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Silybinin injection and its preparation method

A technology of silibinin and injection, which is applied in the field of silibinin injection and its preparation, and can solve problems such as poor stability, easy degradation, and high pH value of aqueous solution

Inactive Publication Date: 2006-04-26
丛晓东 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Silybin and other active ingredients are insoluble in water, and the oral bioavailability is low, with large individual differences. Although the existing silibinin meglumine salt is easily soluble in water, it will still be precipitated in the stomach. Affect absorption and efficacy
Injection administration can solve the above problems, but there is no report on this aspect in the literature. The main reason is technical difficulty: for example, silibinin is soluble in water and insoluble in vegetable oil, so it is difficult to make injections with water or oil as the carrier. , such as making alkali metal salts can solve the problem of water solubility, but the pH value of the aqueous solution is too high, which is difficult to accept physiologically. easy to degrade

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Take 48.2 grams of silibinin and 19.5 grams of meglumine, heat and dissolve in ethanol, reflux overnight, evaporate the ethanol to dryness under reduced pressure, and obtain silybin meglumine as a solid.

[0020] Take 48.2 grams of silibinin and 17.9 grams of glucosamine, heat and dissolve in ethanol, reflux overnight, evaporate the ethanol to dryness under reduced pressure, and obtain silybin glucosamine as a solid.

[0021] Take 48.2 grams of silibinin and 17.4 grams of arginine, heat and dissolve in ethanol, reflux overnight, evaporate the ethanol to dryness under reduced pressure, and obtain silybin arginine as a solid.

Embodiment 2

[0023] Get the silybin meglumine solid obtained in an appropriate amount of Example 1, dissolve in an appropriate amount of water for injection, stir and dissolve, the concentration is 5 mg / ml, add an appropriate amount of co-solvent, adjust the pH, add 0.05% (g / ml) gac, and use Dilute with water for injection to volume, heat and stir for 30 minutes, filter, subpackage, and sterilize to obtain silybin meglumine injection.

Embodiment 3

[0025] Take an appropriate amount of silibinin glucosamine solid obtained in Example 1, dissolve it in an appropriate amount of water for injection, stir to dissolve, the concentration is 8 mg / ml, add an appropriate amount of co-solvent, adjust the pH, add 0.05% (g / ml) activated carbon, and inject Dilute to volume with water, heat and stir for 40 minutes, filter, subpackage, and sterilize to obtain silybin glucosamine injection.

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PUM

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Abstract

The invention relates to a silybin injection and its preparation method, which comprises silybin meglumine, glucosamine, alkaline amino acid solubiliser and pharmaceutically acceptable solvent, or compound of silybin and alkaline solubiliser and pharmaceutically acceptable solvent, the pH is 4-11. The injection also comprises one or more of pharmaceutically acceptable solubilizer, pH regulator, isotonic conditioning agent, painkiller, anti-oxidant agent, preservative and complexing agent.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a silybin injection and a preparation method thereof. technical background [0002] Silymarin (Silymarin) is a loose powder obtained by extracting and refining the fruit of Silybum marianum (L.) Gaertn., a plant of the Compositae family. It tastes slightly bitter, has hygroscopicity, is insoluble in water, and has obvious protection and stabilize the liver cell membrane; it has different degrees of protective and therapeutic effects on various types of liver damage caused by carbon tetrachloride, acetamide sulfide and other liver poisons; Elevation has a certain blocking effect. It is clinically used in the treatment of chronic persistent hepatitis, chronic active hepatitis, early liver cirrhosis, liver poisoning and other diseases, and it can significantly improve the symptoms, signs and liver function of patients with acute and chronic hepatitis. Silymar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/357A61K9/08A61P1/16
Inventor 丛晓东
Owner 丛晓东
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