[生脉注射液适宜增溶剂筛选研究]

[Study on selecting the suitable solubilizing excipients for Shengmai injection].

作者信息

Zhang Shao-Feng, Yan Dan, Tang Hui-Ying, Li Han-Bing, Wang Yue-Sheng, Xiao Xiao-He, Yang Ming

机构信息

China Military Institute of Chinese Materia Medica, 302 Military Hospital of China, Beijing 100039, China.

出版信息

Zhong Yao Cai. 2009 Jun;32(6):969-72.

PMID:19764337

Abstract

OBJECTIVE

To select the suitable solubilizing excipients for Shengmai injection by the mean of hemolysis.

METHODS

The hemolysis ratio of Shengmai injection, solubilizing excipients and different proportion of them were determined by absorption spectrometry.

RESULTS

In the experimental concentration, Shengmai injection itself had no hemolytic effect. Polysorbate 80, Polyethylene glycol 400, Polyethylene glycol 600, Poloxamer 188 solution had no hemolytic effect to appear, but all the experimental concentrations of Polysorbate 20 had hemolytic effect. When combining with different proportion of Polysorbate 20, Polyethylene glycol 400, Polyethylene glycol 600, Poloxamer 188 and Polysorbate 80 of high concentration (0.75% - 1%), Shengmai injection had hemolytic effect.

CONCLUSIONS

The absorption spectrometry is more reliable for the judgement of hemolysis than macroscopic observation, and it is helpful to improve the accuracy to select the solubilizing excipients for the TCM injection. Polysorbate 80 can be used as solubilizing excipient of Shengmai injection, which is safe in the concentration range of 0.1% to 0.5%.

摘要

目的

通过溶血试验筛选适合参麦注射液的增溶剂。

方法

采用吸收光谱法测定参麦注射液、增溶剂及其不同比例混合液的溶血率。

结果

在实验浓度范围内，参麦注射液本身无溶血作用。聚山梨酯80、聚乙二醇400、聚乙二醇600、泊洛沙姆188溶液均未出现溶血作用，但各实验浓度的聚山梨酯20均有溶血作用。当与不同比例的聚山梨酯20、聚乙二醇400、聚乙二醇600、泊洛沙姆188及高浓度（0.75% - 1%）的聚山梨酯80混合时，参麦注射液有溶血作用。