CN104288096A - Injection for treating pyrexia and hoof disease of dairy cows, and its preparation method - Google Patents
Injection for treating pyrexia and hoof disease of dairy cows, and its preparation method Download PDFInfo
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- CN104288096A CN104288096A CN201410290814.3A CN201410290814A CN104288096A CN 104288096 A CN104288096 A CN 104288096A CN 201410290814 A CN201410290814 A CN 201410290814A CN 104288096 A CN104288096 A CN 104288096A
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Abstract
The invention discloses an injection for treating pyrexia and the hoof disease of dairy cows, and its preparation method, and belongs to the technical field of veterinary western medicines. Every 100 ml of the injection is composed of 2-10g of diclofenac sodium, 0.1-0.5g of an antioxidant, 0.01-0.05g of a stabilizer, 20-80 ml of a cosolvent, and the balance of water for injection. The injection meets the veterinary drug market's demands on new antipyretic analgesic drugs, and has the advantages of good curative effect, small side effects and no accumulation in the clinical use process. Propylene glycol or polyethylene glycol-400 adopted as a cosolvent and the stabilizer disodium ethylenediaminetetraacetate synergistically enhance the dissolvability of diclofenac sodium in water, so the stability of the injection is increased. Anhydrous sodium sulfite has a stable anti-oxidation effect in alkaline environment with the pH value of 7.5-9.0. The preparation method of the diclofenac sodium injection has the advantages of simple and convenient preparation, low production cost, and suitableness for large-scale industrial production.
Description
Technical field
The present invention relates to a kind of injection being used for the treatment of milch cow heating and hoof disease, and the preparation method of this injection, belong to technical field of western medicines for animals.
Background technology
Milch cow heating and hoof disease are common diseases, have a strong impact on the development of milk cow production.Hoof disease frequent species has hoof lobe and transverse fissure, dermatitis, cellulitis, laminitis etc.Cowshed is moist, environment is poor, and ground is hard, and sports ground is uneven, hydrops all the year round, has sharp object or has hard corner angle, be easy to cause hoof disease.In addition, multiple cow disease can cause heating paresthesia.At present, need that a kind of milch cow is special clinically badly, good effect, side effect are little, without the antipyretic-antalgic dosage form of accumulation, be used for the treatment of milch cow heating and hoof disease.
Diclofenac sodium has another name called diclofenac, is the potent nonsteroidal antiinflammatory drug of the third generation, has stronger antiinflammatory, analgesia and refrigeration function, acts on comparatively aspirin, acetaminophen and indomethacin strong, is about 26 ~ 50 times of aspirin.The mechanism of action of this medicine is mainly reflected in by suppressing cyclooxygenase pathway to suppress arachidonic metabolism, promote that arachidonic acid and triglyceride (triacylglycerol) combine simultaneously, reduce the arachidonic concentration of endocellular liberation, indirectly suppress the synthesis of leukotriene.At present, the Diclofenac Sodium Injection of folk prescription is not yet had to be applied to veterinary clinic.
Summary of the invention
The object of this invention is to provide a kind of injection being used for the treatment of milch cow heating and hoof disease.
Meanwhile, the present invention also provides a kind of preparation method being used for the treatment of the injection of milch cow heating and hoof disease.
In order to realize above object, the technical solution adopted in the present invention is:
Be used for the treatment of an injection for milch cow heating and hoof disease, every 100mL injection is composed of the following components: diclofenac sodium 2 ~ 10g, antioxidant 0.1 ~ 0.5g, stabilizing agent 0.01 ~ 0.05g, cosolvent 20 ~ 80mL, and surplus is water for injection.
Described antioxidant is anhydrous sodium sulfite.
Described stabilizing agent is disodiumedetate (i.e. EDETATE SODIUM or EDTA-2Na).
Described cosolvent is one or both in propylene glycol (i.e. 1,2-PD), PEG-4000 (i.e. PEG-400).
Preferably, cosolvent is propylene glycol or PEG-4000.Be more preferably propylene glycol.
Preferably, be used for the treatment of the injection of milch cow heating and hoof disease, comprise following component in every 100mL injection: diclofenac sodium 5g, anhydrous sodium sulfite 0.3g, disodiumedetate 0.02, propylene glycol 35mL or PEG-4000 55mL, surplus is water for injection.Be more preferably propylene glycol 35mL.
Be used for the treatment of a preparation method for the injection of milch cow heating and hoof disease, comprise the following steps:
(1) accurately get each component according to formula ratio, cosolvent and appropriate water for injection (partial syringe water, as 10 ~ 30%) are mixed, obtains solution A;
(2) antioxidant and stabilizing agent are dissolved in 35 ~ 45 DEG C of appropriate waters for injection (as 10 ~ 30%), obtain solution B;
(3) solution A, B are mixed and heated to 50 ~ 60 DEG C, add diclofenac sodium, then add appropriate water for injection (as 10 ~ 30%), stirring and dissolving;
(4) regulate solution ph to be 7.5 ~ 9.0, water for injection standardize solution, fill, sterilizing, to obtain final product.
Described antioxidant is anhydrous sodium sulfite.
Described stabilizing agent is disodiumedetate.
Described cosolvent is one or both in propylene glycol, PEG-4000.Preferred propylene glycol or PEG-4000.Be more preferably propylene glycol.
Beneficial effect of the present invention:
In the present invention, Diclofenac Sodium Injection adopts propylene glycol or PEG-4000 as cosolvent, can work in coordination with strengthen the dissolubility of diclofenac sodium in water with stabilizing agent disodiumedetate, increases the stability of injection.
In adjuvant of the present invention, PEG-4000 is conventional pharmaceutic adjuvant, can be used as solvent, cosolvent, O/W type emulsifying agent and stabilizing agent, to medicine not diffluent in water, can be used as the carrier of solid dispersion, reaches solid dispersal object; Propylene glycol and water, ethanol and multiple immiscible organic solvent; Disodiumedetate is conventional antioxidant synergist, stabilizing agent, chelating agen (can form stable complex with many metal ions), soluble in water, can increase drug solubility, improves drug absorption, reduce medicine irritation etc.; Anhydrous sodium sulfite is conventional alkaline antioxidant, performance antioxidation that can be more stable in the alkaline injection of pH value 7.5 ~ 9.0.
The injection that the present invention is used for the treatment of milch cow heating and hoof disease has filled up the demand of veterinary drug market to ntipyretic analgesic medicine novel formulation, good effect in Clinical practice process, and side effect is little, nothing accumulation.
In the present invention, the preparation technology of Diclofenac Sodium Injection is simple and convenient, and production cost is low, is suitable for large-scale industrial production.
Detailed description of the invention
Following embodiment is only described in further detail the present invention, but does not form any limitation of the invention.
Embodiment 1
The injection of milch cow heating and hoof disease is used for the treatment of in the present embodiment, every 100mL injection is composed of the following components: diclofenac sodium 2g, anhydrous sodium sulfite 0.1g, disodiumedetate 0.01g, 1,2-propylene glycol 10mL, PEG-4000 10mL, surplus is water for injection.
Be used for the treatment of the preparation method of the injection of milch cow heating and hoof disease in the present embodiment, comprise the following steps:
(1) precision measures the 1,2-PD of 10mL, the PEG-4000 mixing of 10mL, and adds 10mL water for injection simultaneously, puts on magnetic stirring apparatus, is heated with stirring to 40 DEG C;
(2) 0.1g anhydrous sodium sulfite and 0.01g EDTA-2Na are dissolved in 10mL, the water for injection of 40 DEG C, mix homogeneously, for subsequent use;
(3) get two kinds of solution in step (1), (2) to mix, continuous agitating heating;
(4) treat that in step (3), mixeding liquid temperature is heated to 55 DEG C, adds wherein by 2g diclofenac sodium, slowly add 10mL water for injection, being stirred to solution is clear liquid simultaneously;
(5) be 8.0 by the HCl solution adjust ph of 0.1mol/L, water for injection supplements volume to full dose;
(6) conventional method is filled with nitrogen fill, and at 105 DEG C, sterilizing 20min, to obtain final product, outer package, Quan Jian, warehouse-in.
Embodiment 2
The injection of milch cow heating and hoof disease is used for the treatment of in the present embodiment, every 100mL injection is composed of the following components: diclofenac sodium 5g, anhydrous sodium sulfite 0.3g, disodiumedetate 0.02g, 1,2-PD 35mL, and surplus is water for injection.
Be used for the treatment of the preparation method of the injection of milch cow heating and hoof disease in the present embodiment, comprise the following steps:
(1) precision measures the 1,2-PD of 35mL, adds 10mL water for injection, puts on magnetic stirring apparatus, is heated with stirring to 45 DEG C;
(2) 0.3g anhydrous sodium sulfite and 0.02g EDTA-2Na are dissolved in 10mL, the water for injection of 45 DEG C, mix homogeneously, for subsequent use;
(3) get two kinds of solution in step (1), (2) to mix, continuous agitating heating;
(4) treat that in step (3), mixeding liquid temperature is heated to 50 DEG C, adds wherein by 5g diclofenac sodium, constantly add 10mL water for injection, being stirred to solution is clear liquid simultaneously;
(5) be 8.2 by the HCl solution adjust ph of 0.1mol/L, water for injection supplements volume to full dose;
(6) conventional method is filled with nitrogen fill, and at 105 DEG C, sterilizing 20min, to obtain final product, outer package, Quan Jian, warehouse-in.
Embodiment 3
The injection of milch cow heating and hoof disease is used for the treatment of in the present embodiment, every 100mL injection is composed of the following components: diclofenac sodium 8g, anhydrous sodium sulfite 0.4g, disodiumedetate 0.03g, PEG-4000 55mL, and surplus is water for injection.
Be used for the treatment of the preparation method of the injection of milch cow heating and hoof disease in the present embodiment, comprise the following steps:
(1) precision measures the PEG-4000 of 55mL, adds 10mL water for injection, puts on magnetic stirring apparatus, is heated with stirring to 35 DEG C;
(2) 0.4g anhydrous sodium sulfite and 0.03g EDTA-2Na are dissolved in 10mL, the water for injection of 35 DEG C, mix homogeneously, for subsequent use;
(3) get two kinds of solution in step (1), (2) to mix, continuous agitating heating;
(4) treat that in step (3), mixeding liquid temperature is heated to 60 DEG C, adds wherein by 8g diclofenac sodium, constantly add 10mL water for injection, being stirred to solution is clear liquid simultaneously;
(5) be 7.9 by the HCl solution adjust ph of 0.1mol/L, water for injection supplements volume to full dose;
(6) conventional method is filled with nitrogen fill, and at 105 DEG C, sterilizing 20min, to obtain final product, outer package, Quan Jian, warehouse-in.
Embodiment 4
The injection of milch cow heating and hoof disease is used for the treatment of in the present embodiment, every 100mL injection is composed of the following components: diclofenac sodium 10g, anhydrous sodium sulfite 0.5g, disodiumedetate 0.05g, 1,2-PD 70mL, and surplus is water for injection.
Be used for the treatment of the preparation method of the injection of milch cow heating and hoof disease in the present embodiment, comprise the following steps:
(1) precision measures the 1,2-PD of 70mL, adds 10mL water for injection, puts on magnetic stirring apparatus, is heated with stirring to 40 DEG C;
(2) 0.5g anhydrous sodium sulfite and 0.05g EDTA-2Na are dissolved in 5mL, the water for injection of 40 DEG C, mix homogeneously, for subsequent use;
(3) get two kinds of solution in step (1), (2) to mix, continuous agitating heating;
(4) treat that in step (3), mixeding liquid temperature is heated to 55 DEG C, adds wherein by 10g diclofenac sodium, constantly add 5mL water for injection, being stirred to solution is clear liquid simultaneously;
(5) be 7.5 by the HCl solution adjust ph of 0.1mol/L, water for injection supplements volume to full dose;
(6) conventional method is filled with nitrogen fill, and at 105 DEG C, sterilizing 20min, to obtain final product, outer package, Quan Jian, warehouse-in.
Embodiment 5
The injection of milch cow heating and hoof disease is used for the treatment of in the present embodiment, every 100mL injection is composed of the following components: diclofenac sodium 10g, anhydrous sodium sulfite 0.3g, disodiumedetate 0.05g, PEG-4000 80mL, and surplus is water for injection.
Be used for the treatment of the preparation method of the injection of milch cow heating and hoof disease in the present embodiment, comprise the following steps:
(1) precision measures the PEG-4000 of 80mL, adds 5mL water for injection, puts on magnetic stirring apparatus, is heated with stirring to 35 DEG C;
(2) 0.3g anhydrous sodium sulfite and 0.05g EDTA-2Na are dissolved in 5mL, 35 DEG C of waters for injection, mix homogeneously, for subsequent use;
(3) get two kinds of solution in step (1), (2) to mix, continuous agitating heating;
(4) treat that in step (3), mixeding liquid temperature is heated to 60 DEG C, adds wherein by 10g diclofenac sodium, constantly add 5mL water for injection, being stirred to solution is clear liquid simultaneously;
(5) be 9.0 by the HCl solution adjust ph of 0.1mol/L, water for injection supplements volume to full dose;
(6) conventional method is filled with nitrogen fill, and at 105 DEG C, sterilizing 20min, to obtain final product, outer package, Quan Jian, warehouse-in.
Test example
(1) cosolvent optimization test
Examination is carried out to following several common medicinal supplementary material, comprises 1,2-PD, PEG-4000,95% ethanol, 1-Methyl-2-Pyrrolidone, glycerol formal, benzyl alcohol and glycerol.
Test method: get 14g diclofenac sodium, divide and be divided into 7 equal portions, every part of 2g is stand-by, and dissolve with above-mentioned solvent respectively, amount of solvent and investigation the results are shown in following table 1.
The investigation result of table 1 different solvents
Result shows: 1,2-PD, PEG-4000 are the good cosolvents of diclofenac sodium.
(2) synergism between cosolvent and stabilizing agent investigates test
Test method: take diclofenac sodium 8g, is divided into 4 parts, every part of 2g;
Test grouping:
First group: after getting propylene glycol 35mL, water for injection 20mL mixing, dissolve 2g diclofenac sodium, inject water to 100mL;
Second group: get propylene glycol 35mL, then get 10mL water for injection dissolving disodiumedetate 0.02g; Dissolve 2g diclofenac sodium by after two kinds of solution mixing, inject water to 100mL;
3rd group: taking polyethylene glycol-40055mL, after water for injection 20mL mixes, dissolve 2g diclofenac sodium, inject water to 100mL;
4th group: taking polyethylene glycol-40055mL, then get 10mL water for injection dissolving disodiumedetate 0.02g; Dissolve 2g diclofenac sodium by after two solution mixing, inject water to 100mL;
Result: the mixed liquor of first group and the 3rd group needs to be heated to 50 ~ 60 DEG C, after adding diclofenac sodium, stirs the solution that more than 30min just can obtain clarifying; Second group and the 4th group, owing to adding disodiumedetate, mix and are moltenly heated to 50 ~ 60 DEG C, add diclofenac sodium and stir 5min and can obtain the uniform solution of clear.Illustrate that Diclofenac Sodium Injection adopts propylene glycol or PEG-4000 as cosolvent, can work in coordination with stabilizing agent disodiumedetate and strengthen the dissolubility of diclofenac sodium in water, improve the stability of injection simultaneously.
(3) content of Diclofenac Sodium Injection and 6 months accelerated stability tests
Detection method: the accurate Diclofenac Sodium Injection appropriate (being about equivalent to diclofenac sodium 50mg) measuring embodiment 1 ~ 5 and prepare respectively, put in 100mL measuring bottle, add ethanol dilution to scale, shake up, precision measures 2mL, puts in 100mL measuring bottle, add ethanol dilution to scale, shake up, according to spectrophotography (Chinese veterinary pharmacopoeia version in 2010 appendix 26), measure trap at 284nm wavelength place; Another precision takes the diclofenac sodium reference substance 50mg being dried to constant weight at 105 DEG C, is measured in the same method, and calculates, to obtain final product.The accelerated stability carried out 0 ~ 6 month is investigated, and detects and investigate to the results are shown in following table 2.
The content detection of table 2 Diclofenac Sodium Injection and accelerated stability investigate result
Result shows: Diclofenac Sodium Injection prepared by embodiment 1 ~ 5 is all qualified, and it is qualified that accelerated stability investigates result, and character is constant, and content is without significant change.
(4) Diclofenac Sodium Injection detects the therapeutic effect of milch cow heating paresthesia
Experimental animal: 90 ill milch cows (Luoyang, henan cattle farm), in normal feeding process, natural infection causes heating paresthesia.
Test grouping and process: 90 cow heads are divided into 6 groups at random, test group 1 ~ 5 and negative control group, often organize 15.The Diclofenac Sodium Injection that test group 1 ~ 5 adopts embodiment 1 ~ 5 to prepare successively is treated, and intramuscular injection every day Diclofenac Sodium Injection 2.5mg/kg body weight, every day 1 time, is used in conjunction 3 days; Negative control group not administration process.
Test method: after the administration of above each group respectively 0,20,60,120min carries out body temperature measurement, observe antipyretic response, the results are shown in following table 3.
The each treatment group of table 3 causes the therapeutic effect of heating paresthesia to milch cow natural infection
Result shows: Diclofenac Sodium Injection can take effect after 1 hour in use, starts to bring down a fever, Be very effective.
(5) Diclofenac Sodium Injection detects the therapeutic effect of milch cow laminitis
Experimental animal: 90 ill milch cows (Zhengzhou, henan cattle farm), symptomatic diagnosis suffers from acute laminitis.
Diagnostic criteria: body temperature is up to 40 ~ 41 DEG C, and loss of appetite, perspire, muscular tremor, the swelling of coronet portion, sufficient wall percussion has pain.During two forelimb morbidities, two forelimbs intersections are born a heavy burden; After two during hoof morbidity, head is low, two forelimb post leggeds, and two hind legs, slightly toward protracting, are reluctant to walk about; During walking, gait is arrested by force, and stomach wall tightens; During four hoof morbidities, extremity again and again alternately bear a heavy burden, and for avoiding pain often to change posture, hogback is stood.Sick cattle happiness is walked on hag, and hide hard place, happiness is sleeping, and behind sleeping ground, extremity stretch in lateral position.
Test grouping and process: 90 cow heads are divided into 6 groups at random, test group 1 ~ 5 and negative control group, often organize 15.The Diclofenac Sodium Injection that test group 1 ~ 5 adopts embodiment 1 ~ 5 to prepare successively is treated, and intramuscular injection every day Diclofenac Sodium Injection 2.5mg/kg body weight, every day 1 time, is used in conjunction 3 days; Negative control group not administration process.
Test method: after the administration of above each group respectively 0,20,60,120min carries out body temperature measurement, observe antipyretic-antalgic effect, the results are shown in following table 4.
The each treatment group of table 4 is to the therapeutic effect of dairy cow acute laminitis
Result shows: Diclofenac Sodium Injection can take effect in 2 hours after a procedure, and after medication, analgesic effect is remarkable, and animal walks normal, and percussion is without pain.
Claims (8)
1. one kind is used for the treatment of the injection of milch cow heating and hoof disease, it is characterized in that: every 100mL injection is composed of the following components: diclofenac sodium 2 ~ 10g, antioxidant 0.1 ~ 0.5g, stabilizing agent 0.01 ~ 0.05g, cosolvent 20 ~ 80mL, surplus is water for injection.
2. the injection being used for the treatment of milch cow heating and hoof disease according to claim 1, is characterized in that: described antioxidant is anhydrous sodium sulfite.
3. the injection being used for the treatment of milch cow heating and hoof disease according to claim 1, is characterized in that: described stabilizing agent is disodiumedetate.
4. be according to claim 1ly used for the treatment of milch cow heating and the injection of hoof disease, it is characterized in that: described cosolvent is one or both in propylene glycol, PEG-4000.
5. the injection being used for the treatment of milch cow heating and hoof disease according to claim 4, is characterized in that: described cosolvent is the one in propylene glycol, PEG-4000.
6. the injection being used for the treatment of milch cow heating and hoof disease according to claim 5, is characterized in that: described cosolvent is propylene glycol.
7. the injection being used for the treatment of milch cow heating and hoof disease according to claim 1, it is characterized in that: comprise following component in every 100mL injection: diclofenac sodium 5g, anhydrous sodium sulfite 0.3g, disodiumedetate 0.02, propylene glycol 35mL or PEG-4000 55mL, surplus is water for injection.
8. the preparation method being used for the treatment of the injection of milch cow heating and hoof disease as described in any one of claim 1-7, is characterized in that: comprise the following steps:
(1) accurately get each component according to formula ratio, cosolvent and partial syringe use water are mixed, obtains solution A;
(2) be dissolved in partial syringe water by antioxidant and stabilizing agent, the temperature of water for injection is 35 ~ 45 DEG C, obtains solution B;
(3) solution A, B are mixed and heated to 50 ~ 60 DEG C, add diclofenac sodium, then adding portion water for injection, stirring and dissolving;
(4) regulate solution ph to be 7.5 ~ 9.0, water for injection standardize solution, fill, sterilizing, to obtain final product.
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| CN201410290814.3A CN104288096A (en) | 2014-06-24 | 2014-06-24 | Injection for treating pyrexia and hoof disease of dairy cows, and its preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105748836A (en) * | 2016-02-24 | 2016-07-13 | 宁夏钰丰科技有限公司 | Dairy cattle hoof protection liquid with stable drug function and preparation method of dairy cattle hoof protection liquid |
| CN108785681A (en) * | 2018-09-05 | 2018-11-13 | 成都导飞科技有限公司 | A kind of compound antipyretic antalgic anti-inflammatory agent composite preparation and its application for animals |
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| CN101485650A (en) * | 2009-02-19 | 2009-07-22 | 山东鲁抗辰欣药业有限公司 | Diclofenac sodium and lidocaine hydrochloride injection and preparation method thereof |
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- 2014-06-24 CN CN201410290814.3A patent/CN104288096A/en active Pending
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| US5389681A (en) * | 1992-10-22 | 1995-02-14 | Ciba-Geigy Corporation | Parenteral solutions for diclofenac salts |
| CN101485650A (en) * | 2009-02-19 | 2009-07-22 | 山东鲁抗辰欣药业有限公司 | Diclofenac sodium and lidocaine hydrochloride injection and preparation method thereof |
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| CN105748836A (en) * | 2016-02-24 | 2016-07-13 | 宁夏钰丰科技有限公司 | Dairy cattle hoof protection liquid with stable drug function and preparation method of dairy cattle hoof protection liquid |
| CN108785681A (en) * | 2018-09-05 | 2018-11-13 | 成都导飞科技有限公司 | A kind of compound antipyretic antalgic anti-inflammatory agent composite preparation and its application for animals |
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