CN109521130A - A method of for detecting antioxidant in Key works Drug packing elastomeric seal - Google Patents
A method of for detecting antioxidant in Key works Drug packing elastomeric seal Download PDFInfo
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- CN109521130A CN109521130A CN201811235005.7A CN201811235005A CN109521130A CN 109521130 A CN109521130 A CN 109521130A CN 201811235005 A CN201811235005 A CN 201811235005A CN 109521130 A CN109521130 A CN 109521130A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/62—Detectors specially adapted therefor
- G01N30/74—Optical detectors
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/86—Signal analysis
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N2030/022—Column chromatography characterised by the kind of separation mechanism
- G01N2030/027—Liquid chromatography
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Abstract
The invention belongs to technical field of analytical chemistry, disclose a kind of method for detecting antioxidant in Key works Drug packing elastomeric seal, with the test solution of liquid chromatograph detection preparation, record chromatogram；By calibration curve method with the content of antioxidant and degradation product in calculated by peak area elastomeric seal and medical fluid.The method that the present invention establishes antioxidant in Screening analysis Key works Drug packing elastomeric seal, using the above-mentioned 12 kinds of antioxidants of high performance liquid chromatography first separation and degradation product, using retention time as qualitative foundation.Various antioxidants and degradation product are dissolved in dichloromethane solution, carry out Mechanical Crushing to sealing element, then stay overnight rear microwave heating extraction with methylene chloride swelling, are detected after filtering with high performance liquid chromatography.The present invention has extraction operation simple and effective, low for equipment requirements using liquid-phase chromatographic analysis detection, and one needle of the Screening analysis completion detection speed of 12 kinds of substances is fast, the comprehensive advantage of the coverage area of antioxidant.
Description
Technical field
The invention belongs to technical field of analytical chemistry, more particularly to one kind is for detecting Key works Drug packing elastomeric seal
The method of middle antioxidant.
Background technique
Drug packing material, which refers to, meets product for manufacturing packing container, packing and decorating, packages printing, packed and transported etc.
Material used in packing instructions.Elastomeric seal: elastomer refers under external force, the strain and stress of interior point
It corresponds, the object of original state can be restored to after external force removes.Elastomeric seal herein refers mainly to Key works Drug packing
Rubber sealing element and thermoplastic elastomer (TPE) sealing element in material.The common rubber material of Key works Drug packing is according to polymerization reaction institute
The difference of monomer can be divided into: polyisoprene rubber, butyl rubber, halogenated butyl rubber, silicon rubber, EP rubbers
Class；According to the structure and processing technology of rubber assembly, it can be divided into: coated seal, non-coated seal；Coated seal includes
Overlay film, film and plated film etc..Thermoplastic elastomer (TPE) is divided into copoly type (chemical synthesis type) thermoplastic elastomer (TPE) according to preparation method
With blending type (blend rubber type) thermoplastic elastomer (TPE).Styrenic block Copolymer can be divided into according to chemical structure
(Styreneic block copolymers, SBCs), polyurethanes (Thermoplastic polyurethanes, TPU),
Polyesters (Thermoplastic polyethylene elastomer, TPEE), polyamide-based (Thermoplastic
Polyamide elastomer, TPAE) and polyolefins (Thermoplastic polyolefin, TPO) etc..Antioxidant:
Antioxidant is a kind of chemical substance, in the presence of it is only a small amount of in polymeric system, so that it may delay or inhibit polymer to aoxidize
The progress of process, to prevent the aging of polymer and prolong its service life, be otherwise known as " anti-aging agent ".As packages groups
On the one hand part, sealing element should meet requirement of the packaging system to leakproofness, providing to protect and meet for drug makes expected from packaging
Use function；On the other hand should also have good compatibility with drug, i.e., can not introduce the extract there are security risks, or
Extract level meets security requirement；And drug will not be influenced because of the effective component or functional auxiliary material in absorption drug
Quality, efficacy and saferry.Antioxidant is as the auxiliary agent routinely added in a kind of elastomer, in packaging and storage and transportation drug
There is the risk moved in drug in the process, so especially drug is compatible with packaging material during drug quality control
During Journal of Sex Research, need to pay close attention to the actual migration amount of antioxidant in the transportable amount of antioxidant and drug in elastomer.
The production and processing process of elastomer is longer, and can all relate to from the raw material of elastomer to storage and transportation to the molding multiple links of final products
And the addition to antioxidant, this result in the type of the target antioxidant in actually detected be it is various, it is different types of
The concentration difference of antioxidant is larger.In addition, antioxidant, there is also auto-degradation, there is also move to shadow in drug for degradation product
Ring the risk that drug effect even generates toxicity.Therefore in the analyte detection process of antioxidant, the degradation product of antioxidant is same
It is very difficult and necessary that antioxidant itself carries out analysis detection together.Against the background of the prior art, do not have still
A kind of method can be extracted and detect various antioxidants and its degradation product common in elastomer.Key works Drug packing elastomeric seal
Common antioxidant in part includes BHT, 3114,1010,1330,1076,168 and its serial antioxidant catabolite
BHT-OH, BHT-COOH, BHT-CHO, BHT-Q (catabolites of BHT, 1330,1076 etc.), 2,4- di-tert-butylphenol (168
Catabolite), catabolite 1310 (1010,1076 catabolites).
In conclusion problem of the existing technology is1. sample preparation link generallys use, refluxing toluene etc. is opposite to be consumed
When, waste material, the biggish technological means of environmental pollution.2. detection object type be confined to one to two kinds it is specific anti-oxidant
Agent object, and there are many antioxidant type of actual interpolation and kind number in elastomer, if traditionally method, need to carry out
Plurality of target object distinguishes sample introduction, and test of many times is needed to complete qualitatively screening and quantitative analysis to potential extractable, lacks
Systematicness, screening efficiency are low.3. target tightening for the detection of pair antioxidant in antioxidant itself, ignores antioxidant and exist
The various products that degradation in processing and elastomer survival phase generates.4. it is anti-to carry out small part using the expensive instrument such as LC-MS
The screening of oxidant, it is not only inefficent, but also high request is proposed to instrument and equipment.
Solve the difficulty and meaning of above-mentioned technical problem:1 provides one kind quickly for the antioxidant in screening elastomer
The extraction means of easy environmental protection；2 provide a kind of systemic screening antioxidant and degradation product detection means；3 screening efficiencies are big
It is big to improve, while detecting 12 kinds of antioxidants and only needing 55 minutes；4 use liquid chromatography, each detection machine low to instrument requirements
Structure is able to satisfy testing conditions.
Summary of the invention
In view of the problems of the existing technology, the present invention provides one kind for detecting Key works Drug packing elastomeric seal
The method of middle antioxidant.
The invention is realized in this way a kind of for detecting the side of antioxidant in Key works Drug packing elastomeric seal
Method, the method for detecting antioxidant in Key works Drug packing elastomeric seal detect the confession of preparation with liquid chromatograph
Test sample solution records chromatogram；By calibration curve method with antioxidant and degradation in calculated by peak area elastomeric seal and medical fluid
The content of object.
Further, described for detecting the high-efficient liquid phase color of the method for antioxidant in Key works Drug packing elastomeric seal
Spectral condition: C18 forward direction chromatographic column；Mobile phase A is that chromatography goes out acetonitrile, and Mobile phase B is Chromatographic Pure Methanol, and mobile phase C is concentration 1%
Aqueous acetic acid；Column temperature: 35 DEG C；Detection wavelength 277nm；Flow velocity: 1.0ml/min；Sample volume: 10 μ l.
Further, it is needed before the test solution with liquid chromatograph detection preparation:
Elastomer to be detected is broken into the little particle of 5mm × 5mm or so by step 1, weighs broken rubber plug 0.5g, is packed into microwave
In digestion tube, 10ml methylene chloride is added, is swollen 12 hours, 40 DEG C of micro-wave digestion 45min are cooled to room temperature；
Step 2 is filtered with glass funnel, removes elastomer little particle, and filtrate is vacuumized revolving, removes methylene chloride
Solvent；Residue after volatilizing is dissolved with 8ml methanol ultrasonic oscillation, transfer lysate to 10ml volumetric flask, methanol solution constant volume；
Step 3, the solution after taking constant volume are filtered with 0.45 μm of nylon leaching film, and filtrate is detected with liquid chromatography.
Another object of the present invention is to provide be used to detect in Key works Drug packing elastomeric seal described in a kind of application
The Key works Drug packing case of the method for antioxidant.
In conclusion advantages of the present invention and good effect are12 kinds 12 kinds
Detailed description of the invention
Fig. 1 is the method provided in an embodiment of the present invention for detecting antioxidant in Key works Drug packing elastomeric seal
Flow chart.
Fig. 2 is mixing reference substance liquid chromatogram provided in an embodiment of the present invention.
Specific embodiment
In order to make the objectives, technical solutions, and advantages of the present invention clearer, with reference to embodiments, to the present invention
It is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, it is not used to
Limit the present invention.
As shown in Figure 1, provided in an embodiment of the present invention for detecting antioxidant in Key works Drug packing elastomeric seal
Method the following steps are included:
Elastomer to be detected: being broken into the little particle of 5mm × 5mm or so by S101, weighs broken rubber plug 0.5g, is packed into microwave and is disappeared
10ml methylene chloride is added in Xie Guanzhong, is swollen overnight (12 hours or so), 40 DEG C of micro-wave digestion 45min are cooled to room temperature；
S102: being filtered with glass funnel, removes elastomer little particle, and filtrate is vacuumized revolving, it is molten to remove methylene chloride
Agent；Residue after volatilizing is dissolved with 8ml methanol (containing 0.1% methylene chloride) ultrasonic oscillation, transfer lysate to 10ml capacity
Bottle, methanol (0.1% methylene chloride) solution constant volume；
S103: the solution after taking constant volume is filtered with 0.45 μm of nylon leaching film, and filtrate is detected with above-mentioned liquid chromatography；
S104: with the test solution of liquid chromatograph detection preparation, chromatogram is recorded；By calibration curve method with peak area
Calculate in elastomeric seal and medical fluid the content of antioxidant and degradation product to get.
In a preferred embodiment of the invention: high-efficient liquid phase chromatogram condition: selecting conventional C18 forward direction chromatographic column
(choosing Waters company Symmetry RP18 type chromatogram column length 250mm × diameter 4.6mm, packing material size 5um herein)；Stream
Dynamic phase A is that chromatography goes out acetonitrile, and Mobile phase B is Chromatographic Pure Methanol, and mobile phase C is the aqueous acetic acid of concentration 1%；Column temperature: 35 DEG C；
Detection wavelength 277nm；Flow velocity: 1.0ml/min；Sample volume: 10 μ l.Number of theoretical plate is calculated by principal component peak, must not be lower than 3000.
The detection limit of each object should be not more than 200ug/L.
1 eluent gradient elution requirement of table
| Time (min) | A (acetonitrile, %) | B (methanol, %) | C (1% Acetic Acid-Water, %) |
| 0 | 10 | 50 | 40 |
| 3 | 10 | 50 | 40 |
| 6 | 20 | 50 | 30 |
| 9 | 25 | 50 | 25 |
| 12 | 25 | 50 | 25 |
| 15 | 30 | 50 | 20 |
| 21 | 90 | 5 | 5 |
| 24 | 90 | 5 | 5 |
| 30 | 80 | 20 | 0 |
| 33 | 60 | 40 | 0 |
| 36 | 0 | 100 | 0 |
| 42 | 0 | 100 | 0 |
| 45 | 10 | 50 | 40 |
| 55 | 10 | 50 | 40 |
Measuring method: with the test solution of liquid chromatograph detection preparation, chromatogram is recorded.Such as Fig. 2；By standard curve
Method with the content of antioxidant and degradation product in calculated by peak area elastomeric seal and medical fluid to get.
Prove part (specific embodiment/experiment/emulation /)
1. methodology validation part:
It is true and reliable that process method of proof is verified by common analyzing detecting method:
1.1. detection limits:
1.2 assay threshold values (AET)
The above result shows that this method detection limit is significantly lower than assay threshold requirement, it is fully available for analysis rubber plug
The content of middle antioxidant and its catabolite.
1.3 linear and ranges:
In 0.2~20ppm concentration range, peak area and concentration are in good line for 12 kinds of antioxidant and its catabolite
Sexual intercourse
1.4 precision
| 1 | 2 | 3 | 4 | 5 | 6 | RSD | |
| BHT-OH | 24824 | 24814 | 24902 | 24752 | 24797 | 24886 | 0.23% |
| BHT-COOH | 113948 | 113801 | 113869 | 113918 | 112970 | 113967 | 0.34% |
| BHT-CHO | 178444 | 178386 | 178231 | 178443 | 179657 | 173901 | 1.12% |
| BHT-Q | 28810 | 28818 | 28705 | 28792 | 28950 | 28787 | 0.28% |
| BHT | 29731 | 29605 | 29815 | 29819 | 30007 | 29812 | 0.44% |
| 2,4- di-tert-butylphenol | 31443 | 31598 | 31405 | 31440 | 31793 | 31444 | 0.47% |
| 1310 | 14920 | 15897 | 16124 | 16156 | 15902 | 16285 | 3.11% |
| 3114 | 16179 | 16104 | 16160 | 16203 | 16158 | 16217 | 0.25% |
| 1010 | 20422 | 20506 | 20394 | 20521 | 20535 | 20577 | 0.34% |
| 1330 | 25418 | 25279 | 25438 | 25967 | 26026 | 25920 | 1.29% |
| 1076 | 10023 | 10298 | 10050 | 10252 | 10225 | 10174 | 1.10% |
| 168 | 13126 | 13242 | 13367 | 13426 | 13309 | 13466 | 0.94% |
The reference substance solution that concentration is about 5ppm is taken, 6 needle of continuous sample introduction records chromatogram, calculates antioxidant peak area
RSD, it is as shown in the table, and method precision is good.
1.5 stability
Take about the contrast solution of 5ppm respectively at 0,9,35,53 hour sample introduction is analyzed, calculate the RSD of peak area, as a result
Show that 12 kinds of antioxidant and its reference substance solution of catabolite, extractable sulphur are stablized in 53 hours
1.6 accuracy:
Confirm the accuracy of method by way of standard items are added and detect the rate of recovery, the rate of recovery except 168 75.2% with
Outside, remaining between 86.2%-102.4%, the rate of recovery is good.
2. detection technique application:
It is as follows for the rubber plug progress test result of 9 butyl rubber plug manufacturers of collection:
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all in essence of the invention
Made any modifications, equivalent replacements, and improvements etc., should all be included in the protection scope of the present invention within mind and principle.
Claims (4)
1. a kind of method for detecting antioxidant in Key works Drug packing elastomeric seal, which is characterized in that described to be used for
The method for detecting antioxidant in Key works Drug packing elastomeric seal detects the test solution of preparation, note with liquid chromatograph
Record chromatogram；By calibration curve method with the content of antioxidant and degradation product in calculated by peak area elastomeric seal and medical fluid.
2. the method as described in claim 1 for detecting antioxidant in Key works Drug packing elastomeric seal, feature
It is, it is described for detecting the high-efficient liquid phase chromatogram condition of the method for antioxidant in Key works Drug packing elastomeric seal: C18
Positive chromatographic column；Mobile phase A is trifluoroacetic acid aqueous solution, and Mobile phase B is Chromatographic Pure Methanol, and mobile phase C is that the acetic acid of concentration 1% is water-soluble
Liquid；Column temperature: 35 DEG C；Detection wavelength 277nm；Flow velocity: 1.0ml/min；Sample volume: 10 μ l.
3. the method as described in claim 1 for detecting antioxidant in Key works Drug packing elastomeric seal, feature
It is, is needed before the test solution with liquid chromatograph detection preparation:
Elastomer to be detected is broken into the little particle of 5mm × 5mm or so by step 1, weighs broken rubber plug 0.5g, is packed into micro-wave digestion
10ml methylene chloride is added in Guan Zhong, is swollen 12 hours, 40 DEG C of micro-wave digestion 45min are cooled to room temperature；
Step 2 is filtered with glass funnel, removes elastomer little particle, and filtrate is vacuumized revolving, removes dichloromethane solvent；
Residue after volatilizing is dissolved with 8ml methanol ultrasonic oscillation, transfer lysate to 10ml volumetric flask, methanol solution constant volume；
Step 3, the solution after taking constant volume are filtered with 0.45 μm of nylon leaching film, and filtrate is detected with liquid chromatography.
4. anti-oxidant in Key works Drug packing elastomeric seal for detecting described in a kind of application claims 1 to 3 any one
The detection method of agent.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111323515A (en) * | 2020-03-26 | 2020-06-23 | 重庆市食品药品检验检测研究院 | Method for determining antioxidant THP-24 in plastic packaging material |
| CN116840278A (en) * | 2023-07-06 | 2023-10-03 | 中国食品药品检定研究院 | Evaluation method of oxygen absorbent added in infusion and peritoneal dialysis fluid products |
| CN117368350A (en) * | 2023-10-12 | 2024-01-09 | 华夏生生药业(北京)有限公司 | Method for simultaneously detecting 7 antioxidants by liquid chromatography and application thereof |
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| CN111323515A (en) * | 2020-03-26 | 2020-06-23 | 重庆市食品药品检验检测研究院 | Method for determining antioxidant THP-24 in plastic packaging material |
| CN111323515B (en) * | 2020-03-26 | 2022-08-05 | 重庆市食品药品检验检测研究院 | Method for determining antioxidant THP-24 in plastic packaging material |
| CN116840278A (en) * | 2023-07-06 | 2023-10-03 | 中国食品药品检定研究院 | Evaluation method of oxygen absorbent added in infusion and peritoneal dialysis fluid products |
| CN117368350A (en) * | 2023-10-12 | 2024-01-09 | 华夏生生药业(北京)有限公司 | Method for simultaneously detecting 7 antioxidants by liquid chromatography and application thereof |
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