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Ambroxol hydrochloride composition

A technology of ambroxol hydrochloride and composition, applied in the field of ambroxol hydrochloride composition freeze-dried orally disintegrating tablet and its preparation, can solve the problem of affecting the therapeutic effect of ambroxol hydrochloride, long disintegration time of ambroxol hydrochloride, Children and the elderly have difficulty swallowing and other problems, and achieve the effects of improving bioavailability, rapid drug onset, and shortening dissolution time

Active Publication Date: 2012-08-01
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The ordinary tablets of ambroxol hydrochloride take a long time to disintegrate, children and the elderly have difficulty swallowing, patients are inconvenient to take, and their compliance is poor, which affects the therapeutic effect of ambroxol hydrochloride.

Method used

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  • Ambroxol hydrochloride composition
  • Ambroxol hydrochloride composition
  • Ambroxol hydrochloride composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Preparation of ambroxol hydrochloride composition freeze-dried orally disintegrating tablets,

[0052] Prescription: 1000 tablets

[0053]

[0054] Preparation Process:

[0055] Dissolve the prescribed amount of povidone K30, crospovidone, lactose, and aspartame in purified water of 10%-15% of the total prescription water, and add the prescribed amount of gelatin to 10% of the total prescription water. 10%-15% purified water, heated to boiling and dissolved under stirring, dissolved the prescribed amount of ambroxol hydrochloride in purified water with prescribed water consumption of 25%-30%, combined the raw materials and auxiliary materials, and continued to stir for 3 Hour, measure PH, adjust PH to 6.0 with the hydrochloric acid solution of 2mol / L, according to the ambroxol hydrochloride composition freeze-drying orally disintegrating tablet specification, after determining the loading amount, the medicinal liquid after merging is subpackaged according to the loa...

Embodiment 2

[0057] Preparation of ambroxol hydrochloride composition freeze-dried orally disintegrating tablets,

[0058] Prescription: 1000 tablets

[0059] Prescription: 1000 tablets

[0060]

[0061] Preparation Process:

[0062] Dissolve the prescribed amount of povidone K30, crospovidone, lactose, and aspartame in purified water of 10%-15% of the total prescription water, and add the prescribed amount of gelatin to 10% of the total prescription water. 10%-15% purified water, heated to boiling and dissolved under stirring, dissolved the prescribed amount of ambroxol hydrochloride in purified water with prescribed water consumption of 25%-30%, combined the raw materials and auxiliary materials, and continued to stir for 3 Hour, measure PH, adjust PH to 6.0 with the hydrochloric acid solution of 2mol / L, according to the ambroxol hydrochloride composition freeze-drying orally disintegrating tablet specification, after determining the loading amount, the medicinal liquid after mergin...

Embodiment 3

[0064] Preparation of ambroxol hydrochloride composition freeze-dried orally disintegrating tablets,

[0065] Prescription: 1000 tablets

[0066]

[0067]

[0068] Preparation Process:

[0069] Dissolve the prescribed amount of povidone K30, crospovidone, lactose, and aspartame in purified water of 10%-15% of the total prescription water, and add the prescribed amount of gelatin to 10% of the total prescription water. 10%-15% purified water, heated to boiling and dissolved under stirring, dissolved the prescribed amount of ambroxol hydrochloride in purified water with prescribed water consumption of 25%-30%, combined the raw materials and auxiliary materials, and continued to stir for 3 Hour, measure PH, adjust PH to 6.0 with the hydrochloric acid solution of 2mol / L, according to the ambroxol hydrochloride composition freeze-drying orally disintegrating tablet specification, after determining the loading amount, the medicinal liquid after merging is subpackaged accordin...

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Abstract

The invention discloses an ambroxol hydrochloride composition, and relates to the technical field of pharmaceutical preparations. The formula of the composition comprises a main drug and adjuvants, wherein the main drug is ambroxol hydrochloride, the adjuvants comprise a skeleton agent, a forming agent, an assistant suspending agent, a correctant, and a disintegrating agent, the skeleton agent isselected from lactose, the forming agent is selected from gelatin, the assistant suspending agent is selected from povidone K30, the correctant is selected from aspartame, and the disintegrating agent is selected from cross-linked povidone. In addition, freeze-dried orally disintegrating tablets of the ambroxol hydrochloride composition have the following characteristics that: the components are simple; no water is required during taking; no chewing is required; the disintegrating time in the human oral cavity is less than 2 seconds; the onset is rapid; the residue in the intestinal tract is less; the absorption is adequate; the side effect is low; the taste is good; the tablets are especially suitable for infant patient taking. The present invention further provides a preparation method for the freeze-dried orally disintegrating tablets of the ambroxol hydrochloride composition, wherein the method has characteristics of mild conditions and easy control, and is suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an ambroxol hydrochloride composition and an ambroxol hydrochloride composition freeze-dried orally disintegrating tablet made from the composition and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride is a new active product of ambroxol fused with HCL and formed into a salt. It is a new mucus-dissolving drug. Form and regulate serous and mucous secretions, improve the elimination of ciliated and non-ciliated areas of the respiratory tract, reduce the adhesion of sputum and cilia, further make sputum easy to cough up, achieve significant expectoration, relieve cough, and improve respiratory conditions . It has low toxicity, strong expectorant and lung function improvement effects, and is one of the most commonly used expectorant drugs. It is mainly used clinically for reducing phlegm and anti-inflammation. [0003] The chemic...

Claims

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Application Information

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IPC IPC(8): A61K31/137A61K9/20A61K47/42A61P11/10
Inventor 汪六一汪金灿李祖红
Owner HAINAN WEI KANG PHARMA QIANSHAN
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