CN104274411A - Tilmicosin micron preparation and preparation method thereof - Google Patents
Tilmicosin micron preparation and preparation method thereof Download PDFInfo
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- CN104274411A CN104274411A CN201410585345.8A CN201410585345A CN104274411A CN 104274411 A CN104274411 A CN 104274411A CN 201410585345 A CN201410585345 A CN 201410585345A CN 104274411 A CN104274411 A CN 104274411A
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Abstract
The invention discloses a tilmicosin micron preparation and a preparation method thereof. The tilmicosin micron preparation is prepared from the following components in parts by weight: 5-20 parts of tilmicosin, 5-20 parts of styrene-maleic acid copolymer, 5-20 parts of zein, 2-5 parts of ethylcellulose, 10-40 parts of one or two of medicinal ethanol and propylene glycol, 5-15 parts of one or several of methyl acetate, acetic ether and butyl acetate and 20-80 parts of one or several maltodextrin, sucrose powder (20-80 meshes) and glucose. The tilmicosin, the styrene-maleic acid copolymer, the zein and ethylcellulose carrier materials are fused to form emulsion, the carrier can be used for effectively encapsulating tilmicosin, the tilmicosin is uniformly dispersed in the carrier material, the original medicinal bitter taste is covered, and the effect of improving the bioavailability is achieved. The preparation method is simple, economic, low in cost, environment-friendly, safe and high in reproducibility. The product is high in bioavailability, convenient in administration and good in bitter taste masking effect, and the palatability of the medicine is improved.
Description
Technical field
The present invention relates to a kind of veterinary drug production technology preparation, be specifically related to a kind of tilmicosin micron preparation and preparation method thereof.
Background technology
Tilmicosin (Tilmicosin) be Lilly Co., Eli. develop in Elanco company of subordinate branch company the eighties in 20th century by the special antibiotic of tylosin semisynthetic Macrolide poultry.The antimicrobial spectrum of tilmicosin is similar to tylosin, both all have stronger fungistatic effect to gram negative bacteria, eggs crack detection, erysipelothrix ruhsiopathiae, Actinobacillus pleuropneumoniae and chicken virus mycoplasma, then show as the more weak or Drug resistance of fungistatic effect to other bacterium.But in hemorrhage pasteurella septica and pasteurella hemolytica, there is potentiation.In body and external test also all confirm the antibacterial action of tilmicosin to pasteurella multocida and pasteurella hemolytica.When tilmicosin is for preventing and treating swine mycoplasma pneumonia, the main mode adopting spice to feed.When prevention and therapy avian mycoplasmas is sick, then add into drinking-water medication.
At present, the dosage form recorded in People's Republic of China's veterinary drug allusion quotation has tilmicosin injection, tilmicosin pre-mixing agent, tilmicosin solution three kinds of dosage forms.Tilmicosin is water insoluble, its injection has certain defect: the research and production process of the injection of tilmicosin is comparatively complicated, and because injection requires aseptic without thermal source, production process is strict, need higher appointed condition, also than solid preparation poor stability in storage process.In addition, the injection of tilmicosin has potential nephrotoxicity to pig.The production technology of tilmicosin pre-mixing agent is simple, by means of only with being simply mixed with of adjuvant, but exist and feedstuff mixing time and effort consuming in use procedure, easily cause the shortcomings such as mixing is uneven, mixed feeding dosage is inaccurate, and its bitterness is overweight, cannot use by recommended dose in pharmacopeia (200 ~ 400g/ ton feedstuff calculates according to tilmicosin active substance), have a strong impact on the feed intake of pig, bioavailability is low.The veterinary dosage form that modern large-scale cultivation factory more gladly accepts is not only can mixed feeding but also can mix the powder of drink.
In prior art, application number be 201210173727.0 Chinese invention patent disclose a kind of tilmicosin soluble powder and preparation method thereof, this preparation method can make soluble powder, facilitate feasible time prepared by laboratory, but commercial production is a large amount of with an organic solvent adds production cost on the one hand, can cause environmental pollution on the other hand.Application number be 201310021437.9 Chinese invention patent disclose a kind of production method of 20% tilmicosin granule, the method, through twice pelletization, is produced comparatively loaded down with trivial details, increases production cost.Application number is 201310301120.0 disclose a kind of compound tilmicosin soluble powder and its preparation method and application, and it is prepared from through simple physical mixed tilmicosin, Radix Glycyrrhizae extract, carrier, and water solublity effect is unsatisfactory.
Summary of the invention
The object of the invention is to the defect overcoming above-mentioned prior art, a kind of tilmicosin micron preparation and preparation method thereof is provided, its production technology is simple, Environmental Safety, preparation cost is low, and medicine stability is strong, encapsulate effective, bioavailability is high, and mouthfeel is without bad smell and bitterness, and medication is convenient.
For achieving the above object, the present invention adopts following technical scheme: a kind of tilmicosin micron preparation, it is made up of following component by weight: tilmicosin 5-20 part, styrol maleic acid copolymers 5-20 part, zein 5-20 part, ethyl cellulose 2-5 part, the one of medicinal alcohol, propylene glycol or two kinds of 10-40 parts, one or more 5-15 parts of methyl acetate, ethyl acetate, butyl acetate, one or more the 20-80 parts in maltodextrin, cane sugar powder (80 order), glucose.Tilmicosin of the present invention is dispersed in carrier material, and product is solid, is easy to preserve and transport.
Based on technique scheme, preferably, the weight portion of above-mentioned each component is: tilmicosin 5 parts, styrol maleic acid copolymers 5 parts, zein 10 parts, ethyl cellulose 2 parts, the one of medicinal alcohol, propylene glycol or two kinds 20 parts, methyl acetate, ethyl acetate, butyl acetate one or more 5 parts, one or more 28 parts in maltodextrin, cane sugar powder (80 order), glucose.
A preparation method for tilmicosin micron preparation, the method comprises the following steps:
Step one, get the raw materials ready: prepare raw material according to the following ratio: tilmicosin 5-20 part, carrier material: styrol maleic acid copolymers 5-20 part, zein 5-20 part and ethyl cellulose 2-5 part, solvent: the one of medicinal alcohol, propylene glycol or two kinds of 10-40 parts, non-solvent: one or more 5-15 parts of methyl acetate, ethyl acetate, butyl acetate, one or more the 20-80 parts in maltodextrin, cane sugar powder (80 order), glucose;
Step 2, first by standby raw material carrier material and solvent-medicinal alcohol, the one of propylene glycol or two kinds be mixed and made into carrier solution;
Step 3, adds tilmicosin mix homogeneously, makes emulsion;
Step 4, then one or more mixture adding non-solvent-methyl acetate, ethyl acetate, butyl acetate, make carrier solubility reduce, cause and be separated, microporous filter, be separated to obtain micron;
Step 5, then add one or more in maltodextrin, cane sugar powder (80 order), glucose, mixing granulation;
Step 6, carries out granulate by the granule obtained in step 5 drying under reduced pressure 2-3 hour, 30-50 order at 50-60 DEG C, obtains tilmicosin micron preparation.
Based on technique scheme, the fineness of microporous filter in step 4 described in above-mentioned preparation method is 0.45 micron membrane filter.
Based on technique scheme, proportioning of getting the raw materials ready in step one described in above-mentioned preparation method is: tilmicosin 5 parts, styrol maleic acid copolymers 5 parts, zein 10 parts, ethyl cellulose 2 parts, the one of medicinal alcohol, propylene glycol or two kinds 20 parts, methyl acetate, ethyl acetate, butyl acetate one or more 5 parts, one or more 28 parts in maltodextrin, cane sugar powder (80 order), glucose.
Beneficial effect of the present invention: carrier selected by the present invention is styrol maleic acid copolymers, zein and ethyl cellulose, this carrier effectively can encapsulate tilmicosin, all there is nontoxic, non-carcinogenesis, not with medicine generation chemical change, the chemical stability not affecting principal agent, the drug effect not affecting medicine and content detection, medicine can be made to obtain optimum dispersion state, the advantage such as cheap and easy to get, tilmicosin is dispersed in carrier material, plays the effect improving bioavailability while covering its original bitter taste of drug.The easy economy of preparation method of the present invention, cost are low, Environmental Safety, existing property are good.The bioavailability of obtained product is high, and medication is convenient, and taste masking effect is better, improves the palatability of medicine.
Detailed description of the invention
Below in conjunction with specific embodiment, the invention will be further described.
Embodiment 1: a kind of tilmicosin micron preparation, said preparation is made up of following component by weight: tilmicosin 5 parts, carrier material: styrol maleic acid copolymers 5 parts, zein 10 parts and ethyl cellulose 2 parts, solvent: medicinal alcohol 20 parts, non-solvent: methyl acetate 5 parts, adjuvant: maltodextrin and cane sugar powder (80 order) add up to 28 parts.
The preparation method of above-mentioned tilmicosin micron preparation, concrete steps are:
1) first carrier material is amounted to 17 parts and join 5 parts of medicinal alcohol solvents, stir, dissolve.
2) add 5 parts of tilmicosins while stirring, make tilmicosin and carrier material solution make emulsion;
3) non-solvent material is added again--ethyl acetate 5 parts, makes carrier solubility reduce, causes and be separated;
4) microporous filter (0.45 micron membrane filter), is separated to obtain micron; Filtrate recycles and reuses;
5) micron adds adjuvant: maltodextrin and cane sugar powder (80 order) add up to 28 parts, mixing granulation;
6) granule 55 DEG C of drying under reduced pressure 2.5 hours, 40 orders carry out granulate, obtain tilmicosin micron preparation.
Embodiment 2: a kind of tilmicosin micron preparation, said preparation is made up of following component by weight: tilmicosin 20 parts; Carrier material: styrol maleic acid copolymers 20 parts, zein 5 parts, ethyl cellulose 5 parts; Solvent: medicinal alcohol 25 parts, propylene glycol 15 parts; Non-solvent: methyl acetate 8 parts, butyl acetate 7 parts, glucose 65 parts.
The preparation method of above-mentioned tilmicosin micron preparation, concrete steps are:
1), in first added up to by carrier material 40 parts to join solvent that 25 parts of medicinal alcohols and 15 parts of propylene glycol make, stir, dissolve;
2) add 20 parts of tilmicosins while stirring, make tilmicosin and carrier material solution make emulsion;
3) non-solvent material is added again--methyl acetate 8 parts, butyl acetate 7 parts, make carrier solubility reduce, cause and be separated;
4) microporous filter (0.45 micron membrane filter), is separated to obtain micron; Filtrate recycles and reuses;
5) in step 4 gained micron, glucose 65 parts is added, mixing granulation;
6) granule 50-60 DEG C of drying under reduced pressure 2 hours, 30 orders carry out granulate, obtain tilmicosin micron preparation.
Embodiment 3: a kind of tilmicosin micron preparation, said preparation is made up of following component by weight: tilmicosin 10 parts; Carrier material: styrol maleic acid copolymers 10 parts, zein 20 parts, ethyl cellulose 4 parts; Solvent: each 10 parts of medicinal alcohol, propylene glycol; Non-solvent: each 5 parts of ethyl acetate, butyl acetate; Adjuvant: maltodextrin, cane sugar powder (80 order), each 20 parts of glucose.
The preparation method of above-mentioned tilmicosin micron preparation, concrete steps are:
1) first all carrier materials 34 parts are joined in the solvent that 10 parts of medicinal alcohols and 10 parts of propylene glycol make, stir, dissolve;
2) add 10 parts of tilmicosins while stirring, make tilmicosin and carrier material solution make emulsion;
3) non-solvent material is added again--ethyl acetate 5 parts and butyl acetate 5 parts, make carrier solubility reduce, cause and be separated;
4) microporous filter (0.45 micron membrane filter), is separated to obtain micron; Filtrate recycles and reuses;
5) micron to add in maltodextrin, cane sugar powder (80 order), glucose each 20 parts, mixing granulation;
6) granule 50-60 DEG C of drying under reduced pressure 3 hours, 40 orders carry out granulate, obtain tilmicosin micron preparation.
Embodiment 4: a kind of tilmicosin micron preparation, said preparation is made up of following component by weight::
Tilmicosin 15 parts; Carrier material: styrol maleic acid copolymers 5 parts, zein 15 parts, ethyl cellulose 5 parts; Solvent: propylene glycol 30 parts; Non-solvent: methyl acetate 5 parts, ethyl acetate 5 parts; Adjuvant: maltodextrin and each 20 parts of glucose.
The preparation method of above-mentioned tilmicosin micron preparation, concrete steps are:
1) first all carrier materials 25 parts are joined 30 parts of propylene glycol solvent, stir, dissolve;
2) add 10 parts of tilmicosins while stirring, make tilmicosin and carrier material solution make emulsion;
3) non-solvent material is added again--methyl acetate 5 parts, ethyl acetate 5 parts, makes carrier solubility reduce, causes and be separated;
4) microporous filter (0.45 micron membrane filter), is separated to obtain micron; Filtrate recycles and reuses;
5) micron adds adjuvant: maltodextrin and each 20 parts of glucose, mixing granulation;
6) granule 50-60 DEG C of drying under reduced pressure 2 hours, 40 orders carry out granulate, obtain tilmicosin micron preparation.
Embodiment 5: product is at the palatability testing on pig farm
Test method: the applicant carries out palatability testing on Mu Yuan pig farm, Neixiang County, Henan Province to above-mentioned tilmicosin micron preparation, is specially: choose healthy fattening pig 45, is divided into A, B, C 3 groups at random, often organizes 15.A group is blank group, and not administration is feeding feed stuff only; B group give embodiment 1 prepare tilmicosin micron preparation (Zhengzhou He Run Biology Pharmacy Co., Ltd provides, lot number 20140822), by 0.1% mixed feeding, the common pre-mixing agent (10% tilmicosin pre-mixing agent market being bought certain animal pharmaceutical factory to produce, lot number 20140805) that C group gives market is bought is by 0.1% mixed feeding; A, B, C 3 groups of feedings and managements are identical, and in 4h, the material of A, B two groups is all eaten up, and about the material of C group residue half.
Experiment conclusion: the palatability of tilmicosin micron of the present invention on pig feed does not affect.
Embodiment 6: tilmicosin micron preparation of the present invention is to the clinical trial of pig pleuropneumonia, specific as follows:
Material: A:10% tilmicosin micron preparation, product prepared by embodiment 1
B:10% tilmicosin pre-mixing agent, purchased from market products
Test method: choose Mu Yuan pig farm, Neixiang County, Henan Province from numerous autotrophy, age in days is close, feeding and management condition is substantially identical, be diagnosed as respiratory tract disease, the fattening pig of non-administration in the recent period 60, is divided into 2 groups at random, i.e. experimental group, matched group, often organize 30.Experimental group is by 0.1% spice, and the tilmicosin micron preparation A(Zhengzhou He Run Biology Pharmacy Co., Ltd giving to prepare by the embodiment of the present invention 1 provides), be used in conjunction 5 days; Matched group, by 0.1% spice, gives the common pre-mixing agent B(10% tilmicosin pre-mixing agent that market is bought, and market is bought certain animal pharmaceutical factory and produces, lot number 20140805), be used in conjunction 5 days, two groups of feedings and managements are identical.
Outcome measure method is as follows:
Cure rate: during medication, administration pig clinical symptoms disappears completely, and spirit, appetite, body temperature, feces, breathing, cough etc. recover to be healing normally, cures number calculate its cure rate according to each treated animal.
Effective percentage: during medication, administration pig spirit, appetite take a turn for the better, and symptom alleviates, and cough obviously alleviates as effectively, calculates its effective percentage according to the significant figure in every treated animal.
Inefficiency: duration of test, after medication, clinical symptoms has no and alleviates or continue to worsen and the pig of death is all judged to invalid, calculates its inefficiency according to the invalid number in every treated animal.
Table 1 tilmicosin micron preparation is to the clinical trial result of pig pleuropneumonia:
Tabular analysis: 10% tilmicosin pre-mixing agent group is because of the bitterness of tilmicosin, and the feed intake of pig declines to some extent, as can be seen from the test results: the therapeutic effect of 10% tilmicosin micron preparation is better than the therapeutic effect of 10% tilmicosin pre-mixing agent.
Experiment conclusion: the effective percentage of experimental group and cure rate are all high than matched group, tilmicosin micron preparation of the present invention embodies good clinical effectiveness in treatment porcine respiratory disease as can be seen here.
Conclusion: compared with tilmicosin pre-mixing agent, tilmicosin micron preparation of the present invention is without the pole bitterness of tilmicosin raw material, and after improve poultry morbidity, feed intake declines and affects the problem of ingestion of medicines; Be simultaneously slow releasing preparation due to it, tilmicosin is more easily absorbed in vivo, and effective blood drug concentration is held time longer, and bioavailability is higher, is conducive to raising therapeutic effect.
In sum, tilmicosin micron preparation production technique of the present invention is simple, and there is not environmental pollution, good palatability, medicament slow release, clinical application effect is remarkable.
Claims (5)
1. a tilmicosin micron preparation, it is characterized in that: said preparation is made up of following component by weight: tilmicosin 5-20 part, styrol maleic acid copolymers 5-20 part, zein 5-20 part, ethyl cellulose 2-5 part, the one of medicinal alcohol, propylene glycol or two kinds of 10-40 parts, one or more 5-15 parts of methyl acetate, ethyl acetate, butyl acetate, one or more the 20-80 parts in maltodextrin, cane sugar powder (80 order), glucose.
2. tilmicosin micron preparation according to claim 1, it is characterized in that: the weight portion of each component of said preparation is: tilmicosin 5 parts, styrol maleic acid copolymers 5 parts, zein 10 parts, ethyl cellulose 2 parts, the one of medicinal alcohol, propylene glycol or two kinds 20 parts, methyl acetate, ethyl acetate, butyl acetate one or more 5 parts, one or more 28 parts in maltodextrin, cane sugar powder (80 order), glucose.
3. a preparation method for tilmicosin micron preparation, is characterized in that: the method comprises the following steps:
Step one, get the raw materials ready: prepare raw material according to the following ratio: tilmicosin 5-20 part, carrier material: styrol maleic acid copolymers 5-20 part, zein 5-20 part and ethyl cellulose 2-5 part, solvent: the one of medicinal alcohol, propylene glycol or two kinds of 10-40 parts, non-solvent: one or more 5-15 parts of methyl acetate, ethyl acetate, butyl acetate, one or more the 20-80 parts in maltodextrin, cane sugar powder (80 order), glucose;
Step 2, first by standby raw material carrier material and solvent-medicinal alcohol, the one of propylene glycol or two kinds be mixed and made into carrier solution;
Step 3, adds tilmicosin mix homogeneously, makes emulsion;
Step 4, then one or more mixture adding non-solvent-methyl acetate, ethyl acetate, butyl acetate, make carrier solubility reduce, cause and be separated, microporous filter, be separated to obtain micron;
Step 5, then add one or more in maltodextrin, cane sugar powder (80 order), glucose, mixing granulation;
Step 6, carries out granulate by the granule obtained in step 5 drying under reduced pressure 2-3 hour, 30-50 order at 50-60 DEG C, obtains tilmicosin micron preparation.
4. the preparation method of tilmicosin micron preparation according to claim 3, is characterized in that: the fineness of microporous filter in described step 4 is 0.45 micron membrane filter.
5. the preparation method of tilmicosin micron preparation according to claim 3, it is characterized in that: the proportioning of getting the raw materials ready in described step one is: tilmicosin 5 parts, styrol maleic acid copolymers 5 parts, zein 10 parts, ethyl cellulose 2 parts, the one of medicinal alcohol, propylene glycol or two kinds 20 parts, methyl acetate, ethyl acetate, butyl acetate one or more 5 parts, one or more 28 parts in maltodextrin, cane sugar powder (80 order), glucose.
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Citations (3)
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|---|---|---|---|---|
| US4824675A (en) * | 1987-07-13 | 1989-04-25 | Alza Corporation | Dispenser with movable matrix comprising a plurality of tiny pills |
| CN101879141A (en) * | 2009-05-05 | 2010-11-10 | 烟台绿叶动物保健品有限公司 | Taste-masking tilmicosin gastric-soluble particle preparation |
| CN102670516A (en) * | 2012-05-29 | 2012-09-19 | 广东大华农动物保健品股份有限公司 | Tilmicosin soluble powder and preparation method thereof |
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- 2014-10-28 CN CN201410585345.8A patent/CN104274411B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4824675A (en) * | 1987-07-13 | 1989-04-25 | Alza Corporation | Dispenser with movable matrix comprising a plurality of tiny pills |
| CN101879141A (en) * | 2009-05-05 | 2010-11-10 | 烟台绿叶动物保健品有限公司 | Taste-masking tilmicosin gastric-soluble particle preparation |
| CN102670516A (en) * | 2012-05-29 | 2012-09-19 | 广东大华农动物保健品股份有限公司 | Tilmicosin soluble powder and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 王建华，黄永中: "高分子载体材料在药用微球中的应用及进展", 《高分子通报》 * |
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