CN101929992B - Method for measuring oxidizable substance of drug packing material with total organic carbon analyser - Google Patents
Method for measuring oxidizable substance of drug packing material with total organic carbon analyser Download PDFInfo
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Abstract
The invention discloses a method for measuring the oxidizable substance of a drug packing material with a total organic carbon analyzer, which comprises the following steps of: a) taking the water for examining the total organic carbon as blank liquid, and measuring the content of the total organic carbon of the water for examining the organic carbon with the total organic carbon analyze; b) measuring the standard value of the content of the total organic carbon, wherein the standard value of the content of the total organic carbon is 5.016mg/L; c) sampling: collecting the packing material of the drug, respectively selecting the material according to the internal surface area of 600 cm2, cutting into small blocks with 0.5cm*0.5cm; d) washing a sample; e) treating the sample; f) measuring the content of the total organic carbon; and g) comparing. Compared with the conventional chemic titration, the method is more convenient and faster, does not need to prepare and demarcate the titrating solution of sodium thiosulfate and potassium permanganate, can perform the parallel measurement for many times, avoids the artificial operation error when titrating, and guarantees the accuracy and the availability of test data.
Description
Technical field
The present invention relates to a kind of material inspection method, particularly a kind of method of measuring oxidizable substance of drug packing material with total organic carbon analyser.
Background technology
Total organic carbon analytic approach (TOC method) is a kind of method of simple and direct effective quantitative measurement total content of organic carbon, its measuring principle is that the inorganic carbonate in the water sample is eliminated, be carbon dioxide with organic molecule complete oxidation in the water then, by measuring the response of carbon dioxide, thereby obtain the concentration of total organic carbon in the water sample.Because easy and simple to handle, quick and precisely, thereby the organism that is widely used for various water samples detects.
The detection method of oxidizable substance of drug packing material routine is a chemical titration.Experimental principle is with pretreated sample water leachate of process and blank solution, add excessive permanganate titration liquid respectively and carry out redox reaction, use the remaining permanganate titration liquid of sodium thiosulfate vs residual titration again, the difference of utilizing water-leach liquor and blank solution to consume the sodium thiosulfate vs reflects the content of readily oxidizable substance in the sample water leachate.The traditional detection method step is numerous and diverse, and the manual operation error is big, requires the experimenter to possess stronger operating ability.And the at present domestic research report that does not still have cartridge bag material readily oxidizable substance context of detection, Just because of this, the inventor attempts utilizing total organic carbon analyzer to detect readily oxidizable substance content in tygon (PE), polypropylene (PP) and the polyester cartridge bag materials such as (PET), so that seek a kind of more easy detection method.Find that after deliberation measuring the total content of organic carbon of variable concentrations sucrose water with total organic carbon analyzer has identical linear relationship with content with measuring oxidizable substance of drug packing material with total organic carbon analyser.
Summary of the invention
Purpose of the present invention is exactly at the deficiencies in the prior art, and a kind of method of measuring oxidizable substance of drug packing material with total organic carbon analyser is provided.
For achieving the above object, the present invention adopts following technical scheme:
A kind of method of measuring oxidizable substance of drug packing material with total organic carbon analyser is characterized in that may further comprise the steps:
A), check that with total organic carbon water is a blank solution, with the total content of organic carbon of total organic carbon analyzer mensuration total organic carbon inspection water;
B), the mensuration of total content of organic carbon standard value
It is an amount of that precision takes by weighing 105 ℃ of control sucrose product that are dried to constant weight, checks that with total organic carbon water is mixed with 1.56mgL
-1, 3.12mgL
-1, 4.69mgL
-1, 7.81mgL
-1, 15.62mgL
-1, 31.25mgL
-1, 78.12mgL
-1, 156.25mgL
-1Solution, precision is measured above-mentioned each concentration solution 20ml, the respectively accurate permanganate titration liquid (0.002molL that adds
-1) 20ml and dilute sulfuric acid 1ml, to boil 3 minutes, cooling rapidly adds potassium iodide 0.1g, in the dark places 5 minutes, with sodium thiosulfate vs (0.01molL
-1) titration, titration adds starch indicator solution 0.25ml during to nearly terminal point, continues titration to colourless, and other gets total organic carbon and checks that water operates with method, writes down the poor of control sucrose product solution and water blank solution consumption sodium thiosulfate vs volume respectively.With control sucrose product solution concentration (mgL
-1) be X-axis, poor (ml) that consume the vs volume is Y-axis, carries out linear recurrence.Linear equation is: Y=0.1007X+0.4185 (r=0.986); The result shows that control sucrose product solution concentration is linear with the difference that consumes sodium thiosulfate vs volume; For the readily oxidizable substance inspection in the drug packing material, the limit of traditional chemistry titration law regulation is that the difference of sample water leachate and water blank solution consumption sodium thiosulfate vs volume must not be crossed 1.5ml.Numerical value substitution linear equations is learnt that corresponding control sucrose liquid concentration is 10.74mgL
-1
It is an amount of that precision takes by weighing 105 ℃ of control sucrose product that are dried to constant weight, checks that with total organic carbon water is mixed with 10.74mgL
-1, repetitive operation three times, with measuring on the total organic carbon analyzer, every part of control sucrose product solution is surveyed 4 times;
Proofread and correct with total organic carbon inspection water, promptly use 10.74mgL
-1The value of control sucrose product solution total organic carbon deducts the value that total organic carbon is checked water, and several parts of results are average, is control sucrose product solution total content of organic carbon standard value; Measurement result is: after checking that with total organic carbon water is proofreaied and correct, record control sucrose product solution and total organic carbon and check that the mean value of water total organic carbon difference is 5.016mg/L, three parts of control sucrose product solution results' RSD (relative standard deviation) is 0.49%, the RSD of the end value of 4 parallel detections is respectively 0.11%, 0.20% and 0.17%, and the total content of organic carbon standard value is 5.016mg/L;
The result shows that the reappearance of batch intermittent gauging value and batch interior measured value is all better, illustrates that the readily oxidizable substance that uses total organic carbon analyzer to replace chemical titration to detect in the drug packing material is feasible;
The result of determination that traditional chemical titration detects readily oxidizable substance in the drug packing material is " sample water leachate and water blank solution consume the difference of sulfo-sodium sulphide vs must not cross 1.5ml "; The measurement result mean value of total organic carbon analyzer is 5.016mg/L, for simplicity, the result of determination that total organic carbon analyzer can be detected the readily oxidizable substance in the drug packing material is formulated and to be " difference of the total organic carbon value of sample water leachate and water blank solution must not be crossed 5mg/L ";
C), sampling
Gather drug packing material, respectively by internal surface area 600cm
2Draw materials, be cut into the fritter of 0.5cm * 0.5cm;
D), sample cleans
To gather drug packing material and check that with total organic carbon water cleans up drying at room temperature;
E), sample preparation
Sample after cleaning is placed the 500ml conical flask, add total organic carbon and check water 200ml, put in the autoclave sterilizer, 121 ℃ of heating 30min are put and are chilled to room temperature, make the water-leach liquor of drug packing material;
F), total content of organic carbon is measured
The water-leach liquor of drug packing material is measured total content of organic carbon on total organic carbon analyzer;
G), relatively
The total content of organic carbon of drug packing material is deducted the total content of organic carbon that total organic carbon is checked water, draw the total content of organic carbon value of drug packing material reality, and the total content of organic carbon value and the standard value of drug packing material reality compared, greater than total content of organic carbon standard value 5.016mg/L be defective, less than total content of organic carbon standard value 5.016mg/L is qualified.
What this experiment was adopted is the sievers 900 type total organic carbon analyzers that GE company produces.What it adopted is ultraviolet and persulfate wet oxidation dual system, has oxidation and waits advantage fully, and what detection system adopted is carbon dioxide selectivity membrane conductance method, has characteristics such as high sensitivity, high stability.
Adopt the total organic carbon analytic approach not need specific system condition and other requirements, can carry out quantitative test multiple organism and aqueous solution thereof.Because the absorption of organic pollution and carbon dioxide all can influence the authenticity of measurement result, so each link of mensuration all should be noted avoiding polluting.For example: should adopt closed container during sampling, sample is avoided uncovered and is positioned in the air, and the head space of container should be as far as possible little; After the sampling, should test immediately; Employed glassware must strictness be known organic substance residues, and must use water as last rinsing with the total organic carbon inspection.
The beneficial effect of the method for a kind of measuring oxidizable substance of drug packing material with total organic carbon analyser of the present invention is, compare with traditional chemical titration, the readily oxidizable substance that uses total organic carbon analyzer to detect in the drug packing material is more convenient, quick, it need not preparation, demarcates sodium thiosulfate and permanganate titration liquid, can repeatedly parallel detection, avoid the manual operation error of titration, guaranteed the accurate and effective of test figure.
Description of drawings
Fig. 1 is control sucrose product solution concentration of the present invention and consumes the linear relationship synoptic diagram of the difference of sodium thiosulfate vs volume.
Embodiment
The present invention is further illustrated below in conjunction with accompanying drawing, but therefore do not limit the present invention among the described scope of embodiments.
Instrument and reagent
The portable total organic carbon analyzer of Sievers 900 types (GE company);
Control sucrose product (lot number: 111507-200001; Specification: 50mg; Content: 100%; Nat'l Pharmaceutical ﹠ Biological Products Control Institute provides);
High-density polyethylene bottle, polypropylene infusion bottle, each 1 batch of polyester transfusion cork (lot number, specification and manufacturer are slightly)
Total organic carbon checks that water is my homemade ultrapure water.
Embodiment 1
A kind of method of measuring oxidizable substance of drug packing material with total organic carbon analyser is characterized in that may further comprise the steps:
A), check that with total organic carbon water is a blank solution, with the total content of organic carbon of total organic carbon analyzer mensuration organic carbon inspection water;
B), the mensuration of total content of organic carbon standard value
It is an amount of that precision takes by weighing 105 ℃ of control sucrose product that are dried to constant weight, checks that with total organic carbon water is mixed with 10.74mgL
-1, repetitive operation three times, with measuring on the total organic carbon analyzer, every part of control sucrose product solution is surveyed 4 times;
Proofread and correct with total organic carbon inspection water, promptly use 10.74mgL
-1The value of control sucrose product solution total organic carbon deducts the value that total organic carbon is checked water, and several parts of results are average, is control sucrose product solution total content of organic carbon standard value; Measurement result is: after checking that with total organic carbon water is proofreaied and correct, the total content of organic carbon standard value is 5.016mg/L;
The system availability test
(the fixed 105 ℃ of control sucrose product that are dried to constant weight of accurate title are an amount of to get control sucrose product solution respectively, add total organic carbon inspection water dissolving and be diluted to every liter and contain 1.2mg approximately) and 1, (precision takes by weighing 1 to 4-1,4-benzoquinone reference substance solution, 4-1,4-benzoquinone reference substance is an amount of, add total organic carbon inspection water dissolving and be diluted to every liter and contain 0.75mg approximately) and total organic carbon inspection water sample introduction, register instrument total organic carbon response successively is with the oxidability of investigating instrument and the applicability of system; (r by formula
Ss-r
w)/(r
s-r
w) calculate, response efficiency should be 85%～115%; (annotate: r
wCheck the blank response of water for total organic carbon; r
SsBe 1, the response of 4-1,4-benzoquinone reference substance solution; r
sResponse for control sucrose product solution)
Linear relationship is investigated
It is an amount of that precision takes by weighing 105 ℃ of control sucrose product that are dried to constant weight, checks that with total organic carbon water is mixed with 1.56mgL
-1, 3.12mgL
-1, 4.69mgL
-1, 7.81mgL
-1, 15.62mgL
-1, 31.25mgL
-1, 78.12mgL
-1, 156.25mgL
-1Solution, precision is measured above-mentioned each concentration solution 20ml, the respectively accurate permanganate titration liquid (0.002molL that adds
-1) 20ml and dilute sulfuric acid 1ml, to boil 3 minutes, cooling rapidly adds potassium iodide 0.1g, in the dark places 5 minutes, with sodium thiosulfate vs (0.01molL
-1) titration, titration adds starch indicator solution 0.25ml during to nearly terminal point, continues titration to colourless, and other gets total organic carbon and checks that water operates with method, writes down the poor of control sucrose product solution and water blank solution consumption sodium thiosulfate vs volume respectively.With control sucrose product solution concentration (mgL
-1) be X-axis, poor (m1) that consume the vs volume is Y-axis, carries out linear recurrence.Linear equation is: Y=0.1007X+0.4185 (r=0.986).The result shows, control sucrose product solution concentration and the difference linear (referring to Fig. 1) that consumes sodium thiosulfate vs volume.
| X-axis | 1.5625 | 3.125 | 4.6875 | 7.8125 | 15.625 | 31.25 | 78.125 | 156.25 |
| Y-axis | 0.02 | 0.19 | 0.38 | 1.41 | 2 | 4.08 | 10.22 | 15.11 |
Limit converts
For the readily oxidizable substance inspection in the drug packing material, the limit of traditional chemistry titration law regulation is that the difference of sample water leachate and water blank solution consumption sodium thiosulfate vs volume must not be crossed 1.5ml.Numerical value substitution linear equations is learnt that corresponding control sucrose liquid concentration is 10.74mgL
-1
The mensuration of total content of organic carbon standard value and precision are investigated
It is an amount of that precision takes by weighing 105 ℃ of control sucrose product that are dried to constant weight, checks that with total organic carbon water is mixed with 10.74mgL
-1, repetitive operation three times is measured on total organic carbon analyzer, and every part of control sucrose product solution is surveyed 4 times, and the result is proofreaied and correct with total organic carbon inspection water.Record control sucrose product solution and total organic carbon and check that the mean value of water total organic carbon difference is 5.016mg/L, three parts of control sucrose product solution results' RSD (relative standard deviation) is that the RSD of the end value of 0.49%, 4 parallel detection is respectively 0.11%, 0.20% and 0.17%.The result shows that the reappearance of batch intermittent gauging value and batch interior measured value is all better, illustrates that the readily oxidizable substance that uses total organic carbon analyzer to replace chemical titration to detect in the drug packing material is feasible.
Draft the limit standard: the result of determination that traditional chemical titration detects readily oxidizable substance in the drug packing material is " sample water leachate and water blank solution consume the difference of sulfo-sodium sulphide vs must not cross 1.5ml ".The measurement result mean value of total organic carbon analyzer is 5.016mg/L, for simplicity, the result of determination that total organic carbon analyzer can be detected the readily oxidizable substance in the drug packing material is formulated and to be " difference of the total organic carbon value of sample water leachate and water blank solution must not be crossed 5mg/L ".
C), sampling
Get each 1 batch of polypropylene (PP) infusion bottle, polyester (PET) transfusion cork, respectively by internal surface area 600cm
2Draw materials, be cut into the fritter of 0.5cm * 0.5cm;
D), sample cleans
To gather drug packing material and check that with total organic carbon water cleans up drying at room temperature;
E), sample preparation
Sample after cleaning is placed the 500ml conical flask, respectively add total organic carbon and check water 200ml, put in the autoclave sterilizer, 121 ℃ of heating 30min are put and are chilled to room temperature, make two kinds of corresponding water-leach liquors of sample; And check that with total organic carbon water is a blank solution, operates with method.
F), total content of organic carbon is measured
Then above-mentioned three kinds of solution respectively are divided into two parts, portion is measured on total organic carbon analyzer, and the result is followed successively by 0.628mg/L (RSD=0.17%), 0.504mg/L (RSD=0.32%) and 0.123mg/L (RSD=0.13%);
G), relatively
The total content of organic carbon of drug packing material is deducted the total content of organic carbon that the blank solution organic carbon is checked water, draw the total content of organic carbon of drug packing material reality, and the total content of organic carbon of drug packing material reality compared in standard value, greater than total content of organic carbon in standard value 5.016mg/L for exceeding standard, be qualified less than total content of organic carbon in standard value 5.016mg/L.
The difference of the total organic carbon value of two batch sample water-leach liquors and water blank solution is respectively 0.505mg/L (PP infusion bottle), 0.381mg/L (PET transfusion cork), all is lower than the limit value of 5mg/L.Another part detects (concrete experimental procedure is referring to " investigation of 1.3 linear relationships ") according to traditional chemical titration, the difference that two batch sample water-leach liquors and water blank solution consume sulfo-sodium sulphide vs is respectively 0.16ml (PP infusion bottle), 0.12ml (PET transfusion cork), all far below the limit value of the 1.5ml of standard code.
A kind of method of measuring oxidizable substance of drug packing material with total organic carbon analyser is characterized in that may further comprise the steps:
A), check that with total organic carbon water is a blank solution, with the total content of organic carbon of total organic carbon analyzer mensuration organic carbon inspection water;
B), total content of organic carbon is in the mensuration of standard value
It is an amount of that precision takes by weighing 105 ℃ of control sucrose product that are dried to constant weight, checks that with total organic carbon water is mixed with 10.74mgL
-1, repetitive operation three times, with measuring on the total organic carbon analyzer, every part of control sucrose product solution is surveyed 4 times;
Proofread and correct with total organic carbon inspection water, promptly use 10.74mgL
-1The value of control sucrose product solution total organic carbon deducts the value that total organic carbon is checked water, and several parts of results are average, is control sucrose product solution total content of organic carbon standard value; Measurement result is: after checking that with total organic carbon water is proofreaied and correct, the total content of organic carbon standard value is 5.016mg/L;
C), sampling
Get 1 batch in high density polyethylene (PE) bottle, by internal surface area 600cm
2Draw materials, be cut into the fritter of 0.5cm * 0.5cm;
D), sample cleans
It is an amount of that high density polyethylene (PE) the bottle fritter of gathering is added water, and jolting washing small pieces discard water, and repetitive operation once after 40 ℃ of dryings, adds total organic carbon and checks that water (70 ℃ ± 2 ℃) 200ml soaked after 24 hours, takes out to put to be chilled to room temperature;
E), sample preparation
Check that with total organic carbon water is supplemented to original volume as the sample water leachate; And check that with total organic carbon water is a blank solution, operates with method;
F), total content of organic carbon is measured
Then above-mentioned two kinds of solution respectively are divided into two parts, portion is measured on total organic carbon analyzer, and the result is 0.972mg/L (RSD=0.22%) and 0.143mg/L (RSD=0.18%);
G), relatively
The difference of the total organic carbon value of water-leach liquor and water blank solution is respectively 0.829mg/L (PE bottle); All far below the limit value of 5mg/L.
Another part detects (concrete experimental procedure is referring to " linear relationship investigations ") according to traditional chemical titration, and the difference of sample water leachate and water blank solution consumption sulfo-sodium sulphide vs is respectively 0.27ml, far below the limit value of the 1.5ml of standard code.
The result shows that the readily oxidizable substance content of three batches of cartridge bag material samples all is lower than the specified standard limit, and is all qualified through chemical titration and two kinds of inspection methods detections of total organic carbon analytic approach.
Described embodiments of the present invention though combine accompanying drawing, those of ordinary skill in the art can make various distortion or modification within the scope of the appended claims.The technician of the industry should understand; the present invention is not restricted to the described embodiments; that describes in the foregoing description and the instructions just illustrates principle of the present invention; without departing from the spirit and scope of the present invention; the present invention also has various changes and modifications, and these changes and improvements all fall in the claimed scope of the invention.The claimed scope of the present invention is defined by appending claims and equivalent thereof.
Claims (1)
1. the method for a measuring oxidizable substance of drug packing material with total organic carbon analyser is characterized in that may further comprise the steps:
A), check that with total organic carbon water is a blank solution, with the total content of organic carbon of total organic carbon analyzer mensuration total organic carbon inspection water;
B), the mensuration of total content of organic carbon standard value
It is an amount of that precision takes by weighing 105 ℃ of control sucrose product that are dried to constant weight, checks that with total organic carbon water is mixed with 10.74mgL
-1, repetitive operation three times is measured with total organic carbon analyzer, and every part of control sucrose product solution is surveyed 4 times;
Proofread and correct with total organic carbon inspection water, promptly use 10.74mgL
-1The value of control sucrose product solution total organic carbon deducts the value that total organic carbon is checked water, and several parts of results are average, is control sucrose product solution total content of organic carbon standard value;
C), sampling
Gather drug packing material, respectively by internal surface area 600cm
2Draw materials, be cut into the fritter of 0.5cm * 0.5cm;
D), sample cleans
To gather drug packing material and check that with total organic carbon water cleans up drying at room temperature;
E), sample preparation
Sample after cleaning is placed the 500ml conical flask, add total organic carbon and check water 200ml, put in the autoclave sterilizer, 121 ℃ of heating 30min are put and are chilled to room temperature, make the water-leach liquor of drug packing material;
F), total content of organic carbon is measured
The water-leach liquor of drug packing material is measured total content of organic carbon on total organic carbon analyzer;
G), relatively
The total content of organic carbon of drug packing material is deducted the total content of organic carbon that total organic carbon is checked water, draw the total content of organic carbon value of drug packing material reality, and the total content of organic carbon value and the control sucrose product solution total content of organic carbon standard value of drug packing material reality compared, greater than the total content of organic carbon standard value be defective, less than the total content of organic carbon standard value is qualified.
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| JP5941553B2 (en) * | 2012-01-09 | 2016-06-29 | ゼネラル・エレクトリック・カンパニイ | Method for stabilizing a non-acidified standard TOC level for a total organic carbon (TOC) analyzer at room temperature |
| CN105067666B (en) * | 2015-08-21 | 2018-02-02 | 中国环境科学研究院 | A kind of method that plant biomass TOC is detected using heat analysis |
| CN105628562A (en) * | 2016-01-04 | 2016-06-01 | 华北电力科学研究院有限责任公司 | Water tank antirot material dissolvent characteristic detection test method |
| CN106290333A (en) * | 2016-07-27 | 2017-01-04 | 浙江景嘉医疗科技有限公司 | A kind of detection method of sacculus product reducing substances |
| WO2022076500A1 (en) | 2020-10-08 | 2022-04-14 | Ecolab Usa Inc. | System and technique for detecting cleaning chemical usage to control cleaning efficacy |
| CN118130409A (en) * | 2024-05-07 | 2024-06-04 | 中国地质调查局昆明自然资源综合调查中心 | Method for continuously measuring easily oxidized organic carbon and inert organic carbon in soil |
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