Polyethylene glycol 12-hydroxy stearate-containing danshen root medicament injection preparation and preparation method thereof

Abstract

The invention discloses a method for preparing polyethylene glycol 12-hydroxy stearate-containing danshen root medicament injection preparation. The preparation method comprises the following steps: adding water to 1500g of the root of red-rooted salvia and boiling for three times, the first time being 2h, the second time and the third time each being 1.5h, combining the boiled liquid, filtering, concentrating under decompression to 750ml, adding alcohol and precipitating twice, the alcohol content in the first time being 75% and in the second time being 85%, each all filtering after refrigerating, recovering the alcohol from filtrate and concentrating to 250ml, adding injection water to 400ml, blending, refrigerating, filtering, adjusting pH value to 6.8 by using 10% of sodium hydroxide solution, boiling for half an hour, filtering, adding 2.0g of polyethylene glycol 12-hydroxy stearate to the filtrate, and adding the injection water to 1000ml, mixing uniformly, adjusting the pH value to 6.8 by using the 10% of the sodium hydroxide solution, filtering, embedmenting, sterilizing and obtaining the product. The method of the invention solves the problems of easy precipitation and opacities during the storage and high temperature sterilization processes of the root of red-rooted salvia injection with satisfaction.

Description

technical field

[0001] The invention belongs to the technical field of medicine, and in particular relates to a salvia miltiorrhiza drug injection preparation containing polyethylene glycol lauryl hydroxystearate and a preparation method thereof. Background technique

[0002] The standard of Danshen injection is recorded in the drug standard issued by the Ministry of Health (WS3-B-3766-98, Volume 20 of Traditional Chinese Medicine Preparations), and it is a sterilized aqueous solution made from the extract of Danshen medicinal material. Take 1500g of Salvia miltiorrhiza, add water and decoct three times, the first time for 2 hours, the second and third times for 1.5 hours each, combine the decoction, filter, and concentrate the filtrate to 750ml under reduced pressure. Add ethanol for precipitation twice, the first time the alcohol content is 75%, the second time the alcohol content is 85%, each time it is refrigerated and then filtered. The filtrate recovers ethanol and con...

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