CN104814965A - Compound levofloxacin hydrochloride injection and preparation method thereof - Google Patents
Compound levofloxacin hydrochloride injection and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a compound levofloxacin hydrochloride injection and a preparation method thereof, relates to an injection and a preparation method thereof and particularly provides a drug for treating piglet diarrhea. Bacteria have no resistance to the drug, and the drug has the advantages of wide antibacterial range, long half-life period, low drug residue and the like. The compound levofloxacin hydrochloride injection is prepared from palmatine, levofloxacin hydrochloride, a compound organic solvent, a surfactant, an antioxidant and injection water. The preparation method comprises the steps of 1, weighing raw materials; 2, dissolving palmatine; 3, dissolving levofloxacin hydrochloride; 4, adding the antioxidant; 5, mixing; and 6, adding the residual injection water, encapsulating and sterilizing. Through the mutual matching of traditional Chinese medicines and western medicines, the compound levofloxacin hydrochloride injection disclosed by the invention takes an effect of treating both symptoms and root causes; and the antibacterial range of the drug is widened, the piglet diarrhea can be prevented and controlled, the survival rate of a pig group can be increased, and the breeding efficiency can be increased.
Description
Technical field
The present invention relates to a kind of 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.
Antibacterial has certain toleration for antibacterials, and drug resistance is once produce, and the Chemotherapy of medicine just obviously declines; Therefore, the therapeutic effect of monomer antibacterials worse and worse, even causes secondary infection, causes the generation of other diseases.
Summary of the invention
The object of the invention is to provide a kind of medicine for the treatment of piglet diarrhea, and antibacterial does not develop immunity to drugs to this medicine, this medicine has the advantages such as antibacterial range is wide, long half time, drug residue are low.
The every 1000ml of compound hydrochloric acid levofloxacin of the present invention is made up of the water for injection of 10 ~ 50g fibrauretin, 20 ~ 50g levofloxacin hydrochloride, 100 ~ 300g compounded organic solvent, 1 ~ 5g surfactant, 1g ~ 10g antioxidant and surplus.
Above-mentioned compound hydrochloric acid levofloxacin is prepared according to the following steps:
One, raw material is taken in the ratio of every 1000ml compound hydrochloric acid levofloxacin 10 ~ 50g fibrauretin, 20 ~ 50g levofloxacin hydrochloride, 100 ~ 300g compounded organic solvent, 1 ~ 5g surfactant, 1g ~ 10g antioxidant and surplus water for injection;
Two, the water for injection getting injection total amount 30% is heated to 60 ~ 80 DEG C, then adds the fibrauretin that step one takes, and stirs to add the compounded organic solvent that step one takes again after fibrauretin is dissolved completely and continue to be stirred to evenly, makes A liquid;
Three, the water for injection getting injection total amount 30% is heated to 60 ~ 90 DEG C, then adds the levofloxacin hydrochloride that step one takes, and stirs and levofloxacin hydrochloride is dissolved completely, make B liquid;
Four, the water for injection getting injection total amount 30% adds the antioxidant that step one takes, and dissolves make C liquid completely;
Five, joined in A liquid by C liquid and stir, then slowly add B liquid, limit edged stirs, and adds the surfactant that step one takes afterwards again;
Six, add remaining water for injection, embedding, sterilizing, namely obtain compound hydrochloric acid levofloxacin.
Compound hydrochloric acid levofloxacin of the present invention is yellow to yellowish-brown clear liquid.
Compound hydrochloric acid levofloxacin of the present invention 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, can prevention and corntrol diarrhea of pigs, improve swinery survival rate, promote cultivation efficiency.
Compound hydrochloric acid levofloxacin of the present invention is applicable to the treatment of various domestic animal, poultry and other economic animals and house pet, and medicine approach can select intramuscular injection or subcutaneous injection.
Compound hydrochloric acid levofloxacin constant product quality of the present invention, storage period is 2 years, storage period inner liquid medicine do not become turbid, precipitate, the phenomenon such as variable color or gas leakage, the detections such as the character of product and content are all in prescribed limit.
Compound hydrochloric acid levofloxacin of the present invention can industrialized mass, and cost is lower: because batch is large, reduces 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.
Detailed description of the invention
Technical solution of the present invention is not limited to following cited detailed description of the invention, also comprises the combination in any between each detailed description of the invention.
Detailed description of the invention one: the every 1000ml of present embodiment compound hydrochloric acid levofloxacin is made up of the water for injection of 10 ~ 50g fibrauretin, 20 ~ 50g levofloxacin hydrochloride, 100 ~ 300g compounded organic solvent, 1 ~ 5g surfactant, 1g ~ 10g antioxidant and surplus.
Detailed description of the invention two: the difference of present embodiment and detailed description of the invention one is: compounded organic solvent is made up of two kinds and two or more material in ethanol, propylene glycol and dimethyl formamide.Other is identical with embodiment one.
In present embodiment, compounded organic solvent is made up of two or more material, can be arbitrary proportion relation between each component.
Detailed description of the invention three: the difference of present embodiment and detailed description of the invention one or two is: surfactant is span, tween or poloxamer.Other is identical with embodiment one or two.
Detailed description of the invention four: the difference of present embodiment and detailed description of the invention one, two or three is: antioxidant is selected from sodium sulfite, thiourea, sodium pyrosulfite and EDTA-2Na.Other with embodiment one, two or three identical.
When in present embodiment, antioxidant is made up of two or more material, can be arbitrary proportion relation between each component.
Detailed description of the invention five: present embodiment compound hydrochloric acid levofloxacin is prepared according to the following steps:
One, raw material is taken in the ratio of every 1000ml compound hydrochloric acid levofloxacin 10 ~ 50g fibrauretin, 20 ~ 50g levofloxacin hydrochloride, 100 ~ 300g compounded organic solvent, 1 ~ 5g surfactant, 1g ~ 10g antioxidant and surplus water for injection;
Two, the water for injection getting injection total amount 30% is heated to 60 ~ 80 DEG C, then adds the fibrauretin that step one takes, and stirs to add the compounded organic solvent that step one takes again after fibrauretin is dissolved completely and continue to be stirred to evenly, makes A liquid;
Three, the water for injection getting injection total amount 30% is heated to 60 ~ 90 DEG C, then adds the levofloxacin hydrochloride that step one takes, and stirs and levofloxacin hydrochloride is dissolved completely, make B liquid;
Four, the water for injection getting injection total amount 30% adds the antioxidant that step one takes, and dissolves make C liquid completely;
Five, joined in A liquid by C liquid and stir, then slowly add B liquid, limit edged stirs, and adds the surfactant that step one takes afterwards again;
Six, add remaining water for injection, embedding, sterilizing, namely obtain compound hydrochloric acid levofloxacin.
Detailed description of the invention six: the difference of present embodiment and detailed description of the invention five is: compounded organic solvent is made up of two kinds and two or more material in ethanol, propylene glycol and dimethyl formamide.Other step and parameter identical with embodiment five.
Detailed description of the invention seven: the difference of present embodiment and detailed description of the invention five or six is: surfactant is span, tween or poloxamer.Other step and parameter identical with embodiment five or six.
Detailed description of the invention eight: the difference of present embodiment and detailed description of the invention five, six or seven is: antioxidant is selected from sodium sulfite, thiourea, sodium pyrosulfite and EDTA-2Na.Other step and parameter and embodiment five, six or seven identical.
Detailed description of the invention nine: the difference of present embodiment and detailed description of the invention five, six, seven or eight is: step 6 adopts flowing steam to carry out sterilizing, live steam temperature is 100 DEG C, sterilization time is 30min.Other step and parameter and embodiment five, six, seven or eight identical.
Embodiment 1
Compound hydrochloric acid levofloxacin is prepared according to the following steps:
One, raw material is taken in the ratio of every 1000ml compound hydrochloric acid levofloxacin 15g fibrauretin, 20 levofloxacin hydrochlorides, 150g compounded organic solvent, 2g surfactant, 1.3g antioxidant and surplus water for injection;
Two, the water for injection getting injection total amount 30% is heated to 65 DEG C, then adds the fibrauretin that step one takes, and stirs to add the compounded organic solvent that step one takes again after fibrauretin is dissolved completely and continue to be stirred to evenly, makes A liquid;
Three, the water for injection getting injection total amount 30% is heated to 65 DEG C, then adds the levofloxacin hydrochloride that step one takes, and stirs and levofloxacin hydrochloride is dissolved completely, make B liquid;
Four, the water for injection getting injection total amount 30% adds the antioxidant that step one takes, and dissolves make C liquid completely;
Five, joined in A liquid by C liquid and stir, then slowly add B liquid, limit edged stirs, and adds the surfactant that step one takes afterwards again;
Six, add remaining water for injection, embedding, sterilizing, namely obtain compound hydrochloric acid levofloxacin;
Wherein, compounded organic solvent is made up of the ethanol of 100g and the propylene glycol of 50g in proportion;
Antioxidant is made up of the sodium sulfite of 1g and the EDTA-2Na of 0.3g in proportion;
Surfactant is the Arlacel-80 of 2g in proportion.
Embodiment 2
Compound hydrochloric acid levofloxacin is prepared according to the following steps:
One, raw material is taken in the ratio of every 1000ml compound hydrochloric acid levofloxacin 20g fibrauretin, 25 levofloxacin hydrochlorides, 160g compounded organic solvent, 1g surfactant, 2g antioxidant and surplus water for injection;
Two, the water for injection getting injection total amount 30% is heated to 70 DEG C, then adds the fibrauretin that step one takes, and stirs to add the compounded organic solvent that step one takes again after fibrauretin is dissolved completely and continue to be stirred to evenly, makes A liquid;
Three, the water for injection getting injection total amount 30% is heated to 75 DEG C, then adds the levofloxacin hydrochloride that step one takes, and stirs and levofloxacin hydrochloride is dissolved completely, make B liquid;
Four, the water for injection getting injection total amount 30% adds the antioxidant that step one takes, and dissolves make C liquid completely;
Five, joined in A liquid by C liquid and stir, then slowly add B liquid, limit edged stirs, and adds the surfactant that step one takes afterwards again;
Six, add remaining water for injection, embedding, sterilizing, namely obtain compound hydrochloric acid levofloxacin;
Wherein, compounded organic solvent is made up of the dimethyl formamide of 150g and the propylene glycol of 10g in proportion;
Antioxidant is sodium pyrosulfite;
Surfactant is tween 80.
Embodiment 3
Compound hydrochloric acid levofloxacin is prepared according to the following steps:
One, raw material is taken in the ratio of every 1000ml compound hydrochloric acid levofloxacin 40g fibrauretin, 35 levofloxacin hydrochlorides, 280g compounded organic solvent, 4g surfactant, 7g antioxidant and surplus water for injection;
Two, the water for injection getting injection total amount 30% is heated to 80 DEG C, then adds the fibrauretin that step one takes, and stirs to add the compounded organic solvent that step one takes again after fibrauretin is dissolved completely and continue to be stirred to evenly, makes A liquid;
Three, the water for injection getting injection total amount 30% is heated to 85 DEG C, then adds the levofloxacin hydrochloride that step one takes, and stirs and levofloxacin hydrochloride is dissolved completely, make B liquid;
Four, the water for injection getting injection total amount 30% adds the antioxidant that step one takes, and dissolves make C liquid completely;
Five, joined in A liquid by C liquid and stir, then slowly add B liquid, limit edged stirs, and adds the surfactant that step one takes afterwards again;
Six, add remaining water for injection, embedding, sterilizing, namely obtain compound hydrochloric acid levofloxacin;
Wherein, compounded organic solvent is made up of the dimethyl formamide of 150g and the ethanol of 130g in proportion;
Antioxidant is thiourea;
Surfactant is poloxamer.
Embodiment 4
The difference of the present embodiment and embodiment 1 is: the water for injection getting injection total amount 30% in step 2 is heated to 40 DEG C, then the fibrauretin that step one takes is added, stir and add the compounded organic solvent that step one takes again after fibrauretin is dissolved completely and continue to be stirred to evenly, make A liquid.Other step and parameter identical with embodiment 1.
Embodiment 5
The difference of the present embodiment and embodiment 2 is: the water for injection getting injection total amount 30% in step 2 is heated to 80 DEG C, then adds the fibrauretin that step one takes, and stirring makes fibrauretin dissolve completely and makes A liquid.Other step and parameter identical with embodiment 2.
Test 1 product stability test (accelerated test):
Under compound hydrochloric acid levofloxacin prepared by embodiment 1 ~ 5 is stored in the ambient temperature of 40 DEG C, by observation and the detection of 6 months, result was as shown in table 1.
Table 1
Result of the test shows that the shelf-life of the compound hydrochloric acid levofloxacin prepared according to the inventive method should be and is not less than 2 years regulation effect duration; And product quality, character are stablized in the shelf-life.
Test 2 acute toxicity tests:
Get healthy mice 360, accurate weighed body weight, average weight is that 16.1g is evenly divided into 18 groups by body weight size, respectively by the compound hydrochloric acid levofloxacin of per kilogram of body weight 0.05ml, the preparation of 0.1ml, 0.2ml, 0.4ml, 0.6ml and 1ml intramuscular injection embodiment 1 ~ 3.Observe 3 days after injection, none example of result occurs dead, also finds no any untoward reaction.
Result of the test shows, it is safe that compound hydrochloric acid levofloxacin prepared by the inventive method uses under the normal using dosage of per kilogram of body weight 0.2ml.
Test 3 drug metabolism tests:
Get healthy test rabbit 120, accurate weighed body weight, average weight 2.6 kilograms, the compound hydrochloric acid levofloxacin 0.2ml of embodiment 1 ~ 3 preparation is injected respectively by per kilogram of body weight muscle, 0.5h, 2h, 4h, 8h, 16h, 24h, 48h adopt test Cor Leporis blood after injection, fibrauretin, levofloxacin hydrochloride content in determination test rabbit blood respectively, result still to detect in every ml blood containing the fibrauretin and the levofloxacin hydrochloride that are not less than 1 μ g when 24h, still can detect levofloxacin hydrochloride at 48 hours in blood.
Result of the test shows, the drug effect of compound hydrochloric acid levofloxacin prepared by the inventive method is more than 48h, long half time.
Test 4 In Vitro Bacteriostasis contrast tests:
The compound hydrochloric acid levofloxacin that enchashment has Levofloxacin Hydrochloride Injection (commercially available prod) and embodiment 1 ~ 3 to prepare, respectively using 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 virus (TGEV) as test organisms.With doubling dilution, trial drug is diluted.
Existing Levofloxacin Hydrochloride Injection (commercially available prod) only has fungistatic effect to escherichia coli, Salmonella, pasteurella multocida, enterotoxigenic escherichia coli (ETEC), Minireovirus, visible peristalsis visible intestinal peristalsis adenovirus and swine dysentery spirillum.
Compound hydrochloric acid levofloxacin prepared by embodiment 1 ~ 3 all has obvious fungistatic effect to 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 virus (TGEV).And, compound hydrochloric acid levofloxacin prepared by embodiment 1 ~ 3 to the minimal inhibitory concentration of 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 virus (TGEV) for being only 1/4 of existing Levofloxacin Hydrochloride Injection (commercially available prod).
Result of the test shows, compound hydrochloric acid levofloxacin prepared by the inventive method has wider antibacterial range, and fungistatic effect is obviously better than existing Levofloxacin Hydrochloride Injection (commercially available prod).
Test the 5 clinical tests of pesticide effectiveness:
Get natural occurrence Hakuri piglet 300,10 groups are divided at random by body weight size, often organize 30, average weight 29.3 kilograms, respectively by the existing Luteal function failure of compound hydrochloric acid levofloxacin (commercially available prod) and the Levofloxacin Hydrochloride Injection (commercially available prod) of the preparation of per kilogram of body weight 0.2ml intramuscular injection embodiment 1 ~ 3.
One time cure rate embodiment 1 ~ 3 average out to 93%, one time cure rate Luteal function failure (commercially available prod) is 74%, and one time cure rate Levofloxacin Hydrochloride Injection (commercially available prod) is 77%.Secondary cure rate embodiment 1 ~ 3 average out to 97%, secondary cure rate Luteal function failure (commercially available prod) is 78%, and secondary cure rate Levofloxacin Hydrochloride Injection (commercially available prod) is 83%.
Result of the test shows, the clinical drug effect of compound hydrochloric acid levofloxacin prepared by the inventive method is better than folk prescription Luteal function failure and single Levofloxacin Hydrochloride Injection.
Test 6
Get natural occurrence Hakuri piglet 300, average weight 30.23 kilograms, is divided into 10 groups at random, often organizes 30.Respectively by per kilogram of body weight 0.2ml injection, be used in conjunction 3 days.Compound hydrochloric acid levofloxacin, existing Luteal function failure (commercially available prod) and Levofloxacin Hydrochloride Injection (commercially available prod) prepared by example 1 ~ 3.The cure rate of compound hydrochloric acid levofloxacin prepared by example 1 ~ 3 reaches 98%.Existing Luteal function failure (commercially available prod) cure rate 72%, Levofloxacin Hydrochloride Injection (commercially available prod) cure rate 78%.
Get the piglet of above healing, raise after one month, piglet infected experimentally, it is made to suffer from piglet Huang, Hakuri, the therapeutic outcome that uses the same method again shows, with compound hydrochloric acid levofloxacin cure rate 97% prepared by example 1 ~ 3, existing Luteal function failure (commercially available prod) cure rate 63%, Levofloxacin Hydrochloride Injection (commercially available prod) cure rate 60%.
Show that compound hydrochloric acid levofloxacin prepared by example 1 ~ 3 does not have drug resistance substantially by above result, and commercially available Luteal function failure, Levofloxacin Hydrochloride Injection there is certain drug resistance.Prove that compound hydrochloric acid levofloxacin of the present invention does not produce drug resistance.
Test 7
The piglet of getting test 6 healing is divided into three groups, compound hydrochloric acid levofloxacin prepared by 1 group of example 1 ~ 3; 2 groups of Luteal function failure (commercially available prod); 3 groups of Levofloxacin Hydrochloride Injections (commercially available prod); Dissect extraction liver respectively to detect drug residue according to national standard, testing result is as shown in table 2.
Table 2
Experiment proves that compound hydrochloric acid levofloxacin drug residue of the present invention is low.
Claims (9)
1. compound hydrochloric acid levofloxacin, is characterized in that the every 1000ml of compound hydrochloric acid levofloxacin is made up of the water for injection of 10 ~ 50g fibrauretin, 20 ~ 50g levofloxacin hydrochloride, 100 ~ 300g compounded organic solvent, 1 ~ 5g surfactant, 1g ~ 10g antioxidant and surplus.
2. compound hydrochloric acid levofloxacin according to claim 1, is characterized in that compounded organic solvent is made up of two kinds and two or more material in ethanol, propylene glycol and dimethyl formamide.
3. compound hydrochloric acid levofloxacin according to claim 1, is characterized in that surfactant is span, tween or poloxamer.
4. compound hydrochloric acid levofloxacin according to claim 1, is characterized in that antioxidant is selected from sodium sulfite, thiourea, sodium pyrosulfite and EDTA-2Na.
5. the preparation method of compound hydrochloric acid levofloxacin described in claim 1, is characterized in that compound hydrochloric acid levofloxacin is prepared according to the following steps:
One, raw material is taken in the ratio of every 1000ml compound hydrochloric acid levofloxacin 10 ~ 50g fibrauretin, 20 ~ 50g levofloxacin hydrochloride, 100 ~ 300g compounded organic solvent, 1 ~ 5g surfactant, 1g ~ 10g antioxidant and surplus water for injection;
Two, the water for injection getting injection total amount 30% is heated to 60 ~ 80 DEG C, then adds the fibrauretin that step one takes, and stirs to add the compounded organic solvent that step one takes again after fibrauretin is dissolved completely and continue to be stirred to evenly, makes A liquid;
Three, the water for injection getting injection total amount 30% is heated to 60 ~ 90 DEG C, then adds the levofloxacin hydrochloride that step one takes, and stirs and levofloxacin hydrochloride is dissolved completely, make B liquid;
Four, the water for injection getting injection total amount 30% adds the antioxidant that step one takes, and dissolves make C liquid completely;
Five, joined in A liquid by C liquid and stir, then slowly add B liquid, limit edged stirs, and adds the surfactant that step one takes afterwards again;
Six, add remaining water for injection, embedding, sterilizing, namely obtain compound hydrochloric acid levofloxacin.
6. the preparation method of compound hydrochloric acid levofloxacin according to claim 5, is characterized in that compounded organic solvent is made up of two kinds and two or more material in ethanol, propylene glycol and dimethyl formamide.
7. the preparation method of compound hydrochloric acid levofloxacin according to claim 5, is characterized in that surfactant is span, tween or poloxamer.
8. the preparation method of compound hydrochloric acid levofloxacin according to claim 5, is characterized in that antioxidant is selected from sodium sulfite, thiourea, sodium pyrosulfite and EDTA-2Na.
9. the preparation method of compound hydrochloric acid levofloxacin according to claim 5, it is characterized in that step 6 adopts flowing steam to carry out sterilizing, live steam temperature is 100 DEG C, sterilization time is 30min.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111467343A (en) * | 2020-06-08 | 2020-07-31 | 九江学院 | Antibacterial drug and preparation and application thereof |
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| CN101433518A (en) * | 2007-11-14 | 2009-05-20 | 天津生机集团有限公司 | Compound ofloxacin injection for animals |
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| CN111467343B (en) * | 2020-06-08 | 2022-03-25 | 九江学院 | Antibacterial drug and preparation and application thereof |
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