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Ambroxol hydrochloride tablets and preparation method thereof

A technology of ambroxol hydrochloride tablets and ambroxol hydrochloride, which are applied in directions such as pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of poor stability, ambroxol hydrochloride tablets The quality process is not easy to control and other problems, to achieve the effect of more stability, less energy consumption and better stability

Active Publication Date: 2019-08-30
HARBIN ZHENBAO PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] But the quality process of the ambroxol hydrochloride tablet that obtains through above-mentioned preparation method is not easy to control, poor stability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0022] Present embodiment provides a kind of preparation method of ambroxol hydrochloride sheet, it may further comprise the steps:

[0023] S1. Raw material drug treatment.

[0024] Put the raw material into a sieving device such as a rotary vibrating sieve for sieving treatment, pass through a 20-60 mesh sieve, no agglomeration or agglomeration can be seen visually, preferably pass the raw material through a 40 mesh sieve.

[0025] Specifically, the raw material of the ambroxol hydrochloride tablet in the present embodiment includes ambroxol hydrochloride, lactose, pregelatinized starch, colloidal silicon dioxide and magnesium stearate, preferably, its mass percentage is ambroxol hydrochloride 10-15%, lactose 70-73%, pregelatinized starch 13-18%, colloidal silicon dioxide 0.1-1%, and magnesium stearate 0.1-1%. More preferably, the raw materials of the ambroxol hydrochloride tablet include by mass percentage: 12.50% of ambroxol hydrochloride, 71.25% of lactose, 15.25% of pre...

Embodiment 1

[0043]This embodiment provides a kind of ambroxol hydrochloride tablet and preparation method thereof, the raw material of this ambroxol hydrochloride tablet comprises 12.50% of ambroxol hydrochloride, 71.25% of lactose, 15.25% of pregelatinized starch, colloidal Silicon Dioxide 0.50% and Magnesium Stearate 0.50%.

[0044] The preparation method comprises: putting the above-mentioned raw materials into a rotary vibrating sieve and passing through a 40-mesh sieve for later use. Then add ambroxol hydrochloride, lactose, pregelatinized starch and colloidal silicon dioxide into the multi-directional motion mixer, mix for 20 minutes at a stirring speed of 15r / min, and continue to add magnesium stearate into the multi-directional motion mixer , at a stirring speed of 15r / min for total mixing for 3min. Then directly press the tablet according to the theoretical tablet weight, control the hardness at 50N-80N, punch the tablet with a 9.0mm flat and inclined single-sided score, and the...

Embodiment 2-4

[0046] Embodiment 2-4 is substantially the same as embodiment 1, and difference is that stirring speed and stirring time are different;

[0047] In Example 2, ambroxol hydrochloride, lactose, pregelatinized starch and colloidal silicon dioxide were added in the multi-directional motion mixer, mixed for 30min at a stirring speed of 10r / min, and magnesium stearate was added continuously Into a motion mixer, total mixing was carried out for 5 minutes at a stirring speed of 10 r / min.

[0048] In Example 3, ambroxol hydrochloride, lactose, pregelatinized starch and colloidal silicon dioxide were added to the multi-directional motion mixer, mixed for 28 minutes at a stirring speed of 13 r / min, and magnesium stearate was added continuously Into a motion mixer, total mixing was carried out for 4 minutes at a stirring speed of 13 r / min.

[0049] In Example 4, ambroxol hydrochloride, lactose, pregelatinized starch and colloidal silicon dioxide were added in the multi-directional motion...

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Abstract

The invention provides ambroxol hydrochloride tablets and a preparation method thereof, and relates to the field of a medicine production technology. The preparation method comprises the steps of mixing raw materials of the ambroxol hydrochloride tablets at the rotational speed of 10-18r / min for 11-35min, and directly performing tabletting, wherein the raw materials of the ambroxol hydrochloride tablets comprise ambroxol hydrochloride, lactose, pregelatinized starch, colloidal silicon dioxide and magnesium stearate. According to the ambroxol hydrochloride tablets and the preparation method thereof disclosed by the application of the invention, through low rotational speed (10-18r / min), the raw materials of the ambroxol hydrochloride tablets are mixed for 11-35min, and the pregelatinized starch and the colloidal silicon dioxide are selected for cooperation, so that the fluidity and the tabletting properties of the raw materials can be improved, the situation that the powder is directlytabletted can be facilitated, the whole technology is simple, quality control is simple, and energy consumption is lower; and besides, in the preparation course, conditions of wet mixing, heat dryingand the like are not used, and the stability of the prepared ambroxol hydrochloride tablets is better.

Description

technical field [0001] The invention relates to the field of medicine production technology, in particular, it provides an ambroxol hydrochloride tablet and a preparation method thereof. Background technique [0002] Tablet is currently the most widely used dosage form, and its preparation can be divided into two categories: granule compression method and direct compression method. The granule compression method can be divided into wet granulation and dry granulation according to the different preparation techniques of granules. Direct tablet compression means that the powder of the drug is sieved and mixed with appropriate excipients, and then directly compressed into tablets without granulation (wet granulation or dry granulation). [0003] Drugs for powder direct compression should have good fluidity, compressibility and lubricity. But most medicines do not have these characteristics, so can not adopt the method for powder direct tabletting, therefore in the prior art, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/04A61K47/26A61K47/36A61K31/137A61P11/00A61P11/10
CPCA61K9/2059A61K9/2009A61K9/2018A61K31/137A61P11/00A61P11/10
Inventor 方同华闫久江王喜军韩冰许国徽杨阳周艳谋
Owner HARBIN ZHENBAO PHARMA