CN104586757A - Veterinary enrofloxacin injection and preparation method thereof - Google Patents

Abstract

The invention discloses veterinary enrofloxacin injection and a preparation method thereof, belonging to the technical field of preparation of veterinary drugs. The veterinary enrofloxacin injection is prepared from the following raw materials in percentage by weight: 2-20 percent of enrofloxacin, 2-30 percent of L-arginine alkali, 10-30 percent of a pH value regulator, 0.1-0.2 percent of an antioxidant, 0.01-0.02 percent of a chelating agent, 10-50 percent of an organic solvent, 1-13 percent of a cosolvent, 1-5 percent of a controlled release formulation and the balance of water for injection. The veterinary enrofloxacin injection is high in stability, low in cost and safe and convenient to use and has the advantages of long-acting effect, high efficiency and low drug tolerance. Moreover, the veterinary enrofloxacin injection is compatible with L-arginine alkali to achieve a special effect of treating mixed infection caused by sensitive bacteria and mycoplasma of beasts and birds.

Description

A kind of Enrofloxacin injection for livestock and preparation method thereof

Technical field

The present invention relates to a kind of Enrofloxacin injection for livestock, specifically a kind of Enrofloxacin injection for livestock and preparation method thereof, belong to veterinary drug preparing technical field.

Background technology

Enrofloxacin is the third generation carbostyril family antibacterial drugs of synthesis, and have another name called ENR, be animal specific antibacterials, enjoy veterinary circle to pay attention to, China succeeded in developing in 1993, was now widely used in veterinary clinic.Enrofloxacin can be assembled in macrophage, and be 2 to 3 times of blood concentration, it can discharge rapidly from inflammation part, plays anti-inflammation and sterilization effect.Enrofloxacin is mainly through renal excretion, and secondly by liver, main metabolites is original shape and ciprofloxacin.Enrofloxacin and metabolite ciprofloxacin thereof in animal body combined effect are the maximum features of this medicine, are also that this drug effect fruit is better than other similar drugs and a major reason of extensive use in animal.

L-arginine alkali is the necessary aminoacid of a kind of condition, for a kind of immunity nutrient that must supplement under pathological state, there is physiology and the pharmacological action of multiple uniqueness, in close relations with body's immunity, by lymphopoiesis, differentiation and the synthetic cell factor are required, the activity of macrophage, neutrophilic granulocyte, mononuclear cell and Tumor-infiltrating lymphocytes can also be maintained.In enrofloxacin injection, principal agent not only can be assisted to improve its bacteriostasis, play certain antiinflammation, and it can be made to maintain certain stability when low tempertaure storage.

Current clinical case mostly is mixed infection, due to enrofloxacin has a broad antifungal spectrum, both can be used alone, also can with the partner treatment poultry mixed infections such as other antibiotic, Chinese herbal medicine, nourishing additive agent, therefore livestock and poultry breeding industry is widely used in, be mainly used in treatment fowl bacterial disease and mycoplasma infection, especially have specially good effect to mycoplasma infection.And enrofloxacin injection cure rate commercially available in the prior art is at present low, the drug effect phase is short, less stable, and cost is higher.

Summary of the invention

For the technical problem that above-mentioned prior art exists, the invention provides a kind of Enrofloxacin injection for livestock, not only good stability, cost is lower, and it is safe and convenient to use, have long-acting, efficient, that drug resistance is low advantage, treating with L-arginine alkali compatibility the mixed infection that sensitive organism and the mycoplasmas etc. such as poultry cause has specially good effect.

To achieve these goals, this Enrofloxacin injection for livestock calculates formulated by following raw materials by weight:

Enrofloxacin 2 ~ 20%;

L-arginine alkali 2 ~ 30%;

PH value regulator 10 ~ 30%;

Antioxidant 0.1 ~ 0.2%;

Chelating agen 0.01 ~ 0.02%;

Organic solvent 10 ~ 50%;

Cosolvent 1 ~ 13%;

Slow releasing agent 1 ~ 5%;

Surplus is water for injection.

As preferably of the present invention, described pH value regulator is sodium hydroxide solution or potassium hydroxide solution; Described antioxidant is anhydrous sodium sulfite; Described chelating agen two is EDTA-2Na; Described organic solvent is propylene glycol; Described cosolvent is benzyl alcohol or n-butyl alcohol; Described slow releasing agent is polyvinylpyrrolidone.

Further, described pH value regulator is sodium hydroxide solution; Described cosolvent is benzyl alcohol.

To achieve these goals, present invention also offers a kind of preparation method of Enrofloxacin injection for livestock, comprise following concrete steps simultaneously:

(1), by described percentage by weight get slow releasing agent, organic solvent, cosolvent and appropriate water for injection to add and densely join in cylinder, logical vapour is heated to 60 DEG C;

(2), with appropriate water for injection dissolve antioxidant and the chelating agen of corresponding percentage by weight, add under stirring and densely join in cylinder;

(3), add enrofloxacin and the L-arginine alkali of corresponding percentage by weight, be stirred to dissolve;

(4), the mixed liquor of gained, by pH value regulator solution, after adjusting pH value to 9.5 ~ 10.5, is filtered to and rarely joins cylinder, add to the full amount of water for injection in above-mentioned steps;

(5), after gained mixed liquor detects qualified, fine straining by intermediate, fills nitrogen embedding in above-mentioned steps, 115 DEG C of vapor sterilization 30 minutes, be cooled to room temperature, pack, put in storage to be checked.

Compared with prior art,

1, in the enrofloxacin injection prepared by the present invention, enrofloxacin and L-arginine alkali compatibility are applied, and not only treating the mixed infection that sensitive organism and the mycoplasma etc. such as poultry cause has specially good effect, and injection is more stable, easier low tempertaure storage.

2, in the enrofloxacin injection prepared by the present invention, enrofloxacin concentration is high, reaches as high as 20%, and during single injection, dosage just can reach curative effect less, can reduce the stimulation that produces when injecting animal with grieved, safe ready more during Clinical practice.

3, the enrofloxacin injection prepared by the present invention, scientific formulation, each supplementary material is cheap and easy to get, with the addition of again slow-release material and slow release solvent, has long-acting, efficient, low cost and other advantages, be suitable for large-scale production and application.

Detailed description of the invention

Below in conjunction with specific embodiment, the present invention will be further described.

Embodiment 1:

(1), by aforementioned weight percentage ratio get polyvinylpyrrolidone 1%, benzyl alcohol 1.5%, propylene glycol 40% and appropriate water for injection to add and densely join in cylinder, logical vapour is heated to 60 DEG C;

(2), with appropriate water for injection dissolve anhydrous sodium sulfite 0.1%, EDTA-2Na 0.01%, under agitation add and densely join in cylinder;

(3), add the enrofloxacin 2.5% of aforementioned weight percentage ratio, L-arginine alkali 10%, is stirred to dissolve;

(4), use 10% sodium hydrate aqueous solution, adjust pH value to 9.5 ~ 10.5, be filtered to and rarely join cylinder, add to the full amount of water for injection;

(5), intermediate detects qualified, fine straining, fills nitrogen embedding, then 115 DEG C of vapor sterilization 30 minutes, be cooled to room temperature, pack, put in storage to be checked.

Embodiment 2:

(1), by aforementioned weight percentage ratio get polyvinylpyrrolidone 1.5%, benzyl alcohol 3%, propylene glycol 35% and appropriate water for injection to add and densely join in cylinder, logical vapour is heated to 60 DEG C;

(2), with appropriate water for injection dissolve anhydrous sodium sulfite 0.15%, EDTA-2Na 0.015%, under agitation add and densely join in cylinder;

(3), add the enrofloxacin 5% of aforementioned weight percentage ratio, L-arginine alkali 15%, is stirred to dissolve;

(4), use 15% sodium hydrate aqueous solution, adjust pH value to 9.5 ~ 10.5, be filtered to and rarely join cylinder, add to the full amount of water for injection;

(5), intermediate detects qualified, fine straining, fills nitrogen embedding, then 115 DEG C of vapor sterilization 30 minutes, be cooled to room temperature, pack, put in storage to be checked.

Embodiment 3:

(1), by aforementioned weight percentage ratio get polyvinylpyrrolidone 1.8%, benzyl alcohol 5%, propylene glycol 30% and appropriate water for injection to add and densely join in cylinder, logical vapour is heated to 60 DEG C;

(2), with appropriate water for injection dissolve anhydrous sodium sulfite 0.18%, EDTA-2Na 0.018%, under agitation add and densely join in cylinder;

(3), add the enrofloxacin 10% of aforementioned weight percentage ratio, L-arginine alkali 20%, is stirred to dissolve;

(4), use 20% sodium hydrate aqueous solution, adjust pH value to 9.5 ~ 10.5, be filtered to and rarely join cylinder, add to the full amount of water for injection;

(5), intermediate detects qualified, fine straining, fills nitrogen embedding, then 115 DEG C of vapor sterilization 30 minutes, be cooled to room temperature, pack, put in storage to be checked.

Embodiment 4:

(1), by aforementioned weight percentage ratio get polyvinylpyrrolidone 2%, benzyl alcohol 10%, propylene glycol 25% and appropriate water for injection to add and densely join in cylinder, logical vapour is heated to 60 DEG C;

(2), with appropriate water for injection dissolve anhydrous sodium sulfite 0.2%, EDTA-2Na 0.02%, under agitation add and densely join in cylinder;

(3), add the enrofloxacin 20% of aforementioned weight percentage ratio, L-arginine alkali 25%, is stirred to dissolve;

(4), use 25% sodium hydrate aqueous solution, adjust pH value to 9.5 ~ 10.5, be filtered to and rarely join cylinder, add to the full amount of water for injection;

(5), intermediate detects qualified, fine straining, fills nitrogen embedding, then 115 DEG C of vapor sterilization 30 minutes, be cooled to room temperature, pack, put in storage to be checked.

Clinical effect trial:

Enrofloxacin injection of the present invention treats the clinical effect trial of the mixed infection of pig pulmonary infection and the mycoplasma pneumoniae of swine caused by haemophilus parasuis, mycoplasma, pasteurella multocida, pleura Actinobacillus etc.

Choose the pig 60 suffering from asthma, cough symptom, in sick pig body, isolate haemophilus parasuis, mycoplasma, pasteurella multocida, pleura Actinobacillus, test is divided into two groups at random.

Commercially available enrofloxacin injection test data contrast table in enrofloxacin injection of the present invention and prior art:

After this result of the test statistical analysis, from above-mentioned test data contrast table, Enrofloxacin injection for livestock of the present invention cure rate compared with commercially available enrofloxacin injection significantly improves; And compared with commercially available enrofloxacin injection, weightening finish obvious difference; After Enrofloxacin injection for livestock administration of the present invention simultaneously, after 1 hour, most of temperature of pig body has started to decline, in 5 hours, temperature of pig body is down in normal range, and adopting common group of temperature of pig body of commercially available enrofloxacin injection to decline slowly, difference is extremely remarkable compared with Enrofloxacin injection for livestock of the present invention.

Claims (4)

1. an Enrofloxacin injection for livestock, is characterized in that, described enrofloxacin injection calculates formulated by following raw materials by weight:

Enrofloxacin 2 ~ 20%;

L-arginine alkali 2 ~ 30%;

PH value regulator 10 ~ 30%;

Antioxidant 0.1 ~ 0.2%;

Chelating agen 0.01 ~ 0.02%;

Organic solvent 10 ~ 50%;

Cosolvent 1 ~ 13%;

Slow releasing agent 1 ~ 5%;

Surplus is water for injection.

2. a kind of Enrofloxacin injection for livestock according to claim 1, is characterized in that,

Described pH value regulator is sodium hydroxide solution or potassium hydroxide solution;

Described antioxidant is anhydrous sodium sulfite;

Described chelating agen is EDTA-2Na;

Described organic solvent is propylene glycol;

Described cosolvent is benzyl alcohol or n-butyl alcohol;

Described slow releasing agent is polyvinylpyrrolidone.

3. a kind of Enrofloxacin injection for livestock according to claim 2, is characterized in that,

Described pH value regulator is sodium hydroxide solution;

Described cosolvent is benzyl alcohol.

4. the preparation method of a kind of Enrofloxacin injection for livestock according to claims 1 to 3 any one, is characterized in that, comprises following concrete steps:

(1), by described percentage by weight get slow releasing agent, organic solvent, cosolvent and appropriate water for injection to add and densely join in cylinder, logical vapour is heated to 60 DEG C;

(2), with appropriate water for injection dissolve antioxidant and the chelating agen of corresponding percentage by weight, add under stirring and densely join in cylinder;

(3), add enrofloxacin and the L-arginine alkali of corresponding percentage by weight, be stirred to dissolve;

(4), the mixed liquor of gained, by pH value regulator solution, after adjusting pH value to 9.5 ~ 10.5, is filtered to and rarely joins cylinder, add to the full amount of water for injection in above-mentioned steps;

(5), after gained mixed liquor detects qualified, fine straining by intermediate, fills nitrogen embedding in above-mentioned steps, 115 DEG C of vapor sterilization 30 minutes, be cooled to room temperature, pack, put in storage to be checked.