US EPA

1460323 

Journal Article 

Comparison of Two Separation Technologies Applied in the Manufacture of Botanical Injections: Second Ethanol Precipitation and Solvent Extraction 

Gong, X; Wang, S; Qu, H 

2011 

Yes 

Industrial and Engineering Chemistry Research
ISSN: 0888-5885
EISSN: 1520-5045 

50 

12 

7542-7548 

10.1021/ie2004972 

WOS:000291323000050 

http://pubs.acs.org/doi/abs/10.1021/ie2004972
Exit
 

A botanical injection is a special drug preparation with extremely high safety requirements. Therefore, many separation technologies, such as ethanol precipitation and liquid liquid extraction, are applied in the manufacturing process of botanical injections to purify efficacy compounds and remove impurities. In this work, second ethanol precipitation and 1-butanol extraction were compared in the purification of the concentrated supernatant of danshen (the dried root of Salvia miltiorrhiza). These two separation technologies showed satisfactory recovery of phenolic compounds and similar removal of total protein. Liquid-liquid extraction removed more saccharides than second ethanol precipitation. Accordingly, the purity of phenolic compounds increased remarkably after liquid-liquid extraction. According to the characteristics of the two separation technologies, the combination technology of "ethanol precipitation + liquid liquid extraction" showed more advantages in drug safety and product quality control than the combination technology of "ethanol precipitation + second ethanol precipitation".