Study On Preparation Process And Quality Standard Of Yiyuanguben Oral Lequid

YiYuan GuBen Oral Lequid, composed of Ginseng, Angelica, prepared Rehmannia root,fried Atractylodes macrocephala Koidz, prepared Radix Glycurrhizae, originates to Wufu Drink from Jingyue Quanshu, which is written by Zhang Jingyue, a medical scientist living in Ming Dynasty of ancient China. In theory of Chinese Medicine, the main effect of Wufu Drink is to supply WuZang of human body.Based on founctions and properties of chemical ingredients to the prescription, we choose monofactorial experiments, the central composite design and response surface method as the method to the optimize the extracting progress with the content of total polysaccharide and tatal saponin as evaluating indicator. Using orthogonal design to determinate the preparation technique. The optimum process was: 11 times water was added, soaked for 45 minutes and extracted twice, 1 hour for each time. In the purification process of YiYuan GuBen oral liquid, three agents including ZTC, 101 juice clarifying agents and chitosan natural clarifying agents were compared to observe the effects of impurities removing. It turned out that chitosan was better than the other ones. The process was obtained as follows:the extraction liquid was concentrated at the ratio 1:8(gruffs to water). Then 0.6 mg/mL chitosan and the mixtures was stirred for 10 minutes at 20℃, remove the mixture to centrifugal machine for 20 minutes at the rotate speed of 5000 r/min and then separate liquid supernatant with residue by suction filtration. Then 0.2% sodium cyclamate as corrigent and0.2% natrium benzoicum as antiseptic was added to the liquid. Finally, the liquid was encapsulated and sterilized.While we were studying the quality standard, we used the TLC to identify ginseng and angelica, it turned out that separation of the stains were apparent and the negative control was not disturbed. The content of Ferulic acid and Ginsenoside Re was assayed by HPLC,through the systematic methodology, we found all conditions conform to the requirements by the experiments. According to the anylysis of multi-batch samples, the content limitation of Ferulic acid was temporarily designated at 16.0 μg/mL and Ginsenoside Re at 6.0 μg/mL.Stability research was to keep YiYuan GuBen oral liquid 3 months at room temperature, and the results show that preparation was stable and the packing was suitable.