The crude ambroxol hydrochloride is an intermediate of ambroxol hydrochloride. CMC file package can be provided for registration
Ambroxol hydrochloride (AmbroxolHydrochloride) is the active metabolite of expectorant bromhexine (N-demethyl, cyclohexyl para-introduced trans-hydroxyl), the toxicity is lower than bromhexine, and the activity is higher than bromhexine. Ambroxol hydrochloride is a mucolytic agent developed by Boehringer Ingelheim, Germany. The drug was first marketed in Germany in the early 1980s, and subsequently in many countries such as France, Italy, Japan, and Spain. It is a new generation of mucolytic agents. Sputum dissolving agent, can improve expectoration, and has the effect of promoting pulmonary surfactant and airway secretion and ciliary movement. Clinically, it can regulate the secretion of mucus and mucus, activate the ciliary swing, easily dilute sputum, and strengthen the chemicalbooking of mucus to transport outward, which is easy to discharge. It can also promote the synthesis of pulmonary surfactant to maintain alveolar tension and ensure lung function. indicator; promote the penetration of antibiotics into tissues to increase the concentration and enhance the bactericidal effect; anti-oxidation, reduce the release of inflammatory mediators to reduce the inflammatory response; synergize with bronchial antispasmodic substances to improve the efficacy of antispasmodic drugs. Therefore, the drug can be widely used clinically for acute and chronic respiratory diseases accompanied by abnormal secretion of the respiratory tract, especially the expectorant treatment of chronic bronchitis, the adjuvant treatment of neonatal respiratory distress and pulmonary surgery, with low toxicity and curative effect. It is one of the most commonly used expectorants because of its advantages, such as being exact, and being able to be used in combination with antibiotics to produce a good synergistic effect.