CN103083229A - Preparation method of compound analgin injection for livestock - Google Patents
Preparation method of compound analgin injection for livestock Download PDFInfo
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- CN103083229A CN103083229A CN2012101200114A CN201210120011A CN103083229A CN 103083229 A CN103083229 A CN 103083229A CN 2012101200114 A CN2012101200114 A CN 2012101200114A CN 201210120011 A CN201210120011 A CN 201210120011A CN 103083229 A CN103083229 A CN 103083229A
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Abstract
本发明涉及兽用复方安乃近注射液及其制备方法；注射液每100ml按重量包括：安乃近10～30g、L-半胱氨酸2～4g、地塞米松磷酸钠50～150mg、EDTA-Na2：0.05g、注射用水至100ml、pH调节剂调节pH值在5.5-6.5之间；制备步骤包括溶解地塞米松磷酸钠制备成溶液，其余组分也溶解为溶液，两部分合并搅拌均匀，继续搅拌，调整PH值在5.5-6.5之间并定容；药液经有机滤膜过滤后滤液用灌封机分别灌装于瓶中，经115℃、压力0.2MPa灭菌20分钟后打开灭菌柜，自然冷却10分钟后关闭灭菌柜，再次灭菌20分钟得成品。本发明解决了注射液在贮藏过程中变色、含量降解、毒性增加等问题。并且具有更好的解热效果、又同时赋予了抗炎抗过敏功能。改善了产品外观品质和使用疗效。使用更方便，用途更广泛。The invention relates to veterinary compound Analgin injection and a preparation method thereof; each 100ml of the injection comprises by weight: Analgin 10-30g, L-cysteine 2-4g, dexamethasone sodium phosphate 50-150mg, EDTA-Na2: 0.05g, water for injection to 100ml, pH adjuster to adjust the pH value between 5.5-6.5; the preparation steps include dissolving dexamethasone sodium phosphate to prepare a solution, and other components are also dissolved into a solution, and the two parts are combined and stirred Evenly, continue to stir, adjust the pH value between 5.5-6.5 and constant volume; after the liquid medicine is filtered through an organic filter membrane, the filtrate is filled in bottles with a filling and sealing machine, and sterilized at 115°C and a pressure of 0.2MPa for 20 minutes. Open the sterilizing cabinet, close the sterilizing cabinet after natural cooling for 10 minutes, and sterilize again for 20 minutes to obtain the finished product. The invention solves the problems of discoloration, content degradation and increased toxicity of the injection during storage. And it has a better antipyretic effect, and at the same time endows it with anti-inflammatory and anti-allergic functions. Improve product appearance quality and use curative effect. It is more convenient to use and has a wider range of uses.
Description
Technical field
The present invention relates to a kind of veterinary drug, be specifically related to animal compound analgin injection and preparation method thereof.
Background technology
Dipyrone (Metamizole Sodium Tablet s), common veterinary's prescription drugs.Compound for aminophenazone and sodium sulfite combine absorbs rapidly in animal body, and effect is very fast, and drug effect was kept 3-4 hour.Refrigeration function is more remarkable, and analgesic activity is also stronger, and certain antiinflammatory and anti rheumatism action are arranged.Gastrointestinal motility is had no significant effect.Be used for febrile disease, myalgia, colic and rheumatism etc.
In veterinarian's actual clinical is used, the inconsistent discoloration problem of the same box herb liquid of analgin injection ubiquity shade.Record in one one of " Chinese veterinary pharmacopoeia " version in 2010, the analgin injection character: this product is colourless or yellowish clear liquid, and its character can become yellow under storage environment.Concrete reason is the easily oxidized 4-monomethylaminoantipyrine that decomposites of dipyrone, and it has facilitation high temperature, light, little mark metal pair.Present analgin injection for animals manufacturer is all less than effectively controlling the production technology of its variable color.Not only affect the neat and attractive in appearance of product after the medicinal liquid variable color, the more important thing is that its essence is oxidation and the variation of material, the problems such as effective content decline, derivant toxicity occur.
Summary of the invention
The invention provides a kind of animal compound analgin injection and preparation method thereof, solved the technical barrier of the Character instabilities such as analgin injection variable color.
Technical scheme of the present invention is achieved in that a kind of animal compound analgin injection, it is characterized in that: every 100ml comprises by weight:
PH adjusting agent, consumption are enough to the regulation system pH value between 5.5-6.5
Surplus is water for injection.
Further, described pH adjusting agent is sodium hydroxide solution or hydrochloric acid.During actual preparation, according to circumstances regulate, pH value is high to go beyond the scope, and available hydrochloric acid is regulated, and pH value is lower than this scope, and the available hydrogen sodium hydroxide solution is regulated.
Preferably, in described every 100ml injection:
Preferably, in described every 100ml injection:
That is to say effective ingredient is further limited, still will regulate pH value with pH adjusting agent, surplus is still water for injection.
The preparation method of analgin compound injection of the present invention, it comprises the steps:
1), get the room temperature water for injection of 80% recipe quantity, the inflated with nitrogen protection adds respectively EDTA-Na2, Cys, dipyrone after 10 minutes successively, stirs and makes its whole dissolvings, a small amount of pH adjusting agent is regulated pH value to 5.5-6.5, is prepared into A liquid;
2), get micro-injection water dissolution dexamethasone sodium phosphate, be prepared into B liquid;
3), above-mentioned B liquid added in A liquid stir, continue to stir 20 minutes, reuse after medicinal liquid is clear and bright that pH regulator reagent is adjusted pH value between 5.5-6.5 and with the water for injection standardize solution to 100ml;
4), with above-mentioned medicinal liquid after organic membrane filtration filtrate with filling and sealing machine respectively fill in bottle, open sterilizing cabinet through 115 ℃, pressure 0.2MPa sterilization after 20 minutes, natural cooling was closed sterilizing cabinet after 10 minutes, the finished product of again sterilizing 20 minutes to get.
Further, described step 1), the water for injection temperature is 18-25 ℃.
During fill, can fill in cillin bottle, ampoule bottle, vial or other similarly in bottle, loading amount such as 2ml, 5ml, 10ml etc.Regulator uses acid or alkali commonly used, and is not only easy to use, also avoids occuring simultaneously compatibility reaction.First can avoid Acidity of Aikalinity to depart from product requirement with the pH adjusting agent adjusting during preparation A liquid too large, cause substance reaction or variation.Core of the present invention is to utilize the antioxidant Cys; Two of feature is: the segmented high-temperature autoclaving also extends sterilization time.
In the present invention, Cys is compared with traditional antioxidants sodium sulfite, sodium metabisulfite mainly as the high-efficiency antioxidant agent, and Cys has more antioxygenic activity, easily controls the advantages such as dosage, good stability.Cys is one of sulfur-containing amino acid, is white crystals or crystalline powder, and monoclinic system belongs to non essential amino acid.In vivo, replaced mutually by sulphur atom and the serine hydroxyl oxygen atom of methionine, synthesize via cystathionie, can generate glutathion from Cys.Cys is stable to acid, and easy oxidation generates cystine in neutrality and alkaline solution, so can protect the not oxidated decomposition of dipyrone.Cys has side effect such as the gastrointestinal reaction that the obvolvent Detoxication can also alleviate dipyrone in vivo, also have in addition the effect of reducing phlegm of eliminating the phlegm, auxiliary treatment pig transmissible bronchitis, pleuropneumonia, the disease of breathing, bird flu, chicken chronic respiratory tract disease are had specially good effect.
And utilize the segmented high-temperature autoclaving and extend sterilization time, both having reduced high temperature to the temperatures involved of injection, guaranteeing again sterilization effect simultaneously, making the stability of medicine greatly improve, being difficult for variable color rotten.
Another technical advantage of the present invention is: the dexamethasone sodium phosphate in the present invention is Aeroseb-Dex.Its antiinflammatory, antiallergic immunosuppressive action and dipyrone compatibility.The mechanism of action is: (1) antiinflammatory action: this product alleviates and prevents from organizing reaction to inflammation, thus the performance that reduces inflammation.can the inflammation-inhibiting cell, comprise macrophage and leukocyte gathering at inflammation part, and inhibition phagocytosis, the release of lysosomal enzyme and inflammation chemistry mediator synthetic and discharge (2) immunosuppressive action: comprise preventing or suppressing cell-mediated immunoreation, the anaphylaxis of retardance, reduce the T lymphocyte, mononuclear cell, bite the number of acid cell, reduce the binding ability of immunoglobulin and cell surface receptor, and suppress the synthetic of interleukin and discharge, thereby reduce the T lymphocyte to lymphoblastic transformation, and alleviate and formerly send out expansion immunoreactive.Simultaneously, also reduce immunity and check thing by basement membrane, and can reduce the concentration of complement component and immunoglobulin.Make medicinal scope of the present invention and purposes further enlarge, further facilitated clinical use.
Totally come the advantage of injection of the present invention to be in particular in:
1. new technology has effectively been controlled the problems such as analgin injection variable color in storage, content degraded, toxicity increase.Improve simultaneously outward appearance and the interior quality of product, improved the use curative effect of product.
2.L-cysteine has the obvolvent Detoxication simultaneously, can keep the activity of the coloured glaze base enzymes such as gallbladder phosphorus vinegar enzyme, improves inflammation and allergy, can alleviate the untoward reaction after dipyrone is injected.Usually can cause granulocytopenia in the dipyrone use procedure in prior art, so birds inflammation infection heating need keep away often and use dipyrone, the compatibility of Cys has significantly prevented this type of untoward reaction situation.
3. the solution thermal effect that in injection, the reasonable compatibility dexamethasone sodium phosphate has strengthened, given simultaneously the antiinflammatory antianaphylaxis function again.
4. this injection with the several drugs use that is mixed, has been saved production cost, has improved added value of product.The toxic and side effects that has occurred due to the medicine mismate when having reduced simultaneously treatment.
The specific embodiment
The principal agent dipyrone anhydride meter content that uses in embodiment is 99.9%, is purchased from SouthWest Synthetic Pharmaceutical Corp. Ltd;
The anhydrous solvent-free meter content of dexamethasone sodium phosphate is 98.3%, is purchased from Tianjin Tianyao Pharmaceutical Co., Ltd.;
Cys dry product meter content 99.6% is purchased from Jizhou City China thing Science and Technology Ltd. of Hang Seng.
Embodiment 1
10% animal compound analgin injection
1, formula
Dipyrone: 10g, Cys: 2g, dexamethasone sodium phosphate: 50mg, EDTA-Na2:0.05g, water for injection; 10ml concentration is that sodium hydroxide solution and each portion of hydrochloric acid of 0.5mol/L is standby.
2: preparation method
The water for injection of getting 80% recipe quantity lets cool to 20 ℃, and the inflated with nitrogen protection adds respectively EDTA-Na2, Cys, dipyrone after 10 minutes successively, stirs and makes its whole dissolvings, and a small amount of pH adjusting agent is adjusted between 5.5-6.5, is prepared into A liquid, and is standby;
Get micro-injection water dissolution dexamethasone sodium phosphate, be prepared into B liquid;
Above-mentioned B liquid is added in A liquid stir, continue to stir 20 minutes, reuse after medicinal liquid is clear and bright that pH adjusting agent is adjusted pH value between 5.5-6.5 and standardize solution.
Obtain filtrate after organic membrane filtration;
With above-mentioned filtrate with filling and sealing machine respectively fill in bottle, open sterilizing cabinet through 115 ℃, pressure 0.2MPa sterilization after 20 minutes, close sterilizing cabinet after slightly cold 10 minutes, again sterilized 20 minutes, can obtain the analgin compound injection of colourless clear liquid.
Embodiment 2
20% animal compound analgin injection
1, formula
Dipyrone: 20g, Cys: 3g, dexamethasone sodium phosphate: 100mg, EDTA-Na2:0.05g, water for injection, 10ml concentration is that sodium hydroxide solution and each portion of hydrochloric acid of 0.5mol/L is standby.
2: preparation method: identical with the described method of embodiment 1.
Embodiment 3
30% animal compound analgin injection
1, formula
Dipyrone: 30g, Cys: 4g, dexamethasone sodium phosphate: 150mg, EDTA-Na2:0.05g, water for injection, 10ml concentration is that sodium hydroxide solution and each portion of hydrochloric acid of 0.5mol/L is standby.
2: preparation method: identical with the described method of embodiment 1.
Embodiment 4
The folk prescription analgin injection contrast that pharmacopeia is recorded
1, formula
Dipyrone: 30g, sodium sulfite: 0.2g, EDTA-Na2:0.05g, water for injection, 10ml concentration is that sodium hydroxide solution and each portion of hydrochloric acid of 0.5mol/L is standby.
2: preparation method:
The water for injection of getting 80% recipe quantity lets cool to 20 ℃ of room temperatures, and the inflated with nitrogen protection adds respectively EDTA-Na2, sodium sulfite, dipyrone after 10 minutes successively, stirs and makes its whole dissolvings, and a small amount of pH adjusting agent is adjusted between 5.5-6.5, and is standby;
Continue after the standardize solution medicine liquid volume to stir 20 minutes, reuse after medicinal liquid is clear and bright and regulate reagent adjustment pH value between 5.5-6.5.Obtain filtrate after organic membrane filtration;
With above-mentioned filtrate with filling and sealing machine respectively fill in bottle, after 30 minutes, can obtain the analgin injection of colourless clear liquid through 115 ℃, pressure 0.2MPa sterilization.
Three, the stability test of animal compound analgin injection
1, materials and methods: the contrast folk prescription analgin injection of getting embodiment 1-3 animal compound analgin injection and embodiment 4, carry out hot and humid high light according to appendix medicine stability experimental technique of " Chinese veterinary pharmacopoeia " version in 2010 and accelerate experiment, press commercially available back, placed 6 months in the medicine stability experimental box (Chongqing immortality experimental apparatus factory) of 40 ± 2 ℃ of temperature, relative humidity 75 ± 5%, illumination 4500 ± 500LX, take a sample respectively once at experimental session the 1st, 2,3,6 the end of month, color, pH value, the content of injection are investigated.
2, the results are shown in Table 1, as shown in Table 1: animal compound analgin injection of the present invention is in accelerated test after 6 months, color, pH value, each component content have no significant change, have good stability, and the analgin injection of traditional handicraft method after the accelerated test of 3 months, color, pH value and Determination of Analgin diversity all occurs and change.
The acceleration experimental result of table 1, animal compound analgin injection
Four, animal compound analgin injection solution heat test
1, method and material
1.1 medicine
The analgin compound injection, the sample of employing embodiment of the present invention 1-3.
Analgin injection adopts embodiment 4 samples.
0.9% normal saline, laboratory is provided for oneself.
The typhoid fever attenuated vaccine is purchased from Chinese biological technology group company.
1.2 laboratory animal: get body weight 1.5-2.0kg, body temperature 50 of the healthy rabbits of 39.0 ± 5 ℃, is divided into 5 groups at random for three days on end, 10 every group, male and female half and half.
1.3 implementation process: front 3 groups of rabbit are injected respectively the analgin compound injection of embodiment 1-example 3, and injected dose is pressed 0.3g/ and only distinguished injection 3ml, 1.5ml and 1ml.Matched group injection embodiment 4 analgin injections, every injection 1ml.Blank group injection 0.9% normal saline, every injection 1ml.Each organizes rabbit injection according to dosage 1ml/kg ear vein injection typhoid fever attenuated vaccine after 30 minutes, then before and after vaccinate 30,60,90,120,150,180,210,240min measures the anus temperature in the time, record data the results are shown in Table 2.
2, result: as can be seen from Table 2: after the weak malicious Seedling 30min of injection typhoid fever, respectively organize that rabbit body temperature significantly rises, 60min reaches peak value constantly, the sick rabbit body temperature of the analgin compound injection of embodiment 1-example 3 basic controlling when 120min is normal, and the sick rabbit body temperature of analgin injection basic controlling when 180min is normal, analgin compound injection of the present invention is also less in each time period temperature fluctuation difference, and analgesic successful is better than existing analgin injection.
Table 2, the analgesic result of the test of fever in rabbit (℃, ± S)
Five, Synergistic treatment chicken chronic respiratory tract infection test
1, method and material
Choose Xiao Jia town, Hechuan chicken house, veterinary clinic is judged to be the chicken chronic respiratory tract infection, and (spirit is depressed, and feed consumption reduces, and becomes thin; Slight until serious respiratory symptom comprises cough, sheds tears in a large number; Head and face edema, heating, neurological disorders) sick chicken, be divided at random three groups of A, B, C, all adopt the treatment of throwing something and feeding of same dose enrofloxacin soluble powder.A assembly is simultaneously only closed embodiment 3 analgin compound injection injection 1ml/, and the B assembly is only closed embodiment 4 analgin injection injection 1ml/, and assembly is only closed 0.9% normal saline injection 1ml/.
2, decision procedure as a result
Observe the treatment case in one week, pay a return visit and record the state of an illness.
Cure: 3 future trouble poultry diseases of medication disappear fully, and spirit, body temperature, appetite recover normal, and urine feces is normal.
Effectively: 3 future trouble poultry diseases of medication disappear substantially, and spirit, body temperature, appetite make moderate progress, and urine feces is normal.
Invalid: 4 future troubles of medication poultry diseases do not disappear, and sb.'s illness took a turn for the worse or dead, and urine stool colour, character are undesired.
3, result: as can be seen from Table 3, medicaments compound analgin injection of the present invention has significant curative effect to collaborative antibiotic therapy poultry bacterial infection.Interior effective percentage reached 98.1%, cured 96.72% one week of experimental group A; And not using the antipyretic and anti-inflammatory medicine, the experimental group C effective percentage that uses separately antibiotic therapy is only 89.84%, cures 81.27%; Using the folk prescription analgin injection to coordinate the experimental group B effective percentage of antibiotic therapy is 96.15%, cures 92.94%, and during antibiotic sterilization treatment that this has tested also simultaneous verification, 5 use the ntipyretic analgesic medicine significance.
Table 3, chicken chronic respiratory tract infection Synergistic treatment result
Claims (5)
1. the preparation method of an animal compound analgin injection, it is characterized in that: every 100ml comprises by weight:
PH adjusting agent is appropriate
Surplus is water for injection;
Step:
1), get the room temperature water for injection of 80% recipe quantity, the inflated with nitrogen protection adds respectively EDTA-Na2, Cys, dipyrone after 10 minutes successively, stirs and makes its whole dissolvings, regulates pH value to 5.5-6.5 with pH adjusting agent, is prepared into A liquid;
2), get micro-injection water dissolution dexamethasone sodium phosphate, be prepared into B liquid;
3), above-mentioned B liquid added in A liquid stir, continue to stir 20 minutes, reuse after medicinal liquid is clear and bright that pH regulator reagent is adjusted pH value between 5.5-6.5 and with the water for injection standardize solution to 100ml;
4), with above-mentioned medicinal liquid after organic membrane filtration filtrate with filling and sealing machine respectively fill in bottle, open sterilizing cabinet through 115 ℃, pressure 0.2MPa sterilization after 20 minutes, natural cooling was closed sterilizing cabinet after 10 minutes, the finished product of again sterilizing 20 minutes to get.
2. the preparation method of a kind of animal compound analgin injection according to claim 1, it is characterized in that: described pH adjusting agent is sodium hydroxide solution or hydrochloric acid.
3. the preparation method of a kind of animal compound analgin injection according to claim 1 is characterized in that: described step 1), the water for injection temperature is 18-25 ℃.
4. the preparation method of a kind of animal compound analgin injection according to claim 1 is characterized in that: in described every 100ml injection:
5. the preparation method of a kind of animal compound analgin injection according to claim 1 is characterized in that: in described every 100ml injection:
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| Application Number | Priority Date | Filing Date | Title |
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| CN201210120011.4A CN103083229B (en) | 2012-04-23 | 2012-04-23 | Preparation method of compound analgin injection for livestock |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201210120011.4A CN103083229B (en) | 2012-04-23 | 2012-04-23 | Preparation method of compound analgin injection for livestock |
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| CN103083229A true CN103083229A (en) | 2013-05-08 |
| CN103083229B CN103083229B (en) | 2014-12-10 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107028877A (en) * | 2017-04-24 | 2017-08-11 | 浙江大飞龙动物保健品股份有限公司 | A kind of long-acting veterinary analgin injection and preparation method thereof |
| CN109010266A (en) * | 2018-09-10 | 2018-12-18 | 贵州天地药业有限责任公司 | A kind of preparation method of analgin injection |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1245058A (en) * | 1998-08-18 | 2000-02-23 | 曾泳铭 | Antivirus veterinary composition |
| CN1520292A (en) * | 2001-05-25 | 2004-08-11 | 爱诗爱诗制药株式会社 | pharmaceutical composition |
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2012
- 2012-04-23 CN CN201210120011.4A patent/CN103083229B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1245058A (en) * | 1998-08-18 | 2000-02-23 | 曾泳铭 | Antivirus veterinary composition |
| CN1520292A (en) * | 2001-05-25 | 2004-08-11 | 爱诗爱诗制药株式会社 | pharmaceutical composition |
Non-Patent Citations (1)
| Title |
|---|
| 张中举等: "如何克服安乃近注射液的变色现象", 《河南畜牧兽医》, vol. 19, no. 3, 31 December 1998 (1998-12-31), pages 35 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107028877A (en) * | 2017-04-24 | 2017-08-11 | 浙江大飞龙动物保健品股份有限公司 | A kind of long-acting veterinary analgin injection and preparation method thereof |
| CN107028877B (en) * | 2017-04-24 | 2020-10-27 | 浙江大飞龙动物保健品股份有限公司 | Veterinary long-acting analgin injection and preparation method thereof |
| CN109010266A (en) * | 2018-09-10 | 2018-12-18 | 贵州天地药业有限责任公司 | A kind of preparation method of analgin injection |
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Address after: 401519 Hechuan Industrial Park, Chongqing, Chongqing, Chongqing Patentee after: Jinhe animal husbandry (Chongqing) biological science and Technology Co.,Ltd. Address before: 401519 Hechuan Industrial Park, Chongqing, Chongqing, Chongqing Patentee before: JINBANG ANIMAL PHARMACEUTICAL |
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