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Fast detection method of nitrazepam doped in medicine and health care food

A technology of health food and determination method, which is applied in the direction of material analysis by observing the influence of chemical indicators, and analysis by chemical reaction of materials, etc. problem, to achieve the effect of high accuracy, wide application range and strong specificity

Active Publication Date: 2010-10-20
SHENZHEN INST FOR DRUG CONTROL SHENZHEN TESTING CENT OF MEDICAL DEVICES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantages of this method are: (1) The chromatographic resolution is low, the ingredients of traditional Chinese medicine preparations are complicated, and there are many interference factors, so it is easy to misjudge some coexisting ingredients as nitrazepam ingredients. The proximity of the components to be measured will interfere with the detection of the target components
(2) The time for chromatographic development and drying is long, which is not enough to meet the requirements of rapid determination
(3) Thin-layer chromatography plates need to be dried and stored in a dry place, and the ambient temperature and humidity have a great influence on the separation effect
(4) A fixed place is required, and it is not suitable for on-site testing with high mobility
The disadvantages are: (1) the instrument is expensive, the sample pretreatment time is long, the chromatographic column is easily polluted, and the analysis cost is high; (2) when the retention time of the coexisting chromatographic peak is close to that of the nitrazepam chromatographic peak, it is easy to make mistakes (3) The instrument has high requirements for the use environment and needs to be placed fixedly, so it is not suitable for on-site testing with large fluidity
[0017] The test paper preparation process of the immunochromatographic detection method takes at least 3 hours, and requires professionals to prepare nitrazepam-conjugated polyclonal antibodies and anti-nitrazepam polyclonal antibodies, and commercial colloidal gold test strips are expensive. Application is very difficult
[0018] At present, the drug and health food industry has not released a rapid screening method for nitrazepam using physical and chemical reactions. For pharmacies and grassroots drug inspection units, a rapid screening method for unauthorized addition of nitrazepam in Chinese patent medicines and health food has been developed. Rapid analysis of samples is necessary to provide timely evidence for drug supervision, crack down on counterfeiting by criminals and ensure the safety of people's medication

Method used

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  • Fast detection method of nitrazepam doped in medicine and health care food
  • Fast detection method of nitrazepam doped in medicine and health care food
  • Fast detection method of nitrazepam doped in medicine and health care food

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Tianxingjian Wanan Capsules (capsules, the labeled dosage is 2 capsules each time, the test results of this product contain 0.567mg of nitrazepam per capsule by high performance liquid chromatography-mass spectrometry)

[0053] Take one grain of content, put it in a 10ml sample tube, add 3ml of hydrochloric acid solution, vortex for 3 minutes; add 5 drops of 0.1mol / L sodium nitrite solution to the hydrochloric acid solution, vortex for 1 minute; add dropwise 0.2 Vortex 1ml of mol / L urea for 2 minutes; add 5 drops of alkaline β-naphthol test solution dropwise, and the solution will gradually appear red flocculent precipitate within 3 minutes, so it can be judged that the sample contains illegally added nitrazepam.

Embodiment 2

[0055] Naolibao pills (pills, the marked dosage is 4 pills each time, each pill (vegetarian pill) weighs about 0.2g, the test results of high-performance liquid chromatography-mass spectrometry This product does not contain nitrazepam, simulated addition of nitrazepam for control product 0.25mg)

[0056] Take 5 pills of Naolibao pills, about 1.0g, add 0.25mg of nitrazepam reference substance, put them in a 10ml sample tube, add 2ml of hydrochloric acid solution, vortex for 5 minutes; add 0.05mol / L nitrous acid dropwise to the hydrochloric acid solution 6 drops of sodium solution, vortexed for 2 minutes; 0.1mol / L urea 1.5ml was added dropwise and vortexed for 4 minutes; 5 drops of alkaline β-naphthol test solution was added dropwise, and the solution gradually appeared red flocculent precipitate within 3 minutes, thus It can be judged that the sample contains illegally added nitrazepam.

Embodiment 3

[0058] Anshen Bunao Liquid (oral solution, the labeled dosage is 10ml each time, the test result of high performance liquid chromatography-mass spectrometry does not contain nitrazepam, and 0.20mg of nitrazepam reference substance is simulated)

[0059] Take 5ml of Anshenbunao liquid, add 0.20mg of nitrazepam reference substance, put it in a 10ml sample tube, add 4ml of hydrochloric acid solution, vortex for 4 minutes; add 2 drops of 0.2mol / L sodium nitrite solution to the hydrochloric acid solution , vortexed for 1 minute; 0.3mol / L urea 0.5ml was added dropwise and vortexed for 3 minutes; 5 drops of alkaline β-naphthol test solution was added dropwise, and the solution gradually appeared red flocculent precipitate within 3 minutes, so it can be judged that Contains illegally added nitrazepam.

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Abstract

The invention discloses a fast detection method of nitrazepam doped in medicine and health care food, which consists of the following steps: (1) hydrolyzing nitrazepam in the medicine and the health care food; (2) adding diazotization reagents; (3) neutralizing interfering substances; and (4) adding detecting agents. The detection method of the invention has the advantages of high speed, simplicity, convenience, strong specificity, high accuracy, sensitive reaction and wide application range, and is suitable for being used for detecting whether the nitrazepam is doped into the medicine and the health care food. A nitrazepam fast defection reagent kit manufactured according to the invention can meet the requirements of developing medicine and health care food supervision and inspection in wide rural areas and small and medium-sized cities with lagging detection technical conditions.

Description

technical field [0001] The invention relates to a method for detecting nitrazepam components, in particular to a method for detecting whether nitrazepam components are added in medicines and health foods, especially in traditional Chinese medicine preparations for tranquilizing and calming the nerves and functional health foods for nourishing the mind and calming the nerves. Background technique [0002] Nitrazepam is a benzodiazepine sedative-hypnotics, chemical name is 1,3-dihydro-7-nitro-5-phenyl-2H-1,4-benzodiazepine-2-one. Mainly treat insomnia and anticonvulsant, infantile spasms, myoclonic epilepsy. Clinical pharmacology studies have shown that this drug is superior to barbiturates and other sedative and hypnotic drugs in terms of sedative and hypnotic effects, and drug overdose generally does not cause life-threatening, so nitrazepam is widely used clinically. [0003] Nitrazepam is a central nervous system depressant, which can cause inhibition of different parts o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/79
Inventor 王铁杰肖丽和杨敏付春旺殷果王珏黎雪清
Owner SHENZHEN INST FOR DRUG CONTROL SHENZHEN TESTING CENT OF MEDICAL DEVICES
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