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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. [Copyright &y& Elsevier]

Abstract: Musk is a precious and wide applied material in traditional Chinese medicine, also, an important material for the perfume industry all over the world. To establish a rapid, cost-effective and relatively objective assessment for the quality of musk, different musk samples, including authentic, fake and adulterate, were collected. A oxide sensor based electronic nose (E-nose) was employed to measure the musk samples, the E-nose generated data were analyzed by principal component analysis (PCA), the responses of 18 sensors of E-nose were evaluated by loading analysis. Results showed that a rapid evaluation of complex response of the samples could be obtained, in combination with PCA and the perception level of the E-nose was given better results in the recognition values of the musk aroma. The authentic, fake and adulterate musk could be distinguished by E-nose coupled with PCA, sensor 2, 3, 5, 12, 15 and 17 were found to be able to better discriminate between musk samples, confirming the potential application of an electronic instrument coupled with chemometrics for a rapid and on-line quality control for the traditional medicines. [Copyright &y& Elsevier]