Butylphthalide medicine active composition and preparation method of butylphthalide medicine active composition

Abstract

The invention provides a butylphthalide medicine active composition, which comprises the following ingredients: first ingredients: the butylphthalide content is higher than or equal to 98.0 percent; second ingredients: the second ingredients are one kind of materials or several kinds of materials selected from methylene phthalide, ethylene phthalide, propylene phthalide, butane phthalide, amylene phthalide, phthalide, methyl phthalide, ethyl phthalide, propyl phthalide and amyl phthalide, in addition, the content of the second ingredients is higher than 0 but is lower than or equal to 2.0 percent, when the second ingredients comprise any one kind of materials from methylene phthalide, ethylene phthalide, propylene phthalide, butane phthalide and amylene phthalide, the content of any one kind of included ingredients does not exceed 0.5 percent, and when the second ingredients comprise any one kind of materials from phthalide, methyl phthalide, ethyl phthalide, propyl phthalide and amyl phthalide, the content of any one kind of included ingredients does not exceed 1.0 percent. The quality of the medicine active composition is stable, and the clinic curative effect and the medication safety of the butylphthalide preparation can be ensured.

Description

Technical field [0001] The present invention is a pharmaceutical technology field, which involves a drug activity composition and preparation method that contains 3-butyl-L (H)-isopen bephone (butadylene). Background technique [0002] Benzylene, chemical name is 3-butyl-L (H)-isopen bepholone, also known as celery nailin, is an anti-rotor from celery seeds, which can also be synthesized by artificially; patent in China; patent in China;In CN1100097, the application of celery nailin in preparation and treatment of diseases caused by mammals or human cerebral ischemia. Celery nailin is a butadylene pheneine without light activity.The strong celery fragrance, the chemical structure is shown in the formula 1: [0003] Essence [0004] 1 [0005] Butadylene pyrades 2 The level of the cells in the cell, the release of glutamic acid, the content of the peanutic acid, the inhibitory of oxygen free radicals, and the improvement of antioxidase activity and other mechanisms to act on mul...

AI Technical Summary

Problems solved by technology

[0015] Indexes such as the butylphthalide product content that adopts said method to prepare, impurity improve to some extent, as butylphthalide content improves to about 97%, and impurity content reduces to about 3.0%, but this product stability is still relatively poor, after placing During the process, the content of the product is significantly reduced, and the impurities are significantly increased, so the product cannot be used as a medicine; (2) At the same time, this method uses formatted reagents in the production process, which need to be stored in an anhydrous and oxygen-free sealed environment. It is made now, the operation is cumbersome, and there are safety hazards in the production process, so it is not suitable for industrial production

[0016] In view of the low content (or purity) of the above products, during the storage process, the quality is unstable, uncontrollable, and cannot be used as a medicine. Therefore, it is still necessary to improve the existing technology to reduce the content of various impurities in butylphthalide , obtain butylphthalide products with stable quality, and use the butylphthalide products with stable quality to prepare pharmaceutical preparations to ensure the clinical efficacy and drug safety of the preparations

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