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Stable ambroxol hydrochloride taste-masking granule and preparation method thereof

A technology of ambroxol hydrochloride and taste-masking granules, applied in the field of ambroxol hydrochloride taste-masking granules and preparation thereof, can solve the problems such as failure to effectively mask the bitter taste of ambroxol hydrochloride, unsatisfactory stability, and the like, and improve compliance , the effect of improving taste

Active Publication Date: 2017-02-22
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

[0010] Chinese invention patent application 201310245823.6 discloses a taste-masking drug compound of ambroxol hydrochloride, which uses Polyclin IRP64, Pollack Phosphorous Potassium IRP88, and Sodium Polystyrene Sulfonate IRP69 as taste-masking agents. The granules are not Effectively mask the bitter taste of ambroxol hydrochloride, and its stability does not meet the requirements

Method used

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  • Stable ambroxol hydrochloride taste-masking granule and preparation method thereof
  • Stable ambroxol hydrochloride taste-masking granule and preparation method thereof
  • Stable ambroxol hydrochloride taste-masking granule and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] prescription:

[0061]

[0062] making process:

[0063] The drug-loaded pill core is prepared by adding medicine to the fluidized bed suspension, and the isolation layer and the taste-masking layer are sequentially wrapped around the drug-loaded pill core. A semi-finished product is obtained by mixing pellets with flavoring materials.

[0064] 1. Preparation of drug-loaded pellet core:

[0065] The drug-loaded pellet core is prepared by using a fluidized bed drug method.

[0066] 1.1 Preparation of drug suspension:

[0067] Dissolve hypromellose 603 in purified water, add ambroxol hydrochloride and talcum powder to the solution in a state of stirring, and stir to form a uniform suspension solution.

[0068] 1.2 Fluidized bed medicine process:

[0069] Use 0.5-0.6mm sucrose-type pellets as the drug-loaded base pellets, and use fluidized bed bottom spray to carry out the drug application process of the suspension. During the drug application process, the temperat...

experiment example

[0087] Effect of Particle Size of Raw Drugs on Drug Adding Process

[0088] 1.1 Prescription of medicine (comparative example):

[0089] name Unit dosage 0.5~0.6mm sucrose pellets 200.0

[0090] core Ambroxol hydrochloride 15.0 Hypromellose 603 10.0 purified water 308.0

[0091] 1.2 Compare the effect of particle size d(0.9): 27.886μm and d(0.9): 6.933μm on drug yield.

[0092] 1.3 Evaluation index: drug yield

[0093] 1.4 Results:

[0094] 1) The particle size is d(0.9): the physical yield of the raw drug of 27.886 μm is 97.2%, and the content yield is 64.0%.

[0095] 2) The particle size is d(0.9): the physical yield of the raw drug of 6.933 μm is 99.9%, and the content yield is 91.1%.

[0096] 1.5 Conclusion:

[0097]The particle size is d(0.9):6.933μm API, and the yield meets the process preparation requirements.

[0098] 2. The effect of the addition of anti-adhesive agent on the drug application process

[0...

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Abstract

The invention provides an ambroxol hydrochloride taste-masking granule, which is prepared from drug-loaded pellets coated by a taste-masking layer and a taste modifying material. Specifically, the drug-loaded pellets coated by a taste-masking layer consist of three layers from the inside out: a drug-loaded pellet core, an isolation layer and a taste-masking layer. The drug-loaded pellets provided by the invention are prepared by a fluidized bed suspension drug-feeding way, the drug-loaded pellet core is externally coated with the isolation layer and the taste-masking layer in order, each layer is coated with a fluidized bed, the taste modifying material is prepared by wet granulation, and the pellets and the taste modifying material are mixed to prepare the granule. The ambroxol hydrochloride taste-masking granule provided by the invention completely covers up the peculiar smell of drug itself, improves the compliance of medication for children, and is added with a sweetener and sugar-containing granules suitable for children to take so as to remove the bitter taste and peculiar smell of chemical drugs, in addition to sugar, the ambroxol hydrochloride taste-masking granule is also added with some fruit essence to greatly improve the mouthfeel of drug, so that children patients can easily accept or actively require to accept the drug, thus enhancing compliance of medication for children. By controlling the particle size of the bulk drugs, the drug feeding yield is increased, the content of drug-loaded pellets is improved, and the particle number of pellets in unit preparation can be reduced, thus reducing the weight increment range of the taste-masking layer, and reaching the purposes of saving labor-hour and cost, and increasing yield.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a stable ambroxol hydrochloride taste-masking granule and a preparation method thereof. Background technique [0002] In recent years, under the influence of various factors such as the environment, the morbidity and mortality of respiratory diseases in my country have remained high. The relevant statistics of the Ministry of Health show that more than 80 million people in my country suffer from respiratory diseases every year. From the perspective of the age structure of patients, the elderly and children are the high-risk groups of respiratory diseases. As our country enters an aging society, the prospect of medication for respiratory system diseases will be very broad. Ambroxol hydrochloride occupies an important position in respiratory system medication. [0003] Ambroxol hydrochloride, chemical name: trans 4-[(2-amino-3,5 dibromo-phenyl)methyl-amino]cyclohexanol h...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/137A61K47/04A61K47/38A61P11/12A61P11/10
Inventor 王锦刚蒋海松朱德志朱广辉
Owner 山东科成医药科技有限公司
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