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A kind of oxcarbazepine tablet and preparation method thereof

An oxcarbazepine tablet and a technology for oxcarbazepine are applied in the field of oxcarbazepine tablet and its preparation, and can solve the problems of cumbersome procedures, difficulty in converting a prescription process, high cost, and the like

Active Publication Date: 2022-04-19
武汉人福药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The method disclosed in the Chinese patent (pharmaceutical preparation of oxcarbazepine and its preparation method, application number: 2007800023534.8) needs to use the wide and multimodal particle size distribution of the raw material drug oxcarbazepine, which can only be achieved in the laboratory and by well-trained It is realized by professionally trained technicians, and the process is cumbersome and expensive, so it cannot be used for commercial production of oxcarbazepine tablet preparations
[0006] In view of the biopharmaceutical characteristics of oxcarbazepine, which is insoluble and low-osmotic, and the problem that most of the preparation methods in the prior art are difficult to transform into the actual production of the prescription process, it is necessary to develop a commercially-produced, beneficial for in vivo absorption, Environmentally friendly and economical formulation process for the production of oxcarbazepine tablets

Method used

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  • A kind of oxcarbazepine tablet and preparation method thereof
  • A kind of oxcarbazepine tablet and preparation method thereof
  • A kind of oxcarbazepine tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] The preparation method of oxcarbazepine tablet, comprises the following steps:

[0065] (1) Premixing: Put the prescribed amount of oxcarbazepine raw material, sodium laurylsulfonate, and colloidal silicon dioxide into the mixer, and mix evenly.

[0066] (2) Micronization: The pre-mixed mixture is subjected to airflow pulverization, and the particle size distribution after pulverization is controlled.

[0067] (3) Granulation: Add the micronized mixture, microcrystalline cellulose, and hypromellose in sequence in a high-shear wet granulator. Turn on stirring and shearing, mix until uniform, and take samples to test the content uniformity. Turn on stirring and shearing, add an appropriate amount of purified water to the granulator with a spray gun to granulate, and the amount of pure water added is 25% of the weight of the granulated dry powder.

[0068] (4) Drying: Dry with a boiling dryer, turn on the steam to enter the system, lift the hopper after the hopper is pos...

Embodiment 2

[0074] The only difference between the preparation method and Example 1 is that the amount of pure water added in step (3) is 25% of the weight of the granulated dry powder, and the solid content of the coating solution in step (8) is 15%.

Embodiment 3

[0076] The difference between the preparation method and Example 1 is that the amount of pure water added in step (3) is 20% of the weight of the granulated dry powder, and the solid content of the coating solution in step (8) is 12%.

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Abstract

The invention provides an oxcarbazepine tablet and a preparation method thereof, and relates to the field of pharmaceutical preparations. The oxcarbazepine tablet includes a film coating premix and an oxcarbazepine tablet core; the oxcarbazepine tablet core is composed of In terms of weight percentage, it includes the following raw materials: oxcarbazepine 60%-80%, microcrystalline cellulose 13%-22%, hypromellose 3%-5%, croscarmellose sodium 2%-8 %, colloidal silicon dioxide 0.5%‑1%, sodium lauryl sulfate 1%‑3%, and magnesium stearate 0.5%‑1%. Through the optimization of composition, proportion and preparation method, it can be produced commercially, is environmentally friendly and economical, and the prepared oxcarbazepine tablet has a better dissolution rate in a short time and is easily absorbed by the human body.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an oxcarbazepine tablet and a preparation method thereof. Background technique [0002] Oxcarbazepine is a second-generation antiepileptic drug and a derivative of the first-generation antiepileptic drug carbamazepine. The drug acts mainly through its pharmacologically active metabolite (10-monohydroxy derivative, MHD). The quality of oxcarbazepine tablets sold in the domestic market is uneven, and it is not clear whether it is clinically equivalent to the original research product, and the product quality needs to be improved through consistency evaluation. However, there are various shortcomings in the preparation technology adopted in the existing invention patent of oxcarbazepine tablets, for example: [0003] The method disclosed in the Chinese patent (pharmaceutical preparation of oxcarbazepine and its preparation method, application number: 2007800023534.8) nee...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K31/55A61K47/02A61K47/20A61K47/22A61P25/08
CPCA61K31/55A61K9/2866A61K47/20A61K47/02A61K9/2095A61K47/22A61K9/2013A61P25/08
Inventor 方智陈诗郭芬杜波陈宗意
Owner 武汉人福药业有限责任公司