SI2620153T1 - 5 Alfa-androstan(alkil)-3beta, 5,6 beta-triol injiciranje in pripravljalna metoda le tega - Google Patents
5 Alfa-androstan(alkil)-3beta, 5,6 beta-triol injiciranje in pripravljalna metoda le tega Download PDFInfo
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- SI2620153T1 SI2620153T1 SI201131508T SI201131508T SI2620153T1 SI 2620153 T1 SI2620153 T1 SI 2620153T1 SI 201131508 T SI201131508 T SI 201131508T SI 201131508 T SI201131508 T SI 201131508T SI 2620153 T1 SI2620153 T1 SI 2620153T1
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- injection
- cyclodextrin
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- hydroxypropyl
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- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
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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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
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- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B82—NANOTECHNOLOGY
- B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
- B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nanotechnology (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Crystallography & Structural Chemistry (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- General Engineering & Computer Science (AREA)
- Biotechnology (AREA)
- Biophysics (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Urology & Nephrology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Steroid Compounds (AREA)
Claims (10)
- 5 ALFA-ANDR0STAN(ALKIL)-3 BETA, 5,6 BETA-TRIOL INJICIRANJE IN PRIPRAVLJALNA METODA LE TEGA PATENTNI ZAHTEVKI1. Injiciranje(ang.«injection«) 5a-androstan-33, 5,63-triola, ki vključuje tekoče injiciranje, ki ima topilo ali trdno injiciranje, ki obsega vsaj en topen ekscipient, kjer vsaj en topen ekscipient vključuje hidroksipropil-fi-ciklodekstrin.
- 2. Injiciranje po zahtevku 1, kjer je 5a-androstan-33,5,63-triot prisoten v masnem deležu 1 ~20: 40-500 do hidroksipropil-3-ciklodekstrina.
- 3. Injiciranje po zahtevku 1 ali 2, kjer topni ekscipient nadalje obsega izotonično sredstvo za prilagajanje in/ali liofilizirano polnilo.
- 4. Injiciranje po zahtevku 3, kjer je izotonično sredstvo za prilagajanje izbrano iz skupine, ki jo sestavljajo natrijev klorid, glukoza, manitol, laktozo, ksilitol, sorbitol, maltitol in njihove zmesi.
- 5. Injiciranje po zahtevku 3, kjer je liofilizirno polnilo izbrano iz skupine, ki jo sestavljajo natrijev klorid, glukoza, manitol, laktoza, ksilitol, sorbitol, maltitol in njihove zmesi.
- 6. Injiciranje po zahtevku 1 ali 2, kjer je topilo tekočega injiciranja izbrano iz skupine, ki jo sestavljajo propandiol, etanol, polietilen glikol 400, polietilen glikol 200, glicerol, voda in njihove zmesi.
- 7. Injiciranje po zahtevku 3, kjer je injiciranje sestavljeno iz (po teži): 1-20 delcev 5a-androstan-3p,5,63-triola, 40-500 delov hidroksipropil-β-ciklodekstrina, 1-100 delov izotoničnega sredstva za prilagajanje, 0-200 delov liofiliziranega polnila in 0-2000 delov topila.
- 8. Metoda za pripravo injiciranja po zahtevku 1, ki obsega korake (a) raztapljanje hidroksipropil-3-ciklodekstrina, 5a-androstan-33, 5,63-triola in dodatnih topnih ekscipientov v vodi za injiciranje v zaporedju, da dobimo surovo raztopino za injiciranje, in (b1) izpostavitev surove raztopine za injiciranje dekolorizaciji, depirogenaciji, filtriranju in sterilizaciji, da dobimo injekcijo(ang.«injection«) ali (b2) izpostavitev surove raztopine za injiciranje razbarvanju, depirogenizaciji, filtraciji in polnjenju filtrata proizvedenega s filtracijo v ampule, ki ji sledi liofilizacija, da dobimo liofiliziran prašek, ali (b3) izpostavitev surove raztopine za injiciranje razbarvanju, depirogenizaciji, filtriranju in razpršilnem sušenju filtrata proizvedenega s filtriranjem, čemur sledi pakiranje.
- 9. Metoda po zahtevku 8, kjer se dekolorizacija doseže z uporabo aktivnega oglja v količini 0.05-0.3 ut.% injiciranja.
- 10. Metoda po zahtevku 8 ali 9, kjer se sterilizacijo izvede pri 115°C za 30 min ali pri 121°C za 15 min.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201010292234XA CN101961311B (zh) | 2010-09-21 | 2010-09-21 | 一种5α-雄甾(烷)-3β,5,6β-三醇注射剂及其制备方法 |
EP11826361.5A EP2620153B1 (en) | 2010-09-21 | 2011-07-08 | 5 alpha-androstane (alkyl)-3 beta,5,6 beta-triol injection and preparation method therefor |
PCT/CN2011/076968 WO2012037834A1 (zh) | 2010-09-21 | 2011-07-08 | 一种5α-雄甾(烷)-3β,5,6β-三醇注射剂及其制备方法 |
Publications (1)
Publication Number | Publication Date |
---|---|
SI2620153T1 true SI2620153T1 (sl) | 2018-08-31 |
Family
ID=43514490
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
SI201131508T SI2620153T1 (sl) | 2010-09-21 | 2011-07-08 | 5 Alfa-androstan(alkil)-3beta, 5,6 beta-triol injiciranje in pripravljalna metoda le tega |
Country Status (22)
Country | Link |
---|---|
US (2) | US9161985B2 (sl) |
EP (1) | EP2620153B1 (sl) |
JP (1) | JP5750680B2 (sl) |
KR (1) | KR101468153B1 (sl) |
CN (1) | CN101961311B (sl) |
AU (1) | AU2011304917B2 (sl) |
BR (1) | BR112013005763B1 (sl) |
CA (1) | CA2809646C (sl) |
CY (1) | CY1120724T1 (sl) |
DK (1) | DK2620153T3 (sl) |
ES (1) | ES2677069T3 (sl) |
HR (1) | HRP20181002T1 (sl) |
HU (1) | HUE038230T2 (sl) |
LT (1) | LT2620153T (sl) |
PL (1) | PL2620153T3 (sl) |
PT (1) | PT2620153T (sl) |
RS (1) | RS57409B1 (sl) |
RU (1) | RU2532354C1 (sl) |
SG (2) | SG188393A1 (sl) |
SI (1) | SI2620153T1 (sl) |
TR (1) | TR201809354T4 (sl) |
WO (1) | WO2012037834A1 (sl) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101884638B (zh) | 2010-07-09 | 2011-11-09 | 中山大学 | 5α-雄甾(烷)-3β,5,6β-三醇在制备神经元保护药物中的应用 |
CN103626818B (zh) | 2012-03-08 | 2016-03-30 | 广州市赛普特医药科技有限公司 | 雄甾-3β,5α,6β-三醇的晶型化合物及其制备方法 |
CN103330946B (zh) * | 2013-05-29 | 2015-03-25 | 广州市赛普特医药科技有限公司 | 5α-雄甾-3β,5,6β-三醇注射剂其制备方法 |
CN104288110B (zh) * | 2013-06-26 | 2017-05-10 | 广州市赛普特医药科技股份有限公司 | 5α‑雄甾‑3β,5,6β‑三醇注射剂及其制备方法 |
WO2015047999A1 (en) * | 2013-09-26 | 2015-04-02 | Polyone Corporation | Sustainable poly(vinyl halide) mixtures for thin-film applications |
CN113350359B (zh) * | 2017-12-29 | 2022-08-16 | 广州市赛普特医药科技股份有限公司 | 5α-雄甾-3β,5,6β-三醇在制备治疗出血性脑卒中药物中的应用 |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2191576A (en) * | 1936-11-21 | 1940-02-27 | Soc Of Chemical Ind | 3,5,6-trihydroxy androstane and pregnane compounds |
IE62095B1 (en) * | 1988-03-29 | 1994-12-14 | Univ Florida | Pharmaceutical formulations for parenteral use |
FR2668945B1 (fr) * | 1990-11-12 | 1993-02-19 | Theramex | Nouveau procede de cristallisation des substances organiques et les composes ainsi obtenus. |
US5563131A (en) * | 1994-08-04 | 1996-10-08 | Pherin Corporation | Pregnane steroids as neurochemical initiators of change in human hypothalamic function and related pharmaceutical compositions and methods |
WO1997017992A1 (en) * | 1995-11-13 | 1997-05-22 | Supergen, Inc. | Improved formulation for administration of steroid compounds |
US5824668A (en) * | 1996-11-07 | 1998-10-20 | Supergen, Inc. | Formulation for administration of steroid compounds |
US20030060425A1 (en) * | 1998-11-24 | 2003-03-27 | Ahlem Clarence N. | Immune modulation method using steroid compounds |
CN1232539C (zh) * | 2002-05-10 | 2005-12-21 | 刘云清 | 有机药物与倍他环糊精衍生物的配合物及其制备方法 |
WO2004070048A1 (en) * | 2003-02-07 | 2004-08-19 | Pharmacia & Upjohn Company Llc | A microbial process to prepare 5-androsten-3beta, 7alpha, 15alpha-triol-17-one and related analogues |
CN1706501A (zh) * | 2005-05-27 | 2005-12-14 | 沈阳药科大学 | 亲脂性药物环糊精包合物的制备方法 |
CN101884638B (zh) * | 2010-07-09 | 2011-11-09 | 中山大学 | 5α-雄甾(烷)-3β,5,6β-三醇在制备神经元保护药物中的应用 |
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2010
- 2010-09-21 CN CN201010292234XA patent/CN101961311B/zh active Active
-
2011
- 2011-07-08 BR BR112013005763-7A patent/BR112013005763B1/pt active IP Right Grant
- 2011-07-08 SG SG2013016126A patent/SG188393A1/en unknown
- 2011-07-08 RU RU2013105216/15A patent/RU2532354C1/ru active
- 2011-07-08 KR KR1020137006176A patent/KR101468153B1/ko active IP Right Grant
- 2011-07-08 JP JP2013527453A patent/JP5750680B2/ja active Active
- 2011-07-08 WO PCT/CN2011/076968 patent/WO2012037834A1/zh active Application Filing
- 2011-07-08 SI SI201131508T patent/SI2620153T1/sl unknown
- 2011-07-08 HU HUE11826361A patent/HUE038230T2/hu unknown
- 2011-07-08 CA CA2809646A patent/CA2809646C/en active Active
- 2011-07-08 LT LTEP11826361.5T patent/LT2620153T/lt unknown
- 2011-07-08 TR TR2018/09354T patent/TR201809354T4/tr unknown
- 2011-07-08 RS RS20180765A patent/RS57409B1/sr unknown
- 2011-07-08 EP EP11826361.5A patent/EP2620153B1/en active Active
- 2011-07-08 SG SG10201400723UA patent/SG10201400723UA/en unknown
- 2011-07-08 PL PL11826361T patent/PL2620153T3/pl unknown
- 2011-07-08 AU AU2011304917A patent/AU2011304917B2/en active Active
- 2011-07-08 PT PT118263615T patent/PT2620153T/pt unknown
- 2011-07-08 US US13/821,849 patent/US9161985B2/en active Active
- 2011-07-08 ES ES11826361.5T patent/ES2677069T3/es active Active
- 2011-07-08 DK DK11826361.5T patent/DK2620153T3/en active
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2015
- 2015-08-28 US US14/839,869 patent/US9265837B1/en active Active
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2018
- 2018-06-28 HR HRP20181002TT patent/HRP20181002T1/hr unknown
- 2018-06-29 CY CY181100681T patent/CY1120724T1/el unknown
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