Liver Fat Qing Capsules Compound Pharmacokinetics

Objective To research and develop a new preparation of a compound of Chinese Medicine, Ganzhi Qing Capsule, which is effective on fatty liver, especially on NASH(nonalcoholic steatohapatitis). To discuss the rationality of the compound Chinese medicine through contrast of pharmacokinetic experiments between preparation and single extract of curcuma.Methods Simplifying the compound Chinese medicine through the theory of TCM and pharmacological experiments; determining the preparing process of the effective parts of the four herbs; establishing the quality control methods of the five extracts and the preparation by TLC, HPLC and Spectrophotograph; examining the stability of Ganzhi Qing Capsule through primary stability experiment; Simulating the pharmacokinetics models, calculating the pharmacokinetic parameters and giving the difference through determining the concentration of bioactive composition in rabbits' and rats' blood. Results The best preparing process is: 1) Alismatis extracted with 80% alcohol. After evaporation of the solvent, the residue was dissolved in water and extracted with ethyl acetate. The organic layer was separated and washed with aqueous sodium bicarbonate to remove acidic substances; the ethyl acetate layer thus obtained is Alismatis Alisols. 2) Scutellariae extracted with water and precipitated with Hydrochloric acid. The sediment was washed with water and alcohol. The residue is crude baicalin. 3) Curcuma distilled with water to extract the volatile oil. The crude drug left was extracted with 80% alcohol. And after evaporation of the solvent the residue was mixed with Kieselguhr and dried. Then the mixture extracted with Petroleum ether. After evaporation of the solvent the residue was crude curcumin. The volatile oil was enveloped with β-CD. 4) Bupleurum extracted with 70% alcohol (pH=8.0). After evaporation of the solvent the residue was dissolved in water and precipitated for 12hr below 4℃. The liquid was separated by macrospore resin AB-8. Elution with 70% alcohol followed by water gave a solution. The solution passed through a column to remove coloring material. After evaporation and dryness crude saikosaponin is obtained. The five ingredients were mixed, granulated, and divided into capsules. The content of Curcumin in one capsule should be no less than 20mg. Curcumin is themain composition that makes Ganzhi Qing Capsule reducing the blood-lipid. Distributing and eliminating rates of Curcumin in Ganzhi Qing Capsule are moderate, but absorbing degree of the crude curcumin is less than that of preparation.Conclusion Ganzhi Qing Capsule is a new preparation with rationable technology and stable quality.