Study On Sanqi TongShu Intestinal Solution Pellets (Capsule-type)

This project is a research on Sanqi TongShu Intestinal Solution pellets (capsule-type), It emphasized the study of technique and quality control which refers to the registration process in EU, and solved the key technologic problem of TCM when marketing toward to EU, In the hope of setting a model for traditional Chinese medicine to head for EU in the form of drug.Through the systematic study of the PTS raw materials, this project solved the formation difficulties which included that the active ingredients were easy to be destroyed by gastric acid, strong hygroscopic and high viscosity. We made them into intestinal micropill to improve the bioavailability, and also increased the effectiveness and safety.Firstly, this project took forming characteristics and Physical parameters as indicators, combined with new technique and new pharmaceutical excipients, studied deeply and systematically on the preparation technique and preparation formula of micro-pill, especially the key excipients of pills forming. Determined the best technological parameters for making pellets by Tangential spray mode of Fluidized bed and coating. The formula was PTS120g,cellulose microcrystallisate90g,starch90g,PVPK306.0g;8%PVPK30 ethanol solution (alcohol concentration is 50%(w/w)) used as cementing agent to make pill, used Acryl-EZE(?) as enterosoluble coating. Three pilot trials demonstrated that the preparation process was stable, feasible and Suitable for industrial mass production.Then, established the quality standard systerm of PTS raw materials and SanQiTongShu Intestinal Solution pellets (capsule-type) which meet the EU's Drug Standard. Stressed on the strictly safety control of the raw herb, extractive and preparation, also investigated the detection of heavy metal, pesticide residue deeply. detected eight kinds of heave metal (Cd, Cu, Fe.et al.). and made the limit indicators by Microwave Digestion and Atomic Absorption spectometry. used trithion as internal standard to detect thirty-one kinds of pesticide (organochlorine, orgnaophosphorus, pytethrin. et al..), detected eleven kinds of solvent residue of macroporous adsorptive resins(benzene and methyl benzene. et al.), and made limit standards by Headspace Gas Chromatography. Aslo used ginsenoside-RgⅠ, ginsenoside-Re and Notoginsenoside-RⅠas evaluating indicators, probed into the pharmacokinetic in dogs of the active ingredients of SanQiTongShu Intestinal Solution pellets (capsule-type)。Finally, through the research of finger printing, established common technology and method for the quality (efficacy) evaluating of the Panax Notoginseng-PTS raw materials SanQiTongShu Intestinal Solution pellets (capsule-type), monitor the whole process of preparation from raw material, intermediate to finished product by finger printing to guarantee the stability and homogenicity of the finished preparation. This project laid a good technique foundation of the access of Sanqi Tongshu intestinal pellets (Capsule-Type) to the EU market.