CN101961311A - 一种5α-雄甾(烷)-3β,5,6β-三醇注射剂及其制备方法 - Google Patents
一种5α-雄甾(烷)-3β,5,6β-三醇注射剂及其制备方法 Download PDFInfo
- Publication number
- CN101961311A CN101961311A CN201010292234XA CN201010292234A CN101961311A CN 101961311 A CN101961311 A CN 101961311A CN 201010292234X A CN201010292234X A CN 201010292234XA CN 201010292234 A CN201010292234 A CN 201010292234A CN 101961311 A CN101961311 A CN 101961311A
- Authority
- CN
- China
- Prior art keywords
- injection
- preparation
- beta
- androstane
- parts
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
- 239000007924 injection Substances 0.000 title claims abstract description 67
- 238000002347 injection Methods 0.000 title claims abstract description 67
- 238000002360 preparation method Methods 0.000 title claims abstract description 25
- QZLYKIGBANMMBK-UGCZWRCOSA-N 5α-Androstane Chemical compound C([C@@H]1CC2)CCC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CCC[C@@]2(C)CC1 QZLYKIGBANMMBK-UGCZWRCOSA-N 0.000 title claims abstract description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 22
- 239000008215 water for injection Substances 0.000 claims abstract description 12
- 239000000706 filtrate Substances 0.000 claims abstract description 11
- 239000002904 solvent Substances 0.000 claims abstract description 11
- 239000000945 filler Substances 0.000 claims abstract description 7
- 230000001954 sterilising effect Effects 0.000 claims abstract description 7
- 239000007788 liquid Substances 0.000 claims abstract description 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 25
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 13
- 239000011780 sodium chloride Substances 0.000 claims description 12
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 10
- 239000000843 powder Substances 0.000 claims description 10
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 8
- 239000002671 adjuvant Substances 0.000 claims description 7
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 7
- 239000008103 glucose Substances 0.000 claims description 7
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 6
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 6
- 239000003795 chemical substances by application Substances 0.000 claims description 6
- 238000004659 sterilization and disinfection Methods 0.000 claims description 6
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 4
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 4
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 4
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 4
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims description 4
- 229930195725 Mannitol Natural products 0.000 claims description 4
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 4
- 239000008101 lactose Substances 0.000 claims description 4
- 239000000594 mannitol Substances 0.000 claims description 4
- 235000010355 mannitol Nutrition 0.000 claims description 4
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 4
- 239000000600 sorbitol Substances 0.000 claims description 4
- 239000000811 xylitol Substances 0.000 claims description 4
- 235000010447 xylitol Nutrition 0.000 claims description 4
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 4
- 229960002675 xylitol Drugs 0.000 claims description 4
- 238000004108 freeze drying Methods 0.000 claims description 3
- 238000001694 spray drying Methods 0.000 claims description 3
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 2
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims description 2
- 239000003708 ampul Substances 0.000 claims description 2
- 229910052799 carbon Inorganic materials 0.000 claims description 2
- 239000004615 ingredient Substances 0.000 claims description 2
- 229960003511 macrogol Drugs 0.000 claims description 2
- 238000012856 packing Methods 0.000 claims description 2
- JLFNLZLINWHATN-UHFFFAOYSA-N pentaethylene glycol Chemical compound OCCOCCOCCOCCOCCO JLFNLZLINWHATN-UHFFFAOYSA-N 0.000 claims description 2
- 239000000243 solution Substances 0.000 claims description 2
- 206010062717 Increased upper airway secretion Diseases 0.000 claims 1
- 239000003463 adsorbent Substances 0.000 claims 1
- 208000026435 phlegm Diseases 0.000 claims 1
- 230000000694 effects Effects 0.000 abstract description 6
- 238000001914 filtration Methods 0.000 abstract description 6
- 239000003814 drug Substances 0.000 abstract description 4
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 abstract 3
- 239000000463 material Substances 0.000 abstract 2
- 238000011082 depyrogenation Methods 0.000 abstract 1
- 238000001035 drying Methods 0.000 abstract 1
- 239000007787 solid Substances 0.000 abstract 1
- 230000000638 stimulation Effects 0.000 abstract 1
- 229940090044 injection Drugs 0.000 description 37
- 238000003756 stirring Methods 0.000 description 9
- 239000003978 infusion fluid Substances 0.000 description 7
- 230000000324 neuroprotective effect Effects 0.000 description 7
- 239000013505 freshwater Substances 0.000 description 5
- 238000009413 insulation Methods 0.000 description 5
- 239000012982 microporous membrane Substances 0.000 description 5
- 238000000034 method Methods 0.000 description 4
- 239000008354 sodium chloride injection Substances 0.000 description 4
- 239000008121 dextrose Substances 0.000 description 3
- 229940093181 glucose injection Drugs 0.000 description 3
- 239000012046 mixed solvent Substances 0.000 description 3
- 210000003462 vein Anatomy 0.000 description 3
- 229940127291 Calcium channel antagonist Drugs 0.000 description 2
- 241000700199 Cavia porcellus Species 0.000 description 2
- 206010008190 Cerebrovascular accident Diseases 0.000 description 2
- 206010018910 Haemolysis Diseases 0.000 description 2
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- 208000006011 Stroke Diseases 0.000 description 2
- 239000003146 anticoagulant agent Substances 0.000 description 2
- 239000000480 calcium channel blocker Substances 0.000 description 2
- VNWKTOKETHGBQD-AKLPVKDBSA-N carbane Chemical class [15CH4] VNWKTOKETHGBQD-AKLPVKDBSA-N 0.000 description 2
- 206010008118 cerebral infarction Diseases 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 238000007796 conventional method Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 230000008588 hemolysis Effects 0.000 description 2
- 239000002932 luster Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- JGSARLDLIJGVTE-UHFFFAOYSA-N 3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-UHFFFAOYSA-N 0.000 description 1
- 239000003477 4 aminobutyric acid receptor stimulating agent Substances 0.000 description 1
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 201000006474 Brain Ischemia Diseases 0.000 description 1
- 108090000312 Calcium Channels Proteins 0.000 description 1
- 102000003922 Calcium Channels Human genes 0.000 description 1
- 206010008120 Cerebral ischaemia Diseases 0.000 description 1
- 229940123457 Free radical scavenger Drugs 0.000 description 1
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 238000012449 Kunming mouse Methods 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 101100489867 Mus musculus Got2 gene Proteins 0.000 description 1
- 241000699670 Mus sp. Species 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 241000283977 Oryctolagus Species 0.000 description 1
- 240000007711 Peperomia pellucida Species 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000036783 anaphylactic response Effects 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000000601 blood cell Anatomy 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 201000008247 brain infarction Diseases 0.000 description 1
- 230000002490 cerebral effect Effects 0.000 description 1
- 238000004737 colorimetric analysis Methods 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000003748 differential diagnosis Methods 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 230000003511 endothelial effect Effects 0.000 description 1
- 235000013922 glutamic acid Nutrition 0.000 description 1
- 239000004220 glutamic acid Substances 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 208000028867 ischemia Diseases 0.000 description 1
- 230000000302 ischemic effect Effects 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 239000002516 radical scavenger Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 210000000278 spinal cord Anatomy 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000002537 thrombolytic effect Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Classifications
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (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)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Crystallography & Structural Chemistry (AREA)
- General Engineering & Computer Science (AREA)
- Biotechnology (AREA)
- Biophysics (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Steroid Compounds (AREA)
Abstract
Description
样品号 | 配伍(25-30℃) |
A | YC-6注射液5ml*2支+5%葡萄糖注射液250ml |
B | YC-6注射液5ml*2支+0.9%氯化钠注射液250ml |
C | YC-6注射液5ml*2支+葡萄糖氯化钠注射液250ml |
D | YC-6注射液5ml*2支+复方氯化钠注射液500ml |
E | YC-6注射液5ml*2支+5%碳酸氢钠注射液250ml |
样品号 | 0h | 2h | 8h | 24h |
A | 375.4 | 364.7 | 367.7 | 363.4 |
B | 379.2 | 373.5 | 380.4 | 386.1 |
C | 385.6 | 387.6 | 383.4 | 384.5 |
D | 382.0 | 383.7 | 387.2 | 380.8 |
E | 386.7 | 375.1 | 381.3 | 376.5 |
Claims (10)
Priority Applications (24)
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 |
SG2013016126A SG188393A1 (en) | 2010-09-21 | 2011-07-08 | 5ALPHA-ANDROSTANE (ALKYL)-3ß,5,6ß-TRIOL INJECTION AND PREPARATION METHOD THEREFOR |
SG10201400723UA SG10201400723UA (en) | 2010-09-21 | 2011-07-08 | 5 a-Androstane (Alkyl)-3ß, 5, 6ß – Triol Injection And Preparation Method Therefor |
SI201131508T SI2620153T1 (en) | 2010-09-21 | 2011-07-08 | 5 Alpha-androstane (alkyl) -3beta, 5.6 beta-triol injection and the preparative method of this |
PT118263615T PT2620153T (pt) | 2010-09-21 | 2011-07-08 | Injecção de 5α-androstano-3β,5,6β-triol e método de preparação desta |
LTEP11826361.5T LT2620153T (lt) | 2010-09-21 | 2011-07-08 | 5 alfa-androstano (alkil)-3 beta,5,6 beta-triolio injekcija ir jos gavimo būdas |
JP2013527453A JP5750680B2 (ja) | 2010-09-21 | 2011-07-08 | 5α−アンドロスタン−3β,5,6β−トリオール注射剤及びその調製方法 |
BR112013005763-7A BR112013005763B1 (pt) | 2010-09-21 | 2011-07-08 | Injeção de 5a-androstano-3ss, 5, 6ss-triol e método para prrparação da injeção |
DK11826361.5T DK2620153T3 (en) | 2010-09-21 | 2011-07-08 | 5 ALPHA-ANDROSTAN (ALKYL) -3 BETA, 5,6 BETA-TRIOL INJECTION AND PROCEDURE FOR PREPARING THEREOF |
PL11826361T PL2620153T3 (pl) | 2010-09-21 | 2011-07-08 | Zastrzyk 5alfa-androstano(alkilo)-3beta,5,6beta-triolu i sposób jego wytwarzania |
CA2809646A CA2809646C (en) | 2010-09-21 | 2011-07-08 | 5.alpha.-androstane-3.beta.,5,6.beta.-triol injection and preparation method therefor |
US13/821,849 US9161985B2 (en) | 2010-09-21 | 2011-07-08 | 5α-androstane (alkyl)-3β, 5, 6β-triol injection and preparation method therefor |
HUE11826361A HUE038230T2 (hu) | 2010-09-21 | 2011-07-08 | 5 alfa-androsztán (alkil)-3ß,5,6ß-triol injekció és eljárás annak elõállítására |
KR1020137006176A KR101468153B1 (ko) | 2010-09-21 | 2011-07-08 | 5α-안드로스테인-3β,5,6β-트리올 주사제 및 제조방법 |
AU2011304917A AU2011304917B2 (en) | 2010-09-21 | 2011-07-08 | 5alpha-androstane (alkyl)-3beta,5,6beta-triol injection and preparation method therefor |
TR2018/09354T TR201809354T4 (tr) | 2010-09-21 | 2011-07-08 | 5 alfa androstan (alkil) 3 beta,5,6 beta triol enjeksiyonu ve Bunun hazırlanmasına yönelik yöntem. |
RU2013105216/15A RU2532354C1 (ru) | 2010-09-21 | 2011-07-08 | ИНЪЕКЦИОННАЯ ФОРМА 5α АНДРОСТАН-3β,5,6β-ТРИОЛА И СПОСОБ ЕЕ ПОЛУЧЕНИЯ |
RS20180765A RS57409B1 (sr) | 2010-09-21 | 2011-07-08 | Injekcija 5 alfa-androstan (alkil)-3 beta,5,6 beta-triola i postupak njene pripreme |
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 |
ES11826361.5T ES2677069T3 (es) | 2010-09-21 | 2011-07-08 | Inyección de 5 alfa-androstano (alquil)-3 beta,5,6 beta-triol y su método de preparación |
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 |
US14/839,869 US9265837B1 (en) | 2010-09-21 | 2015-08-28 | 5α-androstane-3β,5,6β-triol injection and preparation method therefor |
HRP20181002TT HRP20181002T1 (hr) | 2010-09-21 | 2018-06-28 | Injekcija 5 alfa-androstan (alkil)-3 beta, 5, 6 beta-triola i postupak pripreme |
CY181100681T CY1120724T1 (el) | 2010-09-21 | 2018-06-29 | Ενεση 5 αλφα-ανδροστανο (αλκυλο)-3-βητα,5,6 βητα-τριολης και μεθοδος παρασκευης για αυτη |
Applications Claiming Priority (1)
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 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN101961311A true CN101961311A (zh) | 2011-02-02 |
CN101961311B CN101961311B (zh) | 2012-11-21 |
Family
ID=43514490
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201010292234XA Active 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 |
Country Status (22)
Country | Link |
---|---|
US (2) | US9161985B2 (zh) |
EP (1) | EP2620153B1 (zh) |
JP (1) | JP5750680B2 (zh) |
KR (1) | KR101468153B1 (zh) |
CN (1) | CN101961311B (zh) |
AU (1) | AU2011304917B2 (zh) |
BR (1) | BR112013005763B1 (zh) |
CA (1) | CA2809646C (zh) |
CY (1) | CY1120724T1 (zh) |
DK (1) | DK2620153T3 (zh) |
ES (1) | ES2677069T3 (zh) |
HR (1) | HRP20181002T1 (zh) |
HU (1) | HUE038230T2 (zh) |
LT (1) | LT2620153T (zh) |
PL (1) | PL2620153T3 (zh) |
PT (1) | PT2620153T (zh) |
RS (1) | RS57409B1 (zh) |
RU (1) | RU2532354C1 (zh) |
SG (2) | SG10201400723UA (zh) |
SI (1) | SI2620153T1 (zh) |
TR (1) | TR201809354T4 (zh) |
WO (1) | WO2012037834A1 (zh) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102617685A (zh) * | 2012-03-08 | 2012-08-01 | 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 |
CN103330946A (zh) * | 2013-05-29 | 2013-10-02 | 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 |
CN104288110A (zh) * | 2013-06-26 | 2015-01-21 | 广州市赛普特医药科技有限公司 | 5α-雄甾-3β,5,6β-三醇注射剂及其制备方法 |
AU2018396897B2 (en) * | 2017-12-29 | 2021-08-05 | Guangzhou Cellprotek Pharmaceutical Co., Ltd. | Application of compound in preparation of drug for treatment of haemorrhagic stroke |
Families Citing this family (2)
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 |
WO2015047999A1 (en) * | 2013-09-26 | 2015-04-02 | Polyone Corporation | Sustainable poly(vinyl halide) mixtures for thin-film applications |
Citations (1)
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 |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
US5824668A (en) * | 1996-11-07 | 1998-10-20 | Supergen, Inc. | Formulation for administration of steroid compounds |
IL124001A (en) * | 1995-11-13 | 2004-07-25 | Supergen Inc | Composition for administration of steroids |
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 |
-
2010
- 2010-09-21 CN CN201010292234XA patent/CN101961311B/zh active Active
-
2011
- 2011-07-08 WO PCT/CN2011/076968 patent/WO2012037834A1/zh active Application Filing
- 2011-07-08 AU AU2011304917A patent/AU2011304917B2/en active Active
- 2011-07-08 TR TR2018/09354T patent/TR201809354T4/tr unknown
- 2011-07-08 CA CA2809646A patent/CA2809646C/en active Active
- 2011-07-08 DK DK11826361.5T patent/DK2620153T3/en active
- 2011-07-08 SG SG10201400723UA patent/SG10201400723UA/en unknown
- 2011-07-08 PL PL11826361T patent/PL2620153T3/pl unknown
- 2011-07-08 HU HUE11826361A patent/HUE038230T2/hu unknown
- 2011-07-08 ES ES11826361.5T patent/ES2677069T3/es active Active
- 2011-07-08 EP EP11826361.5A patent/EP2620153B1/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 SI SI201131508T patent/SI2620153T1/en unknown
- 2011-07-08 JP JP2013527453A patent/JP5750680B2/ja active Active
- 2011-07-08 RS RS20180765A patent/RS57409B1/sr unknown
- 2011-07-08 BR BR112013005763-7A patent/BR112013005763B1/pt active IP Right Grant
- 2011-07-08 KR KR1020137006176A patent/KR101468153B1/ko active IP Right Grant
- 2011-07-08 RU RU2013105216/15A patent/RU2532354C1/ru active
- 2011-07-08 LT LTEP11826361.5T patent/LT2620153T/lt unknown
- 2011-07-08 SG SG2013016126A patent/SG188393A1/en unknown
-
2015
- 2015-08-28 US US14/839,869 patent/US9265837B1/en active Active
-
2018
- 2018-06-28 HR HRP20181002TT patent/HRP20181002T1/hr unknown
- 2018-06-29 CY CY181100681T patent/CY1120724T1/el unknown
Patent Citations (1)
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 |
Non-Patent Citations (2)
Title |
---|
《中国药理学与毒理学杂志》 20011031 李群等 孕甾烷-3beta,5alpha,6beta-三醇抑制低钾诱导的小脑颗粒神经元凋亡 第337-341页 1-10 第15卷, 第5期 2 * |
《中山医科大学学报》 20000331 蔡翔等 海洋甾体YC-1抑制低钾诱导大鼠小脑颗粒神经元的凋亡 第161-164页 1-10 第21卷, 第3期 2 * |
Cited By (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2015511587A (ja) * | 2012-03-08 | 2015-04-20 | グァンチョウ セルプロテック ファーマシューティカル カンパニー リミテッド | アンドロスタン−3β,5α,6β−トリオールの結晶形化合物及びその製造方法 |
US9688716B2 (en) | 2012-03-08 | 2017-06-27 | Guangzhou Cellprotek Pharmaceutical Co., Ltd. | Crystalline forms of 5α-androstane-3β,5,6β-triol and preparation methods therefor |
CN103626819B (zh) * | 2012-03-08 | 2016-01-20 | 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 |
CN103626817B (zh) * | 2012-03-08 | 2016-01-20 | 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 |
CN103626819A (zh) * | 2012-03-08 | 2014-03-12 | 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 |
CN103626818A (zh) * | 2012-03-08 | 2014-03-12 | 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 |
CN103626817A (zh) * | 2012-03-08 | 2014-03-12 | 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 |
CN102617685A (zh) * | 2012-03-08 | 2012-08-01 | 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 |
US9944673B2 (en) | 2012-03-08 | 2018-04-17 | Guangzhou Cellprotek Pharmaceutical Co., Ltd. | Crystalline forms of 5α-androstane-3β,5,6β-triol and preparation methods therefor |
US9944672B2 (en) | 2012-03-08 | 2018-04-17 | Guangzhou Cellprotek Pharmaceutical Co., Ltd. | Crystalline forms of 5α-androstane-3β,5,6β-triol and preparation methods therefor |
CN102617685B (zh) * | 2012-03-08 | 2014-01-22 | 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 |
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 |
WO2013131305A1 (zh) * | 2012-03-08 | 2013-09-12 | 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 |
CN103330946A (zh) * | 2013-05-29 | 2013-10-02 | 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 |
CN104288110A (zh) * | 2013-06-26 | 2015-01-21 | 广州市赛普特医药科技有限公司 | 5α-雄甾-3β,5,6β-三醇注射剂及其制备方法 |
US11382921B2 (en) | 2017-12-29 | 2022-07-12 | Guangzhou Cellprotek Pharmaceutical Co., Ltd | Use of compounds in preparation of a medicament for treatment of hemorrhagic stroke |
AU2018396897B2 (en) * | 2017-12-29 | 2021-08-05 | Guangzhou Cellprotek Pharmaceutical Co., Ltd. | Application of compound in preparation of drug for treatment of haemorrhagic stroke |
Also Published As
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN101961311B (zh) | 一种5α-雄甾(烷)-3β,5,6β-三醇注射剂及其制备方法 | |
CN102100666B (zh) | 一种新的盐酸莫西沙星注射剂 | |
CN102481287B (zh) | 含维生素c或其衍生物的替莫唑胺药物组合物及其制备方法 | |
CN103054883B (zh) | 一种含有果糖二磷酸钠化合物的药物组合物 | |
CN103393693A (zh) | 一种盐酸昂丹司琼和地塞米松的药物组合物 | |
CN104940135A (zh) | 一种氟康唑注射液及其制备方法 | |
CN102688183A (zh) | 一种稳定的盐酸莫西沙星注射剂 | |
CN102008461B (zh) | 一种注射用布洛芬药物组合物 | |
CN103520186B (zh) | 一种注射用脂溶性维生素的药物组合物及其制备方法 | |
CN103385877B (zh) | 一种紫杉醇和西咪替丁的药物组合物 | |
CN103330933A (zh) | 含有米卡芬净或其盐的药物组合物 | |
CN105311040A (zh) | 一种含有果糖二磷酸钠的用于治疗循环系统疾病的新药物组合物针剂 | |
CN103040737B (zh) | 一种含有兰索拉唑化合物的药物组合物及其制备方法 | |
CN100377712C (zh) | 葫芦素脂质体组方及其制剂 | |
CN103585119A (zh) | 一种包含依前列醇及其药用盐的稳定化制剂及其制备方法 | |
CN103385883B (zh) | 一种含盐酸托烷司琼和果糖的药物组合物 | |
CN103330932B (zh) | 一种米卡芬净或其盐的药物组合物 | |
CN102764437B (zh) | 甲氧沙林注射液及其制备方法 | |
CN102895232B (zh) | 一种含头孢尼西化合物药物组合物及其制备方法 | |
CN102716107B (zh) | 水溶性布洛芬药物组合物 | |
CN103330946B (zh) | 5α-雄甾-3β,5,6β-三醇注射剂其制备方法 | |
CN100563664C (zh) | 一种液体药剂及其制备方法和用途 | |
CN104013951A (zh) | 一氧化氮供体型谷胱甘肽类化合物注射液及应用 | |
CN102198136B (zh) | 一种新型稳定的尤利沙星甲磺酸盐在制备抗感染药物中的应用 | |
JP2022519343A (ja) | ベンゾアゼピン化合物含有医薬組成物 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Guangzhou Saipute Medical Technology Co., Ltd. Assignor: Sun Yat-sen University Contract record no.: 2011440000671 Denomination of invention: Preparation of N,N,N',N',-tetraacetyl-3,5,3',5'-tetrabromo(chloro)-4,4'-diaminodiphenyl methane License type: Exclusive License Open date: 20110202 Record date: 20110712 |
|
EC01 | Cancellation of recordation of patent licensing contract |
Assignee: Guangzhou Saipute Medical Technology Co., Ltd. Assignor: Sun Yat-sen University Contract record no.: 2011440000671 Date of cancellation: 20120911 |
|
LICC | Enforcement, change and cancellation of record of contracts on the licence for exploitation of a patent or utility model | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
ASS | Succession or assignment of patent right |
Owner name: GUANGZHOU SEPATEC PHARMACEUTICAL TECHNOLOGY CO., L Free format text: FORMER OWNER: SUN YAT-SEN UNIVERSITY Effective date: 20121205 |
|
C41 | Transfer of patent application or patent right or utility model | ||
COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 510080 GUANGZHOU, GUANGDONG PROVINCE TO: 510663 GUANGZHOU, GUANGDONG PROVINCE |
|
TR01 | Transfer of patent right |
Effective date of registration: 20121205 Address after: 510663 Guangdong province Guangzhou Science City skim Springs Road No. 3, Guangzhou international business incubator C208 Patentee after: Guangzhou Saipute Medical Technology Co., Ltd. Address before: 510080 Guangzhou 74 north campus, two Zhongshan Road, Guangdong, China Patentee before: Sun Yat-sen University |
|
C56 | Change in the name or address of the patentee | ||
CP03 | Change of name, title or address |
Address after: The city on 510663 Guangzhou Road, Guangdong province science No. 3 Guangzhou International Business Incubator Building G 401-415 Patentee after: GUANGZHOU SAIPUTE PHARMACEUTICAL TECHNOLOGY CO., LTD. Address before: 510663 Guangdong province Guangzhou Science City skim Springs Road No. 3, Guangzhou international business incubator C208 Patentee before: Guangzhou Saipute Medical Technology Co., Ltd. |