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Method for rapid detection of illegally added biguanide substances in products

A technology of biguanides and products, applied in the direction of material electrochemical variables, etc., can solve problems such as unsatisfactory effects, interference with sample solution conductivity, total dissolved solids, technical difficulties of biguanide hypoglycemic substances, etc., and achieve an intuitive judgment method

Active Publication Date: 2015-12-02
BEIJING INST FOR DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Then, is it possible to directly detect hypoglycemic drugs, health products or foods suspected of adding biguanide compounds by electrochemical methods that detect the conductivity or total dissolved solids in water? It was found that the effect was not ideal, because the complex matrix of hypoglycemic drugs, health products or foods that may add biguanide compounds contains other hydrophilic substances, which will seriously interfere with the conductivity of the sample solution and the total concentration of the solution. Dissolved solids (TDS), resulting in results that do not correlate with biguanide addition
Therefore, it is technically difficult to directly detect whether biguanide hypoglycemic substances are illegally added to hypoglycemic drugs, health products or foods by electrochemical methods that detect the conductivity or total dissolved solids in the solution.

Method used

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  • Method for rapid detection of illegally added biguanide substances in products
  • Method for rapid detection of illegally added biguanide substances in products
  • Method for rapid detection of illegally added biguanide substances in products

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Example 1. General operating conditions for detecting whether biguanides are contained in medicines / health products

[0059] 1. Sampling volume:

[0060] Sampling recommendations for different types of samples are as follows:

[0061] sample type

Sampling volume

tablet

One oral dose (need to be crushed)

[0062] Capsules

Oral dose at one time (take the contents and grind them)

big honey pill

One-time oral dose (need to be crushed)

Granules

One-time oral dose (need to be crushed)

other solid

oral dose

[0063] This shows that the amount of the product to be inspected that the inventive method uses is few, so that the interests of the innocent operators are damaged as little as possible, the dosage of the above various types of samples is about 0.5 ~ 5g at a time, such as capsules and tablets at a time of about 0.5g. 0.5g, while the dosage of granules and big honeyed pills is about 5g a...

Embodiment 2

[0068] Example 2, General operating conditions for detecting whether biguanides are contained in medicines / health products

[0069] 1. Sampling volume:

[0070] Sampling recommendations for different types of samples are as follows:

[0071] sample type

Sampling volume

tablet

One oral dose (need to be crushed)

Capsules

Oral dose at one time (take the contents and grind them)

big honey pill

One-time oral dose (need to be crushed)

Granules

One-time oral dose (need to be crushed)

other solid

oral dose

[0072] This shows that the amount of the sample to be inspected used by the method of the present invention is small, so as to damage the interests of innocent operators as little as possible.

[0073] 2. Preparation of the test solution

[0074] Take medicine, health food or food, add 20ml of ethanol, and shake for 1 minute.

[0075] 3. Develop color and judge the result

[0076] It is determined by ...

Embodiment 3

[0077] Embodiment 3, the test whether there is biguanide substance in detection medicine, health food and food

[0078]Adopt the method of embodiment 1 to detect 20 batches of samples rapidly (all are the sampling samples of drug supervision department). In addition, in accordance with the "Supplementary Inspection Methods and Inspection Items Approval Documents 2006005 and 2007003 of the State Drug and Food Administration", the samples were tested by the LCMS method to verify the screening results.

[0079] The LCMS detection methods recorded in the drug inspection supplementary inspection methods and inspection items approval documents 2006005 and 2007003 are as follows:

[0080] Liquid chromatography conditions: mobile phase A is 0.1% formic acid aqueous solution (adjust pH to 3.5 with ammonia water), mobile phase B is acetonitrile, and elution is performed according to the following gradient table.

[0081] time (min)

A(%)

B(%)

0.00

85

15...

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Abstract

The invention relates to a method used for rapid detection of illegal additives in hypoglycemic drugs, health care products, or foods, and specifically relates to a method used for determining whether a product, which is suspected to be mixed with a biguanide compound, contains the biguanide compound. The method comprises following steps: (1) an appropriate amount of the product is collected, is mixed with a special solvent, and an obtained mixture is subjected to shaking or ultrasonic assisted dissolving so as to obtain a mixed liquid; (2) specific electrochemical parameters of the mixed liquid are determined using an appropriate detector based on specific electrochemical principles; and (3) illegal addition of the biguanide compound of the product can be determined based on the value of the electrochemical parameters. According to the method, filtration of sample solution is not needed; time consuming of the whole detection processes ranges from 2 to 3min; the method is rapid, convenient, and safe, is high in sensitivity, and is friendly to the environment.

Description

technical field [0001] The invention relates to the technical field of analysis of medicines, health food or food, in particular to a method for quickly screening biguanide hypoglycemic drugs illegally added in medicine, health food or food based on electrochemical principles. Background technique [0002] Biguanide compounds have the effect of lowering blood sugar, and their mechanism of action is to promote the uptake and glycolysis of glucose by muscle cells, reduce the production of glucose by the liver, and thus play an anti-hyperglycemic effect. The biguanide hypoglycemic drugs clinically used in my country are metformin hydrochloride and phenformin hydrochloride. [0003] Wherein the chemical name of metformin hydrochloride is 1,1-dimethylbiguanide hydrochloride, and its English name is MetforminHydrochloride, and its structure is as shown in formula (I). Its common aliases include "Medicam", "Metformin Hydrochloride", "Ligram Sugar" and so on. Formula (I) [0004...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N27/26
Inventor 王威王铁松车宝泉张喆高青赵明王志斌郭洪祝
Owner BEIJING INST FOR DRUG CONTROL
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