Megestrol acetate nano dry suspension and preparation method thereof
A technology of megestrol acetate and dry suspension, which is applied in the direction of pharmaceutical formulations, medical preparations containing no active ingredients, and medical preparations containing active ingredients. Problems such as large particle size and complex preparation process, etc., to achieve the effects of favorable drug efficacy, high dissolution rate, and simple production process
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Embodiment 1
[0052] A kind of megestrol acetate dry suspension and preparation method thereof, comprises the steps:
[0053] Weigh 1gHPMC and 1.5gTPGS into 500ml deionized water to obtain a clear solution. Take by weighing 10g megestrol acetate bulk drug again, and it is evenly dispersed in the previously obtained clarification solution. Finally, pour the slurry obtained in the previous step into a sand mill for grinding at 2500 r / min for 5 hours. The milled slurry was spray dried at 120°C.
[0054] The average particle diameter of the megestrol acetate dry suspension powder prepared in this experimental example is 333nm, and the PDI is 0.207. According to the Pharmacopoeia, the dissolution rate in 0.1% Tween 80pbs buffer at pH=6.2 is 98.7% for 2 hours. After the above dry suspension was placed for 4 months, the particle size was 346nm, and the PDI was 0.231, and the dry suspension was left standing for 3 hours and 7 days after reconstitution, and no obvious precipitation was formed.
Embodiment 2
[0056] A kind of megestrol acetate dry suspension and preparation method thereof, comprises the steps:
[0057] Weigh 1g of sodium carboxymethylcellulose and 2g of sodium dodecylsulfonate into 500ml of deionized water to obtain a clear solution. Take by weighing 10g megestrol acetate bulk drug again, and it is evenly dispersed in the previously obtained clarification solution. Finally, pour the slurry obtained in the previous step into a sand mill for grinding at 2000r / min for 5h. The milled slurry was spray dried at 120°C.
[0058] The average particle diameter of the megestrol acetate dry suspension powder prepared in this experimental example is 376nm, and the PDI is 0.172. According to the Pharmacopoeia, the dissolution rate in 0.1% Tween 80pbs buffer at pH=6.2 is 95.4% for 2 hours. After the above dry suspension was placed for 4 months, the particle size was 391nm, and the PDI was 0.272, and the dry suspension was left standing for 3 hours and 7 days after reconstituti...
Embodiment 3
[0061] A kind of megestrol acetate dry suspension and preparation method thereof, comprises the steps:
[0062] Weigh 2gHPMC and 1gSDS into 500ml deionized water to obtain a clear solution. Take by weighing 10g megestrol acetate bulk drug again, and it is evenly dispersed in the previously obtained clarification solution. Finally, put the slurry obtained in the previous step into an ultrasonic pulverizer for pulverization at 100HZ for 4 hours. The slurry after sonication was spray dried at 120°C.
[0063] The average particle diameter of the megestrol acetate dry suspension powder prepared in this experimental example is 383nm, and the PDI is 0.236. According to the Pharmacopoeia, the dissolution rate in 0.1% Tween 80pbs buffer at pH=6.2 is 93.2% for 2 hours. After the above dry suspension was placed for 4 months, the particle size was 397nm, and the PDI was 0.241, and the dry suspension was left standing for 3 hours and 7 days after reconstitution, and no obvious precipita...
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