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Quick test method of biguanide compounds added in hypoglycemic medicine, health care products or food and application thereof

A detection method and technology of health products, applied in the rapid detection of biguanide compounds added to health products or foods, and in the field of hypoglycemic drugs, it can solve the problems of easy contamination of chromatographic columns, high analysis cost, time for chromatographic development and drying Long and other problems, to achieve the effects of strong anti-interference ability of coexisting substances, high accuracy of test conclusions, and fast color reaction speed

Active Publication Date: 2009-11-18
广东省药品检验所
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  • Summary
  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0010] At present, the methods for illegally adding biguanide hypoglycemic drugs in medicines, health products and foods mainly include thin-layer chromatography, high-performance liquid chromatography and high-performance liquid chromatography-mass spectrometry, etc. The advantages of thin-layer chromatography are: There is no need to use expensive analytical instruments, but this method is greatly affected by external conditions, the ratio shift value is unstable, and there are edge effects. High, but also high technical requirements for experimenters; the advantages of high performance liquid chromatography are high chromatographic separation efficiency and high sensitivity, but its disadvantages are expensive instruments, long sample pretreatment time, easy contamination of chromatographic columns, and analysis costs High, when the chromatographic retention time of the coexisting components is close to the chromatographic retention time of phenformin hydrochloride and metformin hydrochloride, it is easy to make a wrong judgment. The instrument has high requirements for the use environment and needs to be placed fixedly, which is not suitable for on-site detection with large fluidity; High-performance liquid chromatography-mass spectrometry is suitable for the analysis of samples with complex components and severe background interference. This analysis method can improve the reliability of the test results, but the method is more complicated to operate, and the instrument has higher requirements for the use environment and needs to be fixed. Placement, not suitable for on-site testing with high mobility

Method used

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  • Quick test method of biguanide compounds added in hypoglycemic medicine, health care products or food and application thereof
  • Quick test method of biguanide compounds added in hypoglycemic medicine, health care products or food and application thereof

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Effect test

Embodiment 1

[0039] The detection of embodiment 1 capsule

[0040] Sample: natose TM Hibiscus pollen, capsules, HPLC detection, each capsule of this product contains 287mg of metformin hydrochloride.

[0041] Adopt rapid detection method of the present invention to detect sample, its specific steps are as follows:

[0042] (1) Take 1 sample, put its contents (about 0.32g) in a 2ml syringe, add 1ml of dichloromethane, filter, discard the filtrate, and collect the filter residue; add 1ml of absolute ethanol to the filter residue, and filter with organic Filter through the head (0.45 μm pore size, 12 mm outer diameter), discard the first 5 drops of filtrate, and collect the subsequent filtrate, which is the extract;

[0043] (2) Take 2 μl of the above-mentioned extract, and place it on the reaction support plate; immerse the reaction support plate in the chromogenic agent (10% sodium nitrosyl ferricyanide solution-10% potassium ferricyanide solution-10% sodium hydroxide solution , 1:1:1 vo...

Embodiment 2

[0044] The detection of embodiment 2 capsules

[0045] Sample: Shengshou Brand Qiaoqi Capsules, capsules, HPLC method detects that each capsule of this product contains 16.6mg of phenformin hydrochloride.

[0046] Adopt rapid detection method of the present invention to detect sample, its specific steps are as follows:

[0047] (1) Take 1 sample, put its contents (about 0.4g) into a 2ml syringe, add 1ml of ethyl acetate, filter, discard the filtrate, and collect the filter residue; Filter through the head (0.45 μm pore size, 12 mm outer diameter), discard the first 5 drops of filtrate, and collect the subsequent filtrate, which is the extract;

[0048] (2) Take 2 μl of the above-mentioned extract, and place it on the reaction support plate; immerse the reaction support plate in the chromogenic agent (10% sodium nitrosyl ferricyanide solution-10% potassium ferricyanide solution-10% sodium hydroxide solution , 1:1:1 volume ratio), quickly picked up and observed; immediately vi...

Embodiment 3

[0049] The detection of embodiment 3 tablet

[0050] Sample: Clearing blood and nourishing pancreas TM Lingqu pueraria root compound plant tablets, tablets, each tablet of this product contains 6.0mg of phenformin hydrochloride as detected by HPLC.

[0051] Adopt rapid detection method of the present invention to detect sample, its specific steps are as follows:

[0052] (1) Take 1 piece of sample, grind it finely, place it in a 2ml syringe, add 1ml ethyl acetate, filter, discard the filtrate, and collect the filter residue; outer diameter 12mm), discard the first 5 drops of filtrate, and collect the subsequent filtrate, which is the extract;

[0053] (2) Take 2 μl of the above-mentioned extract, and place it on the reaction support plate; immerse the reaction support plate in the chromogenic agent (10% sodium nitrosyl ferricyanide solution-10% potassium ferricyanide solution-10% sodium hydroxide solution , 1:1:1 volume ratio), quickly picked up and observed; immediately vi...

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Abstract

The invention discloses a quick test method of biguanide compounds added in hypoglycemic medicine, health care products or food and an application thereof. The method comprises: extracting biguanide compounds from hypoglycemic medicine, health care products or food, and collecting extract; then adding color development reagenet into the extract, and determining whether hypoglycemic medicine, health care products or food are added with biguanide compounds according to the result of color development. The method of the invention features low analysis cost, strong resistant capability of interference from coexisting substances, no need of special device, high sensitivity, obvious color development effect, easy for observation and judgment and high accuracy of test conclusion, and is suitable for fast testing whether hypoglycemic medicine, health care products or food are added with biguanide compounds on site. Based on the quick test method of the invention, a quick test kit of biguanide compounds is prepared, the requirements for carrying out related food and drug administration and inspection in rural areas can be satisfied.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to the field of detection of compounds illegally added in hypoglycemic drugs, health products and foods, and in particular to a rapid detection method for adding biguanide compounds in hypoglycemic drugs, health products or foods and its application. Background technique [0002] Biguanide compounds are one of the elders of the hypoglycemic drug family, mainly including metformin hydrochloride, phenformin hydrochloride and buformin hydrochloride. Biguanide compounds are cheap and can enhance the hypoglycemic effect when used in combination with other chemical hypoglycemic drugs. The frequency of illegal addition is high, but when biguanide compounds are used as drugs to lower blood sugar, there are serious adverse reactions including lactic acidosis, which is an adverse reaction with a high mortality rate, especially for the elderly. [0003] The English name of Metformin Hydrochlorid...

Claims

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Application Information

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IPC IPC(8): G01N31/22C07C279/26
Inventor 赖宇红李延志关日晴李晨辉谭婉清
Owner 广东省药品检验所
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