CN109498580B - A kind of Florfenicol granular preparation and its preparation process - Google Patents
A kind of Florfenicol granular preparation and its preparation process Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
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Abstract
The invention belongs to technical field of veterinary, and in particular to a kind of Florfenicol granular preparation and its preparation process.Florfenicol granular preparation of the present invention is mainly prepared by the raw material of following parts by weight meter by dry granulation process: 1~30 part of Florfenicol, 60~99 parts of filler；The filler is at least one of DEXTROSE ANHYDROUS, lactose, maltodextrin and dextrin.The bulk pharmaceutical chemicals content of Florfenicol granular preparation of the present invention is high, good water solubility, uses for drinking-water, can also spice administration, it is easy to use, can be reduced dosage in production application, store up cost to reduce；Its stability height, good fluidity simultaneously, it is prevented from caking, be conducive to the storage and transport of Florfenicol granular preparation, have a good application prospect.
Description
Technical field
The invention belongs to technical field of veterinary, and in particular to a kind of Florfenicol granular preparation and its preparation process.
Background technique
Florfenicol, also known as Florfenicol, its chemical name is D (+)-Soviet Union -1- to methylsulfonyl phenyl -2- dichloroacetyl
Amino -3- fluorine propyl alcohol, white in appearance or off-white color crystalline powder, odorless, bitter.The medicine be Schering Plough company, the U.S. in
The animal specific broad spectrum antibiotic that late 1970s develop, has a broad antifungal spectrum, to gram-positive bacteria, gram-negative
Property bacterium has powerful killing effect.Medicine absorption is rapid, widely distributed in vivo, and noresidue or residual are lower in vivo,
Safely and effectively, it is widely used in veterinary clinic.
Florfenicol belongs to time dependence drug, and bactericidal effect depends primarily on blood concentration more than targeted bacterium
Minimum inhibitory concentration (MIC) duration, it is little with blood peak concentration of drug relationship, after administration, effective blood drug concentration maintain when
Between it is longer, clinical effectiveness is better.In addition, Florfenicol belongs to II class drug in Biopharmaceutics Classification system (BCS), i.e., it is low
Dissolubility/high osmosis drug.The medicine can be absorbed and used quickly through for oral administration or intramuscular injection, but its solubility in water
It is extremely low, it is slow in gastrointestinal tract dissolution, and then limit the absorption of drug.How Florfenicol solubility in water is improved, at
One of research hotspot for florfenicol formulations and one of difficult point.
Currently, the method for improving florfenicol water soluble can be divided mainly into two kinds: one is physical methods, including are added and help
Solvent, micronization processes, beta-cyclodextrin include, solid dispersion are made etc.；Another kind is chemical method, i.e., by Florfenicol system
At water-soluble prodrug, into animal body in after be metabolized to Florfenicol and play a role.Chemical method preparation condition is harsh, required
Expensive reagents, and the bioactivity of Florfenicol raw medicine may be had an impact, and physical method is relatively easy, cost
It is low, it is easy to industrialize.
Such as patent document CN104922073A discloses a kind of soluble florfenicol powder comprising Florfenicol 1~
10%, cosolvent 1~15% (polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, polyoxyethylene, polyacrylic acid), phagostimulant
1~5%, (one of soluble starch, glucose, lactose, maltodextrin, chitosan and mannitol are more for filler surplus
Kind, preferably glucose).Florfenicol powder is made by physical mixed in above-mentioned raw materials, and the florfenicol powder is water-soluble good, can
It is used for drinking-water, and masks the original bad smell of Florfenicol and irritation.Glucose is as preferred in the program
Filler can cooperate with the water solubility for improving Florfenicol, but glucose has hygroscopicity, therefore the florfenicol powder is easily inhaled
Water agglomeration, need to be sealed, while the content of Florfenicol raw material medicine only up to reach 10% in the pulvis, otherwise the fluorobenzene
Buddhist nun, which examines powder, will be insoluble in water.
Dry granulation process is the crystallization water using material itself, by mechanical presses principle, directly to raw material powder into
Row compression, molding, coarse crushing, are made graininess finished product.Bulk density dramatically increases after granulation, improves material appearance and mobility,
Convenient for storing and transporting, solubility, porosity and specific surface area etc. also can control.Dry granulation process applies upper, phase in people's medicine
To extensive, it is usually used in heat sensitive material, meets the granulation that water easily decomposes drug, convenient for subsequent tabletting again or encapsulated.In prescription
Face is usually used in preparing Chinese medicinal granule, and relative to wet granulation, has many advantages, such as that simple process, low energy consumption, amount of filler are few.
Currently, dry granulation process in terms of veterinary drug using relatively fewer, through retrieving, it is not yet found that the dry method about Florfenicol
Granulating process.
Summary of the invention
In order to overcome the problems, such as in the prior art there is that (such as bulk pharmaceutical chemicals content is low in florfenicol formulations, the easy moisture absorption
Agglomeration etc.), the present invention provides a kind of Florfenicol granular preparation, the bulk pharmaceutical chemicals content of the Florfenicol granular preparation is high, water
Dissolubility is good, uses for drinking-water, and stability is high, good fluidity, is conducive to the popularization and application of Florfenicol.
Florfenicol granular preparation provided by the invention mainly passes through dry granulation process by the raw material of following parts by weight meter
It is prepared: 1~30 part of Florfenicol, 60~99 parts of filler.
Preferably, the filler is at least one of DEXTROSE ANHYDROUS, lactose, maltodextrin and dextrin.
More preferably, the filler is the composition of DEXTROSE ANHYDROUS and maltodextrin.
It is highly preferred that the parts by weight of the DEXTROSE ANHYDROUS are 60~95 parts, the parts by weight of the maltodextrin are 4
~10 parts.
As a preferred embodiment of the present invention, the Florfenicol granular preparation is mainly by the raw material of following parts by weight meter
It is prepared by dry granulation process: 30 parts of Florfenicol, 65 parts of DEXTROSE ANHYDROUS and 5 parts of maltodextrin.
More preferably, Florfenicol granular preparation of the present invention further includes 1~6 parts by weight of L MALIC ACID.
Correspondingly, the present invention also provides the preparation processes of above-mentioned Florfenicol granular preparation, comprising the following steps: setting
The feeding revolving speed of dry granulating machine is 15~20 turns, extruding revolving speed is 14~16 turns, squeeze pressure is 45~55kgf and work pressure
Power is 50~58kgf, then by Florfenicol and filler investment dry granulating machine, starts and is compressed, formed, coarse crushing,
40~60 meshes are crossed, Florfenicol granular preparation is made.
It further, further include investment 1~6 parts by weight of L MALIC ACID into dry granulating machine.
The present invention prepares Florfenicol granular preparation by dry granulation process, can effectively improve bulk pharmaceutical chemicals therein and contain
Amount, while its good water solubility is kept, so that can be reduced dosage in production application, cost is stored up to reduce.
And when using DEXTROSE ANHYDROUS and maltodextrin as filler, by Florfenicol particle system made from dry granulation process
Agent, the mobility of the Florfenicol granular preparation be improved significantly, overcome using glucose as suction brought by main stuffing
Water agglomeration problems are conducive to the storage and transport of Florfenicol granular preparation.But inventor has found that these materials were squeezing
It is easy fever in journey, needs to be equipped with refrigeration machine, otherwise will affect the stability of Florfenicol, thus it is speculated that may be due to heat and to squeeze
The comprehensive function of pressure makes Florfenicol that the change of crystalline structure have occurred, and leads to the reduction of its stability.L MALIC ACID can be used as feeding
Feed additives, health and growth to animal have positive effect, and inventor in dry granulation process it was unexpectedly observed that answer
The stability of Florfenicol can be effectively improved with L MALIC ACID, but L MALIC ACID need to control in a certain range, otherwise meeting again
Lead to the hygroscopic agglomeration of Florfenicol granular preparation.
Therefore, compared with prior art, present invention has an advantage that
(1) the bulk pharmaceutical chemicals content of Florfenicol granular preparation of the present invention is high, and good water solubility is used for drinking-water, can also be mixed
Material administration, it is easy to use, and the original bad smell of Florfenicol and irritation are masked, it can subtract in production application
Few dosage stores up cost to reduce；Its stability height, good fluidity, prevented from caking simultaneously, is conducive to Florfenicol particle
The storage and transport of preparation, have a good application prospect.
(2) preparation method and equipment of Florfenicol granular preparation of the present invention are simple, process stabilizing, and amount of filler is few, energy
Consume low, and grain forming made from the technique is good, epigranular, and high yield rate can satisfy the needs of production, can industrialize
Production, securely and reliably, is conducive to the popularization and application of safe and effective veterinary drug Florfenicol.
Specific embodiment
Below in conjunction with specific embodiment, the present invention will be described in detail, herein illustrative examples and explanation of the invention
For explaining the present invention, but it is not as a limitation of the invention.
Dry granulating machine of the present invention is purchased from Ningbo Hua Quan Machinery Co., Ltd., model LGJ-300.
Embodiment 1, Florfenicol granular preparation of the present invention and its preparation process
Formula: Florfenicol 10kg, DEXTROSE ANHYDROUS 86kg, maltodextrin 4kg.
Preparation process: the feeding revolving speed that dry granulating machine is arranged is 15 turns, extruding revolving speed is 14 turns, squeeze pressure is
45kgf and operating pressure are 50kgf, then put into dry granulating machine Florfenicol, DEXTROSE ANHYDROUS and maltodextrin, open
It moves and is compressed, formed, coarse crushing, crossing 40 meshes, Florfenicol granular preparation is made.
Embodiment 2, Florfenicol granular preparation of the present invention and its preparation process
Formula: Florfenicol 20kg, DEXTROSE ANHYDROUS 75kg, maltodextrin 5kg.
Preparation process: the feeding revolving speed that dry granulating machine is arranged is 20 turns, extruding revolving speed is 16 turns, squeeze pressure is
55kgf and operating pressure are 58kgf, then put into dry granulating machine Florfenicol, DEXTROSE ANHYDROUS and maltodextrin, open
It moves and is compressed, formed, coarse crushing, crossing 40 meshes, Florfenicol granular preparation is made.
Embodiment 3, Florfenicol granular preparation of the present invention and its preparation process
Formula: Florfenicol 30kg, DEXTROSE ANHYDROUS 65kg, maltodextrin 5kg.
Preparation process: the feeding revolving speed that dry granulating machine is arranged is 16 turns, extruding revolving speed is 15 turns, squeeze pressure is
50kgf and operating pressure are 54kgf, then put into dry granulating machine Florfenicol, DEXTROSE ANHYDROUS and maltodextrin, open
It moves and is compressed, formed, coarse crushing, crossing 40 meshes, Florfenicol granular preparation is made.
Embodiment 4, Florfenicol granular preparation of the present invention and its preparation process
Formula: Florfenicol 20kg, DEXTROSE ANHYDROUS 70kg, maltodextrin 10kg.
Preparation process: reference implementation example 3.
Embodiment 5, Florfenicol granular preparation of the present invention and its preparation process
Formula: Florfenicol 30kg, lactose 65kg, maltodextrin 5kg.
Preparation process: reference implementation example 3.
Embodiment 6, Florfenicol granular preparation of the present invention and its preparation process
Formula: Florfenicol 30kg, lactose 65kg, dextrin 5kg.
Preparation process: reference implementation example 3.
Embodiment 7, Florfenicol granular preparation of the present invention and its preparation process
Formula: Florfenicol 30kg, DEXTROSE ANHYDROUS 64kg, maltodextrin 5kg, L MALIC ACID 1kg.
Preparation process: the feeding revolving speed that dry granulating machine is arranged is 16 turns, extruding revolving speed is 15 turns, squeeze pressure is
50kgf and operating pressure are 54kgf, and Florfenicol, DEXTROSE ANHYDROUS, maltodextrin and L MALIC ACID are then put into dry method system
In grain machine, start and compressed, formed, coarse crushing, crossing 40 meshes, Florfenicol granular preparation is made.
Embodiment 8, Florfenicol granular preparation of the present invention and its preparation process
Formula: Florfenicol 30kg, DEXTROSE ANHYDROUS 60kg, maltodextrin 4kg, L MALIC ACID 6kg.
Preparation process: reference implementation example 7.
Embodiment 9, Florfenicol granular preparation of the present invention and its preparation process
Formula: Florfenicol 30kg, lactose 64kg, maltodextrin 5kg, L MALIC ACID 1kg.
Preparation process: reference implementation example 7.
Comparative example 1
Formula: Florfenicol 30kg, DEXTROSE ANHYDROUS 55kg, maltodextrin 5kg, L MALIC ACID 10kg.
Preparation method reference implementation example 8.
Comparative example 2
Florfenicol powder is made in the embodiment 1 of referenced patent document CN104922073A.
Test example one, the water-soluble of Florfenicol granular preparation of the present invention are investigated
Examples 1 to 9 each 0.5g of Florfenicol granular preparation is weighed, is placed in nessler colorimetric tube, under the conditions of 25 DEG C, is added
Enter 100ml water, spin upside down 10 times, stand 10min, observes dissolution phenomena.The results show that 1~9 fluorobenzene Buddhist nun of the embodiment of the present invention
It examines granular preparation all to dissolve, acquired solution clarification is bright.It can be seen that Florfenicol granular preparation of the present invention contains in raising bulk pharmaceutical chemicals
In the case where amount, excellent water solubility is still kept, dosage is advantageously reduced, reduced for raiser and store up cost.
The Their Dissolution Test in vitro of test example two, Florfenicol granular preparation of the present invention
Fluorobenzene of the present invention is carried out referring to the basket method of " Chinese veterinary pharmacopoeia " (version in 2015) first annex dissolution method
Buddhist nun examines the dissolution in vitro test of granular preparation, and relevant curve graph is made, and is spat by Florfenicol granular preparation containing 0.5%
Dissolution curve in PBS (pH=6.8) solution of temperature it is found that Florfenicol granular preparation sample of the present invention substantially in 15min
Dissolution completely, curve tends towards stability 15min later.Test result prompts Florfenicol granular preparation of the present invention can be in the gastrointestinal tract
Fast Stripping, and then promote the absorption of drug.
The study on the stability of test example three, Florfenicol granular preparation of the present invention
Warm and humid accelerated test: referring to " Chinese veterinary pharmacopoeia " (version in 2015), temperature is 40 DEG C ± 2 DEG C, relative humidity is
Under conditions of 75% ± 5%, to 2 florfenicol powder of Examples 1 to 9 Florfenicol granular preparation, 1 particle of comparative example and comparative example
The accelerated test for carrying out 6 months, as a result as shown in the following table 2 and table 3.
The accelerated test result of 2 Examples 1 to 6 Florfenicol product of table
The accelerated test result of 1~2 Florfenicol product of 3 embodiment 7~9 of table and comparative example
From upper table 2 and 3:
(1) pass through 6 months warm and humid accelerated tests, Examples 1 to 6 Florfenicol granular preparation turns yellow, and opposite mark
Amount decline；Compared with Examples 1 to 6,7~9 Florfenicol granular preparation of embodiment is added to L MALIC ACID, Florfenicol
Grain preparation is still white particle state, keeps good mobility, no caking phenomenon, while the indexs of correlation such as appearance uniform degree are equal
Meet States Pharmacopoeia specifications, Florfenicol is with respect to labelled amount 96% or more.As it can be seen that a certain amount of L MALIC ACID can effectively improve this hair
The stability of bright Florfenicol granular preparation.
(2) pass through 6 months warm and humid accelerated tests, a large amount of knot occur in 1 particle of comparative example and 2 pulvis of comparative example
Block, and 1 pulvis of comparative example turns yellow.As it can be seen that will affect Florfenicol particle if L MALIC ACID dosage is excessively high in the present invention
The storage stability of preparation.
The using effect of test example three, Florfenicol granular preparation of the present invention
First part: In Vitro Bacteriostasis test
(1) extracorporeal bacteria inhibitor test is carried out to Escherichia coli (reference culture 25922) using Florfenicol raw material medicine of the present invention.
The results show that Florfenicol raw material medicine of the present invention is 2ug/ml to the MIC value of Escherichia coli.
(2) using 1~9 Florfenicol granular preparation of the embodiment of the present invention to Escherichia coli (reference culture 25922), clinic
Bacterial strain 11 (KX-11), clinical strains 13 (KX-13) and clinical strains 14 (KX-14) carry out extracorporeal bacteria inhibitor test.The results show that
Florfenicol raw material medicine of the present invention is 2ug/ml to the MIC value of Escherichia coli, to clinical strains 11, clinical strains 13 and clinical bacterium
The MIC value of strain 14 is 4ug/ml.
It can be seen that external suppression of 1~9 Florfenicol granular preparation of the embodiment of the present invention to Escherichia coli and clinical strains
Bacterium effect is consistent with Florfenicol raw material medicine.
Second part: the intracorporal pharmacokinetic trial of animal
(1) medicament: 1 florfenicol powder of the embodiment of the present invention 3, the Florfenicol granular preparation of embodiment 7 and comparative example.
(2) test pig and grouping: selecting 18 healthy bi-crossbreedings, and 25~30kg of weight is randomly divided into 3 groups, every group 6
Head, respectively 3 groups of embodiment, 7 groups of embodiment and 1 group of comparative example.According to taking a blood sample after 30mg/kg single dose gastric infusion, detect
Drug concentration, as a result as shown in table 4 below.
The 4 main medicine kinetic parameter of each Florfenicol product of table compares
Note: * is significant difference (0.01 < p < 0.05)
By upper table 4 it is found that medicine is in mechanical test in pig body, compared with 1 florfenicol powder stomach-filling of comparative example, the present invention
After the 7 granule stomach-filling of embodiment 3 and embodiment, peak mass concentration (Cmax) significantly improve, area (AUC) is aobvious under drug-time curve
It writes and increases, internal mean residence time (MRT) is obviously prolonged, and eliminates half-life period (T1/ 2kel) difference is significant.Prompt this hair
Bright Florfenicol granular preparation than existing florfenicol powder in pig body can Fast Stripping, and eliminate and slow down, in vivo effective blood medicine
Concentration is held time longer, can play its effect well in animal body.
The above-described embodiments merely illustrate the principles and effects of the present invention, and is not intended to limit the present invention.It is any ripe
The personage for knowing this technology all without departing from the spirit and scope of the present invention, carries out modifications and changes to above-described embodiment.Cause
This, institute is complete without departing from the spirit and technical ideas disclosed in the present invention by those of ordinary skill in the art such as
At all equivalent modifications or change, should be covered by the claims of the present invention.
Claims (5)
1. a kind of Florfenicol granular preparation, which is characterized in that mainly pass through dry granulation work by the raw material of following parts by weight meter
Skill is prepared: 1~30 part of Florfenicol, 60~99 parts of filler；
The filler is the composition of DEXTROSE ANHYDROUS and maltodextrin；
The parts by weight of the DEXTROSE ANHYDROUS are 60~95 parts, and the parts by weight of the maltodextrin are 4~10 parts；
The dry granulation process is the following steps are included: the feeding revolving speed of setting dry granulating machine is 15~20 turns, squeezes revolving speed
For 14~16 turns, squeeze pressure be 45~55kgf and operating pressure is 50~58kgf, then puts into Florfenicol and filler
In dry granulating machine, start and compressed, formed, coarse crushing, crossing 40~60 meshes, Florfenicol granular preparation is made.
2. Florfenicol granular preparation according to claim 1, which is characterized in that the Florfenicol particle mainly by with
The raw material of lower parts by weight meter is prepared by dry granulation process: 30 parts of Florfenicol, 65 parts of DEXTROSE ANHYDROUS and malt paste
5 parts of essence.
3. Florfenicol granular preparation according to claim 1 or 2, which is characterized in that further include 1~6 weight of L MALIC ACID
Measure part.
4. a kind of preparation process of Florfenicol granular preparation according to claim 1 or claim 2, which is characterized in that including following
Step: it is 14~16 turns that the feeding revolving speed that dry granulating machine is arranged, which is 15~20 turns, squeezes revolving speed, squeeze pressure be 45~
55kgf and operating pressure are 50~58kgf, then by Florfenicol and filler investment dry granulating machine, start and are pressed
Contracting, molding, coarse crushing, cross 40~60 meshes, and Florfenicol granular preparation is made.
5. the preparation process of Florfenicol granular preparation according to claim 4, which is characterized in that further include toward dry granulation
1~6 parts by weight of L MALIC ACID are put into machine.
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| CN110302163A (en) * | 2019-07-23 | 2019-10-08 | 东莞正大康地饲料有限公司 | A kind of florfenicol soluble powder and preparation method thereof |
| CN112641954B (en) * | 2020-12-30 | 2023-07-04 | 广东正大康生物科技股份有限公司 | Water-soluble florfenicol compound and simple molecular coating method thereof, and prepared solid preparation |
| CN113197868B (en) * | 2021-05-11 | 2022-10-21 | 四川省畜牧科学研究院 | Synergistic compound florfenicol particle |
| CN113171345B (en) * | 2021-05-26 | 2022-09-30 | 浙江耐司康药业有限公司 | Florfenicol soluble powder and preparation method thereof |
| CN113632889A (en) * | 2021-08-13 | 2021-11-12 | 河南惠通天下生物工程有限公司 | Traditional Chinese medicine compound type nonreactive and immunity-enhancing feed additive and preparation method thereof |
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| CN104434797A (en) * | 2014-12-02 | 2015-03-25 | 中国药科大学 | Solid self-emulsifying preparation of florfenicol |
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| CN1459282A (en) * | 2003-05-29 | 2003-12-03 | 季华 | Method for prodn. of water soluble fluorophenylnicol |
| CN1947699A (en) * | 2006-11-04 | 2007-04-18 | 庄晓峰 | Method for producing water soluble fluorophenylnico |
| BRPI0818906A2 (en) * | 2007-11-09 | 2015-05-12 | Intervet Int Bv | Solid quick release formulation, preparation and use |
| CN104922073B (en) * | 2015-05-29 | 2016-05-04 | 广东腾骏动物药业股份有限公司 | A kind of solubility fluorobenzene Buddhist nun examines powder and preparation method thereof |
| CN105687144B (en) * | 2016-03-28 | 2019-01-25 | 宁波科瑞特动物药业有限公司 | A kind of solubility Florfenicol particle and preparation method thereof |
| CN105902497B (en) * | 2016-06-01 | 2019-06-11 | 洛阳瑞华动物保健品有限公司 | A kind of preparation method of water-solubility florfenicol veterinary drug preparation |
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| CN109498580A (en) | 2019-03-22 |
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