Refining method of high-stability radix astragali seu hedysari injection solution and radix astragali seu hedysari injection solution

Abstract

The invention relates to the technical field of production of a radix astragali seu hedysari injection and in particular discloses a refining method of a high-stability radix astragali seu hedysari injection solution and the radix astragali seu hedysari injection solution prepared by the refining method. The method comprises the following steps: carrying out water extraction and alcohol precipitation on radix astragali seu hedysari; after recycling ethanol from an obtained alcohol solution, carrying out water precipitation treatment; after concentrating an obtained water precipitation solution, cooling and filtering; adjusting the pH (Potential of Hydrogen) by utilizing an alkali until the pH is 9.0 to 10.0; heating and boiling; filtering and adding injection water into filtrate; adjusting the pH to be 7.3 to 7.5 by utilizing the alkali and filling; sterilizing to obtain the high-stability radix astragali seu hedysari injection solution. According to the method provided by the invention, a medicinal material foundation of the radix astragali seu hedysari is not limited, and impurities including tannin, proteins and the like are completely removed; meanwhile, saponins and flavones components are kept to the greatest extent; the prepared radix astragali seu hedysari injection solution has relatively high stability and also has the advantages of short production period, simplicity and convenience in operation and low production cost.

Description

technical field [0001] The invention relates to the technical field of astragalus injection production. Background technique [0002] Astragalus is used as a medicinal material. At present, the original plant germplasm of cultivated Astragalus is mainly the leguminous herb Astragalus mongolica and Astragalus membranaceus, and there is almost no commercial supply of wild Astragalus membranaceus. [0003] The chemical components of Astragalus injection mainly include astragalus saponins, flavonoids, polysaccharides and other components, among which saponins and flavonoids are the main medicinal components of Astragalus injection. Astragalus total saponins can protect vascular endothelium, improve blood rheology, etc., and have protective effects on ischemic-hypoxic myocardium, virus-infected myocardium, and myocardium injured by adriamycin and isoproterenol; Perfusion, acute myocardial infarction, viral myocarditis and barium chloride-induced arrhythmia have protective effect...

AI Technical Summary

Problems solved by technology

The preparation method is divided into two parts: water extraction and alcohol extraction. Each part is extracted 2 to 3 times, and the extraction time is 1.5 to 2 hours each time. The extraction process is complicated and the extraction time is relatively long.

In addition to using ethanol for extraction, the whole process also has two alcohol precipitations with different concentrations, which leads to large consumption of ethanol, high production cost and high equipment requirements.

[0008] The Huangqi injection prepared by the above method has poor stability, short shelf life, many insoluble particles, and visible foreign matter is easy to appear, and the quality of the injection product is unstable.

[0009] In addition, comparative document 3, Chinese patent CN99106225.6 discloses a method for refining Astragalus injection by using three consecutive alcohol precipitations, which also loses a large amount of active ingredients while achieving the refining effect, and the amount of ethanol used for three alcohol precipitations is large, and the production cost High; comparative document 4, Chinese patent CN102631402A discloses the use of astragalus extract through titanium rod filtration, microporous ultrafiltration, adding non-ionic surfactant polysorbate 80 and water for injection to prepare astragalus injection, which uses polysorbate in large quantities 80 may cause adverse reactions and increase the unsafe factors of medication; comparative document 5, Chinese patent CN101049339A discloses a process for refining Astragalus injection using freezing technology, which has a long production cycle, and the application of freezing technology requires high equipment. Increased production cost; comparative document 6, Chinese patent CN1515295A discloses the preparation of Astragalus injection by separation and purification of macroporous resin, the production process is complicated, and the obtained eluent may contain resin degradation products and porogen components. Subsequent steps do not remove this type of substance very well

[0010] It can be seen that there are still certain problems in the current refining method of Astragalus injection, such as complex production process, long production cycle, high production cost, unstable quality of the obtained Astragalus injection product, and low content of active ingredients.

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