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Method for removing aristolochic acid from Chinese medicine and limit standard thereof

A technology of aristolochic acid and aristolochic acid salts, which is applied in the fields of pharmaceutical formulas, medical preparations containing active ingredients, plant raw materials, etc.

Inactive Publication Date: 2008-09-17
INST OF CHINESE MATERIA MEDICA CHINA ACAD OF CHINESE MEDICAL SCI
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, there are still many Chinese medicinal materials containing aristolochic acid used clinically, such as Aristolochia, Tianxianteng, Cinnabar lotus, Xugufeng, Asarum, etc., involving nearly 300 kinds of Chinese patent medicines, only relying on substitutes to replace the original The use or simple prohibition of traditional Chinese medicines cannot effectively solve all the problems of traditional Chinese medicines containing aristolochic acid. We should give full play to the advantages of traditional Chinese medicine, and use processing methods to achieve the purpose of attenuating and detoxifying, so as to ensure safe and rational drug use in clinical practice.

Method used

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  • Method for removing aristolochic acid from Chinese medicine and limit standard thereof
  • Method for removing aristolochic acid from Chinese medicine and limit standard thereof
  • Method for removing aristolochic acid from Chinese medicine and limit standard thereof

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preparation example Construction

[0021] Preparation of Reference Substance Solution Accurately weigh 11.83mg of aristolochic acid A reference substance, dissolve it in 10mL volume with absolute ethanol, shake well, and constant volume. Accurately weigh 1mL into a 10mL volumetric flask, add absolute ethanol to dilute to the mark, and shake well to obtain (every 1mL contains 0.1mg of aristolochic acid A).

[0022] Preparation of the test solution: Take about 1.5g of the powder of this product (through a 40-mesh sieve), accurately weigh it, place it in a 50mL stoppered Erlenmeyer flask, accurately add methanol: 10% formic acid water (4: 1) 25mL, soak for 1 Hours later, weigh. Sonicate 3 times, 15 minutes each time, make up the weight, draw about 13mL from it, centrifuge (3000 rpm -1 , 10min), accurately draw 10mL into an evaporating dish, evaporate to dryness, dissolve with methanol: 10% formic acid water (4:1), dilute to a 2mL volumetric flask, filter, and take the subsequent filtrate to obtain the final produ...

example 1

[0025] Example 1 Guan Mutong processing

[0026] Weigh 500g of Guan Mutong raw product, and use concentration of 0.1N NaHCO 3 Soak in 10 times the amount of solution for 24 hours, wash 3 times with water, about 10 times the amount of water each time, wash until colorless, then soak for the next time, repeat soaking-rinsing 5 times, drain, make with vinegar, stuffy, fry dry , to remove the Guan Mutong product of aristolochic acid, the consumption of rice vinegar is 20% (V / W) of the original medicinal material amount. Analysis by HPLC shows that the removal rate of aristolochic acid in the product is more than 93%.

example 2

[0027] Example 2 Aokixiang processed

[0028] Hebei Anguo Qingmuxiang raw product 10kg, with a concentration of 0.05N NaHCO 3 Soak in solution 6 times (V / W) for 24 hours, rinse with water for 3 times, slice 5-6 mm, soak in water for 3 hours, repeat the above process of alkali soaking-rinsing-water soaking-rinsing 6 times, drain, make with vinegar, and soak in water for 3 hours. Stew for 3 hours, stir-fry with a slow fire to obtain the Aokixiang decoction pieces from which the aristolochic acid has been removed, and the dosage of rice vinegar is 20% (V / W) of the original medicinal material. Analyzing by HPLC, the removal rate of aristolochic acid in Zhiqingmuxiang reaches more than 99%, and the residual amount of aristolochic acid A is 5ppm.

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Abstract

The invention relates to a method of removing the toxic ingredient of aristolochic acid from Traditional Chinese Medicine and the corresponding limit standard. Being aimed at the traditional Chinese medicinal materials containing aristolochic acid, the method is to obtain the processed medical herb in pieces with more than 99% f removal rate for the aristolochic acid after the process of repeated soaking - rinsing with weak acid strong alkali saline water and soaking - rinsing with clear water, draining and then vinegar baking. The invention is characterized in that the method can realize the purpose of selectively removing the toxic ingredient of aristolochic acid from the traditional Chinese medicine through the particular processing way, meanwhile, the limit standard of aristolochic acid is also formulated passing the systematical evaluation.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine research, and in particular relates to a method for removing aristolochic acid in traditional Chinese medicine and its limit standard. technical background [0002] Aristolochic acids are a series of nitrophenanthrene compounds, commonly found in plants of the genus Aristolochias pp. and Asarum spp. Sour traditional Chinese medicine can cause aristolochic acid nephropathy. The State Food and Drug Administration cancels the medicinal standards of Guan Mu Tong, Guang Fang Ji, and Qing Mu Xiang, and stipulates that Mu Tong, Fang Ji, and Tu Mu Xiang can be used instead of medicinal or clinical formulas. However, there are still many Chinese medicinal materials containing aristolochic acid used clinically, such as Aristolochia, Tianxianteng, Cinnabar lotus, Xugufeng, Asarum, etc., involving nearly 300 kinds of Chinese patent medicines, only relying on substitutes to replace the original Th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/264
Inventor 王智民高慧敏王金华李建荣王维皓刘凤山
Owner INST OF CHINESE MATERIA MEDICA CHINA ACAD OF CHINESE MEDICAL SCI
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