High-dispersity composition of low-dose drugs and preparation method of high-dispersity composition

[0083] Preparation of Embodiment 1 Alfacalcidol Tablets, Small Test Process

[0084] 1. Prescription

[0085]

[0086] 2. The preparation method specifically comprises the following steps:

[0087] 1) dissolving the crude drug alfacalcidol in absolute ethanol to make a solution;

[0088] 2) Weigh the prescribed amount of anhydrous lactose, povidone, and propyl gallate in a wet mixing granulator, and the mixing time is greater than or equal to 5 minutes to make dry powder;

[0089] 3) Add the dry powder obtained in the above step 2) into the solid feeder, and after the solution obtained in the above step 1) is connected to the extruder through a low-pulse peristaltic pump, control the granulation temperature of the twin-screw extruder at 20-25 Between ℃, adjust the feeding speed of dry powder to 1.0-2.0kg / hr, the speed of peristaltic pump to 2rpm-4rpm, and the speed of twin-screw to 100rpm-200rpm, and the above-mentioned dry powder and solution enter the twin-screw extrude...

[0093] Example 2 Preparation of Alfacalcidol Tablets, Pilot Test Process

[0094] 1. Prescription

[0095]

[0096] 2. The preparation method specifically comprises the following steps:

[0097] 1) dissolving the crude drug alfacalcidol in absolute ethanol to make a solution;

[0098] 2) Weigh the prescribed amount of anhydrous lactose, povidone, and propyl gallate in a wet mixing granulator, and the mixing time is greater than or equal to 5 minutes to make dry powder;

[0099] 3) Add the dry powder obtained in the above step 2) into the solid feeder, and after the solution obtained in the above step 1) is connected to the extruder through a low-pulse peristaltic pump, control the granulation temperature of the twin-screw extruder at 20-25 Between ℃, adjust the feeding speed of dry powder to 2.0-3.0kg / hr, the speed of peristaltic pump to 4rpm-8rpm, and the speed of twin-screw to 300rpm-400rpm, and the above-mentioned dry powder and solution enter the twin-screw extruder w...

[0103] Example 3 Comparative Example 1 CN104739793A discloses a kind of alfacalcidol tablet and its preparation method, adopts traditional wet granulation, according to the preparation method of Example 1 in the text, uses the same prescription of the present invention, obtains comparative example 1 Alpha tablets. The process description is as follows: Weigh the raw and auxiliary materials of the prescription amount, pass through 80 mesh sieves respectively for standby; configure the adhesive solution; Soft material; after granulating with a 40-mesh sieve, dry at 50°C for 30 minutes, pass through a 20-mesh sieve for granulation, add magnesium stearate, mix evenly, and press into tablets.

[0104] Example 4 Comparative Example 2 CN1196677A discloses a preparation method of a very low-dose solid dosage form of medicine, using high-speed shear mixing granulation technology, according to the preparation method in the text, using the same prescription of the present invention, to o...