Oxcarbazepine tablets and preparation method thereof

A technology for oxcarbazepine tablets and oxcarbazepine tablets, which is applied in the field of tablet formulations of neurological drugs, can solve problems such as poor stability, and achieve the effects of less impurities, lower production costs, and shorter production cycles.

Active Publication Date: 2014-04-23
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

[0007] The technical problem to be solved in the present invention is that the oxcarbazepine tablet prepared by the existing wet granulation method has poor stability

Method used

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  • Oxcarbazepine tablets and preparation method thereof
  • Oxcarbazepine tablets and preparation method thereof
  • Oxcarbazepine tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] 10000 tablets product formula:

[0077] Oxcarbazepine raw material 1500g (accounting for 47.00% of the total weight of the tablet)

[0078] Partially pregelatinized starch 223g (accounting for 7.00% of the total weight of the tablet)

[0079] Starch lactose complex 957g (accounting for 30.00% of the total weight of the tablet)

[0080] S-630 copovidone 159g (accounting for 5.00% of the total weight of the tablet)

[0081] Croscarmellose Sodium 191g (6.00% of the total tablet weight)

[0082] Sodium stearyl fumarate 64g (accounting for 2.00% of the total weight of the tablet);

[0083] Coating (3 % of total tablet weight):

[0084] Hypromellose 41.2 g (43.00 % of coating weight)

[0085] Talc powder 34.5g (accounting for 36.00% of coating weight)

[0086] Titanium dioxide 9.6g (10.00% of coating weight)

[0087] Polyethylene glycol 4000 7.7g (accounting for 8.00% of coating weight)

[0088] Iron oxide yellow 2.9g (3.00% of coating weight).

[0089] Preparation ...

Embodiment 2

[0092] 10000 tablets product formula:

[0093] Oxcarbazepine raw material 1500g (accounting for 55.00% of the total weight of the tablet)

[0094] Partially pregelatinized starch 136g (5.00% of the total weight of the tablet)

[0095] Starch lactose complex 764g (28.00% of the total weight of the tablet)

[0096] S-630 copovidone 109g (accounting for 4.00% of the total weight of the tablet)

[0097] Croscarmellose sodium 136g (5.00% of the total tablet weight)

[0098] Sodium stearyl fumarate 27g (accounting for 1.00% of the total weight of the tablet);

[0099] Coating: (2 % of total tablet weight)

[0100] Hypromellose 25.6 g (47.00 % of coating weight)

[0101] Talc powder 18.0g (33.00% of coating weight)

[0102] Titanium dioxide 4.9g (9.00% of coating weight)

[0103] Polyethylene glycol 4000 4.9g (9.00% of coating weight)

[0104] Iron oxide yellow 1.1g (2.00 % of coating weight).

[0105] Preparation Process:

[0106] 1. Pass oxcarbazepine raw material, pa...

Embodiment 3

[0107] Embodiment 3: 10000 product formulas:

[0108] Oxcarbazepine raw material 1500g (accounting for 45.00% of the total weight of the tablet)

[0109] Partially pregelatinized starch 333g (10.00% of the total weight of the tablet)

[0110] Starch lactose complex 1067g (32.00% of the total weight of the tablet)

[0111] S-630 copovidone 100g (accounting for 3.00% of the total weight of the tablet)

[0112] Croscarmellose Sodium 200g (6.00% of the total tablet weight)

[0113] Sodium stearyl fumarate 83g (accounting for 2.50% of the total weight of the tablet);

[0114] Coating: (1.5 % of total tablet weight)

[0115] Hypromellose 25g (50.00 % of coating weight)

[0116] Talc powder 15g (accounting for 30.00% of coating weight)

[0117] Titanium dioxide 5.5g (11.00 % of coating weight)

[0118] Polyethylene glycol 4000 3.5g (7.00% of coating weight)

[0119] Iron oxide yellow 1g (2.00% of coating weight).

[0120] Preparation Process:

[0121]1. Pass oxcarbazepine...

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Abstract

The invention discloses oxcarbazepine tablets and a preparation method thereof. The oxcarbazepine tablets comprise tablet cores and coating, wherein the tablet cores are obtained by directly pressing, and comprise the following components in percentage by weight in the oxcarbazepine tablets: 45 to 60 percent of oxcarbazepine, 5 to 10 percent of partially pregelatinized starch, 25 to 35 percent of starch and lactose compound, 3 to 7 percent of S-630 copovidone, 2 to 6 percent of cross-linked sodium carboxymethyl cellulose and 0.5 to 2.5 percent of sodium stearyl fumarate. By combining the characteristics that the oxcarbazepine is unstable in light and water, and is easy to deteriorate, the processes of adding water and drying are omitted in the preparation process of the oxcarbazepine, so that the production time is shortened, the production energy consumption is reduced, and manpower rand material resources are saved. The oxcarbazepine tablets disclosed by the invention have reasonable compositions, few impurities in a finished product, and obvious advantages of high dissolution rate and high tablet uniformity.

Description

technical field [0001] The invention relates to a tablet preparation of neurological drugs, in particular to an oxcarbazepine tablet and a preparation method thereof. Background technique [0002] Tablet refers to a disc-shaped or special-shaped tablet-shaped solid preparation that is uniformly mixed with a suitable excipient and compressed. Due to its advantages of accurate measurement, uniform content, good chemical stability, convenient use, and high degree of production mechanization, it has become one of the most widely used dosage forms at present. The preparation method of tablet comprises granulation tabletting method (specific process steps, see figure 1 ) and direct compression method (specific process steps, see figure 2 ), the granulation and tableting method is divided into wet granulation and tableting method and dry granulation and tableting method, and the direct compression method is divided into powder direct compression method and semi-dry granule table...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/55A61P25/08
Inventor 陈秋实王正雄刘艳红
Owner 武汉人福药业有限责任公司
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