Preparation method of ambroxol hydrochloride

Through the three-step reaction method of condensation, reduction and salt formation, the sodium borohydride zinc chloride system is used to reduce the carbon-nitrogen double bond, which solves the problems of harsh conditions and low yield in the synthesis route of ambroxol hydrochloride, and realizes the production of ambroxol hydrochloride. The low-cost and efficient preparation is suitable for industrial production and reduces environmental pollution.

CN113004157AInactive Publication Date: 2021-06-22康普药业股份有限公司
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Patent Information

Application Number
CN201911327181.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2019-12-20
Publication Date
2021-06-22
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

The existing synthesis route of ambroxol hydrochloride has problems such as harsh conditions, low output, high cost, large environmental pollution and low raw material utilization, making it difficult to be suitable for industrial production.

Method used

Adopt a three-step reaction method of condensation, reduction and salt formation, use aldehyde and amine group to react to generate Schiff base, reduce the carbon-nitrogen double bond through sodium borohydride and zinc chloride complex system, and finally use hydrogen chloride and ethyl acetate solution to form a salt. Ambroxol hydrochloride simplifies the process and reduces costs.

Benefits of technology

The method realizes the low-cost and efficient preparation of ambroxol hydrochloride under mild conditions, reduces production costs, simplifies the process flow, is suitable for industrial production, and reduces environmental pollution and equipment requirements.

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Abstract

The invention discloses a preparation method of ambroxol hydrochloride, which comprises the steps of 1) reacting (A) o-aminodibromobenzaldehyde (I) with (E)-p-aminocyclohexanol (II) to obtain Schiff base; 2) reducing a carbon-nitrogen double bond C = N by (E)-4-[(2-amino-3, 5-dibromobenzylidene) amino] cyclohexanol to obtain ambroxol; and 3) salifying to obtain the finished product ambroxol hydrochloride (compound 1). The route is simple, the product is obtained through condensation, reduction and salification, aldehyde and amido react to generate Schiff base, and the reaction yield is relatively high; and in the reduction reaction of ambroxol, a sodium borohydride zinc chloride complexing system is adopted, the catalytic effect is better, and the production cost is further reduced. The method has the advantages of simple process, low safety and environmental protection risk, easily available raw materials, simple equipment requirements, very little generated wastewater, and easy treatment of three wastes to reach the standard.
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