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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

Active Publication Date: 2021-08-24
DIAO GRP CHENGDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The object of the present invention is to provide a kind of cloperidine hydrochloride tablet and preparation method thereof, in order to solve the technical problem of complex preparation process and low production efficiency of existing cloperidine hydrochloride tablet

Method used

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  • Cloperadine hydrochloride tablet and preparation method thereof
  • Cloperadine hydrochloride tablet and preparation method thereof
  • Cloperadine hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[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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Abstract

The invention discloses a cloperidine hydrochloride tablet and a preparation method thereof, and belongs to the technical field of pharmacy, the cloperidine hydrochloride tablet comprises the following parts: cloperidine hydrochloride, lactose, pregelatinized starch, hydroxypropyl cellulose, talcum powder and magnesium stearate, and the tablet preparation steps are premixing, total mixing and tableting. On the basis of the prior art, granulation and drying are not needed, all the materials are directly premixed and totally mixed, and the mixed powder is directly pressed into tablets, so that the process steps are greatly saved, the production efficiency is obviously improved, and the energy consumption is also greatly reduced due to omission of the drying step on the production cost.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a cloperidine hydrochloride tablet and a preparation method thereof. Background technique [0002] Cloperidine hydrochloride inhibits the cough center and antitussive, which was first approved in Japan in May 1965. On August 19, 2019, the State Food and Drug Administration announced the announcement of the catalog of generic drug reference preparations (the twenty-second batch) (2019 No. 56). Cloperidine hydrochloride is used in the pharmaceutical market in the form of tablets, and it is determined that The reference preparation of 10 mg cloperidine hydrochloride tablets is licensed by NiproES Pharma Co., Ltd., and the trade name is Hustazol. [0003] The preparation process of the existing cloperidine hydrochloride tablet consists of several steps: granulation, drying, premixing, granulation, total mixing, tablet compression and sugar coating. The overall process i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/26A61K47/36A61K47/38A61K47/02A61K47/12A61P11/14
CPCA61K9/2853A61K9/2095A61K9/2018A61K9/2059A61K9/2054A61K9/2009A61K9/2013A61K31/451A61P11/14Y02W90/10
Inventor 彭熙琳黄磊王远赵至东陈娟胡海波彭珊珊
Owner DIAO GRP CHENGDU PHARMA
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