| Bidens bipinnata L., a species of the genus Bidens (Compositae), is widely distributed in majority provinces in China. It has been used for many years for its heat-clearing, detoxicating and subduing swelling by eliminating stasis. It is bitter in taste, neutral in nature and innocuity. Bidens bipinnata L. is rich in flavonoids, which make up 6.617% of the leaves by mass. Bidens bipinnata L. and its composite have special effects to treating virus hepatitis. On the foundation of the study on extraction, purification and pharmacodynamics, and to develop a clinical medication, the preformulation study, capsule preparation techniques and the quality standard of TFB (total flavonoids of Bidens bipinnata L.) are studied in this paper, which mainly includes three parts as follows:1 TFB's intestinal absorption property in ratsThe absorption mechanism of TFB in the rat intestine is studied by taking the amount of hyperoside as the chief index. After single-pass intestinal perfusion to rats, the concentration of the hyperoside in the perfusate is determined by HPLC, and then the effective permeability coefficients (Peff) of the three different concentrations from low to high in the four segments of the rat intestine, contains duodenum, jejunum, ileum and colon, are calculated. The Peff of hyperoside in TFB are (1.89±0.53)×10-4, (1.29±0.32)×10-4, (0.88±0.33)×10-4, (0.86±0.34)×10-4cm/s in duodenum, jejunum, ileum and colon respectively. The Peff values at different concentrations are all greater than 0.2×10-4cm/s, and have no statistically significant differences (P>0.05). Addiction of P-gp inhibitor has little influence on the absorption of hyperoside. These results suggest that hyperoside is a hypertonicity drug which is absorbed in all intestine segments of rats by means of passive diffusion. It's good for absorption that raising the dissolution rate and dissolvability of TFB for litte influence of P-gp inhibitor on the absorption.2 Preparation technology of TFB capsuleThe excipient and formation technologies of TFB capsules is optimized. In consideration of the indexes, which contain repose angle, hygroscopicity, forming quality, bulk density, critical relative humidity and dissolution rate, the research chooses lactose as excipient, size 2 capsule with 0.18g diameters each, and keeps the relative humidity of the production shop below 68%. The study provides reference for the production of TFB capsules.3 Quality standard of TFB capsuleThis experiment researches into the quality standard of TFB capsule. According to the Chinese Pharmacopoeia (2005), the moisture content, content uniformity, and dissolution of TFB capsules are investigated to be up to the mustard. The NaNO2-Al(NO3)-NaOH chromogenic system is used to determine the content of TFB by ultraviolet spectrophotometry method. There are 77.79mg total flavones per capsule, and the average recovery rate is 99.79%(RSD:1.61%). The method is simple, fast with good reproducibility and can be used for the quality control for TFB capsule.
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