Polyoxyethylene-660-12-hydroxy stearate containing collateral-generating injection preparation and preparation method thereof

Abstract

The invention provides a collateral-generating injection preparation with higher security and a preparation method thereof, the collateral-generating injection preparation is an injection drug mainly prepared by together dissolving a red ginseng extract, a dwarf lilyturf root extract, a fructus schisandrae extract 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 0.5g / 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 collateral-generating injection liquid using the polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) as the solubilizer is obviously better than that of a collateral-generating 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 Shengmai injection preparation containing polyethylene glycol lauryl hydroxystearate and a preparation method thereof. Background technique [0002] The standard of Shengmai injection is recorded in the drug standard issued by the Ministry of Health (WS3-B-2865-98, the fifteenth volume of traditional Chinese medicine preparations). . Take 100g of red ginseng, 312g of Ophiopogon japonicus, and 156g of schisandra. For the above three flavors, crush the red ginseng into fine particles, reflux and extract with ethanol for 4 to 5 times, each time for 2 hours, use the thin layer method to control the extraction end point, combine the extracts, refrigerate, filter, and concentrate the filtrate to a thick paste , add water for injection to 400ml, stir well, refrigerate, filter, and the filtrate is used for liquid preparation; Schisandra chinensis is used for steam distillat...

AI Technical Summary

Problems solved by technology

[0004] Red ginseng extract, Ophiopogon japonicus extract and Schisandra chinensis extract obtained according to the production method in the quality standard of Shengmai injection. Problems such as precipitation and solution turbidity are prone to occur during high temperature sterilization and long-term storage

The current Shengmai injections all use polysorbate 80 as a solubilizer, but 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 effect. Sexuality and allergenicity, 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