Preparation And Evaluation Of Geranium Tanin Colon-Specific Pellets

[Objective] To prepare calcium pectinate colon-specific pellets with Geranium tannin as the model drug, then put the pellets into intestinal dissolving capsule, make into colon-specific preparations, and to establish an initial quality standards.[Method] Geranium tannin-based drug, low methoxyl pectin as a carrier, prepared by curing liquid pellets, the release degree of pellets in the artificial intestinal fluid for the index, single factor experiment screening preparations prescription; to thin-layer chromatograpHy identification; with Gallic acid as reference substance, by HPLC to Geranium tannin colon-specific pellets content determination and established quality standards; using ultraviolet-visible spectrophotometry determinate the content of Geranium total tannins. Examine the colon positioning preparations’ release degree in artificial gastric fluid and artificial intestinal fluid, then to evaluate colon positioning features.[Results] pellets optimal formula was as:LMP concentration of 12%, feed solution 0.3% drug content; process parameters:calcium chloride concentration of 10%. Regression equation: Y= 18840x+198.9, r=0.9996, the results shows Gallic acid in 0.1μg·mL-1～1.6μg·mL-1 linear relationship is good. Gallic acid average content in the pellets which made by prescription and parameters is 7.20μg/g, reproducibility is good. pellets in the tannin content was 0.324 mg/g. Average recovery is 100.95%, RSD is 1.88%, by prescription and parameters of the pellets in vitro intestinal preparation 2h cumulative release of not more than 16%, with 0.5% pectinase in the artificial colon fluid 1 h cumulative release rate of more than 80%. [Conclusion] The pellets of the formula was reasonable, with colon-specific delivery characteristics; preparation of quality control, quality standards established by application of the draft.