CN102895228A - Amoxicillin and sulbactam sodium medicinal composition injection and preparation method thereof - Google Patents
Amoxicillin and sulbactam sodium medicinal composition injection and preparation method thereof Download PDFInfo
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- CN102895228A CN102895228A CN201210430518XA CN201210430518A CN102895228A CN 102895228 A CN102895228 A CN 102895228A CN 201210430518X A CN201210430518X A CN 201210430518XA CN 201210430518 A CN201210430518 A CN 201210430518A CN 102895228 A CN102895228 A CN 102895228A
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- amoxicillin
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Abstract
The invention discloses an amoxicillin and sulbactam sodium medicinal composition injection and a preparation method thereof. According to a formula, the medicinal composition injection comprises the following components in part by weight: 1 to 10 parts of amoxicillin, 0.5 to 5 parts of sulbactam sodium, 0.4 to 8 parts of lactose, 0.4 to 8 parts of sodium chloride, and a proper amount of sodium dihydrogen phosphate, wherein sodium dihydrogen phosphate is used for regulating the pH value of a solution to be 7.0. The preparation method for the medicinal composition injection comprises the following steps of: weighing a certain amount of amoxicillin, sulbactam sodium, lactose and sodium chloride, dissolving by using water for injection, regulating the pH value of a solution to be 7.0 by using sodium dihydrogen phosphate, fixing the volume till 5,000ml by using water for injection, filtering by using a filtering membrane, drying, performing sterile crushing, and filling to obtain the amoxicillin and sulbactam sodium medicinal composition injection. The amoxicillin and sulbactam sodium medicinal composition injection prepared by the method has the advantages of low impurity content, high solubility and stability, difficulty in color change and the like.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparations composition, particularly relate to prescription of a kind of injection preparation and preparation method thereof.
Background technology:
Synthesizing of amoxicillin energy anti-bacteria cell wall, make it to become rapidly the dissolving of spheroid swelling fracture; Because many Gram-positives and negative bacteria produce beta-lactamase clinically, the amoxicillin belongs to the penicillins medicine, easily by the beta-lactam enzyme hydrolysis, makes the amoxicillin lose antibacterial activity.
Sulbactam can suppress the beta-lactamase (the II type is to the IV type) that most of antibacterial produces, its stability is better than other beta-lactamase inhibitor, it can run through rapidly bacteria cell wall and irreversibly destroy beta-lactamase, makes the antibacterial recovery to the sensitivity of amoxicillin.
In order to strengthen the activity of amoxicillin, clinical the amoxicillin has appearred and the beta-lactamase inhibitor combination is used, reach synergistic curative effect.Because the unstability of penicillin medicine causes can not depositing for a long time after the dissolving, hospital also is now with the current.
Patent documentation CN101322701B discloses and has utilized high speed adverse current chromatogram purification amoxicillin and sulbactam sodium, but just with simple aseptic subpackaged being mixed with of two kinds of components, has had a strong impact on dissolution velocity and the stability of pharmaceutical composition.
Patent documentation CN101632660B discloses simple amoxicillin sulbactam sodium injection and has had the unstability factor, prepared a kind of amoxicillin compositions suspensoid by lyophilization and reach to make can stablize behind the amoxicillin sulbactam sodium drug regimen and deposit for addressing this problem this invention, but there is suspensoid injectio in this invention prescription is complicated, preparation technology is more loaded down with trivial details problem.
Therefore, demand urgently developing a kind of new easy to use, can increase dissolution velocity, can avoid again the amoxicillin sulbactam sodium ejection preparation of the stability problem that long storage time produces simultaneously.
Summary of the invention:
The defectives such as the dissolution velocity that exists in the prior art is slow in order to solve, poor stability, the object of the present invention is to provide that a kind of impurity content is low, dissolubility is high, good stability, not allochroic amoxicillin sulbactam sodium pharmaceutical composition injection, this drug combination injection is comprised of amoxicillin, sulbactam sodium, sodium chloride, lactose and sodium dihydrogen phosphate.Another object of the present invention is to provide a kind of preparation method of amoxicillin sulbactam sodium pharmaceutical composition injection.
Amoxicillin sulbactam sodium pharmaceutical composition injection that the present invention relates to and preparation method thereof is achieved through the following technical solutions:
The invention provides a kind of amoxicillin sulbactam sodium pharmaceutical composition injection, in weight portion, the prescription of this drug combination injection is as follows:
Amoxicillin 1-10 part;
Sulbactam sodium 0.5-5 part;
Lactose 0.4-8 part;
Sodium chloride 0.4-8 part;
Sodium dihydrogen phosphate is an amount of, is used for pH is adjusted to 7.0.
Amoxicillin sulbactam sodium pharmaceutical composition injection of the present invention, in weight portion, the prescription of this drug combination injection is:
10 parts of amoxicillin;
5 parts of sulbactam sodium;
4 parts of lactose;
4 parts in sodium chloride;
Sodium dihydrogen phosphate is an amount of, is used for pH is adjusted to 7.0.
The pH value of amoxicillin sulbactam sodium pharmaceutical composition injection of the present invention can remain on 6.8-7.5.
The present invention also provides a kind of preparation method of amoxicillin sulbactam sodium pharmaceutical composition injection, may further comprise the steps:
Take by weighing according to quantity amoxicillin, sulbactam sodium, lactose, sodium chloride, the dissolving of employing water for injection, using an amount of sodium dihydrogen phosphate regulator solution pH value is 7.0, be settled to 5000ml with water for injection again, then the filter membrane of via hole diameter 0.22um filters, drying, sterile crushing, fill namely gets amoxicillin sulbactam sodium pharmaceutical composition injection.
Drying means of the present invention is spray drying.
Compared with prior art, the present invention has the following advantages:
1, the present invention has used sodium dihydrogen phosphate to make the pH value of amoxicillin sulbactam sodium pharmaceutical composition injection remain on 6.8-7.5, and fluctuation range is minimum, guarantees its stability.
2, adopt lactose to make enhanced dissolution rate, use sodium chloride to guarantee that it places in use the long period and also can not change, guarantee its stability.
3, injection Amoxicillin medicinal composition injection provided by the invention has good stability, and the advantages such as rapid are dissolved in invariant color.
4, the present invention fills a prescription simply, preparation method is easy, has overcome the defective that prior art formula is complicated, preparation technology is loaded down with trivial details.
The specific embodiment
Further specify by the following examples the present invention, but not as limitation of the present invention.
Embodiment 1The screening of amoxicillin sulbactam sodium pharmaceutical composition injection prescription
Drug combination injection of the present invention, comprise amoxicillin and sulbactam sodium, add respectively in lactose, sodium chloride or the sodium dihydrogen phosphate one or more, take dissolution time as index, carry out the screening experiment of drug combination injection prescription of the present invention, the results are shown in Table 1.
Table 1: the prescription screening experiment take dissolution time as index
Table 1 experimental result shows, during take dissolution time as index, 4 optimums of filling a prescription, the content that namely adds each component in prescription is all under the identical condition, the required dissolution time of the prescription that is comprised of amoxicillin, sulbactam sodium, lactose, sodium chloride, sodium dihydrogen phosphate is the shortest, and only needing 8 seconds is solubilized.Obviously, compare the drug combination injection that formed by amoxicillin, sulbactam sodium, lactose, sodium chloride, sodium dihydrogen phosphate of prescription 4(with the prescription that only is grouped into by amoxicillin, two kinds of one-tenth of sulbactam sodium) dissolution time shorten nearly one times.
Embodiment 2Amoxicillin sulbactam sodium pharmaceutical composition injection and preparation thereof
The prescription of drug combination injection (1000 bottles):
Amoxicillin 2000g;
Sulbactam sodium 1000g;
Lactose 800g;
Sodium chloride 800g;
Sodium dihydrogen phosphate is an amount of, makes pH be adjusted to 7.0;
Water for injection is settled to 5000mL;
Preparation method:
Get amoxicillin, sulbactam sodium, lactose, the sodium chloride of above-mentioned amount, the dissolving of employing water for injection, using an amount of sodium dihydrogen phosphate regulator solution pH value is 7.0, be settled to 5000ml with water for injection again, membrane filtration mistake after filtration then, the aperture of filter membrane is preferably 0.22um, spray drying, sterile crushing, fill namely gets amoxicillin sulbactam sodium pharmaceutical composition injection.
Embodiment 3Amoxicillin sulbactam sodium pharmaceutical composition injection and preparation thereof
The prescription of drug combination injection (1000 bottles):
Amoxicillin 1000g;
Sulbactam sodium 500g;
Lactose 400g;
Sodium chloride 400g;
Sodium dihydrogen phosphate is an amount of, makes pH be adjusted to 7.0;
Water for injection is settled to 5000mL;
Preparation method:
Get amoxicillin, sulbactam sodium, lactose, the sodium chloride of above-mentioned amount, the dissolving of employing water for injection, using an amount of sodium dihydrogen phosphate regulator solution pH value is 7.0, be settled to 5000ml with water for injection again, membrane filtration mistake after filtration then, the aperture of filter membrane is preferably 0.22um, spray drying, sterile crushing, fill namely gets amoxicillin sulbactam sodium pharmaceutical composition injection.
Embodiment 4Amoxicillin sulbactam sodium pharmaceutical composition injection and preparation thereof
The prescription of drug combination injection (1000 bottles):
Amoxicillin 1000g;
Sulbactam sodium 750g;
Lactose 400g;
Sodium chloride 800g;
Sodium dihydrogen phosphate is an amount of, makes pH be adjusted to 7.0;
Water for injection is settled to 5000mL;
Preparation method:
Get amoxicillin, sulbactam sodium, lactose, the sodium chloride of above-mentioned amount, the dissolving of employing water for injection, using an amount of sodium dihydrogen phosphate to regulate pH value is 7.0, be settled to 5000ml with water for injection again, membrane filtration mistake after filtration then, the aperture of filter membrane is preferably 0.22um, spray drying, sterile crushing, fill namely gets amoxicillin sulbactam sodium pharmaceutical composition injection.
Embodiment 5Amoxicillin sulbactam sodium pharmaceutical composition injection and preparation thereof
The prescription of drug combination injection (1000 bottles):
Amoxicillin 1250g;
Sulbactam sodium 625g;
Lactose 500g;
Sodium chloride 500g;
Sodium dihydrogen phosphate is an amount of, makes pH be adjusted to 7.0;
Water for injection is settled to 5000mL;
Preparation method:
Get amoxicillin, sulbactam sodium, lactose, the sodium chloride of above-mentioned amount, the dissolving of employing water for injection, using an amount of sodium dihydrogen phosphate regulator solution pH value is 7.0, be settled to 5000ml with water for injection again, membrane filtration mistake after filtration then, the aperture of filter membrane is preferably 0.22um, spray drying, sterile crushing, fill namely gets amoxicillin sulbactam sodium pharmaceutical composition injection.
Embodiment 6Amoxicillin sulbactam sodium pharmaceutical composition injection and preparation thereof
The prescription of drug combination injection (1000 bottles):
Amoxicillin 500g;
Sulbactam sodium 250g;
Lactose 300g;
Sodium chloride 300g;
Sodium dihydrogen phosphate is an amount of, makes pH be adjusted to 7.0;
Water for injection is settled to 5000mL;
Preparation method:
Get amoxicillin, sulbactam sodium, lactose, the sodium chloride of above-mentioned amount, the dissolving of employing water for injection, using an amount of sodium dihydrogen phosphate regulator solution pH value is 7.0, be settled to 5000ml with water for injection again, membrane filtration mistake after filtration then, the aperture of filter membrane is preferably 0.22um, spray drying, sterile crushing, fill namely gets amoxicillin sulbactam sodium pharmaceutical composition injection.
Embodiment 7Amoxicillin sulbactam sodium pharmaceutical composition injection and preparation thereof
The prescription of drug combination injection (1000 bottles):
Amoxicillin 500g;
Sulbactam sodium 250g;
Lactose 40g;
Sodium chloride 40g;
Sodium dihydrogen phosphate is an amount of, makes pH be adjusted to 7.0;
Water for injection is settled to 5000mL;
Preparation method:
Get amoxicillin, sulbactam sodium, lactose, the sodium chloride of above-mentioned amount, the dissolving of employing water for injection, using an amount of sodium dihydrogen phosphate regulator solution pH value is 7.0, be settled to 5000ml with water for injection again, membrane filtration mistake after filtration then, the aperture of filter membrane is preferably 0.22um, spray drying, sterile crushing, fill namely gets amoxicillin sulbactam sodium pharmaceutical composition injection.
Embodiment 8Amoxicillin sulbactam sodium pharmaceutical composition injection and preparation thereof
The prescription of drug combination injection (1000 bottles):
Amoxicillin 500g;
Sulbactam sodium 250g;
Lactose 20g;
Sodium chloride 20g;
Sodium dihydrogen phosphate is an amount of, makes pH be adjusted to 7.0;
Water for injection is settled to 5000mL;
Preparation method:
Get amoxicillin, sulbactam sodium, lactose, the sodium chloride of above-mentioned amount, the dissolving of employing water for injection, using an amount of sodium dihydrogen phosphate regulator solution pH value is 7.0, be settled to 5000ml with water for injection again, membrane filtration mistake after filtration then, the aperture of filter membrane is preferably 0.22um, spray drying, sterile crushing, fill namely gets amoxicillin sulbactam sodium pharmaceutical composition injection.
Embodiment 9Amoxicillin sulbactam sodium pharmaceutical composition injection and preparation thereof
The prescription of drug combination injection (1000 bottles):
Amoxicillin 250g;
Sulbactam sodium 125g;
Lactose 100g;
Sodium chloride 100g;
Sodium dihydrogen phosphate is an amount of, makes pH be adjusted to 7.0;
Water for injection is settled to 5000mL;
Preparation method:
Get amoxicillin, sulbactam sodium, lactose, the sodium chloride of above-mentioned amount, the dissolving of employing water for injection, using an amount of sodium dihydrogen phosphate regulator solution pH value is 7.0, be settled to 5000ml with water for injection again, membrane filtration mistake after filtration then, the aperture of filter membrane is preferably 0.22um, spray drying, sterile crushing, fill namely gets amoxicillin sulbactam sodium pharmaceutical composition injection.
Embodiment 10Amoxicillin sulbactam sodium pharmaceutical composition injection and preparation thereof
The prescription of drug combination injection (1000 bottles):
Amoxicillin 500g;
Sulbactam sodium 250g;
Lactose 400g;
Sodium chloride 400g;
Sodium dihydrogen phosphate is an amount of, makes pH be adjusted to 7.0;
Water for injection is settled to 5000mL;
Preparation method:
Get amoxicillin, sulbactam sodium, lactose, the sodium chloride of above-mentioned amount, the dissolving of employing water for injection, using an amount of sodium dihydrogen phosphate regulator solution pH value is 7.0, be settled to 5000ml with water for injection again, membrane filtration mistake after filtration then, the aperture of filter membrane is preferably 0.22um, spray drying, sterile crushing, fill namely gets amoxicillin sulbactam sodium pharmaceutical composition injection.
Embodiment 11The experiment of drug combination injection pH value
As everyone knows, for drug combination injection, pH is advisable in neutral range, and pH variation less then pharmaceutical composition itself is more stable.In the rear variation along with storage time of pharmaceutical composition preparation, certain fluctuation can occur because of the variation of medicine itself in pH, this just need at first determine the optimal pH of solution when pharmaceutical compositions solution, so that pharmaceutical composition place after the long period pH change little, thereby guaranteeing that pharmaceutical composition maintains stablizes qualified character.
To at room temperature place 60 days simultaneously according to the sample of prescription 4 preparations among embodiments of the invention 2-10 and the embodiment 1 and according to the samples of the prescription 1-3 among the matched group embodiment 1 and 5 preparations of filling a prescription, respectively above sample was used the water for injection dissolving at 0 day, 30 days and 60 days, measure the pH value of drug combination injection solution, the results are shown in Table 2.
The experiment of table 2 drug combination injection pH value
Table 2 is the result show, the fluctuation range of the sample solution pH value of the prescription 4 among embodiment 2-10 and the embodiment 1 is 6.8-7.5, and the fluctuation range of the prescription 1-3 among the matched group embodiment 1 and 5 the sample solution pH value of filling a prescription is 6.8～10.3.Obviously, the pH fluctuation range of drug combination injection sample of the present invention is less.
Embodiment 12The dissolution velocity experiment
According to prescription 1-3 among prescription 4 among embodiments of the invention 2-10 and the embodiment 1 and the matched group embodiment 1 and fill a prescription and 5 prepare respectively three batch samples, use water for injection to dissolve above-mentioned sample, carry out the dissolution velocity experiment, the results are shown in Table 3.
The experiment of table 3 dissolution velocity
Table 3 result shows that the dissolution time of the sample of prescription 4 is 7.9-8.1 second among embodiments of the invention 2-10 and the embodiment 1, and the dissolution time of the prescription 1-3 among the matched group embodiment 1 and 5 the sample of filling a prescription is 9.3-14.0 second.Obviously, the dissolution velocity of the dissolution velocity contrast group sample of drug combination injection sample of the present invention is fast.
Embodiment 13The storage-stable experiment
Will according to the samples of prescription 4 preparations among embodiments of the invention 2-10 and the embodiment 1 with according to the samples of prescription 1-3 among the matched group embodiment 1 and 5 preparations of filling a prescription the lower storage of conventional refrigeration temperature (2 ~ 8 ℃) 18 months, take related substance and color level as investigating index, carry out long-time stability and investigate test.The results are shown in Table 4.Wherein, the content of drug standard requirement related substance should be greater than 2.5%, and the color level is not more than 3#.
Long-time stability experiment under ℃ holding conditions of table 42 ~ 8
Table 4 result shows, prescription 4 samples among embodiments of the invention 2-10 and the embodiment 1 are more stable than the prescription 1-3 among the matched group embodiment 1 and 5 the sample of filling a prescription, can be 2 ~ 8 ℃ of lower storages of conventional refrigeration temperature 18 months, product quality still meets the national drug standards, and matched group can only store 12 months.
Although illustrate and described exemplary embodiments more of the present invention, but those skilled in the art should know, without departing from the principles and spirit of the present invention, can make change to these exemplary embodiments, scope of the present invention is limited by claim and equivalent thereof.
Claims (6)
1. an amoxicillin sulbactam sodium pharmaceutical composition injection is characterized in that, in weight portion, the prescription of described drug combination injection is:
Amoxicillin 1-10 part;
Sulbactam sodium 0.5-5 part;
Lactose 0.4-8 part;
Sodium chloride 0.4-8 part;
Sodium dihydrogen phosphate is an amount of, is used for pH is adjusted to 7.0.
2. amoxicillin sulbactam sodium pharmaceutical composition injection according to claim 1 is characterized in that, in weight portion, the prescription of described drug combination injection is:
10 parts of amoxicillin;
5 parts of sulbactam sodium;
4 parts of lactose;
4 parts in sodium chloride;
Sodium dihydrogen phosphate is an amount of, is used for pH is adjusted to 7.0.
3. amoxicillin sulbactam sodium pharmaceutical composition injection according to claim 1 and 2 is characterized in that the pH value of described drug combination injection remains on 6.8-7.5.
4. the preparation method of an amoxicillin sulbactam sodium pharmaceutical composition injection is characterized in that, said method comprising the steps of:
Take by weighing according to quantity amoxicillin, sulbactam sodium, lactose, sodium chloride, the dissolving of employing water for injection, using an amount of sodium dihydrogen phosphate regulator solution pH value is 7.0, be settled to 5000ml with water for injection again, then membrane filtration mistake after filtration, drying, sterile crushing, fill namely gets amoxicillin sulbactam sodium pharmaceutical composition injection.
5. the preparation method of amoxicillin sulbactam sodium pharmaceutical composition injection according to claim 4 is characterized in that, the pH value of described drug combination injection remains on 6.8-7.5.
6. the preparation method of amoxicillin sulbactam sodium pharmaceutical composition injection according to claim 4 is characterized in that, described drying means is spray drying.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103142588A (en) * | 2013-04-09 | 2013-06-12 | 黑龙江省汇丰动物保健品有限公司 | Amoxicillin sodium sulbactam sodium for injection and preparation method of amoxicillin sodium sulbactam sodium |
| CN104586843A (en) * | 2014-12-25 | 2015-05-06 | 重庆福安药业(集团)股份有限公司 | Amoxicillin sodium sulbactam sodium compound pharmaceutical composition for injector and preparation process thereof |
| CN106729658A (en) * | 2017-01-02 | 2017-05-31 | 武汉新联大生物有限公司 | A kind of amoxicillin solid dispersion and preparation method thereof |
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| CN1481786A (en) * | 2003-07-29 | 2004-03-17 | 吉林市卓怡康纳制药有限公司 | Method for preparing sotalol hydrochloride of injection |
| CN1623544A (en) * | 2003-12-01 | 2005-06-08 | 沈阳华泰药物研究有限公司 | Preparation of injection amoxicillin subaton |
| CN101632660A (en) * | 2009-08-18 | 2010-01-27 | 海南永田药物研究院有限公司 | Suspensoid powder injection of amoxicillin sodium sulbactam sodium medicine composition and novel application thereof |
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2012
- 2012-11-01 CN CN201210430518.XA patent/CN102895228B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1481786A (en) * | 2003-07-29 | 2004-03-17 | 吉林市卓怡康纳制药有限公司 | Method for preparing sotalol hydrochloride of injection |
| CN1623544A (en) * | 2003-12-01 | 2005-06-08 | 沈阳华泰药物研究有限公司 | Preparation of injection amoxicillin subaton |
| CN101632660A (en) * | 2009-08-18 | 2010-01-27 | 海南永田药物研究院有限公司 | Suspensoid powder injection of amoxicillin sodium sulbactam sodium medicine composition and novel application thereof |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103142588A (en) * | 2013-04-09 | 2013-06-12 | 黑龙江省汇丰动物保健品有限公司 | Amoxicillin sodium sulbactam sodium for injection and preparation method of amoxicillin sodium sulbactam sodium |
| CN104586843A (en) * | 2014-12-25 | 2015-05-06 | 重庆福安药业(集团)股份有限公司 | Amoxicillin sodium sulbactam sodium compound pharmaceutical composition for injector and preparation process thereof |
| CN104586843B (en) * | 2014-12-25 | 2017-05-10 | 重庆福安药业(集团)股份有限公司 | Amoxicillin sodium sulbactam sodium compound pharmaceutical composition for injector and preparation process thereof |
| CN106729658A (en) * | 2017-01-02 | 2017-05-31 | 武汉新联大生物有限公司 | A kind of amoxicillin solid dispersion and preparation method thereof |
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| CN102895228B (en) | 2014-07-23 |
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