Neck Kang Dispersible Tablets Preparation Process And Quality Standards

Objective: A Jing Shu dispersible tablet, the subject of current study, was originated from an effective prescription in clinical practice. It can expel wind, alleviate pain and clear minds. It mainly treats cervical spondylotic radiculopathy. The dosage form was chosen by considering the drug's nature and clinical needs, and was designed on the basis of dripping pills and dispersible tablets' making techniques. In this study, the basic pharmaceutical research of dispersible tablets was achieved, together with the selection of manufacturing techniques, establishment of quality standards, the appraise of preliminary stability. In the same time, using common pellicle-clothing tablets as contrast, the solubable point experiment was carried out.Methods: To determine the contents of effective compositions by HPLC; To optimize the extraction process with the method of orthogonal experiment. Extraction of herbs whose compositions had not been defined was guided under pharmacological experiments' results. Comparative researches, multi-index testings, orthogonal experiments were carried out. Best prescription of dispersible tablets, the contents of gastrodin and chlorogenic acid were determined through HPLC, all drugs were evaluated by TLC methods. To investigate the stability of prescription, observing the remain specimen was done.Results: Compared through various data, the prescription of the dispersible tablets was decided. Determined the optimum extraction process, Rhizoma Gastrodiae was extracted with 70% alcohol refluxing, Radix Ligusticum chuanxiong and Radix Angelica dahurica percolated, using 80% alcohol percolating. Radix Cibotium darometz and Flavone glycosides were extracted with water and precipitated by 80% alcohol. The prescription was selected and the kind and quantity of auxiliary materials were decided. The quality standard of Jing Shu dispersible tablets was established, the content of gastrodin should not be lower than 0.2%, chlorogenic acid should not be lower than 0.07%, the method was sensitive, repeatable and specific. The preliminary of stability research indicated the quality is steady and can ensure the quality that the clinical medicine required.Contrasting pellicle-clothing tablets, dispersible tablets dissolved faster than the rate of dripping pills.Conclusion: Studies have shown: under the guidance of clinical medicine, it was proved to be feasible to make Jing Shu dispersible tablets, quality was steady and controllable. It provided a valuable reference for the research of dispersible tablets which were made of TCM composed fomula. The project goals were achieved.