The Preclinical Research Of Dangyaohugan Tablrt, The Class V Of New TCM Drug

This topic researches on Swertia pseudochinensis, in which iridoid compounds from Swertia pseudochinensis are active ingredient, with swertiamain as positive control are carried out in this thesis according to the registration requirements of traditional Chinese new medicines class V, in which the content of the efficient fractions should be more than 50%. Aimed atComplete pre-clinical research work, That Iridoid compounds as an active ingredient (effective area), The Swertia glycosides for active monomer of new anti-hepatitis drugThis study from the Swertia pseudochinensis extraction methods, purification process, preparation process for dosage form, quality standards and pharmacological effect study. Among them, Extraction Process, after further by Orthogonal test to Optimization and verification, Ultimately determine the extraction process. Get the extract powder of Swertia pseudochinensis Active site, The active monomer for Swertia glycosides contents to 34% and Iridoid compounds content to 72%, and Reach the Technical requirements to Examination and approval of the class V of new TCM drugs. Preparation Process For Dosage Form, Studied Accessories Molding process results of the preparation, Ultimately determine a prescription preparation molding process. In addition, Established the TLC identification of Dangyaohugan Tablet for Swertia glycosides and Mangiferin, and respectively research results of High moisture conditions, low temperature conditions, The results did not see the bad influence; The team Checked the Weight difference, crumbling time limit, microbial limits, heavy metal, arsenic salt, and resin residue, according to Related inspection of the 2010 edition of CP; And Established HPLC determination of Swertia glycosides and UV detection method for the determination of Iridoid compounds, Formulation of this product containing Swertia glycosides shall not be less than 12%,36mg/tablet; with Iridoid compounds (to Swertia glycosides representative for) shall be not less than 26%,78 mg/tablet. Furthermore, The study also of major efficacy and toxicological tests, By Pharmacodynamic experimental validation, According to the above process to produce Dangyaohugan Tablet can inhibit the role of elevated aminotransferases and reduce liver damage that CC14 or D-Gal cause acute liver injury of mice and ANIT cause jaundice of rats, this indicates that Swertia pseudochinensis after extraction and purification of Dangyaohugan Tablet contains the active ingredient, the purification process effectively eliminates impurities. After acute toxicology experimental study Dangyaohugan Tablet product has a significantly protective effect, Acute toxicology test results show that the LD5o is 35.4g Swertia pseudochinensis extract/kg (95% confidence 31.3～40. Og/kg) for mouse, its equivalent to 3550 times the clinical dose, showed that the Swertia pseudochinensis extract has good securityThe Results Show That, the good druggability of Swertia pseudochinensis, Safe, effective, quality can be controlled, conform the requirements of register class V new TCM drug in the 《DRUG REGISTRATION REGULATION》...