Research And Development Of A New Drug (Ganshuang Capsule) For Treating Fatty Liver Diseases

Guided by the TCM theory and the investigation on the pathomechanism of fatty liver diseases, combined with the modern pharmacological and phytochemical researches of TCM, Ganshuang, a conventional prescription which was applicable for treating many types of fatty liver was established and optimized. Consequently, a series of the pre-clinical researches of Ganshuang Capsule consisting of compound effective franctions had been carried out according to the claims of State Act for Drug Registration. The registration of 3 patents about Ganshuang Capsule is being applied and the approval of clinical trial for Ganshuang Capsule is being applied to SFDA. The main research results followed as:1 The technique of Supercritical Fluid extraction-CO₂(SFE-CO₂) was applied firstly to manufacture the effective fractions(total coumarins) from Artemisia capillaries. Compared with conventional techniques organic solvent extraction, it has many advantages such as avoiding effectively the damage to coumarins which are unstable to high temperature and acid- alkaline, higher accumulation of active components, and is more economical, environment-friendly, well-molded and suitable for industrial production.2 The technique based on SFE- CO₂ and conjunct solvent has been established to prepare the effective fractions(total curcuminoids) from Curcuma longa. Compared with the reported techniques used in the extraction and purification of curcuminoids, such as using alkaline, activated charcoal, macroreticular resin and so on, the SFE- CO₂ technique for C. longa also has the above advantages mentioned in the SFE- CO2 technique for A. capillaries.3 Methods and standards for the quality control of medicinal material, semi-final products and final product of Ganshuang capsule have been established by using HPLC, TLC and UV, etc. Each method are proved to be exclusive, accurate, sensitive and repeatable. Results showed that the total content of detectable components in Ganshuang Capsule is more than 50%, which meet the requirements of the V class of new Chinese drugs according to the State Act for Drug Registration.4 Several phamacological models had been established to evaluate the drugs for treating fatty liver diseases. Hence, the effects of prevention and treatment of Ganshuang Capsule on experimental fatty liver caused by multi-factors were confirmed.In conclusion, the above investigation has provided a solid foundation for the further reseach and development of Ganshuang Capsule .