CN106667898B - Decoquinate preparation and preparation method and application thereof - Google Patents
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- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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Abstract
The invention provides a decoquinate preparation, a preparation method and application thereof. In the method, the used raw and auxiliary materials are low in price, the preparation process is simple, large-scale high-end equipment is not needed, the decoquinate preparation can be conveniently and quickly prepared, and the prepared preparation has good dissolubility and dissolution rate. Meanwhile, in the preparation, the decoquinate is matched with the wetting agent, the dispersing agent, the lipophilic surfactant, the soluble diluent and other components for use, so that the dissolution rate of the decoquinate can be effectively improved, the decoquinate can be further prepared into granules, tablets, dry suspension or premix, the requirements for use in different occasions can be met, meanwhile, the preparation can be further used for preparing medicines for treating coccidiosis, and a good treatment effect can be achieved.
Description
Technical Field
The invention relates to the field of insecticidal preparations, and particularly relates to a decoquinate preparation as well as a preparation method and application thereof.
Background
Coccidiosis is an important disease in the poultry industry worldwide and is caused by a variety of parasites of the genus Eimeria, including Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria tenella, Eimeria necatrix, and Eimeria varians. These parasites multiply in the intestinal epithelial cells, destroying the integrity of the intestinal mucosa, reducing the digestive and absorptive capacity of the intestinal tract. In birds, 6% to 10% of mortality is caused by coccidiosis; at the same time, coccidiosis also causes a reduction in the growth rate and feed conversion rate of poultry, thereby causing global economic losses of billions of dollars per year.
At present, the prevention and treatment of coccidiosis are mainly based on medicines, and chemical medicines are still the main means for prevention and treatment. The chemical drugs are easy to generate drug resistance after long-term use. Therefore, in order to solve the problem, a huge market exists for researching and developing a novel antiparasitic drug with high efficiency, low toxicity and broad spectrum.
Decoquinate (Decoquinate) is firstly synthesized by being developed by May-Baker company in England in the 60 th century, has broad-spectrum anticoccidial activity, becomes a quinoline medicament with better effect of preventing and treating coccidiosis of livestock and poultry, and can be used for preventing and treating coccidiosis caused by tender, toxic, heap type, giant, dislocated and Eimeria brunetti of livestock and poultry, particularly poultry.
Decoquinate has been widely used in many countries for the prevention and treatment of avian coccidiosis since the 60's of the 20 th century. However, it was not registered in china by american gifts until 2002 and marketed. At present, the decoquinate premix is mainly 6 percent or 3 percent or 2.25 percent of decoquinate solution in China for veterinary clinical use. After the product is marketed, the product is widely applied to the prevention of poultry coccidiosis. However, decoquinate is a fat-soluble compound, the water solubility of decoquinate is very poor, poultry mainly take drinking water as a main medicine, and a decoquinate solution has inconvenience in storage and transportation, so that the development of soluble decoquinate powder is used for further popularizing the application of decoquinate.
In the related art, studies have been made on solid preparations of decoquinate, and for example, in the related art, decoquinate solid dispersion and its preparation (patent No. 200910020452.5), a technical scheme is disclosed in which a polymer carrier (polyvinylpyrrolidone, polyvinyl alcohol, poloxamer, hydroxypropyl methylcellulose) is dissolved in a solvent such as water or ethanol, decoquinate and a surfactant are added, and the solid dispersion is prepared by high-pressure homogeneous grinding, reduced-pressure drying or spray drying, pulverization, or the like. However, the solvent used in the method for dissolving the polymer carrier is more than or equal to 30 percent, the prepared dispersion needs decompression drying or spray drying, the equipment price of decompression drying or spray drying is expensive, the purchase cost is high, and small and medium-sized enterprises are difficult to bear;
meanwhile, in the prior art of decoquinate soluble powder and a preparation method thereof (patent application No. 200910041022.1), a technical scheme for preparing the decoquinate soluble powder by heating and melting decoquinate and a solid dispersion carrier (comprising poloxamer 188, poloxamer 407, polyethylene glycol 6000, polyethylene glycol 4000 and polyvinylpyrrolidone K30) at 120-150 ℃, airing at room temperature, crushing and the like is disclosed. However, in this method, melting by heating is required, and the temperature is high, which tends to decrease the content of decoquinate.
In view of the above, the present invention is particularly proposed.
Disclosure of Invention
The invention aims to provide a preparation method of a decoquinate preparation, the method has the advantages of low raw material price, simple preparation process, no need of large-scale high-end equipment, convenient and rapid preparation of the decoquinate preparation, and good dissolubility and dissolution rate of the prepared preparation.
The second object of the present invention is to provide a decoquinate preparation, wherein the decoquinate is used in combination with wetting agent, dispersant, lipophilic surfactant, soluble diluent, etc., so as to effectively improve the dissolution rate of the decoquinate, and the decoquinate can be further prepared into granules, tablets, dry suspensions or premixes in one step, and meet the use requirements of different occasions.
The third purpose of the invention is to provide the application of the decoquinate preparation. The decoquinate preparation can effectively treat coccidiosis, so that the decoquinate preparation can be further used for preparing a medicine for treating the coccidiosis and can obtain a good treatment effect.
In order to achieve the above purpose of the present invention, the following technical solutions are adopted:
a method of preparing a decoquinate formulation, the method comprising the steps of:
dissolving a dispersing agent in a wetting agent to obtain a mixed solution;
pulverizing the soluble diluent;
mixing decoquinate, lipophilic surfactant and partially crushed soluble diluent to obtain a mixture A;
mixing the mixture A with the mixed solution, drying and crushing to obtain a mixture B;
and mixing the mixture B with the rest crushed soluble diluent to obtain the decoquinate preparation.
Optionally, in the present invention, the wetting agent is water, ethanol or an ethanol aqueous solution.
Optionally, in the present invention, the dispersant is one or a mixture of several of polyvinylpyrrolidone, sodium carboxymethyl cellulose, and crospovidone.
Optionally, in the present invention, the lipophilic surfactant is one or more of sorbitan monolaurate, sorbitan trilaurate, sorbitan monopalmitate, sorbitan monostearate, sorbitan tristearate, sorbitan monooleate, sorbitan trioleate, or lecithin derivatives.
Optionally, in the present invention, the lecithin derivative is one or a mixture of more of soybean lecithin, egg yolk lecithin, and rapeseed lecithin.
Optionally, in the present invention, the soluble diluent is one or a mixture of several of maltodextrin, anhydrous glucose, pregelatinized starch, soluble starch, lactose, sucrose and mannitol.
Optionally, in the invention, the partially crushed soluble diluent accounts for 10-30% of the total amount of the crushed soluble diluent.
Optionally, in the present invention, the method further comprises a step of preparing the obtained decoquinate preparation into granules, tablets, dry suspensions or premixes.
Meanwhile, the invention also provides a decoquinate preparation prepared by the method.
Further, the invention also provides the application of the decoquinate preparation in preparing medicines for treating coccidiosis.
Compared with the prior art, the invention has the beneficial effects that:
(1) the method has simple process and does not need large-scale high-end equipment; the steps in the process are firstly mixed with a part of soluble diluent and are dried in the subsequent steps, and compared with the complete wet granulation, the method reduces the total amount of the medicine to be dried, saves the drying time, reduces the requirement on a drying box in the large-scale production engineering and improves the production efficiency;
(2) in the invention, the raw and auxiliary materials are common pharmaceutical auxiliary materials, so the price is low, the popularization is easy, and the cost is low;
(3) the prepared system has good dispersibility, dissolubility, dissolution rate and suspensibility, can be further processed into granules, tablets, dry suspensions and premixes, can be taken by drinking water on the premise of meeting the quality standard, and can also meet the requirement of material mixing.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.
In the invention, the decoquinate preparation is prepared from the following components: decoquinate, a wetting agent, a dispersing agent, a lipophilic surfactant, and a soluble diluent;
in a preferable scheme of the invention, in the decoquinate preparation, the decoquinate serving as a raw material accounts for 1-10% of the total mass of raw and auxiliary materials; preferably, the decoquinate accounts for 3-6% of the total mass of the raw and auxiliary materials;
and/or the wetting agent accounts for 1-5% of the total mass of the raw and auxiliary materials, and can be, but is not limited to, 2, 3 or 4% and the like;
and/or the dispersant accounts for 0.1-3% of the total mass of the raw and auxiliary materials, and can be, but is not limited to, 0.5, 1 or 2% and the like;
and/or the lipophilic surfactant accounts for 0.1-1% of the total mass of the raw and auxiliary materials, and can be, but is not limited to, 0.2, 0.5 or 0.7% and the like;
and/or the soluble diluent accounts for 82-98% of the total mass of the raw and auxiliary materials, and can be, but is not limited to, 85, 90 or 95%.
Wherein the wetting agent is water, ethanol or ethanol water solution; preferably, in the ethanol aqueous solution, the concentration of ethanol is lower than 60%;
meanwhile, the using amount of the wetting agent needs to be controlled, the waste of water and/or ethanol can be effectively avoided by controlling the using amount of the wetting agent, and the time required by later-period drying can be reduced;
wherein the dispersant is one or a mixture of several of polyvinylpyrrolidone (K12-K120), sodium carboxymethylcellulose or crospovidone; similarly, the dosage of the dispersant is also controlled, and the mass gram ratio of the wetting agent to the dispersant is required to be more than 1, for example, the mass gram ratio of the wetting agent to the dispersant can be controlled to be (1.5-10): 1, etc.; this ensures that the dispersant is fully soluble in the wetting agent;
the lipophilic surfactant is one or a mixture of more of sorbitan monolaurate, sorbitan trilaurate, sorbitan monopalmitate, sorbitan monostearate, tristearyl sorbitan, sorbitan monooleate, sorbitan trioleate or lecithin derivatives, wherein the lecithin derivatives are one or a mixture of more of soybean lecithin, egg yolk lecithin or rapeseed lecithin; preferably, the lipophilic surfactant is a lecithin derivative; more preferably, the lipophilic surfactant is soybean phospholipid;
wherein the soluble diluent is one or a mixture of more of maltodextrin, anhydrous glucose, pregelatinized starch, soluble starch, lactose, sucrose and mannitol.
The preparation method has simple process, does not need large-scale high-end equipment, and is particularly suitable for small and medium enterprises, and the enterprises with relatively laggard production equipment; the preparation method comprises the following steps:
(a) dissolving a dispersing agent in a wetting agent to obtain a mixed solution of the dispersing agent and the wetting agent;
preferably, in this step, stirring is carried out so that the dispersing agent is completely dissolved in the wetting agent;
(b) pulverizing the soluble diluent;
preferably, in this step, the soluble diluent is pulverized until the particle size of the particles is 80 mesh or less;
(c) mixing decoquinate, lipophilic surfactant and partially crushed soluble diluent to obtain a mixture A;
preferably, in the step, the crushed soluble diluent accounts for 10-30% of the total mass of the diluent;
(d) mixing the mixture A with the mixed solution, drying and crushing to obtain a mixture B;
preferably, in the step, the dried mixed system is crushed to the particle size of 24-80 meshes;
in the present invention, it is through drying in the intermediate step of (d), which can reduce the components and amount required for drying, and thus reduce the time required for drying; if all the raw and auxiliary materials are mixed and then finally dried, the materials needing to be dried are too many, the requirement on the number of drying equipment is increased, the cost is increased, and meanwhile, the production efficiency is reduced;
(e) and mixing the mixture B with the rest crushed soluble diluent to obtain the decoquinate preparation.
Furthermore, in the invention, the prepared decoquinate preparation can be prepared into granules, tablets, dry suspensions or premixes;
wherein the granule can be prepared by dry granulation of decoquinate preparation; tablets may be prepared by compressing decoquinate formulations.
Example 1
Respectively weighing or measuring appropriate amounts of decoquinate, ethanol, polyvinylpyrrolidone K12, soybean phospholipid and lactose;
meanwhile, the mass of decoquinate is 6% of the total mass of the raw and auxiliary materials, the mass of ethanol is 5% of the total mass of the raw and auxiliary materials, the mass of polyvinylpyrrolidone is 1% of the total mass of the raw and auxiliary materials, the mass of soybean phospholipid is 1% of the total mass of the raw and auxiliary materials, and the balance is lactose;
then, a decoquinate formulation was prepared as follows:
(a) dissolving polyvinylpyrrolidone in ethanol to completely dissolve the polyvinylpyrrolidone to obtain a mixed solution;
(b) pulverizing lactose to obtain lactose powder with particle size below 80 mesh;
(c) mixing decoquinate, soybean phospholipid and partial lactose powder to obtain a mixture A;
wherein the partial lactose powder accounts for 30 percent of the total mass of the lactose powder;
(d) mixing the mixture A and the mixed solution, drying, and crushing to obtain a mixture B with the particle size of below 24-80 meshes;
(e) and mixing the mixture B with the rest of lactose powder to obtain the decoquinate preparation of the example 1.
Example 2
Respectively weighing or measuring appropriate amounts of decoquinate, ethanol-water solution (ethanol concentration is 50%), sodium carboxymethylcellulose, sorbitan monostearate and pregelatinized starch;
simultaneously, the mass of decoquinate is 1 percent of the total mass of the raw and auxiliary materials, the mass of the ethanol-water solution is 3 percent of the total mass of the raw and auxiliary materials, the mass of sodium carboxymethyl cellulose is 0.5 percent of the total mass of the raw and auxiliary materials, the mass of sorbitan monostearate is 0.3 percent of the total mass of the raw and auxiliary materials, and the balance is pregelatinized starch;
then, a decoquinate formulation was prepared as follows:
(a) dissolving sodium carboxymethylcellulose in an ethanol-water solution to completely dissolve the sodium carboxymethylcellulose to obtain a mixed solution;
(b) pulverizing pregelatinized starch to particle size below 80 mesh; obtaining crushed pregelatinized starch;
(c) mixing decoquinate, sorbitan monostearate and partially crushed pregelatinized starch to obtain a mixture A;
wherein the partially pulverized pregelatinized starch is 30% of the total mass of the pregelatinized starch required by the medicament;
(d) mixing the mixture A and the mixed solution, drying, and crushing to obtain a mixture B with the particle size of below 24-80 meshes;
(e) the mixture B was mixed with the remaining pulverized pregelatinized starch to obtain the decoquinate preparation of example 2.
Example 3
Respectively weighing or measuring appropriate amounts of decoquinate, ethanol, crospovidone, sorbitan trioleate and mannitol;
meanwhile, the mass of decoquinate is 3% of the total mass of the raw and auxiliary materials, the mass of ethanol is 5% of the total mass of the raw and auxiliary materials, the mass of crospovidone is 2% of the total mass of the raw and auxiliary materials, the mass of sorbitan trioleate is 0.6% of the total mass of the raw and auxiliary materials, and the balance of mannitol;
then, a decoquinate formulation was prepared as follows:
(a) dissolving crospovidone in the ethanol-water solution, and completely dissolving the crospovidone to obtain a mixed solution;
(b) pulverizing mannitol to particle size below 80 mesh to obtain mannitol powder;
(c) mixing decoquinate, sorbitan trioleate and part of mannitol powder to obtain a mixture A;
wherein, the part of mannitol powder accounts for 30 percent of the total mass of the mannitol powder;
(d) mixing the mixture A and the mixed solution, drying, and crushing to obtain a mixture B with the particle size of below 24-80 meshes;
(e) and mixing the mixture B with the rest of mannitol powder to obtain the decoquinate preparation of the example 3.
Experimental example 1
(1) Suspension demonstration test
1g of the decoquinate preparation prepared in examples 1 to 3 was weighed out separately and put in 100ml of water separately; the results show that all the solutions present a uniform dispersion system, no obvious foreign matters appear and the solution conforms to a drinking water system.
(2) Solubility test
The decoquinate formulations prepared in examples 1 to 3 were respectively dry granulated and respectively granulated, and then subjected to a solubility test;
the test method comprises the following steps: 10g of each group of granules are respectively taken, added into 200ml of hot water, stirred for 5min and observed.
As a result, it was found that the solutions of the respective groups exhibited uniform dispersion without any significant foreign matter.
(3) Test of drug efficacy
Selecting 30 1-day-old cocks, feeding the cocks in a healthy animal room for 14 days, and randomly dividing the cocks into 3 groups of 10 cocks each; respectively as experiment 1 group, experiment 2 group and experiment 3 group;
80000 Eimeria tenella sporulated oocysts were obtained from the cock of experiment 1 and experiment 2, respectively; the third group of cocks were not infected;
then, the drug of example 1 was mixed in a chicken feed in an amount of 25mg/Kg in terms of decoquinate, and the chicken feed was fed to the experimental group 1 cocks; meanwhile, the experiment 2 group and the experiment 3 group are fed with the same amount of common feed;
counting the number of the surviving cocks in each group 15 days after infection, and calculating the survival rate; the results show that the survival rate of the cocks in the experimental groups 1 and 3 is 100%, and the survival rate of the cocks in the experimental group 2 is 60%.
The method is simple to operate, the decoquinate preparation with good dissolubility, dissolution rate and other properties can be conveniently prepared without using large instruments, and the prepared decoquinate preparation also has good coccidiosis treatment effect.
While particular embodiments of the present invention have been illustrated and described, it would be obvious that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.
Claims (3)
1. A method for preparing a decoquinate formulation, comprising the steps of:
respectively weighing or measuring appropriate amounts of decoquinate, ethanol, polyvinylpyrrolidone K12, soybean phospholipid and lactose;
meanwhile, the mass of decoquinate is 6% of the total mass of the raw and auxiliary materials, the mass of ethanol is 5% of the total mass of the raw and auxiliary materials, the mass of polyvinylpyrrolidone is 1% of the total mass of the raw and auxiliary materials, the mass of soybean phospholipid is 1% of the total mass of the raw and auxiliary materials, and the balance is lactose;
then, a decoquinate formulation was prepared as follows:
(a) dissolving polyvinylpyrrolidone in ethanol to completely dissolve the polyvinylpyrrolidone to obtain a mixed solution;
(b) pulverizing lactose to obtain lactose powder with particle size below 80 mesh;
(c) mixing decoquinate, soybean phospholipid and partial lactose powder to obtain a mixture A;
wherein the partial lactose powder accounts for 30 percent of the total mass of the lactose powder;
(d) mixing the mixture A and the mixed solution, drying, and crushing to obtain a mixture B, wherein the particle size of the mixture B is 24-80 meshes;
(e) and mixing the mixture B with the rest lactose powder to obtain the decoquinate preparation.
2. A decoquinate formulation prepared according to the process of claim 1.
3. Use of the decoquinate formulation of claim 2 in the preparation of a medicament for the treatment of coccidiosis.
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| WO2020140197A1 (en) * | 2019-01-02 | 2020-07-09 | Bluelight Pharmatech Co., Ltd | Nanoparticle formulations of decoquinate in the form of solid solution |
| CN115944593B (en) * | 2022-12-29 | 2024-09-24 | 福建技术师范学院 | Compound decoquinate effervescent granule for poultry and preparation method thereof |
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| CN101590055B (en) * | 2009-07-07 | 2011-07-06 | 河南亚卫动物药业有限公司 | Water soluble decoquinate and method for preparing same |
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