CN105362325A - Traditional Chinese medicine chrysanthemum indicum extract and preparation method, pharmaceutical composition and application thereof - Google Patents
Traditional Chinese medicine chrysanthemum indicum extract and preparation method, pharmaceutical composition and application thereof Download PDFInfo
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- CN105362325A CN105362325A CN201410442671.3A CN201410442671A CN105362325A CN 105362325 A CN105362325 A CN 105362325A CN 201410442671 A CN201410442671 A CN 201410442671A CN 105362325 A CN105362325 A CN 105362325A
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Abstract
The invention provides chrysanthemum indicum extract and a preparation method, a pharmaceutical composition containing the chrysanthemum indicum extract and application thereof. The chrysanthemum indicum extract contains flavonoids compounds and caffeic acid ester compounds. The chrysanthemum indicum extract is prepared through the steps that chrysanthemum indicum is extracted, filtered, concentrated and centrifuged, and liquid supernatant and sediment are obtained; the liquid supernatant is purified through macroreticular resin, and extract I is obtained; alkaline methanol or ethyl alcohol for sediment is dissolved and then purified through an acid sediment method, and extract II is obtained; the extract I and the extract II are combined, and the chrysanthemum indicum extract is obtained; the chrysanthemum indicum extract can be clinically used for prevention and treatment of haemorrhoids, varicose vein of lower limbs and other diseases. According to the chrysanthemum indicum extract, the preparation method, the pharmaceutical composition containing the chrysanthemum indicum extract and application thereof, raw materials are easy to obtain, industrialization is easy to achieve, various dosage forms can be made according to requirements, modern traditional Chinese medicine which is more convenient to use, more effective in treatment and more controllable in quality is provided for the clinic, more benefits are brought to patients, and thus huge social benefits are generated.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of Chinese medicine Herba Dendranthematis indici extract and preparation method thereof, comprise pharmaceutical composition and the purposes of this Herba Dendranthematis indici extract.
Background technology
Varicosis has become the common disease of harm people's life health, weight, lack exercise, oral contraceptive, pregnancy, climacteric, obesity, aging, the factor such as heredity all can cause varicosis.Varicosis can cause the generation of hemorrhoid, and hemorrhoid are that be a kind of common disease, its sickness rate is about 25-40%, and the sickness rate of more than 50 years old old people is 60-70% due under the mucosa of rectum lower end and anal canal or the subcutaneous varicosis of anus edge, expand and cause.When patient suffers from hemorrhoid, there will be have blood in stool, the symptom such as hemorrhoid block comes off, pain, pruritus, bring very large inconvenience and misery to the life of patient.Varicose veins of the lower extremity is also varicose vein disease the most common, and prevalence is up to about 5-30%.Main clinical manifestation comprises lower limb Superficial veins and expands, extends, bends to bulk; Patient has that leg is heavy, weak, swollen, the twinge of acid, feeling of numbness, edema, scratchiness, exacerbation of symptoms after standing for a long time or walking; End-stage disease can occur that the scleroma of Superficial veins thrombosis is formed, venous ulcer (being commonly called as " always rotten lower limb ").There is affected part angiorrhexis acute hemorrhage in some patients, or chronic skin ulcer is prolonged does not heal, amputation and even threat to life.
It is cause cirsoid main cause that vein tube wall strength reduction and intravenous pressure raise, and therefore, increases the tension force of vein blood vessel, reduces intravenous pressure and just effectively can treat varicosis.
Herba Dendranthematis indici is the dry aerial parts of feverfew Herba Dendranthematis indici ChrysanthemumindicumL..Its sweet in the mouth, hardship, cold nature; Return liver, heart channel.There is heat-clearing and toxic substances removing, effect of improving eyesight.Clinical in flu, dysentery, carbuncle, furuncle, conjunctival congestion and swelling pain, dizzy, scrofula, the treatment of eczema etc.Have no the related application and the research report that are used for the treatment of varicose disease about Herba Dendranthematis indici.
Summary of the invention
An object of the present invention is to provide one and there is good detumescence, antiinflammatory action, be used for the treatment of the Herba Dendranthematis indici extract of varicosis relevant disease.
Another object of the present invention is the preparation method providing a kind of above-mentioned Herba Dendranthematis indici extract.
Another object of the present invention is to provide a kind of pharmaceutical composition comprising above-mentioned Herba Dendranthematis indici extract.
Another object of the present invention is to provide the purposes of above-mentioned Herba Dendranthematis indici extract.
The present invention on the basis that Herba Dendranthematis indici chemical composition and pharmacologically active are studied, find the flavone compound that comprises in this plant and caffeic acid ester compounds have significantly suppress local inflammation to cause edema, reduce faint pulse vascular permeability and shorten the effect of normal mouse bleeding time and clotting time.
The object of the invention is to be achieved through the following technical solutions:
On the one hand, the invention provides a kind of Herba Dendranthematis indici extract, described Herba Dendranthematis indici extract comprises flavone compound and caffeic acid ester compounds.
Preferably, described flavone compound mainly comprises acacetin-7-O-rhamnose glucoside, luteolin-7-O-rhamnose glucoside, acacetin, luteolin and apigenin etc.; Described caffeic acid ester compounds mainly comprises 3-coffee acyl quinic acid, 3,5-bis-coffee acyl quinic acids and 4,5-bis-coffee acyl quinic acid etc.
On the other hand, the invention provides a kind of method preparing above-mentioned Herba Dendranthematis indici extract, said method comprising the steps of:
(1) Herba Dendranthematis indici medical material is got through solvent extraction;
(2) the crude drug volume such as the extracting solution of step (1) gained to be evaporated to, to put to room temperature, centrifugal, must precipitate and supernatant, for subsequent use;
(3) supernatant in above-mentioned (2) is passed through macroporous adsorbent resin or polycaprolactam, use aqueous solution eluting, discard eluent;
(4) with high concentration methanol or ethanol water eluting, collect eluent, recycling design is also dry, obtains extract I;
(5) precipitation precipitation in step (2) is added debita spissitudo sodium hydroxide solution, and add appropriate alcoholic solution, be stirred to dissolve, filter, get filtrate, with acid for adjusting pH to 6-7, separate out precipitation, sucking filtration, after filter cake distilled water fully cleans, dry, pulverize, obtain extract II.
(6) extract I and extract II are merged, obtain Herba Dendranthematis indici extract.
Preferably, the extracting method in described step (1) is warm macerating, hot reflux and/or percolation; Solvent in described step (1) be selected from water, aqueous slkali, methanol, ethanol and acetone one or more.Macroporous adsorbent resin in described step (3) is selected from HPD100, HPD300 or AB-8.Alcoholic solution in described step (5) is methanol, ethanol or the mixed solution etc. of the two; Acid in described step (5) is concentrated hydrochloric acid, glacial acetic acid or concentrated sulphuric acid etc.
Above-mentioned preparation method is simple, extraction effect good, be easy to commercial introduction application.
Another aspect, the invention provides a kind of pharmaceutical composition, and described pharmaceutical composition comprises above-mentioned Herba Dendranthematis indici extract.
Preferably, described pharmaceutical composition is capsule, conventional tablet, granule, drop pill, soft capsule, dispersible tablet, oral cavity disintegration tablet, slow releasing tablet, controlled release tablet, injection, transfusion or injectable sterile powder.
Conventional method can be adopted Herba Dendranthematis indici extract and any one or more than one pharmaceutic adjuvants, as starch, dextrin, lactose, microcrystalline Cellulose, hydroxypropyl methylcellulose, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, Polyethylene Glycol, magnesium stearate, micropowder silica gel, glucose, mannitol, xylitol, glycine etc. are mixed and made into above-mentioned dosage form.
Again on the one hand, the invention provides described Herba Dendranthematis indici extract and prepare the purposes prevented and/or treated in the medicine of varicose vein disease.
Preferably, wherein said varicose vein disease is hemorrhoid or varicose veins of the lower extremity etc.
In Herba Dendranthematis indici extract, the content assaying method of total flavones is as follows:
The mensuration (spectrophotography) of total flavones
The preparation of reference substance solution: the acacetin-7-O-rhamnose glucoside reference substance that precision takes dry constant weight is appropriate, makes the solution of every 1ml containing 15 μ g with dissolve with methanol, to obtain final product.
The preparation of need testing solution: precision takes this product powder 50mg, and put in 10ml measuring bottle, adding distil water is dissolved to scale, shakes up, filters.Precipitation connects filter paper and is placed in 100ml tool plug conical flask, and add methanol 50ml, accurately weighed weight, supersound process 30min, weighs again, adds the weight that methanol supplies less loss, shakes up, and filters.Get subsequent filtrate 1ml, put in 25ml measuring bottle, add methanol to scale, shake up, to obtain final product.
The drafting of standard curve: precision measure acacetin-7-O-rhamnose glucoside reference substance solution (0.13mg/ml) 1.0,2.0,3.0,4.0,5.0,6.0ml, put in 25ml measuring bottle respectively, add methanol to scale, shake up, take methanol as blank, measure absorbance at 326mn wavelength place.With trap (A) for vertical coordinate, concentration C (μ gml-1) is abscissa, drawing standard curve.
Algoscopy: get need testing solution take methanol as blank, according to spectrophotography (China's coastal port annex VA), measures trap at 326nm wavelength place.
Preliminary study is carried out to the pharmacodynamics part of medicine of the present invention, found that medicine Dichlorodiphenyl Acetate of the present invention causes rat Perianal ulceration and has obvious therapeutic action.On the basis of above-mentioned pharmacological activity test, Herba Dendranthematis indici extract can be used for the prevention and treatment of diseases such as hemorrhoid, varicose veins of the lower extremity clinical.
Medicine material source of the present invention is easy to get, be easy to industrialization, various dosage form can be made as required, for clinical providing uses convenient, that treatment is more effective, quality is more controlled modern Chinese medicine, for patient brings more benefit, thus create huge social benefit.
Detailed description of the invention
Below in conjunction with detailed description of the invention, the present invention is further described in detail, the embodiment provided only in order to illustrate the present invention, instead of in order to limit the scope of the invention.
embodiment 1
Get Herba Dendranthematis indici medical material 10kg, extract three times with 100L80% (volume) alcohol heat reflux, each 1 hour.Collect extracting solution, decompression recycling ethanol, and be concentrated into 10L, be placed to room temperature, centrifugal, collect supernatant and precipitation respectively, for subsequent use.Get above-mentioned supernatant, by HPD-300 type macroporous adsorptive resins (resin volume 20L), first use 3 times of resinite hydrops eluant solutions, water elution liquid discards, use 3 times of resin volume 70% concentration ethanol eluant solutions again, collect 70% ethanol elution, decompression recycling ethanol is also concentrated into dry, obtains extract I.Get above-mentioned precipitation and add 1.5L concentration 10% sodium hydroxide solution, add 4.5L ethanol, be stirred to dissolve, filter, get filtrate, add concentrated hydrochloric acid and regulate pH to 6-7, leave standstill and separate out precipitation, sucking filtration, filter cake dry, pulverize, obtains extract II after fully cleaning with 50% ethanol and distilled water respectively.United extraction thing I and II, obtains Herba Dendranthematis indici extract.
embodiment 2
Get Herba Dendranthematis indici medical material 2kg, with 60L80% (volume) ethanol percolate extraction, collect percolate, decompression recycling ethanol, and be concentrated into 2L, be placed to room temperature, collect supernatant and precipitation respectively, for subsequent use.Get above-mentioned supernatant, by AB-8 type macroporous adsorptive resins (resin volume 4L), first use 3 times of resinite hydrops eluant solutions, water elution liquid discards, use 3 times of resin volume 60% concentration ethanol eluant solutions again, collect 60% ethanol elution, decompression recycling ethanol is also concentrated into dry, obtains extract I.Get above-mentioned precipitation and add 0.4L concentration 5% sodium hydroxide solution, add 1.2L ethanol, be stirred to dissolve, filter, get filtrate, add concentrated sulphuric acid and regulate pH to 6-7, leave standstill and separate out precipitation, sucking filtration, after filter cake distilled water fully cleans, dry, pulverize, obtains extract II.United extraction thing I and II, obtains Herba Dendranthematis indici extract.
embodiment 3
Get Herba Dendranthematis indici medical material 2kg, with 20L70% (volume) methanol circumfluence distillation secondary, each 1.5 hours.Collect extracting solution, reclaim under reduced pressure methanol, and be concentrated into 2L, be placed to room temperature, centrifugal, collect supernatant and precipitation respectively, for subsequent use.Get above-mentioned supernatant, by HPD-100 type macroporous adsorptive resins (resin volume 4L), first use 3 times of resinite hydrops eluant solutions, water elution liquid discards, use 3 times of resin volume 50% concentration ethanol eluant solutions again, collect 50% ethanol elution, decompression recycling ethanol is also concentrated into dry, obtains extract I.Get above-mentioned precipitation and add 0.2L concentration 10% sodium hydroxide solution, add 0.6L ethanol, be stirred to dissolve, filter, get filtrate, add 20% sulfur acid for adjusting pH to 6-7, leave standstill and separate out precipitation, sucking filtration, after filter cake distilled water fully cleans, dry, pulverize, obtain extract II.United extraction thing I and II, obtains Herba Dendranthematis indici extract.
embodiment 4
Get Herba Dendranthematis indici medical material 2kg, extract secondary with 30L85% (volume) alcohol heat reflux, each 2 hours.Collect extracting solution, decompression recycling ethanol, and be concentrated into 2L, be placed to room temperature, centrifugal, collect supernatant and precipitation respectively, for subsequent use.Get above-mentioned supernatant, by polyamide column (column volume 4L), first use 5 times of column volume aqueous solution eluting, water elution liquid discards, then uses 3 times of resin volume 70% concentration methanol solution eluting, collects 70% meoh eluate, reclaim under reduced pressure methanol is also concentrated into dry, obtains extract I.Get above-mentioned precipitation and add 0.2L concentration 10% sodium hydroxide solution, add 0.6L methanol, be stirred to dissolve, filter, get filtrate, add 20% sulfur acid for adjusting pH to 6-7, leave standstill and separate out precipitation, sucking filtration, after filter cake distilled water fully cleans, dry, pulverize, obtain extract II.United extraction thing I and II, obtains Herba Dendranthematis indici extract.
embodiment 5
Get Herba Dendranthematis indici extract 100g, micropowder silica gel is appropriate, mix homogeneously, adopts capsules preparation technique preparation, obtains Herba Dendranthematis indici extract capsule.
embodiment 6
Get Herba Dendranthematis indici extract 100g, be added in the polyethylene glycol 6000 of 200g melting, adopt drop pill preparation technology preparation, obtain Herba Dendranthematis indici extract dripping pill.
embodiment 7
Get Herba Dendranthematis indici extract 100g, dextrin 200g, mix homogeneously, granulate, sieve, dry, obtain the granule of Herba Dendranthematis indici extract; Maybe by obtained granule through further tabletting, dry, obtain the tablet of Herba Dendranthematis indici extract.
embodiment 8
Get Herba Dendranthematis indici extract 100g, hydroxypropyl emthylcellulose 100g, sodium carboxymethyl cellulose 60g, lactose 40g, mix homogeneously, granulate, dry, tabletting, obtains the slow releasing tablet of Herba Dendranthematis indici extract.
embodiment 9
Get Herba Dendranthematis indici extract 100g, microcrystalline Cellulose 120g, sodium carboxymethyl cellulose 30g, micropowder silica gel 1g, mix homogeneously, tabletting, obtain the dispersible tablet of Herba Dendranthematis indici extract.
embodiment 10
Get Herba Dendranthematis indici extract 100g, vegetable oil 250g, mixing, makes capsule casing material with gelatin, is pressed into soft capsule, obtain the soft capsule of Herba Dendranthematis indici extract.
embodiment 11
Get Herba Dendranthematis indici extract 10g, be dissolved in 500ml water for injection, adopt existing injectable sterile powder preparation technology to prepare, obtain Herba Dendranthematis indici extract injectable sterile powder dosage form.
embodiment 12
Get Herba Dendranthematis indici extract 10g, be dissolved in 1000ml water for injection, adopt process for preparation of injection, obtain Herba Dendranthematis indici extract injection (containing transfusion).
embodiment 13
The curative effect of medicine of the present invention is proved by following pharmacodynamics test:
1, test material
1.1 medicines and reagent
Herba Dendranthematis indici extract: sample prepared by embodiment 1, brown powder.The solution being made into suitable concn with normal saline is for experiment.
Dexamethasone acetate tablets: Tianjin Pacific Pharmaceutical Co., Ltd..
Alvenor (diosmin sheet): Shi Weiya (Tianjin) pharmaceutical Co. Ltd.
1.2 animal
Rat: SD rat, male and female dual-purpose, body weight 160-180g, purchased from Hua Bukang biotech inc, Beijing.
Mice: Kunming kind, male and female dual-purpose, body weight 18-22g, purchased from Hua Bukang biotech inc, Beijing.
2, xylol causes the impact of mice auricle swelling
Get mice 40, male and female half and half.Be divided into model group (normal saline), positive controls, Herba Dendranthematis indici extract 200,400mg/kg dosage group at random, often organize 10.Model group (normal saline), ig, 1 time/d, continuous 7d, is evenly applied to mouse right ear exterior feature with dimethylbenzene 0.02mL after last administration 1h and causes inflammation, and after 1h, animal is put to death in dislocation, two ears are cut along auricle baseline, lay circular auricle at same position respectively with the card punch that diameter is 9mm and weigh, using ear edema degree (differences of two auricle quality) as inflammation index, calculating medication group inhibitory rate of intumesce (%).
Table 1 Herba Dendranthematis indici extract xylol cause mice ear impact (
n=10)
* P<0.05**P<0.01 is compared with model control group
Table 1 result shows, Herba Dendranthematis indici extract 200 and 400mg/kg dosage group are compared with model group, and mice auricle swelling degree significantly declines (P<0.01).
3, Dichlorodiphenyl Acetate causes the impact of mice capillary permeability
Grouping and medication are with 2,1h after last medicine, tail iv0.5% azovan blue normal saline solution 0.01mLg
-1, ip0.6% acetum 10mLkg simultaneously
-1, after 20min, dislocation is put to death, ip5mL normal saline flushing, and washing liquid, with the centrifugal 5min of 1500rmin, gets supernatant in 590nm place, measures absorbance (A).
Table 2 Dichlorodiphenyl Acetate cause mice capillary permeability impact (
n=10)
* P<0.05**P<0.01 is compared with model control group
Table 2 result shows, Herba Dendranthematis indici extract 200 and 400mg/kg dosage group are compared with model group, and azovan blue seepage discharge significantly declines (P<0.01).
3, Dichlorodiphenyl Acetate causes the impact of rat Perianal ulceration
Get SD rat 50, male and female half and half, body weight 160-180g.Perianal ulcer is caused: be that the filter paper of 8mm launches and put into glacial acetic acid fully to soak by equal and opposite in direction internal diameter with acetic acid, then all rats filter paper being soaked with glacial acetic acid is sticked anus, filter paper need be close to anal skin and mucosa, and 0.5min, 1min change filter paper.Within 2nd day, divide 4 groups at random by rat, gastric infusion by body weight and ulcer level.Model control group is to equal-volume distilled water; Herba Dendranthematis indici extract 200,400mg/kg group; Positive controls.In administration the 3rd, 5,7,9 days according to rat ulcer healing state, evaluation ulcer level.Evaluation criteria: have ulcer sepage 1 point; A little ulcer sepage 2 points; Eschar is had substantially to heal 3 points; Heal 4 points completely.White ulcer surface, crissum swelling have inflammatory seep is all there is in each treated animal after sticking the glacial acetic acid filter paper of 99%.
Table 3 Herba Dendranthematis indici extract Dichlorodiphenyl Acetate cause rat Perianal ulceration impact (
n=10)
* P<0.05**P<0.01 is compared with model control group
Table 3 result shows, Herba Dendranthematis indici extract 200 and 400mg/kg dosage treated animal self administration of medication play Perianal ulceration on the 5th day and namely take an evident turn for the better, substantially, healed by the 9th day, ulcer level scoring is compared with model control group significant difference (P<0.05 or P<0.01).
Therefore, Chinese medicine Herba Dendranthematis indici extract of the present invention has obvious antiinflammatory action, has good therapeutic effect to Perianal ulceration, the edema that can local inflammation be suppressed significantly to cause, reduction microvascular permeability.
Claims (11)
1. a Herba Dendranthematis indici extract, is characterized in that, described Herba Dendranthematis indici extract is flavone compound and caffeic acid ester compounds.
2. Herba Dendranthematis indici extract according to claim 1, is characterized in that, described flavone compound comprises acacetin-7-O-rhamnose glucoside, luteolin-7-O-glucoside, acacetin, luteolin and apigenin.
3. Herba Dendranthematis indici extract according to claim 1, is characterized in that, described caffeic acid ester compounds comprises 3-coffee acyl quinic acid, 3,5-bis-coffee acyl quinic acids, 4,5-bis-coffee acyl quinic acids.
4. Herba Dendranthematis indici extract according to claim 1 and 2, is characterized in that, in described Herba Dendranthematis indici extract, the weight percentage of flavone compound is greater than 30%.
5. prepare a method for the Herba Dendranthematis indici extract according to any one of claims 1 to 3, it is characterized in that, said method comprising the steps of:
(1) Herba Dendranthematis indici medical material is got through solvent extraction;
(2) the crude drug volume such as the extracting solution of step (1) gained to be evaporated to, to put to room temperature, centrifugal, must precipitate and supernatant, for subsequent use;
(3) supernatant in above-mentioned (2) is passed through macroporous adsorbent resin or polycaprolactam, use aqueous solution eluting, discard eluent;
(4) with high concentration methanol or ethanol water eluting, collect eluent, recycling design is also dry, obtains extract I;
(5) precipitation precipitation in step (2) is added debita spissitudo sodium hydroxide solution, and add proper amount of methanol or alcoholic solution, be stirred to dissolve, filter, get filtrate, with acid for adjusting pH to 6-7, separate out precipitation, sucking filtration, after filter cake distilled water fully cleans, dry, pulverize, obtain extract II.
6. method according to claim 5, is characterized in that, the solvent in described step (1) be selected from water, aqueous alkali, methanol, ethanol and acetone one or more.
7. method according to claim 5, is characterized in that, the macroporous adsorbent resin in described step (3) is selected from HPD100, HPD300 or AB-8.
8. the method according to any one of claim 5 to 7, is characterized in that, the extracting method in described step (1) is warm macerating, hot reflux and/or percolation.
9. a pharmaceutical composition, it comprises the Herba Dendranthematis indici extract according to any one of claims 1 to 3.
10. pharmaceutical composition according to claim 9, it is characterized in that, described pharmaceutical composition is capsule, tablet, granule, drop pill, soft capsule, dispersible tablet, oral cavity disintegration tablet, slow releasing tablet, controlled release tablet, injection, transfusion or injectable sterile powder.
11. Herba Dendranthematis indici extracts according to any one of claim 1 to 3 are preparing the purposes prevented and/or treated in the medicine of varicosis relevant disease, and preferably, described varicose vein disease is hemorrhoid or varicose veins of the lower extremity.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107625867A (en) * | 2017-09-28 | 2018-01-26 | 南阳市中心医院 | Treat Chinese medicine composition of varix of lower limb and preparation method thereof |
| CN108992436A (en) * | 2018-08-16 | 2018-12-14 | 岭南师范学院 | It is a kind of prevent and treat prawn virus disease Honegsukle flower P.E composition and its application |
| CN114727961A (en) * | 2019-06-26 | 2022-07-08 | 绿十字生命健康有限公司 | Pharmaceutical composition with improved stability comprising natural product extract |
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| CN107625867A (en) * | 2017-09-28 | 2018-01-26 | 南阳市中心医院 | Treat Chinese medicine composition of varix of lower limb and preparation method thereof |
| CN108992436A (en) * | 2018-08-16 | 2018-12-14 | 岭南师范学院 | It is a kind of prevent and treat prawn virus disease Honegsukle flower P.E composition and its application |
| CN114727961A (en) * | 2019-06-26 | 2022-07-08 | 绿十字生命健康有限公司 | Pharmaceutical composition with improved stability comprising natural product extract |
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Application publication date: 20160302 |