High-purity silybin meglumine, preparation method as well as application in preparing medicine treating hepatitis and liver hurt thereof

A technology of silibinin and meglumine, which is applied in the field of medicine, can solve the problems of low purity, achieve high purity, improve human bioavailability, eliminate potential safety hazards in clinical application and poor quality controllability

Inactive Publication Date: 2008-05-14
江苏联创医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Compared with the prior art, the high-purity silybin meglumine provided by the present invention is determined by HPLC, and the content is more than 98%, which overcomes the low purity of silybin meglumine and the content of more than 75%. Insufficient, eliminating the hidden dangers of clinical application safety and poor quality controllability caused by the low purity of silibinin meglumine

Method used

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  • High-purity silybin meglumine, preparation method as well as application in preparing medicine treating hepatitis and liver hurt thereof
  • High-purity silybin meglumine, preparation method as well as application in preparing medicine treating hepatitis and liver hurt thereof
  • High-purity silybin meglumine, preparation method as well as application in preparing medicine treating hepatitis and liver hurt thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0134] Take 30g of commercially available silybin meglumine, add 1500ml of isopropanol, heat and reflux to dissolve the sample, keep it for 0.5 hours, filter while it is hot, place the filtrate in a refrigerator at 4°C for 8 hours, filter, and concentrate the filtrate at 70°C under reduced pressure Evaporate the solvent to dryness, and dry under vacuum at 40°C for 24 hours to obtain a khaki powder; add 360ml of distilled water, stir at 10°C for 10 minutes to dissolve, filter, add 480ml of saturated saline to the filtrate, place it in a refrigerator at 4°C overnight, filter, and filter at 40°C Vacuum dry for 24 hours to obtain a light yellow powder; add 2000ml of isopropanol, heat to reflux to dissolve the sample, filter while it is hot, place the filtrate in a refrigerator at 4°C for 8 hours, filter, and concentrate the filtrate at 70°C under reduced pressure to evaporate the solvent to dryness, 40 °C and vacuum-dried for 24 hours to obtain 16.8 g of light yellow powder.

[01...

Embodiment 2

[0140] Take 30g of commercially available silybin meglumine, add 900ml of isopropanol, heat and reflux to dissolve the sample, keep it for 45 minutes, filter while it is hot, place the filtrate in a refrigerator at 4°C for 8 hours, filter, and concentrate the filtrate under reduced pressure at 40°C Evaporate the solvent to dryness, and dry in vacuum at 40°C for 24 hours to obtain a khaki powder; add 120ml of distilled water, stir at 0°C for 10 minutes to dissolve, filter, add 240ml of saturated saline to the filtrate, place it in a refrigerator at 4°C overnight, filter, and filter at 40°C Vacuum dry for 24 hours to obtain a light yellow powder; add 1200ml of isopropanol, heat to reflux to dissolve the sample, filter while it is hot, place the filtrate in a refrigerator at 4°C for 8 hours, filter, and concentrate the filtrate at 40°C under reduced pressure to evaporate the solvent to dryness, 40 °C and vacuum dried for 24 hours to obtain 17.5 g of light yellow powder.

[0141] ...

Embodiment 3

[0143] Take 30g of commercially available silybin meglumine, add 1200ml of isopropanol, heat and reflux to dissolve the sample, keep it for 15 minutes, filter while it is hot, place the filtrate in a refrigerator at 4°C for 8 hours, filter, and concentrate the filtrate at 60°C under reduced pressure Evaporate the solvent to dryness, and dry under vacuum at 40°C for 24 hours to obtain a khaki powder; add 240ml of distilled water, stir at 3°C ​​for 10 minutes, dissolve, filter, add 360ml of saturated saline to the filtrate, place it in a refrigerator at 4°C overnight, filter, and filter at 40°C Vacuum dry for 24 hours to obtain a light yellow powder; then add 1600ml of isopropanol, heat to reflux to dissolve the sample, filter while it is hot, place the filtrate in a refrigerator at 4°C for 8 hours, filter, and concentrate the filtrate at 50°C under reduced pressure to evaporate the solvent to dryness, 40 °C and vacuum dried for 24 hours to obtain 18.5 g of light yellow powder. ...

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Abstract

The invention relates to silibinin meglumine with high purity, the preparation method and the application in preparing the drugs for treating acute attack of acute hepatitis and chronic hepatitis and toxic liver injury, belonging to medical technical field. The content of the silibinin meglumine with high purity is more than 98% tested using HPLC, thereby the drawbacks of bad safety for clinical application and bad quality controllability due to low purity of silibinin meglumine are overcome. The invention has the advantages of high purity, good stability and safety and improved human bioavailability compared to former oral preparation since the silibinin meglumine with high purity can be used for injection preparation.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to a high-purity silybin meglumine, its preparation method and its use in the preparation of medicines for the treatment of acute hepatitis, acute exacerbation of chronic hepatitis and toxic liver damage. application. Background technique: [0002] In the 1960s, West German pharmacists represented by H Wagner discovered that the seeds of the Compositae plant Silybum marianum contained new flavonoids, including silybin, silymarin, and silybum. Jiting and silymarin, collectively known as silymarin. The main ingredient is silibinin, which has been proved by pharmacological experiments to protect the liver cell membrane, improve liver function, resist liver damage caused by various liver poisons, and has extremely low toxicity, which has attracted the attention of many countries and led to Research efforts on milk thistle have spanned five continents. By 1978, in just ten years, mo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D407/04A61K31/357A61P1/16
Inventor 丛晓东
Owner 江苏联创医药技术有限公司
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