Study Of Preparation Process And Quality Standard Of Huanghao Xiaoyan Granules

Huanghaoxiaoyan Granule is a modern Chinese herbal drug for the therapy of Acute gingivitis.It consists of Scutellaria, Artemisia annua,Anemarrhena and many other Chinese herbs.The topics to Chinese medicine theory,according to correlative regulations of patent traditional chinses medicine,the pre-clinical pharmaceutical research were done including preparation,quality stangdard and preparation stability.According to the prescription indication and the nature of the effective parts of herbs.Screening Process were done by single factor and orthogonal experiments.The optimum conditions are that extract Angelica,Moutan 2 times, with 8-fold volume of 60% of ethanol,1.5 hours each time, then filtering and reserving liquid;Extract the essential oil of Ligusticum wallichii and Artemisia annua with 12-fold volume of water.then filtering and reserving liquid; Volatile oils was inclosed by stir at 50℃with 6 times as the amount of beta cyclodextrins.The two kinds of dregs for a decoction above with Scutellaria ect.the other six drugs of the prescription adding 10 times the amount of water decocted two times which required 1.5h, filtering. After filtrating, mixed the filtrate and volatile oils. Concentrate the water-decoct ed liquid until to the volume is as 1.5 times as the weight of the herbs,add ethanol and make the ethanol concentration reached to 60%. stick this in the fridge for 24 hours, filter impurities, combine the filtrate and the Ethanol-extraction liquid, decompress and reclaim the ethanol, dry and break it up,mixed with the inclusion. Add the inclusion complex of volatile oil and moderate dextrin, lactose and MCCEvenly spray into 85% ethanol and granulating, dry it at 60℃. then made in 1000g. and the Granule is made finally.In the study of the quality standard, focus on the identification,examination and determination were studied.Established the Thin Layer Chromatograph(TLC) method of Scutellaria, Anemarrhena,Angelica, Ligusticum wallichii and Trichosanthes skin,and income of the product quality standards body.The content of the Baicalin is taken as the inherent index of the product by the mothod of High Performance Liquid Chromatographic (HPLC). and we make a systematic study on methodology on the Analysis Method. The Baicalin limitation is made according to the mensuration result of some samples, the temporary content of Baicalin is no less than 18.5mg/g.The preliminary stability research is made in ordinary temperature as long as 3 months. The result shows that Character, identification, inspection, the content determination are consistent with the quality standard,preliminary evidence that the quality of preparation and stability.