CN104586802B - A kind of pharmaceutical composition containing Suo Feibuwei - Google Patents

A kind of pharmaceutical composition containing Suo Feibuwei Download PDF

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Publication number
CN104586802B
CN104586802B CN201510051134.0A CN201510051134A CN104586802B CN 104586802 B CN104586802 B CN 104586802B CN 201510051134 A CN201510051134 A CN 201510051134A CN 104586802 B CN104586802 B CN 104586802B
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Prior art keywords
suo feibuwei
pharmaceutical composition
mannitol
feibuwei
sodium sulfate
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CN104586802A (en
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栾建
刘纵横
周明
尚宇
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CHANGCHUN HAIYUE PHARMACEUTICAL Co Ltd
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CHANGCHUN HAIYUE PHARMACEUTICAL Co Ltd
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Abstract

The invention belongs to pharmaceutical technology field, and in particular to a kind of pharmaceutical composition containing Suo Feibuwei, described pharmaceutical composition contain Suo Feibuwei, filler, surfactant.The product stability of the invention of the present invention is good, and dissolution is complete, has more outstanding product quality;Operation is simple for the production of the present invention, is suitable for industrial production.

Description

A kind of pharmaceutical composition containing Suo Feibuwei
Technical field
The invention belongs to pharmaceutical technology field, and in particular to a kind of pharmaceutical composition containing Suo Feibuwei and its tablet Preparation method.
Background technology
Hepatitis C(Hepatitis)Come from HCV(HCV)Infection, mainly passes through contact infection person's blood born.Third Liver can be divided into it is acute with it is chronic.Acute hepatitis c virus infection refers to the acute disease in initial 6 months after hepatitis c virus infection.For For most people, acute infection generally translates into chronic infection.Chronic hepatitis C virus infection refers to that hepatitis C virus is deposited for a long time The chronic disease stayed in human body.Hepatitis c virus infection can cause serious liver diseases, such as hepatic sclerosis and liver with even lifelong Cancer.75%~85% can develop into chronic hepatitis C virus infection in hepatitis c virus infection person, and 60%~70% can develop into chronic liver disease, 5%~20% can develop into hepatic sclerosis between 20 to 30 years, and 1%~5% can die from hepatic sclerosis or liver cancer.
Treatment currently for hepatitis is mainly the use in conjunction of a variety of antiviral drugs.In December, 2013 in U.S. The medicine Suo Feibuwei (Sofosbuvir) of state's Initial Public Offering, chemical name are N- [[P (S), 2 ' R] -2 '-deoxidations -2 '-fluoro- 2 '-methyl-P- phenyl -5 '-uridine acyl group]-L- isopropyl propionates, molecular formula: C22H29FN3O9P, it is that a kind of white is extremely or white Color crystalline solid, is slightly soluble in water.
Suo Feibuwei is a kind of NS5B AG14361s, is without the use of interferon to the HCV of some genotype, can Side effect is reduced, there is the effect of good.
The content of the invention
, should the medicine containing Suo Feibuwei it is an object of the invention to provide a kind of new pharmaceutical composition containing Suo Feibuwei The stability of compositions is good, and dissolution rate is good.
It is another object of the present invention to provide a kind of preparation method of the pharmaceutical composition containing Suo Feibuwei, the party Method is adapted to industrial production.
Specifically, the invention provides:
A kind of 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 are:
The parts by weight of Suo Feibuwei 30 ~ 50
The parts by weight of surfactant 3 ~ 5
The parts by weight of filler 30 ~ 60.
The one kind of described filler in microcrystalline cellulose, Lactis Anhydrous, amylum pregelatinisatum, PVP, mannitol It is or several.
Described filler is the composition that PVP and mannitol form, and more preferably weight ratio is 1:(5~8) PVP and mannitol composition composition.
Shown surfactant is lauryl sodium sulfate.
The described pharmaceutical composition containing Suo Feibuwei prepares piece agent, and its preparation method comprises the following steps:
(1) stirred after mixing Suo Feibuwei, surfactant, obtain pulverulent solids;
(2) powder obtained by step (1) is well mixed with filler, direct tablet compressing, get Suo Feibuwei tablets.
The present invention has the advantages that compared with prior art:
1st, product stability of the invention is good, and dissolution is complete.
2nd, operation is simple for production of the invention, is suitable for industrial production.
The content of the invention
, should the medicine containing Suo Feibuwei it is an object of the invention to provide a kind of new pharmaceutical composition containing Suo Feibuwei The stability of compositions is good, and dissolution rate is good.
It is another object of the present invention to provide a kind of preparation method of the pharmaceutical composition containing Suo Feibuwei, the party Method is adapted to industrial production.
Specifically, the invention provides:
A kind of 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 are:
The parts by weight of Suo Feibuwei 30 ~ 50
The parts by weight of surfactant 3 ~ 5
The parts by weight of filler 30 ~ 60.
The one kind of described filler in microcrystalline cellulose, Lactis Anhydrous, amylum pregelatinisatum, PVP, mannitol It is or several.
Described filler is the composition that PVP and mannitol form, and more preferably weight ratio is 1:(5~8) PVP and mannitol composition composition.
Shown surfactant is lauryl sodium sulfate.
The described pharmaceutical composition containing Suo Feibuwei prepares piece agent, and its preparation method comprises the following steps:
(1) stirred after mixing Suo Feibuwei, surfactant, obtain pulverulent solids;
(2) powder obtained by step (1) is well mixed with filler, direct tablet compressing, get Suo Feibuwei tablets.
The present invention has the advantages that compared with prior art:
1st, product stability of the invention is good, and dissolution is complete.
2nd, operation is simple for production of the invention, is suitable for industrial production.
Embodiment
Below by way of the description of embodiment, the invention will be further described, but this is not the limit to the present invention System, those skilled in the art according to the present invention basic thought, various modifications may be made or improve, but without departing from this The basic thought of invention, within the scope of the present invention.
Suo Feibu Wiegands are according to U.S. Patent Publication No.:It is prepared by 2010/0298257 and 2100/0251152 methods described.
Test method
Relevant material takes this product 25mg, accurately weighed, puts in 25mL measuring bottles, adds dilution【Water-acetonitrile(80:20), under Together】Dissolve and be diluted to scale, shake up, as need testing solution.Precision measures in right amount, is quantitatively diluted and is made often with dilution Containing about the μ g of Suo Feibuwei 1 solution in 1ml, as contrast solution.According to high performance liquid chromatography(Chinese Pharmacopoeia version two in 2010 Annex V D)Experiment, is filler with octadecylsilane chemically bonded silica(4.6 × 250mm, 5 μm), with 10mmol/L di(2-ethylhexyl)phosphates Hydrogen potassium solution(Phosphoric acid adjusts pH to 3.0)- acetonitrile(80:20)For mobile phase A, with acetonitrile-methanol(80:20)For Mobile phase B, press Table carries out gradient elution;Column temperature is 30 °C, and flow velocity is 1.0ml per minute, Detection wavelength 260nm.The μ l of contrast solution 10 are taken, are noted Enter liquid chromatograph, adjust detection sensitivity, the peak height for making principal component chromatographic peak is about the 10% of full scale, then precision measures confession Each 10 μ l of test sample solution, liquid chromatograph is injected, record chromatogram.It is single if any impurity peaks in the chromatogram of need testing solution Impurity peak area cannot be greater than contrast solution main peak area(0.1%), each impurity peaks peak area and cannot be greater than contrast solution master 10 times of the peak area at peak(1.0%).
Dissolution rate takes this product, according to dissolution method(Chinese Pharmacopoeia two annex X the second methods of C of version in 2010), with water 900ml is dissolution medium, and rotating speed is 50 turns per minute, is operated in accordance with the law, during through 10 minutes, takes solution to filter, according to assay item Under chromatographic condition, precision measures the μ l of subsequent filtrate 20, injects liquid chromatograph, records chromatogram.Suo Feibuwei reference substances separately are taken, Accurately weighed, be dissolved in water and quantify the solution for diluting and being made in every 1ml containing about 0.1mg, is measured in the same method.By external standard method with peak face Product calculates the stripping quantity of every.
【Assay】According to high performance liquid chromatography(Two D of annex V of Chinese Pharmacopoeia version in 2010)Measure.
Chromatographic condition is filler with octadecylsilane chemically bonded silica with system suitability(4.6 × 250mm, 5 μ m), with water-acetonitrile(60:40)For mobile phase, column temperature is 30 °C, and flow velocity is 1.0ml per minute, Detection wavelength 260nm.It is theoretical Plate number should be not less than 3000 in terms of Suo Feibuwei.
Determination method takes this product 20, accurately weighed, and finely ground, precision weighs in right amount(It is approximately equivalent to Suo Feibuwei 100mg), Put in 200ml measuring bottles, add mobile phase(Water-acetonitrile(80:20), similarly hereinafter)Shaking dissolves Suo Feibuwei and is diluted to scale, shakes Even, filtration, precision measures the μ l of subsequent filtrate 10 injection liquid chromatographs, records chromatogram;Suo Feibuwei reference substances separately are taken, are surveyed with method It is fixed.By external standard method with calculated by peak area, produce.
Test example 1:Prescription screening experiment-surfactant selection
Suo Feibuwei 40g are taken respectively(Content 99.9%, total miscellaneous 0.09%), by following prescriptions(It is shown in Table 1)It is made and contains Suo Fei Cloth Wei piece, dissolution rate and relevant material are detected, the results are shown in Table 4:
The Suo Feibuwei prescriptions of table 3(Unit:g)
The preparation method of prescription 1:
(1) Suo Feibuwei is well mixed with microcrystalline cellulose, PVPP, obtains pulverulent solids;
(2) magnesium stearate mixes with the pulverulent solids obtained by step (1), direct tablet compressing, get Suo Feibuwei tablets.
The preparation method of prescription 2 ~ 4:
(1) stirred after Suo Feibuwei is mixed with lauryl sodium sulfate, obtain pulverulent solids;
(2) it is well mixed to the powder obtained by step (1) with microcrystalline cellulose, PVPP, obtains pulverulent solids;
(3) magnesium stearate mixes with the pulverulent solids obtained by step (2), tabletting, get Suo Feibuwei tablets.
The result of the test of table 2
Result of the test shows:The Suo Feibuwei Dissolution of Tablet prepared using prescription of the present invention is significantly higher than no surface-active The prescription of agent addition, but the dissolution rate increase not in direct ratio after the amount of lauryl sodium sulfate increases to certain degree, And there is downward trend;But add product sliver rate increase after Surfactant SDS.
Test example 2:Prescription screening experiment-filler selection
Suo Feibuwei 40g are taken respectively(Content 99.9%, total miscellaneous 0.09%), by following prescriptions(It is shown in Table 1)It is made and contains Suo Fei Cloth Wei piece, dissolution rate and relevant material are detected, the results are shown in Table 4:
The Suo Feibuwei prescriptions of table 3(Unit:g)
The preparation method of prescription 1 ~ 3:
(1) stirred after Suo Feibuwei is mixed with lauryl sodium sulfate, obtain pulverulent solids;
(2) it is well mixed to the powder obtained by step (1) with filler, obtains pulverulent solids;
(3) magnesium stearate mixes with the pulverulent solids obtained by step (2), tabletting, get Suo Feibuwei tablets.
The preparation method of prescription 4 ~ 7:
(1) stirred after Suo Feibuwei is mixed with lauryl sodium sulfate, obtain pulverulent solids;
(2) after mannitol is well mixed by weight proportion with PVP, add thereto to the powder obtained by step (1) End, it is well mixed, obtains pulverulent solids, direct tablet compressing, get Suo Feibuwei tablets.
The result of the test of table 4
Result of the test shows:The Suo Feibuwei tablets prepared using mannitol with povidone mixture as filler are split Piece rate significantly reduces.
Test example 3:Accelerated test
The product of Example 3,5,6,8 carries out accelerated test, the results are shown in Table 3.
The Suo Feibuwei piece accelerated test data of table 4
Packaging:Commercially available back, investigate condition:40 DEG C of temperature, humidity 75%
Conclusion:Road as seen from the above table, the product prepared by the inventive method, stability under high temperature and illumination better than pair Ratio.
Preparation example
Embodiment 1
Prescription
Suo Feibuwei 40g
Lauryl sodium sulfate 5.6g
Amylum pregelatinisatum 135g
Preparation method
(1) stirred after Suo Feibuwei is mixed with lauryl sodium sulfate, obtain pulverulent solids;
(2) powder obtained by step (1) is well mixed with amylum pregelatinisatum, direct tablet compressing, get Suo Feibuwei tablets.
Embodiment 2
Prescription
Suo Feibuwei 35g
Lauryl sodium sulfate 5.5g
Lactis Anhydrous 138g.
Preparation method
(1) stirred after Suo Feibuwei is mixed with lauryl sodium sulfate, obtain pulverulent solids;
(2) powder obtained by step (1) is well mixed with Lactis Anhydrous, direct tablet compressing, get Suo Feibuwei tablets.
Embodiment 3
Prescription
Suo Feibuwei 40g
Lauryl sodium sulfate 8.0g
Microcrystalline cellulose 145g.
Preparation method
(1) stirred after Suo Feibuwei is mixed with lauryl sodium sulfate, obtain pulverulent solids;
(2) powder obtained by step (1) is well mixed with microcrystalline cellulose, direct tablet compressing, get Suo Feibuwei tablets.
Embodiment 4
Prescription
Suo Feibuwei 45g
Lauryl sodium sulfate 6.3g
Mannitol 154g.
Preparation method
(1) stirred after Suo Feibuwei is mixed with lauryl sodium sulfate, obtain pulverulent solids;
(2) powder obtained by step (1) is well mixed with mannitol, direct tablet compressing, get Suo Feibuwei tablets.
Embodiment 5
Prescription
Suo Feibuwei 43g
Lauryl sodium sulfate 7.2g
Mannitol 120g
PVP 20g.
Preparation method
(1) stirred after Suo Feibuwei is mixed with lauryl sodium sulfate, obtain pulverulent solids;
(2) after mannitol is well mixed by weight proportion with PVP, add thereto to the powder obtained by step (1) End, it is well mixed, obtains pulverulent solids, direct tablet compressing, get Suo Feibuwei tablets.
Embodiment 6
Prescription
Suo Feibuwei 38g
Lauryl sodium sulfate 6.4g
Mannitol 126g
PVP 16g.
Preparation method
(1) stirred after Suo Feibuwei is mixed with lauryl sodium sulfate, obtain pulverulent solids;
(2) after mannitol is well mixed by weight proportion with PVP, add thereto to the powder obtained by step (1) End, it is well mixed, obtains pulverulent solids, direct tablet compressing, get Suo Feibuwei tablets.
Embodiment 7
Prescription
Suo Feibuwei 40g
Lauryl sodium sulfate 6.2g
Mannitol 125g
Mannitol 25g.
Preparation method
(1) stirred after Suo Feibuwei is mixed with lauryl sodium sulfate, obtain pulverulent solids;
(2) after mannitol is well mixed by weight proportion with mannitol, add thereto to the powder obtained by step (1) End, it is well mixed, obtains pulverulent solids, direct tablet compressing, get Suo Feibuwei tablets.
Embodiment 8
Prescription
Suo Feibuwei 37g
Lauryl sodium sulfate 5.3g
Mannitol 124g
PVP 15g.
Preparation method
(1) stirred after Suo Feibuwei is mixed with lauryl sodium sulfate, obtain pulverulent solids;
(2) after mannitol is well mixed by weight proportion with PVP, add thereto to the powder obtained by step (1) End, it is well mixed, obtains pulverulent solids, direct tablet compressing, get Suo Feibuwei tablets.
Embodiment 9
Prescription
Suo Feibuwei 20g
Lauryl sodium sulfate 4.5g
Mannitol 60g
PVP 7.5g.
Preparation method
(1) stirred after Suo Feibuwei is mixed with lauryl sodium sulfate, obtain pulverulent solids;
(2) after mannitol is well mixed by weight proportion with PVP, add thereto to the powder obtained by step (1) End, it is well mixed, obtains pulverulent solids, direct tablet compressing, get Suo Feibuwei tablets.
Embodiment 10
Prescription
Suo Feibuwei 4.0g
Lauryl sodium sulfate 6.1g
Mannitol 10g
PVP 3g.
Preparation method
(1) stirred after Suo Feibuwei is mixed with lauryl sodium sulfate, obtain pulverulent solids;
(2) after mannitol is well mixed by weight proportion with PVP, add thereto to the powder obtained by step (1) End, it is well mixed, obtains pulverulent solids, direct tablet compressing, get Suo Feibuwei tablets.

Claims (2)

1. a kind of pharmaceutical composition containing Suo Feibuwei, it is characterised in that the weight ratio of pharmaceutical composition each component is:
The parts by weight of Suo Feibuwei 30~50
The parts by weight of surfactant 5~15
The parts by weight of filler 130~160;
Described filler is the composition that PVP and mannitol form, and PVP and mannitol weight ratio are 1:5~8;Institute The surfactant stated is lauryl sodium sulfate.
2. the pharmaceutical composition according to claim 1 containing Suo Feibuwei, it is characterised in that pharmaceutical composition is prepared into Tablet, its preparation method are:
(1) stirred after mixing Suo Feibuwei, surfactant, obtain pulverulent solids;
(2) powder obtained by step (1) is well mixed with filler, direct tablet compressing, get Suo Feibuwei tablets.
CN201510051134.0A 2015-02-02 2015-02-02 A kind of pharmaceutical composition containing Suo Feibuwei Active CN104586802B (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2999215A1 (en) * 2015-10-07 2017-04-13 Sandoz Ag Solid pharmaceutical composition comprising amorphous sofosbuvir
CA3033319A1 (en) * 2016-08-12 2018-02-15 Sandoz Ag Solid pharmaceutical composition comprising amorphous sofosbuvir

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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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Denomination of invention: A drug combination containing soffebuvir

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Pledgor: CHANGCHUN HAIYUE PHARMACEUTICAL Co.,Ltd.

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