Arformoterol tartrate aerosol and preparation method thereof
A tartaric acid and aerosol technology, applied in the field of biomedicine, can solve the problems of complex preparation process, unfavorable portability, high price, etc., and achieve the effect of simple preparation process, preparation uniformity and high quality standard
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Embodiment 1
[0045] Weigh 0.45g of arformoterol tartrate, add it into a 20L predissolved tank containing 18L water for injection, use a heating mantle outside the predissolved tank (hot water can be passed through, cold water can control the temperature in the tank), stir at 15°C to completely dissolve and clarify, and weigh again Add 9g of thiourea into the pre-dissolving tank, and stir at 15°C to dissolve completely. Weigh 30g of ethanol and add it to the above solution, continue to stir at this temperature for 5 minutes, transfer the above-prepared arformoterol tartrate aqueous solution to a 100L liquid mixing tank, add water for injection at about 15°C, and make the total solution reach 48L. Add 455g of sodium chloride, the test osmotic pressure is 276mOsmol / kg, and use acetic acid-sodium acetate buffer solution to adjust the pH value of the solution in the mixing tank to 5.0, continue stirring in the mixing tank and when the temperature is maintained at 15°C, add 15°C The volume of wa...
Embodiment 2
[0047] Weigh 0.474g of arformoterol tartrate, add it into a 30L predissolved barrel containing 24L water for injection, use a heating mantle outside the predissolved barrel (hot water can be passed through, cold water can control the temperature in the canister), stir at 25°C to completely dissolve and clarify, and weigh again Add 24g of glycine into the pre-dissolving tank, and stir at 25°C to dissolve completely. Weigh 150g of ethanol and add it to the above solution, continue to stir at this temperature for 7 minutes, transfer the above-prepared arformoterol tartrate aqueous solution to a 100L liquid mixing tank, add water for injection at about 25°C, and make the total solution reach 51L. Add 2680g of glucose, test the osmotic pressure to be 282mOsmol / kg, and use citric acid-sodium citrate buffer solution to adjust the pH value of the solution in the mixing tank to 5.5, continue stirring in the mixing tank and keep the temperature at 25°C, add Set the volume to 60L with wa...
Embodiment 3
[0049] Weigh 0.465g of arformoterol tartrate, add it into a 30L predissolved tank containing 20L water for injection, use a heating mantle outside the predissolved tank (hot water can be passed through, cold water can control the temperature in the tank), stir at 20°C to completely dissolve and clarify, and weigh again Add 20g of nicotinamide into the pre-dissolve tank, and stir at 20°C to dissolve completely. Weigh 100g of propylene glycol and add it to the above solution, continue to stir at this temperature for 6 minutes, transfer the above-prepared arformoterol tartrate aqueous solution to a 100L liquid mixing tank, add water for injection at about 20°C, and make the total solution reach 50L. Add 448g of sodium chloride, the test osmotic pressure is 288mOsmol / kg, and use phosphoric acid-sodium phosphate buffer solution to adjust the pH value of the solution in the liquid mixing tank to 5.2, continue stirring in the liquid mixing tank and when the temperature is maintained a...
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