying mixer 1 to be under vacuum-0.05 MPa, setting stirring (25.0 rpm), passing the prepared oil phase solution through a filter provided with a stainless steel screen with 80 meshes, slowly adding the oil phase solution into the stirred water phase solution, mixing the two phases, and recovering normal pressure;
in the emulsification process, the temperature of a jacket medium is controlled, the temperature of the material is kept at 70 ℃, the stirring speed (25.0 rpm) is set, and the material is homogenized and emulsified for 10min at 3000.0+/-100.0 rpm; then stopping homogenizing, (25.0 rpm) stirring for 5min; maintaining stirring speed, homogenizing and emulsifying at 3000.0+ -100.0 rpm for 10min;
step four: setting stirring (15.0 rpm), regulating jacket medium temperature, cooling to 55deg.C, setting vacuum to-0.03 MPa, maintaining stirring until foam amount is stable, breaking vacuum, defoaming, repeating vacuum setting and breaking operation for 20min, or until foam amount is not increased, and cooling to 48deg.C;
vacuum regulating the vacuum emulsification mixer 1 to-0.03 Mpa, maintaining stirring (15.0 rpm), keeping the temperature of intermediate products at 48 ℃, temporarily storing the intermediate products in the vacuum emulsification mixer 1, and temporarily storing the intermediate products for no more than 24 hours;
step five: pressurizing the vacuum emulsifying stirrer 1 to 0.03Mpa, opening a bottom discharge port valve, transferring the intermediate product to the next procedure for continuous filling through a clean turnover container, and temporarily storing the material to be filled in the vacuum emulsifying stirrer 1.
Example 3: a cream for dermatitis comprises the following mixture of components in parts by weight: pimecrolimus 0.1g, oleyl alcohol 1.0g, medium chain triglyceride 1.5g, cetyl alcohol 0.4g, stearyl alcohol 0.4g, glyceryl monostearate 0.2g, propylene glycol 0.5g, sodium cetostearyl sulfate 0.1g, citric acid 0.005g, sodium hydroxide 0.002g, benzyl alcohol 0.1g, and purified water 5.7g.
A production process of a cream for dermatitis comprises the following steps:
step one: adding prescribed amounts of medium-chain triglyceride, oleyl alcohol, cetyl alcohol, stearyl alcohol, propylene glycol and glyceryl monostearate into a pretreatment pot B, starting stirring (960 rpm), adjusting the temperature of a jacket medium to heat the material to 75 ℃, and continuing stirring (960 rpm) for at least 30min until the visual solution is clear;
adding pimecrolimus raw material medicine into the pretreatment pot B, maintaining the material temperature, and stirring (960 rpm) for at least 2 hours until no insoluble matters are visible;
regulating the temperature of the jacket, and cooling the oil phase liquid medicine to 70 ℃ for standby;
step two: vacuum sucking 95% of purified water in the prescription amount in a vacuum emulsification mixer 1, and weighing 5% of purified water in the prescription amount to a stainless steel container for standby;
adding benzyl alcohol, anhydrous citric acid and sodium hydroxide with the prescribed amount into a vacuum emulsification mixer 1, washing benzyl alcohol and a sodium hydroxide container twice with purified water with the prescribed amount of 5% for later use, and adding the washing liquid into the vacuum emulsification mixer 1;
heating the aqueous solution to 70deg.C, setting stirring speed (25.0 rpm), and stirring for at least 10min until the solution is clear visually;
adding sodium cetylstearyl sulfate into the solution, maintaining the temperature of the material at 70deg.C, stirring at 25.0rpm, stirring for at least 30min until no insoluble substances are visible, and stopping stirring;
step three: regulating the temperature of the oil phase and the water phase to ensure that the temperature difference of the oil phase and the water phase is not more than 2 ℃, regulating the vacuum emulsifying mixer 1 to be under vacuum-0.05 MPa, setting stirring (25.0 rpm), passing the prepared oil phase solution through a filter provided with a stainless steel screen with 80 meshes, slowly adding the oil phase solution into the stirred water phase solution, mixing the two phases, and recovering normal pressure;
in the emulsification process, the temperature of a jacket medium is controlled, the temperature of the material is kept at 70 ℃, the stirring speed (25.0 rpm) is set, and the material is homogenized and emulsified for 10min at 3000.0+/-100.0 rpm; then stopping homogenizing, (25.0 rpm) stirring for 5min; maintaining stirring speed, homogenizing and emulsifying at 3000.0+ -100.0 rpm for 10min;
step four: setting stirring (15.0 rpm), regulating jacket medium temperature, cooling to 55deg.C, setting vacuum to-0.03 MPa, maintaining stirring until foam amount is stable, breaking vacuum, defoaming, repeating vacuum setting and breaking operation for 20min, or until foam amount is not increased, and cooling to 48deg.C;
vacuum regulating the vacuum emulsification mixer 1 to-0.03 Mpa, maintaining stirring (15.0 rpm), keeping the temperature of intermediate products at 48 ℃, temporarily storing the intermediate products in the vacuum emulsification mixer 1, and temporarily storing the intermediate products for no more than 24 hours;
step five: pressurizing the vacuum emulsifying stirrer 1 to 0.03Mpa, opening a bottom discharge port valve, transferring the intermediate product to the next procedure for continuous filling through a clean turnover container, and temporarily storing the material to be filled in the vacuum emulsifying stirrer 1.
The following table is prepared with reference to examples 1-3:
from the above table, the preparation scheme used in example 1 has short treatment course in actual use and no obvious side effect during treatment.
In order to solve the problems of caking and uneven stirring existing in the process of stirring the emulsion raw materials by the existing emulsion stirrer, referring to fig. 1-3, the embodiment provides the following technical scheme:
a production facility of cream for dermatitis comprises a vacuum emulsification mixer 1, wherein the vacuum emulsification mixer 1 comprises a platform frame 2, an emulsification stirring tank 3 and a stirring shaft assembly 4, raw materials required for preparing cream are poured into the emulsification stirring tank 3, then the emulsification stirring tank 3 is moved below the stirring shaft assembly 4, the stirring shaft assembly 4 is controlled to descend through lifting brackets 201 on two sides of the platform frame 2, the stirring shaft assembly 4 enters the emulsification stirring tank 3, a stirring platform 202 is arranged above the platform frame 2, the stirring platform 202 is connected with the platform frame 2 through the lifting brackets 201, one end of the inside of the stirring platform 202 is provided with a vacuum pump 203, the vacuum pump 203 can pump air in the tank, the other end of the inside of the stirring platform 202 is provided with a driving motor 204, one side of the driving motor 204 is provided with a transmission box 205, the inside of the lifting support 201 is provided with a telescopic connecting rod 2021, one side of the middle section of the lifting support 201 is provided with a damping hoop 2011, the damping hoop 2011 is in fit connection with the emulsifying stirring tank 3, both sides of the damping hoop 2011 are provided with screw rod lock catches 2012, the emulsifying stirring tank 3 can be locked and fixed through the screw rod lock catches 2012, the emulsifying stirring tank 3 is fixed on the platform frame 2, the situation that the tank body shifts and slides in the stirring process is avoided, the outer surface of the platform frame 2 is provided with a limiting abutting block 2013, the bottom of the emulsifying stirring tank 3 is provided with a movable tray 301, the movable tray 301 is connected with the limiting abutting block 2013 through a clamping groove, the movable tray 301 can realize the movable operation of the emulsifying stirring tank 3, and meanwhile, the positioning of the tank body can be carried out by matching with the limiting abutting block 2013 on the surface of the platform frame 2 so as to ensure that the stirring shaft assembly 4 can be accurately abutted with the emulsifying stirring tank 3, the emulsification stirring tank 3 is provided with a tank body sealing cover 302 above, the tank body sealing cover 302 is connected with the emulsification stirring tank 3 through a flange, a stirring shaft assembly 4 is arranged in the tank body sealing cover 302, a protective housing 401 is arranged on the outer surface of the stirring shaft assembly 4, the stirring shaft assembly 4 comprises a transmission main shaft 4052, a first stirring shaft 402, a second stirring shaft 403 and a scraper supporting shaft 404, a speed reducing assembly 4051 is arranged at the top of the transmission main shaft 4052, the speed reducing assembly 4051 is rotationally connected with a transmission box 205 through a transmission belt pulley 405, the stirring shaft assembly 4 is formed by two groups of stirring shafts and one scraper supporting shaft 404, in the emulsification stirring process, the first stirring shaft 402 and the second stirring shaft 403 are simultaneously driven by the transmission main shaft 4052 to stir raw materials, and stirring effects achieved by the two groups of stirring shafts are different, so that uneven stirring of the raw materials can be avoided.
In order to solve the technical problem that in the prior art, wall sticking and caking easily occur when stirring raw materials, please refer to fig. 3-5, the present embodiment provides the following technical scheme:
the outer surface of the transmission main shaft 4052 is provided with an upper gear 4053, a lower gear 4054 is arranged below the upper gear 4053, one end of a second stirring shaft 403 is in meshed rotation connection with the lower gear 4054, one end of a first stirring shaft 402 is in meshed rotation connection with the upper gear 4053, the transmission ratio of the upper gear 4053 to the lower gear 4054 is different, thus the rotation speeds reached by the second stirring shaft 403 and the first stirring shaft 402 during stirring are different, a front-back pulling can be formed on the emulsion raw material by utilizing the differential speed, the agglomeration and caking raw material is prevented from being positioned in a gap dead angle area between the two stirring shafts, a hanging disc 406 is arranged at the bottom of the transmission main shaft 4052, the first stirring shaft 402, the second stirring shaft 403 and the scraping plate supporting shaft 404 are all in rotary connection with the hanging disc 406, the outer surface of the first stirring shaft 402 is provided with a rotary cutting blade 4021 and a turbulent blade 4022, the rotary cutting blade 4021 and the turbulent blade 4022 are arranged in a staggered manner, the turbulence blade 4022 utilizes the self holes to rotationally filter the cream, the rotary cutting blade 4021 can crush the block structure in the cream and mix the block structure into the cream again after the operation, the contact area between the second stirring shaft 403 and the cream is larger than that of the first stirring shaft 402, the raw materials in the tank body can be rapidly stirred and mixed through the second stirring shaft 403, the scraper support shaft 404 comprises a scraper support 4041 and a suspension link 4044, the scraper support 4041 is rotationally connected with the suspension link 4044 through an angle motor 4043, one side of the scraper support 4041 is provided with an inner wall scraper 4042, the inner wall scraper 4042 is in fit connection with the emulsifying stirring tank 3, the scraper support shaft 404 can clean the inside of the tank body by means of the inner wall scraper 4042, a large amount of raw materials are prevented from being stuck on the inner wall of the tank body, the angle motor 4043 can adjust the angle of the inner wall scraper 4042, the gap distance between the scraper and the tank can be controlled by the angular adjustment of the inner wall scraper 4042.
It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made therein without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (8)
1. A cream for dermatitis, which is characterized by comprising the following mixture of components in parts by weight: pimecrolimus 0.1-0.2g, oleyl alcohol 1.0-1.1g, medium chain triglyceride 1.5-1.6g, cetyl alcohol 0.4-0.5g, stearyl alcohol 0.4-0.5g, glyceryl monostearate 0.2-0.3g, propylene glycol 0.5-0.6g, sodium cetostearyl sulfate 0.1-0.2g, anhydrous citric acid 0.005-0.006g, sodium hydroxide 0.002-0.003g, benzyl alcohol 0.1-0.2g, and purified water 5.5-5.7g.
2. A production process of a cream for dermatitis, which is realized based on the cream for dermatitis as claimed in claim 1, wherein the production process comprises the following steps:
step one: adding prescribed amounts of medium-chain triglyceride, oleyl alcohol, cetyl alcohol, stearyl alcohol, propylene glycol and glyceryl monostearate into a pretreatment pot B, starting stirring at 900-960rpm, adjusting the temperature of a jacket medium to heat the material to 70-80 ℃, and continuing stirring at 900-960rpm for at least 30min until the visual solution is clear;
adding pimecrolimus raw material medicine into the pretreatment pot B, maintaining the material temperature, and stirring at 900-960rpm for at least 2 hours until no insoluble matters are visible;
regulating the temperature of the jacket, and cooling the oil phase liquid medicine to 65-75 ℃ for standby;
step two: the purified water with the prescription amount of 95% is sucked into the vacuum emulsification mixer (1) in vacuum, and the purified water with the prescription amount of 5% is weighed to a stainless steel container for standby;
adding benzyl alcohol, anhydrous citric acid and sodium hydroxide with the prescribed amount into a vacuum emulsification mixer (1), and washing benzyl alcohol and a sodium hydroxide container twice with purified water with the prescribed amount of 5% for standby, wherein the washing liquid is added into the vacuum emulsification mixer (1);
heating the aqueous phase solution to 65-75 ℃, setting stirring speed to 20.0-25.0 rpm, and stirring for at least 10min until the solution is clear visually;
step three: regulating the temperature of the oil phase and the water phase to ensure that the temperature difference of the oil phase and the water phase is not more than 2 ℃, regulating the vacuum of a vacuum emulsification mixer (1) to be between-0.04 and-0.07 MPa, setting stirring at 20.0-25.0 rpm, slowly adding the prepared oil phase solution into the water phase solution in stirring through a filter with a stainless steel screen of 80 meshes, and recovering normal pressure after mixing the two phases;
in the emulsification process, the temperature of a jacket medium is controlled, the temperature of the materials is kept at 65-75 ℃, the stirring speed is set at 20.0-25.0 rpm, and the materials are homogenized and emulsified for 10min at 3000.0+/-100.0 rpm; then stopping homogenizing, and stirring for 5min at 20.0-25.0 rpm; maintaining stirring speed, homogenizing and emulsifying at 3000.0+ -100.0 rpm for 10min;
step four: setting stirring at 10.0-15.0 rpm, regulating jacket medium temperature, cooling to 53-57 ℃, setting vacuum at-0.02 to-0.06 MPa, maintaining stirring until the foam amount is stable, breaking vacuum and defoaming, repeatedly setting vacuum and breaking vacuum operation for 20min, or until the foam amount is not increased any more, and cooling to 45-50 ℃;
vacuum regulating the vacuum in the vacuum emulsification mixer (1) to-0.02 to-0.06 Mpa, maintaining stirring at 10.0-15.0 rpm, keeping the temperature of the intermediate product at 45-50 ℃, temporarily storing the intermediate product in the vacuum emulsification mixer (1), and temporarily storing the intermediate product for no more than 24 hours;
step five: pressurizing the vacuum emulsifying mixer (1) to 0.02-0.05 Mpa, opening a bottom discharge outlet valve, transferring the intermediate product to the next procedure for continuous filling through a clean turnover container, and temporarily storing the material to be filled in the vacuum emulsifying mixer (1).
3. The production process of the cream for dermatitis as claimed in claim 2, wherein: in the second step, sodium cetylstearyl sulfate is added into the solution, the temperature of the material is maintained at 65-75 ℃, the stirring speed is 20.0-25.0 rpm, and the stirring is stopped until the solution is visually free of insoluble substances for at least 30 min.
4. A production facility of cream for dermatitis, which is applied to the production process of the cream for dermatitis as claimed in claim 2, and is characterized in that: including vacuum emulsification mixer (1), vacuum emulsification mixer (1) include platform frame (2), emulsification agitator tank (3) and (mixing) shaft subassembly (4), the top of platform frame (2) is provided with stirring platform (202), is connected through elevating bracket (201) between stirring platform (202) and platform frame (2), the inside one end of stirring platform (202) is provided with vacuum pump (203), and the inside other end of stirring platform (202) is provided with driving motor (204), one side of driving motor (204) is provided with transmission case (205).
5. The production facility of a cream for dermatitis as claimed in claim 4, wherein: the inside of lifting support (201) is provided with flexible connecting rod (2021), and one side in lifting support (201) middle section is provided with shock attenuation staple bolt (2011), shock attenuation staple bolt (2011) are connected with emulsification agitator tank (3) laminating, and the both sides of shock attenuation staple bolt (2011) all are provided with lead screw hasp (2012), the surface of platform frame (2) is provided with spacing piece (2013) that support, the bottom of emulsification agitator tank (3) is provided with movable tray (301), and movable tray (301) are connected through the draw-in groove with spacing piece (2013).
6. The production facility of a cream for dermatitis as claimed in claim 5, wherein: the emulsification agitator tank (3) top is provided with jar body closing cap (302), and jar body closing cap (302) passes through flange joint with emulsification agitator tank (3), the inside of jar body closing cap (302) is provided with (mixing) shaft subassembly (4), and the surface of (mixing) shaft subassembly (4) is provided with protection shell (401), (mixing) shaft subassembly (4) are including transmission main shaft (4052), first (mixing) shaft (402), second (mixing) shaft (403) and scraper blade hold in the palm axle (404), and the top of transmission main shaft (4052) is provided with speed reduction subassembly (4051), speed reduction subassembly (4051) are connected with transmission case (205) rotation through driving pulley (405).
7. The production apparatus of dermatitis cream as claimed in claim 6, wherein: the outer surface of transmission main shaft (4052) is provided with gear (4053), and the below of gear (4053) is provided with gear (4054) down, the one end and the lower gear (4054) meshing rotation of second (403) stirring axle are connected, and the one end and the last gear (4053) meshing rotation of first (402) stirring axle are connected, the bottom of transmission main shaft (4052) is provided with suspension hanging scaffold (406), and first (402), second (403) stirring axle and scraper blade holds in the palm axle (404) all with hang hanging scaffold (406) rotation and be connected.
8. The production apparatus of dermatitis cream as claimed in claim 7, wherein: the external surface of first (402) stirring axle is provided with rotary-cut blade (4021) and vortex leaf (4022), and staggered installation between rotary-cut blade (4021) and the vortex leaf (4022), scraper blade holds in palm axle (404) including scraper blade strut (4041) and suspension link arm (4044), and scraper blade strut (4041) are connected with suspension link arm (4044) rotation through angle motor (4043), one side of scraper blade strut (4041) is provided with inner wall scraper blade (4042), and inner wall scraper blade (4042) are connected with emulsion agitator tank (3) laminating.
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