CN114652733A - Tylosin tartrate premix and preparation method thereof - Google Patents
Tylosin tartrate premix and preparation method thereof Download PDFInfo
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- CN114652733A CN114652733A CN202210571778.2A CN202210571778A CN114652733A CN 114652733 A CN114652733 A CN 114652733A CN 202210571778 A CN202210571778 A CN 202210571778A CN 114652733 A CN114652733 A CN 114652733A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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Abstract
The invention discloses a tylosin tartrate premix and a preparation method thereof, and relates to the technical field of veterinary drugs, wherein the tylosin tartrate premix comprises 22.88 wt% of tylosin tartrate (20 wt% of tylosin tartrate), 1-4 wt% of fatty alcohol-polyoxyethylene ether and 73.12-76.12 wt% of kaolin, and the tylosin tartrate in the product has good stability, good drug effect and greatly improved bioavailability.
Description
Technical Field
The invention relates to the technical field of veterinary drugs, and in particular relates to a tylosin tartrate premix and a preparation method thereof.
Background
Tylosin tartrate, also known as acetylisovaleryltylosin tartrate, is a novel antibiotic special for macrolides animals developed by Iceca England health-care Co., Ltd, and is a derivative of tylosin. It features wider antibacterial spectrum (stronger antibacterial activity to mycoplasma, spirochete, most gram-positive bacteria and part gram-negative bacteria; special effect to tylosin resistant bacteria), high antibacterial activity (3-10 times of activity of tylosin), low dosage and low residue in animal body. It has new molecular structure and is not easy to produce resistance. Is a latest specific medicine which is recognized in the world for treating and preventing mycoplasma infection of livestock and poultry, so the tylosin has wide market application prospect. However, the tylosin tartrate raw material has poor stability, and the main component of the tylosin A is easy to degrade to generate other substances, so that the bioavailability of the drug is reduced.
Application number CN201610877537.5 discloses tylosin tartrate granular preparation and a preparation method thereof, and although main medicines are uniformly distributed and round in granules, the flowability and the dispersibility of the granular preparation are improved, the preparation prepared by the scheme has poor stability and low bioavailability.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: aiming at the defects in the prior art, the tylosin tartrate premix and the preparation method thereof are provided, the premix can effectively ensure the stability of the main component tylosin A, improves the bioavailability, and is simple and convenient in production process, low in cost and very suitable for large-scale production.
In order to solve the technical problem, the technical scheme of the invention is as follows:
the tylosin tartrate premix comprises, by weight, 22.88% of tylosin tartrate (calculated by 20% of tylosin), 1-4% of fatty alcohol-polyoxyethylene ether and 73.12-76.12% of kaolin.
A preparation method of a high-stability tylosin tartrate premix comprises the following steps:
A. feeding tylosin tartrate and fatty alcohol-polyoxyethylene ether into a spiral airflow pulverizer to be pulverized to obtain a mixed material;
B. and putting the mixed material and kaolin into a stirring device for continuous mixing to obtain the tylosin tartrate premix.
Preferably, the feeding pressure of the spiral jet mill is 0.53MPa, and the grinding pressure is 0.47 MPa.
Preferably, the particle size of the mixed material is 12-44 μm.
Preferably, the rotating speed of the stirring device is 200 r/min.
Preferably, the stirring time of the mixed materials and the kaolin in the step B is 20-30 min.
Due to the adoption of the technical scheme, the invention has the beneficial effects that:
1. the fatty alcohol-polyoxyethylene ether can obviously improve the stability of the tylosin tartrate, prolong the degradation period and greatly improve the bioavailability.
2. The mixture obtained after the jet mill is used for crushing has uniform granularity, good particle fluidity and dispersibility, uniform distribution of the main drug after being mixed with the kaolin and good drug effect.
Detailed Description
The invention is further illustrated by the following examples.
Example 1
The tylosin tartrate premix comprises, by weight, 22.88% of tylosin tartrate (calculated by 20% of tylosin), 1% of fatty alcohol-polyoxyethylene ether and 76.12% of kaolin.
The preparation method of the tavermectin tartrate premix comprises the following steps:
firstly, preparing materials according to the following raw material and auxiliary material formula
Tylosin tartrate 11.44g
Fatty alcohol polyoxyethylene ether 0.5g
Kaolin 38.06g
Secondly, airflow crushing: airflow crushing tylosin tartrate and fatty alcohol-polyoxyethylene ether by using a spiral airflow crusher, wherein the feeding pressure is 0.53MPa, and the grinding pressure is 0.47 MPa; the particle size after jet milling is between 12 and 44 um.
Mixing: and continuously mixing the material crushed by the spiral jet mill and the kaolin for 20min at the rotating speed of 200r/min to finally obtain the tylosin tartrate premix.
And (3) stability detection:
the sealed tavermectin tartrate premix aluminum foil bag in the third step of the example 1 is sealed and placed in a constant temperature and humidity environment (40 ℃, 75 percent of relative humidity) for 6 months, and the content and the property change of the tavermectin A are detected once every month. The results of the measurements are shown in the following table. (according to the requirements of veterinary drug quality standard, the content of tylosin A related to the tylosin tartrate premix is not lower than 80%)
Example 2
The tylosin tartrate premix comprises, by weight, 22.88% of tylosin tartrate (calculated by 20% of tylosin), 2% of fatty alcohol-polyoxyethylene ether and 75.12% of kaolin.
The preparation method of the tavermectin tartrate premix comprises the following steps:
firstly, preparing materials according to the following raw material and auxiliary material formula
Tylosin tartrate 11.44g
Fatty alcohol polyoxyethylene ether 1g
Kaolin 37.56g
Secondly, airflow crushing: airflow crushing tylosin tartrate and fatty alcohol-polyoxyethylene ether by using a spiral airflow crusher, wherein the feeding pressure is 0.53MPa, and the grinding pressure is 0.47 MPa; the particle size after jet milling is between 12 and 44 um.
Mixing: and continuously mixing the material crushed by the spiral jet mill and the kaolin for 20min at the rotating speed of 200r/min to finally obtain the tylosin tartrate premix.
And (3) stability detection:
the sealed tavermectin tartrate premix aluminum foil bag in the third step of the example 2 is sealed and placed in a constant temperature and humidity (40 ℃, 75 percent of relative humidity) for 6 months, and the content and the property change of the related component tavermectin A are detected once every month. The results of the measurements are shown in the following table. (according to the requirements of veterinary drug quality standard, the content of tylosin A related to the tartaric acid tylosin premix is not lower than 80%)
Example 3
The tylosin tartrate premix comprises, by weight, 22.88% of tylosin tartrate (calculated by 20% of tylosin), 3% of fatty alcohol-polyoxyethylene ether and 74.12% of kaolin.
The preparation method of the tavermectin tartrate premix comprises the following steps:
firstly, preparing materials according to the following raw material and auxiliary material formula
Tylosin tartrate 11.44g
Fatty alcohol polyoxyethylene ether 1.5g
Kaolin 37.06g
Secondly, airflow crushing: airflow crushing tylosin tartrate and fatty alcohol-polyoxyethylene ether by using a spiral airflow crusher, wherein the feeding pressure is 0.53MPa, and the grinding pressure is 0.47 MPa; the particle size after jet milling is between 12 and 44 um.
Mixing: and continuously mixing the material crushed by the spiral jet mill and the kaolin for 20min at the rotating speed of 200r/min to finally obtain the tylosin tartrate premix.
And (3) stability detection:
the sealed tavermectin tartrate premix aluminum foil bag in the third step of the example 3 is sealed and placed in a constant temperature and humidity environment (40 ℃, 75 percent of relative humidity) for 6 months, and the content and the property change of the related component tavermectin A are detected once every month. The results are shown in the following table. (according to the requirements of veterinary drug quality standard, the content of tylosin A related to the tylosin tartrate premix is not lower than 80%)
Example 4
The tylosin tartrate premix comprises, by weight, 22.88% of tylosin tartrate (calculated by 20% of tylosin), 4% of fatty alcohol-polyoxyethylene ether and 73.12% of kaolin.
The preparation method of the tavermectin tartrate premix comprises the following steps:
firstly, preparing materials according to the following raw material and auxiliary material formula
Tylosin tartrate 11.44g
Fatty alcohol polyoxyethylene ether 2g
Kaolin 36.56g
Secondly, airflow crushing: airflow crushing tylosin tartrate and fatty alcohol-polyoxyethylene ether by using a spiral airflow crusher, wherein the feeding pressure is 0.53MPa, and the grinding pressure is 0.47 MPa; the particle size after jet milling is between 12 and 44 um.
Mixing: and continuously mixing the material crushed by the spiral airflow crusher and the kaolin for 20min at the rotating speed of 200r/min to finally obtain the tylosin tartrate premix.
And (3) stability detection:
the sealed tavermectin tartrate premix aluminum foil bag in the third step of the example 4 is sealed and placed in a constant temperature and humidity environment (40 ℃, 75 percent of relative humidity) for 6 months, and the content and the property change of the tavermectin A are detected once every month. The results of the measurements are shown in the following table. (according to the requirements of veterinary drug quality standard, the content of tylosin A related to the tylosin tartrate premix is not lower than 80%)
Comparative example 1
The tylosin tartrate premix comprises, by weight, 22.88% of tylosin tartrate (calculated by 20% of tylosin), and 77.12% of kaolin.
The preparation method of the tavermectin tartrate premix comprises the following steps:
firstly, preparing materials according to the following raw and auxiliary material formula
Tylosin tartrate 11.44g
Kaolin 38.56g
Mixing: and mixing the tylosin tartrate and the kaolin for 20min at the rotating speed of 200r/min to finally obtain the tylosin tartrate premix.
And (3) stability detection:
the sealed tavermectin tartrate premix aluminum foil bag in the third step of the example 4 is sealed and placed in a constant temperature and humidity environment (40 ℃, 75 percent of relative humidity) for 6 months, and the content and the property change of the tavermectin A are detected once every month. The results of the measurements are shown in the following table. (according to the requirements of veterinary drug quality standard, the content of tylosin A related to the tylosin tartrate premix is not lower than 80%)
The preparation without the fatty alcohol polyoxyethylene ether is placed for 6 months at constant temperature and humidity (40 ℃, 75 percent of relative humidity), the content of the tylosin A is reduced to 73.04 percent, and the tylosin A does not meet the quality standard of veterinary drugs.
Comparative example 2
A20% tylosin tartrate premix (calculated as tylosin) produced by Aomo pharmaceutical Co., Ltd, Jiangsu, which is manufactured by a batch number of 2020062201, was sealed and placed in an aluminum foil bag under constant temperature and humidity (40 ℃, 75% relative humidity) to be stored for 6 months, and the content and property change of the related component tylosin A were detected once a month. The results of the measurements are shown in the following table. According to the requirements of veterinary drug quality standard: the content of the tavermectin A related to the tartaric acid tavermectin premix is not lower than 80%.
Comparative example 3
A20% tylosin tartrate premix (calculated as tylosin) manufactured by Ainuo biotechnology limited of Nanjing and having a batch number of 202108006 is sealed in an aluminum foil bag and stored in a constant temperature and humidity environment (40 ℃, 75% relative humidity) for 6 months, and the content and the property change of the related component tylosin A are detected once every month. The results are shown in the following table. According to the requirements of veterinary drug quality standard: the content of the tavermectin A related to the tartaric acid tavermectin premix is not lower than 80%.
The tylosin tartrate premix provided by the invention is very stable in properties and related component tylosin A, long-term acceleration experiments are carried out, the tylosin tartrate premix is sealed by an aluminum foil bag and then is stored in constant temperature and humidity (40 ℃, 75% relative humidity) for 6 months, no caking and no color change are caused in the storage period, the content of the related component tylosin A meets the requirement, and compared with the commercially available tylosin tartrate premix product, the tylosin tartrate premix has the advantages of better stability, simplicity in preparation and convenience in popularization.
It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Further, it should be understood that various changes or modifications of the present invention may be made by those skilled in the art after reading the teaching of the present invention, and such equivalents may fall within the scope of the present invention as defined in the appended claims.
Claims (6)
1. The tylosin tartrate premix is characterized in that: the anti-bacterial agent comprises, by weight, 22.88% of tylosin tartrate, 1-4% of fatty alcohol-polyoxyethylene ether and 73.12-76.12% of kaolin.
2. The method for preparing the tylosin tartrate premix according to claim 1, comprising the following steps:
A. adding tylosin tartrate and fatty alcohol-polyoxyethylene ether into a spiral jet mill for crushing to obtain a mixed material;
B. and putting the mixed material and kaolin into a stirring device for continuous mixing to obtain the tylosin tartrate premix.
3. The method for preparing the tylosin tartrate premix as claimed in claim 2, wherein the method comprises the following steps: the feeding pressure of the spiral jet mill is 0.53MPa, and the grinding pressure is 0.47 MPa.
4. The method for preparing the tylosin tartrate premix as claimed in claim 2, wherein the method comprises the following steps: the granularity of the mixed material is 12-44 mu m.
5. The method for preparing the tylosin tartrate premix as claimed in claim 2, wherein the method comprises the following steps: the rotating speed of the stirring device is 200 r/min.
6. The method for preparing the tylosin tartrate premix as claimed in claim 2, wherein the method comprises the following steps: and B, stirring the mixture and the kaolin for 20-30 min.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202210571778.2A CN114652733A (en) | 2022-05-25 | 2022-05-25 | Tylosin tartrate premix and preparation method thereof |
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| CN202210571778.2A CN114652733A (en) | 2022-05-25 | 2022-05-25 | Tylosin tartrate premix and preparation method thereof |
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Application publication date: 20220624 |