CN1291475A - 细胞保护剂氨磷汀制剂及其制备方法 - Google Patents
细胞保护剂氨磷汀制剂及其制备方法 Download PDFInfo
- Publication number
- CN1291475A CN1291475A CN00119038A CN00119038A CN1291475A CN 1291475 A CN1291475 A CN 1291475A CN 00119038 A CN00119038 A CN 00119038A CN 00119038 A CN00119038 A CN 00119038A CN 1291475 A CN1291475 A CN 1291475A
- Authority
- CN
- China
- Prior art keywords
- amifostine
- ethyol
- crystallization
- preparation
- freezing
- 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
- JKOQGQFVAUAYPM-UHFFFAOYSA-N amifostine Chemical compound NCCCNCCSP(O)(O)=O JKOQGQFVAUAYPM-UHFFFAOYSA-N 0.000 title claims abstract description 51
- 229960001097 amifostine Drugs 0.000 title claims abstract description 35
- 238000000034 method Methods 0.000 title description 5
- 238000007710 freezing Methods 0.000 claims abstract description 7
- 230000008014 freezing Effects 0.000 claims abstract description 7
- 238000002360 preparation method Methods 0.000 claims description 18
- 238000002425 crystallisation Methods 0.000 claims description 17
- 230000008025 crystallization Effects 0.000 claims description 17
- 229940098617 ethyol Drugs 0.000 claims description 16
- HEMHJVSKTPXQMS-UHFFFAOYSA-M sodium hydroxide Inorganic materials [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 14
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 13
- 239000003814 drug Substances 0.000 claims description 11
- 239000002245 particle Substances 0.000 claims description 9
- 229940079593 drug Drugs 0.000 claims description 8
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims description 6
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 4
- 239000003513 alkali Substances 0.000 claims description 4
- 238000010979 pH adjustment Methods 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 3
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims description 2
- 235000011114 ammonium hydroxide Nutrition 0.000 claims description 2
- 230000001120 cytoprotective effect Effects 0.000 claims description 2
- 229910000029 sodium carbonate Inorganic materials 0.000 claims description 2
- 239000008215 water for injection Substances 0.000 claims 1
- 238000002347 injection Methods 0.000 abstract description 6
- 239000007924 injection Substances 0.000 abstract description 6
- 230000001012 protector Effects 0.000 abstract 1
- 230000001105 regulatory effect Effects 0.000 abstract 1
- 238000007873 sieving Methods 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
- 239000000843 powder Substances 0.000 description 15
- 230000000694 effects Effects 0.000 description 8
- 238000009527 percussion Methods 0.000 description 5
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 4
- LKCWBDHBTVXHDL-RMDFUYIESA-N amikacin Chemical compound O([C@@H]1[C@@H](N)C[C@H]([C@@H]([C@H]1O)O[C@@H]1[C@@H]([C@@H](N)[C@H](O)[C@@H](CO)O1)O)NC(=O)[C@@H](O)CCN)[C@H]1O[C@H](CN)[C@@H](O)[C@H](O)[C@H]1O LKCWBDHBTVXHDL-RMDFUYIESA-N 0.000 description 4
- 229960004821 amikacin Drugs 0.000 description 4
- 229960004756 ethanol Drugs 0.000 description 3
- 238000004108 freeze drying Methods 0.000 description 3
- 238000001959 radiotherapy Methods 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- CMSMOCZEIVJLDB-UHFFFAOYSA-N Cyclophosphamide Chemical compound ClCCN(CCCl)P1(=O)NCCCO1 CMSMOCZEIVJLDB-UHFFFAOYSA-N 0.000 description 2
- 230000000973 chemotherapeutic effect Effects 0.000 description 2
- 238000002512 chemotherapy Methods 0.000 description 2
- 229960004397 cyclophosphamide Drugs 0.000 description 2
- 230000000857 drug effect Effects 0.000 description 2
- 239000000428 dust Substances 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 238000012856 packing Methods 0.000 description 2
- 239000012047 saturated solution Substances 0.000 description 2
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 2
- 235000017557 sodium bicarbonate Nutrition 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- DLYUQMMRRRQYAE-UHFFFAOYSA-N tetraphosphorus decaoxide Chemical compound O1P(O2)(=O)OP3(=O)OP1(=O)OP2(=O)O3 DLYUQMMRRRQYAE-UHFFFAOYSA-N 0.000 description 2
- 238000001291 vacuum drying Methods 0.000 description 2
- 239000003643 water by type Substances 0.000 description 2
- NWXMGUDVXFXRIG-WESIUVDSSA-N (4s,4as,5as,6s,12ar)-4-(dimethylamino)-1,6,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide Chemical compound C1=CC=C2[C@](O)(C)[C@H]3C[C@H]4[C@H](N(C)C)C(=O)C(C(N)=O)=C(O)[C@@]4(O)C(=O)C3=C(O)C2=C1O NWXMGUDVXFXRIG-WESIUVDSSA-N 0.000 description 1
- 229930195573 Amycin Natural products 0.000 description 1
- ASSMDJONQXBMSW-IDWMTUBTSA-N N(=[N+]=[N-])[C@H]1[C@H](C(O[C@@H]1CO)CC=1C(NC(NC1)=O)=O)O Chemical compound N(=[N+]=[N-])[C@H]1[C@H](C(O[C@@H]1CO)CC=1C(NC(NC1)=O)=O)O ASSMDJONQXBMSW-IDWMTUBTSA-N 0.000 description 1
- XDVMCVGTDUKDHL-UHFFFAOYSA-N [amino(2-azaniumylethylsulfanyl)methylidene]azanium;dibromide Chemical compound Br.Br.NCCSC(N)=N XDVMCVGTDUKDHL-UHFFFAOYSA-N 0.000 description 1
- 229910021529 ammonia Inorganic materials 0.000 description 1
- 150000008064 anhydrides Chemical class 0.000 description 1
- 239000003005 anticarcinogenic agent Substances 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- DQLATGHUWYMOKM-UHFFFAOYSA-L cisplatin Chemical compound N[Pt](N)(Cl)Cl DQLATGHUWYMOKM-UHFFFAOYSA-L 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 229960000935 dehydrated alcohol Drugs 0.000 description 1
- 125000004494 ethyl ester group Chemical group 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000011275 oncology therapy Methods 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 239000003223 protective agent Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000004334 sorbic acid Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 238000004448 titration Methods 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
Classifications
-
- 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
- A61K31/66—Phosphorus compounds
- A61K31/661—Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims (9)
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB001190385A CN1148192C (zh) | 2000-10-19 | 2000-10-19 | 细胞保护剂氨磷汀制剂及其制备方法 |
AU2001248229A AU2001248229A1 (en) | 2000-10-19 | 2001-02-28 | Amifostine powder injection and its method of process |
RU2003114443/15A RU2264808C2 (ru) | 2000-10-19 | 2001-02-28 | Амифостин в виде порошка для инъекций и способ его получения |
PCT/CN2001/000310 WO2002032401A1 (fr) | 2000-10-19 | 2001-02-28 | Produit a injecter sous forme de poudre a base d'amifostine et son procede de preparation |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB001190385A CN1148192C (zh) | 2000-10-19 | 2000-10-19 | 细胞保护剂氨磷汀制剂及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1291475A true CN1291475A (zh) | 2001-04-18 |
CN1148192C CN1148192C (zh) | 2004-05-05 |
Family
ID=4587433
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB001190385A Expired - Lifetime CN1148192C (zh) | 2000-10-19 | 2000-10-19 | 细胞保护剂氨磷汀制剂及其制备方法 |
Country Status (4)
Country | Link |
---|---|
CN (1) | CN1148192C (zh) |
AU (1) | AU2001248229A1 (zh) |
RU (1) | RU2264808C2 (zh) |
WO (1) | WO2002032401A1 (zh) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101347412B (zh) * | 2008-09-02 | 2011-07-27 | 大连美罗药业股份有限公司 | 三水合氨磷汀结晶冻干制剂及其制备方法 |
CN102286019A (zh) * | 2011-07-11 | 2011-12-21 | 大连美罗大药厂 | 二水合3-氨基丙基胺乙基硫代磷酸的制备方法 |
CN109694386A (zh) * | 2019-01-23 | 2019-04-30 | 美罗药业股份有限公司 | 氨磷汀三水合物的制备方法 |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2007096901A1 (en) * | 2006-02-24 | 2007-08-30 | Natco Pharma Limited | Novel dihydrate form of amifostine and process for its preparation |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5167947A (en) * | 1989-10-26 | 1992-12-01 | Southwest Research Institute | Enhancement of absorption of radioprotective drugs |
SG47101A1 (en) * | 1992-07-31 | 1998-03-20 | Us Bioscience | Crystalline amifostine compositions and methods for the preparation and use of same |
-
2000
- 2000-10-19 CN CNB001190385A patent/CN1148192C/zh not_active Expired - Lifetime
-
2001
- 2001-02-28 WO PCT/CN2001/000310 patent/WO2002032401A1/zh active Application Filing
- 2001-02-28 RU RU2003114443/15A patent/RU2264808C2/ru active
- 2001-02-28 AU AU2001248229A patent/AU2001248229A1/en not_active Abandoned
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101347412B (zh) * | 2008-09-02 | 2011-07-27 | 大连美罗药业股份有限公司 | 三水合氨磷汀结晶冻干制剂及其制备方法 |
CN102286019A (zh) * | 2011-07-11 | 2011-12-21 | 大连美罗大药厂 | 二水合3-氨基丙基胺乙基硫代磷酸的制备方法 |
CN102286019B (zh) * | 2011-07-11 | 2014-02-05 | 大连美罗大药厂 | 二水合3-氨基丙基胺乙基硫代磷酸的制备方法 |
CN109694386A (zh) * | 2019-01-23 | 2019-04-30 | 美罗药业股份有限公司 | 氨磷汀三水合物的制备方法 |
CN109694386B (zh) * | 2019-01-23 | 2021-03-23 | 美罗药业股份有限公司 | 氨磷汀三水合物的制备方法 |
Also Published As
Publication number | Publication date |
---|---|
CN1148192C (zh) | 2004-05-05 |
AU2001248229A1 (en) | 2002-04-29 |
RU2264808C2 (ru) | 2005-11-27 |
WO2002032401A1 (fr) | 2002-04-25 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C06 | Publication | ||
PB01 | Publication | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
ASS | Succession or assignment of patent right |
Owner name: NANJING KANGHAI PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: NANJING ZHENZHONG BIOLOGICAL ENGINEERING CO., LTD. Effective date: 20040702 |
|
C41 | Transfer of patent application or patent right or utility model | ||
TR01 | Transfer of patent right |
Effective date of registration: 20040702 Address after: 210061 Nanjing hi tech Industrial Development Zone, Jiangsu Patentee after: Kanghai Pharmaceutical Co.,Ltd. Nanjing Address before: 210061 hi tech Industrial Development Zone, Jiangsu, Nanjing Patentee before: Nanjing Zhenzhong Bioengineering Co.,Ltd. |
|
EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Nanjing Cike Pharmaceutical Co.,Ltd. Assignor: Kanghai Pharmaceutical Co.,Ltd. Nanjing Contract fulfillment period: 2008.7.30 to 2013.7.29 Contract record no.: 2008320000282 Denomination of invention: Cell-protecting amifostine and its preparing process Granted publication date: 20040505 License type: Exclusive license Record date: 20080923 |
|
LIC | Patent licence contract for exploitation submitted for record |
Free format text: EXCLUSIVE LICENCE; TIME LIMIT OF IMPLEMENTING CONTACT: 2008.7.30 TO 2013.7.29 Name of requester: NANJING SIKE PHARMACEUTICAL CO., LTD. Effective date: 20080923 |
|
ASS | Succession or assignment of patent right |
Owner name: NANJING SIKE PHARMA CO., LTD. Free format text: FORMER OWNER: NANJING KANGHAI PHARMACEUTICAL CO., LTD. Effective date: 20101213 |
|
C41 | Transfer of patent application or patent right or utility model | ||
C56 | Change in the name or address of the patentee |
Owner name: NANJING LVYE SIKE PHARMA CO., LTD. Free format text: FORMER NAME: NANJING SIKE PHARMA CO., LTD. |
|
COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 210061 HIGH-TECH INDUSTRIAL DEVELOPMENT ZONE, NANJING CITY, JIANGSU PROVINCE TO: 210061 NEW + HIGH TECHNOLOGY INDUSTRY DEVELOPMENT ZONE, NANJING CITY, JIANGSU PROVINCE |
|
CP03 | Change of name, title or address |
Address after: High road 210061 Jiangsu city of Nanjing province high tech Industrial Development Zone No. 28 Patentee after: NANJING LVYE PHARMACEUTICAL CO.,LTD. Address before: 210061 hi tech Industrial Development Zone, Jiangsu, Nanjing Patentee before: Nanjing Cike Pharmaceutical Co.,Ltd. |
|
TR01 | Transfer of patent right |
Effective date of registration: 20101213 Address after: 210061 hi tech Industrial Development Zone, Jiangsu, Nanjing Patentee after: Nanjing Cike Pharmaceutical Co.,Ltd. Address before: 210061 Nanjing hi tech Industrial Development Zone, Jiangsu Patentee before: Kanghai Pharmaceutical Co.,Ltd. Nanjing |
|
C56 | Change in the name or address of the patentee | ||
CP01 | Change in the name or title of a patent holder |
Address after: High road 210061 Jiangsu city of Nanjing province high tech Industrial Development Zone No. 28 Patentee after: NANJING LUYE PHARMACEUTICAL Co.,Ltd. Address before: High road 210061 Jiangsu city of Nanjing province high tech Industrial Development Zone No. 28 Patentee before: NANJING LVYE PHARMACEUTICAL CO.,LTD. |
|
CX01 | Expiry of patent term |
Granted publication date: 20040505 |
|
CX01 | Expiry of patent term |