Pharmaceutical composition and application thereof
A composition and medicine technology, applied in the field of medicine, to achieve the effects of excellent pharmacokinetic properties, simple preparation method and good stability
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[0125] A preparation method of the above-mentioned pharmaceutical preparation, comprising the steps of: uniformly mixing the formula I compound or its pharmaceutically acceptable salt, filler, disintegrating agent and lubricant in recipe quantity, filling by capsule filling machine into capsules or compressed into tablets by a tablet machine.
[0126] In some specific embodiments, the preparation method comprises the steps:
[0127] The formula I compound of the recipe quantity or its pharmaceutically acceptable salt, filler, disintegrating agent and lubricant is first passed through the screen for subsequent use, and the screen is selected from 30-50 mesh sieves, preferably 40 mesh sieves;
[0128] After mixing uniformly with a mixer, it can be filled into capsules by a capsule filling machine or compressed into tablets by a tablet press.
[0129] A preparation method of the above-mentioned pharmaceutical preparation, comprising the steps of: mixing the formula I compound or...
Embodiment 1
[0165] Table 1 Screening of formula II compound tablet formulation excipients
[0166]
[0167]
[0168] Preparation Process:
[0169] (1) Treatment of APIs and excipients: Pass the APIs and excipients through a 40-mesh sieve respectively and set aside for later use;
[0170] (2) Technological process: take the raw materials, fillers and disintegrants in the prescribed amount, mix them uniformly through a mixer, use 50% ethanol solution to make soft materials, and make wet granules by high-speed shearing; the wet granules are boiled and dried below 65°C ; After granulation, add the lubricant in the prescribed amount and mix it evenly with a mixer;
[0171] (3) Determining the content of the main drug in the dry granules, determining the weight of the tablet, and compressing the tablet by a tablet machine to prepare a tablet.
[0172] It should be understood that in the preparation process, the order of addition of the components, as well as the modification of mixing a...
Embodiment 2
[0176] Table 2 Screening of formula II compound tablet formulation excipients
[0177]
[0178]
[0179] The preparation process is the same as in Example 1.
[0180] The combined use of microcrystalline cellulose, lactose, mannitol and sorbitol, and the combined use of starch, calcium carbonate and dibasic calcium phosphate were investigated. The results in Table 2 show that the compressibility of microcrystalline cellulose, lactose, mannitol and sorbitol is good in terms of compressibility; prescription, good dissolution rate. Comprehensive consideration, microcrystalline cellulose, lactose, sorbitol and mannitol were selected as fillers for further screening.
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