颈康分散片制剂工艺研究及质量标准

【作者】 许钧钧；

【导师】 王玉蓉；

【作者基本信息】 北京中医药大学 ， 中药制剂学， 2005， 硕士

【摘要】 目的:本课题研究的颈康分散片来源于临床经验方,具有疏风止痛、清利头目的功效,用于治疗神经根型颈椎病。根据药材性质和临床用药特点,拟以滴丸和分散片的制备技术为支撑,进行剂型筛选。对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,并以普通薄膜衣片为对照,进行溶出度实验验证。 方法:以HPLC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,对成分不明确的药味以药效为指标,指导药物的提取。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法对制剂中的天麻素、绿原酸进行含量测定,TLC法对方中各药进行定性鉴别,留样观察法考察颈康分散片成品的稳定性。 结果:通过多指标比较,确定分散片剂型。确定天麻用70%乙醇回流提取,川芎、白芷采用70%乙醇渗漉,狗脊与菊花用水共煎,80%醇沉等提取工艺条件。通过处方筛选,确定分散片的辅料种类及用量。建立颈康分散片的质量标准,每克含天麻素不低于2mg,绿原酸不低于0.7mg,测定方法灵敏度高、重现好、专属性强;初步稳定性实验表明该制剂较稳定,可保证临床用药的质量。以普通薄膜衣片为对照,表明本分散片较滴丸溶出为快。 结论:研究表明,根据中医药理论制成颈康分散片的制剂工艺可行,质量稳定可控,为中药复方制成分散片提供了有价值的实验数据。本研究达到了课题预期目的。更多还原

【Abstract】 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.更多还原