title: A strategy for the detection of quality fluctuation of a Chinese herbal injection based on chemical fingerprinting combined with biological fingerprinting.
abstract: Herbal injections are powerful preparations of traditional Chinese medicines. However, the quality control (QC) of these formulations is difficult to establish. Recently, chemical fingerprinting (CF) has been recommended as a potential strategy for the QC of herbal injections. However, some constituents cannot be detected by chromatographic methods. To establish a comprehensive QC process, biological fingerprinting (BF) was combined with CF to detect the fluctuation in quality of a herbal injection from chemical and biological aspects. Yinzhihuang injection was selected as a representative herbal injection. Ten batches of normal samples and six batches of artificially abnormal samples were collected. High-performance liquid chromatography and thermal activity monitoring were applied to develop CF and BF, respectively. The CF and BF of normal samples were similar, with good stability and consistency, but the abnormal samples were not. The results were analyzed by hierarchical clustering analysis: all abnormal samples could be correctly distinguished when CF and BF were combined. The recognition ratio was higher for CF (87.5%) than for BF (93.75%). The key factors of quality fluctuation were bacterial contamination, high temperature, lighting, and sterilizing conditions. The described method could be used for early prediction of adverse drug events, which could help improve the safety of herbal injections.
authors.affiliation: Military Institute of Chinese Materia Medica, 302th Military Hospital of China, Beijing 100039, PR China.
authors.forename: Yongshen
authors.initials: Y
authors.lastname: Ren
authors.forename: Ping
authors.initials: P
authors.lastname: Zhang
authors.forename: Dan
authors.initials: D
authors.lastname: Yan
authors.forename: Jiabo
authors.initials: J
authors.lastname: Wang
authors.forename: Xiaoxi
authors.initials: X
authors.lastname: Du
authors.forename: Xiaohe
authors.initials: X
authors.lastname: Xiao
mesh_terms: D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000592:standards; D016000:Cluster Analysis; D004340:Drug Contamination; D004355:Drug Stability; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000032:analysis* / Q000592:standards; D007267:Injections; D011786:Quality Control; D015203:Reproducibility of Results; D013211:Staphylococcus aureus / Q000187:drug effects / Q000254:growth & development; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards; D013696:Temperature
chemical_list: D004365:Drugs, Chinese Herbal; C070600:yin zhi huang