CN102784128A - Felodipine sustained release preparation and preparation method of felodipine sustained release preparation - Google Patents
Felodipine sustained release preparation and preparation method of felodipine sustained release preparation Download PDFInfo
- Publication number
- CN102784128A CN102784128A CN2012102701613A CN201210270161A CN102784128A CN 102784128 A CN102784128 A CN 102784128A CN 2012102701613 A CN2012102701613 A CN 2012102701613A CN 201210270161 A CN201210270161 A CN 201210270161A CN 102784128 A CN102784128 A CN 102784128A
- Authority
- CN
- China
- Prior art keywords
- felodipine
- release preparation
- preparation
- felodipine sustained
- surfactant
- 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
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention relates to a felodipine sustained release preparation, which consists of active ingredients of felodipine dissolved into medical auxiliary materials containing surfactants. The felodipine sustained release preparation is characterized in that the weight ratio of the surfactants to the active ingredients of felodipine is 1:1 to 10:1, the surfactants are selected from one kind of materials or several kinds of materials from lauryl sodium sulfate, diisostearyl fumarate, lecithin, poloxamer, polyoxyethylene stearate, polyoxyethylene castor oil derivatives, glycerin monostearate, glycerylmonooleate, glyceryl triacetate, glyceride linoleate and polyethyleneglycol fatty glyceride, and the medical auxiliary materials also comprise antioxidants with the consumption being 0.1 to 10 percent of the weight of the felodipine. The invention also provides a preparation method of the felodipine sustained release preparation. The felodipine sustained release preparation provided by the invention has the advantages that the raw material and auxiliary material compatibility is good, the in-vitro release is stable, the biological effect is equivalent to that of similar preparations of plendil, the safety is high, in addition, the preparation process is simple, and the industrial production is easy to realize.
Description
Technical field
The invention belongs to field of medicine preparing technology, be specifically related to a kind of felodipine sustained-release preparation and preparation method thereof.
Background technology
Felodipine sustained-release tablets is mainly used in all types of hypertension, anginal treatment.After felodipine is processed slow releasing preparation, drug slow is discharged, reduce the blood concentration fluctuation amplitude, make blood pressure maintain state comparatively stably, reduce the generation of untoward reaction.
One Chinese patent application " a kind of slow releasing preparation that contains felodipine and preparation method thereof " (application number 200610036546.8; Publication number CN101103964A; Open January 16 2008 date), " method that a kind of felodipine sustained-release tablets and control felodipine sustained-release tablets thereof discharge " (application number CN200910147870.0; Publication number CN101574324A, open day on November 11st, 2009), " method for preparing of felodipine sustained-release tablets " (application number 201010193842.5, publication number CN101843598A; Disclosed JIUYUE 29 2010 date) and " method for preparing of felodipine sustained-release tablets " (application number CN200810116750.X; Publication number CN101627976A, open January 20 2010 date) in the disclosed method, all directly felodipine is dissolved in the certain density alcoholic solution; Again with mixing granulations such as framework material, filleies; Perhaps felodipine directly and method such as framework material mixing granulation prepare felodipine sustained-release preparation, but the preparation that adopts this method to make, the utilization rate of its active component felodipine is very low; This is because felodipine dissolubility in water is extremely low, and usually dissolving not exclusively becomes the obstacle that influence absorbs in limited gastrointestinal tract environment.
Process the slow releasing preparation of same specification, complete for the absorption that guarantees medicine, the blood drug level of remaining valid, researcher adopt the whole bag of tricks to increase the dissolving of felodipine in gastro-intestinal Fluid.One Chinese patent application " a kind of felodipine sustained-release tablets and preparation method thereof " (application number 201010291477.1; Publication number CN101953837A; Open January 26 2011 date) adopted the method for cyclodextrin inclusion compound the active component felodipine to be dissolved in the macromole gap of cyclodextrin, because the cyclodextrin good hydrophilic property, thereby preparation discharges steadily; But the long time of needs when adopting this method to prepare the felodipine cyclodextrin to be clathrate, technology is loaded down with trivial details and wayward.
Other has researcher to adopt the method that adds solubilizing agent to increase the dissolving of felodipine in gastro-intestinal Fluid; One Chinese patent application " a kind of prescription of felodipine sustained-release tablets and method for preparing " (application number 200810243940.8 for example; Publication number CN101744786A; Open June 23 2010 date) adopted surfactant polyoxyethylene sorbitan monoleate (Tween 80) to increase the dissolving of felodipine, but the bioavailability of slow releasing tablet is not high.PCT patent application " new pharmaceutical formulation " (application number 99811100.7; Publication number CN1319004A) adopted surfactant Spheron MD 30/70, glyceride etc. to increase the dissolving of felodipine; But possibly worry too much surfactant to the tabletting Effect on Performance owing to method for making is improper, dosage of surfactant is little in the technical scheme, though also made felodipine sustained-release tablets; Can reach the purpose that improves drug release, discharge incomplete shortcoming but occur the later stage when discharging.
Summary of the invention
To the defective that exists in the prior art, an object of the present invention is to provide a kind of supplementary material compatibility good, safe, discharge felodipine sustained-release preparation stably.
Another object of the present invention provides the method for preparing of above-mentioned felodipine sustained-release preparation, and preparation technology is simple, is easy to suitability for industrialized production.
For reaching above purpose; The technical scheme that the present invention adopts is: a kind of felodipine sustained-release preparation; Be dissolved in the pharmaceutic adjuvant that mainly contains surfactant and framework material by the active component felodipine and form; It is characterized in that surfactant is selected from one or more in sodium lauryl sulphate, stearyl alcohol fumaric acid sodium, lecithin, poloxamer, Myrj 45, castor oil derivatives, glyceryl monostearate, glyceryl monooleate, glyceryl triacetate, single glyceryl linoleate, the polyethylene glycol fatty acid glyceride type; Also comprise the antioxidant that consumption is a felodipine weight 0.1～10% in the pharmaceutic adjuvant.
Further, the weight ratio of surfactant and active component felodipine is 3:1～7:1.
Further, surfactant is poloxamer, castor oil derivatives or polyethylene glycol fatty acid glyceride type.
Further, antioxidant be selected from sodium thiosulfate, sodium sulfite, sodium sulfite, sodium pyrosulfite, thioglycerol, thiourea, cysteine, ascorbic acid, arabo-ascorbic acid, ascorbyl palmitate, propyl gallate, gallateoctylester, isoamyl gallate, vitamin E, in hydroxyl tert-butyl group methoxybenzene and the toluene di-tert-butyl phenol one or more.
Further again, antioxidant is selected from thioglycerol, ascorbyl palmitate, propyl gallate, gallateoctylester, vitamin E, in the hydroxyl tert-butyl group methoxybenzene one or more.
Further; It is that the hydroxypropyl cellulose of 1500～3000mpas or 4000～6500mpas (is the high viscosity hydroxypropyl cellulose that said framework material is selected from hydroxypropyl methylcellulose (HPMC), viscosity; This paper representes with HPC) and polyoxyethylene in one or more, the consumption of said framework material is 20～70% of a tablet skeleton weight.The tablet skeleton is meant the solid adjuvant material that does not contain felodipine, antioxidant and surfactant.
Further, said pharmaceutic adjuvant also comprises filler and the coating material that accounts for tablet skeleton weight 30～80%; Said filler is selected from one or more in lactose, starch, pregelatinized Starch, mannitol, Icing Sugar, cellulose derivative, low-substituted hydroxypropyl cellulose (L-HPC), dextrin, sorbitol, calcium hydrogen phosphate and the calcium sulfate.
The method for preparing of above-mentioned felodipine sustained-release preparation provided by the invention may further comprise the steps:
(1) active component felodipine and antioxidant are joined in the surfactant, heating for dissolving adds the alcoholic solution dilution in case of necessity, obtains raw material medicine solution;
(2) will be except that lubricant and other solid adjuvant material mix homogeneously the coating material, and mix with the raw material medicine solution of step (1), stir;
(3) get the mixture that step (2) obtains and carry out wet granulation, drying;
(4) to dried granule tabletting, add proper amount of lubricating agent in case of necessity;
(5) adopt coating material that tablet is carried out coating, promptly get product.
Further; In the step (3); During wet granulation, in the mixture that step (2) obtains, add binding agent in advance, binding agent is selected from one or more in water, alcoholic solution, PVP solution, hydroxypropyl methylcellulose, methylcellulose, starch slurry, sodium carboxymethyl cellulose and the gelatine size.Adhesive consumption guarantees to make suitable wet granular.
Further; In the step (4); Add lubricant in the dried granule of tabletting forward direction, lubricant is selected from one or more in magnesium stearate, calcium stearate, zinc stearate, stearic acid, Pulvis Talci, silicon dioxide, micropowder silica gel, Polyethylene Glycol, hydrogenated vegetable oil, aluminium-magnesium silicate, sodium laurylsulfate, fumaric acid and the polyoxyethylene monostearate.Usually, the weight of lubricant accounts for 0～2% of tablet skeleton weight.
Further, the interior temperature of control coating pan is 25～60 ℃ during coating, coating weightening finish 2～4%.
The present invention has selected the kinds of surfactants that relatively is suitable for preparing felodipine sustained-release preparation for use; And amount of surfactant is bigger; Simultaneously in the preparation through the active component felodipine is joined heating for dissolving in the surfactant, thereby can make the common solution that contains felodipine, surfactant, significantly improve the dispersion effect of felodipine; Improve the solubility property of insoluble drug felodipine in water, improve the absorption in gastrointestinal tract environment.Simultaneously; Be prone to the material that becomes sour because the surfactant of oils belongs to, and in this formulation preparation process, need the common solution of preparation felodipine, surfactant, also might cause the increase of felodipine oxide; Therefore; Through adding antioxidant, well solved this problem among the present invention, effectively guaranteed preparation stablizing at preparation and storage process.
It is similar with the release profiles of existing felodipine sustained-release tablets Plendil (trade name) that the present invention prepares the release in vitro curve of preparation, discharges steadily; Test shows, felodipine sustained-release preparation provided by the invention and Plendil bioequivalence, and have safety preferably.
Description of drawings
Fig. 1 be experimenter's single oral embodiment of the invention 3 preparations with listing preparation Plendil after average blood drug level (mean ± sd)-time graph comparison diagram; Wherein curve a represents average blood drug level behind experimenter's single oral embodiment of the invention 3 preparations (mean ± sd)-time plot, curve b represent behind experimenter's single oral listing preparation Plendil on average blood drug level (mean ± sd)-time plot.
The specific embodiment
Below in conjunction with the accompanying drawing and the specific embodiment the present invention is further described.
Employed reagent all can be buied from market in embodiment and the stability test.Among the embodiment, % representes percentage by weight (indicate especially except).
Embodiment 1
Supplementary material and consumption that embodiment 1 adopts are as shown in table 1.
Table 1
| The supplementary material title | Consumption |
| Felodipine | 5mg |
| Ascorbic acid | 0.05mg |
| Poloxamer | 35mg |
| Microcrystalline Cellulose | 43.5mg |
| Lactose | 100mg |
| LHPC | 10mg |
| HPMC?K100LV | 25mg |
| HPMC?K4M | 15mg |
| Pulvis Talci | 1.0mg |
| Opadry (coating material) | Coating increases weight about 3% |
Method for preparing:
By consumption shown in the table 1 felodipine and ascorbic acid are joined in the poloxamer, heating for dissolving, and add the adequate amount of ethanol solution dilution, process raw material medicine solution; With filler microcrystalline Cellulose, lactose, LHPC and framework material HPMC K100LV, HPMC K4M mix homogeneously, and further mix, stir with the above-mentioned raw material medicine solution that makes; 80% (volumetric concentration) alcoholic solution that in the gained mixture, adds ten thousand consumptions of about 15kg/10 carries out wet granulation as binding agent, is 2～5% with the particle drying that makes to water content; In dried granules, add Pulvis Talci, mix homogeneously, tabletting; In coating pan, the gained tabletting is carried out coating with the Opadry coating material, the coating temperature is 40 ℃, and coating increases weight about 3%.
Embodiment 2
Supplementary material and consumption that embodiment 2 adopts are as shown in table 2.Method for preparing is with embodiment 1, and binding agent replaces 80% alcoholic solution among the embodiment 1 with the alcoholic solution that contains 5%PVP, and consumption is ten thousand of about 12kg/10.
Table 2
| The supplementary material title | Consumption |
| Felodipine | 5mg |
| Vitamin E | 0.1mg |
| Poloxamer | 15mg |
| Microcrystalline Cellulose | 40mg |
| Lactose | 80mg |
| HPMC?K100LV | 45mg |
| HPMC?K15M | 15mg |
| HPC | 10mg |
| Micropowder silica gel | 2.0mg |
| Opadry (coating material) | Coating increases weight about 3% |
Embodiment 3
Supplementary material and consumption that embodiment 3 adopts are as shown in table 3.Method for preparing is with embodiment 1.
Table 3
| The supplementary material title | Consumption |
| Felodipine | 5mg |
| Propyl gallate | 0.01mg |
| Polyoxyl 40 hydrogenated castor oil | 24mg |
| Microcrystalline Cellulose | 30mg |
| Lactose | 58mg |
| HPMC?K100LV | 64mg |
| HPMC?K15M | 16mg |
| HPC | 10mg |
| Magnesium stearate | 1.6mg |
| Opadry (coating material) | Coating increases weight about 3% |
Embodiment 4
Supplementary material and consumption that embodiment 4 adopts are as shown in table 4.Method for preparing is with embodiment 1.
Table 4
| The supplementary material title | Consumption |
| Felodipine | 5mg |
| Propyl gallate | 0.5mg |
| Polyoxyl 40 hydrogenated castor oil | 50mg |
| Lactose | 120mg |
| HPMC?K4M | 10mg |
| HPMC?K100M | 30mg |
| HPC | 10mg |
| Opadry (coating material) | Coating increases weight about 3% |
Embodiment 5
Supplementary material and consumption that embodiment 5 adopts are as shown in table 5.Method for preparing is with embodiment 1.
Table 5
| The supplementary material title | Consumption |
| Felodipine | 5mg |
| To hydroxyl tert-butyl group methoxybenzene | 0.1mg |
| Polyoxyl 40 hydrogenated castor oil | 14mg |
| Sodium lauryl sulphate | 10mg |
| Lactose | 88mg |
| HPMC?K4M | 50mg |
| HPMC?K15M | 30mg |
| HPC | 10mg |
| Aluminium-magnesium silicate | 2.0mg |
| Opadry (coating material) | Coating increases weight about 3% |
Embodiment 6
Supplementary material and consumption that embodiment 6 adopts are as shown in table 6.Method for preparing is with embodiment 1.
Table 6
| The supplementary material title | Consumption |
| Felodipine | 5mg |
| Propyl gallate | 0.08mg |
| Lecithin | 8mg |
| Polyoxyl 40 hydrogenated castor oil | 22mg |
| Lactose | 55mg |
| LHPC | 10mg |
| HPMC?K100LV | 80mg |
| HPMC?K4M | 30mg |
| Magnesium stearate | 1.0mg |
| Opadry (coating material) | Coating increases weight about 3% |
Embodiment 7
Supplementary material and consumption that embodiment 7 adopts are as shown in table 7.Method for preparing is with embodiment 1.
Table 7
| The supplementary material title | Consumption |
| Felodipine | 5g |
| Propyl gallate | 0.01g |
| Castor oil hydrogenated | 10g |
| Microcrystalline Cellulose | 60g |
| Lactose | 80g |
| LHPC | 10g |
| HPMC?K100M | 30g |
| HPMC?K15M | 10g |
| Magnesium stearate | 1.6g |
| Opadry (coating material) | Coating increases weight about 3% |
The release in vitro behavior test
The felodipine sustained-release tablets agent of embodiment 3 preparations is carried out the comparative study of release in vitro degree with existing similar tablet Plendil.
Drug release determination adopts the method for regulation in the national drug standards [standard No. WS1-(X-152)-2005Z] to carry out: the device that adopts dissolution method second method; With 0.4% cetyl trimethyl ammonium bromide phosphate buffer 500mL is solvent; Rotating speed was 200rpm, 1,4 and 7 hour sampling and measuring.
Get tablet samples and 6 Plendil tablet samples that 6 embodiment of the invention 3 make respectively; Under current national drug standard release degree method condition, measure the release in vitro degree of each sample; Its result sees table 8 and 9 respectively, and the release profiles comparison diagram of the following two kinds of samples of this condition is seen Fig. 1.
Table 8
Table 9
See that from table 4 sample of the embodiment of the invention 3 is respectively 19.3%, 76.1%, 99.6% in the release degree meansigma methods of 1h, 4h, 7h, all meets the national drug standards, explain that the quality of the pharmaceutical preparations of the present invention is stable, discharges steadily.
See from Fig. 1; Under national drug standards drug release determination condition; The release in vitro behavior basically identical of the sample of the embodiment of the invention 3 and Plendil sample, and the slow phenomenon in fast back before when discharging, not occurring do not occur the later stage yet and discharge incomplete phenomenon.
Stability test
The tablet samples that the embodiment of the invention 3 is made is carried out long-term 6 months (25 ℃ ± 2 ℃ of temperature, humidity RH60% ± 10%) respectively and is quickened the stability test of 6 months (40 ℃ ± 2 ℃ of temperature, humidity RH75% ± 5%), and its result sees table 10, table 11 respectively.
Table 10
Table 11
Can find out from the data of table 8, table 9; In the condition held 6 months of 25 ℃ ± 2 ℃ of temperature, humidity RH60% ± 10% and in the condition held of 40 ℃ ± 2 ℃ of temperature, humidity RH75% ± 5% after 6 months, the outward appearance of product and stability all show well the tablet that the embodiment of the invention 3 makes respectively.
Application examples
The tablet (receiving test preparation) that embodiment 3 is made has carried out the bioequivalence test of 24 routine healthy males through behind 6 months stability tests.After health volunteer's single oral 5mg received test preparation and existing preparation Plendil (reference preparation), (mean ± sd n=24) saw table 12 to the main pharmacokinetic parameter of felodipine.
Table 12
* Tmax representes with median (minima, maximum)
The relative bioavailability that receives test preparation that * calculates with AUC0 – t
After single oral dose received test preparation and reference preparation, the average blood drug level-time graph of experimenter was seen Fig. 1.
Main pharmacokinetic parameter C
Max, AUC
0-t, AUC
0-∞Through to after the number conversion, carry out evaluation of bioequivalence.Two-way one-side t check shows: the C that receives test preparation
Max, AUC
0-t, AUC
0-∞Variance P value<0.05, the high limit and the lower bound that receive test preparation to surpass the reference preparation of stipulating are described, all satisfy the bioequivalence evaluation criterion.90% confidence interval is analyzed and is shown: the AUC that receives test preparation
0-tAt 99.2%～120.2% scope of reference preparation, AUC
0-∞At 96.2%～117.8% scope of reference preparation, C
MaxIn the 70%-143% of reference preparation scope, all satisfy the bioequivalence evaluation criterion; Receive the T of test preparation and reference preparation
MaxNon parametric method check variance P＞0.05, the difference not statistically significant.
Statistical result shows, receives test preparation and reference preparation bioequivalence, and receives test preparation and reference preparation that safety is preferably arranged in healthy Chinese subjects.
The foregoing description just illustrates of the present invention, and the present invention also can implement with other ad hoc fashion or other particular form, and does not depart from main idea of the present invention or substitutive characteristics.Therefore, the embodiment of description all should be regarded as illustrative from any aspect but not be determinate.Scope of the present invention should be by additional claim explanation, and any intention and equivalent variation of scope with claim also should be within the scope of the present invention.
Claims (10)
1. felodipine sustained-release preparation; Be dissolved in the pharmaceutic adjuvant that mainly contains surfactant and framework material by the active component felodipine and form; It is characterized in that; The weight ratio of surfactant and active component felodipine is 1:1～10:1, and surfactant is selected from one or more in sodium lauryl sulphate, stearyl alcohol fumaric acid sodium, lecithin, poloxamer, Myrj 45, castor oil derivatives, glyceryl monostearate, glyceryl monooleate, glyceryl triacetate, single glyceryl linoleate, the polyethylene glycol fatty acid glyceride type; Also comprise the antioxidant that consumption is a felodipine weight 0.1～10% in the pharmaceutic adjuvant.
2. a kind of felodipine sustained-release preparation according to claim 1 is characterized in that, the weight ratio of surfactant and active component felodipine is 3:1～7:1.
3. a kind of felodipine sustained-release preparation according to claim 1 and 2 is characterized in that, surfactant is poloxamer, castor oil derivatives or polyethylene glycol fatty acid glyceride type.
4. a kind of felodipine sustained-release preparation according to claim 1; It is characterized in that antioxidant is selected from sodium thiosulfate, sodium sulfite, sodium sulfite, sodium pyrosulfite, thioglycerol, thiourea, cysteine, ascorbic acid, arabo-ascorbic acid, ascorbyl palmitate, propyl gallate, gallateoctylester, isoamyl gallate, vitamin E, in hydroxyl tert-butyl group methoxybenzene and the toluene di-tert-butyl phenol one or more.
5. a kind of felodipine sustained-release preparation according to claim 4; It is characterized in that antioxidant is selected from thioglycerol, ascorbyl palmitate, propyl gallate, gallateoctylester, vitamin E, in the hydroxyl tert-butyl group methoxybenzene one or more.
6. a kind of felodipine sustained-release preparation according to claim 1; It is characterized in that; It is the hydroxypropyl cellulose (HPC) of 1500～3000mpas or 4000～6500mpas and in the polyoxyethylene one or more that said framework material is selected from hydroxypropyl methylcellulose, viscosity, and the consumption of said framework material is 20～70% of a tablet skeleton weight.
7. a kind of felodipine sustained-release preparation according to claim 1 and 2 is characterized in that, said pharmaceutic adjuvant also comprises filler and the coating material that accounts for tablet skeleton weight 30～80%; Said filler is selected from one or more in lactose, starch, pregelatinized Starch, mannitol, Icing Sugar, cellulose derivative, low-substituted hydroxypropyl cellulose (L-HPC), dextrin, sorbitol, calcium hydrogen phosphate and the calcium sulfate.
8. the method for preparing of the described a kind of felodipine sustained-release preparation of claim 7 may further comprise the steps:
(1) antioxidant with active component felodipine and institute's expense joins in the surfactant of institute's expense, and heating for dissolving adds the alcoholic solution dilution in case of necessity, obtains raw material medicine solution;
(2) will be except that lubricant and other solid adjuvant material mix homogeneously the coating material, and mix with the raw material medicine solution of step (1), stir;
(3) get the mixture that step (2) obtains and carry out wet granulation, drying;
(4) to dried granule tabletting, add proper amount of lubricating agent in case of necessity;
(5) adopt coating material that tablet is carried out coating, promptly get product.
9. the method for preparing of a kind of felodipine sustained-release preparation according to claim 8; It is characterized in that; In the step (3); During wet granulation, in the mixture that step (2) obtains, add binding agent in advance, binding agent is selected from one or more in water, alcoholic solution, PVP solution, hydroxypropyl methylcellulose, methylcellulose, starch slurry, sodium carboxymethyl cellulose and the gelatine size.
10. the method for preparing of a kind of felodipine sustained-release preparation according to claim 8; It is characterized in that; In the step (4); Add lubricant in the dried granule of tabletting forward direction, lubricant is selected from one or more in magnesium stearate, calcium stearate, zinc stearate, stearic acid, Pulvis Talci, silicon dioxide, micropowder silica gel, Polyethylene Glycol, hydrogenated vegetable oil, aluminium-magnesium silicate, sodium laurylsulfate, fumaric acid and the polyoxyethylene monostearate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210270161.3A CN102784128B (en) | 2012-07-31 | 2012-07-31 | Felodipine sustained release preparation and preparation method of felodipine sustained release preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210270161.3A CN102784128B (en) | 2012-07-31 | 2012-07-31 | Felodipine sustained release preparation and preparation method of felodipine sustained release preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102784128A true CN102784128A (en) | 2012-11-21 |
| CN102784128B CN102784128B (en) | 2015-01-07 |
Family
ID=47149850
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210270161.3A Active CN102784128B (en) | 2012-07-31 | 2012-07-31 | Felodipine sustained release preparation and preparation method of felodipine sustained release preparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102784128B (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114712319A (en) * | 2022-03-25 | 2022-07-08 | 北京诺康达医药科技股份有限公司 | Felodipine propranolol hydrochloride compound preparation and preparation method thereof |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997002017A1 (en) * | 1995-07-03 | 1997-01-23 | Elan Corporation, Plc | Controlled release formulations for poorly soluble drugs |
| CN1319004A (en) * | 1999-07-20 | 2001-10-24 | 阿斯特拉曾尼卡有限公司 | New pharmaceutical formulation |
| CN1640400A (en) * | 2004-01-08 | 2005-07-20 | 曹德英 | Felodipine controlled-release preparation |
| CN101744786A (en) * | 2008-12-17 | 2010-06-23 | 南京星银药业有限公司 | Prescription of felodipine sustained-release tablets and preparation method |
| CN101843598A (en) * | 2010-06-07 | 2010-09-29 | 常州制药厂有限公司 | Preparation method of felodipine sustained release tablets |
| CN101953837A (en) * | 2010-09-20 | 2011-01-26 | 山西康宝生物制品股份有限公司 | Felodipine sustained-release tablets and preparation method thereof |
| CN102552200A (en) * | 2012-02-19 | 2012-07-11 | 河北菲尼斯生物技术有限公司 | Felodipine sustained-release tablets |
-
2012
- 2012-07-31 CN CN201210270161.3A patent/CN102784128B/en active Active
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997002017A1 (en) * | 1995-07-03 | 1997-01-23 | Elan Corporation, Plc | Controlled release formulations for poorly soluble drugs |
| CN1319004A (en) * | 1999-07-20 | 2001-10-24 | 阿斯特拉曾尼卡有限公司 | New pharmaceutical formulation |
| CN1640400A (en) * | 2004-01-08 | 2005-07-20 | 曹德英 | Felodipine controlled-release preparation |
| CN101744786A (en) * | 2008-12-17 | 2010-06-23 | 南京星银药业有限公司 | Prescription of felodipine sustained-release tablets and preparation method |
| CN101843598A (en) * | 2010-06-07 | 2010-09-29 | 常州制药厂有限公司 | Preparation method of felodipine sustained release tablets |
| CN101953837A (en) * | 2010-09-20 | 2011-01-26 | 山西康宝生物制品股份有限公司 | Felodipine sustained-release tablets and preparation method thereof |
| CN102552200A (en) * | 2012-02-19 | 2012-07-11 | 河北菲尼斯生物技术有限公司 | Felodipine sustained-release tablets |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114712319A (en) * | 2022-03-25 | 2022-07-08 | 北京诺康达医药科技股份有限公司 | Felodipine propranolol hydrochloride compound preparation and preparation method thereof |
| CN114712319B (en) * | 2022-03-25 | 2024-01-09 | 北京诺康达医药科技股份有限公司 | Felodipine and propranolol hydrochloride compound preparation and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102784128B (en) | 2015-01-07 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Fahmy et al. | Enhancement of famotidine dissolution rate through liquisolid tablets formulation: in vitro and in vivo evaluation | |
| US10064826B2 (en) | Direct compression and dry granulation processes for preparing carglumic acid tablets having less impurities than those produced by wet granulation process | |
| WO2020249001A1 (en) | Oral solid tablet comprising bruton's tyrosine kinase inhibitor and preparation method therefor | |
| KR20120135356A (en) | Solid dosage forms of valsartan and amlodipine and method of making the same | |
| MX2009002336A (en) | Imatinib compositions. | |
| US20120009258A1 (en) | Compacted cinacalcet | |
| JP7231255B2 (en) | Improved bromocriptine formulation | |
| AU2009235426A1 (en) | Granulation of active pharmaceutical ingredients | |
| CN102138911B (en) | Divalproex sodium sustained release tablets and preparation method thereof | |
| WO2015051747A1 (en) | Pramipexole extended release tablet and preparation method and use thereof | |
| US20120270949A1 (en) | Melt-granulated cinacalcet | |
| EP3616696A1 (en) | Orally administrable enzalutamide-containing pharmaceutical composition | |
| CN105125545A (en) | Medicine composition containing pitavastatin calcium and preparing method thereof | |
| CN102781430B (en) | The solid pharmaceutical preparation of ramipril and Amlodipine Besylate Tablet and preparation thereof | |
| WO2016175230A1 (en) | Pharmaceutical composition for oral administration | |
| CN102784128A (en) | Felodipine sustained release preparation and preparation method of felodipine sustained release preparation | |
| CN102824644B (en) | High-stability sustained-release tablet prepared by using hydroxy propyl cellulose | |
| CN103007286B (en) | General smooth solid composite medicament is cut down in a kind of holder | |
| CN104721827A (en) | Insoluble antifungal medicament solid dispersion and preparation method thereof | |
| CN103405394A (en) | Metoprolol tartrate sustained release tablet and preparation method thereof | |
| CN102614188A (en) | Capsule containing valsartan, levoamlodipine and hydrochlorothiazide and preparing method thereof | |
| CN101642433B (en) | Nimesulide liposome solid preparation and preparation method of drug composite thereof | |
| CN112220765A (en) | Oral preparation containing simvastatin and preparation method thereof | |
| CN104644632A (en) | Orally taken tablet containing Azilsartan and benzenesulfonate amlodipine and preparation method thereof | |
| CN102302453B (en) | Paroxetine hydrochloride liposome solid preparation |
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 | ||
| CP03 | Change of name, title or address |
Address after: 102600 building 7, 37 Yongwang Road, Daxing biomedical industrial base, Zhongguancun Science and Technology Park, Daxing District, Beijing Patentee after: Beijing Xiehe Pharmaceutical Co.,Ltd. Address before: 102600 Beijing Xiehe pharmaceutical factory, Xingye North Road, Huangcun Town, Daxing District, Beijing Patentee before: Beijing Union Pharmaceutical Factory |
|
| CP03 | Change of name, title or address |