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Sustained release preparation containing ambroxol hydrochloride and clenbuterol hydrochloride, and preparation method thereof

A technology of clenbuterol hydrochloride and ambroxol hydrochloride, which is applied in the preparation field of the sustained-release preparation, can solve the problems of easily causing adverse reactions, fluctuation of blood drug concentration, poor patient compliance, etc. The effect of stable drug concentration and symptom relief

Inactive Publication Date: 2012-11-14
INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantages of these preparations are that they are ordinary compound preparations with short action time, need to be administered 2 to 3 times a day, and the patient's compliance is poor; and the blood drug concentration fluctuates, which is easy to cause adverse reactions

Method used

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  • Sustained release preparation containing ambroxol hydrochloride and clenbuterol hydrochloride, and preparation method thereof
  • Sustained release preparation containing ambroxol hydrochloride and clenbuterol hydrochloride, and preparation method thereof
  • Sustained release preparation containing ambroxol hydrochloride and clenbuterol hydrochloride, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1: Low specification compound ambroterol double-layer sustained-release tablet

[0041] prescription:

[0042]

[0043] Preparation:

[0044] Immediate-release layer: Weigh clenbuterol hydrochloride bulk drug, lactose, starch, and red iron oxide in the prescribed amount through an 80-mesh sieve, mix well, add Tween 80, stir well, and use an appropriate amount of 5% PVP aqueous solution as a viscous Mixture soft material, the dosage is subject to the actual dosage required for granulation, pass through a 20-mesh sieve to granulate, dry in an oven at 50°C for 1 hour, granulate with a 18-mesh sieve, and then add cross-linked carboxymethyl fiber Su Na, micronized silica gel and magnesium stearate, mix well.

[0045] Sustained-release layer: Weigh the ambroxol hydrochloride bulk drug, lactose, hypromellose (HPMC) K100LV and HPMC K4M that have passed the 80-mesh sieve, mix them evenly, and add an appropriate amount of 5% PVP ethanol solution as a binder For maki...

Embodiment 2

[0047] Example 2: Compound Ambroterol Double-Layer Sustained Release Tablets of Medium Specification

[0048] prescription:

[0049]

[0050] Preparation:

[0051] Immediate-release layer: Weigh the clenbuterol hydrochloride bulk drug, lactose, microcrystalline cellulose, and red iron oxide with the prescribed amount passed through an 80-mesh sieve, mix well, add Tween 80, stir well, and add an appropriate amount of 3% HPMC aqueous solution As a soft material made of binder, the dosage is subject to the actual dosage required for granulation, granulated with a 20-mesh sieve, dried in an oven at 50°C for 1 hour, granulated with a 18-mesh sieve, and then added with crospovidone , micronized silica gel and magnesium stearate, and mix well.

[0052] Sustained-release layer: Weigh the ambroxol hydrochloride raw material drug, lactose, carbomer and glyceryl behenate that have passed the 80-mesh sieve, mix them evenly, and add an appropriate amount of 5% PVP ethanol solution as a ...

Embodiment 3

[0054] Example 3: High specification compound ambroterol double-layer sustained-release tablet

[0055] prescription:

[0056]

[0057] Note: 10% starch slurry is the binder in this product, and its dosage is based on the amount required for actual granulation.

[0058] Preparation:

[0059] Immediate-release layer: Weigh the clenbuterol hydrochloride raw material, lactose, starch, and red iron oxide with the prescribed amount passed through an 80-mesh sieve, mix well, add Tween 80, stir well, and make a viscous layer with an appropriate amount of 10% starch slurry Mixture soft material, its dosage is subject to the actual dosage required for granulation, granulated with a 20-mesh sieve, dried in an oven at 50°C for 1 hour, granulated with a 18-mesh sieve, and then added with low-substituted hydroxypropyl cellulose, Micronized silica gel and magnesium stearate, mixed evenly.

[0060] Sustained-release layer: Weigh the ambroxol hydrochloride crude drug, lactose, acrylic r...

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Abstract

The invention relates to a sustained release preparation containing ambroxol hydrochloride and clenbuterol hydrochloride. The preparation comprises a sustained release part and a quick release part, wherein the quick release part comprises clenbuterol hydrochloride, a quick release adjuvant and another pharmaceutic adjuvant, the sustained release part comprises ambroxol hydrochloride, a sustained release adjuvant and another pharmaceutic adjuvant, and the another pharmaceutic adjuvant is one or more selected from the group consisting of a filler, a binder and a lubricant. The invention also relates to a preparation method for the sustained release preparation. The sustained release preparation provided in the invention has the following advantages: the quick release part has fast action, and the sustained release part has a long-acting drug effect.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a slow-release preparation containing ambroxol hydrochloride and clenbuterol hydrochloride, and a preparation method for the slow-release preparation. Background technique [0002] Respiratory system disease is a common disease and frequently-occurring disease. It has a relatively high incidence worldwide and has an increasing trend. It is the second largest factor of population death in my country. The main symptoms of respiratory diseases are cough, sputum production and asthma, but there are not many clinically available drugs and their effects are slow. [0003] Clenbuterol hydrochloride is a potent selective adrenergic β2 receptor agonist, which can relax bronchial smooth muscle. Its bronchodilator effect is 100 times stronger than that of albuterol, but it has a weak effect on the cardiovascular system. In addition to relieving asthma, clenbuterol hydrochloride a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K9/20A61P11/00A61P11/10
Inventor 杨美燕王玉丽高春生单利梅兴国
Owner INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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