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Ambroxol hydrochloride granules and preparation method thereof

A technology of ambroxol hydrochloride and granules, which can be used in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. It can cover the bad smell and taste, avoid the sticking phenomenon, and reduce the phenomenon of moisture absorption.

Active Publication Date: 2015-09-16
HAINAN HULUWA PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Patent No. CN1628647A discloses a kind of ambroxol hydrochloride granule and its production process in the Chinese invention patent application. This method adopts a large amount of sucrose to granulate, and the granulation process is easy to stick to the wall, and the long-term storage stability is poor
[0004] Patent No. CN1836654A discloses a stable pharmaceutical composition of ambroxol hydrochloride granules in the Chinese invention patent application, in which aspartame excipients are added, and aspartame is heated to 30 degrees Celsius, which will lead to the production of methanol Toxic substances, long-term use of large amounts can cause abdominal pain, anxiety, arthritis, asthma and other adverse reactions
[0005] Because ambroxol hydrochloride has a strong bitter taste, which limits the application of the elderly and children, directly adding flavoring agents cannot effectively cover the bitter taste

Method used

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  • Ambroxol hydrochloride granules and preparation method thereof
  • Ambroxol hydrochloride granules and preparation method thereof
  • Ambroxol hydrochloride granules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Pass the raw material medicine and auxiliary materials through a 100-mesh sieve respectively, and set aside.

[0030] Weigh the raw materials of the following prescription quantities:

[0031]

[0032] Weigh 0.02g of hypromellose (model: HT-K, viscosity: 4000mPa.s) and 0.03g of acrylic resin No. II (manufacturer: Xi'an Zaolotang Pharmaceutical Group Rehabilitation Medicine Co., Ltd., medicinal) in Slowly add distilled water under constant stirring to make a 2% water dispersion by mass, and put it in a spray tank for later use. Put 0.3g of ambroxol hydrochloride into the fluidized bed, the inlet air temperature is 60°C-80°C, the outlet air temperature is 50°C-70°C, and the feeding rate is 10ml / min, spray it, and pass through a 30-mesh sieve after forming microcapsules. Add 9 g of mannitol and 0.1 g of stevioside, spray and mix evenly, dry at 50-60° C., and sieve with 20 meshes for sizing to obtain 1,000 bags of ambroxol hydrochloride granules.

Embodiment 2

[0034] Pass the raw material medicine and auxiliary materials through a 100-mesh sieve respectively, and set aside.

[0035] Weigh the raw materials of the following prescription quantities:

[0036]

[0037] Weigh 0.02g of hypromellose (model: HT-K, viscosity: 6000mPa.s) and 0.03g of acrylic resin No. II (manufacturer: Xi'an Zaolotang Pharmaceutical Group Rehabilitation Medicine Co., Ltd., medicinal) in Slowly add distilled water under constant stirring to make a 2% water dispersion by mass, and put it in a spray tank for later use. Put 0.4g of ambroxol hydrochloride into the fluidized bed, the inlet air temperature is 60°C-80°C, the outlet air temperature is 50°C-70°C, and the feed rate is 10ml / min, spray it, and pass through a 30-mesh sieve after forming microcapsules. Add 8 g of mannitol and 0.1 g of stevioside, spray and mix evenly, dry at 50-60° C., and sieve through a 20-mesh sieve to obtain 1,000 bags of ambroxol hydrochloride granules.

Embodiment 3

[0039] Pass the raw material medicine and auxiliary materials through a 100-mesh sieve respectively, and set aside.

[0040] Weigh the raw materials of the following prescription quantities:

[0041]

[0042] Weigh 0.02g of hypromellose (model: HT-K, viscosity: 2000mPa.s) and 0.03g of acrylic resin No. II (manufacturer: Xi'an Zaolotang Pharmaceutical Group Rehabilitation Medicine Co., Ltd., medicinal) in Slowly add distilled water under constant stirring to make a 2% water dispersion by mass, and put it in a spray tank for later use. Put 0.5g of ambroxol hydrochloride into the fluidized bed, the inlet air temperature is 60°C-80°C, the outlet air temperature is 50°C-70°C, and the feeding rate is 10ml / min, spray it, and pass through a 30-mesh sieve after forming microcapsules. Add 8 g of mannitol and 0.2 g of stevioside, spray and mix evenly, dry at 50-60° C., sieve with 20 meshes for granulation, and obtain 1000 bags of ambroxol hydrochloride granules.

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Abstract

The invention discloses an ambroxol hydrochloride grain which is prepared from the following components in parts by weight: 20-50 parts of ambroxol hydrochloride, 500-1,000 parts of mannitol, 10-50 parts of a corrigent and 1-5 parts of binding agent, wherein the binding agent consists of hydroxypropyl methylcellulose and an acrylic resin II according to a mass ratio of 1:(0.5-1). Toxic and side effects of medicaments can be reduced, oral odor and smell can be shielded, the stability of the medicaments in intestines and stomachs is improved, and the irritation of the medicaments to the stomachs is alleviated. Through selection of auxiliary materials, not only is the adhesion phenomenon avoided, but also the quality standard of the prepared ambroxol hydrochloride is improved, and moreover the moisture absorption phenomenon in the storage process is reduced. The invention further discloses a preparation method of the ambroxol hydrochloride grain. The preparation method is simple, short in drying time, short in production period, low in cost and applicable to industrial production, and no special equipment is demanded.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to ambroxol hydrochloride granules and a preparation method thereof. Background technique [0002] So far, there are many domestic and foreign research reports on ambroxol hydrochloride. In the early 1980s, ambroxol hydrochloride was first declared and listed by the German Boehringer Ingelheim company. Its scientific name is ambroxol hydrochloride (Ambroxol HCl). ), trade name Mucosolvan (Mucosolvan). Later, it was successively listed in many countries such as France, Italy, Japan, and Spain, and ambroxol hydrochloride in different dosage forms was also listed in succession in China. So far, the formulations of ambroxol hydrochloride on the market include tablets, granules, capsules, sustained-release capsules, sustained-release pellets, syrup, oral liquid, chewable tablets, orally disintegrating tablets, effervescent tablets and injections. [0003] The patent No. is th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/137A61K47/38A61K47/26A61P11/10
Inventor 刘全国陈克领林文君
Owner HAINAN HULUWA PHARMA GRP CO LTD
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