Sparingly soluble active component particle, particle preparation and preparation method thereof
An active ingredient and insoluble technology, which is applied in the field of insoluble active ingredient particles, particle preparations and their preparation, can solve the problems of easy aggregation of particles, poor dispersion performance and wettability, and poor dissolution performance of insoluble active ingredients.
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[0147] Example 1 Domperidone particles
[0148] Disperse 3g of domperidone in 300ml of 30% ethanol, put it in a constant temperature water bath at 25°C, use a stirrer to disperse it at a linear speed of 190 m / min, add a dilute hydrochloric acid solution with a concentration of 8.9% until the domperidone is dissolved, and add acrylic resin Eudragit EPO0.15g, filter the solution after it is dissolved; add 9.8% sodium hydroxide solution to the solution at a speed of 0.75ml / min, control the pH of the solution to 7.2, continue to stir for 30min, and filter to obtain The eutectoid was washed 3 times with water, dried at 40° C. for 48 hours, then pulverized lightly, and passed through an 80-mesh sieve to obtain a sample (denoted as 1A) with a content of 99.79%.
[0149] Using the above method, only changing the amount of acrylic resin Eudragit EPO to 3g, the obtained product is recorded as 1B, and the sample content is 102.6%.
Example Embodiment
[0150] Comparative Example 1 Domperidone particles
[0151] Disperse 3g of domperidone in 300ml of 30% ethanol, put it in a constant temperature water bath at 25°C, use a stirrer to disperse it at a linear speed of 190 m / min, add a dilute hydrochloric acid solution with a concentration of 8.9% until the domperidone is dissolved, and add PVPK301. 5g, filter the solution after it is dissolved; add 9.8% sodium hydroxide solution to the solution at a speed of 0.75ml / min, control the pH of the solution to 7.2, continue to stir for 30min, suction filter to obtain the eutectoid, water After washing 3 times, drying at 40°C for 48 hours, lightly pulverizing, and passing through an 80-mesh sieve to obtain a sample (recorded as Comparative 1A) with a content of 99.67%.
[0152] Three kinds of domperidone microparticles were prepared by the above method for comparison. The PVPK30 was added to 9g in the sample marked as Comparative 1B, and other conditions were unchanged; the sample marked as C...
Example Embodiment
[0153] Example 2 Estradiol microparticles
[0154] Disperse 1g of estradiol in 120ml of 30% ethanol, use a stirrer to disperse it at a linear speed of 250 m / min, then add 0.5g of acrylic resin Eudragit L100 to it and disperse it at 15ml / min Add 9.8% sodium hydroxide solution at a speed of 9.8% and continue stirring until the two are completely dissolved; add 8.9% hydrochloric acid solution to the solution at a speed of 15ml / min until the pH of the mixed solution is 5; filter to obtain the eutectoid, and deionize After washing with water for 5 times, drying at 55°C under reduced pressure for 5 hours; pulverize lightly in a mortar and pass through an 80-mesh sieve to obtain a sample (denoted as 2A) with a content of 101.5%.
[0155] Using the above method, only changing the amount of the acrylic resin Eudragit L100 to 0.2g to obtain samples, denoted as 2B, the sample content is 99.4% respectively.
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