CN105456270A - Dipeptidyl peptidase IV inhibitor pharmaceutical composition, use and preparation method thereof - Google Patents
Dipeptidyl peptidase IV inhibitor pharmaceutical composition, use and preparation method thereof Download PDFInfo
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- CN105456270A CN105456270A CN201410425927.XA CN201410425927A CN105456270A CN 105456270 A CN105456270 A CN 105456270A CN 201410425927 A CN201410425927 A CN 201410425927A CN 105456270 A CN105456270 A CN 105456270A
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Abstract
The invention discloses a pharmaceutical composition containing a dipeptidyl peptidase IV inhibitor linagliptin, use and preparation method thereof. The linagliptin containing pharmaceutical composition provided by the invention consists of linagliptin or a salt thereof serving as the active ingredient, and pharmaceutical excipients mannitol, pregelatinized starch, corn starch and magnesium stearate. The linagliptin containing pharmaceutical composition provided by the invention reduces the types of excipients, increases the stability of the preparation, reduces the cost of raw materials, and solves the hardness and friability problems of linagliptin tablets by controlling the particle size of the key excipient mannitol. The obtained table has all indicators especially the dissolution rate in line with the drug quality standards, and the process is simple, thus being more suitable for large scale production.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to a kind of dipeptidy peptidase in inhibitors pharmaceutical composition, its purposes and preparation method thereof, relate more specifically to a kind of Li Gelieting pharmaceutical composition, its purposes and preparation method thereof.
Background technology
Dipeptidyl peptidase IV (DPP-IV) can be degraded gut incretin hormones sample polypeptide (GLP-1) and glucose-dependent-insulinotropic polypeptide (GIP), and these two kinds of gut incretin hormones all take part in the physiological regulation of glucose homeostasis.DPP-IV inhibitor, can the concentration of increased activity gut incretin hormones, stimulates insulin releasing, reduce the Plasma Glucagon Level in circulation, be considered to the valuable medicine for the treatment of diabetes in the mode of glucose dependency.
Li Gelieting (Linagliptin, structural formula as shown in Equation 1), it is a kind of dipeptidy peptidase in inhibitors, chemistry 1-[(4-methyl-quinazoline-2-base) methyl]-3-methyl-7-(2-butyne-1-base)-8-[3-(R)-amino-piperadine-1-base]-xanthine by name, by Boehringer Ingelheim, company develops.This product and metformin and sulfonylurea drugs conbined usage, coordinate diet control and motion, can be used for the glycemic control of adult type 2 diabetes mellitus patient.
Containing primary amine groups in Li Gelieting structure, can react with reducing sugar and other reactive carbonyl and carboxylic acid functional etc., therefore show as with multiple pharmaceutic adjuvant as microcrystalline Cellulose, sodium starch glycollate, cross-linked carboxymethyl cellulose receive, tartaric acid, citric acid, glucose, fructose, sucrose, lactose, maltodextrin etc. are incompatible, easily to degrade, bring difficulty to the excellent Li Gelieting preparation of preparation.
Chinese patent CN101437493A discloses a kind of Li Gelieting preparation, comprises the first diluent, the second diluent, binding agent, disintegrating agent and lubricant.Wherein, diluent is cellulose powder, calcium phosphate dibasic anhydrous, calcium phosphate dibasic dihydrate, erithritol, low-substituted hydroxypropyl cellulose, mannitol, pregelatinized Starch or xylitol, disintegrating agent is corn starch, crospolyvinylpyrrolidone, and lubricant is Pulvis Talci, Polyethylene Glycol, behenic acid calcium, calcium stearate, castor oil hydrogenated or magnesium stearate; Binding agent is copovidone, hydroxypropyl emthylcellulose, hydroxypropyl cellulose or polyvinylpyrrolidone.Optimizing prescriptions is: the first diluent is mannitol, and the second diluent is pregelatinized Starch, and binding agent is copovidone, and disintegrating agent is corn starch, lubricant is magnesium stearate.But the effect not providing prepared Li Gelieting preparation in this patent as stability how.And the Li Gelieting preparation that present inventor prepares according to its open formulation and technology is all defective in stability, tablet hardness and friability etc.
Therefore, also need to study Li Gelieting preparation prescription technique, to obtaining superior in quality formulation products.
Summary of the invention
Present inventor conducts in-depth research Li Gelieting preparation prescription technique, many-sided investigation has been carried out to the defective reason of Li Gelieting preparation in prior art, as: 1. the binding agent in open for CN101437493A prescription is replaced with hydroxypropyl cellulose (HPC) and hydroxypropyl methylcellulose (HMPC) etc. by copovidone, find the Li Gelieting tablet still less stable that obtains, acceleration for stabilization Journal of Sex Research places 6 months, relevant thing increases very fast, and dissolution obviously reduces; 2. disintegrating agent is replaced with the stronger low-substituted hydroxypropyl cellulose of disintegrative (L-HPC) by corn starch, although find that the Li Gelieting Dissolution of Tablet that obtains increases, relevant thing still increases comparatively fast; 3. the first diluent is replaced with sorbitol by mannitol, find that the Li Gelieting tablet stability that obtains is not improved.Accidental, inventor finds: when removing the binding agent in preparation prescription as copovidone, preparation Ge Lieting preparation stability of getting profit is good, acceleration for stabilization Journal of Sex Research places 6 months, relevant thing is without obvious increase, dissolution without significant change, this may with the incompatibility of Li Gelieting and multiple auxiliary materials, the supplementary product kind comprised in its preparation prescription should not be too much correlated with.
Hardness and friability all have a direct impact the disintegrate of tablet, the dissolution of principal agent.Present inventor gropes the hardness of Li Gelieting tablet and the defective reason of friability, unexpected discovery, the particle diameter of mannitol affects very large on the hardness of Li Gelieting tablet and friability, when the particle diameter of mannitol is greater than 30 μm, the hardness of Ge Lieting tablet of getting profit and friability defective.
Therefore, excellent Li Gelieting preparation that the technical problem to be solved in the present invention is to provide a kind of and has good stability, every Testing index of tablet is as all qualified in hardness, friability and dissolution etc. and preparation method thereof.
Therefore, one aspect of the present invention provides a kind of pharmaceutical composition comprising Li Gelieting, by as the Li Gelieting of active component or its salt, and pharmaceutic adjuvant mannitol, pregelatinized Starch, corn starch and magnesium stearate composition.
Preferably, the component and the percentage by weight (%) that comprise the pharmaceutical composition of Li Gelieting described in are:
Further preferably, the component and the percentage by weight (%) that comprise the pharmaceutical composition of Li Gelieting described in are:
Further preferably, the component and the percentage by weight (%) that comprise the pharmaceutical composition of Li Gelieting described in are:
Wherein:
When described active component is Li Gelieting salt, described percentage by weight is for being converted to the percentage ratio shared by corresponding Li Gelieting weight.
Described pregelatinized Starch can be whole pregelatinized Starch or partially pregelatinized starch, as the Srarch1500 that U.S. Ka Lekang produces, and the pregelatinized Starch that Huzhou Zhanwang Pharmaceutical Co., Ltd., Anhui Shanhe Medicinal Subsidiary Material Co., Ltd. etc. produce.
The present invention also provides a kind of purposes of pharmaceutical composition in useful in preparing drug formulations comprising Li Gelieting of the present invention on the other hand.
The present invention also provides a kind of pharmaceutical preparation on the other hand, comprises the pharmaceutical composition comprising Li Gelieting of the present invention.
Pharmaceutical preparation of the present invention is used for oral administration, can be tablet, capsule, granule, and be preferably tablet, described tablet comprises ordinary tablet and film coated tablet.
Preferably, when described pharmaceutical preparation is tablet, described mannitol particle diameter is less than 30 μm, is more preferably and is less than 20 μm, is more preferably less than 10 μm.
Preferably, when described pharmaceutical preparation is film coated tablet, film-coating material used is for containing stomach dissolution type macromolecular material, optionally, the coatings of described film coated tablet also comprises plasticizer, opacifier, color element, described stomach dissolution type macromolecular material is selected from hydroxypropyl emthylcellulose (HPMC), hydroxypropyl cellulose (HPC), polyvinyl alcohol (PVA), No. VI, acrylic resin and one or more in polyvinylpyrrolidone (PVP), described plasticizer is selected from propylene glycol, Oleum Ricini, Polyethylene Glycol, silicone oil, glycerol, one or more in diethyl phthalate or dibutyl ester, described opacifier is selected from titanium dioxide, described pigment is selected from amaranth, carmine, lemon yellow, sunset yellow and indigo in one or more, described film-coating material also can be bought commercially as easily released beautiful stomach dissolution type coating series, Opadry stomach dissolution type coating series etc.Coating adhesive therefor is alcoholic solution or the water of suitable concentration, is preferably the alcoholic solution (concentration of volume percent) of water or 85%.Film-coating material uses with the amount of the film coating that can provide about 3 ~ 4% of film coated cores weight.
Prepared by the pharmaceutical composition comprising Li Gelieting of the present invention, preparation is through by dissolution and determination of related substances, all meets medicine quality standard.By Li Gelieting preparation of the present invention after simulation listing packaging, carry out stability test, result of the test shows that Li Gelieting preparation stability of the present invention is good.When Li Gelieting preparation of the present invention is tablet, well, disintegrate and stripping all meet medicine quality standard for gained tablet hardness and friability.Therefore, Li Gelieting preparation of the present invention be a kind ofly to have good stability, every Testing index such as hardness, friability and dissolution etc. all meet the elegant formulations of medicine quality standard.
The present invention also provides a kind of preparation method of above-mentioned Li Gelieting pharmaceutical composition on the other hand, comprise: active component Li Gelieting or its salt are mixed with mannitol, pre-paying starch, corn starch, mixing, add purified water to granulate, then wet granular is carried out drying, add magnesium stearate again, mixing, Ge Lieting pharmaceutical composition of namely getting profit.
Wherein:
Described baking temperature is 40 ~ 60 DEG C, and dry terminal is to moisture≤3.5%.
Preferably, gained wet granular is carried out granulate, described granulate mesh size used is 1.6mm-3mm.
Preferably, granule after drying is carried out granulate, described granulate mesh size used is 1mm-2mm.
Also providing a kind of comprises the preparation method comprising the pharmaceutical preparation of the pharmaceutical composition of Li Gelieting of the present invention on the other hand in the present invention, comprising:
The pharmaceutical composition of the Li Gelieting of comprising of the present invention is incapsulated shell, Ge Lieting capsule of namely getting profit;
Or the pharmaceutical composition of the Li Gelieting of comprising of the present invention is carried out tabletting, optionally carry out coating, Ge Lieting tablet of namely getting profit, wherein, coating weight gain is about 3 ~ 4% of label;
Or the pharmaceutical composition direct packaging of the Li Gelieting of comprising of the present invention is become bag, Ge Lieting granule of namely getting profit.
Li Gelieting pharmaceutical composition of the present invention decreases supplementary product kind; add preparation stability; decrease supplementary material cost; and by controlling the particle diameter of crucial adjuvant mannitol; solve the hardness of Li Gelieting tablet and the problem of friability; gained tablet indices especially dissolution all meets medicine quality standard, and technique is simple, is more suitable for large-scale production.
Detailed description of the invention
Further illustrate the present invention by the following example, but should not form any limitation of the invention.
embodiment 1: the pharmaceutical composition comprising Li Gelieting
Prescription composition (1000 unit dose)
Preparation technology:
Li Gelieting raw material is mixed homogeneously with mannitol, pregelatinized Starch, corn starch in high shear mixer, adds purified water and granulate, and wet granular is optionally carried out wet whole granule with 1.6mm-3mm screen cloth.Wet granular is carried out drying, and dried material temperature is 40 ~ 60 DEG C, is dried to moisture≤3.5%.Dry granule, after 1mm-2mm screen cloth granulate, adds magnesium stearate mixing, must comprise the pharmaceutical composition of Li Gelieting.
embodiment 2: the pharmaceutical composition comprising Li Gelieting
Pregelatinized Starch, with embodiment 1, is just replaced with the pregelatinized Starch that Huzhou Zhanwang Pharmaceutical Co., Ltd. produces by prescription composition.
Preparation technology is with embodiment 1.
embodiment 3: Li Gelieting capsule
The pharmaceutical composition comprising Li Gelieting of embodiment 1 gained is incapsulated shell, Ge Lieting capsule of namely getting profit.
embodiment 4: Li Gelieting granule
The compositions direct packaging comprising Li Gelieting of embodiment 2 gained is become bag, Ge Lieting granule of namely getting profit.
embodiment 5: Li Gelieting capsule (adding binding agent copolyvidone)
Prescription composition (1000)
Preparation technology:
Li Gelieting raw material is mixed homogeneously with mannitol, pregelatinized Starch, corn starch, copolyvidone in high shear mixer, adds purified water and granulate, and wet granular is optionally carried out wet whole granule with 1.6mm-3mm screen cloth.Wet granular is carried out drying, and dried material temperature is 40 ~ 60 DEG C, is dried to moisture≤3.5%.Dry granule, after 1mm-2mm screen cloth granulate, adds magnesium stearate mixing, must comprise the pharmaceutical composition of Li Gelieting;
Pharmaceutical composition gained being comprised Li Gelieting loads softgel shell, Ge Lieting capsule of namely getting profit.
embodiment: 6: study on the stability
Ge Lieting formulation samples that embodiment 3-5 is got profit aluminium-plastic bubble plate packing, 40 DEG C under acceleration conditions ± 2 DEG C/75%RH ± 5%RH places 6 months, and respectively at 0,1,2,3 and sampling in June, carry out the relevant thing of sample, dissolution detects, result is as follows:
Experimental result shows, Li Gelieting preparation stability of the present invention is good.In stability put procedure, the relevant thing of Li Gelieting preparation of the present invention increases less, and within 6 months, only increase less than 0.3%, dissolution is almost unchanged; And the Li Gelieting preparation 0 day dissolution adding copolyvidone in prescription is lower, be about 90%, in accelerated stability put procedure, related substance increases very fast, and within 6 months, increase 0.6%, dissolution obviously reduces, and within 6 months, is low to moderate 85%.
embodiment 6-13: Li Gelieting sheet (investigation of mannitol particle diameter)
Embodiment 6-9 prescription composition is with embodiment 1, and embodiment 10-13 prescription forms with embodiment 5,
Preparation technology: respectively with reference to embodiment 1 and 5 preparation technology, just got profit Ge Lieting pharmaceutical composition is carried out tabletting (use rotary tablet machine tabletting, tabletting owner pressure pressure is about 40KN), Ge Lieting sheet of getting profit
| Embodiment | Mannitol particle diameter (μm) | Hardness kg/cm 2 | Friability % | Outward appearance | Dissolution %(15min) |
| 6 | ＜50 | 4.3 | 1.1 | Crack limit between the teeth obvious | 99.7 |
| 7 | ＜30 | 6.3 | 0.4 | Slightly crack limit between the teeth | 100.1 |
| 8 | ＜20 | 8.3 | 0.2 | Bright and clean, complete | 99.5 |
| 9 | ＜10 | 9.1 | 0.1 | Bright and clean, complete | 100.2 |
| 10 | ＜50 | 4.4 | 1.1 | Crack limit between the teeth obvious | --- |
| 11 | ＜30 | 6.1 | 0.5 | Slightly crack limit between the teeth | 91.7 |
| 12 | ＜20 | 8.4 | 0.3 | Bright and clean, complete | 91.1 |
| 13 | ＜10 | 9.0 | 0.1 | Bright and clean, complete | 90.9 |
Experimental result shows: mannitol particle diameter on the hardness of Li Gelieting sheet and friability impact comparatively large, when the particle diameter of mannitol is greater than 30 μm, the hardness of Ge Lieting tablet of getting profit and friability defective; As the particle diameter < 30 μm of mannitol, hardness and the friability of Li Gelieting tablet are qualified, as the particle diameter < 20 μm of mannitol, hardness and the friability of Li Gelieting tablet are better, as the particle diameter < 10 μm of mannitol, the hardness of Li Gelieting tablet and friability the best.
In following examples, the preparation of Li Gelieting tablet will adopt the mannitol of particle diameter < 10 μm.
embodiment 14: Li Gelieting sheet
Prescription composition (1000)
| Composition | Consumption g | Percentage by weight % |
| Li Gelieting | 5.0 | 2.8 |
| Mannitol | 118.3 | 65.7 |
| Pregelatinized Starch (Starch 1500) | 36.0 | 20.0 |
| Corn starch | 18.0 | 10.0 |
| Magnesium stearate | 1.8 | 1.0 |
| Sheet weight | 180 | --------- |
Preparation process: with embodiment 6-9,
The dissolution (15min) of Ge Lieting sheet of getting profit be 95.8%.
embodiment 15: Li Gelieting sheet
Prescription composition (1000)
| Composition | Consumption g | Percentage by weight % |
| Li Gelieting | 5.0 | 2.8 |
| Mannitol | 118.3 | 65.7 |
| Pregelatinized Starch (Starch 1500) | 36.0 | 20.0 |
| Corn starch | 18.0 | 10.0 |
| Magnesium stearate | 2.7 | 1.5 |
| Sheet weight | 180 | --------- |
Preparation process: with embodiment 6-9.
The dissolution (15min) of Ge Lieting sheet of getting profit be 90.4%.
As can be seen from embodiment 9,14 and 15 experimental result, in Li Gelieting preparation, the consumption of magnesium stearate lubricant also has certain influence to dissolution, when lubricant weight percentage ratio is 0.5-1.5%, dissolution is all more than 90%, but along with the increase of lubricant quantity, dissolution is on a declining curve, and therefore in Li Gelieting preparation of the present invention, the percentage by weight of lubricant is preferably 0.5-1.5%, is more preferably 0.5-1%.
embodiment 16: Li Gelieting film coated tablet
Prescription composition (1000)
Preparation process:
With reference to embodiment 6-9 preparation method, just after tabletting, then carry out coating, coating weight gain is 3% of label, Ge Lieting film coated tablet of namely getting profit.
the study on the stability of embodiment 17: Li Gelieting tablet
By embodiment 9 and embodiment 16 Ge Lieting sheet sample aluminium-plastic bubble plate packing of getting profit, place 6 months under acceleration 40 DEG C ± 2 DEG C/75%RH ± 5%RH condition, respectively at 0,1,2,3 and sampling in June, carry out the relevant thing of sample, dissolution detects, result is as follows:
Experimental result shows, Li Gelieting coated tablet stability of the present invention is slightly better than ordinary tablet, but all has good stability, and in accelerated stability put procedure, both dissolutions are all almost unchanged; Relevant thing increases all less, and ordinary tablet only increases 0.3% in 6 months, and coated tablet only increases 0.2% in 6 months.
comparative example 1-4: Li Gelieting capsule (prescription investigation)
Remarks: pregelatinized Starch used is Starch1500.
Preparation technology:
Li Gelieting raw material is mixed homogeneously with the first diluent, the second diluent, disintegrating agent, binding agent in high shear mixer, adds purified water and granulate, and wet granular is optionally carried out wet whole granule with 1.6mm-3mm screen cloth.Wet granular is carried out drying, and dried material temperature is 40 ~ 60 DEG C, is dried to moisture≤3.5%.Dry granule, after 1mm-2mm screen cloth granulate, adds mix lubricant, Ge Lieting pharmaceutical composition of getting profit.Got profit Ge Lieting pharmaceutical composition is loaded softgel shell, Ge Lieting capsule of namely getting profit.
Study on the stability:
To be got profit by comparative example 1-4 Ge Lieting capsule sample aluminium-plastic bubble plate packing, place 6 months under acceleration 40 DEG C ± 2 DEG C/75%RH ± 5%RH condition, respectively at 0,1,2,3 and sampling in June, carry out the relevant thing of sample, dissolution detects, result is as follows:
Experimental result shows, binding agent in open for CN101437493A prescription is replaced with hydroxypropyl cellulose and hydroxypropyl methylcellulose, or the first diluent is replaced with sorbitol by mannitol, find that the Li Gelieting tablet stability that obtains is not improved, acceleration for stabilization Journal of Sex Research places 6 months, relevant thing increases very fast, and dissolution obviously reduces; Disintegrating agent is replaced with L-HPC, although dissolution increases, less stable, acceleration for stabilization Journal of Sex Research places 6 months, and relevant thing increases very fast.
To sum up, Li Gelieting preparation of the present invention is a kind of good stability, and indices such as hardness, friability and dissolution all meet the elegant formulations of drug standard, and pharmaceutic adjuvant kind is few, and technique is simple, is more suitable for large-scale production.
Claims (10)
1. comprise a pharmaceutical composition of Li Gelieting, by as the Li Gelieting of active component or its salt, and pharmaceutic adjuvant mannitol, pregelatinized Starch, corn starch and magnesium stearate composition.
2. comprise the pharmaceutical composition of Li Gelieting as claimed in claim 1, it is characterized in that: the component of described pharmaceutical composition and percentage by weight are:
。
3. comprise the pharmaceutical composition of Li Gelieting as claimed in claim 1, it is characterized in that: the component of described pharmaceutical composition and percentage by weight are:
。
4. the purposes of pharmaceutical composition in useful in preparing drug formulations comprising Li Gelieting according to claim 1, described pharmaceutical preparation is tablet, capsule, granule, and described tablet comprises ordinary tablet and film coated tablet.
5. a pharmaceutical preparation, comprises the pharmaceutical composition comprising Li Gelieting as claimed in claim 1, and described pharmaceutical preparation is tablet, capsule, granule, and described tablet comprises ordinary tablet and film coated tablet.
6. pharmaceutical preparation as claimed in claim 5, it is characterized in that: when described pharmaceutical preparation is tablet, described mannitol particle diameter is less than 30 μm, is preferably less than 20 μm, is more preferably and is less than 10 μm.
7. pharmaceutical preparation as claimed in claim 5, it is characterized in that: when described tablet is film coated tablet, film-coating material used is for containing stomach dissolution type macromolecular material, optionally, the coatings of described film coated tablet also comprises plasticizer, opacifier, color element, described stomach dissolution type macromolecular material is selected from hydroxypropyl emthylcellulose, hydroxypropyl cellulose, polyvinyl alcohol, No. VI, acrylic resin and one or more in polyvinylpyrrolidone, described plasticizer is selected from propylene glycol, Oleum Ricini, Polyethylene Glycol, silicone oil, glycerol, one or more in diethyl phthalate or dibutyl ester, described opacifier is selected from titanium dioxide, described pigment is selected from amaranth, carmine, lemon yellow, sunset yellow and indigo in one or more.
8. pharmaceutical preparation as claimed in claim 7, is characterized in that: described film-coating material weight is 3 ~ 4% of coated cores weight.
9. the preparation method comprising the pharmaceutical composition of Li Gelieting according to claim 1, comprise: active component Li Gelieting or its salt are mixed with mannitol, pregelatinized Starch, corn starch, mixing, adds purified water and granulates, then wet granular is carried out drying, add magnesium stearate again, mixing, Ge Lieting pharmaceutical composition of namely getting profit, preferably, described baking temperature is 40 ~ 60 DEG C, and dry terminal is to moisture≤3.5%.
10. a preparation method for pharmaceutical preparation described in claim 5, is characterized in that: the pharmaceutical composition of the Li Gelieting of comprising according to claim 1 is incapsulated shell, Ge Lieting capsule of namely getting profit; Or the Li Gelieting of comprising pharmaceutical composition according to claim 1 is carried out tabletting, optionally carry out coating, Ge Lieting tablet of namely getting profit; Or the pharmaceutical composition direct packaging of the Li Gelieting of comprising according to claim 1 is become bag, Ge Lieting granule of namely getting profit.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105853382A (en) * | 2016-05-19 | 2016-08-17 | 广州迈达康医药科技有限公司 | Lige column dean orally-disintegrating tablet and preparing method thereof |
| CN106137991A (en) * | 2016-08-01 | 2016-11-23 | 合肥远志医药科技开发有限公司 | A kind of Li Gelieting sheet method of granulating |
| CN106236754A (en) * | 2016-07-31 | 2016-12-21 | 合肥远志医药科技开发有限公司 | A kind of compositions comprising Li Gelieting active component and preparation method thereof |
| CN106389365A (en) * | 2016-10-28 | 2017-02-15 | 迪沙药业集团有限公司 | Trajenta tablet composition |
| CN106389364A (en) * | 2016-10-28 | 2017-02-15 | 迪沙药业集团有限公司 | Trajenta tablet composition and preparation method thereof |
| CN109771651A (en) * | 2019-03-18 | 2019-05-21 | 河南医学高等专科学校 | The pharmaceutical composition of DP-IV inhibitor |
| CN110840856A (en) * | 2019-12-20 | 2020-02-28 | 青岛黄海制药有限责任公司 | Composition containing linagliptin and application thereof |
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| CN102883711A (en) * | 2010-05-05 | 2013-01-16 | 贝林格尔.英格海姆国际有限公司 | Pharmaceutical formulations comprising pioglitazone and linagliptin |
| WO2014026939A1 (en) * | 2012-08-13 | 2014-02-20 | Sandoz Ag | Stable pharmaceutical composition containing 8-[(3r)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-1h-purine-2,6-dione or a pharmaceutically acceptable salt thereof |
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- 2014-08-27 CN CN201410425927.XA patent/CN105456270B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102883711A (en) * | 2010-05-05 | 2013-01-16 | 贝林格尔.英格海姆国际有限公司 | Pharmaceutical formulations comprising pioglitazone and linagliptin |
| WO2014026939A1 (en) * | 2012-08-13 | 2014-02-20 | Sandoz Ag | Stable pharmaceutical composition containing 8-[(3r)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-1h-purine-2,6-dione or a pharmaceutically acceptable salt thereof |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105853382A (en) * | 2016-05-19 | 2016-08-17 | 广州迈达康医药科技有限公司 | Lige column dean orally-disintegrating tablet and preparing method thereof |
| CN105853382B (en) * | 2016-05-19 | 2019-07-19 | 广州迈达康医药科技有限公司 | A kind of Li Gelieting oral disintegrating tablet and preparation method thereof |
| CN106236754A (en) * | 2016-07-31 | 2016-12-21 | 合肥远志医药科技开发有限公司 | A kind of compositions comprising Li Gelieting active component and preparation method thereof |
| CN106137991A (en) * | 2016-08-01 | 2016-11-23 | 合肥远志医药科技开发有限公司 | A kind of Li Gelieting sheet method of granulating |
| CN106389365A (en) * | 2016-10-28 | 2017-02-15 | 迪沙药业集团有限公司 | Trajenta tablet composition |
| CN106389364A (en) * | 2016-10-28 | 2017-02-15 | 迪沙药业集团有限公司 | Trajenta tablet composition and preparation method thereof |
| CN109771651A (en) * | 2019-03-18 | 2019-05-21 | 河南医学高等专科学校 | The pharmaceutical composition of DP-IV inhibitor |
| CN110840856A (en) * | 2019-12-20 | 2020-02-28 | 青岛黄海制药有限责任公司 | Composition containing linagliptin and application thereof |
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|---|---|
| CN105456270B (en) | 2021-03-16 |
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