Preparation technology of racanisodamine hydrochloride injection

Abstract

The invention discloses a preparation technology of racanisodamine hydrochloride injection. A high pressure ultrafiltration device is used to overcome a defect that precious traditional preparation technologies of the racanisodamine hydrochloride injection cannot effectively ensure the clarity or the filtering safety of fibers or other impurities. The preparation technology disclosed in the invention has the advantages of low cost, high yield, and stable quality of the above finished product. The technology comprises the following steps: (1) putting injection water in a preparation tank, and decreasing the water temperature to 39-41DEG C; (2) taking the injection water in the tank, dissolving sodium chloride to prepare a solution for later use, adding racanisodamine into the preparation tank, starting a stirrer, adding 0.2mol / L of hydrochloric acid into the preparation tank, circulating, and stirring until racanisodamine is completely dissolved; and (3) adjusting the pH value of the soup obtained in step 2 by 0.2mol / L of hydrochloric acid to 5.5-6.0, filtering the soup through a high pressure ultrafiltration machine, inspecting, and canning qualified intermediate products. The preparation technology enhances the market competitiveness of the products, is convenient for the marketing of the products, and is worth to be popularized.

Description

technical field

[0001] 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

[0002] The main component 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.

[0003] There are several domestic enterprises producing it, and the preparation and production processes adopted are all traditional ones; the amount of raw materials used is calculated according to 100% of the marked amount; the required amount of water for injection is put ...