两面针分散片制备工艺和质量标准的分析-中药学专业论文.docxVIP

ii ii investigate the amount of the various results of the multilevel orthogonal and to optimization the best formulation and preparation from the experimental results. ④Study on the quality standards Including the Zanthoxylum nitidum extraction and the formulation of dispersible tablets of Zanthoxylum nitidum.Use the qualitative identification,quantitative identification to control the quality of Zanthoxylum nitidum extraction.And the inspection items such as the appearance of tables,characters,qualitative identification,quantitative identification,weight difference,in vitro disintregration time and dissolution,etc,are include in the tablet quality standards inside.Finally, to formulate the draft quality standards of dispersible tablets of Zanthoxylum nitidum.⑤Investigation on the initial stability Use the means of accelerated testing ande long-term stability testing to study the stability of our preparation. Results ： ①Identification of Zanthoxylum nitidum herbs The nitidinechloride content in is up to 0.13%,and the similarity of the fringerprint peaks during 10 different origins is to 90%.These could use as for the basis of the identification from the origin and the quality of the medicines.②Extraction and refining the effective components of Zanthoxylum nitidum To extract the Zanthoxylum nitidum herbs four times,each time 1.5 hours,with 8 times the amount of 70% ethanol.Make the extraction refined using silica-gel column chromatography after combining and concentrating the extracts.The nitidinechloride content is finnaly obtained refined extratct are to 17.3mg/g .③Study on preparation formula and production process The disintegrants in the optimization of the preparation prescription include MCC and PVPP. The final preparation prescription as follows: Zanthoxylum nitidum ext ration 100mg per film, SiO2 50mg per film, CaHPO4 163mg per film, MCC:PVPP (4:1)86mg per film,HPC26mg per film,Magnesium sterate 4mg per film. Use