CN108853025A - A kind of Tilmicosin solid dispersions and preparation method thereof - Google Patents
A kind of Tilmicosin solid dispersions and preparation method thereof Download PDFInfo
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- CN108853025A CN108853025A CN201810854880.7A CN201810854880A CN108853025A CN 108853025 A CN108853025 A CN 108853025A CN 201810854880 A CN201810854880 A CN 201810854880A CN 108853025 A CN108853025 A CN 108853025A
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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
- A61K9/146—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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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
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- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- 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 kind of Tilmicosin solid dispersions, and by Tilmicosin and complex carrier, ratio is 1 based on parts by weight of raw materials:3 compositions, the complex carrier is based on parts by weight of raw materials by PEG6000 and PLURONICS F87 by 20:1 mixed proportion composition.The present invention accurately defines the raw material composition and ratio of complex carrier, avoids the various defects that single carrier prepares solid dispersions appearance, enables the invention to be quickly dissolved in water and convenient for storage.For improving, its bioavilability, stability, drinking water administration convenience, treatment disease has important clinical value to the resulting Tilmicosin solid dispersions of the present invention in time.Preparation method simple process of the invention, operation controllability is strong, is conducive to large-scale industrial production.
Description
Technical field
The present invention relates to field of veterinary, in particular to a kind of medicinal solid dispersion.
Background technique
Tilmicosin is a kind of Novel macrocyclic lactone livestock and poultry dedicated antibiotic semi-synthetic by tylosin, to gram
Positive bacteria and part Gram-negative bacteria, mycoplasma, conveyor screw etc. have good inhibiting effect, to pleuropneumonia actinomyces,
Pasteurella has antibacterial activity more stronger than tylosin, with clinical common antibiotics without drug resistance of reporting to the leadship after accomplishing a task.It is clinically main
For the mazoitis of animal respiratory disease and lactating mammal, especially in treatment porcine respiratory disease syndrome and pig breeding and breathing
Significant superiority is shown when syndrome.But Tilmicosin has certain irritation, Tilmicosin mainly take it is for oral administration and
Injected s.c. administration, is especially used with caution drug administration by injection to pig, causes it to promote and apply in veterinary clinic and be restricted.
Tilmicosin is insoluble in water, has bitter taste, is in alkalinity, oral irritating to stomach mucosa, causes sometimes
Quick reaction, the target organ of toxic action are hearts, when too fast, excess dosage vein or intramuscular injection Tilmicosin, can cause to bear
Property mental and physical efforts effect, leads to animal dead.In the market it is mainly its phosphate, is easily destroyed by gastric acid after for oral administration, is absorbed not exclusively, it is raw
Object availability is low, and Half-life in vivo is short.It is clinical mainly by spice administration, but the easy loss of appetite of infected animal, cannot play and
When the effect treated.Water solubility, bioavilability, the targeting for improving Tilmicosin, extend its half-life period in vivo, enhance
Curative effect, it has also become one of the important topic of the efficient research on utilization of current Tilmicosin.In recent years, micro-capsule, microballoon, pellet, receive
The new technologies such as rice milk, enteric coating particle, inclusion compound, liposome, solid dispersions obtain in the research of tilmicosin micro-capsule preparation
Application, to a certain extent, improves the solubility of drug, masks the bitter taste of Tilmicosin, and has sustained release, targeting
Effect.But Tilmicosin targeting itself has the effect of targeted therapy in pulmonary alveolar macrophage, and for some
Acute disease, sustained release preparation can not play the role for the treatment of in time.Most of technology needs to be added organic reagent, and dosage compared with
Greatly, higher cost, and be difficult to eliminate sometimes, environment is polluted, currently, these new agent technologies do not obtain in actual production also
Using.
Summary of the invention
It is an object of the invention in view of the above shortcomings of the prior art, provide a kind of Tilmicosin solid dispersions,
For the soluble powder that one kind can cover bitter taste, be dissolved in water, bioavilability can be effectively improved.The solid dispersions are provided simultaneously
Preparation method.
The technical solution adopted by the present invention is that：A kind of Tilmicosin solid dispersions, by Tilmicosin and compound load
Body ratio based on parts by weight of raw materials is 1:3 compositions, the complex carrier is based on parts by weight of raw materials by PEG6000 and poloxamer
188 press 20:1 mixed proportion composition.
The present invention it has been investigated that, such as the single Tilmicosin solid dispersions being prepared into using PEG6000 carrier be not easy
It bonds and solution rate is slightly slow, and the single Tilmicosin solid dispersions being prepared into using PLURONICS F87 as carrier are viscous
Property is larger and easy bonding, but solution rate is very fast.It is i.e. single to use above two carrier in actual production and application process
Existing cannot be neglected defect.The present invention is assisted from solid dispersions viscosity, solution rate and maximum dissolution rate various aspects
With consideration, accurately define that the ratio based on parts by weight of raw materials is 20 to complex carrier by PEG6000 and PLURONICS F87:1 group
At so that the complex carrier has moderate viscosity and a good dissolution rate, dissolution rate reaches 71.8% or more when 2min, is
22.4 times of Tilmicosin raw medicine, when 15min, substantially completely dissolve, to effectively improve the biological utilisation of Tilmicosin
Degree.
A kind of preparation method of Tilmicosin solid dispersions as described above comprising following processing step：
1) PEG6000 and PLURONICS F87 is taken to be collectively disposed in container by parts by weight of raw materials, heating water bath melting, stirring
Tilmicosin is added simultaneously, continues stirring and is melted into medium completely to Tilmicosin, obtain semi-finished product；
2) it takes out container and pours into semi-finished product in the metal tray of pre-cooled processing, be then transferred to -20 DEG C of temperature strips
Solidify under part, then be placed in drying under the conditions of 35 DEG C of temperature, is ground, is sieved, obtain Tilmicosin solid dispersions finished product.
As a further improvement of the foregoing solution, the temperature of heating water bath described in step 1) is controlled at 57 DEG C.
As a further improvement of the foregoing solution, the mixing time of stirring described in step 1) is 1h.
As a further improvement of the foregoing solution, cured curing time described in step 2) is 12h.
As a further improvement of the foregoing solution, drying time dry described in step 2) is for 24 hours.
As a further improvement of the foregoing solution, sieving described in step 2) was 80 meshes.
The beneficial effects of the invention are as follows：
The present invention accurately defines the raw material composition and ratio of complex carrier, avoids single load preparation of solid dispersion
The various defects that body occurs enable the invention to be quickly dissolved in water and convenient for storage.The resulting Tilmicosin solid point of the present invention
For improving, its bioavilability, stability, drinking water administration convenience, treatment disease has important clinical application to granular media in time
Value.
Preparation method simple process of the invention, operation controllability is strong, is conducive to large-scale industrial production.
Specific embodiment
The present invention is specifically described below with reference to embodiment, in order to technical field personnel to of the invention
Understand.It is necessary to it is emphasized that embodiment is only intended to, the present invention will be further described herein, should not be understood as to this
The limitation of invention protection scope, fields person skilled in the art, the non-intrinsically safe that the present invention is made according to foregoing invention content
The modifications and adaptations of property, should still fall within protection scope of the present invention.Mentioned raw materials following simultaneously are unspecified, are
Commercial product；The processing step or preparation method not referred in detail be processing step known to a person skilled in the art or
Preparation method.
Embodiment 1
A kind of Tilmicosin solid dispersions, by Tilmicosin and complex carrier, ratio is 1 based on parts by weight of raw materials:3
Composition, the complex carrier is based on parts by weight of raw materials by PEG6000 and PLURONICS F87 by 20:1 mixed proportion composition.
Preparation method：
1) 20 parts of PEG6000 and 1 part of PLURONICS F87s are taken to be collectively disposed in container by parts by weight of raw materials, 57 DEG C of water-baths add
Heat fusing, stirring are added 7 parts of Tilmicosins simultaneously, mixing time 1h, until Tilmicosin is melted into medium completely, obtain partly at
Product；
2) it takes out container and pours into semi-finished product in the metal tray of pre-cooled processing, be then transferred to -20 DEG C of temperature strips
Solidify 12h under part, then be placed under the conditions of 35 DEG C of temperature it is dry for 24 hours, ground, cross 80 meshes, obtain 1 Tilmicosin solid of embodiment
Dispersion finished product.
1 gained finished product of embodiment is pressed through Their Dissolution Test in vitro《Republic of China Veterinary Pharmacopoeia》Version one in 2015
Annex 160 second method (paddle method) testing drug dissolution rate, measurement result show that maximum dissolution rate is 72.02%, 15min in 2min
When be completely dissolved.
Embodiment 2
A kind of Tilmicosin solid dispersions, by Tilmicosin and complex carrier, ratio is 1 based on parts by weight of raw materials:3
Composition, the complex carrier is based on parts by weight of raw materials by PEG6000 and PLURONICS F87 by 20:1 mixed proportion composition.
Preparation method：
1) 10 parts of PEG6000 and 0.5 part of PLURONICS F87s are taken to be collectively disposed in container by parts by weight of raw materials, 57 DEG C of water-baths
Heating melting, 3.5 parts of Tilmicosins of stirring while addition, mixing time 1h obtain half until Tilmicosin is melted into medium completely
Finished product；
2) it takes out container and pours into semi-finished product in the metal tray of pre-cooled processing, be then transferred to -20 DEG C of temperature strips
Solidify 12h under part, then be placed under the conditions of 35 DEG C of temperature it is dry for 24 hours, ground, cross 80 meshes, obtain 2 Tilmicosin solid of embodiment
Dispersion finished product.
2 gained finished product of embodiment is pressed through Their Dissolution Test in vitro《Republic of China Veterinary Pharmacopoeia》Version one in 2015
Annex 160 second method (paddle method) testing drug dissolution rate, measurement result show that maximum dissolution rate is 71.85%, 15min in 2min
When be completely dissolved.
Embodiment 3
A kind of Tilmicosin solid dispersions, by Tilmicosin and complex carrier, ratio is 1 based on parts by weight of raw materials:3
Composition, the complex carrier is based on parts by weight of raw materials by PEG6000 and PLURONICS F87 by 20:1 mixed proportion composition.
Preparation method：
1) 40 parts of PEG6000 and 2 part of PLURONICS F87s are taken to be collectively disposed in container by parts by weight of raw materials, 57 DEG C of water-baths add
Heat fusing, stirring are added 14 parts of Tilmicosins simultaneously, mixing time 1h, until Tilmicosin is melted into medium completely, obtain partly at
Product；
2) it takes out container and pours into semi-finished product in the metal tray of pre-cooled processing, be then transferred to -20 DEG C of temperature strips
Solidify 12h under part, then be placed under the conditions of 35 DEG C of temperature it is dry for 24 hours, ground, cross 80 meshes, obtain 3 Tilmicosin solid of embodiment
Dispersion finished product.
3 gained finished product of embodiment is pressed through Their Dissolution Test in vitro《Republic of China Veterinary Pharmacopoeia》Version one in 2015
Annex 160 second method (paddle method) testing drug dissolution rate, measurement result show that maximum dissolution rate is 72.36%, 15min in 2min
When be completely dissolved.
Above-described embodiment is the preferred embodiment of the present invention, all with similar technique of the invention and made equivalence changes,
It should belong to protection category of the invention.
Claims (8)
1. a kind of Tilmicosin solid dispersions, it is characterised in that：By Tilmicosin and complex carrier based on parts by weight of raw materials ratio
Example is 1:3 compositions, the complex carrier is based on parts by weight of raw materials by PEG6000 and PLURONICS F87 by 20:1 mixed proportion
Composition.
2. a kind of Tilmicosin solid dispersions according to claim 1, it is characterised in that：When solid dispersions 2min
It is substantially completely dissolved when dissolution rate reaches 71.8% or more, 15min.
3. a kind of preparation method of Tilmicosin solid dispersions as claimed in claim 1 or 2, it is characterised in that including as follows
Processing step：
1) PEG6000 and PLURONICS F87 is taken to be collectively disposed in container by parts by weight of raw materials, heating water bath melting, stirring is simultaneously
Tilmicosin is added, continues stirring and is melted into medium completely to Tilmicosin, obtain semi-finished product；
2) it takes out container and pours into semi-finished product in the metal tray of pre-cooled processing, be then transferred under the conditions of -20 DEG C of temperature
Solidification, then it is placed in drying under the conditions of 35 DEG C of temperature, it ground, be sieved, obtain Tilmicosin solid dispersions finished product.
4. a kind of preparation method of Tilmicosin solid dispersions according to claim 3, it is characterised in that：In step 1)
The temperature of the heating water bath is controlled at 57 DEG C.
5. a kind of preparation method of Tilmicosin solid dispersions according to claim 3, it is characterised in that：In step 1)
The mixing time of the stirring is 1h.
6. a kind of preparation method of Tilmicosin solid dispersions according to claim 3, it is characterised in that：In step 2)
The cured curing time is 12h.
7. a kind of preparation method of Tilmicosin solid dispersions according to claim 3, it is characterised in that：In step 2)
The drying time of the drying is for 24 hours.
8. a kind of preparation method of Tilmicosin solid dispersions according to claim 3, it is characterised in that：In step 2)
The sieving was 80 meshes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201810854880.7A CN108853025B (en) | 2018-07-30 | 2018-07-30 | Tilmicosin solid dispersion and preparation method thereof |
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| CN201810854880.7A CN108853025B (en) | 2018-07-30 | 2018-07-30 | Tilmicosin solid dispersion and preparation method thereof |
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| CN108853025B CN108853025B (en) | 2020-12-29 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109953997A (en) * | 2019-04-22 | 2019-07-02 | 佛山科学技术学院 | A kind of preparation method of tilmicosin micro-capsule preparation |
| CN111407728A (en) * | 2020-04-16 | 2020-07-14 | 重庆市畜牧科学院 | Tilmicosin enteric solid dispersion and preparation method and application thereof |
| CN115645376A (en) * | 2022-10-26 | 2023-01-31 | 山东德州神牛药业有限公司 | Tilmicosin efficient double-layer coated pellet and preparation method thereof |
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| CN104721826A (en) * | 2015-04-14 | 2015-06-24 | 四川美嘉龙生物科技有限公司 | Tilmicosin preparation and preparation method thereof |
| CN105582019A (en) * | 2014-10-27 | 2016-05-18 | 河南惠通天下生物工程有限公司 | Tilmicosin solid dispersing agent and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109953997A (en) * | 2019-04-22 | 2019-07-02 | 佛山科学技术学院 | A kind of preparation method of tilmicosin micro-capsule preparation |
| CN109953997B (en) * | 2019-04-22 | 2021-06-29 | 佛山科学技术学院 | Preparation method of tilmicosin preparation |
| CN111407728A (en) * | 2020-04-16 | 2020-07-14 | 重庆市畜牧科学院 | Tilmicosin enteric solid dispersion and preparation method and application thereof |
| CN111407728B (en) * | 2020-04-16 | 2022-02-22 | 重庆市畜牧科学院 | Tilmicosin enteric solid dispersion and preparation method and application thereof |
| CN115645376A (en) * | 2022-10-26 | 2023-01-31 | 山东德州神牛药业有限公司 | Tilmicosin efficient double-layer coated pellet and preparation method thereof |
| CN115645376B (en) * | 2022-10-26 | 2023-10-31 | 山东德州神牛药业有限公司 | Efficient double-layer coated tilmicosin pellets and preparation method thereof |
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| CN108853025B (en) | 2020-12-29 |
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Effective date of registration: 20210423 Address after: 528000 Guangdong Province, Foshan city Shunde District Daliang Honggang Industrial Zone Patentee after: GUANGDONG YANGBLE BIOPHARMACEUTICALS Co.,Ltd. Address before: 528000 Foshan University, Guangdong Province, Nanhai District, Nanhai District, Xian Xi reservoir West Road, Foshan University Patentee before: FOSHAN University |