Study On Preparation Technology And Quality Standard Of HEW Capsule

Radix Polygoni multiflori,derived from the dried root tuber of Polygonum multiflorum Thunb.of the family Polygonaceae, is one of the commonly used traditional Chinese herbal medicines. There are 4 main chemical components in polygonum multiflorum,namely stilbene derivative,anthraquinones, phospholipid and starch. Stilbene glucoside is the main compound of stilbene derivative which is also the distinctive compound in polygonum multiflorum. Pharmacological experiments showed that stilbene glucoside had distinct effects on treating AD.This experiment has separated an anti-AD effective part from Polygonum multiflorum and then prepared it into capsules.The author has made systematic study on its extraction、purification、formulation process and quality standard.1 Study on extraction processAccording to the properties of stilbene glucoside in Polygonum multiflorum, with the content of stilbene glucoside and extract ratio as evaluating index, First we investigated several factors affecting the process such as whether needing grinding the drug or not before extracting、extracting temperature、extracting times、soaking time, the results show that Polygonum multiflorum should be grinded into rough powder before extracting, extract the drug two times at 80℃, needing not soaking, then use ethanol concentration、solvent volume、and extraction time as test factors,the optimum extraction condition was studied by the orthogonal design. The optimum extraction process was: extract the rough powder of Polygonum multiflorum two times with 8 times of 70% ethanol,2.0、1.5 hours respectively.2 study on purification process The purification of TSG was carried out with the method of macroporous adsorption resin. Seven types of resins were selected to study the adsorption and desorption of TSG on them. The result indicated that S-8 macroporous resin fits for the separation of TSG and its static state adsorption ratio reaches 199.6mg/g dried resin. The optimal operation condition was:original concentration was 5.31mg/ml, flowing rate of adding sample was 1BV/h, the aspect ratio of the chromatographic column of 1:8, after adsorption, using 6BV water.4 BV 10% ethanol to elute the impurity at the rate of 2BV/h successively, then use 60% ethanol to desorb TSG at the same rate.3 study on formulation processThe optimum formulation process was ascertained by contrast experiment. According to experiment results, we selected dextrin as diluting agent and 85% alcohol solution as wetting and bond agent.4 study on quality standardPolygonum multiflorum was identified by TLC. The content of stilbene glucoside was determined by HPLC. The average recovery was 100.9% and RSD was 1.56%. The method is simple, accurate, reproducible and can be applied for quality control.