CN1302774C - Efferverscent tablets containing troxerutin and their preparation - Google Patents

Efferverscent tablets containing troxerutin and their preparation Download PDF

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CN1302774C
CN1302774C CNB2003101035565A CN200310103556A CN1302774C CN 1302774 C CN1302774 C CN 1302774C CN B2003101035565 A CNB2003101035565 A CN B2003101035565A CN 200310103556 A CN200310103556 A CN 200310103556A CN 1302774 C CN1302774 C CN 1302774C
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effervescent tablet
troxerutin
acid
heavy
content
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CN1613444A (en
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邱学良
权奇哲
张冬平
崔永南
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邱学良
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Abstract

The present invention relates to an effervescent tablet containing troxerutin and a preparation method thereof. The effervescent tablet is used for treating cerebrovascular diseases and contains 40 to 1440 milligrams of troxerutin, acid-base pair accepted by pharmaceutics, filling agent, binding agent, lubricating agent, sweetening agent, corrigent, etc. The preparation method comprises the steps that the raw materials are put in a container and are mixed for 10 to 40 minutes; the mixed raw materials are moved to a stamping machine with a flat stamping tablet with 5/4 inches and are pressed to large tablets with 3/8 inches; the large tablets are sieved, granulated, mixed and pressed to tablets. The effervescent tablet containing troxerutin in the present invention has the advantages of quicker effect taking than an oral medicinal liquid, convenient storage, transportation and carrying and no preservative with the same as a general tablet, suitability for travel application, good taste in application, good sensation with the same as drinking soda water and simple preparation method and is more suitable for old people and patients who can not swallow solid medicines.

Description

A kind of effervescent tablet and method for making that contains troxerutin
One, technical field
The present invention relates to be shaped as a kind of medicament and the method for making of feature, a kind of effervescent tablet and preparation method that contains troxerutin of more specifically saying so with specific physical.
Two, background technology
Troxerutin, but cry song rutin (Troxerrutin) again, also be troxerutin (Trihydroxyethylrutoside), troxerutin (Venoruton), be the derivant of rutin (being rutosids Rutoside again), belong to flavone compound.Main pharmacological has the capillary fragility of reduction and permeability, antiviral, antiinflammatory, analgesia, microcirculation improvement etc.
Troxerutin is a kind of medicine that is mainly used in the treatment cardiovascular and cerebrovascular disease, have the erythropoiesis of inhibition and platelet aggregation, prevent and treat thrombotic effect, the blood vessel injury that the anti-5-azanol of while energy, Kallidin I cause, increase capillary resistance, reduce capillary permeability, can prevent the edema that vascular permeability raises and causes.The acute ischemic brain injury there is significant protective effect.Be applicable to the treatment of conditions such as edema that syndrome before hemiplegia, aphasia and the myocardial infarction due to cerebral thrombosis and the cerebral embolism, arteriosclerosis, central serous chorioretinopathy, thrombophlebitis, varicosis, vascular permeability raise and cause.
Preparations such as the tablet of troxerutin, capsule, oral liquid, injection are used for clinical treatment already.Troxerutin oral liquid, injection be than troxerutin tablet, capsule instant effect, but the troxerutin tablet has and is easy to deposit, transportation, easy to carry and need not add the advantage of antiseptic.Troxerutin injection, especially intravenous fluid must carry out under medical worker's operation in hospital, clinic, use very inconveniently, more can not use on the road, and injection, especially intravenous fluid require very strict in preparation process.
Three, summary of the invention
Purpose of the present invention just is to develop a kind of troxerutin effervescent tablet that has tablet and oral liquid advantage concurrently, it is had than troxerutin oral liquid instant effect, have common troxerutin tablet again and be convenient to deposit, transport, carry, need not add the advantage of antiseptic.
Another object of the present invention is the method that works out the above-mentioned troxerutin effervescent tablet of preparation.
Said effervescent tablet is discharging carbon dioxide and make the disintegration of tablet dissolving and form foamy tablet compared with chemical reaction from suitable bronsted lowry acids and bases bronsted lowry.When effervescent tablet contacted with water, acid-base reaction generated carbon dioxide, impels whole tablet to dissolve at short notice.
A kind of effervescent tablet that contains troxerutin of the present invention, it contains acceptable acid-base pair on troxerutin and the pharmaceutics, the content of acid-base pair in each effervescent tablet is to satisfy the solution that effervescent tablet dissolving back generated to be acid to PH7, said acid-base pair be at least a its aqueous solution be tart acid compound with at least a with in the acid with the time can discharge the alkali compounds of carbon dioxide.
Every carrying capacity of troxerutin is the 0.04-1.440 gram, and promptly 40mg-1440mg is good.
The pH value of the solution that said effervescent tablet dissolving back is generated for well, is that 5.0-6.5 is better with its PH with 4.0-7.0 again.
Acid compound in the said acid-base pair, can be wherein at least a of citric acid, tartaric acid, fumaric acid, adipic acid, malic acid, ascorbic acid, water-soluble amino acid (for example arginine) dilute hydrochloric acid, boric acid, sodium bitartrate, potassium hydrogen tartrate, natrium hydrocitricum, hydrogen citrate potassium, potassium dihydrogen phosphate, sodium dihydrogen phosphate, can be wherein a kind of, two kinds, three kinds or four kinds, or even multiple.All edible organic acid, mineral acid and water-soluble after be tart their salt, all can be used as acid compound and use.In acid compound, be good with citric acid and/or tartaric acid.The content of acid compound in each troxerutin effervescent tablet is the heavy 10-70% of every effervescent tablet, is preferably the 15-40% of every weight.
Alkali compounds in the said acid-base pair, it can be sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium carbonate, sodium glycine carbonate, the glycine potassium carbonate is wherein at least a, can be wherein a kind of, two kinds, three kinds, four kinds, even it is multiple, the carbonate of every edible alkali metal or alkaline-earth metal, percarbonate and bicarbonate and their mixed carbonate all can be used as the alkali compounds that can produce carbon dioxide, in alkali compounds with sodium carbonate, sodium bicarbonate, potassium carbonate, at least wherein a kind of for well of potassium bicarbonate can be wherein a kind of, two kinds, three kinds, four kinds.The content of alkali compounds in each troxerutin effervescent tablet is the 10-35% of every weight, again with the 20-30% of every weight for better.In actual use, the consumption of acid compound often surpasses theoretical consumption, is beneficial to stablize agreeable to the taste.In addition, also should consider to take in one day the situation that repeatedly contains the sodium effervescent tablet, can make like this should not polyphagia sodium patient bring adverse consequences, therefore when preparation troxerutin effervescent tablet, should consider fewly not contain sodium or contain the low carbon dioxide source replacement of sodium with potassium bicarbonate, potassium carbonate, calcium carbonate etc. with sodium carbonate, sodium bicarbonate.
In order to make effervescent tablet be convenient to molding, in the effervescent tablet of troxerutin, contain filler for well.Filler can be at least wherein a kind of of mannitol, sugar alcohol, Sorbitol (higher alcohol), lactose, maltose (hydrocolloid), dextrin, starch, edible cellulose, can be wherein a kind of, two kinds, three kinds or four kinds, or even it is multiple, the content of filler in each troxerutin effervescent tablet is the 5-70% of every weight, is preferably the 10-50% of every weight.
For each composition in the effervescent tablet is bonded together well, in the effervescent tablet of troxerutin, contain binding agent for well, binding agent can be at least wherein a kind of of alcoholic solution, glycine of Polyethylene Glycol of aqueous isopropanol, molecular weight 12000-20000 of Polyethylene Glycol of syrup, the molecular weight 12000-20000 of dehydrated alcohol, Different concentrations of alcohol solution, crospolyvinylpyrrolidone, polyvinylpyrrolidone, sugar and polyhydric alcohol, can be wherein a kind of, two kinds, three kinds, four kinds, even more kinds of.The content of binding agent in each troxerutin effervescent tablet is the 0.01-15% of every weight, is preferably 0.1-15%.
For making the troxerutin effervescent tablet behind tabletting, be easy to the demoulding, it is good containing lubricant in the effervescent tablet of troxerutin.Said lubricant can be at least wherein a kind of of Polyethylene Glycol, magnesium stearate, calcium stearate, Stepanol MG, sodium lauryl sulphate, lauryl sulphate acid potassium, hydrogenated vegetable oil, sodium stearate, sodium benzoate, Potassium Benzoate, enuatrol of molecular weight 4000-6000, can be a kind of, two kinds, three kinds, four kinds, or even more kinds of.The content of lubricant in each troxerutin effervescent tablet is the 0.1-4% of every weight, is preferably 1-3%.
In order to make the troxerutin effervescent tablet pleasantly sweet when taking, in the effervescent tablet of troxerutin, contain sweeting agent for well.Said sweeting agent can be at least wherein a kind of of protein sugar, aspartame, sweet close element, saccharin sodium, Calcium o-benzolsulfimide, cyclohexane sulfamic acid, cyclohexane sulfamic acid sodium, cyclohexane sulfamic acid potassium, agedoite, glycyrrhizin, alcohol sugar.Can be wherein a kind of, two kinds, three kinds, four kinds, or even wherein multiple.The content of sweeting agent in each QUKELUDING PIAN is the 0.01-5% of every weight.And protein sugar, aspartame, sweet close element, saccharin sodium, Calcium o-benzolsulfimide, cyclohexane sulfamic acid, cyclohexane sulfamic acid sodium, the content of cyclohexane sulfamic acid potassium in each troxerutin effervescent tablet to be the 0.01-1% of every weight be advisable, agedoite, glycyrrhizin, alcohol sugar are every heavy 0.5-5% for well at the content of each troxerutin.
Better for the taste that makes the troxerutin effervescent tablet, in the troxerutin effervescent tablet, contain correctives, said correctives can be at least wherein a kind of of Oleum menthae, various edible essence, Cortex Cinnamomi, various fruity material, two kinds, three kinds or four kinds.The content of correctives in each troxerutin effervescent tablet is the 0.1-3% of every weight, is preferably 0.5-2%.
The preparation method of effervescent tablet has multiple.
A kind of method for making that contains the effervescent tablet of troxerutin of the present invention has two kinds, a kind of is to get the raw materials ready by the amount of the needed each component of troxerutin effervescent tablet, the raw material that is equipped with placed the container mixing 10-40 minute, be transferred to and be equipped with on 5/4 cun flat tablet machine that dashes, suppress 3/8 cun sheet, cross the 12-16 mesh sieve, granulate, mix 4-8 minute tabletting.
Another kind method is, amount by the required each component of troxerutin effervescent tablet is got the raw materials ready, get troxerutin, acid compound in a quantity as required, respectively at dry under 50-65 ℃ the temperature, pulverizing, cross the 60-120 mesh sieve, again with troxerutin powder, acid compound powder and correctives and/or sweeting agent mix homogeneously, add binding agent and/or filler on one side, cross 12-18 mesh sieve on one side, granulate, under 50-65 ℃ temperature, dry, cross the 5-12 mesh sieve, add the chemical compound of alkalescence, mix homogeneously, add lubricant at last, the mixing tabletting.
In the production process of preparation troxerutin effervescent tablet, must strictness prevent that moisture content from absorbing, will control the temperature and the humidity of air with the tabletting workshop so granulate.Relative humidity is controlled at 20-25%, and temperature is controlled at 1g-21 ℃ and is advisable.Because effervescent tablet is to moisture-sensitive.Effervescent tablet should be stored in airtight, and in the moistureproof packaging material, effervescent tablet is stored in the common vessel, answers liner with double-layer polyethylene, and other puts a pouch silica gel, and the way of improvement is to adopt thick metal forming lining with polyethylene.
Taking the method for troxerutin effervescent tablet of the present invention, is that the troxerutin effervescent tablet is placed watered glass for drinking, adds an amount of water, makes the rapid disintegrate of troxerutin effervescent tablet, and dissolving also produces carbon dioxide, taking convenience.
For the highest blood drug level separately of more common troxerutin tablet, troxerutin oral liquid and troxerutin effervescent tablet of the present invention, carried out taking respectively the mensuration of the people's blood drug level behind above-mentioned three kinds of preparations.Its method is to divide three groups by 6 volunteers, every group two people single dose respectively takes general troxerutin tablet, troxerutin oral liquid or troxerutin effervescent tablet of the present invention, every all contains the 900mg troxerutin in general troxerutin tablet and troxerutin effervescent tablet of the present invention, the content of troxerutin also is 900mg in the troxerutin oral liquid, in 0-12 hour, vein is got blood 3ml at regular intervals, isolate blood plasma, get plasma sample 1ml and put extraction column (SweVa XAD-2, carry out sample treatment on the 1cm * 5cm), prepare need testing solution, get above-mentioned three kinds of solution, 20 μ l and inject chromatograph of liquid, press internal standard method and calculate, test sample and blank respectively with the difference of interior mark peak area ratio, chromatographic condition is chromatographic column: ODS (250mm * 4.6mm, 7 μ m); Mobile phase: acetonitrile-water (460: 2050); Flow velocity: 1.5ml*min -1Fluoroscopic examination wavelength 360nm/470nm.Used instrument is the SP1000 high performance liquid chromatograph, 821-FP type fluorescence spectrophotometer checker, Spectraphysics integrator.Result of the test shows that oral a slice contains the general troxerutin tablet of 900mg, about 2.0 hours, the highest blood drug level of this tablet is about 3.75ng/ml, and the oral 900mg troxerutin effervescent tablet that contains of the present invention, the highest blood drug level about 1.2 hours is about 14.5ng/ml, and the oral 900mg troxerutin oral liquid that contains, the highest blood drug level about 1.2 hours is 12.6ng/ml.
Illustrate that the highest blood medicine of troxerutin effervescent tablet of the present invention about 1.2 hours surpassed the oral level of troxerutin, take effervescent tablet of the present invention and do not have untoward reaction, the untoward reaction of having avoided intravenous injection to cause has been avoided again owing to there being the generation that solid particle endangers patient's situation in the intravenous fluid accidentally.It is formulated that the troxerutin effervescent tablet of the present invention that the volunteer took in experiment is that the amount with embodiment 3 each component multiply by 3 amount.
The advantage of a kind of effervescent tablet that contains troxerutin of the present invention and preparation method thereof is:
1 effervescent tablet its highest blood drug level about 1.2 hours that contains troxerutin of the present invention is 14.5ng/ml, have the advantage more rapid-action than oral medicine liquid, have common troxerutin tablet again and be convenient to deposit, transport, carry, need not add the advantage of antiseptic.So it has had the advantage of above-mentioned two kinds of dosage forms concurrently, it more is applicable on the road and takes.
2 owing to contain sweeting agent in a kind of effervescent tablet that contains troxerutin of the present invention, correctives, mouthfeel is good when taking, contain acid compound, alkali compounds again, when contacting with water, generate the carbon dioxide class, impel whole tablet to dissolve at short notice, have point image to drink the sensation of soda pop when taking, make us producing happy sense, be specially adapted to the old people and the patient of the solid chemicals of can not swallowing.
3 technologies of the present invention are simple, be easy to the demoulding.
Four, the specific embodiment
Below with specific embodiment a kind of effervescent tablet that contains troxerutin of the present invention and preparation method thereof is further described, will help troxerutin effervescent tablet of the present invention, method for making and advantage are had a better understanding.But embodiment does not limit protection scope of the present invention.Protection scope of the present invention is decided by claim.
Embodiment 1
Prescription (1000)
0.9 kilogram of troxerutin (quite a slice troxerutin effervescent tablet contains 900 milligrams of troxerutins)
3.32 kilograms of anhydrous citric acids (be equivalent to a slice troxerutin effervescent tablet heavy 60.7%)
1.25 kilograms of sodium bicarbonate (be equivalent to a slice troxerutin effervescent tablet heavy 22.85%).
With 3.32 kilograms of 0.9 kilogram troxerutin, anhydrous citric acids, 1.25 kilograms of sodium bicarbonate place container to mix 30 minutes, are transferred to and are equipped with on 5/4 cun flat tablet machine that dashes, and suppress 3/8 cun sheet, cross 16 mesh sieves and granulate, and mix tabletting 5 minutes.
Embodiment 2
Prescription (1000)
Its prescription and preparation method are substantially with embodiment 1,3.30 kilograms of only different is 0.04 kilogram of troxerutins (quite a slice troxerutin effervescent tablet contains 40 milligrams of troxerutins), anhydrous citric acid (be equivalent to a slice troxerutin effervescent tablet heavy 66.13%, after the troxerutin effervescent tablet that 1.65 kilograms of potassium bicarbonates (be equivalent to a slice QUKELUDING PIAN heavy 33.07%) are generated was water-soluble, the pH value of the solution that is generated was 4.2.
Embodiment 3
Prescription (1000)
Troxerutin 300 grams (being equivalent to contain in a slice troxerutin effervescent tablet 300 milligrams of troxerutins),
Anhydrous citric acid 170 gram (be equivalent to a slice troxerutin effervescent tablet heavy 22.34%),
Sodium bicarbonate 120 gram, potassium bicarbonate 100 grams, totally 220 grams (be equivalent to a slice QUKELUDING PIAN heavy 28.91%);
Binding agent glycine 50 gram (be equivalent to a slice troxerutin effervescent tablet heavy 6.57%),
Sweeting agent protein sugar 6 gram (be equivalent to a slice troxerutin effervescent tablet heavy 0.79%),
Lubricant Polyethylene Glycol-4000,15 gram (be equivalent to a slice troxerutin effervescent tablet heavy 1.97%).
Amount by above-mentioned needed each component is got the raw materials ready, with 300 gram troxerutins, and 170 gram anhydrous citric acids, under 60 ℃ temperature, drying is ground into powder, cross 100 mesh sieves, again with the troxerutin powder, anhydrous citric acid powder and sweeting agent 6 gram protein sugar, mix homogeneously, Yi Bian add the binding agent glycine, Yi Bian cross 16 mesh sieves, granulate, under 60 ℃ temperature, 10 mesh sieves are crossed in oven dry, add alkali compounds sodium bicarbonate 120 grams, potassium bicarbonate 100 grams, mix homogeneously adds lubricant Polyethylene Glycol-4000 (molecular weight) 15 grams, mixing, tabletting, after the troxerutin effervescent tablet of being produced was water-soluble, the pH value of the solution that is generated was 5.89.
Embodiment 4
(filling a prescription 1000)
Troxerutin 500 grams (being equivalent to contain in a slice troxerutin effervescent tablet 500 milligrams of troxerutins)
Tartaric acid 160 gram (be equivalent to a slice troxerutin effervescent tablet heavy 15.28%),
Sodium bicarbonate 90 gram, potassium bicarbonate 200 grams be totally 290 grams (be equivalent to a slice troxerutin effervescent tablet heavy 27.70%)
Binding agent polyvidon (PVP) 60 gram (be equivalent to a slice troxerutin effervescent tablet heavy 5.73%, add with the form of the aqueous solution of 15% percetage by weight.)
Correctives Oleum menthae 7 gram (be equivalent to a slice troxerutin effervescent tablet heavy 0.67%), lubricant stearic acid sodium 30 grams (be equivalent to the bent rutin tablets of a slice heavy 2.87%)
Amount by above-mentioned needed each component is got the raw materials ready, and 500 gram troxerutins, 160 are restrained tartaric acid respectively under 65 ℃ the temperature, drying, be ground into powder, cross 80 mesh sieves, again with troxerutin powder tartaric acid powder and correctives 6 gram mix homogeneously, cross the granulation of 12 mesh sieves while adding binding agent, under 65 ℃ temperature, dry, cross 5 mesh sieves, add alkali compounds, sodium bicarbonate 90 grams, potassium bicarbonate 200 grams, mix homogeneously, add lubricant stearic acid sodium 30 grams, mixing, tabletting.PH value after the troxerutin effervescent tablet that is produced is water-soluble is 6.3.
Embodiment 5
(filling a prescription 1000)
Troxerutin 370 grams (being equivalent to contain in a slice troxerutin effervescent tablet 370 milligrams of troxerutins)
Ascorbic acid 240 gram (be equivalent to a slice troxerutin effervescent tablet heavy 24%),
Sodium carbonate 110 gram, (be equivalent to a slice troxerutin effervescent tablet heavy 11%)
Filler starch 150 gram (be equivalent to a slice troxerutin effervescent tablet heavy 15%)
Binding agent glycine 70 gram (be equivalent to a slice troxerutin effervescent tablet heavy 7.0%)
Magnesium stearate lubricant 15 gram (be equivalent to a slice troxerutin effervescent tablet heavy 1.5%
Sweeting agent agedoite 30 gram (be equivalent to a slice troxerutin effervescent tablet heavy 3.0%)
Correctives Cortex Cinnamomi 15 gram (be equivalent to a slice troxerutin effervescent tablet heavy 1.5%).
Amount by above-mentioned needed each component is got the raw materials ready, and 370 gram troxerutins, 240 are restrained ascorbic acid respectively under 50 ℃ the temperature, drying, be ground into powder, cross 60 mesh sieves, again with troxerutin powder, ascorbic acid, sweeting agent agedoite 30 grams, correctives Cortex Cinnamomi 15 gram mix homogeneously, add binding agent, filler on one side, cross 18 mesh sieves granulation on one side, under 50 ℃ temperature, dry, cross 12 mesh sieves, add sodium carbonate 110 grams, mixing adds magnesium stearate lubricant 15 grams, mixing, tabletting.The pH value of its solution of the water-soluble back of the troxerutin effervescent tablet that is produced is 6.7.
Embodiment 6
(filling a prescription 1000)
Troxerutin 100 grams (being equivalent to contain in a slice troxerutin effervescent tablet 100 milligrams of troxerutins)
Anhydrous citric acid 400 gram (be equivalent to a slice troxerutin effervescent tablet heavy 40%),
Sodium bicarbonate 300 gram, (be equivalent to a slice troxerutin effervescent tablet heavy 30%)
Filler dextrin 100 gram (be equivalent to a slice troxerutin effervescent tablet heavy 10%)
Binding agent polyvinylpyrrolidone 15 gram (be equivalent to a slice troxerutin effervescent tablet heavy 1.5%, add with the form of the aqueous solution of 15% percetage by weight),
Lubricant stearic acid calcium 35 gram (be equivalent to a slice troxerutin effervescent tablet heavy 3.5%)
Sweeting agent glycyrrhizin 30 gram (be equivalent to a slice troxerutin effervescent tablet heavy 3.0%)
Correctives Fructus Mali pumilae taste substance 20 gram (be equivalent to a slice troxerutin effervescent tablet heavy 2.0%).
Amount by above-mentioned needed each component is got the raw materials ready, and 100 gram troxerutins, 400 are restrained anhydrous citric acids respectively under 60 ℃ the temperature, drying, be ground into powder, cross 120 mesh sieves, again with troxerutin powder, anhydrous Fructus Citri Limoniae powder and sweeting agent, glycyrrhizin 30 grams, correctives Fructus Mali pumilae 20 grams, mix homogeneously Yi Bian add binding agent, filler, is granulated Yi Bian cross 12 mesh sieves, in 60 ℃ of oven dry, cross 8 mesh sieves, add sodium bicarbonate 300 gram mix homogeneously, add lubricant stearic acid calcium 35 grams, mixing, tabletting.The pH value of its solution of the water-soluble back of the troxerutin effervescent tablet of being produced is 4.8.

Claims (25)

1, a kind of effervescent tablet that contains troxerutin, it is characterized in that, it contains acceptable acid-base pair on troxerutin and the pharmaceutics, the content of acid-base pair in each effervescent tablet be satisfy solution that effervescent tablet dissolving back generated be acid to PH be 7, said acid-base pair be at least a kind of its aqueous solution be tart acid compound with at least a with in the acid with the time can discharge the alkali compounds of carbon dioxide; Wherein every of troxerutin carrying capacity is the 40-1440 milligram, the content of acid compound in each troxerutin effervescent tablet is the heavy 10-70% of every effervescent tablet, and the content of alkali compounds in each troxerutin effervescent tablet is the heavy 10-35% of every effervescent tablet.
According to a kind of effervescent tablet that contains troxerutin of claim 1, it is characterized in that 2, the pH value of the solution that said effervescent tablet dissolving back is generated is 4.0-7.0.
According to a kind of effervescent tablet that contains troxerutin of claim 2, it is characterized in that 3, the pH value of the solution that said effervescent tablet dissolving back is generated is 5.0-6.5.
4, according to a kind of effervescent tablet that contains troxerutin of claim 1, it is characterized in that said acid compound is wherein at least a of citric acid, tartaric acid, fumaric acid, adipic acid, malic acid, ascorbic acid, water-soluble amino acid, dilute hydrochloric acid, boric acid, sodium bitartrate, potassium hydrogen tartrate, natrium hydrocitricum, hydrogen citrate potassium, sodium dihydrogen phosphate, potassium dihydrogen phosphate.
According to a kind of effervescent tablet that contains troxerutin of claim 1 or 4, it is characterized in that 5, the content of acid compound in each troxerutin effervescent tablet is the heavy 15-40% of every effervescent tablet.
According to a kind of effervescent tablet that contains troxerutin of claim 1, it is characterized in that 6, said alkali compounds is that sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium carbonate, sodium glycine carbonate, glycine potassium carbonate are wherein at least a.
According to a kind of effervescent tablet that contains troxerutin of claim 1 or 6, it is characterized in that 7, alkali compounds is the heavy 20-30% of every effervescent tablet at the content of each troxerutin effervescent tablet.
8, according to a kind of effervescent tablet that contains troxerutin of claim 1, it is characterized in that, also contain filler, said filler is that mannitol, sugar alcohol, Sorbitol, lactose, maltose, dextrin, starch, edible cellulose are wherein at least a, and the content of filler in each troxerutin effervescent tablet is the heavy 5-70% of every effervescent tablet.
9, a kind of effervescent tablet that contains troxerutin according to Claim 8 is characterized in that, the content of filler in each troxerutin effervescent tablet is the heavy 10-50% of every effervescent tablet.
10, according to a kind of effervescent tablet that contains troxerutin of claim 1 or 8, it is characterized in that, also contain binding agent, said binding agent is dehydrated alcohol, Different concentrations of alcohol solution, crospolyvinylpyrrolidone, polyvinylpyrrolidone, sugar and at least wherein a kind of of the alcoholic solution of the Polyethylene Glycol of the Polyethylene Glycol aqueous isopropanol of the syrup of polyhydric alcohol, molecular weight 12000-20000, molecular weight 12000-20000, glycine, and the content of binding agent in each troxerutin effervescent tablet is the 0.01-15% of every effervescent tablet weight.
According to a kind of effervescent tablet that contains troxerutin of claim 10, it is characterized in that 11, the content of binding agent in each troxerutin effervescent tablet is the heavy 0.1-15% of every effervescent tablet.
12, according to a kind of effervescent tablet that contains bent Ke Luding of claim 1 or 8, it is characterized in that, also contain lubricant, said lubricant is the Polyethylene Glycol of molecular weight 4000-6000, at least wherein a kind of of magnesium stearate, calcium stearate, Stepanol MG, sodium lauryl sulphate, lauryl sulphate acid potassium, hydrogenated vegetable oil, sodium stearate, sodium benzoate, Potassium Benzoate, enuatrol, the content of lubricant in each troxerutin effervescent tablet is the heavy 0.1-4% of every effervescent tablet.
13, according to a kind of effervescent tablet that contains bent Ke Luding of claim 10, it is characterized in that, also contain lubricant, said lubricant is at least wherein a kind of of Polyethylene Glycol, magnesium stearate, calcium stearate, Stepanol MG, sodium lauryl sulphate, lauryl sulphate acid potassium, hydrogenated vegetable oil, sodium stearate, sodium benzoate, Potassium Benzoate, enuatrol of molecular weight 4000-6000, and the content of lubricant in each troxerutin effervescent tablet is the heavy 0.1-4% of every effervescent tablet.
According to a kind of effervescent tablet that contains troxerutin of claim 12, it is characterized in that 14, the content of lubricant in each troxerutin effervescent tablet is the heavy 0.1-3% of every effervescent tablet.
15, according to a kind of effervescent tablet that contains troxerutin of claim 1 or 8, it is characterized in that, also contain sweeting agent, said sweeting agent is at least wherein a kind of of protein sugar, aspartame, cyclamate, saccharin sodium, Calcium o-benzolsulfimide, cyclohexane sulfamic acid, cyclohexane sulfamic acid sodium, cyclohexane sulfamic acid potassium, agedoite, glycyrrhizin, alcohol sugar, and the content of sweeting agent in each troxerutin effervescent tablet is the heavy 0.01-5% of every effervescent tablet.
16, according to a kind of effervescent tablet that contains troxerutin of claim 10, it is characterized in that, also contain sweeting agent, said sweeting agent is at least wherein a kind of of protein sugar, aspartame, cyclamate, saccharin sodium, Calcium o-benzolsulfimide, cyclohexane sulfamic acid, cyclohexane sulfamic acid sodium, cyclohexane sulfamic acid potassium, agedoite, glycyrrhizin, alcohol sugar, and the content of sweeting agent in each troxerutin effervescent tablet is the heavy 0.01-5% of every effervescent tablet.
17, according to a kind of effervescent tablet that contains troxerutin of claim 12, it is characterized in that, also contain sweeting agent, said sweeting agent is at least wherein a kind of of protein sugar, aspartame, cyclamate, saccharin sodium, Calcium o-benzolsulfimide, cyclohexane sulfamic acid, cyclohexane sulfamic acid sodium, cyclohexane sulfamic acid potassium, agedoite, glycyrrhizin, alcohol sugar, and the content of sweeting agent in each troxerutin effervescent tablet is the heavy 0.01-5% of every effervescent tablet.
18, according to a kind of effervescent tablet that contains troxerutin of claim 15, it is characterized in that, protein sugar, aspartame, cyclamate, saccharin sodium, Calcium o-benzolsulfimide, cyclohexane sulfamic acid, cyclohexane sulfamic acid sodium, cyclohexane sulfamic acid potassium, the content in each troxerutin effervescent tablet are the heavy 0.01-1% of every effervescent tablet; Agedoite, glycyrrhizin, alcohol sugar, the content in each troxerutin effervescent tablet are the heavy 0.5-5% of every effervescent tablet.
19, according to a kind of effervescent tablet that contains troxerutin of claim 1 or 8, it is characterized in that, also contain correctives, said correctives is at least wherein a kind of of Oleum menthae, edible essence, Cortex Cinnamomi, fruity material, and the content in each troxerutin effervescent tablet is the heavy 0.1-3% of every effervescent tablet.
20, according to a kind of effervescent tablet that contains troxerutin of claim 10, it is characterized in that, also contain correctives, said correctives is at least wherein a kind of of Oleum menthae, edible essence, Cortex Cinnamomi, fruity material, and the content in each troxerutin effervescent tablet is the heavy 0.1-3% of every effervescent tablet.
21, according to a kind of effervescent tablet that contains troxerutin of claim 12, it is characterized in that, also contain correctives, said correctives is at least wherein a kind of of Oleum menthae, edible essence, Cortex Cinnamomi, fruity material, and the content in each troxerutin effervescent tablet is the heavy 0.1-3% of every effervescent tablet.
22, according to a kind of effervescent tablet that contains troxerutin of claim 15, it is characterized in that, also contain correctives, said correctives is at least wherein a kind of of Oleum menthae, edible essence, Cortex Cinnamomi, fruity material, and the content in each troxerutin effervescent tablet is the heavy 0.1-3% of every effervescent tablet.
But 23,, it is characterized in that, but correctives content in each song rutin effervesce sheet is the heavy 0.5-2% of every effervescent tablet according to a kind of effervescent tablet that contains the song rutin of claim 19.
24, any one described method for making that contains the effervescent tablet of troxerutin of claim 1-23, it is characterized in that, amount by the needed each component of troxerutin effervescent tablet is got the raw materials ready, the raw material that is equipped with is placed the container mixing 10-40 minute, be transferred to and be equipped with on 5/4 cun flat tablet machine that dashes, suppress 3/8 cun sheet, cross the 12-16 mesh sieve, granulate, mixed tabletting 4-8 minute.
25, any one described method for making that contains the effervescent tablet of troxerutin of claim 1-23, it is characterized in that, amount by the needed each component of troxerutin effervescent tablet is got the raw materials ready, get troxerutin in a quantity as required, acid compound, under 50-65 ℃ temperature, drying, pulverize, cross the 60-120 mesh sieve, again with the troxerutin powder, acid compound powder and correctives and/or sweeting agent mix homogeneously Yi Bian add binding agent and/or filler, are granulated Yi Bian cross the 12-18 mesh sieve, under 50-65 ℃ temperature, dry, cross the 5-12 mesh sieve, add alkali compounds, mix homogeneously, add the lubricant mixing at last, tabletting.
CNB2003101035565A 2003-11-07 2003-11-07 Efferverscent tablets containing troxerutin and their preparation Expired - Fee Related CN1302774C (en)

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CN101676022A (en) * 2008-09-19 2010-03-24 江西汇仁药业有限公司 Granulating method
CN104688704B (en) * 2015-02-10 2018-03-09 苏州亚宝药物研发有限公司 A kind of pharmaceutical composition containing Troxerutin and preparation method thereof
CN106619318A (en) * 2017-02-07 2017-05-10 泉州医学高等专科学校 Making method of herbal effervescent tablets for rinsing mouth
CN108967807A (en) * 2017-05-31 2018-12-11 江苏汉典生物科技股份有限公司 A kind of preparation method of effervescent tablet

Citations (2)

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Publication number Priority date Publication date Assignee Title
CN1331697A (en) * 1998-12-11 2002-01-16 纳吉玛实验室 Troxerutin with high trihydroxy-ethyl-rutin content and method for preparing same
CN1336172A (en) * 2001-08-06 2002-02-20 牛俊江 Venoruton injecta specially for intravenous of ethyhdroxirutini

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1331697A (en) * 1998-12-11 2002-01-16 纳吉玛实验室 Troxerutin with high trihydroxy-ethyl-rutin content and method for preparing same
CN1336172A (en) * 2001-08-06 2002-02-20 牛俊江 Venoruton injecta specially for intravenous of ethyhdroxirutini

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