Microencapsulated butylphthalide medicine composition, preparation method and applications

A technology of butylphthalide and composition, applied in the field of medicine, can solve problems such as research reports on the preparation method of butylphthalide pharmaceutical composition that have not yet been found, and achieve the effects of improving drug release behavior, high encapsulation rate and good stability

Active Publication Date: 2013-12-04
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

Recently, drug microencapsulation technology has been widely used in the pharmaceutical field. Various drugs are often used to make microcapsules, and then processed into various common dosage forms by adding other excipients, such as powders, tablets, c...

Method used

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  • Microencapsulated butylphthalide medicine composition, preparation method and applications
  • Microencapsulated butylphthalide medicine composition, preparation method and applications

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1 Preparation of microencapsulated butylphthalide pharmaceutical composition by single coacervation method

[0048] Weigh 2.5 g of sodium alginate and 0.5 g of starch and dissolve them in distilled water so that the concentrations of sodium alginate and starch are 2.5% and 0.5% (w / w), respectively. Weigh 3.5g of racemic butylphthalide, dissolve it with a small amount of isooctane, add it to the sodium alginate-starch solution, disperse it evenly with a stirrer at 200r / min to make an emulsion, add 25% CaCl 2 Sodium alginate is made into calcium alginate to condense into capsules and solidified, filtered, washed with distilled water for 3-5 times, and vacuum-dried for 12 hours to obtain the microencapsulated butylphthalide pharmaceutical composition.

Embodiment 2

[0049] Example 2 Preparation of microencapsulated butylphthalide pharmaceutical composition by complex coacervation method

[0050] Weigh 3 g of gelatin, add 20 ml of water to fully swell, and keep warm to dissolve. Disperse 1.5g of L-butylphthalide in the gelatin solution and stir with a stirrer at 200 r / min for 30min until emulsified. Weigh 1.4g gum arabic, prepare a gum arabic solution with a concentration of 3.5%, add the levobutylphthalide-gelatin solution into the gum arabic in a linear form at a certain speed, adjust the pH to 4.0-4.5 with hydrochloric acid, and use an ice-water bath to Cool the solution to 5°C, cross-link and solidify the newly formed microcapsules with 25% glutaric acid amide, raise the solution system to room temperature, filter, wash off excess colloid and glutaric acid amide with distilled water, and vacuum dry for 12 hours to obtain Microencapsulated butylphthalide pharmaceutical composition.

Embodiment 3

[0051] Example 3 Preparation of microencapsulated butylphthalide pharmaceutical composition by spray drying method

[0052] Dissolve 10g of methylcellulose and 15g of sodium carboxymethylcellulose in distilled water to prepare spray solutions with a concentration of 10% and 15% respectively, and disperse 3g of L-butylphthalide in methylcellulose-carboxymethyl Sodium cellulose solution was stirred with a stirrer at 200 r / min for 30 minutes, and then spray-dried. The air inlet temperature is 135-145°C, the outlet temperature is 65-80°C, the feeding speed is 10 ml / min, and the compressed air flow rate is 600 NL / h, to obtain the microencapsulated butylphthalide pharmaceutical composition.

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Abstract

The invention relates to a microencapsulated butylphthalide medicine composition, a preparation method and applications. Butylphthalide is microencapsulated to raise the solubility of butylphthalide, prevent volatilization, develop required solid preparations and liquid preparations clinically and give play to therapeutical effects of butylphthalide better. The composition contains butylphthalide effective component with a mass percent of 1-55%. Butylphthalide is coated with natural or synthesized high polymer materials as capsule wall materials or carrier materials to form microencapsules. The composition can be prepared into various preparations of powder, capsules, chewable tablets, buried tablets, buccal tablets, other oral compressed tablets, injection, liquid suspension, lotion, powder-injection, coating preparations, thin film preparations and the like.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a pharmaceutical composition, in particular to a microencapsulated pharmaceutical composition of butylphthalide and its preparation method and application. Background technique [0002] Butylphthalide (n-butylphthalide, Butylphthalidle, NBP), also known as apigenin, is a natural compound extracted from celery seeds, and it can also be synthesized artificially. Its structure contains a chiral carbon atom, so it There are two optical isomers, namely L-butylphthalide and D-butylphthalide, whose chemical structures are as follows, [0003] . [0004] Butylphthalide is a light yellow clear oily liquid with celery aroma and strong volatility. It is easily soluble in methanol, soluble in ethanol, ether and chloroform, and insoluble in water. Butylphthalide can reduce the infarction after focal cerebral ischemia, increase the cerebral blood flow in the ischemic area and i...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K31/365A61P9/10A61P25/28
Inventor 王金戌曹金娜耿佳
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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