CN1095934A - Breviscapine powder for injection and its preparation method - Google Patents
Breviscapine powder for injection and its preparation method Download PDFInfo
- Publication number
- CN1095934A CN1095934A CN 93106319 CN93106319A CN1095934A CN 1095934 A CN1095934 A CN 1095934A CN 93106319 CN93106319 CN 93106319 CN 93106319 A CN93106319 A CN 93106319A CN 1095934 A CN1095934 A CN 1095934A
- Authority
- CN
- China
- Prior art keywords
- breviscapine
- injection
- water
- powder injection
- soluble salt
- 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
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- DJSISFGPUUYILV-UHFFFAOYSA-N UNPD161792 Natural products O1C(C(O)=O)C(O)C(O)C(O)C1OC(C(=C1O)O)=CC2=C1C(=O)C=C(C=1C=CC(O)=CC=1)O2 DJSISFGPUUYILV-UHFFFAOYSA-N 0.000 title claims abstract description 32
- DJSISFGPUUYILV-ZFORQUDYSA-N scutellarin Chemical compound O1[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1OC(C(=C1O)O)=CC2=C1C(=O)C=C(C=1C=CC(O)=CC=1)O2 DJSISFGPUUYILV-ZFORQUDYSA-N 0.000 title claims abstract description 31
- 238000002347 injection Methods 0.000 title claims abstract description 24
- 239000007924 injection Substances 0.000 title claims abstract description 24
- 239000000843 powder Substances 0.000 title claims abstract description 18
- 238000002360 preparation method Methods 0.000 title claims abstract description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 27
- 150000003839 salts Chemical class 0.000 claims abstract description 16
- 239000008215 water for injection Substances 0.000 claims abstract description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 14
- 241001013934 Erigeron breviscapus Species 0.000 claims description 10
- 239000000243 solution Substances 0.000 claims description 9
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 8
- 238000012856 packing Methods 0.000 claims description 5
- 238000001035 drying Methods 0.000 claims description 4
- 238000001914 filtration Methods 0.000 claims description 4
- 230000007935 neutral effect Effects 0.000 claims description 4
- 239000002994 raw material Substances 0.000 claims description 4
- -1 amino acid salt Chemical class 0.000 claims description 3
- 238000004108 freeze drying Methods 0.000 claims description 3
- 230000001476 alcoholic effect Effects 0.000 claims description 2
- 239000003513 alkali Substances 0.000 claims description 2
- 150000001413 amino acids Chemical class 0.000 claims description 2
- 238000000034 method Methods 0.000 claims description 2
- 239000008227 sterile water for injection Substances 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 4
- 239000004480 active ingredient Substances 0.000 abstract 1
- 239000002552 dosage form Substances 0.000 abstract 1
- 238000007689 inspection Methods 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- 239000000047 product Substances 0.000 description 5
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 4
- 239000011734 sodium Substances 0.000 description 4
- 229910052708 sodium Inorganic materials 0.000 description 4
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 3
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 3
- 239000008103 glucose Substances 0.000 description 3
- KDXKERNSBIXSRK-UHFFFAOYSA-M lysinate Chemical compound NCCCCC(N)C([O-])=O KDXKERNSBIXSRK-UHFFFAOYSA-M 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000011780 sodium chloride Substances 0.000 description 3
- 208000024172 Cardiovascular disease Diseases 0.000 description 2
- 241000196324 Embryophyta Species 0.000 description 2
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 235000001014 amino acid Nutrition 0.000 description 2
- 239000000706 filtrate Substances 0.000 description 2
- 229910017053 inorganic salt Inorganic materials 0.000 description 2
- 150000007530 organic bases Chemical class 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- DWNBOPVKNPVNQG-LURJTMIESA-N (2s)-4-hydroxy-2-(propylamino)butanoic acid Chemical compound CCCN[C@H](C(O)=O)CCO DWNBOPVKNPVNQG-LURJTMIESA-N 0.000 description 1
- 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 description 1
- 239000004475 Arginine Substances 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 206010008132 Cerebral thrombosis Diseases 0.000 description 1
- 108010023832 Florigen Proteins 0.000 description 1
- 241000628997 Flos Species 0.000 description 1
- 206010019468 Hemiplegia Diseases 0.000 description 1
- 201000001429 Intracranial Thrombosis Diseases 0.000 description 1
- 235000019766 L-Lysine Nutrition 0.000 description 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 1
- 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 description 1
- 239000004472 Lysine Substances 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 238000003916 acid precipitation Methods 0.000 description 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- AXCZMVOFGPJBDE-UHFFFAOYSA-L calcium dihydroxide Chemical compound [OH-].[OH-].[Ca+2] AXCZMVOFGPJBDE-UHFFFAOYSA-L 0.000 description 1
- 239000000920 calcium hydroxide Substances 0.000 description 1
- 229910001861 calcium hydroxide Inorganic materials 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 235000008504 concentrate Nutrition 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 230000001261 florigenic effect Effects 0.000 description 1
- 235000013312 flour Nutrition 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 238000007670 refining Methods 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 239000006188 syrup Substances 0.000 description 1
- 235000020357 syrup Nutrition 0.000 description 1
- 238000010792 warming Methods 0.000 description 1
- 238000003809 water extraction Methods 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a medicine with special dosage form for curing angiocardiopathy and its preparation process. The breviscapine powder for injection consists of breviscapine water soluble salt in 5-30 wt% and water soluble supplementary material for injection in the rest amount. The powder injection is prepared by using breviscapine water-soluble salt as a main active ingredient, is convenient to transport and store due to dry conditions, has good product stability and shelf life of more than two years, and has quality indexes meeting Yunnan Q/WS 697-1984 standard after quality standard inspection of injection liquid obtained by adding water for injection into the powder injection.
Description
The present invention relates to a kind of medicine of the special form that is used for the treatment of cardiovascular disease and the preparation technology of this medicine.
Chinese patent application CN1053609A(application number 9010045.0) a kind of " extraction process of Herba Erigerontis tablet crude drug " disclosed, this technology is with Herba Erigerontis Herb coarse powder, through the ethanol lixiviate, when being evaporated to rare syrup, alcohol extract emits concentrate, behind the hot water extraction, with Acid precipitation, the deacidification remove impurity, the portable lighter small cup florigen coarse-grain of going forward side by side is refining, obtains the breviscapine elaboration.
Breviscapine is by a kind of plant amedica that is used for the treatment of cardiovascular disease of extracting in the Herba Erigerontis plant of Yunnan, the eighties successively has pin, tablet to appear on the market, injection is used for the treatment of cerebral thrombosis hemiplegia, coronary heart disease etc. in clinical have better curative effect, but present employed injection poor stability, the product storage life is short, it is low to criticize qualification rate, is difficult to the large scale investment commercial production, for extensive use is clinically made troubles.
Purpose of the present invention is intended to overcome the deficiencies in the prior art, the industrial production in enormous quantities of a kind of energy, steady quality is provided and is convenient to transport the erigeron breviscapus powder injection and the preparation technology thereof of preservation.
Oil lamp pollen hormone injection of the present invention is made up of breviscapine water soluble salt and water for injection dissolubility pharmaceutic adjuvant, and the content of breviscapine water soluble salt is the 5-30%(percentage by weight), surplus is a pharmaceutic adjuvant.The breviscapine water soluble salt is divided into water solublity organic salt and water-soluble inorganic salt, and water solublity organic salt is breviscapine and basic amino acid salt, as breviscapine lysinate, breviscapine arginine salt etc.; Water-soluble inorganic salt is breviscapine sodium, breviscapine potassium, breviscapine calcium etc.The water solublity pharmaceutic adjuvant is all purpose flour injection water solublity pharmaceutic adjuvants such as sodium chloride, glucose, lactose, sucrose.
The preparation method of erigeron breviscapus powder injection of the present invention is:
(1), with the breviscapine is raw material, add 15-25 times of weight in the water of raw material, under 50-80 ℃ condition, adding concentration is the aqueous slkali of 10-20%, transfers pH value to neutral, solution filters, add isopyknic alcoholic solution, shake up, leaving standstill under 0-15 ℃ more than 4 hours, sucking filtration, drying under aseptic condition make the breviscapine water soluble salt;
(2), in proportion add sterile water for injection dissolubility pharmaceutic adjuvant,, handle, get product by lyophilization or weight packing method, packing.
The aqueous slkali that step () is added can be organic base solution or inorganic alkali solution, and organic base is a basic amino acid, and as propylhomoserin, arginine etc., mineral acid is sodium hydroxide, potassium hydroxide, calcium hydroxide etc.
Erigeron breviscapus powder injection of the present invention is to be that main active is prepared from the plain water soluble salt of oil lamp, owing to be drying condition transportation and storage, comparatively convenient, and product stability is good, shelf-life is more than 2 years, the gained injection was checked through quality standard after injectable powder added water for injection, and every quality index all meets Yunnan Q/WS697-1984 standard.The injectable powder production technology is simple, and working condition is controlled easily, can put into production in enormous quantities.
Be embodiments of the invention below:
Embodiment 1: dissolve in L-lysine 5g in the 300ml distilled water, heat temperature raising to 60 ℃, stir adding breviscapine 16g, it is neutral that pH value is measured in the dissolving back, sucking filtration, add equal-volume 95% ethanol in the filtrate, left standstill 8 hours in 8 ℃, separate out crystallization, drain, drying gets water solublity breviscapine lysinate.
Get this salt and be equipped with the sodium chloride for injection adjuvant, porphyrize by 100 mesh sieve holes, is pressed breviscapine lysinate 5mg, and sodium chloride 95mg packing gets product.
Embodiment 2: it is an amount of to get breviscapine, dissolve in the water of 18 times of weight, be warming up to 75 ℃, sodium hydroxide with 20% is carefully regulated pH value to neutral, filter, filtrate adds equal-volume 95% ethanol, shake up, left standstill sucking filtration, dry concentrating 12 hours in 0 ℃, make 2.5%(w/v) the breviscapine sodium solution, ratio in breviscapine sodium (dry measure) 15%, glucose 85% adds glucose for injection adjuvant, every packing 0.6ml, lyophilization, sealing by fusing promptly gets every and contains breviscapine sodium 15mg(effective ingredient) the specification product.
Claims (7)
1, a kind of erigeron breviscapus powder injection is characterized in that being made up of breviscapine water soluble salt and water for injection dissolubility pharmaceutic adjuvant, and the content of breviscapine water soluble salt is 5-30% (percentage by weight), and surplus is a pharmaceutic adjuvant.
2, erigeron breviscapus powder injection according to claim 1 is characterized in that the breviscapine water soluble salt is a breviscapine and basic amino acid salt.
3, erigeron breviscapus powder injection according to claim 1 is characterized in that the breviscapine water soluble salt is the breviscapine inorganic salts.
4, the preparation method of erigeron breviscapus powder injection according to claim 1 is characterized in that being made up of following steps:
(1), with the breviscapine is raw material, add 15-25 times of weight in the water of raw material, under 50-80 ℃ condition, adding concentration is the aqueous slkali of 10-20%, transfers pH value to neutral, solution filters, add isopyknic alcoholic solution, shake up, leaving standstill under 0-15 ℃ more than 4 hours, sucking filtration, drying under aseptic condition make the breviscapine water soluble salt;
(2), in proportion add sterile water for injection dissolubility pharmaceutic adjuvant, according to lyophilization or weight dress method, packing is handled, and gets product.
5, the preparation method of erigeron breviscapus powder injection according to claim 4 is characterized in that the aqueous slkali that is added is a basic amino acid solution.
6, the preparation method of erigeron breviscapus powder injection according to claim 4 is characterized in that the aqueous slkali that is added is an inorganic alkali solution.
7, the preparation method of erigeron breviscapus powder injection according to claim 4 is characterized in that the ethanol that is added is the ethanol of 95% concentration.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN93106319A CN1049121C (en) | 1993-05-29 | 1993-05-29 | Breviscapine powder for injection and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN93106319A CN1049121C (en) | 1993-05-29 | 1993-05-29 | Breviscapine powder for injection and its preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1095934A true CN1095934A (en) | 1994-12-07 |
| CN1049121C CN1049121C (en) | 2000-02-09 |
Family
ID=4986179
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN93106319A Expired - Lifetime CN1049121C (en) | 1993-05-29 | 1993-05-29 | Breviscapine powder for injection and its preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1049121C (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1055844C (en) * | 1995-04-10 | 2000-08-30 | 昆明龙津药业有限公司 | Erigeron breviscapus basic element freezed drying preparation for injection and preparation process |
| CN1062161C (en) * | 1997-01-08 | 2001-02-21 | 大连弘丰制药厂 | Stable prescription and process of fleabane extract injection |
| CN1069520C (en) * | 1998-03-17 | 2001-08-15 | 昆明制药股份有限公司 | Breviscapine soft capsule and its production method |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1053609A (en) * | 1990-01-25 | 1991-08-07 | 云南省生物制药厂 | The extraction process of Herba Erigerontis tablet bulk drug |
-
1993
- 1993-05-29 CN CN93106319A patent/CN1049121C/en not_active Expired - Lifetime
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1055844C (en) * | 1995-04-10 | 2000-08-30 | 昆明龙津药业有限公司 | Erigeron breviscapus basic element freezed drying preparation for injection and preparation process |
| CN1062161C (en) * | 1997-01-08 | 2001-02-21 | 大连弘丰制药厂 | Stable prescription and process of fleabane extract injection |
| CN1069520C (en) * | 1998-03-17 | 2001-08-15 | 昆明制药股份有限公司 | Breviscapine soft capsule and its production method |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1049121C (en) | 2000-02-09 |
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| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C56 | Change in the name or address of the patentee |
Owner name: KUNMING MEDICINE GROUP STOCK CO., LTD. Free format text: FORMER NAME OR ADDRESS: KUNMING MEDICINE STOCK CO., LTD. |
|
| CP01 | Change in the name or title of a patent holder |
Patentee after: Kunming Pharmaceutical Industry Group Corp., Ltd. Patentee before: Kunming Pharmaceutical Co., Ltd. |
|
| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Hengyang Hengsheng Pharmaceutical Co., Ltd. Assignor: Jiangxi Yide pharmaceutical science and Technology Development Co Ltd Contract fulfillment period: 2008.11.22 to 2013.5.29 contract change Contract record no.: 2008360000059 Denomination of invention: Erigeron breviscapus powder injection and preparation thereof Granted publication date: 19991127 License type: General permission Record date: 20081127 Assignee: Jiangxi Yide pharmaceutical science and Technology Development Co Ltd Assignor: Kunming Pharmaceutical Industry Group Corp., Ltd. Contract fulfillment period: 2008.8.18 to 2013.5.29 contract change Contract record no.: 2008520000002 Denomination of invention: Erigeron breviscapus powder injection and preparation thereof Granted publication date: 19991127 License type: exclusive license Record date: 2008.9.5 |
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| LIC | Patent licence contract for exploitation submitted for record |
Free format text: EXCLUSIVE LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2008.8.18 TO 2013.5.29; CHANGE OF CONTRACT Name of requester: JIANGXI YIDE MEDICINE SCIENCE DEVELOPMENT CO., LTD Effective date: 20080905 Free format text: COMMON LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2008.11.22 TO 2013.5.29; CHANGE OF CONTRACT Name of requester: HENGYANG HENGSHENG PHARMACEUTICAL CO., LTD. Effective date: 20081127 |
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| C17 | Cessation of patent right | ||
| CX01 | Expiry of patent term |
Expiration termination date: 20130529 Granted publication date: 20000209 |