CN107693514A - A kind of glug arranges net composition - Google Patents
A kind of glug arranges net composition Download PDFInfo
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- CN107693514A CN107693514A CN201711256366.5A CN201711256366A CN107693514A CN 107693514 A CN107693514 A CN 107693514A CN 201711256366 A CN201711256366 A CN 201711256366A CN 107693514 A CN107693514 A CN 107693514A
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- glug
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- lactose
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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
- A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
- A61K31/382—Heterocyclic compounds having sulfur as a ring hetero atom having six-membered rings, e.g. thioxanthenes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
-
- 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
- A61K9/2009—Inorganic compounds
-
- 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
-
- 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
-
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
Abstract
The present invention relates to a kind of glug to arrange net tablet composition, belongs to technical field of medicine.The technical scheme is that：In the composition of unit dose, net 2.5 5mg is arranged containing the glug that D90 is 48 76 microns, the 86mg of lactose 70, the 1.5mg of lauryl sodium sulfate 0.8, the 15mg of sodium citrate 8, the 7mg of sodium acid carbonate 4, the 16mg of beta cyclodextrin 8, the 8mg of PVP K30 3, the 8mg of PVPP 3, the 1.5mg of magnesium stearate 1.Technical solution of the present invention provides a kind of high-dissolution, and the stable glug of uniformity of dosage units arranges net tablet composition.
Description
Technical field
The present invention relates to a kind of glug to arrange net tablet composition, belongs to technical field of medicine.
Background technology
Diabetes are one group of metabolic diseases characterized by hyperglycaemia.Counted according to IDF, 2014 complete
Ball diabetic is up to 3.87 hundred million people, it is contemplated that is up to 5.92 hundred million people within 2035.Type ii diabetes are the most common shape of diabetes
Formula, account for the 90% of diabetic.
Diabetes can cause the various tissues of human body, especially eye, kidney, heart, blood vessel, the chronic lesion of nerve, function
Obstacle.Once as diabetic, it is necessary to take medicine throughout one's life.Diabetes not only influence the quality of life of patient, it is also possible to lead
Cause the shortening in life-span.
Glug row are net, English name Luseogliflozin, have 2.5mg, two specifications of 5mg, belong to small dose drug system
Agent；Japanese big positive pharmaceutical development, for improving the glycemic control of diabetes B adult patient, glug row are net not soluble in water.
It is not up to standard there is dissolution rate in the development process of preparation, in order to improve dissolution rate, come typically in a manner of controlling main ingredient granularity
Dissolution is improved, but for glug row are net, there is very big Electrostatic Absorption, generates what uniformity of dosage units was difficult to control again
Problem.
The content of the invention
Goal of the invention：
It is an object of the invention to provide a kind of glug to arrange net composition, solves the relatively low technical problem of preparation dissolution rate, Yi Jihan
Measure the problem of uniformity is exceeded.
Technical scheme：
The technical scheme is that：
A kind of glug arranges net composition, in the composition of unit dose, contains the glug that D90 is 48-76 microns and arranges net 2.5-
5mg, lactose 70-86mg, lauryl sodium sulfate 0.8-1.5mg, sodium citrate 8-15mg, sodium acid carbonate 4-7mg, beta cyclodextrin
8-16mg, PVP K30 3-8mg, PVPP 3-8mg, magnesium stearate 1-1.5mg.
Currently preferred technical scheme is：A kind of glug arranges net composition, in the composition of unit dose, contains D90
Net 2.5-5mg, lactose 75-82mg, lauryl sodium sulfate 1.0-1.3mg, sodium citrate 10- are arranged for the glug of 56-75 microns
13mg, sodium acid carbonate 5-6mg, beta cyclodextrin 10-14mg, PVP K30 3-8mg, PVPP 3-8mg, magnesium stearate 1-
1.5mg。
Currently preferred technical scheme is：A kind of glug arranges net composition, in the composition of unit dose, contains D90
Net 2.5mg, lactose 78mg, lauryl sodium sulfate 1.2mg, sodium citrate 10mg, sodium acid carbonate are arranged for 60 microns of glugs
5mg, beta cyclodextrin 10mg, PVP K30 5mg, PVPP 5mg, magnesium stearate 1.3mg.
Currently preferred technical scheme is：A kind of glug arranges net composition, in the composition of unit dose, contains D90
Net 5mg, lactose 79mg, lauryl sodium sulfate 1.3mg, sodium citrate 12mg, sodium acid carbonate 6mg, β are arranged for 65 microns of glugs
Cyclodextrin 12mg, PVP K30 7mg, PVPP 7mg, magnesium stearate 1.5mg.
In technical solution of the present invention, glug arranges net Task-size Controlling, lauryl sodium sulfate, sodium citrate, sodium acid carbonate,
Beta cyclodextrin is to realize the indispensable factor of the object of the invention.
The net granularity of glug row is too thin, and Electrostatic Absorption is serious, and film-making and crushing process have unnecessary loss；Granularity
Too greatly, it is not easy to dissolution.The granularity of technical solution of the present invention is optimum granularity.Sodium citrate, sodium acid carbonate can assist
The acid-base environment of control tablet is helped, is advantageous to main ingredient dissolution, lauryl sodium sulfate, beta cyclodextrin, which rise, assists main ingredient dissolution
Effect.
The preparation method of canagliflozin composition of the present invention, comprises the following steps：
It is 48-76 micrometer ranges that first step glug row are crushed to D90 only, and other auxiliary materials cross 100 mesh sieves；
Second step weighs the row of the glug after the crushing of recipe quantity only, lauryl sodium sulfate, beta cyclodextrin and cone with recipe quantity
30-60 minutes are mixed in shape batch mixer, then are mixed with the sodium citrate of recipe quantity, then are mixed with the lactose of half recipe quantity
It is even, with the PVP K30 wet granulation of 2/3rds recipe quantities, 45 DEG C of vacuum drying, cross 80 mesh sieves；
3rd step mixes the sodium acid carbonate of particle obtained by second step and recipe quantity, PVPP, then with remaining half
The lactose of recipe quantity mixes, and with the PVP K30 wet granulation of remaining 1/3rd recipe quantities, 45 DEG C of vacuum drying, crosses 80 mesh
Sieve；
4th step adds the magnesium stearate of recipe quantity, mixes, tabletting.
Useful achievement：
Technical solution of the present invention provides a kind of high-dissolution, and the stable glug of uniformity of dosage units arranges net tablet composition.
Preparation method of the present invention solves the problems, such as that uniformity of dosage units is not up to standard, solves glug to a certain extent
Arrange the relatively low problem of net dissolution rate.Preparation method of the present invention, dissolution rate can be up to more than 95%.Technical solution of the present invention
A kind of dissolution rate height is provided, the stable glug of uniformity of dosage units arranges net tablet composition.
The glug that the D90 of embodiment 1. is 48 microns arranges net 2.5g, lactose 70g, lauryl sodium sulfate 1.5g, citric acid
Sodium 8g, sodium acid carbonate 7g, beta cyclodextrin 8g, PVP K30 8mg, PVPP 3g, magnesium stearate 1g.By technical scheme institute
State preparation method and prepare 1000.
The glug that the D90 of embodiment 2. is 76 microns arranges net 5g, lactose 86g, lauryl sodium sulfate 0.8g, sodium citrate
15g, sodium acid carbonate 4g, beta cyclodextrin 16g, PVP K30 3g, PVPP 8g, magnesium stearate 1.5g.By technical scheme
The preparation method prepares 1000.
The glug that the D90 of embodiment 3. is 60 microns arranges net 2.5g, lactose 78g, lauryl sodium sulfate 1.2g, citric acid
Sodium 10g, sodium acid carbonate 5g, beta cyclodextrin 10g, PVP K30 5g, PVPP 5g, magnesium stearate 1.3g.By technical side
Preparation method described in case prepares 1000.
The glug that the D90 of embodiment 4. is 65 microns arranges net 5g, lactose 79g, lauryl sodium sulfate 1.3g, sodium citrate
12g, sodium acid carbonate 6g, beta cyclodextrin 12g, PVP K30 7g, PVPP 7g, magnesium stearate 1.5g.By technical scheme
The preparation method prepares 1000.
The prescription of 1. embodiment of reference examples 3, cuts sodium citrate and sodium acid carbonate.It is specific as follows：
The glug that D90 is 60 microns arranges net 2.5g, lactose 93g, lauryl sodium sulfate 1.2g, beta cyclodextrin 10g, PVP
K30 5g, PVPP 5g, magnesium stearate 1.3g.Preparation method prepares 1000 as described in technical scheme.
It is 60 micrometer ranges that first step glug row are crushed to D90 only, and other auxiliary materials cross 100 mesh sieves；
Second step weighs the row of the glug after the crushing of recipe quantity only, lauryl sodium sulfate, beta cyclodextrin and cone with recipe quantity
Mix 60 minutes in shape batch mixer, then mixed with the lactose of half recipe quantity, with the PVP of 2/3rds recipe quantities
K30 wet granulations, 45 DEG C of vacuum drying, cross 80 mesh sieves；
3rd step mixes the PVPP of particle obtained by second step and recipe quantity, then with remaining half recipe quantity
Lactose mixes, and with the PVP K30 wet granulation of remaining 1/3rd recipe quantities, 45 DEG C of vacuum drying, crosses 80 mesh sieves；
4th step adds the magnesium stearate of recipe quantity, mixes, tabletting.
The prescription of 2. embodiment of reference examples 4, one-step method granulation are specific as follows
First step glug row are crushed to D only90For 65 micrometer ranges, other auxiliary materials cross 100 mesh sieves；
Second step weighs the row of the glug after the crushing of recipe quantity only, lauryl sodium sulfate, beta cyclodextrin and cone with recipe quantity
Mix 60 minutes in shape batch mixer, then mixed with the sodium citrate of recipe quantity, lactose, sodium acid carbonate, PVPP, use prescription
The PVP K30 wet granulation of amount, 45 DEG C of vacuum drying, crosses 80 mesh sieves；
3rd step adds the magnesium stearate of recipe quantity, mixes, tabletting.
Test example 1, determine respectively according to the Rotating shaker of States Pharmacopoeia specifications embodiment 1-4 and reference examples 1-2 product dissolution
Degree, dissolution medium is done with 0.1mol/L hydrochloric acid solutions, the record accumulation dissolution rate of the 60th minute is in table 1.
Table 1
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Reference examples 1 | Reference examples 2 | |
| 60 minutes accumulation dissolution rates, % | 96.23 | 97.08 | 97.23 | 97.32 | 68.96 | 79.36 |
The data of table 1 illustrate, technical scheme of the embodiment of the present invention, for improve main ingredient dissolution rate served it is good, have meaning
Unimaginable effect.
Test example 2, the uniformity of dosage units for determining embodiment 1-3 and reference examples 1-2 respectively, detection sample is analyzed by HPLC
The content of active component in product, the content of the mark of active component content and active component, obtains every batch in more each sample
The secondary average mixture content uniformity.Data record is in table 2.
Table 2
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Reference examples 1 | Reference examples 2 | |
| Uniformity of dosage units, % | 99.8 | 99.97 | 100.1 | 100.0 | 99.94 | 99.76 |
| RSD, % | 1.5 | 1.3 | 1.2 | 1.2 | 2.7 | 4.2 |
The data of table 2 illustrate that 1-4 of embodiment of the present invention product, its uniformity of dosage units is stable, meet standard compendial regulation
Requirement, and reference examples especially reference examples 2, its RSD is much larger than the 2 of States Pharmacopoeia specifications.Illustrate preparation method pair of the present invention
The stabilization of uniformity of dosage units serves positive role.
Claims (5)
1. a kind of glug arranges net composition, it is characterised in that in the composition of unit dose, contains the Shandong that D90 is 48-76 microns
Lattice arrange net 2.5-5mg, lactose 70-86mg, lauryl sodium sulfate 0.8-1.5mg, sodium citrate 8-15mg, sodium acid carbonate 4-
7mg, beta cyclodextrin 8-16mg, PVP K30 3-8mg, PVPP 3-8mg, magnesium stearate 1-1.5mg.
2. arrange net composition according to glug described in claim 1, it is characterised in that in the composition of unit dose, be containing D90
The glug of 56-75 microns arranges net 2.5-5mg, lactose 75-82mg, lauryl sodium sulfate 1.0-1.3mg, sodium citrate 10-
13mg, sodium acid carbonate 5-6mg, beta cyclodextrin 10-14mg, PVP K30 3-8mg, PVPP 3-8mg, magnesium stearate 1-
1.5mg。
3. arrange net composition according to glug described in claim 1, it is characterised in that in the composition of unit dose, be containing D90
60 microns of glug arranges net 2.5mg, lactose 78mg, lauryl sodium sulfate 1.2mg, sodium citrate 10mg, sodium acid carbonate 5mg, β
Cyclodextrin 10mg, PVP K30 5mg, PVPP 5mg, magnesium stearate 1.3mg.
4. arrange net composition according to glug described in claim 1, it is characterised in that in the composition of unit dose, be containing D90
65 microns of glug arranges net 5mg, lactose 79mg, lauryl sodium sulfate 1.3mg, sodium citrate 12mg, sodium acid carbonate 6mg, β ring
Dextrin 12mg, PVP K30 7mg, PVPP 7mg, magnesium stearate 1.5mg.
5. the preparation method of canagliflozin composition described in claim 1, it is characterised in that comprise the following steps：
It is 48-76 micrometer ranges that first step glug row are crushed to D90 only, and other auxiliary materials cross 100 mesh sieves；
Second step weighs the row of the glug after the crushing of recipe quantity only, lauryl sodium sulfate, beta cyclodextrin and cone with recipe quantity
30-60 minutes are mixed in shape batch mixer, then are mixed with the sodium citrate of recipe quantity, then are mixed with the lactose of half recipe quantity
It is even, with the PVP K30 wet granulation of 2/3rds recipe quantities, 45 DEG C of vacuum drying, cross 80 mesh sieves；
3rd step mixes the sodium acid carbonate of particle obtained by second step and recipe quantity, PVPP, then with remaining half
The lactose of recipe quantity mixes, and with the PVP K30 wet granulation of remaining 1/3rd recipe quantities, 45 DEG C of vacuum drying, crosses 80 mesh
Sieve；
4th step adds the magnesium stearate of recipe quantity, mixes, tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711256366.5A CN107693514A (en) | 2017-12-04 | 2017-12-04 | A kind of glug arranges net composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711256366.5A CN107693514A (en) | 2017-12-04 | 2017-12-04 | A kind of glug arranges net composition |
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| Publication Number | Publication Date |
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| CN107693514A true CN107693514A (en) | 2018-02-16 |
Family
ID=61181083
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Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103655539A (en) * | 2013-12-13 | 2014-03-26 | 重庆医药工业研究院有限责任公司 | Oral solid preparation of canagliflozin and preparation method thereof |
| CN105456211A (en) * | 2015-12-11 | 2016-04-06 | 香港九华华源集团滁州药业有限公司 | Empagliflozin tablet and preparation method thereof |
| CN106539766A (en) * | 2015-09-18 | 2017-03-29 | 天津市汉康医药生物技术有限公司 | Glug arranges net tablet and preparation method thereof |
| CN106606505A (en) * | 2015-10-22 | 2017-05-03 | 天津市汉康医药生物技术有限公司 | Tofogliflozin pharmaceutical composition and preparation method thereof |
| CN106606488A (en) * | 2015-10-22 | 2017-05-03 | 天津市汉康医药生物技术有限公司 | Luseogliflozin pharmaceutical composition, and preparation method thereof |
| CN106692069A (en) * | 2017-02-14 | 2017-05-24 | 佛山市腾瑞医药科技有限公司 | Empagliflozin solid dispersion preparation and preparation method thereof |
| CN107106873A (en) * | 2015-01-09 | 2017-08-29 | 吉利德阿波罗公司 | ACC inhibitor combined therapies for treating non-alcoholic fatty liver disease |
| CN107281145A (en) * | 2016-04-01 | 2017-10-24 | 天津市汉康医药生物技术有限公司 | A kind of net tablets of En Gelie |
-
2017
- 2017-12-04 CN CN201711256366.5A patent/CN107693514A/en active Pending
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103655539A (en) * | 2013-12-13 | 2014-03-26 | 重庆医药工业研究院有限责任公司 | Oral solid preparation of canagliflozin and preparation method thereof |
| CN107106873A (en) * | 2015-01-09 | 2017-08-29 | 吉利德阿波罗公司 | ACC inhibitor combined therapies for treating non-alcoholic fatty liver disease |
| CN106539766A (en) * | 2015-09-18 | 2017-03-29 | 天津市汉康医药生物技术有限公司 | Glug arranges net tablet and preparation method thereof |
| CN106606505A (en) * | 2015-10-22 | 2017-05-03 | 天津市汉康医药生物技术有限公司 | Tofogliflozin pharmaceutical composition and preparation method thereof |
| CN106606488A (en) * | 2015-10-22 | 2017-05-03 | 天津市汉康医药生物技术有限公司 | Luseogliflozin pharmaceutical composition, and preparation method thereof |
| CN105456211A (en) * | 2015-12-11 | 2016-04-06 | 香港九华华源集团滁州药业有限公司 | Empagliflozin tablet and preparation method thereof |
| CN107281145A (en) * | 2016-04-01 | 2017-10-24 | 天津市汉康医药生物技术有限公司 | A kind of net tablets of En Gelie |
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