Study On Preparation Technology And Quality Standard Of Wuzhi Dispersible Tablets

In the clinical study, the lignose which is extracted from Schisandra sphenanthera Rehd.et Wils has the bioactivities such as de-hypertension, liver-protecting, anti-tumor and antibacterial. In this article, the Wuzhi dispersible tablet is prepared from Schisandra sphenanthera Rehd.et Wils and excipient, and its characteristics are studied as below:It is compared that the three kinds of common extract methods such as aqueous decoction, alcohol circumfluence and alcohol infiltration. And the alcohol circumfluence method is selected as extraction way to obtain the active agents from Schisandra sphenanthera Rehd.et Wils. The extracted lignose amount is set as index to study the technique factors of the ethanol concentration, ethanol amount, extraction time and extraction times by L₉(3⁴) orthogonal experimental. Finally the optimized process to extract lignose from Schisandra sphenanthera Rehd.et Wils is extracting with 8 times volume amount of 70% ethanol in 1 hour for 3 times.The optimum purification factors to obtain rough extractions from Schisandra sphenanthera Rehd.et Wils by macroporous resin are concluded as below: with macroporous resin HPD100, the amount ratio of solvent for herb and herb is 1:2, the diameter and height of chromatogram volume is 1:9, the amount ratio of herb and resin is 3:2. After adsorbing completely, the chromatogram volume is washed respectively with purified water as 5 times volume and 85% ethanol as 3 times volume to get the extractions from Schisandra sphenanthera Rehd.et Wils, and the contained amount of active agent achieves the request of Chinese Pharmacopoeia (2005 edition) of Traditional Chinese Medicine.The excipient to prepare the Wuzhi dispersible tablet is selected and studied. The final prescription is: the extraction from Schisandra sphenanthera Rehdxt Wils is 8g, the micro-crystal cellulose is 32g, the sodium carboxymethyl starch is 4g, CaHPO₄ is 16g, poly vinyl polypyrrolidone(PVPP) is 3% as collapse agent, micro-powder silica gel is 0.3 % of total weight as lubricant. Then they are mixed, dried and tableted as 0.35g per pill.In the study of quality control, the amount of extractions from Schisandra sphenanthera Rehd.et Wils and Wuzhi dispersible tablet are characterized by TLC, UV spectrum and HPLC, the latter two methods are identified for methodology.The study results indicate that the UV and HPLC are accurate and valuable to control the quality of Wuzhi dispersible tablets.The dissolution test of Wuzhi dispersible tablets is carried as the appendix of Chinese Pharmacopoeia (2005 edition), and the plasm condition is preferred as below: the 0.5% dodecyl sodium sulfate aqueous solution is selected as dissolution agent, the agitation ratio is 100r/min, the sampling time is 30 min. It can be found from the examine result that the dissolution rates of Wuzhi dispersible tablet are all more than 70%, it is accord with the request of Chinese Pharmacopoeia (2005 edition).