Study On The Dispersible Tablets Of Jingangteng

Jingangteng has the function of heat-clearing and detoxifying, dissipating lump and mass, was found effective clinically to treat a variety of gynecologic diseases, such as annexitis, inflammatory masses of ovarian appendages and other gynecological inflammation etc. There are four marketed formulations of Jingangteng, i.e. syrups, capsules, granules and tablets, however, the drug absorption from the tablets were affected by the long disintegration time and the slowly dissolution rate. Similar to other liquid preparations, the syrup has the disadvantages of inconvenient storing and transportation, high cost induced by packaging, although it can be administrated easily. The dispersible tablets was one kind of new formulations exploited in recent years, which had the characteristics of short disintegration time, excellent dispersion state, fast dissolution and absorption rate, high bioavailability, convenient administration and conventional preparation equipment, etc. In order to overcome the disadvantages of the syrup and improve patient compliance, the dispersible tablets of Jingangteng was investigated.The extraction technology was investigated based on the extraction technology of quality standard of Jingangteng syrup, the property of effective component of formulation, modern preparation technology and related pharmacological research. The process was studied by orthogonal design with yield of extract, the content of diosgenin in extract as indexes, the optimum process was as follows: twice extractions with eight-fold water to one volume of the extracted material, each extraction running 2 h. Put together the filtrate of above, the filtrate was concentrated to relative density of 1.06～1.09 (60℃) . Then, add ethanol to extracts until the ethanol concentration about 40%, standing for 24h, filter, concentrate the filtrate and remove ethanol completely. The total dry extract was obtained using the method of vacuum drying (70℃).The formulation and preparation technology of Jingangteng dispersible tablets was optimized using comparative experiment which took the flow property of granules, compressibility, dispersible uniformity and taste the disintegrating time and the dissolution rate of the tablet as indexes. The optimized formula and technology was as follows:The dry extract was crushed and sieved through a 100 mesh size screen, then the appropriate amount of microcrystalline cellulose, mannitol, aspartame and sodium carboxymethy starch were added, well mixed, granulated, dried, then sodium carboxymethy starch and smagnesium stearate were added, well mixed, the tablets were prepared.Diosgenin, main components in tablets, was identified by TLC and determined by HPLC, and disintegration time of the tablets was controlled. The optimized Jingangteng dispersible tablets disintegrated completely in 3min, dispersible uniformity met the require; The results of primary stability test and accelerated stability test showed that the dispersible tablets were stable, and quality controllable.