Mongolian Medicine Ganlu Yi Pharmaceutical Research Of The Liver Capsule

Mongolian medicine Ganlu Yigan Decoction(Mongolian transliteration as Eligen Aerxian) is a empirical formula based on the traditional prescription Natural Salt Four Flavour Decoction whose components were increased and decreased according to its applied effects by Professor Bagenna in College of Mongolian Medicine and Pharmacy in Inner Mongolia University for Nationalities.Its composition included piperum longum,dried ginger,fructus chebulae and natural salt and it possessed the action of protecting liver and alleviating a hangover.We manufactured a new Mongolian drug Ganlu Yigan Capsule on the basis of this empirical formula to meet the clinical demand.The pharmacodynamic effects of Ganlu Yigan Decoction and Natural Salt Four Flavour Decoction on alcohol-induced hepatic injury in rats and mice were compared and analyzed. The prescription of Ganlu Yigan Capsule was established acting on the pharmacodynamic study.The experiment was designed with L₉(3⁴) orthogonal table.The extraction and shift rate of piperine,decoction and shift rate of gallic acid and total amount of extractive were determined and evaluated by HPLC.On the basis of the results the extraction technique was optimized.The optimal extraction conditions for piperum longum and dried ginger with ethanol were A₁B₂C₁,namely 8 times(B₂) 90%ethanol(A₁) with diacolation velocity of 1ml·min^-1(C₁),and the shift rate of piperine reached 99%.The optimal extraction conditions for the admixture of fructus chebulae,natural salt,piperum longum and dried ginger with water were A₃B₃C₃,that was,coarse powder of the drug mixed with 7 times water and decocted for 3 times,each time for 1.5 hours.The decoction and shift rate of gallic acid amounted to 65%.The differential study of piperum longum,dried ginger and fructus chebulae in the prescription was performed by TLC.The concentrations of piperine as main component in principal drug piperum longum and of gallic acid as major constituent in adjunctive drug fructus chebulae were also determined by HPLC.The distinctive punctum of each constituent was clear and specific in TLC.The detection method had the advantages of high precision,and good stability and repeatability.The average recovery of piperine and gallic acid was 99.75%(RSD=2.54%) and 98.72%(RSD=1.93%) respectively(n=6).The content of water,arsenic salt and heavy metals,disintegration time,content uniformity and microbial limit for Ganlu Yigan Capsule were detected as well.All detection results accorded with the regulations in Pharmacopoeia of the People's Republic of China(2005 edition).The stability test was performed on 3 batches of samples of Ganlu Yigan Capsule, combined with accelerated test(40℃,RH75%) for 6 months and long-term test at common temperature to observe the samples for 18 months(still in process).All indexes were consistent with the related regulations.The test results of each month altered little, indicating reliable quality of the capsule within 24 months.The main potency of Ganlu Yigan Capsule on alcohol-reduced hepatic injury in rats and mice and its effect of alleviating a hangover in mice were observed.The results showed that it could obviously reduce the level of ALT and AST in the serum of rats and mice and that of MDA in hepatic tissue.It also could ameliorate the pathological changes in hepatic tissue and apparently shorten the hours of sleep in mice.So Ganlu Yigan Capsule has protective effects against alcohol-induced liver injury and can alleviate a hangover effectively.The acute toxicity test in mice showed that the maximal tolerance dose is 32.0g·kg^-1·d(in capsule),about 700 times of the clinical dose(weight calculated by 70kg),which indicates that Ganlu Yigan Capsule is safe in the regular dose range.