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Pharmaceutical composition of Silybin and preparation method thereof

A technology of silibinin and its composition, which is applied in the field of silibinin drug compound, preparation and its preparation, can solve the problems of no industrial application value, undisclosed method, complicated operation, etc., and achieve convenient clinical use, The effect of good fluidity and simple process flow

Active Publication Date: 2007-05-16
天津天士力圣特制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The method is complicated to operate, the yield is low, a toxic and harmful solvent is used, it has no industrial application value, and there is no disclosure of a method for preparing a preparation suitable for clinical application

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Preparation of silybin

[0029] Take a certain amount of silibinin seeds, crush them, place them in a Soxhlet extractor and extract them with ethyl acetate for 20 hours, concentrate the extract in a rotary evaporator, recover the solvent, and obtain a brownish yellow extract, wash the surface oil with petroleum ether, and obtain Paste crude silibinin. After degreasing, recrystallization and drying, 350 g of silybin was obtained.

[0030] Preparation of silybin medicinal composition

[0031] Add 6000ml of absolute ethanol to 350g of silibinin and 650g of soybean lecithin, heat to reflux to clarify the solution, concentrate under reduced pressure at 60°C until thick, add 1000g of lactose, 375g of talc, 125g of sodium carboxymethyl starch (CMS), 65 ℃ Spray granulation, dry, pass through a No. 2 sieve, and pulverize to obtain capsule fillings, which are divided into capsules to obtain a total of 10,000 finished products. A total of 3 batches of products were prepared acc...

Embodiment 2

[0033] The preparation of silibinin is the same as embodiment 1

[0034] Preparation of silybin medicinal composition

[0035] Add 350g of silibinin and 350g of soybean lecithin to 3500ml of absolute ethanol, heat to reflux to clarify the solution, concentrate under reduced pressure at 40°C until thick, add 460g of lactose, 70g of talc, 70g of sodium carboxymethyl starch (CMS), 50 ℃ Spray granulation, dry, pass through a No. 2 sieve, and pulverize to obtain capsule fillings, which are divided into capsules to obtain a total of 10,000 finished products. A total of 3 batches of products were prepared according to the above method, the capsule filling yields were respectively 97.5%, 97.3% and 97.2%, and the dissolution rates were respectively 97.7%, 97.9% and 98.3%.

Embodiment 3

[0037] The preparation of silibinin is the same as embodiment 1

[0038] Preparation of silybin medicinal composition

[0039] Add 86,100ml of absolute ethanol to 350g of silibinin and 14,000g of lecithin, heat to reflux to clarify the solution, concentrate under reduced pressure at 80°C until thick, add 70,000g of lactose, 40,000g of talc, 19,150g of sodium carboxymethyl starch (CMS), 50 ℃ Spray granulation, dry, pass through a No. 2 sieve, and pulverize to obtain capsule fillings, which are divided into capsules to obtain a total of 10,000 finished products. A total of 3 batches of products were prepared according to the above method, the capsule filling yields were respectively 97.5%, 97.4% and 97.1%, and the dissolution rates were respectively 97.8%, 98.0% and 98.5%.

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PUM

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Abstract

The invention provides a silybin and phosphatidy lcholine compound which is prepared into capsules with high dissolving degree. The invention also provides a process for preparing the silybin and phosphatidy lcholine compound and its capsule medicament, the preparing process is characterized by simple manufacturing method, high yield and fitting for mass production.

Description

technical field [0001] The invention relates to the field of drug compound, preparation and preparation method thereof, in particular to silybin drug compound, preparation and preparation method thereof. technical background [0002] In the late 1960s to 1980s, West German pharmacists represented by H. Wagner extracted and separated the active ingredient from the fruit of Silybum marianum, a plant of the genus Silybum marianum in the family Asteraceae, called silymarin, which is a class of A novel flavonoid compound with a C-9 substituent, that is, flavonoid lignans formed by condensation of dihydroflavonols and phenylpropanoid derivatives. Silybin (Silybin, silibinin) is one of the main components of milk thistle. Pharmacological and toxicological studies have shown that it can obviously protect and stabilize the liver cell membrane, promote the recovery of liver cells, and improve liver function. It has different degrees of protective and therapeutic effects on liver dam...

Claims

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Application Information

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IPC IPC(8): A61K31/357A61K47/24A61P1/16
Inventor 章顺楠杨建会张洪坡董莉娜刘彤孙艳
Owner 天津天士力圣特制药有限公司
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