| The process quality control (PQC) is one of the key part of the modernization of traditional Chinese medicine (TCM), and it has been the new focus. the has been studied. Radix isatidis (BLG), a Chinese medicinal preparation used commonly , effectively in clinical and unclarified in active substance, was chosen as a model to be studied. Based on the concept of production quality control, considering the features of TCM itself, the process of TCM preparation, especially the heating process has been studied. The physico-chemical properties assay, chemical analysis and bioassay, also the bio-thermal activity had been applied in this study. A new pattern of quality control for TCD was explored. The main results are as follows:1 Quality analysis of BLG aqueous extracts dryed by different techniques:1.1 Quality analysis based on the conventional physico-chemical assay: By the design of Signal-factor, four kinds of drying products of BLG extracts were prepared (40 batches totaly) by: spray-drying, freeze drying, vacuum-drying and normal-dryin, were prepared before analysis. The conventional physico-chemical properties of products such as color, trait, solubility, moisture content, critical relative humidity and value of pH were determined and compared. The results showed that there were significant differences lies in different group, the color of sample might reflect the quality, but it need further research to express the relationship between its activities and physico-chemical propertie.1.2 Quality analysis based on the determination of constituents and chemical fingerprints: The contents of constituents (benzoic acid, salicylic acid, adenosine and polysaccharide) and chemical fingerprints of BLG extracts drying samples were determined and analyzed by HPLC. The results showed that: In the different drying process, the content of different constituents should be monitored, especially the content of benzoic acid and adenosine; among all the groups, the contents of benzoic acid and adenosine in the freeze drying group were higher than others, which were 0.3937±0.0010% and 0.1478±0.0054% respectively.2. Quality analysis of BLG ingredients, semi-products and the final products:2.1 Quality analysis based on the determination of constituents and chemical fingerprints:The contents of constituents (adenosine and uridnine) and chemical fingerprints of BLG ingredients, semi-products and the final products samples were determined and analyzed by UPLC. The results showed that: the contents of uridnine and adenosine in BLG ingredients from different sources showed obvious difference but it had no definite trend; the content of adenosine decreased to 59.31% in the final products from ingredients, and 45% of the chromatographic peaks were decreased and the loss were mainly lied in the water soluble constituents. 2.2 Bioassay of BLG ingredients, semi-products and final products based on the antibacterial potency and biothermodynamics method: Escherichia coli had been used as model to build the bioassay method, the results of biothermodynamics had been compared with the results of antibacterial potency based on the cup-plate method. In certain range of dosage, the parameters of biothermaldynamics is significantly linear to the dosage (r>0.95) with good precision (RSD<5%). The biothermodynamics method could be used as a preferred technology for the bioassay of Radix isatidis because of the superiority of its fingerprinting, specificity, universality, and conveniency. Among all the biothermodynamics parameters, P2m, Qt, and P2m/T2m could be used to express the activity of Radix isatidis. Discriminant equation were established based on those parameters: JY=-13038.71+5617.55X1+212.12X2+568.63X3-1228.91X12-6.83X1X2-26.98X1X3-0.79X2-87.13X2X3-87.13X32 (X1=P2m; X2=Qt; X3=P2m/T2m)2.3 The bio-potency of BLG ingredients, semi-products and final products had been compared. The Results showed that the antibacterial potency of those samples were decreased to 100%→61.48%→47.43% respectively, which means that the loss of biopotency lies in the preparation of BLG, also the rationality in preparation of BLG should be concerned with.3. The establishment of BLG quality control method based on the chemical analysis and bioassay: Different strategy should be applied to the corresponding products in the quality control of TCM.1) Sensory evaluation, collecting time, producing area etc. should be more reasonable in the raw material collecting stage.2) The quality fluctuation should be assessment by biothermodynamics, assisted by contents determination in the manufacturing process.3) The bioassay method or the content determination of the related constituents is more suitable to the quality evaluation of the final products.According to the above results, the protocol of quality control for TCM based on the bio assay, content determination had been researched, which might provide technical support for the process quality control, especially for those whose active substances are unclear.Finally,in the quality control of TCM manufacturing , the bioassay method is important and indispensable.The requirements of chemical analysis are not fully suitable to bioassay in not only the specificity of detection parameters but also the quality of methodology. Being under development and improvement, the bioassay for quality control of Chinese medicines is accessible in the near future.
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