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Tablet capsule containing clopidogrel hydrogen sulfate salt tablets and acetylsalicylic acid tablets

A technology of acetylsalicylic acid tablets and bisulfate tablets, which is applied in the direction of medical preparations containing active ingredients, capsule delivery, organic active ingredients, etc., to achieve the effect of improving stability and enhancing compliance

Inactive Publication Date: 2009-11-25
HEILONGJIANG FUHE HUAXING PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The present invention provides a hard capsule filled with clopidogrel bisulfate tablets and acetylsalicylic acid tablets respectively in the capsule. Insufficient of a single preparation, there is provided a form of administration in which clopidogrel bisulfate tablets and acetylsalicylic acid tablets are separately packed into capsules, and the active ingredients of the above tablets are separated

Method used

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  • Tablet capsule containing clopidogrel hydrogen sulfate salt tablets and acetylsalicylic acid tablets
  • Tablet capsule containing clopidogrel hydrogen sulfate salt tablets and acetylsalicylic acid tablets
  • Tablet capsule containing clopidogrel hydrogen sulfate salt tablets and acetylsalicylic acid tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1: see attached figure 1 As shown, a capsule filled with clopidogrel bisulfate tablets, acetylsalicylic acid tablets and starch tablets. The capsule specification is size 0. The capsule is composed of a capsule shell and a filling. The capsule shell is composed of a lower capsule body 1 and an upper capsule body 2. The filling is three cylindrical tablets of different colors. Gray bisulfate tablet 3 (containing clopidogrel 75 mg), acetylsalicylic acid tablet 4 (containing acetylsalicylic acid 75 mg) and the third tablet (starch tablet) 5.

Embodiment 2

[0038] Embodiment 2: see attached Figure 4 As shown, a capsule filled with clopidogrel bisulfate tablets and acetylsalicylic acid tablets. The capsule specification is size 0. The capsule is composed of a capsule shell and a filling. The capsule shell is composed of a lower capsule body 1 and an upper capsule body 2. The filling is two cylindrical tablets of different colors. The tablets are film-coated tablets of different colors, respectively. Clopidogrel bisulfate tablet 3 (containing clopidogrel 75mg) and acetylsalicylic acid tablet 4 (containing acetylsalicylic acid 75mg).

Embodiment 3

[0039] Example 3: The control drug capsule was prepared by the simple mixing method in Example 6 of Chinese Patent CN1359294A. It contains 75mg of clopidogrel and 75mg of acetylsalicylic acid.

[0040] Stability comparison: The samples obtained in Examples 1-3 were respectively sampled and measured at 0, 5, and 10 days under high temperature (40°C) and high humidity (RH75%) conditions, and the influencing factors were investigated. The results are shown in Table 1 and table 2:

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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 [0001] The invention relates to an oral hard capsule, in particular to an oral hard capsule filled with clopidogrel bisulfate tablets and acetylsalicylic acid tablets. Background technique [0002] The combination of clopidogrel bisulfate and acetylsalicylic acid produces a synergistic effect, which is related to the aggregation of platelets and collagen, the principle of which is the metabolism mechanism of ADP and arachidonic acid, and collagen is unique due to its connection dependence available gels. Regarding the combined application of the two, there are currently the following reports: [0003] Orally administrable galenical units containing a composition of clopidogrel hydrogen sulfate and acetylsalicylic acid are described in patent application CN1359294A. [0004] In this document, the above-mentioned applications of clopidogrel hydrogen sulfate and acetylsalicylic acid exist in the same minimum preparation unit in the form of a composition. In th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4365A61K31/616A61P7/02
Inventor 吴光彦吴玉山陈晓伟王景昆王玉松
Owner HEILONGJIANG FUHE HUAXING PHARMA GROUP
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