CN105769776A - 一种治疗非霍奇金淋巴瘤的冻干组合物及其制备方法 - Google Patents
一种治疗非霍奇金淋巴瘤的冻干组合物及其制备方法 Download PDFInfo
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- CN105769776A CN105769776A CN201610175504.6A CN201610175504A CN105769776A CN 105769776 A CN105769776 A CN 105769776A CN 201610175504 A CN201610175504 A CN 201610175504A CN 105769776 A CN105769776 A CN 105769776A
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- CN
- China
- Prior art keywords
- freeze
- dried composition
- maleic acid
- pixantrone
- composition according
- Prior art date
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- Granted
Links
- 238000002360 preparation method Methods 0.000 title claims abstract description 33
- 239000000203 mixture Substances 0.000 title claims abstract description 28
- 208000015914 Non-Hodgkin lymphomas Diseases 0.000 title claims abstract description 23
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 44
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims abstract description 35
- OFOBLEOULBTSOW-UHFFFAOYSA-N Propanedioic acid Natural products OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 claims abstract description 34
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 claims abstract description 34
- 239000011976 maleic acid Substances 0.000 claims abstract description 34
- PEZPMAYDXJQYRV-UHFFFAOYSA-N pixantrone Chemical compound O=C1C2=CN=CC=C2C(=O)C2=C1C(NCCN)=CC=C2NCCN PEZPMAYDXJQYRV-UHFFFAOYSA-N 0.000 claims abstract description 34
- 229960004403 pixantrone Drugs 0.000 claims abstract description 34
- 239000011780 sodium chloride Substances 0.000 claims abstract description 22
- 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 abstract description 20
- 239000008101 lactose Substances 0.000 claims abstract description 20
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims abstract description 19
- 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 abstract description 18
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 60
- 239000000243 solution Substances 0.000 claims description 39
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 30
- 239000008215 water for injection Substances 0.000 claims description 30
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 25
- 239000001632 sodium acetate Substances 0.000 claims description 18
- 235000017281 sodium acetate Nutrition 0.000 claims description 18
- 238000004108 freeze drying Methods 0.000 claims description 15
- 238000011179 visual inspection Methods 0.000 claims description 15
- 238000005303 weighing Methods 0.000 claims description 15
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 6
- 239000003002 pH adjusting agent Substances 0.000 claims description 6
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 4
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 2
- SRSXLGNVWSONIS-UHFFFAOYSA-N benzenesulfonic acid Chemical compound OS(=O)(=O)C1=CC=CC=C1 SRSXLGNVWSONIS-UHFFFAOYSA-N 0.000 claims description 2
- 229940092714 benzenesulfonic acid Drugs 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 4
- 238000000034 method Methods 0.000 abstract description 3
- 239000004480 active ingredient Substances 0.000 abstract 1
- 238000005516 engineering process Methods 0.000 description 17
- 229960001375 lactose Drugs 0.000 description 15
- 230000000052 comparative effect Effects 0.000 description 10
- 239000007924 injection Substances 0.000 description 7
- 238000002347 injection Methods 0.000 description 7
- 238000001990 intravenous administration Methods 0.000 description 4
- 238000002474 experimental method Methods 0.000 description 3
- 238000011835 investigation Methods 0.000 description 3
- 210000001165 lymph node Anatomy 0.000 description 3
- 210000000056 organ Anatomy 0.000 description 3
- 239000008354 sodium chloride injection Substances 0.000 description 3
- 239000012895 dilution Substances 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 description 2
- 229960002668 sodium chloride Drugs 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 125000000022 2-aminoethyl group Chemical group [H]C([*])([H])C([H])([H])N([H])[H] 0.000 description 1
- 208000011776 Aggressive B-cell non-Hodgkin lymphoma Diseases 0.000 description 1
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.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 WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 description 1
- 229920002307 Dextran Polymers 0.000 description 1
- 206010061818 Disease progression Diseases 0.000 description 1
- 206010060891 General symptom Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 206010064390 Tumour invasion Diseases 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 125000005605 benzo group Chemical group 0.000 description 1
- 230000009400 cancer invasion Effects 0.000 description 1
- 208000035269 cancer or benign tumor Diseases 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 229940119744 dextran 40 Drugs 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 230000005750 disease progression Effects 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 235000011087 fumaric acid Nutrition 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 229960001021 lactose monohydrate Drugs 0.000 description 1
- 210000004698 lymphocyte Anatomy 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 230000001613 neoplastic effect Effects 0.000 description 1
- 210000004049 perilymph Anatomy 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 208000037920 primary disease Diseases 0.000 description 1
- 238000004393 prognosis Methods 0.000 description 1
- 230000000306 recurrent effect Effects 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000011125 single therapy Methods 0.000 description 1
- 229960004249 sodium acetate Drugs 0.000 description 1
- 230000004797 therapeutic response Effects 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
Classifications
-
- 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
-
- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
-
- 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
- A61K47/26—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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims (10)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201610175504.6A CN105769776B (zh) | 2016-03-26 | 2016-03-26 | 一种治疗非霍奇金淋巴瘤的冻干组合物及其制备方法 |
CN201810192123.8A CN108113967A (zh) | 2016-03-26 | 2016-03-26 | 一种治疗非霍奇金淋巴瘤的冻干组合物及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201610175504.6A CN105769776B (zh) | 2016-03-26 | 2016-03-26 | 一种治疗非霍奇金淋巴瘤的冻干组合物及其制备方法 |
Related Child Applications (1)
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CN201810192123.8A Division CN108113967A (zh) | 2016-03-26 | 2016-03-26 | 一种治疗非霍奇金淋巴瘤的冻干组合物及其制备方法 |
Publications (2)
Publication Number | Publication Date |
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CN105769776A true CN105769776A (zh) | 2016-07-20 |
CN105769776B CN105769776B (zh) | 2018-05-11 |
Family
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Family Applications (2)
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CN201810192123.8A Pending CN108113967A (zh) | 2016-03-26 | 2016-03-26 | 一种治疗非霍奇金淋巴瘤的冻干组合物及其制备方法 |
CN201610175504.6A Expired - Fee Related CN105769776B (zh) | 2016-03-26 | 2016-03-26 | 一种治疗非霍奇金淋巴瘤的冻干组合物及其制备方法 |
Family Applications Before (1)
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CN201810192123.8A Pending CN108113967A (zh) | 2016-03-26 | 2016-03-26 | 一种治疗非霍奇金淋巴瘤的冻干组合物及其制备方法 |
Country Status (1)
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CN (2) | CN108113967A (zh) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106176630A (zh) * | 2016-08-03 | 2016-12-07 | 湖北丽益医药科技有限公司 | 一种注射用马来酸匹杉琼无菌粉末的制备方法 |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ITMI20021040A1 (it) * | 2002-05-16 | 2003-11-17 | Novuspharma Spa | Composizioni farmaceutiche iniettabili di un derivato antracenedionico ad attivita' antitumorale |
CN101439181B (zh) * | 2008-12-31 | 2012-12-26 | 广东天普生化医药股份有限公司 | 一种稳定的乌司他丁水针剂药物组合物 |
CN103479578B (zh) * | 2012-06-14 | 2016-08-03 | 沈阳药科大学 | 一种马来酸匹杉琼的脂质体制剂及其制备工艺 |
CN105288648B (zh) * | 2015-10-14 | 2018-11-06 | 东南大学 | 一种亲水性药物的磷脂化合物、其药物组合物及应用 |
-
2016
- 2016-03-26 CN CN201810192123.8A patent/CN108113967A/zh active Pending
- 2016-03-26 CN CN201610175504.6A patent/CN105769776B/zh not_active Expired - Fee Related
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106176630A (zh) * | 2016-08-03 | 2016-12-07 | 湖北丽益医药科技有限公司 | 一种注射用马来酸匹杉琼无菌粉末的制备方法 |
CN106176630B (zh) * | 2016-08-03 | 2019-01-04 | 湖北丽益医药科技有限公司 | 一种注射用马来酸匹杉琼无菌粉末的制备方法 |
Also Published As
Publication number | Publication date |
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CN108113967A (zh) | 2018-06-05 |
CN105769776B (zh) | 2018-05-11 |
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SE01 | Entry into force of request for substantive examination | ||
CB03 | Change of inventor or designer information |
Inventor after: Wang Luanqiu Inventor after: Chen Yaokun Inventor after: Wang Xiaoyan Inventor after: Xu Yan Inventor before: Xia Jianming |
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CB03 | Change of inventor or designer information | ||
TA01 | Transfer of patent application right |
Effective date of registration: 20180408 Address after: Qingdao City, Shandong province 266011 four Road No. 127 Applicant after: QINGDAO TUMOUR HOSPITAL Address before: 214263 Jiangsu city of Wuxi province Yixing Zhoutie town under Zhu village Zhang Village No. 53 Applicant before: Xia Jianming |
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CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20180511 Termination date: 20190326 |
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CF01 | Termination of patent right due to non-payment of annual fee |