CN106265527A - A kind of water soluble trimethoprim compositions and complex composition thereof - Google Patents
A kind of water soluble trimethoprim compositions and complex composition thereof Download PDFInfo
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- CN106265527A CN106265527A CN201610981803.9A CN201610981803A CN106265527A CN 106265527 A CN106265527 A CN 106265527A CN 201610981803 A CN201610981803 A CN 201610981803A CN 106265527 A CN106265527 A CN 106265527A
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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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
- A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
- A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
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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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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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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Abstract
The invention provides a kind of water soluble trimethoprim compositions and complex composition thereof, after special process processes trimethoprim, can be dispersed in water with sulfanilamide salt simultaneously, it is possible to effectively solve pre-mixing agent mix in feedstuff uneven, affect the problems such as therapeutic effect.Can pass through drinking water administration, the septicemia causing poultry escherichia coli, Pullorum Disease, avian typhoid, cholera, innominate high fever, respiratory system Secondary bacterial infections etc. have significant therapeutic effect, it may also be used for the preventing and treating of coccidiosis.This preparation method is simple to operate, pollution-free, is suitable for commercial production.
Description
Technical field
The present invention relates to a kind of water soluble trimethoprim compositions and complex composition thereof, belong to field of veterinary.
Background technology
Sulfa drugs, as a class chemotherapeutic agent, serves very well in the control of bacterial disease and coccidiosis
Effect.Sulfa drugs in field of veterinary application has kind more than 10 at present, and this type of medicine has has a broad antifungal spectrum, orally available, suction
Receive the advantages such as rapid, stable in properties；But have that untoward reaction is more, antibacterial is easily generated drug resistance, consumption is big and the course for the treatment of is inclined the most simultaneously
The defects such as length.After being found that the Trimethoprims such as trimethoprim, sulphonamides and synergist are share, make antibacterial activity increase greatly
By force, therefore, one of important drugs during sulfa drugs is the most still poultry infection and coccidiosis treatment.
Sulfa drugs Antibacterial Mechanism is to suppress the growth and breeding of antibacterial by suppression folic acid in endobacillary metabolism.Right
The antibacterial of such medicaments insensitive is during growth and breeding, it is impossible to directly utilize exogenous folates from growing environment, it is necessary to utilize
Para-amino benzoic acid outside bacterial body, in thalline under the participation of dihydrofolate synthetase, synthesizing dihydro together with dihydro pteridine
Folic acid, then the effect formation tetrahydrofolic acid through dihydrofolate reductase, participate in other materials one such as purine, pyrimidine as coenzyme
Play nucleic acid.This class medicine has the chemical constitution similar to para-amino benzoic acid, can compete dihydro leaf with para-amino benzoic acid
Acid enzyme, thus hinder the synthesis of sensitive organism dihydrofoilic acid and play bacteriostasis.Higher mammal can directly utilize exogenous
Folic acid, therefore its metabolism is not disturbed by sulfa drugs.
Trimethoprim, antimicrobial spectrum with sulfa drugs seemingly, has the effect of suppression dihydrofolate reductase, but antibacterial is relatively easily generated
Drug resistance, is seldom used alone.Share with sulphonamides, can make the folic acid metabolism of antibacterial by double blocking, thus antibacterial action
Increase substantially (can potentiation several times to tens times), therefore have the title of trimethoprim (TMP), and the appearance of drug resistance strain can be reduced.These product
Mainly make the synergist of sulfonamides, typically use in the ratio of 1:5, septicemia, chicken that poultry escherichia coli cause can be treated
Hakuri, avian typhoid, cholera, respiratory system Secondary bacterial infections etc., it may also be used for the preventing and treating of coccidiosis.
Trimethoprim is lipophilic alkalescence, is white or off-white color crystalline powder, odorless under room temperature, and bitter in the mouth, at chloroform
Middle the most molten, slightly soluble in ethanol or acetone, the most insoluble in water, the most readily soluble.Clinical practice uses methoxy more
The salt that benzyl pyridine solubization is good, i.e. Trimethoprim lactate.Because sulfa drugs dissolves in the basic conditions, analyse in acid condition
Go out；Trimethoprim dissolves in acid condition, separates out in the basic conditions.At present, sulphonamides and trimethoprim compound clinically
Compositions all exists with pre-mixing agent, injection, oral solution, suspension, tablet form.Injection, oral solution, suspendible
Liquid is tight to technological requirement, and organic solvent content is high, and manufacturing cost is high, and tablet in-convenience in use etc. shortcoming.
Pre-mixing agent can only be administered by spice, and cannot be administered systemically by the most frequently used drinking water administration, at animal cultivation
The especially cultivation of poultry is very inconvenient in using, and particularly poultry feed intake when morbidity declines to a great extent, it is impossible to accurately mixed feeding
Dosage, significantly limit the use clinically of its complex composition.Therefore it is badly in need of a kind of method, can be made both simultaneously
Soluble in water, do not separate out in animal specifically drinks water the time, not precipitation etc..
Summary of the invention
The invention provides a kind of water soluble trimethoprim compositions, solve trimethoprim and be insoluble in the problem of water, this
Invention further provides the complex composition of a kind of compositions containing water soluble trimethoprim, by drinking water administration, has
Effect solves pre-mixing agent and is difficult to mix homogeneously in feedstuff, the problem affecting therapeutic effect.
A kind of water soluble trimethoprim compositions, including trimethoprim and cosolvent.
The particle diameter of described trimethoprim is≤20 μm；Preferable particle size is 5-10 μm.
One or more in following compound of described cosolvent: Polyethylene Glycol, polyvinylpyrrolidone, pool Lip river
Sha Mu, nonionic surfactant or anion surfactant；Preferably Polyethylene Glycol or polyvinylpyrrolidone and anion
The mixture of surfactant.
The complex composition of a kind of water soluble trimethoprim, is made up of the material of following mass fraction: trimethoprim 2～4
Part, sulfanilamide salt 10～20 parts, cosolvent 3～12 parts, carrier 64～85 parts.
One or more in following compound of cosolvent in described complex composition: Polyethylene Glycol, polyethylene
Ketopyrrolidine, poloxamer, nonionic surfactant or anion surfactant；Preferably Polyethylene Glycol or polyvinyl pyrrole
Alkanone and the mixture of anion surfactant.
Trimethoprim in described complex composition processes through micronizing, and its particle diameter is≤20 μm；Preferable particle size is
5-10μm。
Sulfanilamide salt in described complex composition, selected from Prinzone (Squibb), sulfamonomethoxine sodium, sulfadiazine
One or more in sodium, sulfadimidine sodium, Sulfamethoxazole sodium.
In described complex composition, the mass ratio of trimethoprim and sulfanilamide salt is 1:5-10；Preferably 1:5.
Carrier in described complex composition is pharmaceutically acceptable carrier, preferably sucrose, lactose, anhydrous glucose and can
One or more in soluble starch.
The application in manufacturing veterinary drug of this complex composition, is used for preventing and treating fowl bacterial infection, coccidiosis etc..
The invention has the beneficial effects as follows:
1, solve trimethoprim and be insoluble in the problem of water, by micronizing trimethoprim and preferred cosolvent, will
Dissolubility is greatly improved so that it is can be with drinking water administration.
2, provide a kind of drug regimen, comprise the powder complex composition of trimethoprim, sulfanilamide salt, given by drinking-water
Medicine, efficiently solves pre-mixing agent and is difficult to mix homogeneously in feedstuff, the problem affecting therapeutic effect.
3, safety: be administered by water way, drug level is uniform, and animal will not occur intoxicating phenomenon.
4, drug absorption is fast, and bioavailability is high, and convenient drug administration, curative effect is certain.
5, can be distributed to rapidly in the most of histoorgan of whole body and body fluid, in the short time, blood drug level reaches the highest
Peak value.
6, saving medicine: be administered by water way, required dose is that the general of dose needed for spice just can reach same
Therapeutic effect.
7, the preparation technology of the present invention selects adjuvant cheap and easy to get, and production technology is simple, pollution-free, meets commercial production and wants
Summation environmental requirement.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in detail.
Embodiment 1
Trimethoprim (Shouguang Fukang Pharmaceutical Co., Ltd.)
Embodiment 2
Prepared by the complex composition containing trimethoprim:
Trimethoprim 2.0g
Prinzone (Squibb) 10.0g
Preparation method: weigh trimethoprim (Shouguang Fukang Pharmaceutical Co., Ltd.) 2.0g and Prinzone (Squibb) respectively
10.0g, after mix homogeneously, mix homogeneously i.e. obtains powder complex composition.
Embodiment 3
Prepared by the complex composition containing trimethoprim:
Trimethoprim 2.0g
Prinzone (Squibb) 10.0g
Sucrose 88.0g
Preparation method: weigh trimethoprim (Shouguang Fukang Pharmaceutical Co., Ltd.) 2.0g and Prinzone (Squibb) respectively
10.0g, with sucrose 88.0g after mix homogeneously, mix homogeneously i.e. obtains powder complex composition.
Embodiment 4
Prepared by the complex composition containing trimethoprim:
Preparation method: weigh trimethoprim (Shouguang Fukang Pharmaceutical Co., Ltd.) 2.0g, polyethylene glycol 6000 respectively
5.0g, adds Prinzone (Squibb) 10.0g after mix homogeneously, with sucrose 83.0g after mix homogeneously, mix homogeneously i.e. obtains powder
Shape complex composition.
Embodiment 5
The pulverizing of trimethoprim:
Disintegrating apparatus: jet mill (Kunshan close friend Machinery Manufacturing Co., Ltd.), smashing fineness (μm) 0.5-30.
Operation principle: initially with blade boulder crusher to raw material preliminary working, it is in small, broken bits then to carry out secondary pulse, is ultimately delivered to
Jet mill carries out superfine grinding, and material is under the high velocity air impact that several nozzles that comminution by gas stream is indoor produce, mutually
Collision, phase mutual friction, moment rupture, it is achieved superfine grinding.By the sorting of built-in grader, qualified products are discharged with air-flow,
Enter cyclone separator, cleaner unit is collected, and coarse granule returns pulverizing chamber to be continued to pulverize.
Sample source: trimethoprim (Shouguang Fukang Pharmaceutical Co., Ltd.).
Droplet measurement: after sample superfine grinding, use particle size analyzer detection sample particle diameter distribution, qualified after be methoxy
Benzyl pyridine micropowder.
Embodiment 6
The preparation of the complex composition containing trimethoprim:
Trimethoprim micropowder 2.0g
Prinzone (Squibb) 10.0g
Preparation method: weigh trimethoprim micropowder 2.0g and Prinzone (Squibb) 10.0g respectively, i.e. obtains powder after mix homogeneously
Powder complex composition.
Embodiment 7
The preparation of the soluble compounding compositions containing trimethoprim:
Trimethoprim micropowder 2.0g
Prinzone (Squibb) 10.0g
Sucrose 88.0g
Preparation method: weigh respectively after trimethoprim micropowder 2.0g and Prinzone (Squibb) 10.0g mix homogeneously with sucrose
83.0g, mix homogeneously i.e. obtains powder complex composition.
Embodiment 8
The preparation of the soluble compounding compositions containing trimethoprim:
Preparation method: weigh trimethoprim micropowder 2.0g, polyethylene glycol 6000 5.0g respectively, add after mix homogeneously
Prinzone (Squibb) 10.0g, with sucrose 83.0g after mix homogeneously, mix homogeneously i.e. obtains soluble powder powder complex composition.
Embodiment 9
The preparation of the soluble compounding compositions containing trimethoprim:
Preparation method: weigh trimethoprim micropowder 2.0g, Macrogol 4000 2.0g, sodium lauryl sulphate respectively
2.0g, adds Prinzone (Squibb) 10.0g after mix homogeneously, with sucrose 84.0g after mix homogeneously, mix homogeneously i.e. obtains solvable
Property powder complex composition.
Embodiment 10
The preparation of the soluble compounding compositions containing trimethoprim:
Preparation method: weigh trimethoprim micropowder 2.0g, PVP K30 5.0g respectively, after mix homogeneously again
Adding Prinzone (Squibb) 10.0g, add anhydrous glucose 83.0g after mix homogeneously, it is multiple that mix homogeneously i.e. obtains soluble powder powder
Combo compound.
Embodiment 11
The preparation of the soluble compounding compositions containing trimethoprim:
Preparation method: weigh trimethoprim micropowder 2.0g, PVP K30 2.0g, lauryl sulphate acid respectively
Sodium 2.0g, adds Prinzone (Squibb) 10.0g after mix homogeneously, with soluble starch 84.0g, mix homogeneously after mix homogeneously
Obtain soluble powder powder complex composition.
Embodiment 12
The preparation of the soluble compounding compositions containing trimethoprim:
Preparation method: weigh trimethoprim micropowder 2.0g, Macrogol 4000 5.0g, sodium lauryl sulphate respectively
1.0g, adds sulfamonomethoxine sodium 10.0g after mix homogeneously, add anhydrous glucose 82.0g after mix homogeneously, and mixing is all
Even i.e. obtain soluble powder powder complex composition.
Embodiment 13
The preparation of the soluble compounding compositions containing trimethoprim:
Preparation method: weigh trimethoprim micropowder 2.0g, polyethylene glycol 6000 5.0g, sodium lauryl sulphate respectively
1.0g, adds sulfadiazine sodium 10.0g after mix homogeneously, add lactose 82.0g after mix homogeneously, and mix homogeneously i.e. obtains solubility
Powder complex composition.
Embodiment 14
The preparation of the soluble compounding compositions containing trimethoprim:
Preparation method: weigh trimethoprim micropowder 2.0g, Macrogol 4000 5.0g, sodium lauryl sulphate respectively
2.0g, adds Sulfamethoxazole sodium 10.0g after mix homogeneously, with sucrose 81.0g after mix homogeneously, mix homogeneously i.e. obtains solvable
Property powder complex composition.
Embodiment 15
The preparation of the soluble compounding compositions containing trimethoprim:
Preparation method: weigh trimethoprim micropowder 4.0g, polyethylene glycol 6000 10.0g, sodium lauryl sulphate respectively
2.0g, adds sulfadiazine sodium 10.0g, Sulfamethoxazole sodium 10.0g after mix homogeneously, with sucrose 64.0g after mix homogeneously,
Mix homogeneously i.e. obtains soluble powder powder complex composition.
Embodiment 16
The preparation of the soluble compounding compositions containing trimethoprim:
Preparation method: weigh trimethoprim micropowder 4.0g, Macrogol 4000 10.0g, sodium lauryl sulphate respectively
2.0g, adds Prinzone (Squibb) 20.0g after mix homogeneously, add anhydrous glucose 64.0g after mix homogeneously, and mix homogeneously is i.e.
Obtain soluble powder powder complex composition.
Embodiment 17: the dissolubility of the present invention measures
In order to measure present invention dissolubility in water, according to the requirement of " People's Republic of China's veterinary drug allusion quotation ", to enforcement
The product of example 1-16 has carried out dissolubility mensuration.The product 0.4g of Example 1-14, the product 0.2g of embodiment 15-16, put
In nessler colorimetric tube, add water and make the solution (when concentration is Clinical practice amount 2 times of high dose concentration) of 50ml, 25 DEG C ± 2
DEG C spin upside down 10 times, stand 30 minutes and observe solubizations and material separates out situation.
Embodiment of the present invention 1-16 product, is measured by said determination method, and embodiment 8-16 (product that the present invention prepares) is equal
Can all dissolve, there is no muddiness or deposited phenomenon, embodiment 1-7 (product the most within the scope of the present invention) all in muddy shape, one
After the section time, insoluble white solid is arranged at bottom.
Embodiment 17: the stability test in drinking water
Soluble powder can not only meet pharmacopoeial requirements, be also satisfied Clinical practice, by the 2 of the highest clinical consumption in test
Test again.Embodiment 1-14 product is added sample 0.8g according to every 100mL water, stirs 0.5h；Embodiment 15-16 product
Add sample 0.4g according to every 100mL water, stir 0.5h.Carry out the stability test in drinking water.
Table 1 embodiment 1-16 product stability test result in tap water
Can be drawn by upper table, embodiment 1-7 the most within the scope of the present invention all occurs in that suspension or precipitation, and applies
The soluble compounding compositions (embodiment 8-16) containing trimethoprim that the inventive method prepares, at Clinical practice maximum amount
Under 2 multiple doses, dissolve in tap water completely, in colorless cleared solution.Even if placing 16 hours under conditions of standing completely,
Embodiment of the present invention 8-16 product all solution in stable uniform, not precipitation, crystallization.
Embodiment 17
40 natural occurrence pigs are divided into two groups, by first group of (product the most within the scope of the present invention that embodiment 4 prepares
Product) take 400g and mix 1 ton of feedstuff, take 400g by second group (product of the present invention that embodiment 8 prepares) and be dissolved in 1 ton of drinking water.Point
Not at 0.5,1.0,1.5,2.0,2.5,5.0,8.0,10.0,15.0,30.0,50.0,100.0 hours, take a blood sample from vena cava anterior
10ml, analyzes the blood drug level of blood sample and MCPKP software process of fitting treatment draws associated power parameter through HPLC.
Knowable to upper table data: the C of second groupmax, AUC be substantially greater than the C of first groupmax, AUC, it is seen that system of the present invention
The trimethoprim complex composition obtained is compared with other compositionss, hence it is evident that can improve blood drug level.
Embodiment 18:
The sick pig of 60 innominate high fever being equally divided into three groups, respectively it is carried out the treatment of a course for the treatment of, experimental group I adopts
Mixing 1 ton of feedstuff with 400g (product the most within the scope of the present invention that embodiment 4 prepares), experimental group II uses 400g (embodiment 8
The product of the present invention prepared) it is dissolved in 1 ton of drinking water, matched group is the sick pig of innominate high fever, does not give any medication.
To treatment porcine nameless high-fever, cure rate experimental group the to be significantly greater than I of experimental group II, matched group, it is seen that the present invention
The trimethoprim complex composition prepared, compared with other compositionss, can improve the therapeutic effect of innominate high fever pig.
The foregoing is only presently preferred embodiments of the present invention, not in order to limit the present invention, all within principle of the present invention,
Any modification, equivalent substitution and improvement etc. made, should be included within the scope of the present invention.
Claims (9)
1. a water soluble trimethoprim compositions, is characterized by: include trimethoprim and cosolvent.
2. a kind of water soluble trimethoprim compositions as claimed in claim 1, is characterized by: the particle diameter of described trimethoprim
For≤20 μm；Preferable particle size is 5-10 μm.
3. a kind of water soluble trimethoprim compositions as claimed in claim 1, is characterized by: described cosolvent is selected from following
One or more in compound: Polyethylene Glycol, polyvinylpyrrolidone, poloxamer, nonionic surfactant or the moon from
Sub-surface activating agent；Preferably Polyethylene Glycol or polyvinylpyrrolidone and the mixture of anion surfactant.
4. a complex composition for water soluble trimethoprim, is characterized by: be made up of the material of following mass fraction: methoxy benzyl
Pyridine 2～4 parts, sulfanilamide salt 10～20 parts, cosolvent 3～12 parts, carrier 64～85 parts.
The complex composition of described a kind of water soluble trimethoprim the most as claimed in claim 4, is characterized by: cosolvent is selected from
One or more in following compound: Polyethylene Glycol, polyvinylpyrrolidone, poloxamer, nonionic surfactant or
Anion surfactant；Preferably Polyethylene Glycol or polyvinylpyrrolidone and the mixture of anion surfactant.
The complex composition of described a kind of water soluble trimethoprim the most as claimed in claim 4, is characterized by: trimethoprim warp
Crossing micronizing to process, its particle diameter is≤20 μm；Preferable particle size is 5-10 μm.
The complex composition of described a kind of water soluble trimethoprim the most as claimed in claim 4, is characterized by: sulfanilamide salt, choosing
In Prinzone (Squibb), sulfamonomethoxine sodium, sulfadiazine sodium, sulfadimidine sodium, Sulfamethoxazole sodium one
Plant or several.
The complex composition of described a kind of water soluble trimethoprim the most as claimed in claim 4, is characterized by: trimethoprim and
The mass ratio of sulfanilamide salt is 1:5-10；Preferably 1:5.
The complex composition of described a kind of water soluble trimethoprim the most as claimed in claim 4, is characterized by: carrier is medicine
Acceptable carrier, one or more in preferably sucrose, lactose, anhydrous glucose and soluble starch.
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Cited By (3)
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| CN107233342A (en) * | 2017-06-12 | 2017-10-10 | 揭阳市润达肠衣有限公司 | A kind of solid dispersions containing TMP and preparation method thereof |
| CN108524467A (en) * | 2018-07-02 | 2018-09-14 | 合肥中龙神力动物药业有限公司 | A kind of composite sulfamonomethoxine sodium microcapsule formulation and preparation method thereof |
| CN116570556A (en) * | 2023-05-17 | 2023-08-11 | 郑州福源动物药业有限公司 | Compound sulfachlordazine sodium solution for treating escherichia coli and pasteurellosis infection of livestock and poultry and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107233342A (en) * | 2017-06-12 | 2017-10-10 | 揭阳市润达肠衣有限公司 | A kind of solid dispersions containing TMP and preparation method thereof |
| CN108524467A (en) * | 2018-07-02 | 2018-09-14 | 合肥中龙神力动物药业有限公司 | A kind of composite sulfamonomethoxine sodium microcapsule formulation and preparation method thereof |
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