Study On Quality Evaluation And Formula Granules Of Gentiana

Gentianae Macrophyllae Radix,a commonly used traditional Chinese medicine(TCM),has been used to dispel rheumatise and ease pain.There are four species of Gentiana(G.macrophμlla,G.straminea,G.crassicaulis,and G.dahurica)recorded as herbal drugs in the Chinese Pharmacopoeia.Decoction is the most common way of clinical medicine,but the Chinese traditional herbs is not convenient for carrying and conserving,not suitable for mass production,it has been unable to adapt to the fast space of modern life.It is general trend to perpare the Chinese herbal formula granules which is easy to take and the quality is controllable.Therefore,we study on the qualities of crude drugs of Gentiana and Gentiana formula granules.The State Food and Drug Administration issued the "Guidelines for Quality Standard of Chinese Herbal Formula Granules"(2016).This paper puts forward the strict standard for the quality of Chinese herbal formula granules.It is required to carry out the quantitative control of the crude drugs,intermediates and finished products..In addition to the area,growing environment,harvesting time and other factors,different plant sources may be the main factors influencing the quality of crude drugs.In order to better ensure the quality of Gentiana formula granules,the quality of the crude drugs was evaluated first,and the differences between different species of Gentiana were compared.This paper collected fourteen batches of samples,including eight batches of G.dahurica,two batches of G.crassicaulis,two batches of G.straminea and two batches of G.macrophμlla.The qualities of crude drugs of Gentiana are checked by Chinese Pharmacopoeia 2015 with traits,identification,inspection items and determination.There are no significant differences between species of Gentiana in the inspection items.The conditions of TLC identification were optimized,and the contents were different.In the whole,the content of gentiopicroside was significantly higher than that of longan,and the total content of G.macrophμlla and G.crassicaulis was higher than that of G.straminea and G.dahurica.This paper explored the preparation process of Gentiana formula granules.Based on the standard decoction,the parameters of Gentiana formula granules extraction and concentration process were optimized.The paper used the orthogonal test method to prepare Gentiana formula granules by taking the ratio of extraction and the contents of getiopicroside and loganic acid as indexes.The results showed the best preparation of Gentiana formula granules was soaking 1 hour and extracting 3 times for 0.5 hour respectively.The first added amount of water is 11 times,and 2 times amount of water is 9 times,the liquid was filtrated by 200 mesh filter cloth.The filtrate was concentrated by decompression concentration and then spray-dried.Dry granulation needs to mix 2% dextrin.Considering the quality of the 14 batches of samples,the ratio of extraction,the transfer rate,the best medicine was selected to carry out pilot scale-up test to verify the feasibility of the experiment.This paper evaluated the quality and resource of Gentiana.The preparation process of formula granules were optimized.The quality evaluation standard of formula granules were established.The stability of the granules was evaluated by accelerated and long-term tests.The above is the basis for the quality evaluation of Gentiana formula granules.