Polyoxyethylene-660-12-hydroxy stearate containing mulberry ginger cold injection preparation and preparation method thereof

Abstract

The invention provides a mulberry ginger cold injection preparation with higher security and a preparation method thereof, the mulberry ginger cold injection preparation is an injection drug mainly prepared by together dissolving a mulberry extract, a chrysanthemum extract, a perilla extract, a forsythia extract, a semen armeniacae amarae extract, a dried ginger extract, phenylcarbinol and polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) as a solubilizer into injection water, and the use amount of the used polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) is 0.3g / 100ml. The literature research in the prior art confirms that the security of the polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) used in the preparation is far better than that of polysorbate-80; moreover, safety experiment shows that the security of a mulberry ginger cold injection liquid using the polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) as the solubilizer is obviously better than that of a mulberry ginger cold injection liquid using the polysorbate-80 as a solubilizer.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a mulberry ginger cold injection preparation containing polyethylene glycol lauryl hydroxystearate and a preparation method thereof. Background technique [0002] The standard of Sangjiang Ganmao injection is recorded in the drug standard issued by the Ministry of Health (WS3-B-3954-98, the twentieth volume of traditional Chinese medicine preparations). Sterilized aqueous solution made from processed ginger. Take 150g of mulberry leaves, 20g of chrysanthemum, 80g of perilla, 80g of forsythia, 80g of bitter almond, and 50g of dried ginger. The above six flavors are decocted twice with water, the first time is 2 hours, the second time is 1 hour, the decoction is combined, filtered, and the filtrate is concentrated to 100ml. Add ethanol so that the alcohol content is 60%, 70%, and 80% respectively, stand still, filter, recover ethanol, dissolve the residue in water and b...

AI Technical Summary

Problems solved by technology

[0004] The mulberry leaf extract, chrysanthemum extract, perilla extract, forsythia extract, bitter almond extract and dried ginger extract obtained according to the preparation method in the quality standard of mulberry ginger cold injection, its main components include flavonoids, volatile oil and Amygdalin and other functional ingredients make Sangjiang Ganmao Injection prone to problems such as precipitation and solution turbidity during high-temperature sterilization and long-term storage

Current Sangjiang Ganmao injections all use polysorbate 80 as a solubilizer, yet polysorbate 80 is prone to rancidity during high-temperature sterilization and long-term storage, resulting in an increase in impurity content; and polysorbate 80 itself has a strong Hemolytic and allergic, which will increase the incidence of adverse reactions of injections

And the products added with polysorbate 80 as a solubilizer will still have a small amount of precipitation and solution turbidity during long-term storage, which increases the risk of clinical medication