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Tablet capsule filled with amoxicillin tablets and ambroxol hydrochloride tablets

A technology for ambroxol hydrochloride tablets and amoxicillin tablets, which is applied in the directions of capsule delivery, medical preparations containing active ingredients, organic active ingredients, etc., can solve problems such as reducing effect, affecting qualitative and quantitative analysis results, increasing side effects, and the like, Achieve improved stability, easier inspection and quality control, and enhanced compliance

Inactive Publication Date: 2011-04-13
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 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 defects, although there are many advantages in the existing compound dosage form containing amoxicillin, it may still cause adverse effects on product quality and human health

Method used

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  • Tablet capsule filled with amoxicillin tablets and ambroxol hydrochloride tablets
  • Tablet capsule filled with amoxicillin tablets and ambroxol hydrochloride tablets
  • Tablet capsule filled with amoxicillin tablets and ambroxol hydrochloride tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] 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 amoxicillin 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 three cylindrical tablets coated with different colors, which are the first amoxicillin tablet (containing 250 mg of amoxicillin), ambroxol hydrochloride tablet (containing ambroxol hydrochloride 30mg), the second amoxicillin tablet (containing amoxicillin 250mg).

[0029] The first amoxicillin tablet has a yellow gastric-dissolving film coating, the ambroxol tablet has a red film coating, and the second amoxicillin tablet has a black gastric-dissolving film coating or both adopt the same color.

Embodiment 2： pic 4， 1 1 and 1 。0。1 and 2，2，(15mg)、(250mg)。。 Embodiment 3-5

[0030] Embodiment 2: see attached Figure 4 Shown, a tablet capsule filled with an ambroxol hydrochloride tablet and an amoxicillin 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 the above two cylindrical tablets coated with different colors are installed, which are respectively ambroxol hydrochloride tablets (containing 15 mg of ambroxol hydrochloride) and amoxicillin tablets ( Amoxicillin 250mg). Ambroxol hydrochloride tablets are yellow stomach-soluble film-coated. Embodiment 3-5: the kind of installed sheet is the same as embodiment 1 or 2, and difference is the active component content of each sheet:

[0031]

experiment example 1

[0032] 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:

[0033] Table 1. High temperature test

[0034]

Example 1

0 day content

Ambroxol(%)

99.11

Amoxicillin (%)

99.57

0 days related substances

N A873CL

0.02

N AB773XX

0.01

[0035]

Amoxicillin polymer

0.06

5 days content

Ambroxol(%)

99.24

Amoxicillin (%)

99.32

5 days related substances

N A873CL

0.02

N AB773XX

0.02

Amoxicillin polymer

0.07

10 days content

Ambroxol(%)

99.30

Amoxicillin (%)

99.26

10 days related substances

N-A873CL

0.02

N-AB773XX

0.03

Amoxicillin polymer

0.07

...

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PUM

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Abstract

The invention relates to an orally-taken hard capsule, in particular to a table capsule provided with amoxicillin tablets and ambroxol hydrochloride tablets. The table capsule comprises a capsule and tablets in the capsule, wherein the capsule comprises an upper capsule body and a lower capsule body; and tablets with amoxicillin as an active component and tablets with ambroxol hydrochloride as an active component are at least filled in the capsule. Since the active components in the capsule are not mutually contacted, the chemical compatible change and side products can be avoided among components, the stability of products is improved, and degraded products generated by acid-base neutralization after the amoxicillin and the ambroxol hydrochloride contact can be particularly reduced; in addition, by adopting the design of cylindrical pieces and different colors and applying of transparent capsule casings, the products are especially suitable for industrial production and enhance the compliance of patients; meanwhile, the active components in the orally-taken hard capsule are respectively prepared into tablets, thus the inspection and the quality control of medicines are easier.

Description

technical field [0001] The invention relates to an oral hard capsule, in particular to a tablet capsule filled with amoxicillin tablets and ambroxol hydrochloride tablets. Background technique [0002] Pulmonary bacterial infection is a common and frequently-occurring disease of the respiratory system. The main clinical manifestations are cough and expectoration, and antibiotics are usually used for treatment. But sometimes even though antibiotics are used rationally, the desired effect is still not obtained. The reason may be related to the low concentration of drugs in bronchial and lung tissues. After systemic administration in normal people, the drug concentration in the bronchi and lung tissue is often much lower than the blood concentration (1 / 30-1 / 40 of the blood concentration in the same period), suggesting the existence of lung-blood or bronchi-blood barrier . The concentration of antibacterial drugs infiltrated into lung tissue is closely related to its curative ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K31/137A61K9/48A61P31/04A61P11/00
Inventor 吴光彦
Owner HEILONGJIANG FUHE HUAXING PHARMA GROUP