CN101416936A - Preparation method of long-acting composite sulfamonomethoxine suspension - Google Patents
Preparation method of long-acting composite sulfamonomethoxine suspension Download PDFInfo
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- CN101416936A CN101416936A CNA2007101897993A CN200710189799A CN101416936A CN 101416936 A CN101416936 A CN 101416936A CN A2007101897993 A CNA2007101897993 A CN A2007101897993A CN 200710189799 A CN200710189799 A CN 200710189799A CN 101416936 A CN101416936 A CN 101416936A
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Abstract
The invention relates to a long acting compound sulfamonomethoxine suspension which consists of 10g of sulfamonomethoxine, 2g of trimethoprim, 0.3g of sodium hydroxide, 0.3g of carboxymethylcellulose sodium, 30g of propylene glycol and 0.05g of tween-80. A preparation method thereof comprises the steps that: (1) the carboxymethylcellulose sodium swells by using 20ml of water used for injection; (2) then the propylene glycol is added; (3) the sodium hydroxide is dissolved with 5ml of water for standby; (4) the products of Step (1) and Step (2) are placed upside down in a beaker, added with the trimethoprim, the sulfamonomethoxine and the tween-80 in sequence and stirred while being adding; the sodium hydroxide is used for adjusting and controlling the pH value to be 5.3 to 5.6; and (5) the solution is put into a colloid mill so as to be milled for 10 minutes, thus obtaining the compound sulfamonomethoxine suspension. The veterinary drug has the advantages of long half life, less untoward effects, good curative effect, and the like.
Description
Technical field:
The present invention relates to a kind of preparation method of veterinary drug, relate in particular to a kind of preparation method of long-acting composite sulfamonomethoxine suspension.
Background technology:
Sulfamonomethoxine (SMM) is a kind of widely used sulphonamides, and its antibacterial action is the strongest in sulfa drugs.Prevention effect to livestock and poultry bacterial infection is good, and in addition, it all has significant preventive and therapeutic effect to the coccidiosis of animal, toxoplasmosis etc.This product and Trimethoprim trimethoprim use in conjunction, but double blocking antibacterial, protozoacide folic acid metabolism, the effect that strengthens sulphonamides reaches several times to tens times, even bactericidal action occurs.Along with SMM application clinically, its novel formulation continues to bring out.In order to prolong the persistent period of compound sulfamonomethoxine daimeton injection, strive for the single administration cure diseases, SMM absorbs good, and the blood drug level height is kept nearly 24 hours of action time.Can be used for the microbial respiratory tract of various sensitivities, digestive tract, urinary tract infection and coccidiosis, pig toxoplasmosis, eperythrozoonosis, bowel oedema disease, chicken lives leukocyte parasitosis, atrophic rhinitis etc.The chronic toxicity of existing this quasi drugs of document description is not strong.Existing in the market compound sulfonamide is to the listing of Sulfamonomethoxine injection products, and flocculent deposit appears in said preparation long-term placement easily, and effective drug duration shortcoming such as lack, waste time and energy is arranged.To fill a prescription on the basis of original formulation for this reason and further optimize, preparation composite sulfamonomethoxine suspensoid is to remedy the shortcoming of above-mentioned preparation.
Summary of the invention:
In order to overcome above-mentioned defective, the invention provides a kind of preparation method of long-acting composite sulfamonomethoxine suspension, mainly solve technical problems such as effective drug duration weak point, medicine character instability in the prior art.
The preparation method of described long-acting composite sulfamonomethoxine suspension, its suspension prescription is as follows:
Sulfamonomethoxine 10g-30g,
Trimethoprim 2g-6g,
Sodium hydroxide 0.3g-1.0g,
Sodium carboxymethyl cellulose 0.3g-0.5g
Propylene glycol 30g-60g
Tween 80 0.05-2.0g,
The water for injection standardize solution is to 100ml
The preparation method of described composite sulfamonomethoxine suspension, its preparation method is:
1., earlier sodium carboxymethyl cellulose is used 20mL water for injection swelling;
2., add propylene glycol again;
3., with sodium hydroxide with the water dissolution of 5mL, standby;
4., with 1. above and 2. put in the beaker, stirred 5 minutes, add trimethoprim successively, sulfamonomethoxine, tween 80, the limit edged stirred 30 minutes, regulated pH value with sodium hydroxide solution, was controlled at 5.3-5.6; And with the water for injection standardize solution to 100mL;
5., above-mentioned solution put into colloid mill ground 10 minutes, and cross 200 mesh sieves promptly.
The propylene glycol that described suspension uses can also substitute with Polyethylene Glycol, the polyvinylpyrrolidone of equivalent.
The sodium carboxymethyl cellulose of described use, propylene glycol, Polyethylene Glycol, polyvinylpyrrolidone promptly can use separately, also can two or morely use simultaneously.
Because the present invention adopts hydrophilic macromolecule material (sodium carboxymethyl cellulose, propylene glycol, Polyethylene Glycol, polyvinylpyrrolidone etc.) to increase the viscosity of solution, form colloid solution, make medicinal liquid inject the time lengthening of post-absorption in the body, thereby reach long lasting purpose.
The compound sulfamonomethoxine daimeton injection pharmacokinetic
1. experiment content:
1.1 medicine
Test 100mg/ml composite sulfamonomethoxine suspension (A).
The contrast T common compound sulfamonomethoxine daimeton injection of brand 100mg/ml (B).
The sulfamonomethoxine standard substance: content is 99.7%.
The sulfamonomethoxine crude drug: content is 95.5%.
1.2 experimental animal
12 of health pig do not have medication history in the recent period, and body weight 26.67kg ± 3.07kg is available from Agricultural University Of South China experiment pig farm; Raise with not containing antibiotic full price baby pig feedstuff, free choice feeding is freely drunk water, and on-test in preceding 2 weeks are played overbit, grouping, blood sampling.Testing result shows, does not contain sulfamonomethoxine in all pig bloods.
1.3 administration and blood specimen collection
12 pigs are divided into 2 groups at random, use the A injection for the 1st group, use the B injection, carry out intramuscular injection by 0.4mL/kg dosage respectively for the 2nd group.Adopt the primary blank blood sample before the administration, after the administration respectively at the 0.25th, 0.50,0.75,1.00,2.00,3.00,5.00,9.00,12.00,24.00,36.00,48.00,72.00,96.00,108.00,120.00h is from the vena cava anterior blood sample collection.Place the centrifuge tube that contains heparin about each vena cava anterior blood sampling 5mL, mixing, the centrifugal 10min of 3000r/min, separated plasma ,-20 ℃ of preservations are to be measured.
1.4 the detection of SMM in the blood plasma
After treating that blood plasma thaws, shake up, accurately draw 1.0mL in the plastic centrifuge tube with cover of 2.5mL, add the 1.0mL acetonitrile, vortex mixing 2min with the centrifugal 20min of 15000r/min, gets whole supernatant in the 2.0mL bottle, carries out HPLC and measures.Testing conditions: UV-detector, chromatographic column be Hypersil ODS (25 μ m, 4.6mm * 200mm), mobile phase is acetonitrile-methanol-1.5% glacial acetic acid (volume ratio 10: 10: 80) mixture; Sample size is 20 μ L; The detection wavelength is 271nm; Flow velocity is 1.0mL/min; Column temperature is a room temperature.
1.5 date processing
" MCPKP " pharmacokinetics calculation procedure that write in employing Xia Wen river etc. is handled the different time blood drug level data that record, and sets up pharmacokinetic mode, obtains pharmacokinetic parameter.
2. experimental result
2.1 the detection of SMM in the blood plasma
SMM separates with impurity well, disturbs and lacks, and the chromatographic peak symmetry is good, and the retention time of plasma sample sulfamonomethoxine is about 9.6min; In 0.05-100.00 μ g/mL scope, the concentration of sample and absworption peak area have good linear relationship (r=0.999), and the response rate of sample is 87.02% ± 4.38%, detect to be limited to 0.05 μ g/mL.
This result of the test shows, long-acting composite sulfamonomethoxine suspension (A) and common compound sulfamonomethoxine daimeton injection (B) are all with after the 0.4mL/kg intramuscular injection, the elimination half-life of A injection is 20.20h ± 5.31h, significantly be longer than the normal injection agent, and the elimination half-life of B injection is 9.81h ± 1.03h, and the pH value of A is little to the stimulation of injection site near neutral.The pharmacokinetics analysis result shows that A, B sulfamonomethoxine daimeton injection meet two-compartment model in the intravital pharmacokinetics of pig.When eliminating half-life, peak concentration, peak, valid density is held time and parameter such as area under curve on there were significant differences (P＜0.05).The blood drug level testing result shows that the valid density of A injection is held time for 72.07h ± 9.51h, and the B injection only is 48.72h ± 10.83h; The half-life of A injection is 2 times of B.This explanation long-acting composite sulfamonomethoxine suspension (A) is eliminated slow than common compound sulfamonomethoxine daimeton injection (B), the time of keeping blood drug level in vivo is long, and long-acting effect obviously is better than B.
The present invention has following beneficial effect:
The valid density that the present invention has the long half time injection length of holding time, therefore advantage such as untoward reaction is few, and therapeutic effect is good, and is time saving and energy saving will have more wide application prospect at veterinary clinic.
The specific embodiment:
Embodiment 1,
A kind of preparation method of composite sulfamonomethoxine suspension, its suspension prescription is as follows:
Sulfamonomethoxine 10g
Trimethoprim 2g
Sodium hydroxide 0.3g
Sodium carboxymethyl cellulose 0.3g
Tween 80 0.05g
The water for injection standardize solution is to 100mL
The preparation method of described composite sulfamonomethoxine suspension, its preparation method is:
1., earlier sodium carboxymethyl cellulose is used 20mL water for injection swelling;
2., with sodium hydroxide with the water dissolution of 5mL, standby;
3., 1. put in the beaker, stirred 5 minutes, add trimethoprim successively above, sulfamonomethoxine, tween 80, the limit edged stirred 30 minutes, regulated pH value with sodium hydroxide solution, was controlled at 5.3, and with the water for injection standardize solution to 100mL;
4., above-mentioned solution put into colloid mill ground 10 minutes, and cross 200 mesh sieves promptly.
Embodiment 2,
A kind of preparation method of long-acting composite sulfamonomethoxine suspension, its suspension prescription is as follows:
Sulfamonomethoxine 20g
Trimethoprim 4g
Sodium hydroxide 0.5g
Propylene glycol 30g
Sodium carboxymethyl cellulose 0.5g
Tween 80 0.1g
The water for injection standardize solution is to 100mL
The preparation method of described long-acting composite sulfamonomethoxine suspension, its preparation method is:
1., earlier sodium carboxymethyl cellulose is used 20mL water for injection swelling;
2., add propylene glycol again;
3., with sodium hydroxide with the water dissolution of 5mL, standby;
4., with 1. above and 2. put in the beaker, stirred 5 minutes, add trimethoprim successively, sulfamonomethoxine, tween 80, the limit edged stirred 30 minutes, regulated pH value with sodium hydroxide solution, was controlled at 5.6, and with the water for injection standardize solution to 100mL;
5., above-mentioned solution put into colloid mill ground 10 minutes, and cross 200 mesh sieves promptly.
Embodiment 3,
A kind of preparation method of long-acting composite sulfamonomethoxine suspension, its suspension prescription is as follows:
Sulfamonomethoxine 30g
Trimethoprim 6g
Sodium hydroxide 1g
Polyethylene Glycol 60g
Sodium carboxymethyl cellulose 0.45g
Tween 80 1.5g
The water for injection standardize solution is to 100mL
The preparation method of described long-acting composite sulfamonomethoxine suspension, its preparation method is:
1., earlier sodium carboxymethyl cellulose is used 20mL water for injection swelling;
2., add Polyethylene Glycol again;
3., with sodium hydroxide with the water dissolution of 5mL, standby;
4., with 1. above and 2. put in the beaker, stirred 5 minutes, add trimethoprim successively, sulfamonomethoxine, tween 80, the limit edged stirred 30 minutes, sodium hydroxide solution is regulated pH value, is controlled at 5.3, and with the water for injection standardize solution to 100mL;
5., above-mentioned solution put into colloid mill ground 10 minutes, and cross 200 mesh sieves promptly.
Embodiment 4,
A kind of preparation method of long-acting composite sulfamonomethoxine suspension, its suspension prescription is as follows:
Sulfamonomethoxine micropowder 10g
Trimethoprim micropowder 2g
Sodium hydroxide 0.42g
Propylene glycol 30g
Polyethylene Glycol 20g
Sodium carboxymethyl cellulose 0.45g
Tween 80 2.0g
The water for injection standardize solution is to 100mL
The preparation method of described long-acting composite sulfamonomethoxine suspension, its preparation method is:
1., earlier sodium carboxymethyl cellulose is used 20mL water for injection swelling;
2., with Polyethylene Glycol, mixed with propylene glycol, standby;
3., with sodium hydroxide with the water dissolution of 5mL, standby;
4., with 1. above and 2. put in the beaker, stirred 5 minutes, add the trimethoprim micropowder successively, sulfamonomethoxine, tween 80, the limit edged stirred 30 minutes, and with the water for injection standardize solution to 100mL; Sodium hydroxide solution is regulated pH value, is controlled at 5.6;
5., above-mentioned solution put into colloid mill ground 10 minutes, and cross 200 mesh sieves promptly.
In the foregoing description 1,2,3,4, the propylene glycol that described suspension uses can also substitute with Polyethylene Glycol, the polyvinylpyrrolidone of equivalent.The sodium carboxymethyl cellulose of described use, propylene glycol, Polyethylene Glycol, polyvinylpyrrolidone promptly can use separately, also can two or morely use simultaneously.
Claims (4)
1, a kind of long-acting composite sulfamonomethoxine suspension, its prescription is as follows:
Sulfamonomethoxine 10g--30g,
Trimethoprim 2g--6g,
Sodium hydroxide 0.3g--1.0g,
Sodium carboxymethyl cellulose 0.3g-0.5g
Propylene glycol 30g-60g
Tween 80 0.05-2.0g,
The water for injection standardize solution is to 100ml.
2, a kind of preparation method of long-acting composite sulfamonomethoxine suspension, its preparation method is:
1., earlier sodium carboxymethyl cellulose is used 20mL water for injection swelling;
2., add propylene glycol again;
3., with sodium hydroxide with the water dissolution of 5mL, standby;
4., with 1. above and 2. put in the beaker, stirred 5 minutes, add trimethoprim successively, sulfamonomethoxine, tween 80, the limit edged stirred 30 minutes, regulated pH value with sodium hydroxide solution, was controlled at 5.3-5.6; And with the water for injection standardize solution to 100mL;
5., above-mentioned solution put into colloid mill ground 10 minutes, and cross 200 mesh sieves promptly.
3, the preparation method of a kind of long-acting composite sulfamonomethoxine suspension according to claim 2 is characterized in that: the propylene glycol that described suspension uses can also substitute with Polyethylene Glycol, the polyvinylpyrrolidone of equivalent.
4, the preparation method of a kind of long-acting composite sulfamonomethoxine suspension according to claim 3, it is characterized in that: the sodium carboxymethyl cellulose of described use, propylene glycol, Polyethylene Glycol, polyvinylpyrrolidone promptly can use separately, also can two or morely use simultaneously.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101836995A (en) * | 2010-04-29 | 2010-09-22 | 湖南农业大学 | Compound sulfamonomethoxine sodium multivesicular liposome and preparation method thereof |
| 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 |
| CN104127431A (en) * | 2014-07-29 | 2014-11-05 | 刘锦妮 | Veterinary ciprofloxacin-lincomycin long-acting injection liquid and preparing method thereof |
| CN104161724A (en) * | 2013-09-02 | 2014-11-26 | 郑州后羿制药有限公司 | Long-acting compound sulfamonomethoxine nanometer suspension and preparation method thereof |
| CN104274472A (en) * | 2014-09-12 | 2015-01-14 | 安徽天安动物药业有限公司 | Compound sulfamonomethoxine sodium injection and preparation method thereof |
| CN113041219A (en) * | 2021-03-31 | 2021-06-29 | 南京日升昌生物技术有限公司 | Compound sulfadiazine suspension and preparation method and application thereof |
-
2007
- 2007-10-22 CN CN2007101897993A patent/CN101416936B/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN101836995A (en) * | 2010-04-29 | 2010-09-22 | 湖南农业大学 | Compound sulfamonomethoxine sodium multivesicular liposome and preparation method thereof |
| CN104161724A (en) * | 2013-09-02 | 2014-11-26 | 郑州后羿制药有限公司 | Long-acting compound sulfamonomethoxine nanometer suspension and preparation method thereof |
| CN104127431A (en) * | 2014-07-29 | 2014-11-05 | 刘锦妮 | Veterinary ciprofloxacin-lincomycin long-acting injection liquid and preparing method thereof |
| CN104274472A (en) * | 2014-09-12 | 2015-01-14 | 安徽天安动物药业有限公司 | Compound sulfamonomethoxine sodium injection and preparation method thereof |
| CN113041219A (en) * | 2021-03-31 | 2021-06-29 | 南京日升昌生物技术有限公司 | Compound sulfadiazine suspension and preparation method and application thereof |
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| CN101416936B (en) | 2012-03-21 |
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