CN105534912A - High-stability valnemulin hydrochloride soluble powder and uses thereof - Google Patents
High-stability valnemulin hydrochloride soluble powder and uses thereof Download PDFInfo
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- CN105534912A CN105534912A CN201410605050.2A CN201410605050A CN105534912A CN 105534912 A CN105534912 A CN 105534912A CN 201410605050 A CN201410605050 A CN 201410605050A CN 105534912 A CN105534912 A CN 105534912A
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Abstract
The present invention relates to high-stability valnemulin hydrochloride soluble powder used for treating chicken Mycoplasma diseases, and belongs to the technical field of veterinary medicine. According to the present invention, the high-stability valnemulin hydrochloride soluble powder comprises valnemulin hydrochloride, a co-solvent, a stabilizer, a flavoring agent, and a pharmaceutical filler, and has characteristics of improvement of valnemulin hydrochloride stability in water, simple preparation process, convenient medication, and improvement of animal consumption palatability.
Description
Technical field
The invention belongs to veterinary drug technical field, valnemulin hydrochloride soluble powder being specifically related to a kind of high stability and uses thereof.
Background technology
Valnemulin hydrochloride is pleuromulins semisynthetic antibiotics of new generation, belongs to two terpenes, belongs to same class medicine with taimulin, now in the listing of multiple countries, is mainly used in control livestock and poultry mycoplasma and intestinal spirochaete infection.It is a kind of choice drug of generally acknowledged treatment livestock and poultry mycoplasma disease, its antibacterial activity is very strong, be mainly used in treating pig, cattle, sheep, mycoplasma body disease and the bacterial diseasees such as poultry, prevent and treat chronic respiratory disease of fowl (CRD), porcine enzootic pneumonia, actinomycetes property pleuropneumonia, swine dysentery, hog middle spirochetosis (colitis), the novel animal specific antibiotic of one of the diseases such as pig proliferative enteropathy (ileitis), especially swine dysentery is controlled very effective, it is the veterinary drug pre-mixing agent of first all Europe approval, be listed in prescription drugs for animals, allow the long-term antibiotic adding use in feedstuff.
Mycoplasma gallinarum disease is a kind of chronic respiratory infectious disease that septic mycoplasma (Mycoplasma) causes, ubiquity in China chicken farm.In recent years, along with the increase of chicken stocking density, the sick sickness rate of mycoplasma gallinarum is more and more higher.This disease itself can not cause large death, but is difficult to radical cure and easily recurs.Its order of severity and the course of disease are subject to morbidity age in days, secondary with accompanying infection, stress wait various factors: many in recessive when becoming chicken to infect, the hatching of breeding eggs rate between period of disease declines, and the weak young bird hatched is increased; If sick accompanying infection with other during Chickens Infected, mortality rate increases.Proved by test, valnemulin hydrochloride is obvious for the chickling curative effect of mycoplasma gallisepticam infection, and verifies that hydrochloric acid is irrigated Buddhist nun and had significant facilitation for the growth of chickling second by safety testing, and without any safety side effect.
Current Chinese invention patent discloses valnemulin hydrochloride premix and preparation method thereof, but pre-mixing agent has shortcomings such as dissolution is low, bioavailability is not high, and in preparation process, need to make coating, be made into through bag, complex process.Also disclose valnemulin hydrochloride solution and preparation method thereof simultaneously, although overcome the deficiency of pre-mixing agent, relative to soluble powder, solution transports, store inconvenience, cost aspect is higher; Soluble powder relative to other preparations because of its transport, easy to use and be subject to the welcome of numerous raisers.But the fat-soluble height of valnemulin hydrochloride, pole own is insoluble in water and organic solvent.Because valnemulin hydrochloride is poor at water stability, valnemulin hydrochloride soluble powder is not also had to succeed in developing at present.The present invention is exactly overcoming that hydrochloric acid irrigates that Buddhist nun's wonderful pre-mixing agent preparation process is complicated, in the poorly soluble problem of valnemulin hydrochloride, change production technology, add the palatability of medicine, develop valnemulin hydrochloride soluble powder and be applied to the treatment that mycoplasma gallinarum infects.
Summary of the invention
Valnemulin hydrochloride soluble powder that the invention provides a kind of high stability and preparation method thereof, object is that overcoming hydrochloric acid irrigates the wonderful poorly soluble problem of Buddhist nun, enhance the stability of medicine, improve the dissolubility in water and bioavailability, enhance palatability.
The valnemulin hydrochloride soluble powder of high stability of the present invention, each weight percentages of components is: valnemulin hydrochloride 5%-20%, cosolvent 5%-20%, stabilizing agent 5%-20%, correctives 5% ~ 10%, and acceptable filler adds to absolutely.
Cosolvent used is one or more mixture in polyethylene glycols, polyvinylpyrrolidone class, citric acid, tartaric acid, malic acid, glutamic acid, tryptophan.
Stabilizing agent used is one or more mixture in sodium sulfite, sodium sulfite, sodium thiosulfate, EDTA.
Correctives used is one or more mixture in sorbitol, saccharin sodium, essence, sodium alginate, methylcellulose.
Acceptable filler used is one or more mixture in soluble starch, lactose, glucose.
Its preparation method is:
(1) supplementary material used is crossed 80 mesh sieves, if desired pulverization process is carried out to supplementary material.
(2) all supplementary materials are mixed, fully stir 30 minutes, encapsulate and get final product.
The valnemulin hydrochloride soluble powder of described a kind of high stability of the present invention, preparation technology is simple, is used for the treatment of mycoplasma gallinarum disease, easy to use.
Detailed description of the invention
Following examples only elaborate to the present invention, but and limit the present invention never in any form
Embodiment 1
In valnemulin hydrochloride soluble powder, each composition percentage composition is as follows:
Compound method is as follows:
The valnemulin hydrochloride of formula ratio, polyethylene glycol 6000, polyvinylpyrrolidone K15, sodium sulfite, saccharin sodium, soluble starch are pulverized, crossed 80 mesh sieves successively; Above-mentioned supplementary material is mixed, fully stirs 30 minutes, subpackage and get final product.
Embodiment 2
In valnemulin hydrochloride soluble powder, each composition percentage composition is as follows:
Compound method is as follows:
The valnemulin hydrochloride of formula ratio, citric acid, sodium thiosulfate, sodium alginate, glucose are pulverized successively, crossed 80 mesh sieves; Above-mentioned supplementary material is mixed, fully stirs 30 minutes, subpackage and get final product.
Embodiment 3
In valnemulin hydrochloride soluble powder, each composition percentage composition is as follows:
Compound method is as follows:
The valnemulin hydrochloride of formula ratio, tartaric acid, EDTA, essence, lactose are pulverized successively, crossed 80 mesh sieves; Above-mentioned supplementary material is mixed, fully stirs 30 minutes, subpackage and get final product.
Embodiment 4: valnemulin hydrochloride soluble powder of the present invention is tested at water stability
Experimental article: by the valnemulin hydrochloride soluble powder produced described in the embodiment of the present invention 2; Valnemulin hydrochloride raw material
Experimental technique: the valnemulin hydrochloride soluble powder produced described in the embodiment of the present invention 3 and valnemulin hydrochloride raw material are dissolved in respectively in ordinary tap water, drug level is hydrochloric valnemulin 25mg in every premium on currency; Under solution is put in room temperature condition, within latter 0 minute, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, 210 minutes, 240 minutes, carry out content detection respectively at dissolving.
Experimental result: experimental data is in table 1:
Table 1 content detection result
Conclusion: the stability of valnemulin hydrochloride soluble powder of the present invention in water is far above valnemulin hydrochloride raw material.
Embodiment 5: valnemulin hydrochloride soluble powder of the present invention is for the Experiment on therapy of chicken virus mycoplasma disease
Laboratory animal: choose 20 Japanese instar chickling 60.
Experimental article: by the valnemulin hydrochloride soluble powder produced described in the embodiment of the present invention 3
Experimental technique: experimental animal is divided into 3 groups, often organize 20, select chicken virus mycoplasma virulent strain S strain to carry out counteracting toxic substances for wherein first group, second group, counteracting toxic substances concentration is 10
6ccu/ml, every chicken collunarium 0.3ml, eye dripping 0.2ml, close observation chicken clinical change after counteracting toxic substances, as occurred, depressed, the appetite of spirit reduces, feather is fluffy and disorderly, dysstasia, the swelling of eye face, cough, dyspnea, mouth breathing, and have tracheal rale.Cut open inspection and see to have in nasal cavity, trachea, air bag have mucus exudate, balloon membranes is muddy, thicken, airbag wall has yellow cheesy secretions can tentatively be defined as chicken virus mycoplasma disease, and the isolation identification of carrying out serological test and mycoplasma is made a definite diagnosis further.Treat with valnemulin hydrochloride soluble powder described in the embodiment of the present invention 2 after being ill being diagnosed as chicken virus mycoplasma for first group, administration concentration is 100g to 200L water, second group of not administration, the 3rd group, as blank group, calculates and infects each treated animal morbidity in latter 10 days and Cure.
Experimental result: experimental data is in table 2
Table 2 valnemulin hydrochloride soluble powder is to the sick treatment situation of chicken virus mycoplasma
| Test grouping | Laboratory animal number | Affected animal number | Infect and cure number of animals after 10 days | Cure rate |
| First group | 20 | 20 | 18 | 90％ |
| Second group | 20 | 20 | 0 | 0 |
| 3rd group | 20 | 0 | 0 | -- |
Conclusion: valnemulin hydrochloride soluble powder of the present invention can effectively treat chicken virus mycoplasma disease, improves clinical symptoms, reaches 90% to the chicken group cure rate of infected chicken virus mycoplasma virus.
Claims (6)
1. a high stability valnemulin hydrochloride soluble powder, is characterized in that each weight percentages of components is: valnemulin hydrochloride 5%-20%, cosolvent 5% ~ 20%, stabilizing agent 5% ~ 20%, correctives 5% ~ 10%, and acceptable filler adds to absolutely.
2. a kind of high stability valnemulin hydrochloride soluble powder according to claim 1, is characterized in that cosolvent used is one or more mixture in polyethylene glycols, polyvinylpyrrolidone class, citric acid, tartaric acid, malic acid, glutamic acid, tryptophan.
3. a kind of high stability valnemulin hydrochloride soluble powder according to claim 1, is characterized in that stabilizing agent used is one or more mixture in sodium sulfite, sodium sulfite, sodium thiosulfate, EDTA.
4. a kind of high stability valnemulin hydrochloride soluble powder according to claim 1, is characterized in that correctives used is one or more mixture in sorbitol, saccharin sodium, essence, sodium alginate, methylcellulose.
5. a kind of high stability valnemulin hydrochloride soluble powder according to claim 1, is characterized in that acceptable filler used is one or more mixture in soluble starch, lactose, glucose.
6. according to the arbitrary described a kind of high stability valnemulin hydrochloride soluble powder of claim 1-5, for the preparation of the purposes of mycoplasma gallinarum medicine.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107805226A (en) * | 2017-11-23 | 2018-03-16 | 湖北龙翔药业科技股份有限公司 | A kind of valnemulin o-benzoic sulfimide compound and preparation method thereof |
| CN108853022A (en) * | 2017-05-16 | 2018-11-23 | 北京科百大科技有限责任公司 | A kind of preparation method of stable valnemulin hydrochloride composition |
| CN110179758A (en) * | 2019-06-23 | 2019-08-30 | 瑞普（天津）生物药业有限公司 | It is a kind of can drinking water administration crystal state valnemulin hydrochloride soluble powder and its application |
| CN110575532A (en) * | 2018-06-08 | 2019-12-17 | 上海莫息生物科技有限公司 | Nosiheptide soluble powder and preparation method thereof |
| CN117679362A (en) * | 2023-12-06 | 2024-03-12 | 广东温氏大华农生物科技有限公司 | Veterinary valnemulin solution and preparation method and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108853022A (en) * | 2017-05-16 | 2018-11-23 | 北京科百大科技有限责任公司 | A kind of preparation method of stable valnemulin hydrochloride composition |
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| CN110575532A (en) * | 2018-06-08 | 2019-12-17 | 上海莫息生物科技有限公司 | Nosiheptide soluble powder and preparation method thereof |
| CN110179758A (en) * | 2019-06-23 | 2019-08-30 | 瑞普（天津）生物药业有限公司 | It is a kind of can drinking water administration crystal state valnemulin hydrochloride soluble powder and its application |
| CN110179758B (en) * | 2019-06-23 | 2021-06-22 | 瑞普（天津）生物药业有限公司 | Crystalline valnemulin hydrochloride soluble powder capable of being administered by drinking water and application thereof |
| CN117679362A (en) * | 2023-12-06 | 2024-03-12 | 广东温氏大华农生物科技有限公司 | Veterinary valnemulin solution and preparation method and application thereof |
| CN117679362B (en) * | 2023-12-06 | 2024-05-24 | 广东温氏大华农生物科技有限公司 | Veterinary valnemulin solution and preparation method and application thereof |
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