Study On Preparation Technology Of Xianxian Enteric - Coated Sustained - Release Gel Pellets

Cancer has become one of the major threats to human health and the leading causes of death. In the past 10 years, the data indicated the global incidence of cancer showed an increasing trend. In view of the adverse reaction caused by synthetic drugs, the need of traditional Chinese medicine and natural medicine are rising and the desire to use them to maintain health or prevent disease are more intense.Xianchan Table originated from cancer pathogenesis and treatment principles of Chinese medicine by the famous pharmacologist Professor Zhao Dongke. This anticancer drug were resulted from extensive tests, based on traditional Chinese medicine clinical experience combined with modern pharmacological research. But Xianchan Table has vomiting side effects; to solve this problem, the liquid drops of gel process will be applied in this study to change the formulations of Xianchan Table from tablet to enteric sustained-release preparations. Based on single factor study in gel pill preparation technology, accessories and other factors, we finally established the preparation process of Xianchan enteric coated sustained-release capsules by optimizing the process parameters of response surface method. The process is as follows:prepare 50ml sodium alginate solution whose concentration is 1.25%, add 1.5g Xianchan dry cream powder, mix well and set aside; prepare 2.75% calcium chloride solution 100ml, and set aside; prepare 0.5% chitosan (60,000 molecular weight) solution 100ml, and set aside; extract the alginate solution with a syringe which installed a 1.25mm dripper, add the solution with 5 drops per second into calcium chloride solution, and calcium alginate gel beads were formed; gel beads were cured 60min in calcium chloride solution; the gel beads were removed from the calcium chloride solution, and placed in the chitosan solution 30min for reaction coating; remove the gel pellets from chitosan solution, tiled on the dish, placed in a drying box at the temperature of 50℃ dried to constant weight, and all. The process is simple, without large-scale equipment modification, suitable for industrial production, and achieve the purpose of changing formulation. The formulations can cover up the bad smell of medicinal materials in recipe section, but also reduce the drug’s stimulation to human body, and improve bioavailability and stability of the preparation, in order to achieve better efficacy. This study examined the effects of preparation technology, materials, and other factors on the gel pill molding process, established a preparation process of Xianchan enteric sustained-release preparation, which is stable, simple and suitable for industrial production, achieving the purpose of the reform of formulation.