CN107349212A - A kind of albendazole ivermectin pre-mixing agent and preparation method thereof - Google Patents
A kind of albendazole ivermectin pre-mixing agent and preparation method thereof Download PDFInfo
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- CN107349212A CN107349212A CN201710499694.1A CN201710499694A CN107349212A CN 107349212 A CN107349212 A CN 107349212A CN 201710499694 A CN201710499694 A CN 201710499694A CN 107349212 A CN107349212 A CN 107349212A
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- ivermectin
- albendazole
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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- Medicines Containing Plant Substances (AREA)
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Abstract
The invention discloses a kind of albendazole ivermectin pre-mixing agent and preparation method thereof, the component of the following mass percent of the pre-mixing agent：Prevent miscarriage plant extract elite 4.5 ~ 5.5%, surplus of albendazole 5.5 ~ 6.5%, ivermectin 0.22 ~ 0.26%, medical charcoal 10 ~ 15%, maize cob meal 5 ~ 10%, An Gong is starch.During preparation, addition peace palace is prevented miscarriage plant extract elite in formula, can reduce the side effect of albendazole.Prepared using isodensity equal increments mixing method, effective guarantee can be provided for its safe handling.The albendazole ivermectin pre-mixing agent active constituent content deviation of preparation is small, and Small side effects, pregnant domestic animal can use；Preparation process is easy, easy to operate；The A+1.80S average values of ivermectin Determination of Content Uniformity are less than 10.0（National standard is that A+1.80S average values are less than 15.0）.
Description
Technical field
The present invention relates to a kind of albendazole ivermectin pre-mixing agent and preparation method thereof, belong to biotechnology, life
Thing field of medicaments.
Background technology
Albendazole ivermectin pre-mixing agent is a kind of antiparasitic agent.Albendazole has wide spectrum anthelmintic activity, to line
Worm, tapeworm, fluke, which have, stronger kills effect.Its mechanism of action be by with the tubulin binding in worm body, prevent it
Multimerization composition micro-pipe is carried out with alpha-tubulin, so as to influence the mitosis in worm body, albumen assembling and energetic supersession
Deng cell proliferation process.
Ivermectin has to internal epizoa particularly insect and internal nematode well kills effect, main to use
In gastrointestinal nematode parasites, thread lungworm and the vermin of driving away pig.Its expelling parasite mechanism be promote presynaptic neuron release γ-
Aminobutyric acid（GABA）, so as to open the chloride channel of GABA mediations.Chlorion stream can reduce cell membrane impedance, cause cynapse
The slight depolarising of caudacoria rest potential, so as to disturb the signal transmission between neuromuscular, make polypide relaxation paralysis, cause polypide
Death is excreted.
This product main component albendazole has teratogenesis；Ivermectin overdose can cause poisoning, no special efficacy solution
Poison.
The content of the invention
The problem to be solved in the present invention is：Overcome the teratogenesis of albendazole in the prior art and the super agent of ivermectin
Amount feeding causes the deficiency of poisoning, proposes a kind of feasible albendazole ivermectin pre-mixing agent and preparation method thereof.By right
Albendazole ivermectin pre-mixing agent technical recipe is improved, albendazole is prepared using isodensity equal increments mixing method she
Rhzomorph pre-mixing agent is tieed up, effective guarantee can be provided for its safe handling, production to albendazole ivermectin pre-mixing agent and is answered
With being of great immediate significance.
Realizing the technical scheme of the object of the invention is：
A kind of albendazole ivermectin pre-mixing agent, include the component of following mass percent：
Albendazole 5.5 ~ 6.5%,
Ivermectin 0.22 ~ 0.26%,
Medical charcoal 10 ~ 15%,
Maize cob meal 5 ~ 10%,
Peace palace is prevented miscarriage plant extract elite 4.5 ~ 5.5%,
Surplus is starch.
The preparation method of the albendazole ivermectin pre-mixing agent, comprises the following steps：
（1）Each component is weighed by following mass percents, crosses No. 5 sieves respectively, it is standby；
Albendazole 5.5 ~ 6.5%,
Ivermectin 0.22 ~ 0.26%,
Medical charcoal 10 ~ 15%,
Maize cob meal 5 ~ 10%,
Peace palace is prevented miscarriage plant extract elite 4.5 ~ 5.5%,
Surplus is starch；
（2）The premixing of ivermectin；
It is 5 in mass ratio to take starch and maize cob meal:1~1:1 is mixed into the density auxiliary material a equal with ivermectin；
Take the ivermectin of formula ratio and the auxiliary material a of equivalent to be sufficiently mixed uniformly, obtain ivermectin premix 1；
Then it is 5 in mass ratio to take starch and maize cob meal again:1~1:1 to be mixed into density equal with ivermectin premix 1
Auxiliary material b；
Take ivermectin premix 1 and the auxiliary material b of equivalent to be sufficiently mixed uniformly, obtain ivermectin premix 2；
The rest may be inferred, and 5 premixings are carried out to ivermectin using isodensity equal increments mixing method, make ivermectin uniform
It is distributed in auxiliary material, obtains A powder；
（3）Take the albendazole of formula ratio to be well mixed with the starch of equivalent, obtain B powder；
（4）A powder, B powder are always mixed together with other supplementary materials, albendazole ivermectin pre-mixing agent finished product is made.
The content deviation of the obtained albendazole ivermectin pre-mixing agent finished product active ingredient is small, ivermectin content
The A+1.80S average values of cloud test are less than 10.0（National standard is that A+1.80S average values are less than 15.0）.
The original formulation of existing albendazole ivermectin pre-mixing agent be albendazole, ivermectin and activated carbon etc. prepare and
May be with to monster and embryotoxicity into, albendazole in formula；Peace palace plant extract elite of preventing miscarriage can protect cell
Film, the oxidizing process of body is adjusted, promote gonad development, prevent miscarriage and monster；Therefore addition peace palace is prevented miscarriage plant in formula
Thing skims the cream off milk, and can reduce the side effect of albendazole.
At present, content of the ivermectin in standard recipe is extremely low（Containing 0.25%）, prepared according to the mixed method of routine,
Often mix it is uneven, cause during medication some animals because medicine feed intake deficiency do not reach therapeutic effect or feeding it is excessive and in
Poison；The present invention is pre-mixed using isodensity equal increments mixing method to ivermectin, is evenly dispersed to ivermectin
In auxiliary material.
The inventive method compared with prior art, has following features：
（1）The albendazole ivermectin pre-mixing agent Small side effects finally given using the inventive method, pregnant domestic animal can use；
（2）The inventive method step is easy, easy to operate；
（3）The content deviation of albendazole ivermectin pre-mixing agent finished product active ingredient prepared by the present invention is small, and ivermectin contains
The A+1.80S average values for measuring cloud test are less than 10.0（National standard is that A+1.80S average values are less than 15.0.
Embodiment
Present invention is further described with reference to embodiment, but is not limitation of the invention.
Embodiment 1
The albendazole ivermectin pre-mixing agent of preparation, include the component of following mass percent：
Albendazole 5.8%
Ivermectin 0.24%
Prevent miscarriage plant extract elite 5% in peace palace
Medical charcoal 12%
Maize cob meal 2.0%
Starch adds to full dose.
The preparation method of described albendazole ivermectin pre-mixing agent, comprises the following steps：
（1）Each component is accurately weighed by above-mentioned mass percent, crosses No. 5 sieves respectively, it is standby；
（2）The premixing of ivermectin：
It is 5 in mass ratio to take starch and maize cob meal:1~1:1 is mixed into the density auxiliary material a equal with ivermectin；
Take the ivermectin of formula ratio and the auxiliary material a of equivalent to be sufficiently mixed uniformly, obtain ivermectin premix 1；
Then it is 5 in mass ratio to take starch and maize cob meal again:1~1:1 to be mixed into density equal with ivermectin premix 1
Auxiliary material b；
Take ivermectin premix 1 and the auxiliary material b of equivalent to be sufficiently mixed uniformly, obtain ivermectin premix 2；
The rest may be inferred, and 5 premixings are carried out to ivermectin using isodensity equal increments mixing method, make ivermectin uniform
It is distributed in auxiliary material, obtains A powder；
（3）Take albendazole to be well mixed with the starch of equivalent, obtain B powder；
（4）A powder, B powder are always mixed together with other supplementary materials, with obtained albendazole ivermectin pre-mixing agent finished product.
Embodiment 2
The albendazole ivermectin pre-mixing agent of preparation, include the component of following mass percent：
Albendazole 6.0%
Ivermectin 0.25%
Prevent miscarriage plant extract elite 5% in peace palace
Medical charcoal 12%
Maize cob meal 2.3%
Starch adds to full dose.
Preparation method is the same as embodiment 1.
Embodiment 3
The albendazole ivermectin pre-mixing agent of preparation, include the component of following mass percent：
Albendazole 6.3%
Ivermectin 0.26%
Prevent miscarriage plant extract elite 5% in peace palace
Medical charcoal 12%
Maize cob meal 2.6%
Starch adds to full dose.
Preparation method is the same as embodiment 1.
Comparative example 1
Ivermectin is pre-mixed according to conventional equal increments method.
The albendazole ivermectin pre-mixing agent of preparation, include the component of following mass percent：
Albendazole 5.8%
Ivermectin 0.24%
Prevent miscarriage plant extract elite 5% in peace palace
Medical charcoal 12%
Starch adds to full dose.
Described albendazole ivermectin pre-mixing agent preparation method, comprises the following steps：
（1）Each component is accurately weighed by described mass percent, crosses No. 5 sieves respectively, it is standby；
（2）The premixing of ivermectin：
Take ivermectin to be sufficiently mixed uniformly with equivalent starch, obtain ivermectin premix 1；
Then take ivermectin premix 1 to be sufficiently mixed uniformly with equivalent starch again, obtain ivermectin premix 2；
The rest may be inferred, and 5 premixings are carried out to ivermectin using equal increments mixing method, are evenly dispersed to ivermectin
In auxiliary material, A powder is obtained；
（3）Take albendazole to be well mixed with the starch of equivalent, obtain B powder；
（4）A powder, B powder are always mixed together with other supplementary materials, with obtained albendazole ivermectin pre-mixing agent finished product.
Comparative example 2
Ivermectin is pre-mixed according to conventional equal increments method.
The albendazole ivermectin pre-mixing agent of preparation, include the component of following mass percent：
Albendazole 6.0%
Ivermectin 0.25%
Prevent miscarriage plant extract elite 5% in peace palace
Medical charcoal 12%
Maize cob meal 2.3%
Starch adds to full dose.
Preparation method is the same as comparative example 1.
Comparative example 3
Ivermectin is pre-mixed according to conventional equal increments method.
The albendazole ivermectin pre-mixing agent of preparation, include the component of following mass percent：
Albendazole 6.3%
Ivermectin 0.26%
Prevent miscarriage plant extract elite 5% in peace palace
Medical charcoal 12%
Maize cob meal 2.6%
Starch adds to full dose.
Preparation method is the same as comparative example 1.
Comparative example 4
Ivermectin does not add peace palace and prevented miscarriage plant extract elite according to standard recipe.
The albendazole ivermectin pre-mixing agent of preparation, include the component of following mass percent：
Albendazole 6.0%
Ivermectin 0.25%
Medical charcoal 12%
Maize cob meal 2.3%
Starch adds to full dose.
Preparation method is the same as comparative example 1.
Experiment 1
Uniformity of dosage units detects：Prove dispersion of medicine；
Test objective：Verify whether albendazole ivermectin pre-mixing agent uniformity of dosage units provided by the present invention reaches regulation and want
Ask.
Test method：According to《Chinese veterinary pharmacopoeia》（Version in 2015）The Content uniformity test of annex 0941, each batch
Ten Duplicate Samples are respectively taken to be detected.
The ivermectin uniformity of dosage units testing result of embodiment 1, as shown in table 1：
Note：Quality criteria requirements, the 90 ~ 110% of labelled amount are should be containing ivermectin, uniformity of dosage units（A+1.80S）Average value should
Less than 15.0.
From the testing result of table 1, the ivermectin content for the albendazole ivermectin pre-mixing agent that embodiment 1 is provided
The uniformity（A+1.80S）Comply fully with regulation.
The ivermectin uniformity of dosage units testing result of comparative example 1, as shown in table 2：
Note：Quality criteria requirements, the 90 ~ 110% of labelled amount are should be containing ivermectin, uniformity of dosage units（A+1.80S）Average value should
Less than 15.0.
From the testing result of table 2, the ivermectin content for the albendazole ivermectin pre-mixing agent that comparative example 1 is provided
The uniformity（A+1.80S）It is against regulation.
The ivermectin uniformity of dosage units testing result of embodiment 2, as shown in table 3：
Note：Quality criteria requirements, the 90 ~ 110% of labelled amount are should be containing ivermectin, uniformity of dosage units（A+1.80S）Average value should
Less than 15.0.
From the testing result of table 3, the ivermectin content for the albendazole ivermectin pre-mixing agent that embodiment 2 is provided
The uniformity（A+1.80S）Comply fully with regulation.
The ivermectin uniformity of dosage units testing result of comparative example 2, as shown in table 4：
Note：Quality criteria requirements, the 90 ~ 110% of labelled amount are should be containing ivermectin, uniformity of dosage units（A+1.80S）Average value should
Less than 15.0.
From the testing result of table 4, the ivermectin content for the albendazole ivermectin pre-mixing agent that comparative example 2 is provided
The uniformity（A+1.80S）It is against regulation.
The ivermectin uniformity of dosage units testing result of embodiment 3, as shown in table 5：
Note：Quality criteria requirements, the 90 ~ 110% of labelled amount are should be containing ivermectin, uniformity of dosage units（A+1.80S）Average value should
Less than 15.0.
From the testing result of table 5, the ivermectin content for the albendazole ivermectin pre-mixing agent that embodiment 3 is provided
The uniformity（A+1.80S）Comply fully with regulation.
The ivermectin uniformity of dosage units testing result of comparative example 3, as shown in table 6：
Note：Quality criteria requirements, the 90 ~ 110% of labelled amount are should be containing ivermectin, uniformity of dosage units（A+1.80S）Average value should
Less than 15.0.
From the testing result of table 6, the ivermectin content for the albendazole ivermectin pre-mixing agent that comparative example 3 is provided
The uniformity（A+1.80S）It is against regulation.
Experiment 2
Safety testing：Prove that drug side-effect is small；
Test objective：Verify whether pregnant domestic animal can use albendazole ivermectin pre-mixing agent provided by the present invention.
Test method：Parity identical health farrowing sow 150 is selected, is randomly divided into 3 groups, every group 50.
The albendazole ivermectin pre-mixing agent prepared with embodiment 2 and comparative example 4, is used according to as defined in standard specification
Method dosage, feed per ton add sample 1000g, feed farrowing sow respectively, continuous feeding one week；Control group fed blank is raised
Material.Stillborn foetus, the young and weak young quantity of deformity are counted during experiment.
Result of the test counts, as shown in table 7：
Note：Experiment since sow gestation the 46th day, to sows farrowing after terminate.
From the statistical result of table 7, the albendazole ivermectin pre-mixing agent that embodiment 2 is provided will not cause sow to send out
Life and death tire, the young and weak son of deformity, do not act on to monster, can be used in the sow pregnancy period.
Plant extract elite prevent miscarriage by the extraction of this enterprise traditional Chinese medicine extraction workshop oneself, the public in peace palace used in the present invention
Also extraction acquisition can be carried out by buying the prepared slices of Chinese crude drugs；Maize cob meal used can commercially be bought, or by maize cob meal
Broken acquisition.
Claims (3)
1. a kind of albendazole ivermectin pre-mixing agent, it is characterised in that include the component of following mass percent：
Albendazole 5.5 ~ 6.5%,
Ivermectin 0.22 ~ 0.26%,
Medical charcoal 10 ~ 15%,
Maize cob meal 5 ~ 10%,
Peace palace is prevented miscarriage plant extract elite 4.5 ~ 5.5%,
Surplus is starch.
2. a kind of preparation method of albendazole ivermectin pre-mixing agent, it is characterised in that comprise the following steps：
（1）Each component is weighed by following mass percents, crosses No. 5 sieves respectively, it is standby；
Albendazole 5.5 ~ 6.5%,
Ivermectin 0.22 ~ 0.26%,
Medical charcoal 10 ~ 15%,
Maize cob meal 5 ~ 10%,
Peace palace is prevented miscarriage plant extract elite 4.5 ~ 5.5%,
Surplus is starch；
（2）The premixing of ivermectin；
It is 5 in mass ratio to take starch and maize cob meal:1~1:1 is mixed into the density auxiliary material a equal with ivermectin；
Take the ivermectin of formula ratio and the auxiliary material a of equivalent to be sufficiently mixed uniformly, obtain ivermectin premix 1；
Then it is 5 in mass ratio to take starch and maize cob meal again:1~1:1 to be mixed into density equal with ivermectin premix 1
Auxiliary material b；
Take ivermectin premix 1 and the auxiliary material b of equivalent to be sufficiently mixed uniformly, obtain ivermectin premix 2；
The rest may be inferred, and 5 premixings are carried out to ivermectin using isodensity equal increments mixing method, make ivermectin uniform
It is distributed in auxiliary material, obtains A powder；
（3）Take the albendazole of formula ratio to be well mixed with the starch of equivalent, obtain B powder；
（4）A powder, B powder are always mixed together with other supplementary materials, albendazole ivermectin pre-mixing agent finished product is made.
3. preparation method according to claim 2, it is characterised in that obtained albendazole ivermectin pre-mixing agent finished product
The content deviation of active ingredient is small, and the A+1.80S average values of ivermectin Determination of Content Uniformity are less than 10.0.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109045058A (en) * | 2018-09-28 | 2018-12-21 | 佛山市正典生物技术有限公司 | A kind of albendazole ivermectin micro-capsule for animals and preparation method thereof |
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| CN101450068A (en) * | 2007-11-29 | 2009-06-10 | 天津瑞普生物技术集团有限公司 | Premixing agent for preventing and treating livestock nematodiasis |
| WO2015124928A2 (en) * | 2014-02-19 | 2015-08-27 | University Of Southampton | Treating infection |
| CN105687294A (en) * | 2016-03-10 | 2016-06-22 | 福建傲农生物科技集团股份有限公司 | Novel parasite-expelling premix for pigs as well as preparation method and application of premix |
| CN106389456A (en) * | 2016-11-16 | 2017-02-15 | 佛山市正典生物技术有限公司 | Veterinary albendazole ivermectin premixing agent and preparation method thereof |
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2017
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| CN101450068A (en) * | 2007-11-29 | 2009-06-10 | 天津瑞普生物技术集团有限公司 | Premixing agent for preventing and treating livestock nematodiasis |
| WO2015124928A2 (en) * | 2014-02-19 | 2015-08-27 | University Of Southampton | Treating infection |
| CN105687294A (en) * | 2016-03-10 | 2016-06-22 | 福建傲农生物科技集团股份有限公司 | Novel parasite-expelling premix for pigs as well as preparation method and application of premix |
| CN106389456A (en) * | 2016-11-16 | 2017-02-15 | 佛山市正典生物技术有限公司 | Veterinary albendazole ivermectin premixing agent and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109045058A (en) * | 2018-09-28 | 2018-12-21 | 佛山市正典生物技术有限公司 | A kind of albendazole ivermectin micro-capsule for animals and preparation method thereof |
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