CN106539766A - Glug arranges net tablet and preparation method thereof - Google Patents
Glug arranges net tablet and preparation method thereof Download PDFInfo
- Publication number
- CN106539766A CN106539766A CN201510596302.4A CN201510596302A CN106539766A CN 106539766 A CN106539766 A CN 106539766A CN 201510596302 A CN201510596302 A CN 201510596302A CN 106539766 A CN106539766 A CN 106539766A
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- CN
- China
- Prior art keywords
- tablet
- glug
- net
- preparation
- parts
- 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.)
- Pending
Links
- 238000002360 preparation method Methods 0.000 title claims abstract description 27
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 12
- 229930195725 Mannitol Natural products 0.000 claims abstract description 12
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 12
- 239000000594 mannitol Substances 0.000 claims abstract description 12
- 235000010355 mannitol Nutrition 0.000 claims abstract description 12
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 12
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 12
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 12
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 22
- 235000019359 magnesium stearate Nutrition 0.000 claims description 11
- 229920000881 Modified starch Polymers 0.000 claims description 7
- 239000000203 mixture Substances 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 abstract description 3
- 238000000034 method Methods 0.000 description 4
- 238000005469 granulation Methods 0.000 description 3
- 230000003179 granulation Effects 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000000654 additive Substances 0.000 description 2
- 230000000996 additive effect Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- WHSOLWOTCHFFBK-ZQGJOIPISA-N Luseogliflozin Chemical compound C1=CC(OCC)=CC=C1CC1=CC([C@H]2[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)S2)O)=C(OC)C=C1C WHSOLWOTCHFFBK-ZQGJOIPISA-N 0.000 description 1
- 229940123518 Sodium/glucose cotransporter 2 inhibitor Drugs 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 229950004397 luseogliflozin Drugs 0.000 description 1
- 238000005453 pelletization Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
The present invention provides a kind of glug and arranges net tablet and preparation method thereof, and the tablet arranges net, mannitol and microcrystalline cellulose comprising glug.Compared with existing product and its preparation technology, as in the preparation process of direct tablet compressing, active component loss is little, the active component content of the net tablet of glug row of the present invention is higher, and hardness is also improved, and meets the needs of commodity production and clinical application.
Description
Technical field
The invention belongs to field of medicaments, and in particular to a kind of glug arranges net tablet and preparation method thereof.
Background technology
Glug row are net（Luseogliflozin）It is a kind of new SGLT-2 inhibitor medicaments, ratified for treating diabetes B in 2014.
But it is 2.5mg/5mg that existing glug arranges net specification, belongs to low dose of specification, and the preparation of the net tablet of glug row generally adopts wet granulation technology, the technique and its net tablet of obtained glug row to suffer from the drawback that in prior art：1) in preparation process, active component loss is big, about 10-20%；2) not enough, obtained particle is thinner, so being difficult to pressurize during compressing tablet, causes the hardness of tablet little for adhesive viscosities used of pelletizing.Accordingly, it would be desirable to the prescription and its preparation technology that are directed to the net tablet of glug row are improved, net tablet and its preparation technology are arranged so as to develop a kind of new glug that can overcome disadvantage mentioned above.
The content of the invention
It is an object of the present invention to provide a kind of active component content and stability are higher, and the glug that hardness is more suitable for arranges net tablet.
It is as follows for realizing above-mentioned technical purpose technical scheme：
A kind of glug arranges net tablet, and the tablet arranges net, mannitol and microcrystalline cellulose comprising glug.Preferably, count by weight, the tablet arranges net 1 part comprising glug；10～20 parts of mannitol, such as 15～20 parts；9～15 parts of microcrystalline cellulose, such as 10～12.5 parts.
The tablet of the present invention can also include the auxiliary material and/or additive commonly used in one or more pharmaceutics.For example, the tablet can include Ac-Di-Sol, and on the basis of being arranged only by 1 part of glug, the content of Ac-Di-Sol can be 0.5～5 part.The tablet of the present invention can also include magnesium stearate, and on the basis of being arranged only by 1 part of glug, the content of magnesium stearate can be 0.5～5 part.Additionally, the tablet of the present invention can also include pregelatinized starch, on the basis of being arranged only by 1 part of glug, the content of the pregelatinized starch can be 1～5 part.For example, in a specific embodiment of the tablet of the present invention, count by weight, the tablet arranges 2.5 parts of net 1 part, 15 parts of mannitol, 12.5 parts of microcrystalline cellulose, 1 part of Ac-Di-Sol, 0.25 part of magnesium stearate and pregelatinized starch comprising glug.
For example, in another specific embodiment of the tablet of the present invention, count by weight, the tablet arranges 0.25 part of net 1 part, 20 parts of mannitol, 10 parts of microcrystalline cellulose, 1 part of Ac-Di-Sol and magnesium stearate comprising glug.
Further object is that providing the preparation method that above-mentioned glug arranges net tablet.
The invention provides above-mentioned glug arranges the preparation method of net tablet, in the preparation process of the preparation method, glug row net loss is little, and improves the hardness of tablet.
The glug that the present invention is provided arranges the preparation method of net tablet and comprises the following steps：
1) each component is sieved, is well mixed；
2) by step 1) granulating mixture that obtains, compressing tablet.
In above-mentioned preparation method, the step 1) in 60～80 mesh sieves that preferably adopt that sieve.
In order to solve the problems, such as that existing glug arranges active component loss present in net tablet and its preparation technology greatly and hardness is not enough, on the basis of existing additive of tablet and preparation technology, the present invention adopts direct tablet compressing technique and corresponding prescription to overcome disadvantages described above through substantial amounts of screening and experimental study, finally.Specifically, using compatibility test, the present invention confirms that glug row are net suitably compatible with the auxiliary material that direct tablet compressing technique is adopted, can direct mixed pressuring plate.The present invention is further screened and has been compared to the auxiliary material that direct tablet compressing technique is adopted, it is determined that glug arranges the suitable prescription of net tablet.Compared with existing product and its preparation technology, as in the preparation process of direct tablet compressing, active component loss is little, the active component content of the net tablet of glug row of the present invention is higher, and hardness is also improved, and meets the needs of commodity production and clinical application.
Specific embodiment
Following examples are only used for explaining the present invention, rather than limit the present invention.Unless otherwise indicated, the experiment condition in the embodiment of the present invention is the conventional experiment condition in this area.
Embodiment
1
Glug arranges net 5.0g
Mannitol
100g
Microcrystalline cellulose
50g
Ac-Di-Sol
5.0g
Magnesium stearate 1.25g
Make 1000
Preparation method：Each component is weighed by recipe quantity, 60 mesh sieves are crossed, uniform, granulation, single-punch tablet press compressing tablet is sufficiently mixed.
Embodiment
2
Glug arranges net 5.0g
Mannitol 75.0g
Microcrystalline cellulose
62.5g
Pregelatinized starch 12.5g
Ac-Di-Sol 5.0g
Magnesium stearate 1.25g
Make 1000
Preparation method：Each component is weighed by recipe quantity, 80 mesh sieves are crossed, uniform, granulation, single-punch tablet press compressing tablet is sufficiently mixed.
Embodiment
3
Glug arranges net 5.0g
Mannitol
125.0g microcrystalline cellulose
30.0g
Ac-Di-Sol 5.0g
Magnesium stearate 1.5g
Make 1000
Preparation method：Each component is weighed by recipe quantity, 70 mesh sieves are crossed, uniform, granulation, single-punch tablet press compressing tablet is sufficiently mixed.
Experimental example 1Research is compared to above-described embodiment and its preparation technology.
The main technologic parameters of tablet samples prepared by 1 embodiment of table 1～3
Data from table 1 can be seen that the indices of embodiment 1 and 2 and meet the requirements, and mobility of particle and compressibility meet the requirements, and can be used to be commercialized big production.
According to embodiment 1 and 2 prepare sample carry out by commercially available prod packaged form it is aluminum-plastic packaged, 40 DEG C, RH75% and 60 DEG C, under bis- kinds of acceleration environments of RH75% investigate 3 months.Investigate result to show, the content of embodiment 1 and embodiment 2, dissolution rate are not apparent from reducing, and meet regulation.
Claims (9)
1. a kind of glug arranges net tablet, and the tablet arranges net, mannitol and microcrystalline cellulose comprising glug.
2. tablet according to claim 1, it is characterised in that count by weight, the tablet arrange net 1 part comprising glug；10～20 parts of mannitol, such as 15～20 parts；9～15 parts of microcrystalline cellulose, such as 10～12.5 parts.
3. tablet according to claim 1 and 2, it is characterised in that the tablet also includes Ac-Di-Sol, such as 0.5～5 part of Ac-Di-Sol.
4. tablet according to any one of claim 1 to 3, the tablet also include magnesium stearate, such as 0.5～5 part of magnesium stearate.
5. tablet according to any one of claim 1 to 4, the tablet also include pregelatinized starch, such as 1～5 part of pregelatinized starch.
6. tablet according to any one of claim 1 to 5, it is characterized in that, count by weight, the tablet arranges 2.5 parts of net 1 part, 15 parts of mannitol, 12.5 parts of microcrystalline cellulose, 1 part of Ac-Di-Sol, 0.25 part of magnesium stearate and pregelatinized starch comprising glug.
7. tablet according to any one of claim 1 to 6, it is characterised in that count by weight, the tablet arrange 0.25 part of net 1 part, 20 parts of mannitol, 10 parts of microcrystalline cellulose, 1 part of Ac-Di-Sol and magnesium stearate comprising glug.
8. the preparation method of tablet according to any one of claim 1 to 7, the preparation method are comprised the following steps：1) each component is sieved, is well mixed；
2) by step 1) obtained in granulating mixture, compressing tablet.
9. preparation method according to claim 8, it is characterised in that described to sieve using 60～80 mesh sieves.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510596302.4A CN106539766A (en) | 2015-09-18 | 2015-09-18 | Glug arranges net tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510596302.4A CN106539766A (en) | 2015-09-18 | 2015-09-18 | Glug arranges net tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106539766A true CN106539766A (en) | 2017-03-29 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510596302.4A Pending CN106539766A (en) | 2015-09-18 | 2015-09-18 | Glug arranges net tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN106539766A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107693514A (en) * | 2017-12-04 | 2018-02-16 | 威海贯标信息科技有限公司 | A kind of glug arranges net composition |
| WO2022176981A1 (en) * | 2021-02-19 | 2022-08-25 | 大正製薬株式会社 | Oral film preparation |
| RU2836174C2 (en) * | 2021-02-19 | 2025-03-11 | Таишо Фармасьютикал Ко., Лтд. | Oral film preparation |
-
2015
- 2015-09-18 CN CN201510596302.4A patent/CN106539766A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107693514A (en) * | 2017-12-04 | 2018-02-16 | 威海贯标信息科技有限公司 | A kind of glug arranges net composition |
| WO2022176981A1 (en) * | 2021-02-19 | 2022-08-25 | 大正製薬株式会社 | Oral film preparation |
| JP7168133B1 (en) * | 2021-02-19 | 2022-11-09 | 大正製薬株式会社 | Oral film formulation |
| RU2836174C2 (en) * | 2021-02-19 | 2025-03-11 | Таишо Фармасьютикал Ко., Лтд. | Oral film preparation |
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| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| WD01 | Invention patent application deemed withdrawn after publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20170329 |