CN108904514B - Stable and long-acting compound diclazuril solution - Google Patents

Stable and long-acting compound diclazuril solution Download PDF

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CN108904514B
CN108904514B CN201810883335.0A CN201810883335A CN108904514B CN 108904514 B CN108904514 B CN 108904514B CN 201810883335 A CN201810883335 A CN 201810883335A CN 108904514 B CN108904514 B CN 108904514B
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diclazuril
propylene glycol
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CN108904514A (en
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郭怀龙
孙远波
孙远海
李爽
张传美
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Shandong Mubang Animal Pharmaceutical Co ltd
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Rizhao City Mubang Animal Husbandry Technology Co ltd
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Abstract

The invention relates to the technical field of veterinary drug preparation production, in particular to a stable long-acting compound diclazuril solution and a preparation process thereof. The stable long-acting compound diclazuril solution is prepared from diclazuril, Hainanmycin sodium, absolute ethyl alcohol, propylene glycol and polyvinylpyrrolidone K30Ethanolamine and OP-10. The stable long-acting compound diclazuril solution adopts absolute ethyl alcohol as a solvent, ethanolamine as a cosolvent, OP-10 as an emulsifier, propylene glycol and polyvinylpyrrolidone K30The compound is used as a stabilizer to form a uniform, stable and long-acting solution system, is applied to the prevention and treatment of various coccidiosis of broiler chickens, not only improves the bioavailability of a solution preparation and solves the problems of short drug aging and poor stability, but also can adapt to the habit of large-scale drinking water medication of poultry and is deeply welcomed by farmers; meanwhile, the invention has simple preparation process, low cost and obvious curative effect, and can obviously improve the economic benefit of farmers.

Description

Stable and long-acting compound diclazuril solution
Technical Field
The invention relates to the technical field of veterinary drug preparation production, and particularly relates to a stable long-acting compound diclazuril solution.
Background
Coccidiosis in chickens is an acute epidemic parasitic disease caused by one or more unicellular parasites of the genus eimeria. China has classified the animal diseases as two types. Among various chicken diseases, the coccidiosis has the highest incidence rate, which accounts for about 1/6-1/5, especially chicks within 3 months of age are most susceptible to diseases, the mortality rate can reach 70%, and the healed chicks are not easy to recover health within several months. The pathogen not only has long survival period and strong resistance, but also is difficult to kill by common disinfectant, and the pathogen can be still discharged by sick chickens in months after illness, thereby prolonging the pollution period. The feeding conditions of a large-scale and intensive chicken farm are particularly suitable for coccidian oocyst sporulation development, and oocysts are only sensitive to heat and have strong resistance to common disinfectants, so that the occurrence of coccidiosis in chickens is difficult to prevent by using a sanitary management means. Therefore, the chicken coccidiosis is a parasitic disease which has the greatest harm to the chicken industry at present, and the development of the breeding industry in China is seriously influenced.
Through long-term research and screening of dozens of anticoccidial drugs, the anticoccidial effect of the combined application of diclazuril and Hainanmycin sodium is proved.
The diclazuril triazine benzyl cyanide compound is a novel, high-efficiency and low-toxicity anticoccidial drug, has a main action peak period on coccidian, and is different according to different species of coccidian, such as: the main point of action on Eimeria tenella is in the sexual cycle of schizont Eimeria 2, but not on the merozoites of E.maxima, E.brunetti; the point of action on E.maxima is in the zygotic stage of coccidia; has high efficiency on the gametophyte stage of Eimeria brunetti. Diclazuril also has inhibitory effects on sporulation of oocysts. Diclazuril has excellent effects on tenderness, heaps, poison, brucella and Eimeria maxima of chickens, and can effectively control the occurrence and death of caecal coccidiosis and even completely eliminate oocysts of sick chickens after being used, so that diclazuril is an ideal coccidiostat.
The Hainanmycin sodium monovalent glycoside polyether ion carrier antibiotic is polyether antibiotic extracted from a culture solution of oriental variety of Streptomyces padilalis separated from Hainan island soil in China, is a fifteen-science and technology project, is a special drug for originally preventing and treating chicken coccidiosis with intellectual property rights in China, has a wide antibacterial spectrum on gram-positive bacteria such as bacilli and cocci, and also has an antibacterial effect on anaerobic fungi, certain plant pathogenic bacteria, rice sheath blight, sclerotinia rot of colza and other fungi. Hainanmycin sodium is used for preventing and treating chicken coccidiosis, improving feed conversion rate, increasing broiler weight and improving chicken quality, and is called as 'changrenin' because of the characteristics of high activity, no residue, no resistance, high titer and the like and can promote the growth of ruminants such as cattle, sheep and the like.
The diclazuril and the Hainanmycin sodium are combined for synergism, and the excellent effect of killing coccidia can be achieved at different periods and stages by using the diclazuril and the Hainanmycin sodium simultaneously, but the diclazuril and the Hainanmycin sodium have the great weakness that the diclazuril and the Hainanmycin sodium are insoluble in water, and if the diclazuril and the Hainanmycin sodium are used as a premix for mixing and feeding, the mixing and feeding are inconvenient due to the particularity of the chicken eating habits; if the medicine is taken by drinking water, the water drinking device is blocked due to the insolubility in water. Furthermore, diclazuril solution is unstable, making its use very limited.
Disclosure of Invention
The invention aims to provide a stable and long-acting compound diclazuril solution to solve the technical problems.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
a stable and long-acting compound diclazuril solution is characterized in that: is prepared from diclazuril, Hainanmycin sodium, absolute alcohol, propanediol, polyvinyl pyrrolidone K30Ethanolamine and OP-10; each 100L of the solution contains: 0.5-5kg of diclazuril, 0.5-5kg of Hainanmycin sodium, 10-50kg of absolute ethyl alcohol and polyvinylpyrrolidone K300.02-0.05kg, 0.02-0.05kg of ethanolamine, OP-100.5 kg and the balance of propylene glycol.
Preferably, the absolute ethyl alcohol, the propylene glycol, the polyvinylpyrrolidone K30 and the OP-10 are all medicinal grade.
The preparation process of the stable long-acting compound diclazuril solution comprises the following steps:
1. weighing 10-50kg of absolute ethyl alcohol, adding 0.5-5kg of diclazuril and 0.5-5kg of Hainanmycin sodium, and uniformly stirring to obtain a solution A;
2. weighing 0.02-0.05kg of ethanolamine, adding the ethanolamine into the solution A prepared in the step 1, and stirring until the solution is clear to prepare a solution B;
3. weighing 30-60kg of propylene glycol, adding the propylene glycol into the solution B prepared in the step 2, and uniformly stirring to prepare a solution C;
4. weighing 0.02-0.05kg of polyvinylpyrrolidone K30Adding the mixture into the solution C prepared in the step 3, stirring and dissolving the mixture until the mixture is dissolvedClarifying the solution to obtain a solution D;
5. weighing 0.5kg of OP-10, adding the OP-10 into the solution D prepared in the step 4, and uniformly stirring to prepare a solution E;
6. and (5) adding propylene glycol into the solution E prepared in the step (5) to fix the volume to 100L, thus obtaining the stable long-acting compound diclazuril solution.
Has the advantages that: compared with the prior art, the stable long-acting compound diclazuril solution disclosed by the invention adopts absolute ethyl alcohol as a solvent, ethanolamine as a cosolvent, OP-10 as an emulsifier, propylene glycol and polyvinylpyrrolidone K30The compound is used as a stabilizer to form a uniform, stable and long-acting solution system, is applied to the prevention and treatment of various coccidiosis of broiler chickens, not only improves the bioavailability of a solution preparation and solves the problems of short drug aging and poor stability, but also can adapt to the habit of large-scale drinking water medication of poultry and is deeply welcomed by farmers; meanwhile, the invention has simple preparation process, low cost and obvious curative effect, and can obviously improve the economic benefit of farmers.
Detailed Description
The invention is further described with reference to specific examples.
Example 1:
the stable and long-acting compound diclazuril solution described in this embodiment is prepared from diclazuril, Hainanmycin sodium, absolute ethyl alcohol, propylene glycol and polyvinylpyrrolidone K30Ethanolamine and OP-10; each 100L of the solution contains: 0.5kg of diclazuril, 0.5kg of Hainanmycin sodium, 10kg of absolute ethyl alcohol and polyvinylpyrrolidone K300.02kg, ethanolamine 0.02kg, OP-100.5 kg and the balance of propylene glycol.
Preferably, the absolute ethyl alcohol, the propylene glycol, the polyvinylpyrrolidone K30 and the OP-10 are all medicinal grade.
The preparation process of the stable and long-acting compound diclazuril solution comprises the following steps:
1. weighing 10kg of absolute ethyl alcohol, adding 0.5kg of diclazuril and 0.5kg of Hainanmycin sodium, and uniformly stirring to obtain a solution A;
2. weighing 0.02kg of ethanolamine, adding the ethanolamine into the solution A prepared in the step 1, and stirring until the solution is clear to prepare a solution B;
3. weighing 30kg of propylene glycol, adding the propylene glycol into the solution B prepared in the step 2, and uniformly stirring to prepare a solution C;
4. 0.02kg of polyvinylpyrrolidone K is weighed out30Adding the solution C into the solution C prepared in the step 3, and stirring and dissolving the solution C until the solution is clear to prepare a solution D;
5. weighing 0.5kg of OP-10, adding the OP-10 into the solution D prepared in the step 4, and uniformly stirring to prepare a solution E;
6. and (5) adding propylene glycol into the solution E prepared in the step (5) to fix the volume to 100L, thus obtaining the stable long-acting compound diclazuril solution.
Example 2:
the stable and long-acting compound diclazuril solution described in this embodiment is prepared from diclazuril, Hainanmycin sodium, absolute ethyl alcohol, propylene glycol and polyvinylpyrrolidone K30Ethanolamine and OP-10; each 100L of the solution contains: 2.5kg of diclazuril, 2.5kg of Hainanmycin sodium, 30kg of absolute ethyl alcohol and polyvinylpyrrolidone K300.03kg, ethanolamine 0.03kg, OP-100.5 kg and the balance of propylene glycol.
Preferably, the absolute ethyl alcohol, the propylene glycol, the polyvinylpyrrolidone K30 and the OP-10 are all medicinal grade.
The preparation process of the stable and long-acting compound diclazuril solution comprises the following steps:
1. weighing 30kg of absolute ethyl alcohol, adding 2.5kg of diclazuril and 2.5kg of Hainanmycin sodium, and uniformly stirring to obtain a solution A;
2. weighing 0.03kg of ethanolamine, adding the ethanolamine into the solution A prepared in the step 1, and stirring until the solution is clear to prepare a solution B;
3. weighing 50kg of propylene glycol, adding the propylene glycol into the solution B prepared in the step 2, and uniformly stirring to prepare a solution C;
4. 0.03kg of polyvinylpyrrolidone K is weighed out30Adding the solution C into the solution C prepared in the step 3, and stirring and dissolving the solution C until the solution is clear to prepare a solution D;
5. weighing 0.5kg of OP-10, adding the OP-10 into the solution D prepared in the step 4, and uniformly stirring to obtain a solution E;
6. and (5) adding propylene glycol into the solution E prepared in the step (5) to fix the volume to 100L, thus obtaining the stable long-acting compound diclazuril solution.
Example 3:
the stable and long-acting compound diclazuril solution described in this embodiment is prepared from diclazuril, Hainanmycin sodium, absolute ethyl alcohol, propylene glycol and polyvinylpyrrolidone K30Ethanolamine and OP-10; each 100L of the solution contains: 5kg of diclazuril, 5kg of Hainanmycin sodium, 50kg of absolute ethyl alcohol and polyvinylpyrrolidone K300.05kg, ethanolamine 0.05kg, OP-100.5 kg and the balance of propylene glycol.
Preferably, the absolute ethyl alcohol, the propylene glycol, the polyvinylpyrrolidone K30 and the OP-10 are all medicinal grade.
The preparation process of the stable and long-acting compound diclazuril solution comprises the following steps:
1. weighing 50kg of absolute ethyl alcohol, adding 5kg of diclazuril and 5kg of Hainanmycin sodium, and uniformly stirring to obtain a solution A;
2. weighing 0.05kg of ethanolamine, adding the ethanolamine into the solution A prepared in the step 1, and stirring until the solution is clear to prepare a solution B;
3. weighing 30kg of propylene glycol, adding the propylene glycol into the solution B prepared in the step 2, and uniformly stirring to prepare a solution C;
4. 0.05kg of polyvinylpyrrolidone K is weighed out30Adding the solution C into the solution C prepared in the step 3, and stirring and dissolving the solution C until the solution is clear to prepare a solution D;
5. weighing 0.5kg of OP-10, adding the OP-10 into the solution D prepared in the step 4, and uniformly stirring to obtain a solution E;
6. and (5) adding propylene glycol into the solution E prepared in the step (5) to fix the volume to 100L, thus obtaining the stable long-acting compound diclazuril solution.
[ TEST I ] clinical application Effect test
To confirm the efficacy of the stable long-acting compound diclazuril solution, a laboratory simulation clinical efficacy validation test was performed on example 2.
Applying AA broiler, feeding to 11 days old, inoculating 10 ten thousand Eimeria tenella sporulated oocysts by adopting a mode of artificial craw infection, determining the anticoccidial effect of the compound diclazuril solution, and performing the following steps of A group: diclazuril solution (containing 5 mg/ml); group B: hainanmycin solution (containing Hainanmycin: 5 mg/ml); group C: toltrazuril solution was used as a control drug. The test results are shown in table 1:
table 1: results of clinical application tests
Figure GSB0000188758870000051
Note: the larger the anticoccidial index is, the better the anticoccidial effect of the medicine is.
Experimental conclusion as can be seen from the experimental results of table 1: the combined application of diclazuril and Hainanmycin can not only improve the anti-coccidium effect, but also reduce the drug resistance of coccidium. From the aspect of anticoccidial index, the stable long-acting compound diclazuril solution has the highest anticoccidial index and the most obvious anticoccidial effect.
[ TEST II ] stability test
The stability of the product is a basic condition for ensuring the safety and effectiveness of the medicine, and factors influencing the stability of the preparation, such as the formula, the process and the like, and also factors such as temperature, light, humidity and the like. Therefore, the stable and long-acting compound diclazuril solution is subjected to influence factor tests, accelerated tests and room-temperature long-term sample retention and investigation tests.
1.1 sample: example 2 was selected as the sample for stability testing,
1.2 storage time and conditions
1) Influence factor test:
A. and (3) illumination test: the samples are respectively placed in an illumination box, the illumination intensity is 4500 +/-500 Lx, the temperature is 25 ℃ for 10 days, and the samples are sampled and detected once on the 0 th day, 5 th day and 10 th day respectively.
B. High temperature and high humidity test: the samples are respectively placed in a commercial package under the conditions of temperature of 40 +/-2 ℃ and relative humidity of 75% for 6 months, and the detection is carried out once every month.
2) Long-term experiments: the samples are respectively placed in a commercial package under the conditions of 25 +/-2 ℃ of temperature and 60% of relative humidity for 18 months, and are sampled and checked once in 0, 3, 6, 9, 12, 15 and 18 months respectively to determine the effective period of the medicine.
1.3 measurement indexes and methods:
and (4) checking items: a trait; and (4) measuring the content.
Table 2: test results of stability to light
Figure GSB0000188758870000061
Table 3: high temperature stability test results
Figure GSB0000188758870000071
Table 4: long term stability test results
Figure GSB0000188758870000072
Through observation of an illumination influence factor test, a high-temperature test and a room-temperature long-term sample retention investigation test, each index of the sample in the example 2 is in a specified range, which indicates that the solution is stable, and the appearance and the content of the solution meet the requirements, so that the solution can be applied to clinical use.
While the preferred embodiments of the present invention have been described in detail, it should be understood that the invention is not limited thereto, but may be embodied with various modifications and substitutions which may be made by those skilled in the art without departing from the spirit of the present invention and which are intended to be encompassed by the following claims.

Claims (2)

1. A stable and long-acting compound diclazuril solution is characterized in that: is made of diclazurilSodium Hainanmycin, absolute ethyl alcohol, propylene glycol and polyvinylpyrrolidone K30Ethanolamine and OP-10; each 100L of the solution contains: 0.5-5kg of diclazuril, 0.5-5kg of Hainanmycin sodium, 10-50kg of absolute ethyl alcohol and polyvinylpyrrolidone K300.02-0.05kg, 0.02-0.05kg of ethanolamine, OP-100.5 kg and the balance of propylene glycol; the preparation process comprises the following steps:
(1) weighing 10-50kg of absolute ethyl alcohol, adding 0.5-5kg of diclazuril and 0.5-5kg of Hainanmycin sodium, and uniformly stirring to obtain a solution A;
(2) weighing 0.02-0.05kg of ethanolamine, adding the ethanolamine into the solution A prepared in the step (1), and stirring until the solution is clear to prepare a solution B;
(3) weighing 30-60kg of propylene glycol, adding the propylene glycol into the solution B prepared in the step (2), and uniformly stirring to prepare a solution C;
(4) weighing 0.02-0.05kg of polyvinylpyrrolidone K30Adding the solution C into the solution C prepared in the step (3), stirring and dissolving the solution C until the solution is clear, and preparing a solution D;
(5) weighing 0.5kg of OP-10, adding the OP-10 into the solution D prepared in the step (4), and uniformly stirring to prepare a solution E;
(6) and (4) adding propylene glycol into the solution E prepared in the step (5) to fix the volume to 100L, thus obtaining the stable long-acting compound diclazuril solution.
2. The stable long-acting compound diclazuril solution as claimed in claim 1, wherein: the absolute ethyl alcohol, the propylene glycol and the polyvinylpyrrolidone K30And OP-10 are pharmaceutical grade.
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