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Method for rapid detection of illegally added sibutramine in products

A technology for products and testing equipment, applied in the fields of health food or food analysis and pharmaceuticals, can solve the problems of technical difficulties of sibutramine, interference with the conductivity of the sample solution and the total dissolved solids, etc. Simple to use effects

Active Publication Date: 2016-07-27
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 use the electrochemical method of detecting the conductivity or total dissolved solids in water to detect weight loss drugs, health products or foods suspected of adding sibutramine? It was found that the effect was not ideal, because the complex matrix of weight-loss drugs, health care products or food that may add sibutramine contains other hydrophilic substances, which will seriously interfere with the conductivity of the sample solution and the total volume of the solution. Dissolved solids (TDS), resulting in no correlation with whether sibutramine was added
Therefore, it is technically difficult to directly detect whether sibutramine is illegally added to weight loss drugs, health products or food 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 sibutramine in products
  • Method for rapid detection of illegally added sibutramine in products
  • Method for rapid detection of illegally added sibutramine in products

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Example 1. General operating conditions for detecting whether sibutramine is contained in medicines / health products

[0057] 1. Sampling volume:

[0058] Sampling recommendations for different types of samples are as follows:

[0059] sample type

Sampling volume

tablet

One oral dose (need to be crushed)

Capsules

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

[0060] big honey pill

One-time oral dose (need to be crushed)

Granules

One-time oral dose (need to be crushed)

other solid

oral dose

[0061] 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 at a ...

Embodiment 2

[0066] Embodiment 2, the general operation condition that detects whether sibutramine is contained in medicine / health product

[0067] 1. Sampling volume:

[0068] Sampling recommendations for different types of samples are as follows:

[0069] 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)

6 --> other solid

oral dose

[0070] 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.

[0071] 2. Preparation of the test solution

[0072] Take medicine, health food or food, add 20ml of ethanol, and shake for 1 minute.

[0073] 3. Develop color and judge the result

[0074]It is determi...

Embodiment 3

[0075] Embodiment 3, test whether there is sibutramine in detection medicine, health food and food

[0076] 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 "National Drug and Food Administration Drug Inspection Supplementary Inspection Method and Inspection Item Approval Document 2006004", the HPLC / MS / MS method was used to test the samples to verify the screening results.

[0077] The HPLC / MS / MS detection method recorded in the drug inspection supplementary inspection method and inspection item approval document 2006004 is as follows:

[0078] Chromatographic conditions: mobile phase A is 0.02mol / L ammonium acetate, mobile phase B is 0.1% acetic acid aqueous solution / acetonitrile, and the elution is carried out according to the following gradient table.

[0079] time (min)

A(%)

B(%)

0.00

70

30

12.00

70

30 ...

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Abstract

The invention relates to a method used for rapid detection of illegal additives in weight-reducing medicines, health care products, or foods, and specifically relates to a method used for determining whether a product, which is suspected to be mixed with sibutramine, contains sibutramine. 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 sibutramine 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 illegally added sibutramine in medicine, health food or food based on electrochemical principles. Background technique [0002] Sibutramine is a 5-tryptamine and norepinephrine reuptake inhibitor listed by Knoll in 1997. Its chemical name is N-{1-[1-(4-chlorophenyl)cyclidine Base]-3-methylbutyl}-N,N'-dimethylamine, there is a chiral carbon atom in the molecular structure, which can act on the central nervous system, speed up metabolism, suppress appetite, increase satiety, and promote energy in the body Consumption, lower blood lipid levels and cholesterol levels, clinically used for the treatment of obesity, has the characteristics of good absorption and definite curative effect. After sibutramine hydrochloride went on the market, about 10 million people have used this product successively, and its sales have als...

Claims

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Application Information

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