1. It has specific effects on mycoplasma and is used as the first choice drug for anti-mycoplasma
2. The potency per 1mg is not less than 980 tylosin units
3. This product is a special antibiotic for macrolide animals. Its mechanism of action is mainly to inhibit the synthesis of bacterial protein to play a sterilization effect. This product is easily absorbed in the body, excreted quickly, and has no residue in the tissue. Gram-positive bacteria and mycoplasma have special effects. Especially, it has very high activity against Actinobacillus pleuropneumoniae, and it is the first choice medicine for the treatment of chronic respiratory diseases of livestock and poultry caused by mycoplasma.
【Dosage】
Mixed drinking of livestock and poultry: Add 2-4kg of water per 1g of this product (ie 200-400kg per 100g of water) for free or concentrated drinking, continuous use for 3-5 days.
Livestock and poultry mix: 1-2kg per 1g of this product mix (that is, 100-200kg per 100g mix) for free intake, continuous use for 3-5 days. Subcutaneous or intramuscular injection: For every 1 kg of body weight, 5-13 mg of pigs and poultry (calculated as tylosin tartrate) for 3 days.
【Precautions】
Avoid simultaneous use with feeds with higher calcium content.
Tylosin tartrate soluble powder Jiushisuan Tailejunsu kerongxingfen Tylosin Tailejunsu Soluble Powder This product is calculated as a dry product, and the potency per 1mg shall not be less than 800 tylosin units; calculated according to the average filling quantity, containing tylosin should be the labeled amount Of 93.0%～108.0%.
【Properties】
This product is white to light yellow powder.
【Identification】
(1) Take about 3mg of this product, add 7.5ml of pyridine and 2.5ml of acetic anhydride to dissolve it, let it stand for about 10 minutes, the solution should appear green.
(2) Take about 3mg of this product, add 2ml of acetone to dissolve it, add 1ml of hydrochloric acid, and the solution will change from light red to dark purple.
(3) In the chromatogram recorded under the relevant components, the retention time of the tylosin A peak of the test solution should be consistent with the retention time of the tylosin A peak of the standard solution.
(4) The aqueous solution of this product shows the reaction of item (1) in the identification of tartrate (appendix page 20).
[Check] Loss on drying
Take this product, use phosphorus pentoxide as a desiccant, and dry it under reduced pressure at 60°C to a constant weight, with a weight loss of not more than 4.8% (Appendix page 69).
PH: Take 2.5g of this product, add 100ml of water, fully shake it, filter it, take the filtrate, determine according to law (Appendix page 51), the pH value should be 5.2 ~ 7.0.
Tyramine: Take 50mg of this product, add 5ml methanol to dissolve it, add 2ml 10% pyridine solution, 2% ninhydrin solution, seal with tin foil, heat in a water bath at 85°C for 30 minutes, quickly let it cool, and transfer to a 25ml measuring flask Add water to the mark as the test solution; take another 5ml of tyramine methanol solution containing 35ug of tyramine per 1ml, and prepare it in the same way as the control solution. Immediately follow the ultraviolet-visible spectrophotometry (appendix page 23), measure at a wavelength of 570nm, the absorbance of the test solution should not be greater than the absorbance of the control solution.
Tylosin components were tested according to high performance liquid chromatography (appendix page 32).
Chromatographic conditions and system suitability test use octadecylsilane bonded silica as filler; 2mol/L sodium perchlorate solution (adjust the pH value to 2.5+0.1 with 1mol/L hydrochloric acid solution)-acetonitrile (60:40) ) Is the mobile phase; the detection wavelength is 280nm. The number of theoretical plates calculated based on the tylosin A component peak should not be less than 2000, the separation between tylosin D peak and tylosin A peak should not be less than 2.0, and the tailing factor should not exceed 1.5.
Determination method Take 30mg each of this product and the tylosin standard, accurately weigh them, put them in a 100ml measuring flask, add 10ml methanol to dissolve, and dilute to the mark with water. Precisely measure 20ul respectively, and inject it into the high performance liquid chromatograph, and record the chromatogram to 1.5 times the retention time of Tylosin A. The relative retention time of tylosin related components is approximately: tylosin C is 0.5, tylosin B is 0.7, tylosin D is 0.9, and tylosin A is 1. According to the peak area normalization method, the content of tylosin A should not be less than 80%, and the sum of tylosin A, B, C, and D should not be less than 95%.
The filling quantity shall be checked in accordance with the “Minimum Filling Quantity Inspection Method Operation Regulations” (weight method), the average filling quantity shall not be less than 100g, and the filling quantity per bag shall be 99g～102g.
Appearance uniformity Take an appropriate amount of the test product, place it on smooth paper, and spread it about 5cm, flatten its surface, and observe it under a bright background. It should show a uniform color, without patterns and stains.
Solubility: Take an appropriate amount of the test product, place it in a Nessler colorimetric tube, add water to make a 50ml solution (concentration is twice the high dose concentration in clinical use), flip up and down 10 times at 25+2℃, the test product should be Dissolve all, let it stand for 30 minutes, there should be no turbidity or precipitation.
【Assay Determination】
Take 5 of this product, accurately weigh it, calculate the average volume, accurately weigh an appropriate amount of this product, add sterile water to make a solution containing about 1000 units per 1ml. According to the Antibiotic Microbiological Test Method (Appendix page 103). 1000 tylosin units are equivalent to 1 mg of tylosin.
【Category】
Macrolide antibiotics.
【Specification】
(1) 5g (5 million units) (2) 10g (10 million units) (3) 20g (20 million units)
【Storage】
Airtight and store in a dry place. [1]
