CN100577158C - Method for preparing Tengchasu dispersibletablet and its use - Google Patents
Method for preparing Tengchasu dispersibletablet and its use Download PDFInfo
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- CN100577158C CN100577158C CN200610018462A CN200610018462A CN100577158C CN 100577158 C CN100577158 C CN 100577158C CN 200610018462 A CN200610018462 A CN 200610018462A CN 200610018462 A CN200610018462 A CN 200610018462A CN 100577158 C CN100577158 C CN 100577158C
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Abstract
The present invention relates to a preparation method of tengchasu dispersion tablet and its application. Said tengchasu dispersion tablet can be used for making health-care food and medicine for preventing and curing the diseases of hyperglycemia, hyperlipemia, angiocardiopathy and cerebrovascular diseases. Its main effective component includes dihydromyricetin 5-95% and myricetin 95-5%. Besides, said invention also provides the concrete steps of its preparation method.
Description
Technical field
The present invention relates to a kind of is the health food or the pharmaceutical preparation that are used for the treatment of or prevent hyperlipidemia, hyperglycemia and thromboembolia type cardiovascular and cerebrovascular disease that primary raw material is made with the Chinese herbal medicine extract, but is a kind of Preparation method and use that contains the bite-dispersion tablets of Ampelopsis grossedentata extractive of general flavone specifically.
Background technology
Main active in the Ampelopsis grossedentata is the flavonols composition, be mainly two hydrogen myricetins (dihydromyricetin) and myricetin (myricetin), pharmacodynamic study proof Ampelopsis grossedentata total flavones and two hydrogen myricetin and myricetin have significant hypoglycemic activity to four kinds of experimental diabetic animal models, and multiple biological activitys such as blood fat reducing, antithrombotic, antioxidation and hepatoprotective are arranged, toxicologic study proof Ampelopsis grossedentata total flavones toxicity is very little.We once made the Ampelopsis grossedentata extractive of general flavone agent of Ampelopsis grossedentata cellulose capsule and were used for the clinical principium test, but the water solublity of finding two hydrogen myricetins of Ampelopsis grossedentata total flavones and main active thereof and myricetin under study for action is very little, oral administration biaavailability is lower, and clinical effectiveness is not good; Bite-dispersion tablets then has taking convenience, absorb fast, the bioavailability height, untoward reaction is few, the oral characteristics such as dispersion of dissolving rapidly after chewing can overcome above shortcoming.
Summary of the invention
The purpose of this invention is to provide and a kind ofly can improve the principal agent dissolubility, absorb fast, the bioavailability height, helping human body effectively, promptly absorbs, simultaneously for the patient of some hard thing that is difficult to swallow, can after chewing, make medicine dissolve dispersion rapidly, be easy to take and the plain bite-dispersion tablets dosage form of Ampelopsis grossedentata of preparation stabilization, can be used as the health food or the drug use of treatment or prevention hyperlipidemia, hyperglycemia and thromboembolia type cardiovascular and cerebrovascular disease.
But the plain dispersible tablet of Ampelopsis grossedentata of the present invention is a kind of bite-dispersion tablets dosage form that contains the Ampelopsis grossedentata extract, can be plain sheet or the thin film of one deck routine is arranged, contain the plain principal agent composition of Ampelopsis grossedentata and tablet formulation additive commonly used and water soluble adjuvants such as mannitol, xylitol or Sorbitol.Single dose is that to contain the plain total amount of principal agent composition Ampelopsis grossedentata in the every dispersible tablet be 60～1000mg, and wherein the plain principal agent composition of Ampelopsis grossedentata mainly contains two hydrogen myricetins and myricetin for extract refining obtaining from Ampelopsis grossedentata, and its molecular formula is respectively C
15H
12O
8And C
15H
10O
8, structural formula is respectively following (I) and (II):
Its technical characterictic is to be raw material with the Ampelopsis grossedentata, according to the medicinal purpose of difference, at first extracting and obtaining containing two hydrogen myricetins is 5-95%, myricetin is the Ampelopsis grossedentata extract of 95-5%, the special adjuvant such as the crospolyvinylpyrrolidone that add dispersible tablet then, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, pregelatinized Starch, microcrystalline Cellulose, disintegrating agent and mannitol such as sodium lauryl sulphate, water soluble adjuvant such as xylitol or Sorbitol, in, add and combine, and adopt cohesive preferably 30 POVIDONE K 30 BP/USP 30 make binding agent and granulate, and then add micropowder silica gel, essence etc. are made.More than cited be some excipient and adjuvants pharmaceutically commonly used, but should not be construed as limitation of the present invention.
Preparation method of the present invention is:
(1) the plain extraction process of Ampelopsis grossedentata
The extraction of Ampelopsis grossedentata element can have two kinds of methods:
Technology 1: get the Ampelopsis grossedentata that cooks, add 8-12 and doubly measure 50% ethanol water, reflux, extract, 2-3 time is extracted used ethanol one water ratio and be can be 10%～95%, filters, merge extractive liquid,, boil, under the pH6-8 condition, be concentrated to and be equivalent to medical material 4-7 and doubly measure volume, place crystallize, crystallization is through the alcohol-water recrystallization, makes that to contain two hydrogen myricetins be that 70-95%, myricetin are the Ampelopsis grossedentata extractive of general flavone of 5-30%.
Technology 2: get the Ampelopsis grossedentata that cooks, add 8-12 times of water gaging, decoct 2-3 time, merge extractive liquid, boils, and is concentrated to be equivalent to medical material 3-7 and doubly to measure volume under pH 6-8 condition, place crystallize, crystallization is through the alcohol-water recrystallization, makes that to contain two hydrogen myricetins be 5-70%, and myricetin is a 30-95% Ampelopsis grossedentata extractive of general flavone.
(2) weight of raw material is formed (g/g):
Prescription 1: Ampelopsis grossedentata extract 40-70%, crospolyvinylpyrrolidone 5-12%, pregelatinized Starch 10-36%, microcrystalline Cellulose 5-18%, 30 POVIDONE K 30 BP/USP 301-8%, xylitol 5-10%, mannitol 1-5%, micropowder silica gel 1-5%, sodium lauryl sulphate 0.1-3%, fruit essence 0.1-1%;
Prescription 2: Ampelopsis grossedentata extract 40-70%, carboxymethyl starch sodium 1-8%, low-substituted hydroxypropyl cellulose 1-8%, pregelatinized Starch 10-30%, Sorbitol 5-8%, mannitol 1-5%, microcrystalline Cellulose 5-18%, 30 POVIDONE K 30 BP/USP 30 1-8%, micropowder silica gel 1-5%, sodium lauryl sulphate 0.1-3%, fruit essence 0.1-1%.
(3) the adding method of crospolyvinylpyrrolidone, pregelatinized Starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose and microcrystalline Cellulose is in the technology: in add 90-10%, add 10-90%; The best adds 60% in being, adds as 40% outward.
(4) the adding method of 30 POVIDONE K 30 BP/USP 30 and sodium lauryl sulphate is in the technology: earlier 30 POVIDONE K 30 BP/USP 30 is made into the aqueous solution of 10%-15%, then sodium lauryl sulphate is dissolved in the aqueous solution of 30 POVIDONE K 30 BP/USP 30, together join in the solid powder during granulation; Also sodium lauryl sulphate can be dissolved with suitable quantity of water, be injected to during granulate in the granule;
(5) the adding method of mannitol, xylitol or Sorbitol is in the technology: in add;
(6) the adding method of micropowder silica gel in the technology, fruit essence is: add;
(7) particulate baking temperature is 50-80 ℃ in the wet-granulation process, 1-5 hour.The best is 60 ℃, 3 hours.
But the advantage of Ampelopsis grossedentata element bite-dispersion tablets dosage form of the present invention is that production cost is low, operation is fast, is easy to oral administration (do not need water, chew disintegrate fast in the oral cavity), and can improve its principal agent dissolubility, can form even viscosity suspension rapidly and be dispersed into fine particle, the medicine distribution area is increased, absorption point increases, and avoids conventional tablet and capsule too high in the gastrointestinal tract local drug concentration, shortcomings such as stimulating gastrointestinal mucosa, reduce untoward reaction, improve patient adaptability.Also have taking convenience simultaneously, absorb characteristics such as fast, bioavailability height, make things convenient for old man and child patient to take especially.According to different principal agent compositions and content, can be made into the health food or the medicine that 1. are used for the treatment of or prevent hyperlipidemia, hyperglycemia, 2. be used for the treatment of or prevent the health food or the medicine of thromboembolia type cardio-cerebrovascular disorder.
The present invention is as follows to the relevant pharmacodynamic experiment result that the Ampelopsis grossedentata element carries out:
(1) the Ampelopsis grossedentata element is to the influence experiment of alloxan diabetes mice
Get normal mouse tail vein injection alloxan (85mg/kg), predict serum level of glucose behind the 72h, select for use blood glucose value to study the above person of 16mmol/L.Then, mice is divided into the normal control group, the alloxan group, metformin (0.15g/kg) group, plain big small dose group (0.25g/kg and the 0.125g/kg) group of Ampelopsis grossedentata, every day gastric infusion once, matched group and alloxan group give the equal-volume distilled water, continuously 7d.1h measures blood sugar level after the last administration, the results are shown in Table 1.The Ampelopsis grossedentata element can obviously reduce the alloxan diabetes mouse blood sugar, and its heavy dose (250mg/kg) group blood sugar reducing function is similar to the effect of 150mg/kg metformin.
Table 1 Ampelopsis grossedentata element is to the influence of alloxan diabetes mice (X ± S)
Compare * P＜0.05 with the alloxan group
(2) the Ampelopsis grossedentata element is to the influence experiment of adrenal gland's disposition hyperglycemia model mice
Get 50 of mices, be divided into matched group at random, epinephrine group, the plain large and small dosage of glyburide (2.5mg/kg) group and Ampelopsis grossedentata (0.25g/kg and 0.125g/kg) group. every day gastric infusion once, continuous 7d.1h after the last administration, normal control group intraperitoneal injection of saline, all the other respectively organize equal lumbar injection epinephrine (240 μ g/kg).Respectively at injection back 0.5 and 1.0h,, the results are shown in Table 2 from mouse orbit venous plexus measuring blood sugar of blood extracting content.As seen the plain large and small dosage group of Ampelopsis grossedentata all has when 1.0h obviously to adrenolytic blood glucose increasing effect.
Table 2 Ampelopsis grossedentata element causes the influence of hyperglycemia mouse blood sugar to epinephrine
Compare * P＜0.05 with the epinephrine group
(3) the influence experiment of Ampelopsis grossedentata element hyperglycemia model mouse blood sugar that glucose is caused
Get 50 of mices, be divided into matched group at random, glucose group, glyburide (2.5mg/kg) group and the plain large and small dosage of Ampelopsis grossedentata (0.25g/kg and 0.125g/kg) group.Matched group and glucose group give the equal-volume distilled water, medicine or distilled water gastric infusion every day once, continuous 7d.1.0h after the last administration, matched group i.p equal-volume normal saline, all the other respectively organize i.p glucose (2g/kg) solution, respectively behind the i.p glucose 0.5,1.0 and 2h after, from mouse orbit venous plexus measuring blood sugar of blood extracting value.The results are shown in Table 3.The Ampelopsis grossedentata element to 0.5 and the 1.0h blood sugar increasing have obvious inhibitory action.
Table 3 Ampelopsis grossedentata element causes the influence (n=10) of hyperglycemia mouse blood sugar to glucose
Compare * * P＜0.01, * P＜0.05 with glucose group
(4) the Ampelopsis grossedentata element is to the influence of rats in vitro platelet aggregation
Get 32 rats, under etherization abdominal aortic blood is rich in platelet blood plasma (PRP) and platelet poor plasma (PPP) by the well-established law preparation.Raise 100% amplitude with PPP in platelet aggregation instrument, transfer 0% with PRP.(platelet count is in (35 ± 5) * 10 accurately to draw 300ulPRP
4Between), control tube adds 20 μ l0.2mol/L phosphate buffers, and medication tube adds the Ampelopsis grossedentata element or the Radix Salviae Miltiorrhizae Injection of 20ul variable concentrations.Behind 37 ℃ of pre-temperature 3min, add 20 μ l ADP (2 μ mol/L) and do the aggregation inducing agent, trace curve of platelet aggregation, measure curve decline millimeter, comparative drug group and matched group anticoagulant percentage rate the results are shown in Table 4.Plain big small dose group of Ampelopsis grossedentata and Radix Salviae Miltiorrhizae Injection all can suppress the inductive rat platelet aggregation of ADP significantly, point out it that antiplatelet aggregative activity is arranged.
The plain influence (n=8) of table 4 Ampelopsis grossedentata to rat platelet aggregation
Compare * * * P＜0.001 with matched group
(5) the Ampelopsis grossedentata element is to the effect of rat thrombus in vivo formation
Get 32 of SD rats, be divided into 4 groups.Press listed medicine of table 2 and dosage ig administration, once a day, continuous 14d, 1h after the last administration presses literature method
[5], in advance rat is anaesthetized with pentobarbital sodium (30mg/kg), form the platelet thrombus model with external common carotid artery one external jugular vein blood flow bypass, the open blood flow of back 5min is finished in operation, Herba Clinopodii in behind the 15min takes out silk thread and weighs, and gross weight deducts silk thread weight and is wet weight of thrombus.Compare with matched group, calculate its thrombosis suppression ratio, the results are shown in Table 5.Plain heavy dose of group of Ampelopsis grossedentata and FUFANG DANSHEN PIAN can obviously suppress rat suppository and form, and small dose group also has certain inhibitory action.
The influence that table 5 Ampelopsis grossedentata element forms rat suppository
Compare * * * P＜0.001 with matched group
(6) the Ampelopsis grossedentata element is to the influence of hyperlipemia model mice blood fat
Get 50 of mices, be divided into 5 groups at random.Press listed medicine of table 6 and dosage ig administration, once a day, continuous 10d.After the every morning medication, afternoon, all the other only all gave high lipoprotein emulsion 0.5ml/, cause experimental hyperlipidemia except that matched group.Overnight fasting after the 10d administration, get blood, separation of serum from mice vena orbitalis posterior clump morning next day.Press enzyme process and detect serum total cholesterol (TC), triglyceride (TG), HDL-C (HDL-C) and blood glucose (BG) content the results are shown in 6.The Ampelopsis grossedentata element can make hyperlipemia model mice serum TC, TG content and BG level reduce, and shows its tangible effect for reducing fat, and its action intensity is similar to the positive control drug clofibrate.
Table 6 Ampelopsis grossedentata element is to the influence of hyperlipemia in mice TC, TG and BG (n=10, x ± SD)
Compare with matched group
△ △ △* P＜0.05, * * P＜0.01 are compared with model group in P＜0.001.
The specific embodiment
Embodiment 1: be used for the treatment of or prevent the preparation of the plain dispersible tablet of Ampelopsis grossedentata of hyperlipidemia, hyperglycemia.
Get the Ampelopsis grossedentata 3000g that cooks, add 12 times of amount 50% ethanol waters, reflux, extract, 3 times, filter, merge extractive liquid, boils, and is concentrated to be equivalent to 5 times of amounts of medical material volume under pH 6-8 condition, place crystallize, crystallization gets promptly through the alcohol-water recrystallization that to contain two hydrogen myricetins be that 70-95%, myricetin are the Ampelopsis grossedentata extractive of general flavone of 5-30%.
By 1000 calculating that feed intake of preparation, take by weighing said extracted thing 230g, microcrystalline Cellulose 75g, crospolyvinylpyrrolidone 48g, 30 POVIDONE K 30 BP/USP 3018g, micropowder silica gel 6g, xylitol 40g, mannitol 11g, pregelatinized Starch 105g, sodium lauryl sulphate 5g, essence 2g.With powder mixings such as the microcrystalline Cellulose of the crospolyvinylpyrrolidone of extract and prescription amount 90-10%, prescription amount 90-10%, prescription amount 90-10% pregelatinized Starch, xylitol, mannitol, cross 100 mesh sieves; Then 30 POVIDONE K 30 BP/USP 30 is made into the aqueous solution of 10%-15%, and sodium lauryl sulphate is dissolved in the aqueous solution of 30 POVIDONE K 30 BP/USP 30, spray in the above-mentioned powder and stir, make granule, back to be dried granulate, the crospolyvinylpyrrolidone that adding another part need add, microcrystalline Cellulose, pregelatinized Starch, micropowder silica gel, essence etc. and granule mixing are used tablet machine compression moulding, quality inspection, packing; Or in suitable device to the continuous spray webbing material of tablet (contain conventional the coating substance that contains polymer), to coating qualified till, quality inspection, packing, promptly.
This product is yellowish color chips, and every contains Ampelopsis grossedentata extract 230mg, and theoretical average sheet heavily is about 540mg.
Usage and consumption: oral, each 1-2 sheet, 3 times on the one.
Storage: sealing, put shady and cool dry place.
Embodiment 2: be used for the treatment of or prevent the preparation of the plain dispersible tablet of Ampelopsis grossedentata of thromboembolia type cardio-cerebrovascular disorder.
Get the Ampelopsis grossedentata 3000g that cooks, add 8 times of water gagings, decoct 2 times, merge extractive liquid,, boil, be concentrated under pH 6-8 condition and be equivalent to 4 times of medical materials amount volume, place crystallize, crystallization gets promptly through the alcohol-water recrystallization that to contain two hydrogen myricetins be that 5-70%, myricetin are 30-95% Ampelopsis grossedentata extractive of general flavone.
By 1000 calculating that feed intake of preparation, take by weighing said extracted thing 230g, carboxymethyl starch sodium 27g, low-substituted hydroxypropyl cellulose 28g, microcrystalline Cellulose 72g, Sorbitol 41g, mannitol 9g, 30 POVIDONE K 30 BP/USP 30 17g, pregelatinized Starch 110g, micropowder silica gel 6g, sodium lauryl sulphate 8g, essence 2g.With powder mixings such as the microcrystalline Cellulose of the carboxymethyl starch sodium of extract and prescription amount 90-10%, prescription amount 90-10% low-substituted hydroxypropyl cellulose, prescription amount 10-90%, prescription amount 90-10% pregelatinized Starch, Sorbitol, mannitol, cross 100 mesh sieves; Then 30 POVIDONE K 30 BP/USP 30 is made into the aqueous solution of 10%-15%, sprays in the above-mentioned powder and stir, make granule, back to be dried granulate; Sodium lauryl sulphate is dissolved with suitable quantity of water, be injected in the granule during granulate, the carboxymethyl starch sodium that adding another part need add, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, pregelatinized Starch, micropowder silica gel, essence etc. and granule mixing, use tablet machine compression moulding, quality inspection, packing; Or in suitable device to the continuous spray webbing material of tablet (contain conventional the coating substance that contains polymer), to coating qualified till, quality inspection, packing, promptly.
This product is yellowish color chips, and every contains Ampelopsis grossedentata extract 230mg, and theoretical average sheet heavily is about 550mg.
Usage and consumption: oral, each 1-2 sheet, 3 times on the one.
Storage: sealing, put shady and cool dry place.
Claims (5)
1, the plain dispersible tablet of a kind of Ampelopsis grossedentata is characterized in that:
With the Ampelopsis grossedentata is raw material, make the Ampelopsis grossedentata extract, the disintegrating agent crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, pregelatinized Starch, microcrystalline Cellulose, sodium lauryl sulphate and water soluble adjuvant mannitol, xylitol or the Sorbitol that add the preparation dispersible tablet then, inside and outside adding, combine, and adopt cohesive preferably 30 POVIDONE K 30 BP/USP 30 make binding agent and granulate, and then add micropowder silica gel, essence is made, its technology characteristics comprise following some:
(1) weight of raw material is formed:
Prescription 1: Ampelopsis grossedentata extract 40-70%, crospolyvinylpyrrolidone 5-12%, pregelatinized Starch 10-36%, microcrystalline Cellulose 5-18%, 30 POVIDONE K 30 BP/USP 30 1-8%, xylitol 5-10%, mannitol 1-5%, micropowder silica gel 1-5%, sodium lauryl sulphate 0.1-3%, fruit essence 0.1-1%;
Prescription 2: Ampelopsis grossedentata extract 40-70%, carboxymethyl starch sodium 1-8%, low-substituted hydroxypropyl cellulose 1-8%, pregelatinized Starch 10-30%, Sorbitol 5-8%, mannitol 1-5%, microcrystalline Cellulose 5-18%, 30 POVIDONE K 30 BP/USP 30 1-8%, micropowder silica gel 1-5%, sodium lauryl sulphate 0.1-3%, fruit essence 0.1-1%;
(2) the adding method of crospolyvinylpyrrolidone, pregelatinized Starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose and microcrystalline Cellulose is: in add 90-10%, add 10-90%;
(3) the adding method of 30 POVIDONE K 30 BP/USP 30 and sodium lauryl sulphate is: earlier 30 POVIDONE K 30 BP/USP 30 is made into the aqueous solution of 10%-15%, then sodium lauryl sulphate is dissolved in the aqueous solution of 30 POVIDONE K 30 BP/USP 30, together join in the solid powder during granulation; Or sodium lauryl sulphate dissolved with suitable quantity of water, be injected to during granulate in the granule;
(4) the adding method of mannitol, xylitol or Sorbitol is: in add;
The adding method of (5) micropowder silica gel, fruit essence is: add;
(6) particulate baking temperature is 50-80 ℃ in the wet-granulation process, 1-5 hour;
But the plain dispersible tablet of this Ampelopsis grossedentata is the bite-dispersion tablets dosage form, but described bite-dispersion tablets dosage form is plain sheet or the thin film that one deck routine is arranged, wherein the plain principal agent composition of Ampelopsis grossedentata extracts refining obtaining from Ampelopsis grossedentata, and the plain principal agent composition of its Ampelopsis grossedentata contains two hydrogen myricetins 5～95% and myricetin 95～5%.
2, the plain dispersible tablet of Ampelopsis grossedentata as claimed in claim 1, the extracting method that it is characterized in that the Ampelopsis grossedentata element is: get the Ampelopsis grossedentata that cooks, add 8-12 times of water gaging or ethanol water, reflux, extract, 2～3 times, merge extractive liquid, boils, concentrated, crystallize under pH 6～8 conditions, again through ethanol water recrystallization, obtain containing two hydrogen myricetins and be 5～95% and the Ampelopsis grossedentata extractive of general flavone of myricetin 95～5%, extracting used ethanol water ratio is 10%-95%.
3, the plain dispersible tablet of Ampelopsis grossedentata as claimed in claim 1 is characterized in that: single dose is that to contain the plain amount of principal agent composition Ampelopsis grossedentata be 60～1000mg to every dispersible tablet.
4, the plain dispersible tablet of Ampelopsis grossedentata as claimed in claim 1 is characterized in that: as treatment or prevention hyperlipidemia, the health food of hyperglycemia or the application in the medicine.
5, the plain dispersible tablet of Ampelopsis grossedentata as claimed in claim 1 is characterized in that: as treatment or the health food of prevention thromboembolia type cardio-cerebrovascular disorder or the application in the medicine.
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| CN1977926B (en) * | 2006-11-30 | 2010-06-30 | 荆树汉 | Application of ampelopsis for preparing medicine for promoting wound quick healing |
| CN102772587A (en) * | 2011-05-13 | 2012-11-14 | 贵州省生物研究所 | Preparation with cough relieving and phlegm reduction functions and preparation method thereof |
| CN102823654A (en) * | 2012-09-28 | 2012-12-19 | 广西中医药大学 | Series Chinese medicine health-care milk tablet and preparation method thereof |
| CN105125762A (en) * | 2015-10-23 | 2015-12-09 | 广西中医药大学 | Vine tea chewable tablets facilitating dissolution of effective constituents and preparing method of vine tea chewable tablets |
| CN112841388A (en) * | 2021-01-28 | 2021-05-28 | 铜仁职业技术学院 | Lipid-lowering chewing gum containing dihydromyricetin and preparation method thereof |
| CN112717034A (en) * | 2021-02-02 | 2021-04-30 | 铜仁职业技术学院 | Application of vine tea extract in preparation of medicine for treating livestock and poultry digestive tract diseases |
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2006
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