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

Abstract

The invention provides a collateral-calming injection preparation with higher security and a preparation method thereof, the collateral-calming injection preparation is an injection drug mainly prepared by together dissolving a radix achyranthis bidentatae extract, a figwort root extract, a dendrobium extract, a honeysuckle extract, a flos lonicerae 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 1.0g / 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, and safety experiment shows that the security of a collateral-calming injection liquid using the polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) as the solubilizer is obviously better than that of a collateral-calming 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 Mailuoning injection preparation containing polyethylene glycol lauryl hydroxystearate and a preparation method thereof. Background technique [0002] The standard of Mailuoning injection is recorded in the drug standard issued by the Ministry of Health (WS3-B-3462-98, the eighteenth volume of traditional Chinese medicine preparations). A sterile aqueous solution. [0003] Mailuoning Injection has the effects of nourishing yin and clearing heat, nourishing liver and kidney, promoting blood circulation and removing blood stasis. It is clinically used for ischemic cerebrovascular disease, occlusive peripheral vascular disease, coronary heart disease, pregnancy-induced hypertension, etc. . Dosage is intravenous infusion, 10-20ml at a time, diluted with 5% glucose injection or sodium chloride injection 250-500ml before use, 10-14 days is a course of treatment, severe ...

AI Technical Summary

Problems solved by technology

Current Mailuoning 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