CN106420601B - Compound florfenicol injection for livestock and preparation method thereof - Google Patents
Compound florfenicol injection for livestock and preparation method thereof Download PDFInfo
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- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- A—HUMAN NECESSITIES
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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Abstract
The invention discloses a veterinary compound florfenicol injection, belonging to the field of veterinary preparations, wherein each 1L of the veterinary compound florfenicol injection comprises 50-300 g of florfenicol, 5-30 g of flunixin meglumine, 300-600 ml of isopropyl myristate, 150-450 ml of polyethylene glycol stearate-15, 0.5-3 g of anhydrous sodium sulfite and 50-200 ml of water for injection; and discloses a preparation method. The invention has obvious effects on bacterial diseases of livestock and poultry, and preventing and treating viral diseases and secondary bacterial infection of parasitic diseases, and particularly effectively treats paratyphoid fever of piglets with porcine infectious pleuropneumonia, yellow and white scour of piglets, asthma of pigs, atrophic rhinitis, agalactia syndrome, red scour of piglets, postpartum infection, haemophilus parasuis disease and the like; the preparation method has the advantages of simple process, good stability, low cost, no need of adding local analgesic due to the replacement of part of organic solvent with water for injection, good fluidity, good needle penetration property, and reduced irritation during injection.
Description
Technical Field
The invention relates to the field of veterinary drug preparations, in particular to a veterinary compound florfenicol injection and a preparation method thereof.
Background
In recent years, with the improvement of the living standard of people and the development of animal husbandry, the livestock and poultry stock keeping quantity is increased year by year, and various respiratory tract, digestive tract and other livestock and poultry diseases occur along with the increase of the living standard of people and the development of animal husbandry, so that huge losses are caused to the animal husbandry. At present, no ideal medicine with broad-spectrum therapeutic action is available in the market for treating the diseases. The clinical treatment generally selects gentamicin sulfate, enrofloxacin hydrochloride injection and other medicaments, but the medicament resistance is easy to generate and the effect is not obvious.
Florfenicol belongs to amidol broad-spectrum antibacterial drugs and has strong antibacterial activity on various gram-positive bacteria, gram-negative bacteria, mycoplasma and the like. Can be used for treating bacterial diseases of pig and chicken caused by sensitive bacteria, such as porcine infectious pleuropneumonia, typhoid fever and paratyphoid fever caused by salmonella. Florfenicol is mainly a bacteriostatic agent which inhibits the synthesis of bacterial proteins by binding with ribosome 50S subunit. Florfenicol has similar or stronger antibacterial activity to a plurality of microorganisms in vitro with chloramphenicol and thiamphenicol, and some bacteria resistant to chloramphenicol due to acetylation, such as escherichia coli, klebsiella pneumoniae and the like, can still be sensitive to the florfenicol. Pasteurella haemolytica, pasteurella multocida and actinobacillus pleuropneumoniae are highly sensitive to florfenicol. Flunixin meglumine is a potent cyclooxygenase inhibitor and has analgesic, antipyretic, anti-inflammatory and antirheumatic effects. The analgesic action is caused by blocking the transmission of pain impulse by inhibiting the synthesis of peripheral prostaglandin or its hyperalgesic substance or their combined action. The anti-inflammatory effects of peripheral tissues may be caused by inhibition of cyclooxygenase, reduction in prostaglandin precursor formation, and inhibition of local inflammatory responses caused by other mediators. Flunixin meglumine does not affect gastrointestinal motility in horses, but may improve hemodynamics in septic shock animals.
In recent years, most of florfenicol injection on the market is single-component preparation, the effect is poor, the dosage is large, the residue is high, the bioavailability is low, all solvents of the florfenicol injection are organic solvents, the hypodermic irritation is large, the needle penetration is not good, and local analgesic drugs are required to be matched when the injection is used.
Disclosure of Invention
In order to achieve the aim, the invention provides a compound florfenicol injection for animals and a preparation method thereof.
In order to achieve the purpose, the invention provides a veterinary compound florfenicol injection, wherein each 1L of the compound florfenicol injection comprises 50-300 g of florfenicol, 5-30 g of flunixin meglumine, 300-600 ml of isopropyl myristate, 150-450 ml of polyethylene glycol stearate-15, 0.5-3 g of anhydrous sodium sulfite and 50-200 ml of water for injection.
Preferably, the compound florfenicol injection comprises 200g of florfenicol, 20g of flunixin meglumine, 450ml of isopropyl myristate, 300ml of polyethylene glycol stearate-15, 1g of anhydrous sodium sulfite and 100ml of water for injection in each 1L.
Wherein the polyethylene glycol is one of polyethylene glycol 200, polyethylene glycol 400 and polyethylene glycol 600.
Preferably, the polyethylene glycol is polyethylene glycol 400.
Wherein the pyrrolidone is N-methyl-2-pyrrolidone.
In order to achieve the purpose, the invention also provides a preparation method of the veterinary compound florfenicol injection, which comprises the following steps:
step one, adding florfenicol into isopropyl myristate, heating at 45-50 ℃, stirring for dissolving, and cooling for later use to obtain a solution ①;
secondly, adding flunixin meglumine and anhydrous sodium sulfite into water for injection, and stirring and dissolving to obtain a solution ②;
thirdly, mixing the two solutions ① and ②, stirring uniformly, adding polyethylene glycol stearate-15 with the formula amount, stirring uniformly, finally metering the volume to 1L by using the polyethylene glycol stearate-15, and filtering for later use;
and fourthly, checking the semi-finished product, filling nitrogen for encapsulation after the semi-finished product is qualified, and sterilizing at the temperature of 100-105 ℃ for 25-30min to obtain the compound florfenicol injection.
The invention has the beneficial effects that: the main components of the compound florfenicol injection prepared by the invention are florfenicol and flunixin meglumine, wherein the florfenicol is used for bacterial diseases caused by sensitive bacteria, such as porcine infectious pleuropneumonia, typhoid fever and paratyphoid fever caused by salmonella, and the like; flunixin meglumine is a potent cyclooxygenase inhibitor, and has antipyretic, analgesic, anti-inflammatory and antirheumatic effects; compared with the conventional single preparation of the florfenicol injection, the combined use of the florfenicol and the florfenicol has the advantages of good effect, small dosage, low residue, obviously enhanced drug effect and higher bioavailability; the preparation process is simple, the stability is good, the cost is low, the preparation method is suitable for large-scale industrial production, and the preparation method has great significance for the sustainable development of animal husbandry; the injection water is used for replacing part of organic solvents, the selected organic solvents are novel, safe and small-irritation organic solvents in the current market, local analgesics do not need to be added, the fluidity is good, the needle penetration is better, and the irritation is reduced during injection.
Detailed Description
For further explanation, specific examples are given.
Example one
Adding 50g of florfenicol into 300ml of isopropyl myristate, heating at 50 ℃, stirring for dissolving, cooling for later use to obtain a solution ①, adding 5g of flunixin meglumine and 0.5g of anhydrous sodium sulfite into 50ml of water for injection, stirring for dissolving to obtain a solution ②, mixing the two solutions ① and ②, stirring uniformly, adding polyethylene glycol stearate-15 with the amount of a prescription, stirring uniformly, adding polyethylene glycol stearate-15 to a constant volume of 1L, filtering for later use, checking a semi-finished product, filling nitrogen for encapsulation after the inspection is qualified, and sterilizing at 105 ℃ for 30min to obtain the compound florfenicol injection.
Example two
Adding 100g of florfenicol into 350ml of isopropyl myristate, heating at 50 ℃, stirring for dissolving, cooling for later use to obtain a solution ①, adding 10g of flunixin meglumine and 1g of anhydrous sodium sulfite into 75ml of water for injection, stirring for dissolving to obtain a solution ②, mixing the two solutions ① and ②, stirring uniformly, adding polyethylene glycol stearate-15 with the formula amount, stirring uniformly, adding polyethylene glycol stearate-15 to a constant volume of 1L, filtering for later use, testing a semi-finished product, filling nitrogen for encapsulation after passing inspection, and sterilizing at 105 ℃ for 30min to obtain the compound florfenicol injection.
EXAMPLE III
Adding 150g of florfenicol into 400ml of isopropyl myristate, heating at 50 ℃, stirring for dissolving, cooling for later use to obtain a solution ①, adding 15g of flunixin meglumine and 1.5g of anhydrous sodium sulfite into 100ml of water for injection, stirring for dissolving to obtain a solution ②, mixing the two solutions ① and ②, stirring uniformly, adding polyethylene glycol stearate-15 with the formula amount, stirring uniformly, adding polyethylene glycol stearate-15 to a constant volume of 1L, filtering for later use, checking a semi-finished product, filling nitrogen for encapsulation after the inspection is qualified, and sterilizing at 105 ℃ for 30min to obtain the compound florfenicol injection.
Example four
Adding 200g of florfenicol into 450ml of isopropyl myristate, heating at 50 ℃, stirring for dissolving, cooling for later use to obtain a solution ①, adding 20g of flunixin meglumine and 1g of anhydrous sodium sulfite into 100ml of water for injection, stirring for dissolving to obtain a solution ②, mixing the two solutions ① and ②, stirring uniformly, adding polyethylene glycol stearate-15 with the formula amount, stirring uniformly, adding polyethylene glycol stearate-15 to a constant volume of 1L, filtering for later use, testing a semi-finished product, filling nitrogen for encapsulation after passing inspection, and sterilizing at 105 ℃ for 30min to obtain the compound florfenicol injection.
EXAMPLE five
Adding 300g of florfenicol into 500ml of isopropyl myristate, heating at 50 ℃, stirring for dissolving, cooling for later use to obtain a solution ①, adding 30g of flunixin meglumine and 2g of anhydrous sodium sulfite into 150ml of water for injection, stirring for dissolving to obtain a solution ②, mixing the two solutions ① and ②, stirring uniformly, adding polyethylene glycol stearate-15 with the formula amount, stirring uniformly, adding polyethylene glycol stearate-15 to a constant volume of 1L, filtering for later use, testing a semi-finished product, filling nitrogen for encapsulation after passing inspection, and sterilizing at 105 ℃ for 30min to obtain the compound florfenicol injection.
EXAMPLE six
Adding 100g of florfenicol into 350ml of polyethylene glycol 400, heating at 50 ℃, stirring for dissolving, cooling for later use to obtain a solution ①, adding 10g of flunixin meglumine and 1g of anhydrous sodium sulfite into 50ml of water for injection, stirring for dissolving to obtain a solution ②, mixing the two solutions ① and ②, stirring uniformly, adding the N-methyl-2-pyrrolidone with the prescription amount, stirring uniformly, adding the N-methyl-2-pyrrolidone to a constant volume of 1L, filtering for later use, checking a semi-finished product, filling nitrogen for encapsulation after the semi-finished product is qualified, and sterilizing at 105 ℃ for 30min to obtain the compound florfenicol injection.
EXAMPLE seven
Adding 200g of florfenicol into 450ml of polyethylene glycol 400, heating at 50 ℃, stirring for dissolving, cooling for later use to obtain a solution ①, adding 20g of flunixin meglumine and 1.5g of anhydrous sodium sulfite into 100ml of water for injection, stirring for dissolving to obtain a solution ②, mixing the two solutions ① and ②, stirring uniformly, adding the prescribed amount of N-methyl-2-pyrrolidone into the solution, stirring uniformly, finally fixing the volume to 1L by using N-methyl-2-pyrrolidone, filtering, later use, checking a semi-finished product, filling nitrogen for encapsulation after the semi-finished product is qualified, and sterilizing at 105 ℃ for 30min to obtain the compound florfenicol injection.
The amounts of the components described in one of the first to seventh examples are increased or decreased according to the same proportion, and the obtained weight part relationship of the components all belongs to the protection scope of the invention.
Example eight stability test
The test sample is a veterinary compound florfenicol injection prepared in the first embodiment, the second embodiment and the third embodiment; the detection items comprise characters, pH values, related substances and contents.
Accelerated test
Three samples prepared in the first, second and third examples were left at 40 + -2 deg.C and 65 + -5% relative humidity for six months, and sampled at the end of 0, 1, 2, 3 and 6 months, and properties, pH, moisture, related substances, contents and the like were examined, and compared with the results of the 0-day test, the results are shown in Table 1 below.
Long term test
Three batches of samples prepared in the first, second and third examples were placed at 25 + -2 deg.C and 60 + -10% of relative humidity, and sampled at 0, 3, 6, 9, 12, 18 and 24 months, and items such as properties, pH values, moisture, related substances, contents and the like were examined, and compared with the test results of 0 day, the results are shown in Table 2 below.
TABLE 1 accelerated test results for three lots of samples
TABLE 2 Long-term test results for three batches of samples
The results of accelerated tests and long-term tests show that when three batches of samples prepared in the first, second and third examples are placed at 40 +/-2 ℃ and RH65 +/-5% for 6 months and at 25 +/-2 ℃ and RH60 +/-10% for 18 months, the appearance color and luster of the samples are not obviously changed, the pH and related substances are in accordance with the regulations, and the content change is not obvious, so that the compound florfenicol injection prepared by the invention is stable in quality.
EXAMPLE nine irritation test
Skin irritation test
The test sample is a veterinary compound florfenicol injection prepared in the first embodiment; the positive control is a commercial compound florfenicol injection; the test animals are 8 healthy rabbits with female and male halves, and the weight of the test animals is 2-2.5 kg.
Taking 8 healthy rabbits, averagely dividing the rabbits into two groups, wherein each group comprises 2 males and females, and adopting a same-body left-right comparison method and setting a solvent for comparison. Shearing the back 24h before the test, wherein the shearing range is respectively 3cm multiplied by 3cm, the left side is smeared with the medicine and the positive control medicine, and the right side is smeared with a blank solvent which is 0.5 mL; then covering with 2 layers of gauze (2.5cm × 2.5cm) and 1 layer of cellophane, and fixing with non-irritant adhesive plaster; when the patch is applied for 4 hours, the application part is cleaned by warm water warmed to 38 ℃, the condition of erythema and edema on the application part is visually observed and recorded respectively 0.5 hour, 1 hour, 24 hours, 48 hours and 72 hours after the medicine is removed, the evaluation is carried out according to the skin irritation response evaluation standard (table 3), and then the evaluation is carried out according to the skin irritation intensity evaluation standard (table 4).
TABLE 3 skin irritation response and Scoring standards
TABLE 4 evaluation criteria for skin irritation intensity
| Score value | Evaluation of |
| 0～0.49 | Has no irritation |
| 0.5～2.99 | Mild stimulation |
| 3～5.99 | Moderate stimulation |
| 6～8 | Stimulation of intensity |
Test results
According to the skin irritation response scoring standard, each time point of skin irritation is scored, the average value of the response integrals of all time points of the preparation is 0.32, the average value of the response integrals of all time points of the positive control preparation is 1.37, and the solvent control is 0.23, which shows that the compound florfenicol injection has slight irritation to the skin, but has less irritation to the skin compared with the compound florfenicol injection sold in the market.
Muscle irritation test
The test sample is a veterinary compound florfenicol injection prepared in the first embodiment; the positive control is a commercial compound florfenicol injection; the test animals are 8 healthy rabbits with female and male halves, and the weight of the test animals is 2-2.5 kg.
Method and standard
The 8 rabbits were randomly divided into four groups, each group having 1 male and female. The evaluation criteria for the irritation response are shown in Table 5.
The first group and the second group of healthy rabbits No. 1, 2, 5, and 6 were injected with 1mL of each of the example samples and the positive control samples in the left and right thigh quadriceps by a sterile procedure, and the injection sites were marked. The animals were sacrificed 48h after injection, the quadriceps femoris muscle was dissected out, cut longitudinally, and observed for local irritation response at the injection site.
The third, fourth group 3, 4, 7, 8 healthy rabbits were injected with 1mL each of the example sample and the positive control sample in the left and right thigh quadriceps by aseptic technique, and the injection sites were marked. The animals were sacrificed 7d after injection, the quadriceps femoris muscle was dissected out, cut longitudinally, and the injection site was observed for regression of local irritation-responsive lesions.
TABLE 5 evaluation criteria for muscle irritation response
Result evaluation method
The sum of the 4 muscle response levels was calculated for each group. If the difference between the highest and lowest group of quadriceps responses is greater than 2, two additional rabbits should be retested. When the sum of the response grades of 4 quadriceps femoris muscles of 2 rabbits in the initial test or the retrying test is less than 10, the local stimulation test of the test article is considered to be in accordance with the regulation.
Test results
The test results are shown in tables 6-9 below.
TABLE 6 results of the first muscle stimulation group (after 48 h)
TABLE 7 second group of muscle stimulation response results (after 48 h)
TABLE 8 results of regression of third group muscle stimulus response lesions (7d)
| Categories | Stimulation of pathological conditions | Grade of reaction |
| No. 3 rabbit right leg | Basically has no bleeding, muscle necrosis and degeneration phenomena, and has good recovery. | 0 |
| No. 3 rabbit left leg | Mild hemorrhage, within 0.3cm, no muscleDegeneration and necrosis. | 1 |
| No. 4 rabbit right leg | Basically has no bleeding, muscle necrosis and degeneration phenomena, and has good recovery. | 0 |
| No. 4 rabbit left leg | Basically has no bleeding, muscle necrosis and degeneration phenomena, and has good recovery. | 0 |
| Sum of reaction | 1 |
TABLE 9 results of regression of fourth group of muscle stimulus-responsive lesions (7d)
| Categories | Stimulation of pathological conditions | Grade of reaction |
| No. 7 rabbit right leg | Basically has no bleeding, muscle necrosis and degeneration phenomena, and has good recovery. | 0 |
| No. 7 rabbit left leg | Mild bleeding, range 0.3About cm, no muscle degeneration and necrosis. | 1 |
| No. 8 rabbit right leg | Mild hemorrhage, within 0.2cm, without muscle degeneration and necrosis. | 1 |
| No. 8 rabbit left leg | Mild hemorrhage, within 0.4cm, without muscle degeneration and necrosis. | 1 |
| Sum of reaction | 3 |
The anatomical result of the first group of 2 rabbits injected with the sample of the example intramuscularly for 48h shows that one injection site of quadriceps has no bleeding phenomenon, no muscle necrosis and degeneration phenomenon, and the other injection sites of quadriceps have mild bleeding within the range of less than 0.5cm, but no muscle degeneration and necrosis phenomenon. The reaction grade is 0-1 grade, and the total is 3. The sum of the four quadriceps muscle reaction levels is less than 10, and the difference between the highest group level and the lowest group level is less than 2, which shows that the local intramuscular injection test of the compound florfenicol injection of the invention has weak stimulation to animal muscle and accords with the safety test standard.
The dissection result of a third group of 2 rabbits injected with the sample of example 7d intramuscularly shows that three quadriceps muscles have no bleeding phenomenon, no muscle necrosis and degeneration phenomenon and better recovery, the other quadriceps muscle has slight bleeding which is about 0.3cm but has no muscle degeneration and necrosis phenomenon, the reaction level is 0-1 level, the sum is 1 and less than 10 levels, and the difference between the highest level and the lowest level is less than 2, which indicates that the local test of the compound florfenicol injection of the invention has basically complete recovery of the irritation to animal muscle, good reversibility and accordance with the safety test standard.
As can be seen from the comparison between the first group and the second group and between the third group and the fourth group, the compound florfenicol injection prepared by the invention has smaller muscle irritation and quicker recovery than the commercial compound florfenicol injection product, and can be safely used in clinic.
The irritation test shows that the compound florfenicol injection prepared by the invention has small clinical irritation and high safety.
Examples one to seven and one to seven of the above-mentioned components are added or reduced in the same ratio to obtain the combination, and the intramuscular irritation test and the results are all within the scope of the present invention.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (4)
1. The veterinary compound florfenicol injection is characterized in that each 1L of the compound florfenicol injection comprises 50-300 g of florfenicol, 5-30 g of flunixin meglumine, 300-600 ml of isopropyl myristate, 150-450 ml of polyethylene glycol stearate-15, 0.5-3 g of anhydrous sodium sulfite and 50-200 ml of water for injection.
2. The veterinary compound florfenicol injection solution according to claim 1, which is characterized in that each 1L of the compound florfenicol injection solution comprises 200g of florfenicol, 20g of flunixin meglumine, 450ml of isopropyl myristate, 300ml of polyethylene glycol stearate-15, 1g of anhydrous sodium sulfite and 100ml of water for injection.
3. The veterinary compound florfenicol injection solution according to claim 1 or 2, characterized in that the preparation method comprises the following steps:
step one, adding florfenicol into isopropyl myristate, heating at 45-50 ℃, stirring for dissolving, and cooling for later use to obtain a solution ①;
secondly, adding flunixin meglumine and anhydrous sodium sulfite into water for injection, and stirring and dissolving to obtain a solution ②;
thirdly, mixing the two solutions ① and ②, stirring uniformly, adding polyethylene glycol stearate-15 with the formula amount, stirring uniformly, finally metering the volume to 1L by using the polyethylene glycol stearate-15, and filtering for later use;
and fourthly, checking the semi-finished product, filling nitrogen for encapsulation after the semi-finished product is qualified, and sterilizing at the temperature of 100-105 ℃ for 25-30min to obtain the compound florfenicol injection.
4. A method for preparing veterinary compound florfenicol injection according to any one of claims 1-3, comprising the following steps:
step one, adding florfenicol into isopropyl myristate, heating at 45-50 ℃, stirring for dissolving, and cooling for later use to obtain a solution ①;
secondly, adding flunixin meglumine and anhydrous sodium sulfite into water for injection, and stirring and dissolving to obtain a solution ②;
thirdly, mixing the two solutions ① and ②, stirring uniformly, adding polyethylene glycol stearate-15 with the formula amount, stirring uniformly, finally metering the volume to 1L by using the polyethylene glycol stearate-15, and filtering for later use;
and fourthly, checking the semi-finished product, filling nitrogen for encapsulation after the semi-finished product is qualified, and sterilizing at the temperature of 100-105 ℃ for 25-30min to obtain the compound florfenicol injection.
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| CN101288682A (en) * | 2008-06-06 | 2008-10-22 | 广东药学院 | Microemulsion containing brucea javanica oil and preparation method thereof |
| CN102188422A (en) * | 2011-01-11 | 2011-09-21 | 广东大华农动物保健品股份有限公司 | Compound florfenicol injection and preparation method and application thereof |
| CN102920701A (en) * | 2012-11-02 | 2013-02-13 | 青岛康地恩药业股份有限公司 | Compound florfenicol preparation for treating swine respiratory tract infection diseases and preparation method thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101288682A (en) * | 2008-06-06 | 2008-10-22 | 广东药学院 | Microemulsion containing brucea javanica oil and preparation method thereof |
| CN102188422A (en) * | 2011-01-11 | 2011-09-21 | 广东大华农动物保健品股份有限公司 | Compound florfenicol injection and preparation method and application thereof |
| CN102920701A (en) * | 2012-11-02 | 2013-02-13 | 青岛康地恩药业股份有限公司 | Compound florfenicol preparation for treating swine respiratory tract infection diseases and preparation method thereof |
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