ABSTRACT
The quality of Chinese materia medica is the premise to ensure its safety and effectiveness in clinical application， and the standardization of Chinese materia medica quality is the most important to realize the sustainable development of traditional Chinese medicine （TCM）. At present， the quality control system of Chinese materia medica has been transformed from a single chemical evaluation to the overall quality control guided by clinical efficacy. However， some quality control items of decoction pieces are still lacking or imperfect in the drug standard of prescription， which makes it difficult to guarantee the effectiveness and safety of Chinese materia medica in clinical application. Based on this， the quality control models and innovative ideas of Chinese materia medica were analyzed and discussed from the perspectives of chemical analysis， biological evaluation and clinical application in this paper. Aiming at the existing problems and actual needs in the control system of Chinese materia medica， this paper proposed the improvement strategies in accordance with the characteristics of TCM， in order to provide theoretical basis for the related research on quality control of Chinese materia medica.
ABSTRACT
The quality of Chinese materia medica is the premise to ensure its safety and effectiveness in clinical application， and the standardization of Chinese materia medica quality is the most important to realize the sustainable development of traditional Chinese medicine （TCM）. At present， the quality control system of Chinese materia medica has been transformed from a single chemical evaluation to the overall quality control guided by clinical efficacy. However， some quality control items of decoction pieces are still lacking or imperfect in the drug standard of prescription， which makes it difficult to guarantee the effectiveness and safety of Chinese materia medica in clinical application. Based on this， the quality control models and innovative ideas of Chinese materia medica were analyzed and discussed from the perspectives of chemical analysis， biological evaluation and clinical application in this paper. Aiming at the existing problems and actual needs in the control system of Chinese materia medica， this paper proposed the improvement strategies in accordance with the characteristics of TCM， in order to provide theoretical basis for the related research on quality control of Chinese materia medica.
ABSTRACT
OBJECTIVE To establish a met hod for the determination of amentoflavone ，bilobetin，ginkgetin，isoginkgetin and sciadopitysin in Ginkgo biloba leaves tablets. METHODS After extracted with methanol ，ultra-performance liquid chromatography （UPLC）was adopted to determine G. biloba leaves tablets. The determination was performed on Waters Acquity UPLC HSS T 3 column with acetonitrile- 0.4％ phosphoric acid as mobile phase （gradient elution ）at the flow rate of 0.4 mL/min. The column temperature was set at 35 ℃，and the detection wavelength was 340 nm. The sample size were 1 μL（substance control ）and 10 μL （test sample ）. The relative correction factors （RCFs）of bilobetin ，ginkgetin，isoginkgetin and sciadopitysin were calculated by quantitative analysis of multicomponents by single marker （QAMS）using amentoflavone as control. The chromatographic peak was located with the relative retention time method. Then the contents of the above components were calculated ，and the results were compared with those of external standard method （ESM）（except for amentoflavone ）. RESULTS The linear ranges of amentoflavone，bilobetin，ginkgetin，isoginkgetin and sciadopitysin were 0.10-8.21，0.24-19.34，0.16-12.98，0.22-17.66，0.06-4.86 ng，respectively（all r＞0.999）. The quantitation limits were 0.10，0.24，0.16，0.22，0.06 ng，respectively. RSDs of precision ， repeatability and stability tests （36 h）were all lower than 3.00％. The average recoveries were 99.77％-102.85％，and RSDs were 1.90％-4.40％（n＝6）. The average RCFs of bilobetin ，ginkgetin，isoginkgetin and sciadopitysin were 0.91，0.93，0.96 and 0.95， respectively. The average relative retention times were 1.08，1.18，1.19 and 1.30，respectively. The relative deviation between the calculation result of QAMS and ESM was within ±3.00％. CONCLUSIONS The established method is accurate and stable ，and can be applied to the determination of Ginkgo biflavones in G. biloba leaves tablets and control the quality.
ABSTRACT
Objective:To determine residual sulfite in traditional Chinese medicinal materials or pieces processed by sulfur fumi-gation respectively by iodine titration, acid-base titration and ion chromatography and compare the results. Methods:The three meth-ods were used to determine four kinds of Chinese herbal medicines including Codonopsis radix, Dioscoreae rhizoma, Achyranthis bident-atae Radix and Atractulodis Macrocephalae Rhizoma, the recovery tests were also performed and the results were analyzed and compared to summarize the characteristics and quality control requirements of each method. Results:Iodine titration and acid-base titration had the advantages of simple operation process and low cost. However, there were many interference factors in the two methods, and due to different principles, they were suitable for the determination of different varieties of herbal medicines. Ion chromatography method had the advantages of high sensitivity and strong specificity, while the cost was high. Conclusion: It is suggested that proper methods should be chosen for the determination of sulfur dioxide residues according to actual situations.