Cloperadine hydrochloride tablet and preparation method thereof
The cloperidine hydrochloride tablet and the cloperidine hydrochloride technology are applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, medical preparations containing active ingredients, etc., and can solve the problems of complex preparation process, low production efficiency and the like, Achieve the effect of saving process steps, improving production efficiency, and consistent efficacy
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[0061] According to the above steps, a small test is carried out first, and after the data of the small test is qualified, two amplification operations are carried out.
[0062] 1. Preprocessing stage
[0063] The twice-amplified batch ingredients list is shown in Table 4:
[0064] Table 4 Enlarged Batch Ingredients List
[0065]
[0066] As shown in Table 5, cloperidine hydrochloride is pulverized by a vacuum pulverizing unit, which meets the production requirements:
[0067] Table 5 Material balance and yield calculation of raw material drug pretreatment process
[0068] project (1) batch (2) batch acceptable standard Material Balance(%) 97.7 97.6 N / A Yield (%) 97.3 97.5 N / A
[0069] 2. Premixing stage
[0070] Two batches of amplification, the premixing parameters are shown in Table 6:
[0071] Table 6 hydroxypropyl cellulose, pregelatinized starch pretreatment process material balance and yield calculation
[0072] pro...
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