CN104586843B - Amoxicillin sodium sulbactam sodium compound pharmaceutical composition for injector and preparation process thereof - Google Patents
Amoxicillin sodium sulbactam sodium compound pharmaceutical composition for injector and preparation process thereof Download PDFInfo
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- CN104586843B CN104586843B CN201410820258.6A CN201410820258A CN104586843B CN 104586843 B CN104586843 B CN 104586843B CN 201410820258 A CN201410820258 A CN 201410820258A CN 104586843 B CN104586843 B CN 104586843B
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Abstract
The invention discloses an amoxicillin sodium sulbactam sodium compound pharmaceutical composition for injection. The compound pharmaceutical composition is freeze-dried powder needle and is composed of the following raw materials in parts by weight: 1-6 parts of amoxicillin sodium, 0.5-3 parts of sulbactam sodium, 0.25-3 parts of xylitol and appropriate amount of hydrochloric acid-sodium hydroxide. In addition, the invention also provides a preparation method of the amoxicillin sodium sulbactam sodium compound pharmaceutical composition for injection. The stable amoxicillin sodium sulbactam sodium compound pharmaceutical composition is low in related substance content and good in solubleness. Meanwhile, the preparation process is simple and is suitable for industrial production.
Description
Technical field
The invention belongs to technical field of pharmaceuticals, is related to a kind of compound medicine combination of amoxicillin sodium for injection sulbactam
Thing, in addition, further relating to a kind of preparation method of amoxicillin sodium for injection sulbactam compound medicament composition.
Background technology
Amoxicillin sodium and sulbactam sodium is developed by Argentinian Bag ó companies, and at present, its preparation is with trade name Trifamox
IBL in the majority Latin American countries and Korean market such as Argentina, Brazil, Mexico, Colombia, and in import in 1997 I
State.At present, the existing domestic amoxicillin sodium and sulbactam sodium preparation listing of China, wherein, Amoxicillin Sodium and sulbactam
Ratio is 2: 1 (in terms of effective acids).Amoxicillin suppresses bacterium to turn skin enzyme, prevents the friendship that skin is glued in bacteria cell wall building-up process
Connection reaction, destroys the integrality of cell membrane, makes thalline swelling fracture, while inspiring bacterium self-dissolving system, is disintegrated thalline, is to kill
Bacterium property broad-spectrum antibiotic, but bacterium is also easy to produce drug resistance to it when being used alone.Sulbactam is the suppression of irreversibility beta-lactamase
Preparation, can effectively suppress bacteriogenic beta-lactamase, and antienzyme is latent wide, also has very to the beta-lactamase of Chromosome-encoded
Strong inhibitory action, Papillary, antimicrobial spectrum expands, and resistance to enzymatic can also strengthen.
At present, commercially available amoxicillin sodium and sulbactam sodium powder-injection, is by Amoxicillin Sodium and sulbactam sterile raw material
Directly mixing packing is obtained, and homogeneity, stability, dissolubility of the method products obtained therefrom etc. are poor.
Chinese patent document CN101632660A discloses the suspension injection powder of amoxicillin sodium and sulbactam sodium, using emulsification
Suspension technology is prepared by freeze-drying, solves the problems, such as that amoxicillin sodium and sulbactam sodium stability is poor, but it is filled a prescription
Complicated, preparation technology is also unsuitable for industrialized production.
Chinese patent document CN101322701A discloses a kind of amoxicillin sodium for injection sulbactam and its freeze-dried powder
The preparation method of injection, it adopts high-speed countercurrent chromatography, and with the configuration of chloroform, ethyl acetate and water fixing phase, stream are constituted
The dicyandiamide solution of dynamic property, isolates and purifies to Amoxicillin Sodium and sulbactam, obtains the Amoxicillin Sodium of injection and relaxes
Batan sodium, then freeze-drying, aseptic subpackaged, prepared amoxicillin sodium for injection sulbactam.The dissolving of the method products obtained therefrom
Speed and less stable, have a strong impact on its clinical efficacy.
Chinese patent document CN102895228A discloses the injection of amoxicillin sodium and sulbactam sodium, and it is with biphosphate
Sodium adjusts the pH value of mixed liquor to 7.0, and afterwards filtration, dry, sterile crushing are filling, obtain amoxicillin sodium and sulbactam sodium injection
Agent.Although its products obtained therefrom has the advantages such as solubility height, good stability, with phosphate adjust pH value when, be easily caused Ah
, there is afterwards intramolecular cyclization in the lactam nucleus open loop of Amdinocillin, so as to generate 2,5- pyrazine diketone, the relevant material in finished product contains
Amount higher (being more than 1.03%-1.24%).
The content of the invention
The present inventor develops in surprise a kind of about content of material is low, dissolubility is good, stable injection Amoxicillin
Sodium sulbactam sodium medicine composition, said composition is injection, its preparation process is simple, is suitable to industrialized production.
It is an object of the invention to provide a kind of compound medicament composition of amoxicillin sodium for injection sulbactam.
It is a further object of the present invention to provide a kind of system of amoxicillin sodium for injection sulbactam compound medicament composition
Preparation Method.
Specifically, the invention provides a kind of compound medicament composition of amoxicillin sodium for injection sulbactam, is somebody's turn to do
Compound medicament composition is freeze-dried powder, is made up of the raw material of following weight proportion：
Here, the consumption of the Amoxicillin Sodium is with the calculating of Amoxicillin free acid；The consumption of the sulbactam is
With the calculating of Sulbactam free acid；Described hydrochloric acid-sodium hydroxide concentration, refers to above-mentioned Amoxicillin Sodium, sulbactam, wood sugar
Alcohol is dissolved in water for injection, it is to be dissolved completely after, adjust the hydrochloric acid-amount of sodium hydroxide needed for pH value to 7.0-8.2, preferably adjust
To 7.8-8.0, the weight of the water for injection is 8-10 times of Amoxicillin free acid weight to section pH value, it is preferable that for 8 times.
The invention provides a kind of compound medicament composition of amoxicillin sodium for injection sulbactam, the compound medicine group
Compound is freeze-dried powder, is made up of the raw material of following weight proportion：
Here, the consumption of the Amoxicillin Sodium is with the calculating of Amoxicillin free acid；The consumption of the sulbactam is
With the calculating of Sulbactam free acid；Described hydrochloric acid-sodium hydroxide concentration, refers to above-mentioned Amoxicillin Sodium, sulbactam, wood sugar
Alcohol is dissolved in water for injection, it is to be dissolved completely after, adjust the amount of hydrochloric acid-NaOH needed for pH value to 7.0-8.2, it is preferable that
PH value is adjusted to 7.8-8.0, the weight of the water for injection is 8-10 times of Amoxicillin free acid weight, it is preferable that for 8
Times.
A kind of compound medicament composition of amoxicillin sodium and sulbactam sodium that the present invention is provided, is by as follows specifically
The raw material composition of weight proportion：
Here, the consumption of the Amoxicillin Sodium is with the calculating of Amoxicillin free acid；The consumption of the sulbactam is
With the calculating of Sulbactam free acid；Described hydrochloric acid-sodium hydroxide concentration, refers to above-mentioned Amoxicillin Sodium, sulbactam, wood sugar
Alcohol is dissolved in water for injection, it is to be dissolved completely after, adjust the amount of hydrochloric acid-NaOH needed for pH value to 7.0-8.2, preferably adjust
To 7.8-8.0, the weight of the water for injection is 8-10 times of Amoxicillin free acid weight to section pH value, it is preferable that for 8 times.
In addition, present invention also offers a kind of preparation method of amoxicillin sodium and sulbactam sodium freeze-dried powder, by recipe quantity
Amoxicillin Sodium, sulbactam, xylitol be dissolved in the recipe quantity 80%w/w (injections of 8 times of Amoxicillin free acid weight
Water) water for injection in, it is to be dissolved completely after, pH value is adjusted to 7.0-8.2 with hydrochloric acid-NaOH, add recipe quantity 20%
The water for injection of w/w, adds needle-use activated carbon absorption thermal source, and with the molecular filter in 0.45 μm and 0.22 μm aperture degerming mistake is carried out
Filter, during sterile solution is fitted into into bottle or disk, carries out freeze-drying and obtains final product.
In the description of the invention, with regard to " % ", in addition to special provision, the percentage refers to percentage by weight；W/v's
Unit is g/ml.
The amoxicillin sodium for injection sulbactam sodium composition that the present invention is provided, compared with prior art, with relevant thing
The advantage such as matter content is low, stability is excellent, dissolubility is good.
Specific embodiment
Below in conjunction with specific embodiment, the present invention will be further described, but it is above-mentioned this should not to be interpreted as into the present invention
Subject area is only limitted to following embodiments.
Embodiment 1
Prescription：1.5g, 100 bottles of consumptions
The Amoxicillin Sodium of recipe quantity, sulbactam, xylitol are dissolved in the water for injection of 800ml, it is to be dissolved complete
Afterwards, pH value is adjusted to 7.8-8.0 with hydrochloric acid-NaOH, adds the water for injection of 200ml, add needle-use activated carbon heat of adsorption
Source, with the molecular filter in 0.45 μm and 0.22 μm aperture aseptic filtration is carried out, and during sterile solution is fitted into into bottle or disk, carries out freezing dry
It is dry to obtain final product.
Reference examples 1
Prescription：100 bottles of consumptions
With the pH value that phosphoric acid-sodium dihydrogen phosphate adjusts in right amount mixed liquor, other operations are with embodiment 1
Embodiment 2
Prescription：3.0g, 100 bottles of consumptions
The Amoxicillin Sodium of recipe quantity, sulbactam, xylitol are dissolved in the water for injection of 1.6L, it is to be dissolved complete
Afterwards, pH value is adjusted to 7.8-8.0 with hydrochloric acid-NaOH, adds the water for injection of 400ml, add needle-use activated carbon heat of adsorption
Source, with the molecular filter in 0.45 μm and 0.22 μm aperture aseptic filtration is carried out, and during sterile solution is fitted into into bottle or disk, carries out freezing dry
It is dry to obtain final product.
Reference examples 2
Prescription：3.0g, 100 bottles of consumptions
The pH value of mixed liquor is adjusted in right amount to 7.8-8.0 with citric acid-sodium citrate, other methods of operating are with embodiment 2
Embodiment 3
Prescription：1.5g, 500 bottles of consumptions
The Amoxicillin Sodium of recipe quantity, sulbactam, xylitol are dissolved in the water for injection of 4.0L, it is to be dissolved complete
Afterwards, pH value is adjusted to 7.8-8.0 with hydrochloric acid-NaOH, adds the water for injection of 1L, add needle-use activated carbon absorption thermal source,
Aseptic filtration is carried out with the molecular filter in 0.45 μm and 0.22 μm aperture, during sterile solution is fitted into into bottle or disk, freeze-drying is carried out
Obtain final product.
Reference examples 3
Prescription：1.5g, 500 bottles of consumptions
The pH value of mixed liquor is adjusted in right amount to 7.8-8.0 with phosphoric acid-disodium hydrogen phosphate, other methods of operating are with embodiment 3
Embodiment 4
Prescription：1.5g, 500 bottles of consumptions
The Amoxicillin Sodium of recipe quantity, sulbactam, xylitol are dissolved in the water for injection of 4.0L, it is to be dissolved complete
Afterwards, pH value is adjusted to 7.8-8.0 with hydrochloric acid-NaOH, adds the water for injection of 1L, add needle-use activated carbon absorption thermal source,
Aseptic filtration is carried out with the molecular filter in 0.45 μm and 0.22 μm aperture, during sterile solution is fitted into into bottle or disk, freeze-drying is carried out
Obtain final product.
Reference examples 4
Prescription：1.5g, 500 bottles of consumptions
The pH value of mixed liquor is adjusted in right amount to 7.8-8.0 with Acetic acid-sodium acetate, other methods of operating are with embodiment 4.
Embodiment 5
By the gained amoxicillin sodium for injection sulbactam freeze-dried powder of embodiment 1,2,3, respectively etc. quality takes 3 bottles, with reality
Apply the gained sample of example 1 and be labeled as 1,2, No. 3；The gained sample of embodiment 2 is labeled as 4,5, No. 6；The gained sample of embodiment 3 is labeled as
7th, 8, No. 9；The gained sample of reference examples 1 is labeled as 10,11, No. 12；The gained sample of reference examples 2 is labeled as 13,14, No. 15；It is commercially available
Product are labeled as 16,17, No. 18, according to the dissolving method of clinical application, are injected separately into 10ml waters for injection, and it is mixed in whirlpool
Shake on device, it is completely clear and bright as index to dissolve, dissolution velocity is calculated, it is as shown in the table：
As a result show, during with dissolution velocity as inspection target, present invention gained amoxicillin sodium for injection sulbactam is molten
The solution time is most short, hence it is evident that better than control group and commercially available product.
The study on the stability of embodiment 6
Method：Difference Example 1,2, reference examples 1,2 gained samples and commercially available product (the limited public affairs of North China pharmacy group share
Department, lot number：09068217, specification：1.5g), study on the stability is carried out at cool dark (being less than 20 DEG C) place, is packed with Aluminum Bottle
Afterwards, upright and placement of standing upside down, content and the detection method reference injection Amoxicillin about material are investigated simultaneously in 0,3, June
Sodium and sulbactam sodium quality standard WS1- (X-442) -2003Z.Investigate result as shown in the table：
Long-term test results
As a result show, present invention gained amoxicillin sodium for injection sodium and sulbactam sodium, relevant content of material is low, and through 6
The study on the stability of individual month, it changes less about material, content.
Claims (10)
1. a kind of compound medicament composition of amoxicillin sodium for injection sulbactam, the compound medicament composition is freeze-dried powder
Pin, is made up of the raw material of following weight proportion：
Here, the consumption of the Amoxicillin Sodium is with the calculating of Amoxicillin free acid；The consumption of the sulbactam is to relax
Batan free acid is calculated；Described hydrochloric acid-sodium hydroxide concentration, refers to above-mentioned Amoxicillin Sodium, sulbactam, xylitol is molten
In water for injection, it is to be dissolved completely after, adjust the amount of hydrochloric acid-NaOH needed for pH value to 7.0-8.2；The water for injection
Weight be 8-10 times of Amoxicillin free acid weight.
2. compound medicament composition as claimed in claim 1, the compound medicament composition is freeze-dried powder, is by following weight
The raw material composition of proportioning：
3. compound medicament composition as claimed in claim 1, the compound medicament composition is freeze-dried powder, is by following weight
The raw material composition of proportioning：
4. the compound medicament composition as any one of claim 1-3, wherein, described hydrochloric acid-sodium hydroxide concentration,
Refer to and above-mentioned Amoxicillin Sodium, sulbactam, xylitol be dissolved in water for injection, it is to be dissolved completely after, adjust pH value to
The amount of hydrochloric acid-NaOH needed for 7.8-8.0；The weight of the water for injection is 8-10 times of Amoxicillin free acid weight.
5. compound medicament composition as claimed in claim 1, wherein, described hydrochloric acid-sodium hydroxide concentration, referring to will be above-mentioned
Amoxicillin Sodium, sulbactam, xylitol are dissolved in water for injection, it is to be dissolved completely after, adjust salt needed for pH value to 7.8-8.0
The amount of acid-NaOH；The weight of the water for injection is 8 times of Amoxicillin free acid weight.
6. the preparation method of the compound medicament composition as any one of claim 1-4 comprises the steps：
The Amoxicillin Sodium of recipe quantity, sulbactam, xylitol are dissolved in the water for injection of recipe quantity 80%w/w, it is to be dissolved
After completely, pH value is adjusted to 7.0-8.2 with hydrochloric acid-NaOH, add the water for injection of recipe quantity 20%w/w, add pin to use
Charcoal absorption thermal source, with the molecular filter in 0.45 μm and 0.22 μm aperture aseptic filtration is carried out, and sterile solution is loaded into bottle or disk
In, carry out freeze-drying and obtain final product.
7. a kind of compound medicament composition of amoxicillin sodium for injection sulbactam, the compound medicament composition is freeze-dried powder
Pin, specification is 1.5g, 100 bottles of consumptions, and prescription is：
Here, the consumption of the Amoxicillin Sodium is with the calculating of Amoxicillin free acid；The consumption of the sulbactam is to relax
Batan free acid is calculated；Described hydrochloric acid-sodium hydroxide concentration, refers to above-mentioned Amoxicillin Sodium, sulbactam, xylitol is molten
In water for injection, it is to be dissolved completely after, adjust the amount of hydrochloric acid-NaOH needed for pH value to 7.8-8.0；The water for injection
Amount be 1000ml；
Preparation method is：The Amoxicillin Sodium of recipe quantity, sulbactam, xylitol are dissolved in the water for injection of 800ml, treat molten
After solution is complete, pH value is adjusted to 7.8-8.0 with hydrochloric acid-NaOH, add the water for injection of 200ml, add needle-use activated carbon
Absorption thermal source, with the molecular filter in 0.45 μm and 0.22 μm aperture aseptic filtration is carried out, and during sterile solution is fitted into into bottle or disk, is carried out
Freeze-drying is obtained final product.
8. a kind of compound medicament composition of amoxicillin sodium for injection sulbactam, the compound medicament composition is freeze-dried powder
Pin, specification is 3.0g, 100 bottles of consumptions, and prescription is：
Here, the consumption of the Amoxicillin Sodium is with the calculating of Amoxicillin free acid；The consumption of the sulbactam is to relax
Batan free acid is calculated；Described hydrochloric acid-sodium hydroxide concentration, refers to above-mentioned Amoxicillin Sodium, sulbactam, xylitol is molten
In water for injection, it is to be dissolved completely after, adjust the amount of hydrochloric acid-NaOH needed for pH value to 7.8-8.0；The water for injection
Amount be 2.0L；
Preparation method is：The Amoxicillin Sodium of recipe quantity, sulbactam, xylitol are dissolved in the water for injection of 1.6L, treat molten
After solution is complete, pH value is adjusted to 7.8-8.0 with hydrochloric acid-NaOH, add the water for injection of 400ml, add needle-use activated carbon
Absorption thermal source, with the molecular filter in 0.45 μm and 0.22 μm aperture aseptic filtration is carried out, and during sterile solution is fitted into into bottle or disk, is carried out
Freeze-drying is obtained final product.
9. a kind of compound medicament composition of amoxicillin sodium for injection sulbactam, the compound medicament composition is freeze-dried powder
Pin, specification is 1.5g, 500 bottles of consumptions, and prescription is：
Here, the consumption of the Amoxicillin Sodium is with the calculating of Amoxicillin free acid；The consumption of the sulbactam is to relax
Batan free acid is calculated；Described hydrochloric acid-sodium hydroxide concentration, refers to above-mentioned Amoxicillin Sodium, sulbactam, xylitol is molten
In water for injection, it is to be dissolved completely after, adjust the amount of hydrochloric acid-NaOH needed for pH value to 7.8-8.0；The water for injection
Amount be 5.0L；
Preparation method is：The Amoxicillin Sodium of recipe quantity, sulbactam, xylitol are dissolved in the water for injection of 4.0L, treat molten
After solution is complete, pH value is adjusted to 7.8-8.0 with hydrochloric acid-NaOH, add the water for injection of 1L, add needle-use activated carbon absorption
Thermal source, with the molecular filter in 0.45 μm and 0.22 μm aperture aseptic filtration is carried out, and during sterile solution is fitted into into bottle or disk, is freezed
It is drying to obtain.
10. a kind of compound medicament composition of amoxicillin sodium for injection sulbactam, the compound medicament composition is freeze-dried powder
Pin, specification is 1.5g, 500 bottles of consumptions, and prescription is：
Here, the consumption of the Amoxicillin Sodium is with the calculating of Amoxicillin free acid；The consumption of the sulbactam is to relax
Batan free acid is calculated；Described hydrochloric acid-sodium hydroxide concentration, refers to above-mentioned Amoxicillin Sodium, sulbactam, xylitol is molten
In water for injection, it is to be dissolved completely after, adjust the amount of hydrochloric acid-NaOH needed for pH value to 7.8-8.0；The water for injection
Amount be 5L；
Preparation method is：The Amoxicillin Sodium of recipe quantity, sulbactam, xylitol are dissolved in the water for injection of 4.0L, treat molten
After solution is complete, pH value is adjusted to 7.8-8.0 with hydrochloric acid-NaOH, add the water for injection of 1L, add needle-use activated carbon absorption
Thermal source, with the molecular filter in 0.45 μm and 0.22 μm aperture aseptic filtration is carried out, and during sterile solution is fitted into into bottle or disk, is freezed
It is drying to obtain.
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| CN102895228A (en) * | 2012-11-01 | 2013-01-30 | 哈药集团制药总厂 | Amoxicillin and sulbactam sodium medicinal composition injection and preparation method thereof |
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| CN101062032B (en) * | 2006-04-25 | 2011-06-08 | 刘祥华 | Sulbactam sodium bacteriophage complex and the preparing method thereof |
| CN101317843B (en) * | 2008-07-18 | 2012-05-09 | 贵州百灵企业集团制药股份有限公司 | Amoxicillin sulbactam pivoxil oral preparation and preparation method thereof |
| CN101632660B (en) * | 2009-08-18 | 2010-09-08 | 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 |
| CN101822669B (en) * | 2010-04-23 | 2012-06-13 | 海南美兰史克制药有限公司 | Liposome injection of amoxicillin sodium sulbactam sodium medicinal composition |
| CN103142588B (en) * | 2013-04-09 | 2014-09-17 | 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 |
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| CN102895228A (en) * | 2012-11-01 | 2013-01-30 | 哈药集团制药总厂 | Amoxicillin and sulbactam sodium medicinal composition injection and preparation method thereof |
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| Title |
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| 3种含酶抑制剂的青霉素类药在木糖醇注射液中稳定性考察;付秀娟;《中国药师》;20091231;第12卷(第2期);第191页第3.3部分 * |
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