CN100341515C - Film-coated tablet of glycyrrhizinic acid monopotassiium salt and method for preparing the same - Google Patents
Film-coated tablet of glycyrrhizinic acid monopotassiium salt and method for preparing the same Download PDFInfo
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- CN100341515C CN100341515C CNB2006100434114A CN200610043411A CN100341515C CN 100341515 C CN100341515 C CN 100341515C CN B2006100434114 A CNB2006100434114 A CN B2006100434114A CN 200610043411 A CN200610043411 A CN 200610043411A CN 100341515 C CN100341515 C CN 100341515C
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Abstract
The present invention relates to a film-coated tablet of glycyrrhizinic acid monopotassium salt and a preparation method for the production thereof, which belongs to the technical field of medicine. The present invention is characterized in that an oblate plain tablet of glycyrrhizinic acid monopotassium salt is used as a tablet base, wherein the diameter of the plain tablet is 0.8cm to 1.2cm; the surface of the plain tablet is sprayed and coated with one layer of coating material: a film-coated layer of which the thickness is 0.3mm to 0.9mm, wherein the coating material is used as moistureproof type opadry. A preparation method of the film-coated tablet of glycyrrhizinic acid monopotassium salt comprises a plain tablet preparation process and a film-coat coating process. The present invention has the advantages of small blank tablets, low cost, good humidity resistance, and strong stability; a disintegration speed rate and a dissolution speed rate of the tablet are increased, and bioavailability and clinical treatment effect are enhanced. The present invention is suitable for assistant treatment and liver dysfunction patients of an urgency and a chronic liver diseases; at the same time, using limitation to a diabetic is relieved.
Description
Technical field
The present invention relates to a kind of Film coated tablets and preparation method thereof, relate in particular to Film coated tablets of a kind of monopotassium glycyrrhizunate and preparation method thereof.
Background technology
Monopotassium glycyrrhizunate, chemical name is: the positive oleanane of 20 β-carboxyl-11-oxo-12-alkene-3 beta-yls-2-O-β-D-glucopyanosyl aldehydic acid base-α-D-Glucopyranose. aldehydic acid monopotassium salt.
Structural formula:
Molecular formula: C
42H
61KO
16
Molecular weight: 861.02
Character: commercially available and clinical practice product are the monopotassium glycyrrhizunate coated tablet, remove apparent light brown yellow or off-white color behind the sugar-coat, and it is sweet to distinguish the flavor of.
The monopotassium glycyrrhizunate sheet is applicable to the auxiliary treatment and the abnormal liver function patient of acute and chronic hepatopathy, has removed the use restriction to diabetics simultaneously; Therefore, obtained clinically using widely.
Yet commercially available and monopotassium glycyrrhizunate sheet clinical practice all is a coated tablet at present.Though coated tablet is beneficial to patient and takes, mouthfeel is better, but wrapping up sugar-coat in preparation, it can make embryo sheet weight increase, expend more material, especially the coated tablet volume of finished product is bigger, and disintegrate and dissolution time are long, and rate of drying is slow in the manufacturing process simultaneously, the medicine heated time extends, and can have influence on the quality of medicine; Coated tablet easily goes mouldy in addition, easily softening, easily moisture absorption disintegrate; Cause that the coated tablet irregular colour is even, cause sign unclear easily; Moreover coated tablet is produced length consuming time, and production cost is than higher.
In recent years, the tablet film-coat has become the medicament developing direction, is used for the attention that pharmaceutical production has obtained the world of medicine, and the application for a patent for invention relevant with film-coat increases gradually, but up to now, does not also have the technology of film-coated tablet of glycyrrhizinic acid monopotassiium salt open.
Summary of the invention
At the deficiencies in the prior art, the invention provides a kind of Film coated tablets of monopotassium glycyrrhizunate sheet, to increase the kind of this medicine.The present invention also provides the preparation method of this film-coated tablet of glycyrrhizinic acid monopotassiium salt.
Film-coated tablet of glycyrrhizinic acid monopotassiium salt of the present invention is the sheet base with the plain sheet of the oblate monopotassium glycyrrhizunate of diameter 0.8～1.2cm, and the sheet surface spray is coated with the coating material film-coat layer of a bed thickness 0.3～0.9mm.
Preferably, described film-coated tablet of glycyrrhizinic acid monopotassiium salt is the sheet base with the plain sheet of the oblate monopotassium glycyrrhizunate of diameter 0.9～1.1cm, and the sheet surface spray is coated with the coating material film-coat layer of a bed thickness 0.5～0.6mm.
The component of the plain sheet of described monopotassium glycyrrhizunate is as follows, weight portion:
1～10 part of monopotassium glycyrrhizunate, 10～100 parts of starch, 10～100 parts of sucrose, 1～10 part of micropowder silica gel, 10～200 parts of magnesium stearate, 10～200 parts of carboxymethyl starch sodium, 10～100 parts of sodium lauryl sulphates, 10～200 parts of Pulvis Talci, 1～10 part of the ethanol of percent by volume 50%.
Preferably, the component of the plain sheet of described monopotassium glycyrrhizunate is as follows, weight portion: 5～10 parts of monopotassium glycyrrhizunates, 50～80 parts of starch, 40～70 parts of sucrose, 5～10 parts of micropowder silica gels, 120～150 parts of magnesium stearate, 130～170 parts of carboxymethyl starch sodium, 50～80 parts of sodium lauryl sulphates, 150～180 parts of Pulvis Talci, 5～10 parts of the ethanol of percent by volume 50%.
In the film-coated tablet of glycyrrhizinic acid monopotassiium salt of the present invention, described coating material is the damp-proof Opadry, preferred damp-proof Opadry AMB.
The preparation method of film-coated tablet of glycyrrhizinic acid monopotassiium salt of the present invention comprises plain sheet preparation process and bag film-coat process.Wherein plain sheet preparation can the invention provides following method, but be not limited thereto by this area universal method.
The step of the plain sheet preparation process of monopotassium glycyrrhizunate is: (1) crushing screening: the principal agent monopotassium glycyrrhizunate is crossed 100 orders, and magnesium stearate is crossed 40 mesh sieves, and all the other each components are crossed 100 mesh sieves; (2) granulate: take by weighing each component respectively with described weight proportion, earlier with sucrose, starch, micropowder silica gel, carboxymethyl starch sodium, sodium lauryl sulphate with the monopotassium glycyrrhizunate mix homogeneously after, add mass percent again and be 50% ethanol; Mix under 20 ℃～40 ℃, make meet the soft material that granulate to require after, granulate; (3) oven dry granulate: wet granular is put into baking oven inner drying (40～50 ℃), and oven dry total time is 2～3 hours, granulate.(4) mix: the dried granule behind the granulate is added magnesium stearate, Pulvis Talci, behind the mix homogeneously, detect drug content; (5) tabletting: regulate the rotating speed and the pressure of tablet machine, quantitatively the granule after (heavy by sheet) is sent into tablet machine, is pressed into the plain sheet of oblate monopotassium glycyrrhizunate of diameter 0.8～1.2cm.
The step of the plain sheet bag of monopotassium glycyrrhizunate film-coat process is: (1) joins slurry: coating material is placed join the slurry filling, the adding percent by volume is 80% ethanol, coating material and described alcoholic acid w/v are: 1 gram: 9～13 milliliters, stir, and standby; (2) preheating: the plain sheet of the oblate monopotassium glycyrrhizunate of diameter 0.8～1.2cm of suppressing is placed in the coating pan, open hot blast, and rotate main frame, the footpath speed of coating pan is 25-45 rev/min, plain sheet is rolled in coating pan, and plain sheet temperature reaches 38-42 ℃ gradually; (3) spray: regulate spray gun, with the above-mentioned coating material that stirs is under the condition of 3.8-4.5 handkerchief at atomizing pressure, evenly be sprayed on the plain sheet of rolling, even until color and luster, form not wet thoroughly, the air-locked Opadry film-coat layer of a bed thickness 0.3～0.9mm on the plain sheet of monopotassium glycyrrhizunate surface, the conventional method drying promptly makes the film-coated tablet of glycyrrhizinic acid monopotassiium salt product.
In the preparation method of above-mentioned film-coated tablet of glycyrrhizinic acid monopotassiium salt, preferred, the plain sheet 200g coating material of per 10,000 monopotassium glycyrrhizunates; Described coating material is that 80% ethanol is joined slurry with the percent by volume of 2000ml preferably.
In the preparation method of above-mentioned film-coated tablet of glycyrrhizinic acid monopotassiium salt, preferred, the footpath speed of coating pan is 30～40 rev/mins, is preferably 32 rev/mins especially.
In the preparation method of above-mentioned film-coated tablet of glycyrrhizinic acid monopotassiium salt, preferred, the atomizing pressure of described coating material is preferably the 4.0-4.4 handkerchief, is preferably 4.2 handkerchiefs especially.
The drug effect of film-coated tablet of glycyrrhizinic acid monopotassiium salt of the present invention and original monopotassium glycyrrhizunate coated tablet are basic identical, but film-coated tablet of glycyrrhizinic acid monopotassiium salt of the present invention is compared with existing coated tablet, have the following advantages: 1, the embryo sheet is little, uses adjuvant few, thereby has reduced cost; 2, can reduce the tablet fragmentation, improve productive rate, shorten the production cycle greatly; 3, rate of drying is fast, and the medicine reduction that is influenced by heat helps improving drug quality; 4, improved the mode of appearance of tablet; 5, humidity resistance is good, has increased stability of drug; 6, increased the dissolution rate of tablet, made the rapid disintegrate of medicine, rapid-action, improve bioavailability and clinical efficacy.
Film-coated tablet of glycyrrhizinic acid monopotassiium salt of the present invention is an oral formulations, is applicable to the auxiliary treatment and the abnormal liver function patient of acute and chronic hepatopathy, has removed the use restriction to diabetics simultaneously.
Film-coated tablet of glycyrrhizinic acid monopotassiium salt preparation method of the present invention is simple, and processing ease is easy to grasp, and equipment investment is low, and is with short production cycle, and prepared tablet principal agent stable in properties helps improving drug quality, guarantees the drug effect of tablet.
Description of drawings
Fig. 1 is a film-coated tablet of glycyrrhizinic acid monopotassiium salt stereo display tangent plane ideograph of the present invention, wherein, and 1. coating material film-coat layer, the plain sheet of 2. oblate monopotassium glycyrrhizunate.
The specific embodiment
Below in conjunction with embodiment film-coated tablet of glycyrrhizinic acid monopotassiium salt of the present invention is described further:
Embodiment 1:
Film-coated tablet of glycyrrhizinic acid monopotassiium salt is the sheet base with the plain sheet of the oblate monopotassium glycyrrhizunate of diameter 0.8～1.0cm, and the sheet surface spray is coated with the coating material film-coat layer of a bed thickness 0.4～0.5mm.
The component of the plain sheet of described monopotassium glycyrrhizunate is as follows: monopotassium glycyrrhizunate 5g, starch 50g, sucrose 40g, micropowder silica gel 5g, magnesium stearate 120g, carboxymethyl starch sodium 130g, sodium lauryl sulphate 50g, Pulvis Talci 150g, the ethanol 6g of percent by volume 50%.Coating material Opadry 100.0g adds percent by volume and is 80% ethanol 900ml and joins slurry.
Preparation method is as follows:
The preparation of the plain sheet of oblate monopotassium glycyrrhizunate of diameter 0.8～1.0cm: (1) crushing screening: the principal agent monopotassium glycyrrhizunate is crossed 100 orders, and magnesium stearate is crossed 40 mesh sieves, and all the other each components are crossed 100 mesh sieves; (2) granulate: by the amount of taking by weighing earlier with sucrose, starch, micropowder silica gel, carboxymethyl starch sodium, sodium lauryl sulphate with the monopotassium glycyrrhizunate mix homogeneously after, add mass percent again and be 50% ethanol; Mix under 25 ℃～28 ℃, make meet the soft material that granulate to require after, granulate; (3) oven dry granulate: wet granular is put into baking oven inner drying (40～43 ℃), and oven dry total time is 2 hours, granulate.(4) mix: the dried granule behind the granulate is added magnesium stearate, the Pulvis Talci of weighing, behind the mix homogeneously, measure drug content; (5) tabletting: regulate the rotating speed and the pressure of tablet machine, the granule is quantitatively sent into tablet machine, be pressed into the plain sheet of oblate monopotassium glycyrrhizunate of diameter 0.8～1.0cm.
The step of the plain sheet bag of monopotassium glycyrrhizunate film-coat process is: (1) joins slurry: take by weighing coating material Opadry 100.0g, the coating material Opadry is placed join the slurry filling, the adding percent by volume is 80% ethanol 900ml, stirs, and is standby; (2) preheating: plain 5000 of the sheets of the oblate monopotassium glycyrrhizunate of diameter 0.8～1.0cm of suppressing are placed in the coating pan, open hot blast, and rotate main frame, the footpath speed of coating pan is 30 rev/mins, plain sheet is rolled in coating pan, and plain sheet temperature reaches 38-40 ℃ gradually; (3) spray: regulate spray gun, with the above-mentioned coating material that stirs is under the condition of 3.8-4.0 handkerchief at atomizing pressure, evenly be sprayed on the plain sheet of rolling, even until color and luster, form not wet thoroughly, the air-locked Opadry film-coat layer of a bed thickness 0.4～0.5mm on the plain sheet of monopotassium glycyrrhizunate surface, the conventional method drying promptly makes the film-coated tablet of glycyrrhizinic acid monopotassiium salt product.
Embodiment 2:
Film-coated tablet of glycyrrhizinic acid monopotassiium salt is the sheet base with the plain sheet of the oblate monopotassium glycyrrhizunate of diameter 0.9～1.1cm, and the sheet surface spray is coated with the coating material film-coat layer of a bed thickness 0.5～0.6mm.(as shown in Figure 1)
The component of the plain sheet of described monopotassium glycyrrhizunate is as follows: monopotassium glycyrrhizunate 8g, starch 80g, sucrose 70g, micropowder silica gel 8g, magnesium stearate 150g, carboxymethyl starch sodium 170g, sodium lauryl sulphate 80g, Pulvis Talci 180g, the ethanol 8g of percent by volume 50%.Coating material Opadry 200.0g adds percent by volume and is 80% ethanol 2000ml and joins slurry.
Preparation method is as follows:
The preparation of the plain sheet of oblate monopotassium glycyrrhizunate of diameter 0.9～1.1cm: (1) crushing screening: the principal agent monopotassium glycyrrhizunate is crossed 100 orders, and magnesium stearate is crossed 40 mesh sieves, and all the other each components are crossed 100 mesh sieves; (2) granulate: by the amount of taking by weighing earlier with sucrose, starch, micropowder silica gel, carboxymethyl starch sodium, sodium lauryl sulphate with the monopotassium glycyrrhizunate mix homogeneously after, add mass percent again and be 50% ethanol; Mix under 30 ℃～35 ℃, make meet the soft material that granulate to require after, granulate; (3) oven dry granulate: wet granular is put into baking oven inner drying (43～47 ℃), and oven dry total time is 2.5 hours, granulate.(4) mix: the dried granule behind the granulate is added magnesium stearate, Pulvis Talci, behind the mix homogeneously, measure drug content; (5) tabletting: regulate the rotating speed and the pressure of tablet machine, the granule is quantitatively sent into tablet machine, be pressed into the plain sheet of oblate monopotassium glycyrrhizunate of diameter 0.9～1.1cm.
The step of the plain sheet bag of monopotassium glycyrrhizunate film-coat process is: (1) joins slurry: take by weighing coating material Opadry 200.0g, the coating material Opadry is placed join the slurry filling, the adding percent by volume is 80% ethanol 2000ml, stirs, and is standby; (2) preheating: plain 10000 of the sheets of the oblate monopotassium glycyrrhizunate of diameter 0.9～1.1cm of suppressing are placed in the coating pan, open hot blast, and rotate main frame, the footpath speed of coating pan is 32 rev/mins, plain sheet is rolled in coating pan, and plain sheet temperature reaches 39-41 ℃ gradually; (3) spray: regulate spray gun, with the above-mentioned coating material that stirs is under the condition of 4.1-4.2 handkerchief at atomizing pressure, evenly be sprayed on the plain sheet of rolling, even until color and luster, form not wet thoroughly, the air-locked Opadry film-coat layer of a bed thickness 0.5～0.6mm on the plain sheet of monopotassium glycyrrhizunate surface, the conventional method drying promptly makes the film-coated tablet of glycyrrhizinic acid monopotassiium salt product.
Embodiment 3:
Film-coated tablet of glycyrrhizinic acid monopotassiium salt is the sheet base with the plain sheet of the oblate monopotassium glycyrrhizunate of diameter 1.0～1.15cm, and the sheet surface spray is coated with the coating material film-coat layer of a bed thickness 0.6～0.7mm.
The component of the plain sheet of described monopotassium glycyrrhizunate is as follows: monopotassium glycyrrhizunate 10g, starch 100g, sucrose 100g, micropowder silica gel 10g, magnesium stearate 200g, carboxymethyl starch sodium 200g, sodium lauryl sulphate 100g, Pulvis Talci 200g, the ethanol 10g of percent by volume 50%.Coating material Opadry 300.0g adds percent by volume and is 80% ethanol 3600ml and joins slurry.
Preparation method is as follows:
The preparation of the plain sheet of oblate monopotassium glycyrrhizunate of diameter 1.0～1.15cm: (1) crushing screening: the principal agent monopotassium glycyrrhizunate is crossed 100 orders, and magnesium stearate is crossed 40 mesh sieves, and all the other each components are crossed 100 mesh sieves; (2) granulate: by the amount of taking by weighing earlier with sucrose, starch, micropowder silica gel, carboxymethyl starch sodium, sodium lauryl sulphate with the monopotassium glycyrrhizunate mix homogeneously after, add mass percent again and be 50% ethanol; Mix under 35 ℃～40 ℃, make meet the soft material that granulate to require after, granulate; (3) oven dry granulate: wet granular is put into baking oven inner drying (47～50 ℃), and oven dry total time is 3 hours, granulate.(4) mix: the dried granule behind the granulate is added magnesium stearate, the Pulvis Talci of weighing, behind the mix homogeneously, measure drug content; (5) tabletting: regulate the rotating speed and the pressure of tablet machine, the granule is quantitatively sent into tablet machine, be pressed into the plain sheet of oblate monopotassium glycyrrhizunate of diameter 1.0～1.15cm.
The step of the plain sheet bag of monopotassium glycyrrhizunate film-coat process is: (1) joins slurry: take by weighing coating material Opadry 300.0g, the coating material Opadry is placed join the slurry filling, the adding percent by volume is 80% ethanol 3600ml, stirs, and is standby; (2) preheating: the plain sheet of the oblate monopotassium glycyrrhizunate of diameter 1.0～1.15cm of suppressing is placed in the coating pan, open hot blast, and rotate main frame, the footpath speed of coating pan is 45 rev/mins, plain sheet is rolled in coating pan, and plain sheet temperature reaches 40-42 ℃ gradually; (3) spray: regulate spray gun, with the above-mentioned coating material that stirs is under the condition of 4.4-4.5 handkerchief at atomizing pressure, evenly be sprayed on the plain sheet of rolling, even until color and luster, form not wet thoroughly, the air-locked Opadry film-coat layer of a bed thickness 0.6～0.7mm on the plain sheet of monopotassium glycyrrhizunate surface, the conventional method drying promptly makes the film-coated tablet of glycyrrhizinic acid monopotassiium salt product.
Claims (6)
1, a kind of preparation method of film-coated tablet of glycyrrhizinic acid monopotassiium salt comprises plain sheet preparation and bag film-coat, it is characterized in that,
The component of the plain sheet of monopotassium glycyrrhizunate is as follows, weight portion:
1～10 part of monopotassium glycyrrhizunate, 10～100 parts of starch, 10～100 parts of sucrose, 1～10 part of micropowder silica gel, 10～200 parts of magnesium stearate, 10～200 parts of carboxymethyl starch sodium, sodium lauryl sulphate 10～100,10～200 parts of Pulvis Talci, 1～10 part of the ethanol of percent by volume 50%;
The step of bag film-coat is as follows:
(1) coating material is placed join slurry and irritate, add percent by volume and be 80% ethanol, coating material and described alcoholic acid w/v are: 1 restrains: 9～13 milliliters, stir, and standby; Described coating material is the damp-proof Opadry;
(2) the plain sheet of the oblate monopotassium glycyrrhizunate of diameter 0.8～1.2cm of suppressing is placed in the coating pan, open hot blast, and rotate main frame, the footpath speed of coating pan is 25～45 rev/mins, plain sheet is rolled in coating pan, and plain sheet temperature reaches 38～42 ℃ gradually;
(3) use spray gun, with the above-mentioned coating material that stirs is under the condition of 3.8～4.5 handkerchiefs at atomizing pressure, evenly be sprayed on the plain sheet of rolling, even until color and luster, form not wet thoroughly, the air-locked Opadry film-coat layer of a bed thickness 0.3～0.9mm on the plain sheet of monopotassium glycyrrhizunate surface, drying promptly makes the film-coated tablet of glycyrrhizinic acid monopotassiium salt product.
2, the preparation method of film-coated tablet of glycyrrhizinic acid monopotassiium salt as claimed in claim 1, it is characterized in that the component of the plain sheet of described monopotassium glycyrrhizunate is as follows, weight portion: 5～10 parts of monopotassium glycyrrhizunates, 50～80 parts of starch, 40～70 parts of sucrose, 5～10 parts of micropowder silica gels, 120～150 parts of magnesium stearate, 130～170 parts of carboxymethyl starch sodium, 50～80 parts of sodium lauryl sulphates, 150～180 parts of Pulvis Talci, 5～10 parts of the ethanol of percent by volume 50%.
3, as the preparation method of claims 1 described film-coated tablet of glycyrrhizinic acid monopotassiium salt, it is characterized in that the plain sheet 200g coating material of per 10,000 monopotassium glycyrrhizunates; Described coating material is that 80% ethanol is joined slurry with the percent by volume of 2000ml.
As the preparation method of claims 1 described film-coated tablet of glycyrrhizinic acid monopotassiium salt, it is characterized in that 4, the footpath speed of described step (2) coating pan is 30～40 rev/mins.
As the preparation method of claims 1 described film-coated tablet of glycyrrhizinic acid monopotassiium salt, it is characterized in that 5, the atomizing pressure of described step (3) coating material is 4.0～4.4 handkerchiefs.
As the preparation method of claims 1 described film-coated tablet of glycyrrhizinic acid monopotassiium salt, it is characterized in that 6, the atomizing pressure of described step (3) coating material is 4.2 handkerchiefs.
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| CNB2006100434114A CN100341515C (en) | 2006-03-31 | 2006-03-31 | Film-coated tablet of glycyrrhizinic acid monopotassiium salt and method for preparing the same |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1698633A (en) * | 2005-06-10 | 2005-11-23 | 北京正大绿洲医药科技有限公司 | Glycyrrhizin drop pills and preparation method thereof |
| CN1739536A (en) * | 2005-09-12 | 2006-03-01 | 山东山大康诺制药有限公司 | A kind of compound formulation that contains monopotassium glycyrrhizunate and preparation method thereof and application |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1698633A (en) * | 2005-06-10 | 2005-11-23 | 北京正大绿洲医药科技有限公司 | Glycyrrhizin drop pills and preparation method thereof |
| CN1739536A (en) * | 2005-09-12 | 2006-03-01 | 山东山大康诺制药有限公司 | A kind of compound formulation that contains monopotassium glycyrrhizunate and preparation method thereof and application |
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| Title |
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| 欧巴代应用于头孢氨苄片薄膜包衣的试验研究 高鸿雁等，天津药学，第9卷第2期 1997 * |
| 甘草甜素片 国家药典委员会，国家药品标准(新药转正标准)，第Z17-64期 2002 * |
| 药剂学 毕殿洲等，第316－325，340－341页，人民卫生出版社 2002 * |
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