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

Abstract

The invention provides a compound musk injection preparation with higher security and a preparation method thereof, the compound musk injection preparation is an injection drug mainly prepared by together dissolving a compound musk extract, a pogostemon cablin extract, a radix curcumaeextract, a rhizoma acori gramineiextract, borneol, menthol 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 2g / 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 compound musk injection liquid using the polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) as the solubilizer is obviously better than that of a compound musk 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 compound musk injection preparation containing polyethylene glycol lauryl hydroxystearate and a preparation method thereof. Background technique [0002] The standard of Compound Musk Injection is recorded in the National Standard Compilation of Chinese Patent Medicine Brain, Meridian and Limbs (WS-10356 (ZD-0356)-2002). Processed sterile aqueous solution. For the above six medicinal materials, musk, patchouli, turmeric, and calamus were distilled with water steam to obtain the first distillate, and then redistilled to collect the redistillate, and borneol and menthol were co-ground, and 20ml polysorbate 80 was added, and used Dissolve the above distillate in stages, adjust the pH value to 6-7 with 5% sodium hydroxide solution, add 0.2 g of activated carbon to shake well, add water for injection to the specified amount, refrigerate, filter, pot, and sterilize to obta...

AI Technical Summary

Problems solved by technology

[0004] The musk extract, patchouli extract and turmeric extract etc. obtained according to the preparation method in the quality standard of compound musk injection, its main components include muscone, ageol and camphor and other functional components, so that compound musk injection is Problems such as precipitation and solution turbidity are prone to occur during high temperature sterilization and long-term storage

Current compound musk 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