Synthetic technology of polysaccharide superparamagnetic iron oxide raw material medicine
A technology of superparamagnetic iron oxide and synthesis process, which is applied in the direction of pharmaceutical formulations, active ingredients of heavy metals, medical preparations of non-active ingredients, etc., and can solve problems such as complex production methods, unstable processes, and poor quality control stability
Inactive Publication Date: 2019-08-30
澳诺(中国)制药有限公司
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Problems solved by technology
Polysaccharide superparamagnetic iron oxide is produced under water for injection by using ferric chloride, ferrous chloride, PSC and ammonium hydroxide. The hydrocolloid product synthesized therefrom is the raw material drug. The existing production method is complicated and the quality is low. Poor control stability leads to unstable and uncontrolled process, which makes the production cost too high. Therefore, it is particularly important to solve this kind of problem
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[0030] In order to deepen the understanding of the present invention, the present invention will be further described below in conjunction with the examples, which are only used to explain the present invention, and do not constitute a limitation to the protection scope of the present invention.
[0031] according to figure 1 As shown, the present embodiment provides a synthesis process of polysaccharide superparamagnetic iron oxide bulk drug, including the following production steps:
[0032] Step 1: Prepare PSC-ferric chloride solution
[0033] First prepare a solution containing PSC and water for injection, then prepare a solution containing ferric chloride hexahydrate and water for injection, filter the ferric chloride solution to another container with a 0.2 μm filter, then mix the filtrate with the PSC solution, and then use 0.2 Filter through a μm filter into the reactor, cool to 1-6°C and maintain with nitrogen;
[0034] Step 2: Prepare and add ferrous chloride solu...
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Abstract
The present invention discloses a synthetic technology of a polysaccharide superparamagnetic iron oxide raw material medicine. The synthetic technology comprises the following steps: polyglucose sorbitol carboxymethyl ether (PSC) cold liquid, ferric chloride and ferrous chloride injection aqueous solutions react with a refrigerated NH4OH aqueous solution, after each component is mixed for 15 minutes, the mixture is heated to 78 DEG C, the temperature is maintained for 1 hour, air is introduced into the reacted mixture, heating is continued at 78 DEG C for 4 hours, a colloidal product is subjected to ultrafiltration purification using a 100,000 Dalton molecular weight cut-off membrane to remove excess polyglucose sorbitol carboxymethyl ether and low molecular weight impurities, 8 times of ultrafiltration are performed continuously to achieve a desired purification level, and finally, the PSC is added to enable a mass ratio of the PSC to iron is 1:1. The production method is simple, stable in quality control and controlled.
Description
technical field [0001] The invention relates to hydrocolloid products, in particular to a synthesis process of a polysaccharide superparamagnetic iron oxide raw material drug. Background technique [0002] Polysaccharide superparamagnetic iron oxide is a black to reddish-brown liquid composed of non-stoichiometric iron oxide coated with a stabilizing polydextrose sorbitan carboxymethyl ether (PSC) hydration layer The stable aqueous colloid suspension of polysaccharide superparamagnetic iron oxide contains 28 ~ 31mg Fe / g and approximately the same amount of PSC. pH: 7~9, it is a non-buffer solution. Polysaccharide superparamagnetic iron oxide is produced under water for injection by using ferric chloride, ferrous chloride, PSC and ammonium hydroxide. The hydrocolloid product synthesized therefrom is the API. The existing production method is complex and the quality is low. Poor control stability leads to unstable and uncontrolled process, which makes the production cost too...
Claims
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IPC IPC(8): A61K33/26A61K47/36
CPCA61K33/26A61K47/36
Inventor 朱吉安
Owner 澳诺(中国)制药有限公司