The Pharmaceutical Research Of Gastric Floating Tablets Of Kangfuxin

Kangfuxin liquid is the single preparation, made by the refined ethanol extract of dry insect of Periplaneta americana (Per iplaneta Americana L.), with the function of promoting blood circulation and nourishing yin and promoting granulation, oral administration for the treatment of gastric ulcers achieved good curative effect. As the small dosage of Kang Fuxin, to better play the curative effect of Kangfuxin treatment of gastric ulcer, change the Kangfuxin Liquid to the dosage form of gastric floating tablets of Kangfuxin, in order to achieve its slow release in the stomach, improve drug absorption, improve the bioavailability, reduce the individual differences, to achieve targeted therapy of gastric ulcer.In the study of quality standard of Kangfuxin extract powder, HPMC is used to determine proline, alanine, glycine, leucine, valine 5 kinds of free amino acid and uracil, hypoxanthine, inosine 3 kinds of nucleoside components,also the routine examination of extract powder has been made.In the preformulation study, firstly, the above 5 kinds of free amino acids and 3 kinds of nucleosides as index components, to establish a method for determination of the content of index components;secondly, the method for determination of in vitro release rate were screened,and the tolerance test has been made for the screening results, through the verification test shows that the release determination method was stable and feasible, and ultimately choose the in vitro release test method is as follows: the preparation method for the determination of in vitro release with paddle method, speed control was 100 r. min-1, the release medium was 0.1 mol.L-1 of 900 mL, temperature is (37+0.5) C.In the forming process of gastric floating tablets of Kangfuxin, with in vitro floating performance and the cumulative release rate as the index, firstly took a single factor test to determine the compression force, the size and dosage of HPMC* foaming agent and expansive agent, and the usage of MCC; secondly mixture design test were adopted to optimize formulation parameters,and the optimal prescription was:HPMC K4M 29.33%, NaHCO3 13.83%, PVPP 18.85%, MCC 12%, compression force 6kg/cm-2, direct powder compression technique. The results of In vitro drug release mechanismthe study show that the gastric floating tablets of Kangfuxin release process is of synergistic effect of diffusion and matrix erosion, predominantly the diffusion mechanism.In the study of the quality standard of the gastric floating tablets of Kangfuxin, HPLC is adopted to determine the above 5 kinds of free amino acids and 3 kinds of nucleosides, and the preparation of in vitro floating properties and drug release performance examination and other routine examination had been taken.Finally, through the research on the stability of Kangfuxin gastric floating tablets, showed that the quality of the preparation is stable, controllable.