Euro Rscg Capsule Preparation Process And Quality Standards Study

Objective:It is concluded that mild cognition impairment(MCI) is a sign of coming alzhejmer disease(AD).If we can select out MCI patients in its early stage and take proper preventive mean, which will surely helps to improve the patients'living quality. This program is to research and develop a new Chinese medicine-Lingzhi capsule which is hopeful to an efficient, convenient and accepted easily.Methods:To determine the contents of effective compositions by HPLC,VIS spectrophotometry and UV spectrophotometry; To optimize the extraction and purifying process with the method of orthogonal design and central composite design; The macroporus resins were applied to separate and purify the effective part in Radix Polygalae, and to study on the adsorption thermodynamics and kinetics on macroporus resin; The experiment of excipient was developed in hygroscopic character and fluidity to determine the king of pharmaceutical aids and using quantity; To determine the contents of effective compositions by HPLC and UV spectrophotometry, all drugs were evaluated by TLC methods.Results: (1)Determined the optimum extraction process of Herba Epimedii was extracted with water decoction for 3 times, each time 35-fold wate for 1.5hour, using 60% alcohol percolationg.(2)The optimum conditions of extraction process were 60% ethanol, 2.5 hours for reflux, 10-fold solvent and 2 times for extraction. We draw the conclusion that the A resin has the best absorptive ability on the separation and enrichment of the effective fractions from Radix Polygalae. The best technology term is that the ratio of the amount of sample and volume of resins is 0.4, the extraction substance with 0.4g medicinal material l/mL density passed the resin column that d/l is 1:7 with the 0.4mL/min absorbed speed, washed out with 70% ethanol for 5 times of resin volume with 3mL/min eluted speed. (3)Through the study of dosage form, the capsule was prepared successfully.(4)we have established a sensitive, accurate, repeatable and specific quality specification.