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Silybin-phospholipid complex and preparation method thereof

A technology of thisbinin phospholipid and silibinin, which is applied in the field of silibinin phospholipid complex soft capsules, can solve the problems of low oral bioavailability and poor water solubility, and achieve increased bioavailability, increased fat solubility, and drug quick effect

Inactive Publication Date: 2014-04-30
江苏健佳药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The silibinin currently on the market has good fat solubility, poor water solubility, and low oral bioavailability. Therefore, it is necessary to adopt a certain process to obtain silibinin with both water solubility and fat solubility.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Preparation of milk thistle extract

[0035] After screening the full-grained milk thistle seeds, first remove the oil in them by mechanical pressing to obtain milk thistle seed cakes. Take 500 grams of cakes and add 2000ml of acetone. After soaking for 2 hours, heat to 60 degrees Celsius and extract for 16 hours. Concentrate at 60 degrees Celsius for 6 hours, then dry at 85 degrees Celsius for 1 hour to obtain 48.7 grams of milk thistle extract.

Embodiment 2

[0036] Example 2 Preparation of silymarin

[0037] 48.7 grams of the milk thistle extract prepared in Example 1 were added to 200 grams of normal hexane and stirred at 600 RPM for 0.5 hour, and then left to stand for 30 minutes to remove the normal hexane solution by suction filtration (lipophilic properties such as oil in the solution) Substance); Repeat three times to obtain deoiled milk thistle extract; then add the deoiled milk thistle extract to 200 grams of 50% mass concentration of ethanol solution and stir for 0.5 hours after suction filtration to obtain a clear filtrate, The clarified filtrate was concentrated in vacuum at 75 degrees Celsius for 2.5 hours, and then the concentrated paste was spread on a stainless steel baking tray, dried in vacuum at 80 degrees Celsius for 3 hours, and pulverized to obtain 29.2 grams of dry powder of silymarin.

Embodiment 3

[0038] Embodiment 3 Preparation of silibinin

[0039] 29.2 grams of dry powder of silymarin prepared in Example 2 was added to 87.6 grams of 85% mass concentration of ethanol in water, heated to reflux at 70 degrees Celsius for 1 hour, and then left to stand for 24 hours. Separated for 3 hours to obtain the precipitate, and then spread the precipitate on a stainless steel baking tray, vacuum-dried at 80 degrees Celsius for 3 hours, and pulverized to obtain 7.3 grams of dry powder of silibinin.

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PUM

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Abstract

The invention relates to the field of chemical preparation and dosage form modification, in particular to a silybin-phospholipid complex and a preparation process thereof and a silybin-phospholipid complex soft capsule prepared from the complex. According to the silybin-phospholipid complex and the preparation process, a phospholipid complex is prepared from silybin, so that the water solubility of the silybin is greatly improved, the lipid solubility and water solubility of the obtained complex are balanced, and the bioavailability is greatly improved; moreover, the silybin-phospholipid complex soft capsules prepared from the complex also have high bioavailability, and are convenient to take; the utilization of the silybin is greatly promoted.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a silibinin phospholipid complex, a preparation process thereof, and a silibinin phospholipid complex soft capsule prepared by using the compound. [0002] Background technique [0003] Silymarin is derived from the plant Silybum marianum (purple flower) ( Silybum marianum (L.) Gaertn) a flavonoid extracted from the seeds. It is a yellow or brown powder, and its main components are substances such as silibinin, isosilibinin, silybinin and silymarin. Milk thistle is an excellent liver-protecting plant, which was recorded in Greek and Roman classics as early as the 1st century AD. The main active ingredient in milk thistle to protect the liver is silymarin. Silymarin can protect and stabilize the liver cell membrane, resist liver cell necrosis, reduce fatty degeneration, and inhibit the increase of alanine aminotransferase. It is clinically used to treat a...

Claims

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Application Information

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IPC IPC(8): A61K47/48A61K31/357A61K9/48A61P1/16
Inventor 周勇周晓娟梁呈元吴素琴伍晓月
Owner 江苏健佳药业有限公司
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