CN109470762A - A method of whether expired accurately identifying propofol injection - Google Patents
A method of whether expired accurately identifying propofol injection Download PDFInfo
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- CN109470762A CN109470762A CN201710798600.0A CN201710798600A CN109470762A CN 109470762 A CN109470762 A CN 109470762A CN 201710798600 A CN201710798600 A CN 201710798600A CN 109470762 A CN109470762 A CN 109470762A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/62—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating the ionisation of gases, e.g. aerosols; by investigating electric discharges, e.g. emission of cathode
- G01N27/622—Ion mobility spectrometry
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/38—Diluting, dispersing or mixing samples
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Abstract
The whether expired method of propofol injection is accurately identified the invention discloses a kind of.This method is based on ion mobility spectrometry analysis and detection technology, establishes drug component ion mobility spectrometry spectrogram peak position library information according to the variation of clinical application drug component content and type using positive and negative bimodulus mode ion mobility spectrometry.According to the identical analysis detection condition of ion mobility spectrometry, automatic load peak position library information, whether can ion mobility spectrometry software consistent with automatic identification pharmaceutical target ingredient? drug due to the variation of ambient enviroment may cause within the shelf-life cannot with, the variation of the pharmaceutical target constituent content in the shelf-life and the variation of drug component type are identified in life thus, whether confirmation drug is expired and can control Propofol expired medicament again with there will be critically important meaning.This instrument is operated without specialty background personnel, and this method strong operability, it can be achieved that call peak position library information automatically, and directly answer terminal client is as a result, science is feasible.
Description
Technical field
The present invention relates to a kind of Ion transfer spectral methods for accurately identifying Propofol expired medicament.This method is based on ion
Migration spectrum analysis and detection technology, using positive and negative bimodulus mode ion mobility spectrometry, according to clinical application drug component content and type
Variation, identification drug it is whether expired? present invention is mainly applied to food Bureau of Drugs Supervision to carry out supervision area to Expired drug；It is expired
Drug, not only loses drug effect, people take after there are two types of situation, one is useless, without drug effect.It is medicine there are also a kind of situation
Can be poisoned even threat to life safety after having eaten；This method, which is applied to the art, to prevent Expired drug from illegally flowing back
Or illegal flow direction society.
Background technique
Ion mobility spectrometry (Ion Mobility Spectrometry, IMS) technology is the one kind occurred the 1970s
Quick separating detection technique has structure simple, high sensitivity, fast, the as a result reliable feature of analysis speed.It uses extensively in recent years
In fields such as Food Monitoring, medical treatment, chemical warfare agent, drugs, explosive detection and environmental monitorings.
Drug is all to have certain storage environment and storage time limit to require after producing.Most drugs are produced
Afterwards, normally placing drug effect also can slowly reduce, and according to relevant criterion, the drug effect of drug is reduced to a certain extent, that is, be identified as
Failure.As the antibacterials similar drug such as Amoxicillin, Norfloxacin, the speed ratio that drug effect lowers is very fast, if it exceeds validity period, takes
After will not have curative effect, it is also possible to delay the state of an illness.The drug of validity period has been crossed, may resolve into other products, and these
The product of decomposition can generate adverse reaction to body.If taking rotten drug, not only without therapeutic effect, also will cause thin
Bacterium infection.And as external drugs such as Elosons, if it exceeds validity period continue to using, it is more likely that lead to skin allergy；Four
Ring plain piece may will affect liver function.Not necessarily everybody occurs for above-mentioned adverse reaction, but for the sake of security, for expired
Drug must not show mercy, even if appearance, smell without change, can not continue to eat.Then drug storage environment is improper, i.e.,
Make to be that drug in validity period can also go bad.Therefore, food Bureau of Drugs Supervision should supervise Expired drug, prevent Expired drug non-
Method reflux or illegal flow direction society.
The expired detection method of drug: the effective component and main comprise material of drug are determined first, is then made from it
Does it is rotten that the property of substance judge which kind of ingredient is easy to happen, and determines that is the substance after it is rotten according to its chemical property? it can
It can be that a certain component content is changed, it is also possible to be converted into novel substance.According to its chemical property contrived experiment, utilize
The analysis methods such as chromatography, mass spectrum complete verifying.However the pre-treatment of the methods of chromatography, mass spectrum complexity leads to it in practical applications
It is difficult to promote.
Summary of the invention
The object of the present invention is to provide a kind of ion mobility spectrometries that is easy, quick, being easy to correct peak position information to accurately identify
The method of Propofol expired medicament.
Using propofol injection of the same or same medicine quasi-font size within the shelf-life as standard specimen, Propofol to be measured is infused
It penetrates liquid and is proceeded as follows respectively with standard specimen,
1) organic solvent miscible with water is chosen as the first extractant, is B by the first extractant and volume that volume is A
Propofol injection mixing, as the first prepare liquid；
It chooses with the immiscible organic solvent of water as the second extractant, is B by the second extractant and volume that volume is A
Propofol injection mixes, and second is collected after stratification and extracts oxidant layer as the second prepare liquid；
2) positive and negative double mode ion mobility spectrometry is respectively adopted in the first prepare liquid, the second prepare liquid to analyze,
Obtain the transit time and signal strength numerical value of the first prepare liquid holotype ion mobility spectrometry, the second prepare liquid holotype
The transit time and signal strength numerical value of formula ion mobility spectrometry,
The transit time and signal strength numerical value of first prepare liquid negative mode ion mobility spectrometry, the second prepare liquid negative mode from
The transit time and signal strength numerical value of sub- migration spectrum；
3) respectively by holotype ion mobility spectrometry: the first of the standard specimen of identical transit time and propofol injection to be measured to
The signal strength numerical value for surveying liquid compares, the signal strength of the first prepare liquid of propofol injection to be measured subtract the first of standard specimen to
The difference absolute value for surveying the signal strength of liquid is used as evaluation coefficient X divided by the signal strength of the first prepare liquid of standard specimen1；
Respectively by holotype ion mobility spectrometry: the second of the standard specimen of identical transit time and propofol injection to be measured is to be measured
The signal strength numerical value of liquid compares, and it is second to be measured to subtract standard specimen for the signal strength of the second prepare liquid of propofol injection to be measured
The difference absolute value of the signal strength of liquid is divided by the signal strength of the second prepare liquid of standard specimen as evaluation coefficient X2；
Respectively by negative mode ion mobility spectrometry: the first of the standard specimen of identical transit time and propofol injection to be measured is to be measured
The signal strength numerical value of liquid compares, and it is first to be measured to subtract standard specimen for the signal strength of the first prepare liquid of propofol injection to be measured
The difference absolute value of the signal strength of liquid is divided by the signal strength of the first prepare liquid of standard specimen as evaluation coefficient X3；
Respectively by negative mode ion mobility spectrometry: the second of the standard specimen of identical transit time and propofol injection to be measured is to be measured
The signal strength numerical value of liquid compares, and it is second to be measured to subtract standard specimen for the signal strength of the second prepare liquid of propofol injection to be measured
The difference absolute value of the signal strength of liquid is divided by the signal strength of the second prepare liquid of standard specimen as evaluation coefficient X4；
If above-mentioned evaluation coefficient (X1、X2、X3、X4) be respectively less than be equal to 20% when, it is believed that propofol injection to be measured is being protected
In the matter phase, if above-mentioned evaluation coefficient is all larger than 20%, it is believed that propofol injection to be measured is out of date.
The amount ratio of volume A and volume B is 1:80-120.Organic solvent miscible with water is methanol, in ethyl alcohol, isopropanol
One or two or more kinds；With the immiscible organic solvent of water be one of chloroform, a chlorobutane, methylene chloride or two kinds with
On.
Ion mobility spectrometry analysis condition is that atmospheric carrier air 200-400sccm, air float gas 300-600sccm；Migrate tube temperature
90-110 DEG C of degree, 120-150 DEG C of sample injector temperature；High pressure 3000-5000V.
Advantages of the present invention is as follows:
1. be used to accurately identify Propofol expired medicament for the positive and negative mode of ion mobility spectrometry, measurement method is easy, quickly,
It is easy to correct.
2. method of the invention is combined, before the target component in drug carries out solvent extraction with two or more solvent
Processing, expands peak position library information.A kind of different extractants of selection are utilized actually to establish the third pool of peak position library information identification
The method of phenol expired medicament.
Detailed description of the invention
Fig. 1 is that methanol extracts propofol injection anionic textiles ion transfer spectrogram；
Fig. 2 is chloroform recovery propofol injection anionic textiles ion transfer spectrogram；
Fig. 3 is that methanol extracts propofol injection positive ion detection ion transfer spectrogram；
Fig. 4 is chloroform recovery propofol injection positive ion detection ion transfer spectrogram.
Specific embodiment
Ionic migration spectrometer described in embodiment: it is with ionization source63Ni ionization source, positive and negative two kinds of high pressure modes.Described
Ionic migration spectrometer mainly includes sampling device, Ion transfer pipe detector, signal reception and processing system and gas source purification dress
Set processing system.Sampling device mainly includes Thermal desorption sample injector, sampling paper and carrier gas transfer pipeline.
Embodiment intermediate ion migration spectrum analysis condition is that atmospheric carrier air 400sccm, air float gas 600sccm；Migrate tube temperature
100 DEG C, 120 DEG C of sample injector temperature of degree；High pressure 5000V.Propofol injection drug concentration is 1*104Ng/ μ l, organic solvent mention
Taking method is to take 10 μ l propofol injection drugs that 990 μ l solvents are added.Sample injection method takes 2 μ l solvents in sample introduction sheet surface,
Volatilize after solvent that sample introduction is analyzed.
Extractant selects methanol and chloroform respectively, prepares propofol injection standard drug extracting solution according to the method described above.
Embodiment 1
It is detected by ion mobility spectrometry negative ion mode, records spectrogram information, input peak position library；Methanol extracts propofol Injection
Liquid peak position library information: 8.12ms, 168mv；9.8ms, 489mv；11.56ms 250mv；Chloroform recovery propofol injection peak position
Library information: 8.60ms, 322mv；8.84ms 312mv；9.8ms, 211mv；11.56ms 228mv.
Embodiment 2
It is detected by ion mobility spectrometry positive ion mode, records spectrogram information, input peak position library: methanol extracts propofol Injection
Liquid peak position library information: 7.8ms, 258mv；8.4ms, 620mv；Chloroform recovery propofol injection peak position library information: 8.60ms,
404mv；
Embodiment 3
Take propofol injection drug sample to be measured, select pre-treating method same as the previously described embodiments, respectively by from
Sub- migration spectrum positive and negative ion mode detection records spectrogram information.Evaluating coefficient is more than 20%, that is, thinks that drug is expired.
Claims (4)
1. a kind of accurately identify the whether expired method of propofol injection, it is characterised in that: quasi- with same or same traditional Chinese medicines
Propofol injection of the font size within the shelf-life is grasped as standard specimen, by propofol injection to be measured with standard specimen as follows respectively
Make,
1) organic solvent miscible with water is chosen as the first extractant, is the third of B by the first extractant and volume that volume is A
The mixing of phenol injection is moored, as the first prepare liquid；
It chooses with the immiscible organic solvent of water as the second extractant, is that B third is moored by the second extractant and volume that volume is A
Phenol injection mixes, and second is collected after stratification and extracts oxidant layer as the second prepare liquid；
2) positive and negative double mode ion mobility spectrometry is respectively adopted in the first prepare liquid, the second prepare liquid to analyze,
Obtain the transit time and signal strength numerical value of the first prepare liquid holotype ion mobility spectrometry, the second prepare liquid holotype from
The transit time and signal strength numerical value of sub- migration spectrum；
The transit time and signal strength numerical value of first prepare liquid negative mode ion mobility spectrometry, the second prepare liquid negative mode ion move
Move the transit time and signal strength numerical value of spectrum；
3) respectively by holotype ion mobility spectrometry: the standard specimen of identical transit time and the first prepare liquid of propofol injection to be measured
Signal strength numerical value compare, the signal strength of the first prepare liquid of propofol injection to be measured subtracts the first prepare liquid of standard specimen
Signal strength difference absolute value divided by standard specimen the first prepare liquid signal strength as evaluation coefficient X1；
Respectively by holotype ion mobility spectrometry: the second prepare liquid of the standard specimen and propofol injection to be measured of identical transit time
Signal strength numerical value compares, and the signal strength of the second prepare liquid of propofol injection to be measured subtracts the second prepare liquid of standard specimen
The difference absolute value of signal strength is divided by the signal strength of the second prepare liquid of standard specimen as evaluation coefficient X2；
Respectively by negative mode ion mobility spectrometry: the first prepare liquid of the standard specimen and propofol injection to be measured of identical transit time
Signal strength numerical value compares, and the signal strength of the first prepare liquid of propofol injection to be measured subtracts the first prepare liquid of standard specimen
The difference absolute value of signal strength is divided by the signal strength of the first prepare liquid of standard specimen as evaluation coefficient X3；
Respectively by negative mode ion mobility spectrometry: the second prepare liquid of the standard specimen and propofol injection to be measured of identical transit time
Signal strength numerical value compares, and the signal strength of the second prepare liquid of propofol injection to be measured subtracts the second prepare liquid of standard specimen
The difference absolute value of signal strength is divided by the signal strength of the second prepare liquid of standard specimen as evaluation coefficient X4；
If above-mentioned evaluation coefficient (X1、X2、X3、X4) be respectively less than be equal to 20% when, it is believed that propofol injection to be measured is in the shelf-life
It is interior, if above-mentioned evaluation coefficient is all larger than 20%, it is believed that propofol injection to be measured is out of date.
2. according to the method described in claim 1, it is characterized by: the amount ratio of volume A and volume B is 1:80-120.
3. method according to claim 1 or 2, it is characterised in that: organic solvent miscible with water is methanol, ethyl alcohol, different
One of propyl alcohol or two kinds or more；With the immiscible organic solvent of water be one of chloroform, a chlorobutane, methylene chloride or
Two kinds or more.
4. according to the method described in claim 1, it is characterized by: ion mobility spectrometry analysis condition is, atmospheric carrier air 200-
400sccm, air float gas 300-600sccm；90-110 DEG C of migration tube temperature, 120-150 DEG C of sample injector temperature；High pressure 3000-
5000V。
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| CN201710798600.0A CN109470762B (en) | 2017-09-07 | 2017-09-07 | Method for accurately identifying expiration of propofol injection |
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| CN201710798600.0A CN109470762B (en) | 2017-09-07 | 2017-09-07 | Method for accurately identifying expiration of propofol injection |
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Effective date of registration: 20211022 Address after: 518000 No. 4, Yintian Road, Xixiang street, Bao'an District, Shenzhen, Guangdong Patentee after: Shenzhen Nuote biomedical Co.,Ltd. Address before: 116023 No. 457, Zhongshan Road, Liaoning, Dalian Patentee before: DALIAN INSTITUTE OF CHEMICAL PHYSICS, CHINESE ACADEMY OF SCIENCES |