CN101091792A - 多剂量红细胞生成素制剂 - Google Patents
多剂量红细胞生成素制剂 Download PDFInfo
- Publication number
- CN101091792A CN101091792A CNA2006100710932A CN200610071093A CN101091792A CN 101091792 A CN101091792 A CN 101091792A CN A2006100710932 A CNA2006100710932 A CN A2006100710932A CN 200610071093 A CN200610071093 A CN 200610071093A CN 101091792 A CN101091792 A CN 101091792A
- Authority
- CN
- China
- Prior art keywords
- benzethonium chloride
- phenoxyethanol
- concentration
- bottle
- compositions
- 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.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/1816—Erythropoietin [EPO]
-
- 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
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/06—Antianaemics
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
Abstract
Description
防腐剂 | 使用频率 | 用量范围 |
苯扎氯铵 | 1 | 0.02%w/v |
苄索氯铵 | 4 | 0.01% |
苯甲醇 | 74 | 0.75-5% |
三氯叔丁醇 | 17 | 0.25-0.5% |
间甲酚 | 3 | 0.1-0.3% |
肉豆蔻基γ-picolinium chloride | 2 | 0.0195-0.169% |
对羟基苯甲酸甲基酯 | 50 | 0.05-0.18% |
对羟基苯甲酸丙基酯 | 40 | 0.01-0.1% |
苯酚 | 48 | 0.2-0.5% |
2-苯氧乙醇 | 3 | 0.50% |
硝酸苯汞 | 3 | 0.001% |
硫汞撒 | 46 | 0.003-0.01% |
防腐剂 | 月数 | 浓度 | 化学分析(%LC)1 | |
5℃ | 25℃ | |||
苯甲醇苯甲醇 | 7月7月 | 10,000U/ml20,000U/ml | 98.699.7 | 90.093.7 |
苯乙铵苯乙铵 | 4月4月 | 10,000U/ml20,000U/ml | 99.9101.5 | 88.994.4 |
苯氧乙醇苯氧乙醇 | 4月4月 | 10,000U/ml20,000U/ml | 100.5102.6 | 96.997.5 |
苯乙铵和苯氧乙醇(0.005%和0.5%) | 3月 | 20,000U/ml | 98.3 | 97.0 |
防腐剂 | 浓度 | 防腐剂诱发 | |
USP | EP | ||
苯甲醇(1.0%)苯乙铵(0.01%)(0.02%)苯氧乙醇(0.5%)苯乙铵和苯氧乙醇(0.005和0.25%)(0.005和0.5%)(0.01和0.5%)苯乙醇(0.5%)苯乙铵和苯乙醇(0.02和0.25%) | 20,000U/ml20,000U/ml20,000U/ml20,000U/ml20,000U/ml20,000U/ml | 合格合格合格合格合格合格合格 | 未试验失败合格失败合格失败合格 |
Claims (72)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US19821699P | 1999-07-22 | 1999-07-22 | |
US60/198,216 | 1999-07-22 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN00812138A Division CN1371284A (zh) | 1999-07-22 | 2000-07-21 | 多剂量红细胞生成素制剂 |
Publications (1)
Publication Number | Publication Date |
---|---|
CN101091792A true CN101091792A (zh) | 2007-12-26 |
Family
ID=22732468
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN00812138A Pending CN1371284A (zh) | 1999-07-22 | 2000-07-21 | 多剂量红细胞生成素制剂 |
CNA2006100710932A Pending CN101091792A (zh) | 1999-07-22 | 2000-07-21 | 多剂量红细胞生成素制剂 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN00812138A Pending CN1371284A (zh) | 1999-07-22 | 2000-07-21 | 多剂量红细胞生成素制剂 |
Country Status (25)
Country | Link |
---|---|
US (1) | US7432360B2 (zh) |
EP (1) | EP1200115B9 (zh) |
JP (1) | JP2003517462A (zh) |
KR (1) | KR100693263B1 (zh) |
CN (2) | CN1371284A (zh) |
AT (1) | ATE304863T1 (zh) |
AU (1) | AU777397B2 (zh) |
BR (1) | BR0012667A (zh) |
CA (1) | CA2378945C (zh) |
CZ (1) | CZ302750B6 (zh) |
DE (1) | DE60022759T2 (zh) |
DK (1) | DK1200115T3 (zh) |
EA (1) | EA006220B1 (zh) |
EE (1) | EE200200037A (zh) |
ES (1) | ES2248110T3 (zh) |
HK (1) | HK1050318A1 (zh) |
HR (1) | HRP20020159B1 (zh) |
HU (1) | HUP0202246A3 (zh) |
IL (2) | IL147755A0 (zh) |
NO (1) | NO20020303L (zh) |
NZ (1) | NZ516735A (zh) |
PL (1) | PL202945B1 (zh) |
RS (1) | RS50355B (zh) |
WO (1) | WO2001007075A2 (zh) |
ZA (1) | ZA200200742B (zh) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EE200200038A (et) | 1999-07-22 | 2003-04-15 | Aventis Pharmaceuticals Inc. | Konservitud farmatseutilised preparaadid |
HU230874B1 (hu) | 2000-05-15 | 2018-11-29 | F. Hoffmann-La Roche Ag | Pegilezett humán eritropoietin-fehérjét tartalmazó, szobahőmérsékleten stabil folyékony gyógyászati készítmények |
EA010889B1 (ru) * | 2004-03-26 | 2008-12-30 | Янссен Фармацевтика Н.В. | Комбинированная схема дозирования эритропоэтина |
US7772182B2 (en) | 2004-08-05 | 2010-08-10 | Alza Corporation | Stable suspension formulations of erythropoietin receptor agonists |
DE502006000770D1 (de) * | 2005-02-03 | 2008-06-26 | Clariant Produkte Deutschland | Konservierungsmittel |
JP2011116752A (ja) * | 2009-10-29 | 2011-06-16 | Jcr Pharmaceuticals Co Ltd | エリスロポエチン含有水性液剤 |
KR101805087B1 (ko) * | 2010-09-16 | 2017-12-05 | 주식회사 엘지화학 | 높은 방부력을 제공하는 오일 주사 제형 |
CN108135841B (zh) * | 2015-10-22 | 2024-03-05 | 艾尔图制药公司 | Il-2的药物组合物 |
Family Cites Families (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3489837A (en) * | 1968-07-11 | 1970-01-13 | Leroy J Hyman | Synergistic antiseptic composition consisting of 9-aminoacridine hydrochloride and benzethonium chloride |
JPS6045849B2 (ja) | 1980-08-25 | 1985-10-12 | 林原 健 | ヒトエリトロポエチンの製造方法 |
US4703008A (en) | 1983-12-13 | 1987-10-27 | Kiren-Amgen, Inc. | DNA sequences encoding erythropoietin |
JPS6191131A (ja) * | 1984-10-09 | 1986-05-09 | Chugai Pharmaceut Co Ltd | 医薬品の吸着防止方法および組成物 |
JPS6197229A (ja) | 1984-10-18 | 1986-05-15 | Chugai Pharmaceut Co Ltd | 安定なエリトロポエチン製剤 |
JPH0651637B2 (ja) * | 1985-03-28 | 1994-07-06 | エーザイ株式会社 | ペプタイドの吸着防止組成物 |
US5045529A (en) * | 1989-03-27 | 1991-09-03 | Bionostics, Inc. | Tonometric fluid for blood gas and co-oximetry instruments |
JP3249147B2 (ja) * | 1990-06-01 | 2002-01-21 | キリン−アムジエン・インコーポレーテツド | 生理活性蛋白含有経口製剤 |
CA2050425A1 (en) * | 1990-09-03 | 1992-03-04 | Yoshiaki Uda | Pharmaceutical composition and its mucous use |
DE4126983A1 (de) * | 1991-08-15 | 1993-02-18 | Boehringer Mannheim Gmbh | Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke |
US5661125A (en) | 1992-08-06 | 1997-08-26 | Amgen, Inc. | Stable and preserved erythropoietin compositions |
JP2532025B2 (ja) * | 1993-07-23 | 1996-09-11 | 株式会社林原生物化学研究所 | 新リンホカインiiiを有効成分とする抗腫瘍作用を有するリンホカインの活性増強剤 |
US5968899A (en) * | 1994-06-03 | 1999-10-19 | Tsumura & Co. | Medicinal compositions of peptides with EACA or tranexamic acid for enhanced mucosal absorption |
JP2000504319A (ja) * | 1996-01-19 | 2000-04-11 | イーライ・リリー・アンド・カンパニー | 肥満症タンパク質製剤 |
CA2265743A1 (en) * | 1996-09-13 | 1998-03-19 | Advanced Medicine Research Institute | Ophthalmic composition of neurotrophic factor, optic nerve functional disorder-treating agent and method for treating optic nerve functional disorder |
JPH1112193A (ja) * | 1997-06-19 | 1999-01-19 | Sankyo Co Ltd | ヒトカルシトニン含有水溶液製剤 |
GB9726555D0 (en) * | 1997-12-16 | 1998-02-11 | Smithkline Beecham Plc | Vaccine |
-
2000
- 2000-07-21 AT AT00960177T patent/ATE304863T1/de active
- 2000-07-21 DK DK00960177T patent/DK1200115T3/da active
- 2000-07-21 CZ CZ20020264A patent/CZ302750B6/cs not_active IP Right Cessation
- 2000-07-21 EP EP00960177A patent/EP1200115B9/en not_active Expired - Lifetime
- 2000-07-21 RS YUP-47/02A patent/RS50355B/sr unknown
- 2000-07-21 ES ES00960177T patent/ES2248110T3/es not_active Expired - Lifetime
- 2000-07-21 HU HU0202246A patent/HUP0202246A3/hu unknown
- 2000-07-21 NZ NZ516735A patent/NZ516735A/en not_active IP Right Cessation
- 2000-07-21 IL IL14775500A patent/IL147755A0/xx unknown
- 2000-07-21 DE DE60022759T patent/DE60022759T2/de not_active Expired - Lifetime
- 2000-07-21 CA CA2378945A patent/CA2378945C/en not_active Expired - Fee Related
- 2000-07-21 CN CN00812138A patent/CN1371284A/zh active Pending
- 2000-07-21 PL PL353569A patent/PL202945B1/pl not_active IP Right Cessation
- 2000-07-21 BR BR0012667-5A patent/BR0012667A/pt not_active IP Right Cessation
- 2000-07-21 EA EA200200073A patent/EA006220B1/ru not_active IP Right Cessation
- 2000-07-21 KR KR1020027000944A patent/KR100693263B1/ko not_active IP Right Cessation
- 2000-07-21 EE EEP200200037A patent/EE200200037A/xx unknown
- 2000-07-21 CN CNA2006100710932A patent/CN101091792A/zh active Pending
- 2000-07-21 JP JP2001511958A patent/JP2003517462A/ja active Pending
- 2000-07-21 AU AU71374/00A patent/AU777397B2/en not_active Ceased
- 2000-07-21 WO PCT/US2000/040446 patent/WO2001007075A2/en active IP Right Grant
-
2002
- 2002-01-21 IL IL147755A patent/IL147755A/en not_active IP Right Cessation
- 2002-01-21 NO NO20020303A patent/NO20020303L/no not_active Application Discontinuation
- 2002-01-28 ZA ZA200200742A patent/ZA200200742B/xx unknown
- 2002-02-21 HR HR20020159A patent/HRP20020159B1/xx not_active IP Right Cessation
-
2003
- 2003-03-24 HK HK03102133.1A patent/HK1050318A1/zh unknown
-
2005
- 2005-06-27 US US11/167,818 patent/US7432360B2/en not_active Expired - Fee Related
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C41 | Transfer of patent application or patent right or utility model | ||
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Effective date of registration: 20090508 Address after: Delaware Applicant after: Aventis holding company Address before: new jersey Applicant before: Aventis Pharmaceuticals Inc. |
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Owner name: AVENTIS-SAAB CO.,LTD. Free format text: FORMER OWNER: AVENTIS HOLDING COMPANY Effective date: 20100506 |
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TA01 | Transfer of patent application right |
Effective date of registration: 20100506 Address after: Delaware Applicant after: Aventis Pharma Inc. Address before: Delaware Applicant before: Aventis holding company |
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