CN113713004A - Radix isatidis granules and preparation method thereof - Google Patents

Radix isatidis granules and preparation method thereof Download PDF

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Publication number
CN113713004A
CN113713004A CN202111088200.3A CN202111088200A CN113713004A CN 113713004 A CN113713004 A CN 113713004A CN 202111088200 A CN202111088200 A CN 202111088200A CN 113713004 A CN113713004 A CN 113713004A
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parts
extraction
isatis root
weight
concentration
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Inventor
崔赢予
魏成威
刘媚钰
黄臣
赵丽
郝敬友
马刚
张萍
王道成
樊淑颖
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Harbin Lu Da Sheng Animal Pharmaceutical Co ltd
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Harbin Lu Da Sheng Animal Pharmaceutical Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/19Acanthaceae (Acanthus family)
    • A61K36/195Strobilanthes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/233Bupleurum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/31Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • A61K36/315Isatis, e.g. Dyer's woad
    • AHUMAN NECESSITIES
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/704Polygonum, e.g. knotweed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/85Verbenaceae (Verbena family)
    • A61K36/855Clerodendrum, e.g. glorybower
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12Antidiarrhoeals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P11/00Drugs for disorders of the respiratory system
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P31/16Antivirals for RNA viruses for influenza or rhinoviruses
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    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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Abstract

The invention discloses a isatis root and isatis root granule and a preparation method thereof, wherein the isatis root and isatis root granule comprises the following components in parts by weight: 40-100 parts of isatis root, 60-120 parts of dyers woad leaf, 50-80 parts of radix bupleuri, 10-30g of aloe polysaccharide, 10-25 parts of flavoring agent and 50-80 parts of excipient. The extraction method combining traditional Chinese medicine extraction and concentration processes is adopted, 4 extraction principles of decoction extraction, percolation extraction, countercurrent extraction and reflux extraction are integrated, the two processes of extraction and concentration of the isatis root, the dyers woad leaf and the radix bupleuri are synchronously carried out, the high-temperature decoction process with pressure and normal pressure in a traditional extraction tank is changed, the leaching of effective components is facilitated, the effective components of the traditional Chinese medicinal materials are kept to be prevented from being evaporated and lost to the maximum extent, the energy is saved, the water solvent consumption is reduced, the feeding amount is increased, the paste yield is improved, the storage process is reduced, the electric power energy is saved, and the method has higher practical application significance.

Description

Radix isatidis granules and preparation method thereof
Technical Field
The invention relates to the technical field of veterinary traditional Chinese medicines, and particularly relates to isatis root and isatis root granules and a preparation method thereof.
Background
The isatis root and indigowoad root granules are a Chinese patent medicine, have the functions of reducing swelling and resolving masses, strengthening heart, promoting diuresis and benefiting gallbladder, resisting bacteria and inflammation, resisting viruses, enhancing immunity and the like, and are common veterinary medicine prescriptions. The isatis root-isatis root granules have good treatment and prevention effects on influenza, high fever, toroids and other viral diseases, have good effects on the conditions of high fever, decreased feed intake, depression, low immunity of livestock groups and the like clinically, and can effectively solve the problems of substances harmful to animal organisms, such as mycotoxin, antibiotic residues, metabolites of bacteria and viruses, wastes of white body metabolism, various stress factors, harmful toxic gases and the like.
The indigowoad root and indigowoad leaf granules sold in the market have weak drug effect, slow effect and low cure rate, and often cause great loss for large livestock farms. And the preparation process mostly adopts the traditional hydroalcoholic extraction method, wet granulation and the like, has many defects, high loss of effective components, low content, difficult operation of post-production procedures, long production period, serious pollution in the production process and the like.
Therefore, the problem to be solved by the technical personnel in the field is how to provide a novel isatis root granule and a preparation method thereof to effectively improve the medicinal effect.
Disclosure of Invention
In view of the above, the present invention provides isatis root granules with novel components and a novel preparation method of isatis root granules.
In order to achieve the purpose, the invention adopts the following technical scheme:
the isatis root and indigowoad leaf granules comprise the following components in parts by weight:
40-100 parts of isatis root, 60-120 parts of dyers woad leaf, 50-80 parts of radix bupleuri, 10-30g of aloe polysaccharide, 10-25 parts of flavoring agent and 50-80 parts of excipient.
Preferably, the flavoring agent is sewage glucose.
Preferably, the excipient is one of maltodextrin or cyclodextrin.
The preparation method of the indigowoad root and indigowoad root granules in the technical scheme comprises the following steps of:
(1) weighing isatis root, dyers woad leaf and radix bupleuri according to parts by weight, cutting the materials, placing the cut materials into an extraction tank to form a medicinal material layer, adding water with the weight 8-10 times of the total weight of the medicinal materials to soak the materials for 1.5-2.5h, adjusting the temperature of the extraction tank to 60-80 ℃ for extraction, leading out part of an extracting solution from the bottom of the extraction tank in the extraction process, carrying out reduced pressure concentration at the concentration temperature of 50-70 ℃, condensing steam generated by concentration, returning the condensed steam serving as a new solvent into the extraction tank to carry out percolation extraction on the medicinal material layer, repeating the steps for 2-3h, and finally concentrating to obtain a fluid extract;
(2) crushing and mixing the urban aloe polysaccharide, the flavoring agent and the excipient in parts by weight, and filtering through a 80-mesh sieve to obtain an auxiliary material mixture;
(3) and adding the mixture of the fluid extract and the auxiliary materials into a spray drying granulator for granulation to obtain isatis root granules.
Preferably, the liquid medicine ratio of the fluid extract in the step (1) is 0.5-2.5: 1.
preferably, the control parameters of the spray drying granulator in the step (3) are as follows: the spraying frequency of the fluid extract is 10Hz, the flow velocity is 150g/min, the hot air inlet temperature is 65-80 ℃, and the inlet air filtering surface area is 2m2Air door pressure of 0.2-0.3MPa, air outlet temperature of 30-50 ℃, and temperature difference delta T between drying air and product surface in granulation stageGranule20 ℃, temperature difference delta T between air and product surface in drying stageDry matter=35℃。
According to the technical scheme, compared with the prior art, the invention discloses the isatis leaf particle and the preparation method thereof, and the isatis leaf particle has the following beneficial effects:
the veterinary isatis root-folium isatidis granules are simple and effective in material, radix bupleuri with the effects of relieving fever, reducing fever, resisting bacteria and viruses is used as a raw material of the isatis root-folium isatidis granules, and aloe polysaccharide with the functions of sterilizing, diminishing inflammation, invigorating stomach, relieving diarrhea and enhancing the immunity of the organism is added, so that the drug effect of the isatis root-folium isatidis granules can be further enhanced, and the prepared isatis root-folium isatidis granules are strong in drug effect, quick in effect and high in cure rate. The invention takes the crushed anhydrous glucose, maltodextrin or cyclodextrin as the forming auxiliary material, has good spray drying and loose prepared particles, wherein, the dextrin and the cyclodextrin have better solubility and formability, low moisture absorption and good formability, and the yield of the easy-to-form particles is high during the granulation. And has certain physiological functions, can activate and proliferate beneficial bacteria in intestinal tract, namely bifidobacterium, promote digestion and absorption, and provide energy under the critical condition of animal metabolism disorder.
The isatis root granule preparation method adopts an extraction method combining traditional Chinese medicine extraction and concentration processes, integrates 4 extraction principles of decoction extraction, percolation extraction, countercurrent extraction and reflux extraction, synchronously carries out two procedures of extraction and concentration of isatis root, dyers woad leaf and radix bupleuri, and changes the traditional high-temperature decoction process with pressure and normal pressure in an extraction tank. In the extraction process, the working temperature in the extraction tank is controlled to be 60-80 ℃, the concentration temperature is controlled to be 50-70 ℃, the leaching of effective components is facilitated, the leaching of impurities such as tannin is prevented, the effective components of the traditional Chinese medicinal materials are kept to be prevented from being evaporated and lost to the maximum extent, meanwhile, secondary distillation generated by extraction and concentration falls back into the extraction tank and is added into the medicinal materials as a new solvent, the new solvent passes through the medicinal material layer from top to bottom, the dynamic percolation effect is realized, soluble substances for dissolving the medicinal materials reach the bottom of the extraction tank, and the soluble substances enter a concentration process for concentration. Thereby saving energy by 0.3-0.5 times, reducing the dosage of water solvent by 0.5-1 times, increasing the feeding amount by 30-60%, improving the paste yield by more than 10%, reducing the storage procedures and saving electric energy by more than 30%.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments of the present invention, and it should be understood that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
The isatis root and indigowoad leaf granules comprise the following components in parts by weight:
40 parts of isatis root, 120 parts of dyers woad leaf, 50 parts of radix bupleuri, 10g of aloe polysaccharide, 25 parts of anhydrous glucose and 50 parts of maltodextrin.
Example 2
The isatis root and indigowoad leaf granules comprise the following components in parts by weight:
100 parts of isatis root, 60 parts of dyers woad leaf, 80 parts of radix bupleuri, 30g of aloe polysaccharide, 10 parts of anhydrous glucose and 80 parts of cyclodextrin.
Example 3
The isatis root and indigowoad leaf granules comprise the following components in parts by weight:
60 parts of isatis root, 80 parts of dyers woad leaf, 60 parts of radix bupleuri, 20g of aloe polysaccharide, 15 parts of anhydrous glucose and 60 parts of cyclodextrin.
Example 4
The isatis root and indigowoad leaf granules comprise the following components in parts by weight:
80 parts of isatis root, 100 parts of dyers woad leaf, 70 parts of radix bupleuri, 25g of aloe polysaccharide, 20 parts of anhydrous glucose and 70 parts of maltodextrin.
Example 5
The isatis root and indigowoad leaf granules comprise the following components in parts by weight:
90 parts of isatis root, 110 parts of dyers woad leaf, 750 parts of radix bupleuri, 30g of aloe polysaccharide, 25 parts of anhydrous glucose and 75 parts of maltodextrin.
The preparation of the drugs of the above examples 1-5 all adopt the following technical scheme:
(1) weighing isatis root, dyers woad leaf and radix bupleuri according to parts by weight, cutting the materials, placing the cut materials into an extraction tank to form a medicinal material layer, adding water with the weight 8-10 times of the total weight of the medicinal materials to soak the materials for 1.5-2.5h, adjusting the temperature of the extraction tank to 60-80 ℃ for extraction, leading out part of an extracting solution from the bottom of the extraction tank in the extraction process, carrying out reduced pressure concentration at the concentration temperature of 50-70 ℃, condensing steam generated by concentration, returning the condensed steam serving as a new solvent into the extraction tank to carry out percolation extraction on the medicinal material layer, repeating the steps for 2-3h, and finally concentrating to obtain a fluid extract;
(2) crushing and mixing the urban aloe polysaccharide, the flavoring agent and the excipient in parts by weight, and filtering through a 80-mesh sieve to obtain an auxiliary material mixture;
(3) and adding the mixture of the fluid extract and the auxiliary materials into a spray drying granulator for granulation to obtain isatis root granules.
Wherein the liquid medicine ratio of the fluid extract in the step (1) is 0.5-2.5: 1; the control parameters of the spray drying granulator in the step (3) are as follows: the spraying frequency of the fluid extract is 10Hz, the flow velocity is 150g/min, the hot air inlet temperature is 65-80 ℃, and the inlet air filtering surface area is 2m2The air door pressure is 0.2-0.3MPa, the air outlet temperature is 30-50 ℃, and the drying air and the product surface in the granulation stage areTemperature difference delta T between surfacesGranule20 ℃, temperature difference delta T between air and product surface in drying stageDry matter=35℃。
Comparative example 1
In contrast to example 3, no bupleurum was included.
Comparative example 2
Compared to example 3, aloe polysaccharides were not included.
Comparative example 3
Compared to example 3, cyclodextrin was replaced by starch.
Comparative example 4
The flavor was changed to sucrose as compared to example 3.
Comparative example 5
Compared with example 3, a common extraction process, namely a combination of traditional hydroalcoholic extraction and wet granulation, is adopted.
Test examples
The isatis root and indigowoad leaf granules provided by the examples 1-5 and the comparative examples 1-5 are used for treating porcine circovirus infection and mixed infection of newcastle disease and infectious bursal disease, and the treatment results show that the spirit is improved and the food consumption is increased after the medicines of the examples 1-5 are taken for 4-6 days, and the disease symptoms are completely disappeared and the course of disease is controlled after the medicines are taken for 7-9 days. The medicines of comparative examples 1 to 4 have little effect in 4 to 6 days, and the effect is just improved obviously in 7 to 9 days, and the basic cure is achieved after about 20 days of the medicines.
The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other. The device disclosed by the embodiment corresponds to the method disclosed by the embodiment, so that the description is simple, and the relevant points can be referred to the method part for description.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (6)

1. The isatis root and isatis root granules are characterized by comprising the following components in parts by weight:
40-100 parts of isatis root, 60-120 parts of dyers woad leaf, 50-80 parts of radix bupleuri, 10-30g of aloe polysaccharide, 10-25 parts of flavoring agent and 50-80 parts of excipient.
2. The isatis root granules according to claim 1, wherein the flavoring agent is sewage glucose.
3. The lathy granule as claimed in claim 1, wherein the excipient is one of maltodextrin or cyclodextrin.
4. A method of preparing azure granules according to claims 1-3, characterized by comprising the steps of:
(1) weighing isatis root, dyers woad leaf and radix bupleuri according to parts by weight, cutting the materials, placing the cut materials into an extraction tank to form a medicinal material layer, adding water with the weight 8-10 times of the total weight of the medicinal materials to soak the materials for 1.5-2.5h, adjusting the temperature of the extraction tank to 60-80 ℃ for extraction, leading out part of an extracting solution from the bottom of the extraction tank in the extraction process, carrying out reduced pressure concentration at the concentration temperature of 50-70 ℃, condensing steam generated by concentration, returning the condensed steam serving as a new solvent into the extraction tank to carry out percolation extraction on the medicinal material layer, repeating the steps for 2-3h, and finally concentrating to obtain a fluid extract;
(2) crushing and mixing the urban aloe polysaccharide, the flavoring agent and the excipient in parts by weight, and filtering through a 80-mesh sieve to obtain an auxiliary material mixture;
(3) and adding the mixture of the fluid extract and the auxiliary materials into a spray drying granulator for granulation to obtain isatis root granules.
5. The method for preparing a lathyris granule as claimed in claim 4, wherein the liquid medicine ratio of the fluid extract in the step (1) is 0.5-2.5: 1.
6. the method for preparing a lathy granule according to claim 4, wherein the control parameters of the spray drying granulator in the step (3) are as follows: the spraying frequency of the fluid extract is 10Hz, the flow velocity is 150g/min, the hot air inlet temperature is 65-80 ℃, and the inlet air filtering surface area is 2m2Air door pressure of 0.2-0.3MPa, air outlet temperature of 30-50 ℃, and temperature difference delta T between drying air and product surface in granulation stageGranule20 ℃, temperature difference delta T between air and product surface in drying stageDry matter=35℃。
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Publication number Priority date Publication date Assignee Title
CN115177679A (en) * 2022-07-01 2022-10-14 山东琪康生物技术有限公司 Preparation process of veterinary isatis root granules for improving content of effective ingredients and palatability

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CN102727545A (en) * 2012-06-30 2012-10-17 郑州百瑞动物药业有限公司 Preparation method of indigowoad root and indigowoad leaf particles used for livestock and poultry
CN103006914A (en) * 2012-09-27 2013-04-03 河南牧翔动物药业有限公司 Isatis root-folium isatidis grain for livestock and preparation method thereof
CN108186706A (en) * 2018-02-28 2018-06-22 山东信合生物制药有限公司 A kind of isatis root-folium isatidis grain for livestock and preparation method thereof

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CN102727545A (en) * 2012-06-30 2012-10-17 郑州百瑞动物药业有限公司 Preparation method of indigowoad root and indigowoad leaf particles used for livestock and poultry
CN103006914A (en) * 2012-09-27 2013-04-03 河南牧翔动物药业有限公司 Isatis root-folium isatidis grain for livestock and preparation method thereof
CN108186706A (en) * 2018-02-28 2018-06-22 山东信合生物制药有限公司 A kind of isatis root-folium isatidis grain for livestock and preparation method thereof

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CN115177679A (en) * 2022-07-01 2022-10-14 山东琪康生物技术有限公司 Preparation process of veterinary isatis root granules for improving content of effective ingredients and palatability

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Application publication date: 20211130