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Taste-masking ambroxol hydrochloride preparation and preparation method thereof

A technology for ambroxol hydrochloride and preparations, which is applied in the field of ambroxol hydrochloride taste-masking preparations and its preparation, which can solve the problems of unpleasant bitter taste and peculiar smell, poor taste when taking medicine, and poor medication compliance, so as to achieve good taste and improve medication compliance Sex, improve the effect of the applicable population

Active Publication Date: 2018-06-05
山东科成医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The invention provides an easy-to-swallow taste-masking preparation of ambroxol hydrochloride and a preparation method thereof, which mainly solves the problem that the existing ambroxol hydrochloride products on the market produce unpleasant bitter taste and peculiar smell immediately after being taken by children, and the mouthfeel after taking Extremely poor, poor drug compliance and inconvenient medication for children, the multi-layer coating technology is used to mask the taste of the active ingredients of the drug, improve the taste of the drug and endow the active ingredient with good stability, so that the drug can be released quickly. It has a good taste and good taste masking effect while ensuring the stability of the drug

Method used

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  • Taste-masking ambroxol hydrochloride preparation and preparation method thereof
  • Taste-masking ambroxol hydrochloride preparation and preparation method thereof
  • Taste-masking ambroxol hydrochloride preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 and comparative example 1

[0032] Embodiment 1 and comparative example 1. raw materials and consumption thereof are as follows:

[0033]

[0034]

Embodiment 1

[0035] The preparation method of Example 1 is as follows, Comparative Example 1 does not carry out the packaging of the isolation layer, and the other methods are the same as in Example 1.

[0036] 1. Preparation of drug-loaded pills

[0037] Dissolve sodium carboxymethyl cellulose in purified water, add ambroxol hydrochloride and magnesium stearate to the solution in a state of stirring, and stir to form a uniform suspension solution. The sucrose ball core is used as the drug-loaded base ball. The chemical bed bottom spraying is used for the drug application process of the suspension, and the pellets are continued to be dried after the drug application is completed;

[0038] 2. Packaging of the isolation layer

[0039] The hydroxypropyl cellulose is made into an aqueous solution with a concentration of 5%, and polyethylene glycol 6000 and talcum powder are added, and a fluidized bed is used to make the isolation gown;

[0040] 3. Packing of taste masking layer

[0041] Und...

Embodiment 2

[0053] Embodiment 2 and comparative example 2 thereof.

[0054] The raw materials and their amounts are as follows:

[0055]

[0056]

[0057] The preparation method of Example 2 is as follows, Comparative Example 2 does not carry out the packaging of the isolation layer, and the other methods are the same as in Example 2.

[0058] 1. Preparation of drug-loaded pills

[0059] Dissolve hypromellose in purified water, add ambroxol hydrochloride and talcum powder in turn to the solution while stirring, and stir to form a uniform suspension solution. The sucrose core is used as the drug-loaded base pill, and the bottom of the fluidized bed is used. Spray the drug application process of the suspension, and continue to dry the pellets after the drug application is completed;

[0060] 2. Packaging of the isolation layer

[0061] Hypromellose is made into an aqueous solution with a concentration of 5%, polyethylene glycol 6000 and talcum powder are added, and a fluidized bed ...

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Abstract

The invention specifically discloses a taste-masking preparation which can be swallowed without water, has no bitter taste and is applicable to patients, especially children, with difficulties in swallowing, and a preparation method thereof, belonging to the field of pharmaceutical preparations. According to the taste-masking preparation, the active drug ingredient of the preparation is coated byat least three layers of coatings, i.e., a barrier layer, a taste-masking layer and a smooth layer; the taste of the active drug ingredient is masked by using a multi-layer coating technique, so the preparation has improved taste to take, the active drug ingredient is endowed with good stability, the drug can be quickly released, and the preparation has good taste, good taste masking effect and ensures the stability of the drug. Therefore, compliance in medication of the preparation is effectively improved, and the preparation is applicable to a wider population of patients and is especially convenient to take by children.

Description

technical field [0001] The invention belongs to the field of oral solid preparations, and in particular relates to a taste-masking ambroxol hydrochloride preparation suitable for patients with dysphagia, especially children, without bitter taste and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride, chemical name: trans 4-[(2-amino-3,5 dibromo-phenyl)methyl-amino]cyclohexanol hydrochloride, is white to slightly yellow crystalline powder, in Dissolved in methanol, slightly soluble in water, slightly soluble in ethanol, almost odorless, very bitter taste, the structure is as follows: [0003] [0004] Ambroxol hydrochloride is a new generation of airway mucus regulator, which has excellent expectorant effect and can significantly promote the synthesis and secretion of alveolar surfactant. Ambroxol hydrochloride can stimulate bronchial mucus glands to secrete more flowable mucus, dilute sputum, reduce viscosity, and increase the production a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K47/38A61K47/32A61K31/137A61P11/10
CPCA61K9/284A61K9/2846A61K9/2866A61K9/2886A61K31/137
Inventor 朱广辉刘博峰朱德志
Owner 山东科成医药科技有限公司
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