CN109908079A - A kind of Cefadole oral liquor solution and preparation method thereof - Google Patents
A kind of Cefadole oral liquor solution and preparation method thereof Download PDFInfo
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- CN109908079A CN109908079A CN201910285099.7A CN201910285099A CN109908079A CN 109908079 A CN109908079 A CN 109908079A CN 201910285099 A CN201910285099 A CN 201910285099A CN 109908079 A CN109908079 A CN 109908079A
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Abstract
The invention discloses a kind of Cefadole oral liquor solution and preparation method thereof, the Cefadole oral liquor solution, it by weight include following components: 40-60 parts of Cefaclor, 15-35 parts of diammonium glycyrrhizinate, 10-30 parts of dimethyl acetamide, 10-20 parts of surfactant, 25-45 parts of dispersing agent, 1-15 parts of antioxidant, 800-1200 parts of purified water.Cefadole oral liquor solution component of the present invention is simple, and rationally, the content of cosolvent is suitable, to realize the stable dissolution of Cefaclor in aqueous solution, solves the Cefadole oral liquor solution of Cefaclor solubility problems for proportion.Preparation method of the present invention, simple process, condition are suitable.
Description
Technical field
The present invention relates to pharmaceutical fields, and in particular to a kind of Cefadole oral liquor solution；It is prepared the invention further relates to a kind of
The method of above-mentioned Cefadole oral liquor solution.
Background technique
Cefaclor, chemical name are as follows: (6R, 7R) -7- [(R) -2- amino -2- phenylacetylamino] chloro- 8- oxo-of -3-
5- thia -1- azabicyclo [4.2.0] oct-2-ene -2- formic acid monohydrate.Cefaclor category second generation oral cephalosporin,
For wide spectrum semi-synthetic cephalosporins antibiotic, very strong killing is all had to a variety of gram-positive bacterias and Gram-negative bacteria
Effect.Cefaclor is to production penicillase staphylococcus aureus, A group hemolytic streptococcus, Streptococcus viridans and epidermis Portugal
The activity of grape coccus is identical as cefadroxil, to the not antibacterial action of producing enzyme staphylococcus aureus and pneumococcus compared with cephalo
Amoxycillin is 2~4 times strong.It include to the activity of Escherichia coli and Klebsiella pneumoniae etc. compared with cefalexin to gram negative bacilli
By force, similar with cefadroxil, it is strong compared with cefadroxil to the activity of proteus mirabilis, Salmonella and Shigella.Face
Cefaclor is applied to infection caused by sensitive bacteria on bed, such as respiratory tract infection, the infection of ear nose section, urinary system infection contamination, skin
And soft tissue infection etc..
Cefaclor slightly soluble in water, in the organic solvents such as methanol, ethyl alcohol, chloroform or methylene chloride hardly
It is molten, therefore be difficult that oral solution is made.
Summary of the invention
Place that purpose of the invention is to overcome the shortcomings in the prior art, it is simple to provide a kind of component, proportion rationally,
The content of cosolvent is suitable, to realize the stable dissolution of Cefaclor in aqueous solution, it is difficult to solve Cefaclor dissolubility
The Cefadole oral liquor solution of topic.
Correspondingly, another object of the present invention provides a kind of method for preparing above-mentioned Cefadole oral liquor solution.
For Cefadole oral liquor solution, in order to achieve the above object, the present invention uses following scheme:
A kind of Cefadole oral liquor solution, it is characterised in that by weight include following components:
40-60 parts of Cefaclor, 15-35 parts of diammonium glycyrrhizinate, 10-30 parts of dimethyl acetamide, surfactant 10-20
Part, 25-45 parts of dispersing agent, 1-15 parts of antioxidant, 800-1200 parts of purified water.
Spore Crow category second generation cephalosporin class antibiotic in the present invention.Anti-microbial property is similar to cephazoline, takes orally and inhales
Receive good, for plasma protein binding rate up to 22%~26%, half-life period is 0.6~0.9h, and when renal insufficiency slightly extends.It is adult
Oral usual amounts 0.25g, 8h1 times every, 1d maximum is no more than 4g.
Under normal circumstances, Cefaclor slightly soluble in water, it is organic molten in methanol, ethyl alcohol, chloroform or methylene chloride etc.
It is almost insoluble in agent, therefore be difficult that oral solution is made.But it is surfactant in technical solution of the present invention, dispersing agent, anti-
Oxidant, which passes through, cleverly to be designed, and determines suitable ratio, so that realize the stable dissolution of Cefaclor in aqueous solution,
Solve Cefaclor solubility problems.
Diammonium glycyrrhizinate of the present invention is the effective component extracted in glycyrrhiza uralensis fisch, i.e. two di-ammonium salts of 18a body glycyrrhizic acid, is sweet
The renewal product of oxalic acid mono-ammonium is the third generation extract of glycyrrhiza uralensis fisch effective component, has stronger anti-inflammatory, protection
Liver plasma membrane and the effect for improving liver function.
Dimethyl acetamide in the present invention: Chinese name n,N-dimethylacetamide is a kind of non-proton highly polar solvent, molten
Xie Li is very strong.Effectively improve the solubility of Cefaclor in water.
By weight include following components as the further improvement of Cefadole oral liquor solution of the present invention:
45-55 parts of Cefaclor, 20-30 parts of diammonium glycyrrhizinate, 15-25 parts of dimethyl acetamide, surfactant 12-18
Part, 30-40 parts of dispersing agent, 5-10 parts of antioxidant, 900-1000 parts of purified water.
By weight include following components as the further improvement of Cefadole oral liquor solution of the present invention:
50 parts of Cefaclor, 25 parts of diammonium glycyrrhizinate, 20 parts of dimethyl acetamide, 15 parts of surfactant, dispersing agent 35
Part, 10 parts of antioxidant, 1000 parts of purified water.
Another kind as Cefadole oral liquor solution of the present invention improves, and the surfactant is Tween 80, laurel
Acid, benzalkonium chloride, benzalkonium bromide, cetrimonium bromide, fatty acid sorbitan, Myrj 45, polyoxyethylene aliphatic alcohol ether,
The mixture of one or more of cholesteryl ester, phosphatidyl-ethanolamine, phosphatidyl glycerol, polyethylene glycol.
A kind of nonionic surface active agent of Tween 80 and emulsifier, pass through ethoxy by sorbitan and oleic acid in the present invention
Baseization is made.Tween 80 can effectively increase the dissolubility of Cefaclor, establish certain basis to prepare Cefadole oral liquor liquid.
Another kind as Cefadole oral liquor solution of the present invention improves, and the dispersing agent is poloxamer -407 or mountain
Pears alcohol.
Poloxamer -407 in the present invention can be used as dispersing agent, emulsifier, solubilizer, lubricant, wetting agent use.This
Poloxamer -407 can make Cefaclor increase deliquescent simultaneously in invention, and Cefadole oral liquor liquid can be made rapid in vivo
It forms gel and attaches to affected part, to play the effect of its slow releasing pharmaceutical, realize and extend medicine retention in the mesh of action time
, effectively increase the drug effect of Cefadole oral liquor liquid.
Another kind as Cefadole oral liquor solution of the present invention improves, and the antioxidant is BHT.
The chemical name of BHT is 2,6- di-tert-butyl-4-methy phenol in the present invention, it is original with paracresol, isobutanol
Material, using the concentrated sulfuric acid as catalyst, aluminium oxide is dehydrating agent, and reaction generates 2.6- di-tert-butyl p-cresol.BHT can make to improve
The stability of Cefadole oral liquor liquid.
Another kind as Cefadole oral liquor solution of the present invention improves, and the antioxidant is BHA.
The Chinese name of BHA of the present invention: butylated hydroxy anisole is a kind of good antioxidant.
For preparation method, in order to achieve the above object, the present invention uses following scheme,
A method of preparing Cefadole oral liquor solution, comprising the following steps:
A, purified water is heated to 40-60 degrees Celsius；
B, dimethyl acetamide is added to stir and sufficiently dissolve；
C, diammonium glycyrrhizinate is added and sufficiently dissolves；
D, dispersing agent stirring is added, sufficiently dissolves, adjusts pH value to 7-8 with buffer；
E, Cefaclor stirring is added into step D, dissolves abundant Cefaclor sufficiently, obtains cefaclor solution；
F, surfactant is heated to 40-60 degrees Celsius；
G, cefaclor solution in step E is added in the surfactant of step F, and antioxidant is added and sufficiently stirs
It mixes.
Another kind as preparation method of the present invention improves, and dispersing agent is added in step D and stirs 3-8 minutes.
Another kind as preparation method of the present invention improves, and buffer described in step D is phosphate buffer.
In conclusion the present invention compared with the existing technology the beneficial effect is that:
Optimum choice surfactant, the composition of dispersing agent and proportion in Cefadole oral liquor solution of the present invention, and
It is real by the composition of each component and the optimization of proportion so that being substantially insoluble in the Cefaclor of water originally added with antioxidant
Now stable dissolution is in aqueous solution.In addition the residence time of drug in vivo is effectively increased while improving stability, is increased
Add its drug treating time, therapeutic effect significantly improves；
Its realization principle is as follows:
Purified water is first heated into suitable temperature in the present invention, dimethyl acetamide, diammonium glycyrrhizinate, dispersion is then added
Agent, stirring are sufficiently dissolved, and after adjusting pH value with buffer, Cefaclor stirring are added, dissolves abundant Cefaclor sufficiently,
Obtain cefaclor solution；Then the surfactant of heating is added, is eventually adding antioxidant and is sufficiently stirred.Cephalo gram of the present invention
It is wrapped in the emulsifier of dispersing agent, surfactant composition in the oral administration solution of Lip river due to Cefaclor, it can be effectively to cephalo gram
Lip river is protected, and then achievees the purpose that extend stability.
Simultaneously as Cefadole oral liquor liquid can be made rapid in vivo under the action of the dispersing agents such as poloxamer -407
It forms gel and attaches to affected part, to play the effect of its slow releasing pharmaceutical, realize and extend medicine retention in the mesh of action time
, effectively increase the drug effect of Cefadole oral liquor liquid.
Dispersing agent, surfactant, antioxidant can further increase stability and extend drug effect in the present invention
Time, also, Cefaclor can also be significantly improved to the antibacterial activity of microorganism, effect is very significant.
Specific embodiment
The invention will be further described With reference to embodiment:
Embodiment 1
A kind of Cefadole oral liquor solution of the present invention, includes following components by weight:
40 parts of Cefaclor, 15 parts of diammonium glycyrrhizinate, 10 parts of dimethyl acetamide, 10 parts of surfactant, dispersing agent 25
Part, 1 part of antioxidant, 800 parts of purified water.
Embodiment 2
A kind of Cefadole oral liquor solution of the present invention, includes following components by weight:
60 parts of Cefaclor, 35 parts of diammonium glycyrrhizinate, 30 parts of dimethyl acetamide, 20 parts of surfactant, dispersing agent 45
Part, 15 parts of antioxidant, 1200 parts of purified water.
Embodiment 3
A kind of Cefadole oral liquor solution of the present invention, includes following components by weight:
50 parts of Cefaclor, 25 parts of diammonium glycyrrhizinate, 20 parts of dimethyl acetamide, 15 parts of surfactant, dispersing agent 35
Part, 8 parts of antioxidant, 1000 parts of purified water.
Embodiment 4
A kind of Cefadole oral liquor solution of the present invention, includes following components by weight:
40 parts of Cefaclor, 35 parts of diammonium glycyrrhizinate, 30 parts of dimethyl acetamide, 10 parts of Tween 80, poloxamer -407
25 parts, 1 part of BHT, 1200 parts of purified water.
Embodiment 5
A kind of Cefadole oral liquor solution of the present invention, includes following components by weight:
60 parts of Cefaclor, 35 parts of diammonium glycyrrhizinate, 30 parts of dimethyl acetamide, 10 parts of Tween 80, poloxamer -407
45 parts, 5 parts of BHT, BHA2 parts, 1100 parts of purified water.
Embodiment 6
A kind of Cefadole oral liquor solution of the present invention, includes following components by weight:
45 parts of Cefaclor, 15 parts of diammonium glycyrrhizinate, 10 parts of dimethyl acetamide, 15 parts of Tween 80, poloxamer -407
30 parts, 1 part of BHT, BHA10 parts, 900 parts of purified water.
Embodiment 7
A kind of Cefadole oral liquor solution of the present invention, includes following components by weight:
50 parts of Cefaclor, 30 parts of diammonium glycyrrhizinate, 20 parts of dimethyl acetamide, 12 parts of Tween 80, poloxamer -407
35 parts, 5 parts of BHT, 5 parts of BHA, 1000 parts of purified water.
Embodiment 8
A kind of Cefadole oral liquor solution of the present invention, includes following components by weight:
55 parts of Cefaclor, 32 parts of diammonium glycyrrhizinate, 28 parts of dimethyl acetamide, 18 parts of Myrj 45, pool
29 parts of Luo Shamu -407,8 parts of BHT, BHA7 parts, 1100 parts of purified water.
Embodiment 9
A kind of Cefadole oral liquor solution of the present invention, includes following components by weight:
40 parts of Cefaclor, 35 parts of diammonium glycyrrhizinate, 30 parts of dimethyl acetamide, phosphatidyl-ethanolamine and phosphatidyl glycerol
10 parts of the mixture of 1:2 in mass ratio, 45 parts of sorbierite, 1 part of BHT, BHA1 parts, 1200 parts of purified water.
Embodiment 10
A kind of Cefadole oral liquor solution of the present invention, includes following components by weight:
60 parts of Cefaclor, 35 parts of diammonium glycyrrhizinate, 30 parts of dimethyl acetamide, benzalkonium chloride, benzalkonium bromide, the bent bromine in west
Ammonium presses 10 parts of mixture, 25 parts of poloxamer -407,1 part of BHT, 1 part of BHA, 1200 parts of purified water of 1:3:1.
1-10 of the embodiment of the present invention can be prepared by any one method of embodiment 11-13:
Embodiment 11
A method of preparing Cefadole oral liquor solution, comprising the following steps:
A, purified water is heated to 40 degrees Celsius；
B, dimethyl acetamide is added to stir and sufficiently dissolve；
C, diammonium glycyrrhizinate is added and sufficiently dissolves；
D, dispersing agent is added to stir 3 minutes, sufficiently dissolves, adjust pH value to 7 with phosphate buffer；
E, Cefaclor stirring is added into step D, dissolves abundant Cefaclor sufficiently, obtains cefaclor solution；
F, surfactant is heated to 40 degrees Celsius；
G, cefaclor solution in step E is added in the surfactant of step F, and antioxidant is added and sufficiently stirs
It mixes.
Embodiment 12
A method of preparing Cefadole oral liquor solution, comprising the following steps:
A, purified water is heated to 50 degrees Celsius；
B, dimethyl acetamide is added to stir and sufficiently dissolve；
C, diammonium glycyrrhizinate is added and sufficiently dissolves；
D, dispersing agent is added to stir 5 minutes, sufficiently dissolves, adjust pH value to 7.5 with phosphate buffer；
E, Cefaclor stirring is added into step D, dissolves abundant Cefaclor sufficiently, obtains cefaclor solution；
F, surfactant is heated to 50 degrees Celsius；
G, cefaclor solution in step E is added in the surfactant of step F, and antioxidant is added and sufficiently stirs
It mixes.
Embodiment 13
A method of preparing Cefadole oral liquor solution, comprising the following steps:
A, purified water is heated to 60 degrees Celsius；
B, dimethyl acetamide is added to stir and sufficiently dissolve；
C, diammonium glycyrrhizinate is added and sufficiently dissolves；
D, dispersing agent is added to stir 8 minutes, sufficiently dissolves, adjust pH value to 8 with phosphate buffer；
E, Cefaclor stirring is added into step D, dissolves abundant Cefaclor sufficiently, obtains cefaclor solution；
F, surfactant is heated to 60 degrees Celsius；
G, cefaclor solution in step E is added in the surfactant of step F, and antioxidant is added and sufficiently stirs
It mixes.
Basic principles and main features and advantages of the present invention of the invention have been shown and described above.The skill of the industry
Art personnel it should be appreciated that the present invention is not limited to the above embodiments, the above embodiments and description only describe
The principle of the present invention, without departing from the spirit and scope of the present invention, various changes and improvements may be made to the invention, these
Changes and improvements all fall within the protetion scope of the claimed invention.The claimed scope of the invention by appended claims and
Its equivalent thereof.
Claims (10)
1. a kind of Cefadole oral liquor solution, it is characterised in that by weight include following components:
40-60 parts of Cefaclor, 15-35 parts of diammonium glycyrrhizinate, 10-30 parts of dimethyl acetamide, 10-20 parts of surfactant,
25-45 parts of dispersing agent, 1-15 parts of antioxidant, 800-1200 parts of purified water.
2. a kind of Cefadole oral liquor solution according to claim 1, it is characterised in that by weight include following components:
45-55 parts of Cefaclor, 20-30 parts of diammonium glycyrrhizinate, 15-25 parts of dimethyl acetamide, 12-18 parts of surfactant,
30-40 parts of dispersing agent, 5-10 parts of antioxidant, 900-1000 parts of purified water.
3. a kind of Cefadole oral liquor solution according to claim 1, it is characterised in that by weight include following components:
50 parts of Cefaclor, 25 parts of diammonium glycyrrhizinate, 20 parts of dimethyl acetamide, 15 parts of surfactant, 35 parts of dispersing agent, resist
10 parts of oxidant, 1000 parts of purified water.
4. a kind of Cefadole oral liquor solution according to claim 1 to 4, it is characterised in that the surface-active
Agent is Tween 80, lauric acid, benzalkonium chloride, benzalkonium bromide, cetrimonium bromide, fatty acid sorbitan, Myrj 45, gathers
One or more of ethylene oxide fatty alcohol ether, cholesteryl ester, phosphatidyl-ethanolamine, phosphatidyl glycerol, polyethylene glycol
Mixture.
5. a kind of Cefadole oral liquor solution according to claim 1 to 4, it is characterised in that the dispersing agent is
Poloxamer -407 or sorbierite.
6. a kind of Cefadole oral liquor solution according to claim 1, it is characterised in that the antioxidant is BHT.
7. a kind of Cefadole oral liquor solution according to claim 1 or 6, it is characterised in that the antioxidant is BHA.
8. a kind of method for preparing Cefadole oral liquor solution, it is characterised in that the following steps are included:
A, purified water is heated to 40-60 degrees Celsius；
B, dimethyl acetamide is added to stir and sufficiently dissolve；
C, diammonium glycyrrhizinate is added and sufficiently dissolves；
D, dispersing agent stirring is added, sufficiently dissolves, adjusts pH value to 7-8 with buffer；
E, Cefaclor stirring is added into step D, dissolves abundant Cefaclor sufficiently, obtains cefaclor solution；
F, surfactant is heated to 40-60 degrees Celsius；
G, cefaclor solution in step E is added in the surfactant of step F, and antioxidant is added and is sufficiently stirred.
9. a kind of method for preparing Cefadole oral liquor solution according to claim 8, it is characterised in that be added in step D
Dispersing agent stirs 3-8 minutes.
10. a kind of method for preparing Cefadole oral liquor solution according to claim 8, it is characterised in that institute in step D
Stating buffer is phosphate buffer.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4148033A4 (en) * | 2020-06-18 | 2023-11-29 | China Petroleum & Chemical Corporation | Hydrate accelerator, hydrate and preparation method therefor |
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| EP4148033A4 (en) * | 2020-06-18 | 2023-11-29 | China Petroleum & Chemical Corporation | Hydrate accelerator, hydrate and preparation method therefor |
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