CN107084975A - The quick detection reagent and its detection method of a kind of Indomethacin - Google Patents
The quick detection reagent and its detection method of a kind of Indomethacin Download PDFInfo
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- CN107084975A CN107084975A CN201710240962.8A CN201710240962A CN107084975A CN 107084975 A CN107084975 A CN 107084975A CN 201710240962 A CN201710240962 A CN 201710240962A CN 107084975 A CN107084975 A CN 107084975A
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
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Abstract
The quick detection reagent and its detection method of a kind of Indomethacin, including alkaline reagent, acid reagent, the first developer, the second developer, and be correspondingly placed in alkaline reagent bottle, acid reagent bottle, the first developer bottle, the second developer bottle, detecting step is as follows：A. learn from else's experience pre-treatment sample be placed into alkaline reagent bottle in, occlusion shaking, stand；B. alkaline reagent bottle supernatant or lower clear liquid are drawn into acid reagent bottle with suction pipe, shakes up reaction；C. acid reagent bottle solution after answering is negated, filtration, filtrate puts centrifuge tube；D. the first developer and the second developer are added to centrifuge tube, solution colour change in centrifuge tube is observed；E. result judges：If solution colour is changed into light red to aubergine, show that sample contains Indomethacin；If color is unchanged, show that it is free of Indomethacin.Detection process of the present invention is simple and efficient, exclusive, sensitive and accurate, suitable for the field quick detection of Indomethacin class chemical drugs, Chinese patent drug and health products.
Description
Technical field
The present invention relates to compound rapid detection technical field, the quick detection reagent of espespecially a kind of Indomethacin and its inspection
Survey method.
Background technology
Rheumatism is a kind of common frdquently encountered disease, and illness rate is more than 10% in the general population of China, in person in middle and old age's stage
Its incidence of disease increases rapidly.Rheumatism is a kind of systemic disease, is mainly reflected in the lesion of joint, connective tissue and muscle,
Its is touching refractory, brings greatly pain to patient body and psychology and torments.
Indomethacin is conventional powerful pain-stopping NSAIDs, acts on significant to inflammatory pain, gouty is closed
Section inflammation and osteoarthritis good effect, therefore its situation about being added into the health-oriented products such as Chinese patent drug and health products is common.Indoles is beautiful
It is pungent to there is cutaneous anaphylaxis, gastrointestinal reaction, reaction of central nervous system and hemopoietic system reaction etc. in Clinical practice no
Good reaction, and have and specifically disable or use with caution crowd, if not taking illustratively to lead to grave consequences, threat to life.
The many patients selection health-oriented products such as Anti-rheumatism Chinese patent drugs and health products are treated or auxiliary treatment, it is desirable to
It can treat both principal and secondary aspect of disease and reduce toxic side effect.But because of such product own characteristic, its action is slower, therefore some criminals utilize
People are eager to see the psychology of curative effect, and the chemicals beyond illegal addition prescription, exaggerated propaganda advertises " quick-acting " and " high
Effect ", voiding is sold at high price.Energy temporary relief of symptoms after patient takes, therefore take for good effect and largely take for a long time, cause it
In the case of unwitting, medicine is not used according to Correct, consumption, drug induced disease is easily caused, patient health is made
Into great harm.
At present for the detection of Indomethacin, each version《Chinese Pharmacopoeia》, hygienic ministerial standard and new drug standard of becoming a full member mainly adopts
With chemical reaction method, minority uses infra-red sepectrometry；Foreign pharmacopeia（JP16, BP2015, EP9.0, WHO pharmacopeia the 5th edition）Mainly
Using ultraviolet, infra-red sepectrometry, partly using chemical reaction method；Existing essential drugs on the market（Indomethacin）Fast screening reagent
Box（Production unit：Guangdong Dayuan Food Medicine Safety Technology Co., Ltd.）Using chemical reaction method.Using the change of above standard
Learn reaction method or kit is applied to Indomethacin in the health-oriented products such as Indomethacin class chemicals, Chinese patent drug and health products
Quick detection, the specificity of its result, sensitivity and the degree of accuracy are poor, need to partly use equipment or organic reagent, not be suitable for
Field quick detection.
Patent of invention《The quick screening method of illegal addition Indomethacin in a kind of Chinese patent drug and health products》Pass through colour developing
Method judges whether to contain in Indomethacin, but the step C of its method, and solution colour after developer is added dropwise and turns yellow, therefore low concentration
Positive is overlapping color, causes the sensitivity decrease of reaction, the difficulty increase as a result judged；In addition, the chromogenic reaction must be waited
More than 5 minutes judged results again are treated, cause whole detection cycle long, practicality of this method in quick detection is reduced.
The content of the invention
To solve the above problems, the present invention provides a kind of quick detection reagent and its detection method of Indomethacin, detection
Process is simple and efficient, exclusive, sensitive and accurate, quick suitable for the scene of Indomethacin class chemical drugs, Chinese patent drug and health products
Detection.
One of to achieve the above object, a kind of quick detection reagent of Indomethacin of present invention offer, including alkaline reagent,
Acid reagent, the first developer, the second developer, and it is correspondingly placed at alkaline reagent bottle, acid reagent bottle, the first developer
In bottle, the second developer bottle, wherein
Alkaline reagent is sodium hydroxide or potassium hydroxide solution, and mass-volume concentration scope is 0.1%-4.0%, and volume range is 3-
6ml；It can ensure that the Indomethacin in sample is fully hydrolyzed, increase reaction sensitivity；
Acid reagent is one kind of sulfuric acid, nitric acid and hydrochloric acid solution, and molal volume concentration range is 0.1-6.0mol/L, volume model
Enclose for 1-4ml；If selecting hydrochloric acid solution, it is added dropwise after the first developer, solution colour turns yellow, positive color is produced superposition, no
Beneficial to the color change observation of low concentration positive；And salpeter solution is met light, heat and easily decomposed and using relatively hazardous, for storage
And security consideration is used, be not suitable for selecting；Above-mentioned situation can be then avoided to occur during from sulfuric acid solution, therefore preferably sulfuric acid solution,
Preferably 2ml, can now promote other contamination precipitations, and ensure the highly acid of mixed system, prevent false positive, increase is anti-
The sensitivity answered.
First developer is one kind in ferric trichloride, ferric sulfate, ammonium ferric sulfate solution, and mass-volume concentration scope is
1.0-20%；
Second developer is hydrogenperoxide steam generator, and mass-volume concentration scope is 1.5-30%.
To achieve the above object two, the present invention provides a kind of quick determination method of Indomethacin, comprises the following steps：
A. learn from else's experience simple pre-treatment sample be placed into right amount alkaline reagent bottle in, occlusion shaking, stand；Simple pre-treatment is piece
Agent, granule and pill put sampling paper it is slightly finely ground, capsule directly takes content.The sample is specially that tablet takes 1 in right amount,
Capsule takes 1, and granule and pill take about 0.5g.It is preferred that, it is red that such as top layer of sample tablet or pill, which is coated color,
When, color can be first wiped during sampling with water-moistened cotton or paper handkerchief, interference is reduced, occlusion shaking shakes for strength, the time
10 seconds, time of repose about 20 seconds took supernatant liquor as sample, and this operation can make in sample the abundant dissolving of Indomethacin and quiet
Postpone liquid/solid or liquid liquid layering；The alkaline reagent is the sodium hydroxide solution that mass-volume concentration is 0.4%, volume range
For 3-6ml, preferably 4ml；
B. alkaline reagent bottle supernatant or lower clear liquid are drawn into acid reagent bottle with suction pipe, shakes up reaction；The suction pipe is 1 time
Property plastic suction pipe, meter full scale can be 1-3ml, preferably 2ml measuring pipettes；Because sample may be solid or oily liquids, deposit
In liquid/solid and liquid liquid delamination, therefore it need to correspond to and take up/down clear liquid respectively, it is 1ml to take liquid product；
C. negating acid reagent bottle solution after answering, in right amount, filtration, filtrate puts centrifuge tube；The filtration is to be inhaled using 1ml syringes
Solution is taken, plus puts syringe-driven filter filtering；Syringe-driven filter material is water system or organic system, and inside diameter ranges are 13-25mm,
Pore diameter range is 0.22 or 0.45 μm, and preferably internal diameter 25mm, aperture is 0.45 μm of organic system filter, can be reduced during this specification
Filter pressure, convenient operation, prevents filter membrane from perforating, and the filtrate volume is 1ml；The centrifuge tube is PP（Polypropylene）Material
Disposable plastic centrifuge tube, specification limit is 1.5-2ml；
D. the first developer and the second developer are added to centrifuge tube, solution colour change in centrifuge tube is observed；
First developer is one kind in ferric trichloride, ferric sulfate, ammonium ferric sulfate solution, and mass-volume concentration scope is 1.0-
20%, it is contemplated that the sensitivity of the color, chromogenic reaction of solution, preferably 5% 3 after the solubility of three of the above composition and addition
Ferric chloride solution, addition is 1 drop；
Second developer is hydrogenperoxide steam generator, and mass-volume concentration scope is 1.5-30%, with the rise of concentration, its speed that develops the color
Degree is accelerated, if but addition concentration is excessive, and over oxidation is caused, colour fading is turned yellow on the contrary（Blanching effect）, therefore preferably 3% peroxide
Change hydrogen solution, addition is 1 drop, can now accelerate reaction speed and ensure color developing effect, in the range of 25-37 DEG C of normal temperature, instead
Answer developing time to be less than 10 seconds, and color developing effect can be kept in 90 minutes；
It is preferred that, add after the first developer, the second developer, can not shake up first, observation upper strata contacts the color of face ring solution
Change, can now lift the sensitivity of chromogenic reaction observation.Indomethacin is often 25mg/ times with oral dose, and present invention inspection
Rising limit is about 0.25mg/ times, there is very high application value；
E. result judges：If solution colour is changed into light red to aubergine, show that sample contains Indomethacin；If color is unchanged, table
Bright its is free of Indomethacin.
The beneficial effects of the present invention are：
1st, complicated component in testing sample, interfering material is more, prior art testing sample is pre-processed more than using extraction, post
Chromatographic isolation etc. is operated, and complex steps take, and are directed to use with organic reagent, easily cause Health cost and ambient environment, this hair
Bright by reasonable design operation step, the concentration and consumption of scientific offering various reagents effectively eliminate interference component, reaction
Specificity is strong.
2nd, the present inventor is carried out using the quick detection reagent and its detection method of the present invention to 112 batches of samples of collection
Detection, as a result finds positive 16 batches, and quick detection kit and its detection method accuracy through the confirmation present invention are
100%。
3rd, quick detection reagent and its detection method of the invention are easy to operate, without using organic solvent, without extra
Equipment, testing cost is low, the time is short, as a result sensitive, can be obtained a result in general 2~5 minutes, test limit is about 0.25mg/
It is secondary.
4th, the present invention has good practicality and promotional value, can be widely applied to the quick sieve in scene of supervision department
Look into, can deter and rapid strike and criminal manufacturing and marketing the fake illegal activities, lifted Scientific control efficiency.
Embodiment
For the ease of the understanding of those skilled in the art, with reference to the embodiment of specificity, sensitivity and different dosage forms
The present invention is described in further detail, but protection scope of the present invention is not limited to following embodiments.
Embodiment 1
Antirheumatic analgesia class common drug C14H10Cl2NNaO2, brufen, phenylbutazone, piroxicam, aminopyrine, acetic acid is taken to sprinkle Buddhist nun
Pine, hydrocortisone, dexamethasone, aspirin, naproxen, TMP, paracetamol reference substance are appropriate, each add
Enter in negative sample, mix, 12 kinds of specificity test specimens are made.Wherein negative sample is free of Indomethacin, and positive contains
Indomethacin.
Take 12 kinds of intragranulars of sample 1 of the above are tolerant to put sampling paper respectively, be poured into built-in 0.4% sodium hydroxide solution（Volume is
4ml）Alkaline reagent bottle in, occlusion, strength shaking 10 seconds, stand 20 seconds after, with 2ml disposable plastic tubes draw 1ml on
Clear liquid, puts built-in 3mol/L sulfuric acid solutions（Volume is 2ml）Acid reagent bottle in, after shaking up use 1ml syringe draw solutions,
Plus put internal diameter for 25mm, aperture is 0.45 μm, and material is the syringe-driven filter of organic system, filtering, take filtrate 1ml put 2ml from
Heart pipe, sequentially adds the first colour developing examination（5% liquor ferri trichloridi）And the second developer（3% hydrogenperoxide steam generator）Each 1
Drop, centrifuge tube solution colour equal nondiscolouring after 1 minute of final all samples（T=25℃）, show similar antirheumatic analgesia addition
Composition is noiseless, and the specificity of method is strong.
Embodiment 2
Take Indomethacin reference substance to add in negative sample, the positive of 0.25mg/ -10mg/ is made.The above is taken respectively
The intragranular of positive 1 of various concentrations is tolerant to put sampling paper, is poured into built-in 0.4% sodium hydroxide solution（Volume is 4ml）Alkalescence
In reagent bottle, occlusion, strength shaking 10 seconds after standing 20 seconds, draws 1ml supernatants with 2ml disposable plastic tubes, puts built-in
3mol/L sulfuric acid solutions（Volume is 2ml）Acid reagent bottle in, 1ml syringe draw solutions are used after shaking up, plus put internal diameter and be
25mm, aperture is 0.45 μm, and material is the syringe-driven filter of organic system, and filtering takes filtrate 1ml to put 2ml centrifuge tubes, added successively
Enter the first developer（5% liquor ferri trichloridi）And the second developer（3% hydrogenperoxide steam generator）Each 1 drips, as a result each sun
The centrifuge tube solution colour of property sample is respectively changed into rose pink to aubergine after about 10 seconds（T=25℃）, therefore the detection limit of the present invention
For 0.25mg/ times.Oral effective dose in view of Indomethacin is 25mg/ times, and detection limit of the invention is only effective dose
1 percent, therefore sensitivity is high, practical.
Embodiment 3
Deer bone pallas pit viper 1 intragranular of soft capsule for taking Henan Wan Minkang to produce is tolerant, is poured into built-in 0.4% sodium hydroxide solution（Volume is
4ml）Alkaline reagent bottle in, occlusion, strength shaking 10 seconds, stand 20 seconds after, with 2ml disposable plastic tubes draw 1ml under
Clear liquid, puts built-in 3mol/L sulfuric acid solutions（Volume is 2ml）Acid reagent bottle in, after shaking up use 1ml syringe draw solutions,
Plus put internal diameter for 25mm, aperture is 0.45 μm, and material is the syringe-driven filter of organic system, filtering, take filtrate 1ml put 2ml from
Heart pipe, sequentially adds the first developer（5% liquor ferri trichloridi）And the second developer（3% hydrogenperoxide steam generator）Each 1
Drop, centrifuge tube solution colour is constant（T=25℃）, can determine that and Indomethacin is free of in the present embodiment sample.
Embodiment 4
Take Dongguan Hospital of TCM produce Ligusticum wallichii blood circulation promoting slice 1, put sampling paper it is slightly finely ground, be poured into built-in 0.4% sodium hydroxide solution
（Volume is 4ml）Alkaline reagent bottle in, occlusion, strength shaking 10 seconds, stand 20 seconds after, with 2ml disposable plastic tubes inhale
1ml supernatants are taken, built-in 3mol/L sulfuric acid solutions are put（Volume is 2ml）Acid reagent bottle in, after shaking up with 1ml syringes inhale
Solution is taken, plus puts internal diameter for 25mm, aperture is 0.45 μm, material is the syringe-driven filter of organic system, filtering takes filtrate 1ml
2ml centrifuge tubes are put, the first developer is sequentially added（5% liquor ferri trichloridi）And the second developer（3% hydrogen peroxide is molten
Liquid）Each 1 drop, the nondiscolouring after 1 minute of centrifuge tube solution（T=25℃）, can determine that and Indomethacin is free of in the present embodiment sample.
Embodiment 5
The longevity bamboo root electuary for taking Nanning longevity bamboo root to produce（Specification：6g/ bags）About 1/10 bag, put sampling paper it is slightly finely ground, incline
Enter built-in 0.4% sodium hydroxide solution（Volume is 4ml）Alkaline reagent bottle in, occlusion, strength shaking 10 seconds, stand 20 seconds after,
1ml supernatants are drawn with 2ml disposable plastic tubes, built-in 3mol/L sulfuric acid solutions are put（Volume is 2ml）Acid reagent bottle
In, 1ml syringe draw solutions are used after shaking up, plus internal diameter is put for 25mm, aperture is 0.45 μm, and material is the needle-based of organic system
Filter, filtering, takes filtrate 1ml to put 2ml centrifuge tubes, sequentially adds the first developer（5% liquor ferri trichloridi）And second
Developer（3% hydrogenperoxide steam generator）Each 1 drop, the nondiscolouring after 1 minute of centrifuge tube solution（T=25℃）, can determine that the present embodiment
Indomethacin is free of in sample.
Embodiment 6
The FENGSHI GUTONG WAN for taking Liupan Mountain of Ningxia medicine company to produce（Specification：Every 10 weights 1.5g）3, put sampling paper it is finely ground, be poured into
Built-in 0.4% sodium hydroxide solution（Volume is 4ml）Alkaline reagent bottle in, occlusion, strength shaking 10 seconds, stand 20 seconds after, use
2ml disposable plastic tubes draw 1ml supernatants, put built-in 3mol/L sulfuric acid solutions（Volume is 2ml）Acid reagent bottle in,
1ml syringe draw solutions are used after shaking up, plus put internal diameter for 25mm, aperture is 0.45 μm, material is the needle-based mistake of organic system
Filter, filtering, takes filtrate 1ml to put 2ml centrifuge tubes, sequentially adds the first developer（5% liquor ferri trichloridi）And second show
Toner（3% hydrogenperoxide steam generator）Each 1 drop, the nondiscolouring after 1 minute of centrifuge tube solution（T=25℃）, can determine that the present embodiment sample
Indomethacin is free of in product.
Embodiment 7
The Hamburg, Germany for taking Hamburg, Germany Li Haming pharmaceutical factories to produce goes out, and the wet intragranular of pain capsule 1 is tolerant to put sampling paper, is poured into built-in
0.4% sodium hydroxide solution（Volume is 4ml）Alkaline reagent bottle in, occlusion, strength shaking 10 seconds, stand 20 seconds after, use 2ml
Disposable plastic tube draws 1ml supernatants, puts built-in 3mol/L sulfuric acid solutions（Volume is 2ml）Acid reagent bottle in, shake
1ml syringe draw solutions are used after even, plus put internal diameter for 25mm, aperture is 0.45 μm, material filters for the needle-based of organic system
Device, filtering, takes filtrate 1ml to put 2ml centrifuge tubes, sequentially adds the first developer（5% liquor ferri trichloridi）And second colour developing
Agent（3% hydrogenperoxide steam generator）Each 1 drop, centrifuge tube solution colour is changed into royal purple in about 10 seconds（T=25℃）, can determine that this reality
Apply in a sample and contain Indomethacin.
Embodiment 8
Take Hong Kong Ji Zhongtang pharmaceutical factories of traditional Chinese medicine produce Zhuifengtougu pill 1, put sampling paper it is finely ground, be poured into built-in 0.4% sodium hydroxide molten
Liquid（Volume is 4ml）Alkaline reagent bottle in, occlusion, strength shaking 10 seconds, stand 20 seconds after, use 2ml disposable plastic tubes
1ml supernatants are drawn, built-in 3mol/L sulfuric acid solutions are put（Volume is 2ml）Acid reagent bottle in, 1ml syringes are used after shaking up
Draw solution, plus internal diameter is put for 25mm, aperture is 0.45 μm, and material is the syringe-driven filter of organic system, and filtering takes filtrate
1ml puts 2ml centrifuge tubes, sequentially adds the first developer（5% liquor ferri trichloridi）And the second developer（3% peroxidating
Hydrogen solution）Each 1 drop, centrifuge tube solution colour is changed into pale red in about 10 seconds（T=25℃）, can determine that and contain in the present embodiment sample
Indomethacin.
Embodiment 9
Commercially available 112 kinds of medicines and health products altogether are surveyed using the quick detection kit and its detection method of the present invention
It is fixed, while according to《State Food and Drug Administration's drug inspection supplement method of inspection and inspection project approval part
2009025》Appended quality standard is combined method through Liquid Chromatography-Tandem Mass Spectrometry and verified, testing result and the result such as table 1:
The result of table 1
Formulated according to Guangdong Provincial Medicines Checkout station《The rapid screening side of chemical composition is added in Chinese patent drug and health food without authorization
Method guideline and technical requirements (tentative)》Requirement, to the present invention detection reagent and its detection method summarize, see
Table 2：
The conclusive table of table 2
| Formulation index | Capsule, tablet, granule, pill |
| Sensitivity | 100% |
| Specificity | 100% |
| Loss | 0% |
| False drop rate | 0% |
| Accuracy | 100% |
| Correct index | 1 |
Embodiment of above is only that the preferred embodiment of the present invention is described, and not the scope of the present invention is limited
Fixed, on the premise of design spirit of the present invention is not departed from, this area ordinary skill technical staff makees to technical scheme
In the various modifications gone out and improvement, the protection domain that claims of the present invention determination all should be fallen into.
Claims (5)
1. a kind of quick detection reagent of Indomethacin, it is characterised in that including alkaline reagent, acid reagent, the first developer,
Second developer, and be correspondingly placed in alkaline reagent bottle, acid reagent bottle, the first developer bottle, the second developer bottle, wherein
Alkaline reagent is sodium hydroxide or potassium hydroxide solution, and mass-volume concentration scope is 0.1%-4.0%；
Acid reagent is one kind of sulfuric acid, nitric acid and hydrochloric acid solution, and molal volume concentration range is respectively 0.1-6.0mol/L；
First developer is one kind in ferric trichloride, ferric sulfate, ammonium ferric sulfate solution, and mass-volume concentration scope is 1.0-
20%；
Second developer is hydrogenperoxide steam generator, and mass-volume concentration scope is 1.5-30%.
2. the quick determination method of a kind of Indomethacin according to claim 1, it is characterised in that comprise the following steps：
A. learn from else's experience pre-treatment sample be placed into alkaline reagent bottle in, occlusion shaking, stand；
B. alkaline reagent bottle supernatant or lower clear liquid are drawn into acid reagent bottle with suction pipe, shakes up reaction；
C. the interior solution of acid reagent bottle after answering is negated, filtration, filtrate puts centrifuge tube；
D. the first developer and the second developer are added to centrifuge tube, solution colour change in centrifuge tube is observed；
E. result judges：If solution colour is changed into light red to aubergine, show that sample contains Indomethacin；If color is unchanged, table
Bright sample is free of Indomethacin.
3. a kind of quick determination method of Indomethacin according to claim 2, it is characterised in that：In step A, sample
Pre-treatment step is as follows：Sample is placed in alkaline reagent bottle, occlusion shaking 10 seconds stands 20 seconds, takes supernatant liquor or lower clear
Liquid is used as sample.
4. a kind of quick determination method of Indomethacin according to claim 2, it is characterised in that：In step C, the filter
Cross to use 1ml syringe draw solutions, plus put syringe-driven filter filtering；Syringe-driven filter material is water system or organic
System, inside diameter ranges are 13-25mm, and aperture is 0.22 μm or 0.45 μm.
5. a kind of quick determination method of Indomethacin according to claim 2, it is characterised in that：The centrifuge tube is PP
The disposable plastic centrifuge tube of material, specification limit is 1.5-2ml.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113138188A (en) * | 2021-04-21 | 2021-07-20 | 江门蓝湖污水处理有限公司 | Preparation and rapid detection method of heavy metal and cyanide detection reagent pack |
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Application publication date: 20170822 |