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KR910019607A - Process for preparing long-lived cephalexin granules - Google Patents

Process for preparing long-lived cephalexin granules Download PDF

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Publication number
KR910019607A
KR910019607A KR1019910004839A KR910004839A KR910019607A KR 910019607 A KR910019607 A KR 910019607A KR 1019910004839 A KR1019910004839 A KR 1019910004839A KR 910004839 A KR910004839 A KR 910004839A KR 910019607 A KR910019607 A KR 910019607A
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South Korea
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cephalexin
weight
granules
mixture
coating
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KR930006433B1 (en
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김영일
김기만
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연만희
주식회사 유한양행
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

내용 없음No content

Description

지속성 세팔렉신 과립제의 제조방법Process for preparing long-lived cephalexin granules

본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음Since this is an open matter, no full text was included.

제1도 지속성 세팔렉신과립제(실시예2,3,5)및 세팔렉신 분말을 6마리 가토에 경구 투여했을 때의 세팔렉신 혈중농도의 변화 그래프, 제2도는 지속성 세팔렉신과립제(실시예6,7)를 6마리 가토에 경구투여했을 때의 세팔렉신 혈중농도의 변화 그래프, 제3도는 지속성 세팔렉신과립제(실시예8,9)를 6마리 가토에 경구 투여했을 때의 세팔렉신 혈중농도의 변화 그래프.FIG. 1 is a graph showing changes in cephalexin blood concentrations when orally administered 6 cephalexin granules (Examples 2, 3, 5) and cephalexin powders in 6 rabbits, and FIG. 2 shows persistent cephalexin granules (Example 6, 7) Graph of change in cephalexin blood concentration when orally administered to 6 rabbits, Figure 3 shows the change of cephalexin blood concentration when orally administered persistent cephalexin granules (Examples 8 and 9) to 6 rabbits. graph.

Claims (10)

50-500 마이크로 미터 크기의 슈크로오즈 결정을 출발물질로 하여 하이드록시프로필셀로오즈나 폴리비닐피톨리돈 수용액을 회전하는 조립기의 내의 슈크로오즈 결정들에 분무하면서, 세팔렉신과 부형제의 혼합물을 피복하여 일정크기의 과립으로 성형시켜 건조한 후, 420-710 마이크로미터 크기의 과립들을 선별하여 조립기에 넣고 회전시키면서 하이드록시프로필셀룰로오즈나 폴리비닐피톨리돈 수용액을 과립들에 분무하면서 세팔렉신과 부형제의 혼합물을 피복하여 둥글게 성형시키고 건조한 다음, 수불용성 중합체 또는 장용성 기제로 피막을 입히는 것을 특징으로 하는 지속성 세팔렉신 과립제의 제조방법.Mixtures of cephalexin and excipients are sprayed onto sucrose crystals in a rotating granulator with 50-500 micrometer-sized sucrose crystals as starting material and hydroxypropylcellulose or aqueous polyvinylpitolidon solution. After coating, forming into granules of a certain size and drying, the granules of 420-710 micrometer size are selected, put into a granulator, and rotated while spraying hydroxypropyl cellulose or polyvinyl pitolidon aqueous solution onto the granules, a mixture of cephalexin and excipients. Method of producing a continuous cephalexin granules, characterized in that the coating to form a round and dried, then coated with a water-insoluble polymer or enteric base. 제1항에 있어서, 수불용성 중합체로서 에칠셀룰로오즈에 폴리에칠렌글리콜 600을 혼합한 액이나, 공중합시킨 아크릴산－메타릴산메칠에스테르(유드라짓드－RS와 유드라짓드－RL)혼합액을 사용하여 피막을 입히는 것을 특징으로 하는 방법.The method of claim 1, wherein the coating film is prepared by using a mixture of ethylene glycol 600 and ethylene glycol as a water-insoluble polymer, or a mixture of copolymerized acrylic acid-methacrylic acid methyl ester (eudragitide-RS and Eudragitide-RL). Characterized in that the method. 제2항에 있어서, 수불용성 중합체로서 에칠셀룰로오즈 99.0∼60.0중량%에 폴리에칠렌글리콜 6000 1.0－40.0중량%를 혼합하는 것을 사용하여 피막을 입히는 것을 특징으로 하는 방법.The method according to claim 2, wherein the film is coated by using 99.0 to 60.0% by weight of ethyl cellulose and 1.0-40.0% by weight of polyethylene glycol as water-insoluble polymer. 제2항에 있어서, 수불용성 중합체로서 공중합시킨 아크릴산－메타크릴산 메칠에스테르 중 유드라짓드－RS와 유드라짓드－RL을 각각 99.0∼80.0중량%, 1.0∼20.0%로 혼합한 것을 사용하여 피막을 입히는 것을 특징으로 하는 방법.The film according to claim 2, wherein Eudragit-RS and Eudragit-RL are mixed in an acrylic acid-methacrylic acid methyl ester copolymerized as a water-insoluble polymer at 99.0 to 80.0% by weight and 1.0 to 20.0%, respectively. Method of coating. 제1항에 있어서, 장용성 기제로서 하이드록시프로메칠셀룰로오즈프탈레이트 또는 공중합시킨 메타크릴산－메타크릴산메칠에스테르(유드라짓드－S100)를 사용하여 피막을 입히는 것을 특징으로 하는 방법.The method according to claim 1, wherein the coating is performed using hydroxypromethylcellulose phthalate or copolymerized methacrylic acid-methacrylic acid methyl ester (eudragitide-S100) as an enteric base. 제5항에 있어서, 장용성 기제로서 하이드록시프로메칠셀룰로오즈프탈레이트 99.0∼80.0중량%에 아세칠레이티드모노글리세라이드1.0∼20.0중량%를 혼합한 것을 사용하여 피막을 입히는 것을 특징으로 하는 방법.The method according to claim 5, wherein an enteric base is coated with 99.0 to 80.0 wt% of hydroxypromethylcellulose phthalate and 1.0 to 20.0 wt% of acetylated monoglyceride. 제5항에 있어에, 장왕성 기제로서 유드라짓드－S100 99.0∼80.0중량%에 디부칠프탈레이트 1.0－20.0중량%를 혼합한 것을 사용하여 피막을 입히는 것을 특징으로 하는 방법.The method according to claim 5, wherein the film is coated using a mixture of 1.0-20.0% by weight of dibutyl phthalate to 99.0 to 80.0% by weight of Eudragit-S100 as the Uranus base. 제1항에 있어서, 최종 과립내의 슈크로오즈 결정: 세팔렉신 및 부형제의 비가 중량대비로 1: 10－15임을 특징으로 하는 방법.2. The method of claim 1, wherein the ratio of sucrose crystals in the final granules: cephalexin and excipient is 1: 10-15 by weight. 제1항에 있어서, 세팔렉신: 부형제의 비가 중량대비로 2: 1－4: 1임을 특징으로 하는 방법.The method of claim 1 wherein the ratio of cephalexin to excipient is 2: 1-4: 1 by weight. 제1항에 있어서, 입자크기가 150마이크로 미터 이하인 세팔렉신과 부형제의 혼합물을 사용하는 것을 특징으로 하는 방법.The method of claim 1 wherein a mixture of cephalexin and excipient having a particle size of 150 micrometers or less is used. ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.※ Note: The disclosure is based on the initial application.
KR1019910004839A 1990-05-14 1991-03-28 Process for preparing long term release cephalexin granule Expired - Fee Related KR930006433B1 (en)

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KR1019910004839A KR930006433B1 (en) 1990-05-14 1991-03-28 Process for preparing long term release cephalexin granule

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Application Number Priority Date Filing Date Title
KR1019900006809A KR910019609A (en) 1990-05-14 1990-05-14 Process for preparing long-lived cephalexin granules
KR90-6809 1990-05-14
KR1019910004839A KR930006433B1 (en) 1990-05-14 1991-03-28 Process for preparing long term release cephalexin granule

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KR910019607A true KR910019607A (en) 1991-12-19
KR930006433B1 KR930006433B1 (en) 1993-07-16

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KR1019900006809A Pending KR910019609A (en) 1990-05-14 1990-05-14 Process for preparing long-lived cephalexin granules
KR1019910004839A Expired - Fee Related KR930006433B1 (en) 1990-05-14 1991-03-28 Process for preparing long term release cephalexin granule

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KR930006433B1 (en) 1993-07-16

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