CN101933974A - Liver protective particle and preparation method thereof - Google Patents

Liver protective particle and preparation method thereof Download PDF

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Publication number
CN101933974A
CN101933974A CN201010249830XA CN201010249830A CN101933974A CN 101933974 A CN101933974 A CN 101933974A CN 201010249830X A CN201010249830X A CN 201010249830XA CN 201010249830 A CN201010249830 A CN 201010249830A CN 101933974 A CN101933974 A CN 101933974A
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parts
hepatoprotective
granule
hours
radix isatidis
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付宁静
徐晓曦
杨彦平
徐桃枝
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JIANGXI ZHONGCHENG TCM EXTRACT CO Ltd
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JIANGXI ZHONGCHENG TCM EXTRACT CO Ltd
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Abstract

The invention discloses a liver protective particle and a preparation method thereof. The liver protective particle comprises the following main components in parts by weight: 400-500 parts of bupleurum, 400-500 parts of capillary artemisia, 200-300 parts of schisandra chinensis, 400-500 parts of radix isatidis, 10-50 parts of pulvis fellis suis and 100-200 parts of mung beans. The preparation method is as follows: evenly mixing the bupleurum, the capillary artemisia, the radix isatidis and the mung beans; adding water to decoct for twice, wherein each time spends 2 hours; merging decoction and filtering; keeping the temperature at 60 DEG C and reducing pressure to concentrate the decoction to obtain extract the relative density of which is 1.25-1.30g/ml for later use; crushing the schisandra chinensis into crude powder, refluxing to extract the crude powder for three times by ethanol with the concentration of 75%, wherein, the first time spends 3 hours, the second time spends 2 hours and the third time spends 1 hour; merging the extracting solutions and recovering ethanol, keeping the temperature at 60 DEG C and reducing pressure to concentrate the extracting solution to obtain extract the relative density of which is 1.25-1.30g/ml; merging the extracts; crushing; and adding the pulvis fellis suis and proper amount of auxiliary materials to pelletize to obtain the liver protective particles. The liver protective particle prepared by the invention has the advantages of simple process control, high bioavailability, good drug effect, fast curative effect and low cost.

Description

Hepatoprotective granule and preparation method thereof
Technical field
The present invention relates to treat the fatty liver syndrome drug world, be specially and be used for the treatment of syndromic hepatoprotective granule of Animal fat liver and preparation method thereof.
Background technology
Fatty liver syndrome (FLS-Fatty Liver Syndrome) is a kind of meat young fowl and egg fowl of being mainly in, take in too high and some micro-nutrient composition deficiency or uneven mainly due to energy, cause the disorder of body intracellular metabolite, and the lipid metabolism disease that causes liver fat over-deposit and bleeding, mortality rate to increase.Its typical feature is that disease chicken body weight increases, hepatomegaly, greasiness and frangible, and laying hen and broiler are all fallen ill.
Chinese veterinarian treats fatty liver mainly based on dispelling phlegm and eliminating dampness, blood circulation promoting and blood stasis dispelling, dispersing the stagnated live-QI to relieve the stagnation of QI, spleen invigorating food stagnation removing, is aided with methods such as heat-clearing and toxic substances removing, function of gallbladder promoting eliminate indigestion, the kidney invigorating nourishing the liver simultaneously.Modern pharmacological research shows: Rhizoma Alismatis, Fructus Crataegi, Radix Polygoni Multiflori etc. have blood fat reducing and press down the fat effect, and Herba Artemisiae Scopariae, Radix Bupleuri, Radix Scutellariae etc. have the hepatic cholagogic effect, all can be used for the treatment of fatty liver.But fatty liver is still to prevent, to reduce or to avoid paathogenic factor at present.Though the report of treatment by Chinese herbs fatty liver determined curative effect is more, still there are not the approval and the listing of treatment fatty liver syndrome herbal medicine preparation.
" the liver-protecting tablet that Chinese pharmacopoeia is recorded, effect with " depressed liver-energy dispersing and QI regulating, strengthening the spleen to promote digestion ", pharmacological research show have protecting the liver, promote bile secretion, anti-infectious function, be used for hepatitis, fatty liver and drug induced hepatic injury clinically at people's medicine, cheap, have no side effect.Radix Bupleuri has the inhibition hepatic fibroplasia in the side, prevents hepatitis interstitialis chronica, cholesterol reducing, triglyceride effect; Herba Artemisiae Scopariae can increase bile secretion, cholic acid increase, cholesterol is reduced, and participate in the metabolism of bile acid, bilirubin, lipoid and some noxious substance; The biphenyl octene compounds that Fructus Schisandrae Chinensis contains can alleviate the substance metabolism obstacle of toxic liver injury, alleviates hepatic cell fattydegeneration; Radix Isatidis, Pulvis Fellis Suis, Semen phaseoli radiati powder etc. all have heat-clearing and toxic substances removing, removing heat from blood effect.
The clinical practice of liver-protecting tablet, pharmacological action, process recipes, quality control etc. have had certain basis, and its dosage changing form is made the hepatoprotective granule, can effectively reduce the new product development risk, the abundant fast moving product of protecting; And use it for the syndromic treatment of chicken fatty liver, can fill up veterinary drug clinical application blank.
Summary of the invention
Technical problem solved by the invention is to provide a kind of happy granule of liver and gall that is used for the treatment of the animal liver gallbladder disease and preparation method thereof, to solve the shortcoming in the above-mentioned background technology.
The object of the present invention is achieved like this, and its component and weight proportion are as follows:
Radix Bupleuri 400-500 part, Herba Artemisiae Scopariae 400-500 part, Fructus Schisandrae Chinensis 200-300 part, Radix Isatidis 400-500 part, Pulvis Fellis Suis 10-50 part, Semen phaseoli radiati 100-200 part.
Optimum weight proportioning of the present invention is as follows:
434.7 parts of Radix Bupleuri, 434.7 parts of Herba Artemisiae Scopariaes, 233.3 parts of Fructus Schisandrae Chinensis, 434.7 parts of Radix Isatidis, 27.8 parts of Pulvis Fellis Suiss, 177.8 parts in Semen phaseoli radiati.
Radix Bupleuri has the inhibition hepatic fibroplasia, prevents hepatitis interstitialis chronica, cholesterol reducing, triglyceride effect; Herba Artemisiae Scopariae can increase bile secretion, cholic acid increase, cholesterol is reduced, and participate in the metabolism of bile acid, bilirubin, lipoid and some noxious substance; The biphenyl octene compounds that Fructus Schisandrae Chinensis contains can alleviate the substance metabolism obstacle of toxic liver injury, alleviates hepatic cell fattydegeneration; Radix Isatidis, Pulvis Fellis Suis, Semen phaseoli radiati powder etc. all have heat-clearing and toxic substances removing, removing heat from blood effect.
The particulate preparation method of above-mentioned hepatoprotective may further comprise the steps:
With Radix Bupleuri, Herba Artemisiae Scopariae, Radix Isatidis, Semen phaseoli radiati 4 flavor medicine mix homogeneously decoct with water twice, and each 2 hours, collecting decoction filtered, and temperature keeps 60 ℃ and is evaporated to the extractum that relative density is 1.25~1.30g/ml, and is standby; Fructus Schisandrae Chinensis part is ground into coarse powder, and with 75% alcohol reflux three times, 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, merge extractive liquid, reclaimed ethanol, and temperature keeps 60 ℃ and is evaporated to the extractum that relative density is 1.25~1.30g/ml; Extractum merges, and pulverizes, and adds Pulvis Fellis Suis and appropriate amount of auxiliary materials, the system granule, promptly.
The present invention is brown to brown yellow granule; Bitter in the mouth, depressed liver-energy dispersing and QI regulating, strengthening the spleen to promote digestion is used for the chicken fatty liver syndrome, and every premium on currency mixes drink with this product 3.0~4.5g, or every kilogram of feed is added this product 6.0~9.0g mixed feeding.
Clinical trial of the present invention, pharmacological toxicology result of study are as follows:
(1) artificial modeling clinical trial
Choose public young 350 of the blue brown egg in the healthy sea of 1 age in days, be divided into 7 groups at random, 50 every group.The A group is the normal healthy controls group, and B is a model control group, and the C group is hepatoprotective granule prevention group, and D, E, F are 3 treatment groups of the basic, normal, high dosage of hepatoprotective granule (dose difference is 50% between group), and the G group is choline chloride treatment group.All test chickens are fed at the standard hen house, press normally immunity of immune programme for children, and all the other processing are undertaken by table 1.Observe and write down clinical manifestation, morbidity and the death condition of every group of chicken in the process of the test in detail.Dead chicken is in time cutd open inspection, observe internal organs organ morphological changes of various tissue components in detail.Add propylthiouracil with high fat daily ration and feed after 1 week, B, D, E, F, G group part test chicken engender clinical symptoms, along with the continuation symptom of test becomes clear day by day, show the disease rate during to the 14th age in days and reach 70%.It is depressed to be embodied in spirit, is reluctant activity, person's astasia very, and the poly-heap of happiness and crouching, the one-sided paralysis of the appearance that has, appetite decline, cockscomb, meat whisker turn white, and abdominal part is big and sagging, and minority chicken death (table 2) occurs.C group through taking the prevention of hepatoprotective granule does not show tangible clinical symptoms, omnidistance dead 1 chicken of test.Hepatoprotective granule and choline chloride treatment are adopted in D, E, F, G group morbidity back, and the high fat daily ration that stops to feed adds propylthiouracil, make test chicken stop death, and clinical symptoms is alleviated rapidly, alleviated and finally disappears.Each is organized the chicken death situation and sees Table 2.
Table 1: test chicken processing time and method
Figure BSA00000223689000041
Table 2: duration of test is respectively organized chicken death situation (only)
Figure BSA00000223689000042
As seen from the experiment, in the daily ration of chicken, add high fat and propylthiouracil, can successfully cause chicken fatty liver syndrome pathology model continuous 2 weeks; In every 1L drinking-water, add 4.5g hepatoprotective granule the chicken fatty liver syndrome due to the high fat daily ration is had preventive effect; In drinking-water, add the hepatoprotective granule to the chicken fatty liver syndrome tool therapeutical effect due to the high fat daily ration; Wherein (every 1L drinking-water 4.5g), high (every 1L drinking-water 6.0g) dosage curative effect are better, can feed continuously 7 days with every 1L drinking-water 4.5g as clinical recommended dose; Tangible untoward reaction does not all appear in particulate each the dosage group of the hepatoprotective of feeding.
(2) natural cases clinical trial
The blue brown father and mother in 9800 seas that the extensively super animal husbandry company limited in Jilin Province is raised in cages are for kind of a chicken, feedstuff is our company's autogamy, by this breed standard feeding and management and prophylactic immunization, see egg 18 ages in week, this phase survival rate reaches egg-laying peak, average weight 1.64kg 93.82%, 24 age in week, with this batch chicken peak feed ratio shifted to an earlier date habitually in the past nearly 10d give with, and before increased increment ratio weekly.From about 300 ages in days, this batch chicken laying rate occurs and descends day by day, drops to about 86% by 93% in two weeks, and the continuation downward trend is arranged; Every day 3~4 chicken deaths.The chicken group is most individual searches for food the time lengthening except that performance, does not see how tangible clinical symptoms, and minority chicken essence god is poor slightly, yellowish green or watery stools occurs, and cockscomb, meat whisker color are thin out.
Test drug is the hepatoprotective granule, produces lot number: 20081017 on October 17th, 2008 by Jiangxi Zhongcheng TCM Extract Co., Ltd.; Composition: Radix Bupleuri, Herba Artemisiae Scopariae, Radix Isatidis, Fructus Schisandrae Chinensis, Fel Sus domestica powder, Semen phaseoli radiati; Specification: 100g/ bag; The contrast medicine is a choline chloride, is produced on February 6th, 2009 by Tianjin foot draught animal fowl pharmaceutical Co. Ltd, and lot number: pre-word (2005) 011106 is raised in Tianjin; Production licence number: raise pre-(2005) 0891 content: 50%.Test chicken is divided into 2 groups, every group about 4900 at random by fixing cage house; The A group is the treatment by Chinese herbs group, adds the free drink-service of 4.5g hepatoprotective granule, successive administration 7d in every 1L drinking-water; The B group is choline chloride treatment group, and every 1L drinking-water adds 0.6g choline chloride, successive administration 7d.Experimental observation phase 28d.Carry out clinical manifestation, the record of index such as the situation of laying eggs, blood test, liver index and hepatic fat content.Table 3 is serum triglycerides (TG) changes of contents (mmol/L), and table 4 changes (unit: %) for the test chicken hepatic fat content.
Table 3: serum total cholesterol (TC) content changes of contents (mmol/L)
Figure BSA00000223689000052
Table 4: the test chicken hepatic fat content changes (unit: %)
Figure BSA00000223689000061
As seen from the experiment, add the free drink-service of 4.5g hepatoprotective granule hepatoprotective granule in every 1L drinking-water, successive administration 7d has better curative effect to the chicken fatty liver syndrome, and on indexs such as laying rate and triglyceride, the hepatoprotective granule also slightly is better than choline chloride; Add 4.5g hepatoprotective granule in every 1L drinking-water, logotype 7d has better therapeutic effect to the chicken fatty liver syndrome of natural occurrence, can be with this dosage as clinical recommended dose; Use this dosage hepatoprotective granule drinking-water, logotype 7d is safe.
(3) pharmacodynamic study
The hepatoprotective granule is to the protective effect of fatty liver rat model: make rat fat liver model by high lipid food, estimate the liver protection effect of hepatoprotective granule to the fatty liver rat model.Result of the test shows, the blood fat of hepatoprotective granule scalable hyperlipidemia model improves the liver oxidation resistance, reduces the liver coefficient, illustrates that the hepatoprotective granule has the effect of certain protection liver function.
The hepatoprotective granule is to the influence of mice functional dyspepsia: by mice functional dyspepsia model test, estimate its influence to digestive system.Result of the test shows that the hepatoprotective granule can promote the gastric emptying of functional dyspepsia mice, illustrates that the hepatoprotective granule has the digestion promoting effect.
To sum up state test and show that the hepatoprotective granule has liver function protecting, digestion promoting effect.
(4) studies on acute toxicity
The hepatoprotective granule fails to measure LD50.The mouse stomach maximum dosage-feeding is 430.2g crude drug/kg body weight, be equivalent to the clinical consumption per day of rabbit fowl (or fowl) (956 times of 0.45g crude drug/kg), still healthy active after 7 days, none death was put to death after 7 days, the postmortem naked eyes do not see that internal organs have abnormal change.The clinical consumption safety of this medicine animal is described.
(5) long term toxicity research
With 80 of rats, divide four groups at random, 20 every group.Heavy dose of stomach of irritating gives hepatoprotective granule medicament 43.02g crude drug/kg (being equivalent to clinical chicken 96 times with dosage), middle dosage group gives hepatoprotective granule medicament 21.51g crude drug/kg (being equivalent to clinical chicken 48 times with dosage), small dose group gives hepatoprotective granule medicament 4.302g crude drug/kg (being equivalent to clinical chicken 9.6 times with dosage), the administration volume is the 1ml/100g body weight, every day 1 time, matched group gives the isometric(al) normal saline.Successive administration 1 month is observed general situation every day, and administration was got 10 animals for every group and carried out hematology, blood biochemical and main organs pathological examination after 1 month.The residue animal stops administration, observes for 2 weeks, carries out hematology, blood biochemical and main organs pathological examination again.Result of the test shows that each organizes rat during administration and in convalescent period, all no abnormal variation such as rat ordinary circumstance and behavioral activity, feces etc.Each administration treated animal hematology, blood biochemical and main organs pathological examination and matched group relatively have no significant change.Continuously rat oral gavage administration 1 month and 2 weeks of drug withdrawal, do not see rats death, do not see the overt toxicity reaction yet, illustrate that the particulate safety of hepatoprotective is big.
Beneficial effect:
The hepatoprotective granule technology controlling and process that the present invention makes is simple, the bioavailability height, and good drug efficacy, curative effect is fast, and cost is low.
Description of drawings
Fig. 1 is two groups of laying rate of chicken changing trend diagrams;
The specific embodiment
Best embodiment of the present invention divides other scheme according to integral body, implements respectively, below by embodiment the present invention is specifically described:
Embodiment 1:
Get 400 parts of Radix Bupleuri, 400 parts of Herba Artemisiae Scopariaes, 250 parts of Fructus Schisandrae Chinensis, 450 parts of Radix Isatidis, 30 parts of Pulvis Fellis Suiss, 150 parts in Semen phaseoli radiati, and press following processing step and technological parameter preparation: with 400 parts of Radix Bupleuri, 400 parts of Herba Artemisiae Scopariaes, 450 parts of Radix Isatidis, 150 part of 4 flavor of Semen phaseoli radiati medicine mix homogeneously decocts with water twice, each 2 hours, collecting decoction, filter, temperature keeps 55 ℃ and is evaporated to the extractum that relative density is 1.26g/ml, and is standby; 250 parts of Fructus Schisandrae Chinensis are ground into coarse powder, and with 70% alcohol reflux three times, 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, merge extractive liquid, reclaimed ethanol, and temperature keeps 55 ℃ and is evaporated to the extractum that relative density is 1.25g/ml; Extractum merges, and adds 30 parts of Pulvis Fellis Suiss and appropriate amount of auxiliary materials, the system granule, promptly.
Embodiment 2:
Get 434.7 parts of Radix Bupleuri, 434.7 parts of Herba Artemisiae Scopariaes, 233.3 parts of Fructus Schisandrae Chinensis, 434.7 parts of Radix Isatidis, 27.8 parts of Pulvis Fellis Suiss, 177.8 parts in Semen phaseoli radiati; And press following processing step and technological parameter preparation: with 434.7 parts of Radix Bupleuri, 434.7 parts of Herba Artemisiae Scopariaes, 434.7 parts of Radix Isatidis, 177.8 part of 4 flavor of Semen phaseoli radiati medicine mix homogeneously decocts with water twice, each 2 hours, collecting decoction, filter, temperature keeps 55 ℃ and is evaporated to the extractum that relative density is 1.26g/ml, and is standby; 233.3 parts of Fructus Schisandrae Chinensis are ground into coarse powder, and with 70% alcohol reflux three times, 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, merge extractive liquid, reclaimed ethanol, and temperature keeps 55 ℃ and is evaporated to the extractum that relative density is 1.25g/ml; Extractum merges, and adds 27.8 parts of Pulvis Fellis Suiss and appropriate amount of auxiliary materials, the system granule, promptly.
1. raise 30 of the syndromic chickens of suffering from fatty liver, the hepatoprotective granule of producing is mixed drinking water, every 1L water adds 4.0g hepatoprotective granule, raises 7 days, and 27 chickling are fully recovered.
2. raise 30 of the syndromic chickens of suffering from fatty liver, the hepatoprotective granule of producing is mixed with feedstuff, every 1kg feedstuff adding 8.0g hepatoprotective granule was raised 7 days, and 28 chickling are fully recovered.
More than show and described ultimate principle of the present invention and principal character and advantage of the present invention.The technical staff of the industry should understand; the present invention is not restricted to the described embodiments; that describes in the foregoing description and the description just illustrates principle of the present invention; without departing from the spirit and scope of the present invention; the present invention also has various changes and modifications, and these changes and improvements all fall in the claimed scope of the invention.The claimed scope of the present invention is defined by appending claims and equivalent thereof.

Claims (5)

1. the hepatoprotective granule is characterized in that, its main component is formed, and counts by weight, and raw material is composed as follows: Radix Bupleuri 400-500 part, Herba Artemisiae Scopariae 400-500 part, Fructus Schisandrae Chinensis 200-300 part, Radix Isatidis 400-500 part, Pulvis Fellis Suis 10-50 part, Semen phaseoli radiati 100-200 part.
2. hepatoprotective granule according to claim 1 is characterized in that, the optimum weight proportioning is as follows: 434.7 parts of Radix Bupleuri, 434.7 parts of Herba Artemisiae Scopariaes, 233.3 parts of Fructus Schisandrae Chinensis, 434.7 parts of Radix Isatidis, 27.8 parts of Pulvis Fellis Suiss, 177.8 parts in Semen phaseoli radiati.
3. hepatoprotective granule according to claim 1 is characterized in that, described hepatoprotective granule is a granule.
4. the particulate preparation method of hepatoprotective is characterized in that, comprises the steps: with Radix Bupleuri Herba Artemisiae Scopariae, Radix Isatidis, Semen phaseoli radiati 4 flavor medicine mix homogeneously decoct with water twice, each 2 hours, collecting decoction filters, and temperature keeps 60 ℃ and is evaporated to the extractum that relative density is 1.25~1.30g/ml, and is standby; Fructus Schisandrae Chinensis 200-300 part is ground into coarse powder, with 75% alcohol reflux three times, 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, merge extractive liquid, reclaims ethanol, and temperature keeps 60 ℃ and is evaporated to the extractum that relative density is 1.25~1.30g/ml; Extractum merges, and pulverizes, and adds Pulvis Fellis Suis and mixes.
5. the particulate preparation method of hepatoprotective according to claim 4 is characterized in that, also comprises the steps: powder is added right amount of auxiliary materials, makes granule with common process.
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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102397335A (en) * 2011-11-18 2012-04-04 青岛绿曼生物工程有限公司 Pure Chinese medicinal composition for treating poultry fatty liver haemorrhage syndrome and preparation method thereof
CN102512500A (en) * 2012-01-10 2012-06-27 天圣制药集团股份有限公司 Preparation for treating chronic hepatitis and cirrhosis and preparation method of preparation
CN102657827A (en) * 2012-06-01 2012-09-12 金海英 Traditional Chinese medicine used for treating liver and gall diseases and preparation method thereof
CN103300361A (en) * 2013-05-16 2013-09-18 吴永金 Liver-protecting granule electuary and preparation method thereof
CN104083510A (en) * 2014-07-16 2014-10-08 江西中成中药原料有限公司 Liver-protecting granule for poultry and preparation method thereof
CN104738359A (en) * 2015-03-28 2015-07-01 张静芬 Liver-soothing qi-regulating vegetable-stuffed bun
CN105902758A (en) * 2016-05-30 2016-08-31 广西华佳丝绸有限公司 Mulberry leaf liver-protecting granule and processing method thereof
CN114468162A (en) * 2022-02-25 2022-05-13 四川恒通动物营养科技有限公司 Additive for enhancing immunity and reproductive performance of sows and preparation method thereof

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102397335A (en) * 2011-11-18 2012-04-04 青岛绿曼生物工程有限公司 Pure Chinese medicinal composition for treating poultry fatty liver haemorrhage syndrome and preparation method thereof
CN102512500A (en) * 2012-01-10 2012-06-27 天圣制药集团股份有限公司 Preparation for treating chronic hepatitis and cirrhosis and preparation method of preparation
CN102657827A (en) * 2012-06-01 2012-09-12 金海英 Traditional Chinese medicine used for treating liver and gall diseases and preparation method thereof
CN103300361A (en) * 2013-05-16 2013-09-18 吴永金 Liver-protecting granule electuary and preparation method thereof
CN104083510A (en) * 2014-07-16 2014-10-08 江西中成中药原料有限公司 Liver-protecting granule for poultry and preparation method thereof
CN104083510B (en) * 2014-07-16 2016-09-28 江西中成中药原料有限公司 A kind of poultry HuGanNing tablet and preparation method thereof
CN104738359A (en) * 2015-03-28 2015-07-01 张静芬 Liver-soothing qi-regulating vegetable-stuffed bun
CN105902758A (en) * 2016-05-30 2016-08-31 广西华佳丝绸有限公司 Mulberry leaf liver-protecting granule and processing method thereof
CN114468162A (en) * 2022-02-25 2022-05-13 四川恒通动物营养科技有限公司 Additive for enhancing immunity and reproductive performance of sows and preparation method thereof

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