CN103356621A - Novel capsule filled with alogliptin solid preparation and pioglitazone solid preparation - Google Patents
Novel capsule filled with alogliptin solid preparation and pioglitazone solid preparation Download PDFInfo
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- CN103356621A CN103356621A CN 201210084606 CN201210084606A CN103356621A CN 103356621 A CN103356621 A CN 103356621A CN 201210084606 CN201210084606 CN 201210084606 CN 201210084606 A CN201210084606 A CN 201210084606A CN 103356621 A CN103356621 A CN 103356621A
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- capsule
- tablet
- pioglitazone
- alogliptin
- solid preparation
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Abstract
The invention relates to an oral-taking hard capsule, and in particular relates to a tablet capsule filled with an alogliptin tablet and a pioglitazone tablet. The tablet capsule comprises a capsule and tablets in the capsule, wherein the capsule contains an upper capsule body and a lower capsule body; at least one tablet taking alogliptin as an active component and at least one tablet taking pioglitazone as an active component are filled in the capsule. As the active components in the capsule are not in contact with each other, chemical compatibility among various components does not occur and a byproduct is not produced, so that the stability of the product is improved, especially a degradation product produced through the contact of alogliptin and pioglitazone is reduced, and related substances of the tablet capsule conform to the safety range of a human body.
Description
Technical field
The present invention relates to a kind of oral hard capsule, particularly be filled with the tablet capsule of Egelieting sheet and pioglitazone sheet in a kind of capsule.
Background technology
Egelieting pioglitazone sheet, English name: NESINA and ACTOS Tablets (LIOVEL) is the medicine that is applicable to treat diabetes by the research and development of military field.CN200880010374.4 discloses the multilayer tablet of above-mentioned compound preparation.In the prior art, two kinds of active component of Egelieting and pioglitazone all exist in the same minimum preparation unit, and the two has the possibility in external just contact.If active component contacts with each other, have following shortcoming: 1, because multicomponent mixing homogeneity degree affects, each composition is difficult to accurate quantitative analysis; When 2, product detects, because the phase mutual interference is difficult for measuring each component content, affect the qualitative and quantitative analysis result; 3, during long preservation, change because chemical compatibility may occur between each composition, easily produce by-product, reduce effect or increase side effect, product stability is not ideal enough.Because defects exists, there are many advantages although contain the existing compound recipe dosage form of Egelieting, but still may cause harmful effect to product quality and human body health.
Summary of the invention
The invention provides a kind of tablet capsule that Egelieting sheet and pioglitazone sheet are housed, do not contact mutually between the various active component in the capsule, thereby obtain stability tablet capsule better, easy to process, what is more important provides a kind of not to be needed strictly to control the intermediate related substance and can obtain the up-to-standard Egelieting pioglitazone compound preparation of related substance.
Tablet capsule of the present invention is comprised of the tablet in capsule and the capsule, and capsule comprises utricule and lower utricule, active component of filling tablet that is Egelieting at least in the capsule wherein, and active component of filling tablet that is pioglitazone at least.
The form of tablet capsule of the present invention is that tablet is carried out coating preferably, coating solution be chosen as any selection of acceptable on the pharmaceutics.
Tablet of the present invention also can in order to adapt to different medicament demands, be made variform Special-shaped sheet with tablet.
For be fit to mechanization production and be convenient to be identified, but the identical color of the various figure of tablet in the capsule is different.
Particularly in order to adapt to the capsule filling machine that goes on the market and use, the shape of described various tablets is made into column type.Automatic capsule filling machine (KF-S50) such as Korea S INNOTECH SYSTEMS LTD. company.
Tablet capsule of the present invention, wherein capsule is No. 0 or No. 1 capsule, and the upper utricule of capsule and lower utricule are colourless or translucent.Also in order to adapt to the slice, thin piece of different content active component, also can select the capsule of other models simultaneously.
The utilization of technique scheme, the present invention compared with prior art have following advantage:
1. because the active component in the capsule is not contacted each other, therefore chemistry 5 changes can not occur between each composition and produce by-product, the stability of product is improved, especially reduced the catabolite that produces after Egelieting contacts with pioglitazone, so that the related substance of product of the present invention meets the human-body safety scope;
2. owing to having adopted the design of column type slice, thin piece and different colours, and the application of transparent softgel shell, so that product of the present invention is fit to suitability for industrialized production very much, strengthened patient's compliance;
3. because the present invention adopts is respectively film-making of active component, be more prone at check and the quality control of medicine.
Description of drawings
Accompanying drawing 1 is the axonometric chart of the complex capsule of embodiments of the invention 1.Wherein, 1, lower capsule body; 2, upper capsule body; 3, Egelieting sheet; 4, pioglitazone sheet.
Accompanying drawing 2 is the exploded perspective view of the complex capsule of embodiment 1.1, lower capsule body; 2, upper capsule body; 3, Egelieting sheet; 4, pioglitazone sheet.
Accompanying drawing 3 is the A-A cutaway view of the complex capsule of embodiment 1.Wherein, 1, lower capsule body; 2, upper capsule body; 3, Egelieting sheet; 4, pioglitazone sheet.
The specific embodiment
The invention will be further described below in conjunction with drawings and Examples:,
Embodiment 1: shown in accompanying drawing 1-3, and pioglitazone sheet of filling in the seed capsules; The tablet capsule of an Egelieting sheet.The capsule specification is No. 0.Capsule housing is made of lower capsule body 1 and upper capsule body 2 suits, and the slice of cylinder of above-mentioned 2 different colours coatings is housed, and is respectively Egelieting sheet (Egelieting 25mg), pioglitazone sheet (containing pioglitazone 15mg).
The pioglitazone sheet is that yellow stomach dissolution type film-coat, Egelieting sheet are red film-coat.Capsule is contained in the transparent pp bottle packing.
Embodiment 2: different from embodiment 1 only is dosage, wherein Egelieting sheet (Egelieting 12.5mg), pioglitazone sheet (containing pioglitazone 7.5mg).
Describe below in conjunction with test example:
Test example 1 is carried out respectively hot test (60 ℃), high wet test (RH75%), exposure experiments to light (3000LX) with embodiment 1,2 prepared tablet capsules and is carried out test in 10 days.
Table 1 hot test (60 ℃)
Annotate: content is sign content in the table, and related substance is with calculated by peak area
The high wet test of table 2 (RH75%)
Annotate: content is sign content in the table, and related substance is with calculated by peak area
Table 3 exposure experiments to light (3000LX)
Annotate: content is sign content in the table, and related substance is with calculated by peak area.
Stability test is the result show, it is relatively less that embodiments of the invention obtain the generation of product related substance, and content does not reduce.Owing to being to measure respectively, detection method is easy, needn't consider compound medicine between the phase mutual interference.
Claims (4)
1. tablet capsule, be comprised of the tablet in capsule and the capsule, capsule comprises utricule and lower utricule, it is characterized in that, at least active component of filling tablet that is Egelieting in the described capsule, and active component of filling tablet that is pioglitazone at least.
2. tablet capsule as claimed in claim 1 is characterized in that, described tablet is coating.
3. tablet capsule as claimed in claim 2 is characterized in that, the coating of described tablet is different colours, and described tablet is the identical cylinder of shape.
4. tablet capsule as claimed in claim 1 is characterized in that, described capsule is No. 0 or No. 1 capsule, and the upper utricule of capsule and lower utricule are colourless or translucent.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201210084606 CN103356621A (en) | 2012-03-28 | 2012-03-28 | Novel capsule filled with alogliptin solid preparation and pioglitazone solid preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201210084606 CN103356621A (en) | 2012-03-28 | 2012-03-28 | Novel capsule filled with alogliptin solid preparation and pioglitazone solid preparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN103356621A true CN103356621A (en) | 2013-10-23 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 201210084606 Pending CN103356621A (en) | 2012-03-28 | 2012-03-28 | Novel capsule filled with alogliptin solid preparation and pioglitazone solid preparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103356621A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105030724A (en) * | 2015-08-20 | 2015-11-11 | 杭州成邦医药科技有限公司 | Composition of anti-diabetic drugs |
-
2012
- 2012-03-28 CN CN 201210084606 patent/CN103356621A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105030724A (en) * | 2015-08-20 | 2015-11-11 | 杭州成邦医药科技有限公司 | Composition of anti-diabetic drugs |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20131023 |