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Medicine for treating hepatitis and its preparing process

A technology for drugs and hepatitis, applied in the field of drugs and their preparation, can solve the problems of drugs affecting the safety of clinical medication, product quality and stability, failing to reflect the purity of glycyrrhizic acid and its salts, and restricting the scope of use, so as to reduce toxic and side effects. and stimulatory effect, less side effects, reducing the effect of stimuli

Inactive Publication Date: 2004-11-17
CHENGDU SHENGNUO BIOTEC CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The UV method is to measure the total amount of all absorbing compounds at a specific wavelength, so the content determination result cannot reflect the purity of glycyrrhizic acid and its salts
[0004] As we all know, the purity of drugs will directly affect the safety of clinical medication and the stability of product quality, especially when injecting drugs, there will often be toxic and side effects and irritation, thus limiting the scope of clinical use of such drugs, At the same time, the efficacy will be significantly reduced

Method used

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  • Medicine for treating hepatitis and its preparing process
  • Medicine for treating hepatitis and its preparing process
  • Medicine for treating hepatitis and its preparing process

Examples

Experimental program
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Effect test

Embodiment 1

[0027] A medicine for treating hepatitis, characterized in that the active ingredient is a compound represented by the following structural formula (I) with a liquid chromatography purity of 98%, wherein R1, R2, and R3 are H + and / or NH 4 + .

[0028]

[0029] The preparation method of above-mentioned pharmaceutical active ingredient (I) described in the present invention comprises following processing steps:

[0030] A, get the crude product of glycyrrhizic acid or its salt, dissolve with mobile phase, get crude product solution;

[0031] B, filter the crude product solution with a 0.22 μ microporous filter membrane, then inject the filtrate into a chromatographic column with octadecylsilane bonded silica gel (C18) as a filler, and select aqueous acetic acid and acetonitrile by high performance liquid chromatography The mixed solution is used as the mobile phase, and 250nm is selected as the detection wavelength, and the crude product solution of glycyrrhizic acid or it...

Embodiment 2

[0038] Embodiment 2: the preparation of high-purity (HPLC) glycyrrhizic acid

[0039] Take 200 g of crude glycyrrhizic acid, dissolve it in 3.5 L of mobile phase, and filter it with a 0.45 μ microporous membrane. Get glycyrrhizic acid crude product solution 100ml and inject in chromatograph, chromatographic condition: chromatographic column is Varian C18 10 μ (41.4 * 250mm), and mobile phase is 10% acetic acid aqueous solution-% acetonitrile (70: 30), and detection wavelength is 252nm, and flow velocity is 40ml / min. The component solutions were collected and evaporated to dryness under reduced pressure in a 40° C. water bath with a rotary evaporator to obtain 129.6 g of white solid powder with a yield of 64.8%.

[0040] HPLC purity

Embodiment 3

[0041] Embodiment 3: the preparation of diammonium glycyrrhizinate (or monoammonium glycyrrhizinate)

[0042] HPLC purity

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Abstract

The invention relates to a pharmaceutical composition for treating hepatitis and process for preparation, whose reactive constituents is compound with liquid phase chromatogram purity over 95% and has the structural formula (I) disclosed in the specification, wherein the compound can be made into various dosage forms including granule, capsule, tablet, and injection.

Description

Technical field: [0001] The invention relates to a medicine and a preparation method thereof, in particular to a medicine for treating hepatitis and a preparation method thereof. technical background: [0002] Glycyrrhizic acid is an active ingredient extracted from the traditional Chinese medicine licorice, and its ammonium salt has obvious enzyme-lowering, anti-inflammatory and liver-protecting effects. There are many ways to separate and refine glycyrrhizic acid from licorice or licorice extract, such as the classic solvent extraction method, ion exchange resin method, polyamide adsorption separation method, recrystallization method and ultrafiltration method. Complicated, the main component high performance liquid chromatography (HPLC) has low purity, low yield, high cost, time-consuming and labor-intensive and other shortcomings. [0003] Due to the defects of the production process, the currently marketed glycyrrhizic acid and its salts, or glycyrrhizic acid and its s...

Claims

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Application Information

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IPC IPC(8): A61K31/704A61P1/16A61P31/12C07J63/00
Inventor 文永均谢期林谢海峰王晓莉
Owner CHENGDU SHENGNUO BIOTEC CO LTD
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