Preparation method of long-acting injection containing danofloxacin mesylate
A dafloxacin mesylate and injection technology, which is applied in the field of long-acting injections, can solve the problems of affecting animal growth, wasting manpower and financial resources, etc., and achieve the effects of good histocompatibility, reducing irritation and being easy to use
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Embodiment 1
[0023] Embodiment 1, preparation 30% dafloxacin mesylate injection
[0024] Preparation composition: 150g of dafloxacin mesylate, 125g of SAIB, 4.5g of aluminum stearate, 0.05g of BHA, 0.05g of BHT, 0.025g of PG, 100ml of benzyl benzoate, and 500ml of ethyl oleate.
[0025] Preparation method: (1) Add aluminum stearate to ethyl oleate, stir and heat (95-100°C) to prepare oil gel; (2) Dissolve SAIB in benzyl benzoate to prepare SAIB / benzene Benzyl formate solution; (3) Mix danofloxacin mesylate with SAIB / benzyl benzoate solution, grind it with a sand mill until the particle size of dafloxacin mesylate is less than 5 μm, and then mix it with oil gel, And adding an antioxidant, using a high-shear homogenizer under the condition of 15000-21000rpm for multiple times of homogenization, to prepare dafloxacin mesylate injection with a particle size of less than 5 μm.
Embodiment 2
[0026] Embodiment 2, preparation 15% dafloxacin mesylate injection
[0027] Preparation composition: dafloxacin mesylate 150g, SAIB 170g, aluminum stearate 11g, BHA 0.1g, BHT 0.2g, benzyl benzoate 300ml, IPM added to 1000ml.
[0028] Preparation method: (1) Add aluminum stearate to IPM, stir and heat (95-100°C) to prepare oil gel; (2) Dissolve SAIB in benzyl benzoate to prepare SAIB / benzyl benzoate solution; (3) mix danofloxacin mesylate with oil gelatin, pass through a colloid mill and grind until the particle size of dafloxacin mesylate is less than 20 μm, then mix it with SAIB / benzyl benzoate solution, and add antioxidant Dafloxacin mesylate injection was prepared by using a high-shear homogenizer under the condition of 15000-21000rpm for multiple times of homogenization and then passing through a sand mill.
Embodiment 3
[0029] Embodiment 3, preparation 20% dafloxacin mesylate injection
[0030] Preparation composition: Dafloxacin mesylate 200g, SAIB110g, HCO3g, Span-808g, BHA0.1g, BHT0.1g, PG0.05g, ethyl oleate added to 1000ml.
[0031] Preparation method: (1) Add HCO and Span-80 into ethyl oleate, stir and heat (80-90°C) to prepare HCO-containing colloidal liquid; (2) Dissolve SAIB in the colloidal liquid, Prepare HCO and SAIB / ethyl oleate solution; (3) Mix dafloxacin mesylate with about half the amount of HCO and SAIB / ethyl oleate solution, and grind it with a sand mill until dafloxacin mesylate The star particle size is less than 5 μm, then add antioxidant and the remaining solution, and use a high-shear homogenizer under the condition of 15000-21000 rpm for several times to obtain dafluxa mesylate with a particle size of less than 5 μm Star Injection.
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