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Novel process for preparation of silybum mariamum extractive methylglucamine

A technology of meglumine salt and extract, which is applied in the field of new preparation of milk thistle extract meglumine salt, can solve the problems of large fluctuation, unsuitable for drying treatment, low content of silybin meglumine, etc.

Active Publication Date: 2005-03-16
NANJING CHENXIANG MEDICAL RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The product obtained by this method is a brown-red extract-like semi-solid, which is not suitable for drying treatment; the product after drying is a lump and needs to be pulverized; At 85-94%, it is not up to the standards of raw materials for injection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Preparation of silybin meglumine salt

[0022] Weigh silibinin and meglumine according to the prescription listed in Table 1, dissolve with appropriate amount of absolute ethanol respectively, add appropriate amount of needle and stir with activated carbon for 15 minutes, filter, fully stir and mix the two filtrates at room temperature, and then place them at room temperature for 4 hours, filtered and dried. As a result, 170.6 g of silybin meglumine was obtained, with a content of 99.72%.

[0023] Table 1 silybin meglumine dosage

[0024] Ingredients Feed amount

[0025] Silybin 124g

[0026] Meglumine 53g

[0027] Absolute ethanol 150ml

Embodiment 2

[0029] Preparation of Silibinin Meglumine Hard Capsules

[0030] Weigh the silybin meglumine obtained by the method of Example 1, add appropriate amount of starch, pregelatinized starch, and magnesium stearate according to the prescription in Table 2 to make a soft material, pass through a 14-mesh sieve to granulate, and dry at 80°C , through a 16-mesh sieve for whole grains, canned in hard capsules, wiped, fully inspected, subpackaged, and packaged.

[0031] The prescription composition of table 2 silibinin meglumine hard capsule

[0032] Ingredients Feed amount (g)

[0033] Silybin Meglumine 500

[0034] Starch 500

[0035] Pregelatinized Starch Slurry Q.S.

[0036] Magnesium Stearate Q.S.

Embodiment 3

[0038] Preparation of Silybin Meglumine Dispersible Tablets

[0039] Weigh the silibinin meglumine obtained by the method of Example 1, add appropriate amount of microcrystalline cellulose and cross-linked polyvinylpyrrolidone according to the prescription in Table 3, mix evenly, add appropriate amount of magnesium stearate to press into tablets, and obtain.

[0040] The prescription composition of table 3 silibinin meglumine dispersible tablet

[0041] Ingredients Feed amount (g)

[0042] Silybin Meglumine 500

[0043] Microcrystalline Cellulose 900

[0044] Cross-linked polyvinylpyrrolidone 300

[0045] Magnesium Stearate Q.S.

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PUM

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Abstract

The invention relates to the field of pharmaceutical, in particular a novel process for preparation of silybum mariamum extractive methylglucamine, wherein dissolvent method is employed for preparing silybum mariamum extractive methylglucamine from silybum marianum extract at nonrefluence state, compared with the prior art, this method eliminates heating backflow, dissolvent decompression reclamation and long period of decompression drying, the content of silibinin-N-methylglucamine is over 99.0%.

Description

technical field [0001] The invention relates to the field of medicine synthesis, in particular to a new preparation method of milk thistle extract meglumine salt. Background technique [0002] Milk thistle extract is a lignin flavonoid compound obtained from the fruit of Silybum marianum Gaertin., a plant of the genus Silybum in the family Asteraceae, including silymarin and silybin. Pharmacological and toxicological test studies have shown that both have obvious protective and stabilizing effects on liver cell membranes, can promote liver cell regeneration, and have different degrees of protective and therapeutic effects on liver damage caused by various poisons. Clinically, silybin or silymarin is mainly used to treat various acute and chronic hepatitis, initial liver cirrhosis and liver poisoning, and is one of the main therapeutic drugs for chronic persistent hepatitis and liver cirrhosis in the market. [0003] Since silybin or silybin is insoluble in water, the oral b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D407/04
Inventor 邢为藩龚明涛
Owner NANJING CHENXIANG MEDICAL RES
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