Ambroxol hydrochloride compound effervescent tablet and preparation method thereof

Abstract

The invention relates to an ambroxol hydrochloride compound effervescent tablet which comprises acid particles, alkali particles and polyethylene glycol, the acid particles are prepared from the following components in parts by weight: 1.5 parts of ambroxol hydrochloride, 0.001 part of clenbuterol hydrochloride, 15 to 45 parts of an acid disintegrating agent, 50 to 100 parts of sorbitol, 0.3 to 0.8 part of saccharin sodium, 0.3 to 0.8 part of essence and 0.1 to 1 part of docusate sodium; the alkali particles are sodium bicarbonate particles, potassium bicarbonate particles or sodium carbonate particles with the particle size of 20 to 40 meshes. The ambroxol hydrochloride compound effervescent tablet prepared by the invention is non-sticky in the tabletting process, rapid in effervescence dissolution, rich in bubbles, clear in solution after effervescence, free of residues, good in taste and good in patient compliance, and is especially suitable for children.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a compound effervescent ambroxol hydrochloride tablet and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride is a new generation of respiratory mucus regulator, which has superior expectorant effect; clenbuterol hydrochloride is a potent selective adrenergic β2 receptor agonist, which can relax bronchial smooth muscle and strengthen bronchial cilia. Mobility, promote the discharge of sputum, and help improve the curative effect of asthma. The combination of the two has a synergistic effect. [0003] At present, ambroterol compound preparations are mostly tablets, granules, dispersible tablets, oral solutions, etc. Among them, oral solutions have the advantages of good taste, high bioavailability, and convenient and flexible drug use, and are especially suitable for children. However, liquid preparations have problems such as poor stability, hig...

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Problems solved by technology

[0004] Chinese patent CN102772395A provides a sustained-release preparation containing ambroxol hydrochloride and clenbuterol hydrochloride, which consists of a sustained-release part and an immediate-release part, but the target population of this product is children, and the safety of the sustained-release preparation cannot be guaranteed, and Due to the extremely low specification of clenbuterol hydrochloride in this compound combination, there is a serious risk of uneven content

[0005] Chinese patent CN101288658A discloses a pharmaceutical composition oral drop pill preparation with ambroxol hydrochloride and clenbuterol hydrochloride as active ingredients for relieving cough, reducing phlegm and relieving asthma. °C, too high a temperature greatly increases the risk of ambroxol hydrochloride being oxidatively degraded, and there is also a risk of poor applicability for administration and uneven mixing

[0006] Chinese patent CN107519129A provides a kind of ambroxol hydrochloride oral solution and preparation method thereof, selects the reasonable ratio formula of the honey that nourishes the lung and relieves cough clinically, avoids the addition of preservatives, pH regulators and cosolvents, but adds more sub-solvents in the formula Sodium bisulfate, containing sulfide-specific odor, has poor taste; and in order to improve solubility, the dosing temperature is high (45-55°C), which may have risks to product stability

Among them, sucrose is designated as the source of sugar beets, but the amount of sucrose is high, and there is a risk of dental caries

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