Sodium aescinate freeze-dried preparation for injection and preparation method of sodium aescinate freeze-dried preparation

Abstract

The invention discloses a sodium aescinate freeze-dried preparation for injection and a preparation method of the sodium aescinate freeze-dried preparation, and belongs to the field of medicines. Thesodium aescinate freeze-dried preparation comprises and only contains sodium aescinate. The preparation method comprises the following steps: adjusting the pH value of a sodium aescinate solution, performing filtering with a micropore filtration membrane, performing filling, and performing freeze drying in three stages. The sodium aescinate freeze-dried preparation obtained by the method disclosedby the invention is good in appearance, good in redissolving effects, high in main drug purity, not easy to absorb moisture and stable in quality, and the drug purity and the medication safety are improved.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a freeze-dried preparation of sodium aescinate for injection and a preparation method thereof. Background technique [0002] Sodium aescinate is the total saponin extracted from the dried mature seeds of Aescinaceae or Tianshi Chestnut. Various pharmacological studies have shown that sodium aescinate has the functions of anti-exudation, increasing venous tone, detumescence, anti-inflammation, anti-oxygen free radicals, promoting gastrointestinal motility and improving blood circulation. Clinically, it is widely used to treat cerebral edema, swelling caused by trauma or surgery, and it is also used to treat diseases such as venous reflux disorder, and has a good therapeutic effect. [0003] Aescin is a general term for more than 30 kinds of saponins in the seeds of Aesculus aesculus. The study of its chemical composition began in the 19th century when it isolated saponin mixtu...

AI Technical Summary

Problems solved by technology

[0003] Aescin is a general term for more than 30 kinds of saponins in the seeds of Aesculus aesculus. The study of its chemical composition began in the 19th century when it isolated saponin mixtures from the seeds of Aesculus aesculus. So far, saponins, Flavonoids, coumarins and other components, because of their complex structure and similar polarity, brought a lot of trouble to early researchers

However, too many excipients were added in the preparation process of the freeze-dried emulsion, which resulted in the product having different chemical properties and prone to other adverse reactions

In addition, the patent uses freeze-dried emulsion to ensure the stability of the product during storage and transportation, extend the validity period, and improve the quality of the drug. However, since the process is always in the state of emulsion, the clarity of the product will not be good due to poor resolubility during use. close

Chinese patent CN 102836133 B provides "a escin sodium freeze-dried powder and its preparation method" in which a tert-butanol protective agent is added, but tert-butanol is harmful to the body if inhaled or taken orally, and is harmful to the eyes, skin, mucous membranes and respiratory tract Stimulating

The introduction of risky substances in this way is not conducive to commercial production

The "aescin A injection and its preparation method" provided in Chinese patent CN106511282A add amino acid and mannitol as excipients, resulting in the chemical properties of the product are not single, easy to produce other adverse reactions

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