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Butylphthalide dripping pill and preparing method

The technology of butylphthalide dropping pills and butylphthalide is applied in the directions of pill delivery, pharmaceutical formulations, medical preparations containing active ingredients, etc. It can overcome the problems of low bioavailability, simple preparation process and stable product quality.

Active Publication Date: 2009-03-25
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

Cyclodextrin inclusion process effectively solves the problem of oily drug solidification and preparation of common solid dosage forms, but this process consumes a lot of raw materials, affects the yield, complex operation, and long production process
[0005] In another Chinese patent CN1623542A applied by CSPC Zhongqi Pharmaceutical Technology, a soft capsule preparation of butylphthalide is disclosed. The soft capsule is composed of capsule material and medicinal liquid oil, wherein the medicinal liquid is basically composed of butylphthalide and diluent vegetable oil. Composition, butylphthalide is easy to prepare into soft capsule dosage form, but the disadvantage is that the capsule skin is easily affected by temperature and humidity, and the capsule skin is aging, which affects in vitro dissolution and in vivo absorption

Method used

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  • Butylphthalide dripping pill and preparing method
  • Butylphthalide dripping pill and preparing method
  • Butylphthalide dripping pill and preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Butylphthalide 50g 23.3%

[0033] Macrogol 6000 130g 60.4%

[0034] Light micronized silica gel 24g 11.2%

[0035] Crospovidone 4g 1.9%

[0036] Hypromellose 7g 3.2%

[0037] Operation: Weigh butylphthalide, add light differential silica gel and cross-linked povidone, stir well, then add into molten polyethylene glycol 6000 and stir to mix evenly. Drop into pills at a rate of 25-35 drops per minute, shrink into pills by simethicone oil (viscosity: 100 cts) condensate, collect the pills, spin dry, sieve the pills, and coat the pills.

Embodiment 2

[0039] Butylphthalide 50g 15.1%

[0040] Macrogol 4000 200g 60.4%

[0041] Macrogol 20000 40g 12.1%

[0042] Light micronized silica gel 31g 9.4%

[0043] Hydroxypropyl Cellulose 10g 3.0%

[0044] Operation: Weigh butylphthalide, add light differential silica gel and stir evenly, then add into molten polyethylene glycol 4000 and polyethylene glycol 20000, stir and mix evenly, and keep the liquid medicine at 80-90°C for heat preservation. Drop into pills at a rate of 25 to 35 drops per minute, shrink into pills through the liquid paraffin condensate, collect the pills, shake dry, sieve the pills and coat the pills.

Embodiment 3

[0046] Butylphthalide 50g 20.7%

[0047] Macrogol 6000 154g 63.9%

[0048] Poloxamer 5g 2.1%

[0049] Light micronized silica gel 26g 10.8%

[0050] Ethylcellulose 6g 2.5%

[0051] Operation: Weigh butylphthalide, add light differential silica gel and stir evenly, then add molten polyethylene glycol 6000 and poloxamer, stir and mix evenly, and drop the medicine solution at 80-90°C to prepare Pills, the dripping speed is 25-35 drops per minute, shrink into pills by liquid paraffin condensate, collect the dripping pills, shake dry, sieve the pills and then coat the pills.

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PUM

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Abstract

The invention relates to a drip pills of butylbenzene phthalein and its preparation method and it is characterized by comprising butylbenzene phthalein, base material, dispersing agent and coating materials. PEG4000, PEG6000, PEG20000 and poloxamer are selected as base materials. Dispersing agent is from lightweight aerosol and crospovidone. And coating materials are from hypromellose, hydroxypropyl cellulose, ethyl cellulose and Eudragit E30D.

Description

technical field [0001] The invention relates to butylphthalide dropping pills and a preparation method thereof. Background technique [0002] 1-Butylphthalide is an active ingredient isolated from celery seed. dl-Butylphthalide (dl-3-n-butylpphthalide), referred to as NBP, also known as apigenin A, a synthetic racemate, is used to treat mild and moderate acute ischemic stroke. [0003] In recent years, clinical studies of butylphthalide have shown that compared with the control group in phase II and III clinical trials of butylphthalide, the total effective rate in the treatment of acute ischemic stroke can reach 73.2%, and it is a safe and effective drug for the treatment of cerebral ischemic diseases. The marketed product is butylphthalide soft capsule, trade name: Enbipu, and the content of this product is yellow or dark yellow oily liquid. [0004] In the Chinese patent CN1394880A applied by CSPC Zhongqi Pharmaceutical Technology, the inclusion compound of butylphthali...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/365A61K9/20A61P9/10
CPCA61K9/0078A61K31/343A61P9/00A61P9/10
Inventor 周桂荣李云立孙建华孟程军郭文敏梁亚丽杨汉煜
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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