CN101584680A - Tablet capsule containing clopidogrel hydrogen sulfate salt tablets and acetylsalicylic acid tablets - Google Patents
Tablet capsule containing clopidogrel hydrogen sulfate salt tablets and acetylsalicylic acid tablets Download PDFInfo
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- CN101584680A CN101584680A CNA2008100976865A CN200810097686A CN101584680A CN 101584680 A CN101584680 A CN 101584680A CN A2008100976865 A CNA2008100976865 A CN A2008100976865A CN 200810097686 A CN200810097686 A CN 200810097686A CN 101584680 A CN101584680 A CN 101584680A
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Abstract
The invention provides a tablet capsule with various active ingredients which do not contact mutually. The tablet capsule comprises a capsule and a tablet in the capsule, wherein the capsule comprises an upper capsule body and a lower capsule body; the capsule internally contains at least one clopidogrel hydrogen sulfate salt tablet and one acetylsalicylic acid tablet; the active ingredients of the two tablets have pharmaceutic proper forms of containing raw materials or auxiliary materials which do not have physical or chemical reaction with the two tablets, and preferably a blank tablet containing no active components is between the two tablets. Compared with the prior art, the invention has the following advantages that no chemical change or side product is generated among all the ingredients so that the stability of the product is improved. The product of the invention is very suitable for commercial process and enables a sufferer to have good compliance.
Description
Technical field
The present invention relates to a kind of oral hard capsule, be filled with the oral hard capsule of clopidogrel hydrogen sulfate salt tablets and aspirin tablet in particularly a kind of capsule.
Background technology
Clopidogrel hydrogenesulphate and aspirin use in conjunction can produce synergism, this effect is relevant with the cohesion of platelet and collagen, its principle is ADP and arachidonic metabolic mechanism, and collagen is because its join dependency but unique operable gel.About the applied in any combination of the two, following report is arranged at present:
Narrated the Galenic formula unit that can be taken orally of containing clopidogrel hydrogenesulphate and acetysalicylic compositions at application for patent CN1359294A.
In this file, clopidogrel hydrogenesulphate above-mentioned and acetysalicylic application all are to be present in the same minimum preparation unit with composition forms, in 14 specific embodiment of this file, among the preparation technology of the various tablets that relate to, capsule and bag agent, often mention clopidogrel hydrogenesulphate and aspirin prepared granule by distinct methods after, make corresponding dosage forms again.
But there is the possibility that contacts in two kinds of active component of above-mentioned clopidogrel hydrogenesulphate and aspirin.And two kinds of active component are all in same minimum preparation unit.
In addition, India, more Argentine drugmakers have gone on the market, and some contain clopidogrel hydrogenesulphate and acetysalicylic compound preparation.Such as the two kind double-layer tablet of India a company (Ipca Laboratories Ltd) at the above-mentioned active component of the commodity Clopivas-AP by name of India listing, specification is respectively and contains clopidogrel hydrogenesulphate 75mg and aspirin 75mg, contains clopidogrel hydrogenesulphate 75mg and aspirin 150mg.
But though two kinds of active component of above-mentioned clopidogrel hydrogenesulphate and aspirin are present in the different minimum preparation units, still there is the possibility of contact in active component.And the difficulty of processing of double-layer tablet is bigger, and is not easy to operate.
If active component contacts with each other, have following shortcoming: 1, because multicomponent mix homogeneously degree influences, each composition is difficult to accurately quantitatively; When 2, product detects,, influence the qualitative and quantitative analysis result because the phase mutual interference is difficult for measuring each component content; 3, during long preservation, change because chemical compatibility may take place between each composition, be easy to generate by-product, reduce effect or increase side effect, product stability is not ideal enough.Since above-mentioned defective exist at present contain clopidogrel hydrogenesulphate and although there are many advantages in acetysalicylic various dosage form, but still may cause harmful effect to product quality and human body health.
Summary of the invention
The invention provides the hard capsule that is fills up to clopidogrel hydrogen sulfate salt tablets and aspirin tablet in the seed capsules respectively, this capsule can improve the above existing deficiency that contains the unitary agent of clopidogrel hydrogenesulphate and aspirin compositions, provide a kind of clopidogrel hydrogen sulfate salt tablets and aspirin tablet are respectively charged into capsule, and the active component of above-mentioned tablet is isolating form of medication.
In order to achieve the above object, the technical solution used in the present invention is:
A kind of tablet capsule is provided, form by the tablet in capsule and the capsule, capsule comprises utricule and following utricule, at least contain a clopidogrel hydrogen sulfate salt tablets and an aspirin tablet in the capsule, and exist between the active component in above-mentioned two kinds of tablets with the two all do not take place physics or chemical reaction raw material or the appropriate format on the pharmaceutics formed of adjuvant.
Mentioned especially with clopidogrel hydrogenesulphate and aspirin all do not take place physics or chemical reaction raw material or/and the appropriate format on the pharmaceutics that adjuvant is formed be:
Also contain the third tablet at described capsule, and this tablet is between clopidogrel hydrogen sulfate salt tablets and aspirin tablet.
Preferred the third tablet be only for the formation of the adjunct ingredient on the pharmaceutics meaning, does not contain the active component on any pharmacy meaning.
Preferred especially the third tablet is that the adjunct ingredient on the pharmaceutics meaning is the starch sheet that starch is formed.
Surprisingly, capsule contains the technical scheme of the form of the third tablet, and described various tablets are coatings not.
The present invention also mentioned between a kind of clopidogrel hydrogenesulphate and the acetysalicylic active component exist with the two all do not take place physics or chemical reaction raw material or the appropriate format on the pharmaceutics formed of adjuvant be:
Various tablets in the described capsule are coatings.
Having mentioned a kind of coating method especially is Film coated tablets.
The ratio of the clopidogrel hydrogen sulfate salt tablets in the capsule of the present invention and the active component of aspirin tablet is in full with reference to the various ratios of mentioning among the Chinese patent CN1359294A.
Thereby for capsular increase patient's attractive in appearance compliance, the described capsular utricule of going up can be colourless with following utricule.
In order to be fit to that mechanization is produced and to be convenient to be identified, but the identical color difference of shape of the various tablets in the capsule.
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.
In order to adapt to above-mentioned machine, most preferred capsule is No. 0 capsule.
Also in order to adapt to the slice, thin piece of different content active component, also can select the capsule of other models simultaneously.
Most preferredly provided a kind of tablet capsule, form with the identical tablet of different colours shape in the capsule by capsule, capsule comprises transparent last utricule and following utricule, capsule contains a clopidogrel hydrogen sulfate salt tablets and an aspirin tablet, also have a sheet that does not contain active component between above-mentioned two kinds of tablets, above-mentioned tablet is column type.
Most preferredly in addition provided a kind of tablet capsule, form with the identical tablet of different colours shape in the capsule by capsule, capsule comprises transparent last utricule and following utricule, capsule contains a clopidogrel hydrogenesulphate Film coated tablets and an aspirin Film coated tablets, and above-mentioned tablet is column type.
The utilization of technique scheme, the present invention compared with prior art have following advantage:
1. because clopidogrel hydrogenesulphate and aspirin in the capsule are not contacted each other, so chemistry 5 can not take place between each composition become and produce by-product, the stability of product is improved.
2. owing to added the third tablet in the capsule, particularly do not contain the tablet of active component, make clopidogrel hydrogenesulphate can not contact, even can not realize purpose of the present invention during coating yet each slice, thin piece with aspirin.
3. owing to adopted the design of column type slice, thin piece and different colours, and the application of transparent softgel shell, make product of the present invention be fit to very much suitability for industrialized production, strengthened patient's compliance.
Description of drawings
Accompanying drawing 1 is one embodiment of the invention, contains the capsular axonometric chart of the 3rd tablet.Wherein: 1, following capsule body; 2, go up capsule body; 3, clopidogrel sheet; 4, aspirin tablet; 5, the third sheet;
Accompanying drawing 2 is the above-mentioned capsular exploded perspective view that contains the 3rd tablet.Wherein, 1, capsule body down; 2, go up capsule body; 3, clopidogrel sheet; 4, aspirin tablet; 5, the third sheet;
Accompanying drawing 3 is the above-mentioned A-A cutaway view that contains the capsular embodiment of the 3rd tablet.Wherein: 1, following capsule body; 2, go up capsule body; 3, clopidogrel sheet; 4, aspirin tablet; 5, the third sheet.
Accompanying drawing 4 is an another one embodiment of the present invention, and tablet is the A-A cutaway view of bag film-coat.Wherein: 1, following capsule body; 2, go up capsule body; 3, clopidogrel sheet; 5, aspirin tablet.
The specific embodiment
Below in conjunction with drawings and Examples the present invention is further described:
Embodiment 1: shown in accompanying drawing 1, and the capsule of filling clopidogrel hydrogen sulfate salt tablets and aspirin tablet and starch sheet in the seed capsules.The capsule specification is No. 0.This capsule is made up of capsule housing and charges, capsule housing is by capsule body 1 and last capsule body 2 suits constitute down, charges are the slice of cylinder of 3 different colours, three slice, thin pieces are coating not all, is respectively clopidogrel hydrogen sulfate salt tablets 3 (chloride pyrrole Gray 75mg), aspirin tablet 4 (containing aspirin 75mg) and the third tablet (starch sheet) 5.
Embodiment 2: shown in accompanying drawing 4, and the capsule of filling clopidogrel hydrogen sulfate salt tablets and aspirin tablet in the seed capsules.The capsule specification is No. 0.This capsule is made up of capsule housing and charges, capsule housing is by capsule body 1 and last capsule body 2 suits constitute down, charges are the slice of cylinder of 2 different colours, slice, thin piece is the Film coated tablets of different colours, is respectively clopidogrel hydrogen sulfate salt tablets 3 (chloride pyrrole Gray 75mg) and aspirin tablet 4 (containing aspirin 75mg).
Embodiment 3: adopt the simple mixing method among the embodiment 6 among the Chinese patent CN1359294A to make the contrast Drug Capsule.The aspirin that wherein contains 75mg clopidogrel and 75mg.
Stability contrast: the sample of embodiment 1-3 gained respectively under high temperature (40 ℃) and high humidity (RH75%) condition, 0,5,10 day sampling and measuring, is carried out factors influencing respectively, result such as following table 1 and table 2:
Table 1. hot test result
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| 0 day | Clopidogrel hydrogenesulphate (%) | 99.21 | 99.64 | 99.54 |
| Aspirin (%) | 99.42 | 100.3 | 99.37 | |
| Related substance (%) | 0.21 | 0.23 | 0.76 | |
| 5 days | Clopidogrel hydrogenesulphate (%) | 99.19 | 99.61 | 99.51 |
| Aspirin (%) | 99.44 | 100.2 | 99.47 | |
| Related substance (%) | 0.33 | 0.36 | 0.81 | |
| 10 days | Clopidogrel hydrogenesulphate (%) | 99.03 | 99.28 | 99.46 |
| Aspirin (%) | 99.37 | 99.75 | 99.32 | |
| Related substance (%) | 0.39 | 0.41 | 0.96 |
Table 2. high humidity result of the test
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| 0 day | Clopidogrel hydrogenesulphate (%) | 99.21 | 99.64 | 99.54 |
| Aspirin (%) | 99.42 | 100.3 | 99.37 | |
| Related substance (%) | 0.21 | 0.23 | 0.76 | |
| 5 days | Clopidogrel hydrogenesulphate (%) | 99.23 | 99.53 | 99.49 |
| Aspirin (%) | 99.46 | 100.1 | 99.93 | |
| Related substance (%) | 0.36 | 0.34 | 0.88 | |
| 10 days | Clopidogrel hydrogenesulphate (%) | 99.11 | 99.33 | 99.58 |
| Aspirin (%) | 99.12 | 99.66 | 99.23 | |
| Related substance (%) | 0.41 | 0.43 | 1.01 |
Influence factor's result of the test shows that embodiments of the invention obtain product and compare with the contrast medicine, and the generation of related substance is obviously less, owing to be to measure respectively, detection method is easy.
Claims (11)
1. tablet capsule, form by the tablet in capsule and the capsule, capsule comprises utricule and following utricule, it is characterized in that, at least contain a clopidogrel hydrogen sulfate salt tablets and an aspirin tablet in the capsule, and exist between the active component in above-mentioned two kinds of tablets with the two all do not take place physics or chemical reaction raw material or the appropriate format on the pharmaceutics formed of adjuvant.
2. tablet capsule as claimed in claim 1 is characterized in that, also contain the third tablet in the described capsule, and this tablet is between clopidogrel hydrogen sulfate salt tablets and aspirin tablet.
3. tablet capsule as claimed in claim 2 is characterized in that, described the third tablet only is that the adjunct ingredient on the pharmaceutics meaning constitutes, and does not conform to the active component that has on any pharmacy meaning.
4. tablet capsule as claimed in claim 3 is characterized in that, the adjunct ingredient on the described pharmaceutics meaning is a starch.
5. as claim 2,3 or 4 described tablet capsules, it is characterized in that described various tablets are coatings not.
6. tablet capsule as claimed in claim 1 is characterized in that, described various tablets are coatings.
7. tablet capsule as claimed in claim 1 is characterized in that various tablets are Film coated tablets.
8. as claim 1,2 or 6 described tablet capsules, it is characterized in that the described capsular utricule of going up is colourless with following utricule.
9. as claim 1,2 or 6 described tablet capsules, it is characterized in that, but the identical color difference of the shape of described various tablets.
10. tablet capsule as claimed in claim 9 is characterized in that the shape of described various tablets is columniform.
11. tablet capsule as claimed in claim 8 is characterized in that, the various tablets in the capsule are the identical shaped cylinder of different colours.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008100976865A CN101584680A (en) | 2008-05-23 | 2008-05-23 | Tablet capsule containing clopidogrel hydrogen sulfate salt tablets and acetylsalicylic acid tablets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008100976865A CN101584680A (en) | 2008-05-23 | 2008-05-23 | Tablet capsule containing clopidogrel hydrogen sulfate salt tablets and acetylsalicylic acid tablets |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101584680A true CN101584680A (en) | 2009-11-25 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2008100976865A Pending CN101584680A (en) | 2008-05-23 | 2008-05-23 | Tablet capsule containing clopidogrel hydrogen sulfate salt tablets and acetylsalicylic acid tablets |
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| CN (1) | CN101584680A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103957895A (en) * | 2011-11-02 | 2014-07-30 | 韩国联合制药株式会社 | Complex agent containing clopidogrel and aspirin |
-
2008
- 2008-05-23 CN CNA2008100976865A patent/CN101584680A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103957895A (en) * | 2011-11-02 | 2014-07-30 | 韩国联合制药株式会社 | Complex agent containing clopidogrel and aspirin |
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Application publication date: 20091125 |