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

Abstract

The invention provides a breviscapine injection preparation with higher security and a preparation method thereof, the breviscapine injection preparation is an injection drug mainly prepared by together dissolving a breviscapine 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 0.01g / 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 breviscapine injection liquid using the polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) as the solubilizer is obviously better than that of a breviscapine 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 breviscapine injection preparation containing polyethylene glycol lauryl hydroxystearate and a preparation method thereof. Background technique [0002] The standards of breviscapine injection are recorded in the drug standards issued by the Ministry of Health (WS3─B─3822─98, the twentieth volume of traditional Chinese medicine preparations), and it is a sterilized aqueous solution of breviscapine. Dissolve 0.26g of disodium edetate in 280ml of water for injection, add 1g of breviscapine, stir to suspend, add an appropriate amount of sodium bicarbonate, stir while adding until the pH is 7-7.5, and fully stir to make The scutellarin is basically dissolved, add water for injection to 400ml, add 0.1% activated carbon in the solution volume, stir and absorb for 20 minutes, remove carbon, fine filter, fill and seal the semi-finished product after passing the inspection, an...

AI Technical Summary

Problems solved by technology

Therefore, breviscapine injection is prone to problems such as precipitation and solution turbidity during high temperature sterilization and long-term storage.

Current breviscapine injections often 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 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