| Traditional Chinese Medicinal Injection (TCMI) has been used extensively in clinical application. Serious adverse events have been often reported in recent years, and its safety issue has caused widespread concern.To control the quality of TCMI and to ensure proper clinical application, we had made the control of quality consistency as a breakthrough and selected Zhesheyong Shuanghuanglian (SHL) as the model drug for our investigation .And biological profiles were applied to the bio-assessment of quality evaluation in order to ensure the consistency of TCMI.Evaluation methods of quality consistency had been establish based on routine examination, chemical fingerprint and biological profiles, describing the qualities of all samples qualitatively and quantitatively. Another objective was to investigate the compatibility of TCMI with western intravenous agents. Compatibility was tested through integrating the evaluations of particle counting, chemical composition and biothermokinetics. We mainly applied thermographs to the compatibility of SHL with intravenous agents. The main results and conclusion are summarized below:1. The bio-assessment of quality consistency based on routine physics-chemistry examination , chemical characteristic informations and biological profiles1.1 Colletion,Preparation and Routine physics- chemistry examinationWe could collect 10 batches of SHL .And special samples (S11-S19) were kept under specific conditions, such as illumination, high temperature environment and open environment. The blind method was adopt in the research, The routine physical and chemical properties information of all samples were examined ,according to China Pharmacopoeia (ChP).Only S17-S19 were detected by routine physics-chemistry examination.So the routine physics-chemistry examination was not efficient in identification of quality consistency .1.2 Chemical analysisHPLC-DAD fingerprints of SHL had been established and the samples were differentiated by similarity calculation. The similarities of qualified samples were high (>0.997), while the similarities of special samples were high (>0.996), The cluster analysis had indicated that different sorts could be clustered respectively, indicating some special sample and qualified sample were confounding.The determination of 6 compositions had indicated that different degree of fluctuations in different samples. In all, HPLC-DAD fingerprints could not detect quality fluctuation sensitively and the determination of each composition could not show quality fluctuation of SHL. 1.3 Study on the bio-assessment of quality evaluation based on biological profilesThis paper was aimed to provide the methods of quality control for traditional Chinese medicine injections including bioassay method. Biological profiles of SHL on Escherichia coli and staphylococcus aureus (SA) had been established by microcalorimetry,and biological profiles could sensitively detect antibiotic activity alterations of the samples, which were kept under specific conditions.Characterized by two-dimension, Microcalorimetry could supply thermograms as biological profiles characterized to describe the bioactivity of drugs. The samples were differentiated by similarity calculation. Similarity values were calculated using the correlation coefficient, based on quantitative thermo-kinetic parameters. And the cluster analysis had indicated that each sorts could be clustered respectively, indicating that biological profiles were efficient for quality consistency of TCMI.1.4 Aggregate AnalysisThere was good correlation between chemical analysis and bio-assessment, HPLC fingerprints, which showed content changes of chemical components, could not monitor minimal variation of different samples,especially that of biological pollutants, while biological profiles could sensitively detect antibiotic activity alterations of the samples.2 The evaluation of compatibility through particle counting ,chemical analysis and biothermokineticsCompatibility was tested through integrating particle counting, chemical analysis and biothermokinetics.The research was about the compatibility of SHL with such injections as sodium bicarbonate solution, gentamycin sulfate injection and vitamin c injection. The experiment result showed that these western medical injections were not recommended to be combined with SHL.It was helpful to construct the compatibility evaluation system, based on particle counting, chemical analysis and biothermokinetics and ensure the safety of clinic medication. |
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