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Traditional Chinese medicine (TCM) injections have been used as valuable preparations of herbal medicines. However, minor quality variation of TCM injections in the storage and transportation often results in adverse drug reactions and adverse drug events. In this study, biothermal dynamic test combined with chemical analysis was applied to monitor the consistency and stability of TCM injections. Shuang- huang- lian freeze-dried powder for injection (SHLPI) was selected as a representative herbal injection. Ten batches of normal samples and nine batches of artificially abnormal samples were collected. High-performance liquid chromatography (HPLC) fingerprinting was frequently used to characterize the chemical composition of TCM injections. However, it could not monitor minor quality fluctuation of the samples under special conditions such as lighting, high temperature, and bacterial contamination. The biological activity of SHLPI on the growth of Staphylococcus aureus was detected and then analyzed with chemometric methods including similarity evaluation and partial least-squared discriminant analysis. The similarity of abnormal samples in HPLC fingerprinting was > 0.99, whereas most of the abnormal samples in biological fingerprinting was 0.943-0.652, demonstrating the greater discriminating ability of biological fingerprinting. Our study demonstrated that biological fingerprinting is effective to monitor the quality fluctuation of TCM injections and could improve the quality control of herbal medicines. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

As a widely used traditional Chinese medicine (TCM), Radix Aconiti Lateralis Preparata ( Fuzi) is not only efficacious but also poisonous. Its toxicity and processed products should be taken into account and effectively evaluated. In this study, a non-invasive and non-destructive microcalorimetric method was employed to evaluate and compare the toxicity of Fuzi and its three processed products including Yanfupian, Heifupian, and Danfupian on Escherichia coli ( E. coli). Some important metabolic information, such as the power-time curves and some quantitative thermokinetic parameters including growth rate constant k, heat output power P, inhibitory ratio I, and half inhibitory concentration IC, of E. coli growth affected by various concentrations of Fuzi and its processed products were obtained. Combined with chemometric techniques including multivariate analysis of variance and principal component analysis on this information, it could be seen that Fuzi and its processed products could be distinguished according to their toxic effects on E. coli. The IC values of 14.6 mg/mL for Fuzi, 59.2 mg/mL for Yanfupian, 118.3 mg/mL for Heifupian, and 182.7 mg/mL for Danfupian illustrated that the sequence of toxicity on E. coli was Fuzi > Yanfupian > Heifupian > Danfupian. This study provided a useful method and idea of the combination of microcalorimetry and chemometrics for studying the toxic effects of TCMs and other substances. [ABSTRACT FROM AUTHOR]

Chinese Medicine Injections (CMIs) are powerful preparations, but adverse drug reactions can hardly be avoided. Incorrect drug combination is a major cause. Recently, insoluble particulate matter test, pH measurement, and high performance liquid chromatography (HPLC) fingerprint have been recommended as potential strategies for prediction of drug-incompatible reactions. However, these methods were complex to manipulate, subjective to judge, or were of poor relevance and low sensitivity. In this study, a novel application for the detection of compatibility of combination of CMIs based on isothermal titration calorimetry (ITC) has been proposed. Qingkailing Injection (QKL) was selected as a representative drug to blend with Potassium Chloride Injection (KCl) and Calcium Chloride Injection (CaCl). The type of reactions between them was intuitively manifested by the thermodynamic parameters including Gibbs free energy change (Δ G), enthalpy change (Δ H), and entropy change (Δ S). The results indicated that when QKL mixed with CaCl, Δ G < 0, and |Δ H| > T|Δ S|, which meant chemical changes happened between them and ADRs might happen in clinic. On the contrary, the reactions between QKL and KCl existed solely as physical processes, indicating that it was relatively safe. Meanwhile, HPLC fingerprint was also applied, but no significant difference was found. It is hard to distinguish whether incompatible reactions have happened during HPLC. The study suggested that with the advantages of convenience, sensitivity, and reliability, ITC could serve as an essential tool in the detection of incompatible reactions of drug combination. The described method could be used for early prediction of adverse drug reactions, which would be helpful to ensure the rationality of drug combination. [ABSTRACT FROM AUTHOR]