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DK2444068T4 - Brimonidingelsammensætning - Google Patents

Brimonidingelsammensætning Download PDF

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Publication number
DK2444068T4
DK2444068T4 DK11185810.6T DK11185810T DK2444068T4 DK 2444068 T4 DK2444068 T4 DK 2444068T4 DK 11185810 T DK11185810 T DK 11185810T DK 2444068 T4 DK2444068 T4 DK 2444068T4
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DK
Denmark
Prior art keywords
topical gel
gel composition
skin
carbomer
methylparaben
Prior art date
Application number
DK11185810.6T
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English (en)
Other versions
DK2444068T3 (da
Inventor
Cyril Meunier
Jean-Christophe Buge
Fourcade Karine Nadau
Original Assignee
Galderma Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=44789371&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2444068(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from FR1058612A external-priority patent/FR2966366B1/fr
Application filed by Galderma Sa filed Critical Galderma Sa
Application granted granted Critical
Publication of DK2444068T3 publication Critical patent/DK2444068T3/da
Publication of DK2444068T4 publication Critical patent/DK2444068T4/da

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/235—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/498—Pyrazines or piperazines ortho- and peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/08—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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/29—Titanium; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/345—Alcohols containing more than one hydroxy group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/37—Esters of carboxylic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/494—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with more than one nitrogen as the only hetero atom
    • A61K8/4946—Imidazoles or their condensed derivatives, e.g. benzimidazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
    • A61K8/8141—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by only one carboxyl radical, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
    • A61K8/8147—Homopolymers or copolymers of acids; Metal or ammonium salts thereof, e.g. crotonic acid, (meth)acrylic acid; Compositions of derivatives of such polymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/84—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions otherwise than those involving only carbon-carbon unsaturated bonds
    • A61K8/86—Polyethers
    • 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
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • 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
    • A61P17/10—Anti-acne agents
    • 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
    • A61P17/16—Emollients or protectives, e.g. against radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/08—Anti-ageing preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/59—Mixtures
    • A61K2800/592—Mixtures of compounds complementing their respective functions
    • A61K2800/5922—At least two compounds being classified in the same subclass of A61K8/18
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/59—Mixtures
    • A61K2800/594—Mixtures of polymers

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  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Birds (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gerontology & Geriatric Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Toxicology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cosmetics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Colloid Chemistry (AREA)

Claims (8)

1. Topisk gelsammensætning, der omfatter: 0,05 til 5 % (vægt/vægt) brimonidin eller brimonidintartrat; 0,05 til 0,20 % (vægt/vægt) af konserveringsmidlet, methylparaben; 0,3 til 0,5 % (vægt/vægt) af det yderligere konserveringsmiddel, phenoxyethanol; 0,80 til 1,50 % (vægt/vægt) af en carbomer og 9,0 til 13,0 % (vægt/vægt) total polyol; hvor den topiske gelsammensætning har et pH på 4,5 til 7,5, og hvor, når koncentrationen af methylparaben er højere end 0,15 % (vægt/vægt), koncentrationen af carbomer er mindre end 1,25 % (vægt/vægt).
2. Topisk gelsammensætning ifølge krav 1, hvor den totale polyol omfatter ca. 4,5 % til 6,5 % (vægt/vægt) af en første polyol.
3. Topisk gelsammensætning ifølge krav 1, hvor carbomeren er udvalgt fra gruppen, der består af carbomer® 934P (syntetisk polymer af acrylsyre, der er tværbundet med polyalkenylethere eller divinylglycol), Carbopol® 974P (syntetisk polymer af acrylsyre, der er tværbundet med polyalkenylethere eller divinylglycol) og Carbopol® 980 (syntetisk polymer af acrylsyre, der er tværbundet med polyalkenylethere eller divinylglycol).
4. Topisk gelsammensætning ifølge krav 1, hvor sammensætningen omfatter: 0,1 til 0,6 % (vægt/vægt) brimonidintartrat; 0,05 til 0,15 % (vægt/vægt) methylparaben; 0,80 til 1,50 % (vægt/vægt) carbomer; 4.5 til 6,5 % (vægt/vægt) propylenglycol; 4.5 til 6,5 % (vægt/vægt) glycerol og oprenset vand; hvor den topiske gelsammensætnings pH er justeret til 5,0 til 6,5 med en passende mængde vandig natriumhydroxidopløsning.
5. Topisk gelsammensætning ifølge krav 4, hvor sammensætningen omfatter mere end 0,3 (vægt/vægt) phenoxyethanol.
6. Topisk gelsammensætning ifølge krav 1 eller krav 5, der endvidere omfatter 0,04 til 0,08 % (vægt/vægt) af en vanddispergerbar form af titandioxid.
7. Topisk gelsammensætning ifølge et hvilket som helst af kravene 1-6 til anvendelse i behandling eller forebyggelse af en hudforstyrrelse hos et individ, hvor sammensætningen er beregnet til topisk påføring på et hudområde hos det individ, som er eller har tendens til at blive ramt af hudforstyrrelsen.
8. Topisk gelsammensætning til anvendelse ifølge krav 7, hvor hudforstyrrelsen er rosacea, rosacea med erytem, telangiektasi, psoriasis, purpura, akne med erytem, eksem, ikke-rosacea-relateret hudinflammation, rødmen, slap hud, hudfolder og/eller rynker eller et symptom, der er forbundet dermed.
DK11185810.6T 2010-10-21 2011-10-19 Brimonidingelsammensætning DK2444068T4 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US40538810P 2010-10-21 2010-10-21
FR1058612A FR2966366B1 (fr) 2010-10-21 2010-10-21 Composition de gel de brimonidine

Publications (2)

Publication Number Publication Date
DK2444068T3 DK2444068T3 (da) 2014-09-15
DK2444068T4 true DK2444068T4 (da) 2018-03-05

Family

ID=44789371

Family Applications (1)

Application Number Title Priority Date Filing Date
DK11185810.6T DK2444068T4 (da) 2010-10-21 2011-10-19 Brimonidingelsammensætning

Country Status (26)

Country Link
US (2) US20130261126A1 (da)
EP (2) EP2444068B2 (da)
JP (2) JP2013540143A (da)
KR (1) KR101506102B1 (da)
CN (1) CN103298451B (da)
AR (1) AR083651A1 (da)
AU (1) AU2011317554B2 (da)
BR (1) BR112013009578B1 (da)
CA (1) CA2814952C (da)
DK (1) DK2444068T4 (da)
ES (1) ES2498217T5 (da)
HR (1) HRP20140811T1 (da)
IL (2) IL225760A (da)
MX (2) MX354697B (da)
NO (1) NO2444068T3 (da)
NZ (1) NZ610121A (da)
PH (1) PH12013500738A1 (da)
PL (1) PL2444068T5 (da)
PT (1) PT2444068E (da)
RS (1) RS53531B1 (da)
RU (1) RU2571277C2 (da)
SG (1) SG189896A1 (da)
SI (1) SI2444068T1 (da)
SM (1) SMT201400156B (da)
WO (1) WO2012052479A2 (da)
ZA (2) ZA201302859B (da)

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CN104666239A (zh) * 2013-11-27 2015-06-03 杭州赛利药物研究所有限公司 酒石酸溴莫尼定凝胶及其制备方法
CN103919717A (zh) * 2014-04-15 2014-07-16 天津中医药大学 一种酒石酸溴莫尼定眼用凝胶制剂及其制备方法和用途
KR20160037791A (ko) * 2014-09-29 2016-04-06 (주)네오팜 건성 치료용 산성 외용제 조성물
EP3506906A4 (en) * 2016-08-31 2020-08-12 Taro Pharmaceutical Industries Ltd. TOPICAL FORMULATIONS OF FENOLDOPAM FOR THE TREATMENT OF SKIN DISORDERS
US11278548B2 (en) 2017-07-14 2022-03-22 Galderma Research And Development Methods and compositions for reducing side effects in chemotherapeutic treatments
CN108126186B (zh) * 2017-12-28 2021-10-29 未名生物医药有限公司 一种含神经生长因子的水凝胶及其制备方法
MX2021010058A (es) * 2019-02-20 2021-11-12 Ai Therapeutics Inc Formulaciones de rapamicina tópicas y su uso en el tratamiento de angiofibromas faciales y otros trastornos de la piel.
WO2020183322A1 (en) 2019-03-08 2020-09-17 Taro Pharmaceutical Industries Ltd. Stable topical compositions of fenoldopam
WO2020222192A1 (en) * 2019-05-01 2020-11-05 Clexio Biosciences Ltd. Methods of treating pruritus
CN113784712A (zh) 2019-05-01 2021-12-10 克雷西奥生物科技有限公司 治疗瘙痒的方法
CN116159018B (zh) * 2023-03-01 2024-11-01 中国药科大学 一种新型外用溴莫尼定凝胶剂

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