CN109010320A - A kind of double applications released in the agent of type Calcium polycarbophil particle and preparation method and livestock and poultry - Google Patents
A kind of double applications released in the agent of type Calcium polycarbophil particle and preparation method and livestock and poultry Download PDFInfo
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Abstract
The present invention relates to a kind of pair to release type Calcium polycarbophil particle agent and preparation method thereof and the application in livestock and poultry, belongs to veterinary drug and premix field.It is of the invention it is double to release type Calcium polycarbophil particle agent pelletized after spraying to sustained release sandwich layer by immediate release outer layer, then spray coating material soluble in the stomach, be made after dry.Granule calcium polycarbophil of the present invention can in stomach quick release, reach slow release after enteron aisle, extend residence time of the calcium polycarbophil in enteron aisle, antidiarrheal effect is obvious.Calcium polycarbophil is not absorbed in enteron aisle, noresidue, in livestock and poultry breeding alternative antibiotic.
Description
Technical field
The invention belongs to feed additive fields, and in particular to a kind of pair is released the agent of type Calcium polycarbophil particle and its preparation side
Method and the application in livestock and poultry belong to veterinary drug and premix field.
Background technique
Calcium polycarbophil (Calcium polycarbophil) be earliest ground by Abbott of the U.S. original exploitation for controlling
The drug of intestinal irritable syndrome (irritable bowel syndrome, IBS) is treated, in America and Europe, Japan is widely used, and is used for
The alleviation of IBS and a variety of causes constipation symptom, it is domestic also in start within 2011 approval listing.
The active constituent of calcium polycarbophil is diethyl allyl diglycol cross-linked acrylic acid copolymer calcium salt, has extremely strong hydrophily
A kind of resin, have high water absorbing properties, molecular formula (C6H6CaO4) a (C6H10O2) b.Calcium polycarbophil has non-
Normal unique biological chemical performance can rapidly remove calcium therein under acidic environment, form polycarbophil, gather card
Wave it is non-can in the water of 10 times of sole mass is absorbed under acid condition, while after pH value is greater than 4, it may appear that expand, in
More moisture content can be absorbed in property or weakly alkaline environment, at most can achieve 60-100 times.Therefore, when calcium polycarbophil is given birth to
After object takes orally stomach, in gastric acid environment, calcium is removed, and forms polycarbophil；Animal experiments show that after rat takes, in stomach
Decalcification rate can reach 70% at 30 minutes.Because being acidic environment in stomach, it can absorb water, be waited into enteron aisle on a small quantity
Afterwards, since pH value increases, the water imbibition enhancing of polycarbophil can lock moisture absorptions more in enteron aisle.
Calcium polycarbophil mainly has moisture content holding and alimentary canal content feed adjustment in the mechanism that enteron aisle plays a role
Two kinds of effects.Therefore, when organism uses calcium polycarbophil, diarrhea can not only be treated, constipation will not be induced, simultaneously for
The organism of constipation can increase defecation simultaneously and not will cause diarrhea, this characteristic is that other drugs are incomparable.
Calcium polycarbophil is a kind of polymer substance, will not be absorbed in organism enteron aisle, takes orally 14C in rat and dog
After the calcium polycarbophil of isotope labelling, by analyzing the residual at each position of alimentary canal, discovery does not absorb, in urine also not
It was found that calcium polycarbophil remains, all polycarbophils are excreted by excrement, and therefore, calcium polycarbophil is will not to be disappeared
Change road to absorb, finally will not all be excreted by excrement, by microbial metabolism in enteron aisle so not any to organism
Residual.
China's livestock and poultry cultivation is influenced by environmental protection at present, and scale is increasingly concentrated, free-ranging and small-scale farm
It due to not accomplishing environment protection standard, is gradually substituted by the farm of large-scale centralized, large-scale aggregatingization cultivation is improving cultivation effect
Rate reduces breeding pollution, and all has in terms of reducing aquaculture cost and have great advantage, but bring main problem is exactly to hand over simultaneously
Fork infection, most common is exactly animal diarrhea.Usual diarrhea is caused by Different types of etiopathogenises, so having in prevention and treatment and treatment very big
Difficulty, the drug for treating diarrhea at present mainly have three categories, are antibiotic, probiotics, gastrointestinal mucosa protective agent three respectively
Class, wherein effects of antibiotics is best, but the country in the case where subtracting anti-overall situation using being gradually restricted；Probiotics and general
Logical gastrointestinal mucosa protective agent is slow improvement condition intestines and stomach condition, not can solve most of diarrhea problem, and work slower, effect
Uncertain stronger, practical effect is bad.
There are many drug that diarrhea is treated on domestic and international market, but a kind of efficient not yet other than antibiotic, adapt to
Property is wide, and the small drug of toxic side effect is available.In the case where the current whole society all pays close attention to the overall situation of food health, develop a kind of high
It imitates, the non-antibiotic class of low toxicity (nontoxic), wide spectrum enteron aisle for animals adjusts the task of top priority that drug is guarantee food safety.Poly- card wave
Application of the non-calcium in the mankind has appeared in the newspapers, but has no the report applied in livestock and poultry breeding.
Summary of the invention
The purpose of the present invention is to provide a kind of pair to release type Calcium polycarbophil particle agent, and outer layer collapses rapidly after reaching stomach
Solution, immediate release section discharge rapidly drug and reach effective blood drug concentration, and sustained release sandwich layer slow release maintains effective blood drug concentration, realizes
To the timely and effectively preventing of disease, the deficiencies in the prior art are overcome.
It is a further object of the present invention to provide double preparation methods for releasing type Calcium polycarbophil particle agent and its in livestock and poultry
Using.
The technical solution adopted by the present invention to solve the technical problems is:
A kind of pair is released type Calcium polycarbophil particle agent, and the granule is by sustained release sandwich layer, immediate release outer layer and coating material soluble in the stomach
Bed of material composition, each layer mass percent are as follows: 50-70% is sustained sandwich layer, 10-30% immediate release outer layer, 10-20% coating material soluble in the stomach
Layer, wherein
The sustained release sandwich layer is process by the component of following mass percent:
Calcium polycarbophil 2-10%
Gluten 20-50%
Hydroxypropyl cellulose 15-30%
Plasticizer 10%-40%
Surfactant 1-3%
Surplus is pure water；
The immediate release outer layer is process by the component of following mass percent:
Calcium polycarbophil 40-80%
Propylene glycol 3-8%
Binder 20-50%
Disintegrating agent 5-20%
Surplus is pure water.
Gluten is also known as active wheat gluten, wheat gluten protein in the present invention, is extracted from wheat (flour)
Native protein.Its main component is glutenin and alcohol soluble protein, glutenin molecule in threadiness, structure containing beta sheet compared with
It is more；Alcohol soluble protein is intermolecular by hydrogen bond, hydrophobic bond and intramolecular disulfide bond connection, forms more close three-dimensional structure.Paddy
Protein powder is used together the porosity that can increase particulate microsphere body with hydroxypropyl cellulose, delays pharmaceutical release time.In addition,
Gluten, which meets water, may be inhaled itself 2 times of heavy moisture, can cooperate with the water suction improved in enteron aisle with calcium polycarbophil use simultaneously
Property, effectively prevent diarrhea.
Since calcium polycarbophil and hydroxypropyl cellulose are objectionable intermingling system, obtained sandwich layer is simple physical blending
System is in thermodynamic instability state, can be easily separated after long term storage.Proper amount of surfactant is added in sustained release sandwich layer to help
In improving its stability, sapn and poloxamer are nonionic surface active agent, are helped under violent stirring after addition
In forming stable core-shell structure, wherein the core of calcium polycarbophil constitution system, the interfacial film of surfactant constitution system are caused
The shell of hole agent hydroxypropyl cellulose constitution system, reduces interface energy, increases the compatibility and stability of system, simultaneously
By the synergistic effect of hydroxypropyl cellulose and surfactant, the dissolution rate of calcium polycarbophil is further improved, effect is more
It is good.
Preferably, granule is by sustained release sandwich layer, immediate release outer layer and coating material layer soluble in the stomach composition, each layer mass percent
Are as follows: 55% sustained release sandwich layer, 30% immediate release outer layer, 15% coating material layer soluble in the stomach, wherein
The sustained release sandwich layer is process by the component of following mass percent:
Calcium polycarbophil 10%
Gluten 20%
Hydroxypropyl cellulose 20%
Plasticizer 15%
Surfactant 2%
Surplus is pure water；
The immediate release outer layer is process by the component of following mass percent:
Calcium polycarbophil 50%
Propylene glycol 5%
Binder 20%
Disintegrating agent 8%
Surplus is pure water.
Preferably, the binder is at least one of cornstarch, white carbon black, dextrin.
Preferably, the disintegrating agent is croscarmellose sodium, crospovidone, low-substituted hydroxypropyl cellulose, carboxylic
At least one of methyl starch sodium.
Preferably, the plasticizer is polyethylene, ethyl cellulose, acrylic resin, polymethyl methacrylate and silicon
At least one of rubber.
Preferably, the surfactant is sapn and/or poloxamer.
The coating material soluble in the stomach is hydroxypropyl methyl cellulose, hydroxypropyl cellulose, polyvinyl alcohol, acrylic resin VI
Number, polyvinylpyrrolidone, EudragitE, Opadry coating powder soluble in the stomach, soluble in the stomach easily release at least one of beautiful coating powder.
A kind of double preparation methods for releasing type Calcium polycarbophil particle agent, the method comprises the following steps:
The first step, preparation sustained release sandwich layer
The calcium polycarbophil of recipe quantity, Gluten, hydroxypropyl cellulose, plasticizer and surfactant are uniformly mixed
Afterwards, one-step palletizing is carried out on one-step-granulating method, is obtained dry particl after dry on fluidized bed, is crossed 20-60 mesh screen；
Second step prepares immediate release outer layer
The calcium polycarbophil of recipe quantity, propylene glycol, disintegration agent material and binder are uniformly mixed, pure water is added, is mixed
After obtain slurry property material；
Third step, granulation
The grout material for obtaining second step in granulator sprays on the stemness particle that the first step obtains, sieving；
4th step, coating
Coating material soluble in the stomach is sprayed into the stemness particle that package third step obtains on one-step-granulating method, after dry, crosses 20
Mesh obtains Calcium polycarbophil particle.
Releasing type Calcium polycarbophil particle agent for of the present invention pair can be used for preparing the drug of prevention and treatment livestock and poultry diarrhea disease.
The obtained calcium polycarbophil pre-mixing agent of the present invention can be applied in the raising of economic animal, including chicken,
Duck, goose, pig, ox, sheep and rabbit etc..
The obtained calcium polycarbophil pre-mixing agent of the present invention is used to treat the dosage of livestock and poultry according to animal body difference, every head
(only) daily dosage is between 1-20g.Specific daily recommended dose: pig 1-15g/ head, ox 5-20g/ head, sheep 2-10g/ head, rabbit
Only, only, only, goose 0.2-4g/ only, treats diarrhea significant effect to duck 0.1-3g/ to chicken 0.1-3g/ to 0.5-3g/.
Calcium polycarbophil particle agent of the present invention can also be added in feed, be used to prepare the somatotrophic feed of livestock and poultry, such as: this
The premix provided is provided, is also applied to prepare the feeds such as batch, particulate material.
The medicine have the advantages that
1, the achievable double release behaviors of type Calcium polycarbophil particle agent are released for provided by the invention pair, it is rapid that outer layer reaches stomach
Disintegration, immediate release section discharge rapidly drug and reach effective blood drug concentration, and slow release layer slow release maintains effective blood drug concentration, realizes
To the timely and effectively preventing of disease.It is more convenient using drug feasible, moreover it is possible to reduce administration number of times, improve medication compliance.
2, by the synergistic effect of surfactant, the physical stability of Calcium polycarbophil particle sandwich layer is increased, is convenient for
Long term storage and transport.
3, provided by the invention double to release the agent of type Calcium polycarbophil particle in sandwich layer addition Gluten not only to can increase particle micro-
The porosity of sphere, delays pharmaceutical release time, and calcium polycarbophil can also be cooperateed with to improve the water imbibition in enteron aisle, treats water
Property diarrhea significant effect.
4, calcium polycarbophil is used to adjust animal intestinal tract by the present invention, treats animal diarrhea, through animal experiments show that, according to
The difference of target animal, additive amount can be obviously improved the abdomen of animal in the case where (only) the daily usage amount of 1-20g every
Situation is rushed down, is worked rapid.
Specific embodiment
In following embodiment, used calcium polycarbophil is purchased from Zhejiang Top Medicine Co., Ltd, Nosiheptide
Pre-mixing agent is purchased from Zhejiang Hui Neng Biological Co., Ltd..Other used auxiliary materials are purchased from market supply quotient.
Embodiment 1: double preparations for releasing type Calcium polycarbophil particle agent
A kind of pair is released type Calcium polycarbophil particle agent, by the sustained release sandwich layer of mass percent 50%, 30% immediate release outer layer
It is formed with 20% coating material layer soluble in the stomach, wherein
The sustained release sandwich layer is process by the component of following mass percent:
Calcium polycarbophil 10%
Gluten 20%
Hydroxypropyl cellulose 30%
Plasticizer 20%
Surfactant 2%
Surplus is pure water；
The immediate release outer layer is process by the component of following mass percent:
Calcium polycarbophil 50%
Propylene glycol 5%
Binder 20%
Disintegrating agent 8%
Surplus is pure water.
In the present invention, the binder is white carbon black, and the disintegrating agent is sodium carboxymethyl starch, and the plasticizer is poly- second
Alkene, the surfactant are sapn.
In the present invention, it is described it is double release type Calcium polycarbophil particle agent the preparation method is as follows:
The first step, preparation sustained release sandwich layer
The calcium polycarbophil of recipe quantity, Gluten, hydroxypropyl cellulose, plasticizer and surfactant are uniformly mixed
Afterwards, one-step palletizing is carried out on one-step-granulating method, is obtained dry particl after dry on fluidized bed, is crossed 20-60 mesh screen；
Second step prepares immediate release outer layer
The calcium polycarbophil of recipe quantity, propylene glycol, disintegration agent material and binder are uniformly mixed, pure water is added, is mixed
After obtain slurry property material；
Third step, granulation
The grout material for obtaining second step in granulator sprays on the stemness particle that the first step obtains, sieving；
4th step, coating
Coating material soluble in the stomach is sprayed into the stemness particle that package third step obtains on one-step-granulating method, after dry, crosses 20
Mesh obtains Calcium polycarbophil particle.
Embodiment 2: double preparations for releasing Calcium polycarbophil particle agent
A kind of pair is released type Calcium polycarbophil particle agent, by the sustained release sandwich layer of mass percent 60%, 20% immediate release outer layer
Coating material layer soluble in the stomach with 20% forms.
The sustained release sandwich layer is process by the component of following mass percent:
Calcium polycarbophil 8%
Gluten 28%
Hydroxypropyl cellulose 22%
Plasticizer 10%
Surfactant 2%
Surplus is pure water；
The immediate release outer layer is process by the component of following mass percent:
Calcium polycarbophil 50%
Propylene glycol 5%
Binder 20%
Disintegrating agent 8%
Surplus is pure water.
In the present invention, the binder is dextrin, and the disintegrating agent is low-substituted hydroxypropyl cellulose, the plasticizer third
Olefin(e) acid resin, the surfactant are poloxamer.
In the present invention, it is described it is double release type Calcium polycarbophil particle agent the preparation method is as follows:
The first step, preparation sustained release sandwich layer
The calcium polycarbophil of recipe quantity, Gluten, hydroxypropyl cellulose, plasticizer and surfactant are uniformly mixed
Afterwards, one-step palletizing is carried out on one-step-granulating method, is obtained dry particl after dry on fluidized bed, is crossed 20-60 mesh screen；
Second step prepares immediate release outer layer
The calcium polycarbophil of recipe quantity, propylene glycol, disintegration agent material and binder are uniformly mixed, pure water is added, is mixed
After obtain slurry property material；
Third step, granulation
The grout material for obtaining second step in granulator sprays on the stemness particle that the first step obtains, sieving；
4th step, coating
Coating material soluble in the stomach is sprayed into the stemness particle that package third step obtains on one-step-granulating method, after dry, crosses 20
Mesh obtains Calcium polycarbophil particle.
Embodiment 3: double preparations for releasing Calcium polycarbophil particle agent
A kind of pair is released type Calcium polycarbophil particle agent, by the sustained release sandwich layer of mass percent 70%, 10% immediate release outer layer
Coating material layer soluble in the stomach with 20% forms.
The sustained release sandwich layer is process by the component of following mass percent:
Calcium polycarbophil 10%
Gluten 30%
Hydroxypropyl cellulose 15%
Plasticizer 15%
Surfactant 2%
Surplus is pure water；
The immediate release outer layer is process by the component of following mass percent:
Calcium polycarbophil 60%
Propylene glycol 5%
Binder 20%
Disintegrating agent 8%
Surplus is pure water.
In the present invention, the binder is cornstarch, and the disintegrating agent is sodium carboxymethyl starch, and the plasticizer is silicon
Rubber, the surfactant are poloxamer.
In the present invention, it is described it is double release type Calcium polycarbophil particle agent the preparation method is as follows:
The first step, preparation sustained release sandwich layer
The calcium polycarbophil of recipe quantity, Gluten, hydroxypropyl cellulose, plasticizer and surfactant are uniformly mixed
Afterwards, one-step palletizing is carried out on one-step-granulating method, is obtained dry particl after dry on fluidized bed, is crossed 20-60 mesh screen；
Second step prepares immediate release outer layer
The calcium polycarbophil of recipe quantity, propylene glycol, disintegration agent material and binder are uniformly mixed, pure water is added, is mixed
After obtain slurry property material；
Third step, granulation
The grout material for obtaining second step in granulator sprays on the stemness particle that the first step obtains, sieving；
4th step, coating
Coating material soluble in the stomach is sprayed into the stemness particle that package third step obtains on one-step-granulating method, after dry, crosses 20
Mesh obtains Calcium polycarbophil particle.
Embodiment 4: the polycarbophil granule and other similar product comparative tests (piglet) that this patent method obtains
28-60 age in days is chosen, with piglet 120 of obvious symptom of diarrhea, is randomly divided into 4 test groups, every group 30.
4 test groups are respectively drug control group (Nosiheptide additive amount 20mg/kg), low dose group (1g/ daily), middle dose group
(5g/ daily) and high dose group (10g/ daily) is tested 3 days by a definite date, and investigates the diarrhea Cure of each group piglet；It gives
Prescription formula is feeding after mixing Calcium polycarbophil particle agent with pig starter feed, and Nosiheptide premixed agent is fed after mixing with pig starter feed
Food, ad lib during test, while sufficient drinking-water being provided, other every daily management measures according to farm conventional tube
Reason carries out.Therapeutic effect is shown in Table 1.
1 calcium polycarbophil of table treatment grice diarrhoea effect compares (28-60 age in days)
| Group | Total (only) | It cures (only) | Effectively (only) | In vain (only) | Total effective (only) | It is efficient |
| Control group | 30 | 15 | 4 | 1 | 19 | 95% |
| Low dose group | 30 | 14 | 3 | 3 | 17 | 85% |
| Middle dose group | 30 | 19 | 1 | 0 | 20 | 100% |
| High dose group | 30 | 20 | 0 | 0 | 20 | 100% |
As can be seen from Table 1, Calcium polycarbophil particle agent can treat grice diarrhoea, compared with the control group, low dose group
Therapeutic effect is less than drug control group；The therapeutic effect of middle and high dosage group is better than drug control group.
Embodiment 5: the Calcium polycarbophil particle agent and other similar product comparative tests (middle pig) that this patent method obtains
90-120 age in days is chosen, weight 30-60kg, is randomly divided into 4 by middle pig 120 with obvious symptom of diarrhea
Test group, every group 30.4 test groups are respectively drug control group (Nosiheptide additive amount 40mg/kg), and low dose group is (daily
1g/), middle dose group (2g/ daily) and high dose group (3g/ every) are tested 3 days by a definite date, and investigate the healing of each group diarrhea
Situation；Administration mode is feeding after mixing calcium polycarbophil with middle pannage, after Nosiheptide premixed agent is mixed with middle pannage
Feeding, ad lib during test, while sufficient drinking-water being provided, other every daily management measures according to farm routine
Management carries out.Therapeutic effect is shown in Table 2.
Diarrhea of pigs effect compares (90-120 age in days) in the treatment of 2 calcium polycarbophil of table
| Group | Total (only) | It cures (only) | Effectively (only) | In vain (only) | Total effective (only) | It is efficient |
| Control group | 30 | 15 | 3 | 2 | 18 | 90% |
| Low dose group | 30 | 13 | 3 | 4 | 16 | 80% |
| Middle dose group | 30 | 18 | 1 | 1 | 19 | 95% |
| High dose group | 30 | 20 | 0 | 0 | 20 | 100% |
As can be seen from Table 2, Calcium polycarbophil particle agent can treat in diarrhea of pigs, compared with the control group, low dose group
Therapeutic effect is less than drug control group；The therapeutic effect of middle and high dosage group is better than drug control group.
The Calcium polycarbophil particle agent and other similar product comparative tests (broiler chicken) that 6 this patent method of embodiment obtains
It chooses different stages of growth and with broiler chicken 120 of obvious symptom of diarrhea, is randomly divided into 4 test groups, every group
30.4 test groups are respectively drug control group (Nosiheptide additive amount 20mg/kg), low dose group (daily 1g/ is only), and middle dose
Amount group (daily 2g/ is only) and high dose group (daily 3g/ is only), are tested 3 days by a definite date, and investigate each group diarrhea Cure；Administration
Mode is feeding after mixing calcium polycarbophil with broiler fodder, feeding after Nosiheptide premixed agent is mixed with broiler fodder, test
Period ad lib, while sufficient drinking-water being provided, other every daily management measures are carried out according to the Routine Management of farm.
Therapeutic effect is shown in Table 3.
3 calcium polycarbophil of table treatment broiler chicken diarrhea effect compares
| Group | Total (only) | It cures (only) | Effectively (only) | In vain (only) | Total effective (only) | It is efficient |
| Control group | 30 | 16 | 2 | 2 | 18 | 95% |
| Low dose group | 30 | 13 | 3 | 4 | 16 | 80% |
| Middle dose group | 30 | 18 | 1 | 1 | 19 | 95% |
| High dose group | 30 | 20 | 0 | 0 | 20 | 100% |
As can be seen from Table 3, Calcium polycarbophil particle agent can treat broiler chicken diarrhea, compared with the control group, low dose group
Therapeutic effect is less than drug control group；The therapeutic effect of middle and high dosage group quite or better than drug is compareed with drug control group
Group.
The Calcium polycarbophil particle agent and other similar product comparative tests (meat duck) that 7 this patent method of embodiment obtains
It chooses different stages of growth and with meat duck 120 of obvious symptom of diarrhea, is randomly divided into 4 test groups, every group
30.4 test groups are respectively drug control group (Nosiheptide additive amount 20mg/kg), low dose group (daily 1g/ is only), and middle dose
Amount group (daily 2g/ is only) and high dose group (daily 3g/ is only), are tested 3 days by a definite date, and investigate each group diarrhea Cure；Administration
Mode is feeding after mixing Calcium polycarbophil particle agent with fleshy duck fodder, and Nosiheptide premixed agent is fed after mixing with fleshy duck fodder
Food, ad lib during test, while sufficient drinking-water being provided, other every daily management measures according to farm conventional tube
Reason carries out.Therapeutic effect is shown in Table 4.
4 calcium polycarbophil of table treatment meat duck diarrhea effect compares
| Group | Total (only) | It cures (only) | Effectively (only) | In vain (only) | Total effective (only) | It is efficient |
| Control group | 30 | 17 | 1 | 2 | 18 | 95% |
| Low dose group | 30 | 14 | 2 | 4 | 16 | 80% |
| Middle dose group | 30 | 17 | 2 | 1 | 19 | 95% |
| High dose group | 30 | 20 | 0 | 0 | 20 | 100% |
As can be seen from Table 4, Calcium polycarbophil particle agent can treat meat duck diarrhea, compared with the control group, low dose group
Therapeutic effect is less than drug control group；The therapeutic effect of middle and high dosage group quite or better than drug is compareed with drug control group
Group.
Conclusion: livestock and poultry diarrhea can be significantly treated in Calcium polycarbophil particle agent.
Above-mentioned specific embodiment is used to illustrate the present invention, is merely a preferred embodiment of the present invention, rather than
Limit the invention, within the spirit of the invention and the scope of protection of the claims, to the present invention make any modification,
Equivalent replacement, improvement etc., both fall within protection scope of the present invention.
Claims (10)
1. a kind of pair is released type Calcium polycarbophil particle agent, it is characterised in that: the granule is by sustained release sandwich layer, immediate release outer layer stomach function regulating
Molten coating material layer composition, each layer mass percent are as follows: 50-70% is sustained sandwich layer, and 10-30% immediate release outer layer, 10-20% are soluble in the stomach
Coating material layer, wherein
The sustained release sandwich layer is process by the component of following mass percent:
Calcium polycarbophil 2-10%
Gluten 20-50%
Hydroxypropyl cellulose 15-30%
Plasticizer 10%-40%
Surfactant 1-3%
Surplus is pure water；
The immediate release outer layer is process by the component of following mass percent:
Calcium polycarbophil 40-80%
Propylene glycol 3-8%
Binder 20-50%
Disintegrating agent 5-20%
Surplus is pure water.
Double release type Calcium polycarbophil particle agent 2. according to claim 1, it is characterised in that: granule by sustained release sandwich layer,
Immediate release outer layer and coating material layer soluble in the stomach composition, each layer mass percent are as follows: 55% sustained release sandwich layer, 30% immediate release outer layer, 15%
Coating material layer soluble in the stomach, wherein
The sustained release sandwich layer is process by the component of following mass percent:
Calcium polycarbophil 10%
Gluten 20%
Hydroxypropyl cellulose 20%
Plasticizer 15%
Surfactant 2%
Surplus is pure water；
The immediate release outer layer is process by the component of following mass percent:
Calcium polycarbophil 50%
Propylene glycol 5%
Binder 20%
Disintegrating agent 8%
Surplus is pure water.
3. according to claim 1 pair is released type Calcium polycarbophil particle agent, it is characterised in that: the binder is corn shallow lake
At least one of powder, white carbon black, dextrin.
4. a kind of pair according to claim 1 is released type Calcium polycarbophil particle agent, it is characterised in that: the disintegrating agent is to hand over
Join at least one of sodium carboxymethylcellulose, crospovidone, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch.
5. a kind of pair according to claim 1 is released type Calcium polycarbophil particle agent, it is characterised in that: the plasticizer is poly-
At least one of ethylene, ethyl cellulose, acrylic resin, polymethyl methacrylate and silicon rubber.
6. a kind of pair according to claim 1 is released type Calcium polycarbophil particle agent, it is characterised in that: the surfactant
For sapn and/or poloxamer.
7. a kind of double preparation methods for releasing type Calcium polycarbophil particle agent described in claim 1, it is characterised in that: described pair is released
Type Calcium polycarbophil particle agent the preparation method is as follows:
The first step, preparation sustained release sandwich layer
After mixing by the calcium polycarbophil of recipe quantity, Gluten, hydroxypropyl cellulose, plasticizer and surfactant, exist
One-step palletizing is carried out on one-step-granulating method, is obtained dry particl after dry on fluidized bed, is crossed 20-60 mesh screen；
Second step prepares immediate release outer layer
The calcium polycarbophil of recipe quantity, propylene glycol, disintegration agent material and binder are uniformly mixed, pure water is added, after mixing
To slurry property material；
Third step, granulation
The grout material for obtaining second step in granulator sprays on the stemness particle that the first step obtains, sieving；
4th step, coating
Coating material soluble in the stomach is sprayed into the stemness particle that package third step obtains on one-step-granulating method, after dry, crosses 20 meshes,
Obtain Calcium polycarbophil particle.
8. a kind of claim 1-7 described in any item pairs are released the agent of type Calcium polycarbophil particle and prevent and treat livestock and poultry diarrhea disease in preparation
Application in terms of drug.
9. double applications for releasing type Calcium polycarbophil particle agent according to claim 8, it is characterised in that: the various livestock and poultry
Daily recommended dose is respectively pig 1-15g/ head, ox 5-20g/ head, sheep 2-10g/ head, rabbit 0.5-3g/ only, chicken 0.1-3g/ only, duck
Only, goose 0.2-4g/ is only by 0.1-3g/.
10. it is a kind of comprising the described in any item double premixes for releasing type Calcium polycarbophil particle agent of claim 1-7, batch or
Particulate material.
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| CN109010320B (en) | 2021-09-14 |
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