Studies On The Preparation Of Wendan Dripping Pills

Wendan dripping pills (for short WDD) is a new medicine which improved on Wendan Tang. It has curative effects on removing sputum and vomit, and it was widely used for treatment and prevention of insomnia, cardiovascular and cerebrovascular diseases, which has the advantage of good therapy and little side-effect. For using convenient and being suitable to industrial production, a fast release dripping pills was designed and prepared with polyethylene glycol 6000 and polyethylene glycol 4000. This research includes: (1) the establishment of analytical methods of typical principles (2) the optimization on extraction and purification process of medicinal materials (3) the study on prepartion of WDD (4) the study on coating and stability of WDD (5) the pharmacodynamic study on WDD.Citrus reticulate, Glycyrrhiza uralensis, Citrus aurantium and Zingiber officinale were identified by TLC. Hesperidin was determined by HPLC, total flavone was determined by Vs detection. The methods above were accurate, liable, convenient and rapid, which all reach the requirement of measurement.The extraction and purification process of medicinal materials was studied by the content of the total flavone and the extraction rate of the dry solid. Orthogonal tests were used to optimize the decoction time, decoction times and solvent volume. Alcohol precipitation method, chitosan flocculating method and gel flocculating method were used to optimize purification process and the results indicates that the chitosan flocculating method is better than the others because it can make the solution precipitate fast and had higher transference rate of typical principles. The optimum method of extraction and purification process has a good repeatability.WDD were prepared in this process: disperse extracts into the excipients by melting and drip the molten suspension into the condensation fluid, then drops were contracted, cooled and solidified into dripping pills. By the criterion of hardness, degree of circularity and dissolution time, the amounts range of extracts and excipients were obtained through single factor experiment. The formulation was optimized on the basis of three factors and three levels orthogonal design by appearance quality and dissolution time. The dripping condition was optimized using the same design by assessing mean variance of weight. WDD were prepared according to the best components and dripping condition.Eudragit E100 was used as coating material. By the criterion of variance of weight and dissolution time, the drop condition was optimized on the basis of three factors and three levels orthogonal design. Dissolution rate was established by studing the effect of dissolution medium and rotation speed on the accumulative dissolution percentage of the total flavone of WDD. The repeatability of three batches of samples and stability of accelerating and room temperature test showed that WDD was stable, quality-controlled and met the purpose and requirement of dosage form design.The pharmacodynamical experimentation of WDD indicates that WDD has similar curative effect with diazepam. But after persistent perfusing stomach, the mice didn’t appear narcosis and unwakened, it indicates that WDD has relaxative active. So WDD can be used to treat insomnia in clinic.