Slow/controlled release pellet composition containing ginkgo leaf extracts and preparation method thereof

A technology of extract and ginkgo biloba, which is applied in the field of sustained/controlled release pellets containing ginkgo biloba extract and its preparation, can solve the problems of low bioavailability, poor multi-component absorption, frequent administration, etc., and achieve Good reproducibility, stable drug properties, and the effect of reducing toxic and side effects

Inactive Publication Date: 2009-03-04
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The invention especially solves the problem of low bioavailability caused by poor absorption of multiple components in the body due to non-disintegration or frequent administration of ordinary tablets of traditional Chinese medicine

Method used

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  • Slow/controlled release pellet composition containing ginkgo leaf extracts and preparation method thereof
  • Slow/controlled release pellet composition containing ginkgo leaf extracts and preparation method thereof
  • Slow/controlled release pellet composition containing ginkgo leaf extracts and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Prescription 1 for immediate-release pellets:

[0049] Ginkgo Biloba Extract 1000g

[0050] Microcrystalline Cellulose 1600g

[0051] Starch 550g

[0052] Sodium carboxymethyl starch 350g

[0053]Weigh 1000g ginkgo leaf extract, 1600g microcrystalline cellulose, 550g starch, and 350g sodium carboxymethyl starch, mix in a small V-shaped mixer for 15 minutes, add 1500g of purified water in portions, and place a small V-shaped mixing mechanism soft material, Transfer to the extrusion spheronizer, set the speed of 25Hz to pass through the 1mm aperture screen to form thin strips, turn on the turntable, put the thin strips into the turntable, round at the speed of 10Hz for 15 minutes, adjust the reverse, roll the ball for 10 minutes, at 20Hz The speed is forward, and the high-speed rolling is formed for 30 minutes. Turn on the fan to slow down, collect the pellet cores, and dry them in an oven at 45°C for 2 hours to obtain the pellet cores containing medicine. Weighed, t...

Embodiment 2

[0057] Isolation layer coating prescription 1 Eudragit E 100 250g

[0058] Triethyl citrate 50.0g

[0059] Simethicone 10.0g

[0060] Talc powder 150g

[0061] Weigh 250g of Eudragit E, add 220g of purified water in portions, keep stirring to prevent caking, add 50g of triethyl citrate, stir until the material is completely dissolved, pass through an 80-mesh sieve, and obtain the coating solution for the isolation layer. Preheat the above coating solution to 35°C, turn on the fluidized bed coating machine, weigh 250g of the pill core of Example 1, set the air inlet temperature to 45°C, and the relative humidity of the air inlet airflow to be 55% spray gun atomization pressure is 0.35MPa, and the air intake is 100m 3 / h. The coating liquid is connected to the liquid inlet through the infusion pump, and the flow rate is 1.5g / min, and the pellets are coated by continuous spraying, and the slow-release film liquid is continuou...

Embodiment 3

[0068] Immediate-release pellet core prescription 2:

[0069] Ginkgo Biloba Extract 1000g

[0070] Microcrystalline Cellulose 1500g

[0071] Dextrin 600g

[0072] Subeng King 300g

[0073] Weigh 1000g ginkgo biloba extract, 1500g microcrystalline cellulose, 600g dextrin, 300g Subengwang, mix in a small V-shaped mixer for 15 minutes, add 1800g of purified water in portions, put soft materials in a small V-shaped mixing mechanism, and turn Enter the extrusion spheronizer, set the speed of 25Hz to pass through the 1.5mm aperture screen to form thin strip materials, turn on the turntable, put the thin strip materials into the turntable, spheronize at the speed of 10Hz for 15 minutes, adjust the reverse, and roll the pellets for 10 minutes at 20Hz The speed is forward, and the high-speed rolling is formed for 30 minutes. Turn on the fan to slow down, collect the pellet cores, and dry them in an oven at 45°C for 2 hours to obtain the pellet cores containing medicine. Weighed, t...

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Abstract

The invention belongs to the field sustained/controlled-release preparations, in particular to an oral sustained/controlled-release pellet combination containing ginkgo biloba extract and a preparation method. The oral sustained/controlled-release pellet combination is composed of (A) a core containing a pill; (B) an insulating coating layer; (C) a sustained-release coating layer; (D) and an enteric-coated coating layer. The invention is the traditional Chinese medicine multi-component sustained-release pellet combination which is taken once by 24 hours and the multi-unit sustained-release pellet combined preparation with the different drug release systems, the core containing the pill is prepared by adopting the extrusion pill rolling method, a novel sustained-release multi-layer coating technology and a fluidized bed are utilized for coating the sustained-release pellet, the rapid-release part and the sustained-release part of the coated pellet are mixedly filled into a hard capsule or pressed into a pellet tablet. The sustained-release pellet has stable coating process and good reproducibility, thereby being applicable to the industrial mass production; and the drug quality of the preparation is stable through the long-term storage. The in vitro release test shows that the multiple components of the traditional Chinese medicine can achieve the sustained-release role, the sustained-release preparation can significantly increase the transmembrane absorption and the stability of various effective active ingredients by oral drug administration, the curve of plasma drug concentration in vivo is smooth, and the design purpose of 24-hour sustained-release is achieved.

Description

technical field [0001] The invention belongs to the field of sustained / controlled release preparations, and specifically relates to a multi-component high-efficiency sustained / controlled release pellet composition containing traditional Chinese medicine ginkgo leaf extract and a preparation method thereof. / Controlled-release pellet preparation, this preparation technology is suitable for industrial production, and further provides a hard capsule with a multi-unit drug release system for slow / controlled release pellets, or compresses pellets with different release rates into tablets agent. Background technique [0002] Cardiovascular and cerebrovascular diseases such as coronary heart disease and hypertension are common and frequently-occurring clinical diseases. With the continuous improvement of people's living standards and the acceleration of the pace of life, cardiovascular and cerebrovascular diseases are on the rise year by year, becoming the main disease that threate...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/16A61K9/16A61K9/22A61K47/38A61K47/40A61P9/10A61K127/00
Inventor 王广基李娟郝海平赵炎磊张勇赵英超吕华
Owner CHINA PHARM UNIV
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