CN113884412A - Method for testing harmful and potential harmful substances of aerosol - Google Patents
Method for testing harmful and potential harmful substances of aerosol Download PDFInfo
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- 238000000034 method Methods 0.000 title claims abstract description 32
- 238000012216 screening Methods 0.000 claims abstract description 53
- 150000001875 compounds Chemical class 0.000 claims abstract description 50
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- SNICXCGAKADSCV-JTQLQIEISA-N (-)-Nicotine Chemical compound CN1CCC[C@H]1C1=CC=CN=C1 SNICXCGAKADSCV-JTQLQIEISA-N 0.000 claims description 15
- 229960002715 nicotine Drugs 0.000 claims description 15
- SNICXCGAKADSCV-UHFFFAOYSA-N nicotine Natural products CN1CCCC1C1=CC=CN=C1 SNICXCGAKADSCV-UHFFFAOYSA-N 0.000 claims description 15
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- 238000012430 stability testing Methods 0.000 claims description 12
- 235000019640 taste Nutrition 0.000 claims description 8
- 235000011187 glycerol Nutrition 0.000 claims description 5
- 238000011835 investigation Methods 0.000 abstract 2
- WIWXVPHATMUPGK-UHFFFAOYSA-N hexadecyl 3-(trimethylazaniumyl)propyl phosphate Chemical compound CCCCCCCCCCCCCCCCOP([O-])(=O)OCCC[N+](C)(C)C WIWXVPHATMUPGK-UHFFFAOYSA-N 0.000 abstract 1
- PXHVJJICTQNCMI-UHFFFAOYSA-N Nickel Chemical compound [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 description 20
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- 229910001385 heavy metal Inorganic materials 0.000 description 13
- 229910052759 nickel Inorganic materials 0.000 description 10
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- 235000012141 vanillin Nutrition 0.000 description 6
- 239000011133 lead Substances 0.000 description 5
- 235000019505 tobacco product Nutrition 0.000 description 5
- 229940007550 benzyl acetate Drugs 0.000 description 4
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- IKHGUXGNUITLKF-UHFFFAOYSA-N Acetaldehyde Chemical compound CC=O IKHGUXGNUITLKF-UHFFFAOYSA-N 0.000 description 2
- 239000012491 analyte Substances 0.000 description 2
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- 238000001514 detection method Methods 0.000 description 2
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- NOOLISFMXDJSKH-KXUCPTDWSA-N (-)-Menthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O NOOLISFMXDJSKH-KXUCPTDWSA-N 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
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- 230000000711 cancerogenic effect Effects 0.000 description 1
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- 238000006243 chemical reaction Methods 0.000 description 1
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- 239000012669 liquid formulation Substances 0.000 description 1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/0004—Gaseous mixtures, e.g. polluted air
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
- G01N2015/0042—Investigating dispersion of solids
- G01N2015/0046—Investigating dispersion of solids in gas, e.g. smoke
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- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
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Abstract
The invention relates to a method for testing harmful and potential harmful substances in aerosol formed by tobacco tar, which comprises the steps of carrying out a single batch and single compound sample complete harmful and potential harmful substance investigation test on each stock unit to be tested, screening out a target to be further tested according to the investigation test result, and carrying out data stability test on the screened test target in standard batch and standard compound sample harmful and potential harmful substances; the target can be a representative stock unit or a substance harmful to human bodies, standard complete test times (1(SKU) × 3 (batch) × 7 (compound sample) × 36(HPHC substance) × 2 (dense and non-dense) ═ 1512) of each stock unit are compared, and the test targets are screened and then tested according to the standard batch and the standard compound sample, so that the test quantity can be greatly reduced and the test efficiency can be improved on the premise of meeting the scientific conclusion.
Description
Technical Field
The invention relates to the technical field of aerosol detection, in particular to a method for testing harmful and potential harmful substances in aerosol formed by atomized smoke liquid.
Background
The electronic cigarette is an electronic product simulating a cigarette, has similar smoke, taste and feeling as a cigarette, and is a product for converting nicotine and the like into aerosol for a user to suck through atomization. Due to the cool and dazzling appearance, various selectable tastes and convenience in smoking of the electronic cigarette, the electronic cigarette is rapidly popularized and used.
Also because of the rapid expansion of the user population, the FDA has proposed regulations on HPHC (Harmful and potentially Harmful substances) in electronic cigarette products; in 6 months 2019, the FDA issued a "pre-market Tobacco product Application for Electronic Nicotine Delivery Systems" (PMTA for short), which specifies the content required for delivering pre-market applications for Electronic Nicotine Delivery Systems (ENDS for short).
PMTA requires that the ENDS tobacco product to which PMTA is applied should be subjected to product analysis and testing, and that any product sample submitted should be a batch that has been tested within its shelf life. The FDA suggests that for each product analysis or test included in this portion of the PMTA, a complete report of all tests should be submitted, including a data set that can reliably reflect the product and its production. Among these, the FDA provides a list of 36 ENDS analytes in the PMTA guide (see table 1).
TABLE 1 FDA ENDS analyte List provided in the PMTA guide
According to the FDA's list of ENDS analytes provided, the FDA recommended data set should include different batches of products (typically three or more batches), with multiple replicates per batch (typically seven or more); and evaluating the new tobacco product under both non-dense (e.g., lower level exposure and producing a smaller amount of aerosol) and dense (e.g., higher level exposure and producing a larger amount of aerosol) conditions, allowing the FDA to understand the range of possible delivery emissions. That is, in the conventional HPHC test, 1(SKU) × 3 (lot) × 7 (multiple samples) × 36(HPHC substances) × 2 (dense and non-dense) — 1512 tests are performed for each Stock Keeping Unit (SKU).
However, the conventional HPHC test is performed for many times on both the substances contained in the tobacco tar and the substances with extremely low content in the aerosol, so that the test quantity is large and the test efficiency is low.
Disclosure of Invention
In view of the above, there is a need to provide a method for testing harmful and potentially harmful substances in aerosol, which can reduce the number of tests, improve the testing efficiency, and provide scientific and reliable testing results.
A method for testing harmful and potential harmful substances in aerosol, which is used for testing the harmful and potential harmful substances in the aerosol formed by tobacco tar, comprises the following steps:
performing a thorough test, namely performing a single-batch and single-sample test on all stock units to be tested for complete harmful and potential harmful substances, wherein the number of the complete harmful and potential harmful substances is 36;
screening a test target, and screening a target needing further test according to the result of the thorough test;
and (3) testing data stability, namely testing harmful and potential harmful substances in standard batches and standard compound samples aiming at the screened test target.
In one embodiment of the present invention,
in the step of screening the test target, the screened test target is a representative stock unit in a plurality of stock units to be tested;
in the data stability testing step, complete harmful and potential harmful substance tests of standard batches and standard compound samples are carried out aiming at the screened representative stock units.
In one embodiment of the present invention,
in the step of screening the test target, the screened test target is a quantitative harmful substance in complete harmful and potential harmful substances;
in the data stability testing step, the quantitative harmful substance tests of standard batches and standard compound samples of a plurality of stock units to be tested are carried out aiming at the screened quantitative harmful substances.
In one embodiment, in the screening test target step, the screened test target is a quantitative harmful substance in a representative stock keeping unit of a plurality of stock keeping units to be tested;
in the data stability testing step, quantitative harmful substance tests of standard batches and standard compound samples are carried out on quantitative harmful substances in screened representative stock units.
In one embodiment, in the screening test targets step, the screened test targets are a representative stock keeping unit in a plurality of stock keeping units to be tested and quantitative harmful substances in complete harmful and potential harmful substances;
in the data stability testing step, the complete harmful substance and potential harmful substance tests of standard batches and standard compound samples are carried out aiming at the screened representative stock units, and the quantitative harmful substance tests of the standard batches and the standard compound samples are carried out aiming at the quantitative harmful substances in the screened complete harmful substance and potential harmful substances.
In one embodiment of the present invention,
in the step of screening the test target, the screened test target is a representative stock keeping unit in a plurality of stock keeping units to be tested and harmful and potential harmful substances which are not contained in the representative stock keeping unit;
in the data stability testing step, the whole harmful and potential harmful substance tests of standard batches and standard compound samples are carried out aiming at the screened representative stock units, and the quantitative harmful substance tests of standard batches and standard compound samples are carried out aiming at the screened harmful and potential harmful substances which are not contained in the representative stock units.
In one embodiment, before the step of screening test targets, the method further comprises the steps of:
the tobacco tar component analysis is carried out, the component analysis is carried out on the tobacco tar of each stock unit to be tested, and a tobacco tar component list is obtained;
in the step of screening the test target, the screened test target is obtained by screening the result of the blinding test in combination with the tobacco tar component list.
In one embodiment, the method further comprises the steps of:
establishing a database, and forming the data obtained by the past tests of all stock units into the database;
comparing and analyzing, and judging whether the results of the background test fall into one or more stock units of the database; if yes, directly calling the test result of the corresponding stock unit in the database for bridging; if not, carrying out standard batch and standard duplication harmful and potential harmful substance tests on harmful and potential harmful substances or stock units which do not fall into the database.
In one embodiment, in the blinded test, aerosol produced in a dense and/or non-dense form is selected for testing; and/or
In the data stability test, aerosol produced in a dense and/or non-dense mode is selected for testing.
In one embodiment, the inventory unit is classified as one of a product type, a flavor, a nicotine concentration, a propylene glycol to glycerin ratio, a voltage.
The method for testing the harmful and potential harmful substances of the aerosol at least comprises the following advantages:
the testing method comprises the steps of firstly carrying out complete harmful and potential harmful substance testing of a single batch and a single compound sample on stock units to be tested, screening out targets needing further testing according to testing results, wherein the targets can be representative stock units or substances harmful to human bodies, then carrying out harmful and potential harmful substance testing of standard batches and standard compound samples aiming at the screened testing targets, comparing standard complete testing times (1(SKU) 3 (batch) 7 (compound sample) 36(HPHC substance) 2 (dense and non-dense) 1512) of each stock unit, and then carrying out testing of the standard batches and the standard compound samples aiming at the testing targets after screening out the testing targets.
Drawings
FIG. 1 illustrates the steps of the method for testing harmful and potentially harmful substances of an aerosol according to the present invention;
FIG. 2 is a diagram of the harmful and potentially harmful substance testing method of the aerosol of the present invention including the steps of tobacco smoke composition analysis;
fig. 3 is another step of the harmful and potentially harmful substance testing method of the aerosol of the present invention including the analysis of the components of the tobacco smoke.
Detailed Description
In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
Please refer to fig. 1, which shows a testing method according to the present embodiment.
A method for testing harmful and potential harmful substances in aerosol, which is used for testing the harmful and potential harmful substances in the aerosol formed by tobacco tar, comprises the following steps:
s10: testing by probing, namely performing one-time test of single batches and single compound samples of complete harmful substances and potential harmful substances for each stock unit to be tested, wherein the number of the complete harmful substances and the potential harmful substances is 36;
s20: screening a test target, and screening a target needing further test according to the result of the thorough test;
s30: and (3) testing data stability, namely testing harmful and potential harmful substances in standard batches and standard compound samples aiming at the screened test target.
Specifically, harmful and potentially harmful substances in aerosol formed by tobacco tar atomization are tested, the standard complete test frequency of one stock unit is 1(SKU) × 3 (batch) × 7 (multiple samples) × 36(HPHC substance) × 2 (dense and non-dense) ═ 1512, the end-of-touch test is a complete harmful and potentially harmful substance test of a single batch and a single multiple sample for each stock unit to be tested, the test frequency is 1(SKU) × 1 (multiple samples) × 36(HPHC substance) × 1 (dense or non-dense) × 36, and whether substances in the ENDS analyte list provided by FDA in the PMTA guideline exist in the aerosol can be tested, and the corresponding content can be obtained. According to the results of the empirical test, the targets to be further tested can be screened, and the harmful and potential harmful substances of standard batches and standard compound samples are tested according to the screened test targets.
In the step of screening the test target, the screened test target is a representative stock unit in a plurality of stock units to be tested; or in the step of screening the test target, the screened test target is a quantitative harmful substance in the complete harmful and potential harmful substances; or in the step of screening the test target, the screened test target is quantitative harmful substances in a representative stock keeping unit in a plurality of stock keeping units to be tested; or in the step of screening the test target, the screened test target is a representative stock keeping unit in a plurality of stock keeping units to be tested and quantitative harmful substances in complete harmful and potential harmful substances.
As shown in table 1, the results of the blinding test are shown.
Table 1:
in table 1, TPD indicates Tobacco Product Directive tobaco Product Directive, which is a regulation for regulating and supervising the production, sale, display (Product design, packaging, etc.) links and all Tobacco and Tobacco related products (e.g. electronic cigarette products), and is to reduce the attraction of Tobacco products to achieve a higher standard of protection for human health. The eu TPD limit is a health standard set by the eu for tobacco and tobacco-related products. 3R4F is data for an aerosol formed by smoking a reference cigarette, and IQOS THS2.2 MENTHOL is data for an aerosol formed by smoking a reference cigarette without burning tobacco. Among the criteria for harmful and potentially harmful substances to be further tested are: the value less than the detection limit is considered to be none or very weak, and the harmful degree of the value is negligible; secondly, the value of the electronic cigarette is larger than that of the 3R4F reference tobacco, compared with the traditional cigarette, the electronic cigarette is considered as a harm reduction product, the harm degree of the electronic cigarette is smaller than that of the traditional cigarette, so if the value of the electronic cigarette is larger than that of the 3R4F reference tobacco, further tests are needed; all other cases that require or do not require further testing: the method comprises the following steps of (1) nicotine which is the most important component in electronic liquid and aerosol and needs to be further tested; secondly, the propylene glycol and the glycerol in the tobacco tar are easily pyrolyzed into aldehydes which are carcinogenic substances and cause harm to human health, so that the formaldehyde and the acetaldehyde are considered as high-risk compounds and need to be further tested; thirdly, heavy metals in the aerosol generally come from product materials, such as heating wires, are the most important harmful and potential harmful substances and need to be further tested; esters are typically added as fragrances to electronic liquid formulations, in which case the lipid concentration found in the aerosol is lower than the acceptable Safety and Health Administration permission Limits; thus, esters are not in the "high risk and important compound list" and do not require further testing; vanillin is a widely used edible spice, is extracted from plants and has small harm to human health; furfural is extracted from by-products and is less harmful to human health, so vanillin and furfural are not in the "high risk and important compound list" and do not require further testing.
And when the screened test target is a representative stock unit in the plurality of stock units to be tested in the screening test target step, carrying out complete harmful and potential harmful substance tests of standard batches and standard compound samples aiming at the screened representative stock unit in the data stability test step. In this embodiment, the representative stock unit is a stock unit with a high risk compound performance, where the performance of the high risk compound performance means that the data is more prominent than that of other stock units; wherein the high risk compounds are formaldehyde, acetaldehyde, chromium, nickel, lead and cadmium.
Specifically, as shown in table 1, taking 5 stock units with the sub-numbers of 1 to 5 in the table as the object to be tested, conducting a background test on the 5 stock units to obtain data in the table, then selecting two stock units of sub-number 4 and sub-number 5 as test targets to further test by taking the expression of high-risk compounds as screening indexes according to the data result in the table, that is, testing the data stability of the two stock units of sub-number 4 and sub-number 5, and conducting a test on the harmful and potentially harmful substances of a standard batch and a standard copy on the sub-number 4 and the sub-number 5, wherein the test times are as follows: 2(SKU) × 3 (batch) × 7 (replicate) × 36(HPHC substances) × 1 (dense or non-dense) ═ 1512 times, plus the number of end-of-touch tests: 36 x 5-180 times, a total of 1410 tests were performed. If the standard test is performed on all stock units to be tested, the test times are as follows: 5(SKU) × 3 (lot) × 7 (multiple samples) × 36(HPHC substances) × 2 (dense or non-dense) ═ 7560 times. Compared with the prior art, the method for screening the test targets according to the background test and then carrying out standard test on the test targets greatly reduces the test quantity and improves the test efficiency.
And when the screened test target is a representative stock unit in the plurality of stock units to be tested in the screening test target step, carrying out complete harmful and potential harmful substance tests of standard batches and standard compound samples aiming at the screened representative stock unit in the data stability test step. In this embodiment, the representative stock keeping unit is one or several stock keeping units containing all harmful and potentially harmful substances, and the data representation is more prominent than that of other stock keeping units.
Specifically, as shown in table 1, taking 5 stock units with sub-numbers 1 to 5 in the table as objects to be tested, conducting a background test on the 5 stock units to obtain data in the table, then according to data results in the table, taking data which contains all harmful and potential harmful substances and is more prominent than data in other stock units as screening indexes, selecting two stock units of sub-number 4 and sub-number 5 as test targets to conduct further tests, namely testing data stability of the two stock units of sub-number 4 and sub-number 5, conducting harmful and potential harmful substance tests of standard batches and standard duplication on the sub-number 4 and the sub-number 5, and testing times are as follows: 2(SKU) × 3 (batch) × 7 (replicate) × 36(HPHC substances) × 1 (dense or non-dense) ═ 1512 times, plus the number of end-of-touch tests: 36 x 5-180 times, a total of 1410 tests were performed. If the standard test is performed on all stock units to be tested, the test times are as follows: 5(SKU) × 3 (lot) × 7 (multiple samples) × 36(HPHC substances) × 2 (dense or non-dense) ═ 7560 times. Compared with the prior art, the method for screening the test targets according to the background test and then carrying out standard test on the test targets greatly reduces the test quantity and improves the test efficiency.
As for the few harmful and potentially harmful substances highlighted by the data in table 1 over the two stock keeping unit weights of sub-number 4 and sub-number 5, such as propylene glycol, furfural in sub-number 3, vanillin, isoamyl acetate, and benzyl acetate in sub-number 2, and benzyl acetate in sub-number 1, all are substances that are not in the "high risk and important compounds list", no further testing may be required.
In the step of screening the test target, the screened test target is a representative stock keeping unit in a plurality of stock keeping units to be tested and harmful and potential harmful substances which are not contained in the representative stock keeping unit; in the data stability testing step, the whole harmful and potential harmful substance tests of standard batches and standard compound samples are carried out aiming at the screened representative stock units, and the quantitative harmful substance tests of the standard batches and the standard compound samples are carried out aiming at the screened harmful and potential harmful substances which are not contained in the representative stock units. In this embodiment, the representative stock keeping unit is one or several stock keeping units containing all harmful and potentially harmful substances, and the data representation is more prominent than that of other stock keeping units.
Specifically, as shown in table 1, taking 5 stock units with sub-numbers 1 to 5 in the table as objects to be tested, conducting a background test on the 5 stock units to obtain data in the table, then according to data results in the table, taking data which contains all harmful and potential harmful substances and is more prominent than data in other stock units as screening indexes, selecting two stock units of sub-number 4 and sub-number 5 as test targets to conduct further tests, namely testing data stability of the two stock units of sub-number 4 and sub-number 5, conducting harmful and potential harmful substance tests of standard batches and standard duplication on the sub-number 4 and the sub-number 5, and testing times are as follows: 2(SKU) × 3 (lot) × 7 (multiple samples) × 36(HPHC substances) × 1 (dense or non-dense) × 1512 times.
While a few of the data in table 1 highlight harmful and potentially harmful substances compared to the data of two stock keeping unit weights of sub-number 4 and sub-number 5, such as propylene glycol, furfural in sub-number 3, vanillin, isoamyl acetate and benzyl acetate in sub-number 2, and benzyl acetate in sub-number 1, although the substances are not in the "high risk and important compound list", in this example, the substances which are not covered by the contents of the sub-number 4 and sub-number 5 are also tested, and the number of tests is: 1(SKU) × 3 (batch) × 7 (multiple samples) × 6(HPHC substances) × 1 (dense or non-dense) ═ 126 times. And the times of the touch-down test are added: 36 x 5-180 times, a total of 1818 tests. If the standard test is performed on all stock units to be tested, the test times are as follows: 5(SKU) × 3 (lot) × 7 (multiple samples) × 36(HPHC substances) × 2 (dense or non-dense) ═ 7560 times. Compared with the prior art, the method for screening the test targets according to the background test and then carrying out standard test on the test targets greatly reduces the test quantity and improves the test efficiency.
And when the screened test target is a quantitative harmful substance in the complete harmful and potential harmful substances in the step of screening the test target, carrying out complete harmful and potential harmful substance tests in standard batches and standard compound samples aiming at the screened quantitative harmful substance in the step of testing the stability of the data.
Among the harmful substances to be further tested are at least: nicotine, formaldehyde, acetaldehyde, chromium, nickel, lead and cadmium.
Specifically, as shown in table 1, 5 stock units with numbers of 1 to 5 in the table are used as objects to be tested, a background test is performed on the 5 stock units to obtain data in the table, and then, according to the data result in the table, nicotine, formaldehyde, acetaldehyde, heavy metal chromium, heavy metal nickel, heavy metal lead and heavy metal cadmium are screened as further tests, that is, a standard batch and a standard duplicate test are performed on the nicotine, formaldehyde, acetaldehyde, chromium, nickel, lead and cadmium, the number of tests is 5(SKU) × 3 (batch) × 7 (duplicate) × 7(HPHC substance) × 1 (dense or non-dense) × 735, and the number of background test is added: 36 x 5-180 times, 915 times in total. If the standard test is performed on all stock units to be tested, the test times are as follows: 5(SKU) × 3 (lot) × 7 (multiple samples) × 36(HPHC substances) × 2 (dense or non-dense) ═ 7560 times. Compared with the prior art, the method for screening the test targets according to the background test and then carrying out standard test on the test targets greatly reduces the test quantity and improves the test efficiency.
And when the screened test target is quantitative harmful substances in a representative stock keeping unit in a plurality of stock keeping units to be tested in the screening test target step, performing quantitative harmful substance test of standard batches and standard samples aiming at the quantitative harmful substances in the screened representative stock keeping unit in the data stability test step. Specifically, as shown in table 1, 5 stock units with numbers of 1 to 5 in the table are used as objects to be tested, a background test is performed on the 5 stock units to obtain data in the table, and then according to the data result in the table, the toxic nickel and lead contents are used as screening indexes, nicotine, formaldehyde, acetaldehyde, chromium, nickel, lead and cadmium in two stock units of sub-number 4 and sub-number 5 are selected to perform a test of a standard batch and a standard duplicate, the number of tests is 2(SKU) × 3 (batch) × 7 (duplicate) × 7(HPHC substance) × 1 (dense or non-dense) × 394, and the number of background tests is added: 36 x 5-180 tests were performed a total of 474 times. If the standard test is performed on all stock units to be tested, the test times are as follows: 5(SKU) × 3 (lot) × 7 (multiple samples) × 36(HPHC substances) × 2 (dense or non-dense) ═ 7560 times. Compared with the prior art, the method for screening the test targets according to the background test and then carrying out standard test on the test targets greatly reduces the test quantity and improves the test efficiency.
When the screened test target is a representative stock keeping unit in a plurality of stock keeping units to be tested and quantitative harmful substances in complete harmful and potential harmful substances in the step of screening the test target; and (3) carrying out complete harmful and potential harmful substance tests of standard batches and standard compound samples aiming at the screened representative stock units, and carrying out quantitative harmful substance tests of the standard batches and the standard compound samples aiming at quantitative harmful substances in the screened complete harmful and potential harmful substances. In the data stability testing step, the complete harmful substance and potential harmful substance tests of standard batches and standard compound samples are carried out aiming at the screened representative stock units, and the quantitative harmful substance tests of the standard batches and the standard compound samples are carried out aiming at the quantitative harmful substances in the screened complete harmful substance and potential harmful substances. Specifically, as shown in table 1, 5 stock units with the numbers of sub-numbers 1 to 5 in the table are used as objects to be tested, a background test is performed on the 5 stock units to obtain data in the table, then according to the data result in the table, the toxic nickel and lead contents are used as screening indexes, two stock units with the sub-numbers 4 and 5 are selected, nicotine, formaldehyde, acetaldehyde, heavy metal chromium, heavy metal nickel, heavy metal lead and heavy metal cadmium are used as further tests, namely, the harmful and potential harmful substance tests of standard batches and standard samples are performed on the sub-numbers 4 and 5, and the test times are as follows: 2(SKU) × 3 (lot) × 7 (replica) × 36(HPHC substance) × 1 (dense or non-dense) ═ 1512 times, tests were performed on standard lots and standard replicas for formaldehyde, acetaldehyde, nicotine, chromium, nickel, lead, cadmium, whereas standard lots and standard replicas have been performed on nicotine, formaldehyde, acetaldehyde, heavy metal chromium, heavy metal nickel, heavy metal lead, heavy metal cadmium in subnumber 4 and subnumber 5, so the number of tests was 3(SKU) × 3 (lot) × 7 (replica) × 5(HPHC substance) × 1 (dense or non-dense) × 315 times, plus the number of blinding tests: 36 x 5-180 times, for a total of 2007 tests. If the standard test is performed on all stock units to be tested, the test times are as follows: 5(SKU) × 3 (lot) × 7 (multiple samples) × 36(HPHC substances) × 2 (dense or non-dense) ═ 7560 times. Compared with the prior art, the method for screening the test targets according to the background test and then carrying out standard test on the test targets greatly reduces the test quantity and improves the test efficiency.
Referring to fig. 2 and 3, in the present embodiment, before the step of screening the test target, the method further includes the steps of:
s12: and (4) tobacco tar component analysis, namely performing component analysis on the tobacco tar of each stock unit to be tested to obtain a tobacco tar component list. Taking sub-code 3 Cool Mint flavor tobacco tar as an example, the corresponding data shown in table 2 can be obtained by analyzing the components of the tobacco tar.
Table 2:
table 1 in comparison to table 2, it can be seen that Menthol (Menthol), Vanillin (Vanillin) are the self-contained components of the tobacco tar formulation, while glycerol and propylene glycol are the major components of all tobacco tar.
In the step of screening test targets, the screened test targets are screened by combining the results of the empirical test with the tobacco tar ingredient list. That is, by comparing the components and data in tables 1 and 2, it can be known that some components of the aerosol in table 1 are the components of the tobacco tar formulation in table 2, and if the components in the tobacco tar are not harmful, the components in the aerosol do not need to be subjected to further standard tests even if the measured values of the components are large, so that the test quantity is greatly reduced, and the test efficiency is improved.
Step S12 may precede step S10, or step S12 may precede steps S10 and S20.
In this embodiment, in the blinding test, aerosol generated in a dense or non-dense form may be selected for testing according to different types of electronic cigarettes, or aerosol generated in both the dense and non-dense forms may be tested. Even if both dense and non-dense versions of the produced aerosol were selected for testing, the number of tests per stock unit was only 60.
In the data stability test, aerosol produced in a dense or non-dense mode is selected for testing, or aerosol produced in a dense or non-dense mode is tested. Even if the aerosol produced in a dense and non-dense mode is selected for testing, the aim of screening further testing is that whether the aerosol is a representative stock unit, a quantitative harmful substance in the representative stock unit or both the representative stock unit and the quantitative harmful substance, the testing frequency is less than the frequency of performing standard testing on all stock units, the testing number is greatly reduced, and the testing efficiency is improved.
In this embodiment, the method further includes the steps of:
s40: establishing a database, and forming the data obtained by the past tests of all stock units into the database;
s50: and comparing and analyzing, and judging whether the results of the empirical test fall into one or more stock units of the database. If yes, directly calling the test result of the corresponding stock unit in the database for bridging; if not, the parts of harmful and potential harmful substances which do not fall into the database and exceed the content of the corresponding harmful and potential harmful substances in the database can be subjected to quantitative harmful substance tests of standard batches and standard compound samples separately; if the results of the tests do not fall into the stock units of the database, the tests can be screened by referring to the methods for screening the test targets, and then the tests for harmful and potential harmful substances in standard batches and standard compound samples are carried out.
The data in the database may be multiple sets of data formed by products of the same company, multiple sets of data formed by products of different companies, or product data issued by an authority.
Generally, the division of the stock keeping unit may be one of a product type, a taste, a nicotine concentration, a propylene glycol to glycerin ratio, and a voltage. In the embodiment, the electronic cigarette oil is preferably distinguished according to the taste, the electronic cigarette oil with each taste has different smoking taste as required, the components and the proportion of the electronic cigarette oil are different, even if the electronic cigarette oil has the same taste and different nicotine content, the content of partial substances in a component list is different, the electronic cigarette oil is in contact with parts loading the electronic cigarette oil in the electronic cigarette product, the electronic cigarette oil is electrified to heat the electronic cigarette oil, and the like to generate chemical reaction, and the components and the content of generated aerosol are also different.
In summary, the testing method performs the tests of harmful and potentially harmful substances of standard batches and standard compound samples on the screened targets in a way of firstly performing a background test and then screening a further complete test target or combining the background test and the analysis of tobacco tar components and then screening the further complete test target, compares the standard complete test times (1(SKU) × 3 (batch) × 7 (compound sample) × 36(HPHC substance) × 2 (dense and non-dense) × 1512) of each stock unit, and performs the tests of the standard batches and the standard compound samples on the test targets after screening the test targets, thereby greatly reducing the test quantity and improving the test efficiency on the premise of meeting the scientific conclusion.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (10)
1. A method for testing harmful and potential harmful substances in aerosol, which is used for testing the harmful and potential harmful substances in the aerosol formed by tobacco tar, and is characterized by comprising the following steps:
performing a thorough test, namely performing a single-batch and single-sample test on all stock units to be tested for complete harmful and potential harmful substances, wherein the number of the complete harmful and potential harmful substances is 36;
screening a test target, and screening a target needing further test according to the result of the thorough test;
and (3) testing data stability, namely testing harmful and potential harmful substances in standard batches and standard compound samples aiming at the screened test target.
2. The method of claim 1, wherein the aerosol is tested for harmful and potentially harmful substances,
in the step of screening the test target, the screened test target is a representative stock unit in a plurality of stock units to be tested;
in the data stability testing step, complete harmful and potential harmful substance tests of standard batches and standard compound samples are carried out aiming at the screened representative stock units.
3. The method of claim 1, wherein the aerosol is tested for harmful and potentially harmful substances,
in the step of screening the test target, the screened test target is a quantitative harmful substance in complete harmful and potential harmful substances;
in the data stability testing step, the quantitative harmful substance tests of standard batches and standard compound samples of a plurality of stock units to be tested are carried out aiming at the screened quantitative harmful substances.
4. The method of claim 1, wherein the aerosol is tested for harmful and potentially harmful substances,
in the step of screening the test target, the screened test target is a quantitative harmful substance in a representative stock keeping unit in a plurality of stock keeping units to be tested;
in the data stability testing step, quantitative harmful substance tests of standard batches and standard compound samples are carried out on quantitative harmful substances in screened representative stock units.
5. The method of claim 1, wherein the aerosol is tested for harmful and potentially harmful substances,
in the step of screening the test target, the screened test target is a representative stock keeping unit in a plurality of stock keeping units to be tested and quantitative harmful substances in complete harmful and potential harmful substances;
in the data stability testing step, the complete harmful substance and potential harmful substance tests of standard batches and standard compound samples are carried out aiming at the screened representative stock units, and the quantitative harmful substance tests of the standard batches and the standard compound samples are carried out aiming at the quantitative harmful substances in the screened complete harmful substance and potential harmful substances.
6. The method of claim 1, wherein the aerosol is tested for harmful and potentially harmful substances,
in the step of screening the test target, the screened test target is a representative stock keeping unit in a plurality of stock keeping units to be tested and harmful and potential harmful substances which are not contained in the representative stock keeping unit;
in the data stability testing step, the whole harmful and potential harmful substance tests of standard batches and standard compound samples are carried out aiming at the screened representative stock units, and the quantitative harmful substance tests of standard batches and standard compound samples are carried out aiming at the screened harmful and potential harmful substances which are not contained in the representative stock units.
7. The method for testing harmful and potentially harmful substances in an aerosol according to any one of claims 1 to 6,
before the step of screening test targets, the method further comprises the steps of:
the tobacco tar component analysis is carried out, the component analysis is carried out on the tobacco tar of each stock unit to be tested, and a tobacco tar component list is obtained;
in the step of screening the test target, the screened test target is obtained by screening the result of the blinding test in combination with the tobacco tar component list.
8. The method for testing aerosols of claim 7 further comprising the steps of:
establishing a database, and forming the data obtained by the past tests of all stock units into the database;
comparing and analyzing, and judging whether the results of the background test fall into one or more stock units of the database; if yes, directly calling the test result of the corresponding stock unit in the database for bridging; if not, carrying out standard batch and standard duplication harmful and potential harmful substance tests on harmful and potential harmful substances or stock units which do not fall into the database.
9. The method of claim 8, wherein the aerosol is tested for harmful and potentially harmful substances,
in the background test, aerosol produced in a dense and/or non-dense mode is selected for testing; and/or
In the data stability test, aerosol produced in a dense and/or non-dense mode is selected for testing.
10. The method of claim 9, wherein the inventory unit is classified into one of a product type, a taste, a nicotine concentration, a ratio of propylene glycol to glycerin, and a voltage.
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| US20170167963A1 (en) * | 2014-08-05 | 2017-06-15 | China Tobacco Yunnan Industrial Co., Ltd | Method for Evaluating Aerosol Mass of Electronic Cigarette |
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