Process And Quality Standards. The Faerie Gengnian Buck Capsule Study

Purpose:To screen effective components and the compatibility compounds in Epimedium and Ligustrum lucidum under the guide of TCM theory. To design the best method of extraction and purification technology, and establish quality standards. Material and methods: Samples of Epimedium and Ligustrum lucidum was used in the experiment.1. HPLC was adopted to determine the content of icariin in Epimedium sagittatum collected from different areas and establish HPLC fingerprints of the plant. ICP-MS was adopted to determine content of 5 trace elements in Epimedium sagittatum. And three different analysis methods was integrated to evaluate compensivelythe quality of Epimedium sagittatum from different areas.2. By L9 (34) orthogonal test, the best extraction technology of Epimedium and Ligustrum lucidum was established, while icariin and oleanolic acid used as control substance. Investigated macroporous resin Epimedium total flavonoids and icariin and oleanolic acid in Ligustrum lucidum adsorption purification conditions. Macroporous adsorption resin was used to investigate the adsoption and purification condition of total flavonoids and icariin in Epimedium sagittatum and oleanolic acid in Ligustrum lucidum;3. The optimium compatibility of extract of Epimedium sagittatum and Ligustrum lucidum in Xianling climacteric hypertension capsule was determined by uniform design method and pharmacological test of climacteric hypertension rat. The technology process of Xianling climacteric hypertension capsule was established through form proceduce investigating.4. TLC and HPLC was adopted to establish the quality standards of Xianling Hypotention Capsule.Results:1. The results of comprehensive quality evaluation indicated that Epimedium sagittatum collected from Jilin, Jinzhou, Kaiyuan, Xuzhou are in good qulilty, and the areas could realized as genecine locations of Epimedium sagittatum.2. The best extracted procedure of Epimedium sagittatumm was determined as percolating with twelve-fold-weight of 70% EtOH, resion AB-8, at 3mL·min-1.The best extracted procedure of Ligustrum lucidum was determined as reflux extracted with 90% ethanol for 2h, 8 times in volume vs weights.Resion HPD-600 was involved in the study.3. The opmium compatibility ratio of Epimedium and Ligustrum lucidum was determined as 5:3 through uniform design method and pharmacological test of climacteric hypertension rat. The higest rate of blood pressure decression was 89.36%. Combined with clinical medicine, 0# capsule was selected and each capsule was specificated to be 0.50g.4. TLC identification for Epimedium and Ligustrum lucidum gave good specificity. The paper deals with the quality standards of Icariin and oleanolic acid in Xianling climacteric hypertension capsule, The method is proved to be simple, rapid, precision, reproducibility, strong specificity. the average recovery of Icariin and oleanolic acid were 98.7% and 99.6% respectively.Conclusion: The best extraction technology of Epimedium and Ligustrum lucidum was selected according to modern pharmacology medicine research and new process design. The preparation technology give maximum containing of icariin and oleanolic acid with good maneuverability. The quality standardard is with good specificity and reproductivity, could be applied to control the quality of preparation. The formed capsule provide quality control method for effective materia in pharmaceutical medicine laid. This paper provide basic data for the exploration of new Compound Chinese medicine.