CN104586802A - Pharmaceutical composition containing sofosbuvir - Google Patents
Pharmaceutical composition containing sofosbuvir Download PDFInfo
- Publication number
- CN104586802A CN104586802A CN201510051134.0A CN201510051134A CN104586802A CN 104586802 A CN104586802 A CN 104586802A CN 201510051134 A CN201510051134 A CN 201510051134A CN 104586802 A CN104586802 A CN 104586802A
- Authority
- CN
- China
- Prior art keywords
- suo feibuwei
- pharmaceutical composition
- composition containing
- filler
- mannitol
- 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
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 31
- 229960002063 sofosbuvir Drugs 0.000 title abstract description 4
- TTZHDVOVKQGIBA-IQWMDFIBSA-N sofosbuvir Chemical compound N1([C@@H]2O[C@@H]([C@H]([C@]2(F)C)O)CO[P@@](=O)(N[C@@H](C)C(=O)OC(C)C)OC=2C=CC=CC=2)C=CC(=O)NC1=O TTZHDVOVKQGIBA-IQWMDFIBSA-N 0.000 title abstract description 4
- 239000000945 filler Substances 0.000 claims abstract description 22
- 239000004094 surface-active agent Substances 0.000 claims abstract description 15
- 239000007787 solid Substances 0.000 claims description 30
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical group [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 28
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 28
- 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 claims description 27
- 229930195725 Mannitol Natural products 0.000 claims description 27
- 239000004141 Sodium laurylsulphate Substances 0.000 claims description 27
- 239000000594 mannitol Substances 0.000 claims description 27
- 235000010355 mannitol Nutrition 0.000 claims description 27
- 238000002360 preparation method Methods 0.000 claims description 24
- 239000000203 mixture Substances 0.000 claims description 22
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 21
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 21
- 239000000843 powder Substances 0.000 claims description 16
- 238000003756 stirring Methods 0.000 claims description 16
- 238000007907 direct compression Methods 0.000 claims description 15
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 7
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 7
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 7
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 7
- 235000019890 Amylum Nutrition 0.000 claims description 5
- 229920002472 Starch Polymers 0.000 claims description 5
- -1 Lactis Anhydrous Polymers 0.000 claims description 3
- 239000011230 binding agent Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 2
- 238000009776 industrial production Methods 0.000 abstract 1
- 238000012360 testing method Methods 0.000 description 14
- 239000000243 solution Substances 0.000 description 10
- 239000000047 product Substances 0.000 description 8
- 238000004090 dissolution Methods 0.000 description 7
- 238000000034 method Methods 0.000 description 7
- 208000005176 Hepatitis C Diseases 0.000 description 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 6
- 208000010710 hepatitis C virus infection Diseases 0.000 description 5
- 241000711549 Hepacivirus C Species 0.000 description 4
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 238000002347 injection Methods 0.000 description 4
- 238000004811 liquid chromatography Methods 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- PBCJIPOGFJYBJE-UHFFFAOYSA-N acetonitrile;hydrate Chemical compound O.CC#N PBCJIPOGFJYBJE-UHFFFAOYSA-N 0.000 description 3
- 208000019425 cirrhosis of liver Diseases 0.000 description 3
- 239000012535 impurity Substances 0.000 description 3
- 235000019359 magnesium stearate Nutrition 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 208000006154 Chronic hepatitis C Diseases 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- 208000036142 Viral infection Diseases 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 230000001684 chronic effect Effects 0.000 description 2
- 239000003085 diluting agent Substances 0.000 description 2
- 238000010812 external standard method Methods 0.000 description 2
- 239000000706 filtrate Substances 0.000 description 2
- 238000004128 high performance liquid chromatography Methods 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 208000019423 liver disease Diseases 0.000 description 2
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 2
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 description 2
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 2
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 2
- 239000013558 reference substance Substances 0.000 description 2
- 238000012216 screening Methods 0.000 description 2
- 239000000377 silicon dioxide Substances 0.000 description 2
- 230000009385 viral infection Effects 0.000 description 2
- 208000030090 Acute Disease Diseases 0.000 description 1
- 208000017667 Chronic Disease Diseases 0.000 description 1
- 102000014150 Interferons Human genes 0.000 description 1
- 108010050904 Interferons Proteins 0.000 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 208000037581 Persistent Infection Diseases 0.000 description 1
- 101800001554 RNA-directed RNA polymerase Proteins 0.000 description 1
- WEVYAHXRMPXWCK-UHFFFAOYSA-N acetonitrile Substances CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 1
- AUALQMFGWLZREY-UHFFFAOYSA-N acetonitrile;methanol Chemical compound OC.CC#N AUALQMFGWLZREY-UHFFFAOYSA-N 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 208000037621 acute hepatitis C virus infection Diseases 0.000 description 1
- 125000002252 acyl group Chemical group 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 239000003443 antiviral agent Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 238000011978 dissolution method Methods 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 229940079322 interferon Drugs 0.000 description 1
- 125000001449 isopropyl group Chemical group [H]C([H])([H])C([H])(*)C([H])([H])[H] 0.000 description 1
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 1
- 235000019796 monopotassium phosphate Nutrition 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 230000002688 persistence Effects 0.000 description 1
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 description 1
- 229940069328 povidone Drugs 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
Abstract
The invention belongs to the technical field of medicament, and in particular relates to a pharmaceutical composition containing sofosbuvir. The pharmaceutical composition contains sofosbuvir, filler and surfactant. The pharmaceutical composition product has good stability, can be dissolved completely, and has more superior product quality; the pharmaceutical composition product can be produced by simple and easy operations, and is applicable to industrial production.
Description
Technical field
The invention belongs to medical art, be specifically related to a kind of containing the pharmaceutical composition of Suo Feibuwei and the preparation method of tablet thereof.
Background technology
Hepatitis C (hepatitis C) comes from hepatitis C virus (HCV) and infects, mainly through contact infection person blood born.Hepatitis C can be divided into acute and chronic.The acute disease of acute hepatitis c virus infection after referring to hepatitis c virus infection in initial 6 months.For most people, actute infection can change chronic infection into usually.Chronic hepatitis c viral infection refers to the chronic disease of hepatitis C virus longer-term persistence in human body.Hepatitis c virus infection can even lifelong, causes serious hepatic disease, as liver cirrhosis and hepatocarcinoma.In hepatitis c virus infection person, 75% ~ 85% can develop into chronic hepatitis c viral infection, and 60% ~ 70% can develop into chronic hepatopathy, and 5% ~ 20% can develop into liver cirrhosis between 20 to 30 years, and 1% ~ 5% can die from liver cirrhosis or hepatocarcinoma.
At present for the use in conjunction of the treatment mainly multiple antiviral drugs of hepatitis C.In medicine Suo Feibuwei (Sofosbuvir) in U.S.'s Initial Public Offering of in December, 2013; chemical name is N-[[P (S); 2 ' R]-2 '-deoxidation-2 '-fluoro-2 '-methyl-P-phenyl-5 '-uridnine acyl group]-L-isopropyl propionate, molecular formula: C
22h
29fN
3o
9p, is a kind of extremely white or white crystalline solid, is slightly soluble in water.
Suo Feibuwei is a kind of NS5B AG14361, does not need to use interferon, can reduce side effect, have good curative effect some genotypic HCV.
Summary of the invention
The object of this invention is to provide a kind of pharmaceutical composition containing Suo Feibuwei newly, should contain the good stability of the pharmaceutical composition of Suo Feibuwei, dissolution is good.
Another object of the present invention is the preparation method providing a kind of pharmaceutical composition containing Suo Feibuwei, and the method is applicable to commercial production.
Specifically, the invention provides:
A pharmaceutical composition containing Suo Feibuwei, contains: Suo Feibuwei, filler, surfactant.
The described pharmaceutical composition containing Suo Feibuwei is tablet.
The described pharmaceutical composition containing Suo Feibuwei, the weight ratio of each component is:
Suo Feibuwei 30 ~ 50 weight portion
Surfactant 3 ~ 5 weight portion
Filler 30 ~ 60 weight portion.
Described filler is selected from one or more in microcrystalline Cellulose, Lactis Anhydrous, amylum pregelatinisatum, polyvidone, mannitol.
Described filler be polyvidone and mannitol composition compositions, more preferably weight ratio is 1:(5 ~ 8) polyvidone and mannitol composition compositions.
Shown surfactant is sodium lauryl sulphate.
The described pharmaceutical composition containing Suo Feibuwei is prepared into tablet, and its preparation method comprises the following steps:
(1) stir after Suo Feibuwei, surfactant mixing, obtain pulverulent solids;
(2) powder of step (1) gained is mixed homogeneously with filler, direct compression, get Suo Feibuwei tablet.
The present invention compared with prior art has the following advantages and good effect:
1, product stability of the present invention is good, and stripping is complete.
2, operation is simple for production of the present invention, is suitable for commercial production.
Summary of the invention
The object of this invention is to provide a kind of pharmaceutical composition containing Suo Feibuwei newly, should contain the good stability of the pharmaceutical composition of Suo Feibuwei, dissolution is good.
Another object of the present invention is the preparation method providing a kind of pharmaceutical composition containing Suo Feibuwei, and the method is applicable to commercial production.
Specifically, the invention provides:
A pharmaceutical composition containing Suo Feibuwei, contains: Suo Feibuwei, filler, surfactant.
The described pharmaceutical composition containing Suo Feibuwei is tablet.
The described pharmaceutical composition containing Suo Feibuwei, the weight ratio of each component is:
Suo Feibuwei 30 ~ 50 weight portion
Surfactant 3 ~ 5 weight portion
Filler 30 ~ 60 weight portion.
Described filler is selected from one or more in microcrystalline Cellulose, Lactis Anhydrous, amylum pregelatinisatum, polyvidone, mannitol.
Described filler be polyvidone and mannitol composition compositions, more preferably weight ratio is 1:(5 ~ 8) polyvidone and mannitol composition compositions.
Shown surfactant is sodium lauryl sulphate.
The described pharmaceutical composition containing Suo Feibuwei is prepared into tablet, and its preparation method comprises the following steps:
(1) stir after Suo Feibuwei, surfactant mixing, obtain pulverulent solids;
(2) powder of step (1) gained is mixed homogeneously with filler, direct compression, get Suo Feibuwei tablet.
The present invention compared with prior art has the following advantages and good effect:
1, product stability of the present invention is good, and stripping is complete.
2, operation is simple for production of the present invention, is suitable for commercial production.
Detailed description of the invention
Below by way of the description of detailed description of the invention, the invention will be further described, but this is not limitation of the present invention, those skilled in the art are according to basic thought of the present invention, various amendment or improvement can be made, but only otherwise depart from basic thought of the present invention, all within the scope of the present invention.
Suo Feibuwei is according to U.S. Patent Publication No.: method preparation described in 2010/0298257 and 2100/0251152.
Test method
Related substance gets this product 25mg, accurately weighed, puts in 25mL measuring bottle, adds diluent [water-acetonitrile (80:20), lower same] and dissolves and be diluted to scale, shake up, as need testing solution.Precision measures in right amount, quantitatively dilutes the solution made about containing Suo Feibuwei 1 μ g in every 1ml, solution in contrast with diluent.Test according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 two annex V D), be filler (4.6 × 250mm with octadecylsilane chemically bonded silica, 5 μm), with 10mmol/L potassium dihydrogen phosphate (phosphoric acid adjusts pH to 3.0)-acetonitrile (80:20) for mobile phase A, with acetonitrile-methanol (80:20) for Mobile phase B, according to the form below carries out gradient elution; Column temperature is 30 ° of C, and flow velocity is 1.0ml per minute, and determined wavelength is 260nm.Get contrast solution 10 μ l, injection liquid chromatography, regulate detection sensitivity, make the peak height of main constituent chromatographic peak be about 10% of full scale, then precision measures each 10 μ l of need testing solution, injection liquid chromatography, record chromatogram.If any impurity peaks in the chromatogram of need testing solution, single impurity peak area must not be greater than contrast solution main peak area (0.1%), each impurity peaks peak area and 10 times (1.0%) of peak area that must not be greater than contrast solution main peak.
Dissolution gets this product, according to dissolution method (Chinese Pharmacopoeia version in 2010 two annex X C second methods), with water 900ml for dissolution medium, rotating speed is 50 turns per minute, operates in accordance with the law, through 10 minutes time, get solution to filter, according to the chromatographic condition under assay item, precision measures subsequent filtrate 20 μ l, injection liquid chromatography, record chromatogram.Separately get Suo Feibuwei reference substance, accurately weighed, be dissolved in water and quantitatively dilute the solution made about containing 0.1mg in every 1ml, being measured in the same method.By external standard method with the stripping quantity of the every sheet of calculated by peak area.
[assay] measures according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 two annex V D).
Chromatographic condition and system suitability octadecylsilane chemically bonded silica are filler (4.6 × 250mm, 5 μm), and with water-acetonitrile (60:40) for mobile phase, column temperature is 30 ° of C, and flow velocity is 1.0ml per minute, and determined wavelength is 260nm.Number of theoretical plate should be not less than 3000 in Suo Feibuwei.
Algoscopy gets this product 20, accurately weighed, porphyrize, precision takes in right amount (being about equivalent to Suo Feibuwei 100mg), puts in 200ml measuring bottle, add mobile phase (water-acetonitrile (80:20), down together) jolting makes Suo Feibuwei dissolve and is diluted to scale, shaking up, and filters, precision measures subsequent filtrate 10 μ l injection liquid chromatography, record chromatogram; Separately get Suo Feibuwei reference substance, be measured in the same method.By external standard method with calculated by peak area, to obtain final product.
Test example 1: prescription screening test-surfactant is selected
Get Suo Feibuwei 40g(content 99.9% respectively, always mix 0.09%), obtained containing Suo Feibuwei sheet by following prescription (see table 1), detect dissolution and related substance, the results are shown in Table 4:
Table 3 Suo Feibuwei prescription (unit: g)
Prescription 1 preparation method:
(1) Suo Feibuwei is mixed homogeneously with microcrystalline Cellulose, polyvinylpolypyrrolidone, obtain pulverulent solids;
(2) pulverulent solids of magnesium stearate and step (1) gained mixes, direct compression, get Suo Feibuwei tablet.
Prescription 2 ~ 4 preparation method:
(1) stir after Suo Feibuwei being mixed with sodium lauryl sulphate, obtain pulverulent solids;
(2) powder to step (1) gained is mixed homogeneously with microcrystalline Cellulose, polyvinylpolypyrrolidone, obtains pulverulent solids;
(3) pulverulent solids of magnesium stearate and step (2) gained mixes, tabletting, get Suo Feibuwei tablet.
Table 2 result of the test
Result of the test shows: adopt the Suo Feibuwei Dissolution of Tablet of formula preparation of the present invention to be significantly higher than the prescription of surfactant-free interpolation, but dissolution increase not in direct ratio after the amount of sodium lauryl sulphate increases to certain degree, and there is downward trend; But product sliver rate increases after interpolation Surfactant SDS.
Test example 2: prescription screening test-filler is selected
Get Suo Feibuwei 40g(content 99.9% respectively, always mix 0.09%), obtained containing Suo Feibuwei sheet by following prescription (see table 1), detect dissolution and related substance, the results are shown in Table 4:
Table 3 Suo Feibuwei prescription (unit: g)
Prescription 1 ~ 3 preparation method:
(1) stir after Suo Feibuwei being mixed with sodium lauryl sulphate, obtain pulverulent solids;
(2) powder to step (1) gained is mixed homogeneously with filler, obtains pulverulent solids;
(3) pulverulent solids of magnesium stearate and step (2) gained mixes, tabletting, get Suo Feibuwei tablet.
Prescription 4 ~ 7 preparation method:
(1) stir after Suo Feibuwei being mixed with sodium lauryl sulphate, obtain pulverulent solids;
(2), after being mixed homogeneously by weight proportion with polyvidone by mannitol, add the powder to step (1) gained wherein, mix homogeneously, obtains pulverulent solids, direct compression, get Suo Feibuwei tablet.
Table 4 result of the test
Result of the test shows: the sliver rate of the Suo Feibuwei tablet adopting mannitol and povidone mixture to prepare as filler significantly reduces.
Test example 3: accelerated test
Example 3,5,6,8 product carries out accelerated test, the results are shown in Table 3.
Table 4 Suo Feibuwei sheet accelerated test data
Packaging: commercially available back, investigates condition: temperature 40 DEG C, humidity 75%
Conclusion: road as seen from the above table, the product prepared by the inventive method, the stability under high temperature and illumination is better than comparative example.
Preparation example
Embodiment 1
Prescription
Suo Feibuwei 40g
Sodium lauryl sulphate 5.6g
Amylum pregelatinisatum 135g
Preparation method
(1) stir after Suo Feibuwei being mixed with sodium lauryl sulphate, obtain pulverulent solids;
(2) powder of step (1) gained is mixed homogeneously with amylum pregelatinisatum, direct compression, get Suo Feibuwei tablet.
Embodiment 2
Prescription
Suo Feibuwei 35g
Sodium lauryl sulphate 5.5g
Lactis Anhydrous 138g.
Preparation method
(1) stir after Suo Feibuwei being mixed with sodium lauryl sulphate, obtain pulverulent solids;
(2) powder of step (1) gained is mixed homogeneously with Lactis Anhydrous, direct compression, get Suo Feibuwei tablet.
Embodiment 3
Prescription
Suo Feibuwei 40g
Sodium lauryl sulphate 8.0g
Microcrystalline Cellulose 145g.
Preparation method
(1) stir after Suo Feibuwei being mixed with sodium lauryl sulphate, obtain pulverulent solids;
(2) powder of step (1) gained is mixed homogeneously with microcrystalline Cellulose, direct compression, get Suo Feibuwei tablet.
Embodiment 4
Prescription
Suo Feibuwei 45g
Sodium lauryl sulphate 6.3g
Mannitol 154g.
Preparation method
(1) stir after Suo Feibuwei being mixed with sodium lauryl sulphate, obtain pulverulent solids;
(2) powder of step (1) gained is mixed homogeneously with mannitol, direct compression, get Suo Feibuwei tablet.
Embodiment 5
Prescription
Suo Feibuwei 43g
Sodium lauryl sulphate 7.2g
Mannitol 120g
Polyvidone 20g.
Preparation method
(1) stir after Suo Feibuwei being mixed with sodium lauryl sulphate, obtain pulverulent solids;
(2), after being mixed homogeneously by weight proportion with polyvidone by mannitol, add the powder to step (1) gained wherein, mix homogeneously, obtains pulverulent solids, direct compression, get Suo Feibuwei tablet.
Embodiment 6
Prescription
Suo Feibuwei 38g
Sodium lauryl sulphate 6.4g
Mannitol 126g
Polyvidone 16g.
Preparation method
(1) stir after Suo Feibuwei being mixed with sodium lauryl sulphate, obtain pulverulent solids;
(2), after being mixed homogeneously by weight proportion with polyvidone by mannitol, add the powder to step (1) gained wherein, mix homogeneously, obtains pulverulent solids, direct compression, get Suo Feibuwei tablet.
Embodiment 7
Prescription
Suo Feibuwei 40g
Sodium lauryl sulphate 6.2g
Mannitol 125g
Mannitol 25g.
Preparation method
(1) stir after Suo Feibuwei being mixed with sodium lauryl sulphate, obtain pulverulent solids;
(2), after being mixed homogeneously by weight proportion with mannitol by mannitol, add the powder to step (1) gained wherein, mix homogeneously, obtains pulverulent solids, direct compression, get Suo Feibuwei tablet.
Embodiment 8
Prescription
Suo Feibuwei 37g
Sodium lauryl sulphate 5.3g
Mannitol 124g
Polyvidone 15g.
Preparation method
(1) stir after Suo Feibuwei being mixed with sodium lauryl sulphate, obtain pulverulent solids;
(2), after being mixed homogeneously by weight proportion with polyvidone by mannitol, add the powder to step (1) gained wherein, mix homogeneously, obtains pulverulent solids, direct compression, get Suo Feibuwei tablet.
Embodiment 9
Prescription
Suo Feibuwei 20g
Sodium lauryl sulphate 4.5g
Mannitol 60g
Polyvidone 7.5g.
Preparation method
(1) stir after Suo Feibuwei being mixed with sodium lauryl sulphate, obtain pulverulent solids;
(2), after being mixed homogeneously by weight proportion with polyvidone by mannitol, add the powder to step (1) gained wherein, mix homogeneously, obtains pulverulent solids, direct compression, get Suo Feibuwei tablet.
Embodiment 10
Prescription
Suo Feibuwei 4.0g
Sodium lauryl sulphate 6.1g
Mannitol 10g
Polyvidone 3g.
Preparation method
(1) stir after Suo Feibuwei being mixed with sodium lauryl sulphate, obtain pulverulent solids;
(2), after being mixed homogeneously by weight proportion with polyvidone by mannitol, add the powder to step (1) gained wherein, mix homogeneously, obtains pulverulent solids, direct compression, get Suo Feibuwei tablet.
Claims (8)
1. the pharmaceutical composition containing Suo Feibuwei, is characterized in that pharmaceutical composition contains: Suo Feibuwei, filler, binding agent, surfactant.
2., according to the pharmaceutical composition containing Suo Feibuwei described in claim 1, it is characterized in that pharmaceutical composition is prepared into tablet.
3., according to the pharmaceutical composition containing Suo Feibuwei described in claim 1, it is characterized in that the weight ratio of each component is:
Suo Feibuwei 30 ~ 50 weight portion
Surfactant 5 ~ 15 weight portion
Filler 130 ~ 160 weight portion.
4., according to the pharmaceutical composition containing Suo Feibuwei described in claim 1, it is characterized in that: described filler is selected from one or more in microcrystalline Cellulose, Lactis Anhydrous, amylum pregelatinisatum, polyvidone, mannitol.
5. the pharmaceutical composition containing Suo Feibuwei according to claim 4, is characterized in that described filler is the compositions of polyvidone and mannitol composition.
6. the pharmaceutical composition containing Suo Feibuwei according to claim 5, is characterized in that described filler be weight ratio is 1:(5 ~ 8) polyvidone and the compositions of mannitol composition.
7., according to the pharmaceutical composition containing Suo Feibuwei described in claim 1, it is characterized in that described surfactant is sodium lauryl sulphate.
8. the preparation method of the pharmaceutical composition containing Suo Feibuwei according to claim 1, its preparation method comprises the following steps:
(1) stir after Suo Feibuwei, surfactant mixing, obtain pulverulent solids;
(2) powder of step (1) gained is mixed homogeneously with filler, direct compression, get Suo Feibuwei tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510051134.0A CN104586802B (en) | 2015-02-02 | 2015-02-02 | A kind of pharmaceutical composition containing Suo Feibuwei |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510051134.0A CN104586802B (en) | 2015-02-02 | 2015-02-02 | A kind of pharmaceutical composition containing Suo Feibuwei |
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| Publication Number | Publication Date |
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| CN104586802B CN104586802B (en) | 2018-01-16 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017060374A1 (en) * | 2015-10-07 | 2017-04-13 | Sandoz Ag | Solid pharmaceutical composition comprising amorphous sofosbuvir |
| WO2018029262A1 (en) * | 2016-08-12 | 2018-02-15 | Sandoz Ag | Solid pharmaceutical composition comprising amorphous sofosbuvir |
| CN110214711A (en) * | 2019-06-28 | 2019-09-10 | 昱庆塑胶五金制品（惠州）有限公司 | Intelligent pet feeder |
| CN111773192A (en) * | 2020-08-18 | 2020-10-16 | 福建广生堂药业股份有限公司 | Sofosbuvir tablet and preparation method thereof |
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| CN103328480A (en) * | 2011-11-16 | 2013-09-25 | 吉利德科学公司 | Condensed imidazolylimidazoles as antiviral compounds |
| WO2014120981A1 (en) * | 2013-01-31 | 2014-08-07 | Gilead Pharmasset Llc | Combination formulation of two antiviral compounds |
| CN104039319A (en) * | 2011-11-29 | 2014-09-10 | 吉利德法莫赛特有限责任公司 | Compositions and methods for treating hepatitis c virus |
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| CN103328480A (en) * | 2011-11-16 | 2013-09-25 | 吉利德科学公司 | Condensed imidazolylimidazoles as antiviral compounds |
| CN104039319A (en) * | 2011-11-29 | 2014-09-10 | 吉利德法莫赛特有限责任公司 | Compositions and methods for treating hepatitis c virus |
| WO2014120981A1 (en) * | 2013-01-31 | 2014-08-07 | Gilead Pharmasset Llc | Combination formulation of two antiviral compounds |
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| WO2017060374A1 (en) * | 2015-10-07 | 2017-04-13 | Sandoz Ag | Solid pharmaceutical composition comprising amorphous sofosbuvir |
| WO2018029262A1 (en) * | 2016-08-12 | 2018-02-15 | Sandoz Ag | Solid pharmaceutical composition comprising amorphous sofosbuvir |
| CN110214711A (en) * | 2019-06-28 | 2019-09-10 | 昱庆塑胶五金制品（惠州）有限公司 | Intelligent pet feeder |
| CN111773192A (en) * | 2020-08-18 | 2020-10-16 | 福建广生堂药业股份有限公司 | Sofosbuvir tablet and preparation method thereof |
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| CN104586802B (en) | 2018-01-16 |
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Address after: 130012, 672, pioneering street, hi tech Zone, Jilin, Changchun Applicant after: CHANGCHUN HAIYUE PHARMACEUTICAL Co.,Ltd. Address before: 130012, 672, pioneering street, hi tech Zone, Jilin, Changchun Applicant before: Changchun Haiyue Pharmaceutical Co.,Ltd. |
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Denomination of invention: A drug combination containing soffebuvir Effective date of registration: 20231226 Granted publication date: 20180116 Pledgee: China Construction Bank Co.,Ltd. Changchun Science and Technology Sub branch Pledgor: CHANGCHUN HAIYUE PHARMACEUTICAL Co.,Ltd. Registration number: Y2023220000149 |
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