Novel cinobufogenin freeze-drying powder injection, its prepn. method and quality control method

Abstract

A freeze-dried powder injection of cinobufotoxin is prepared from the aquatic extract of dried toad skin and the pharmacologically acceptable carrier. Its preparing process and its quality control method are also disclosed. Its advantages are high curative effect and low poison.

Description

technical field [0001] The invention relates to a new cinobufacin freeze-dried powder injection, a preparation method and a quality control method thereof, and belongs to the technical field of medicine. Background technique [0002] The main component of cinobufacin freeze-dried powder injection is the water-soluble indole alkaloid, which is the main medicinal component of traditional Chinese medicine dried toad skin. Cinobufacin is a water-soluble indole alkaloid extracted from the traditional medicinal material Bufo bufo shade-dried whole skin as the main raw material. Toad skin, first contained in "The Classic of Feng Yuan), has another name called shrimp toad skin. It is the whole skin of Bufo bufo. It is produced all over the country and can be used fresh or dried. The nature and flavor of this product are pungent and cool, sweet and flat, poisonous, and its function is to break the crux of the problem, promote water dampness, detoxify, and relieve pain. Indication...

AI Technical Summary

Problems solved by technology

[0003] Studies have shown that when cinobufacin injection is placed at room temperature for 90 days, the content drops significantly, and the curative effect is affected due to unstable quality. At the same time, the inherent defects of water injection are stability problems and easy breakage during carrying, storage and transportation, which brings many trouble

[0004] At the same time, studies have shown that the toxicity of dry toad skin is reduced during the water extraction process (Wu Jianjun et al. Preliminary observation of the effect of cinobufacin on normal cardiac hemodynamics in anesthetized dogs. Journal of Xuzhou Medical College. 1997, 17(3): 285), It shows that the water extraction of dry toad skin can effectively reduce its toxicity; the patent (application number 20041008994.4) is a freeze-dried powder injection of cinobufacin, and its active ingredient is alcohol extract. suitable for clinical use

[0005] At the same time, the active ingredient is prepared from the water extract of dry toad skin for freeze-dried powder injection, and there is no report