Research Of New Traditional Chinese Medicine Qingganzhi Capsule

Fatty liver, also known as fatty liver disease (FLD) , is a condition where large vacuolesof triglyceride fat accumulate in liver cells via the process of steatosis (i.e abnormal retentionof lipids within a cell). The incidence of FLD is increasing in China. However, it is not clearthat the mechanism of FLD and still lack of effective drugs to cure it. Qingganzhi Capsule isexperied from traditional experience-prescription of Traditional Chinese Medicine (TCM)after appropriate adjustments according to chemistry and pharmacology studies as well asclinical practices. The prescription is composed of eight kinds of TCM which are Scutellariabaicalensis Georgi, Astragalus, membranaceus (Fisch), Bge, Paeonia lactiflora Pall,Atractylodes lancea (Thunb.) DC, Atractylodes macrocephala Koidz, Curcuma wenyujin Y.H. Chen et C. Ling, Alisma orientalis (Sam.) Juzep and Lycium barbarum L which are allincluded by the Chinese Pharmacopoeia. Qingganzhi Capsule is taking orally to treat FattyLiver.The alcohol extraction techniques of Scutellaria baicalensis Georgi and Astragalusmembranaceus (Fisch) Bge and the water extraction techniques of Paeonia lactiflora Palland the other herbs with the remainder above after alcohol extraction were studied byorthogonal test. The molding preparation procedure of Qingganzhi capsule was studied.After the process of validation, the optimum preparation procedure would be established asfollowed:Add 6 times amount of 70% alcohol to Scutellaria baicalensis Georgi and Astragalusmembranaceus (Fisch) Bge and then extract it twice, 3 hours a time. Filter the extraction andrecover ethanol. Add 8 times amount of water to the other herbs with the remainder aboveafter alcohol extraction and extract for 3 times, 2 hour per time. Filter and concentrate theextraction with above to thick paste whose relative density is between 1.10 and 1.15 (80℃),dry under reduced pressure(vacuum degree≤0.08Mpa, at 70~80℃), crush and screen, addmicrocrystalline cellulose appropriately, mix and granulate with 95% ethanol, and then fill in the blank capsule.We had checked the preparation including aspect, weight variation, and so on. Thequalitative thin-layer chromatography (TLC) was accomplished in identifying the Astragalusmembranaceus (Fisch) Bge, Lycium barbarum L, Paeonia lactiflora Pall and Scutellariabaicalensis Georgi of the preparation of Qingganzhi capsule. High performance liquidchromatography (HPLC) was used for assay testing of Baicalin and Paeoniflorin whoselinearity, precision, repeatability, stability and recovery were all proved pretty good. Thecontent of Baicalin was limited to be no less than 8.8 mg per pill while Paeoniflorin was 0.96mg. The stability research and pilot-scale production test of Qingganzhi capsule showed thatall indexes were in accordance with the standard of Chinese Pharmacopoeia.The results of this study showed that it is reasonable in preparation procedure with highreproduction quality, controllable and stable in quality. Qingganzhi capsule should be a veryuseful drug in the treatment of FLD in the future.