CN103494779A - 一种注射用炎琥宁粉针制剂及其制备方法 - Google Patents
一种注射用炎琥宁粉针制剂及其制备方法 Download PDFInfo
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- CN103494779A CN103494779A CN201310460314.5A CN201310460314A CN103494779A CN 103494779 A CN103494779 A CN 103494779A CN 201310460314 A CN201310460314 A CN 201310460314A CN 103494779 A CN103494779 A CN 103494779A
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- Prior art keywords
- andrographolide
- injection
- preparation
- speed
- drying box
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- BOJKULTULYSRAS-OTESTREVSA-N Andrographolide Chemical compound C([C@H]1[C@]2(C)CC[C@@H](O)[C@]([C@H]2CCC1=C)(CO)C)\C=C1/[C@H](O)COC1=O BOJKULTULYSRAS-OTESTREVSA-N 0.000 title claims abstract description 60
- ASLUCFFROXVMFL-UHFFFAOYSA-N andrographolide Natural products CC1(CO)C(O)CCC2(C)C(CC=C3/C(O)OCC3=O)C(=C)CCC12 ASLUCFFROXVMFL-UHFFFAOYSA-N 0.000 title claims abstract description 60
- 238000002360 preparation method Methods 0.000 title claims abstract description 43
- 239000000843 powder Substances 0.000 title claims abstract description 34
- 238000002347 injection Methods 0.000 title claims abstract description 24
- 239000007924 injection Substances 0.000 title claims abstract description 24
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 38
- 239000008215 water for injection Substances 0.000 claims abstract description 31
- 238000004108 freeze drying Methods 0.000 claims description 43
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 36
- 238000010792 warming Methods 0.000 claims description 26
- 238000000034 method Methods 0.000 claims description 25
- 238000003756 stirring Methods 0.000 claims description 25
- 239000000243 solution Substances 0.000 claims description 22
- 229920002678 cellulose Polymers 0.000 claims description 20
- 238000009413 insulation Methods 0.000 claims description 20
- 239000012982 microporous membrane Substances 0.000 claims description 20
- 239000000203 mixture Substances 0.000 claims description 17
- 238000009472 formulation Methods 0.000 claims description 15
- 229910052799 carbon Inorganic materials 0.000 claims description 12
- 239000003002 pH adjusting agent Substances 0.000 claims description 12
- 238000004321 preservation Methods 0.000 claims description 11
- 238000003556 assay Methods 0.000 claims description 10
- 239000003610 charcoal Substances 0.000 claims description 10
- 239000003599 detergent Substances 0.000 claims description 10
- 239000000706 filtrate Substances 0.000 claims description 10
- 239000012467 final product Substances 0.000 claims description 10
- 238000012856 packing Methods 0.000 claims description 10
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 6
- 238000002156 mixing Methods 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 8
- 239000000126 substance Substances 0.000 abstract description 7
- 239000000463 material Substances 0.000 abstract description 6
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- 239000004480 active ingredient Substances 0.000 abstract 1
- 238000012360 testing method Methods 0.000 description 15
- 239000000047 product Substances 0.000 description 13
- 239000002671 adjuvant Substances 0.000 description 11
- 239000002994 raw material Substances 0.000 description 8
- 239000008176 lyophilized powder Substances 0.000 description 7
- 239000003814 drug Substances 0.000 description 5
- 239000012535 impurity Substances 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 3
- 229930195725 Mannitol Natural products 0.000 description 3
- 239000003963 antioxidant agent Substances 0.000 description 3
- 230000003078 antioxidant effect Effects 0.000 description 3
- 230000003139 buffering effect Effects 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 238000011835 investigation Methods 0.000 description 3
- 150000002500 ions Chemical class 0.000 description 3
- 230000007774 longterm Effects 0.000 description 3
- 239000000594 mannitol Substances 0.000 description 3
- 235000010355 mannitol Nutrition 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- 239000003381 stabilizer Substances 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 208000003455 anaphylaxis Diseases 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 206010002199 Anaphylactic shock Diseases 0.000 description 1
- 229920002307 Dextran Polymers 0.000 description 1
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 description 1
- 239000004472 Lysine Substances 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 230000036783 anaphylactic response Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000005352 clarification Methods 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 239000002158 endotoxin Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 125000003588 lysine group Chemical group [H]N([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])(N([H])[H])C(*)=O 0.000 description 1
- 150000002696 manganese Chemical class 0.000 description 1
- 230000007721 medicinal effect Effects 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 239000013618 particulate matter Substances 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- KYEPHZAHIRDQSR-SXASYTFBSA-L potassium;sodium;4-[[(1r,2r,4ar,5r,8as)-2-(3-carboxylatopropanoyloxy)-1,4a-dimethyl-6-methylidene-5-[(e)-2-(5-oxo-2h-furan-4-yl)ethenyl]-3,4,5,7,8,8a-hexahydro-2h-naphthalen-1-yl]methoxy]-4-oxobutanoate Chemical compound [Na+].[K+].C(/[C@@H]1C(=C)CC[C@H]2[C@@]1(C)CC[C@H]([C@]2(COC(=O)CCC([O-])=O)C)OC(=O)CCC([O-])=O)=C\C1=CCOC1=O KYEPHZAHIRDQSR-SXASYTFBSA-L 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
Description
Claims (10)
Priority Applications (1)
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CN201310460314.5A CN103494779B (zh) | 2013-09-30 | 2013-09-30 | 一种注射用炎琥宁粉针制剂及其制备方法 |
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CN201310460314.5A CN103494779B (zh) | 2013-09-30 | 2013-09-30 | 一种注射用炎琥宁粉针制剂及其制备方法 |
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CN103494779A true CN103494779A (zh) | 2014-01-08 |
CN103494779B CN103494779B (zh) | 2014-11-26 |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106474078A (zh) * | 2015-11-30 | 2017-03-08 | 湖南恒生制药股份有限公司 | 注射用炎琥宁的制备方法 |
CN110467589A (zh) * | 2019-08-28 | 2019-11-19 | 武汉大学 | 一种炎琥宁无菌原料药的制备方法 |
CN110496106A (zh) * | 2019-08-20 | 2019-11-26 | 江苏大同盟制药有限公司 | 一种注射用炎琥宁制剂的制备方法 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101780051A (zh) * | 2008-05-08 | 2010-07-21 | 海南斯达制药有限公司 | 炎琥宁及其冻干粉针剂的制备方法 |
CN102603684A (zh) * | 2012-01-19 | 2012-07-25 | 黑龙江珍宝岛药业股份有限公司 | 一种无菌炎琥宁及其制备方法 |
-
2013
- 2013-09-30 CN CN201310460314.5A patent/CN103494779B/zh active Active
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101780051A (zh) * | 2008-05-08 | 2010-07-21 | 海南斯达制药有限公司 | 炎琥宁及其冻干粉针剂的制备方法 |
CN102603684A (zh) * | 2012-01-19 | 2012-07-25 | 黑龙江珍宝岛药业股份有限公司 | 一种无菌炎琥宁及其制备方法 |
Non-Patent Citations (1)
Title |
---|
赵慧芳等: "近红外漫反射光谱法快速判别注射用炎琥宁的冻干骨架结构", 《中国医院药学杂志》, vol. 32, no. 15, 31 December 2012 (2012-12-31), pages 1201 - 1203 * |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106474078A (zh) * | 2015-11-30 | 2017-03-08 | 湖南恒生制药股份有限公司 | 注射用炎琥宁的制备方法 |
CN110496106A (zh) * | 2019-08-20 | 2019-11-26 | 江苏大同盟制药有限公司 | 一种注射用炎琥宁制剂的制备方法 |
CN110467589A (zh) * | 2019-08-28 | 2019-11-19 | 武汉大学 | 一种炎琥宁无菌原料药的制备方法 |
CN110467589B (zh) * | 2019-08-28 | 2023-04-07 | 武汉大学 | 一种炎琥宁无菌原料药的制备方法 |
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CN103494779B (zh) | 2014-11-26 |
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CB03 | Change of inventor or designer information |
Inventor after: Li Liping Inventor after: Li Qi Inventor after: Yang Lei Inventor before: Li Qi Inventor before: Yang Lei |
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Effective date of registration: 20170725 Address after: 100176 No. 6, Hongda Middle Road, Beijing economic and Technological Development Zone, Beijing Patentee after: Li Liping Address before: 100176 No. 6, Hongda Middle Road, Beijing economic and Technological Development Zone, Beijing Patentee before: Yuekang Pharmaceutical Group Co., Ltd. |
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Effective date of registration: 20180417 Address after: 100176 Hongda middle road six, Beijing economic and Technological Development Zone, Beijing Patentee after: Yuekang Pharmaceutical Group Co., Ltd. Address before: 100176 No. 6, Hongda Middle Road, Beijing economic and Technological Development Zone, Beijing Patentee before: Li Liping |
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CP01 | Change in the name or title of a patent holder | ||
CP01 | Change in the name or title of a patent holder |
Address after: No.6 Hongda Middle Road, Beijing Economic and Technological Development Zone, 100176 Patentee after: Yuekang Pharmaceutical Group Co., Ltd. Address before: No.6 Hongda Middle Road, Beijing Economic and Technological Development Zone, 100176 Patentee before: YOUCARE PHARMACEUTICAL GROUP CO., LTD. |