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Pretreatment technology for detecting metal impurity in puerarin active ingredient

A technology for metal impurities and raw materials, applied in the field of analytical chemistry, can solve the problems of unreported application and low detection limit

Inactive Publication Date: 2018-01-23
NANJING XIANCAOTANG BIOLOGICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The ICP-AES method has the advantages of low detection limit, high accuracy, wide dynamic linear range and simultaneous determination of multiple elements. It has certain competitiveness in the analysis of inorganic substances and has been widely used in chemical industry, geology, materials, environment and biological Samples and many other fields, but the application in drug analysis, especially in Chinese herbal medicines, has not been reported

Method used

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  • Pretreatment technology for detecting metal impurity in puerarin active ingredient

Examples

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Comparison scheme
Effect test

Embodiment 1

[0019] Example 1: A pretreatment process for detecting metal impurities in puerarin bulk drug

[0020] (1) Take kudzu root, crush it into powder, pass through a 50-mesh sieve, and then immerse it in 0.05mol / L hydrochloric acid solution for 1 hour.

[0021] (2) Add 0.05 mol / L sodium hydroxide solution to the system in step (1), adjust the pH value to neutral, and then filter to remove the filtrate to obtain a filter residue.

[0022] (3) Use hydrogen peroxide with a mass fraction of 0.1% to treat the filter residue collected in step (2), wash it twice, filter the filter residue, and then dry the filter residue at 55°C.

[0023] (4) Take the filter residue after drying in step (3), add EDTA solution and sodium hydroxide solution to it, and stir and react at 25° C. for 1 hour.

[0024] (5) Take the supernatant after the reaction in step (4), and use high performance liquid chromatography to detect the content of metal ions therein.

Embodiment 2

[0025] Example 2: A pretreatment process for detecting metal impurities in puerarin bulk drug

[0026] A kind of technique that is used to detect metal impurity in puerarin crude drug, described technique comprises the following steps:

[0027] (1) Take kudzu root, crush it into powder, pass through a 70-mesh sieve, and then immerse it in 0.08mol / L hydrochloric acid solution for 2 hours.

[0028] (2) Add 0.08 mol / L sodium hydroxide solution to the system in step (1), adjust the pH value to neutral, and then filter to remove the filtrate to obtain a filter residue.

[0029] (3) Treat the filter residue collected in step (2) with 0.2% hydrogen peroxide, wash it three times, filter the filter residue, and then dry the filter residue at 60°C.

[0030] (4) Take the filter residue after drying in step (3), add EDTA solution and sodium hydroxide solution to it, and stir and react at 30° C. for 2 hours.

[0031] (5) Take the supernatant after the reaction in step (4), and use high p...

Embodiment 3

[0032] Example 3: A pretreatment process for detecting metal impurities in puerarin bulk drug

[0033] A kind of technique that is used to detect metal impurity in puerarin crude drug, described technique comprises the following steps:

[0034] (1) Take kudzu root, crush it into powder, pass through an 80-mesh sieve, and then immerse it in 0.09mol / L hydrochloric acid solution for 2 hours.

[0035] (2) Add 0.09 mol / L sodium hydroxide solution to the system in step (1), adjust the pH value to neutral, and then filter to remove the filtrate to obtain a filter residue.

[0036] (3) Treat the filter residue collected in step (2) with 0.2% hydrogen peroxide, wash it three times, filter the filter residue, and then dry the filter residue at 58°C.

[0037] (4) Take the dried filter residue in step (3), add EDTA solution and sodium hydroxide solution to it, and stir and react at 30°C for 2 hours;

[0038] (5) Take the supernatant after the reaction in step (4), and use high performan...

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Abstract

A technology for detecting a metal impurity in a puerarin active ingredient comprises the following steps: step I: grinding radix puerariae, sieving with a 50-100-mesh sieve to form an undersize product, immersing the undersize product in a hydrochloric acid solution for treatment, step II: regulating a pH (potential of hydrogen) value of a system in step I to be neutral, performing filtration toform filter residue, step III: treating the filter residue obtained in step II with hydrogen peroxide, then performing washing and filtration to take the filter residue, drying the filter residue to form dried filter residue, step IV: adding an EDTA (ethylene diamine tetraacetic acid) solution and a sodium hydroxide solution into the dried filter residue, and stirring for reaction for 1-3h at 25-35 DEG C, and step V: taking a supernate obtained in step IV, and detecting the content of metal ions by adopting high efficiency liquid chromatography. After treatment by the pretreatment technology,the content of the metal ions in the radix puerariae can be detected accurately.

Description

technical field [0001] The invention relates to a method for detecting residual metal impurities, in particular to a pretreatment process for detecting metal impurities in puerarin crude drug, and belongs to the field of analytical chemistry. Background technique [0002] Metal impurities in medicines are the general term for so-called heavy metals, arsenic salts and catalysts, which involve many transition metal elements and metalloid elements. The starting raw materials, catalysts, by-products, unreacted reagents, metal containers, pipes and other metal tools that are not resistant to acid and alkali may introduce metal impurities in the chemical drug synthesis process, and the metal residues in raw and auxiliary materials will further Incorporated into pharmaceutical preparations. These metal impurities usually have no therapeutic effect, and should be strictly controlled based on the requirements of drug safety and quality control. The European Medicines Agency issued a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 史月龙曾宋君吴英亮刘文斌吴坤林汤静
Owner NANJING XIANCAOTANG BIOLOGICAL TECH CO LTD
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