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
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[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
Description
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