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Silybin compound emulsion for intravenous injection and preparation method thereof

A technology of silibinin and water for injection, which is applied in the field of medicine and medicine to achieve the effects of improving bioavailability, increasing effect, and increasing drug loading and drug concentration

Inactive Publication Date: 2009-05-27
YANGTZE RIVER PHARM GRP SICHUAN HAIRONG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, there are two key issues to be solved when using emulsion as a drug carrier: 1. Whether the drug can be prepared into an emulsion depends on the physical and chemical properties of the drug itself and its clinical indications. Not all raw materials are suitable for preparing into an emulsion, and there is no The prescription and preparation process of a drug-loaded emulsion can be obtained simply by applying the existing technology
2. Whether the expected effect can be achieved after the drug is prepared into an emulsion cannot be simply deduced, and experiments must be carried out to verify it
So far, there are no literature and patent reports about silybin fat emulsion at home and abroad

Method used

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  • Silybin compound emulsion for intravenous injection and preparation method thereof
  • Silybin compound emulsion for intravenous injection and preparation method thereof
  • Silybin compound emulsion for intravenous injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Dissolve and disperse 10g of lecithin and 30g of glycerin in 700ml of water for injection preheated to 60°C, stir to disperse the phospholipids evenly in the water phase; add 3g of silibinin to 200g of soybean oil preheated to 60°C, After the dissolution is complete, an oily phase is obtained. Slowly add soybean oil for injection into the water phase stirred at 10,000 rpm, and stir at 60°C for 5 minutes to obtain colostrum; add water for injection to 1000 ml of colostrum, put it in a high-pressure milk homogenizer and repeatedly homogenize melt until the average particle size reaches below 0.4 micron, fill with nitrogen, and sterilize to obtain the finished emulsion for intravenous injection.

Embodiment 2

[0035]Dissolve and disperse 10g soybean lecithin, 4g paloxamer 188 (F-68) and 20g mannitol in 650ml water for injection preheated to 60°C to prepare a uniformly dispersed aqueous phase; add another 4g silibinin In 250g castor oil for injection preheated to 60 ℃, after dissolving completely, the oily phase is obtained. Slowly add the oil phase to the water phase stirred at 10,000 rpm, and stir at 60°C for 10 minutes to prepare colostrum; add water for injection to 1000 ml of colostrum, and homogenize it in a high-pressure homogenizer for 3 times, until the average particle size reaches below 0.4 micron, fill with nitrogen, and sterilize to obtain the finished emulsion for intravenous injection.

Embodiment 3

[0037] Dissolve and disperse 20g of soy lecithin and 25g of glycerin in 600ml of water for injection preheated to 60°C to prepare a uniformly dispersed water phase; take another 2g of silibinin and add it to 150g of soybean oil preheated to 60°C to dissolve completely Afterwards, the oily phase was obtained. Slowly add the oil phase to the water phase stirred at 10,000 rpm, and stir at 60°C for 10 minutes to prepare colostrum; add water for injection to 1,000 ml of colostrum, and put it in a high-pressure homogenizer for repeated internal homogenization When the average particle size reaches below 0.4 micron, it is filled with nitrogen and sterilized to obtain the finished emulsion for intravenous injection.

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Abstract

The invention relates to a silibinin compound emulsion used for intravenous injection and a preparation method. Components for preparing raw material of 1000 ml comprise 0.08 percent to 8 percent silibinin compound, 10 percent to 48 percent triglyceride compound, 0.08 percent to 18 percent emulsifier, 1 percent to 15 percent water-soluble or oil-soluble addition agent and the reminder which is injection water. The distribution range of particle size of the emulsion is ranged from 0.1 micron to 1 micron, and the average particle size is ranged from 0.2 micron to 0.4 micron. The preparation method comprises steps which are colostrum preparation, high pressure homogenization, sterilization, and the like; the emulsion has the advantages of dramatic efficacy, high bioavailability, high drug loading, sustained release, passive liver targeting, low toxic side effect, and the like.

Description

technical field [0001] The invention relates to an emulsion for intravenous injection, in particular to a silybin compound emulsion and a preparation method thereof, which belong to the field of medicines. Background technique [0002] my country is a country with a high incidence of liver disease. At present, there are about 30 million chronic hepatitis B patients and 120 million hepatitis B virus carriers. Most patients with liver disease are accompanied by gallbladder disease, the medication cycle is long, it is difficult to be completely cured, and there are many cases of recurrent attacks. [0003] Silibinin (SL) is a flavonoid compound extracted and refined from the seeds of the Compositae plant, Silibinin, and its chemical structure is as follows: [0004] [0005] It has been reported that silibinin and its isomers have a stabilizing effect on liver cell membranes, which can prevent or avoid the loss of dissolved cellular components (such as transaminases). Sily...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/357A61P1/16
Inventor 李元波薛立安殷建华彭熙林毛声俊
Owner YANGTZE RIVER PHARM GRP SICHUAN HAIRONG PHARM CO LTD