Butylphthalide controlled release preparation and preparation method thereof

A technology of controlled-release preparation and butylphthalide, which is applied in the field of butylphthalide preparations, can solve the problems of large amount of hydrophilic gel skeleton material, large amount of cyclodextrin, unable to meet the requirements of sustained-release tablets, etc.

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

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Problems solved by technology

Chinese patent 200710062273.9, the invention uses cyclodextrin and its derivatives in combination with an emulsifier, and the amount of cyclodextrin is relatively large. The inventor also used the same amount of cyclodextrin and Its derivatives, but found: the release rate of the sustained-release tablets made is higher, the di

Method used

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  • Butylphthalide controlled release preparation and preparation method thereof
  • Butylphthalide controlled release preparation and preparation method thereof
  • Butylphthalide controlled release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Embodiment 1, The liquid medicine contains an emulsifier, but the middle layer does not contain an emulsifier.

[0056] .

[0057] Preparation Process:

[0058] ① Preparation of gelatin solution: take gelatin and add appropriate amount of water to make it absorb water and swell. In addition, heat glycerin, ethylparaben and the remaining water in a colloidal sol pot to 70~80°C, mix well, add expanded gelatin, stir, melt, keep warm for 1~2 hours, let stand to make the foam float up, scrape off The floating foam is filtered with a clean white cloth and kept warm for later use. The viscosity of the formulated glue is generally 2.8~3.2 degrees;

[0059] ②Preparation of liquid medicine oil: weigh the components and stir well to get it;

[0060] ③ Pressing soft capsules: Put the prepared gelatin liquid and butylphthalide into the automatic rotary encapsulating machine, control the temperature at 40~50°C, and press out soft capsules;

[0061] ④ Preparation of the middl...

Embodiment 2

[0068] Embodiment 2, Both the liquid medicine and the intermediate layer contain emulsifiers.

[0069] Preparation process steps: ①~③, ⑤~⑩ are the same as in Example 1; ④ Preparation of intermediate layer solution: Dissolve mannitol, ethoxylated polyoxyethylene glyceride and povidone in ethanol.

Embodiment 3

[0070] Embodiment 3, According to the second method of dissolution determination (paddle method) of appendix XC of the Chinese Pharmacopoeia 2010 edition, with pH6.8 phosphate buffer as the dissolution medium, measure Examples 1 and 2, and draw the release curve, the results are shown in the appendix figure 2 .

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Abstract

The invention relates to a butylphthalide controlled release preparation and a preparation method thereof. Drugs can be uniformly released at a constant speed, and release of liquid drugs from the controlled release preparation in a liquid form is achieved.

Description

technical field [0001] The invention relates to a butylphthalide preparation, in particular to a controlled-release preparation 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 water-insoluble volatile oils. [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. Preventive and therapeutic effects. L-Butylphthalide, which was developed later, also has similar medical effects. [0004] Because the volatile oil is easy to volatilize at room temperature, it is easy to volatilize and lose during the conventional preparation process, so it is diff...

Claims

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Application Information

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IPC IPC(8): A61K9/66A61K31/365A61P9/10A61P9/12
Inventor 张志宏梁敏王世霞王悦辛伟白英
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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