Shugan Particle Preparation Process And Quality Standards

Background. As an important pathogenic characteristic of chronic diseases of liver, hepatic fibrosis is the key step leading to cirrhosis which may cause hepatoma and even kill the patient. Shugan Decoction, consisting of Chishao (Radix Paeoniae), Huangqi(Radix Astragali), Danshen (Radix Salviae Miltriorrhizae) and two other herbs, is an effective prescription in treating hepatic fibrosis and chronic hepatitis B with the syndrome of blood stasis and heat, and possesses the function of activating blood and soothing liver to relieve pain, invigorating Qi and supplementing asthenia. For convenient application and better stability, scientific and systematic research was made to provide a new TCM product. Methods and results. The guidance of the theories of TCM and pharmacy, the related statutes to new TCM products in the"Examining and Approving Method of New Medicine" , and the function of the prescription and properties of active agents in the herbs were all taken into consideration during the design and practice of the research. Adopting modern pharmaceutical techniques and methods of comparison and orthogonal design with multifactor evaluation comprehensively, this paper focused on the preparation procedure, the quality standard, the preliminary stability, and investigations on the changes of properties of film-coated granule. Conclusion. The results suggest that the preparation procedure is reasonable and practical, the standard is controllable, and the quality is stable on the whole.