CN104887679B - A kind of piperacillin-sulbactam sodium sterile powder injection and preparation method thereof - Google Patents
A kind of piperacillin-sulbactam sodium sterile powder injection and preparation method thereof Download PDFInfo
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- CN104887679B CN104887679B CN201510207671.XA CN201510207671A CN104887679B CN 104887679 B CN104887679 B CN 104887679B CN 201510207671 A CN201510207671 A CN 201510207671A CN 104887679 B CN104887679 B CN 104887679B
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- sulbactam
- piperacillin
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Abstract
The present invention provides a kind of piperacillin-sulbactam sodium sterile powder injections, it is made of avocin, sulbactam and stabilizer, the stabilizer is made of trehalose, sodium pyrosulfite and glycine, in parts by weight, the component of the piperacillin-sulbactam sodium sterile powder injection includes：24 parts of avocin, 1 part of sulbactam, 20 40 parts of trehalose, 8 15 parts of sodium pyrosulfite, 10 20 parts of glycine.Compared with prior art, the present invention is using trehalose, the stabilizer of sodium pyrosulfite and glycine composition, avocin and sulbactam is effectively improved to prepare and the stability in storing process, ensure that product is qualified in the term of validity, and formulation dissolution is quick, the effect of not generating crystallization and turbid phenomenon, ensure that Clinical practice and safety.Preparation method is simple, at low cost, is suitable for industrialized production.
Description
Technical field
Belong to pharmaceutical technology field, and in particular to a kind of piperacillin-sulbactam sodium sterile powder injection and its preparation side
Method.
Background technology
Piperacillin category penicillins broad-spectrum antibiotic, mainly by interfere bacteria cell wall synthesis by rise sterilization work
With, the infection that is mainly used for caused by pseudomonas aeruginosa and various gram negative bacillis but easily by bacteriogenic beta-lactamase
It hydrolyzes and generates drug resistance；Sulbactam is in addition to Neisseriaceae and acinetobacter calcoaceticus, to other bacteriums without antibacterial activity, but easypro bar
There is the smooth beta-lactamase important to the majority generated by beta-lactam antibiotic antibody-resistant bacterium the inhibition of irreversibility to make
With.Sulbactam can prevent destruction of the drug-fast bacteria to penicillins and cephalosporins, Sulbactam and penicillins and head
Spore bacteriums have apparent synergistic effect.Early in 2000, Chinese patent CN10590286C disclosed a kind of interior acyls of anti-β-
Amine enzyme antibiotic composition, is made of Sulbactam and piperacillin or cefotaxime.
Piperacillin-sulbactam sodium compound preparation quantity is big, curative for effect, the good and most of cephalo of market prospects
Bacteriums antibiotic is the same, is made by avocin and the packing of sulbactam sterile raw material or freeze-drying.There are one for it
Common defect is exactly that preparation stabilization is poor, the quality requirement that cannot be satisfied the prescriptive period.
The prior art proposes that a variety of solutions are done to overcome the Stable Defects of piperacillin-sulbactam sodium combination preparation
Method, for example, patent document CN101269072A disclose a kind of stable content containing sulbactam and avocin and pH value
Pharmaceutical composition of conditioning agent and preparation method thereof avoids pH caused by clinically compatibility due to adding pH adjusting agent
Value reduces the insoluble or milky research of chaotic phenomenon generated, but same unstable in dilution rear solution, affects curative effect；Patent text
CN1927201A is offered to disclose by avocin, sulbactam and at least one ion chelating agent that can inhibit particles generation
The antibiotic compound of composition, be disadvantageous in that the ion chelating agent especially use of EDTA be easy into sodium in bone, potassium, calcium from
Subflow is lost, moreover, preparation process is using freeze-drying, avocin and sulbactam are in liquid and its drying process
Oxydrolysis can occur quickly for solution state, cause unqualified.
Patent document CN101322702A discloses a kind of piperacillin sodium injection sulbactam and its freeze drying powder injection
Preparation method avocin and sulbactam are isolated and purified using high speed adverse current chromatogram, obtain the piperazine of injection
XiLin sodium and sulbactam are drawn, freeze-drying is aseptic subpackaged, to which piperacillin sodium injection sulbactam be made.Certain
The purity of preparation is improved in degree, but only that two kinds of ingredients are simple aseptic subpackaged obtained, there is no to active constituent piperazine
It draws XiLin sodium and sulbactam to be protected accordingly, also causes product stability poor, seriously affected clinical efficacy.
Invention content
It is an object of the invention to overcome deficiency in the prior art, a kind of piperacillin-sulbactam sodium aseptic powder is provided
Injection, stability is good, and long-term drug stabilizing dissolved of storing is quick, and does not generate crystallization and turbid phenomenon, ensure that clinic makes
With the effect of and safety.The present invention also provides the preparation methods of the piperacillin-sulbactam sodium sterile powder injection.
The first aspect of the invention is to provide a kind of piperacillin-sulbactam sodium sterile powder injection, by Piperacillin
Sodium, sulbactam and stabilizer are made, and the stabilizer is made of trehalose, sodium pyrosulfite and glycine, according to parts by weight
Number meter, the component of the piperacillin-sulbactam sodium sterile powder injection include：
Preferably, in parts by weight, the component of the piperacillin-sulbactam sodium sterile powder injection includes：
It is highly preferred that in parts by weight, the component of the piperacillin-sulbactam sodium sterile powder injection includes：
The second aspect of the invention there is provided the piperacillin-sulbactam sodium described in the first aspect of the present invention without
The preparation method of bacterium powder injection, includes the following steps：
Step 1, under inert gas protection, with water for injection by avocin, sulbactam, trehalose, burnt sulfurous
Sour sodium 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, be freeze-dried to get.
Compared with prior art, the present invention is using trehalose, the stabilizer of sodium pyrosulfite and glycine composition, effectively
The stability of avocin and sulbactam in preparation and storing process is improved, ensures that product is qualified in the term of validity, and
Formulation dissolution is quick, the effect of not generating crystallization and turbid phenomenon, ensure that Clinical practice and safety.Preparation method is simple,
It is at low cost, it is suitable for industrialized production.
Specific implementation mode
With reference to specific embodiment, the invention will be further described, to more fully understand the present invention.
Embodiment 1
A kind of piperacillin-sulbactam sodium sterile powder injection, formula are as follows：
Under inert gas protection, with water for injection 2000ml by avocin, sulbactam, trehalose, burnt sulfurous
Sour sodium and glycine dissolving；Needle-use activated carbon 1g is added, stirs 30min, crosses and filters out carbon；With 0.22 μm of miillpore filter degerming
Filter, filling, half tamponade, freeze-drying, tamponade, visual inspection are packed to get finished product.
Embodiment 2
The present embodiment is specific as follows difference from example 1 is that formula difference：
Embodiment 3
The present embodiment is specific as follows difference from example 1 is that formula difference：
Embodiment 4
The present embodiment is specific as follows difference from example 1 is that formula difference：
Embodiment 5
The present embodiment is specific as follows difference from example 1 is that formula difference：
Comparative example 1
Comparative example 1 chooses the group except composition weight number range difference from example 1 is that formula difference
It closes, it is specific as follows：
Stability test
By the piperacillin sodium injection sulbactam of the sample and listing of the above various embodiments and comparative example, in temperature 40
It DEG C ± 2 DEG C, is placed 6 months under the conditions of relative humidity 75% ± 5%, carries out accelerated test, periodic detection avocin and relaxed
The content of Batan sodium is in terms of 100% by medicament contg, and the results are shown in Table 1.
The Accelerated stability test result of 1 piperacillin-sulbactam sodium sterile powder injection of table/% (n=3)
As shown in Table 1, accelerating 6 months, avocin and sulbactam content reduce in comparative example and listing preparation, and
The unobvious containing change of variable of the sample of the present invention illustrate that the product stability of the present invention is good.
In addition, inventive samples place 6 months white blocks in appearance.After 6 months, water for injection configuration is added
At injection, injection clarification.And comparative example and the clarity of listing preparation are against regulation.Related substance is detected,
The related substance for listing preparation increases, and the related substance of the sample of the present invention changes unobvious.Also this hair is further illustrated
Bright product stability is good.
Specific embodiments of the present invention are described in detail above, but it is intended only as example, the present invention is simultaneously 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
It substitutes also all among scope of the invention.Therefore, without departing from the spirit and scope of the invention made by impartial conversion and
Modification, all should be contained within the scope of the invention.
Claims (2)
1. a kind of piperacillin-sulbactam sodium sterile powder injection, which is characterized in that it is by avocin, sulbactam and steady
Determine agent to be made, the stabilizer is made of trehalose, sodium pyrosulfite and glycine, and in parts by weight, the piperazine draws west
The group of woods sodium and sulbactam sodium sterile powder injection is divided into：
2. a kind of preparation method of piperacillin-sulbactam sodium sterile powder injection as described in claim 1, feature exist
In including the following steps：
Step 1, under inert gas protection, with water for injection by avocin, sulbactam, trehalose, sodium pyrosulfite
It is dissolved with 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, be freeze-dried to get.
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| CN201510207671.XA CN104887679B (en) | 2015-04-27 | 2015-04-27 | A kind of piperacillin-sulbactam sodium sterile powder injection and preparation method thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101804052A (en) * | 2010-04-21 | 2010-08-18 | 海南美兰史克制药有限公司 | Liposome injection based on drug combination of mezlocillin sodium and sulbactam sodium |
| CN101822669A (en) * | 2010-04-23 | 2010-09-08 | 海南美兰史克制药有限公司 | Liposome injection of amoxicillin sodium sulbactam sodium medicinal composition |
| CN102940636A (en) * | 2012-11-01 | 2013-02-27 | 哈药集团制药总厂 | Injection of piperacillin-sulbactum sodium medicine composition and preparation method thereof |
-
2015
- 2015-04-27 CN CN201510207671.XA patent/CN104887679B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101804052A (en) * | 2010-04-21 | 2010-08-18 | 海南美兰史克制药有限公司 | Liposome injection based on drug combination of mezlocillin sodium and sulbactam sodium |
| CN101822669A (en) * | 2010-04-23 | 2010-09-08 | 海南美兰史克制药有限公司 | Liposome injection of amoxicillin sodium sulbactam sodium medicinal composition |
| CN102940636A (en) * | 2012-11-01 | 2013-02-27 | 哈药集团制药总厂 | Injection of piperacillin-sulbactum sodium medicine composition and preparation method thereof |
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