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Helicobacter pylori detection kit

A detection kit and Helicobacter pylori technology, applied in the field of medical devices, can solve the problems of high misjudgment rate of patients, influence on widespread use, and large dosage, so as to reduce usage, improve detection accuracy and accuracy, The effect of high detection precision and accuracy

Active Publication Date: 2022-07-29
浙江省立同德医院(浙江省精神卫生研究院)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Urea[ 13 C] The high cost of reagents is 13 One of the main reasons for the high cost of C breath test; the urea used clinically [ 13 C] Reagent, 13 The abundance of C is high (generally 99%), and the dose used is large (generally 75mg), which leads to higher cost of the drug, which affects the 13 C Extensive use of the breath test
In addition, for patients with upper gastrointestinal bleeding, recent use of antacids, and anti-Hp drugs, the misjudgment rate of these patients is relatively high

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0022] According to a preferred embodiment of the present invention, a Helicobacter pylori detection kit includes:

[0023] 1) A containing 13 Containers for C-labeled urea reagents; wherein 13 The amount of C-labeled urea reagent is 10 to 35 mg, and 13 The abundance of C is 30~60%;

[0024] 2) A container containing a sensitizer, which is formulated into a sensitizer aqueous solution;

[0025] 3) Designate a test bottle for the patient's breath;

[0026] 4) A thin tube for exhaling into the test bottle.

[0027] Another object of the present invention is to provide a method for using the Helicobacter pylori detection kit, the steps of which include:

[0028] (a) The sensitizer is formulated into an aqueous sensitizer solution and administered in one dose 13 C-labeled urea reagent, observe pathology, urease and 13 C the results of the breath test;

[0029] (b) Use a thin tube for exhaling into the test bottle, and use the test bottle to collect the patient's exhaled ga...

Embodiment 1

[0038] A preparation method of a novel organic acid is:

[0039] In parts by weight, 2.5 parts of anhydrous sodium acetate, 10 parts of acetic anhydride and 3 parts of 6-hydroxybenzopyran-3-carbaldehyde were placed in a three-necked flask, and heated to 135 ° C with an oil pan under stirring The reaction was carried out for 6 hours, the solvent was removed by rotary evaporation, 60 parts of deionized water was added to dissolve sodium acetate, filtered, washed with deionized water, and recrystallized with chloroform as a solvent, and 25 parts of sodium hydroxide solution with a concentration of 7.5wt% was added for hydrolysis. , adjust the pH of the system to 5.5 with dilute sulfuric acid with a concentration of 5wt%, suction filtration, wash with deionized water, and recrystallize with hot water to obtain a new type of organic acid whose structural formula is .

[0040] Nuclear magnetic resonance (NMR) spectrometer (VNMRS600) was used for nuclear magnetic characterization. ...

Embodiment 2

[0042] A Helicobacter pylori detection kit, comprising:

[0043] 1) A containing 13 Bubble container of C-labeled urea reagent; wherein 13 The amount of C-labeled urea reagent is 12 mg, and 13 The abundance of C is 40%;

[0044] 2) A cachet containing 2.5 g of a sensitizer, wherein the weight ratio of the novel organic acid and citric acid in Example 1 in the sensitizer is 0.25:1, and the sensitizer is formulated into a sensitizer aqueous solution;

[0045] 3) Designate a test bottle for the patient's breath;

[0046] 4) A thin tube for exhaling into the test bottle.

[0047] In the present embodiment, the preparation method of the sensitizer aqueous solution is:

[0048] Put 2.5g of sensitizer, 0.1g of sodium carbonate, 0.03g of lemon spice (purchased from Jiangsu Caiwei Biotechnology Co., Ltd.), and 0.045g of aspartame in 150g of deionized water to dissolve completely, and stir and mix evenly to obtain pH Aqueous sensitizer solution with a value of 2.5.

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Abstract

The invention discloses a helicobacter pylori detection kit. Belongs to the technical field of biology. The detection kit comprises: a container containing a 13C-labeled urea reagent; a container containing a sensitizer; an expiration test bottle; a thin tube for the test bottle; the sensitizer comprises a novel organic acid, and the novel organic acid is prepared from 6-hydroxybenzopyran-3-formaldehyde and acetic anhydride. The helicobacter pylori detection kit prepared by the invention has relatively high detection precision and accuracy, and meanwhile, the use amount of a urea reagent containing a 13C label in the detection kit and the abundance of 13C can be reduced.

Description

technical field [0001] The invention belongs to the technical field of medical devices, in particular to a detection kit for Helicobacter pylori. Background technique [0002] Helicobacter pylori (Hp) is an important pathogenic bacteria colonized on the surface of gastric mucosa and is closely related to chronic gastritis, peptic ulcer, gastric cancer and other diseases. Helicobacter pylori is mainly transmitted by mouth-to-mouth and fecal-oral, and most of them are infected in families. Therefore, early confirmation of Helicobacter pylori infection is conducive to early diagnosis, treatment and prevention of the disease. Since Helicobacter pylori colonizes the surface of gastric mucosal epithelial cells, normal gastric mucosal epithelial cells are renewed once every 1 to 3 days, and Helicobacter pylori is excreted through the feces along with the exfoliated gastric mucosa. Detecting Helicobacter pylori antigen in saliva or feces can diagnose the present infection of Helico...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/58C12Q1/04C07D311/58C12R1/01
CPCC12Q1/58C12Q1/04C07D311/58C12R2001/01G01N2333/195C12Q2304/46
Inventor 屠越兴孟建标李曦胡马洪江灵芝
Owner 浙江省立同德医院(浙江省精神卫生研究院)