Prepn process of superfine inhaled glucocorticoid medicine powder
A glucocorticoid and drug technology, applied in the field of ultrafine drug powder, can solve the problems of inability to obtain budesonide with controllable particle size, inability to prepare budesonide, complicated production process, etc. Bioavailability, Efficiency of Dispensing Formulations
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Embodiment 1
[0046] Weigh 2.5g of budesonide raw material, dissolve it with methanol to prepare 100ml of budesonide solution, put it in storage tank 1, weigh 0.21g of tyloxabe, prepare 700mL of tyloxabe solution with deionized water and put it in the storage tank 2. Control the temperature at about 5°C. Under the stirring condition of a magnetic stirrer, quickly pour the methanol solution of budesonide into the aqueous solution of Tyloxabe to obtain milky white budesonide precipitate, continue to stir for 30 minutes, filter and wash , Budesonide dry powder granules were obtained after vacuum drying at 60°C. It can be seen from the scanning electron microscope photo shown in Fig. 3 that the average particle size is 3 μm, and more than 80% of the particles have a particle size of 1-5 μm. It can be seen from the XRD spectrum shown in Figure 4 that what is obtained is crystalline budesonide. In the experiment, the ratio of budesonide solution and aqueous solution was 1:7.
Embodiment 2
[0048] Weigh 2.5g of budesonide crude drug, dissolve with methanol to prepare 100ml of budesonide solution, place it in storage tank 1, weigh 0.25g of hydroxypropyl cellulose, prepare 1000mL of hydroxypropyl cellulose solution with deionized water, place In storage tank 2, control the temperature at about 5°C, and under the stirring condition of a magnetic stirrer, quickly pour the methanol solution of budesonide into the aqueous solution of hydroxypropyl cellulose to obtain a milky white budesonide precipitate, and stir for a period of time Afterwards, filter, wash, and vacuum-dry at 60° C. to obtain budesonide dry powder granules. It can be seen from the scanning electron microscope photo shown in Figure 5 that the average particle size is between 1 and 5 μm. In the experiment, the ratio of budesonide solution and aqueous solution was 1:10.
Embodiment 3
[0050] Weigh 2.5g of budesonide raw material, dissolve it in methanol to prepare 100ml of budesonide solution, place it in storage tank 1, measure 1000mL deionized water with a graduated cylinder and place it in storage tank 2, control the temperature at about 5°C, and stir under magnetic force Under the condition of agitator stirring, the methanol solution of budesonide was quickly poured into deionized water to obtain a milky white budesonide precipitate, which was stirred for a period of time, filtered, washed, and vacuum-dried at 60°C to obtain budesonide dry powder particles. It can be seen from the scanning electron microscope photo shown in Figure 6 that the average particle size is between 1 and 5 μm. In the experiment, the ratio of budesonide solution and aqueous solution was 1:10.
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