Pharmaceutical meclofenoxate hydrochloride composition for treating pediatric enuresis

Abstract

The invention discloses a pharmaceutical meclofenoxate hydrochloride composition for treating pediatric enuresis and belongs to the technical field of medicines. The pharmaceutical meclofenoxate hydrochloride composition consists of meclofenoxate hydrochloride and sodium chloride, wherein meclofenoxate hydrochloride is in the form of crystals, and an X-ray powder diffraction pattern obtained through Cu-K alpha ray measurement is as shown in the Figure 1. The novel crystal form of meclofenoxate hydrochloride, provided by the invention, is different from the crystal form structure in the prior art. Tests verify that the provided meclofenoxate hydrochloride composition is remarkably improved in hygroscopicity and fluidity, extremely low in moisture and impurity content and better in stability than the prior art, and provides convenience for agent preparation. The meclofenoxate hydrochloride composition provided by the invention is higher in bioavailability and lower in side reaction rate than the prior art. A powder injection prepared from the novel crystal form compound is excellent in fluidity, extremely low in moisture and impurity content, better in stability, high in bioavailability and low in side reaction rate.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a meclofenoxate hydrochloride composition for treating enuresis in children. Background technique [0002] The chemical name of meclofenoxate hydrochloride is 2-(dimethylamino)ethyl p-chlorophenoxy acetate hydrochloride, which is a central nervous system stimulant and brain neurotrophic drug, which can improve the central nervous system Functions, including causing awakening, invigorating the spirit, exciting breathing, improving nerve reflexes and increasing free activities, it can promote protein assimilation, and can be used as raw materials for the synthesis of choline and acetylcholine in the body, and then synthesize lecithin, thereby changing the neurotransmitter of the central nervous system content, increase the amount of acetylcholine in the brain, have an anti-hypoxic effect, promote the oxidation-reduction reaction of brain cells, promote brain energy metabolism, impro...

AI Technical Summary

Problems solved by technology

Although the existing technology has a certain effect in improving the stability of meclofenoxate hydrochloride in preparation, it needs to add more auxiliary materials and needs to cooperate with relatively complicated processes. Although it has a certain effect, the effect is limited, which limits the application of meclofenoxate hydrochloride. , because the easily hydrolyzed meclofenoxate hydrochloride is unstable in the raw material stage and requires extremely high storage conditions

There are also prior art attempts to obtain meclofenoxate hydrochloride with higher stability from changing the crystal form, such as: Chinese application CN103214382B, the meclofenoxate hydrochloride compound and its drug combination provided by this application are compared with the prior art , has better storage stability and fluidity, the inventor found in the test that although the meclofenoxate hydrochloride obtained in the application has good stability under normal and accelerated conditions, it is not effective in other conditions that affect the quality of drugs. Poor stability in the factor test, especially still has high hygroscopicity, which makes meclofenoxate hydrochloride easy to attract moisture and hydrolyze

Chinese application CN103396328B, the inventor of this application unexpectedly obtained a crystal form of meclofenoxate hydrochloride compound in the course of long-term and extensive research. This compound has very low hygroscopicity, is not easy to hydrolyze by hygroscopicity, and has extremely high quality stability. However, its bioavailability is low and the incidence of side effects is high

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