CN109381435B - 一种右旋兰索拉唑冻干粉针剂、其制备方法及应用 - Google Patents
一种右旋兰索拉唑冻干粉针剂、其制备方法及应用 Download PDFInfo
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- CN109381435B CN109381435B CN201810851914.7A CN201810851914A CN109381435B CN 109381435 B CN109381435 B CN 109381435B CN 201810851914 A CN201810851914 A CN 201810851914A CN 109381435 B CN109381435 B CN 109381435B
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
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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
- A61K47/02—Inorganic compounds
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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
- A61K47/06—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
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- A—HUMAN NECESSITIES
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- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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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
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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Abstract
Description
剂量 | 250.0mg/kg | 225.0mg/kg | 202.5mg/kg | 182.3mg/kg | 164.0mg/kg | LD50 |
死亡率 | 80% | 60% | 20% | 10% | 0% | 221.5mg/kg |
剂量 | 200.0mg/kg | 180.0mg/kg | 162.0mg/kg | 145.8mg/kg | 131.2mg/kg | LD50 |
死亡率 | 90% | 50% | 30% | 10% | 0% | 174.8mg/kg |
组别 | ALT升高发生率 | AST升高发生率 | 共计 |
试验组20mg右旋兰索拉唑 | 2% | 2% | 4% |
试验组30mg右旋兰索拉唑 | 14% | 12% | 26% |
对照组30mg消旋兰索拉唑 | 6% | 6% | 12% |
Claims (5)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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CN201710649837 | 2017-08-02 | ||
CN2017106498372 | 2017-08-02 |
Publications (2)
Publication Number | Publication Date |
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CN109381435A CN109381435A (zh) | 2019-02-26 |
CN109381435B true CN109381435B (zh) | 2021-11-19 |
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Application Number | Title | Priority Date | Filing Date |
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CN201810851914.7A Active CN109381435B (zh) | 2017-08-02 | 2018-07-30 | 一种右旋兰索拉唑冻干粉针剂、其制备方法及应用 |
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CN (1) | CN109381435B (zh) |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1310252A4 (en) * | 2000-08-18 | 2009-06-10 | Takeda Pharmaceutical | INJECTIONS |
CN101057846A (zh) * | 2006-04-17 | 2007-10-24 | 上海秀新臣邦医药科技有限公司 | 注射用兰索拉唑及其制备方法 |
CN100506213C (zh) * | 2008-01-18 | 2009-07-01 | 山东罗欣药业股份有限公司 | 一种注射用兰索拉唑冻干粉及其制备方法 |
CN101716176A (zh) * | 2009-12-21 | 2010-06-02 | 扬子江药业集团上海海尼药业有限公司 | 一种注射用右兰索拉唑及其制备方法 |
CN102552181B (zh) * | 2012-01-20 | 2013-11-13 | 江苏吴中医药集团有限公司 | 一种兰索拉唑冻干粉针制剂及其制备方法 |
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- 2018-07-30 CN CN201810851914.7A patent/CN109381435B/zh active Active
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Address after: 210046 No. 28, Heng Jing Road, Nanjing economic and Technological Development Zone, Jiangsu, China Applicant after: NANJING YOKO BIOMEDICAL R & D Ltd. Applicant after: Nanjing uniclever biological pharmaceutical Limited by Share Ltd. Applicant after: NANJING YOKO PHARMACEUTICAL Co.,Ltd. Applicant after: NANJING LIBOWEI PHARMACEUTICAL CO.,LTD. Address before: 210046 No. 28, Heng Jing Road, Nanjing economic and Technological Development Zone, Jiangsu, China Applicant before: NANJING YOKO BIOMEDICAL R & D Ltd. Applicant before: NANJING YOKO BIOLOGICAL PHARMACEUTICAL GROUP Co.,Ltd. Applicant before: NANJING YOKO PHARMACEUTICAL Co.,Ltd. Applicant before: NANJING LIBOWEI PHARMACEUTICAL Co.,Ltd. |
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Effective date of registration: 20200715 Address after: Room 310, science and technology innovation base, No.3 Hengda Road, Nanjing Economic and Technological Development Zone, Nanjing, Jiangsu Province Applicant after: Nanjing spark Pharmaceutical Technology Co.,Ltd. Address before: 210046 No. 28, Heng Jing Road, Nanjing economic and Technological Development Zone, Jiangsu, China Applicant before: NANJING YOKO BIOMEDICAL R & D Ltd. Applicant before: Nanjing uniclever biological pharmaceutical Limited by Share Ltd. Applicant before: NANJING YOKO PHARMACEUTICAL Co.,Ltd. Applicant before: NANJING LIBOWEI PHARMACEUTICAL Co.,Ltd. |
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