CN104606195A - Compound fibrauretin injection and preparation method thereof - Google Patents

Compound fibrauretin injection and preparation method thereof Download PDF

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Publication number
CN104606195A
CN104606195A CN201510036623.9A CN201510036623A CN104606195A CN 104606195 A CN104606195 A CN 104606195A CN 201510036623 A CN201510036623 A CN 201510036623A CN 104606195 A CN104606195 A CN 104606195A
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injection
compound
fibrauretin
water
adds
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CN201510036623.9A
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CN104606195B (en
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倪荣焱
于慧慧
朱斌
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JIANGXI XINGERCHENG ANIMALS PHARMACEUTICAL CO LTD
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JIANGXI XINGERCHENG ANIMALS PHARMACEUTICAL CO LTD
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Abstract

The invention discloses compound fibrauretin injection which is characterized in that every 1,000 ml of the compound fibrauretin injection contains 10-50 g of fibrauretin, 50-100 g of norfloxacin nicotinate, 100-300 g of a compound organic solvent, 1-5 g of a surfactant, 1-10 g of an antioxidant and the balance of injection water. The compound fibrauretin injection has the advantages that firstly, the compound fibrauretin injection is stable in quality, and especially within a two-year storage period, other detection items such as characters and content of the compound fibrauretin injection are still within a specified range; (2) the compound fibrauretin injection can be subjected to large-scale industrialized production and is relatively low in cost, so that various losses in a production process are reduced and the finished product rate of the compound fibrauretin injection is greatly increased; (3) the compound fibrauretin injection introduces the norfloxacin nicotinate and changes an original formula of existing fibrauretin injection, and combination of traditional Chinese and western medicines effectively improves the antibacterial capability of medicines and achieves an effect of treating both symptoms and root causes, so that the drug effect of the compound fibrauretin injection reaches or exceeds that of similar fibrauretin injection.

Description

A kind of compound herba fibraureae recisea injection and preparation method thereof
Technical field
The present invention relates to a kind of veterinary drug preparation method, specifically a kind of compound herba fibraureae recisea injection and preparation method thereof.
Background technology
Piglet diarrhea is caused to be the typical multi-pathogenesis disease of one under intensive pig production working condition by reasons such as escherichia coli, Salmonella, pasteurella multocida, enterotoxigenic escherichia coli (ETEC), Minireovirus, visible peristalsis visible intestinal peristalsis adenovirus, swine dysentery spirillum, Porcine epidemic diarrhea virus (PEDV) and transmissible gastro-enteritis viruss (TGEV).Repeatedly occur before and after from the Beginning of Winter to the beginning of spring, sickness rate is high, and the course of disease is 5 days ~ 10 days.Sick Corii Sus domestica temperature is not whole, and the cold nose of ear is cool, snivel, abdominal swelling, and fear of cold fears cold curling oneself up, and poor appetite or absolutely useless, without thermal image or grade fever, rushes down more than ten day, and it is rare clearly to rush down excrement, presents progressive emaciation, rapid dehydration after having loose bowels 1 day and losing flesh.Sick pig is controlled or secondary infection and dead because losing, and piglet mortality rate is more than 15%.If treated not in time, be easy to cause piglet dead, bring huge economic loss to pig farm and raiser.
The medicine for the treatment of swine dysentery in the market has monomer, also has compound recipe.Its antibacterial range is narrower, and therapeutic domain is little, and the half-life is short, because antibacterial produces drug resistance, reduces the therapeutic effect that is used alone or does not have effect, thus causing secondary infection.Cause the generation of other diseases.
The present invention expands the antibacterial range of medicine, adopts Integrated TCM, can effectively reduce drug residue, can strengthen its curative effect again.
Summary of the invention
The object of this invention is to provide a kind of compound herba fibraureae recisea injection, it adopts Chinese and western drugs to cooperatively interact, and plays a kind of effect for the treatment of both the principal and secondary aspects of a disease.Strengthen the antibacterial range of medicine.Its quality and performance is made to be better than the Luteal function failure produced now.Prevention and corntrol diarrhea of pigs, improves swinery survival rate, promotes cultivation efficiency.
Another object of the present invention is to provide the preparation method of compound herba fibraureae recisea injection.
It is as follows that the present invention solves the problems of the technologies described above taked technical scheme.
Compound herba fibraureae recisea injection, is made up of following supplementary material medicine: every 1000ml compound herba fibraureae recisea injection is water for injection containing fibrauretin 10 ~ 50g, norfloxacin nicotinate 50 ~ 100g, compounded organic solvent 100-300g, surfactant 1-5g, antioxidant 1g-10g, surplus.
Above-mentioned compounded organic solvent is ethanol, propylene glycol, dimethyl formamide two kinds or two or more mixture.
Above-mentioned surfactant is span, tween, poloxamer.
Above-mentioned antioxidant is sodium sulfite, thiourea, sodium pyrosulfite, EDTA-2Na or its mixture.
Above-mentioned compound herba fibraureae recisea injection preparation carries out according to the following steps:
1. the water for injection getting total amount 30% is heated to 60-80 DEG C and adds fibrauretin, stirs to make to dissolve completely to add compounded organic solvent and stir, and becomes A liquid;
2. the water for injection getting total amount 30% is heated to 60-90 DEG C, adds norfloxacin nicotinate, stirs and makes to be dissolved into B liquid completely;
3. the water for injection getting total amount 30% adds antioxidant to be made to be dissolved into C liquid completely;
4. C liquid joins A liquid, and rapid stirring is even, is more slowly added by B, and limit edged stirs, and adds surfactant;
5. inject and be settled to 1000ml with water, embedding, 100 DEG C, 30 minutes flowing steam sterilizations.
Above-mentioned compound herba fibraureae recisea injection, its applicable object is: various domestic animal, poultry other economic animal or house pets etc., its route of administration can be: intramuscular injection, subcutaneous injection.Its character is: yellow to yellowish-brown clear liquid.
Advantage of the present invention is: (1) constant product quality, especially within 2 year storage period, product characteristics, content, etc. other detections still in prescribed limit.(2) product can industrialized mass, and cost is lower: because batch is comparatively large, which decreases the various losses in production process, substantially increase finished product rate.Mass simultaneous also reduces greatly the other expenditure of production process to greatest extent; (3) product has introduced norfloxacin nicotinate, change the original folk prescription of existing Luteal function failure, the antibacterial ability of the more effective enhancing medicine of Integrated TCM, plays treating both the principal and secondary aspects of a disease effect, so product drug effect all meets or exceeds same similar products Luteal function failure.
Detailed description of the invention
Embodiment one: the water for injection 1. getting total amount 30% is heated to 60-80 DEG C and adds fibrauretin 10g, stir make to dissolve completely add ethanol 100g, propylene glycol 50g stirs, and becomes A liquid;
2. the water for injection getting total amount 30% is heated to 60-90 DEG C, adds norfloxacin nicotinate 50g, stirs and makes to be dissolved into B liquid completely;
3. the water for injection getting total amount 30% adds sodium sulfite 1g, EDTA-2Na 0.3g to be made to be dissolved into C liquid completely;
4. C liquid joins A liquid, and rapid stirring is even, is more slowly added by B, and limit edged stirs, and adds sorbester p17 2g and stirs;
5. inject and be settled to 1000ml with water, embedding, 100 DEG C, 30 minutes flowing steam sterilizations.Obtain.
Embodiment two: the water for injection 1. getting total amount 30% is heated to 60-80 DEG C and adds fibrauretin 20g, stir make to dissolve completely add ethanol 150g, dimethyl formamide 10g stirs, and becomes A liquid;
2. the water for injection getting total amount 30% is heated to 60-90 DEG C, adds norfloxacin nicotinate 55g, stirs and makes to be dissolved into B liquid completely;
3. the water for injection getting total amount 30% adds sodium pyrosulfite 2g to be made to be dissolved into C liquid completely;
4. C liquid joins A liquid, and rapid stirring is even, is more slowly added by B, and limit edged stirs, and adds tween 80 10g and stirs;
5. inject and be settled to 1000ml with water, embedding, 100 DEG C, 30 minutes flowing steam sterilizations.Obtain.
Embodiment three: the water for injection 1. getting total amount 30% is heated to 60-80 DEG C and adds fibrauretin 50g, stir make to dissolve completely add dimethyl formamide 150g, propylene glycol 150g stirs, and becomes A liquid;
2. the water for injection getting total amount 30% is heated to 60-90 DEG C, adds norfloxacin nicotinate 100g, stirs and makes to be dissolved into B liquid completely;
3. the water for injection getting total amount 30% adds thiourea 5g to be made to be dissolved into C liquid completely;
4. C liquid joins A liquid, and rapid stirring is even, is more slowly added by B, and limit edged stirs, and adds poloxamer 5g and stirs;
5. inject and be settled to 1000ml with water, embedding, 100 DEG C, 30 minutes flowing steam sterilizations.Obtain.
Clinical test results
1, acute toxicity test: get healthy mice 120, accurate weighed body weight, average weight is
16.1 g are evenly divided into 6 groups by body weight size, press per kilogram of body weight 0.05ml, 0.1ml, 0.2ml, 0.4ml, 0.6ml and 1ml intramuscular injection this product respectively (containing fibrauretin 1%, norfloxacin nicotinate 5%, below test same concentrations), observe 3 days after injection, none example of result occurs dead, also finds no any untoward reaction.Result shows, it is safe that this product uses under the normal using dosage of per kilogram of body weight 0.2ml.
2, drug metabolism test: get healthy test rabbit 20, accurately weighed, average weight 2.6 is public
Jin, all by per kilogram of body weight intramuscular injection this product 0.2ml, test Cor Leporis blood is adopted respectively at 0.5h, 2h, 4h, 8h, 16h, 24h, 48h, fibrauretin, norfloxacin nicotinate in determination test rabbit blood respectively, result still can detect fibrauretin, norfloxacin nicotinate containing 1 ч g in every ml blood respectively when 24h, still can detect norfloxacin nicotinate at 84 hours in blood.Result shows, the drug effect of this product is more than 48h.
3, In Vitro Bacteriostasis contrast test: get Luteal function failure, respectively using escherichia coli as test organisms, Salmonella, diluted by two kinds of medicines with doubling dilution, the minimal inhibitory concentration of result this product is 1/4 of Luteal function failure.This result shows, shows that the curative effect of this product is better than niacin norfloxacin injection from laboratory test.
4, the clinical test of pesticide effectiveness: get natural occurrence Hakuri piglet 90, three groups are divided at random by body weight size, often organize 30, average weight 29.3 kilograms, respectively by per kilogram of body weight 0.2ml intramuscular injection this product and Luteal function failure (containing fibrauretin 1%), result one time cure rate this product and note B component are not 93% and 77%, and secondary cure rate is respectively 97% and 83%.Result shows, this product is better than folk prescription Luteal function failure in clinical drug effect.
5, the stability test of product: under this product is stored in the ambient temperature of 40 DEG C, by observation and the detection of 6 months, result, product colour change is little, still in the scope of regulation, the relative amount of fibrauretin declines and is only 0.3%, and the relative amount of norfloxacin nicotinate declines and is only 1.8%.Result shows, the shelf-life of this product should be and is not less than 2 years regulation effect duration.

Claims (2)

1. a compound herba fibraureae recisea injection, is characterized in that every 1000ml compound herba fibraureae recisea injection is water for injection containing fibrauretin 10 ~ 50g, norfloxacin nicotinate 50 ~ 100g, compounded organic solvent 100-300g, surfactant 1-5g, antioxidant 1g-10g, surplus; Described compounded organic solvent is ethanol, propylene glycol, dimethyl formamide two kinds or two or more mixture; Described surfactant is span, tween, poloxamer; Described antioxidant is sodium sulfite, thiourea, sodium pyrosulfite, EDTA-2Na or its mixture.
2. the preparation method of an animal compound Luteal function failure according to claim 1, it is characterized in that preparation method is carried out according to the following steps: the water for injection 1. getting total amount 30% is heated to 60-80 DEG C and adds fibrauretin, stirring makes to dissolve completely and adds compounded organic solvent and stir, and becomes A liquid; 2. the water for injection getting total amount 30% is heated to 60-90 DEG C, adds norfloxacin nicotinate, stirs and makes to be dissolved into B liquid completely; 3. the water for injection getting total amount 30% adds antioxidant to be made to be dissolved into C liquid completely; 4. C liquid joins A liquid, and rapid stirring is even, is more slowly added by B, and limit edged stirs, and adds surfactant; 5. inject and be settled to 1000ml with water, embedding, 100 DEG C, 30 minutes flowing steam sterilizations.
CN201510036623.9A 2015-01-26 2015-01-26 A kind of compound herba fibraureae recisea injection and preparation method thereof Expired - Fee Related CN104606195B (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104814965A (en) * 2015-05-13 2015-08-05 哈尔滨千合动物药品制造有限公司 Compound levofloxacin hydrochloride injection and preparation method thereof
CN105125483A (en) * 2015-08-27 2015-12-09 浙江大飞龙动物保健品有限公司 Florfenicol injection solution for veterinary use and preparation method of injection solution

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1602886A (en) * 2003-09-29 2005-04-06 成都三明药物研究所 Pharmaceutical compositions and its application
CN1626079A (en) * 2004-08-13 2005-06-15 贵阳云岩西创药物科技开发有限公司 Fibrauretine injection preparation and preparing method
CN102600159A (en) * 2012-03-09 2012-07-25 深圳松乐生物科技有限公司 Composition comprising tetrandrine, tetrandrine-based ramification and fluoroquinolones and application of composition

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1602886A (en) * 2003-09-29 2005-04-06 成都三明药物研究所 Pharmaceutical compositions and its application
CN1626079A (en) * 2004-08-13 2005-06-15 贵阳云岩西创药物科技开发有限公司 Fibrauretine injection preparation and preparing method
CN102600159A (en) * 2012-03-09 2012-07-25 深圳松乐生物科技有限公司 Composition comprising tetrandrine, tetrandrine-based ramification and fluoroquinolones and application of composition

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104814965A (en) * 2015-05-13 2015-08-05 哈尔滨千合动物药品制造有限公司 Compound levofloxacin hydrochloride injection and preparation method thereof
CN104814965B (en) * 2015-05-13 2017-12-19 哈尔滨千合动物药品制造有限公司 Compound hydrochloric acid levofloxacin and preparation method thereof
CN105125483A (en) * 2015-08-27 2015-12-09 浙江大飞龙动物保健品有限公司 Florfenicol injection solution for veterinary use and preparation method of injection solution

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