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Butylphthalide sublingual tablet and preparation method thereof

A kind of technology of butylphthalide and composition, applied in the field of sublingual tablet of butylphthalide and preparation thereof, can solve the problem that the preparation of sublingual oral preparations is not retrieved and the like

Active Publication Date: 2013-06-26
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012]Gelucire 44 / 14 ) as a pharmaceutical excipient that has been recorded in the European Pharmacopoeia, so far no report on the preparation of sublingual preparations using it as an excipient has been found

Method used

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  • Butylphthalide sublingual tablet and preparation method thereof
  • Butylphthalide sublingual tablet and preparation method thereof
  • Butylphthalide sublingual tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043]

[0044] Preparation method: add butylphthalide, macrogol glyceride laurate and lactose into a twin-screw extruder to extrude. The temperature of the extruder section is set at 30°C-60°C-60°C-60°C-45°C, and the screw speed of the host machine and the speed of the feeder are both set at 25rpm. The extrudate is cooled and cut into pieces.

Embodiment 2

[0046]

[0047] Preparation method: add butylphthalide, macrogol glyceride laurate and lactose into a twin-screw extruder to extrude. The temperature of the extruder section is set at 30°C-60°C-60°C-60°C-45°C, and the screw speed of the host machine and the speed of the feeder are both set at 25rpm. The extruded product is cooled and pulverized into granules, added with micropowdered silica gel and magnesium stearate, and pressed into tablets with a hardness of 4 to 5 kg.

Embodiment 3

[0049]

[0050] The preparation method is the same as in Example 2.

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Abstract

The invention provides a butylphthalide sublingual preparation. The butylphthalid sublingual preparation contains butylphthalide, lauric acid polyethylene glycol glyceride, an excipient, an adsorbent and a lubricating agent. A butylphthalide solid dispersion prepared by taking lauric acid polyethylene glycol glyceride as a carrier can be quickly dissolved in vitro, and a sample is prepared by adopting a hot melting extrusion method, so that drug loading capacity is high and sample stability is good.

Description

technical field [0001] The invention relates to a butylphthalide preparation, in particular to a sublingual tablet of butylphthalide and a preparation method thereof. Background technique [0002] Racemic butylphthalide (dl-3-n-butylphthalide), and its two enantiomers: D-butylphthalide (d-3-n-butylphthalide) and L-butylphthalide (l-3-n -butylphthalide), are oily liquids insoluble in water. [0003] Clinically, butylphthalide is mainly used in the treatment of mild and moderate acute ischemic stroke, and it also has a good effect on the symptoms of cerebrovascular diseases such as angioneurotic headache, hypertension, chronic headache caused by arteriosclerosis, and stroke headache. prevention and treatment. L-Butylphthalide, which was developed later, also has similar medical effects. [0004] As early as in Example 11 of CN93117148.2, a soft capsule dosage form was disclosed, which was composed of dl-apigenin (that is, racemic butylphthalide), dibutyl hydroxytoluene and ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/365A61K47/34A61P9/10A61P9/12
Inventor 赫玉霞白敏郝卫华
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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