Studies On The Quality Standards Of Heluoshugan Capsule

Heluoshugan capsule is involved in the preparation of Chinese medicine in second volume of the Drug Standard which issued by the Ministry of Health.And it has gone on sale.This medicine is made up with Nutgrass Galingale Rhizome,Rhizoma Atractylodis Macrocephalae,Angelica sinensis andother twenty-seven kinds of Chinese herbal medicine,the formula of this prescription is rigorous very much.its function is to evacuate the liver and discipline qi,nourish the liver and kidney,in addition it also has other effects such as cleare heat of wetting and promote blood circulation and remove blood stasis.this shows that it can be used to treat the chronic persistent hepatitis,chronic active hepatitis and early cirrhosis.The effect is widly and well.but as the Quality Standards before is too simple,so it is difficult to control its Quality.To formulate the target substance of content measuring by HPLC.because of Paeoniflorin and Polydatin have distinguished effect on treating the liver,so this paper studied the method to measure these two substances,and certained the limitation about their contents in the product.Moreover,this paper add an other method named TLC to control the Quality Standards of Heluoshugan capsule,it include Atractylodes macrocephala,Cyperus rotundus,Angelica sinensis,pawpaw,Aeruginous Turmeric Rhizome,Paeonia sterniana Fletcher in Journ.so the Quality Standards of Heluoshugan capsule is improved.This paper adopt HPLC and TLC to study the Quality Standards.Firstly the condition about measuring Paeoniflorin and Polydatin,which were showed in the chapter two.We determine the content of Paeoniflorin and Polydatin about 10 batches of samples.The result of Paeoniflorin is 1.06mg/pill,1.06 mg/pill,1.21 mg/pill,0.98 mg/pill,1.02 mg/pill,1.31 mg/pill,0.50 mg/pill,0.50 mg/pill,0.88 mg/pill,1.11 mg/pill and 1.04 mg/pill.The result of Polydatin is 0.708 mg/pill,0.812 mg/pill,0.834 mg/pill,0.752 mg/pill,0.684 mg/pill,0.967 mg/pill,0.704 mg/pill,0.699 mg/pill,0.974 mg/pill and 0.630 mg/pill.Finally,this paper adopt TLC to distinguish 6 medicinal material,the method will be showed in the second chapter.The consequence of this experiment shows that through HPLC to test the Polydatin and Paeoniflorin,it was uncomplicated,highly accurate and reappeared well.It can be used to control the Quality Standards of Heluoshugan capsule.secondly,from observing the results of TLC,the spot of these medicinal herb were clearly very much,and there are not the interferences in the control group.so these TLC methods can be used to control the Quality Standards of Heluoshugan capsule.Through the study of this paper,we formulated the Quality Standards of Heluoshugan capsule,achieved the controlling about its qualitative and quantitative,and put the policy of using the new technology in researching the the Quality Standards of traditional Chinese medicine into practice.