CN1074278C - Preparation of bacteria-free freezing-dried prostaglandin E1 powder injection - Google Patents
Preparation of bacteria-free freezing-dried prostaglandin E1 powder injectionInfo
- Publication number
- CN1074278C CN1074278C CN96121136A CN96121136A CN1074278C CN 1074278 C CN1074278 C CN 1074278C CN 96121136 A CN96121136 A CN 96121136A CN 96121136 A CN96121136 A CN 96121136A CN 1074278 C CN1074278 C CN 1074278C
- Authority
- CN
- China
- Prior art keywords
- injection
- aseptic
- prostaglandin
- pge1
- carries out
- 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 - Fee Related
Links
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention relates to a technology for producing bacterium free lyophilized powder injections of prostaglandin E1. Prostaglandin E1 whose quality satisfies the quality standard in the 23rd edition of American Pharmacopeia, human serum albumin (HSA), lysine, etc. are used as material compositions, and the material compositions are dissolved in physiological saline, sterilized, filled and lyophilized to prepare a bacterium free lyophilized powder injection of prostaglandin E1, which has the advantages of high purity, high stability, high uniformity, high therapeutic effect, no toxicity and slight side effect.
Description
The present invention relates to a kind of production technology of medicine, be meant prostaglandin E especially
1The production technology of aseptic freeze-dried injectable powder.
Existing prostaglandin E
1Aseptic freeze-dried injectable powder is because of reasons such as prescription are not good at, the crude drug quality is low, production technology falls behind, causes the product active constituent content to pass in time and constantly descend even rotten, and clinical side effects is big, as vomiting, pain, heating etc.
The object of the present invention is to provide a kind of advanced person's prostaglandin E
1Aseptic freeze-dried injectable powder production technology with quality and the curative effect that improves this injection, reduces side effect, solves existing prostaglandin E
1The above-mentioned defective that aseptic freeze-dried injectable powder exists.
Prostaglandin E provided by the invention
1The composition of aseptic freeze-dried injectable powder reaches:
Prostaglandin E
1(purity 99.95%) 0.022-0.11%
Human albumin's (injection) 2.0-6.0%
Lysine (injection) 1.0-4.0%
Sodium chloride (injection) 0.9%
Water for injection (aseptic, no thermal source) surplus
This prostaglandin E
1The production technology of aseptic freeze-dried injectable powder is undertaken by following process sequence:
(1) in proportioner, under agitation prepare burden in proportion:
Prostaglandin E
1(purity 99.95%) 0.022-0.11%
Human albumin's (injection) 2.0-6.0%
Lysine (injection) 1.0-4.0%
Sodium chloride (injection) 0.9%
Water for injection (aseptic, no thermal source) surplus
Water for injection filters after various compositions are dissolved fully;
(2) film with 0.2 μ m aperture carries out filtration sterilization in defecator, after clarity test is qualified, carries out fill;
(3) fill is with 2ml ampoule dress liquid, and per ampoule dress liquid 1.10ml carries out lyophilization;
(4)-50-0 ℃, freezing gas-solid drying below the vacuum 2mmHg post, make water sublimed, at 2% following ampule sealing, detect packing until goods moisture.
Above steps is all carried out under aseptic, nonpollution environment.
The present invention compares with domestic and international production, has the following advantages:
One, because prescription rationally, makes product evident in efficacy in treatment, nontoxic, side effect is minimum;
Two, adopt low temperature, vacuum, sublimation drying means to produce, make the product all the components keep original chemistry, physics, biological activity fully, product quality homogeneous, stable, its composition quality is better than the prostaglandin E of 23 editions quality standards of American Pharmacopeia
1Crude drug;
Three, get rid of the drawback that needs refrigerator storage, transportation in the world with the kind medicine fully, the storage transportation is very convenient, greatly reduces storage, cost of transportation;
Need the relieve the pain drawback of agent of adapted when four, exempting, easy to use, safe, no pain in the world with the kind drug use;
Five, with low cost, price only is 1/20th of an imported product.
Embodiments of the invention are provided below.
Embodiment one:
The prostaglandin E that present embodiment provides
1The composition of aseptic freeze-dried injectable powder reaches:
Prostaglandin E
1(purity 99.95%) 0.022%
Human albumin's (injection) 2.0%
Lysine (injection) 1.0%
Sodium chloride (injection) 0.9%
Water for injection (aseptic, no thermal source) 22000ml
The production technology of this injection is as follows:
Add water for injection in mixer, add above-mentioned raw materials, stirring and dissolving becomes true solution, sends in the filter;
Film with 0.2 μ m aperture in filter carries out filtration sterilization, sends into after clarity test is qualified in the filling machine;
With 2ml loading amount ampoule dress liquid, per ampoule is adorned liquid 1.10ml in filling machine, and 20000 of fills are sent in the freezer dryer;
-50-0 ℃, the following lyophilization of vacuum 2mmHg post, make water sublimate in freezer dryer, moisture is below 2% in goods, and ampule sealing detects qualified back packing.
Embodiment two:
The prostaglandin E that present embodiment provides
1The composition of aseptic freeze-dried injectable powder reaches:
Prostaglandin E
1(purity 99.95%) 0.025%
Human albumin's (injection) 4.0%
Lysine (injection) 1.0%
Sodium chloride (injection) 0.9%
Water for injection (aseptic, no thermal source) 11000ml
A same embodiment of the production process of this injection changes 11000 of fills.
Claims (3)
1, the aseptic freeze-dried injectable powder of a kind of PGE1, it is characterized in that: the composition of this injection and weight proportion are:
PGE1 0.022-0.11% purity 99.95%
Human albumin 2.0-6.0% injection
Lysine 1.0-4.0% injection
Sodium chloride 0.9% injection
The water for injection surplus is aseptic, no thermal source
2, the production technology of the aseptic freeze-dried injectable powder of PGE1 according to claim 1 is characterized in that being undertaken by following process sequence:
(1) in proportioner, under agitation prepare burden in proportion:
PGE1 0.022-0.11% purity 99.95%
Human albumin 2.0-6.0% injection
Lysine 1.0-4.0% injection
Sodium chloride 0.9% injection
The water for injection surplus is aseptic, no thermal source
Water for injection filters after various compositions are dissolved fully;
(2) film with 0.2 μ m aperture carries out filtration sterilization in defecator, after clarity test is qualified, carries out fill;
(3) fill is with 2ml ampoule dress liquid, and per ampoule dress liquid 1.10ml carries out lyophilization;
(4), at 2% following ampule sealing, detect packing until goods moisture-50-0 ℃, freezing gas-solid drying below the vacuum 2mmHg post.
3, production technology according to claim 2 is characterized in that: above steps is all carried out under aseptic, nonpollution environment.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96121136A CN1074278C (en) | 1996-11-12 | 1996-11-12 | Preparation of bacteria-free freezing-dried prostaglandin E1 powder injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96121136A CN1074278C (en) | 1996-11-12 | 1996-11-12 | Preparation of bacteria-free freezing-dried prostaglandin E1 powder injection |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1181933A CN1181933A (en) | 1998-05-20 |
| CN1074278C true CN1074278C (en) | 2001-11-07 |
Family
ID=5126766
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN96121136A Expired - Fee Related CN1074278C (en) | 1996-11-12 | 1996-11-12 | Preparation of bacteria-free freezing-dried prostaglandin E1 powder injection |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1074278C (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100443084C (en) * | 2005-09-28 | 2008-12-17 | 北京赛生药业有限公司 | Alprostadil preparation and its making method |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101766631B (en) * | 2009-04-10 | 2014-07-16 | 吉林天强制药有限公司 | Prostaglandin composition for injection |
| CN102366628A (en) * | 2010-12-31 | 2012-03-07 | 华东理工大学 | Quality stabilization technique of antitumor protein medicines |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5231818A (en) * | 1975-09-05 | 1977-03-10 | Yamanouchi Pharmaceut Co Ltd | Process for manufacturing stable preparations of prostaglandin e |
| WO1996009037A1 (en) * | 1994-09-23 | 1996-03-28 | The Liposome Company, Inc. | Method of producing a lyophilized liposome product |
-
1996
- 1996-11-12 CN CN96121136A patent/CN1074278C/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5231818A (en) * | 1975-09-05 | 1977-03-10 | Yamanouchi Pharmaceut Co Ltd | Process for manufacturing stable preparations of prostaglandin e |
| WO1996009037A1 (en) * | 1994-09-23 | 1996-03-28 | The Liposome Company, Inc. | Method of producing a lyophilized liposome product |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100443084C (en) * | 2005-09-28 | 2008-12-17 | 北京赛生药业有限公司 | Alprostadil preparation and its making method |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1181933A (en) | 1998-05-20 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C06 | Publication | ||
| PB01 | Publication | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Jilin jade jade Pharmaceutical Co., Ltd. Assignor: Cai Haide Contract fulfillment period: In November 14, 2016, 14 years Contract record no.: 200210055 Denomination of invention: Production process of prostaglandin E1 aseptic freeze-dried powder injection Granted publication date: 20011107 License type: Pai Ta Record date: 2002.7.1 |
|
| LIC | Patent licence contract for exploitation submitted for record |
Free format text: LICENCE; TIME LIMIT OF IMPLEMENTING CONTACT: 2016.11.14, 14 YEARS Name of requester: JILIN YUHUANG PHARMACEUTICAL INDUSTRY CO., LTD. Effective date: 20020701 |
|
| C19 | Lapse of patent right due to non-payment of the annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |