Study Of Preparation Technology And Quality Standard Of Shanxiangyuan Dispersible Tablet

The effective ingredient of Turpinae folium that is total flavonoids of saciente, has the prominent effect of treating amygdalitis and sphagitis, but the water-solubility of the effective ingredient of Turpinae folium is little, existing issues of the low of bioavailability and stability as the tablet. Because of the existing issues of tablet and considering the need of clinical medication, we made it into dispersible tablet, which has definite effect, quick function. Then we studied preparation technology, quality standard and preliminary stability of Shanxiangyuan dispersible tablet under the relevant regulations. The main contents are as follows:In extracting technology research, using the assistant extracting technology of microwave, taking the yield of total flavonoids of saciente as the evaluation index, adopting the single factor experiment and the orthogonal test to optimizing the process of the the extraction of total flavonoids of saciente, the best parameters were as follows:40times the amount of the70%ethanol, extractive time was5min, microwave power was600w. Compared woth the traditional extractive technology of reflux, the assistant extracting technology of microwave own the advantages of shorter extractive time and higher extraction efficiency.In the purification process studying, using the method of static adsorption sifted the type of macroporous resin, which is HPD400; as the evaluation index to the content of total flavonoids of saciente, utilizing the method of dynamic adsorption investigated the mainly influencing factors, which included flow rate of sample loading,maximum sample volume, the volume, concentration and velocity of the elution. The best parameters were as follows:the concentration of sample was0.1g·mL-1, the volume of sample was3BV, the flow rate of sample was1BV·h-1, the volume of the elution was5BV, the concentration of the elution was the50%ethanol, the velocity of the elution was2BV·h-1.In the inclusion technology of Turpiniae Folium flavonoids clathrate with hydroxypropyl-β-cyclodextrin, taking encapsulation efficiency and drug loading capacity of total flavonoids of saciente as the evaluation index, adopting central composite design-response surface methodology optimized technological parameter. Optimal inclusion technology:the mass ratio of Turpiniae Folium flavonoids with hydroxypropyl-β-cyclodextrin was0.35:1,clathration time was169min, clathration temperature was41℃.In the forming process sudying, taking disintegration time limited, difficulty level of granulating and dissolution as index, using single factor test and central composit design-response surface methodlogy sifted the types and contents of disintegrant, filler, adhesive, lubricant, ultimately accomplished the prescription screening. Prescription screening:the ratio of drug was50%, the ratio of united disintegrant was32%, the ratio of filler was8%, the adhesive was50%ethanol, the lubricant was aerosol, which’s ratio was0.5%, and controlling rigidity in rage of3-4kg-Research in quality standards, adopting TLC distinguish Shanxinagyuan dispersible tablet, and adopting HPLC measure the content of total flavonoids of saciente, nuezhenoside and rhoifolin of Shanxinagyuan dispersible tablet, and to determine dissolution of total flavonoids of saciente. Finally the preliminary stability of sample was studied by retention small samples observation.The studying shows that the preparation technology is scientific, reasonable and practical, the quality standard is controlled, and the quality of the sample is steady as well.