Process for preparing racanisodamine hydrochloride used for injection

Abstract

The invention discloses a process (method) for preparing racanisodamine hydrochloride used for injection. The invention overcomes the defects that the traditional racanisodamine hydrochloride preparation process cannot effectively guarantee clarity and complete filtering of impurities such as fibers by utilizing high pressure ultrafiltration equipment and provides a preparation process with low cost, high yield and more stable quality of the finished product. The preparation process comprises the following steps: (1) placing water used for injection in a preparation tank, lowering water temperature to 39-41 DEG C; (2) dissolving sodium chloride with the water used for injection in the preparation tank for spare use, adding the racanisodamine hydrochloride into the preparation tank, opening a stirrer, adding 0.2mol / L of hydrochloric acid into the preparation tank, adding sodium chloride solution into the preparation tank, circulating and stirring until racanisodamine is completely dissolved; and (3) regulating pH value of liquid medicine obtained in step (2) to be 5.5-6.0 with 0.2mol / L of hydrochloric acid. The liquid medicine is filtered by a high pressure ultrafilter, then whether an intermediate product is qualified is inspected, a filling process is carried out, and the preparation process disclosed by the invention enhances market competitiveness of the racanisodamine hydrochloride product, is convenient to the marketing of the racanisodamine hydrochloride product and is worthy of popularization.

Description

[0001] technical field [0002] The invention relates to a preparation process of injections, in particular to a new preparation process of racemic anisodamine hydrochloride injection which is superior to the traditional process. Background technique [0003] The main ingredient of racemic anisodamine hydrochloride injection is racemic anisodamine hydrochloride, whose chemical name is (±)-6β-hydroxy-1αH,5αH-tropane-3α-ol tropic acid ester hydrochloride. Clinical indications are mainly used to relieve smooth muscle spasm, gastrointestinal colic, biliary spasm, acute microcirculation disturbance and organophosphate poisoning. Because of its good curative effect and few side effects, the market demand is large. [0004] There are several domestic enterprises producing it, and the preparation and production process adopted is the traditional one: calculate the amount of raw materials used according to 100% of the labeled amount; put the required amount of water for injection in...

AI Technical Summary

Problems solved by technology

[0007] In view of the defect that the traditional preparation process of racemic anisodamine hydrochloride injection cannot effectively ensure the complete filtration of impurities such as clarity and fibers, the present invention proposes to use high-pressure ultrafiltration equipment to effectively ensure the complete filtration of impurities such as clarity and fibers, and improve Increased product yield, reduced product cost, and ensured product quality stability