CN106176621A - A kind of maduramicin ammonium premix and preparation method thereof - Google Patents
A kind of maduramicin ammonium premix and preparation method thereof Download PDFInfo
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- CN106176621A CN106176621A CN201610762879.2A CN201610762879A CN106176621A CN 106176621 A CN106176621 A CN 106176621A CN 201610762879 A CN201610762879 A CN 201610762879A CN 106176621 A CN106176621 A CN 106176621A
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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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1664—Compounds of unknown constitution, e.g. material from plants or animals
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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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Abstract
The invention discloses a kind of maduramicin ammonium premix and preparation method thereof, the method comprises step 1 and pulverizes: is pulverized by qualified bean cake and is categorized as qualified bean cake carrier and bean cake fine powder.Step 2 feeds intake: qualified bean cake carrier is put into mixer.Step 3 is prepared: crude drug maduramicin ammonium is mixed in proportion into transparent medicinal liquid with solvent.Step 4 mixes: carry out medicine liquid spray in operating mixer after feeding intake being mixed into uniformly.Step 5 is dried: implementing to be dried to material after mixing, then piling is to be checked.Step 6 detects.Step 7: defective work carries out process of doing over again.Step 8: certified products are packed.Step 9: put in storage after inspection.Maduramicin ammonium premix that the present invention provides and preparation method thereof, give the optimum formulation protocol of a kind of standard, overcome the defect of existing maduramicin ammonium preparation, have method simple possible, constant product quality, easily in feedstuff mix homogeneously, be easy to storage and transport, use the advantages such as safety.
Description
Technical field
The present invention relates to a kind of veterinary drug preparation and preparation method thereof, in particular it relates to a kind of maduramicin ammonium premix and
Its preparation method.
Background technology
Maduramicin ammonium, English name is Maduramicin Ammonium, also known as Maduramycin Ammonium, Maduramicin,
Molecular formula is C47H83NO17, molecular weight 934.17.
Maduramicin ammonium is a kind of monoglycosides polyether ionophoric antibiotics that American Cyanamid Company develops, with its ammonium
Presented in salt the most stable.Maduramicin ammonium is to be produced by microorganism Actinomadurayumaensis fermentation, and it is to many
Gram positive bacteria is effective, has the widest anticoccidial spectrum, can serve as coccidiosis agent for killing, kill the parasite in host,
It all has coccidiostat activity to zygoblast and first generation schizont, eases up tender Amy ear, heap-type Amy ear, Bu Shi Amy ear
Release Amy ear, displacement Amy ear and Eimeria Necatrix and have good effect.
Maduramicin ammonium is white crystalline powder, and fusing point is 165 ~ 167 DEG C, water insoluble, dissolves in organic solvent, its
Not there is mutagenic action, according to the radioactivity determination of 14C labelled compound, after feeding chicken 7 days with the dosage of 55E-6, drug withdrawal 1
It is butchered, and chicken body is respectively organized not measuring residual quantity.Owing to its anticoccidial spectrum is wide, it is not likely to produce drug resistance, therefore applies very
Extensively.But its consumption is minimum, and safety range is the narrowest, it is recommended to use dosage and toxic dose very close to, such as production practices
Middle improper use, it is easy to cause poultry to be poisoned, economic loss is heavy.At present, the product of each producer, animal-use drug on market
Effect difference afterwards is the biggest, it is also very desirable to the optimum formulation protocol of a kind of standard.
Summary of the invention
It is an object of the invention to provide a kind of pre-mixing agent production technology for maduramicin ammonium, overcome existing Maduramicin
The defect of ammonium preparation, have method simple possible, constant product quality, easily in feedstuff mix homogeneously, be easy to storage and fortune
The advantages such as defeated, use safety.
In order to achieve the above object, the invention provides the preparation method of a kind of maduramicin ammonium premix, wherein, the party
Method comprises: step 1 is pulverized: is pulverized by qualified bean cake and is categorized as qualified bean cake carrier and bean cake fine powder;Step 2 feeds intake: warp
Qualified bean cake carrier is also put into mixer after checking by precise, to be mixed;Step 3 is prepared: by crude drug maduramicin ammonium
Transparent medicinal liquid it is mixed in proportion into solvent;Step 4 mixes: medicine liquid spray step 3 prepared carries in step 2-in-1 lattice bean cake
Body carries out in operating mixer after feeding intake being mixed into uniformly;Step 5 is dried: implement to be dried to material after mixing, then code
Pile up neatly to be checked;Step 6 detects: step 5 products obtained therefrom is taken sample and detects;Step 7: defective work carries out process of doing over again;Step
Rapid 8: certified products are packed;Step 9: put in storage after inspection.
The preparation method of above-mentioned maduramicin ammonium premix, wherein, described qualified bean cake is outward appearance yellow or light
Yellow lamellar or graininess, without going mouldy, damage by worms, luming;Loss on drying≤12.0% by mass percentage, crude protein >=
40.0%, crude fat≤2.5%, coarse ash≤6.5%, urease activity 0.02-1.0;Described qualified bean cake carrier is yellow or light
Yellow powder;Loss on drying≤11% by mass percentage;Granularity is that veterinary drug two sieves percent of pass >=95%, and veterinary drug five sieve is logical
Cross rate≤10%.Veterinary drug mesh size is shown in " People's Republic of China's veterinary drug allusion quotation ".
The preparation method of above-mentioned maduramicin ammonium premix, wherein, described feeds intake, and every batch puts into qualified bean cake carrier
Amount is 20 minutes for 1000kg, 1000kg carrier charging time;After mixer is put into 700 ~ 800kg qualified bean cake carrier, open
Dynamic mixer, carries out medicine liquid spray after qualified bean cake carrier all puts into.
The preparation method of above-mentioned maduramicin ammonium premix, wherein, described solvent is to dissolve crude drug Ma Du
Rice star ammonium the organic solvent harmless to animal;Described solvent includes the first solvent and the second solvent;Crude drug Maduramicin
Ammonium, the first solvent, the second solvent, the weight ratio of bean cake carrier are 3:10:(10/3): (2500/9).Crude drug maduramicin ammonium
Outward appearance is white or off-white powder, and quality meets " pesticide portion veterinary medical quality standard ".
The preparation method of above-mentioned maduramicin ammonium premix, wherein, described solvent, itself and crude drug maduramicin ammonium
Process for preparation and with the mixed process of qualified bean cake carrier be: in the heating preparing tank with blood circulation, add first
The 80% of solvent, starts the circulating pump of blood circulation, adds crude drug maduramicin ammonium and the second solvent, by circulating pump pressure
In the qualified bean cake carrier that spray pattern is sprayed onto in mixer, after having sprayed, pour remaining first solvent into preparing tank in three times
20%, it is rinsed, in the qualified bean cake carrier that washing liquid is sprayed onto in mixer equally in the way of circulating pump press atomization, sprays
Mixing 6 minutes after end, when adding other batches, this incorporation time is 8 minutes;Mixed semi-finished product color and dry and wet
Degree is homogeneous.
The preparation method of above-mentioned maduramicin ammonium premix, wherein, the first described solvent is Polyethylene Glycol
(polyethylene glycol, PEG), the second solvent is N-Methyl pyrrolidone.
The preparation method of above-mentioned maduramicin ammonium premix, wherein, described is dried, and passes through Vibratingfluidbeddrier
Carrying out, start heat, cold-blast machine and air-introduced machine time dry successively, make vibration drying fluid bed high-temperature region reach 100 DEG C, charging is dry
Dry;Described fluid bed operationally fin steam pressure is 0.5 ~ 0.6Mpa;Material at bed body inner surface boiling height is
10~20cm;Temperature between bed body low-temperature space and high-temperature region is 30 ~ 90 DEG C;Dry 60 ~ 80 minutes 1000kg material used times;Dry
The loss on drying of the material after dry is 6 ~ 9%.The preparation method of above-mentioned maduramicin ammonium premix, wherein, described detection,
Its standard is loss on drying≤9% by mass percentage;Granularity be veterinary drug two sieve percent of pass >=95%, No. five sieve percent of pass≤
8%;Assay Maduramicin C47H80O17For labelled amount 100.0 ~ 108.0%.
The preparation method of above-mentioned maduramicin ammonium premix, wherein, described packaging is according to different demand packagings
Become different size;Accurately measuring during packaging, error is less than+0.5 ~ 2%;100g/ bag error is less than+1 ~ 2%, i.e. 101-
102g ;25kg/ bag error is less than+0.8%, i.e. 25-25.5kg.
Present invention also offers maduramicin ammonium prepared by the preparation method of a kind of above-mentioned maduramicin ammonium premix pre-
Mixture.
Maduramicin ammonium premix that the present invention provides and preparation method thereof has the advantage that
The present invention gives the optimum formulation protocol of a kind of standard, after testing, product contains gained maduramicin ammonium premix product
Amount, the uniformity reach beast pharmacopoeial quality standard-required, meet export standard, and product quality reaches regulation requirement.This Maduramicin
Ammonium premix steady quality, mixing homogeneity is good, safety is high, it is uneven due to medicament mixed to avoid and in the animal caused
The phenomenon of poison, and easy to use, it is simple to store and transport.In preparation process, maduramicin ammonium uses and is dissolved in the side that solvent sprays into
Formula efficiently solves its mix homogeneously sex chromosome mosaicism, and method is simple.
Accompanying drawing explanation
Fig. 1 is the schematic flow sheet of the preparation method of the maduramicin ammonium premix of the present invention.
Detailed description of the invention
Below in conjunction with accompanying drawing, the detailed description of the invention of the present invention is further described.
As it is shown in figure 1, the preparation method of the maduramicin ammonium premix of present invention offer, comprise:
Step 1 is pulverized: is pulverized by qualified bean cake and is categorized as qualified bean cake carrier and bean cake fine powder.
Step 2 feeds intake: through precise and after checking, qualified bean cake carrier is put into mixer, to be mixed.
Step 3 is prepared: crude drug maduramicin ammonium is mixed in proportion into transparent medicinal liquid with solvent.
Step 4 mixes: medicine liquid spray step 3 prepared is operating mixed after step 2-in-1 lattice bean cake carrier feeds intake
Carry out in conjunction machine being mixed into uniformly.
Step 5 is dried: implementing to be dried to material after mixing, then piling is to be checked.
Step 6 detects: step 5 products obtained therefrom is taken sample and detects.
Step 7: defective work carries out process of doing over again.
Step 8: certified products are packed.
Step 9: put in storage after inspection.
Present invention also offers maduramicin ammonium premix prepared by the preparation method of this maduramicin ammonium premix.
Below in conjunction with embodiment maduramicin ammonium premix that the present invention provides and preparation method thereof done and further retouch
State.
Embodiment 1
Prepare maduramicin ammonium premix according to the following steps.
Step 1 is pulverized: is pulverized by qualified bean cake and is categorized as qualified bean cake carrier and bean cake fine powder.
Qualified bean cake is outward appearance yellow or faint yellow lamellar or graininess, without going mouldy, damage by worms, luming;By percent mass
Than meter loss on drying≤12.0%, crude protein >=40.0%, crude fat≤2.5%, coarse ash≤6.5%, urease activity 0.02-1.0;
Qualified bean cake carrier is yellow or pale yellow powder;Loss on drying≤11% by mass percentage;Granularity is that veterinary drug two sieve is logical
Cross rate >=95%, veterinary drug five sieve percent of pass≤10%.Veterinary drug mesh size is shown in " People's Republic of China's veterinary drug allusion quotation ".
Step 2 feeds intake: through precise and after checking, qualified bean cake carrier is put into mixer, to be mixed.
Every batch put into qualified bean cake carrier amount be 1000kg, 1000kg carrier charging time be 20 minutes;Mixer is thrown
After entering 700 ~ 800kg qualified bean cake carrier, start mixer, after qualified bean cake carrier all puts into, carry out medicine liquid spray.
Step 3 is prepared: crude drug maduramicin ammonium is mixed in proportion into transparent medicinal liquid with solvent.
Solvent is to dissolve crude drug maduramicin ammonium the organic solvent harmless to animal;Including the first solvent and
Two solvents;Crude drug maduramicin ammonium, the first solvent, the second solvent, the weight ratio of bean cake carrier are 3:10:(10/3):
(2500/9).Each material proportion is preferably: crude drug maduramicin ammonium (pure) 10.8kg;First solvent 36kg;Second is molten
Agent 12kg;Bean cake carrier 1000kg.First solvent is Polyethylene Glycol, and the second solvent is N-Methyl pyrrolidone.Crude drug horse
Degree rice star ammonium outward appearance is white or off-white powder, and quality meets " pesticide portion veterinary medical quality standard ".
Step 4 mixes: medicine liquid spray step 3 prepared is operating mixed after step 2-in-1 lattice bean cake carrier feeds intake
Carry out in conjunction machine being mixed into uniformly.
The solvent mixed process with the process for preparation of crude drug maduramicin ammonium and with qualified bean cake carrier is: with
The heating preparing tank of blood circulation adds the 80% of the first solvent, starts the circulating pump of blood circulation, add crude drug Ma Du meter
Star ammonium and the second solvent, by the qualified bean cake carrier that circulating pump press atomization mode is sprayed onto in mixer, divide three after having sprayed
Secondary pouring the 20% of remaining first solvent into preparing tank, be rinsed, washing liquid is sprayed onto equally in the way of circulating pump press atomization
In qualified bean cake carrier in mixer, spraying and mix 6 minutes after terminating, when adding other batches, this incorporation time is 8
Minute;Mixed semi-finished product color and dry and wet degree are homogeneous.
Step 5 is dried: implementing to be dried to material after mixing, then piling is to be checked.
It is dried and is carried out by Vibratingfluidbeddrier, start heat, cold-blast machine and air-introduced machine time dry successively, make vibration
Drying fluidized-bed high-temperature region reaches 100 DEG C, and charging is dried;Fluid bed operationally fin steam pressure is 0.5 ~ 0.6Mpa;
Material is 10 ~ 20cm at bed body inner surface boiling height;Temperature between bed body low-temperature space and high-temperature region is 30 ~ 90 DEG C;Dry
60 ~ 80 minutes 1000kg material used times;The loss on drying of dried material is 6 ~ 9%.
Step 6 detects: step 5 products obtained therefrom is taken sample and detects.Examination criteria is for be dried by mass percentage
Weightless≤9%;Granularity is that veterinary drug two sieves percent of pass >=95%, No. five sieve percent of pass≤8%;Assay Maduramicin C47H80O17
For labelled amount 100.0 ~ 108.0%.
Step 7: defective work carries out process of doing over again.
Step 8: certified products are packed.It is packaged into different size according to different demands;Accurately measure during packaging,
100g/ bag error is less than+1 ~ 2%, i.e. 101-102g;25kg/ bag error is less than+0.8%, i.e. 25-25.5kg.
Step 9: put in storage after inspection.After packaging terminates, the product after quality guarantee portion close inspection can be put in storage.
After preparation process terminates, products obtained therefrom is differentiated: take this product, adds methanol and make the 1ml solution containing about 1mg,
Stirring, takes supernatant as need testing solution, according to maduramicin ammonium test method, aobvious identical result.
Maduramicin ammonium premix and preparation method thereof that the present invention provides, should be noted following item in process of production:
1 technical security item.
1.1 each post operation works must strictly be operated by rule of operation, must not arbitrarily leave post, leaves the post or operate against regulations.
1.2 each elevators, conveyer, pressure vessel, pressure pipeline, motor, measurement instrument all must not over loading make
With.Periodic check equipment, instrument and meter.
The producers of 1.3 all contact medicines must wear protective mask, glove;Drug solution preparing personnel should wear protection and use
Altex glove.
1.4 solvents, medicine must not uncovered be placed.
Must there is sign board when 1.5 all maintenances of equipment or maintenance, two people or two people the above persons operate.
2 fire prevention items.
2.1 all kinds of fire-fighting equipments are forbidden arbitrarily to move or damage.
2.2 passageways for fire apparatus forbid to stack material it is ensured that unimpeded.
2.3 forbid to carry burning things which may cause a fire disaster enters production district or warehousing district, and absolutely no smoking for on-site.
In 2.4 production processes, forbid to carry out producing pyrophoric operation behaviour in production district.
2.5 keep ventilating, it is ensured that assemble without fuel gas.
2.6 all electric equipments all should meet fire prevention, requirement of explosion proof.
2.7 all kinds of fire-fighting equipment should periodically verify.
3 craft sanitary items.
The cleaning of 3.1 each capital equipments is as the criterion with the cleaning regulation of this equipment.
The cleaning of 3.2 work places is as the criterion to produce district's requirement of clearing out a gathering place.
By QA supervisor, 3.3 cleanings and work of clearing out a gathering place check that the granting quality certification of clearing out a gathering place can produce.
Maduramicin ammonium premix that the present invention provides and preparation method thereof, gives the optimum preparation side of a kind of standard
Case, overcomes the defect of existing maduramicin ammonium preparation, have method simple possible, constant product quality, easily in feedstuff
Mix homogeneously, be easy to storage and transport, use safety etc. advantage.
Although present disclosure has been made to be discussed in detail by above preferred embodiment, but it should be appreciated that above-mentioned
Description is not considered as limitation of the present invention.After those skilled in the art have read foregoing, for the present invention's
Multiple amendment and replacement all will be apparent from.Therefore, protection scope of the present invention should be limited to the appended claims.
Claims (10)
1. the preparation method of a maduramicin ammonium premix, it is characterised in that the method comprises:
Step 1 is pulverized: is pulverized by qualified bean cake and is categorized as qualified bean cake carrier and bean cake fine powder;
Step 2 feeds intake: through precise and after checking, qualified bean cake carrier is put into mixer, to be mixed;
Step 3 is prepared: crude drug maduramicin ammonium is mixed in proportion into transparent medicinal liquid with solvent;
Step 4 mixes: medicine liquid spray step 3 prepared is operating mixer after step 2-in-1 lattice bean cake carrier feeds intake
Inside carry out being mixed into uniformly;
Step 5 is dried: implementing to be dried to material after mixing, then piling is to be checked;
Step 6 detects: step 5 products obtained therefrom is taken sample and detects;
Step 7: defective work processes;
Step 8: certified products are packed;
Step 9: put in storage after inspection.
2. the preparation method of maduramicin ammonium premix as claimed in claim 1, it is characterised in that described qualified bean cake
For outward appearance yellow or faint yellow lamellar or graininess, without going mouldy, damage by worms, luming;By mass percentage loss on drying≤
12.0%, crude protein >=40.0%, crude fat≤2.5%, coarse ash≤6.5%, urease activity 0.02-1.0;Described qualified bean cake
Carrier is yellow or pale yellow powder;Loss on drying≤11% by mass percentage;Granularity be veterinary drug two sieve percent of pass >=
95%, veterinary drug five sieve percent of pass≤10%.
3. the preparation method of maduramicin ammonium premix as claimed in claim 1, it is characterised in that described feeds intake, every batch
Put into qualified bean cake carrier amount be 1000kg, 1000kg carrier charging time be 20 minutes;Mixer is put into 700 ~ 800kg close
After lattice bean cake carrier, start mixer, after qualified bean cake carrier all puts into, carry out medicine liquid spray.
4. the preparation method of maduramicin ammonium premix as claimed in claim 1, it is characterised in that described solvent is can
Dissolve crude drug maduramicin ammonium the organic solvent harmless to animal;Described solvent includes the first solvent and the second solvent;
Crude drug maduramicin ammonium, the first solvent, the second solvent, the weight ratio of bean cake carrier are 3:10:(10/3): (2500/9).
5. the preparation method of maduramicin ammonium premix as claimed in claim 4, it is characterised in that described solvent, its with
The process for preparation of crude drug maduramicin ammonium and the mixed process with qualified bean cake carrier is: in the heating with blood circulation
Preparing tank adds the 80% of the first solvent, starts the circulating pump of blood circulation, add crude drug maduramicin ammonium and second molten
Agent, by, in the qualified bean cake carrier that circulating pump press atomization mode is sprayed onto in mixer, falling to preparing tank in three times after having sprayed
Enter the 20% of remaining first solvent, be rinsed, the conjunction that washing liquid is sprayed onto in mixer equally in the way of circulating pump press atomization
In lattice bean cake carrier, spraying and mix 6 minutes after terminating, when adding other batches, this incorporation time is 8 minutes;After mixing
Semi-finished product color and dry and wet degree homogeneous.
6. the preparation method of maduramicin ammonium premix as claimed in claim 5, it is characterised in that the first described solvent is
Polyethylene Glycol, the second solvent is N-Methyl pyrrolidone.
7. the preparation method of maduramicin ammonium premix as claimed in claim 1, it is characterised in that described is dried, successively
Starting heat, cold-blast machine and air-introduced machine, make vibration drying fluid bed high-temperature region reach 100 DEG C, charging is dried;Described fluid bed
Operationally fin steam pressure is 0.5 ~ 0.6Mpa;Material is 10 ~ 20cm at bed body inner surface boiling height;Bed body low temperature
Temperature between district and high-temperature region is 30 ~ 90 DEG C;Dry 60 ~ 80 minutes 1000kg material used times;Being dried of dried material
Weightlessness is 6 ~ 9%.
8. the preparation method of maduramicin ammonium premix as claimed in claim 1, it is characterised in that described detection, its mark
Standard is loss on drying≤9% by mass percentage;Granularity is that veterinary drug two sieves percent of pass >=95%, No. five sieve percent of pass≤8%;
Assay Maduramicin is the 100.0 ~ 108.0% of labelled amount.
9. the preparation method of maduramicin ammonium premix as claimed in claim 1, it is characterised in that described packaging be according to
Different demands is packaged into different size;Accurately measuring during packaging, error is less than+0.5 ~ 2%.
10. the preparation method system of the maduramicin ammonium premix as described in any one claim in claim 1 ~ 9
Standby maduramicin ammonium premix.
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106474073A (en) * | 2016-12-22 | 2017-03-08 | 甘肃汇能生物工程有限公司 | A kind of preparation method of 1% Maduramicin Ammonium granule |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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US4824829A (en) * | 1984-08-15 | 1989-04-25 | American Cyanamid Company | Non-dusting antibiotic, anticoccidial premix compositions and a process for their manufacture |
CN1266684A (en) * | 1999-03-16 | 2000-09-20 | 汪明 | Compound preparation for treating coccidiosis |
CN103479658A (en) * | 2013-10-09 | 2014-01-01 | 郑州福源动物药业有限公司 | Maduramicin ammonium nicarbazin premix and preparation method thereof |
-
2016
- 2016-08-31 CN CN201610762879.2A patent/CN106176621A/en active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4824829A (en) * | 1984-08-15 | 1989-04-25 | American Cyanamid Company | Non-dusting antibiotic, anticoccidial premix compositions and a process for their manufacture |
CN1266684A (en) * | 1999-03-16 | 2000-09-20 | 汪明 | Compound preparation for treating coccidiosis |
CN103479658A (en) * | 2013-10-09 | 2014-01-01 | 郑州福源动物药业有限公司 | Maduramicin ammonium nicarbazin premix and preparation method thereof |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN106474073A (en) * | 2016-12-22 | 2017-03-08 | 甘肃汇能生物工程有限公司 | A kind of preparation method of 1% Maduramicin Ammonium granule |
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Application publication date: 20161207 |