Novel capsule filled with perindopril solid preparation and indapamide solid preparation

A technology of indapamide solid and perindopril, applied in capsule delivery, dipeptide components, cardiovascular system diseases, etc., can solve problems such as poor stability and failure to meet storage requirements, and achieve stability improvement, inspection and Ease of quality control, enhanced compliance

CN103768578AInactive Publication Date: 2014-05-07HEILONGJIANG FUHE HUAXING PHARMA GROUP
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Publication Date
2014-05-07
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention relates to an oral hard capsule, and particularly relates to a novel capsule filled with a perindopril solid preparation and an indapamide solid preparation. The novel capsule comprises a capsule and tablets in the capsule. The capsule comprises an upper capsule body and a lower capsule body; the capsule is filled with at least one tablet with perindopril as an active ingredient, and the capsule is also filled with at least one tablet with indapamide as an active ingredient. The active ingredients in the capsule are not contacted with each other, chemical compatibility changes cannot occur between the ingredients and byproducts cannot be produced, so that the stability of the novel capsule is improved, especially, degradation products produced after the contact of the perindopril and the indapamide are reduced, and related substances of the novel capsule meet the safety range of a human body.
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Description

technical field

[0001] The invention relates to an oral hard capsule, in particular to a novel capsule filled with perindopril tablets and indapamide tablets. Background technique

[0002] Perindopril and Indapamide Tablets, English name: Perindopril and Indapamide Tablets (Baipule), is a compound drug developed by Servier for the treatment of essential hypertension.

[0003] Indapamide undergoes chemical changes under acidic conditions and is poorly stable even at room temperature. Under high humidity (92.5%) conditions, one side of perindopril and indapamide tablets cracked after absorbing moisture, and under high temperature (80°C) conditions, dark yellow spots appeared on one side, so the content of indapamide and other quality indicators All changes. In conclusion, compared with perindopril or indapamide tablets alone, perindopril and indapamide tablets have poorer stability and cannot meet the storage requirements for a longer period of time. Contents of the invent...

Examples

Embodiment 1

[0019] Embodiment 1: see attached Figure 1-3 As shown, a new type of capsule filled with an indapamide tablet and a perindopril tablet in a capsule. The capsule specification is size 0. The capsule shell is composed of a lower capsule body 1 and an upper capsule body 2 set, which are equipped with the above two cylindrical tablets coated with different colors, which are perindopril tablets (perindopril tert-butylamine salt 2.0mg), indapa Amine tablets (containing indapamide 0.625mg).

[0020] Indapamide tablets are yellow gastric-soluble film-coated, and perindopril tablets are red film-coated. The capsules come in a transparent pp bottle packaging.

Embodiment 2

[0021] Example 2: The only difference from Example 1 is the dose, in which perindopril tablets (perindopril tert-butylamine salt 4.0 mg) and indapamide tablets (containing indapamide 1.25 mg) are included.

[0022] The following will be explained in conjunction with the test example: