title: Quality fluctuation detection of an herbal injection based on biological fingerprint combined with chemical fingerprint.
abstract: Herbal injection is one of the most important preparations of traditional Chinese medicine. More than 130 types of herbal injections are used clinically for 400 million patients annually with total sales of over four billion US dollars per year. However, the current quality control (QC) methods relying mainly on chemical fingerprints (CF) can hardly ensure quality and safety of the herbal injections with complex chemical composition and have resulted in an increase in serious adverse drug reactions. In this study, a comprehensive approach for the QC of a controversial herbal injection Shuang-Huang-Lian lyophilized powder (SHL) was established based on the quality fluctuation detection by a combination of CF and biological fingerprint (BF). High-performance liquid chromatography and the impedance-based xCELLigence system were applied to establish the CF and BF, respectively. In addition, multivariate analysis was performed to evaluate the discriminant ability of the two methods. The results showed that being subjected to environmental influence like oxygen/air, high temperature, and extreme illumination could lead to quality fluctuation of SHL. The combination of chemical and biological fingerprint method is a more powerful tool for the QC of SHL because it can clearly discriminate different groups of abnormal samples. This method can be used for the detection of quality fluctuation of SHL and can provide reference for the quality control of other herbal injections.
authors.affiliation: 302 Military Hospital, Beijing, 100039, China.
authors.forename: Lele
authors.initials: L
authors.lastname: Zhang
authors.forename: Lina
authors.initials: L
authors.lastname: Ma
authors.forename: Wuwen
authors.initials: W
authors.lastname: Feng
authors.forename: Congen
authors.initials: C
authors.lastname: Zhang
authors.forename: Feiya
authors.initials: F
authors.lastname: Sheng
authors.forename: Yi
authors.initials: Y
authors.lastname: Zhang
authors.forename: Chen
authors.initials: C
authors.lastname: Xu
authors.forename: Gang
authors.initials: G
authors.lastname: Dong
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Dong
authors.forename: Xiaohe
authors.initials: X
authors.lastname: Xiao
authors.forename: Dan
authors.initials: D
authors.lastname: Yan
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000032:analysis* / Q000592:standards*; D006801:Humans; D008407:Mast Cells / Q000166:cytology / Q000187:drug effects*; D011786:Quality Control; D015203:Reproducibility of Results
chemical_list: D004365:Drugs, Chinese Herbal; C516400:shuang-huang-lian