| Traditional Chinese medicine formula granules are made from traditional Chinese medicine decoction pieces as a raw material.Through modern processing technology and pharmaceutical technology,a series of modern pharmaceutical process procedures are carried out for extracting,separating,concentrating,drying,granulating and packaging the whole ingredients of medicinal materials,compared with traditional Chinese medicine.Pieces of granules,without decocting,are available for direct formulation and blistering.However,there are still many local medicinal materials formula granules lacking uniform process specifications and quality standards.Dioscorea alata L.is a tuber of the perennial grass-wound vines of the yam family.It has the functions of strengthening the spleen,replenishing the lungs,benefiting the essence,reducing swelling and relieving pain.This thesis mainly studies the granules of Dioscorea alata L.formula,carries on the complete quality evaluation of raw materials,and rationally optimizes the production process of traditional Chinese medicine granules with Dioscorea alata L.as raw material,and carries out the quality standard of Dioscorea alata L.formula granules.Preliminary research has provided a scientific basis for the standardization of production processes,the promotion of traditional industrial upgrading,and the scientificization of product quality standards.Specific research work includes:1.This study collected 6 batches of Dioscorea alata L.medicinal materials from different sources,and determined the traits,microscopic identification,physical and chemical identification,moisture,ash and acid-insoluble ash.The moisture,ash and acid-insoluble ash were respectively lower than 13.0%.4.0% and 1.5% are in line with the requirements of the Dioscorea alata L.in the 2014 edition of the "Jiangxi Province Traditional Chinese Medicine Standards";the content of Dioscorea alata L.polysaccharides and flavonoids in the active ingredients of Dioscorea alata L.medicinal herbs are determined by UV-visible spectrophotometry and methodologies are carried out.Verification experiment,the experimental results show that the linear relationship is good,the relative standard deviation of precision,stability and reproducibility is controlled within 2.0%,the recovery rate is between 98.0% ~ 102.0%,and the content of Dioscorea alata L.polysaccharide in the Dioscorea alata L.medicinal materials The content of flavonoids>2.0%,and the content of saponins in the Dioscorea alata L.medicinal materials was determined by high performance liquid chromatography(HPLC),and the method validation experiment was carried out.The experimental results show that the linear relationship is good and precise.The relative standard deviation of degree,stability and reproducibility is controlled within 2.0%,the recovery rate is between 98.0% ~ 102.0%,and the diosgenin in the Dioscorea alata L.herbs>0.1%.2.This topic firstly studied the single factor extraction temperature,and then used L9(34)orthogonal test to study the extraction process of Dioscorea alata L.potato.The extraction rate,the content of Dioscorea alata L.polysaccharide and the transfer rate were evaluated.The best extraction process of Dioscorea alata L.is as follows: the preferred Dioscorea alata L.cake is soaked for 1 hour,added with 10/8 times of water for 2 times,the reflux time is 120min/60 min each time,filtered hot,rapidly cooled and the filtrate is combined and decompressed.Concentrated(60℃),dried at 60℃under reduced pressure to obtain a dry paste powder,mixed with soluble starch 1:0.6,dry granulation,to obtain Dioscorea alata L.formula granules.3.This study studied the quality control of Dioscorea alata L.formula granules.The Dioscorea alata L.formula granules were systematically studied from the aspects of trait inspection and content determination,and the quality control process method of Dioscorea alata L.formula granules was established to provide reference for the quality standard of Dioscorea alata L.formula granules. |
PDF Full Text Request