CN108261410A - A kind of safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid and preparation method - Google Patents
A kind of safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid and preparation method Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
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- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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Abstract
The present invention provides a kind of preparation methods of the safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid, the preparation method is by safe ten thousand rhzomorphs of tartaric acid in hydroxypropyl beta cyclodextrin, and it is directly used in making and carries medicine inner core, then separation layer and coatings are being wrapped up respectively, the safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid are made.Compared with prior art, the coating of safe ten thousand rhzomorphs of tartaric acid of the present invention and granulating process settle at one go, saving production cost easy to operate.Meanwhile the invention avoids the influences that hydrochloric acid in gastric juice generates, and it can be in enteron aisle position targeted release, clinical therapeutic efficacy is more preferable.
Description
Technical field
The present invention relates to veterinary antibiotic preparation technique fields, and in particular to a kind of safe ten thousand rhzomorphs inclusion enteric system of tartaric acid
Agent and preparation method, suitable for anti-plain drug for animals.
Background technology
Ten thousand rhzomorph chemical names of tartaric acid Thailand are tartaric acid acetylisovaleryl tylosin (Acetylisovaleryl
Tylosin Tartrate), be the derivative that Tylosin A is generated through chemical improvement, mainly act on gram-positive bacteria and
Mycoplasma, and have obvious inhibiting effect to part Gram-negative bacteria.It mainly acts on gram-positive bacteria and branch is former
Body, and have obvious inhibiting effect to part Gram-negative bacteria.Be mainly used for treating the Proliferative Enteritis of pig, dysentery,
Mycoplasmal pneumonia (mycoplasma pneumonia of swine) and the mycoplasmosis of chicken, perfringens bacillus, nose tracheae ornithosis bacillus, are poultrys
The ideal medicament of mycoplasma.
At present, common ten thousand rhzomorph of Thailand is common pre-mixing agent and soluble powder in the market, because preparation process is simple so that
Bioavilability is low, while is easily influenced by hydrochloric acid in gastric juice, and drug in itself produces serious influence to gastrointestinal tract, ordinary preparation gas
Taste is big and bitter easily disperses again so that palatability difference feed intake declines, and curative effect of medication reduces, and ideal effect is not achieved；On the other hand
Simple pre-mixing agent is blended in feed easily to be chemically reacted with Multiple components in feed, declines drug effect.
Therefore, urgent clinical needs property stabilization, the safe ten thousand rhzomorph novel formulations of the reliable tartaric acid of curative effect, to ensure that its clinic is treated
Effect, medicine stability and enhancing palatability.
Invention content
To solve the deficiencies in the prior art, the present invention provides a kind of safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid and preparations
Method, said preparation is by containing the safe inner core of ten thousand rhzomorphs/hydroxypropyl-beta-cyclodextrin inclusion of tartaric acid and outer layer enteric coatings
Composition, outer layer enteric coatings ensure that drug avoids being influenced by hydrochloric acid in gastric juice after oral enter in animal body, can be in enteron aisle
Middle targeted release simultaneously as ten thousand rhzomorphs of tartaric acid Thailand are included by hydroxypropyl-β-cyclodextrin, improves the water solubility of drug,
Drug is rapidly dissolvable in intestinal juice after the dissolving of outer layer enteric coating, it is ensured that local concentration of the drug in enteron aisle effectively carries
High therapeutic effect.And its internal layer inclusion ensure that the stability of drug, while mask the disagreeable taste of drug with outer layer coating,
Improve the palatability of drug.
The present invention provides a kind of safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid, realize the technical scheme is that：
A kind of safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid are by the safe ten thousand rhzomorph inclusion compound inner cores of tartaric acid and are wrapped in inner core
Outer coatings composition, coatings are followed successively by separation layer and enteric layer from inside to outside；
The raw material that ten thousand rhzomorph inner cores of tartaric acid Thailand include following parts by weight is made：
Separation layer includes superfine silica gel powder and hydroxypropyl methyl cellulose, mass ratio 4-5：10.
Enteric layer includes acrylic resin L100-55, tributyl citrate, talcum powder and sodium hydroxide, and mass ratio is
100：6：12：0.2.
The preparation method of the safe ten thousand rhzomorphs inclusion enteric coated preparations of above-mentioned tartaric acid, its step are as follows：
(1) pH adjusting agent and cosolvent are added to the water, are heated to 50 DEG C of dissolvings, are configured to solution A；
(2) safe ten thousand rhzomorphs of tartaric acid are added in solution A, keeps 50 DEG C of temperature, stir 15min, tartaric acid Thailand ten thousand is made
Rhzomorph solution；
(3) hydroxypropyl-β-cyclodextrin is dissolved in the water, is configured to solution B；
(4) the safe ten thousand rhzomorph solution of tartaric acid are added in solution B, after being stirred 30min, obtains the safe ten thousand rhzomorph packets of tartaric acid
Polymer solution；
(5) maltodextrin is added in the safe ten thousand rhzomorph inclusion complex in solution of step (4) mesotartaric acid, stirring and dissolving obtains drug containing
Adhesive；
(6) glucose is placed in fluidized-bed coating machine, sprays into the drug containing adhesive obtained in step (5), form particle
It dries 30 minutes afterwards, screens 40-60 mesh particles, obtain the safe ten thousand rhzomorph inclusion compound inner cores of tartaric acid；
(7) separation layer is wrapped up：Be configured 5wt% hydroxypropyl methyl cellulose aqueous solutions, weigh a certain amount of superfine silica gel powder with
After mixing, spraying to will be in the safe ten thousand rhzomorph inclusion compound of tartaric acid obtained by step (6) for hydroxypropyl methyl cellulose aqueous solution
Core is rolled into separation layer, and gained pellet weightening 4%-6%, after 1 hour dry, gained isolation pellet is spare；
(8) enteric layer is wrapped up：Weigh a certain amount of acrylic resin L100-55, tributyl citrate, talcum powder and hydroxide
Sodium is added to the water, and is uniformly mixed, and with obtained enteric coating liquid, the isolation pellet obtained by step (7) is added in fluidized-bed coating machine
In, spray into enteric coating liquid to ball increases 16-22% again, obtains safe ten thousand rhzomorphs inclusion enteric coated preparations.
PH adjusting agent is tartaric acid in the step (1), and cosolvent is polyvinylpyrrolidone PVP-K30, and pH is adjusted
Agent, cosolvent and water quality ratio are 0.5-1：3:50.
Safe ten thousand rhzomorphs of step (2) mesotartaric acid and the mass ratio of water in solution are 1:1.
Hydroxypropyl-β-cyclodextrin and water quality ratio are 0.4-0.5 in the step (3)：1.
Fluidized-bed coating machine sprays fluidized-bed coating machine for DLB-60 bottoms.
The inlet air temperature that fluidized-bed coating machine is pelletized in step (6) is 80 DEG C, and wind turbine frequency is 35Hz, and hydrojet frequency is
85Hz。
Fluidized-bed coating machine inlet air temperature is 85 DEG C in step (7) and (8), and wind turbine frequency is 40Hz, and hydrojet frequency is
30Hz sprays into coating solution processing, is coated subsequent continuous fluidized drying 30 minutes.
Compared with prior art, the advantages of the present invention are：
The present invention prepares the simple for process of the safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid, mainly comprises the following steps drug inclusion, system
Grain and coating, wherein drug inclusion and granulation can a step realize, greatly simplify technique, save production cost, be suitable for expanding
Production.
The safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid obtained by the present invention, are included by internal layer hydroxypropyl-β-cyclodextrin
With outer layer enteric coating technology, gastric juice and other batch mixings can be avoided to have an impact drug, the targeted release in enteron aisle is covered simultaneously
The bad smell of drug has been covered, has improved its palatability, ensure that the therapeutic effect of drug.
Specific embodiment
With reference to specific embodiment, the present invention is described in further detail.
Fluidized-bed coating machine in all the examples below sprays fluidized-bed coating machine for DLB-60 bottoms.
Embodiment 1
A kind of safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid, preparation method are as follows：
(1) 0.5kg tartaric acid and 3kg polyvinylpyrrolidones PVP-K30 are added in 50kg water, be heated to 50 DEG C it is molten
Solution, is configured to solution A；
(2) safe ten thousand rhzomorphs of 50kg tartaric acid are added in solution A, keeps 50 DEG C of temperature, stir 15min, tartaric acid is made
Safe ten thousand rhzomorph solution；
(3) 50kg hydroxypropyl-β-cyclodextrins are dissolved in 100kg water, are configured to solution B；
(4) the safe ten thousand rhzomorph solution of tartaric acid are added in solution B, after being stirred 30min, obtains the safe ten thousand rhzomorph packets of tartaric acid
Polymer solution.
(5) 20kg maltodextrins are added in the safe ten thousand rhzomorph inclusion complex in solution of step (4) mesotartaric acid, stirring and dissolving must contain
The adhesive of medicine.
(6) 75kg glucose is placed in fluidized-bed coating machine, inlet air temperature be 80 DEG C, wind turbine frequency be 35Hz, hydrojet
Frequency is 85Hz, sprays into the drug containing adhesive obtained in step (5), forms 30 minutes dry, screening 40-60 mesh after particle
Grain obtains the safe ten thousand rhzomorph inclusion compound inner cores of tartaric acid.
(7) separation layer is wrapped up：The hydroxypropyl methyl cellulose aqueous solution that 40kg contents are 5wt% is configured, weighs 1kg micro mists
Silica gel and hydroxypropyl methyl cellulose aqueous solution after mixing, by step (6) institute by way of fluidized-bed coating machine spraying
The safe ten thousand rhzomorph inclusion compound inner cores package separation layer of tartaric acid, inlet air temperature is 85 DEG C, and wind turbine frequency is 40Hz, hydrojet frequency
For 30Hz, gained pellet weightening 4%-6%, after 1 hour dry, gained isolation pellet is spare.
(8) enteric layer is wrapped up：Weigh 50kg acrylic resin L100-55,3kg tributyl citrate, 6kg talcum powder and
0.1kg sodium hydroxides are added in 50kg water, are uniformly mixed, with obtained enteric coating liquid, the isolation pellet obtained by step (7) is added
In fluidized bed seed-coating machine, inlet air temperature is 85 DEG C, and wind turbine frequency is 40Hz, and hydrojet frequency is 30Hz, sprays into enteric coating liquid
Increase 16-22% again to ball, obtain safe ten thousand rhzomorphs inclusion enteric coated preparations.
The safe safe ten thousand rhzomorph contents of ten thousand rhzomorphs inclusion enteric coated preparations mesotartaric acid of obtained tartaric acid are 20.8wt%.Implement
Example 2
A kind of safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid, preparation method are as follows：
(1) 0.5kg tartaric acid and 3kg polyvinylpyrrolidones PVP-K30 are added in 50kg water, be heated to 50 DEG C it is molten
Solution, is configured to solution A；
(2) safe ten thousand rhzomorphs of 50kg tartaric acid are added in solution A, keeps 50 DEG C of temperature, stir 15min, tartaric acid is made
Safe ten thousand rhzomorph solution；
(3) 40kg hydroxypropyl-β-cyclodextrins are dissolved in 100kg water, are configured to solution B；
(4) the safe ten thousand rhzomorph solution of tartaric acid are added in solution B, after being stirred 30min, obtains the safe ten thousand rhzomorph packets of tartaric acid
Polymer solution.
(5) 20kg maltodextrins are added in the safe ten thousand rhzomorph inclusion complex in solution of step (4) mesotartaric acid, stirring and dissolving must contain
The adhesive of medicine.
(6) 50kg glucose is placed in fluidized-bed coating machine, inlet air temperature be 80 DEG C, wind turbine frequency be 35Hz, hydrojet
Frequency is 85Hz, sprays into the drug containing adhesive obtained in step (5), forms 30 minutes dry, screening 40-60 mesh after particle
Grain obtains the safe ten thousand rhzomorph inclusion compound inner cores of tartaric acid.
(7) separation layer is wrapped up：The hydroxypropyl methyl cellulose aqueous solution that 40kg contents are 5wt% is configured, weighs 1kg micro mists
Silica gel and hydroxypropyl methyl cellulose aqueous solution after mixing, by step (6) institute by way of fluidized-bed coating machine spraying
The safe ten thousand rhzomorph inclusion compound inner cores package separation layer of tartaric acid, inlet air temperature is 85 DEG C, and wind turbine frequency is 40Hz, hydrojet frequency
For 30Hz, gained pellet weightening 4%-6%, after 1 hour dry, gained isolation pellet is spare.
(8) enteric layer is wrapped up：Weigh 50kg acrylic resin L100-55,3kg tributyl citrate, 6kg talcum powder and
0.1kg sodium hydroxides are added in 50kg water, are uniformly mixed, with obtained enteric coating liquid, the isolation pellet obtained by step (7) is added
In fluidized bed seed-coating machine, inlet air temperature is 85 DEG C, and wind turbine frequency is 40Hz, and hydrojet frequency is 30Hz, sprays into enteric coating liquid
Increase 16-22% again to ball, obtain safe ten thousand rhzomorphs inclusion enteric coated preparations.
The safe safe ten thousand rhzomorph contents of ten thousand rhzomorphs inclusion enteric coated preparations mesotartaric acid of obtained tartaric acid are 24.8wt%.
Embodiment 3
A kind of safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid, preparation method are as follows：
(1) 0.5kg tartaric acid and 3kg polyvinylpyrrolidones PVP-K30 are added in 50kg water, be heated to 50 DEG C it is molten
Solution, is configured to solution A；
(2) safe ten thousand rhzomorphs of 50kg tartaric acid are added in solution A, keeps 50 DEG C of temperature, stir 15min, tartaric acid is made
Safe ten thousand rhzomorph solution；
(3) 50kg hydroxypropyl-β-cyclodextrins are dissolved in 100kg water, are configured to solution B；
(4) the safe ten thousand rhzomorph solution of tartaric acid are added in solution B, after being stirred 30min, obtains the safe ten thousand rhzomorph packets of tartaric acid
Polymer solution.
(5) 20kg maltodextrins are added in the safe ten thousand rhzomorph inclusion complex in solution of step (4) mesotartaric acid, stirring and dissolving must contain
The adhesive of medicine.
(6) 50kg glucose is placed in fluidized-bed coating machine, inlet air temperature be 80 DEG C, wind turbine frequency be 35Hz, hydrojet
Frequency is 85Hz, sprays into the drug containing adhesive obtained in step (5), forms 30 minutes dry, screening 40-60 mesh after particle
Grain obtains the safe ten thousand rhzomorph inclusion compound inner cores of tartaric acid.
(7) separation layer is wrapped up：The hydroxypropyl methyl cellulose aqueous solution that 40kg contents are 5wt% is configured, weighs 1kg micro mists
Silica gel and hydroxypropyl methyl cellulose aqueous solution after mixing, by step (6) institute by way of fluidized-bed coating machine spraying
The safe ten thousand rhzomorph inclusion compound inner cores package separation layer of tartaric acid, inlet air temperature is 85 DEG C, and wind turbine frequency is 40Hz, hydrojet frequency
For 30Hz, gained pellet weightening 4%-6%, after 1 hour dry, gained isolation pellet is spare.
(8) enteric layer is wrapped up：Weigh 50kg acrylic resin L100-55,3kg tributyl citrate, 6kg talcum powder and
0.1kg sodium hydroxides are added in 50kg water, are uniformly mixed, with obtained enteric coating liquid, the isolation pellet obtained by step (7) is added
In fluidized bed seed-coating machine, inlet air temperature is 85 DEG C, and wind turbine frequency is 40Hz, and hydrojet frequency is 30Hz, sprays into enteric coating liquid
Increase 16-22% again to ball, obtain safe ten thousand rhzomorphs inclusion enteric coated preparations.
The safe safe ten thousand rhzomorph contents of ten thousand rhzomorphs inclusion enteric coated preparations mesotartaric acid of obtained tartaric acid are 24.1wt%.
Embodiment 4
A kind of safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid, preparation method are as follows：
(1) 0.5kg tartaric acid and 3kg polyvinylpyrrolidones PVP-K30 are added in 50kg water, be heated to 50 DEG C it is molten
Solution, is configured to solution A；
(2) safe ten thousand rhzomorphs of 50kg tartaric acid are added in solution A, keeps 50 DEG C of temperature, stir 15min, tartaric acid is made
Safe ten thousand rhzomorph solution；
(3) 40kg hydroxypropyl-β-cyclodextrins are dissolved in 100kg water, are configured to solution B；
(4) the safe ten thousand rhzomorph solution of tartaric acid are added in solution B, after being stirred 30min, obtains the safe ten thousand rhzomorph packets of tartaric acid
Polymer solution.
(5) 20kg maltodextrins are added in the safe ten thousand rhzomorph inclusion complex in solution of step (4) mesotartaric acid, stirring and dissolving must contain
The adhesive of medicine.
(6) 75kg glucose is placed in fluidized-bed coating machine, inlet air temperature be 80 DEG C, wind turbine frequency be 35Hz, hydrojet
Frequency is 85Hz, sprays into the drug containing adhesive obtained in step (5), forms 30 minutes dry, screening 40-60 mesh after particle
Grain obtains the safe ten thousand rhzomorph inclusion compound inner cores of tartaric acid.
(7) separation layer is wrapped up：The hydroxypropyl methyl cellulose aqueous solution that 40kg contents are 5wt% is configured, weighs 1kg micro mists
Silica gel and hydroxypropyl methyl cellulose aqueous solution after mixing, by step (6) institute by way of fluidized-bed coating machine spraying
The safe ten thousand rhzomorph inclusion compound inner cores package separation layer of tartaric acid, inlet air temperature is 85 DEG C, and wind turbine frequency is 40Hz, hydrojet frequency
For 30Hz, gained pellet weightening 4%-6%, after 1 hour dry, gained isolation pellet is spare.
(8) enteric layer is wrapped up：Weigh 50kg acrylic resin L100-55,3kg tributyl citrate, 6kg talcum powder and
0.1kg sodium hydroxides are added in 50kg water, are uniformly mixed, with obtained enteric coating liquid, the isolation pellet obtained by step (7) is added
In fluidized bed seed-coating machine, inlet air temperature is 85 DEG C, and wind turbine frequency is 40Hz, and hydrojet frequency is 30Hz, sprays into enteric coating liquid
Increase 16-22% again to ball, obtain safe ten thousand rhzomorphs inclusion enteric coated preparations.
The safe safe ten thousand rhzomorph contents of ten thousand rhzomorphs inclusion enteric coated preparations mesotartaric acid of obtained tartaric acid are 22.3wt%.
Embodiment 5
A kind of safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid, preparation method are as follows：
(1) 1kg tartaric acid and 3kg polyvinylpyrrolidones PVP-K30 are added in 50kg water, be heated to 50 DEG C it is molten
Solution, is configured to solution A；
(2) safe ten thousand rhzomorphs of 50kg tartaric acid are added in solution A, keeps 50 DEG C of temperature, stir 15min, tartaric acid is made
Safe ten thousand rhzomorph solution；
(3) 50kg hydroxypropyl-β-cyclodextrins are dissolved in 100kg water, are configured to solution B；
(4) the safe ten thousand rhzomorph solution of tartaric acid are added in solution B, after being stirred 30min, obtains the safe ten thousand rhzomorph packets of tartaric acid
Polymer solution.
(5) 20kg maltodextrins are added in the safe ten thousand rhzomorph inclusion complex in solution of step (4) mesotartaric acid, stirring and dissolving must contain
The adhesive of medicine.
(6) 75kg glucose is placed in fluidized-bed coating machine, inlet air temperature be 80 DEG C, wind turbine frequency be 35Hz, hydrojet
Frequency is 85Hz, sprays into the drug containing adhesive obtained in step (5), forms 30 minutes dry, screening 40-60 mesh after particle
Grain obtains the safe ten thousand rhzomorph inclusion compound inner cores of tartaric acid.
(7) separation layer is wrapped up：The hydroxypropyl methyl cellulose aqueous solution that 40kg contents are 5wt% is configured, it is micro- to weigh 0.8kg
Powder silica gel and hydroxypropyl methyl cellulose aqueous solution after mixing, by step (6) by way of fluidized-bed coating machine spraying
The safe ten thousand rhzomorph inclusion compound inner cores package separation layer of the tartaric acid of gained, inlet air temperature is 85 DEG C, and wind turbine frequency is 40Hz, and hydrojet is frequently
Rate is 30Hz, and gained pellet weightening 4%-6%, after 1 hour dry, gained isolation pellet is spare.
(8) enteric layer is wrapped up：Weigh 50kg acrylic resin L100-55,3kg tributyl citrate, 6kg talcum powder and
0.1kg sodium hydroxides are added in 50kg water, are uniformly mixed, with obtained enteric coating liquid, the isolation pellet obtained by step (7) is added
In fluidized bed seed-coating machine, inlet air temperature is 85 DEG C, and wind turbine frequency is 40Hz, and hydrojet frequency is 30Hz, sprays into enteric coating liquid
Increase 16-22% again to ball, obtain safe ten thousand rhzomorphs inclusion enteric coated preparations.
The safe safe ten thousand rhzomorph contents of ten thousand rhzomorphs inclusion enteric coated preparations mesotartaric acid of obtained tartaric acid are 21.1wt%.
The experiment of tartaric acid Thailand ten thousand rhzomorphs inclusion enteric coated preparations treatment porcine respiratory disease
Henan pig farm natural occurrence, is diagnosed as the growing and fattening pigs 452 of breathing problem, and the isolation of illness pig is individually raised
It supports, 450 in illness swinery is equally divided into five groups and carry out treatment processing：
The safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid prepared by embodiment 1-5, mixed feeding：In terms of safe ten thousand rhzomorphs of tartaric acid, often
1000kg feeds, pig 75g are used in conjunction 3.
1 porcine respiratory disease therapeutic effect of table
| Group | Illness pig number | Recovery from illness number | Treatment rate |
| Embodiment 1 | 90 | 88 | 97.8% |
| Embodiment 2 | 90 | 89 | 98.9% |
| Embodiment 3 | 90 | 89 | 98.9% |
| Embodiment 4 | 90 | 88 | 97.8% |
| Embodiment 5 | 90 | 88 | 97.8% |
As shown in Table 1, the safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid that prepared by embodiment 1-5 control porcine respiratory disease
More rate is high, and therapeutic effect is good.
The drug effect contrasts experiment of tartaric acid Thailand ten thousand rhzomorphs inclusion enteric coated preparations
Certain pig farm natural occurrence is diagnosed as the growing and fattening pigs 308 of breathing problem, and illness pig isolation individually raising will
Illness swinery is equally divided into two groups and carries out treatment processing：
Experimental group
The safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid prepared by embodiment 1, mixed feeding：In terms of safe ten thousand rhzomorphs of tartaric acid, often
1000kg feeds, pig 75g are used in conjunction 3.
Drug control group
20% tartaric acid, ten thousand rhzomorph soluble powders of Thailand (purchase of Shandong company), mixed feeding：In terms of safe ten thousand rhzomorphs of tartaric acid, often
1000kg feeds, pig 75g are used in conjunction 3.
2 porcine respiratory disease therapeutic effect of table
| Group | Illness pig number | Recovery from illness number | Treatment rate |
| Experimental group | 154 | 150 | 97.40% |
| Drug control group | 154 | 131 | 85.06% |
As shown in Table 2, the safe ten thousand rhzomorphs inclusion enteric coated preparations ratio of tartaric acid that prepared by embodiment 1 purchases 20% winestone on the market
Ten thousand rhzomorph soluble powders of sour Thailand are high to the cure rate of porcine respiratory disease.It can be seen that illustrate safe ten thousand bacterium of tartaric acid of the present invention
Element inclusion enteric coated preparations are to the therapeutic effect of porcine respiratory disease when the common tartaric acid purchased in market safe ten thousand rhzomorph soluble powder
It is good.
Claims (5)
1. a kind of safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid, by the safe ten thousand rhzomorph inclusion compound inner cores of tartaric acid and are wrapped in outside inner core
Coatings composition, it is characterised in that：The composition of the coatings is followed successively by separation layer, enteric layer from inside to outside：
The raw material that ten thousand rhzomorph inner cores of tartaric acid Thailand include following parts by weight is made：
Separation layer includes superfine silica gel powder and hydroxypropyl methyl cellulose, mass ratio 4-5：10.
Enteric layer includes acrylic resin L100-55, tributyl citrate, talcum powder and sodium hydroxide, mass ratio 100：
6：12：0.2.
2. the preparation method of the safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid described in claim 1, which is characterized in that including as follows
Step：
(1) tartaric acid and polyvinylpyrrolidone PVP-K30 are added to the water, tartaric acid, polyvinylpyrrolidone PVP-K30
Mass ratio with water is 0.5-1：3:50,50 DEG C of dissolvings are heated to, are configured to solution A；
(2) safe ten thousand rhzomorphs of tartaric acid are added in solution A, the mass ratio of tartaric acid ten thousand rhzomorphs of Thailand and water in solution A is 1:1, it protects
50 DEG C of temperature are held, stir 15min, the safe ten thousand rhzomorph solution of tartaric acid are made；
(3) hydroxypropyl-β-cyclodextrin is dissolved in the water, hydroxypropyl-β-cyclodextrin is 0.4-0.5 with water quality ratio：1, configuration
Into solution B；
(4) the safe ten thousand rhzomorph solution of tartaric acid are added in solution B, after being stirred 30min, obtains the safe ten thousand rhzomorph inclusion compounds of tartaric acid
Solution；
(5) maltodextrin is added in the safe ten thousand rhzomorph inclusion complex in solution of step (4) mesotartaric acid, stirring and dissolving obtains the bonding of drug containing
Agent；
(6) glucose is placed in fluidized-bed coating machine, sprays into the drug containing adhesive obtained in step (5), done after forming particle
Dry 30 minutes, 40-60 mesh particles are screened, obtain the safe ten thousand rhzomorph inclusion compound inner cores of tartaric acid；
(7) separation layer is wrapped up：5wt% hydroxypropyl methyl cellulose aqueous solutions are configured, weigh a certain amount of superfine silica gel powder and hydroxypropyl
Ylmethyl cellulose aqueous solution after mixing, sprays to the safe ten thousand rhzomorph inclusion compound inner cores package of tartaric acid obtained by step (6)
Into separation layer, gained pellet weightening 4%-6%, after 1 hour dry, gained isolation pellet is spare；
(8) enteric layer is wrapped up：A certain amount of acrylic resin L100-55, tributyl citrate, talcum powder and sodium hydroxide is weighed to add
Enter in water, be uniformly mixed, with obtained enteric coating liquid, the isolation pellet obtained by step (7) is added in fluidized-bed coating machine, spray
Enter enteric coating liquid to ball increases 16-22% again, obtains safe ten thousand rhzomorphs inclusion enteric coated preparations.
3. the preparation method of the safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid according to claim 2, it is characterised in that the stream
Change bed seed-coating machine and spray fluidized-bed coating machine for DLB-60 bottoms.
4. the preparation method of the safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid according to claim 2, it is characterised in that：Step
(6) inlet air temperature that fluidized-bed coating machine is pelletized in is 80 DEG C, and wind turbine frequency is 35Hz, and hydrojet frequency is 85Hz.
5. the preparation method of the safe ten thousand rhzomorphs inclusion enteric coated preparations of tartaric acid according to claim 2, it is characterised in that：Step
(7) and in (8) fluidized-bed coating machine inlet air temperature is 85 DEG C, and wind turbine frequency is 40Hz, and hydrojet frequency is 30Hz, sprays into coating solution
Processing is coated subsequent continuous fluidized drying 30 minutes.
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| CN110604725A (en) * | 2019-11-06 | 2019-12-24 | 山东胜利生物工程有限公司 | Tylosin tartrate preparation and preparation method thereof |
| CN110917145A (en) * | 2019-12-31 | 2020-03-27 | 郑州都灵兽药科技有限公司 | Preparation method of tylosin enteric-coated particles |
| CN114028338A (en) * | 2021-12-28 | 2022-02-11 | 江西英特科胜动保科技有限公司 | Preparation method and application of water-soluble tylosin tartrate premix |
| CN114983944A (en) * | 2022-07-18 | 2022-09-02 | 山东国邦药业有限公司 | Preparation method of tiamulin fumarate soluble powder |
| CN115475150A (en) * | 2022-10-14 | 2022-12-16 | 江西高胜动物保健品有限公司 | Novel enteric coated tylosin tartrate product and preparation method thereof |
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| CN1759829A (en) * | 2004-10-14 | 2006-04-19 | 上海医药工业研究院 | Duloxetine enteric coated tiny pill capsule, and preparation method |
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| CN110604725A (en) * | 2019-11-06 | 2019-12-24 | 山东胜利生物工程有限公司 | Tylosin tartrate preparation and preparation method thereof |
| CN110917145A (en) * | 2019-12-31 | 2020-03-27 | 郑州都灵兽药科技有限公司 | Preparation method of tylosin enteric-coated particles |
| CN114028338A (en) * | 2021-12-28 | 2022-02-11 | 江西英特科胜动保科技有限公司 | Preparation method and application of water-soluble tylosin tartrate premix |
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| CN114983944A (en) * | 2022-07-18 | 2022-09-02 | 山东国邦药业有限公司 | Preparation method of tiamulin fumarate soluble powder |
| CN114983944B (en) * | 2022-07-18 | 2022-10-28 | 山东国邦药业有限公司 | Preparation method of tiamulin fumarate soluble powder |
| CN115475150A (en) * | 2022-10-14 | 2022-12-16 | 江西高胜动物保健品有限公司 | Novel enteric coated tylosin tartrate product and preparation method thereof |
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