CN102525976A - Method for preparing strontium ranelate orally disintegrating tablets with fluidized bed - Google Patents
Method for preparing strontium ranelate orally disintegrating tablets with fluidized bed Download PDFInfo
- Publication number
- CN102525976A CN102525976A CN2011104180372A CN201110418037A CN102525976A CN 102525976 A CN102525976 A CN 102525976A CN 2011104180372 A CN2011104180372 A CN 2011104180372A CN 201110418037 A CN201110418037 A CN 201110418037A CN 102525976 A CN102525976 A CN 102525976A
- Authority
- CN
- China
- Prior art keywords
- strontium ranelate
- fluidized bed
- adhesive
- oral cavity
- lubricant
- 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.)
- Granted
Links
- XXUZFRDUEGQHOV-UHFFFAOYSA-J strontium ranelate Chemical compound [Sr+2].[Sr+2].[O-]C(=O)CN(CC([O-])=O)C=1SC(C([O-])=O)=C(CC([O-])=O)C=1C#N XXUZFRDUEGQHOV-UHFFFAOYSA-J 0.000 title claims abstract description 42
- 229940079488 strontium ranelate Drugs 0.000 title claims abstract description 41
- 238000000034 method Methods 0.000 title claims abstract description 34
- 239000006191 orally-disintegrating tablet Substances 0.000 title abstract 4
- 239000008187 granular material Substances 0.000 claims abstract description 14
- 239000000945 filler Substances 0.000 claims abstract description 12
- 239000000314 lubricant Substances 0.000 claims abstract description 12
- 238000005469 granulation Methods 0.000 claims abstract description 11
- 230000003179 granulation Effects 0.000 claims abstract description 11
- 238000001035 drying Methods 0.000 claims abstract description 7
- 238000003756 stirring Methods 0.000 claims abstract description 5
- 238000007873 sieving Methods 0.000 claims abstract description 4
- 239000007921 spray Substances 0.000 claims abstract description 4
- 239000002904 solvent Substances 0.000 claims abstract description 3
- 210000000214 mouth Anatomy 0.000 claims description 23
- 239000000853 adhesive Substances 0.000 claims description 14
- 230000001070 adhesive effect Effects 0.000 claims description 14
- 239000012530 fluid Substances 0.000 claims description 14
- 239000003795 chemical substances by application Substances 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 229920003081 Povidone K 30 Polymers 0.000 claims description 4
- 238000012545 processing Methods 0.000 claims description 2
- 238000002156 mixing Methods 0.000 abstract description 2
- 239000011230 binding agent Substances 0.000 abstract 3
- 239000007884 disintegrant Substances 0.000 abstract 2
- 230000001105 regulatory effect Effects 0.000 abstract 2
- 238000010298 pulverizing process Methods 0.000 abstract 1
- 238000005507 spraying Methods 0.000 abstract 1
- 239000003826 tablet Substances 0.000 description 21
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 15
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 10
- 239000000243 solution Substances 0.000 description 8
- 238000002360 preparation method Methods 0.000 description 7
- 239000000725 suspension Substances 0.000 description 6
- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 description 5
- 235000019359 magnesium stearate Nutrition 0.000 description 5
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 description 5
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 5
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 5
- 229940013618 stevioside Drugs 0.000 description 5
- OHHNJQXIOPOJSC-UHFFFAOYSA-N stevioside Natural products CC1(CCCC2(C)C3(C)CCC4(CC3(CCC12C)CC4=C)OC5OC(CO)C(O)C(O)C5OC6OC(CO)C(O)C(O)C6O)C(=O)OC7OC(CO)C(O)C(O)C7O OHHNJQXIOPOJSC-UHFFFAOYSA-N 0.000 description 5
- 235000019202 steviosides Nutrition 0.000 description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 3
- 229930195725 Mannitol Natural products 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 239000000594 mannitol Substances 0.000 description 3
- 235000010355 mannitol Nutrition 0.000 description 3
- 208000001132 Osteoporosis Diseases 0.000 description 2
- 238000002835 absorbance Methods 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000000654 additive Substances 0.000 description 2
- 230000000996 additive effect Effects 0.000 description 2
- 239000007910 chewable tablet Substances 0.000 description 2
- 229940068682 chewable tablet Drugs 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 239000012895 dilution Substances 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- 239000012738 dissolution medium Substances 0.000 description 2
- 238000011978 dissolution method Methods 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 239000000706 filtrate Substances 0.000 description 2
- 238000004108 freeze drying Methods 0.000 description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000005374 membrane filtration Methods 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 238000009702 powder compression Methods 0.000 description 2
- 230000002265 prevention Effects 0.000 description 2
- 239000008213 purified water Substances 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 239000006104 solid solution Substances 0.000 description 2
- 238000000870 ultraviolet spectroscopy Methods 0.000 description 2
- 108010011485 Aspartame Proteins 0.000 description 1
- 208000006386 Bone Resorption Diseases 0.000 description 1
- 208000019505 Deglutition disease Diseases 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 229920000881 Modified starch Polymers 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 description 1
- 235000010357 aspartame Nutrition 0.000 description 1
- 239000000605 aspartame Substances 0.000 description 1
- 229960003438 aspartame Drugs 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 230000024279 bone resorption Effects 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 1
- 229960004106 citric acid Drugs 0.000 description 1
- 235000015165 citric acid Nutrition 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000009977 dual effect Effects 0.000 description 1
- 210000003238 esophagus Anatomy 0.000 description 1
- 125000000267 glycino group Chemical group [H]N([*])C([H])([H])C(=O)O[H] 0.000 description 1
- 230000008676 import Effects 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
Images
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention provides a method for preparing strontium ranelate orally disintegrating tablets with a fluidized bed, which mainly comprises the following steps: pulverizing and sieving strontium ranelate, a filler, a binder, a disintegrant, a correctant and a lubricant, or directly sieving the above. The concrete method comprises the following steps: adding the binder into a proper solvent, and stirring to prepare into a solution; adding the treated strontium ranelate and filler into a fluidized bed, regulating parameters, spraying the binder into the fluidized bed with a spray gun for granulation; after granulation, regulating parameters, and drying; mixing the dried granules with the disintegrant, the correctant and the lubricant in a mixer; and tableting the mixed granules as required to obtain the strontium ranelate orally disintegrating tablets. Compared with other methods, the method for preparing strontium ranelate orally disintegrating tablets with the fluidized bed, provided by the invention, has the advantages of low cost, simple process, good mouthfeel, and the like.
Description
Technical field
The present invention relates to a kind of preparation of strontium ranelate oral cavity disintegration tablet, particularly a kind of method of using fluid bed to prepare the strontium ranelate oral cavity disintegration tablet.
Background technology
Strontium ranelate, English name strontium ranelate has another name called Strontium Ranelate.Its chemistry 5-[two (carboxymethyl) amino] by name-2-carboxyl-4-cyanic acid-3-thiophene acetic acid two strontiums, CAS RN:135459-87-1.Be mainly used in treatment and prevention postmenopausal women's osteoporosis.Can suppress bone resorption because of it is exclusive and can promote that again osteoplastic dual function receives much concern.
Strontium ranelate by the development of French Shi Weiya company, goes on the market in European Union in JIUYUE, 2004 the earliest.Dosage form is a dry suspension, and commodity are called Protelos, and specification is the 2g/ bag.
The synthetic patent of strontium ranelate is more, comprises the open or mandate of a plurality of patents of different water compound and different intermediate.The preparation patent comprises dry suspension, granule, chewable tablet, oral liquid and compositions etc.The use fluid bed that the present invention relates to prepares the method for strontium ranelate oral cavity disintegration tablet and does not appear in the newspapers.
Strontium ranelate is mainly used in treatment and prevention postmenopausal women's osteoporosis.Because of some patient of this patient crowd of reasons such as age and disease with in various degree dysphagia.For this part patient, dry suspension, granule, oral liquid, especially chewable tablet are inappropriate for and take.And oral cavity disintegration tablet can disintegrate in about 30 seconds or dissolving in the oral cavity, not water or seldom water can get into esophagus with swallowing act, extremely be fit to this part patient and use.
The method for preparing oral cavity disintegration tablet commonly used has lyophilization, solid solution method, fluidized bed granulation method and direct powder compression.Comparatively speaking, the tablet that lyophilization and solid solution method make does not have grittiness, and mouthfeel is best.But need particular device, cost is very high, and complex process.The direct powder compression cost is minimum, and technology is simple, but mouthfeel is relatively poor, and grittiness is arranged more.Fluidized bed granulation method in cost, technology difficulty and mouthfeel all between above-mentioned two kinds of methods.Along with the development of domestic medicinal machinery, the use of fluid bed also obtains suitable popularizing, and is optimal relatively method of present stage so use fluidized bed granulation method to prepare oral cavity disintegration tablet.
Summary of the invention
Advantages such as the object of the invention provides a kind of method of using fluid bed to prepare the strontium ranelate oral cavity disintegration tablet, with respect to additive method, has cost lower, and technology is simple, and mouthfeel is better.
The quality group of the each component of a kind of strontium ranelate oral cavity disintegration tablet provided by the invention becomes:
Strontium ranelate: 1-2 part
Filler: 0.5-2 part
Disintegrating agent: 0.1-0.5 part
Adhesive: 0.02-0.2 part
Correctives: 0.02-0.2 part
Lubricant: 0.02-0.2 part
Wherein filler is at least a kind of in microcrystalline Cellulose, pregelatinized Starch, lactose or the mannitol.
Disintegrating agent is at least a kind of in polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, the low-substituted hydroxypropyl cellulose.
Adhesive is at least a kind of in polyvidone or the hydroxypropyl methylcellulose.
Correctives is at least a kind of in aspartame, stevioside, citric acid or the Fructus Citri Limoniae essence.
Lubricant is at least a kind of in magnesium stearate, Pulvis Talci or the micropowder silica gel.
A kind of method of using fluid bed to prepare the strontium ranelate oral cavity disintegration tablet provided by the invention mainly may further comprise the steps:
1) strontium ranelate, filler, adhesive, disintegrating agent, correctives and lubricant are pulverized and the processing of sieving, or directly sieved.
2) adhesive is added in the solvent stirs, be configured to solution for standby.
3) strontium ranelate after will handling and filler add in the fluid bed, and ordering parameter uses spray gun that adhesive solution is sprayed in the fluid bed and granulates.
4) after granulation finished, ordering parameter carried out drying.
5) dried granule is mixed in blender with disintegrating agent, correctives and lubricant.
6) mixed granule on request (every contains strontium ranelate 2g) carry out tabletting, promptly get the strontium ranelate oral cavity disintegration tablet.
Sieve number in the step 1) is the 60-120 order, preferred 80-100 order.
Step 2) adhesive in is polyvidone or hydroxypropyl methylcellulose, preferred 30 POVIDONE K 30 BP/USP 30.
Parameter in the step 3) is: EAT 50-60 ℃, and temperature of charge 30-40 ℃, atomizing pressure 0.01-0.05Mpa, 15-30 rev/min of hydrojet speed, intake 35-45 hertz.
Parameter in the step 4) is: EAT 60-70 ℃, and temperature of charge 30-40 ℃, intake 35-50 hertz.
Advantages such as use fluid bed provided by the invention prepares the method for strontium ranelate oral cavity disintegration tablet, with respect to additive method, has cost lower, and technology is simple, and mouthfeel is better.
Description of drawings:
Fig. 1: the strontium ranelate oral cavity disintegration tablet and the external stripping comparison curves of import dry suspension (Ou Simei) of the embodiment of the invention 1 preparation.
Fig. 2: the external stripping curve of the strontium ranelate oral cavity disintegration tablet of the embodiment of the invention 2 preparations.
The specific embodiment:
Embodiment 1
Prescription: (mass ratio)
Method for preparing:
1,100 mesh sieves, adhesive (30 POVIDONE K 30 BP/USP 30), disintegrating agent (polyvinylpolypyrrolidone), correctives (citric acid and stevioside) and direct mistake 80 mesh sieves of lubricant (magnesium stearate) are pulverized and crossed to strontium ranelate, filler (mannitol).
2, adhesive (30 POVIDONE K 30 BP/USP 30) is added in the purified water and stirs, be made into 10% solution for standby.
3, strontium ranelate after will handling and filler add in the fluid bed (fluidised bed granulator that pharmacy is general: accomplish boiling mixing, spray granulation, pneumatic conveying drying); Ordering parameter: EAT 50-60 ℃; Temperature of charge 30-40 ℃, atomizing pressure 0.01-0.05Mpa, 15-30 rev/min of hydrojet speed; Intake 35-45 hertz is granulated.
4, after granulation finished, ordering parameter: EAT 60-70 ℃, temperature of charge 30-40 ℃, intake 35-50 hertz carried out drying.
5, use blender to mix dried granule and disintegrating agent (polyvinylpolypyrrolidone), correctives (citric acid and stevioside) and lubricant (magnesium stearate).
6, mixed granule carries out tabletting (every contains strontium ranelate 2g) on request, promptly gets the strontium ranelate oral cavity disintegration tablet.
Test and result:
The oral cavity disintegration tablet of embodiment 1 preparation, its extracorporeal releasing experiment method is following: select the II method of 2010 editions appendix XC of Chinese Pharmacopoeia dissolution method for use, 1000ml is a dissolution medium with hydrochloric acid solution (9 → 1000), 50 rev/mins of rotating speeds; Operation in accordance with the law is at official hour point (2,4,7; 10,15 minutes) sampling, with the filter membrane filtration of 0.8 μ m; Remove filtrating 5ml just, get 100 times of the accurate 1.0ml of the absorption dilutions of subsequent filtrate 5ml, as need testing solution.According to ultraviolet visible spectrophotometry (two appendix IVA of Chinese Pharmacopoeia version in 2010), measure absorbance in the wavelength of 322nm; Absorptance (E1%1cm) by C12H6N2O8SSr2 is the dissolution of every of 325 calculating.With time is abscissa, and accumulative total degree of release is a vertical coordinate, draws stripping curve.See accompanying drawing 1.Accompanying drawing 1 is the strontium ranelate oral cavity disintegration tablet of embodiment 1 preparation and the external stripping curve comparison diagram of strontium ranelate dry suspension (Ou Simei).
Accompanying drawing 1 can demonstrate clearly with dry suspension and compare, and the dissolution rate of the oral cavity disintegration tablet that the present invention makes is faster, is more conducive to absorb.
Prescription: (mass ratio)
Method for preparing:
1,100 mesh sieves, adhesive (hydroxypropyl methylcellulose E5), disintegrating agent (polyvinylpolypyrrolidone), correctives (citric acid and stevioside) and direct mistake 80 mesh sieves of lubricant (magnesium stearate) are pulverized and crossed to strontium ranelate, filler (mannitol).
2, adhesive (hydroxypropyl methylcellulose E5) is added in the purified water and stirs, be made into 3% solution for standby.
3, strontium ranelate after will handling and filler add in the fluid bed, ordering parameter: EAT 50-60 ℃, and temperature of charge 30-40 ℃, atomizing pressure 0.01-0.05Mpa, 15-30 rev/min of hydrojet speed, intake 35-45 hertz is granulated.
4, after granulation finished, ordering parameter: EAT 60-70 ℃, temperature of charge 30-40 ℃, intake 35-50 hertz carried out drying.
5, use blender to mix dried granule and disintegrating agent (polyvinylpolypyrrolidone), correctives (citric acid and stevioside) and lubricant (magnesium stearate).
6, mixed granule carries out tabletting (every contains strontium ranelate 2g) on request, promptly gets the strontium ranelate oral cavity disintegration tablet.
Test and result:
The oral cavity disintegration tablet of embodiment 2 preparations, its extracorporeal releasing experiment method is following: select the II method of 2010 editions appendix XC of Chinese Pharmacopoeia dissolution method for use, 1000ml is a dissolution medium with hydrochloric acid solution (9 → 1000), 50 rev/mins of rotating speeds; Operation in accordance with the law is at official hour point (2,4,7; 10,15 minutes) sampling, with the filter membrane filtration of 0.8 μ m; Remove filtrating 5ml just, get 100 times of the accurate 1.0ml of the absorption dilutions of subsequent filtrate 5ml, as need testing solution.According to ultraviolet visible spectrophotometry (two appendix IVA of Chinese Pharmacopoeia version in 2010), measure absorbance in the wavelength of 322nm; Absorptance (E1%1cm) by C12H6N2O8SSr2 is the dissolution of every of 325 calculating.With time is abscissa, and accumulative total degree of release is a vertical coordinate, draws stripping curve.See accompanying drawing 2.
Claims (5)
1. method of using fluid bed to prepare the strontium ranelate oral cavity disintegration tablet is characterized in that it may further comprise the steps:
1), strontium ranelate, filler, adhesive, disintegrating agent, correctives and lubricant are pulverized and the processing of sieving, or directly sieve, sieve number is the 60-120 order;
2), adhesive is added in the The suitable solvent water stirs, be configured to solution for standby;
3), the strontium ranelate after will handling and filler add in the fluid bed, adjustment granulation parameter is used spray gun that adhesive solution is sprayed in the fluid bed and is granulated;
4), granulate to finish after, ordering parameter carries out drying;
5), use blender to mix dried granule and disintegrating agent, correctives and lubricant;
6), mixed granule tabletting, promptly get the strontium ranelate oral cavity disintegration tablet.
2. according to the described method of claim 1, it is characterized in that described sieve number is the 80-100 order.
3. according to the described method of claim 1, it is characterized in that described adhesive is a 30 POVIDONE K 30 BP/USP 30.
4. according to the described method of claim 1, it is characterized in that described granulation parameter is: EAT 50-60 ℃, temperature of charge 30-40 ℃, atomizing pressure 0.01-0.05Mpa, 15-30 rev/min of hydrojet speed, intake 35-45 hertz.
5. according to the described method of claim 1, it is characterized in that the described drying parameter of step 4) is: EAT 60-70 ℃, temperature of charge 30-40 ℃, intake 35-50 hertz.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 201110418037 CN102525976B (en) | 2011-12-14 | 2011-12-14 | Method for preparing strontium ranelate orally disintegrating tablets with fluidized bed |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 201110418037 CN102525976B (en) | 2011-12-14 | 2011-12-14 | Method for preparing strontium ranelate orally disintegrating tablets with fluidized bed |
Publications (2)
Publication Number | Publication Date |
---|---|
CN102525976A true CN102525976A (en) | 2012-07-04 |
CN102525976B CN102525976B (en) | 2013-05-22 |
Family
ID=46334810
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN 201110418037 Expired - Fee Related CN102525976B (en) | 2011-12-14 | 2011-12-14 | Method for preparing strontium ranelate orally disintegrating tablets with fluidized bed |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN102525976B (en) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104546950A (en) * | 2015-01-28 | 2015-04-29 | 海南葫芦娃制药有限公司 | Compound endothelium corneum gigeriae galli orally disintegrating tablet for children and preparation method thereof |
CN108567575A (en) * | 2017-03-14 | 2018-09-25 | 重庆润泽医药有限公司 | A kind of Oxiracetam oral preparation preparation method that suitable the elderly takes |
CN111437245A (en) * | 2020-03-30 | 2020-07-24 | 韶关学院 | Camellia chrysantha L-theanine oral preparation for preventing novel coronavirus pneumonia and preparation method and application thereof |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1582927A (en) * | 2003-08-20 | 2005-02-23 | 范敏华 | Oral disintegrants of nimodipine and their preparation |
CN101292977A (en) * | 2007-04-28 | 2008-10-29 | 天津药物研究院 | Pharmaceutical combination with stable strontium ranelate and its preparations |
WO2010021000A2 (en) * | 2008-08-22 | 2010-02-25 | Glenmark Generics Limited | A process for the preparation of strontium ranelate |
JP2011136939A (en) * | 2009-12-28 | 2011-07-14 | Lion Corp | Herbal medicine-containing tablet, and method for producing herbal medicine-carrying particle used for herbal medicine-containing tablet |
-
2011
- 2011-12-14 CN CN 201110418037 patent/CN102525976B/en not_active Expired - Fee Related
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1582927A (en) * | 2003-08-20 | 2005-02-23 | 范敏华 | Oral disintegrants of nimodipine and their preparation |
CN101292977A (en) * | 2007-04-28 | 2008-10-29 | 天津药物研究院 | Pharmaceutical combination with stable strontium ranelate and its preparations |
WO2010021000A2 (en) * | 2008-08-22 | 2010-02-25 | Glenmark Generics Limited | A process for the preparation of strontium ranelate |
JP2011136939A (en) * | 2009-12-28 | 2011-07-14 | Lion Corp | Herbal medicine-containing tablet, and method for producing herbal medicine-carrying particle used for herbal medicine-containing tablet |
Non-Patent Citations (2)
Title |
---|
刘怡,等: "流化床制粒影响因素的探讨", 《中国医药工业杂志》, vol. 35, no. 9, 31 December 2004 (2004-12-31) * |
刘蜀宝: "《药剂学》", 31 July 2004, article "片剂常用的辅料", pages: 176-181 * |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104546950A (en) * | 2015-01-28 | 2015-04-29 | 海南葫芦娃制药有限公司 | Compound endothelium corneum gigeriae galli orally disintegrating tablet for children and preparation method thereof |
CN104546950B (en) * | 2015-01-28 | 2017-11-24 | 海南葫芦娃药业集团股份有限公司 | Children's compound the membrane of a chicken's gizzard oral disnitegration tablet and preparation method thereof |
CN108567575A (en) * | 2017-03-14 | 2018-09-25 | 重庆润泽医药有限公司 | A kind of Oxiracetam oral preparation preparation method that suitable the elderly takes |
CN111437245A (en) * | 2020-03-30 | 2020-07-24 | 韶关学院 | Camellia chrysantha L-theanine oral preparation for preventing novel coronavirus pneumonia and preparation method and application thereof |
Also Published As
Publication number | Publication date |
---|---|
CN102525976B (en) | 2013-05-22 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
ES2768349T3 (en) | Pharmaceutical preparation comprising a phenylalanine derivative | |
RU2466717C2 (en) | Pharmaceutical solid preparation containing benzazepin and method for preparing it | |
CN102470178B (en) | Tolvaptan solid dispersion and its preparation method | |
CN113939289A (en) | Oral solid tablet containing Bruton's tyrosine kinase inhibitor and preparation method thereof | |
CN105412036A (en) | Brexpiprazole orally disintegrating tablets | |
CN103830184A (en) | Solid dispersion system of febuxostat and preparation method of solid dispersion system, and pharmaceutical applications | |
CN103393617B (en) | Febustat tablet and preparation method thereof | |
KR101834559B1 (en) | Solid composite formulation for oral administration comprising ezetimibe and rosuvastatin | |
CN102525976B (en) | Method for preparing strontium ranelate orally disintegrating tablets with fluidized bed | |
WO2023070985A1 (en) | Abidor hydrochloride tablet and preparation method therefor | |
CN104271134B (en) | Tablet containing 5-hydroxyl-1H-imidazoles-4-Methanamide | |
CN104906160B (en) | A kind of enteric coated preparations of erigeron breviscapus extract | |
CN106511291A (en) | Acotiamide hydrochloride controlled release tablet and preparation method thereof | |
CN101011362A (en) | Dispersible tablet of pidotimod and its preparing process and use | |
CA2782498C (en) | Tablet composition containing kampo medicinal extract and its manufacturing process | |
CN103271886B (en) | Pirfenidone tablet and preparation method thereof | |
CN115531327A (en) | Irbesartan tablets and preparation method thereof | |
CN111803456A (en) | Rapidly disintegrating composite auxiliary material and preparation method thereof | |
CN113368073A (en) | Method for producing a pharmaceutical preparation for reducing blood uric acid levels | |
CN112057427A (en) | Oral solid tablet containing Bruton's tyrosine kinase inhibitor and preparation method thereof | |
CN108514550A (en) | Solid drugs and preparation method thereof containing Abiraterone acetate | |
WO2022042646A1 (en) | Lurasidone hydrochloride composition and preparation method therefor | |
CN102525975B (en) | Strontium ranelate orally disintegrating tablets and preparation method thereof | |
CN107375938B (en) | Glucosamine hydrochloride adhesive, tablets and preparation method thereof | |
CN107684548B (en) | Mosapride citrate preparation and preparation method thereof |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20130522 |