CN101606908A - Decoquinate soluble powder and preparation method thereof - Google Patents
Decoquinate soluble powder and preparation method thereof Download PDFInfo
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- CN101606908A CN101606908A CNA2009100410221A CN200910041022A CN101606908A CN 101606908 A CN101606908 A CN 101606908A CN A2009100410221 A CNA2009100410221 A CN A2009100410221A CN 200910041022 A CN200910041022 A CN 200910041022A CN 101606908 A CN101606908 A CN 101606908A
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Abstract
The invention provides Decoquinate soluble powder and preparation method thereof.Preparation method is with deccox, solid dispersion carrier mix homogeneously, is heated to molten condition in 120 ℃～150 ℃, at room temperature dries then, pulverizes, and adds anhydrous glucose again and mixes promptly.Said preparation consists of: deccox 1%～20%, solid dispersion carrier 4%～80% and anhydrous glucose.The soluble powder dissolubility that the present invention makes is good, stability is high, deposited 6 months under accelerated test condition (40 ℃ ± 2 ℃), or deposited 1 year under room temperature (25 ℃ ± 2 ℃), character, dissolubility all do not change, content descends and meets the galenic pharmacy requirement, can reach 3 years through calculating its effect duration; Content descends not obvious under the exposure experiments to light condition; Effective ingredient 4 hours content in drinking-water can keep more than 90%.The pharmaceutical preparation that the present invention makes is effective, and is easy to use, has excellent popularization and using value.
Description
Technical field
The present invention relates to poultry and use soluble powder technology, particularly against-coccidia pharmaceutical formulation Decoquinate soluble powder and preparation method thereof.
Background technology
The coccidiosis of chicken mainly is that the intestinal protozoan parasite by Eimeria causes.Chicken coccidiosis has following characteristics: the one, and ubiquity extensively takes place.Coccidiosis all takes place in nearly all place of raising chickens, and particularly in today of development scaleization, intensification aviculture, coccidiosis is quite outstanding to the influence of poultry.If can not effectively control coccidiosis, the sickness rate of chicken can reach 50%～70%, and mortality rate reaches 20～30%, reaches 80% when serious, and brings out other diseases easily.Coccidiosis has become the raise chickens global disease of production development of obstruction set reduction.The 2nd, hazardness is big, and the harm that coccidiosis causes the chicken group can be summarized as three aspects: 1, cause large quantities of morbidities and the death of chicken; 2, hinder the chicken growth promoter, losing weight to reach 30～70%; 3, reduce the price of deed.
For a long time, the coccidiosis of chicken is main mode with medical treatment still.Anticoccidial drug for the harm that alleviates chicken coccidiosis, improve the price of deed, the aspects such as development of guaranteeing poultry husbandry are all bringing into play effect greatly.But along with reasons such as coccidiostat are widely used, using method is improper, the chicken coccidiosis has almost all produced drug resistance to a certain degree to all used coccidiostats, cause the anticoccidial drug service life to shorten, prevent and treat failure or poor effect, as Salinomycin, sulfa drugs, Maduramicin, monensin, clopidol etc., the coccidiosis drug resistance has become the most serious problem in the treating and preventing coccidiosis of chicken countermeasure, has caused enormous economic loss to poultry husbandry.In addition, owing to European Union, Japan, the U.S. etc. do not comprise multiple coccidiostat to not allowing to add list of substance in the import poultry product, cause the application of coccidiostat to be subjected to great restriction.Therefore, seek a kind of sensitivity, efficient, safe coccidiostat, just become the emphasis of domestic each veterinary drug manufacturing enterprise research and development.
Deccox, chemistry 6-oxygen in last of the ten Heavenly stems base by name-7-ethyoxyl-4-hydroxyl-3-quinoline carboxylic acid ethyl ester, be the quinolines coccidiostat, has chemism and low toxicity efficiently, it has good effect to the chicken coccidiosis that 7 kinds of coccidiosiss of Eimeria cause, is mainly used in the chicken coccidiosis that prevention is caused by various coccidiosiss.Since entering Chinese market in 2004, all kept higher sensitivity in China each department.
Suo Xun etc. show the test of pesticide effectiveness of the tender eimeria tenella disease of deccox prevention artificial challenge's broiler chicken, use in deccox group chicken group's feces and the cecal content and all do not detect egg capsule, the anticoccidial index is all greater than 180, belong to efficient coccidiostat, tender eimeria tenella is infected to have prevent curative effect preferably.According to Guo etc., deccox all has sensitivity preferably to the tender eimeria tenella sensitive strain of laboratory with in the isolating 20 strain field strains of chicken house.Simultaneously; deccox has excellent anticoccidial effect and growth promotion performance, and the coccidiosis life cycle promptly begin in early days play a role, can effectively protect intestinal to avoid the infringement of coccidiosis; and the continuous action time is long, to endangering 7 kinds of maximum chicken coccidiosiss good effect is arranged all.Deccox toxicity is low, and better tolerance is used 80 times of recommended amounts still safety, and metabolism is fast, and left drug concentration is low in each tissue, is that the whole world is unique by the chemical type anticoccidial drug of Japan, European Union, the U.S., Chinese Government's approval use.
In sum, deccox was a kind of novel against-coccidia medicine with wide application prospect, but a kind of dosage form of pre-mixing agent is only arranged at present, and Qingdao health ground benefactor department has developed 3% deccox solution in 2008.
Deccox is water insoluble, also is insoluble to most organic solvents, and therefore how solving its dissolubility becomes a difficult problem.
Summary of the invention
The objective of the invention is in order to overcome the deficiency of anticoccidial sensitive medicaments in the market, simultaneously also in order to overcome the inferior position of deccox pre-mixing agent on result of use and ease of use, and the defective that exists of deccox solution, producing for raising chickens of spreading unchecked of anticoccidial drug provides a kind of sensitivity, high-quality and efficient, low toxicity, Decoquinate soluble powder easy to use and preparation method thereof.
For achieving the above object, the present invention has adopted following technical scheme through a large amount of tests:
The preparation method of Decoquinate soluble powder, this method is with deccox, solid dispersion carrier mix homogeneously, be heated to molten condition in 120 ℃～150 ℃, at room temperature dry then, pulverize and make Decoquinate soluble powder, perhaps add again anhydrous glucose mixed Decoquinate soluble powder.
In the above-mentioned preparation method, the weight ratio of deccox and solid dispersion carrier is 1: 2～1: 8.
In the above-mentioned preparation method, the percentage ratio that the consumption of deccox, solid dispersion carrier and anhydrous glucose accounts for these three kinds of material gross weights is respectively 1%～20%, and 4%～80% and 0%～85%.
In the above-mentioned preparation method, described solid dispersion carrier is at least two kinds among poloxamer 188, poloxamer 407, polyethylene glycol 6000, Macrogol 4000, the polyvinylpyrrolidone K30.
In the above-mentioned preparation method, after the described pulverizing, cross 60 mesh sieves, add anhydrous glucose again and mix promptly.
In the above-mentioned preparation method, described deccox with before the solid dispersion carrier mixes through pulverization process.
The present invention has carried out stability test to the Decoquinate soluble powder that above-mentioned preparation method makes, comprise accelerated test, long term test, exposure experiments to light and water stability test, the result shows, this soluble powder stability is high, under accelerated test condition (40 ℃ ± 2 ℃), deposited 6 months, or deposited 1 year under the room temperature (25 ℃ ± 2 ℃), character, dissolubility all do not change, and content descends and meets the galenic pharmacy requirement; Content descends not obvious under the exposure experiments to light condition; Effective ingredient 4 hours content in drinking-water can keep more than 90%.
Specifically, the present invention has following advantage and beneficial effect:
The Decoquinate soluble powder that the present invention makes has been compared following advantages with deccox pre-mixing agent, deccox solution:
1, by the decision of the medicinal property of deccox, its granule is thinner, and anti-ball effect is stronger, make diameter and be the good effect of microgranule competence exertion about 1.8 microns.And such requirement is concerning pre-mixing agent, having relatively high expectations on preparation process, and the most of manufacturers of China all can not reach.And the medicine in the solid dispersion is to be dispersed in formed dispersion in the solid-state carrier with molecule, colloidal state, crystallite or amorphous state etc.; the dissolubility of medicine and dissolution rate will significantly be accelerated; anticoccidial effect strengthens than common pre-mixing agent; simultaneously simple on preparation technology, accomplish scale production easily.
2, after the chicken morbidity, feed intake can descend under the situation mostly, and the amount of drinking water influence is little.If the use pre-mixing agent makes drug level can not reach effective dose owing to the foodstuff amount is few, easily affect the state of an illness adversely.And Decoquinate soluble powder adopts the drinking-water administration, can not influence the absorption of medicine effective dose.
Though 3 deccox solution have solved the problem of drinking-water administration, it is a much progress, but owing to used organic solvents such as N-Methyl pyrrolidone, dimethyl acetylamide in the solution, these organic solvents can produce certain toxicity to animal body, must not surpass 60% of preparation total amount so stipulate general consumption, and comparatively inconvenience of the transportation of solution.And the solid dispersion carrier that uses in the Decoquinate soluble powder prescription is all more general, does not have toxicity problem, and simple, the convenient transportation of powder packing.
By relatively, Decoquinate soluble powder all has incomparable advantage in result of use, ease of use, safety and convenient transportation as can be seen, and many a kind of dosage form selection is provided for the drinking-water administration.
The present invention determines through a large amount of test, the particularly screening of solid dispersion carrier and preparation technology (parameter), has solved deccox indissoluble and dissolving back problem of unstable.On preparation technology, adopt solid dispersion technology, improved the dissolubility and the dissolution rate of medicine effectively.The soluble powder dissolubility that makes is good, stability is high, deposited 6 months under accelerated test condition (40 ℃ ± 2 ℃), or deposited 1 year under room temperature (25 ℃ ± 2 ℃), character, dissolubility all do not change, content descends and meets the galenic pharmacy requirement, can reach 3 years through calculating its effect duration; Content descends not obvious under the exposure experiments to light condition; Effective ingredient 4 hours content in drinking-water can keep more than 90%.
The present invention adopts solid dispersion technology, the deccox of utmost point indissoluble is made soluble powder, can guarantee that this soluble powder can be dispersed in the drinking-water in use keeps stable, overcome the deficiency of pre-mixing agent spice inequality, improved the convenience that insoluble drug uses greatly, improved the anticoccidial effect of medicine, for plant provides a kind of sensitivity, efficient, low toxicity, stable, easy to use coccidiostat.
The specific embodiment
Below in conjunction with specific embodiment, the specific embodiment of the present invention is described in detail, but be not that protection scope of the present invention is limited to specific details.
Embodiment 1
Table 1
| Composition | 100g (always) |
| Deccox | ??1g |
| Macrogol 4000 | ??1g |
| Polyvinylpyrrolidone K30 | ??1g |
| Anhydrous glucose | ??97g |
The raw material consumption of present embodiment is as shown in table 1.
Preparation method and step: the deccox raw material of the pulverization process of learning from else's experience, Macrogol 4000, polyvinylpyrrolidone K30, mix after 30 minutes in mixer and take out; Mixed sample is heated 3 hours to molten condition with 125 ℃ in baking oven; Fused mass is taken out, dry at ambient temperature, pulverize; Add anhydrous glucose, in mixer, mix 30min; By the loading amount specification packing of product, seal, promptly get 1% (weight) Decoquinate soluble powder.
Embodiment 2
The raw material consumption of present embodiment is as shown in table 2.
Preparation method and step: the deccox raw material of the pulverization process of learning from else's experience, Macrogol 4000, polyvinylpyrrolidone K30, mix after 30 minutes in mixer and take out; With mixed sample in baking oven 135 ℃ the heating 3 hours to molten condition; Fused mass is taken out, dry at ambient temperature, pulverize; Add anhydrous glucose, in mixer, mixed 30 minutes; By the loading amount specification packing of product, seal, promptly get 3% Decoquinate soluble powder.
Table 2
| Composition | 100g (always) |
| Deccox | ??3g |
| Macrogol 4000 | ??6g |
| Polyvinylpyrrolidone K30 | ??6g |
| Anhydrous glucose | ??85g |
Embodiment 3
Table 3
| Composition | 100g (always) |
| Deccox | ??6g |
| Polyethylene glycol 6000 | ??12g |
| Poloxamer 188 | ??12g |
| Anhydrous glucose | ??70g |
The raw material consumption of present embodiment is as shown in table 3.
Preparation method and step: the deccox raw material of the pulverization process of learning from else's experience, polyethylene glycol 6000, poloxamer 188, mix after 30 minutes in mixer and take out; With mixed sample in baking oven 130 ℃ the heating 3 hours to molten condition; Fused mass is taken out, dry at ambient temperature, pulverize; Add anhydrous glucose, in mixer, mixed 30 minutes; By the loading amount specification packing of product, seal, promptly get 6% Decoquinate soluble powder.
Embodiment 4
The raw material consumption of present embodiment is as shown in table 4.
Preparation method and step: the deccox raw material of the pulverization process of learning from else's experience, polyethylene glycol 6000, poloxamer 407, mix after 30 minutes in mixer and take out; With mixed sample in baking oven 130 ℃ the heating 3 hours to molten condition; Fused mass is taken out, dry at ambient temperature, pulverize; Add anhydrous glucose, in mixer, mixed 30 minutes; By the loading amount specification packing of product, seal, promptly get 10% Decoquinate soluble powder.
Table 4
| Composition | 100g (always) |
| Deccox | ??10g |
| Polyethylene glycol 6000 | ??40g |
| Poloxamer 407 | ??40g |
| Anhydrous glucose | ??10g |
Embodiment 5
The raw material consumption of present embodiment is as shown in table 5.
Preparation method and step: the deccox raw material of the pulverization process of learning from else's experience, polyethylene glycol 6000, poloxamer 188, mix after 30 minutes in mixer and take out; With mixed sample in baking oven 140 ℃ the heating 3 hours to molten condition; Fused mass is taken out, dry at ambient temperature, pulverize; By the loading amount specification packing of product, seal, promptly get 20% Decoquinate soluble powder.
Table 5
| Composition | 100g (always) |
| Deccox | ??20g |
| Polyethylene glycol 6000 | ??60g |
| Poloxamer 188 | ??20g |
Stability test
1, the stability test design is as shown in table 6.
Table 6
2, test material, as shown in table 7.
Table 7
3, concrete test method and step:
Accelerated test: Decoquinate soluble powder is put in 40 ℃ ± 2 ℃ calorstats, placed 6 months, sample when being sampled as zero immediately in sampling at the 1st, 2,3,6 the end of month, detects by stable high spot reviews project, and sample compares with zero the time.
Long-term stable experiment: Decoquinate soluble powder is put under 25 ℃ ± 2 ℃ environment, placed 1 year, detect, and sample compares with zero time by stable high spot reviews project in the 0th, 3,6,9,12 the end of month samplings.
Exposure experiments to light: Decoquinate soluble powder is put in the clarity detector that intensity of illumination is 4500LX, under room temperature, placed 20 days, sampling in 1,3,5,10,15,20 day, detect respectively, and sample compares with zero the time by stable high spot reviews project.
Effective ingredient water stability test: Decoquinate soluble powder is added tap water and mineral water is diluted to the concentration that contains the about 45 μ g/mL of deccox, be positioned under the room temperature environment in the airtight container, sample when being sampled as zero immediately, and respectively at 1,2,4,8,12,24 hour point in time sampling, detect the concentration of deccox in the solution of drinking water under each time point, sample concentration is 100% with zero the time, conversion percentage ratio during the concentration Relative Zero of other times point is to investigate the stability of deccox in aqueous solution.
Result of the test
1, accelerated test: under 40 ± 2 ℃ of conditions of temperature, the Decoquinate soluble powder accelerated test, the result is as shown in table 8.
Table 8
2, long-term stable experiment: under 25 ± 2 ℃ of conditions of temperature, it is as shown in table 9 that the Decoquinate soluble powder long term test is investigated the result.
Table 9
3, exposure experiments to light: the result is as shown in table 10 for the Decoquinate soluble powder exposure experiments to light.
Table 10
4, effective ingredient is tested at water stability, and the stability test result in water is as shown in table 11 for the Decoquinate soluble powder effective ingredient.
Above-mentioned result of the test shows, this soluble powder stability is high, accelerated test 6 months, long term test 1 year and exposure experiments to light 20 days, and character, the dissolubility of three batches of Decoquinate soluble powders all do not change, content descends and meets the galenic pharmacy requirement, can reach 3 years through calculating its effect duration; Content descends not obvious under the exposure experiments to light condition; Effective ingredient 4 hours content in drinking-water can keep more than 90%.
Table 11
In order to prove the stability of against-coccidia pharmaceutical formulation Decoquinate soluble powder provided by the invention, chosen a routine embodiment and carried out above-mentioned accelerated test, long-term stable experiment, exposure experiments to light and the stability test of medicine active ingredient in water, result of the test has shown feasibility of the present invention.
The foregoing description; the composition, preparation technology and the stability test that comprise Decoquinate soluble powder; the present invention is described in detail; these descriptions are illustrative but not determinate; can list several embodiment according to institute's limited range; therefore in the variation and the modification that do not break away under the general plotting of the present invention, should belong within protection scope of the present invention.
Claims (8)
1, the preparation method of Decoquinate soluble powder, it is characterized in that deccox, solid dispersion carrier mix homogeneously, be heated to molten condition in 120 ℃～150 ℃, at room temperature dry then, pulverize and make Decoquinate soluble powder, perhaps add again anhydrous glucose mixed Decoquinate soluble powder.
2, preparation method according to claim 1, the weight ratio that it is characterized in that deccox and solid dispersion carrier is 1: 2～1: 8.
3, preparation method according to claim 1, the percentage ratio that the consumption that it is characterized in that deccox, solid dispersion carrier and anhydrous glucose accounts for these three kinds of material gross weights is respectively 1%～20%, 2%～80% and 0%～85%.
4, preparation method according to claim 3, the percentage ratio that the consumption that it is characterized in that deccox, solid dispersion carrier and anhydrous glucose accounts for these three kinds of material gross weights is respectively 1%～20%, 4%～80% and 0%～85%.
5, preparation method according to claim 1 is characterized in that described solid dispersion carrier is at least two kinds among poloxamer 188, poloxamer 407, polyethylene glycol 6000, Macrogol 4000, the polyvinylpyrrolidone K30.
6, according to each described preparation method of claim 1～5, it is characterized in that after the described pulverizing, cross 60 mesh sieves, add anhydrous glucose again and mix promptly.
7, preparation method according to claim 6, it is characterized in that described deccox with before the solid dispersion carrier mixes through pulverization process.
8, the Decoquinate soluble powder that makes by the described method of claim 1.
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Cited By (6)
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| CN101933930A (en) * | 2010-08-23 | 2011-01-05 | 山东步步赢生物科技有限公司 | Novel compound anti-coccidiosis medicament and preparation method thereof |
| CN102274189A (en) * | 2011-07-21 | 2011-12-14 | 瑞普（天津）生物药业有限公司 | Decoquinate-containing suspension formula and preparation method thereof |
| CN106137973A (en) * | 2016-08-10 | 2016-11-23 | 河南牧翔动物药业有限公司 | A kind of compound sulfonamide chloropyrazine soluble powder of sodium and preparation method thereof |
| CN106491538A (en) * | 2016-12-05 | 2017-03-15 | 郑州百瑞动物药业有限公司 | carbasalate calcium soluble powder and preparation method thereof |
| CN106491549A (en) * | 2016-12-14 | 2017-03-15 | 成都乾坤动物药业股份有限公司 | A kind of deccox dispersible tablet and its production and use |
| CN107427504A (en) * | 2015-12-08 | 2017-12-01 | 广州中科蓝华生物科技有限公司 | Decoquinate solid dispersoid, preparation method and use |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101933930A (en) * | 2010-08-23 | 2011-01-05 | 山东步步赢生物科技有限公司 | Novel compound anti-coccidiosis medicament and preparation method thereof |
| CN102274189A (en) * | 2011-07-21 | 2011-12-14 | 瑞普（天津）生物药业有限公司 | Decoquinate-containing suspension formula and preparation method thereof |
| CN107427504A (en) * | 2015-12-08 | 2017-12-01 | 广州中科蓝华生物科技有限公司 | Decoquinate solid dispersoid, preparation method and use |
| EP3388065A4 (en) * | 2015-12-08 | 2019-08-07 | Bluelight Pharmatech Co., Ltd | SOLID DISPERSION OF DECOQUINATE, PREPARATION METHOD AND USE THEREOF |
| CN107427504B (en) * | 2015-12-08 | 2020-10-09 | 广州蓝亮医药科技有限公司 | Decoquinate solid dispersion, preparation method and application thereof |
| CN106137973A (en) * | 2016-08-10 | 2016-11-23 | 河南牧翔动物药业有限公司 | A kind of compound sulfonamide chloropyrazine soluble powder of sodium and preparation method thereof |
| CN106491538A (en) * | 2016-12-05 | 2017-03-15 | 郑州百瑞动物药业有限公司 | carbasalate calcium soluble powder and preparation method thereof |
| CN106491538B (en) * | 2016-12-05 | 2019-01-08 | 郑州百瑞动物药业有限公司 | carbasalate calcium soluble powder and preparation method thereof |
| CN106491549A (en) * | 2016-12-14 | 2017-03-15 | 成都乾坤动物药业股份有限公司 | A kind of deccox dispersible tablet and its production and use |
| CN106491549B (en) * | 2016-12-14 | 2019-10-22 | 成都乾坤动物药业股份有限公司 | A kind of decoquinate dispersible tablet and its preparation method and application |
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Address after: 510642 next to building 9 in Wushan South China Agricultural University, Tianhe District, Guangzhou, Guangdong Province Patentee after: Guangdong Huanong Gaoke biopharmaceutical Co.,Ltd. Address before: 510642 next to building 9 in Wushan South China Agricultural University, Tianhe District, Guangzhou, Guangdong Province Patentee before: GUANGZHOU SCAU EXPERIMENTAL VETERINARY MEDICINE Co.,Ltd. |