CN101077338A - Nano lanthanum carbonate and orally disintegrating tablet and preparation method - Google Patents
Nano lanthanum carbonate and orally disintegrating tablet and preparation method Download PDFInfo
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Abstract
The present invention is orally disintegrated nanometer lanthanum carbonate tablet and its preparation process. The orally disintegrated nanometer lanthanum carbonate tablet is prepared through one dry tabletting process, which includes the steps of drying the main medicine ingredient and supplementary material, including disintegrant, stuffing, effervescent, etc, sieving and tabletting; or one wet tabletting process, which includes the steps of mixing the main medicine ingredient and partial supplementary material, including disintegrant, stuffing, corrective, etc, sieving, drying, mixing with the other supplementary material and tabletting. The tabletting pressure is 2-15 MPa, and prepared orally disintegrated tablet has hardness of 2-5kg and extracorporeal disintegrating period of 20-80 sec. The orally disintegrated nanometer lanthanum carbonate tablet has high bioavailability, small dosage and high patient' s compliance.
Description
Technical field
The invention belongs to technical field of nano material, and the pharmaceutical science field.
Background technology
Hyperphosphatemia is a kind of complication of chronic kidney hypofunction, and 80% kidney dialysis patient suffers from this disease.Therefore and dead this disease may cause bone lesion, and skin is itched, even outside the disease of aspect such as skin ulcer, also can cause the infringement of cardiovascular system, has 50% patient.Taking the phosphorus bonding agent is the main treatment means for the treatment of hyperphospheremia at present.
The phosphorus of phosphate binders in can chelating food stops the absorption of gastrointestinal tract to phosphorus.First generation phosphorus bonding agent is an aluminum salt, and it can effectively reduce the phosphate level in chronic renal failure patients's serum, but life-time service can cause dementia and osteomalacia, thereby its clinical practice is restricted.Calcareous phosphorus bonding agent (as calcium acetate, calcium carbonate) also can reduce hyperphosphatemia patient's serum paraoxonase level, but can increase the incidence rate of hypercalcemia and calcification, this situation is particularly outstanding in the patient who uses vitamin D, and patient is to the poor compliance of this type of medicine.Therefore people wish to develop non-aluminum, calcium type phosphorus bonding agent.GenzymeGenerals in 1998 and the Sheng Productivity of drugmaker of GelTex Two family go out Renagel sheet Elixirs, and this also is the medicine of a kind of Wan Qi Kidney patient's who is used for controlling the dialysis of Treatment promoting the circulation of blood liquid hyperphospheremia.Renagel is a kind of fluoropolymer resin, and it carries a plurality of amidos can be in the small intestinal inner protonization and positively charged, reduces serium inorganic phosphorus thereby combine with phosphate radical in the small intestinal by ion exchange and hydrogen bond.But can Renagel effectively suppress parathyroid hyperplasia and reduce high PTH, the level of blood calcium is had or not influence, and the experimental data of this respect is also limited.
Lanthanum (atomic number 57, atomic mass 159) be a kind of to the oxygen donor atom have the rare element of strong affinity, lanthanum salt to combine to produce with hydrocarbon and phosphoric acid salt chemical compound water solublity little, be difficult for seeing through biomembranous lanthanum orthophosphate molecule.As the phosphorus bonding agent of a kind of non-calcium, non-aluminum, lanthanum chloride, lanthanum carbonate etc. has the effect that reduces the phosphate level among the patients serum with the conventional junction mixture equally, and can not cause the rising of serum calcium and produce serious side effects, and toleration is also better; It will become the medicine of a new generation's treatment hyperphospheremia.The lanthanum carbonate medicine Fosrenl that Britain Schilling company releases was a kind of chewable tablet, in listing in 2004.Wherein the particle diameter of effective ingredient lanthanum carbonate is the key that influences curative effect of medication, and shilling company does not relate to the size of lanthanum carbonate crystal particle diameter.Existing lanthanum carbonate crystal grain yardstick is bigger, so specific surface area is little, causes absorbability not high.
Summary of the invention
In order to solve the deficiencies in the prior art, the present invention proposes the preparation method of a kind of nano lanthanum carbonate and orally disintegrating tablet and preparation method and nano lanthanum carbonate.
The preparation method of nano lanthanum carbonate and orally disintegrating tablet:
1). the formulated composition:
Lanthanum carbonate is nanocrystalline: 5-40 part
Disintegrating agent: 10-70 part
Filler: 15-60 part
Correctives: 0-5 part
Effervescent: 0-5 part
Fluidizer: 0-4 part
Lubricant: 0-2 part
Bonding agent: 0.5-3 part;
Adopt compressing dry granulation and two kinds of technology of wet method tabletting to prepare nano lanthanum carbonate and orally disintegrating tablet.Compressing dry granulation is that principal agent and adjuvant etc. were descended dry 2-4 hour at 40-80 ℃, crosses the 40-100 mesh sieve, and tabletting obtains oral cavity disintegration tablet then.Adjuvant comprises disintegrating agent, filler, effervescent, fluidizer, lubricant, correctives etc.The wet method tabletting is earlier principal agent and part disintegrating agent, filler, correctives and bonding agent to be mixed, and crosses the 30-60 mesh sieve, 40-90 ℃ dry 2-10 hour down; Even with remaining disintegrating agent, filler, correctives and effervescent, fluidizer, mix lubricant then, tabletting obtains oral cavity disintegration tablet.The pressure of above-mentioned film-making is 2-15Mpa, and gained oral cavity disintegration tablet hardness is 2～5kg, and external disintegration time is 20-80 second.
Described disintegrating agent is a kind of and above-mentioned two or more the combination of above-mentioned polymer of cross-linking sodium carboxymethyl cellulose (cCMC-Na), crosslinked carboxymethyl fecula sodium (CMS-Na), low-substituted hydroxypropyl cellulose (LSHPC), crospolyvinylpyrrolidone (PPVP) or microcrystalline Cellulose (MCC).
Described disintegrating agent is one or more the combination of polymer of cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone or microcrystalline Cellulose.
Described filler is one or more the combination of polymer of mannitol, erythrol, lactose, sucrose, xylitol or sorbitol.
Described correctives is one or more the combination of polymer of menthol, Oleum menthae, Radix Glycyrrhizae, citric acid, tartaric acid, Cortex Cinnamomi or essence.
Described effervescent is a sodium bicarbonate.
Described fluidizer is micropowder silica gel.
Described lubricant is magnesium stearate or Pulvis Talci.
Described bonding agent is polyvidone, Polyethylene Glycol, give one or more the combination of polymer of gelatinized starch, dextrin or methylcellulose.
Lanthanum carbonate is nanocrystalline can select existing products for use, and the lanthanum carbonate that can certainly prepare with the method that we invent is nanocrystalline.
The nano lanthanum carbonate of the present invention's preparation adopts following method preparation:
1) preparation 0.1-10wt% stabiliser solution and 0.01-0.9mol/L lanthanum compound solution, and with two kinds of solution mix homogeneously, left standstill 10-30 minute, the 0.01-1.2mol/L carbonate solution for preparing is joined in the above-mentioned mixed solution, be controlled to nuclear temperature 5-30 ℃, stirring reaction 5-20 minute; Then 10-50 ℃ and stir under continue reaction 30min-4h, stop to stir, adding concentration is the 0.1-5wt% surfactant solution, places then 10-60 minute;
2) with above-mentioned products therefrom centrifugal sedimentation 10-40min, and with distilling washing 2-4 time; With solid drying product in Muffle furnace roast 1-5 hour, temperature was controlled at 150-400 ℃ then, and heating rate is 5-10 ℃/min;
Described stabilizing agent is natural macromolecular gelatin, chitosan, alginate, collagen, starch, cellulose and derivant thereof; Or the synthetic organic macromolecule of polyvinyl alcohol, poly butyric ester and copolymer, poly-anhydride, polyvinyl pyrrolidone, polyoxyethylene, Polyethylene Glycol; Or the polyhydric alcohol of xylitol, sorbitol, mannitol, glycerol; Or the polysaccharide or the monosaccharide of sucrose, lactose, glucose; They mix use.
Described lanthanum compound is lanthanum chloride, Lanthanum (III) nitrate, lanthanum sulfate, lanthanum acetate or lanthanum oxalate.
Described carbonate is sodium carbonate, potassium carbonate, carbonic acid ammonia, sodium bicarbonate, potassium bicarbonate or ammonium hydrogencarbonate.
Described surfactant is dodecyl sodium sulfate, sorbester p17, sorbester p18 or polysorbate40.
Feature part of the present invention is:
1. adopt the sedimentation method can prepare nanoscale lanthanum carbonate crystal, control crystalline nucleation and crystal growth by attemperation.
2. control crystalline size by adjusting feed way.
3. utilize the absorption of stabilizing agent molecule, stable and space boundary effect, control crystalline yardstick of lanthanum carbonate and shape.
4. add surfactant and can make crystalline dispersion more evenly, prevent to reunite.
Nano lanthanum carbonate and orally disintegrating tablet has taken into full account drug mechanism, and greatly the curative effect of limit performance medicine reduces patient's dosage, improves patient's compliance.
Description of drawings
Fig. 1: nano lanthanum carbonate electron microscope photo scanning;
Fig. 2: nano lanthanum carbonate electron microscope photo scanning partial enlarged drawing.
The specific embodiment
Example 1
It is stand-by at first to prepare 1wt% gelatin solution, 0.3mol/L sodium carbonate liquor, 0.2mol/L lanthanum chloride solution, takes out the 50ml lanthanum chloride solution then, adds the 20ml gelatin solution, stirs and makes it mix homogeneously.With ice/aqueous mixtures water-bath control temperature is 5 ℃, adds the 50ml sodium carbonate liquor, stirring reaction 10min, then heat up, stop up to 30 ℃, under this temperature, react 30min with 3 ℃/min speed, the dodecyl sodium sulfate 0.2ml that adds 1wt% then, and place 20min.Turbid liquid is put into centrifugal separator separate 30min (3000r/min down together), take out precipitum, wash with water 3 times, the precipitum that obtains is placed crucible.The crucible that fills product is put into Muffle furnace heat, heating rate is 10 ℃/min, up to 400 ℃, this roasting temperature 1 hour, naturally cools to room temperature then, obtains the nano lanthanum carbonate crystal and sees attached Fig. 1 and 2.
Example 2
It is stand-by at first to prepare 0.1wt% polyoxyethylene solution, 0.06mol/L solution of potassium carbonate, 0.04mol/L lanthanum nitrate hexahydrate, takes out the 50ml lanthanum nitrate hexahydrate then, adds the 20ml polyglycol solution, stirs and makes it mix homogeneously.With ice/aqueous mixtures water-bath control temperature is 10 ℃, adds the 50ml solution of potassium carbonate, stirring reaction 15min, then heat up, stop up to 30 ℃, and under this temperature, react 50min with 5 ℃/min speed, add the sorbester p17 that 0.2ml concentration is 0.1wt% then, and place 40min.The emulsion that obtains is put into centrifugal separator separate 40min, take out precipitum, wash with water 2 times, the precipitum that obtains is placed crucible.Institute's crucible is put into the Muffle furnace roasting, and heating rate is 5 ℃/min, up to 300 ℃, this roasting temperature 0.5 hour, naturally cools to room temperature then, obtains the nano lanthanum carbonate crystal.
Example 3
At first prepare 10wt% glycerol solution, 1.2mol/L ammonium bicarbonate solution, 0.9mol/L acetic acid lanthanum solution for later use, take out 100ml lanthanum acetate solution then, add 2ml glycerol solution, stir and make it mix homogeneously.With ice/aqueous mixtures water-bath control temperature is 15 ℃, dropwise add the 100ml ammonium bicarbonate solution, added in 20 minutes, stirring reaction 5min, then heat up, stop up to 25 ℃, under this temperature, react 70min with 2 ℃/min speed, add the polysorbate40 that 0.5ml concentration is 5wt% then, and place 30min.Turbid liquid is put into centrifugal separator separate 20min, take out precipitum, wash with water 4 times, the precipitum that obtains is placed crucible.The crucible that fills product is put into Muffle furnace heat, heating rate is 10 ℃/min, up to 250 ℃, this roasting temperature 1 hour, naturally cools to room temperature then, obtains the lanthanum carbonate nanocrystal.
Example 4
At first prepare 2wt% lactose solution, 0.6mol/L sodium bicarbonate solution, 0.4mol/L sulphation lanthanum solution for later use, take out 80ml lanthanum carbonate solution then, add the 3ml lactose solution, stir and make it mix homogeneously.With ice/aqueous mixtures water-bath control temperature is 12 ℃, adds the 80ml sodium bicarbonate solution, stirring reaction 5min, then heat up, stop up to 30 ℃, under this temperature, react 40min with 3 ℃/min speed, add the polysorbate40 that 0.5ml concentration is 1wt% then, and place 30min.Turbid liquid is put into centrifugal separator separate 20min, take out precipitum, wash with water 3 times, the precipitum that obtains is placed crucible.The crucible that fills product is put into Muffle furnace heat, heating rate is 5 ℃/min, up to 150 ℃, this roasting temperature 1 hour, naturally cools to room temperature then, obtains the lanthanum carbonate nanocrystal.
Example 5
At first prepare 1wt% polyoxyethylene solution, 2wt% polyvinyl alcohol, 0.015mol/L sodium bicarbonate solution, 0.01mol/L sulphation lanthanum solution for later use, take out 100ml lanthanum carbonate solution then, add 3ml polyoxyethylene solution and 3ml poly-vinyl alcohol solution, stir and make it mix homogeneously.With water-bath control temperature is 30 ℃, adds the 100ml sodium bicarbonate solution, and stirring reaction 20min then heats up with 3 ℃/min speed, stops up to 50 ℃, reacts 40min under this temperature, adds the polysorbate40 that 0.5ml concentration is 1wt% then, and places 30min.Turbid liquid is put into centrifugal separator separate 20min, take out precipitum, wash with water 3 times, the precipitum that obtains is placed crucible.The crucible that fills product is put into Muffle furnace heat, heating rate is 5 ℃/min, up to 300 ℃, this roasting temperature 1 hour, naturally cools to room temperature then, obtains the lanthanum carbonate nanocrystal.
Example 6
It is stand-by at first to prepare 0.5wt% gelatin solution, 0.1wt% polyoxyethylene solution, 1wt% sorbitol, 0.6mol/L sodium carbonate liquor, 0.4mol/L lanthanum chloride solution, take out the 50ml lanthanum chloride solution then, add 20ml gelatin, polyoxyethylene, sorbitol solution, stir and make it mix homogeneously.With ice/aqueous mixtures water-bath control temperature is 12 ℃, adds the 50ml sodium carbonate liquor, stirring reaction 15min, then heat up, stop up to 30 ℃, under this temperature, react 30min with 3 ℃/min speed, the polyvinyl pyrrolidone 0.1ml that adds 1wt% then, and place 20min.Turbid liquid is put into centrifugal separator separate 30min (3000r/min down together), take out precipitum, wash with water 3 times, the precipitum that obtains is placed crucible.The crucible that fills product is put into Muffle furnace heat, heating rate is 14 ℃/min, up to 400 ℃, this roasting temperature 1 hour, naturally cools to room temperature then, obtains the nano lanthanum carbonate crystal
Example 7
Get that the lanthanum carbonate nanocrystal fully mixes with 38 portions of mannitol in 12 parts of above-mentioned examples that make 2, then with 35 parts 60 ℃ following microcrystalline Cellulose, 3 parts of PPVP, 6 parts of LSHPC mix homogeneously of dry 3 hours, and mistake 100 mesh sieves, add 1 part of sodium bicarbonate, 2 parts of micropowder silica gels, 1.5 parts of magnesium stearate, 1 part of citric acid and 0.5 part of Fructus Citri tangerinae essence then, and mix homogeneously, at 5Mpa pressure lower sheeting, obtain oral cavity disintegration tablet then.Sheet hardness is 3kg, and be 53s external disintegration.
Example 8
Getting 7 parts of above-mentioned lanthanum carbonate nanocrystals that make fully mixes with 24 parts of xylitol, 15 lactose, then with 28 parts 60 ℃ following microcrystalline Cellulose, 11 parts of LSHPC mix homogeneously of dry 3 hours, and mistake 80 mesh sieves, add 5 parts of sodium bicarbonate, 3 parts of micropowder silica gels, 3 parts of Pulvis Talci, 3 parts of citric acids and 1 portion of Radix Glycyrrhizae then, and mix homogeneously, at 10Mpa pressure lower sheeting, obtain oral cavity disintegration tablet then.Sheet hardness is 5kg, and be 75s external disintegration.
Example 9
Getting 10 parts of above-mentioned lanthanum carbonate nanocrystals that make fully mixes with 23 parts of erythrol, 10 lactose, then with 36 parts 60 ℃ following microcrystalline Cellulose, 14 parts of low-substituted hydroxypropyl cellulose mix homogeneously of dry 5 hours, and mistake 80 mesh sieves, add 2 parts of sodium bicarbonate, 2 parts of micropowder silica gels, 1 part of magnesium stearate, 1 part of citric acid and 1 portion of Radix Glycyrrhizae then, and mix homogeneously, at 7Mpa pressure lower sheeting, obtain oral cavity disintegration tablet then.Sheet hardness is 4kg, and be 15s external disintegration
Example 10
Getting 19 parts of above-mentioned lanthanum carbonate nanocrystals that make fully mixes with 14 portions of mannitol, 5 parts of sorbitol, 2 portions of sucrose, then with 42 parts 60 ℃ following dry 3 hours microcrystalline Cellulose, 10 parts of cross-linking sodium carboxymethyl celluloses (cCMC-Na), 2 parts of crosslinked carboxymethyl fecula sodium (CMS-Na) mix homogeneously, and mistake 100 mesh sieves, add 1.5 parts of sodium bicarbonate, 2 parts of micropowder silica gels, 0.5 part of magnesium stearate, 1 part of citric acid and 1 part of menthol then, and mix homogeneously, at 3Mpa pressure lower sheeting, obtain oral cavity disintegration tablet then.Sheet hardness is 3kg, and be 38s external disintegration.
Example 11
Getting 22 parts of above-mentioned lanthanum carbonate nanocrystals that make fully mixes with 25 parts of xylitol, 16 lactose, descend 3 hours microcrystalline Cellulose mix homogeneously of drying with 37 parts 60 ℃ then, and cross 100 mesh sieves, and mix homogeneously, at 10Mpa pressure lower sheeting, obtain oral cavity disintegration tablet then.Sheet hardness is 5kg, and be 83s external disintegration.
Example 12
Getting 16 parts of above-mentioned lanthanum carbonate nanocrystals that make fully mixes with 24 parts of xylitol, 21 lactose, then with 26 parts 60 ℃ following microcrystalline Cellulose, 10 parts of LSHPC mix homogeneously of dry 4 hours, and mistake 80 mesh sieves, add 2 parts of micropowder silica gels, 1 part of Pulvis Talci then, and mix homogeneously, at 10Mpa pressure lower sheeting, obtain oral cavity disintegration tablet then.Sheet hardness is 5kg, and be 46s external disintegration.
Example 13
Getting 20 parts of lanthanum carbonates (Weihai Baidexin New Material Co., Ltd.'s production) fully mixes with 20 parts of xylitol, 24 sucrose, then with 34 parts 60 ℃ following dry 5 hours microcrystalline Cellulose mix homogeneously, and mistake 80 mesh sieves, add 1 part of micropowder silica gel, 1 part of Pulvis Talci then, and mix homogeneously, at 10Mpa pressure lower sheeting, obtain oral cavity disintegration tablet then.Sheet hardness is 4kg, and be 59s external disintegration.
Example 14
Get 10 parts of above-mentioned lanthanum carbonate nanocrystals that make and 10 portions of mannitol, 10 parts of microcrystalline Cellulose, 1 portion of sucrose, 3 parts of abundant mix homogeneously of PPVP, 0.5 citric acid and 5 parts of polyvidone ethanol-water solutions (concentration is 10wt%), cross 40 mesh sieves, drying is 4 hours under 60 ℃; Descend drying microcrystalline Cellulose, 12 parts of LSHPC, 1 part of PPVP, 15 portions of mannitol, 2 parts of lactose mix homogeneously of 3 hours with 28 parts 60 ℃ then, and cross 80 mesh sieves; Add 1 part of sodium bicarbonate, 2 parts of micropowder silica gels, 2 parts of magnesium stearate, 1 part of citric acid and 1 part of menthol then, and mix homogeneously, at 5Mpa pressure lower sheeting, obtain oral cavity disintegration tablet then.Sheet hardness is 3.5kg, and be 58s external disintegration.
Example 15
Get fully mix homogeneously of 15 parts of above-mentioned lanthanum carbonate nanocrystals that make and 14 portions of mannitol, 12 parts of microcrystalline Cellulose, 1 portion of sucrose, 5 parts of LSHPC, 1 part of crosslinked carboxymethyl fecula sodium (CMS-Na), 0.5 citric acid and 1 part of PEG, 2 parts of dextrin (concentration is the aqueous solution of 25wt%), cross 40 mesh sieves, drying is 6 hours under 50 ℃; Descend drying microcrystalline Cellulose, 7 parts of LSHPC, 3 parts of PPVP, 10 parts of xylitol, 2 parts of lactose mix homogeneously of 3 hours with 24 parts 60 ℃ then, and cross 100 mesh sieves; Add 0.5 part of sodium bicarbonate, 1.5 parts of micropowder silica gels, 1 part of magnesium stearate, 0.5 citric acid and 0.5 flavoring pineapple essence then, and mix homogeneously, at 4Mpa pressure lower sheeting, obtain oral cavity disintegration tablet then.Sheet hardness is 3kg, and be 49s external disintegration.
Example 16
Get 40 parts of above-mentioned lanthanum carbonate nanocrystals that make and 20 portions of mannitol, 16 parts of abundant mix homogeneously of microcrystalline Cellulose, cross 40 mesh sieves, drying is 5 hours under 60 ℃; Microcrystalline Cellulose, 3 parts of Polyethylene Glycol of dry 3 hours are also crossed 100 mesh sieves down with 21 parts 60 ℃ then; Mix homogeneously at 10Mpa pressure lower sheeting, obtains oral cavity disintegration tablet then.Sheet hardness is 5kg, and be 80s external disintegration.
Example 17
Get fully mix homogeneously of 6 parts of above-mentioned lanthanum carbonate nanocrystals that make and 5 portions of mannitol, 5 parts of sorbitol, 10 parts of microcrystalline Cellulose, 8 crosslinked carboxymethyl fecula sodium, 5 fens low-substituted hydroxypropyl celluloses, 1 portion of sucrose, 2 parts of PPVP, 0.5 citric acid and 3 parts of polyvidone ethanol-water solutions (concentration is 10wt%), cross 40 mesh sieves, drying is 3 hours under 60 ℃; Descend drying microcrystalline Cellulose, 9 parts of LSHPC, 1 part of PPVP, 15 portions of mannitol, 1.5 parts of lactose mix homogeneously of 3 hours with 20 parts 60 ℃ then, and cross 80 mesh sieves; Add 1 part of sodium bicarbonate, 0.5 part of micropowder silica gel, 4 parts of magnesium stearate, 1.5 parts of citric acids and 1 part of menthol then, and mix homogeneously, at 5Mpa pressure lower sheeting, obtain oral cavity disintegration tablet then.Sheet hardness is 3.5kg, and be 58s external disintegration.
The present invention is not limited to the technology described in the embodiment; its description is illustrative; and it is nonrestrictive; authority of the present invention is limited by claim; based on present technique field personnel according to the present invention can change, technology related to the present invention that method such as reorganization obtains, all within protection scope of the present invention.
Claims (10)
1. the preparation method of a nano lanthanum carbonate and orally disintegrating tablet:
1). the formulated composition:
Lanthanum carbonate is nanocrystalline: 5-40 part
Disintegrating agent: 10-70 part
Filler: 15-60 part
Correctives: 0-5 part
Effervescent sodium bicarbonate: 0-5 part
Fluidizer micropowder silica gel: 0-4 part
Magnesium stearate lubricant or Pulvis Talci: 0-2 part
Bonding agent: 0.5-3 part;
2) component was descended dry 2-4 hour at 40-80 ℃, crossed the 40-100 mesh sieve, and tabletting obtains oral cavity disintegration tablet then.
2. the preparation method of nano lanthanum carbonate and orally disintegrating tablet as claimed in claim 1, it is characterized in that step 2) employing nanocrystalline and part disintegrating agent, filler, correctives and bonding agent mixing with lanthanum carbonate, cross the 30-60 mesh sieve, descended dry 2-10 hour at 40-90 ℃; Even with remaining disintegrating agent, filler, correctives and effervescent, fluidizer, mix lubricant then, tabletting obtains oral cavity disintegration tablet.
3. the preparation method of nano lanthanum carbonate and orally disintegrating tablet as claimed in claim 1 or 2 is characterized in that the nano lanthanum carbonate and orally disintegrating tablet pressure that makes is 2-15Mpa, and gained oral cavity disintegration tablet hardness is 2～5kg, and external disintegration time is 20-80 second.
4. the preparation method of nano lanthanum carbonate and orally disintegrating tablet as claimed in claim 1 or 2 is characterized in that described disintegrating agent is one or more the combination of polymer of cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone or microcrystalline Cellulose.
5. the preparation method of nano lanthanum carbonate and orally disintegrating tablet as claimed in claim 1 or 2 is characterized in that described filler is one or more the combination of polymer of mannitol, erythrol, lactose, sucrose, xylitol or sorbitol.
6. the preparation method of nano lanthanum carbonate and orally disintegrating tablet as claimed in claim 1 or 2 is characterized in that described correctives is one or more the combination of polymer of menthol, Oleum menthae, Radix Glycyrrhizae, citric acid, citric acid, tartaric acid, Cortex Cinnamomi or essence.
7. the preparation method of nano lanthanum carbonate and orally disintegrating tablet as claimed in claim 1 or 2 is characterized in that described bonding agent is polyvidone, Polyethylene Glycol, gives one or more the combination of polymer of gelatinized starch, dextrin or methylcellulose.
8. the preparation method of nano lanthanum carbonate and orally disintegrating tablet as claimed in claim 1 or 2 is characterized in that described nano lanthanum carbonate adopts following method preparation:
1) preparation 0.1-10wt% stabiliser solution and 0.01-0.9mol/L lanthanum compound solution, and with two kinds of solution mix homogeneously, left standstill 10-30 minute, the 0.01-1.2mol/L carbonate solution for preparing is joined in the above-mentioned mixed solution, be controlled to nuclear temperature 5-30 ℃, stirring reaction 5-20 minute; Then 10-50 ℃ and stir under continue reaction 30min-4h, stop to stir, adding concentration is the 0.1-5wt% surfactant solution, places then 10-60 minute;
2) with above-mentioned products therefrom centrifugal sedimentation 10-40min, and with distilling washing 2-4 time; With solid drying product in Muffle furnace roast 1-5 hour, temperature was controlled at 150-400 ℃ then, and heating rate is 5-10 ℃/min;
9. nano lanthanum carbonate as claimed in claim 11 adopts following method preparation, it is characterized in that described stabilizing agent is natural macromolecular gelatin, chitosan, alginate, collagen, starch, cellulose and derivant thereof; Or the synthetic organic macromolecule of polyvinyl alcohol, poly butyric ester and copolymer, poly-anhydride, polyvinyl pyrrolidone, polyoxyethylene, Polyethylene Glycol; Or the polyhydric alcohol of xylitol, sorbitol, mannitol, glycerol; Or the polysaccharide or the monosaccharide of sucrose, lactose, glucose; They mix use.
10. nano lanthanum carbonate as claimed in claim 11 adopts following method preparation, it is characterized in that described lanthanum compound is lanthanum chloride, Lanthanum (III) nitrate, lanthanum sulfate, lanthanum acetate or lanthanum oxalate; Carbonate is sodium carbonate, potassium carbonate, carbonic acid ammonia, sodium bicarbonate, potassium bicarbonate or ammonium hydrogencarbonate; Surfactant is dodecyl sodium sulfate, sorbester p17, sorbester p18 or polysorbate40.
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| US20220347210A1 (en) * | 2010-05-12 | 2022-11-03 | Unicycive Therapeutics, Inc. | Lanthanum Carbonate Hydroxide, Lanthanum Oxycarbonate and Methods of Their Manufacture and Use |
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| GB9506126D0 (en) * | 1995-03-25 | 1995-05-10 | Johnson Matthey Plc | Pharmaceutical composition and method |
| CN1302772C (en) * | 2005-05-24 | 2007-03-07 | 中国人民解放军第二军医大学 | Orally disintegrated sodium ferulate tablet and its prepn process |
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2006
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