Tafluprost eye drop agent and preparation method thereof
A technology of tafluprost and eye drops, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of poor API solubility and stability, complex prescription composition, impurities, etc. Wait for the question
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Embodiment 1
[0050] Weigh 100g of methyl cellulose (MC), add it into a 10L predissolved tank containing 4L 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 10°C to completely dissolve and clarify, Then weigh 0.2 g of tafluprost and add it into the pre-dissolved bucket, and stir at 10° C. to dissolve completely. Weigh 2g of lauryl alcohol and dissolve it in 1L of 10°C water for injection, stir to disperse evenly, pour into the tafluprost aqueous solution prepared above, and continue to stir until the solution is clear. Transfer the solution in the pre-dissolved bucket to a 25L liquid mixing tank, add water for injection at about 10°C to make the total solution reach 18L, test the pH value of the solution to 5.0, continue stirring in the liquid mixing tank and maintain the temperature at 10°C , use the prepared 1mol / L sodium hydroxide aqueous solution to adjust its pH value t...
Embodiment 2
[0052]Weigh 600g of carboxymethylcellulose sodium (CMC-Na), add it into a 10L predissolved tank containing 6L 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), and stir at 20°C Completely dissolve and clarify, then weigh 0.5g of tafluprost and add it to the pre-dissolve bucket, and stir at 20°C to dissolve completely. Weigh 8g of oleic acid and dissolve it in 3L of 20°C water for injection, stir and disperse evenly, pour it into the tafluprost aqueous solution prepared above, and continue stirring until the solution is clear. Transfer the solution in the pre-dissolved bucket to a 25L liquid mixing tank, add water for injection at about 20°C to make the total solution reach 18L, test the pH value of the solution to 7.2, continue stirring in the liquid mixing tank and maintain the temperature at 20°C , use the prepared 1mol / L sodium hydroxide aqueous solution to adjust it...
Embodiment 3
[0054] Weigh 400g of hydroxypropylmethylcellulose (HPMC), add it into a 10L predissolved barrel containing 5L 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), and stir at 15°C to dissolve completely After clarification, weigh 0.4g of tafluprost and add it into the pre-dissolved bucket, and stir at 15°C to dissolve completely. Weigh 5g of pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)]propionate and dissolve it in 2L of 15°C water for injection, stir and disperse evenly, and pour it into the above-prepared taflur In the plain aqueous solution, continue to stir until the solution is clear. Transfer the solution in the pre-dissolved barrel to a 25L liquid mixing tank, add water for injection at about 15°C to make the total solution reach 18L, and test the pH value of the solution to be 5.8. When the liquid mixing tank continues to stir and the temper...
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