Xiangdan medicament injection preparation containing polyethylene glycol 12-hydroxystearate and preparation method thereof

Abstract

The invention discloses a Xiangdan medicament injection preparation containing polyethylene glycol 12-hydroxystearate and a preparation method thereof. The Xiangdan medicament injection preparation is the injection medicament mainly prepared by dissolving a root of red-rooted salvia extract, a rosewood extract and polyethylene glycol 12-hydroxystearate for improving the clarity of the injection in injection water, wherein the using amount of the polyethylene glycol 12-hydroxystearate is 0.2g-1.0g / 100ml. The Xiangdan medicament injection preparation of the invention can stably ensure that the detection of visible foreign matters of the injection complies with the medicament quality standard, improve the clarity of the Xiangdan medicament injection preparation, solve the problems of easy rancidity, high impurity content and chemical change with medicinal ingredients of the Xiangdan medicament injection preparation adopting the conventional cosolvent during storage and high-temperature sterilization, and small white spots, white blocks and turbidity of the product during storage, and ensure that the detection of the visible foreign matters of the Xiangdan medicament injection preparation complies with the medicament quality standard so as to facilitate clinic administration and popularization.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a medicine injection preparation of Xiangdan containing polyethylene glycol lauryl hydroxystearate and a preparation method thereof. Background technique [0002] The standard of Xiangdan injection is recorded in the drug standard issued by the Ministry of Health (WS3-B-3289-98, traditional Chinese medicine preparation), and the raw materials are Danshen and Jiangxiang. For the above two flavors, add balm and water to infiltrate, carry out steam distillation, collect about 500ml of distillate, refrigerate for 24 hours, separate to remove the oil layer, and collect the aqueous solution in another device. Add dan to the water and decoct three times, add 8 times the amount of water for the first time, and decoct for 2 hours; add 6 times and 5 times the amount of water for the second and third times, decoct for 1.5 hours each time, combine the decoction, filter, and the ...

AI Technical Summary

Problems solved by technology

[0004] According to the quality standard preparation method of Xiangdan injection, the main components of Salvia miltiorrhiza extract and Jiangxiang extract are complex, and contain volatile oil of Jiangxiang that is insoluble in water, which makes Xiangdan injection easy to store and sterilize at high temperature. Problems such as small white spots, precipitation and solution turbidity appear

At present, polysorbate 80 is used as a co-solvent in Xiangdan injection, but polysorbate 80 is prone to rancidity during storage and high-temperature sterilization, resulting in high impurity content and chemical changes with drug ingredients. There are still a small number of small white spots, precipitation and solution turbidity problems, resulting in the inspection of visible foreign matter of the product does not meet the requirements of the drug quality standards, which brings inconvenience to clinical drug use and promotion

[0005] Patent document CN200510051488.1A discloses Xiangdan injection and its preparation method, which is mainly made of 1-1000 parts by weight of Salvia miltiorrhiza and 1-1000 parts by weight of jiangxiang. In order to solve the problems of precipitation and cloudy solution during storage, Add Tween-80 in ultrafiltration and injection as solubilizer, because the water solubility of tanshinone and balm oil in the main ingredients of this product is very poor, and Tween-80 has strong hemolytic and allergic properties, Therefore, using the above methods to obtain injections still cannot satisfactorily solve the problems of precipitation and turbidity of Xiangdan injection during placement, and cannot meet the actual clinical needs.

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