CN101559052A - Oral pharmaceutical composition containing mitiglinide and voglibose - Google Patents
Oral pharmaceutical composition containing mitiglinide and voglibose Download PDFInfo
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- CN101559052A CN101559052A CNA2008101044618A CN200810104461A CN101559052A CN 101559052 A CN101559052 A CN 101559052A CN A2008101044618 A CNA2008101044618 A CN A2008101044618A CN 200810104461 A CN200810104461 A CN 200810104461A CN 101559052 A CN101559052 A CN 101559052A
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- voglibose
- mitiglinide
- pharmaceutical composition
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Abstract
The invention discloses an oral pharmaceutical composition containing mitiglinide and voglibose. The mitiglinide and the voglibose are dispersed to respective pharmaceutically acceptable carriers. The composition has good stability and is used for treatment of type 2 diabetes.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that is used for the treatment of type 2 diabetes mellitus, be specifically related to a kind of oral solid drug composition that contains Mitiglinide and voglibose.
Background technology
Type 2 diabetes mellitus be a kind of be the autoimmune disease of feature with the beta Cell of islet damage, in diabetic, type 2 diabetes mellitus accounts for 90%.The sickness rate of China's patient of diabetes rises rapidly in the period of surplus in the of nearly 10, and the diabetics of the whole nation more than 20 years old reaches more than 2,500 ten thousand people, and impaired glucose tolerance patient's (prediabetes) is not less than 3,500 ten thousand people.
Mitiglinide went on the market in Japan early than 2004, was the derivant of phenylalanine, and it can stimulate the BI secretion, and the effect reverse rapidly, is used for the treatment of type 2 diabetes mellitus, better tolerance, patient's compliance height.
Voglibose went on the market in Japan in 1994, was used for the treatment of the diabetes post-prandial glycemia and raise, and was a kind of alpha-glucosidase inhibitor, suppress the hydrolysis of disaccharidase and postpone the absorption of sugar, it is active high, and effective dose is little, selectivity to alpha-glucosidase is higher, and the intestinal side effect is lower.
CA2401356 discloses voglibose and Mitiglinide use in conjunction, the purposes of treatment type 2 diabetes mellitus.Right people applicant finds that directly with the pharmaceutical composition that obtains after Mitiglinide and the voglibose mixing, through after the storage of long period, the content of Mitiglinide and voglibose reduces, and impurity increases simultaneously.Therefore need provide a kind of can long term store, and content and the related substance Mitiglinide that can not increase and the compound medicament composition of voglibose.
Summary of the invention
The invention provides a kind of technical scheme, can obtain the pharmaceutical composition that stable Mitiglinide and voglibose are formed.
The invention discloses a kind of pharmaceutical composition that contains Mitiglinide and voglibose, wherein Mitiglinide and voglibose are dispersed in Pharmaceutical composition in separately the pharmaceutically acceptable carrier material.
The invention provides a kind of pharmaceutical composition that contains Mitiglinide and voglibose, wherein Mitiglinide and voglibose are dispersed in separately the pharmaceutically acceptable carrier material.
The invention provides a kind of pharmaceutical composition that contains Mitiglinide and voglibose, wherein Mitiglinide is scattered in the different pharmaceutically acceptable carrier materials with voglibose.
The invention provides a kind of pharmaceutical composition that contains Mitiglinide and voglibose, wherein the pharmaceutically acceptable carrier of Mitiglinide comprises filler, coating material, binding agent, lubricant and disintegrating agent.
The invention provides a kind of pharmaceutical composition that contains Mitiglinide and voglibose, wherein coating material is selected from a kind of or its mixture in acid resin, cellulose acetate phthalate ester, hypromellose phthalate ester and the Lac.
The invention provides a kind of pharmaceutical composition that contains Mitiglinide and voglibose, wherein Mitiglinide and carrier thereof exist in the form of coated tablet or piller.
The invention provides a kind of pharmaceutical composition that contains Mitiglinide and voglibose, wherein the pharmaceutically acceptable carrier of voglibose comprises filler, disintegrating agent, binding agent and lubricant.
The invention provides a kind of pharmaceutical composition that contains Mitiglinide and voglibose, wherein voglibose and carrier thereof exist with tablet, piller or form of powder.
The invention provides a kind of pharmaceutical composition that contains Mitiglinide and voglibose, wherein the compositions of the compositions of Mitiglinide and carrier thereof formation and voglibose and carrier formation thereof mixes uniformly.
The specific embodiment
The present invention is described in further detail below in conjunction with embodiment.
Embodiment 1
Preparation method: take by weighing the Mitiglinide of recipe quantity, add lactose, microcrystalline Cellulose, cross-linked carboxymethyl cellulose sodium mix homogeneously, add water and granulate, drying adds the magnesium stearate mixing, tabletting; Alcoholic solution coating with acrylic resin.Other takes by weighing the voglibose of recipe quantity, adds corn starch, hydroxypropyl cellulose, lactose mix homogeneously, adds water and granulates, and drying adds the magnesium stearate mixing, tabletting.The small pieces or the granule of Mitiglinide and voglibose are put into capsule shells.
Embodiment 2
Preparation method: take by weighing the Mitiglinide of recipe quantity, add lactose, microcrystalline Cellulose, cross-linked carboxymethyl cellulose sodium mix homogeneously, add water and granulate, drying adds the magnesium stearate mixing, tabletting; Alcoholic solution coating with the hypromellose phthalate ester.Other takes by weighing the voglibose of recipe quantity, adds lactose, microcrystalline Cellulose, cross-linked carboxymethyl cellulose sodium mix homogeneously, adds water and granulates, and drying adds the magnesium stearate mixing, tabletting.The small pieces or the granule of voglibose and Mitiglinide are put into capsule shells.
Embodiment 3
Preparation method: take by weighing the Mitiglinide of recipe quantity, add starch, microcrystalline Cellulose mix homogeneously, add water and squeeze ball, drying is with the alcoholic solution coating of acrylic resin.Other takes by weighing the voglibose of recipe quantity, adds starch, microcrystalline Cellulose, mix homogeneously, adds water and squeezes ball, drying.The piller of Mitiglinide and voglibose is put into capsule shells; Promptly.
Embodiment 4
Preparation method: take by weighing the Mitiglinide and the voglibose of recipe quantity, add lactose, microcrystalline Cellulose and cross-linked carboxymethyl cellulose sodium mix homogeneously, add water and granulate, drying adds magnesium stearate, mixing, tabletting; The plain sheet alcoholic solution coating of acrylic resin.
Embodiment 5
The pharmaceutical composition that embodiment 1, embodiment 2, embodiment 3, embodiment 4 are prepared carries out stability test, in accelerated tests (40 ± 2 ℃ of temperature, humidity 75% ± 5%) and long-time stability experiments (25 ± 2 ℃ of temperature, humidity 60% ± 5%) under the condition, in study group's compound the variation of related substance be listed in the table below 1 respectively, in the table 2.
Table 1. accelerated tests result
| 1 month | 2 months | 3 months | 6 months | |
| Embodiment 1 | - | - | - | - |
| Embodiment 2 | - | - | - | - |
| Embodiment 3 | - | - | - | - |
| Embodiment 4 | - | - | + | ++ |
Table 2. long-time stability experimental result
| 0 month | 3 months | 6 months | 9 months | 12 months | 18 months | |
| Embodiment 1 | - | - | - | - | - | - |
| Embodiment 2 | - | - | - | - | - | - |
| Embodiment 3 | - | - | - | - | - | - |
| Embodiment 4 | - | - | - | + | + | ++ |
Annotate :-: the related substance growth was compared with 0 day and is no more than 0.05%; +: related substance increased with 0 day to be compared above 0.1%; ++: related substance increased with 0 day to be compared above 0.5%
From above-mentioned test data as can be known, the pharmaceutical composition that contains Mitiglinide and voglibose that the embodiment of the invention 1,2,3 obtains is relatively stable, and the compositions that adopts conventional method that Mitiglinide and voglibose are mixed the back preparation, stability is not good enough.
Claims (8)
1. pharmaceutical composition that contains Mitiglinide and voglibose is characterized in that Mitiglinide and voglibose are dispersed in separately the pharmaceutically acceptable carrier material.
2. pharmaceutical composition according to claim 1 is characterized in that Mitiglinide and voglibose are scattered in the different pharmaceutically acceptable carrier materials.
3. pharmaceutical composition according to claim 1 is characterized in that the pharmaceutically acceptable carrier of Mitiglinide comprises filler, coating material, binding agent, lubricant and disintegrating agent.
4. pharmaceutical composition according to claim 3 is characterized in that its described coating material selects a kind of or its mixture in cellulose acetate phthalate ester or the hypromellose phthalate ester.
5. pharmaceutical composition according to claim 1 is characterized in that Mitiglinide and carrier thereof exist in the form of coated tablet or piller.
6. pharmaceutical composition according to claim 1 is characterized in that the pharmaceutically acceptable carrier of voglibose comprises filler, disintegrating agent, binding agent and lubricant.
7. pharmaceutical composition according to claim 6 is characterized in that voglibose and carrier thereof exist with tablet, piller or form of powder.
8. pharmaceutical composition according to claim 1 is characterized in that the compositions of voglibose and carrier thereof formation and the compositions of Mitiglinide and carrier formation thereof mix uniformly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101044618A CN101559052A (en) | 2008-04-18 | 2008-04-18 | Oral pharmaceutical composition containing mitiglinide and voglibose |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101044618A CN101559052A (en) | 2008-04-18 | 2008-04-18 | Oral pharmaceutical composition containing mitiglinide and voglibose |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101559052A true CN101559052A (en) | 2009-10-21 |
Family
ID=41218144
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2008101044618A Pending CN101559052A (en) | 2008-04-18 | 2008-04-18 | Oral pharmaceutical composition containing mitiglinide and voglibose |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101559052A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102631332A (en) * | 2012-04-28 | 2012-08-15 | 邹立兴 | Voglibose tablet and preparation method thereof |
| JP2019031491A (en) * | 2017-08-08 | 2019-02-28 | 日本ケミファ株式会社 | Diabetes therapeutic agent |
-
2008
- 2008-04-18 CN CNA2008101044618A patent/CN101559052A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102631332A (en) * | 2012-04-28 | 2012-08-15 | 邹立兴 | Voglibose tablet and preparation method thereof |
| JP2019031491A (en) * | 2017-08-08 | 2019-02-28 | 日本ケミファ株式会社 | Diabetes therapeutic agent |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| DD01 | Delivery of document by public notice |
Addressee: Beijing Pharmasece Co., Ltd. Document name: Notification of before Expiration of Request of Examination as to Substance |
|
| DD01 | Delivery of document by public notice |
Addressee: Liu Xingmin Document name: Notification that Application Deemed to be Withdrawn |
|
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20091021 |