Preparation method for ambroxol hydrochloride capsule

A technology of ambroxol hydrochloride and capsules, which is applied in the field of preparation of ambroxol hydrochloride capsules, can solve problems such as uneven capsule quality, poor capsule drug stability, and affecting the stability of raw materials, achieving good stability and fewer types of raw materials , low cost effect

Inactive Publication Date: 2020-05-12
ANHUI PIOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the above process, ethanol is used as a granulation binder, and drying is required after granulation, which wastes energy a

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0021] Example 1

[0022] This embodiment provides a method for preparing ambroxol hydrochloride capsules, including the following steps:

[0023] S1: Weigh 700g ambroxol hydrochloride, 100g microcrystalline cellulose, 1000g pregelatinized starch, 200g gelatin, 100g talcum powder and 350g magnesium stearate according to the ratio;

[0024] S2: Put the above-mentioned raw materials into the grinder in turn, grind for 20-30 minutes, take out the 100-mesh sieve, weigh, and set aside;

[0025] S3: Take a stirred tank, add ambroxol hydrochloride, microcrystalline cellulose, pregelatinized starch, gelatin and talc into the stirred tank, adjust the speed to 600-900 rpm, and mix for 5-10 minutes to obtain a mixture ;

[0026] S4: Dry the mixture into granules, and pass through a 30-mesh sieve to obtain granules;

[0027] S5: Blend the granules with magnesium stearate and mix them uniformly to obtain a filling; fill the filling into a capsule to form ambroxol hydrochloride capsules.

Example Embodiment

[0028] Example 2

[0029] This embodiment provides a method for preparing ambroxol hydrochloride capsules, including the following steps:

[0030] S1: Weigh 625g ambroxol hydrochloride, 300g microcrystalline cellulose, 1500g pregelatinized starch, 500g gelatin, 200g talcum powder and 312g magnesium stearate in proportion;

[0031] S2: Put the above-mentioned raw materials into the grinder in turn, grind for 20-30 minutes, take out the 100-mesh sieve, weigh, and set aside;

[0032] S3: Take a stirred tank, add ambroxol hydrochloride, microcrystalline cellulose, pregelatinized starch, gelatin and talc into the stirred tank, adjust the speed to 600-900 rpm, and mix for 5-10 minutes to obtain a mixture ;

[0033] S4: Dry the mixture into granules, and pass through a 30-mesh sieve to obtain granules;

[0034] S5: Blend the granules with magnesium stearate and mix them uniformly to obtain a filling; fill the filling into a capsule to form ambroxol hydrochloride capsules.

Example Embodiment

[0035] Example 3

[0036] This embodiment provides a method for preparing ambroxol hydrochloride capsules, including the following steps:

[0037] S1: Weigh 600g ambroxol hydrochloride, 500g microcrystalline cellulose, 2000g pregelatinized starch, 800g gelatin, 300g talcum powder and 300g magnesium stearate according to the ratio;

[0038] S2: Put the above-mentioned raw materials into the grinder in turn, grind for 20-30 minutes, take out the 100-mesh sieve, weigh, and set aside;

[0039] S3: Take a stirred tank, add ambroxol hydrochloride, microcrystalline cellulose, pregelatinized starch, gelatin and talc into the stirred tank, adjust the speed to 600-900 rpm, and mix for 5-10 minutes to obtain a mixture ;

[0040] S4: Dry the mixture into granules, and pass through a 30-mesh sieve to obtain granules;

[0041] S5: Blend the granules with magnesium stearate and mix them uniformly to obtain a filling; fill the filling into a capsule to form ambroxol hydrochloride capsules.

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Abstract

The invention relates to the technical field of medicine preparation, and particularly discloses a preparation method for an ambroxol hydrochloride capsule. The preparation method comprises the following steps of: according to a ratio, weighing ambroxol hydrochloride and other pharmaceutical auxiliary medicines; adding the above raw materials into a grinding machine in sequence, and grinding the above raw materials for 20-30 minutes; taking out the grinded raw materials, screening by a sieve of 100 meshes, and weighing for standby; taking an agitated vessel, and adding the ambroxol hydrochloride and the auxiliary medicines into the agitated vessel; regulating a revolving speed to be 600-900 turns/ minute, and mixing for 5-10 minutes to obtain a mixture; carrying out dry pressing granulation on the mixture, screening by a sieve of 30 meshes to obtain granules; blending the granules with magnesium stearate, and evenly mixing to obtain a filler; and filling a capsule with the filler to obtain the ambroxol hydrochloride capsule. According to the preparation method disclosed by the invention, deficiencies in the prior art are overcome, the time of a preparation technology is shortened,the problem of being unstable due to wet granulation can be avoided by dry granulation, meanwhile, the consumption of energy and resources is reduced, and cost is lower.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a preparation method of ambroxol hydrochloride capsules. Background technique [0002] Ambroxol hydrochloride is a new generation of mucus-dissolving agent, which is mainly used clinically to treat acute and chronic respiratory diseases. Secretion, thereby reducing sputum viscosity; at the same time, it can promote the secretion of pulmonary surfactant, increase bronchial ciliary movement, make sputum easy to cough up, achieve significant expectoration, and improve respiratory conditions. Ambroxol hydrochloride was first listed in Germany in the early 1980s, and later in France, Italy, Japan, Spain and many other countries. It is in the forefront of the drug rankings of key hospitals in major cities in my country. [0003] The Chinese patent with the application number CN201710893697.3 discloses a sustained-release ambroxol hydrochloride capsule and a preparation me...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/12A61K47/38A61K47/36A61K47/42A61K47/04A61K31/137A61P11/10A61P11/00
CPCA61K9/1611A61K9/1652A61K9/1658A61K9/4858A61K31/137A61P11/00A61P11/10
Inventor 汝宝江中赞王艳山
Owner ANHUI PIOM PHARMA
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