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Tablet capsules with Loratadine tablets and Ambroxol hydrochloride tablets

A technology of ambroxol hydrochloride tablets and ambroxol hydrochloride, applied in the direction of capsule delivery, medical preparations containing active ingredients, organic active ingredients, etc., can solve the problems of reducing effect, affecting qualitative and quantitative analysis results, increasing side effects, etc. Achieve the effects of improved stability, easy inspection and quality control, and enhanced compliance

Inactive Publication Date: 2011-04-20
HEILONGJIANG FUHE HUAXING PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Yet two kinds of active ingredients of loratadine and ambroxol hydrochloride are in the same minimum preparation unit, can produce a lot of potential safety hazards
If the active ingredients are in contact with each other, there are still 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
Due to the existence of the above-mentioned defects, although there are many advantages in the existing compound dosage form containing loratadine, it may still cause adverse effects on product quality and human health

Method used

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  • Tablet capsules with Loratadine tablets and Ambroxol hydrochloride tablets
  • Tablet capsules with Loratadine tablets and Ambroxol hydrochloride tablets
  • Tablet capsules with Loratadine tablets and Ambroxol hydrochloride tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1: see attached Figure 1-3 Shown, a kind of ambroxol hydrochloride tablet is filled in a kind of capsule; 4, the tablet capsule of loratadine 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-mentioned 2 cylindrical tablets coated with different colors, which are loratadine tablets (containing 5 mg of loratadine) and ambroxol hydrochloride tablets (Containing Ambroxol Hydrochloride 60mg).

[0026] Loratadine tablets are yellow stomach-soluble film-coated, and Ambroxol tablets are red film-coated.

Embodiment 2

[0027] Embodiment 2: a tablet capsule filled with an ambroxol hydrochloride tablet and a loratadine tablet in a kind of 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, and is equipped with the above two cylindrical tablets coated with different colors, which are respectively ambroxol hydrochloride tablets (containing 30 mg of ambroxol hydrochloride) and loratadine tablets (loratadine 5mg). Ambroxol hydrochloride tablets are yellow stomach-soluble film-coated.

experiment example 1

[0028] Experimental Example 1 The tablets and capsules prepared in Examples 1 and 2 were subjected to high temperature test (60° C.), high humidity test (RH75%), and light test (3000LX) respectively for 10 days. The results are shown in Table 1-3:

[0029] Table 1. High temperature test

[0030]

Example 1

0 day content

Ambroxol(%)

99.28

Loratadine (%)

99.14

0 days related substances

N-A873CL

0.02

N-AB773XX

0.02

5 days content

Ambroxol(%)

99.46

Loratadine (%)

99.17

5 days related substances

N-A873CL

0.02

N AB773XX

0.02

10 days content

Ambroxol(%)

99.33

Loratadine (%)

99.57

10 days related substances

N A873CL

0.03

N AB773XX

0.04

[0031] Note: The content in the table is the marked content, and the related substances are calculated by the peak ...

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PUM

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Abstract

The invention relates to oral hard capsules, in particular to tablet capsules filled with Loratadine tablets and Ambroxol hydrochloride tablets. Each tablet capsule consists of a capsule and a tablet in the capsule, wherein the capsule comprises an upper capsule body and a lower capsule body, and the capsule is at least filled with one tablet with the active ingredient of Loratadine and one tablet with the active ingredient of Ambroxol hydrochloride. The active ingredients in the capsule do not contact with one another, so chemical change and side products do not generate among all the active ingredients, the stability of the products is improved, and particularly, degradation products caused by the contact of the Loratadine and the Ambroxol are reduced; cylindrical tablets, different colors and a transparent capsule shell are adopted, so the products are very suitable for industrialized production and the compliance of patients is improved; and the tablets are prepared from the active ingredients respectively, so medicaments are detected easily and the quality is controlled easily.

Description

technical field [0001] The invention relates to an oral hard capsule, in particular to a tablet capsule filled with loratadine tablets and ambroxol hydrochloride tablets. Background technique [0002] Loratadine combined with ambroxol hydrochloride is used for allergic respiratory diseases, and is suitable for relieving symptoms such as runny nose of allergic rhinitis, and viscous sputum and difficulty in expectoration caused by respiratory diseases. [0003] Loratadine is a long-acting tricyclic antihistamine that competitively inhibits histamine H1 receptors and inhibits allergic symptoms caused by histamine. This product has no obvious anticholinergic and central inhibitory effects. [0004] Ambroxol Hydrochloride, whose chemical name is trans-4-[(2-amino 3.5-dibromobenzyl) amino] cyclohexanol hydrochloride, is a viscose used clinically in the early 1980s. Phlegm-dissolving medicine, which has low toxicity and strong effect of expectorant and improvement of lung functio...

Claims

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Application Information

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IPC IPC(8): A61K31/4545A61K31/137A61K9/48A61P11/00A61P37/08A61P11/02
Inventor 吴光彦
Owner HEILONGJIANG FUHE HUAXING PHARMA GROUP
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