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HRP20200859T1 - Meke kapsule kalcifediola - Google Patents

Meke kapsule kalcifediola Download PDF

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Publication number
HRP20200859T1
HRP20200859T1 HRP20200859TT HRP20200859T HRP20200859T1 HR P20200859 T1 HRP20200859 T1 HR P20200859T1 HR P20200859T T HRP20200859T T HR P20200859TT HR P20200859 T HRP20200859 T HR P20200859T HR P20200859 T1 HRP20200859 T1 HR P20200859T1
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Croatia
Prior art keywords
soft capsule
pharmaceutically acceptable
pharmaceutical composition
once
mixtures
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HRP20200859TT
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English (en)
Inventor
Josep María SUÑÉ NEGRE
Ignacio Ortega Azpitarte
Pepa Del Arenal Barrios
Gonzalo HERNÁNDEZ HERRERO
Original Assignee
Faes Farma, S.A.
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Application filed by Faes Farma, S.A. filed Critical Faes Farma, S.A.
Publication of HRP20200859T1 publication Critical patent/HRP20200859T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/59Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/5939,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/662Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
    • A61K31/663Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833Encapsulating processes; Filling of capsules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/485Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/18Drugs for disorders of the endocrine system of the parathyroid hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Diabetes (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nutrition Science (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Urology & Nephrology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Carbon And Carbon Compounds (AREA)
  • Lubricants (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Paints Or Removers (AREA)
  • Manufacturing Of Micro-Capsules (AREA)

Claims (14)

1. Meka kapsula koja sadrži: a) omotač meke kapsule, pri čemu omotač meke kapsule sadrži: - 40 do 80 mas.% želatine, - 10 do 50 mas.% plastifikatora koji je izabran iz grupe koja se sastoji od glicerola, sorbitola, propilen glikola, polietilen glikola, dibutil sebakata, dietil ftalata, dimetil ftalata, triacetina, tributil citrata, trietil citrata, i njihovih smjesa, količine po masi su izražene u odnosu na ukupnu masu omotača meke kapsule; i b) farmaceutski sastav koji sadrži: - kalcifediol, - uljnu komponentu izabranu iz grupe koja se sastoji od triglicerida srednjeg lanca, izopropil miristrata, C14-C18 alkil alkohola, C14-C18 alkenil alkohola, lanolin alkohola i njihovih smjesa, i - farmaceutski prihvatljivo organsko otapalo izabrano iz grupe koja se sastoji od etanola, izopropanola, propilen glikola, polietilen glikola, benzil alkohola i njihovih smjesa, pri čemu omotač meke kapsule inkapsulira farmaceutski sastav i gdje spomenuti farmaceutski sastav je lišen voska.
2. Meka kapsula prema zahtjevu 1, pri čemu farmaceutska formulacija sadrži: - 0,001 do 0,2 mas.% kalcifediola, - 80 do 99,9 mas.% uljne komponente, i - 0,3 do 6 mas.% farmaceutski prihvatljivog organskog otapala; količine po masi su izražene u odnosu na ukupnu masu kalcifediola, uljne komponente i farmaceutski prihvatljivog organskog otapala prisutnih u farmaceutskom sastavu.
3. Meka kapsula prema bilo kojem od prethodnih zahtjeva, gdje je uljna komponenta izabrana iz grupe koja se sastoji od triglicerida srednjeg lanca, izopropil miristrata, C14-C18 alkenil alkohola, i njihovih smjesa.
4. Meka kapsula prema bilo kojem od prethodnih zahtjeva, gdje je uljna komponenta triglicerid srednjeg lanca, poželjno kaprilni/kaprinski triglicerid , i/ili gdje je farmaceutski prihvatljivo organsko otapalo izabrano iz grupe koja se sastoji od etanola, izopropanola, propilen glikola, polietilen glikola i njihovih smjesa, poželjno etanola.
5. Meka kapsula prema bilo kojem od prethodnih zahtjeva, koja je lišena surfaktanata.
6. Meka kapsula prema bilo kojem od prethodnih zahtjeva, pri čemu farmaceutski sastav dalje sadrži kalcij ili njegov farmaceutski prihvatljiv derivat.
7. Meka kapsula prema bilo kojem od prethodnih zahtjeva, pri čemu farmaceutski sastav dalje sadrži željezo ili njegov farmaceutski prihvatljiv derivat, vitamin B12, vitamin B9, levomefolnu kiselinu ili njenu farmaceutski prihvatljivu sol, i/ili esencijalnu nezasićenu masnu kiselinu, ili njihove smjese.
8. Meka kapsula prema bilo kojem od prethodnih zahtjeva, pri čemu farmaceutski sastav dalje sadrži bisfosfonat.
9. Meka kapsula prema bilo kojem od prethodnih zahtjeva, pri čemu omotač meke kapsule dalje sadrži farmaceutski prihvatljivo sredstvo za zamućivanje i/ili farmaceutski prihvatljivo sredstvo za bojenje.
10. Meka kapsula prema bilo kojem od prethodnih zahtjeva koja sadrži od 200 do 180000 IU kalcifediola.
11. Meka kapsula kako je definirano u bilo kojem od prethodnih zahtjeva za upotrebu u medicini.
12. Meka kapsula kako je definirano u bilo kojem od zahtjeva od 1 do 10 za upotrebu u liječenju i/ili spriječavanju bolesti izabrane iz grupe koja se sastoji od nedostatka vitamina D, demineralizacije kao što je hipokalcemija i hipofosfatemija, bubrežne osteodistrofije, rahitisa, osteoporoze, osteopenije, osteoartritisa, osteoartroze, osteomalacije, hipoparatireoidizma, i upalne bolesti crijeva.
13. Meka kapsula za upotrebu prema zahtjevu 12, pri čemu je meka kapsula za primjenu jednom svaka tri mjeseca, jednom svaka dva mjeseca, jednom mjesečno, jednom svaka tri tjedna, jednom svaka dva tjedna, jednom tjedno, ili jednom dnevno.
14. Postupak za pripremanje meke kapsule kao što je definirano u bilo kojem od zahtjeva 1 do 10, pri čemu spomenuti postupak sadrži: a) pripremanje smjese koja sadrži kalcifediol; uljnu komponentu; i farmaceutski prihvatljivo organsko otapalo; i opcionalno kalcij ili njegov farmaceutski prihvatljiv derivat, željezo ili njegov farmaceutski prihvatljiv derivat, vitamin B12, vitamin B9, levomefolnu kiselinu ili njenu farmaceutski prihvatljivu sol, esencijalnu nezasićenu masnu kiselinu i/ili bisfosfonat; b) pripremanje smjese koja sadrži želatinu; plastifikator; vodu; i opcionalno farmaceutski prihvatljivo sredstvo za zamućivanje i/ili farmaceutski prihvatljivo sredstvo za bojenje; c) stvaranje omotača iz smjese iz koraka b); d) punjenje omotača sa smjesom iz koraka a), i e) sušenje kapsule dobivene u koraku d).
HRP20200859TT 2015-02-06 2020-05-28 Meke kapsule kalcifediola HRP20200859T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15382042.8A EP3053598A1 (en) 2015-02-06 2015-02-06 Calcifediol soft capsules
PCT/EP2016/052458 WO2016124724A1 (en) 2015-02-06 2016-02-05 Calcifediol soft capsules
EP16702960.2A EP3204047B1 (en) 2015-02-06 2016-02-05 Calcifediol soft capsules

Publications (1)

Publication Number Publication Date
HRP20200859T1 true HRP20200859T1 (hr) 2020-08-21

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HRP20200859TT HRP20200859T1 (hr) 2015-02-06 2020-05-28 Meke kapsule kalcifediola

Country Status (31)

Country Link
US (1) US10525018B2 (hr)
EP (3) EP3053598A1 (hr)
JP (2) JP6427270B2 (hr)
KR (1) KR101971384B1 (hr)
CN (2) CN112843014A (hr)
AU (1) AU2016214336B2 (hr)
BR (1) BR112017010657B1 (hr)
CA (1) CA2967170C (hr)
CL (1) CL2017001335A1 (hr)
CO (1) CO2017004545A2 (hr)
CY (1) CY1122976T1 (hr)
DK (2) DK3689380T3 (hr)
EA (1) EA034821B1 (hr)
ES (2) ES2941385T3 (hr)
HR (1) HRP20200859T1 (hr)
HU (1) HUE050133T2 (hr)
LT (1) LT3204047T (hr)
MA (2) MA52507A (hr)
MD (1) MD3204047T2 (hr)
ME (1) ME03739B (hr)
MX (1) MX367999B (hr)
MY (2) MY189432A (hr)
PE (1) PE20170911A1 (hr)
PH (1) PH12017501350A1 (hr)
PL (1) PL3204047T3 (hr)
PT (1) PT3204047T (hr)
RS (2) RS60467B1 (hr)
SI (1) SI3204047T1 (hr)
SM (1) SMT202000278T1 (hr)
WO (1) WO2016124724A1 (hr)
ZA (1) ZA201703444B (hr)

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EP3053598A1 (en) 2015-02-06 2016-08-10 Faes Farma, S.A. Calcifediol soft capsules
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CR20210158A (es) 2018-08-31 2021-05-21 Opko Ireland Global Holdings Ltd Formas de dosificación pediátricas de vitamina d, métodos de elaboración y uso
CN109662953B (zh) * 2019-02-18 2022-05-10 威海金思力生物科技股份有限公司 一种维生素d软胶囊及其制作方法
WO2021011538A1 (en) * 2019-07-15 2021-01-21 R.P. Scherer Technologies, Llc Capsule dosage forms, methods of preparation and methods of use thereof
EP4081221A1 (en) * 2019-08-22 2022-11-02 Industrial Technologies & Biotechnologies Hormone d (vitamin d) and its derivatives for the treatment and prevention of cancer
CN113559079B (zh) * 2020-04-28 2023-10-20 江苏恒瑞医药股份有限公司 一种软胶囊及其制备方法和用途
CA3198547A1 (en) * 2020-11-16 2022-05-19 Mark RIDALL Rapidly infusing platform and compositions for therapeutic treatment in humans
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WO2022224001A1 (en) 2021-04-22 2022-10-27 Faes Farma, S.A. Universal dosage regime of 25-hydroxy vitamin d3
CN114159402A (zh) * 2021-12-21 2022-03-11 湖州展望天明药业有限公司 一种不透明植物胶囊及其制备方法
CN116350598A (zh) * 2021-12-28 2023-06-30 人福普克药业(武汉)有限公司 一种用于维生素d类药物的成膜组合物及其药物制剂和制备方法
CN114712505B (zh) * 2022-03-10 2023-09-05 南方医科大学南方医院 维生素d受体激动剂在制备预防和/或治疗炎症性骨丢失的药物中的应用
WO2024129811A1 (en) * 2022-12-14 2024-06-20 R.P. Scherer Technologies, Llc Softgel capsules and a method for preparing the softgel capsules
CN116270520A (zh) * 2023-03-03 2023-06-23 正大制药(青岛)有限公司 一种维生素d胶囊型滴剂及其制备方法

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