CN101849913A - Method for preparing veterinary florfenicol lung targeting gelatin microsphere - Google Patents
Method for preparing veterinary florfenicol lung targeting gelatin microsphere Download PDFInfo
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Abstract
The invention relates to a method for preparing a veterinary florfenicol lung targeting gelatin microsphere, which belongs to the technical field of veterinary preparation. In the method, florfenicol serves as a main component; gelatin serves as a carrier; and polyvinyl pyrrolidone is added in a preparation process. The method of the invention has the advantages that: the medicament encapsulation rate of the florfenicol lung targeting gelatin microsphere can be obviously improved and medicament loading rate can be increased so as to reduce dosage and the use cost of the medicament; the medicament has higher release rate, quicker response and more remarkable effect; and the florfenicol lung targeting gelatin microsphere prepared by the method can obviously improve the quality and curative effect of the florfenicol microsphere and is a novel efficient targeting medicinal preparation for veterinary surgeons to clinically apply the florfenicol to the treatment of diseases of livestock and poultry.
Description
Technical field
The invention belongs to the technical field of veterinary formulations, relate to the preparation method of florfenicol lung targeting gelatin microsphere.
Background technology
Florfenicol (Florfenicol) is the animal specific antibacterials, is used for the treatment of the bacterial infection of respiratory system.The ordinary preparation of florfenicol, as injection, powder etc., medicine uniform distribution in blood and tissue after the medication, there is not targeting, and after medicine enters blood circulation, want and protein binding, stand the metabolism of plurality of enzymes, tissue, organ and drainage etc., therefore have only small amount of drug just can reach target site.If improve the drug level of target area, just must increase dosage, the waste that this not only causes medicine has increased in animal body residual of the toxic and side effects of medicine and medicine, and has increased and produce chemical sproof probability.
Florfenicol lung targeting gelatin microsphere is a kind of efficient targeting novel formulation that is used for the treatment of the poultry pulmonary infection, has significant advantages such as targeting, efficient, long-acting, low toxicity, has represented the new high degree of veterinary formulations.Medicine can be transported to lung tissue to greatest extent after the administration of lung targeting preparation, make medicine at pulmonary the concentrate several times that exceed conventional formulation and even hundreds of times, therapeutic effect obviously improves; Reduce amount of drug simultaneously, reduce adverse effect, and be convenient to control the speed and the mode of administration, reach the therapeutic effect of high-efficiency low-toxicity.In addition, because targeting preparation has improved antimicrobial efficiency, therefore might reduce the possibility that antibacterial develops immunity to drugs to medicine, this is highly significant for the more effective use antimicrobial drug of veterinary clinic.But, Florfenicol raw material medicine dissolubility is relatively poor, cause the envelop rate of florfenicol in the preparation process very low, and the drug loading of florfenicol is also very low in the gelatine microsphere that makes, can not satisfy preparation and clinical requirement, become one of topmost factor of restriction florfenicol lung targeting gelatin microsphere curative effect and application.
Polyvinylpyrrolidone (Polyvinyl Pyrrolidone, be called for short PVP) be to be the water-soluble high-molecular compound that monomer is polymerized under certain condition with the N-vinyl pyrrolidone, have molecular weight from thousands of to the homopolymer more than 1,000,000, copolymer and crosslinking series of polymers product.PVP is divided into some grades by the size of molecular weight, generally uses the K value representation of Fikentscher method, and the K value is the parameter relevant with the high polymer viscosity.Existing hydrophilic group in the structure of PVP has lipophilic group and many solvent molecules to have affinity again, can be water-soluble, can be dissolved in the organic solvents such as alcohol, carboxylic acid, amine, halogenated hydrocarbons again, be a kind of good non-ionic (polymeric surfactant), is the novel medicament adjuvant.
PVP has good physiology inertia, does not participate in the human body metabolism, and skin, mucosa, eye etc. are not produced any stimulation.The acute toxicity of all application modes of PVP aspect medical all is lower, uses the PVP of molecular weight 30000 that rat is tested, and oral median lethal dose(LD 50) is greater than 25g/kg.PVP does not have antigenicity, does not suppress production of antibodies, finds no any carcinogenesis yet.Can be under digestive tract, abdomen, subcutaneous and intravenous route accepts.
Summary of the invention
The object of the present invention is to provide a kind of preparation method for preparing florfenicol lung targeting gelatin microsphere.This method adds polyvinylpyrrolidone family macromolecule chemical compound in the process of preparation florfenicol lung targeting gelatin microsphere, can improve the envelop rate of florfenicol and the drug loading of florfenicol microsphere, thereby reduces the consumption of florfenicol microsphere, and improves drug effect.The florfenicol lung targeting gelatin microsphere of this method preparation can obviously improve the quality and the curative effect of florfenicol microsphere, provides efficiently, had the new medicinal preparation of targeting for veterinary clinic uses florfenicol treatment livestock and poultry.
The objective of the invention is to be achieved through the following technical solutions:
The invention provides a kind of preparation method of veterinary florfenicol lung targeting gelatin microsphere, it is characterized in that with the florfenicol being main component, is carrier with the gelatin, adds polyvinylpyrrolidone in preparation process.
Wherein, described polyvinylpyrrolidone can be any one among PVP k10, PVP k15, PVP k17, PVP k25, PVP k30, the PVP k50.
The used florfenicol and the weight ratio of gelatin can be other ratios among the present invention, but for better reaching effect of the present invention, the weight ratio scope of florfenicol and gelatin is 2: 1～1: 5.
Further, the weight ratio preferable range of florfenicol and gelatin is 1: 1～1: 3.
The weight ratio scope of florfenicol and polyvinylpyrrolidone is 15: 1～1: 15 in the preparation method of the present invention.
Further, the weight ratio preferable range of florfenicol and polyvinylpyrrolidone is 5: 1～1: 5.
The particle size range of the florfenicol lung targeting gelatin microsphere that preparation method of the present invention makes is 5-30 μ m.
The preparation method of veterinary florfenicol lung targeting gelatin microsphere of the present invention is characterized in that step is as follows:
(1) in abundant swollen gelatin solution, add polyvinylpyrrolidone by weight ratio, dissolving adds florfenicol, stirring and evenly mixing, preheating in 55 ℃ of-65 ℃ of water-baths;
(1) that (2) will obtain splashes in the container that contains Arlacel-80 and liquid paraffin, 55 ℃ of-65 ℃ of stirred in water bath, to milky;
(3) ice-water bath cools off rapidly, adds formaldehyde with the thread shape, is stirred to crosslinking curing, stirs sucking filtration with isopropanol dehydration;
(4) with isopropyl alcohol-ether washing, to washing most formaldehyde, with the liquid paraffin of petroleum ether flush away microsphere surface, vacuum drying, promptly.
The present invention is different from the conventional method for preparing florfenicol lung targeting gelatin microsphere, and maximum difference is: the present invention has added polyvinylpyrrolidone family macromolecule chemical compound in preparation process.The adding of this material has improved the envelop rate and the drug loading of florfenicol, reduces the consumption of florfenicol microsphere, and improves drug effect.The florfenicol lung targeting gelatin microsphere of this method preparation can obviously improve the quality and the curative effect of florfenicol microsphere, thereby provides efficiently, had the new medicinal preparation of targeting for veterinary clinic uses florfenicol treatment livestock and poultry.
, it should be understood that described embodiment only is for the present invention is described, rather than limit the scope of the invention by any way more specific description the present invention by the following example.
The specific embodiment
Embodiment 1
Technology:
(1) get 10% gelatin solution 10mL, add PVP k302g, dissolving adds florfenicol 2g, stirring and evenly mixing, preheating in 60 ℃ of water-baths;
(1) that (2) will obtain splashes in the container that contains 2mL span-8 and 60mL liquid paraffin, stirs 15 minutes fast to milky in 60 ℃ of water-baths, and rotating speed is 1500r/min;
(3) ice-water bath is cooled to rapidly below 5 ℃, adds formaldehyde 5mL with the thread shape, stirs crosslinking curing 1 hour, stirs 1 hour sucking filtration with isopropanol dehydration;
(4) with isopropyl alcohol-ether washing, to washing most formaldehyde, with the liquid paraffin of petroleum ether flush away microsphere surface, vacuum drying, promptly.
Embodiment 2
Technology:
(1) get 10% gelatin solution 10mL, add PVP k107.5g, dissolving adds florfenicol 0.5g, stirring and evenly mixing, preheating in 60 ℃ of water-baths;
(1) that (2) will obtain splashes in the container that contains 2mL span-8 and 60mL liquid paraffin, stirs 15 minutes fast to milky in 60 ℃ of water-baths, and rotating speed is 1500r/min;
(3) ice-water bath is cooled to rapidly below 5 ℃, adds formaldehyde 5mL with the thread shape, stirs crosslinking curing 1 hour, stirs 1 hour sucking filtration with isopropanol dehydration;
(4) with isopropyl alcohol-ether washing, to washing most formaldehyde, with the liquid paraffin of petroleum ether flush away microsphere surface, vacuum drying, promptly.
Embodiment 3
Technology:
(1) get 10% gelatin solution 10mL, add PVP k155g, dissolving adds florfenicol 1g, stirring and evenly mixing, preheating in 60 ℃ of water-baths;
(1) that (2) will obtain splashes in the container that contains 2mL span-8 and 60mL liquid paraffin, stirs 15 minutes fast to milky in 60 ℃ of water-baths, and rotating speed is 1500r/min;
(3) ice-water bath is cooled to rapidly below 5 ℃, adds formaldehyde 5mL with the thread shape, stirs crosslinking curing 1 hour, stirs 1 hour sucking filtration with isopropanol dehydration;
(4) with isopropyl alcohol-ether washing, to washing most formaldehyde, with the liquid paraffin of petroleum ether flush away microsphere surface, vacuum drying, promptly.
Embodiment 4
Technology:
(1) get 10% gelatin solution 10mL, add PVP k170.5g, dissolving adds florfenicol 7.5g, stirring and evenly mixing, preheating in 60 ℃ of water-baths;
(1) that (2) will obtain splashes in the container that contains 2mL span-8 and 60mL liquid paraffin, stirs 15 minutes fast to milky in 60 ℃ of water-baths, and rotating speed is 1500r/min;
(3) ice-water bath is cooled to rapidly below 5 ℃, adds formaldehyde 5mL with the thread shape, stirs crosslinking curing 1 hour, stirs 1 hour sucking filtration with isopropanol dehydration;
(4) with isopropyl alcohol-ether washing, to washing most formaldehyde, with the liquid paraffin of petroleum ether flush away microsphere surface, vacuum drying, promptly.
Embodiment 5
Technology:
(1) get 10% gelatin solution 10mL, add PVP k501g, dissolving adds florfenicol 5g, stirring and evenly mixing, preheating in 60 ℃ of water-baths;
(1) that (2) will obtain splashes in the container that contains 2mL span-8 and 60mL liquid paraffin, stirs 15 minutes fast to milky in 60 ℃ of water-baths, and rotating speed is 1500r/min;
(3) ice-water bath is cooled to rapidly below 5 ℃, adds formaldehyde 5mL with the thread shape, stirs crosslinking curing 1 hour, stirs 1 hour sucking filtration with isopropanol dehydration;
(4) with isopropyl alcohol-ether washing, to washing most formaldehyde, with the liquid paraffin of petroleum ether flush away microsphere surface, vacuum drying, promptly.
Embodiment 6
Technology:
(1) get 10% gelatin solution 10mL, add PVP k173g, dissolving adds florfenicol 2g, stirring and evenly mixing, preheating in 65 ℃ of water-baths;
(1) that (2) will obtain splashes in the container that contains 2mL span-8 and 60mL liquid paraffin, stirs 15 minutes fast to milky in 65 ℃ of water-baths, and rotating speed is 1500r/min;
(3) ice-water bath is cooled to rapidly below 5 ℃, adds formaldehyde 5mL with the thread shape, stirs crosslinking curing 1 hour, stirs 1 hour sucking filtration with isopropanol dehydration;
(4) with isopropyl alcohol-ether washing, to washing most formaldehyde, with the liquid paraffin of petroleum ether flush away microsphere surface, vacuum drying, promptly.
Embodiment 7
Technology:
(1) get 10% gelatin solution 10mL, add PVP k304g, dissolving adds florfenicol 2g, stirring and evenly mixing, preheating in 55 ℃ of water-baths;
(1) that (2) will obtain splashes in the container that contains 2mL span-8 and 60mL liquid paraffin, stirs 15 minutes fast to milky in 55 ℃ of water-baths, and rotating speed is 1500r/min;
(3) ice-water bath is cooled to rapidly below 5 ℃, adds formaldehyde 5mL with the thread shape, stirs crosslinking curing 1 hour, stirs 1 hour sucking filtration with isopropanol dehydration;
(4) with isopropyl alcohol-ether washing, to washing most formaldehyde, with the liquid paraffin of petroleum ether flush away microsphere surface, vacuum drying, promptly.
Experimental example 1 is according to the preparation of the investigation control drug of the envelop rate of the florfenicol gelatine microsphere of embodiment 1 preparation: (1) gets 10% gelatin solution 10mL, adds florfenicol 2g, stirring and evenly mixing, preheating in 60 ℃ of water-baths;
(1) that (2) will obtain splashes in the container that contains 2mL span-8 and 60mL liquid paraffin, stirs 15 minutes fast to milky in 60 ℃ of water-baths, and rotating speed is 1500r/min;
(3) ice-water bath is cooled to rapidly below 5 ℃, adds formaldehyde 5mL with the thread shape, stirs crosslinking curing 1 hour, stirs 1 hour sucking filtration with isopropanol dehydration;
(4) with isopropyl alcohol-ether washing, to washing most formaldehyde, with the liquid paraffin of petroleum ether flush away microsphere surface, vacuum drying, promptly.
Experimental result: the lung-targeting florfenicol microsphere envelop rate according to embodiment 1 preparation the results are shown in Table 1
Table 1 is according to the lung-targeting florfenicol microsphere envelop rate result of embodiment 1 preparation
| Envelop rate (%) | |
| Florfenicol gelatine microsphere according to embodiment 1 preparation | ??85％ |
| Control drug | ??20％ |
Experimental example 2 is according to the investigation of the envelop rate of the florfenicol gelatine microsphere of embodiment 6 preparations
The preparation of control drug: (1) gets 10% gelatin solution 10mL, adds florfenicol 2g, stirring and evenly mixing, preheating in 65 ℃ of water-baths;
(1) that (2) will obtain splashes in the container that contains 2mL span-8 and 60mL liquid paraffin, stirs 15 minutes fast to milky in 65 ℃ of water-baths, and rotating speed is 1500r/min
(3) ice-water bath is cooled to rapidly below 5 ℃, adds formaldehyde 5mL with the thread shape, stirs crosslinking curing 1 hour, stirs 1 hour sucking filtration with isopropanol dehydration;
(4) with isopropyl alcohol-ether washing, to washing most formaldehyde, with the liquid paraffin of petroleum ether flush away microsphere surface, vacuum drying, promptly.
Experimental result: the lung-targeting florfenicol microsphere envelop rate according to embodiment 6 preparations the results are shown in Table 2
Table 2 is according to the lung-targeting florfenicol microsphere envelop rate result of embodiment 6 preparations
| Envelop rate (%) | |
| Florfenicol gelatine microsphere according to embodiment 1 preparation | ??81％ |
| Control drug | ??23％ |
Experimental example 3 is according to the investigation of the clinical drug effect of the florfenicol gelatine microsphere of embodiment 1 preparation
The preparation of control drug: (1) gets 10% gelatin solution 10mL, adds florfenicol 2g, stirring and evenly mixing, preheating in 60 ℃ of water-baths;
(1) that (2) will obtain splashes in the container that contains 2mL span-8 and 60mL liquid paraffin, stirs 15 minutes fast to milky in 60 ℃ of water-baths, and rotating speed is 1500r/min;
(3) ice-water bath is cooled to rapidly below 5 ℃, adds formaldehyde 5mL with the thread shape, stirs crosslinking curing 1 hour, stirs 1 hour sucking filtration with isopropanol dehydration;
(4) with isopropyl alcohol-ether washing, to washing most formaldehyde, with the liquid paraffin of petroleum ether flush away microsphere surface, vacuum drying, promptly.
Experimental technique: 1, choose body weight 20-30kg, be diagnosed as 60 of the pigs of asthma, be divided into three groups at random, be respectively A, B, C group, 20 every group.The intravenous injection of A group is equivalent to the medicine by the preparation of embodiment 1 method of 10mg/kg florfenicol dosage, once a day, and logotype three days.The intravenous injection of B group is equivalent to the control drug of 10mg/kg florfenicol dosage, once a day, and logotype three days.C organizes the not administration of negative matched group.
2, curative effect is judged.Cure: after medication a couple of days, appetite, breathe and recover normal, the complete obiteration of coughing, breathe, recidivist not in 20 days is called healing after the drug withdrawal; Take a turn for the better: clinical symptoms alleviates to some extent, or clinical symptoms temporarily disappears, but recidivist again in 20 days after the drug withdrawal is called improvement.
Experimental result: the clinical test of pesticide effectiveness of lung-targeting florfenicol microsphere according to embodiment 1 preparation the results are shown in Table 3.T check (P＜0.05) shows: the florfenicol lung targeting gelatin microsphere clinical effectiveness of the inventive method preparation significantly is better than control drug B group and negative control C group, property that there were significant differences.
Table 3 is according to the clinical test of pesticide effectiveness result of lung-targeting florfenicol microsphere of embodiment 1 preparation
Claims (6)
1. the preparation method of a veterinary florfenicol lung targeting gelatin microsphere is characterized in that with the florfenicol being main component, is carrier with the gelatin, adds polyvinylpyrrolidone in preparation process.
2. the preparation method of veterinary florfenicol lung targeting gelatin microsphere according to claim 1 is characterized in that the polyvinylpyrrolidone that adds can be any one among PVP k10, PVP k15, PVP k17, PVP k25, PVPk30, the PVP k50.
3. the preparation method of veterinary florfenicol lung targeting gelatin microsphere according to claim 1, the weight ratio scope that it is characterized in that florfenicol and polyvinylpyrrolidone is 15: 1～1: 15.
4. the preparation method of veterinary florfenicol lung targeting gelatin microsphere according to claim 3, the weight ratio preferable range that it is characterized in that florfenicol and polyvinylpyrrolidone is 5: 1～1: 5.
5. the preparation method of veterinary florfenicol lung targeting gelatin microsphere according to claim 1, the particle size range that it is characterized in that florfenicol lung targeting gelatin microsphere is 5-30 μ m.
6. as the preparation method of each described veterinary florfenicol lung targeting gelatin microsphere of claim 1-5, it is characterized in that step is as follows:
(1) in abundant swollen gelatin solution, add polyvinylpyrrolidone by weight ratio, dissolving adds florfenicol, stirring and evenly mixing, preheating in 55 ℃ of-65 ℃ of water-baths;
(1) that (2) will obtain splashes in the container that contains Arlacel-80 and liquid paraffin, 55 ℃ of-65 ℃ of stirred in water bath, to milky;
(3) ice-water bath cools off rapidly, adds formaldehyde with the thread shape, is stirred to crosslinking curing, stirs sucking filtration with isopropanol dehydration;
(4) with isopropyl alcohol-ether washing, to washing most formaldehyde, with the liquid paraffin of petroleum ether flush away microsphere surface, vacuum drying, promptly.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013071457A1 (en) * | 2011-11-18 | 2013-05-23 | Universidad De Santiago De Chile | Injectable veterinary composition for controlled, sustained release of ceftiofur and florfenicol in animal species, based on polyhydroxybutyrate hydroxyvalerate (phbv) microparticles |
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| CN1985812A (en) * | 2005-12-21 | 2007-06-27 | 天津市润拓生物技术有限公司 | Lung-targeting florfenicol microsphere for animal and birds and its preparing method |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1985812A (en) * | 2005-12-21 | 2007-06-27 | 天津市润拓生物技术有限公司 | Lung-targeting florfenicol microsphere for animal and birds and its preparing method |
Non-Patent Citations (4)
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| OKKE FRANSSEN,ET AL: "A novel preparation method for polymeric microparticles without the use of organic solvents", 《INTERNATIONAL JOURNAL OF PHARMACEUTICS》 * |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2013071457A1 (en) * | 2011-11-18 | 2013-05-23 | Universidad De Santiago De Chile | Injectable veterinary composition for controlled, sustained release of ceftiofur and florfenicol in animal species, based on polyhydroxybutyrate hydroxyvalerate (phbv) microparticles |
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Effective date of registration: 20220729 Address after: 101407 Beijing city Huairou District Yanqi Economic Development Zone No. 10 North Street Patentee after: Beijing Dabeinong Animal Health Care Technology Co.,Ltd. Patentee after: Shaoshan Dabeinong Animal Medicine Co.,Ltd. Address before: 100080, Zhongguancun building, No. 27 Zhongguancun street, Beijing, Haidian District, China, 14 floor Patentee before: BEIJING DABEINONG TECHNOLOGY GROUP Co.,Ltd. Patentee before: Beijing Dabeinong Animal Health Care Technology Co.,Ltd. Patentee before: Shaoshan Dabeinong Animal Medicine Co.,Ltd. |