Pharmaceutical Research Of Xiaoer Feike Oral Liquid

Xiaoer Feike Oral Liquid prescription consists of twenty-two flavor traditional Chinese medicine,such as ginseng,Dried ginger,pericarpium citri reticulatae, atractylodes macrocephalae, etc.It can be used to cure such symptoms as cough,pant syndrome characterized dyspnea,wheezy phlegm by deficiency of both lung and spleen. The original dosage crushed kinds of Chinese medicine into granulates which incompletely and inconvenient.With the guidance of the theories of traditional Chinese medicine,compound Xiaoer Feike was secondary development into oral liquid by studied on Preclinical pharmaceutical with modern pharmaceutical technology to enhance adaptability and bioavailability.According to the active component and pharmacological effects of the effective components of prescription, the extraction and pharmaceutics technology was determined on the basis of preliminary pharmacodynamic esperiment. Single factor experiments and orthogonal experimental design to optimize the process conditions.Finally,we obtained optimal processing parameter:adding 8 folds of water, extracting for 8 h after 0.5 h of soaking and the yield of volatile oil was 0.81 mL; The best conditions for alcohol-extracting were adding 75%alcohol 8 times, heating circumfluence 3 times for 2 hours per time. Extraction was centrifuged at 10000 r·min-1 for 10 min and add the volatile oil,0.1% potassium sorbate and 0.2% corrective.Through the three batches of pilot scale experiment and clarify the traits of three batches of samples, the content of hesperidin was 0.240 mg·mL-1,the content of glycyrrhizic acid is 0.0568mg·mL-1,The results indicated that the process has good reproducibility and is suitable for mass production.On the quality standard study,we founded quantity determination method of hesperidin and glycyrrhizic acid and founded TLC identified methods of ginseng,Licorice,rheum officinale,etc.Based on quality standards of oral liquid,Xiaoer Feike had been examined.All provided basis for quality control.In this study, the pharmacodynamic tests to determine the extraction and purification process, ensure the formulation of clinical efficacy, and optimize the prescription extraction, the optimum technological parameters of purification, to finish the study of oral liquid preparation, the establishment of a stable and controllable quality control method, to provide safe, effective, stable and controllable in quality children’s Chinese medicine preparation for clinical.