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Liver protecting prepn containing silybin and total arasaponin and its prepn process and quality control method

A technology of silibinin and Panax notoginseng total saponins, which is applied to liver protection preparations containing silybin and Panax notoginseng total glucosides and the fields of their preparation and quality control, can solve the problem of limited curative effect, no compatibility of Panax notoginseng and silymarin Research reports, drug shortages, etc.

Inactive Publication Date: 2006-05-17
NANJING UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] At present, there are many liver injury diseases in China, and the market for therapeutic drugs is large, especially for injections, where drugs are in short supply. Glycyrrhizic acid injections are mainly used in a large number of clinical applications, but their curative effect is limited, so there is no good treatment in our country. Specific drugs for liver damage, and there are no research reports and related research information on the compatibility of Panax notoginseng and milk thistle

Method used

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  • Liver protecting prepn containing silybin and total arasaponin and its prepn process and quality control method
  • Liver protecting prepn containing silybin and total arasaponin and its prepn process and quality control method
  • Liver protecting prepn containing silybin and total arasaponin and its prepn process and quality control method

Examples

Experimental program
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Effect test

Embodiment 1

[0081] The preparation of embodiment one liver-protecting injection

[0082] Take 100g of silibinin meglumine, add 5L of water for injection, stir, dissolve, centrifuge, add 100g of Panax notoginseng saponins to the supernatant, and then add 3L of co-solvent, which is either polyethylene glycol or propylene glycol , dissolved, diluted to 20L with an appropriate amount of water for injection, mixed evenly, filtered, the filtrate was ultrafiltered through an ultrafiltration membrane with a flux of 50,000 molecular weight, potted, 10ml / branch, and the injection was obtained.

Embodiment 2

[0083] The preparation of embodiment two compound medicine freeze-dried powder injection

[0084] Take 125g of silybin meglumine, add 4L of water for injection, stir, dissolve, centrifuge, add 125g of Panax notoginseng saponins and 750g of molding agent to the supernatant, the molding agent is at least one of mannitol or glucose, and dissolve , diluted to 10L with an appropriate amount of water for injection, mixed evenly, filtered, the filtrate solution was ultrafiltered by an ultrafiltration membrane with a flux of 100,000 molecular weight, aseptically dried, divided into 2500 bottles, 4ml per bottle, freeze-dried, and capped , label, you can get the powder needle.

Embodiment 3

[0085] The rabbit erythrocyte hemolysis test comparison of embodiment three compound drug lyophilized powder and Panax notoginseng saponins solution

[0086] Referring to the pharmacological experiment methodology, take 20ml of blood from the heart of a rabbit, put it in a clean and dry beaker, stir it with a bamboo stick to remove fibrin, then transfer the blood into a centrifuge tube, add normal saline, mix well and centrifuge for 5 minutes (2500r / min) , discard the supernatant, add normal saline, mix and centrifuge, wash repeatedly until the supernatant is colorless and transparent, and then dilute the obtained red blood cells into a 2% suspension with normal saline according to its volume. Take 12 test tubes and divide them into two groups, put the number 1-6 on the test tube rack, put the number 1-6 on the test tube rack, add normal saline 2.4, 2.3, 2.2, 2.1, 2.0, 2.5ml, add 2% blood cell suspension solution of 2.5ml to each tube, then add No. 1-5 total saponins solution ...

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Abstract

The present invention is one kind compound Chinese medicine preparation for protecting liver and treating various hepatopathy and its preparation process and quality control method. The compound preparation consists of water soluble silybin derivative silybin meglumine and total arasaponin as the effective components of notoginseng in the weight ratio of 1 to 0.2-2. It is prepared into injection through dissolving, adding polyglycol or propylene glycol as co-solvent, filtering, ultrafiltering and packing; or into powder for injection through dissolving, adding mannitol or glucose as forming agent, filtering, ultrafiltering and freeze drying. Its contents of silybin and total arasaponin and its fingerprint are determined via HPLC process. The compound preparation of the present invention has curative effect obviously higher than its single components, and has the features of high curative effect and high safety.

Description

[technical field] [0001] The invention relates to a medicine for injection with hepatoprotective effect for treating various liver damage diseases, a preparation method and a quality control method thereof. The drug is made from the water-soluble derivative silibinin meglumine, which is a flavonoid component silybin extracted from the traditional Chinese medicine milk thistle, and the effective component Panax notoginseng saponins extracted from the traditional precious traditional Chinese medicine Panax notoginseng. [Background technique] [0002] The liver is an important metabolic organ of the human body, with complex structures and functions, and is susceptible to various pathogens, toxins and immunopathology. Viruses, chemicals, drugs, alcohol, and autoimmunity can all cause liver damage. Viral hepatitis, in particular, is distributed all over the world. Because it is difficult to cure and has a wide range of harm, it is also called "the three chronic diseases of the c...

Claims

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Application Information

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IPC IPC(8): A61K31/704A61K9/19A61K31/357A61P1/16G01N30/90G01N33/15
Inventor 彭国平阮鸣李红阳
Owner NANJING UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
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