CN100337629C - Milrinone sodium chloride injection and production thereof - Google Patents
Milrinone sodium chloride injection and production thereof Download PDFInfo
- Publication number
- CN100337629C CN100337629C CNB2004100308269A CN200410030826A CN100337629C CN 100337629 C CN100337629 C CN 100337629C CN B2004100308269 A CNB2004100308269 A CN B2004100308269A CN 200410030826 A CN200410030826 A CN 200410030826A CN 100337629 C CN100337629 C CN 100337629C
- Authority
- CN
- China
- Prior art keywords
- injection
- sodium chloride
- milrinone
- lactic acid
- water
- 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.)
- Expired - Lifetime
Links
- PZRHRDRVRGEVNW-UHFFFAOYSA-N milrinone Chemical compound N1C(=O)C(C#N)=CC(C=2C=CN=CC=2)=C1C PZRHRDRVRGEVNW-UHFFFAOYSA-N 0.000 title claims abstract description 28
- 229960003574 milrinone Drugs 0.000 title claims abstract description 28
- 239000008354 sodium chloride injection Substances 0.000 title claims abstract description 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 37
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims abstract description 36
- 239000004310 lactic acid Substances 0.000 claims abstract description 18
- 235000014655 lactic acid Nutrition 0.000 claims abstract description 18
- 239000011780 sodium chloride Substances 0.000 claims abstract description 18
- 238000002347 injection Methods 0.000 claims abstract description 14
- 239000007924 injection Substances 0.000 claims abstract description 14
- 238000002360 preparation method Methods 0.000 claims abstract description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 15
- 239000008215 water for injection Substances 0.000 claims description 15
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 9
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 3
- 229910052799 carbon Inorganic materials 0.000 claims description 3
- 238000001914 filtration Methods 0.000 claims description 3
- 239000000243 solution Substances 0.000 claims description 3
- 230000001954 sterilising effect Effects 0.000 claims description 3
- 238000004659 sterilization and disinfection Methods 0.000 claims description 3
- 238000003756 stirring Methods 0.000 claims description 3
- 206010019280 Heart failures Diseases 0.000 abstract description 9
- 206010007559 Cardiac failure congestive Diseases 0.000 abstract description 5
- 230000001225 therapeutic effect Effects 0.000 abstract description 2
- 229940090044 injection Drugs 0.000 description 7
- 210000004369 blood Anatomy 0.000 description 3
- 239000008280 blood Substances 0.000 description 3
- 206010025482 malaise Diseases 0.000 description 3
- 230000003204 osmotic effect Effects 0.000 description 3
- 229960002105 amrinone Drugs 0.000 description 2
- RNLQIBCLLYYYFJ-UHFFFAOYSA-N amrinone Chemical compound N1C(=O)C(N)=CC(C=2C=CN=CC=2)=C1 RNLQIBCLLYYYFJ-UHFFFAOYSA-N 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- 239000012895 dilution Substances 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 206010007558 Cardiac failure chronic Diseases 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 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 1
- 206010058558 Hypoperfusion Diseases 0.000 description 1
- 229940099471 Phosphodiesterase inhibitor Drugs 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 230000006793 arrhythmia Effects 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
- 230000003683 cardiac damage Effects 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- 230000003177 cardiotonic effect Effects 0.000 description 1
- 230000007012 clinical effect Effects 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 239000006184 cosolvent Substances 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 230000000916 dilatatory effect Effects 0.000 description 1
- 239000002934 diuretic Substances 0.000 description 1
- 230000001882 diuretic effect Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 229930182470 glycoside Natural products 0.000 description 1
- 150000002338 glycosides Chemical class 0.000 description 1
- 230000000297 inotrophic effect Effects 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 230000003211 malignant effect Effects 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 229940082795 milrinone injection Drugs 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000008520 organization Effects 0.000 description 1
- 210000005259 peripheral blood Anatomy 0.000 description 1
- 239000011886 peripheral blood Substances 0.000 description 1
- 239000002570 phosphodiesterase III inhibitor Substances 0.000 description 1
- 239000002571 phosphodiesterase inhibitor Substances 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 230000004088 pulmonary circulation Effects 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 230000001839 systemic circulation Effects 0.000 description 1
- 230000001256 tonic effect Effects 0.000 description 1
- 230000024883 vasodilation Effects 0.000 description 1
- 230000002861 ventricular Effects 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention discloses a sodium chloride injection for treating congestive heart failure and a preparation method thereof. The sodium chloride injection of the present invention is characterized in that every 100 milliliters of the injections contain the following components: 15 to 30 mg of milrinone, 830 to 920 mg of sodium chloride and 26 to 32 mg of lactic acid; every 100 milliliters of the injections contain the following preferred components: 20 mg of milrinone, 872 mg of sodium chloride and 28 mg of lactic acid. The injection provided by the present invention has the advantages of simple preparation technology, convenient clinical application and good therapeutic effects and patient tolerance.
Description
Technical field
The present invention relates to a kind of injection, particularly a kind of milrinone sodium chloride injection for the treatment of congestive heart failure and preparation method thereof belongs to field of medicaments.
Background technology
Heart failure claims congestive heart failure again, be meant under the normal situation of venous return, because former heart damage causes blood discharge amount and reduces, can not satisfy a kind of syndrome of tissue metabolism's needs, clinically with pulmonary circulation and (or) congestion of systemic circulation and tissue blood hypoperfusion be principal character.According to World Health Organization's statistics, the sickness rate of chronic heart failure in the crowd is 1.5～5.6%, and over-65s reaches 7.4%; The mortality rate that patients with heart failure was made a definite diagnosis 2 years is that the mortality rate after 37%, 5 year is 82%.Along with the aging of society, the sickness rate of heart failure is ascendant trend year by year, becomes the cardiovascular disease that unique sickness rate rises.
The drug main for the treatment of heart failure at present clinically will comprise cardiotonic glycoside, diuretic, vasodilation, phosphodiesterase inhibitor.Milrinone (milrinone) is a kind of novel cardiac tonic, belongs to the phosphodiesterase iii inhibitor, is the homologue of amrinone, and its activity is 10～30 times of amrinone, has positive inotropic and peripheral blood vessel dilating effect concurrently.
Milrinone is developed successfully by U.S. Sterling company the earliest, goes on the market in the U.S. first in 1987.Because milrinone oral formulations treatment congestive heart failure is eliminated to survival rate unfavorable (compare with matched group, case fatality rate increases by 28%, and the malignant arrhythmia incidence rate also obviously increases, P＜0.05).The specification of the milrinone injection of Xiao Shouing has 5ml:5mg, 10ml:10mg, 20ml:20mg in the market, but all needs to use very inconvenient with normal saline or glucose dilution before injection.
Summary of the invention
The purpose of this invention is to provide a kind of milrinone sodium chloride injection that can effectively treat congestive heart failure rapidly.
Another object of the present invention provides the preparation method of milrinone sodium chloride injection.
Each components contents is among the every 100ml of injection provided by the present invention:
Milrinone 15～30mg
Sodium chloride 830～920mg
Lactic acid 26～32mg
Preferably, each components contents is among the every 100ml of this injection:
Milrinone 20mg
Sodium chloride 872mg
Lactic acid 28mg
Above-mentioned sodium chloride is as osmotic pressure regulator, the osmotic pressure of injection can be adjusted to close with the osmotic pressure of people's blood; Lactic acid makes milrinone can be dissolved in water for injection as cosolvent.
The preparation method of this injection may further comprise the steps:
(1) sodium chloride is dissolved in an amount of water for injection, adds 0.1% active carbon, heated and boiled is filtered;
(2) get an amount of water for injection in addition and add milrinone and lactic acid, stir and make the milrinone dissolving, be added to then in the sodium chloride solution after the filtration, add to the full amount of water for injection;
(3) regulating pH value with lactic acid or sodium hydroxide is 3.2～4.0, after the fill sterilization promptly.
The using method of this injection is: earlier by after the slow intravenous injection of 37.5～50 μ g/kg 10 minutes (inject too fast may bring out ventricular premature contraction), continuation is with 0.375～0.75 μ g/kg/min intravenous drip, after this according to clinical effect adjustment consumption.
Advantage of the present invention is that preparation technology is simple, and is clinical easy to use, do not need dilution, and therapeutic effect and patient tolerability are all fine.
The specific embodiment
The present invention is further illustrated below in conjunction with embodiment, but range of application of the present invention is not limited only to the following example.
Embodiment 1
Milrinone 15g
Sodium chloride 830g
Lactic acid (85%) 31g
Water for injection is an amount of
Preparation technology: sodium chloride is dissolved in an amount of water for injection, adds 0.1% active carbon, heated and boiled 10 minutes is filtered; Other gets an amount of water for injection and adds milrinone and lactic acid, stirs to make the milrinone dissolving, is added to then in the sodium chloride solution after the filtration, add to the full amount of water for injection, regulating pH value with lactic acid or sodium hydroxide is 3.2～4.0, after the fill sterilization, make 1000 bottles, promptly.
Embodiment 2
Milrinone 22g
Sodium chloride 858g
Lactic acid (85%) 34g
Water for injection is an amount of
Preparation technology is with embodiment 1.
Embodiment 3
Milrinone 24g
Sodium chloride 862g
Lactic acid (85%) 35g
Water for injection is an amount of
Preparation technology is with embodiment 1.
Embodiment 4
Milrinone 27g
Sodium chloride 885g
Lactic acid (85%) 36g
Water for injection is an amount of
Preparation technology is with embodiment 1.
Embodiment 5
Milrinone 30g
Sodium chloride 920g
Lactic acid (85%) 37g
Water for injection is an amount of
Preparation technology is with embodiment 1.
Claims (3)
1, a kind of milrinone sodium chloride injection is characterized in that each components contents is in every 100ml injection: milrinone 15～30mg; Sodium chloride 830～920mg; Lactic acid 26～32mg.
2, injection according to claim 1 is characterized in that each components contents is in every 100ml injection: milrinone 20mg; Sodium chloride 872mg; Lactic acid 28mg.
3, the preparation method of the described injection of claim 1 is characterized in that may further comprise the steps:
A, sodium chloride is dissolved in an amount of water for injection, adds 0.1% active carbon, heated and boiled is filtered;
B, get an amount of water for injection in addition and add milrinone and lactic acid, stir and make the milrinone dissolving, be added to then in the sodium chloride solution after the filtration, add to the full amount of water for injection;
C, to regulate pH value with lactic acid or sodium hydroxide be 3.2～4.0, after the fill sterilization promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100308269A CN100337629C (en) | 2004-04-07 | 2004-04-07 | Milrinone sodium chloride injection and production thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100308269A CN100337629C (en) | 2004-04-07 | 2004-04-07 | Milrinone sodium chloride injection and production thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1679566A CN1679566A (en) | 2005-10-12 |
| CN100337629C true CN100337629C (en) | 2007-09-19 |
Family
ID=35066583
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004100308269A Expired - Lifetime CN100337629C (en) | 2004-04-07 | 2004-04-07 | Milrinone sodium chloride injection and production thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100337629C (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552121B (en) * | 2010-12-22 | 2015-04-15 | 北大方正集团有限公司 | Milrinone injection |
| CN102579329B (en) * | 2012-03-06 | 2013-04-17 | 北京六盛合医药科技有限公司 | Milrinone lactate injection and preparation method thereof |
| CN104173343B (en) * | 2014-08-15 | 2015-06-17 | 朗天药业(湖北)有限公司 | Milrinone compound and pharmaceutical composition containing milrinone compound |
| CN105663034A (en) * | 2014-11-17 | 2016-06-15 | 扬子江药业集团上海海尼药业有限公司 | Milrinone pharmaceutical composition and preparation method thereof |
| CN104739759B (en) * | 2015-04-02 | 2018-03-02 | 海南合瑞制药股份有限公司 | A kind of pharmaceutical composition containing milrinone compound |
| CN108158988B (en) * | 2018-02-27 | 2021-03-23 | 河北化工医药职业技术学院 | Preparation method of milrinone injection |
| CN114886851B (en) * | 2022-06-01 | 2023-04-25 | 平顶山市第二人民医院 | Milrinon liposome, preparation and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999022731A1 (en) * | 1997-10-30 | 1999-05-14 | Vaysman, Pyotr | Method and composition for treatment of sexual dysfunction |
-
2004
- 2004-04-07 CN CNB2004100308269A patent/CN100337629C/en not_active Expired - Lifetime
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999022731A1 (en) * | 1997-10-30 | 1999-05-14 | Vaysman, Pyotr | Method and composition for treatment of sexual dysfunction |
Non-Patent Citations (1)
| Title |
|---|
| 静注米力农治疗难治性心力衰竭疗效观察 金燕等，心功能杂志，第10卷第4期 1998 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1679566A (en) | 2005-10-12 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 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 | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: LUNNAN BETTER PHARMACEUTICAL Co.,Ltd. Assignor: LUNAN PHARMACEUTICAL Group Corp. Contract record no.: 2010370000513 Denomination of invention: Milrinone sodium chloride injection and production thereof Granted publication date: 20070919 License type: Exclusive License Open date: 20051012 Record date: 20100909 |
|
| EC01 | Cancellation of recordation of patent licensing contract |
Assignee: LUNNAN BETTER PHARMACEUTICAL Co.,Ltd. Assignor: LUNAN PHARMACEUTICAL Group Corp. Contract record no.: 2010370000513 Date of cancellation: 20131016 |
|
| LICC | Enforcement, change and cancellation of record of contracts on the licence for exploitation of a patent or utility model | ||
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20161214 Address after: 276005 Hongqi Road, Shandong, Linyi, No. 209 Patentee after: LUNNAN BETTER PHARMACEUTICAL Co.,Ltd. Address before: 276005 Hongqi Road, Shandong, Linyi, No. 209 Patentee before: LUNAN PHARMACEUTICAL Group Corp. |
|
| CX01 | Expiry of patent term | ||
| CX01 | Expiry of patent term |
Granted publication date: 20070919 |