Study On Preparation Technology And Quality Standard Of Compound Ginkgo Biloba Leaves

Fufang Yinxingye Tablet, which is made from Extractum Ginkgo Siccus and Pheretima and Herba Epimedii and other two kinds of herbs, is an effective prescription in treating vascular dementia, heart and vein’s problem. The author has made a systematic study on its preparation and quality standards, and the study has laid the foundations for further developing it into a new Colon filmcoating tablet preparation.1. Study of the Preparation.(1)Study of the extractionAccording to the compatibility experiment, the extraction line was confirmed. Pheretima, Herba Epimedii, Radix Polygalae and Rhizoma Chuanxiong were extracted by ethanol. On the basis of the transferring ratio of icariin and extracting ratio as index, the optimum ethanol extraction confirmed by the orthogonal test was:1.5 hours of soaking,2 times of refluxing with 70% ethanol,10,8 times of ethanol-adding amount and 2,1.5 hours of refluxing time respectively.(2)Study of the concentration and desiccationWith contrast experiment on the effects of different temperature on the alteration and the contents of icariin after vacuum drying, we got the following results:60℃was the best temperature for vacuum drying (relative density of concentrate was 1.30-1.35).(3)Study of the preparation processAccording to the proportion of prescription, put the Extractum Ginkgo Siccus and the powder of the other four extraction of herbs into together. Taking the parameters of making Granules and Tablets into consideration, we obtained the optimized prescription:the microcrystalline cellulose used as diluting agent; dry extract powder vs. microcrystalline cellulose was 3:2; 2%PVP using 95%ethanol solution worked as the wetting and bond agent; disintegrating agents used 3%PVPP which added before; then 3%CMS-Na in addition; lubricating agent used 0.3% magnesium stearate.2. Study of Quality Standard.The Rhizoma Chuanxiong, Radix Polygalae and Extractum Ginkgo Siccus were identified respectively by TLC. The examinations of heavy metal and As and Tablets were carried by pharmacopeia. The content of icariin was determined by HPLC method.The average recovery rate was 99.28%, while RSD was 1.40%. the methods above are precise, reliable and repeatable and can be applied for quality control.