CN1957938B - Effervescence tablet of Glucurolactone, and preparation method - Google Patents
Effervescence tablet of Glucurolactone, and preparation method Download PDFInfo
- Publication number
- CN1957938B CN1957938B CN2005100158942A CN200510015894A CN1957938B CN 1957938 B CN1957938 B CN 1957938B CN 2005100158942 A CN2005100158942 A CN 2005100158942A CN 200510015894 A CN200510015894 A CN 200510015894A CN 1957938 B CN1957938 B CN 1957938B
- Authority
- CN
- China
- Prior art keywords
- glucurolactone
- tablet
- acid
- sodium
- powder
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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- UYUXSRADSPPKRZ-SKNVOMKLSA-N D-glucurono-6,3-lactone Chemical compound O=C[C@H](O)[C@H]1OC(=O)[C@@H](O)[C@H]1O UYUXSRADSPPKRZ-SKNVOMKLSA-N 0.000 title claims abstract description 88
- 229950002441 glucurolactone Drugs 0.000 title claims abstract description 86
- 238000002360 preparation method Methods 0.000 title claims description 16
- 239000000314 lubricant Substances 0.000 claims abstract description 14
- 239000000853 adhesive Substances 0.000 claims abstract description 4
- 230000001070 adhesive effect Effects 0.000 claims abstract description 4
- 150000001875 compounds Chemical class 0.000 claims description 20
- 239000000843 powder Substances 0.000 claims description 17
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 12
- 239000000203 mixture Substances 0.000 claims description 12
- 239000011230 binding agent Substances 0.000 claims description 10
- 239000002994 raw material Substances 0.000 claims description 9
- 239000000243 solution Substances 0.000 claims description 9
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 8
- 239000008187 granular material Substances 0.000 claims description 8
- 238000002156 mixing Methods 0.000 claims description 8
- 239000011975 tartaric acid Substances 0.000 claims description 8
- 235000002906 tartaric acid Nutrition 0.000 claims description 8
- 239000003513 alkali Substances 0.000 claims description 7
- -1 polyethylene pyrrolidone Polymers 0.000 claims description 7
- 239000011736 potassium bicarbonate Substances 0.000 claims description 7
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- 235000015497 potassium bicarbonate Nutrition 0.000 claims description 7
- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 claims description 6
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- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims description 4
- 239000007864 aqueous solution Substances 0.000 claims description 4
- XRRONFCBYFZWTM-UHFFFAOYSA-N octadecanoic acid;sodium Chemical compound [Na].CCCCCCCCCCCCCCCCCC(O)=O XRRONFCBYFZWTM-UHFFFAOYSA-N 0.000 claims description 4
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- 239000007938 effervescent tablet Substances 0.000 abstract description 27
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- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 description 2
- WRFYIYOXJWKONR-UHFFFAOYSA-N 4-bromo-2-methoxyaniline Chemical compound COC1=CC(Br)=CC=C1N WRFYIYOXJWKONR-UHFFFAOYSA-N 0.000 description 2
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- 229960003975 potassium Drugs 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- KYKNRZGSIGMXFH-ZVGUSBNCSA-M potassium bitartrate Chemical compound [K+].OC(=O)[C@H](O)[C@@H](O)C([O-])=O KYKNRZGSIGMXFH-ZVGUSBNCSA-M 0.000 description 1
- 229940086065 potassium hydrogentartrate Drugs 0.000 description 1
- DBCAVMLQRAABFF-UHFFFAOYSA-M potassium;carbonic acid;hydrogen carbonate Chemical compound [K+].OC(O)=O.OC([O-])=O DBCAVMLQRAABFF-UHFFFAOYSA-M 0.000 description 1
- 238000010298 pulverizing process Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 235000019615 sensations Nutrition 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
- 229940119126 sodium bitartrate Drugs 0.000 description 1
- 235000017550 sodium carbonate Nutrition 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 1
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 238000005728 strengthening Methods 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 235000019605 sweet taste sensations Nutrition 0.000 description 1
- 239000006188 syrup Substances 0.000 description 1
- 235000020357 syrup Nutrition 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
An effervescent tablet of glucuronolactone for protecting liver contains glucuronolactone, pharmacologically acceptable acid-base pairs, additive, adhesive, lubricant, sweetening agent and flavouring. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to field of medicaments, be specifically related to a kind of effervescent tablet and preparation method that contains glucurolactone.
Background technology
Glucurolactone (Glucurolactone) is synthetic by this big plug (Stacey) in nineteen thirty-nine, 1963 Si Tanke (Stanek) determine its chemical constitution.China began to produce in nineteen fifty-nine.Other names are called glucuronolatone, Glucuronic acid lactone, Glucurolactone, Glucurone, Guronsan, Glycurone.The raw material glucurolactone is white crystals or crystalline powder; Odorless, mildly bitter flavor is met light color and is deepened gradually.The character instability, soluble in water, be slightly soluble in ethanol, slightly be dissolved in methanol.
Glucurolactone is for strengthening the hepatoprotective of liver detoxification function.When hepatocyte injury, the function of detoxification of liver descends, and glucurolactone enters in the body under the effect of enzyme, becomes glucuronic acid, can combine with the poisonous substance that contains hydroxyl or carboxyl, forms the glucuronide conjugate of nontoxic or low toxicity, discharges from urine.In addition, glucurolactone can reduce the activity of glycogen enzyme, stops glycogenolysis, and hepatic glycogen content is increased, and reduces fat accumulating in liver.Be mainly used in acute, chronic hepatitis, the auxiliary treatment of liver cirrhosis.
The Tabules of glucurolactone is used for clinical treatment already, declaring maximum at present is glucurolactone injection dosage form, but effervescence tablet of Glucurolactone is now had no talent and is studied, and the glucurolactone tablet has and is easy to deposit, transportation, easy to carry and need not add the advantage of antiseptic.Glucurolactone 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 requires very strict in preparation process.
Summary of the invention
Purpose of the present invention just is to develop a kind of effervescence tablet of Glucurolactone agent that has tablet and oral liquid advantage concurrently, makes it have glucurolactone oral liquid instant effect, has the glucurolactone tablet again and is convenient to deposit, transports, carries, and need not add the advantage of antiseptic.
Another object of the present invention has provided the preparation method of above-mentioned effervescence tablet of Glucurolactone.
Effervescent tablet of the present invention is to make the disintegration of tablet dissolving from the carbon dioxide that discharges compared with chemical reaction of suitable bronsted lowry acids and bases bronsted lowry and form foamy tablet.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 glucurolactone of the present invention, it contains acceptable acid-base pair on glucurolactone 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 effervescence tablet of Glucurolactone of the present invention is the 0.01-1.20 gram, and promptly 10mg-1200mg is good.
For well, be preferable over PH is 5.0-6.5 to the pH value of the solution that effervescent tablet of the present invention dissolving back is generated with 4.0-7.0.
Acid compound in the soda acid of the present invention is selected from one or more of following compounds: citric acid, tartaric acid, fumaric acid, ethanedioic 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, sodium dihydrogen phosphate, potassium dihydrogen phosphate.All edible organic acid, mineral acid and water-soluble after be tart their salt, all can be used as acid compound and use, be preferably citric acid and/or tartaric acid.Its consumption is the heavy 10-70% of effervescence tablet of Glucurolactone, is preferably 15-40%.
Acid-base pair neutral and alkali chemical compound of the present invention is selected from one or more of following compounds: sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium carbonate, sodium glycine carbonate, glycine potassium carbonate.Its consumption is the heavy 10-35% of effervescence tablet of Glucurolactone, is preferably 20-30%.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 the inferior more than a day situation that repeatedly contains the sodium effervescent tablet of taking, can make like this should not polyphagia sodium patient bring adverse consequences, therefore when the preparation effervescent tablet, should consider few sodium carbonate, sodium bicarbonate used, and not contain sodium or contain the low carbon dioxide source replacement of sodium with potassium carbonate, potassium bicarbonate, calcium carbonate etc.
In order to make effervescent tablet be convenient to molding, in the effervescent tablet of glucurolactone, contain filler for well.Filler is selected from one or more of following compounds: mannitol, sugar alcohol, Sorbitol (higher alcohol), lactose, maltose (hydrocolloid), dextrin, starch, edible cellulose.Its consumption is the heavy 1-70% of effervescence tablet of Glucurolactone, is preferably 15-50%.
For each composition in the effervescent tablet is well sticked together, contain binding agent for well in the effervescent tablet of glucurolactone, binding agent is selected from one or more of following compounds: alcoholic solution, the glycine of the Polyethylene Glycol of the syrup of dehydrated alcohol, Different concentrations of alcohol solution, crospolyvinylpyrrolidone, sugar and polyhydric alcohol, the Polyethylene Glycol aqueous isopropanol of molecular weight 12000-20000, molecular weight 12000-20000.Its consumption is the heavy 0.01-15% of effervescence tablet of Glucurolactone, is preferably the 0.1-15% of every weight.
In order to make effervescence tablet of Glucurolactone behind tabletting, be easy to the demoulding, in the effervescent tablet of glucurolactone, contain lubricant.Lubricant is selected from one or more of following compounds: the Polyethylene Glycol of molecular weight 4000-6000, magnesium stearate, calcium stearate, Stepanol MG, sodium lauryl sulphate, lauryl sulphate acid potassium, hydrogenated vegetable oil, sodium stearate, sodium benzoate, enuatrol.Its consumption is the heavy 0.1-5% of effervescence tablet of Glucurolactone, is preferably the 1-3% of every weight.
For making effervescence tablet of Glucurolactone pleasantly sweet when taking, in the effervescent tablet of glucurolactone, contain sweeting agent for well.Described sweeting agent is selected from one or more of following compounds: protein sugar, aspartame, cyclamate, saccharin sodium, Calcium o-benzolsulfimide, cyclohexane sulfamic acid, cyclohexane sulfamic acid sodium, cyclohexane sulfamic acid potassium, agedoite, glycyrrhizin, alcohol sugar.Its consumption is the heavy 0.01-5% of effervescence tablet of Glucurolactone.And the consumption of protein sugar, aspartame, cyclamate, saccharin sodium, Calcium o-benzolsulfimide, cyclohexane sulfamic acid, cyclohexane sulfamic acid sodium, cyclohexane sulfamic acid potassium is the heavy 0.01-1% of effervescence tablet of Glucurolactone; The consumption of agedoite, glycyrrhizin, alcohol sugar is the heavy 0.5-5% of effervescence tablet of Glucurolactone.
For the taste that makes effervescence tablet of Glucurolactone better, it is good containing correctives in the effervescent tablet of glucurolactone, described correctives is selected from one or more of following compounds: Oleum menthae, edible essence, Cortex Cinnamomi, fruity material, its consumption is the heavy 0.1-3% of effervescence tablet of Glucurolactone, is preferably the 0.5-2% of every weight.
The preparation method of effervescent tablet has multiple.
A kind of method for making that contains the effervescent tablet of glucurolactone 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 effervescence tablet of Glucurolactone, with the raw material that is equipped with as for mixing 10-40 minute in the container, be transferred to and be equipped with on 5/4 cun flat tablet machine that dashes, suppress 3/8 cun sheet, ground the 12-16 mesh sieve, granulate, mixed tabletting 4-8 minute.
Another kind method is to get the raw materials ready by the amount of the needed each component of effervescence tablet of Glucurolactone, get glucurolactone in a quantity as required, acid compound, under 50-60 ℃ temperature, dry, pulverizing, cross the 60-120 mesh sieve, again with glucurolactone powder, acid compound powder and correctives and/or sweeting agent mix homogeneously, Yi Bian add binding agent and/or filler, Yi Bian cross 12-18 mesh sieve grain, under 50-65 ℃ temperature, dry, cross the 5-12 mesh sieve, add alkali compounds, mix homogeneously, add the lubricant mixing at last, tabletting.
In the production process of preparation effervescence tablet of Glucurolactone, must strictness prevent moisture absorption, will control the humidity and the temperature of air with the tabletting workshop so granulate.Relative humidity is controlled at 20-25%, and temperature is controlled at 18-21 ℃ 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 method for improvement is to adopt thick metal forming lining with polyethylene.
Take the method for effervescence tablet of Glucurolactone of the present invention, be with effervescence tablet of Glucurolactone as in the watered glass for drinking, add an amount of water, make the rapid disintegrate of effervescence tablet of Glucurolactone, dissolving and produce carbon dioxide, taking convenience.
Following table is the comparing data of effervescence tablet of Glucurolactone and commercially available glucurolactone tablet.
Measuring the dissolution method is: change the oar method, dissolution medium is a 900ml water, 37 ℃ of temperature, and rotating speed is 100 rev/mins, calculates with glucurolactone.
Illustrate that effervescence tablet of Glucurolactone of the present invention has surpassed the level of glucurolactone sheet at 5 minutes dissolution, 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.
The advantage of the preparation method of a kind of effervescent tablet that contains glucurolactone of the present invention is:
1, the present invention's effervescent tablet of containing glucurolactone has advantages such as disintegration rate is fast, dissolution rate is fast, and it has common glucurolactone tablet and is convenient to the advantage of depositing, transport, carrying.Have the rapid-action advantage of oral liquid formulations again, be more suitable for taking on the road.
2, because a kind of effervescent tablet that contains glucurolactone of the present invention contains sweeting agent, correctives, mouthfeel is good when taking, contain acid compound, alkali compounds again, when contacting with water, generate carbon dioxide, impel whole tablet to dissolve at short notice, have a few the sensation that picture is drunk 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, technology of the present invention is simple, is easy to the demoulding.
The specific embodiment
Below with specific embodiment a kind of effervescent tablet and preparation method that contains glucurolactone of the present invention is further described, will help effervescence tablet of Glucurolactone 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):
Glucurolactone 0.20kg
Anhydrous citric acid 0.60kg
Sodium bicarbonate 0.24kg
Preparation method: with 0.2kg glucurolactone, anhydrous citric acid 0.60kg, sodium bicarbonate 0.24kg, mixed 30 minutes, be transferred to and be equipped with on 5/4 cun flat tablet machine that dashes, suppress 3/8 cun sheet, ground 16 mesh sieves, granulate, mixed tabletting 5 minutes as for container.
Embodiment 2
Prescription (1000)
Glucurolactone 50g
Anhydrous citric acid 200g
Sodium bicarbonate 150g
Filler dextrin 50g
Adhesive polyethylene pyrrolidone 7.5g
Sweeting agent glycyrrhizin 15g
Lubricant stearic acid calcium 18g
Correctives Fructus Mali pumilae taste substance 10g
Preparation method: the amount by above-mentioned required each component is got the raw materials ready, with glucurolactone, and anhydrous citric acid, under 60 ℃ temperature, drying is ground into powder, crosses 120 mesh sieves, with the glucurolactone powder, anhydrous citric acid powder and sweeting agent glycyrrhizin, correctives Fructus Mali pumilae taste substance, mix homogeneously, add on one side binding agent (with the form of the aqueous solution of 15% percetage by weight), filler, cross 12 mesh sieves on one side, granulate, under 60 ℃ temperature, oven dry, cross 8 mesh sieves, add sodium bicarbonate, mix homogeneously, add lubricant stearic acid calcium mixing, tabletting.After the effervescence tablet of Glucurolactone of being produced was water-soluble, the pH value of its solution was 5.1.
Embodiment 3
Prescription (1000)
Glucurolactone 100g
Anhydrous citric acid 85g
Bicarbonate potassium bicarbonate 100g
Binding agent glycine 25g
Sweeting agent protein sugar 3g
Lubricant Polyethylene Glycol-4000 7.5g
Preparation method: the amount by above-mentioned required each component is got the raw materials ready, with glucurolactone, and anhydrous citric acid, under 60 ℃ temperature, drying is ground into powder, cross 100 mesh sieves, with the glucurolactone powder, anhydrous citric acid powder and sweeting agent 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 the alkali compounds potassium bicarbonate, mix homogeneously adds lubricant Polyethylene Glycol-4000 (molecular weight), mixing, tabletting, after the effervescence tablet of Glucurolactone of being produced was water-soluble, the pH value of the solution that is generated was 5.42.
Embodiment 4
Prescription (1000):
Glucurolactone 50g
Tartaric acid 16g
Sodium bicarbonate 9g, potassium bicarbonate 20g
Adhesive polyethylene pyrrolidone (PVP) 6g
Correctives Oleum menthae 0.7g
Lubricant stearic acid sodium 3g
Preparation method: the amount by above-mentioned required each component is got the raw materials ready, with glucurolactone, tartaric acid, under 65 ℃ temperature, drying is ground into powder, cross 80 mesh sieves, with glucurolactone powder tartaric acid powder and correctives Oleum menthae mix homogeneously, cross 12 mesh sieves while add binding agent (with the form of the aqueous solution of 15% percetage by weight), granulate, under 65 ℃ temperature, 12 mesh sieves are crossed in oven dry, add the alkali compounds sodium bicarbonate, potassium bicarbonate, mix homogeneously, add lubricant stearic acid sodium, mixing, tabletting, after the effervescence tablet of Glucurolactone of being produced was water-soluble, the pH value of the solution that is generated was 6.5.
Embodiment 5
Prescription (1000)
Glucurolactone 100g
Ascorbic acid 80g
Sodium carbonate 40g
Filler starch 50g
Binding agent glycine 25g
Sweeting agent agedoite 10g
Magnesium stearate lubricant 5g
Correctives Cortex Cinnamomi 5g
Preparation method: the amount by above-mentioned required each component is got the raw materials ready, with glucurolactone, ascorbic acid, under 50 ℃ temperature, drying is ground into powder, crosses 60 mesh sieves, with glucurolactone powder ascorbic acid and sweet taste agedoite, correctives Cortex Cinnamomi mix homogeneously, Yi Bian add binding agent, filler, Yi Bian cross 18 mesh sieves, granulate, under 50 ℃ temperature, oven dry, cross 12 mesh sieves, add sodium carbonate, mixing, add magnesium stearate lubricant, mixing, tabletting.After the effervescence tablet of Glucurolactone of being produced was water-soluble, the pH value of the solution that is generated was 6.54.
Claims (1)
1. an effervescence tablet of Glucurolactone is characterized in that, glucurolactone 50g, tartaric acid 16g, sodium bicarbonate 9g, potassium bicarbonate 20g, adhesive polyethylene pyrrolidone 6g, correctives Oleum menthae 0.7g, lubricant stearic acid sodium 3g;
Described preparation method is as follows:
Amount by above-mentioned required each component is got the raw materials ready, with glucurolactone, tartaric acid, under 65 ℃ temperature, drying is ground into powder, crosses 80 mesh sieves, with glucurolactone powder tartaric acid powder and correctives Oleum menthae mix homogeneously, Yi Bian add the binder aqueous solution of 15% percetage by weight, Yi Bian cross 12 mesh sieves, granulate, under 65 ℃ temperature, oven dry, cross 12 mesh sieves, add alkali compounds sodium bicarbonate, potassium bicarbonate, mix homogeneously, add lubricant stearic acid sodium, mixing, tabletting;
After described effervescence tablet of Glucurolactone was water-soluble, the pH value of the solution that is generated was 6.5.
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| JP2009137872A (en) * | 2007-12-05 | 2009-06-25 | Lion Corp | Glucuronolactone-containing solid preparation for oral use |
| JP2010024181A (en) * | 2008-07-18 | 2010-02-04 | Takeda Chem Ind Ltd | Solid preparation and method for producing the same |
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| CN1579385A (en) * | 2003-08-06 | 2005-02-16 | 孙明杰 | New Preparation of Gantaile |
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| 朱盛山.药物新剂型 1.化学工业出版社,2003,115-117. |
| 朱盛山.药物新剂型 1.化学工业出版社,2003,115-117. * |
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