CN107773547A - A kind of Yi Dushaban sustained releases tablet medicament composition and preparation method thereof - Google Patents
A kind of Yi Dushaban sustained releases tablet medicament composition and preparation method thereof Download PDFInfo
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- CN107773547A CN107773547A CN201610708702.4A CN201610708702A CN107773547A CN 107773547 A CN107773547 A CN 107773547A CN 201610708702 A CN201610708702 A CN 201610708702A CN 107773547 A CN107773547 A CN 107773547A
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- dushaban
- hydroxypropyl methylcellulose
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- sustained release
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/444—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
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Abstract
The invention discloses a kind of Yi Dushaban to be sustained tablet medicament composition, and the sustained release tablets contain Yi Dushaban, high viscosity hydroxypropyl methylcellulose, middle viscosity hydroxypropyl methylcellulose and water-soluble filler, also containing other pharmaceutic adjuvants.The invention also discloses the preparation method of Yi Dushaban sustained release tablet medicament compositions.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, more particularly to medicament slow release solid pharmaceutical preparation, and in particular to a kind of Yi Dusha
Class's sustained release tablet medicament composition and preparation method thereof.
Background technology
Yi Dushaban is the small molecule oral anticoagulation that Japanese Sankyo Co. develops, and is Stuart factor（FXa）
Retarding agent.In coagulation process, the Stuart factor of activation（FXa）By factor（FII）Activation turns into fibrin ferment（FIIa）, promote
Fibrin is formed, is consequently formed thrombus, thus FXa turns into the major target class for developing anticoagulant of new generation.Yi Dusha
Class passes through selectivity, invertibity and the direct oral anticoagulation thing for suppressing FXa and reaching inhibition thrombosis, its selection to FXa
Property is higher than FIIa 104 times.Outer clinical test in Japan confirms that this product can effectively suppress to receive lower limb plastic surgery operations trouble
The concurrent VTE of person, and securely and reliably.
Solubility in Japanese specification on this product：Dimethyl sulfoxide, DMF are soluble in, is slightly soluble in first
Alcohol, water, acetonitrile, are slightly soluble in ethanol（99.5）, it is atomic to be dissolved in acetone, ethyl acetate, it is almost insoluble in isopropanol.
CN201410153345.0 is related to a kind of Yi Dushaban sustained release tablets and preparation method thereof, the tool of Yi Dushaban sustained release tablets
Body composition (g/g)：Yi Dushaban is to benzene methanesulfonic acid salt hydrate 14%~21%；Hydroxypropyl methylcellulose 0~36%；Carbomer 0
~28%；Lactose 10% ~ 28%；Diluent 29%~38%；PVP 0~3%；Lubricant 0.6~4%.
Yi Dushaban easy moisture absorptions due to its own molecular structure, manufactured preparation are easily unstable；Put in room temperature
Put certain time, it may appear that the undesirable situation of dissolution；Simultaneously because it draws by force moist and poor mobility, preparation band is also given
Carry out certain operation difficulty.In addition, the Yi Dushaban sustained release tablets prepared in the prior art still run into, sustained release is unstable, fluctuates
Greatly, auxiliary material is difficult to select, preparation is unstable, the easy moisture absorption etc. needs to solve the problems, such as.
The content of the invention
The invention provides a kind of Yi Dushaban to be sustained tablet medicament composition.The Yi Dushaban sustained release tablets medicine groups of the present invention
Compound contains Yi Dushaban, high viscosity HPMC, middle viscosity HPMC and water-soluble filler, also containing other pharmaceutic adjuvants.This hair
Ming Yidushaban sustained release tablet medicament composition in Yi Dushaban account for total tablet weight 10%-25%, high viscosity hydroxypropyl methylcellulose, in stick
Degree hydroxypropyl methylcellulose and the total 65%-98% for accounting for total tablet weight altogether of water-soluble filler three, other pharmaceutic adjuvants account for total tablet
The 0.1%-13% of weight.It is preferred that the present invention Yi Dushaban sustained release tablet medicament composition in high viscosity hydroxypropyl methylcellulose, in stick
It is 1 to spend weight ratio between hydroxypropyl methylcellulose and water-soluble filler three:(0.3~1):(2~4).More preferably of the invention
High viscosity hydroxypropyl methylcellulose, middle viscosity hydroxypropyl methylcellulose and water-soluble filler in Yi Dushaban sustained release tablet medicament compositions
Weight ratio is 1 between three:0.6:2.
It is used cooperatively in the present invention using HPMC, the water-soluble filler of high viscosity and middle viscosity, formation carries microporosity
Sustained-release matrix, Yi Dushaban prepared therefrom sustained release tablet medicament composition can effectively control Yi Dushaban rate of release again
Contained Yi Dushaban in label can be made to discharge completely within a certain period of time, so that slightly solubility Yi Dushaban is easy to steady, effective
Release, effectively, curative effect is smoothly played, avoid generation from fluctuating widely.
High viscosity hydroxypropyl methylcellulose be viscosity be more than 3000mPa s hydroxypropyl methylcellulose, selected from 75RT4000,
60RT10000, wherein it is preferred that 60RT10000.
Middle viscosity hydroxypropyl methylcellulose is selected from SM-1500.
Water-soluble filler is selected from lactose, sucrose etc., preferably lactose.
It is slower that high viscosity hydroxypropyl methylcellulose forms hydrated gel interval velocity in water, for a long time Yi Dushaban can be maintained to delay
On The Drug Release, but release rate is low, it is more difficult to maintain effectively blood concentration；Middle viscosity hydroxypropyl methylcellulose can be formed quickly in water
Hydrated gel layer, but the slow release of medicine can not be maintained for a long time.With reference to the hydroxypropyl methylcellulose of two kinds of viscositys, make it can
With stable, sustained release Yi Dushaban within a certain period of time, held stationary, effective blood concentration, so as to the hair of continuous and effective
Curative effect is waved, avoids fluctuation from causing damage human body.It is logical that water-soluble filler can quickly dissolve formation drug release in water
Road, formed to dash forward and released, patient is ensured effective blood concentration initial stage in medication, play curative effect.
The Yi Dushaban sustained release tablet medicament compositions of the present invention also contain other pharmaceutic adjuvants, contain in other pharmaceutic adjuvants
Lubricant, optionally containing adhesive etc..It is preferred that other pharmaceutic adjuvants are made up of adhesive, lubricant.Lubricant is selected from
Magnesium stearate, talcum powder, superfine silica gel powder etc..Adhesive is selected from PVP K30, sodium carboxymethylcellulose etc..
The Yi Dushaban sustained release tablet medicament compositions of the present invention can be coated, and coating agent dosage is the 2%- of total tablet weight
5%, coating agent is preferably color coat powder.
In a preferred embodiment of the present invention, high viscosity hypromellose in Yi Dushaban sustained release tablet medicament compositions
Element is selected from hydroxypropyl methylcellulose 60RT10000, and middle viscosity hydroxypropyl methylcellulose is selected from hydroxypropyl methylcellulose SM-1500, water-soluble
Filler is selected from lactose, and wherein Yi Dushaban, which accounts for total tablet and weighs 20%, hydroxypropyl methylcellulose 60RT10000 and account for total tablet, weighs 20%, hydroxyl
Third methylcellulose SM-1500, which accounts for total tablet and weighs 12%, lactose and account for total tablet, weighs 40%.
High viscosity hydroxypropyl methylcellulose in the present composition:Middle viscosity hydroxypropyl methylcellulose:Water-soluble filler weight
Than for 1:0.6:When 2, the Yi Dushaban sustained release tablet medicament composition slow release effects prepared by the present composition are optimal.
Yi Dushaban amount refers to the amount of Yi Dushaban sterlings in the present invention, can be according to moisture, content through rolling over the pure meter of water
Draw, the pure computational methods of folding water are known to the skilled person.
Present invention also offers the preparation method of Yi Dushaban sustained release tablet medicament compositions.By Yi Dushaban, high viscosity hydroxyl
Third methylcellulose, middle viscosity hydroxypropyl methylcellulose, water-soluble filler mixing, add adhesive granulation, and lubrication is added after drying
Agent is well mixed, tabletting, coating, that is, Yi Dushaban sustained releases tablet medicament composition of the present invention is made.
It is used cooperatively in the present invention using high viscosity, the slow-release material of middle viscosity, water-soluble filler, especially HPMC
(60RT10000, SM-1500), lactose are used cooperatively, and formation carries micro porous sustained-release matrix, reach i.e. effective control according to degree
Husky class's rate of release and can makes the effect that contained Yi Dushaban discharges completely within a certain period of time in label.And the present invention according to
Du Shaban sustained release tablet medicament compositions can be covered with color coat, have more preferably stability compared with plain piece.
Embodiment
Following experiments and embodiment further illustrate the present invention, but are not construed as limiting the invention.
The preparation of the Yi Dushaban sustained release tablets of embodiment 1
Prescription matches：
Yi Dushaban 25g
Hydroxypropyl methylcellulose (60RT10000) 55g
Hydroxypropyl methylcellulose (SM-1500) 40g
Lactose 85g
PVP K30 12g
Magnesium stearate 2g
Film coating agent 6g
Technique：
(1) Yi Dushaban, hydroxypropyl methylcellulose (60RT10000), hydroxypropyl methylcellulose (SM-1500), lactose are sieved, it is standby
With.
(2) PVP K30 ethanol solution is prepared as adhesive, it is standby.
(3) weigh recipe quantity Yi Dushaban, hydroxypropyl methylcellulose (60RT10000), hydroxypropyl methylcellulose (SM-1500),
Lactose mixes, and adds adhesive granulation, and adding recipe quantity magnesium stearate after drying is well mixed.
(4) tabletting.
(5) it is coated：The coloured film coating agent of recipe quantity is taken to be configured to coating solution (oxygen barrier, lucifuge).Plain piece puts coating pan
It is interior, wrap film clothing of spraying, it is drying to obtain.
The preparation of the Yi Dushaban sustained release tablets of embodiment 2
Prescription：
Yi Dushaban 20g
The g of hydroxypropyl methylcellulose (75RT4000) 20
The g of hydroxypropyl methylcellulose (SM-1500) 12
The g of lactose 40
The g of PVP K30 3
The g of magnesium stearate 2
The g of film coating agent 3
Technique：
(1) Yi Dushaban, hydroxypropyl methylcellulose (75RT4000), hydroxypropyl methylcellulose (SM-1500), lactose are sieved for subsequent use.
(2) PVP K30 ethanol solution is prepared as adhesive, it is standby.
(3) recipe quantity Yi Dushaban, hydroxypropyl methylcellulose (75RT4000), hydroxypropyl methylcellulose (SM-1500), breast are weighed
Sugar mixing, adhesive granulation is added, adding recipe quantity magnesium stearate after drying is well mixed.
(4) tabletting.
(5) it is coated：The coloured film coating agent of recipe quantity is taken to be configured to coating solution (oxygen barrier, lucifuge).Plain piece puts coating
In pot, wrap film clothing of spraying, it is drying to obtain.
The preparation of the Yi Dushaban sustained release tablets of embodiment 3
Prescription：
Yi Dushaban 50g
The g of hydroxypropyl methylcellulose (75RT4000) 25
The g of hydroxypropyl methylcellulose (SM-1500) 25
The g of lactose 100
PVP K30 8g
Magnesium stearate 3g
Film coating agent 6g
Technique：
(1) Yi Dushaban, hydroxypropyl methylcellulose (75RT4000), hydroxypropyl methylcellulose (SM-1500), lactose are sieved for subsequent use.
(2) PVP K30 ethanol solution is prepared as adhesive, it is standby.
(3) recipe quantity Yi Dushaban, hydroxypropyl methylcellulose (75RT4000), hydroxypropyl methylcellulose (SM-1500), breast are weighed
Sugar mixing, adhesive granulation is added, adding recipe quantity magnesium stearate after drying is well mixed.
(4) tabletting.
(5) it is coated：The coloured film coating agent of recipe quantity is taken to be configured to coating solution (oxygen barrier, lucifuge).Plain piece puts coating
In pot, wrap film clothing of spraying, it is drying to obtain.
The drug release determination of embodiment 4
Example 1-3 samples are studied releasing effect.Assay method:This product is taken, according to drug release determination method (Chinese Pharmacopoeia
Two methods of annex XD first of version in 2010), using the device of the method for dissolution method second, with 0.1mol/L hydrochloric acid solutions
1000mL is dissolution medium, and rotating speed is 200 revs/min, is operated in accordance with the law.Solution 5mL is taken to filter respectively in stipulated time point, and
Same solvent 5mL is supplemented in process container in time, subsequent filtrate is taken, according to high performance liquid chromatography (Chinese Pharmacopoeia version two in 2010
Portion annex VD) experiment.Chromatographic condition and system suitability：It is filler with octadecylsilane chemically bonded silica；With second
Nitrile-phosphate buffer (takes potassium dihydrogen phosphate 2.72g, be dissolved in water and be diluted to 1000mL, add triethylamine 2mL, shake up)
(45:55) it is mobile phase；Detection wavelength is 230nm.It is appropriate that another precision weighs felodipine reference substance, after being dissolved with ethanol, then
Quantitatively it is diluted in every 1mL containing about 10 μ g solution, is measured in the same method plus solvent is stated.Every releasing in different time is calculated respectively
High-volume.
Release result is as follows：
| 1h | 2h | 3h | 4h | 5h | 6h | 7h | 8h | 9h | |
| Embodiment 1 | 13.1 | 24.7 | 37.0 | 56.6 | 77.4 | 92.7 | 100.4 | 100.0 | 100.1 |
| Embodiment 2 | 14.1 | 25.7 | 38.8 | 55.3 | 72.7 | 81.7 | 93.3 | 100.1 | 100.2 |
| Embodiment 3 | 15.4 | 27.5 | 39.7 | 53.3 | 70.7 | 93.2 | 99.8 | 100.0 | 100.2 |
Above experimental result shows that embodiment 2 is high viscosity hydroxypropyl methylcellulose:Middle viscosity hydroxypropyl methylcellulose:Water solubility is filled out
Fill agent=1:0.6:2 reached release completely at 8 hours, and present invention process is simple simultaneously, is easy to amplify metaplasia production, and cost
It is relatively low, advantageously reduce product price.
Claims (8)
1. a kind of Yi Dushaban is sustained tablet medicament composition, it is characterised in that wherein Yi Dushaban accounts for total tablet weight 10%-25%, height
Viscosity hydroxypropyl methylcellulose, middle viscosity hydroxypropyl methylcellulose and water-soluble filler composition sustained-release matrix simultaneously account for total tablet weight altogether
65%-98.9%, other pharmaceutic adjuvants account for the 0.1-13% of total tablet weight.
2. Yi Dushaban as claimed in claim 1 is sustained tablet medicament composition, it is characterised in that the high viscosity hydroxypropyl first is fine
It is 1 to tie up weight ratio between plain, middle viscosity hydroxypropyl methylcellulose and water-soluble filler:（0.3~1）:（2~4）.
3. Yi Dushaban as claimed in claim 2 is sustained tablet medicament composition, it is characterised in that the high viscosity hydroxypropyl first is fine
It is 1 to tie up weight ratio between plain, middle viscosity hydroxypropyl methylcellulose and water-soluble filler:0.6:2.
4. the Yi Dushaban sustained release tablet medicament compositions as any one of claim 1-3, it is characterised in that described high glutinous
Degree hydroxypropyl methylcellulose is selected from 75RT4000.
5. the Yi Dushaban sustained release tablet medicament compositions as any one of claim 1-3, it is characterised in that sticked in described
Degree hydroxypropyl methylcellulose is selected from SM-1500.
6. the Yi Dushaban sustained release tablet medicament compositions as any one of claim 1-3, it is characterised in that described water-soluble
Property filler is selected from lactose and/or sucrose.
7. the Yi Dushaban sustained release tablet medicament compositions as any one of claim 1-6, it is characterised in that described other
Pharmaceutic adjuvant is made up of adhesive, lubricant.
8. a kind of preparation method of Yi Dushaban sustained release tablet medicament compositions as any one of claim 1-7, it is special
Sign is, comprises the following steps：Yi Dushaban, high viscosity hydroxypropyl methylcellulose, middle viscosity hydroxypropyl methylcellulose, water solubility are filled out
Agent mixing is filled, adds adhesive granulation, addition mix lubricant is uniform after drying, and tabletting produces.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610708702.4A CN107773547A (en) | 2016-08-24 | 2016-08-24 | A kind of Yi Dushaban sustained releases tablet medicament composition and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610708702.4A CN107773547A (en) | 2016-08-24 | 2016-08-24 | A kind of Yi Dushaban sustained releases tablet medicament composition and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107773547A true CN107773547A (en) | 2018-03-09 |
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ID=61387836
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610708702.4A Pending CN107773547A (en) | 2016-08-24 | 2016-08-24 | A kind of Yi Dushaban sustained releases tablet medicament composition and preparation method thereof |
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| CN (1) | CN107773547A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112494489A (en) * | 2020-12-18 | 2021-03-16 | 浙江诺得药业有限公司 | Apixaban-containing compound sustained-release preparation and preparation method thereof |
| CN112791057A (en) * | 2021-02-07 | 2021-05-14 | 齐飞 | Slow release preparation containing edoxaban and preparation method thereof |
-
2016
- 2016-08-24 CN CN201610708702.4A patent/CN107773547A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112494489A (en) * | 2020-12-18 | 2021-03-16 | 浙江诺得药业有限公司 | Apixaban-containing compound sustained-release preparation and preparation method thereof |
| CN112494489B (en) * | 2020-12-18 | 2021-09-03 | 浙江诺得药业有限公司 | Apixaban-containing compound sustained-release preparation and preparation method thereof |
| CN112791057A (en) * | 2021-02-07 | 2021-05-14 | 齐飞 | Slow release preparation containing edoxaban and preparation method thereof |
| CN112791057B (en) * | 2021-02-07 | 2022-03-18 | 齐飞 | Slow release preparation containing edoxaban and preparation method thereof |
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Application publication date: 20180309 |