Polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) containing radix bupleuri injection drug preparation and preparation method thereof

Abstract

The invention provides a radix bupleuri injection drug preparation with higher security and a preparation method thereof, the radix bupleuri injection drug preparation is an injection drug mainly prepared by together dissolving a fresh radix bupleuri 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 0.3g / 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 radix bupleuri injection liquid using the polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) as the solubilizer is obviously better than that of a radix bupleuri injection liquid using the polysorbate-80 as a solubilizer.

Description

Technical field [0001] The invention involves the field of pharmaceutical preparations, and specifically involves a refreshment of refreshing diol diol -hydroxyl hydroxyl acid ester and its preparation methods. Background technique [0002] Chaihu injection standards are collected by the Ministry of Health (WS3 -B -3297-98, and the 17th volume of Chinese medicine formula preparations).Take Chaihu 1000g, cut off, add water temperature, distille through water vapor, collect the initial distillation, and then distille, collect a distillation of about 1000ml, add 3g of polyshan pear ester-80, stir to fully dissolve the oil, add 9g chlorine chlorine, then add 9g chlorine chlorineAfter the sodium, after dissolving, filtering, adding water to 1000ml, adjusting the pH value, determining absorption, fine filtering, irrigation, sterilization, and obtaining. [0003] Chaihu injection has the effect of clearing heat and solving the table.Clinically for the treatment of fever of colds, popula...

AI Technical Summary

Problems solved by technology

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

Current Bupleurum 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 relatively high Strong hemolytic and allergic, which will increase the incidence of adverse reactions of injections

And the products added with polysorbate-80 as a solubilizer still have problems such as a small amount of precipitation and solution turbidity during long-term storage, which increases the risk of clinical medication