CN108261410B - Tylosin tartrate inclusion enteric-coated preparation and preparation method thereof - Google Patents
Tylosin tartrate inclusion enteric-coated preparation and preparation method thereof Download PDFInfo
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- 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
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- 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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Abstract
The invention provides a preparation method of tylosin tartrate inclusion enteric-coated preparation, which comprises the steps of including tylosin tartrate in hydroxypropyl-beta-cyclodextrin, directly preparing a medicine carrying inner core, and respectively wrapping an isolation layer and a coating layer to prepare the tylosin tartrate inclusion enteric-coated preparation. Compared with the prior art, the coating and granulating process of the tylosin tartrate has the advantages of one-step operation, simple operation and production cost saving. Meanwhile, the invention avoids the influence of gastric acid, can be directionally released at intestinal tract parts, and has better clinical treatment effect.
Description
Technical Field
The invention relates to the technical field of veterinary antibiotic preparations, in particular to a tylosin tartrate inclusion enteric-coated preparation and a preparation method thereof, which are applicable to veterinary antibiotic medicines.
Background
The chemical name of the tylosin Tartrate is AcetylisovalerylTylosin Tartrate, which is a derivative generated by chemically modifying tylosin A, mainly acts on gram-positive bacteria and mycoplasma, and has a relatively obvious inhibiting effect on part of gram-negative bacteria. Mainly acts on gram-positive bacteria and mycoplasma, and has obvious inhibiting effect on partial gram-negative bacteria. Is mainly used for treating the hyperplastic enteritis, the dysentery and the mycoplasmal pneumonia (swine enzootic pneumonia) of pigs, the mycoplasmosis of chickens, bacillus perfringens and bird's disease of nose gas pipe, and is an ideal medicine for livestock mycoplasma.
At present, the common tulathromycin in the market is a common premix and soluble powder, the preparation process is simple, the bioavailability is low, the preparation is easily influenced by gastric acid, the medicine has serious influence on gastrointestinal tracts, the common preparation has large smell and bitter taste, the medicine is easy to scatter, the palatability is poor, the food consumption is reduced, the curative effect of the medicine is reduced, and the ideal effect cannot be achieved; on the other hand, the simple premix is mixed in the feed and is easy to react with various components in the feed, so that the drug effect is reduced.
Therefore, a new tylosin tartrate preparation with stable property and reliable curative effect is urgently needed in clinic, so that the clinical curative effect, the drug stability and the palatability are ensured.
Disclosure of Invention
In order to solve the defects of the prior art, the invention provides a tylosin tartrate inclusion enteric preparation and a preparation method thereof, the preparation consists of an inner core containing a tylosin tartrate/hydroxypropyl-beta-cyclodextrin inclusion compound and an outer enteric coating layer, the outer enteric coating layer ensures that the medicament is prevented from being influenced by gastric acid after being orally taken into an animal body and can be directionally released in an intestinal tract, meanwhile, the tylosin tartrate is included by hydroxypropyl-beta-cyclodextrin, the water solubility of the medicament is improved, the medicament can be quickly dissolved in intestinal juice after the outer enteric coating layer is dissolved, the local concentration of the medicament in the intestinal tract is ensured, and the treatment effect is effectively improved. And the inner layer coating and the outer layer coating ensure the stability of the medicine, cover the bad taste of the medicine and improve the palatability of the medicine.
The invention provides a tylosin tartrate inclusion enteric-coated preparation, which realizes the technical scheme that:
a tylosin tartrate inclusion enteric-coated preparation consists of a tylosin tartrate inclusion compound inner core and a coating layer coated outside the inner core, wherein the coating layer sequentially comprises an isolation layer and an enteric-coated layer from inside to outside;
the tylosin tartrate inner core is prepared from the following raw materials in parts by weight:
the isolating layer comprises micropowder silica gel and hydroxypropyl methyl cellulose, and the mass ratio of the micropowder silica gel to the hydroxypropyl methyl cellulose is 4-5: 10.
the enteric layer comprises acrylic resin L100-55, tributyl citrate, talcum powder and sodium hydroxide, and the mass ratio of the acrylic resin L100 to the tributyl citrate to the talcum powder is as follows: 6: 12: 0.2.
the preparation method of the tylosin tartrate inclusion enteric-coated preparation comprises the following steps:
(1) adding a pH regulator and a cosolvent into water, heating to 50 ℃ to dissolve, and preparing a solution A;
(2) adding the tylosin tartrate into the solution A, keeping the temperature at 50 ℃, and stirring for 15min to prepare a tylosin tartrate solution;
(3) dissolving hydroxypropyl-beta-cyclodextrin in water to prepare a solution B;
(4) adding the tylosin tartrate solution into the solution B, and stirring and mixing for 30min to obtain a tylosin tartrate clathrate compound solution;
(5) adding maltodextrin into the tylosin tartrate clathrate compound solution in the step (4), and stirring and dissolving to obtain a drug-containing adhesive;
(6) putting glucose into a fluidized bed coating machine, spraying the medicine-containing adhesive obtained in the step (5) into the fluidized bed coating machine, forming granules, drying the granules for 30 minutes, and screening the granules with 40-60 meshes to obtain a tylosin tartrate clathrate inner core;
(7) wrapping an isolation layer: preparing 5wt% of hydroxypropyl methyl cellulose aqueous solution, weighing a certain amount of superfine silica gel powder, uniformly mixing with the hydroxypropyl methyl cellulose aqueous solution, spraying the mixture on the inner core of the tylosin tartrate inclusion compound obtained in the step (6) to wrap the inner core into an isolation layer, increasing the weight of the obtained pellets by 4-6%, and drying for 1 hour to obtain isolated pellets for later use;
(8) wrapping an enteric layer: weighing a certain amount of acrylic resin L100-55, tributyl citrate, talcum powder and sodium hydroxide, adding into water, uniformly mixing to obtain an enteric coating solution, adding the isolated pellet obtained in the step (7) into a fluidized bed coating machine, and spraying the enteric coating solution until the weight of the pellet is increased by 16-22% to obtain the tylosin inclusion enteric preparation.
In the step (1), the pH regulator is tartaric acid, the cosolvent is polyvinylpyrrolidone PVP-K30, and the mass ratio of the pH regulator to the cosolvent to water is 0.5-1: 3:50.
The mass ratio of the tylosin tartrate in the step (2) to the water in the solution is 1: 1.
The mass ratio of the hydroxypropyl-beta-cyclodextrin to the water in the step (3) is 0.4-0.5: 1.
the fluidized bed coating machine is a DLB-60 bottom jet fluidized bed coating machine.
In the step (6), the air inlet temperature of the fluidized bed coating machine for granulation is 80 ℃, the frequency of the fan is 35Hz, and the frequency of the liquid spraying is 85 Hz.
And (7) in the step (8), the air inlet temperature of the fluidized bed coating machine is 85 ℃, the frequency of a fan is 40Hz, the frequency of liquid spraying is 30Hz, coating liquid is sprayed in for treatment, and the fluidized drying is continued for 30 minutes after coating.
Compared with the prior art, the invention has the advantages and beneficial effects that:
the preparation method of the tylosin tartrate inclusion enteric-coated preparation has a simple process, and comprises the main steps of medicine inclusion, granulation and coating, wherein the medicine inclusion and the granulation can be realized in one step, so that the process is greatly simplified, the production cost is saved, and the preparation method is suitable for expanded production.
The tylosin tartrate inclusion enteric-coated preparation prepared by the invention can avoid the influence of gastric juice and other mixed materials on the medicament by the inner-layer hydroxypropyl-beta-cyclodextrin inclusion and the outer-layer enteric-coated technology, can be directionally released in intestinal tracts, covers the unpleasant smell of the medicament, improves the palatability and ensures the treatment effect of the medicament.
Detailed Description
The present invention will be described in further detail with reference to specific examples.
The fluid bed coater in all the following examples was a DLB-60 bottom jet fluid bed coater.
Example 1
An enteric coated preparation of tylosin tartrate inclusion, which is prepared by the following steps:
(1) adding 0.5kg of tartaric acid and 3kg of polyvinylpyrrolidone PVP-K30 into 50kg of water, heating to 50 ℃ to dissolve, and preparing into solution A;
(2) adding 50kg of tylosin tartrate into the solution A, keeping the temperature at 50 ℃, and stirring for 15min to prepare a tylosin tartrate solution;
(3) dissolving 50kg of hydroxypropyl-beta-cyclodextrin in 100kg of water to prepare a solution B;
(4) and adding the tylosin tartrate solution into the solution B, and stirring and mixing for 30min to obtain a tylosin tartrate clathrate compound solution.
(5) And (3) adding 20kg of maltodextrin into the tylosin tartrate inclusion compound solution in the step (4), and stirring and dissolving to obtain the drug-containing adhesive.
(6) And (3) putting 75kg of glucose into a fluidized bed coating machine, spraying the medicine-containing adhesive obtained in the step (5) at the air inlet temperature of 80 ℃, the fan frequency of 35Hz and the liquid spraying frequency of 85Hz, forming granules, drying for 30 minutes, and screening the granules of 40-60 meshes to obtain the tylosin tartrate clathrate compound inner core.
(7) Wrapping an isolation layer: preparing 40kg of hydroxypropyl methyl cellulose aqueous solution with the content of 5wt%, weighing 1kg of superfine silica gel powder and the hydroxypropyl methyl cellulose aqueous solution, uniformly mixing, coating the tylosin tartrate inclusion compound inner core obtained in the step (6) with an isolation layer in a spraying manner of a fluidized bed coating machine, wherein the air inlet temperature is 85 ℃, the fan frequency is 40Hz, the liquid spraying frequency is 30Hz, the weight of the obtained pellet is increased by 4-6%, and drying for 1 hour to obtain the isolation pellet for later use.
(8) Wrapping an enteric layer: weighing 50kg of acrylic resin L100-55, 3kg of tributyl citrate, 6kg of talcum powder and 0.1kg of sodium hydroxide, adding into 50kg of water, uniformly mixing to obtain an enteric coating solution, adding the isolated pellet obtained in the step (7) into a fluidized bed coating machine, spraying the enteric coating solution until the weight of the pellet is increased by 16-22% to obtain the tylosin inclusion enteric preparation, wherein the air inlet temperature is 85 ℃, the fan frequency is 40Hz, and the liquid spraying frequency is 30 Hz.
The content of the tylosin tartrate in the prepared tylosin tartrate inclusion enteric-coated preparation is 20.8 wt%. Example 2
An enteric coated preparation of tylosin tartrate inclusion, which is prepared by the following steps:
(1) adding 0.5kg of tartaric acid and 3kg of polyvinylpyrrolidone PVP-K30 into 50kg of water, heating to 50 ℃ to dissolve, and preparing into solution A;
(2) adding 50kg of tylosin tartrate into the solution A, keeping the temperature at 50 ℃, and stirring for 15min to prepare a tylosin tartrate solution;
(3) dissolving 40kg of hydroxypropyl-beta-cyclodextrin in 100kg of water to prepare a solution B;
(4) and adding the tylosin tartrate solution into the solution B, and stirring and mixing for 30min to obtain a tylosin tartrate clathrate compound solution.
(5) And (3) adding 20kg of maltodextrin into the tylosin tartrate inclusion compound solution in the step (4), and stirring and dissolving to obtain the drug-containing adhesive.
(6) And (3) putting 50kg of glucose into a fluidized bed coating machine, spraying the medicine-containing adhesive obtained in the step (5) at the air inlet temperature of 80 ℃, the fan frequency of 35Hz and the liquid spraying frequency of 85Hz, forming granules, drying for 30 minutes, and screening the granules of 40-60 meshes to obtain the tylosin tartrate clathrate compound inner core.
(7) Wrapping an isolation layer: preparing 40kg of hydroxypropyl methyl cellulose aqueous solution with the content of 5wt%, weighing 1kg of superfine silica gel powder and the hydroxypropyl methyl cellulose aqueous solution, uniformly mixing, coating the tylosin tartrate inclusion compound inner core obtained in the step (6) with an isolation layer in a spraying manner of a fluidized bed coating machine, wherein the air inlet temperature is 85 ℃, the fan frequency is 40Hz, the liquid spraying frequency is 30Hz, the weight of the obtained pellet is increased by 4-6%, and drying for 1 hour to obtain the isolation pellet for later use.
(8) Wrapping an enteric layer: weighing 50kg of acrylic resin L100-55, 3kg of tributyl citrate, 6kg of talcum powder and 0.1kg of sodium hydroxide, adding into 50kg of water, uniformly mixing to obtain an enteric coating solution, adding the isolated pellet obtained in the step (7) into a fluidized bed coating machine, spraying the enteric coating solution until the weight of the pellet is increased by 16-22% to obtain the tylosin inclusion enteric preparation, wherein the air inlet temperature is 85 ℃, the fan frequency is 40Hz, and the liquid spraying frequency is 30 Hz.
The content of the tylosin tartrate in the prepared tylosin tartrate inclusion enteric-coated preparation is 24.8 wt%.
Example 3
An enteric coated preparation of tylosin tartrate inclusion, which is prepared by the following steps:
(1) adding 0.5kg of tartaric acid and 3kg of polyvinylpyrrolidone PVP-K30 into 50kg of water, heating to 50 ℃ to dissolve, and preparing into solution A;
(2) adding 50kg of tylosin tartrate into the solution A, keeping the temperature at 50 ℃, and stirring for 15min to prepare a tylosin tartrate solution;
(3) dissolving 50kg of hydroxypropyl-beta-cyclodextrin in 100kg of water to prepare a solution B;
(4) and adding the tylosin tartrate solution into the solution B, and stirring and mixing for 30min to obtain a tylosin tartrate clathrate compound solution.
(5) And (3) adding 20kg of maltodextrin into the tylosin tartrate inclusion compound solution in the step (4), and stirring and dissolving to obtain the drug-containing adhesive.
(6) And (3) putting 50kg of glucose into a fluidized bed coating machine, spraying the medicine-containing adhesive obtained in the step (5) at the air inlet temperature of 80 ℃, the fan frequency of 35Hz and the liquid spraying frequency of 85Hz, forming granules, drying for 30 minutes, and screening the granules of 40-60 meshes to obtain the tylosin tartrate clathrate compound inner core.
(7) Wrapping an isolation layer: preparing 40kg of hydroxypropyl methyl cellulose aqueous solution with the content of 5wt%, weighing 1kg of superfine silica gel powder and the hydroxypropyl methyl cellulose aqueous solution, uniformly mixing, coating the tylosin tartrate inclusion compound inner core obtained in the step (6) with an isolation layer in a spraying manner of a fluidized bed coating machine, wherein the air inlet temperature is 85 ℃, the fan frequency is 40Hz, the liquid spraying frequency is 30Hz, the weight of the obtained pellet is increased by 4-6%, and drying for 1 hour to obtain the isolation pellet for later use.
(8) Wrapping an enteric layer: weighing 50kg of acrylic resin L100-55, 3kg of tributyl citrate, 6kg of talcum powder and 0.1kg of sodium hydroxide, adding into 50kg of water, uniformly mixing to obtain an enteric coating solution, adding the isolated pellet obtained in the step (7) into a fluidized bed coating machine, spraying the enteric coating solution until the weight of the pellet is increased by 16-22% to obtain the tylosin inclusion enteric preparation, wherein the air inlet temperature is 85 ℃, the fan frequency is 40Hz, and the liquid spraying frequency is 30 Hz.
The content of the tylosin tartrate in the prepared tylosin tartrate inclusion enteric-coated preparation is 24.1 wt%.
Example 4
An enteric coated preparation of tylosin tartrate inclusion, which is prepared by the following steps:
(1) adding 0.5kg of tartaric acid and 3kg of polyvinylpyrrolidone PVP-K30 into 50kg of water, heating to 50 ℃ to dissolve, and preparing into solution A;
(2) adding 50kg of tylosin tartrate into the solution A, keeping the temperature at 50 ℃, and stirring for 15min to prepare a tylosin tartrate solution;
(3) dissolving 40kg of hydroxypropyl-beta-cyclodextrin in 100kg of water to prepare a solution B;
(4) and adding the tylosin tartrate solution into the solution B, and stirring and mixing for 30min to obtain a tylosin tartrate clathrate compound solution.
(5) And (3) adding 20kg of maltodextrin into the tylosin tartrate inclusion compound solution in the step (4), and stirring and dissolving to obtain the drug-containing adhesive.
(6) And (3) putting 75kg of glucose into a fluidized bed coating machine, spraying the medicine-containing adhesive obtained in the step (5) at the air inlet temperature of 80 ℃, the fan frequency of 35Hz and the liquid spraying frequency of 85Hz, forming granules, drying for 30 minutes, and screening the granules of 40-60 meshes to obtain the tylosin tartrate clathrate compound inner core.
(7) Wrapping an isolation layer: preparing 40kg of hydroxypropyl methyl cellulose aqueous solution with the content of 5wt%, weighing 1kg of superfine silica gel powder and the hydroxypropyl methyl cellulose aqueous solution, uniformly mixing, coating the tylosin tartrate inclusion compound inner core obtained in the step (6) with an isolation layer in a spraying manner of a fluidized bed coating machine, wherein the air inlet temperature is 85 ℃, the fan frequency is 40Hz, the liquid spraying frequency is 30Hz, the weight of the obtained pellet is increased by 4-6%, and drying for 1 hour to obtain the isolation pellet for later use.
(8) Wrapping an enteric layer: weighing 50kg of acrylic resin L100-55, 3kg of tributyl citrate, 6kg of talcum powder and 0.1kg of sodium hydroxide, adding into 50kg of water, uniformly mixing to obtain an enteric coating solution, adding the isolated pellet obtained in the step (7) into a fluidized bed coating machine, spraying the enteric coating solution until the weight of the pellet is increased by 16-22% to obtain the tylosin inclusion enteric preparation, wherein the air inlet temperature is 85 ℃, the fan frequency is 40Hz, and the liquid spraying frequency is 30 Hz.
The content of the tylosin tartrate in the prepared tylosin tartrate inclusion enteric-coated preparation is 22.3 wt%.
Example 5
An enteric coated preparation of tylosin tartrate inclusion, which is prepared by the following steps:
(1) adding 1kg of tartaric acid and 3kg of polyvinylpyrrolidone PVP-K30 into 50kg of water, heating to 50 ℃ to dissolve, and preparing a solution A;
(2) adding 50kg of tylosin tartrate into the solution A, keeping the temperature at 50 ℃, and stirring for 15min to prepare a tylosin tartrate solution;
(3) dissolving 50kg of hydroxypropyl-beta-cyclodextrin in 100kg of water to prepare a solution B;
(4) and adding the tylosin tartrate solution into the solution B, and stirring and mixing for 30min to obtain a tylosin tartrate clathrate compound solution.
(5) And (3) adding 20kg of maltodextrin into the tylosin tartrate inclusion compound solution in the step (4), and stirring and dissolving to obtain the drug-containing adhesive.
(6) And (3) putting 75kg of glucose into a fluidized bed coating machine, spraying the medicine-containing adhesive obtained in the step (5) at the air inlet temperature of 80 ℃, the fan frequency of 35Hz and the liquid spraying frequency of 85Hz, forming granules, drying for 30 minutes, and screening the granules of 40-60 meshes to obtain the tylosin tartrate clathrate compound inner core.
(7) Wrapping an isolation layer: preparing 40kg of hydroxypropyl methyl cellulose aqueous solution with the content of 5wt%, weighing 0.8kg of superfine silica gel powder and the hydroxypropyl methyl cellulose aqueous solution, uniformly mixing, coating the tylosin tartrate inclusion compound inner core obtained in the step (6) with an isolation layer in a spraying manner of a fluidized bed coating machine, wherein the air inlet temperature is 85 ℃, the fan frequency is 40Hz, the liquid spraying frequency is 30Hz, the weight of the obtained pellets is increased by 4-6%, and drying for 1 hour to obtain the isolation pellets for later use.
(8) Wrapping an enteric layer: weighing 50kg of acrylic resin L100-55, 3kg of tributyl citrate, 6kg of talcum powder and 0.1kg of sodium hydroxide, adding into 50kg of water, uniformly mixing to obtain an enteric coating solution, adding the isolated pellet obtained in the step (7) into a fluidized bed coating machine, spraying the enteric coating solution until the weight of the pellet is increased by 16-22% to obtain the tylosin inclusion enteric preparation, wherein the air inlet temperature is 85 ℃, the fan frequency is 40Hz, and the liquid spraying frequency is 30 Hz.
The content of the tylosin tartrate in the prepared tylosin tartrate inclusion enteric-coated preparation is 21.1 wt%.
Experiment for treating porcine respiratory disease by tylosin tartrate inclusion enteric-coated preparation
452 fattening pigs with respiratory diseases are naturally attacked in a certain pig farm in Henan, sick pigs are separately raised, and 450 pigs in sick pig herds are averagely divided into five groups for treatment:
tylosin tartrate inclusion enteric formulations prepared in examples 1-5 were mixed with: calculated by tylosin tartrate, 75g of pigs are fed by 1000kg of feed for 3 consecutive days.
TABLE 1 porcine respiratory disease treatment
| Group of | Number of pigs affected | Number of recovery | Rate of treatment |
| Example 1 | 90 | 88 | 97.8％ |
| Example 2 | 90 | 89 | 98.9％ |
| Example 3 | 90 | 89 | 98.9％ |
| Example 4 | 90 | 88 | 97.8％ |
| Example 5 | 90 | 88 | 97.8％ |
As can be seen from Table 1, the tylosin tartrate inclusion enteric-coated preparations prepared in examples 1 to 5 have high cure rate and good treatment effect on the porcine respiratory diseases.
Drug effect contrast experiment of tylosin tartrate inclusion enteric-coated preparation
308 fattening pigs with respiratory diseases are naturally attacked in a certain pig farm, sick pigs are separately raised, and sick pig groups are averagely divided into two groups for treatment:
experimental group
Tylosin tartrate inclusion enteric formulations prepared in example 1 were mixed with: calculated by tylosin tartrate, 75g of pigs are fed by 1000kg of feed for 3 consecutive days.
Drug control group
20% tylosin tartrate soluble powder (purchased from Shandong company), mixed feed: calculated by tylosin tartrate, 75g of pigs are fed by 1000kg of feed for 3 consecutive days.
TABLE 2 porcine respiratory disease treatment
| Group of | Number of pigs affected | Number of recovery | Rate of treatment |
| Experimental group | 154 | 150 | 97.40％ |
| Drug control group | 154 | 131 | 85.06％ |
As can be seen from table 2, the tylosin tartrate inclusion enteric preparation prepared in example 1 has a higher cure rate for porcine respiratory diseases than the commercially available 20% tylosin tartrate soluble powder. Therefore, the tylosin tartrate inclusion enteric-coated preparation has better treatment effect on the porcine respiratory diseases than the common tylosin tartrate soluble powder which is purchased on the market.
Claims (4)
1. A tylosin tartrate inclusion enteric-coated preparation is composed of a tylosin tartrate inclusion compound inner core and a coating layer coated outside the inner core, and is characterized in that: the coating layer comprises an isolating layer and an enteric layer from inside to outside in sequence,
the tylosin tartrate clathrate inner core is prepared from the following raw materials in parts by weight:
tartaric acid 0.5-1 part
Polyvinyl pyrrolidone PVP-K303 parts
50 portions of tylosin tartrate
40-50 parts of hydroxypropyl-beta-cyclodextrin
Maltodextrin 20 parts
50-75 parts of glucose
The isolating layer is selected from micro-powder silica gel and hydroxypropyl methyl cellulose, and the mass ratio of the isolating layer is 4-5: 10;
the enteric layer is selected from acrylic resin L100-55, tributyl citrate, talcum powder and sodium hydroxide, and the mass ratio of the enteric layer is 100: 6: 12: 0.2;
the preparation method of the tylosin tartrate inclusion enteric-coated preparation comprises the following steps:
(1) adding tartaric acid and polyvinylpyrrolidone PVP-K30 into water, wherein the mass ratio of the tartaric acid to the polyvinylpyrrolidone PVP-K30 to the water is 0.5-1: 3:50, heating to 50 ℃ for dissolution to prepare a solution A;
(2) adding the tylosin tartrate into the solution A, wherein the mass ratio of the tylosin tartrate to water in the solution A is 1:1, keeping the temperature at 50 ℃, and stirring for 15min to prepare a tylosin tartrate solution;
(3) dissolving hydroxypropyl-beta-cyclodextrin into water, wherein the mass ratio of the hydroxypropyl-beta-cyclodextrin to the water is 0.4-0.5: 1, preparing a solution B;
(4) adding the tylosin tartrate solution into the solution B, and stirring and mixing for 30min to obtain a tylosin tartrate clathrate compound solution;
(5) adding maltodextrin into the tylosin tartrate clathrate compound solution in the step (4), and stirring and dissolving to obtain a drug-containing adhesive;
(6) putting glucose into a fluidized bed coating machine, spraying the medicine-containing adhesive obtained in the step (5) into the fluidized bed coating machine, forming granules, drying the granules for 30 minutes, and screening the granules with 40-60 meshes to obtain a tylosin tartrate clathrate inner core;
(7) wrapping an isolation layer: preparing 5wt% of hydroxypropyl methyl cellulose aqueous solution, weighing a certain amount of superfine silica gel powder, uniformly mixing with the hydroxypropyl methyl cellulose aqueous solution, spraying the mixture to the tylosin tartrate inclusion compound inner core obtained in the step (6) through a fluidized bed coating machine to wrap an isolation layer, increasing the weight of the obtained pellets by 4-6%, and drying for 1 hour to obtain isolation pellets for later use;
wrapping an enteric layer: weighing a certain amount of acrylic resin L100-55, tributyl citrate, talcum powder and sodium hydroxide, adding into water, uniformly mixing to obtain an enteric coating solution, adding the isolated pellet obtained in the step (7) into a fluidized bed coating machine, and spraying the enteric coating solution until the weight of the pellet is increased by 16-22% to obtain the tylosin inclusion enteric preparation.
2. The tylosin tartrate inclusion enteric formulation according to claim 1, wherein the fluid bed coater is a DLB-60 bottom jet fluid bed coater.
3. The tylosin tartrate inclusion enteric formulation of claim 1, wherein: in the step (6), the air inlet temperature of the fluidized bed coating machine for granulation is 80 ℃, the frequency of the fan is 35Hz, and the frequency of the liquid spraying is 85 Hz.
4. The tylosin tartrate inclusion enteric formulation of claim 1, wherein: and (7) in the step (8), the air inlet temperature of the fluidized bed coating machine is 85 ℃, the frequency of a fan is 40Hz, the frequency of liquid spraying is 30Hz, coating liquid is sprayed in for treatment, and the fluidized drying is continued for 30 minutes after coating.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201611270158.6A CN108261410B (en) | 2016-12-30 | 2016-12-30 | Tylosin tartrate inclusion enteric-coated preparation and preparation method thereof |
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| CN201611270158.6A CN108261410B (en) | 2016-12-30 | 2016-12-30 | Tylosin tartrate inclusion enteric-coated preparation and preparation method thereof |
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| CN108261410A CN108261410A (en) | 2018-07-10 |
| CN108261410B true CN108261410B (en) | 2020-10-27 |
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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 |
| CN114028338B (en) * | 2021-12-28 | 2023-11-03 | 江西英特科胜动保科技有限公司 | Preparation method and application of water-soluble telavancin tartrate premix |
| 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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| 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 |
| CN103271931A (en) * | 2013-05-20 | 2013-09-04 | 广东大华农动物保健品股份有限公司 | Compound acetylisovalery tylosin tartrate pellet 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 |
| CN103271931A (en) * | 2013-05-20 | 2013-09-04 | 广东大华农动物保健品股份有限公司 | Compound acetylisovalery tylosin tartrate pellet and preparation method thereof |
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