CN102727447A - Florfenicol controlled release preparation and preparation method thereof - Google Patents
Florfenicol controlled release preparation and preparation method thereof Download PDFInfo
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- CN102727447A CN102727447A CN2011100894829A CN201110089482A CN102727447A CN 102727447 A CN102727447 A CN 102727447A CN 2011100894829 A CN2011100894829 A CN 2011100894829A CN 201110089482 A CN201110089482 A CN 201110089482A CN 102727447 A CN102727447 A CN 102727447A
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Abstract
The invention discloses a florfenicol controlled release preparation and a preparation method thereof and belongs to the field of veterinary drug technology. The florfenicol controlled release preparation mainly comprises, by weight, florfenicol, sustained and controlled release materials and other auxiliary materials and can be made in forms of tablets, pills, granules, framework controlled release preparation of capsules, membrane controlled release preparation or osmotic pump controlled release preparation. The florfenicol controlled release preparation has a reasonable scientific formula, safe and high efficient auxiliary materials, strong adaptability, advanced technology, safe quality, good stability, reduces peak-valley phenomena of blood drug concentration, maintains stably the effective blood drug concentration for 24 hours, reduces toxic side effects of medicines, and widens a usage scope of the florfenicol.
Description
Technical field
The invention belongs to the veterinary drug technical field, relate to a kind of florfenicol controlled release preparation, particularly the method for preparing of this florfenicol controlled release preparation.
Background technology
Florfenicol has another name called Florfenicol; Be chloromycetin animal specific broad ectrum antibiotic of new generation, have has a broad antifungal spectrum, antibacterial activity strong, absorb the characteristics such as extensive that distribute in good, the body, do not have potential aplastic anemia effect; There are not teratogenesis, carcinogenic and mutagenic action yet; Therefore begin from the nineties, in country's listings such as Japan, the U.S., France, Mexico and Spain, alternative chloromycetin is used to prevent and treat the bacterial disease of Fish, cattle, pig and poultry to florfenicol successively; Also can be used as feed additive, especially on food animal, have broad application prospects.China is in approval listing in 1999, is mainly used in the control of the bacterial disease due to the sensitive bacterial.Yet Florfenicol raw material liquid medicine dissolubility is very low, and is water-soluble hardly, and oral administration biaavailability is very low, limited it as the use of medicine on veterinary clinic.Improve the water miscible method of florfenicol at present and mainly be divided into two big types: physical method and chemical method.Chemical method is that florfenicol is processed water-soluble prodrug; Like the phosphate ester prodrug of the florfenicol of Schering-Plough company preparation, Lee prodrug florfenicol mono succinate ester derivant by preparations such as ripples; Though fundamentally improved the shortcoming of florfenicol low aqueous solubility,, operating process loaded down with trivial details etc. harsh because of synthesis condition all fails extensively to promote.Physical method comprises and adds cosolvent, micronization, beta-cyclodextrin inclusion compound, HP-enclose, solid dispersion etc., but solubilizing effect is not remarkable, fails to reach the desirable requirement of clinical preparation.The present used conventional formulation that is on the China market, the half-life is shorter relatively, needs multiple dosing, complex operation, to animal stress be bigger.Normal the mixing of large-scale cultivation raised administration, and appetite subtracts greatly or useless cutting off during owing to the poultry morbidity, mixes and raises often unsatisfactory curative effect of administration.The organic solvent dimethyl formamide that liquid preparation uses, Polyethylene Glycol, propylene glycol, N-Methyl pyrrolidone etc. all can cause toxic and side effects in various degree; Reduced the safety of medicine; And cause serious residually, had a strong impact on the clinical practice of florfenicol.Developing its sustained-release preparation can address the above problem, not only can persistent transmission medicine, reduce the medication number of times, stable blood concentration is provided, reduces the blood drug level peak valley phenomenon, and improve drug effect and safety, thereby the development of aquaculture is played an important role.
Along with the fast development of intensification, scale and modernized aquaculture, the conventional formulation that generally uses on the veterinary clinic at present can't satisfy market demand, and medicine novel formulation new technique is applied to field of veterinary becomes the veterinary drug Development Trend.Sustained-release preparation as a kind of special medicine-releasing system always in the pharmaceutics field by extensive concern; Begin to develop oral sustained-release preparation at the fifties abroad; The seventies is approved by medical circle; Its theory and technology development at present is ripe day by day, and the types of drugs of listing increases gradually, wherein with fastest developing speed surely belongs to oral sustained-release preparation.Slow releasing preparation refers to can continue to discharge medicine in a long time to reach the preparation of long-acting after the medication.Controlled release preparation refer to medicine only concentrate with controlled form constant speed be discharged into effect organ or particular target organ and bring into play the preparation of therapeutical effect, medicine rate of release from preparation does not receive the influence of extraneous factors such as environment and enzyme.Sustained-release preparation makes body obtain effectively to treat blood drug level stably and makes curative effect-dosage optimization, reduces dosage, reduces medicining times and adverse effect.Simultaneously with respect to other preparations; Short because of its research and development cycle, fund input is few, economic risk is little, with high content of technologyly, lucrative valued by pharmaceuticals industry circle; Be a crucial direction of external medical industry development, therefore more and more get more and more people's extensive concerning.
The present invention designs florfenicol slowly-releasing part and immediate release section respectively, prepares the florfenicol controlled release preparation, to keep its blood drug level stable state, widens the range of application of florfenicol, improves its bioavailability, heightens the effect of a treatment.
In open source literature, do not retrieve at present the relevant report of florfenicol controlled release preparation and preparation method thereof as yet.
Summary of the invention
In view of this, one of the object of the invention is to provide a kind of florfenicol controlled release preparation, its scientific formulation, quality safety, good stability.
For reaching this purpose, a kind of florfenicol controlled release preparation provided by the invention comprises following component and mass percent thereof: florfenicol 1%～50%, slow controlled-release material 1%～90%, other adjuvants 1%～90%.
Further, said florfenicol controlled release preparation is that in the said components one or more are processed tablet, pill, granule, capsular matrix type controlled release preparation or film controlling type controlled release preparation or osmotic pump type controlled release preparation.
Further, said slow controlled-release material is selected from one or more in the polymer such as natural goods adjuvant, cellulose derivative, crylic acid resin or polyethylene kind.
Further, other adjuvants also comprise the filler that accounts for weight of formulation 1%～90% in the said matrix type controlled release preparation.Other adjuvants of said film controlling type controlled release preparation or infiltration die mould controlled release preparation comprise one or more in the ready-made clothes filmogen that accounts for coating solution gross weight 1～50%, solvent, porogen, the plasticizer.
Further, said filler is selected from one or more in lactose, sucrose, glucose, mannitol, sorbitol, starch, carboxymethyl starch, pregelatinized Starch, calcium carbonate, calcium sulfate two water things, calcium hydrogen phosphate, the tricalcium phosphate.
Further, said ready-made clothes filmogen is selected from one or more in acrylic resin analog derivative, polyvinylpyrrolidone, silicone elastomer, crosslinked alginate, polyethylene glycols or the cellulose derivative.Said solvent is selected from one or more in ethanol, methanol, isopropyl alcohol, acetone, chloroform, dichloromethane/ethanol, methylene chloride, dichloromethane/isopropyl alcohol, the dichloromethane/acetone.Said porogen is selected from one or more among polyvinyl alcohol, dextrin, sodium lauryl sulphate, lactose, sodium chloride, the PEG.Said plasticizer is selected from one or more in glycerol, polyvinyl alcohol, propyleneglycoles, triacetin, Oleum Ricini, the olive oil.
Further, said other adjuvants also comprise one or more in disintegrating agent, wetting agent, the adhesive.
Further, said disintegrating agent is selected from one or more in starch, pregelatinized Starch, carboxymethyl starch sodium, guar gum, microcrystalline Cellulose, pure lignocellulose, alginic acid, ion exchange resin methylcellulose, the carboxymethyl cellulose.Said wetting agent is selected from one or more in corn starch, pregelatinized starch, pregelatinized corn starch, gelatin, sucrose, the arabic gum.Said adhesive is selected from one or more in methylcellulose, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, the Polyethylene Glycol.
Another object of the present invention is to provide the method for preparing of florfenicol controlled release preparation, its preparation technology is advanced, scientific and reasonable, and adjuvant is safe and efficient, adaptability good, and bioavailability is high, has widened the scope of application of florfenicol.
For reaching this purpose, the invention provides three kinds of florfenicol controlled release preparation method for preparinies, be respectively the method for preparing of florfenicol matrix type controlled release preparation, film controlling type controlled release preparation and osmotic pump type controlled release preparation.
Further, the method for preparing of described florfenicol matrix type controlled release preparation is with florfenicol, matrix type material, filler crushing screening; Mix homogeneously adds wetting agent system soft material, requires to cross respectively different model sieve series grain by size; Dry; Granulate, dry grain adds disintegrating agent, mix lubricant is even, processes granule, tablet, pill or capsule.
Further, the method for preparing of described florfenicol film controlling type controlled release preparation is to get florfenicol, proper auxiliary materials mixing, with an amount of adhesive system soft material, granulates drying, granulate; Quantitatively medicine-containing particle is carried out coating with coating solution and process the coating medicine-containing particle,, mix by a certain percentage, add mix homogeneously such as disintegrating agent, lubricant, process granule, tablet, pill or capsule coating or coating two parts granule not.
Further, the method for preparing of described florfenicol osmotic pump type controlled release preparation is that florfenicol and wetting agent, filler are processed the sheet heart; Bag semi permeability film-coat, bag osmotic pressure active substance is played drug release hole; Wrap peplos at last, process tablet, pill or capsule.
Useful result of the present invention is: florfenicol controlled release preparation scientific formulation of the present invention is reasonable, and adjuvant is safe and efficient, adaptability good, and technology is advanced; Quality safety, good stability has reduced the peak valley phenomenon of blood drug level; Effective blood drug concentration is steadily kept reached 72 hours; Reduce administration number of times, reduced the toxicity of medicine, widened the scope of application of florfenicol.
The specific embodiment
For making the object of the invention, technical scheme and advantage clearer, carry out detailed description in the face of the preferred embodiments of the present invention down.
The preparation of embodiment 1,5% florfenicol matrix type controlled release preparation
Prescription:
Technology: A, PVP is dissolved in the florfenicol alcoholic solution, adds the micropowder silica gel mixing, add stearic acid and hexadecanol, be heated to 60 ℃, make molten.B, microcrystalline Cellulose, lactose, talcous homogeneous mixture are added in the above-mentioned thawing system, stir 1h.C, above-mentioned viscous mixture room temperature is placed 20min, when treating into agglomerate, process granule, 30 ℃ of dryings, granulate.Add the magnesium stearate tabletting, promptly get florfenicol matrix type controlled release preparation.
The preparation of embodiment 2,30% florfenicol film controlling type controlled release preparation
Prescription:
Technology: A, coating medicine-containing particle: get florfenicol, hexadecanol, lecithin mix homogeneously, do wetting agent with ethanol and granulate, dry back granulate; The granule that screens required magnitude range is through fluidized bed coating equipment; On granule, spray into ready-made clothes filmogen solution (be dissolved in isopropyl alcohol process cotmar, acrylic resin, polyvinyl alcohol), 50 ℃ of coating temperature, flow velocity 8mL/min; Rotating speed 30rpm promptly gets the coating medicine-containing particle.B, coating medicine-containing particle not: get florfenicol, hexadecanol, lecithin and add an amount of ethanol and process soft material, granulate, dry back granulate promptly gets not coating medicine-containing particle.C, with coating or coating two parts medicine-containing particle by 3: 1 mixed uneven, promptly get florfenicol film controlling type sustained and controlled release granule.
The preparation of embodiment 3,10% florfenicol osmotic pump type controlled release preparation
Prescription:
Technology: A, with florfenicol, mannitol, polyvinylpyrrolidone mixing; Doing wetting agent with ethanol granulates; Adding the magnesium stearate tabletting after 60 ℃ of dryings, be dissolved as the film material with cellulose acetate, hydroxypropyl cellulose, Polyethylene Glycol again, is solvent with the methylene chloride-methanol; Wrapping thickness is 154.2 μ m film-coats, uses laser boring (230W) at last.The aqueous solution of this osmotic pump tablet external sorbitol, polyvinylpyrrolidone is wrapped the film that one deck is called zonation, wrap peploses such as cellulose acetate, sorbitol at last again, promptly get the florfenicol osmotic pump type controlled release preparation.
The release in vitro degree experiment of experimental example, florfenicol controlled release preparation
By " People's Republic of China's veterinary drug allusion quotation " 2005 editions regulations about slow release, controlled release preparation drug release determination method, adopt the blue laws device, release medium is 10% sodium lauryl sulphate-sodium dihydrogen phosphate citrate buffer 1000mL, and rotating speed is 50rpm, and medium temperature is measured the release degree down for 37 ± 0.5 ℃; Respectively at the 1st, 2 after the timing, 4,6; 8,10,12,14; 16,18,20,22; 24 hours sampling 4mL also in time replenish dissolution medium 4mL, and sample is crossed the filter membrane of 0.45 μ m, discards filtrating just, get subsequent filtrate 10 μ L and measure down according to the florfenicol item.The result shows: medicine began at a distance from 1～2 hour to discharge, and reach 24 hours lasting release time, and the release degree all reaches more than 90%.
The release degree experimental data of embodiment 1,2,3 is seen table 1,2,3. respectively
72 hours release degree in water of table 1 florfenicol matrix type controlled release preparation
72 hours release degree in water of table 2 florfenicol film controlling type controlled release preparation
72 hours release degree in water of table 3 florfenicol osmotic pump type controlled release preparation
Theoretically, compare with conventional formulation, it is steady that controlled release preparation has in the body blood drug level, and the effective blood drug concentration length of holding time reduces " peak valley " phenomenon of blood drug level, thereby alleviates the toxicity of medicine, reduces administration number of times, makes things convenient for characteristics such as medication.
Say that from the therapeutics compliance conventional formulation blood drug level presents peak valley phenomenon, often surpass valid density during high concentration, be prone to cause untoward reaction.And controlled release preparation can reduce medicining times, makes things convenient for administration, and can keep 72 hours blood drug level steadily, help patient treatment.
Explanation is at last; Above embodiment is only unrestricted in order to technical scheme of the present invention to be described; Although through invention has been described with reference to the preferred embodiments of the present invention; But those of ordinary skill in the art should be appreciated that and can make various changes to it in form with on the details, and the spirit and scope of the present invention that do not depart from appended claims and limited.
Claims (11)
1. the florfenicol controlled release preparation is characterized in that being made up of slow-released part and immediate release section, comprises following component and mass percent thereof: florfenicol 1%～50%, slow controlled-release material 1%～90%, other adjuvants 1%～90%.
2. the described florfenicol controlled release preparation of claim 1 is characterized in that in the said components one or more are processed lamellar, pill, granule, capsular matrix type controlled release preparation or film controlling type controlled release preparation or osmotic pump type controlled release preparation.
3. according to the described florfenicol controlled release preparation of claim 1～2, it is characterized in that said slow controlled-release material is selected from one or more in the polymer such as natural goods adjuvant, cellulose derivative, crylic acid resin or polyethylene kind.
4. according to the described florfenicol controlled release preparation of claim 1～3, it is characterized in that other adjuvants also comprise the filler that accounts for weight of formulation 1%～90% in the said matrix type controlled release preparation.Other adjuvants of said film controlling type controlled release preparation or osmotic pump type controlled release preparation comprise one or more in the ready-made clothes filmogen that accounts for coating solution gross weight 1～50%, solvent, porogen, the plasticizer.
5. according to the described florfenicol controlled release preparation of claim 1～4; It is characterized in that described filler is selected from one or more in lactose, sucrose, glucose, mannitol, sorbitol, starch, carboxymethyl starch, pregelatinized Starch, calcium carbonate, calcium sulfate two water things, calcium hydrogen phosphate, the tricalcium phosphate.
6. according to the described florfenicol controlled release preparation of claim 1～5; It is characterized in that described ready-made clothes filmogen is selected from one or more in acrylic resin analog derivative, polyvinylpyrrolidone, silicone elastomer, crosslinked alginate, polyethylene glycols or the cellulose derivative.Said solvent is selected from one or more in ethanol, methanol, isopropyl alcohol, acetone, chloroform, dichloromethane/ethanol, methylene chloride, dichloromethane/isopropyl alcohol, the dichloromethane/acetone.Said porogen is selected from one or more among polyvinyl alcohol, dextrin, sodium lauryl sulphate, lactose, sodium chloride, the PEG.Said plasticizer is selected from one or more in glycerol, polyvinyl alcohol, propyleneglycoles, triacetin, Oleum Ricini, the olive oil.
7. according to the described florfenicol controlled release preparation of claim 1～6, it is characterized in that described other adjuvants also comprise one or more in disintegrating agent, wetting agent, the adhesive.
8. according to the described florfenicol controlled release preparation of claim 1～7; It is characterized in that described disintegrating agent is selected from one or more in starch, pregelatinized Starch, carboxymethyl starch sodium, guar gum, microcrystalline Cellulose, pure lignocellulose, alginic acid, ion exchange resin methylcellulose, the carboxymethyl cellulose.Said wetting agent is selected from one or more in corn starch, pregelatinized starch, pregelatinized corn starch, gelatin, sucrose, the arabic gum.Said adhesive is selected from one or more in methylcellulose, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, the Polyethylene Glycol.
9. according to the method for preparing of the described florfenicol matrix type of claim 1～8 controlled release preparation, it is characterized in that, florfenicol, matrix type controlled-release material, filler crushing screening; Mix homogeneously adds wetting agent system soft material, requires to cross respectively different model sieve series grain by size; Dry; Granulate, dry grain adds disintegrating agent, mix lubricant is even, processes granule, tablet, pill or capsule.
10. according to the method for preparing of the described florfenicol film controlling type of claim 1～8 controlled release preparation, it is characterized in that, get florfenicol, proper auxiliary materials mixing,, granulate drying, granulate with an amount of adhesive system soft material; Quantitatively medicine-containing particle is carried out coating with coating solution and process the coating medicine-containing particle,, mix by a certain percentage, add mix homogeneously such as disintegrating agent, lubricant, process granule, tablet, pill or capsule coating or coating two parts granule not.
11. method for preparing according to the described florfenicol osmotic pump type controlled release preparation of claim 1～8; It is characterized in that, florfenicol and wetting agent, filler are processed the sheet heart, bag semi permeability film-coat; Bag osmotic pressure active substance; Play drug release hole, wrap peplos at last, process tablet, pill or capsule.
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| CN2011100894829A CN102727447A (en) | 2011-04-11 | 2011-04-11 | Florfenicol controlled release preparation and preparation method thereof |
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| CN2011100894829A CN102727447A (en) | 2011-04-11 | 2011-04-11 | Florfenicol controlled release preparation and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104162144A (en) * | 2013-08-30 | 2014-11-26 | 郑州后羿制药有限公司 | Compound florfenicol suspension and preparation method thereof |
| CN104825400A (en) * | 2015-05-28 | 2015-08-12 | 中牧南京动物药业有限公司 | Florfenicol included controlled-release preparation and its preparing method and application |
| CN109498579A (en) * | 2018-12-10 | 2019-03-22 | 华南农业大学 | A kind of florfenicol slowly-releasing particle and preparation method thereof |
| CN113230233A (en) * | 2021-05-14 | 2021-08-10 | 中国农业科学院兰州畜牧与兽药研究所 | Florfenicol solid dispersion inclusion microcapsule and preparation method and application thereof |
| CN113288876A (en) * | 2021-03-25 | 2021-08-24 | 华南农业大学 | Quality evaluation and control method of florfenicol sustained-release particles |
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| CN201426855Y (en) * | 2009-07-13 | 2010-03-24 | 上海恒丰强动物药业有限公司 | Florfenicol enteric coated granule |
| CN101909600A (en) * | 2007-11-09 | 2010-12-08 | 英特维特国际股份有限公司 | Fast release solid formulation, preparation and use thereof |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101909600A (en) * | 2007-11-09 | 2010-12-08 | 英特维特国际股份有限公司 | Fast release solid formulation, preparation and use thereof |
| CN201426855Y (en) * | 2009-07-13 | 2010-03-24 | 上海恒丰强动物药业有限公司 | Florfenicol enteric coated granule |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104162144A (en) * | 2013-08-30 | 2014-11-26 | 郑州后羿制药有限公司 | Compound florfenicol suspension and preparation method thereof |
| CN104162144B (en) * | 2013-08-30 | 2016-04-20 | 郑州后羿制药有限公司 | A kind of compound florfenicol suspension and preparation method thereof |
| CN104825400A (en) * | 2015-05-28 | 2015-08-12 | 中牧南京动物药业有限公司 | Florfenicol included controlled-release preparation and its preparing method and application |
| CN109498579A (en) * | 2018-12-10 | 2019-03-22 | 华南农业大学 | A kind of florfenicol slowly-releasing particle and preparation method thereof |
| CN113288876A (en) * | 2021-03-25 | 2021-08-24 | 华南农业大学 | Quality evaluation and control method of florfenicol sustained-release particles |
| CN113230233A (en) * | 2021-05-14 | 2021-08-10 | 中国农业科学院兰州畜牧与兽药研究所 | Florfenicol solid dispersion inclusion microcapsule and preparation method and application thereof |
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Application publication date: 20121017 |