CN104922126B - A kind of piperacillin sodium and tazobactam sodium sterile powder injection and preparation method thereof - Google Patents
A kind of piperacillin sodium and tazobactam sodium sterile powder injection and preparation method thereof Download PDFInfo
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- CN104922126B CN104922126B CN201510204379.2A CN201510204379A CN104922126B CN 104922126 B CN104922126 B CN 104922126B CN 201510204379 A CN201510204379 A CN 201510204379A CN 104922126 B CN104922126 B CN 104922126B
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Abstract
The invention provides a kind of piperacillin sodium and tazobactam sodium sterile powder injection, component includes：68 parts of avocin, 1 part of sodium-tazobactam, 40 80 parts of mannitol, 10 30 parts of vitamin C, 8 15 parts of sodium pyrosulfite, 5 10 parts of glycine.Under inert gas shielding, each component is dissolved with water for injection；Activated carbon decolorizing is added, is then filtered to remove activated carbon；With 0.22 μm of 0.80 μm of miillpore filter refined filtration；Freeze-drying, is produced.Compared with prior art, the stabilizer that the present invention is formed using mannitol, vitamin C, sodium pyrosulfite and glycine, it is effectively improved the stability of preparation, preparing and the stabilization in storing process, avocin and sodium-tazobactam it is substantially unchanged, polymer content is low, ensures that product is qualified in the term of validity, the effect of ensure that Clinical practice and security.Preparation method is simple, and cost is low, is suitable for industrialized production.
Description
Technical field
The invention belongs to pharmaceutical technology field, more particularly to a kind of piperacillin sodium and tazobactam sodium sterile powder injection and its
Preparation method.
Background technology
Piperacillin is a kind of wide spectrum semi-synthetic penicillins antibiotic, is widely used to clinic.Due to Piperacillin
Long-term use and reason, the therapeutic effect of Piperacillin such as improper use just constantly decline, this largely have impact on
The application of Piperacillin.Sodium-tazobactam is lactamase restrainer, belongs to the strong synergist of third generation antibacterial, with Piperacillin or
Cefoperazone shares the drug effect that can strengthen the two and extends action time.When sodium-tazobactam is used in combination with avocin,
Obvious synergy is produced, is widely used in treatment serious systemic and local infection, abdominal cavity infection, ALRI, soft
Tissue infection, septicemia etc., other antibacterial complexing agents than having used have wider antimicrobial spectrum and indication, resistance to overcoming
Huge advantage is shown in terms of the property of medicine.
Piperacillin sodium and tazobactam sodium compound preparation is domestic at present have been sold, and is aseptic powdery direct packaging system
, its exist one it is common the defects of be exactly that preparation stabilization is poor, it is impossible to the quality requirement to satisfy the prescriptive period.
Patent document CN1732930A discloses a kind of piperacillin sodium and tazobactam sodium compound preparation for injection, it be by
Avocin is mixed with sodium-tazobactam with 3-4: 0.8-1.2 weight than raw material.Patent document CN101265263A
Disclose one kind and high-purity avocin and sodium-tazobactam are prepared using column chromatography, be then made into compound powder-injection
Method.Patent document CN101269072A discloses a kind of drug regimen containing beta-lactamase inhibitor and avocin
Thing and preparation method thereof, the composition is by avocin of the weight proportion for 1-100: 1: 0.001-2, beta-lactamase suppression
Preparation and pH value regulator composition.
Piperacillin sodium and tazobactam sodium compound preparation described in above-mentioned disclosed patent is deposited as listing compound preparation
The preparation stability difference the defects of, it is impossible to the quality requirement to satisfy the prescriptive period, had a strong impact on clinical efficacy.And due to piperazine
Draw XiLin sodium and tazobactam sodium compound preparation to belong to antibiotics, easily trigger allergic reaction, cause fash or anaphylaxis
Shock, to the very harmful of patient.However, trigger clinically anaphylactoid main allergen and non-drug in itself, but medicine
Present in thing caused by polymer." piperacillin sodium and tazobactam sodium for injection (4:1) polymer study on determination method "【Liu Jun
Magnificent piperacillin sodium and tazobactam sodium for injection (4:1) polymer study on determination method [J], today pharmacy, 2012,22 (11)：
664-674】Show that the polymer in piperacillin sodium and tazobactam sodium for injection is mainly derived from Piperacillin.Therefore, strictly
Control the content of polymer in avocin bulk drug, improve its stability to ensureing piperacillin sodium injection Tazobactam Sodium
The quality of preparation of sodium and clinical application are particularly important safely.
The content of the invention
It is an object of the invention to overcome deficiency of the prior art, there is provided a kind of piperacillin sodium and tazobactam sodium is sterile
Powder-injection, stability is good, and long-term medicine of depositing is stable, and polymer content is less, the effect of ensure that Clinical practice and security.
Present invention also offers the preparation method of the piperacillin sodium and tazobactam sodium sterile powder injection.
The first aspect of the invention is to provide a kind of piperacillin sodium and tazobactam sodium sterile powder injection, and it draws west by piperazine
Woods sodium, sodium-tazobactam and stabilizer are made, and the stabilizer is by mannitol, vitamin C, sodium pyrosulfite and glycine group
Into in parts by weight, the component of the piperacillin sodium and tazobactam sodium sterile powder injection includes：
Preferably, include according to parts by weight meter, the component of the piperacillin sodium and tazobactam sodium sterile powder injection：
It is highly preferred that in parts by weight, the component of the piperacillin sodium and tazobactam sodium sterile powder injection includes：
The second aspect of the invention there is provided the piperacillin sodium and tazobactam sodium described in one side of the invention
The preparation method of sterile powder injection, it is characterised in that comprise the following steps：
Step 1, under inert gas shielding, avocin, sodium-tazobactam, mannitol, dimension are given birth to water for injection
Plain C, sodium pyrosulfite and glycine dissolving；
Step 2, activated carbon decolorizing is added, is then filtered to remove activated carbon；
Step 3, with 0.22 μm of -0.80 μm of miillpore filter refined filtration；
Step 4, it is freeze-dried, produces.
Compared with prior art, the stabilization that the present invention is formed using mannitol, vitamin C, sodium pyrosulfite and glycine
Agent, be effectively improved the stability of preparation, prepare and storing process in stabilization, avocin and sodium-tazobactam
Substantially unchanged, polymer content is low, ensures that product is qualified in the term of validity, the effect of ensure that Clinical practice and security.System
Preparation Method is simple, and cost is low, is suitable for industrialized production.
Embodiment
With reference to specific embodiment, the invention will be further described, to more fully understand the present invention.
Embodiment 1
A kind of piperacillin sodium and tazobactam sodium sterile powder injection, formula are as follows：
Under inert gas shielding, avocin, sodium-tazobactam, mannitol, dimension are given birth to water for injection 2000ml
Plain C, sodium pyrosulfite and glycine dissolving；Needle-use activated carbon 1g is added, stirs 30min, crosses and filters out carbon；Filtered with 0.22 μm of micropore
Film aseptic filtration, filling, half tamponade, freeze-drying, tamponade, visual inspection, packaging, get product.
Embodiment 2
The present embodiment is that formula is different from the difference of embodiment 1, specific as follows：
Embodiment 3
The present embodiment is that formula is different from the difference of embodiment 1, specific as follows：
Embodiment 4
The present embodiment is that formula is different from the difference of embodiment 1, specific as follows：
Embodiment 5
The present embodiment is that formula is different from the difference of embodiment 1, specific as follows：
Comparative example 1
Comparative example 1 is that formula is different from the difference of embodiment 1, chooses the group outside composition weight number scope
Close, it is specific as follows：
Stability test
By the sample of various embodiments above and comparative example with listing piperacillin sodium and tazobactam sodium for injection, in temperature
40 DEG C ± 2 DEG C, placed 6 months under the conditions of relative humidity 75% ± 5%, carry out accelerated test, periodic detection avocin, he
The content of TZB sodium and polymer, and analyzing compared with the data of 0 month, wherein avocin, sodium-tazobactam
Content is to be measured according at 0 month for 100%, and recipe comprising piperacillin polymer is in terms of Piperacillin, as a result as shown in table 1.
The Accelerated stability test result of the piperacillin sodium and tazobactam sodium sterile powder injection of table 1/% (n=3)
Can be seen that compared with the prior art from above-mentioned result of the test, piperacillin sodium and tazobactam sodium of the invention without
Bacterium powder injection has significantly reduced polymer content and more excellent stability.
In addition, inventive samples accelerate 6 months, add water for injection and be configured to parenteral solution, parenteral solution clarification.To relevant thing
Matter is detected, the relevant material change unobvious of sample of the invention, meets the relevant regulations of Chinese Pharmacopoeia.This is also further
Illustrate that the product stability of the present invention is good.
The specific embodiment of the present invention is described in detail above, but it is intended only as example, it is of the invention and unlimited
It is formed on particular embodiments described above.To those skilled in the art, it is any to the equivalent modifications that carry out of the present invention and
Substitute also all among scope of the invention.Therefore, the impartial conversion made without departing from the spirit and scope of the invention and
Modification, all should be contained within the scope of the invention.
Claims (2)
1. a kind of piperacillin sodium and tazobactam sodium sterile powder injection, it is characterised in that it is by avocin, sodium-tazobactam
It is made with stabilizer, the stabilizer is made up of mannitol, vitamin C, sodium pyrosulfite and glycine, according to parts by weight
Meter, the component of the piperacillin sodium and tazobactam sodium sterile powder injection include：
2. a kind of preparation method of piperacillin sodium and tazobactam sodium sterile powder injection as claimed in claim 1, its feature exist
In comprising the following steps：
Step 1, under inert gas shielding, with water for injection by avocin, sodium-tazobactam, mannitol, vitamin C,
Sodium pyrosulfite and glycine；
Step 2, activated carbon decolorizing is added, is then filtered to remove activated carbon；
Step 3, with 0.22 μm of -0.80 μm of miillpore filter refined filtration；
Step 4, it is freeze-dried, produces.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510204379.2A CN104922126B (en) | 2015-04-27 | 2015-04-27 | A kind of piperacillin sodium and tazobactam sodium sterile powder injection and preparation method thereof |
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| CN201510204379.2A CN104922126B (en) | 2015-04-27 | 2015-04-27 | A kind of piperacillin sodium and tazobactam sodium sterile powder injection and preparation method thereof |
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| CN104922126A CN104922126A (en) | 2015-09-23 |
| CN104922126B true CN104922126B (en) | 2018-03-09 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112618486B (en) * | 2020-12-24 | 2023-07-18 | 浙江昂利康制药股份有限公司 | Suspension oil for injection and preparation method thereof |
| CN113209030B (en) * | 2021-04-27 | 2023-04-25 | 海南通用康力制药有限公司 | Preparation method of piperacillin sodium and tazobactam sodium sterile powder injection |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101269072A (en) * | 2008-05-09 | 2008-09-24 | 郑飞雄 | Pharmaceutical composition containing beta-lactamase restrainer and piperacillin sodium with steady content and preparation method thereof |
| CN101632670A (en) * | 2009-08-26 | 2010-01-27 | 海南永田药物研究院有限公司 | Suspension powder injection of piperacillin sodium and tazobactam sodium pharmaceutical composition and new application thereof |
| CN101890015A (en) * | 2010-07-29 | 2010-11-24 | 郝志艳 | Liposome injection of pharmaceutical composition comprising piperacillin sodium and tazobactam sodium |
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2015
- 2015-04-27 CN CN201510204379.2A patent/CN104922126B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101269072A (en) * | 2008-05-09 | 2008-09-24 | 郑飞雄 | Pharmaceutical composition containing beta-lactamase restrainer and piperacillin sodium with steady content and preparation method thereof |
| CN101632670A (en) * | 2009-08-26 | 2010-01-27 | 海南永田药物研究院有限公司 | Suspension powder injection of piperacillin sodium and tazobactam sodium pharmaceutical composition and new application thereof |
| CN101890015A (en) * | 2010-07-29 | 2010-11-24 | 郝志艳 | Liposome injection of pharmaceutical composition comprising piperacillin sodium and tazobactam sodium |
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