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Frozen powder injection of silybin and its preparing method

A technology of silibinin and freeze-dried powder injection, which is applied in the direction of freeze-dried transportation, powder transportation, digestive system, etc., and can solve the problems that freeze-dried products cannot be used and cannot meet the needs of production time.

Inactive Publication Date: 2005-10-12
SHANDONG GREENERY NATURAL MEDICINE RES & DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] When silibinin meglumine is prepared into a freeze-dried agent, it first needs to be formulated into an aqueous solution, and the aqueous solution of silibinin meglumine becomes turbid within 30 minutes at room temperature, which cannot meet the time requirement for production. The lyophilized product in this case is not clinically usable

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Dosing: Weigh 500.00g of silibinin meglumine, put it in a container, add 100g of mannitol, 10g of sodium bisulfite, 0.5g of EDTA-2Na, add an appropriate amount of water to dissolve, adjust the pH to 10.5 with sodium hydroxide solution , add water to 10000ml, stir evenly; filter and pack: use 0.22μ microporous filter membrane to filter, and pack the filtrate according to 2.0ml each; freeze-dry: cool down at a rate of 5°C per minute until the product cools down to -40°C , maintain for 3 hours; start vacuuming, control the vacuum degree at 100±50μbas, control the product temperature at -20℃, and maintain it for 15 hours; then, gradually increase the temperature to 20℃, control the vacuum degree at 200±50μbas, after reaching 20℃2 , continue to maintain for 3 hours, vacuum stopper, that is.

Embodiment 2

[0016] Dosing: Weigh 100.00g of 2-hydroxypropyl-β-cyclodextrin, add water to dissolve, weigh 100.00g of silibinin meglumine, put it in the above solution, stir well; then add 400g of lactose, thio Sodium sulfate 3.0g, EDTA-2Na 0.5g, stir to dissolve, adjust the pH to 9 with sodium hydroxide solution, add water to 10000ml, stir evenly; filter and pack: use 0.22μ microporous filter membrane to filter, the filtrate is divided by each 1.0ml aliquots; freeze-drying: cool down at a rate of 5°C per minute until the temperature of the product drops to -40°C, and maintain for 3 hours; start vacuuming, control the vacuum degree at 100±50μbas, control the product temperature at -20°C, and maintain 15 hours; then, gradually raise the temperature to 20°C, control the degree of vacuum at 200±50μbas, after reaching 20°C2, continue to maintain it for 3 hours, and vacuum stopper to obtain.

Embodiment 3

[0018] Dosing: Weigh 50.00g of 2-hydroxypropyl-β-cyclodextrin, add water to dissolve, weigh 100.00g of silibinin meglumine, put it in the above solution, and stir well; then add 400g of mannitol, sulfur Sodium sulfite 5.0g, EDTA-2Na 0.5g, stir to dissolve, adjust pH to 9.5 with sodium hydroxide solution, add water to 10000ml, stir evenly; filter and pack: use 0.22μ microporous membrane filter, filtrate Only 2.0ml aliquots; freeze-drying: cool down at a rate of 5°C per minute until the product cools down to -40°C, and maintain for 3 hours; start vacuuming, control the vacuum at 100±50μbas, and control the product temperature at -20°C. Maintain for 15 hours; then, gradually raise the temperature to 20°C, control the degree of vacuum at 200±50μbas, after reaching 20°C, continue to maintain for 3 hours, vacuum stopper, and the product is obtained.

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PUM

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Abstract

A freeze-dried powder injection of silibinin salt features that it contains silibinin salt which may be the inorganic or organic alkaline salt of silibinin or its salt of amino acid, the pH regulator and / or solubilizer.

Description

technical field [0001] The present invention relates to a kind of silybin salt as an active ingredient, clinically used for the treatment of acute and chronic hepatitis freeze-dried powder and its preparation method, in particular to silybin organic alkali salt, inorganic alkali salt or alkaline Freeze-dried powder injection of amino acid salt and preparation method thereof. Background technique [0002] Milk thistle is a plant of Compositae, native to southern Europe and North Africa, and is used in folk medicine to treat liver diseases. In 1968, Wagner et al. extracted a flavonoid compound from it and named it Silymarin. It has been proved that the main component of silymarin is Silybin. Its chemical name is: 2-[2,3-Dihydro- 2-(4-hydroxy-3-methoxyphenyl)-3-(hydroxymethyl)-1,4-benzodioxin-6-yl]-2,3-dihydro-3,5,7-trihydroxy-4H-1-benzopyran-4 -one, clinically used for acute hepatitis, chronic hepatitis, early liver cirrhosis, fatty liver, toxic liver damage (such as taking ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/357A61P1/16A61P31/12
Inventor 赵大州王振华傅风华何杰苟海涛
Owner SHANDONG GREENERY NATURAL MEDICINE RES & DEV
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