CN100586441C - Compound sulfamonomethoxine sodium injection and preparation method thereof - Google Patents
Compound sulfamonomethoxine sodium injection and preparation method thereof Download PDFInfo
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- CN100586441C CN100586441C CN200810158292A CN200810158292A CN100586441C CN 100586441 C CN100586441 C CN 100586441C CN 200810158292 A CN200810158292 A CN 200810158292A CN 200810158292 A CN200810158292 A CN 200810158292A CN 100586441 C CN100586441 C CN 100586441C
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Abstract
The invention relates to a compound sulfamonomethoxine sodium injection for veterinary use and a preparation method thereof, and belongs to the technical field of medicines for veterinary use. The rawmaterial components of the compound sulfamonomethoxine sodium injection for veterinary use comprise sulfamonomethoxine sodium, dexamethasone sodium phosphate, trimethoprim, imidocarb, astragalus polysaccharide, organic solvent and water for injection. As a special compound preparation for veterinary use, the injection has remarkable efficacy on strengthening resistance of livestock and poultry, and treating mixed infection and severe diseases caused by a plurality of pathogenic bacteria and viruses. The injection has the advantages of convenient use, short treatment course, low drug resistance and the like.
Description
Technical field
The present invention relates to a kind of compound sulfamonomethoxine sodium injection, particularly a kind of compound preparation of making by sulfamonomethoxine sodium and trimethoprim, imidazophenylurea, astragalus polysaccharides etc. and preparation method thereof.
Background technology
1, current, the mixed infection of aquaculture poultry is occurred frequently, complication is serious, and market in urgent need specific aim new product can strengthen the poultry Abwehrkraft des Koepers, can treat mixed infection and critical illness that multiple pathogenic bacteria, virus cause again.
2, present, in the clinical use, sulfamonomethoxine sodium and synergistic factor trimethoprim compatibility use and can make antibacterial effect strengthen tens of times, add dexamethasone sodium phosphate, imidazophenylurea, astragalus polysaccharides and can reach antibiotic, antiinflammatory, anthelmintic, antiviral simultaneously, remove the purpose of surface symptoms fast, clinical therapeutic efficacy is apparently higher than single preparations of ephedrine.
Application for a patent for invention CN101053568 (200710034835.9) discloses a kind of prescription and processing technology of composite sulfamonomethoxine sodium injection, aim to provide a kind of energy multiple virus of control and antibacterial, mycoplasma, the prescription and the processing technology of the compound preparation composite sulfamonomethoxine sodium injection of the mixed infection of Tubifex, it is characterized in that its prescription is sulfamonomethoxine sodium 150g, trimethoprim 30g, ofloxacin 20g, dexamethasone sodium phosphate 1g, propylene glycol 600ml, the an amount of benzyl alcohol 40ml of ethanolamine, disodiumedetate 100mg, anhydrous sodium sulfite 2g, active carbon 3g, water for injection adds to 1000ml; Sulfamonomethoxine sodium, trimethoprim, ofloxacin, dexamethasone sodium phosphate are organically combined, can play effectively that medicine is collaborative, potentiation, long lasting effect, improve curative effect of medication, enlarged antimicrobial spectrum, improved drug side effect, can a pin onset at mixing the sense disease, the purpose that heals of 3-5 acupuncture; And save packaging material, reduced product cost.
By comparison, the present invention has increased the chemicals imidazophenylurea and the anti virus herb astragalus polysaccharides of protozoacide, rickettsia and the Eperythrozoon of animal specific, further strengthens its antibiotic, antiviral effect.
Sulfamonomethoxine sodium (Sulfamonomethoxime Sodium) belongs to the sulfonamides synthetic antibacterial drug, is the strongest sulphonamides of inside and outside antibacterial action, have has a broad antifungal spectrum, stable in properties, not perishable, easy to use, can mass production etc. advantage.Most of gram positive bacterias and negative bacterium are all had strong inhibitory action, and it is slower that antibacterial produces drug resistance to this medicine.Be mainly used in the caused various diseases of various sensitive organisms, as respiratory tract, digestive tract, urinary tract infection, to pig toxoplasmosis, bowel oedema disease, fowl, rabbit coccidiosis have curative effect preferably, and mastitis and endometritis etc. can be treated by regional perfusion.Its antibacterial mechanisms is by suppressing the synthetic growth and breeding that suppresses antibacterial of folic acid.This product intramuscular injection post-absorption is good, the blood level height, and the acetylation rate is low, and acetylate dissolubility in urine is big, is difficult for taking place crystalluria.Hold time Babalus bubalis L. 24 hours of effective blood drug concentration, pig 5.8 hours, goat 7 hours, sheep 2 hours.
Synergistic factor is selected trimethoprim (Trimethoprim) for use, have another name called TMP, be artificial synthetic antibacterial drug, can strengthen sulfonamides and multiple antibiotic effect, antimicrobial spectrum is similar and active to sulfonamides stronger, and multiple gram positive bacteria and negative bacterium are all had antibacterial action, its mechanism of action is to suppress dihydrofolate reductase, make dihydrofoilic acid can not be reduced into tetrahydrofolic acid, thereby hinder sensitive organism folic acid metabolism and utilization, thereby overslaugh thalline nucleic acid is synthetic.When this class medicine and sulfonamides share, can block folic acid metabolism simultaneously and the double blocking effect from two different links, make antibacterial action strengthen several times to nearly a hundred times, even make bacteriostasis become bactericidal action, and can reduce the generation of Resistant strain, the drug-fast escherichia coli of sulfanilamide, Bacillus proteus, streptococcus pyogenes etc. also there are effect.Can be used for respiratory tract, urinary tract infection and cellulitis that streptococcus, staphylococcus and gram negative bacteria cause, peritonitis, mastitis, traumatic infection etc. with the compound preparation of sulphonamides.TMP mainly discharges from urine, discharges 40%～60% of total amount in 24 hours, also can be from excrement, milk, bile excretion.
Imidazophenylurea (imidocarb) has another name called imidocarb, belongs to the derivant of equal diphenyl urea, is a kind of chemicals of protozoacide, rickettsia and Eperythrozoon of animal specific.By subcutaneous or intramuscular injection, in order to this insect infection of BABEI and the rickettsial infection of animals such as treatment cattle, sheep, pig, dog.Absorb rapidly after the injection and be distributed in body tissue, can reach the blood peak concentration of drug after 1 hour.This product mainly excretes with original shape by feces and urine.At present, has only U.S. Schering Plough company
The products such as Imdocarb 120Inj. of Holland Kepro company, the main component of its product is all imidazophenylurea.
Dexamethasone sodium phosphate (Dexamethasone Sodium Phosphate) belongs to the glucocorticoids medicine, has tangible pharmacological action, comprise antiinflammatory, antiallergic, antitoxin, shock, influence metabolism etc., be usually used in serious infectious disease, anaphylactic disease, shock, local inflammation, milch cow ketonemia and sheep pregnancy induced hypertension syndrome, induced labor and prevention operation sequela etc., the application of its effect is similar to hydrocortisone, but act on stronger, effective time is long, side effect is less, antiinflammatory action and glyconeogenesis are 25 times of hydrocortisone, and water is received retention and excretory effect and only is 3/4 of hydrocortisone, and is stronger to the inhibitory action of hypophysis-adrenal cortex axle.
Antiviral agent is selected astragalus polysaccharides (Astragaluspolysaccharides.APS) for use, astragalus polysaccharides is the main bioactive ingredients of leguminous plant Radix Astagali, a large amount of experiment in vivo and vitro and clinical research show, APS has the enhancing human body immunity function, multiple pharmacological effects such as heart tonifying blood pressure lowering, blood sugar lowering, anti-stress, antitumor, antiviral, radioprotective, antioxidation are unique anti virus herb preparations of present Ministry of Agriculture approval.
Injection means confession injection intravital sterile solution, emulsion or the suspension that medicine is made, and for the sterilized powder or the concentrated solution of facing with preceding wiring solution-forming or suspension.The characteristics of injection mainly show route of administration without digestive system and defence tissue (liver) and directly inject tissue or blood vessel, so drug effect are rapid, is applicable to first aid.But also the curative effect of some injection is extended, to adapt to the needs in the medical treatment.The dosage of injection is accurate, and reliable effect may suffer the influence of Digestive system, food etc., and make the dosage of taking that curative effect can not take place fully unlike endo-medicine.In addition, can make some drugs bring into play localized effect again.
Summary of the invention
The present invention is directed to the deficiencies in the prior art, a kind of compound sulfamonomethoxine sodium injection and preparation method thereof is provided.
A kind of compound sulfamonomethoxine sodium injection, raw material comprise following component:
Sulfamonomethoxine sodium 8-12g, trimethoprim 1.6-2.4g, dexamethasone sodium phosphate 0.03-0.07g, imidazophenylurea 0.8-1.2g, astragalus polysaccharides 1.6-2.4g, organic solvent 70-85g, water for injection 10-13g, pH regulator agent ethanolamine 2-3g.
Described organic solvent is alpha-pyrrolidone, N, and dinethylformamide and propylene glycol mix the solution that obtains by weight 20-30: 25-35: 10-20 respectively.
Preferably, described organic solvent is alpha-pyrrolidone, N, and dinethylformamide and propylene glycol mix the solution that obtains by weight 25-30: 30-35: 15-20 respectively.
Above-mentioned sulfamonomethoxine sodium, trimethoprim, imidazophenylurea, astragalus polysaccharides are all in pure product.
Water for injection meets national veterinary drug allusion quotation standard.
The preparation method of above-mentioned compound sulfamonomethoxine sodium injection, step is as follows:
1), gets trimethoprim solution with trimethoprim and organic solvent mixed dissolution; Sulfamonomethoxine sodium is joined in the trimethoprim solution;
2) with dexamethasone sodium phosphate and an amount of water for injection mixed dissolution, get dexamethasone sodium phosphate solution;
3) with imidazophenylurea and an amount of water for injection mixed dissolution, get imidazophenylurea solution;
4) with astragalus polysaccharides and surplus water for injection mixed dissolution, add ethanol, make concentration of alcohol reach 80%-90%wt, leave standstill, precipitation is filtered; With the filtrate decompression distillation, remove ethanol, get the astragalus polysaccharides aqueous solution;
5) with step 2) the dexamethasone sodium phosphate solution that makes, the imidazophenylurea solution that step 3) makes, astragalus polysaccharides aqueous solution that step 4) makes under agitation join respectively in the solution that step 1) makes, and mixes, and stirs evenly, and add an amount of ethanolamine and regulate pH; Organic filter membrane with 0.22-0.45um filters, and gets filtrate;
6) filtrate that step 5) is made promptly gets compound sulfamonomethoxine sodium injection 121 ℃, 0.15mpa sterilization 15-20 minute.
Preferably, the pH of filtrate is 8.8-9.2 in the described step 5).
Beneficial effect of the present invention is as follows:
The present invention makes raw material with sulfamonomethoxine sodium, dexamethasone sodium phosphate in addition, imidazophenylurea, be equipped with synergistic factor, antiviral agent, its prescription and production technology be domestic initiation only, scientific formulation, form through a large amount of experiment sievings, and through secular study on the stability, prove the stable of character ten minutes, be subjected to the influence of exterior ambient environment little, easily absorb after the animal intramuscular injection, long action time, local irritant effect is little, treating both the principal and secondary aspects of a disease, strengthening ill poultry Abwehrkraft des Koepers, treat multiple pathogenic bacteria, mixed infection that virus causes and critical illness aspect effect are remarkable.And easy to use, short treating period, drug resistance is low, has than vast market prospect.
The pH value 8.8-9.2 of injection of the present invention can satisfy the adaptability requirement of body, quickens absorption, the minimizing local excitation of body tissue to medicine, can keep the stability of medicinal liquid again.
The specific embodiment
Embodiment 1
A kind of compound sulfamonomethoxine sodium injection, raw material comprise following component:
Sulfamonomethoxine sodium 10g, trimethoprim 2g, dexamethasone sodium phosphate 0.05g, imidazophenylurea 1.0g, astragalus polysaccharides 2.0g, alpha-pyrrolidone 25g, N, dinethylformamide 30g, propylene glycol 15g, water for injection 12g, pH regulator agent ethanolamine 2.5g.
The preparation method of this compound sulfamonomethoxine sodium injection, step is as follows:
1) with trimethoprim 2g and alpha-pyrrolidone 25g, N, dinethylformamide 30g, propylene glycol 15g mixed dissolution gets trimethoprim solution; Sulfamonomethoxine sodium 10g is joined in the trimethoprim solution;
2), get dexamethasone sodium phosphate solution with dexamethasone sodium phosphate 0.05g and water for injection 4g mixed dissolution;
3), get imidazophenylurea solution with imidazophenylurea 1.0g and water for injection 4g mixed dissolution;
4) with astragalus polysaccharides 2.0g and water for injection 4g mixed dissolution, add ethanol, make concentration of alcohol reach 82%wt, leave standstill, precipitation is filtered; With the filtrate decompression distillation, remove ethanol, get the astragalus polysaccharides aqueous solution;
5) with step 2) the dexamethasone sodium phosphate solution that makes, the imidazophenylurea solution that step 3) makes, astragalus polysaccharides aqueous solution that step 4) makes under agitation join respectively in the solution that step 1) makes, mix, stir evenly, adding pH regulator agent ethanolamine 2.5g adjusting pH is 8.8, organic filter membrane with 0.45um filters, and gets filtrate;
6) filtrate that step 5) is made promptly gets compound sulfamonomethoxine sodium injection 121 ℃, 0.15mpa sterilization 15 minutes.
The test data of this compound sulfamonomethoxine sodium injection is as follows:
Table 1 clinical therapeutic efficacy of the present invention
Table 2 the present invention and sulfamonomethoxine sodium injection clinical treatment comparative test result
Xi Dong town, Zouping County Liu raises 350 of pigs, when August, fall ill, show as fervescence, delay, back myasthenia of limbs, walking is rocked, dyspnea, purple congestion speckle appears in have sharp ears, extremity and breast abdominal part, sick constipation just, later stage diarrhoea, farrowing sow has the miscarriage symptom, pathology cuts open inspection and finds pulmonary edema and hyperemia, the thoracic cavity inner product has the liquid that contains blood, lymphadenectasis, and liver, lung, the heart, spleen and kidney are all seen downright bad point, lab testing, the Pulmonis Sus domestica of taking to die of illness is done contact, and Ji's nurse Sa dyeing microscopic examination finds polypide, trophozoite.Comprehensive diagnos is an arch insect infection.Use injection for treating of the present invention, after the injection once, constipation, symptom of diarrhea obviously alleviate, and continue treatment, after three days, and basic rehabilitation, cure rate reaches 98.86%.
Safety testing result: the no abnormal death of the injection sick pig in back.Observed 30 days, the trouble poultry after the administration grows fine, and does not have any disease dead 2 of matched group takes place.
Show by above experiment, for because of the microbial respiratory tract of various sensitivities, digestive tract, urinary tract infection and coccidiosis, pig toxoplasmosis, Eperythrozoon infection etc. have significant curative effect, it is rapid to suffer from poultry injection back onset in clinical treatment for injection of the present invention; Treat mixed infection and the critical illness that multiple pathogenic bacteria, virus cause good curative effect is arranged.
Contrast therapy result shows that injection for treating of the present invention is 87.00% to the cure rate of eperythrozoon suis, is higher than matched group, is better than sulfamonomethoxine sodium injection group.
Safety test proves that the present invention does not show toxic and side effects.
Embodiment 2
A kind of compound sulfamonomethoxine sodium injection, raw material comprise following component:
Sulfamonomethoxine sodium 8g, trimethoprim 1.6g, dexamethasone sodium phosphate 0.03g, imidazophenylurea 0.8g, astragalus polysaccharides 1.6g, alpha-pyrrolidone 20g, N, dinethylformamide 35g, propylene glycol 15g, water for injection 13g, pH regulator agent ethanolamine 2g.
Preparation process is with embodiment 1.
Embodiment 3
A kind of compound sulfamonomethoxine sodium injection, raw material comprise following component:
Sulfamonomethoxine sodium 12g, trimethoprim 2.4g, dexamethasone sodium phosphate 0.07g, imidazophenylurea 1.2g, astragalus polysaccharides 2.4g, alpha-pyrrolidone 30g, N, dinethylformamide 30g, propylene glycol 20g, water for injection 10g, pH regulator agent ethanolamine 3g.
Preparation process is with embodiment 1.
Claims (4)
1, a kind of compound sulfamonomethoxine sodium injection is characterized in that, raw material comprises following component:
Sulfamonomethoxine sodium 8-12g, trimethoprim 1.6-2.4g, dexamethasone sodium phosphate 0.03-0.07g, imidazophenylurea 0.8-1.2g, astragalus polysaccharides 1.6-2.4g, organic solvent 70-85g, water for injection 10-13g, pH regulator agent ethanolamine 2-3g;
Described organic solvent is alpha-pyrrolidone, N, and dinethylformamide and propylene glycol mix the solution that obtains by weight 20-30: 25-35: 10-20 respectively.
2, compound sulfamonomethoxine sodium injection as claimed in claim 1, it is characterized in that, described organic solvent is alpha-pyrrolidone, N, and dinethylformamide and propylene glycol mix the solution that obtains by weight 25-30: 30-35: 15-20 respectively.
3, the preparation method of a kind of compound sulfamonomethoxine sodium injection of claim 1 is characterized in that, step is as follows:
1), gets trimethoprim solution with trimethoprim and organic solvent mixed dissolution; Sulfamonomethoxine sodium is joined in the trimethoprim solution;
2) with dexamethasone sodium phosphate and an amount of water for injection mixed dissolution, get dexamethasone sodium phosphate solution;
3) with imidazophenylurea and an amount of water for injection mixed dissolution, get imidazophenylurea solution;
4) with astragalus polysaccharides and surplus water for injection mixed dissolution, add ethanol, make concentration of alcohol reach 80%-90%wt, leave standstill, precipitation is filtered; With the filtrate decompression distillation, remove ethanol, get the astragalus polysaccharides aqueous solution;
5) with step 2) the dexamethasone sodium phosphate solution that makes, the imidazophenylurea solution that step 3) makes, astragalus polysaccharides aqueous solution that step 4) makes under agitation join respectively in the solution that step 1) makes, and mixes, and stirs evenly, and add an amount of ethanolamine and regulate pH; Organic filter membrane with 0.22-0.45um filters, and gets filtrate;
6) filtrate that step 5) is made promptly gets compound sulfamonomethoxine sodium injection 121 ℃, 0.15mpa sterilization 15-20 minute.
4, the preparation method of a kind of compound sulfamonomethoxine sodium injection as claimed in claim 3 is characterized in that, the pH of filtrate is 8.8-9.2 in the described step 5).
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| CN200810158292A CN100586441C (en) | 2008-10-28 | 2008-10-28 | Compound sulfamonomethoxine sodium injection and preparation method thereof |
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| CN100586441C true CN100586441C (en) | 2010-02-03 |
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101574355B (en) * | 2009-06-01 | 2011-05-04 | 河南新正好生物工程有限公司 | Compound antibacterial injection for livestock and preparation method thereof |
| CN101658526B (en) * | 2009-09-24 | 2010-12-29 | 陈建波 | Veterinary compound enrofloxacin injection and preparation method thereof |
| CN101804062A (en) * | 2010-04-23 | 2010-08-18 | 镇江威特药业有限责任公司 | Long-acting veterinary compound doxycycline injection and preparation method thereof |
| CN102988404B (en) * | 2012-12-13 | 2014-07-23 | 江苏恒丰强生物技术有限公司 | Astragalus polysaccharide injection and preparation method thereof |
| CN104306420A (en) * | 2014-11-07 | 2015-01-28 | 广西大学 | Balsamiferou blumea herb and sulfamonomethoxine sodium containing compound medicine for livestock and poultry |
| CN107334731B (en) * | 2017-07-07 | 2021-06-04 | 中国农业科学院饲料研究所 | Cattle imidocarb dipropionate injection and preparation method and application thereof |
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Application publication date: 20090318 Assignee: Shandong Enkang Pharmaceutical Co., Ltd. Assignor: Chen Jianbo Contract record no.: 2010370000090 Denomination of invention: Compound sulfamonomethoxine sodium injection and preparation method thereof Granted publication date: 20100203 License type: Exclusive License Record date: 20100319 |
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