FK分散片的药学研究

【作者】 王建；

【导师】 吴纯洁；

【作者基本信息】 成都中医药大学 ， 药剂学， 2006， 硕士

【摘要】 目的：本课题研究的FK分散片系由FK片改剂型而制得的新剂型。具有清热除湿，益气化瘀之功效。用于湿热瘀阻所致的带下病、腹痛，症见带下量多、色黄质稠、臭秽，小腹疼痛，腰骶酸痛，神疲乏力；盆腔炎，子宫内膜炎，宫颈炎见上述证候者。但FK片崩解、溶出迟缓，起效慢，不能满足病人希望迅速治疗疾病的要求。为了适应临床需要，使药物崩解、溶出快，治疗迅速，将其制成速释剂型分散片。本课题以传统中医药理论为指导原则，运用现代制药技术，对该分散片进行制剂学基础研究，完成制剂工艺筛选、质量标准和初步稳定性研究。并以普通糖衣片为对照，进行了制剂学评价。 方法：根据处方的功能主治及药物所含成分的理化性质，以适当的含量测定方法测定有效成分的含量，用正交实验设计法优选药物的最佳提取工艺条件。通过比较实验、多指标综合评分、正交实验等法优选分散片的最佳配方。采用HPLC法对制剂中的穿心莲内酯和脱水穿心莲内酯进行含量测定，以TLC法对方中各药进行鉴别，并对其进行了方法学考察。以留样观察法考察FK分散片成品的初步稳定性。 结果：通过多指标综合评价，确定最佳提取工艺为穿心莲粗粉用80％乙醇渗漉；单面针、功劳木用70％乙醇回流提取：千斤拔、金樱根、党参等药味加水煎煮提取。通过处方筛选，确定分散片的辅料种类及用量。质量标准建立了功劳木、金樱根、党参的TLC鉴别方法；对片重差异、崩解时限、分散均匀性、溶出度、重金属、砷盐、微生物限度等进行了控制；制定了本品每片含穿心莲内酯和脱水穿心莲内酯的总量不少于0.24％，测定方法灵敏度高、重现性好、专属性强。初步稳定性实验表明该制剂稳定。 结论：研究表明，分散片的制剂工艺合理可行，质量稳定可控，并为中药复方制成分散片提供一定的参考。更多还原

【Abstract】 Objective: A FK dispersible tablet, the subject of current study, was originated from the FK tablet but making of a new dosage form.The FK tablet can clear humid heat, nourish qi and dissipate blood stasis.It mainly treats leucorrhea, abdominal pain caused by humid heat blocking, for instance, the leucorrhea is excessive, yellow, thick and osmyl;the hypogastrium pains; sacro-waist aching pain; debilitation; pelvic inflammation, endometritis, cervicitis showing above-mentioned symptom.But the FK tablets have a few shortcoming, e.g. the slow disaggregation and dissolution can’t satisfy the patients’ aspiration of curing disease quickly.In order to suit the clinical requirement,we consider to make the FK dispersible tablet that has the good quality of quick disaggregation and dissolution.Under the guidance of traditional Chinese medicine theory and the modern technique,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 appreciation of galenic pharmacy was carried out.Methods: modo prescripto function and indication and physico-chemical property of the herb,to determine the contents of effective compositions by proper assaying method,to optimize the extraction process with the method of orthogonal experiment. Comparative researches, multi-index testings, orthogonal experiments were carried out to optimize prescription of the dispersible tablets.The contents of andrographolide and dehydroandrographolide were determined through HPLC, all drugs were evaluated by TLC methods. The consideration of methodology were carried out.To investigate the stability of prescription, observing the remain specimen was done.Results: Synthetic estimated through various index,the optimum extraction process was determined, common andrographis herb were extracted with 80% alcohol percolating; Zanthoxylum dissitum Hemsl and mahoniae caulis were extracted更多还原