| Ku Die Zhi is the whole dried herb of Ixeris sonchifolia(Beg) hance.lt is distributed in Northeast inner Mongolia of China mainly as a Chinese traditional medicine. The chemical constituents of Ku Die Zhi are complex contained triterpene, flavonoids, terpene, lactone, et al.. At now, The injection of Ku Die Zhi was listed in the national standard as a Chinese traditional medicine-Ku Die Zhi Injection, it contained flavonoids about 1.0mg/ml, means flavonoids is the main active component of the injection. The studies on the pharmacological showed that the luteolin, apigenin, and other flavonoids have the significant effects of enhance the blood amount and decline the restraction of the artery.For the quality control of the injection, special for control the homogenous on the kinds and amount of chemical constituents of Ku Die Zhi injection between different butch, the finger print pattern of the injection was set up by thisresearch work. Based on the chemical and physical properties of the component contained in the injection, the Re-High liquid Performance Chromatography (re-HPLC) was used for setting up the finger print pattern. By the investigation on column, mobile phase, detector, temperature, and wavelength, the best suitable conditions were determined for detecting the finger print pattern of the injection of Ku Die Zhi.Based on the determined method of the finger print pattern of the injection, the final product, from two company about 30 butches, were detected and 14 peaks appeared in whole finger print pattern(concured peaks) were chosen to be used in the pattern. The number 10 peak was used as the standard (S peak). The amount of area of peak 3 or peak 11 was over 10% of total amount of area of the 14 peaks, therefore, the restriction for the peak 3 and peak 11 was set which the amount of area of the peak is not allowed to be over 25%. Another peaks were indicated by the retention time, and total amount of the area of the non-concured peakswas restricted which the total amount of area of non-concured peaks is below 5% of total area amount of 14 peaks.The methodology was performed to investigated the stability, accuracy, and repeatability of the method. The result showed that: for the stability study, the RSD of the relative area of peak 3 and peak 11 is below 0.51%, and the RSD of relative retention time of every concured peak is below 0.3. The conclusion for the stability studies is that the injection in room temperature is good; For the accuracy study, the RSD of the relative area of peak 3 and peak 11 is below 0.63, and the RSD of the relative retention time of every concured peak is belowO.1%, the conclusion for the accuracy studies is that the whole system of detector is suitable for the detecting the finger print pattern of the injection; For the repeatability studies, the RSD of the relative area of the peak 3 and peak His below 1.31%. The RSD of relative area of every concured peak is below 1.0%, showed the repeatability is meet with the need of the detection for finger print pattern of the injection.Since the difference of instrument, the finger print pattern of injection could change which may influence the conclusion of the pattern. So, three instrument of HPLC were used to compare the finger print pattern. The results showed that the finger print pattern of same sample may be different in the relative retention time and relative area of peak since detected and different pump system with different instrument. The result indicated that the influence of different instrument and the type of injector should be considered when compared with the standard of the finger print pattern.After the method was set up, The influence of different drug material and each procedure of extract and purification were studied for enhance the understanding to carryout the method and enhance the finished product. 22 butches of drug materials from different location and collected time were used in the study. The result showed that the different drug material may influence the relative area of peak... |
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