Methodc for preparing sub-micron gemfibrozil medicament powder
A technology for gemfibrozil and medicine, which is applied in the field of preparing submicron superfine gemfibrozil medicine powder by a reactive crystallization method, and can solve the problems of large amount of surfactant and the like
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Embodiment 1
[0034] Weigh 0.16g of polyvinylpyrrolidone K30 and dissolve it in 100ml of aqueous hydrochloric acid solution with a concentration of 0.25mol / L. After it is completely dissolved, pour it into a reaction kettle and stir at a speed of 1000rpm. Then weigh 3.0 g of the gemfibrozil bulk drug and dissolve it in 100 ml of aqueous sodium hydroxide with a concentration of 0.15 mol / L to obtain a gemfibrozil bulk drug solution. The obtained bulk drug solution was quickly added into the reaction kettle, and the gemfibrozil drug was reacted and crystallized at 20° C. to obtain a suspension of gemfibrozil drug particles, and the stirring was continued for 30 minutes. Then filter and rinse the filter cake with deionized water. The obtained filter cake was put into a forced air drying oven at 40° C. to dry for more than 3 hours to obtain the dried gemfibrozil drug powder. Observation with a scanning electron microscope, such as figure 2 As shown in the scanning electron microscope photos, ...
Embodiment 2
[0036] Weigh 0.15 g of methylcellulose and dissolve it in 100 ml of aqueous hydrochloric acid solution with a concentration of 0.25 mol / L. After it is completely dissolved, pour it into a reaction kettle and stir at a speed of 10,000 rpm. Then weigh 3.0 g of the gemfibrozil bulk drug and dissolve it in 100 ml of aqueous sodium hydroxide with a concentration of 0.15 mol / L to obtain a gemfibrozil bulk drug solution. Quickly add the obtained raw material drug solution into the reaction kettle, so that the gemfibrozil drug is reacted and crystallized at 18° C. to obtain a suspension of gemfibrozil drug particles, continue to stir and age for 30 minutes, then filter, and use deionized water Rinse filter cake. Put the obtained filter cake into a beaker, add water with a weight equivalent to 5 times the weight of the wet filter cake, and redisperse the filter cake in water under the action of ultrasound to obtain a uniform suspension. The resulting suspension was poured into liquid ...
Embodiment 3
[0038] Weigh 0.39g of methylcellulose and dissolve it in 500ml of aqueous hydrochloric acid solution with a concentration of 0.05mol / L. After it is completely dissolved, pour it into a reaction kettle and stir at a speed of 2000rpm. Then weigh 2.6g of the gemfibrozil bulk drug and dissolve it in 100ml of sodium hydroxide solution with a concentration of 0.10mol / L to obtain the gemfibrozil bulk drug solution. Quickly add the obtained raw drug solution into the reaction kettle, make the gemfibrozil drug react and crystallize at 20° C. to obtain a suspension of gemfibrozil drug particles, continue to stir and age for 30 minutes, then filter, and use deionized water Rinse filter cake. The obtained filter cake is put into a quick drying apparatus for drying to obtain dry gemfibrozil drug powder. Observed by scanning electron microscope, the drug particles of gemfibrozil are spherical, with a particle size of 500nm to 2μm and a narrow particle size distribution, such as Figure 4 ...
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