Danofloxacin mesylate-amoxicillinsuspension injection applicable to livestock and poultry as well as preparation and application thereof
A technique for dafloxacin mesylate and suspension injection, which is applied in the field of preparation and application of animal medicines, and can solve the problem of unsatisfactory dispersion of drugs that have not yet been reported on the compound preparation of dafloxacin mesylate and amoxicillin. Uniform, prone to sedimentation and other problems, to achieve the effect of prolonging the effective action time of drugs, high practical value, delaying diffusion and dissolution
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Embodiment 1
[0047] The preparation process of dafloxacin mesylate-amoxicillin suspension injection of the present invention is as follows:
[0048] (1) Get dafloxacin mesylate and amoxicillin raw materials, and pulverize them with an ultrafine pulverizer in the aseptic operation room to obtain dafloxacin mesylate and amoxicillin raw materials with particle diameters less than 10 microns Micronized.
[0049] (2) Take 1000mL of soybean oil for injection into a 1000mL beaker, add 10g of aluminum monostearate, heat and stir at 150-160°C for 40min to make a transparent gel, filter through a 65-mesh gauze sieve, and store at room temperature for later use.
[0050] (3) Take 25 g of dafloxacin mesylate bulk drug micropowder and 150 g of amoxicillin micropowder obtained in step (1) into a 1000 mL beaker, add a small amount of gel prepared in step (2) to fully infiltrate the drug, add butyl 0.04g of hydroxyanisole, 0.04g of butylated hydroxytoluene, 0.5g of lecithin and 1.5g of Span-801.5g, then ...
Embodiment 2
[0054] The preparation process of dafloxacin mesylate-amoxicillin suspension injection of the present invention is as follows:
[0055] (1) Take dafloxacin mesylate and amoxicillin raw materials, and use an ultrafine pulverizer in the aseptic operation room to obtain dafloxacin mesylate and amoxicillin with a particle size of less than 10 μm through ultrafine pulverization API micropowder.
[0056] (2) Take 1000mL of soybean oil for injection to a 1000mL beaker, add 20g of aluminum monostearate, heat and stir at 150-160°C for 40min to make a transparent gel, filter through a 65-mesh gauze sieve, and store at room temperature for later use.
[0057] (3) Take 25g of dafloxacin mesylate micropowder and 150g of amoxicillin micropowder obtained in step (1) in a 1000mL beaker, add a small amount of gel prepared in step (2) to fully infiltrate the drug, add butyl hydroxyfennel Add 0.12g of ether, 0.12g of butylated hydroxytoluene, 0.5g of lecithin and 3.0g of Span-803.0g, then add t...
Embodiment 3
[0061] The preparation technology of dafloxacin mesylate-amoxicillin suspension injection of the present invention is as follows:
[0062] (1) Take dafloxacin mesylate and amoxicillin raw materials, and use an ultrafine pulverizer in the aseptic operation room to obtain dafloxacin mesylate and amoxicillin with a particle size of less than 10 μm through ultrafine pulverization API micropowder.
[0063] Table 1 Cross-over experimental design in the bioavailability experiment
[0064]
[0066] Determination of dafloxacin mesylate: Plasma samples were thawed naturally at room temperature. Accurately draw 0.5 mL of plasma into a centrifuge tube, add 2 mL of acetonitrile, vortex for 5 min, centrifuge at 10,000 r / min for 10 min, take the supernatant in another centrifuge tube, add 1 mL of acetonitrile to the precipitate for extraction, and combine the extracted supernatant again liquid, blown dry with nitrogen at 50°C. The residue was dissolved wit...
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