CN113171345B - Florfenicol soluble powder and preparation method thereof - Google Patents
Florfenicol soluble powder and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
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Abstract
The invention provides florfenicol soluble powder and a preparation method thereof. The florfenicol soluble powder comprises the following components in parts by weight: 18-22 parts of florfenicol; 3.5-4.5 parts of poloxamer; 9-11 parts of a cosolvent; the cosolvent is one or more of polyvidone K30, nicotinamide and polyethylene glycol 6000; 59-73 parts of a diluent; the diluent is selected from one or more of anhydrous glucose, lactose, sorbitol and mannitol. The florfenicol soluble powder prepared by the embodiment of the invention obviously improves the solubility.
Description
Technical Field
The invention relates to florfenicol soluble powder and a preparation method thereof.
Background
Florfenicol (Florfenicol), also known as Florfenicol, is a fluoride of thiamphenicol, and belongs to special amide alcohol antibiotics for animals. Florfenicol mainly acts on 50s subunit of 70s ribosome of bacteria to inhibit transpeptidase, so that the growth of peptidase is hindered, and the formation of peptide chain is inhibited, thereby preventing the synthesis of protein and achieving the aim of antibiosis. The most important characteristics are that the antibacterial spectrum is wide, the absorption is good, the distribution in the body is wide, especially, the curative effect on animal diseases caused by sensitive bacteria is obvious without potential aplastic anemia effect, and the medicine is the first choice medicine for treating various infections caused by typhoid bacillus, paratyphoid bacillus and salmonella. The florfenicol has the advantages of small dosage, quick effect, long half-life period and high blood concentration, and can maintain the blood concentration for a long time, so the application prospect is wide.
However, florfenicol is poor in water solubility and hardly dissolved in water, so that the administration mode is limited in clinical application, and the florfenicol is low in absorption and bioavailability in animal bodies, and cannot fully utilize the drug effect thereof. Thus the solubility of florfenicol is to be further improved.
Disclosure of Invention
The invention provides florfenicol soluble powder and a preparation method thereof. The florfenicol soluble powder prepared by the invention obviously improves the solubility.
The florfenicol soluble powder comprises the following components in parts by weight:
18-22 parts of florfenicol;
3.5-4.5 parts of poloxamer;
9-11 parts of a cosolvent; the cosolvent is one or more of polyvidone K30, nicotinamide and polyethylene glycol 6000;
59-73 parts of a diluent; the diluent is selected from one or more of anhydrous glucose, lactose, sorbitol and mannitol.
Further, the florfenicol soluble powder comprises the following components in parts by weight:
19-21 parts of florfenicol;
3.8-4.2 parts of poloxamer;
9.5-10.5 parts of cosolvent; the cosolvent is one or more of polyvidone K30, nicotinamide and polyethylene glycol 6000;
62-70 parts of a diluent; the diluent is selected from one or more of anhydrous glucose, lactose, sorbitol and mannitol.
Further, the florfenicol soluble powder comprises the following components in parts by weight:
20 parts of florfenicol;
4 parts of poloxamer;
povidone K3010 parts;
66 parts of anhydrous glucose.
Wherein poloxamer and anhydrous glucose are used as cosolvent, and povidone K30 mainly plays a role in adhesion and dispersion; under the comprehensive action of the components, the solubility of the florfenicol can be enhanced, and the bioavailability of the florfenicol is greatly improved.
Further, the total amount of the raw materials of the florfenicol soluble powder is 100 parts by weight.
Further, the content of florfenicol in the florfenicol soluble powder is 18-22 wt%, optionally 19-21 wt%, for example 20 wt%.
Further, the content of poloxamer in the florfenicol soluble powder is 3.5-4.5 wt%, optionally 3.8-4.2 wt%, for example 4%.
Further, in the florfenicol soluble powder, the content of the cosolvent is 9-11 wt%, optionally 9.5-10.5 wt%, for example 10 wt%.
Further, the content of the diluent in the florfenicol soluble powder is 59-73 wt%, optionally 62-70 wt%, for example 66 wt%.
Further, the florfenicol soluble powder is prepared by adopting dry granulation. The dry granulation method is a method for uniformly mixing the powder of the medicine and the auxiliary materials, compressing the mixture into large tablets, plates or hard strips, and crushing the large tablets, the plates or the hard strips into particles with required sizes.
The research of the inventor discovers that the florfenicol soluble powder prepared by the dry granulation method can obviously improve the florfenicol solubility and the bioavailability, thereby not only ensuring the curative effect of the medicament, but also reducing the material waste, improving the production efficiency, reducing the energy consumption and reducing the environmental pollution.
The invention also provides a preparation method of the florfenicol soluble powder, which comprises the following steps: uniformly mixing florfenicol, poloxamer, part of diluent (such as anhydrous glucose) and cosolvent, and then performing dry granulation; then pulverized, and then mixed with the rest of the diluent (powder).
In some embodiments, the portion of diluent refers to 30-60% of the total weight of the diluent, e.g., 30%, 35%, 40%, 45%, 50%, 55%, 60%.
In some embodiments, the pressure used during dry granulation is 2-5MPa, so that florfenicol and corresponding auxiliary materials can be ensured to be sufficiently close to form intermolecular van der Waals force, the raw and auxiliary materials are tightly combined, the prepared particles are well formed, the yield is high, and the prepared florfenicol soluble powder has better solubility.
In some embodiments, the dry granulation is carried out at a feed rate of 30-60 rpm and at a pressure wheel speed of 10-25 rpm.
In some embodiments, a dry granulator conventional in the art is used.
In some embodiments, the dry granulation machine used in dry granulation has the following parameter settings: the pressure of the pressure wheel is 2-5Mpa, the feeding speed is 30-60 r/min, the rotating speed of the pressure wheel is 10-25 r/min, the crushing speed is 150-.
In some embodiments, the particles prepared by dry granulation are pulverized to 16-24 mesh, optionally 16-20 mesh, which has advantages in that the prepared florfenicol-soluble powder has uniform particles, is easily mixed with the rest of the auxiliary materials, and has moderate pulverization degree, so that florfenicol which is combined with the corresponding auxiliary materials is prevented from being separated from the auxiliary materials, and the prepared florfenicol-soluble powder has better solubility.
In some embodiments, the granules prepared by dry granulation are milled using a universal mill, the parameters of which are set as follows: the main shaft rotating speed is 4000-.
In some embodiments, the balance of the diluent is milled to 50-65 mesh and blended with the dry granulated granulation granules.
In some embodiments, the method of making the florfenicol soluble powder comprises the steps of:
1) uniformly mixing florfenicol raw material, poloxamer, diluent (such as anhydrous glucose) accounting for 30-60% of the total weight and cosolvent, and then carrying out dry granulation; firstly, compressing the premix into a sheet or a plate, and then crushing the premix into particles with required sizes;
wherein, the parameters of the dry granulating machine are set as follows: the pressure of the pressing wheel is 2-5Mpa, the feeding speed is 30-60 r/min, the rotating speed of the pressing wheel is 10-25 r/min, the crushing speed is 150-;
2) putting the florfenicol mixture obtained by dry granulation into a universal pulverizer for pulverization; setting parameters of the universal pulverizer: the rotating speed is 4000 plus 5000r/min, and the aperture of the sieve sheet is 0.6 mm;
3) uniformly mixing the material obtained in the step 2) with the rest of diluent powder; wherein the particle size of the diluent powder is 50-65 meshes.
The invention also provides the florfenicol soluble powder prepared by the method.
The invention mainly solves the problem of difficult solubility of the florfenicol, simplifies the preparation process of the florfenicol soluble powder, improves the yield, saves energy and reduces environmental pollution on the basis.
Detailed Description
The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention. The examples do not specify particular techniques or conditions, and are to be construed in accordance with the description of the art in the literature or with the specification of the product. The reagents or instruments used are conventional products available from regular distributors, not indicated by the manufacturer.
Example 1
The florfenicol soluble powder is prepared from the following raw materials in parts by weight: 20 parts of florfenicol; 4 parts of poloxamer; 10 parts of povidone K30; 66 parts of anhydrous glucose.
The preparation method comprises the following steps:
1) uniformly mixing a florfenicol raw material, poloxamer, anhydrous glucose accounting for 50% of the total weight, and povidone K30, and then performing dry granulation; firstly, compressing the premix into a sheet or a plate, and then crushing the premix into particles with required sizes;
wherein, the parameters of the dry granulating machine are set as follows: the pressure of the pressing wheel is 5Mpa, the feeding speed is 55 r/min, the rotating speed of the pressing wheel is 20 r/min, the crushing speed is 300r/min, and the particle size is set to be 20 meshes;
2) putting the florfenicol mixture obtained by dry granulation into a universal pulverizer for pulverization; setting parameters of the universal pulverizer: the rotating speed is 4500r/min, and the aperture of the sieve sheet is 0.6 mm;
3) uniformly mixing the material obtained in the step 2) with the balance of anhydrous glucose powder; wherein the particle size of the anhydrous glucose powder is 50 meshes.
Example 2
The florfenicol soluble powder is prepared from the following raw materials in parts by weight: 20 parts of florfenicol; 4 parts of poloxamer; 10 parts of nicotinamide; 66 parts of anhydrous glucose. The preparation method is as in example 1.
Example 3
The florfenicol soluble powder is prepared from the following raw materials in parts by weight: 20 parts of florfenicol; 4 parts of poloxamer; 10 parts of polyethylene glycol 6000; 66 parts of anhydrous glucose. The preparation method is referred to example 1.
Example 4
The florfenicol soluble powder is prepared from the following raw materials in parts by weight: 22 parts of florfenicol; 4.4 parts of poloxamer; 11 parts of povidone K30; 62.6 parts of anhydrous glucose. The preparation method is referred to example 1.
Example 5
The florfenicol soluble powder is prepared from the following raw materials in parts by weight: 18 parts of florfenicol; 3.6 parts of poloxamer; 9 parts of povidone K30; and 69.4 parts of anhydrous glucose. The preparation method is as in example 1.
Example 6
A florfenicol soluble powder, the formula of which is the same as that of example 1. The preparation method is as in example 1. The difference lies in the parameter settings of the dry granulator: the pressure of the pressing wheel is 2Mpa, the feeding speed is 30 r/min, the rotating speed of the pressing wheel is 10 r/min, the crushing speed is 150 r/min, and the particle size is set to be 16 meshes.
Example 7
A florfenicol soluble powder, the formula of which is the same as that of example 1. The preparation method is as in example 1. The difference lies in the parameter settings of the dry granulator: the pressure of the pressing wheel is 3Mpa, the feeding speed is 60 r/min, the rotating speed of the pressing wheel is 25 r/min, the crushing speed is 350 r/min, and the particle size is 24 meshes.
Comparative example 1
A florfenicol soluble powder, the formula of which is the same as that of example 1, and the difference is only in the preparation method. The preparation method of the comparative example does not comprise a dry granulation step and is prepared by only mixing the raw materials; the preparation method comprises the following steps: uniformly mixing a florfenicol raw material, poloxamer, anhydrous glucose accounting for 50% of the total weight, and povidone K30; crushing the mixture by using a universal crusher, wherein the crushing parameters are as follows: the rotating speed is 4500r/min, and the aperture of the sieve sheet is 0.6 mm. Mixing the obtained material with the rest anhydrous glucose powder.
Comparative example 2
A florfenicol soluble powder differing from example 1 only in that: prepared by replacing povidone K30 with an equivalent amount of acetamide according to the method of example 1.
Comparative example 3
A florfenicol soluble powder differing from example 1 only in that: prepared according to the method of example 1, replacing anhydrous glucose with an equal amount of maltodextrin.
Comparative example 4
A florfenicol soluble powder differing from example 1 only in that: setting parameters of the universal pulverizer: the rotating speed is 3500r/min, and the aperture of the sieve sheet is 0.7 mm.
Comparative example 5
A florfenicol soluble powder differing from example 1 only in that: setting parameters of the universal pulverizer: the rotating speed is 5500r/min, and the aperture of the sieve sheet is 0.5 mm.
Experimental example 1
1. Water solubility investigation of florfenicol soluble powder
According to the specification of florfenicol soluble powder specification in the 'Chinese animal pharmacopoeia' 2020 edition, the use method and the use amount are as follows: the specification is 20%. The mixture is administered in a dose of 0.5-2.5g per 1L water for 3-5 days. The specification of the florfenicol soluble powder prepared by the invention is 20%, so that 0.5g of the florfenicol soluble powder is weighed and dissolved in 1L of water under the normal drinking condition.
In order to examine the water solubility of the florfenicol soluble powder, the solubility of the florfenicol soluble powder prepared in example 1 of the present invention and comparative examples 1, 2, 4 and 5 in 1000ml of purified water at the sampling amounts of 1 time, 6 times, 12 times and 24 times, respectively, was compared. 0.5g, 3g, 6g and 12g of florfenicol soluble powder prepared in example 1 and comparative examples 1, 2, 4 and 5 of the present invention) were taken and put into 1000ml of purified water, a stirrer was adjusted to 300r/min, and dissolution was carried out under stirring at 25 ℃, and the dissolution rates were compared. The results are shown in Table 1 below.
TABLE 1 solubility comparisons
As shown in table 1, the florfenicol-soluble powder prepared in example 1 of the present invention has better solubility in the dry granulation method of example 1 than the florfenicol powder of comparative example 1 (direct pulverization method), comparative example 2, comparative example 4, and comparative example 5.
2. Application experiments
The experiment was divided into 4 groups, experimental group 1 and control groups 1-3, respectively. 90 adult pigs with respiratory symptoms are selected and divided into an experimental group 1, a control group 1 and a control group 2 randomly, each group has 30 pigs and is fed in a circle, the experimental group 1 uses the florfenicol soluble powder prepared in the embodiment 1 of the invention to administer, the control group 1 uses the sample of the comparative example 2 to administer, the control group 2 uses the sample of the comparative example 3 to administer, and the environment and the food of each group of pigs are the same. Control group 3 was a healthy control group of 30 healthy pigs raised alone.
The administration mode comprises the following steps: mixing, dissolving 0.5g of water per 1L, and continuously drinking for 5 days.
And (4) observation indexes are as follows: the respiratory condition, body temperature, gasp and the like of the pigs during the administration period were observed.
Treatment judgment criteria:
the effect is shown: the pig body temperature is normal, no diarrhea exists, the breathing is normal, and the spirit is normal;
improvement: the pig body temperature is normal, no diarrhea exists, slight respiratory symptoms exist, and the spirit is normal;
and (4) invalidation: abnormal body temperature of pigs, diarrhea, respiratory symptoms and inappetence.
Therapeutic efficacy evaluation instructions:
the mortality rate is as follows: during the experiment, the pigs showed typical symptoms of the porcine respiratory tract and died, and the mortality rate was calculated from the number of these pigs.
The cure rate is as follows: during the experiment, the appetite of the pigs is recovered to be normal after the medicine is taken, the pigs with diarrhea and respiratory symptoms do not appear any more, and the cure rate is calculated according to the number of the pigs.
The effective rate is as follows: the cured pigs recover normal appetite after being administrated, but the pigs with slight respiratory symptoms are judged to be effective, and the effective rate is calculated according to the judgment.
Relative rate of weight gain: calculated according to the average weight gain ratio of each medicine group and the healthy control group, wherein the healthy control group is set as 100 percent.
The results are shown in Table 2.
TABLE 2 results of the experiment
The experimental conclusion is that: the results in Table 2 show that the florfenicol soluble powder prepared by the invention can treat respiratory diseases of pigs with those commercially available, and the florfenicol soluble powder prepared by the invention has better effect than those commercially available.
Comparison of Process technologies
The florfenicol soluble powder prepared by the invention has good solubility and also has great advantages in process technology.
The inclusion compound technology comprises the following steps: the insoluble drug is wrapped in the cavity structure of the cyclodextrin, so that the water solubility of the insoluble drug can be obviously improved. However, the technical operation steps are complicated, the inclusion material beta-cyclodextrin is expensive, and the cyclodextrin substances have limited water solubility and renal toxicity, so that the use of the cyclodextrin substances is limited.
The process technology of the present invention is compared with other processes in table 3.
TABLE 3 comparison of several processes
As shown in Table 3, the florfenicol soluble powder prepared by dry granulation has better solubility, simpler process, higher yield, reduced environmental pollution and energy consumption by comparing the processes of the florfenicol soluble powder.
Although the invention has been described in detail hereinabove with respect to a general description and specific embodiments thereof, it will be apparent to those skilled in the art that modifications or improvements may be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.
Claims (7)
1. The florfenicol soluble powder is characterized by comprising the following components in parts by weight:
18-22 parts of florfenicol;
3.5-4.5 parts of poloxamer;
9-11 parts of a cosolvent; the cosolvent is one or more of polyvidone K30, nicotinamide and polyethylene glycol 6000;
59-73 parts of a diluent; the diluent is selected from one or more of anhydrous glucose, lactose, sorbitol and mannitol
The preparation method of the florfenicol soluble powder comprises the following steps:
1) uniformly mixing a florfenicol raw material, poloxamer, a diluent accounting for 30-60% of the total weight and a cosolvent, and then performing dry granulation; firstly, compressing the premix into a sheet or a plate, and then crushing the premix into particles with required sizes;
wherein, the parameters of the dry granulating machine are set as follows: the pressure of the pressing wheel is 2-5Mpa, the feeding speed is 30-60 r/min, the rotating speed of the pressing wheel is 10-25 r/min, the crushing speed is 150-;
2) putting the florfenicol mixture obtained by dry granulation into a universal pulverizer to be pulverized; setting parameters of the universal pulverizer: the rotating speed is 4000-;
3) uniformly mixing the material obtained in the step 2) with the rest of diluent powder; wherein the particle size of the diluent powder is 50-65 meshes.
2. The florfenicol soluble powder according to claim 1 comprising, in parts by weight:
19-21 parts of florfenicol;
3.8-4.2 parts of poloxamer;
9.5-10.5 parts of cosolvent; the cosolvent is one or more of polyvidone K30, nicotinamide and polyethylene glycol 6000;
62-70 parts of a diluent; the diluent is selected from one or more of anhydrous glucose, lactose, sorbitol and mannitol.
3. The florfenicol soluble powder of claim 1, characterized in that,
comprises the following components in parts by weight:
20 parts of florfenicol;
4 parts of poloxamer;
povidone K3010 parts;
66 parts of anhydrous glucose.
4. The florfenicol soluble powder according to any one of claims 1-3, wherein the total amount of raw materials of the florfenicol soluble powder is 100 parts by weight.
5. The florfenicol soluble powder according to any one of claims 1-3, wherein in the method for preparing the florfenicol soluble powder, the parameter settings of a dry granulator during dry granulation are as follows: the pressure of the pressing wheel is 5Mpa, the feeding speed is 55 rpm, the rotating speed of the pressing wheel is 20 rpm, the crushing speed is 300 rpm, and the particle size is set to be 20 meshes.
6. A process for the preparation of a florfenicol soluble powder according to any one of claims 1-5, comprising the steps of:
1) uniformly mixing a florfenicol raw material, poloxamer, a diluent accounting for 30-60% of the total weight and a cosolvent, and then performing dry granulation; firstly, compressing the premix into a sheet or a plate, and then crushing the premix into particles with required sizes;
wherein, the parameters of the dry granulating machine are set as follows: the pressure of the pressing wheel is 2-5Mpa, the feeding speed is 30-60 r/min, the rotating speed of the pressing wheel is 10-25 r/min, the crushing speed is 150-;
2) putting the florfenicol mixture obtained by dry granulation into a universal pulverizer to be pulverized; setting parameters of the universal pulverizer: the rotating speed is 4000-;
3) uniformly mixing the material obtained in the step 2) with the rest of diluent powder; wherein the particle size of the diluent powder is 50-65 meshes.
7. The method according to claim 6, wherein the dry granulation is performed with the following parameters: the pressure of the pressing wheel is 5Mpa, the feeding speed is 55 rpm, the rotating speed of the pressing wheel is 20 rpm, the crushing speed is 300 rpm, and the particle size is set to be 20 meshes.
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| CN109498580A (en) * | 2018-12-13 | 2019-03-22 | 广东温氏大华农生物科技有限公司 | A kind of Florfenicol granular preparation and its preparation process |
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| CN109498580A (en) * | 2018-12-13 | 2019-03-22 | 广东温氏大华农生物科技有限公司 | A kind of Florfenicol granular preparation and its preparation process |
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