CN106821975A - A kind of Mo Naitaier oral liquids and its preparation method and application - Google Patents
A kind of Mo Naitaier oral liquids and its preparation method and application Download PDFInfo
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- CN106821975A CN106821975A CN201710211052.7A CN201710211052A CN106821975A CN 106821975 A CN106821975 A CN 106821975A CN 201710211052 A CN201710211052 A CN 201710211052A CN 106821975 A CN106821975 A CN 106821975A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/275—Nitriles; Isonitriles
- A61K31/277—Nitriles; Isonitriles having a ring, e.g. verapamil
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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Abstract
The invention provides a kind of Mo Naitaier oral liquids, to treating and controlling ox, sheep gastrointestinal nematode parasites to be all suitable for, especially the preventing and treating to milk cow is very applicable；Mo Naitaier oral liquids of the invention, it is easy to use, after diluting in proportion, can directly never forget where one's happiness comes from.Oral bioavilability of the invention is high, and anthelminthic effect is strong, it is possible to reduce times for spraying, so as to reduce drug cost.Synergistic effect substantially, and can simultaneously kill the parasites such as nematode and worm, therefore, preparation of the invention is practical, medication is convenient, there is very big market potential and competitiveness.Present invention also offers the preparation method and application of the Mo Naitaier oral liquids.
Description
Technical field
The present invention relates to anti parasitic field, in particular to Mo Naitaier oral liquids and its preparation method and application.
Background technology
The preventing and treating of cattle and sheep nematode and vermin as a global problem, every year in Australia, New Zealand, U.S.
State is western and Irish, and ox, sheep nematodiasis occur extensively, also has generation every year in the area such as Xinjiang of China and Inner Mongol more.Animal
Sound development of the parasitic disease to animal husbandry causes tremendous influence, brings serious economic loss, hinders the health hair of animal husbandry
Exhibition.Meanwhile, infecting both domestic animals and human parasitic disease is impacted to the quality of animal products, serious to threaten people's health and public defend
Raw safety.The vaccine prevention technology of current most of parasitic diseases is very limited, and the preventions to animal parasitosis are mainly gone back
It is chemicals.
Mo Naitaier (Monepantel, MNP) is used as a kind of novel amino acetonitrile derivative class expelling parasite researched and developed in recent years
Medicine, for treating and controlling cattle and sheep intestinal nematode infection, at present, the medicine is in the national land such as Australia, New Zealand and Brazil
Continuous listing, existing numerous studies show that the medical instrument has and preferably drive nematode effect.Mo Naitaier can specifically act on nematode
Distinctive nAChR subfamily ACR-23 albumen, with quick, efficient and permeability neuromuscular effect, by drawing
Playing body wall muscle excess shrinkage causes to swallow anterior paralysis, spasmodic contraction and final dead, can effectively kill tolerance other classes
The nematode of other medicine.Due to not having this receptor in mammal, therefore Mo Naitaier is equal to other organisms in addition to nematode
Hypotoxicity is shown as, with preferable security.
Mo Naitaier is affirmed, especially on veterinary clinic as new pest-resistant medicine, its good insect resistant effect
It is to having produced the nematode of drug resistance there is preferable effect.Because the medicine is not likely to produce drug resistance and toxicity is low, Mo Naitaier
Played a significant role in the preventing and treating of parasites in animals disease from now on.
Mo Naitaier oral liquids of the invention are all suitable for treatment and control ox, sheep gastrointestinal nematode parasites, especially to milk cow
Preventing and treating it is very applicable；Mo Naitaier oral liquids of the invention, it is easy to use, after diluting in proportion, can directly never forget where one's happiness comes from.This
The oral bioavilability of invention is high, and anthelminthic effect is strong, it is possible to reduce times for spraying, so as to reduce drug cost.Synergy is made
With obvious, and the parasites such as nematode and worm can be simultaneously killed, therefore, preparation of the invention is practical, medication is convenient, has
Very big market potential and competitiveness.
The content of the invention
The purpose of the present invention is directed to the deficiency in existing Mo Naitaier oral liquids, there is provided one kind treatment and control cattle and sheep stomach
The Mo Naitaier oral liquids of intestinal nematode infection and relevant disease.
Another purpose of the invention is to provide a kind for the treatment of and the infection of control cattle and sheep gastrointestinal nematode parasites and relevant disease
The preparation method of Mo Naitaier oral liquids.
Another purpose of the invention is to provide a kind for the treatment of and the infection of control cattle and sheep gastrointestinal nematode parasites and relevant disease
The application of Mo Naitaier oral administration mixed suspensions.
To achieve the above object, the present invention is adopted the technical scheme that：
A kind of Mo Naitaier oral liquids, according to percent by weight, the Mo Naitaier oral liquids include following component：
Mo Naitaier：1.0~20.0%,
Medicinal slow release agent：1.0~30.0%,
Surfactant：1.0~10.0%,
Sweetener：1.0~10.0%,
Antioxidant：0.1-3%,
Molten medium：Polishing
Preferably, in the present invention, according to percent by weight, the Mo Naitaier oral liquids are consisted of the following composition:Not
Nai Taier：1.0~5.0%；Medicinal slow release agent：10.0~20.0%；Surfactant：5.0~10.0%；Sweetener：1.0~
3.0%；Antioxidant：0.1-1%, balance of molten medium.
Preferably, in the present invention, medicinal slow release agent is selected from polyvinylpyrrolidone -15, polyvinylpyrrolidone -17, carboxylic
In sodium carboxymethylcellulose pyce and alpha-pyrrolidone one or two.
Preferably, in the present invention, surfactant is various selected from Tween-80, lecithin, the hydroxyl of polyethylene glycol 15
In stearate and Crodaret (RH-40) one or two.
Preferably, in the present invention, sweetener is Sucralose sodium, saccharin sodium, sucrose, analogous components or its mixture.
Preferably, in the present invention, molten medium is one or more selected from water, ethanol, propane diols, Liquid Macrogol, poly- second
One or more compounds in glycol 400, glycerine, polyoxyethylenated castor oil, polyethylene glycol 200, hydroxy stearic acid ester.
Preferably, in the present invention, antioxidant is selected from one kind or two in alpha-tocopherol, beta carotene, sodium hydrogensulfite
Kind.
Meanwhile, present invention also offers aquatic products fenvalerate oil solution method for producing insecticide, methods described bag
Include following steps：
Mo Naitaier, medicinal slow release agent, surfactant, sweetener, antioxidant are dissolved in successively by prescription consumption molten
In medium, stirring dissolves medicine complete, and molten medium is quantified, and last rove filtering, packing, sterilizing, thus obtaining the product Mo Naitaier are oral
Liquid.
Further, present invention provides described aquatic products with fenvalerate oil solution insecticide in aquatic product body surface desinsection
In application, the parasitic nematode for treating ox, sheep intestines and stomach.
Compared with prior art, beneficial effects of the present invention are：
The component and consumption of Mo Naitaier oral liquids of the present invention are to be screened by scientific method and a large amount of repeatedly real
Drawn in trampling, with advantages below：
1st, Mo Naitaier oral liquids of the present invention are novel amino acetonitrile derivative class antinematodal agents, and selectivity is strong,
There is notable therapeutic effect to the disease caused by ox, the parasitic nematode of sheep intestines and stomach, and be not likely to produce medicine cross resistance.
2nd, using being administered orally, intake of the animal body to medicine stimulates small to Mo Naitaier oral liquids of the present invention,
And it is easy to use, save productive manpower cost.
3rd, after Mo Naitaier oral liquids oral administration of the present invention, Mo Naitaier can quickly absorb and quickly inhale
Receive, distribution and be metabolized, by targeting gastrointestinal nematode parasites, be rapidly achieved therapeutic effect, and medicine is in cattle and sheep body and milk products
In residual quantity it is low.
4th, Mo Naitaier oral liquids biological safety of the present invention is high, without equal to other organisms in addition to nematode
Show as hypotoxicity.
5th, Mo Naitaier oral liquids of the present invention select new auxiliary material, and pharmaceutical preparation safety and stability is good, right
The Small side effects of cattle and sheep.
Specific embodiment
Embodiment of the present invention is described in detail below in conjunction with embodiment, but those skilled in the art will
Understand, the following example is merely to illustrate the present invention, and is not construed as limiting the scope of the present invention.It is unreceipted specific in embodiment
Condition person, the condition advised according to normal condition or manufacturer is carried out.Agents useful for same or the unreceipted production firm person of instrument, are
The conventional products that can be obtained by commercially available purchase.
The purpose of the present invention is directed to the deficiency in existing Mo Naitaier oral liquids, there is provided one kind treatment and control cattle and sheep stomach
The Mo Naitaier oral liquids of intestinal nematode infection and relevant disease.
Another purpose of the invention is to provide a kind for the treatment of and the infection of control cattle and sheep gastrointestinal nematode parasites and relevant disease
The preparation method of Mo Naitaier oral liquids.
Another purpose of the invention is to provide a kind for the treatment of and the infection of control cattle and sheep gastrointestinal nematode parasites and relevant disease
The application of Mo Naitaier oral administration mixed suspensions.
To achieve the above object, the present invention is adopted the technical scheme that：
A kind of Mo Naitaier oral liquids, according to percent by weight, the Mo Naitaier oral liquids include following component：
Mo Naitaier：1.0~20.0%,
Medicinal slow release agent：1.0~30.0%,
Surfactant：1.0~10.0%,
Sweetener：1.0~10.0%,
Antioxidant：0.1-3%,
Molten medium：Polishing
Preferably, in the present invention, according to percent by weight, the Mo Naitaier oral liquids are consisted of the following composition:Not
Nai Taier：1.0~5.0%；Medicinal slow release agent：10.0~20.0%；Surfactant：5.0~10.0%；Sweetener：1.0~
3.0%；Antioxidant：0.1-1%, balance of molten medium.
Preferably, in the present invention, according to percent by weight, wherein Mo Naitaier：Medicinal slow release agent is preferably in a proportion of
1:3。
Preferably, in the present invention, according to percent by weight, Mo Naitaier：The ratio of surfactant is 1:2.
Preferably, in the present invention, medicinal slow release agent is selected from polyvinylpyrrolidone -15, polyvinylpyrrolidone -17, carboxylic
In sodium carboxymethylcellulose pyce and alpha-pyrrolidone one or two.
Preferably, in the present invention, medicinal slow release agent is that polyvinylpyrrolidone -17 and alpha-pyrrolidone press 1:1.5 ratios
Compound.
Preferably, in the present invention, surfactant is various selected from Tween-80, lecithin, the hydroxyl of polyethylene glycol 15
In stearate and Crodaret (RH-40) one or two.
Preferably, in the present invention, surfactant is that Tween-80 and Solutol HS 15 press 1:1
The compound of ratio.
Preferably, in the present invention, sweetener is Sucralose sodium, saccharin sodium, sucrose, analogous components or its mixture.
Most preferably, in the present invention, sweetener is saccharin sodium.
Preferably, in the present invention, molten medium is one or more selected from water, ethanol, propane diols, Liquid Macrogol, poly- second
One or more compounds in glycol 400, glycerine, polyoxyethylenated castor oil, polyethylene glycol 200, hydroxy stearic acid ester.
Most preferably, in the present invention, molten medium is the compound of water, Liquid Macrogol and ethanol.
Preferably, in the present invention, antioxidant is selected from one kind or two in alpha-tocopherol, beta carotene, sodium hydrogensulfite
Kind.
Meanwhile, present invention also offers aquatic products fenvalerate oil solution method for producing insecticide, methods described bag
Include following steps：
Mo Naitaier, medicinal slow release agent, surfactant, sweetener, antioxidant are dissolved in successively by prescription consumption molten
In medium, stirring dissolves medicine complete, and molten medium is quantified, and last rove filtering, packing, sterilizing, thus obtaining the product Mo Naitaier are oral
Liquid.
Further, present invention provides described aquatic products with fenvalerate oil solution insecticide in aquatic product body surface desinsection
In application, the parasitic nematode for treating ox, sheep intestines and stomach.
Embodiment 1
Mo Naitaier：1.0,
Polyvinylpyrrolidone -15：1.0%,
Tween-80：5%,
Saccharin sodium：0.1%,
Beta carotene：0.1%,
Ethanol：The aqueous solution=3:7：Polishing.
Embodiment 2
Mo Naitaier：10%,
Polyethylene glycol 200：10%,
Solutol HS 15：10%,
Sucrose：0.3%,
Sodium hydrogensulfite：0.2%,
Polyoxyethylenated castor oil:Propane diols and water=2：3:5：Polishing.
Embodiment 3
Mo Naitaier：2.5%,
Polyvinylpyrrolidone -17 and alpha-pyrrolidone=1:1.5：15%,
Tween-80:Solutol HS 15=1:1:6%,
Saccharin sodium：0.3%,
Beta carotene：0.1%,
Alpha-tocopherol：0.05,
Liquid Macrogol:Ethanol and aqueous mixtures (polyethylene glycol：Ethanol：The aqueous solution=2：1:7)：Polishing.
Embodiment 4
Mo Naitaier：20%,
Sodium carboxymethylcellulose：8%,
Lecithin：3%,
Saccharin sodium：0.3%,
Alpha-tocopherol：1%,
Propane diols:Ethanol：Water=1：2:7：Polishing.
Experimental example
Although illustrate and describing the present invention with specific embodiment, but will be appreciated that without departing substantially from of the invention
Many other changes and modification can be made in the case of spirit and scope.It is, therefore, intended that in the following claims
Including belonging to all such changes and modifications in the scope of the invention.
The drug substance stable Journal of Sex Research of experimental example 1.
Trial drug：2.5% Mo Naitaier oral liquids prepared by the embodiment of the present invention 3.
Test method：Promulgated according to the Ministry of Agriculture《(the examination of veterinary chemicals stability study technological guidance principle
OK)》Method, using the Accelerated stability test under temperature, three environmental factors of illumination and humidity.
This is tested in August, 2016 No. 1~No. 13 and is carried out in the big animal pharmaceuticals assessment centers of east Australia dragon, test products by
East Ao Long pharmaceutical Co. Ltds (oral liquid GMP certifications production line) produce, and have investigated three batches of stability of actual production medicine,
Product batch number is respectively 160801,160802,160803.
Result of the test：The stability observing of the embodiment of the present invention 3 the results are shown in Table 1,2,3, and test data shows, 0,5,10
Under its temperature, three environmental factors of illumination and humidity, the appearance character of 2.5% Mo Naitaier oral liquids, pH value (3.0~4.5),
Sterility testing and content (accounting for labelled amount=90%~110%) meet quality standard.
Stability test observation (product batch number 160801) of the embodiment of the present invention 3 of table 1
Stability test observation (lot number lot number 160802) of the embodiment of the present invention 3 of table 2
(lot number lot number 160803) is observed in the stability test of 3 embodiment of the present invention of table 3
The pharmacokinetics experiment of experimental example 2, medicine
This is tested is carried out in August, 2016 No. 5~No. 15 at the big animal clinical drug evaluation center of east Australia dragon, and experiment is produced
(2.5% Mo Naitaier of the embodiment of the present invention 3 that product are produced by east Ao Long pharmaceutical Co. Ltds (oral liquid GMP certifications production line)
Oral liquid), product batch number is 160805, is promulgated according to the Ministry of Agriculture《Veterinary chemicals Clinical pharmacokinetics are tested
Guideline (tentative)》Method is carried out, and from adult Leizhou Goats (180-190 ages in days), body weight 45-48kg is healthy, active,
The small Leizhou Goats 14 of stress reaction are divided into test group 9, blank group 3, standby group 2, prerun 7 days, 3 days formal phases,
According to the feeding and management of science, earmarking number record.
Weighed in the morning on an empty stomach before experiment, and 4 groups are randomly divided into by body weight, and every group 3, I, II, III group are experimental group, respectively
By per kilogram of body weight 2.5mg dosage, gavage, IV groups are not administered for blank group, and concrete condition is shown in Table 4.By high performance liquid chromatography-
Tandem mass spectrum method determines the content of Mo Naitaier in blood plasma.
The pharmacokinetics result of the test statistics of medicine is shown in Table 5, and result of the test shows, Mo Naitaier 3 hours in vivo, and blood medicine is dense
Degree can just peak, can absorb rapidly, and it is widely distributed after, while also show Mo Naitaier can keep one in animal body
Section keeps blood concentration higher, is conducive to Mo Naitaier drug effects in itself to play, to reach the purpose of targeting.
The pharmacokinetics experimental animal grouping sheet of the medicine of table 4
The pharmacokinetics result of the test statistical form of the medicine of table 5
The clinical test of the medicine of experimental example 3.
This is tested is carried out in August, 2016~October at the big animal clinical drug evaluation center of east Australia dragon, according to China
What the Ministry of Agriculture promulgated《Chemical drugs clinical test technological guidance principle (tentative) for animals》Method, it is limited from the refined herding of Zhaoqing Guangdong fine horse
Infected animal is chosen in company and Zhanjiang Leizhou Goats cultivation Co., Ltd, two experiments of experimental group and control group are randomly divided into
Group, specifying information is shown in Table 6.
Therapeutic dose：Test group, per 1kg body weight, gavages 2.5ng, 1 times a day, at most in terms of Mo Naitaier effective contents
Successive administration 3 times.After treatment starts, with identical administering mode and corresponding disease, per day entry infected animal body situation of change,
Treatment counts treatment results after 2 days.
The clinical application effect statistics of medicine is shown in Table 7, and embodiments of the invention 3 and control group are to nematodirus, sth. made by twisting
The therapeutic effect for turning blood lance line and brace nematode is excellent, cure rate all be higher than 90%, and treat brace nematode in terms of on, this hair
Bright embodiment 3 is better than shines group.This experiment absolutely proves the cure rate of embodiments of the invention 3, can reach and control curative effect well
Really.
The clinical test experimental group of table 6 and control group information table
The clinical application effect statistical form of the embodiment 3 of table 7
Claims (9)
1. a kind of Mo Naitaier oral liquids, it is characterised in that according to percent by weight, the Mo Naitaier oral liquids include with
Lower composition：
Mo Naitaier：1.0~20.0%,
Medicinal slow release agent：1.0~30.0%,
Surfactant：1.0~10.0%,
Sweetener：1.0~10.0%,
Antioxidant：0.1-3%,
Molten medium：Polishing.
2. a kind of Mo Naitaier oral liquids according to claim 1, it is characterised in that described according to percent by weight
Mo Naitaier oral liquids include following component：
Mo Naitaier：1.0~5.0%；
Medicinal slow release agent：10.0~20.0%；
Surfactant：5.0~10.0%；
Sweetener：1.0~3.0%；
Antioxidant：0.1-1%；
Balance of molten medium.
3. a kind of Mo Naitaier oral liquids according to claim 1, it is characterised in that medicinal slow release agent is selected from polyethylene pyrrole
In pyrrolidone -15, polyvinylpyrrolidone -17, sodium carboxymethylcellulose and alpha-pyrrolidone one or two.
4. a kind of Mo Naitaier oral liquids according to claim 1, it is characterised in that surfactant is for various selected from poly-
Sorb ester -80, lecithin, Solutol HS 15 and Crodaret (RH-40) middle a kind of or
Two kinds.
5. a kind of Mo Naitaier oral liquids according to claim 1, it is characterised in that sweetener is Sucralose sodium, sugar
Smart sodium, sucrose, analogous components or its mixture.
6. a kind of Mo Naitaier oral liquids according to claim 1, it is characterised in that molten medium is selected from for one or more
Water, ethanol, propane diols, Liquid Macrogol, PEG400, glycerine, polyoxyethylenated castor oil, polyethylene glycol 200, hydroxyl
One or more compounds in stearate.
7. a kind of Mo Naitaier oral liquids according to claim 1, it is characterised in that in the present invention, antioxidant is selected from
In alpha-tocopherol, beta carotene, sodium hydrogensulfite one or two.
8. a kind of preparation method of the Mo Naitaier oral liquids described in any one of claim 1-7, it is characterised in that the side
Method comprises the following steps：
Mo Naitaier, medicinal slow release agent, surfactant, sweetener, antioxidant are dissolved in molten medium successively by prescription consumption
In, stirring dissolves medicine complete, and molten medium is quantified, last rove filtering, packing, sterilizing, thus obtaining the product Mo Naitaier oral liquids.
9. a kind of Mo Naitaier oral liquids described in any one of claim 1-7 are used to treat ox, the parasitic nematode of sheep intestines and stomach.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113662917A (en) * | 2021-09-15 | 2021-11-19 | 谢彩华 | Moneratel emulsion and preparation method thereof |
| CN113662917B (en) * | 2021-09-15 | 2023-01-10 | 谢彩华 | Moneratel emulsion and preparation method thereof |
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Application publication date: 20170613 |