Method used for rapid detection of illegally added diclofenac compound in product

A technology of diclofenac and its products, which is applied in the field of diclofenac non-steroidal anti-inflammatory drugs, which can solve problems such as unsatisfactory effects, interference with the conductivity of the sample solution, total dissolved solids, technical difficulties of diclofenac anti-inflammatory substances, etc., and achieve an intuitive judgment method Effect

Active Publication Date: 2014-06-11
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 anti-inflammatory drugs, health products or foods that may be added with diclofenac 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 anti-inflammatory drugs, health care products or food that may add diclofenac compounds 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 results that do not correlate with addition of diclofenac compounds
Therefore, it is technically difficult to directly use the electrochemical method of detecting the conductivity or total dissolved solids in the solution to detect whether anti-inflammatory drugs, health products or food are illegally added with diclofenac anti-inflammatory substances.

Method used

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  • Method used for rapid detection of illegally added diclofenac compound in product
  • Method used for rapid detection of illegally added diclofenac compound in product
  • Method used for rapid detection of illegally added diclofenac compound in product

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Embodiment 1. General operating conditions for detecting whether diclofenac substances are contained in medicines / health products pieces

[0061] 1. Sampling volume:

[0062] Sampling recommendations for different types of samples are as follows:

[0063] sample type

Sampling volume

tablet

One oral dose (need to be crushed)

Capsules

One-time oral dose (take the content and grind it)

big honey pill

One-time oral dose (need to be crushed)

Granules

One-time oral dose (need to be crushed)

other solid

oral dose

[0064] 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. , the dosage of the above various types of samples is about 0.5~5g at a time, for example, the dosage of capsules and tablets is about 0.5g at a time, while the dosage of granules and honeyed pills ...

Embodiment 2

[0069] Embodiment 2. General operating conditions for detecting whether diclofenac substances are contained in medicines / health products pieces

[0070] 1. Sampling volume:

[0071] Sampling recommendations for different types of samples are as follows:

[0072] sample type

Sampling volume

tablet

One oral dose (need to be crushed)

Capsules

One-time oral dose (take the content and grind it)

big honey pill

One-time oral dose (need to be crushed)

Granules

One-time oral dose (need to be crushed)

other solid

oral dose

[0073] 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.

[0074] 2. Preparation of the test solution

[0075] Take medicine, health food or food, add 20ml of ethanol, and shake for 1 minute.

[0076] 3. Develop color and judge the result

[0077] It is...

Embodiment 3

[0078] Embodiment 3, detection whether there is diclofenac substance in medicine, health food and food test

[0079] 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 2006006", the HPLC / MS / MS method was used to test the samples to verify the screening results.

[0080] The HPLC / MS / MS detection method recorded in the drug inspection supplementary inspection method and inspection item approval document 2006006 is as follows:

[0081] Chromatographic conditions: mobile phase A is 0.02mol / L ammonium acetate, mobile phase B is 0.1% acetic acid aqueous solution / methanol, and the elution is carried out according to the following gradient table.

[0082] time (min)

A(%)

B(%)

0.00

70

30

15.00

30 ...

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Abstract

The invention relates to a method used for rapid detection of illegal additives in anti-inflammatory agents, health products, or foods, and specifically relates to a method used for determining whether a product, which is suspected to be mixed with a diclofenac compound, contains the diclofenac 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 diclofenac compound of the product can be determined based on the value of the electrochemical parameters. According to the method, filtration of a sample solution is not needed; time consuming of the whole detection process 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 diclofenac non-steroidal anti-inflammatory drugs in medicine, health food or food based on electrochemical principles. Background technique [0002] Diclofenac is a clinically widely used non-steroidal anti-inflammatory drug, which has anti-inflammatory, analgesic and antipyretic effects. Its sodium salt is commonly used clinically, and is mainly used for acute attack or persistent joint swelling and pain of various chronic arthritis such as rheumatoid arthritis and rheumatoid arthritis. [0003] Diclofenac (Diclofenac), the chemical name is 2-[(2,6-dichlorophenyl)amino]phenylacetic acid. The structural formula of diclofenac is shown in formula (I), and molecular formula is C 14 h 11 Cl 2 NO 2 , Cas number is 15307-86-5. Formula (I) [0004] Diclofenac Sodium (Diclofenac Sodium), the chemica...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N27/26
Inventor 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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