CN105891405A - Device for diagnosing human body helicobacter pylori (Hp) infection and method for detecting content of ammonia in breath of human body - Google Patents

Device for diagnosing human body helicobacter pylori (Hp) infection and method for detecting content of ammonia in breath of human body Download PDF

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Publication number
CN105891405A
CN105891405A CN201610194783.0A CN201610194783A CN105891405A CN 105891405 A CN105891405 A CN 105891405A CN 201610194783 A CN201610194783 A CN 201610194783A CN 105891405 A CN105891405 A CN 105891405A
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CN
China
Prior art keywords
ammonia
human body
breath
exhaled breath
helicobacter pylori
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Pending
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CN201610194783.0A
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Chinese (zh)
Inventor
纪效波
周文强
李向芝
丁莹莹
周旭
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Kanichi Research Services Ltd
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Shenzhen Sanxiang Biological Sensing Technology Co Ltd
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Priority to CN201610194783.0A priority Critical patent/CN105891405A/en
Publication of CN105891405A publication Critical patent/CN105891405A/en
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/96Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation using ion-exchange

Abstract

The invention discloses a device for diagnosing human body helicobacter pylori (Hp) infection and a method for detecting the content of ammonia in breath of the human body. The device comprises a breath diagnostic kit and an ion chromatograph. The breath diagnostic kit is internally provided with a medicament pond I and a medicament pond II. The medicament pond I contains a urea electuary and an ammonia capturing agent. The method for detecting the content of ammonia in the breath of the human body comprises the steps that firstly, the breath of the human body is collected; then, the ammonia capturing agent is used for absorbing ammonia in the breath of the human body; finally, the content of fixed ammonia is measured through the ion chromatograph. By means of the device and method, the content of ammonia in the breath of the human body can be accurately and quickly detected, human body Hp infection can be diagnosed more accurately and efficiently, the hidden danger of toxic and side effects of original medicament is eliminated while the medicament production cost is reduced, and the device and method can be used and popularized.

Description

A kind of method of ammonia level in device for diagnosing human body helicobacter pylori infections and detection human exhaled breath
Technical field
The present invention relates to ammonia in a kind of device diagnosing human body helicobacter pylori infections and detection human exhaled breath The method of content;Being specifically related to one utilizes human body to take common urea electuary, by carbamide and human body pylorus spiral shell Bacillus mark urease effect release ammonia, then with the ammonia in ammonia trapping agent capture sample, use ion color The device and method of the fixing ammonia of spectral method detection;By ammonia level in human exhaled breath is diagnosed human body pylorus Pylori (Hp) infection degree, belongs to medical detection technology.
Background technology
Helicobacter pylori (being called for short Hp) is one of the most modal pathogen, the sense in population of China Dye rate is up to 60%, and annual new infeetioa case is more than 12,000,000 people.The duodenum of the most about more than 90% is burst Infections, the gastric ulcer of more than 70%, the Patients with Chronic Gastritis of more than 60% exist Hp to be infected, World Health Organization (WHO) It is defined as the first kind carcinogen of gastric cancer.
At present, the method system that existing detection Hp infects mainly has gastroscope detection system, immunology detection body System, polymerase chain reaction detection system, saliva method detection system, urease detection system,13C/14C carbamide Breath test detection system etc..Above system has or brings misery or detection accuracy, ageing to person under inspection The defects such as poor or toxic side effect.
Summary of the invention
In order to make up the deficiency having diagnosed the method system that Hp infects, it is an object of the invention to be to provide one Kind utilize the device that unmarked urea breath test coupled ion chromatograph detects, this device can more accurately, higher Diagnosis human body Hp in effect ground infects, and while reducing medicament production cost, eliminates conventional medicament toxic and side effects Hidden danger.
Ammonia level in a kind of detection human exhaled breath simple and quick, accurate of offer is provided Method, thus realize sensitive, quick, specific detection helicobacter pylori infections degree.
In order to realize above-mentioned technical purpose, the invention provides a kind of for diagnosing human body helicobacter pylori infections Device, this device includes breath diagnosis test kit and ion chromatograph;It is provided with in described breath diagnosis test kit Medicament pond I and medicament pond II;Described medicament pond I and medicament pond II is respectively provided with carbamide electuary and ammonia trapping agent.
Preferably scheme, carbamide electuary comprises without isotope-labeled urea components.
Preferably scheme, ammonia trapping agent includes at least HNO3、H3PO4、HCl、H2SO4, in TGA At least one acid composition.Ammonia trapping agent can be HNO3、H3PO4、HCl、H2SO4, in TGA At least one, or be HNO3、H3PO4、HCl、H2SO4, at least one is weak with other in TGA The combination of acid.
Preferably scheme, test kit also includes sampler bag.
More preferably scheme, sampler bag is made up of polyvinyl-fluoride material, and sampler bag is provided with supporting threaded cap.
The device for diagnosing human body helicobacter pylori infections of the present invention.Main body includes sampler bag, breath diagnosis Test kit and ion chromatograph.Breath diagnosis test kit use common rectangle, square, circle or they The one of variant or combination, material is selected from wooden, papery, irony or it is with the entity of coat.Respectively Medicament pond I and medicament pond II equipped with common urea electuary and equipped with ammonia trapping agent are placed in breath diagnosis test kit In.Sampler bag volume 250mL, sampler bag uses polyvinyl-fluoride complex material to make, and has supporting Threaded cap.During detection, first employing sampler bag collection human exhaled breath is as blank, then takes to human body Carbamide electuary, after a period of time, collects human exhaled breath by sampler bag, then by human exhaled breath by ammonia trapping agent, Ammonia is converted ammonium salt, is accurately detected the content of ammonium salt by ion chromatograph.
Present invention also offers and a kind of detect the method for ammonia level in human exhaled breath, the method includes following step Rapid:
1) human exhaled breath is collected by sampler bag;
2) human exhaled breath that collection bag is collected is incorporated in breath diagnosis test kit;Described test kit includes One medicament pond II, described medicament pond II are built with ammonia trapping agent, described ammonia trapping agent and the ammonia in human exhaled breath Gas generation chemical reaction generates ammonium salt;
3) amounts of ammonium salt generated by ion chromatograph detection reaction, is i.e. calculated ammonia in human exhaled breath and contains Amount.
Preferably scheme, ammonia trapping agent includes at least HNO3、H3PO4、HCl、H2SO4, in TGA At least one acid composition.
Preferably scheme, also includes a medicament pond I in breath diagnosis test kit;Described medicament pond I built with The carbamide electuary of ammonia is discharged for acting on helicobacter pylori mark urease.
More preferably scheme, described carbamide electuary comprises without isotope-labeled urea components.
The human exhaled breath of the present invention includes the expiration of release in human body normal sensation in the mouth nose.
Assembly of the invention for diagnosing the principle of human body helicobacter pylori infections is: carbamide and human body helicobacter pylorus Bacterium mark urease effect release ammonia, then capture the ammonia of release with ammonia trapping agent and realize the fixing life of ammonia Become ammonium salt, finally use ion chromatographic method detection ammonium salt, such that it is able to draw human body helicobacter pylori infections journey Degree.
For prior art, the beneficial effect that technical scheme is brought:
(1) assembly of the invention is combined with the chromatography of ions by urea breath test, it is possible to quick and precisely Measure ammonia level in human exhaled breath, it is achieved thereby that simple and quick, safety and precise ground diagnosing helicobacter pylori sense The degree of dye.
(2) assembly of the invention uses the common urea reagent of No Parity element labelling, little to human toxicity, right Human body stimulates little, it is easy to accept.
(3) assembly of the invention is by the collection to expiration, and uses ammonia trapping agent to fix, it is possible to quickly accurate Really determine the content of ammonia in expiration by chromatography of ions, and then realize sensitive, quick, specific detection pylorus Pylori (Hp) infection degree.
(4) medicament of assembly of the invention and employing is all existing routine, reduces testing cost.
(5) in the detection human exhaled breath of the present invention, the method for ammonia level can realize based on assembly of the invention, Simply, quickly, can sensitive, quick, specific detection helicobacter pylori infections degree.
Accompanying drawing explanation
[Fig. 1] represents the chromatogram of ammonia in the blank sample that experimenter 1 breathes out;
[Fig. 2] represents the chromatogram of ammonia in the sample that experimenter 1 breathes out;
[Fig. 3] represents the chromatogram of ammonia in the blank sample that experimenter 2 breathes out;
[Fig. 4] represents the chromatogram of ammonia in the sample that experimenter 2 breathes out;
[Fig. 5] represents the chromatogram of ammonia in the blank sample that experimenter 3 breathes out;
[Fig. 6] represents the chromatogram of ammonia in the sample that experimenter 3 breathes out;
[Fig. 7] represents the chromatogram of ammonia in the blank sample that experimenter 4 breathes out;
[Fig. 8] represents the chromatogram of ammonia in the sample that experimenter 4 breathes out;
[Fig. 9] represents the chromatogram of ammonia in the blank sample that experimenter 5 breathes out;
[Figure 10] represents the chromatogram of ammonia in the sample that experimenter 5 breathes out.
Detailed description of the invention
Following example are intended to further illustrate present invention rather than limit the protection of the claims in the present invention Scope.
Embodiment 1
1, detection object: experimenter 1, man, 41 years old, warp13C-urea breath test is diagnosed as the positive.
2, detection method:
(1), require experimenter on an empty stomach or fasting in more than two hours in advance.
(2), experimenter exhales, and entrance sampler bag is the most full is labeled as blank sample.
(3) test kit warm boiled water common urea medicament, is taken.
(4), after 30min, experimenter again exhales and is labeled as sample into sampler bag to full.
(5), the gas in the sampler bag being marked with blank sample and sample is passed through ammonia trapping agent, and uses ion Ammonia in chromatograph detection characteristics of contaminated respiratory droplets gas.
(6), experimenter's Helicobacter pylori infection is diagnosed further by the ammonia level in expired gas.
3, testing result: testing result such as table 1.
The chromatograph detection data of ammonia in the blank sample of table 1 experimenter 1 exhalation and sample
4 conclusions:
As can be seen from Table 1, standard curve method can accurately calculate the content of ammonia during experimenter exhales, and take medicine Before in rear expiration, the content of ammonia is much larger than taking medicine.
Embodiment 2
1, detection object: experimenter 2, man, 35 years old, warp13C-urea breath test is diagnosed as feminine gender.
2, detection method: the detection method of the present embodiment is identical with a upper embodiment, obtains its detection Result such as table 2:
The chromatograph detection data of ammonia in the blank sample of table 2 experimenter 2 exhalation and sample
3 conclusions: as can be seen from Table 2, by standard curve method accurately calculate experimenter take medicine front and back exhale in ammonia Content essentially identical, and be positioned at reduced levels.
Embodiment 3
1, detection object: experimenter 3, man, 26 years old, warp13C-urea breath test is diagnosed as feminine gender.
2, detection method: the detection method of the present embodiment is identical with a upper embodiment, obtains its detection Result such as table 3:
The chromatograph detection data of ammonia in the blank sample of table 3 experimenter 3 exhalation and sample
3 conclusions: as can be seen from Table 3, by standard curve method accurately calculate experimenter take medicine front and back exhale in ammonia Content essentially identical, and be positioned at reduced levels.
Embodiment 4
1, detection object: experimenter 4, man, 43 years old, warp13C-urea breath test is diagnosed as feminine gender.
2, detection method: the detection method of the present embodiment is identical with a upper embodiment, obtains its detection Result such as table 4:
The chromatograph detection data of ammonia in the blank sample of table 4 experimenter 4 exhalation and sample
3 conclusions: as can be seen from Table 4, by standard curve method accurately calculate experimenter take medicine front and back exhale in ammonia Content essentially identical, and be positioned at reduced levels.
Embodiment 5
1, detection object: experimenter 5, female, 30 years old, warp13C-urea breath test is diagnosed as the positive.
2, detection method: the detection method of the present embodiment is identical with a upper embodiment, obtains its detection Result such as table 5:
The chromatograph detection data of ammonia in the blank sample of table 5 experimenter 5 exhalation and sample
3 conclusions: as can be seen from Table 5, are accurately calculated the content clothes of ammonia during experimenter exhales by standard curve method Before relatively larger than taking medicine after medicine.
Experiment shows, use the present invention detection system, can not only Accurate Diagnosis human body helicobacter pylori infections with No, also can accurately detect the degree of helicobacter pylori infections.Ammonia content in human exhaled breath can be made tentatively simultaneously Statistics, ammonia content scope 0~2.0ppm in normal person's expiration, the most densely distributed interval is 1.0~1.5 Ppm scope;Ammonia content scope 1.7~10ppm in infected with Helicobacter pylori expiration, the most densely distributed Interval is 2.2~6.0ppm scopes.There is provided reliable basis for treatment helicobacter pylori infections, can fully meet and examine The application requirement of disconnected human body helicobacter pylori infections.

Claims (10)

1. the device being used for diagnosing human body helicobacter pylori infections, it is characterised in that: include breath diagnosis reagent Box and ion chromatograph;Medicament pond I and medicament pond II it is provided with in described breath diagnosis test kit;Described medicine Agent pond I and medicament pond II is respectively provided with carbamide electuary and ammonia trapping agent.
Device for diagnosing human body helicobacter pylori infections the most according to claim 1, it is characterised in that: Described carbamide electuary comprises without isotope-labeled urea components.
Device for diagnosing human body helicobacter pylori infections the most according to claim 1, it is characterised in that: Described ammonia trapping agent includes at least HNO3、H3PO4、HCl、H2SO4, at least one in TGA Acid composition.
Device for diagnosing human body helicobacter pylori infections the most according to claim 1, it is characterised in that: Also include sampler bag.
Device for diagnosing human body helicobacter pylori infections the most according to claim 4, it is characterised in that: Described sampler bag is made up of polyvinyl-fluoride material, and sampler bag is provided with supporting threaded cap.
6. one kind is detected the method for ammonia level in human exhaled breath, it is characterised in that:
1) human exhaled breath is collected by sampler bag;
2) human exhaled breath that collection bag is collected is incorporated in breath diagnosis test kit;Described test kit includes one Medicament pond II, described medicament pond II send out with the ammonia in human exhaled breath built with ammonia trapping agent, described ammonia trapping agent Biochemical reaction generates ammonium salt;
3) amounts of ammonium salt generated by ion chromatograph detection reaction, then calculate ammonia level in human exhaled breath.
The method of ammonia level in detection human exhaled breath the most according to claim 6, it is characterised in that: described Ammonia trapping agent including at least HNO3、H3PO4、HCl、H2SO4, at least one acid in TGA becomes Point.
The method of ammonia level in detection human exhaled breath the most according to claim 6, it is characterised in that: described Breath diagnosis test kit in also include a medicament pond I;Described medicament pond I is built with being used for acting on pylorus spiral shell Bacillus mark urease and discharge the carbamide electuary of ammonia.
The method of ammonia level in detection human exhaled breath the most according to claim 8, it is characterised in that: described Carbamide electuary comprise without isotope-labeled urea components.
The method of ammonia level in detection human exhaled breath the most according to claim 6, it is characterised in that: described Human exhaled breath include in human body normal sensation in the mouth nose the expiration of release.
CN201610194783.0A 2016-03-30 2016-03-30 Device for diagnosing human body helicobacter pylori (Hp) infection and method for detecting content of ammonia in breath of human body Pending CN105891405A (en)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997026827A1 (en) * 1996-01-26 1997-07-31 Battelle Memorial Institute Optical non-radioactive breath analysis
WO1997030351A1 (en) * 1996-02-14 1997-08-21 The Boots Company Plc Diagnostic method for measuring the ammonia content in breath
CN101881763A (en) * 2009-10-27 2010-11-10 天津赛德生物制药有限公司 Urea breath detection kit for detecting stomach helicobacter pylori
CN103487481A (en) * 2013-10-16 2014-01-01 无锡市尚沃医疗电子股份有限公司 Expiration ammonia gas analyzer
CN104561241A (en) * 2015-01-09 2015-04-29 天津市宝坻区人民医院 Method for detecting helicobacter pylori infection in gastric juice
CN105431724A (en) * 2014-04-30 2016-03-23 长沙三相医疗器械有限公司 Ammonia trap

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997026827A1 (en) * 1996-01-26 1997-07-31 Battelle Memorial Institute Optical non-radioactive breath analysis
WO1997030351A1 (en) * 1996-02-14 1997-08-21 The Boots Company Plc Diagnostic method for measuring the ammonia content in breath
CN101881763A (en) * 2009-10-27 2010-11-10 天津赛德生物制药有限公司 Urea breath detection kit for detecting stomach helicobacter pylori
CN103487481A (en) * 2013-10-16 2014-01-01 无锡市尚沃医疗电子股份有限公司 Expiration ammonia gas analyzer
CN105431724A (en) * 2014-04-30 2016-03-23 长沙三相医疗器械有限公司 Ammonia trap
CN104561241A (en) * 2015-01-09 2015-04-29 天津市宝坻区人民医院 Method for detecting helicobacter pylori infection in gastric juice

Non-Patent Citations (3)

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Title
KEI TODA 等: "Measurement of Ammonia in Human Breath with a Liquid-Film Conductivity Sensor", 《ANAL. CHEM.》 *
张健 等: "空气中氨的离子色谱测定法", 《环境与健康杂》 *
马永健 等: "氨呼气试验用于幽门螺杆菌感染诊断的可行性", 《世界华人消化杂志》 *

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Effective date of registration: 20170323

Address after: 410600 Hunan Province, Changsha high tech Development Zone, No. 459 East Road, Pine Road, the extension of the village of red building, building 1460C, room

Applicant after: KANICHI RES SERVICES LTD.

Address before: 518000 Guangdong city of Shenzhen province Qianhai Shenzhen Hong Kong cooperation zone before Bay Road No. 1 building 201 room A

Applicant before: Shenzhen Sanxiang Biological Sensing Technology Co., Ltd.

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Application publication date: 20160824