CN101791315B - 复方甘草酸单铵s药物组合物及其大容量注射剂制备方法 - Google Patents
复方甘草酸单铵s药物组合物及其大容量注射剂制备方法 Download PDFInfo
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- CN101791315B CN101791315B CN2010101130184A CN201010113018A CN101791315B CN 101791315 B CN101791315 B CN 101791315B CN 2010101130184 A CN2010101130184 A CN 2010101130184A CN 201010113018 A CN201010113018 A CN 201010113018A CN 101791315 B CN101791315 B CN 101791315B
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- sodium chloride
- monoammonium glycyrrhizinate
- injection
- sodium
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- 238000000034 method Methods 0.000 title claims abstract description 33
- -1 Compound monoammonium glycyrrhizinate Chemical class 0.000 title claims abstract description 30
- 239000007924 injection Substances 0.000 title claims abstract description 14
- 238000002347 injection Methods 0.000 title claims abstract description 14
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 10
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 70
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims abstract description 57
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims abstract description 40
- 239000011780 sodium chloride Substances 0.000 claims abstract description 35
- ILRKKHJEINIICQ-OOFFSTKBSA-N Monoammonium glycyrrhizinate Chemical compound N.O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C(O)=O)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O ILRKKHJEINIICQ-OOFFSTKBSA-N 0.000 claims abstract description 23
- 239000008354 sodium chloride injection Substances 0.000 claims abstract description 21
- QIJRTFXNRTXDIP-UHFFFAOYSA-N (1-carboxy-2-sulfanylethyl)azanium;chloride;hydrate Chemical compound O.Cl.SCC(N)C(O)=O QIJRTFXNRTXDIP-UHFFFAOYSA-N 0.000 claims abstract description 20
- 239000004471 Glycine Substances 0.000 claims abstract description 20
- 229960001305 cysteine hydrochloride Drugs 0.000 claims abstract description 20
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 claims abstract description 20
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 19
- 239000001509 sodium citrate Substances 0.000 claims abstract description 16
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims abstract description 16
- 239000008215 water for injection Substances 0.000 claims abstract description 16
- 239000000203 mixture Substances 0.000 claims abstract description 10
- 238000002360 preparation method Methods 0.000 claims description 18
- 239000000243 solution Substances 0.000 claims description 18
- 229940101006 anhydrous sodium sulfite Drugs 0.000 claims description 17
- 238000003756 stirring Methods 0.000 claims description 12
- 239000003610 charcoal Substances 0.000 claims description 9
- 238000003556 assay Methods 0.000 claims description 8
- 238000001914 filtration Methods 0.000 claims description 6
- 238000005303 weighing Methods 0.000 claims description 6
- 238000013019 agitation Methods 0.000 claims description 3
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 3
- 229910052782 aluminium Inorganic materials 0.000 claims description 3
- 239000004411 aluminium Substances 0.000 claims description 3
- 238000010009 beating Methods 0.000 claims description 3
- 238000005262 decarbonization Methods 0.000 claims description 3
- 238000011010 flushing procedure Methods 0.000 claims description 3
- 239000007788 liquid Substances 0.000 claims description 3
- 239000012528 membrane Substances 0.000 claims description 3
- 238000009287 sand filtration Methods 0.000 claims description 3
- 239000000825 pharmaceutical preparation Substances 0.000 abstract 1
- 230000000052 comparative effect Effects 0.000 description 21
- 239000013618 particulate matter Substances 0.000 description 18
- 238000002474 experimental method Methods 0.000 description 6
- 239000003963 antioxidant agent Substances 0.000 description 5
- 230000003078 antioxidant effect Effects 0.000 description 5
- 238000011160 research Methods 0.000 description 5
- 239000004531 microgranule Substances 0.000 description 4
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 description 3
- 239000008176 lyophilized powder Substances 0.000 description 3
- SHWNNYZBHZIQQV-UHFFFAOYSA-J EDTA monocalcium diisodium salt Chemical compound [Na+].[Na+].[Ca+2].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O SHWNNYZBHZIQQV-UHFFFAOYSA-J 0.000 description 2
- 206010018691 Granuloma Diseases 0.000 description 2
- 210000004556 brain Anatomy 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 230000002950 deficient Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 208000006454 hepatitis Diseases 0.000 description 2
- 231100000283 hepatitis Toxicity 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- 210000003734 kidney Anatomy 0.000 description 2
- 210000004185 liver Anatomy 0.000 description 2
- 210000004072 lung Anatomy 0.000 description 2
- 208000008964 Chemical and Drug Induced Liver Injury Diseases 0.000 description 1
- 206010013700 Drug hypersensitivity Diseases 0.000 description 1
- 208000005189 Embolism Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 231100000643 Substance intoxication Toxicity 0.000 description 1
- 208000001435 Thromboembolism Diseases 0.000 description 1
- 206010070863 Toxicity to various agents Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000002052 anaphylactic effect Effects 0.000 description 1
- 206010003230 arteritis Diseases 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 230000002596 correlated effect Effects 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 201000005311 drug allergy Diseases 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 235000013905 glycine and its sodium salt Nutrition 0.000 description 1
- 210000002216 heart Anatomy 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 239000003978 infusion fluid Substances 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 230000003908 liver function Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000017074 necrotic cell death Effects 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 239000007800 oxidant agent Substances 0.000 description 1
- 230000001590 oxidative effect Effects 0.000 description 1
- 230000002085 persistent effect Effects 0.000 description 1
- 208000001297 phlebitis Diseases 0.000 description 1
- 230000035755 proliferation Effects 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 229940001482 sodium sulfite Drugs 0.000 description 1
- 235000010265 sodium sulphite Nutrition 0.000 description 1
- 210000000952 spleen Anatomy 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 230000008359 toxicosis Effects 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
0月 6月 12月 18月 24月 |
本发明实施例1 99.1 99.1 98.7 98.5 97.9 |
本发明实施例2 98.5 98.3 98.0 97.4 97.5 |
本发明实施例3 99.0 99.2 97.9 97.8 96.7 |
对比实施例1 98.5 98.0 94.3 92.2 87.1 |
对比实施例2 99.2 99.0 96.2 94.8 92.5 |
对比实施例3 100.1 99.7 98.2 98.6 97.8 |
对比实施例4 99.3 98.7 98.4 98.1 97.2 |
0月 6月 12月 18月 24月 |
本发明实施例1 99.5 99.2 98.0 97.2 97.4 |
本发明实施例2 99.5 99.4 98.7 98.0 97.6 |
本发明实施例3 99.9 99.7 98.9 98.3 98.0 |
对比实施例1 99.8 99.4 95.0 93.3 90.7 |
对比实施例2 99.2 98.8 97.5 95.0 93.9 |
对比实施例3 99.3 99.3 98.2 97.4 97.5 |
对比实施例4 99.8 99.0 97.6 97.6 97.0 |
0月 6月 12月 18月 24月 |
本发明实施例1 99.5 99.5 99.0 98.6 98.2 |
本发明实施例2 98.9 98.5 98.6 98.1 98.0 |
本发明实施例3 99.7 99.3 98.7 97.7 97.6 |
对比实施例1 99.0 98.2 95.3 93.3 91.6 |
对比实施例2 98.7 98.4 97.0 94.2 93.9 |
对比实施例3 99.3 99.2 98.1 98.0 98.1 |
对比实施例4 99.1 98.0 97.9 98.0 97.4 |
0月 6月 12月 18月 24月 |
本发明实施例1 5 7 8 8 10 |
本发明实施例2 4 6 6 8 9 |
本发明实施例3 7 8 8 9 11 |
对比实施例1 6 9 10 11 13 |
对比实施例2 7 12 15 21 28 |
对比实施例3 9 11 19 24 35 |
对比实施例4 8 15 23 27 44 |
0月 6月 12月 18月24月 |
本发明实施例1 0 0 0 1 1 |
本发明实施例2 0 0 0 1 1 |
本发明实施例3 0 0 0 0 0 |
对比实施例1 0 0 1 1 1 |
对比实施例2 0 1 2 4 4 |
对比实施例3 1 3 3 5 6 |
对比实施例4 0 2 6 8 10 |
Claims (5)
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CN2010101130184A CN101791315B (zh) | 2010-02-24 | 2010-02-24 | 复方甘草酸单铵s药物组合物及其大容量注射剂制备方法 |
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CN2010101130184A CN101791315B (zh) | 2010-02-24 | 2010-02-24 | 复方甘草酸单铵s药物组合物及其大容量注射剂制备方法 |
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Publication Number | Publication Date |
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CN101791315A CN101791315A (zh) | 2010-08-04 |
CN101791315B true CN101791315B (zh) | 2012-04-18 |
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CN2010101130184A Active CN101791315B (zh) | 2010-02-24 | 2010-02-24 | 复方甘草酸单铵s药物组合物及其大容量注射剂制备方法 |
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Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
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KR20130132496A (ko) | 2010-12-09 | 2013-12-04 | 마루이시세이야쿠가부시키가이샤 | 아세트아미노펜의 안정화제 |
CN104138385B (zh) * | 2014-08-14 | 2015-07-08 | 广州一品红制药有限公司 | 一种含复方甘草酸单铵s的组合物 |
CN108553415A (zh) * | 2018-06-19 | 2018-09-21 | 吉林百年汉克制药有限公司 | 一种复方甘草酸单铵s注射液药物组合物及其制备方法和应用 |
CN109364087A (zh) * | 2018-10-26 | 2019-02-22 | 山西普德药业有限公司 | 一种注射用复方甘草酸单铵s |
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2010
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Application publication date: 20100804 Assignee: Qingdao Jinfeng Pharmaceutical Co., Ltd. Assignor: Wang Baoming Contract record no.: 2012110000153 Denomination of invention: Compound monoammonium glycyrrhizinate S pharmaceutical composition and method for preparing high-capacity injection Granted publication date: 20120418 License type: Common License Record date: 20120918 |
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Application publication date: 20100804 Assignee: Jiangsu Pengyao Pharmaceutical Inc. Assignor: Wang Baoming Contract record no.: 2013990000591 Denomination of invention: Compound monoammonium glycyrrhizinate S pharmaceutical composition and method for preparing high-capacity injection Granted publication date: 20120418 License type: Common License Record date: 20130913 |
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Effective date of registration: 20160121 Address after: 100022 Beijing Jianguo Road No. 93, building 12, building 1901, No. Patentee after: Beijing Bobangjiayuan Medical Technology Development Co.,Ltd. Address before: Room 12, building 93, Wanda Plaza, No. 100022 Jianguo Road, Beijing, Chaoyang District, China Patentee before: Wang Baoming |
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TR01 | Transfer of patent right |
Effective date of registration: 20161222 Address after: 100022 Beijing Jianguo Road No. 93, building 12, building 1901, No. Patentee after: XIZANG JIURUI HEALTH Co.,Ltd. Address before: 100022 Beijing Jianguo Road No. 93, building 12, building 1901, No. Patentee before: Beijing Bobangjiayuan Medical Technology Development Co.,Ltd. |
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Addressee: XIZANG JIURUI HEALTH Co.,Ltd. Document name: Notification of Passing Examination on Formalities |
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Address after: 100022 Beijing Jianguo Road No. 93, building 12, building 1901, No. Patentee after: JIURUI health Co.,Ltd. Address before: 100022 Beijing Jianguo Road No. 93, building 12, building 1901, No. Patentee before: XIZANG JIURUI HEALTH Co.,Ltd. |
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