CN102188513A - Medical composition with auxiliary protection function for chemical liver damage - Google Patents

Medical composition with auxiliary protection function for chemical liver damage Download PDF

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CN102188513A
CN102188513A CN2011101367194A CN201110136719A CN102188513A CN 102188513 A CN102188513 A CN 102188513A CN 2011101367194 A CN2011101367194 A CN 2011101367194A CN 201110136719 A CN201110136719 A CN 201110136719A CN 102188513 A CN102188513 A CN 102188513A
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extract
protection function
chemical liver
liver
pharmaceutical composition
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孙亚丽
唐弟康
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Zunyi Lusheng Health-Source & Technology Development Co Ltd
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Zunyi Lusheng Health-Source & Technology Development Co Ltd
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Abstract

The invention relates to a medical composition with an auxiliary protection function for chemical liver damage, which takes tea extractive-tea polyphenol, a hovenia dulcis thumb extractive, a Salvia miltiorrhiza extractive, a kudzuvine root extractive and a Schisandra chinensis extractive as active components to prepare a new oral formulation. The Chinese medicine formulation in the invention has the advantages of safety and no toxicity and has the auxiliary protection function for chemical liver damage.

Description

The pharmaceutical composition that chemical liver injury is had assistant protection function
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of Chinese medicine preparation that chemical liver injury is had assistant protection function.
Background technology
Liver function has infringement in various degree during hepatopathy, its detoxifcation, excretory function and stock and regeneration capacity reduces, and hepatic blood flow reduces, and the various medicines that enter liver increase the weight of the metabolism load, thus environment disorder in taking place, and then cause hepatic injury.Hepatic injury is the pathological changes result of various hepatic disease, domestic in recent years many scholars are at occurrence factor and the pathomechanism of modern medicine to hepatic injury, done big quantity research, due to antiradiation drug, think aspect the treatment of hepatic injury and there is no specific drug, nutrition, vitimin supplement and symptomatic treatments etc. are had a rest, strengthened to adopt more, severe patient even be forced to stop medication.
Hepatic injury is the disease of clinical common harm humans health, and the pathological factor that hepatic injury relates to is more extensive, relates to many factors, as virus, biology, medicine, physics and chemistry, ethanol etc., can cause hepatic injury.
Along with the development of society, the people of hepatic injury is more and more, and the health food of hepatic injury auxiliary protection is had very big adaptation population.Successive dynasties medical book Huangdi's Internal Classics, Shennong's Herbal, " prescriptions worth thousand gold ", Compendium of Material Medica, " Mingyi Bielu " etc. have all been put down in writing the Chinese herbal medicine of hepatoprotective.Various hepatoprotective prescriptions more appearred modern age.Chinese patent (application number 90105366, publication number 1058907A) has been reported a kind of Chinese medicine oral liquid of Antialcoholic liver-protecting, and manufacture method adopts the Chinese medicine decocting method, and effective ingredient is unclear, and the mechanism of action is not clear, does not provide enough pharmacology and pathology to explain.Animal or human's body experiment of being correlated with simultaneously, the toxicity hazardness is indeterminate.Chinese patent (application number 96103872, publication number 1164397), also there is similar problem in the liver protecting and sobering preparation that Chinese patent (application number 995100420, publication number 1189368) is provided.
Summary of the invention
The objective of the invention is in order to overcome disadvantages of background technology, and a kind of good effect, the instant effect that provide and have no side effect chemical liver injury is had the pharmaceutical composition of assistant protection function.
The inventor is in tcm clinical practice and drug research decades, the treatment patient is up on ten thousand person-times of bases surplus 30, the combination of oral medication of having invented.
To achieve these goals, the technical solution used in the present invention is: a kind of have a pharmaceutical composition that chemical liver injury is had assistant protection function, and said preparation is to be the oral formulations that active ingredient is made with Semen Hoveniae extract (Fructus Hoveniae extract), Radix Salviae Miltiorrhizae extract, Radix Puerariae extract, tea polyphenols, Fructus Schisandrae Chinensis extrat; Wherein the active ingredient percentage by weight consists of: Semen Hoveniae extract (Fructus Hoveniae extract) 10-50%, Radix Salviae Miltiorrhizae extract 10-50%, Radix Puerariae extract 10-40%, tea polyphenols 10-30%, Fructus Schisandrae Chinensis extrat 5-20%; Or the oral formulations of making by Dulcis seed extract, Radix Salviae Miltiorrhizae extract, Radix Puerariae extract, four kinds of raw materials of tea polyphenols, all the other are adjuvant.
Optimized technical scheme of the present invention is; a kind of have a pharmaceutical composition that chemical liver injury is had assistant protection function, and its primary raw material consists of: Semen Hoveniae extract (Fructus Hoveniae extract) 20-30%, Radix Salviae Miltiorrhizae extract 20-30%, Radix Puerariae extract 15-25%, tea polyphenols 10-20%, Fructus Schisandrae Chinensis extrat 5-10%.
The invention reside in wherein said oral formulations is that medically acceptable various dosage forms comprise tablet, capsule, granule or oral liquid.Chinese medicine active ingredient extract mixes, and makes tablet, capsule, granule, drop pill or oral liquid with pharmaceutic adjuvant according to a conventional method.
The application of described pharmaceutical composition in preparing the health product that chemical liver injury had assistant protection function.
Preparation active ingredient quantitative criterion of the present invention is respectively by " pertinent regulations under 2010 editions Radix Puerariae items of Chinese pharmacopoeia are carried out, the related request of puerarin 2.0g/100g and " QB 2154-1995 food additive tea polyphenols " carries out tea polyphenols 10.0g/100g.
The present invention has the oral dose of assistant protection function Chinese medicine preparation to be to chemical liver injury: 2-3g.
30 days courses of treatment.
So that the relieving restlessness of quenching the thirst to be arranged, it is damp and hot to disappear, the Semen Hoveniae extract (Fructus Hoveniae extract) of alcoholic intoxication function in the present invention's prescription; Promoting blood flow to regulate menstruation, stasis-dispelling and pain-killing, the removing heat from blood eliminating carbuncle, the relieving restlessness that clears away heart-fire, the nourishing blood to tranquillize the mind Radix Salviae Miltiorrhizae extract is a monarch drug; Being aided with induces sweat brings down a fever, and promotes the production of body fluid rash, yang invigorating antidiarrheal Radix Puerariae extract; There is extremely strong removing to be harmful to free radical, stops the effect tea polyphenols of lipid peroxidation; The accent liver is reinforced the kidney, restrains astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, the Fructus Schisandrae Chinensis extrat of kidney calming; All flavor compatibilities, the effect of playing hepatoprotective altogether has auxiliary protection function to chemical liver injury.
Liver is general's official, and the chief instigator considers.The traditional Chinese medical science is thought: forming an integral part for liver and gallbladder, has one's ideas straightened out in order liver storing blood, liver controlling conveyance and dispersion, the function that storage is arranged and regulate blood." element asks that the five internal organs generate ": " the tissue connected with the liver being tendon, its flourish pawl also.”
Among the we, Semen Hoveniae (Fructus Hoveniae) is flat, and sweet in the mouth is gone into heart channel, spleen channel, the relieving restlessness of quenching the thirst, and it is damp and hot to disappear, and alcoholic intoxication, modern study have anti peroxidation of lipid and protection hepatic injury effect.Can alleviate fibrosis and hepatocellular degeneration necrosis and inflammatory cell infiltration, mitochondrial membrane is in time recovered, reduce reticulum dilatation, promote cell regeneration, block developing of hepatic fibrosis.
The Radix Salviae Miltiorrhizae bitter in the mouth, cold nature.GUIXIN, Liver Channel tool blood-activating and qi-promoting, the merit of inducing menstruation to relieve menalgia.Modern medicine thinks that Radix Salviae Miltiorrhizae has coronary artery dilator, coronary blood flow increasing; prevent core ischemia and myocardial infarction, accelerate microcirculation blood flow, promote capillary network open; suppress myocardial contraction, reduce energy expenditure, blood vessel dilating; cholesterol reducing, blood fat press down blood, activate fibrinolytic; stablize erythrocyte membrane, improve anoxia endurance, increase the liver blood volume; protection hepatic injury cell, anti-hepatic fibrosis suppresses effects such as central nervous system and thirst quenching bacterium.
Radix Puerariae is cool in nature, gas is flat, sweet in the mouth, and the master goes into spleen, stomach warp, tool heat clearing away, pathogenic fire reducing, all effects of toxin expelling, and main helping digestion separated all poison, controls on day row.Modern study finds that Radix Puerariae has significant protective effect to the chronic hepatic injury animal model, and its mechanism is relevant with effects such as protection liver plasma membrane, removing free radical, anti peroxidation of lipid and fibrosis.
Tea polyphenols is the All Pure Nature antioxidant food that extracts from Folium Camelliae sinensis, and it is strong to have oxidation resistance, has no side effect characteristics such as free from extraneous odour.Tea polyphenols has very strong antioxidation, and its oxidation resistance is 5-10 a times of VC, and consumption is few: 0.01-0.03% can work, and does not have the potential toxic and side effects of synthetic.Tea polyphenols has the generation of the endotoxemia of reduction in the ethanol liver damage in early days, may play the certain protection effect to the ethanol liver damage.
Fructus Schisandrae Chinensis is warm in nature; Sour in the mouth, sweet; Return lung, the heart, kidney channel, restrain astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming.Modern study has found that Fructus Schisandrae Chinensis has significant protective effect to the effect of liver.Bao Tiantong; usefulness carbon tetrachloride such as Liu Gengtao, thiacetic acid. amine and quinesterol cause that mouse liver injury is a model; find the ethanol extract of Fructus Schisandrae Chinensis and the serum transaminase rising effect that isolated above-mentioned deoxyschizandrin, second element, third element, pure first, pure second, ester first and ester second all have reduction in various degree to cause because of chemical substance from Fructus Schisandrae Chinensis; can obviously alleviate the necrosis of lobules of liver; the author infers that Fructus Schisandrae Chinensis may be realized by hepatocyte internal protein anabolism the protective effect of carbon tetrachloride injury rats liver.Use Chinese Magnoliavine Fruit alcohol extract, 24 h administrations in advance can significantly reduce the mouse death rate due to heavy dose of acetaminophen liver poisoning, and prevent the exhaustion of the sweet peptide of paddy look down in the liver, strengthen the speed of hepatomicrosome metabolism acetaminophen, and acetaminophen content descends in the blood.The Radix Schisandrae Bicoloris polysaccharide can significantly lower MDA content in the carbon tetrachloride poisoning Mouse Liver, suppresses the mouse liver lipid peroxidation, the regeneration of liver behind the bile secretion of promotion normal mouse and the partially hepatectomized.Fructus Schisandrae Chinensis single or be used for the treatment of acute and chronic hepatic injury with other drug matchings can promote to damage hepatocellular reparation, reduce serum glutamic pyruvic transminase (ALT) activity.The schisandrol extracting solution has the certain protection effect to the rat chronic hepatic injury; the cardiovascular system Fructus Schisandrae Chinensis there is vasodilative effect; and promotion spleen immunologic function; and the immunosuppressive action of schisandrol extracting solution energy adrenal cortex reinforcing hormone; can resist allohisto compatibility's graft-rejection, delaying senility function.
Make a general survey of all medicine compatibilities of the present invention, the effect of playing hepatoprotective altogether has auxiliary protection function to chemical liver injury.
Pharmacological evaluation proves:
Preparation of the present invention (Sheng Kang source, land HUAGAN JIAONANG) is to the influence of MDA content in the acute liver damage murine liver tissue.Compare with normal group, model group hepatic tissue MDA level significantly raises (P<0.01), and preparation height of the present invention, middle dosage group have remarkable decline (P<0.01) with the model group ratio.Prompting: preparation of the present invention has lipid peroxide content in the hepatic tissue that reduces acute liver damage, reduces the effect of hepatocyte injury.
Preparation of the present invention is to the influence of acute liver damage mice serum transaminase (ALT), aspartate amino transferase (AST).Compare with normal group, model group Serum ALT, AST level significantly raise (P<0.01), and murine liver tissue has been caused major injury, and animal model is set up successfully.Preparation height of the present invention, middle dosage group have been compared obvious decline with model group.
Table one: preparation of the present invention is to CCl 4Induce acute liver damage mice serum ALT, AST level and hepatic tissue MDA influence (x ± s, n=10)
* compare P<0.01 with normal group, * * and model group be P<0.01 relatively
Preparation of the present invention is to the therapeutical effect of chronic hepatic injury.Adopt D-Glan, CCl 4Preparation mice chronic hepatic injury model is measured the ALT in the mice serum, acetylcholine esterase CHE and hepatic tissue MAD level, and carry out the hepatic pathology histological examination.Result's preparation of the present invention can make mice serum ALT significantly reduce, and CHE significantly raises, and can remove MAD accumulating at hepatic tissue.Histopathologic examination's results suggest preparation of the present invention has remarkable repair, liver cell regeneration to show the good curing effect to two kinds of chronic hepatic injuries.
Table two: preparation of the present invention is to D-Glan, CCl 4Induce acute liver damage mice serum ALT, CHE level and hepatic tissue MDA influence (x ± s, n=10)
Figure 222265DEST_PATH_IMAGE002
* compare P<0.01 with normal group, * * and model group be P<0.01 relatively
Preparation of the present invention is to the auxiliary treatment effect of rat alcoholic liver injury.Make up rat alcoholic liver injury model with the ethanol administration by gavage, treat with preparation of the present invention, detect rat blood serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), malonaldehyde (MDA), observe the action effect of preparation of the present invention the control alcoholic liver injury.The result shows: the hepatic injury effect due to the preparation antagonism ethanol of the present invention.
Modelling: rat is divided into normal control group, model group, treatment group and treatment matched group, 12 every group at random.Model group ethanol every day 56% is irritated stomach lOml/kg, continuous 12 weeks; The matched group distilled water is irritated stomach (10ml/kg.d -1), continuous 12 weeks; Treatment group and treatment matched group ethanol every day 56% are irritated stomach 10ml/kg, in continuous 12 weeks, add filling preparation (10ml/kg.d of the present invention from 9 all begin treatment groups -1), the treatment matched group adds irritates normal saline (10ml/kg.d -1), continuous 4 weeks.All put to death the detection corresponding index 12 weekends.
Table three: preparation of the present invention to the influence of Serum ALT, AST level and the hepatic tissue MDA of rat alcoholic liver injury (x ± s, n=10)
Figure 676249DEST_PATH_IMAGE003
* compare P<0.01 with normal group, * * and model group be P<0.01 relatively
The pharmacological action prompting, pharmaceutical composition of the present invention is applicable to that virus, biology, medicine, physics and chemistry, ethanol etc. cause hepatic injury, have assistant protection function to chemical liver injury.
Acute toxicity test proves:
Sheng Kang source, mouse stomach land HUAGAN JIAONANG acute toxic reaction.Method adopts the maximum dosage-feeding method to measure the acute toxicity of the former powder of Sheng Kang source, mouse stomach land HUAGAN JIAONANG; With 100g crude drug/kg.d -1Sheng Kang source, land HUAGAN JIAONANG (being equivalent to 205 times of clinical consumptions) irritate stomach, continuous 2 weeks, growth promoter, body constitution amount and the main organs index variation of observing mice.The general situation of mice, growth of weight, the equal no significant difference of main organs coefficient or unusual as a result.Using in Sheng Kang source, the conclusion land HUAGAN JIAONANG clinical application scope is comparison safety.
Table four: preparation of the present invention to mouse stomach with the acute toxic reaction test main organs of the former powder of Sheng Kang source, land HUAGAN JIAONANG change (x ± s, n=10)
Group The heart Liver Spleen Lung Kidney
Normal control ?0.52±0.05 ?5.31±0.05 ?0.35±0.02 0.76±0.02 0.87±0.08
The administration group 0.50±0.03 ?5.25±0.06 0.36±0.04 0.78±0.03 0.88±0.07
Two groups of groups compare P〉0.05
Acute toxicity test proves that pharmaceutical composition of the present invention is not observed toxicity.
Pharmaceutical composition of the present invention has certain therapeutical effect to acute liver damage, chronic hepatic injury, the alcoholic liver injury of animal, and toxic reaction is not observed in pharmaceutical composition acute toxic reaction test of the present invention, illustrates that pharmaceutical composition of the present invention is safely and effectively.
The present invention compares with existing external preparation, have under advantage, pharmaceutical composition of the present invention is not for containing the pure Chinese medicinal preparation of toxicity medical material, has that curative effect is obvious, cost is low, curative effect is high, an instant effect, the characteristics that have no side effect.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
Below by concrete embodiment technical scheme of the present invention is further described, the embodiment that wherein exemplifies only is to explanation of the present invention, and can not limit protection scope of the present invention by any way.
Embodiment 1
Prescription: Semen Hoveniae extract (Fructus Hoveniae extract) 115g, Radix Salviae Miltiorrhizae extract 100g, Radix Puerariae extract 83g, tea polyphenols 50g, Fructus Schisandrae Chinensis extrat 33g, dextrin 17g, magnesium stearate 2g.The raw material mix homogeneously adds suitable adjuvant dextrin, magnesium stearate again, sieves, and pours into capsule, makes capsule.
Embodiment 2
Prescription: Semen Hoveniae extract (Fructus Hoveniae extract) 110g, Radix Salviae Miltiorrhizae extract 98g, Radix Puerariae extract 80g, tea polyphenols 50g, Fructus Schisandrae Chinensis extrat 30g, starch 20g, magnesium stearate 2g.The raw material mix homogeneously adds suitable adjuvant dextrin, magnesium stearate again, sieves, and tabletting makes tablet.
Embodiment 3
Prescription: Semen Hoveniae extract (Fructus Hoveniae extract) 112g, Radix Salviae Miltiorrhizae extract 99g, Radix Puerariae extract 83g, tea polyphenols 52g, Fructus Schisandrae Chinensis extrat 31g, starch 25g, Icing Sugar 30g, magnesium stearate 2g.The raw material mix homogeneously adds suitable adjuvant dextrin, magnesium stearate again, sieves, and granulates, and makes granule.

Claims (4)

1. one kind has the pharmaceutical composition of assistant protection function to chemical liver injury, it is characterized in that: the said composition preparation is to be the oral formulations that raw material is made with Semen Hoveniae extract (Fructus Hoveniae extract), Radix Salviae Miltiorrhizae extract, Radix Puerariae extract, tea polyphenols, Fructus Schisandrae Chinensis extrat; Its percentage by weight consists of: Semen Hoveniae extract (Fructus Hoveniae extract) 10-50%, Radix Salviae Miltiorrhizae extract 10-50%, Radix Puerariae extract 10-40%, tea polyphenols 10-30%, Fructus Schisandrae Chinensis extrat 5-20%; Or the oral formulations of making by Dulcis seed extract, Radix Salviae Miltiorrhizae extract, Radix Puerariae extract, four kinds of raw materials of tea polyphenols.
2. the pharmaceutical composition that chemical liver injury is had assistant protection function according to claim 1, it is characterized in that primary raw material consists of: Semen Hoveniae extract (Fructus Hoveniae extract) 20-30%, Radix Salviae Miltiorrhizae extract 20-30%, Radix Puerariae extract 15-25%, tea polyphenols 10-20%, Fructus Schisandrae Chinensis extrat 5-10%; Or by Dulcis seed extract 20-30%, Radix Salviae Miltiorrhizae extract 20-30%, Radix Puerariae extract 15-25%, tea polyphenols 10-20%, all the other are adjuvant.
3. according to claim 1 have the pharmaceutical composition of assistant protection function to chemical liver injury, it is characterized in that: wherein said oral formulations comprises tablet, capsule, granule or oral liquid for various dosage forms medically.
4. according to claim 1 have the pharmaceutical composition of assistant protection function to chemical liver injury, and it is characterized in that: this pharmaceutical composition is used in preparation has assistant protection function to chemical liver injury health product.
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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103250947A (en) * 2012-04-23 2013-08-21 乔德京 Liver protection assisting health food
CN104172159A (en) * 2014-07-24 2014-12-03 北京中泰天和科技有限公司 Composition with auxiliary protection effect on alcoholic liver injury and preparation method thereof
CN104432023A (en) * 2014-11-03 2015-03-25 深圳市麦金利实业有限公司 Product capable of protecting liver injury
CN104474135A (en) * 2014-04-29 2015-04-01 遵义陆圣康源科技开发有限责任公司 Pharmaceutical composition with auxiliary protection function of treating chemical liver injury
CN104585757A (en) * 2015-01-05 2015-05-06 洛阳新春都生物制药有限公司 Preparation process of auxiliary liver protection health product
CN104623099A (en) * 2015-01-05 2015-05-20 洛阳新春都生物制药有限公司 Health product with auxiliary protecting effect for chemical liver injury
CN106421208A (en) * 2016-08-08 2017-02-22 北京中医药大学 Pharmaceutical composition with chemical liver injury preventing function and preparation method thereof
CN108904752A (en) * 2018-07-30 2018-11-30 湖南科技学院 A kind of chemical damage therapeutic agent and preparation method thereof
CN109432188A (en) * 2018-12-05 2019-03-08 天津铸源健康科技集团有限公司 A kind of pair of chemical damage has composition of defencive function and preparation method thereof
CN110420264A (en) * 2019-07-16 2019-11-08 江苏康缘药业股份有限公司 A kind of Chinese medicine composition and its preparation method and application

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103250947A (en) * 2012-04-23 2013-08-21 乔德京 Liver protection assisting health food
CN104474135A (en) * 2014-04-29 2015-04-01 遵义陆圣康源科技开发有限责任公司 Pharmaceutical composition with auxiliary protection function of treating chemical liver injury
CN104172159A (en) * 2014-07-24 2014-12-03 北京中泰天和科技有限公司 Composition with auxiliary protection effect on alcoholic liver injury and preparation method thereof
CN104432023A (en) * 2014-11-03 2015-03-25 深圳市麦金利实业有限公司 Product capable of protecting liver injury
CN104585757A (en) * 2015-01-05 2015-05-06 洛阳新春都生物制药有限公司 Preparation process of auxiliary liver protection health product
CN104623099A (en) * 2015-01-05 2015-05-20 洛阳新春都生物制药有限公司 Health product with auxiliary protecting effect for chemical liver injury
CN106421208A (en) * 2016-08-08 2017-02-22 北京中医药大学 Pharmaceutical composition with chemical liver injury preventing function and preparation method thereof
CN106421208B (en) * 2016-08-08 2020-08-07 北京中医药大学 Pharmaceutical composition with chemical liver injury resistance function and preparation method thereof
CN108904752A (en) * 2018-07-30 2018-11-30 湖南科技学院 A kind of chemical damage therapeutic agent and preparation method thereof
CN109432188A (en) * 2018-12-05 2019-03-08 天津铸源健康科技集团有限公司 A kind of pair of chemical damage has composition of defencive function and preparation method thereof
CN110420264A (en) * 2019-07-16 2019-11-08 江苏康缘药业股份有限公司 A kind of Chinese medicine composition and its preparation method and application
CN110420264B (en) * 2019-07-16 2021-10-08 江苏康缘药业股份有限公司 Traditional Chinese medicine composition and preparation method and application thereof

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Application publication date: 20110921