CN104083324A - Veterinary suspoemulsion containing rifaximin as well as preparation method and application thereof - Google Patents
Veterinary suspoemulsion containing rifaximin as well as preparation method and application thereof Download PDFInfo
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- CN104083324A CN104083324A CN201410329427.6A CN201410329427A CN104083324A CN 104083324 A CN104083324 A CN 104083324A CN 201410329427 A CN201410329427 A CN 201410329427A CN 104083324 A CN104083324 A CN 104083324A
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Abstract
The invention belongs to the field of veterinary antibiotic medicaments, and particularly relates to a suspoemulsion containing rifaximin as well as a preparation method and application of the suspoemulsion in preventing and treating mastitis infection of cow in the dry period. The suspoemulsion is prepared from rifaximin, an oil phase, an emulsifier and a water phase.
Description
Technical field
The invention belongs to antibiotic medicine for animals field, be specifically related to a kind of suspension emulsion of rifaximin, preparation method, and in the application preventing and treatment mammitis of dairy cattle during nonlactating infects.
Background technology
Rifaximin (Rifaximin) is Ryfamycin derivative, is first non-aminoglycosides intestinal antibiotic.Rifaximin effect is strong, and has a broad antifungal spectrum, to the aurococcus in Gram-positive aerobe, staphylococcus epidermidis and streptococcus faecalis; To Salmonella, escherichia coli, Shigella, yersinia enterocolitica, the coccus in the irregular oxygen bacterium of Gram-negative; Bacteroides in gram-negative anaerobic bacteria has high activity.
Rifaximin anti-bacteria RNA's by the irreversible combination of b-subunit with DNA of bacteria-dependenc RNA polymerase is synthetic, and finally anti-bacteria protein is synthetic.Because the combination of itself and enzyme is irreversible, so its activity is the bactericidal activity to sensitive organism.To studies show that of rifaximin antibacterial activity, rifaximin and rifamycin have antimicrobial spectrum equally widely, to most Gram-positives and gram negative bacteria, comprise that the infection of aerobe and anaerobe has bactericidal action.Rifaximin is used for the treatment of mammitis of dairy cattle during nonlactating in calendar year 2001 in Australia's approval.
Rifaximin is widely adopted in people's medication, the dosage form such as the dosage form of having gone on the market has tablet, injection, it is outstanding to be dry mixed, capsule.
Chinese patent CN102716168A discloses a kind of rifaximin and Herba Taraxaci compound recipe suspension formulations and preparation method, by following component and percentage by weight, formed: rifaximin 0.5-1%, Herba Taraxaci extract 5-5.5%, thickening agent poloxamer188 4-6%, adhesion agent isopropyl myristate 1-2%, antioxidant BHT 0.05-0.1%, all the other are pharmaceutical grade Oleum Ricini, amount to 100%.Chinese patent CN102218078A discloses a kind of compound recipe Rifaximin suspension and preparation method containing Montmorillonitum, by following component and percentage by weight, formed: rifaximin 5-15%, Montmorillonitum 7.5-22.5%, suspending agent 0.5-2%, surfactant 0.2-1%, deflocculant 0.2-1%, all the other are water.
Above-mentioned suspensoid utilization Chinese medicine ingredients and Montmorillonitum, Semen Ricini wet goods composition, make preparation becoming difficulty, products obtained therefrom is difficult for mixing, and occurs demulsifying phenomenon, and medicament contg is also unstable, hurt like hell is used in injection, and Oleum Ricini has certain toxicity in addition, is unfavorable for the preparation of injection.
Suspension emulsion (Suspoemulsion, SE), is by water-fast solid drugs, the suspension emulsus system that solid suspension body and emulsion are mixed to form.Suspension emulsion is a kind of three-phase mixed system being comprised of oil phase, water and solid phase, and it not only has the characteristic of suspensoid and Emulsion, but also has self special performance.(1) suspension emulsion has the effect of potion multiple-effect.Suspension emulsion can wrap simultaneously and carry plurality of active ingredients, several active component bags can be loaded in the not homophase in system, can play like this potion multiple-effect function.For example, in oil-in-water type suspension emulsion, emulsion can wrap and carry one or more active substances, and wherein some component is water miscible, and some active component is oil-soluble, and both can wrap, carried the effective ingredient existing with solid particulate form in continuous phase, also can wrap and carry water-soluble actives.(2) suspension emulsion has compared with high bioactivity.Because suspension emulsion can wrap simultaneously, carry plurality of active ingredients, each component with collaborative or enhancement effect is present in same system, thereby can increase the biological activity of medicine.(3) suspension emulsion can delay or control drug release, oiliness medicine or pressed powder medicine can be made to suspension emulsion dosage form, performance long-acting, also avoided preparing liquid dosage form needs shortcoming with an organic solvent simultaneously, product cost and toxicity have been reduced, especially Pesticidal products, has avoided with an organic solvent and dust medicine pollution on the environment.(4) suspension emulsion is easy to use, can oral administration, the approach such as injection uses.
For rifaximin is prepared into suspension emulsion, the present invention has carried out a large amount of research, has screened a large amount of medicinal reagents, finally finds that a kind of toxicity is low, good stability, non-irritating rifaximin suspension emulsion.
Summary of the invention
The object of the present invention is to provide a kind of rifaximin injection suspension emulsion.
The suspension emulsion of rifaximin of the present invention, is characterized in that, comprises following component:
Described oil phase preferably vegetable oil, described vegetable oil is selected from: the mixture of one or more any ratios of soybean oil, Oleum Gossypii semen, Oleum Arachidis hypogaeae semen, Oleum Sesami, Semen Maydis oil, Oleum Camelliae, Oleum Helianthi, Oleum Ricini or olive oil.
Described emulsifying agent comprises naturally occurring emulsifying agent and surfactant-based emulsifying agent.Naturally occurring emulsifying agent is selected from: arabic gum, tragakanta, gelatin, apricot glue, lecithin, soybean phospholipid.Surfactant-based emulsifying agent preferred nonionic surfactants, is selected from: the mixture of one or more any ratios of fatty glyceride, sucrose fatty acid ester, polyoxyethylene sorbitan fatty acid ester (Tween series), sorbitan fatty acid ester (Span series), polyoxyethylene fatty acid ester (Myrij series), polyoxyethylene aliphatic alcohol ether (Brij series), castor oil polyoxyethylene ether (EL series), poloxamer (Poloxamer).
The present invention also provides the preparation method of rifaximin suspension emulsion, said method comprising the steps of:
(1) get rifaximin and vegetable oil, by stirring, make oil phase;
(2) get emulsifying agent and add appropriate water for injection stirring and dissolving, make water;
(3) water is added to oil phase, by colloid mill, mix homogeneously;
(4) add water to full dose, stir evenly and obtain the suspension emulsion of rifaximin.
Rifaximin suspension emulsion of the present invention, also can comprise auxiliary agent as required; Described auxiliary agent comprises emulsifying agent stabilizing agent, suspending agent, antioxidant, antiseptic, correctives.The addition of auxiliary agent is determined according to pharmaceutical technology field routine techniques.
Wherein, described emulsifying agent stabilizing agent can improve the viscosity of Emulsion, strengthen emulsifying film strength, prevent that emulsion droplet from merging, comprise the spermol, Cera Flava, glyceryl monostearate, stearic acid, stearyl alcohol of the methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, sodium alginate, agar, arabic gum, tragakanta, xanthan gum, pectin and the increase oil phase viscosity that increase water viscosity etc.
Described suspending agent is selected from: Polyethylene Glycol, castor oil hydrogenated that sodium carboxymethyl cellulose, methylcellulose, arabic gum, xanthan gum, polyvinylpyrrolidone, molecular weight are greater than 1000.
Described antioxidant is selected from, lipophile antioxidant and water solublity antioxidant, preferably pyrosulfite, sulphite, thiourea, gallic acid and esters thereof, BHA, BHT, tocopherol, ascorbic acid.
Described antiseptic is selected from: p-Hydroxybenzoate, benzyl alcohol, methaform, phenoxyethanol, phenol and its derivatives, benzoic acid, sorbic acid and their basic salt, described quaternary ammonium compound is such as benzalkonium bromide and benzyl rope chloramines.
Make used additives, described rifaximin suspension emulsion, comprises following component:
Its preparation method, comprises the following steps:
(1) proportionally measure rifaximin and vegetable oil, by stirring, make oil phase;
(2) take emulsifying agent and add a small amount of water for injection stirring and dissolving, make water;
(3) water is added to oil phase, by colloid mill, mix homogeneously;
(4) add auxiliary agent, be ground;
(5) add water to full dose, stir evenly and obtain the suspension emulsion of rifaximin.
The present invention provides the application of rifaximin suspension emulsion of the present invention in the veterinary drug of preparation treatment mammitis of dairy cattle during nonlactating simultaneously.
The present invention preferably fills a prescription composed as follows:
The most preferred formula of the present invention is composed as follows:
Preparation method is:
Get rifaximin, soybean oil, by colloid mill, rifaximin is dispersed in soybean oil; Add Tween 80, sorbester p17, methylcellulose rubber cement and appropriate water for injection, by colloid mill, mix homogeneously; Add auxiliary agent, add water to full dose, stir evenly and obtain the suspension emulsion containing rifaximin.
The most preferred formula of the present invention obtains through screening, and screening process is as follows:
With suspension emulsion and the Chinese patent CN102716168A of the embodiment of the present invention 1, the rifaximin suspensoid in Chinese patent CN102218078A carries out stability control experiment, and experimental result is as follows:
With suspension emulsion and the Chinese patent CN102716168A of the embodiment of the present invention 1, the rifaximin suspensoid in Chinese patent CN102218078A carries out slow release effect control experiment, and experimental result is as follows:
With suspension emulsion and the Chinese patent CN102716168A of the embodiment of the present invention 1, the injection in the rifaximin suspensoid in Chinese patent CN102218078A carries out local irritation control experiment, and experimental result is as follows:
In the embodiment of the present invention 1 animal body, slow release effect detection data are as follows:
| ? | The embodiment of the present invention 1 rifaximin blood drug level |
| 2 hours | 0 |
| 4 hours | 0 |
| 6 hours | 0 |
| 8 hours | 0 |
| 10 hours | 0 |
| 12 hours | 0 |
| 14 hours | 0 |
| 16 hours | 0 |
| 18 hours | 0 |
| 20 hours | 0 |
| 22 hours | 0 |
| 24 hours | 0 |
The advantage of rifaximin maximum is not absorb in body, after cow breast injects, the detection of drug concentration method of rifaximin in milk adopts HPLC-MS/MS to detect, milk sheep passes through acetonitrile extraction, add isopropyl alcohol and revolve steaming, finally use 2mL30% acetonitrile water dissolution, through 0.2 μ m membrane filtration, adopt liquid chromatography tandom mass spectrometry determination.
The invention has the beneficial effects as follows:
Rifaximin suspension emulsion of the present invention, better stability of preparation, drug effect and crude drug remain unchanged, by the test of pesticide effectiveness, show that single administration can prevent the whole dry milk phase to infect, there is obvious slow release effect, the ejection preparation for animals that can be applicable to prepare rifaximin, the preparation method of described suspension emulsion is simple, low cost of manufacture.
The rifaximin suspension emulsion of preparing by this method has guaranteed that rifaximin suspension emulsion crystal formation is consistent with rifaximin crude drug crystal formation, guaranteed the drug effect of rifaximin suspension emulsion, and gained suspensoid good stability, the slow release effect that tool is good, heighten the effect of a treatment, improve the stability of medicine, tool long-acting.
The specific embodiment
Below in conjunction with specific embodiment, further describe the present invention.
Embodiment 1 prepares each component according to following ratio:
Preparation method is:
According to prescription, measure rifaximin, soybean oil, by colloid mill, rifaximin is dispersed in soybean oil; The Tween 80, sorbester p17, methylcellulose rubber cement and the appropriate water for injection that add recipe quantity, by colloid mill, mix homogeneously; The auxiliary agent that adds recipe quantity, adds water to full dose, stirs evenly and obtain the suspension emulsion containing rifaximin.
Embodiment 2 prepares each component according to following ratio:
Preparation method is:
Get recipe quantity rifaximin and adjuvant, according to above-mentioned preparation method preparation, obtain rifaximin suspending agent.
Embodiment 3 prepares each component according to following ratio:
Preparation method is:
Get recipe quantity rifaximin and adjuvant, according to above-mentioned preparation method preparation, obtain rifaximin suspending agent.
The rifaximin suspension emulsion that the present invention prepares, better stability of preparation, good biocompatibility, slow release effect is remarkable, can adopt existing routine techniques to be prepared into the ejection preparation of rifaximin.
Claims (10)
1. a suspension emulsion for rifaximin, is characterized in that, comprises following component:
2. rifaximin suspension emulsion according to claim 1, it is characterized in that, described oil phase is vegetable oil, and described vegetable oil is selected from: the mixture of one or more any ratios of soybean oil, Oleum Gossypii semen, Oleum Arachidis hypogaeae semen, Oleum Sesami, Semen Maydis oil, Oleum Camelliae, Oleum Helianthi, Oleum Ricini or olive oil.
3. rifaximin suspension emulsion according to claim 1, it is characterized in that, described emulsifying agent comprises naturally occurring emulsifying agent and surfactant-based emulsifying agent, and naturally occurring emulsifying agent is selected from: arabic gum, tragakanta, gelatin, apricot glue, lecithin, soybean phospholipid; Surfactant-based emulsifying agent is non-ionic surface active agent, is selected from: the mixture of one or more any ratios of fatty glyceride, sucrose fatty acid ester, polyoxyethylene sorbitan fatty acid ester, sorbitan fatty acid ester, polyoxyethylene fatty acid ester, polyoxyethylene aliphatic alcohol ether, castor oil polyoxyethylene ether, poloxamer.
4. the preparation method of rifaximin suspension emulsion claimed in claim 1, is characterized in that, comprises the following steps:
(1) get rifaximin and vegetable oil, by stirring, make oil phase;
(2) get emulsifying agent and add appropriate water for injection stirring and dissolving, make water;
(3) water is added to oil phase, by colloid mill, mix homogeneously;
(4) add water to full dose, stir evenly and obtain the suspension emulsion of rifaximin.
5. a rifaximin suspension emulsion, comprises following component:
Its preparation method, comprises the following steps:
(1) proportionally measure rifaximin and vegetable oil, by stirring, make oil phase;
(2) take emulsifying agent and add a small amount of water for injection stirring and dissolving, make water;
(3) water is added to oil phase, by colloid mill, mix homogeneously;
(4) add auxiliary agent, be ground;
(5) add water to full dose, stir evenly and obtain the suspension emulsion of rifaximin.
6. rifaximin suspension emulsion according to claim 5, is characterized in that,
Described oil phase preferably vegetable oil, comprises the mixture of one or more any ratios of soybean oil, Semen Maydis oil, Oleum Camelliae, Oleum Helianthi, Oleum Gossypii semen, Oleum Arachidis hypogaeae semen, Oleum Sesami, Oleum Ricini or olive oil;
Described emulsifying agent comprises the mixture of one or more any ratios of arabic gum, tragakanta, gelatin, apricot glue, lecithin, soybean phospholipid, fatty glyceride, sucrose fatty acid ester, Tween series polyoxyethylene sorbitan fatty acid ester, Span series sorbitan fatty acid ester, Myrij series polyoxyethylene fatty acid ester, Brij series polyoxyethylene aliphatic alcohol ether, EL series castor oil polyoxyethylene ether or poloxamer;
Described auxiliary agent comprises emulsifying agent stabilizing agent, suspending agent, antioxidant, antiseptic, correctives.
7. rifaximin suspension emulsion according to claim 6, is characterized in that,
In auxiliary agent, described emulsifying agent stabilizing agent comprises spermol, Cera Flava, glyceryl monostearate, stearic acid, the stearyl alcohol of the methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, sodium alginate, agar, arabic gum, tragakanta, xanthan gum, pectin and the increase oil phase viscosity that increase water viscosity;
Described suspending agent is selected from: Polyethylene Glycol, castor oil hydrogenated that sodium carboxymethyl cellulose, methylcellulose, arabic gum, xanthan gum, polyvinylpyrrolidone, molecular weight are greater than 1000;
Described antioxidant is selected from, lipophile antioxidant and water solublity antioxidant, preferably pyrosulfite, sulphite, thiourea, gallic acid and esters thereof, BHA, BHT, tocopherol, ascorbic acid;
Described antiseptic is selected from: p-Hydroxybenzoate, benzyl alcohol, methaform, phenoxyethanol, phenol and its derivatives, benzoic acid, sorbic acid and their basic salt, described quaternary ammonium compound is such as benzalkonium bromide and benzyl rope chloramines.
8. rifaximin suspension emulsion according to claim 5, fill a prescription composed as follows:
9. rifaximin suspension emulsion according to claim 8, fill a prescription composed as follows:
Preparation method is:
Get rifaximin, soybean oil, by colloid mill, rifaximin is dispersed in soybean oil; Add Tween 80, sorbester p17, methylcellulose rubber cement and appropriate water for injection, by colloid mill, mix homogeneously; Add auxiliary agent, add water to full dose, stir evenly and obtain the suspension emulsion containing rifaximin.
10. the application of the rifaximin suspension emulsion of claim 1 in the veterinary drug of preparation treatment mammitis of dairy cattle during nonlactating.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410329427.6A CN104083324B (en) | 2014-07-10 | 2014-07-10 | Veterinary suspoemulsion containing rifaximin as well as preparation method and application thereof |
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| CN201410329427.6A CN104083324B (en) | 2014-07-10 | 2014-07-10 | Veterinary suspoemulsion containing rifaximin as well as preparation method and application thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104382923A (en) * | 2014-10-27 | 2015-03-04 | 郑州百瑞动物药业有限公司 | Lincomycin hydrochloride breast injectant for dairy cow and preparation method thereof |
| CN108542881A (en) * | 2018-04-28 | 2018-09-18 | 黑龙江省兽医科学研究所 | A kind of rifaximin microemulsion and preparation method thereof |
| CN110812326A (en) * | 2019-11-04 | 2020-02-21 | 黑龙江省农业科学院畜牧兽医分院 | Simvastatin suspension emulsion and preparation method and application thereof |
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| US20080132530A1 (en) * | 2003-11-07 | 2008-06-05 | Alfa Wassermann S.P.A. | Use of polymorphic forms of rifaximin for medical preparations |
| CN101444484A (en) * | 2008-12-24 | 2009-06-03 | 华南农业大学 | Suspension emulsion of florfenicol, preparation method and application thereof |
| CN101862294A (en) * | 2010-06-22 | 2010-10-20 | 华南农业大学 | Ivermectin suspending agent, preparation method and application thereof |
| CN102274221A (en) * | 2011-06-30 | 2011-12-14 | 山东恩康药业有限公司 | Veterinary compound rifaximin liposome medicament and preparation method thereof |
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Patent Citations (5)
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| US20080132530A1 (en) * | 2003-11-07 | 2008-06-05 | Alfa Wassermann S.P.A. | Use of polymorphic forms of rifaximin for medical preparations |
| WO2007103448A2 (en) * | 2006-03-09 | 2007-09-13 | Salix Pharmaceuticals, Inc. | Rifaximin anti-rectal dysfunction preparation |
| CN101444484A (en) * | 2008-12-24 | 2009-06-03 | 华南农业大学 | Suspension emulsion of florfenicol, preparation method and application thereof |
| CN101862294A (en) * | 2010-06-22 | 2010-10-20 | 华南农业大学 | Ivermectin suspending agent, preparation method and application thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104382923A (en) * | 2014-10-27 | 2015-03-04 | 郑州百瑞动物药业有限公司 | Lincomycin hydrochloride breast injectant for dairy cow and preparation method thereof |
| CN108542881A (en) * | 2018-04-28 | 2018-09-18 | 黑龙江省兽医科学研究所 | A kind of rifaximin microemulsion and preparation method thereof |
| CN110812326A (en) * | 2019-11-04 | 2020-02-21 | 黑龙江省农业科学院畜牧兽医分院 | Simvastatin suspension emulsion and preparation method and application thereof |
| CN110812326B (en) * | 2019-11-04 | 2022-04-22 | 黑龙江省农业科学院畜牧兽医分院 | Simvastatin suspension emulsion and preparation method and application thereof |
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| CN104083324B (en) | 2017-05-10 |
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