CN101596213A - The pharmaceutical composition that is used for blood sugar lowering and blood fat - Google Patents
The pharmaceutical composition that is used for blood sugar lowering and blood fat Download PDFInfo
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- CN101596213A CN101596213A CNA2009100816875A CN200910081687A CN101596213A CN 101596213 A CN101596213 A CN 101596213A CN A2009100816875 A CNA2009100816875 A CN A2009100816875A CN 200910081687 A CN200910081687 A CN 200910081687A CN 101596213 A CN101596213 A CN 101596213A
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Abstract
A kind of pharmaceutical composition that is used for blood sugar lowering and blood fat, said composition comprises berberine, compound vitamin B, vitamin E and trace element zinc, selenium, chromium, molybdenum, be used for hyperglycemia, people with hyperlipidemia, very effective at blood sugar lowering and lipid aspects, but chronic administration or use by the course of treatment.
Description
Technical field:
The present invention relates to the Medicines and Health Product technical field; Pharmaceutical composition in particular for blood sugar lowering and blood fat.
Background technology:
Said composition comprises berberine, compound vitamin B, vitamin E and trace element zinc, selenium, chromium, molybdenum.
Berberine is from the crude drug Rhizoma Coptidis, and Cortex Phellodendri etc. contain the alkaloid that extracts in the medicine of berberine, but also synthetic; Modern clinical its treatment antibacterial dysentery commonly used, diseases such as acute gastroenteritis; There is scholar's research to show that Rhizoma Coptidis can improve high fat diet rat insulin opposing, makes that liver glycogen is synthetic to be increased; Clinical report is used berberine treatment diabetes separately has significant difference before the treatment; Berberine not only has significant hypoglycemic activity, and to diabetics with complication hypertension, hyperlipidemia, thrombosis etc. good preventive and therapeutic effect, clinical practice safety are arranged.
Vitamin B group participates in body internal protein, fat and sugar metabolism, makes the excitement of brain cell and inhibition be in poised state, and it comprises vitamin B
1, vitamin B
2, nicotiamide, pantothenic acid, biotin, vitamin B
6, vitamin B
12, folic acid etc., collaborative in vivo performance physiological action.Vitamin B
1Participate in body internal protein, fat, breakdown of carbohydrates metabolism and anabolism, can show vitamin B1 deficiency during shortage is the various dysbolismus of representative, vitamin B in addition
1Also participate in the neural impulse reaction, keep myocardium normal function, keep normal appetite, gastrointestinal peristalsis and digestive juice secretion etc.; Vitamin B
2Have another name called riboflavin, it is the ingredient of many important coenzyme in the body, participate in intravital substance metabolism, guarantee that vivo oxidation reduction reaction and energy generate, participate in anti-oxidative defense system in the body, mainly show oral cavity reproductive system syndrome, retardation of growth, iron deficiency anemia, moisture dermatitis, minimizing erythropoiesis, the systemic-function that affects the nerves, the vision etc. that reduces during shortage; Nicotiamide claims niacin amide or vitamin PP again, and its physiological function is to participate in the body intracellular metabolic, keeps normal neurological function, and pellagra can take place during shortage in synthesizing of assurance gonadal hormone etc., mainly shows as dermatitis, diarrhoea, dull-witted three big symptoms; Pantothenic acid extensively exists in each organism, participates in metabolic activity widely, and known have 70 plurality of enzymes all to need pantothenic acid to participate in all kinds of biochemical reaction of catalysis body, otherwise just can Metabolic disorder; Biotin also is a kind of vitamin B group, coordinates to participate in the metabolism of human body matter and energy with other vitamin B group, and it is synthetic with nucleic acid, and the compositive relation of gonadal hormone is close, and it also has control poliosis, bareheaded effect; Vitamin B
6Play the coenzyme effect of transaminase, amino acid decarboxylases in vivo, guarantee the metabolism of materials such as aminoacid, glycogen, fatty acid and one carbon unit, nicotinic acid, guarantee the normal propagation of nucleic acid and proteinic synthetic and cell, guarantee homergy with neurotransmitteies such as a hydroxytryptamine, taurine, dopamine, guarantee normal immunologic function, immunity degradation during shortage also can cause neural infringement; Vitamin B
12Participate in nucleic acid in vivo, choline, amino acid whose synthetic and fat and sugared metabolism, to hemopoietic function of bone marrow, the gastrointestinal epithelial cells function, liver function and nervous system myelin functional integrity have certain effect, it is the necessary vitamin of intelligence of bringing into normal play, not only cause dysnoesia if lack, also nutritional anemia can occur, influence is to blood supply in the brain; Folic acid participates in the synthetic of aminoacid and nucleic acid, and and vitamin B
12The common generation that promotes cell is with ripe, and normal cell can not carry out mitosis during shortage, the neurological symptom can occur, as: the loss of memory, depression and dementia etc.;
Vitamin E is all general designations with the bioactive chromone derivative of alpha-tocopherol, and wherein the activity of alpha-tocopherol is the highest, has antioxidation, avoids the effect of biomembrane generation lipid peroxidation; Stop the effect of LDL oxidation formation, thereby prevent the generation of atherosclerosis and cardiovascular disease; Also have to regulate immunity, slow down aging, inhibition tumor in addition, promote fetal development and reproductive performance to reach the protective effect of nerve and skeleton etc.
Trace element zinc is merged in the biomacromolecule ligand---in protein, nucleic acid, the film (being mainly memebrane protein), generate stable metallic biomacromolecule complex---metalloprotein, metalloproteinase nucleic acid complex etc., at present, known these materials participate in the synthetic and degradation process of carbohydrate, lipid, protein and nucleic acid, and the existence of zinc enzyme is all arranged in six big fermentoids; Zinc also is the essential element of enhance immunity vigor; Zinc can promote that proinsulin is converted into insulin by activating protaminase, and zinc deficiency makes insulin be obstructed in the activity of peripheral tissues, and it is unusual to cause glucose tolerance curve.
Trace element-selenium has obvious reduction serum total cholesterol, triglyceride and lipid peroxide, improves high density lipoprotein, the metabolic effect of superabundant fats in the acceleration bodies; Selenium also has the strong anti-oxidation function, but prevention of cardiac; Anticancer by enhance immunity recognition system removing cancerous cell; Remove and the drainage heavy metal ion, hydrargyrum, methyl mercury, cadmium, lead etc. are had Detoxication; Scarce selenium can make the human insulin secretion reduce, impaired glucose tolerance, and oxidation resistance descends and quickens human senility and intelligence decline.
Chromium is insulin " collaborative hormone ", to have the effect of active organochromium compounds " glucose tolerance factor (GTF) " form enhancing insulin, mainly be to keep normal carbohydrate metabolism of body and lipid metabolism, following symptom can occur when not enough: weaken glucose tolerance, increase the weight of hyperglycemia, glucose in urine, hypoglycemia, the circulation of acceleration insulin, reduce Insulin receptor INSR quantity, reduce the insulin binding ability, lose weight, increase fat content, increase vision pressure etc.The chromium of two kinds of valence states of stable existence in the environment, i.e. trivalent chromium and Cr VI, trivalent chromium has physiologically active, uses useful and harmlessly in an amount of scope, and Cr VI is a kind of strong oxidizer, and human body is had toxic and side effects.
Molybdenum is one of micro elements needed by human, and it is the formation element of plurality of enzymes, can help the metabolism of carbohydrate and fat, it participates in removing the murder by poisoning of poisonous aldehydes in the human body, eliminate human free radical, have anticancer, defying age, enhancing immunity and anticariogenic function; Scarce molybdenum can bring out cardiovascular disease, cancer and dental caries.
Application contains berberine, vitamin B
1, vitamin B
2, vitamin B
6, nicotiamide, pantothenic acid, biotin, vitamin B
12, folic acid, vitamin E and trace element zinc, selenium, chromium, molybdenum be known as the compositions of active component, but with berberine, vitamin B
1, vitamin B
2, nicotiamide, pantothenic acid, biotin, vitamin B
6, vitamin B
12, folic acid, vitamin E and trace element zinc, selenium, chromium, the molybdenum compatibility pharmaceutical composition report as yet that is used for blood sugar lowering and blood fat.
Current medicine that is used for blood sugar lowering and blood fat or health product kind have multiple, but the medicine class of toxic side effect is a lot, and the few link shortcoming of health food target spot needs perfectly, and cost and price are all very high.
Summary of the invention: in order to overcome the shortcoming and defect of existing blood sugar lowering and hypolipidemic medicine, the purpose of this invention is to provide a kind of compositions, said composition increases vitamin B by berberine
1, vitamin B
2, vitamin B
6, nicotiamide, pantothenic acid, biotin, vitamin B
12, folic acid, vitamin E and trace element zinc, selenium, chromium, molybdenum blood sugar lowering and blood fat effect, simultaneously by trace element zinc, selenium, chromium, molybdenum and vitamin B
1, vitamin B
2, nicotiamide, pantothenic acid, biotin, vitamin B
6, vitamin B
12, folic acid, vitamin E, replenish and strengthen the effect that berberine suppresses blood sugar increasing and blood middle cholesterol content, even chronic administration is also without any side effect; Because the result of broad research, the inventor has found berberine, vitamin B
1, vitamin B
2, nicotiamide, pantothenic acid, biotin, vitamin B
6, vitamin B
12, folic acid, vitamin E and and trace element zinc, selenium, chromium, molybdenic novel combination, this novel combination has synergy for blood sugar lowering and blood fat; And single with berberine, compound vitamin B, vitamin E and trace element zinc, selenium, chromium, molybdenum, its effect is all not as good as this compositions; There is not incompatibility in this compositions, have no side effect, and cost is low, thereby constitutes the present invention.
The invention provides the pharmaceutical composition that is used for blood sugar lowering and blood fat, it comprises berberine, vitamin B as active component
1, vitamin B
2, nicotiamide, pantothenic acid, biotin, vitamin B
6, vitamin B
12, folic acid, vitamin E and trace element zinc, selenium, chromium, molybdenum.
Rhizoma Coptidis have professional production factory and supplier.
Be used for vitamin B of the present invention
1(VitaminB
1), vitamin B
2(VitaminB
2), nicotiamide (Nicotinamide), pantothenic acid (Pantothenic Acid), biotin (Vitamin H), vitamin B
6(VitaminB
6), vitamin B
12(VitaminB
12), folic acid (Folic Acid), all are water soluble vitamins, do not accumulate in vivo; Vitamin E (Vitamin E) is a fatsoluble vitamin, and is useful and harmless by the used dosage of the present invention; Zinc (Zn), selenium (Se), chromium (Cr), molybdenum (Mo) are micro elements needed by human; Trace element zinc among the present invention can be selected zinc citrate, zinc acetate, zinc carbonate, zinc oxide, zinc chloride, zinc lactate, zinc sulfate, zinc gluconate, single zinc methionine etc. for use, trace element-selenium can be selected Selenomethionine, methoxybenzyl cyanic acid selenium, the two cyanic acid selenium of phenylene, selenocarrageenan, selenocysteine, selenizing methionine, sodium selenite, sodium selenate etc. for use, trace element chromium selects for use trivalent chromium as chromium trichloride, nicotinic acid chromium, chromium picolinate, chromium yeast etc., trace element molybdenum can be selected ammonium molybdate, sodium molybdate etc. for use, and professional production factory and supplier are all arranged.
Compositions of the present invention mainly is applicable to hyperglycemia and people with hyperlipidemia, and by the present invention, the effective dose of berberine is 600-1500mg/ days concerning the adult, vitamin B
1Effective dose be 0.5-20mg/ days, vitamin B
2Effective dose be 0.5-20mg/ days, the effective dose of nicotiamide is 5-50mg/ days, the effective dose of pantothenic acid is 2-20mg/ days, the effective dose of biotin is 0.01-0.1mg/ days, vitamin B
6Effective dose be 0.5-10mg/ days, vitamin B
12Effective dose be 0.001-0.025mg/ days, the effective dose of folic acid is 0.1-1mg/ days, the effective dose of vitamin E (in the alpha-tocopherol equivalent) is 5-150mg α-TE/ days, the effective dose of trace element zinc is counted 5-20mg/ days with element zinc, selenic effective dose is counted 0.015-0.1mg/ days with elemental selenium, the effective dose of chromium is counted 0.015-0.15mg/ days with elemental chromium, and molybdenic effective dose is counted 0.02-0.06mg/ days with molybdenum.
Compositions of the present invention can or directly be taken by following pharmaceutical dosage forms dispenser, for example, oral formulations is (as granule, powder, capsule, ball, sheet, dry syrup, liquid formulation), or food such as food (as cookies), mix and prepare with other known additives, this class additive is for example: carrier, disintegrating agent, slow releasing agent, excipient, filler, covering, binding agent, lubricant, antioxidant, apply agent, coloring agent, correctives, sweeting agent, sucrose succedaneum, nutrition enhancer, flavouring agent, surfactant, plasticizer, the PH regulator, freshener, suspending agent, defoamer, antiseptic, thickening agent, solubilisation aids etc. are prepared or they are added food as functional component or additive by usual way.
By the present invention, berberine, vitamin B
1, vitamin B
2, nicotiamide, pantothenic acid, biotin, vitamin B
6, vitamin B
12, folic acid, vitamin E and trace element zinc, selenium, chromium, molybdenum each component can distinguish preparation, the preparation of each component can be mixed the back when using and use or do not mix simultaneously and use.
Advantage of the present invention is the effect of this compositions from too many levels collaborative performance blood sugar lowering and blood fat, and blood sugar lowering and blood fat are had significant effect, sufficient raw, and cost is low, and each component has no side effect in the compositions, no incompatibility.
Subordinate list 1 causes diabetic mice blood sugar lowering test effect relatively for this compositions and berberine component and vitamin added elements component to alloxan.
Subordinate list 2 causes diabetes model rat blood fat reducing test effect relatively for this compositions and berberine component and vitamin added elements component to (STZ).
Relatively tabulate below with reference to embodiment and test implementation example effect and to be described in detail the present invention.
Embodiment 1:
Berberine 650mg,
Vitamin B
13mg,
Vitamin B
23mg,
Vitamin B
62mg,
Vitamin B
120.003mg,
Folic acid 0.3mg,
Zinc lactate (in trace element zinc) 10mg,
Sodium selenate (in trace element-selenium) 0.02mg,
Nicotinic acid chromium (in trace element chromium) 0.1mg,
Vitamin E (in the alpha-tocopherol equivalent) 10mg α-TE.
Said components is further mixed equably with the additive of appropriate amount such as aluminosilicate magnesium, poly-solvate 60 and propylene glycol, the gained mixture is inserted capsule equably and 9 capsules, every day 3 times, each 3 capsules.
Embodiment 2:
Berberine 700mg,
Vitamin B
13mg,
Vitamin B
23mg,
Vitamin B
62mg,
Vitamin B
120.003mg,
Folic acid 0.3mg,
Nicotiamide 10mg,
Zinc lactate (in trace element zinc) 8mg,
Sodium selenate (in trace element-selenium) 0.02mg,
Chromium yeast (in trace element chromium) 0.02mg,
Vitamin E (in the alpha-tocopherol equivalent) 10mg α-TE.
Said components is further mixed equably with the additive of appropriate amount such as aluminosilicate magnesium, poly-solvate 60 and propylene glycol, the gained mixture is inserted capsule equably and 9 capsules, every day 3 times, each 3 capsules.
Embodiment 3:
Berberine 800mg,
Vitamin B
13mg,
Vitamin B
23mg,
Vitamin B
62mg,
Vitamin B
120.003mg,
Folic acid 0.3mg,
Nicotiamide 10mg,
Zinc lactate (in trace element zinc) 10mg,
Sodium selenate (in trace element-selenium) 0.02mg,
Chromium yeast (in trace element chromium) 0.02mg,
Sodium molybdate (in trace element molybdenum) 0.03mg,
Vitamin E (in the alpha-tocopherol equivalent) 10mg α-TE.
Said components is further mixed equably with the additive of appropriate amount such as aluminosilicate magnesium, poly-solvate 60 and propylene glycol, the gained mixture is inserted capsule equably and 9 capsules, every day 3 times, each 3 capsules.
Embodiment 4:
Berberine 1000mg,
Vitamin B
13mg,
Vitamin B
23mg,
Vitamin B
62mg,
Vitamin B
120.003mg,
Folic acid 0.3mg,
Nicotiamide 10mg,
Biotin 0.01-0.1mg,
Zinc lactate (in trace element zinc) 10mg,
Sodium selenate (in trace element-selenium) 0.02mg,
Chromium yeast (in trace element chromium) 0.02mg,
Sodium molybdate (in trace element molybdenum) 0.03mg,
Vitamin E (in the alpha-tocopherol equivalent) 10mg α-TE.
Above-mentioned component is further mixed equably with additive such as mannitol, hydroxypropyl cellulose, aluminosilicate magnesium and the flavoring agent of appropriate amount, again the gained mixture is made 3 bag shot-like particles; Obey every day 3 times, obey a bag at every turn.
Embodiment 5:
Berberine 600mg,
Vitamin B
10.5mg,
Vitamin B
20.5mg,
Vitamin B
60.5mg,
Vitamin B
120.001mg,
Folic acid 0.1mg,
Nicotiamide 5mg,
Pantothenic acid 2mg,
Biotin 0.01mg,
Zinc lactate (in trace element zinc) 5mg,
Sodium selenate (in trace element-selenium) 0.015mg,
Chromium yeast (in trace element chromium) 0.015mg,
Sodium molybdate (in trace element molybdenum) 0.02mg,
Vitamin E (in the alpha-tocopherol equivalent) 5mg α-TE.
Above-mentioned component is further mixed equably with additive such as mannitol, hydroxypropyl cellulose, aluminosilicate magnesium and the flavoring agent of appropriate amount, again the gained mixture is made 3 bag shot-like particles; Obey every day 3 times, obey a bag at every turn.
Embodiment 6:
Berberine 1500mg,
Vitamin B
11mg,
Vitamin B
210mg,
Vitamin B
60.025mg,
Vitamin B
1220mg,
Folic acid 20mg,
Nicotiamide 50mg,
Pantothenic acid 20mg,
Biotin 0.1mg,
Zinc lactate (in trace element zinc) 20mg,
Sodium selenate (in trace element-selenium) 0.1mg,
Chromium yeast (in trace element chromium) 0.15mg,
Sodium molybdate (in trace element molybdenum) 0.06mg,
Vitamin E (in the alpha-tocopherol equivalent) 150mg α-TE.
Above-mentioned component is further mixed equably with additive such as mannitol, hydroxypropyl cellulose, aluminosilicate magnesium and the flavoring agent of appropriate amount, again the gained mixture is made 3 bag shot-like particles; Obey every day 3 times, obey a bag at every turn, serve on 10, withdrew 5, obeyed again 10.
Confirm that through animal experiment this compositions belongs to nontoxic level; The crowd takes and does not also see toxicity.
Embodiment 7:
Select 60 of Kunming mouses, male female half and half; Wherein 48 mices are male female half and half, and fasting is after 16 hours, tail vein injection alloxan 70mg/kg
-1After 72 hours, measure fasting blood sugar, blood glucose value is higher than 16.7mmolL
-1The person is the hyperglycemia mice, according to blood sugar level the hyperglycemia mice is divided into 4 groups: model control group (B group), and the C group, the D group, the E group, each group of test is pressed 0.2mL10g
-1Continuous 10 days of body weight gastric infusion, fasting in the 10th day gastric infusion after 7 hours is measured after the administration 1 hour with method, 2 hours blood glucose value; 12 remaining mices, as normal control group (A group), model control group and normal control group irritate stomach once for the equal-volume normal saline every day.
Related data sees attached list 1.
Subordinate list 1: this compositions causes diabetic mice blood sugar lowering test effect relatively with berberine component and vitamin added elements component to alloxan:
Embodiment 8:
Selecting SD is 48 feeds of male rat high lipid food, press an intraperitoneal injection STZ of 25mg/kg body weight (streptozotocin) after raising for 4 weeks, fasting is after 8 hours after 2 weeks, gavage the 20%D-glucose solution by the 2g/kg body weight, do the oral glucose tolerance test, all 0 and 2 hour blood glucose is respectively greater than 7.0 and the rat of 11.0mmol/L, as diabetes modeling success rat, modeling success rat is divided into 4 groups at random, every group 12, be respectively the A group, the B group, the C group, D group, test are respectively organized distilled water suspension oral gavage that every day, per os gave checking matter and equivalent once, and matched group gives the equivalent normal saline and irritate stomach once every day, in administration 12 week back fasting on the 3rd 10 hours, the carotid artery blood sampling is measured T-CHOL respectively, triglyceride, high density lipoprotein, three indexs.
Related data sees attached list 2.
Subordinate list 2: this compositions causes diabetes model rat blood fat reducing test effect relatively with berberine component and vitamin added elements component to (STZ):
From table 1, can obviously find out, take this composite preparation and take berberine component and vitamin added elements component contrast diabetic mice blood sugar lowering test effect the difference of highly significant is arranged.
From table 2, can obviously find out, take this composite preparation and take berberine component and vitamin added elements component contrast high blood lipid model rat blood fat reducing test effect the difference of highly significant is arranged.
Claims (5)
1, a kind of pharmaceutical composition that is used for blood sugar lowering and blood fat is characterized in that, it is pressed column weight amount proportioning by following bulk drugs and makes:
Berberine 600-1500mg,
Vitamin B
10.5-20mg,
Vitamin B
20.5-20mg,
Vitamin B
60.5-10mg,
Vitamin B
120.001-0.025mg,
Folic acid 0.1-1mg,
Nicotiamide 0-50mg,
Pantothenic acid 0-20mg,
Biotin 0-0.1mg,
Zinc 5-20mg,
Selenium 0.015-0.1mg,
Chromium 0.015-0.15mg,
Molybdenum 0-0.06mg,
Vitamin E 5-150mg a-TE.
2, the pharmaceutical composition that is used for blood sugar lowering and blood fat according to claim 1 is characterized in that, it is pressed column weight amount proportioning by following bulk drugs and makes:
Berberine 600-1500mg,
Vitamin B
10.5-20mg,
Vitamin B
20.5-20mg,
Vitamin B
60.5-10mg,
Vitamin B
120.001-0.025mg,
Folic acid 0.1-1mg,
Nicotiamide 5-50mg,
Pantothenic acid 0-20mg,
Biotin 0-0.1mg,
Zinc 5-20mg,
Selenium 0.015-0.1mg,
Chromium 0.015-0.15mg,
Molybdenum 0-0.06mg,
Vitamin E 5-150mg a-TE.
3, the pharmaceutical composition that is used for blood sugar lowering and blood fat according to claim 1 is characterized in that, it is pressed column weight amount proportioning by following bulk drugs and makes:
Berberine 600-1500mg,
Vitamin B
10.5-20mg,
Vitamin B
20.5-20mg,
Vitamin B
60.5-10mg,
Vitamin B
120.001-0.025mg,
Folic acid 0.1-1mg,
Nicotiamide 5-50mg,
Pantothenic acid 0-20mg,
Biotin 0-0.1mg,
Zinc 5-20mg,
Selenium 0.015-0.1mg,
Chromium 0.015-0.15mg,
Molybdenum 0.02-0.06mg,
Vitamin E 5-150mg a-TE.
4, the pharmaceutical composition that is used for blood sugar lowering and blood fat according to claim 1 is characterized in that, it is pressed column weight amount proportioning by following bulk drugs and makes:
Berberine 600-1500mg,
Vitamin B
10.5-20mg,
Vitamin B
20.5-20mg,
Vitamin B
60.5-10mg,
Vitamin B
120.001-0.025mg,
Folic acid 0.1-1mg,
Nicotiamide 5-50mg,
Pantothenic acid 0-20mg,
Biotin 0.01-0.1mg,
Zinc 5-20mg,
Selenium 0.015-0.1mg,
Chromium 0.015-0.15mg,
Molybdenum 0.02-0.06mg,
Vitamin E 5-150mg a-TE.
5, the pharmaceutical composition that is used for blood sugar lowering and blood fat according to claim 1 is characterized in that, it is pressed column weight amount proportioning by following bulk drugs and makes:
Berberine 600-1500mg,
Vitamin B
10.5-20mg,
Vitamin B
20.5-20mg,
Vitamin B
60.5-10mg,
Vitamin B
120.001-0.025mg,
Folic acid 0.1-1mg,
Nicotiamide 5-50mg,
Pantothenic acid 2-20mg,
Biotin 0.01-0.1mg,
Zinc 5-20mg,
Selenium 0.015-0.1mg,
Chromium 0.015-0.15mg,
Molybdenum 0.02-0.06mg,
Vitamin E 5-150mg a-TE.
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