Tablet capsule filled with irbesartan tablet and thiazole hydrochloride tablet

A technology of sartan tablets and chlorothiazide tablets, applied in the directions of capsule delivery, cardiovascular system diseases, drug combination, etc., can solve problems such as increasing side effects, affecting qualitative and quantitative analysis results, reducing effects, etc., to enhance compliance, inspection And the effect of easy quality control and improved stability

Inactive Publication Date: 2013-10-23
HEILONGJIANG FUHE HUAXING PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the active ingredients are in contact with each other, there are the following disadvantages: 1. Due to the influence of multi-component mixing uniformity, it is difficult to quantify each component accurately; 2. During product testing, it is difficult to determine the content of each component due to mutual interference, which affects the qualitative and quantitative analysis results; 3. . During long-term storage, due to possible chemical compatibility changes among the components, by-products are likely to be produced, reducing the effect or increasing side effects, and the product stability is not ideal.
[0004] In addition, the main reason for the quality of irbesartan and hydrochlorothiazole compound preparations is the related substance items, which often exceed the range, and for such impurities, they are basically close to the peak of the main drug in the detected liquid chromatogram, and are generally not easy to remove

Method used

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  • Tablet capsule filled with irbesartan tablet and thiazole hydrochloride tablet
  • Tablet capsule filled with irbesartan tablet and thiazole hydrochloride tablet
  • Tablet capsule filled with irbesartan tablet and thiazole hydrochloride tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: see attached Figure 1-3 As shown, a tablet capsule filled with one hydrochlorothiazole tablet; two irbesartan tablets. The capsule specification is size 0. The capsule shell is composed of a lower capsule body 1 and an upper capsule body 2 set, and is equipped with the above three cylindrical tablets coated with different colors, which are the first irbesartan tablet (containing irbesartan 75 mg), hydrochlorothiazol tablet (containing hydrochlorothiazole 12.5mg) and the second irbesartan tablet (containing irbesartan 75mg).

[0023] The first hydrochlorothiazole tablet has a yellow gastric-dissolving film coating, the irbesartan tablet has a red film coating, and the second hydrochlorothiazole tablet has a black gastric-dissolving film coating or both adopt the same color.

Embodiment 2

[0024] Embodiment 2: see attached Figure 4 As shown, a tablet capsule filled with a hydrochlorothiazole tablet and an irbesartan tablet. The capsule specification is size 0. The capsule shell is composed of a lower capsule body 1 and an upper capsule body 2 set, and is equipped with the above two cylindrical tablets coated with different colors, which are hydrochlorothiazole tablets (containing 12.5 mg of hydrochlorothiazole) and irbesartan tablets ( Irbesartan 150mg). Hydrochlorothiazole tablets are yellow stomach-soluble film-coated. The capsules come in a transparent pp bottle packaging.

[0025] The following will be explained in conjunction with the test example:

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PUM

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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 irbesartan tablet and a thiazole hydrochloride 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 irbesartan as an active component and at least one tablet taking thiazole hydrochloride as an active component are filled in the capsule. According to the tablet capsule filled with the irbesartan tablet and the thiazole hydrochloride tablet, various active components in the capsule are not in contact with each other, thus the tablet capsule with good stability and convenience for processing is obtained; more importantly, an irbesartan and thiazole hydrochloride compound preparation with qualified quality of related substances can be obtained without strictly controlling intermediate-related substances.

Description

technical field [0001] The invention relates to an oral hard capsule, in particular to a tablet capsule filled with irbesartan tablets and hydrochlorothiazole tablets. Background technique [0002] Irbesartan and hydrochlorothiazide tablets, English name: IRBESARTAN and hydrochlorothiazide tablets (Ambonor), are patients whose blood pressure cannot be adequately controlled by hydrochlorothiazol monotherapy or irbesartan monotherapy developed by Sanofi This product can be used instead for combined treatment, as disclosed in the domestic patent CN200810126745. Other dosage forms include capsules disclosed in 02146334 and 201010112077, dispersible tablets disclosed in 200410049756, chewable tablets disclosed in 200610008456, and liposomes disclosed in 201010211291. There is following deficiency in above-mentioned prior art: [0003] There is currently no dosage form in which irbesartan and hydrochlorothiazole are present in the same formulation and the active ingredients do n...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/549A61K31/4184A61K9/48A61P9/12
Inventor 吴光彦
Owner HEILONGJIANG FUHE HUAXING PHARMA GROUP
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