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Good-stability right-handed oxiracetam capsule and preparation method thereof

A technology of capsules and pregelatinized starch, which is applied in capsule delivery, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of no further prompts from Dexoxiracetam , to achieve high bioavailability, high dissolution rate and low content of related substances

Inactive Publication Date: 2019-10-29
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, how to obtain a more excellent dissolution rate through the dissolution adjustment formula and process adjustment of dexoxiracetam, how to improve its fluidity and loading difference through verified process methods, how to select suitable process conditions to To avoid problems such as the degradation of dextro-oxiracetam, the prior art does not give further hints, in view of this, this invention is proposed

Method used

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  • Good-stability right-handed oxiracetam capsule and preparation method thereof
  • Good-stability right-handed oxiracetam capsule and preparation method thereof
  • Good-stability right-handed oxiracetam capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Dissolve 1g of Dexoxiracetam in 6mL of mixed solvent (3mL of dimethylacetamide, 3mL of ethyl acetate), heat to dissolve at 50°C, filter, seal the filtrate, and heat at 180-200r / min Stir at a high speed for about 18 hours, and filter again. After filtration, the filtrate is left to stand in a desiccator to evaporate the solvent to form crystals, collect the crystals, and dry the collected crystals at 30±2°C and a relative humidity of 80±2% for 5 hours to obtain Dexo-oxiracetam crystals. The obtained dextro-oxiracetam crystal is carried out powder diffraction experiment: powder diffraction determination (XRPD): test instrument condition: use Bruker D2PHASER powder diffractometer to carry out normal temperature test, test condition is: with Cu Ka It is the light source, the voltage is 30kV, the current is 10mA, the test step is 0.014°, the scanning speed is 0.1s / step, and the scanning range is 5-40° (2θ). After testing, the D-oxiracetam crystal prepared in Example 1 has ...

Embodiment 2

[0020] Dissolve 2g of Dexoxiracetam in 8mL of a mixed solvent (2mL of dimethylacetamide, 6mL of ethyl acetate), heat to dissolve at 40°C, filter, seal the filtrate, and heat at 150-180r / min Stir at a high speed for about 15 hours, and filter again. After filtration, the filtrate is left to stand in a desiccator to evaporate the solvent to form crystals, collect the crystals, and dry the collected crystals at 20±2°C and a relative humidity of 70±2% for 4 hours to obtain Dexo-oxiracetam crystals. As determined by powder diffraction, the crystalline form of dexoxiracetam prepared in Example 2 is the same as the crystalline form of dexoxiracetam prepared in Example 1.

Embodiment 3

[0022] Dissolve 1g of Dexoxiracetam in 8mL of mixed solvent (3mL of dimethylacetamide, 5mL of ethyl acetate), heat to dissolve at 45°C, filter, cover and seal the filtrate at 220-250r / min Stir at a high speed for about 24 hours, and filter again. After filtration, the filtrate is left to stand in a desiccator to evaporate the solvent to form crystals, collect the crystals, and dry the collected crystals at 40±2°C and a relative humidity of 85±2% for 6 hours to obtain Dexo-oxiracetam crystals. As determined by powder diffraction, the crystalline form of dexoxiracetam prepared in Example 3 is the same as the crystalline form of dexoxiracetam prepared in Example 1.

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Abstract

The invention provides a right-handed oxiracetam capsule. The right-handed oxiracetam capsule is prepared from the following components in percentage by weight: 72-88% of crystalline-form right-handedoxiracetam, 8-15% of pregelatinized starch, 1-3% of sodium carboxymethylcellulose, and 2-5% of a lubricant; and the lubricant is selected from one or more of talcum powder, silicon dioxide and magnesium stearate. The right-handed oxiracetam capsule has the advantages of high dissolution rate and low content of related substances, meanwhile, in the storage process of the right-handed oxiracetam capsule, contents of the capsule are not gathered and condensed, and the characteristic of high stability is achieved.

Description

technical field [0001] The invention relates to dextro-oxiracetam capsules, in particular to a stable dextro-oxiracetam capsule and a preparation method thereof. Background technique [0002] Studies have shown that R-Oxiracetam has obvious effects in the treatment of epileptic generalized seizures, epileptic partial seizures and status epilepticus. The structure of Dexo-oxiracetam is as follows: [0003] [0004] Chinese patent CN101766596A discloses a solid preparation with Dexoxiracetam as an active ingredient, which contains Dexoxiracetam and pharmaceutically acceptable excipients. This method effectively reduces the side effects of Oxiracetam. Through the research on the prior art, the stability problem of Dexoxiracetam is still a problem that bothers people and needs to be solved urgently. In addition, the appropriate preparation method and process conditions, the type and amount of diluent are very important to the dissolution effect, fluidity and loading differe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/36A61K47/38A61K31/4015A61P25/08
CPCA61K9/4866A61K31/4015A61P25/08
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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