导　　师： 徐满才;王隶书

学科专业： 070303

授予学位： 硕士

作　　者： ;

机构地区： 湖南师范大学

摘　　要： 妇炎康分散片系由妇炎康片/(收载在中华人民共和国中药部颁标准10册上/)剂改而来。妇炎康片上市多年，临床应用证明它对慢性附件炎、盆腔炎等各种妇科炎症都有明显疗效，但该药由于剂型为普通片剂，存在崩解及溶出速度慢、起效慢的缺点。为此，我们将它改为崩解及溶出速度相对较快、吸收快、起效快、生物利用度高及服用方便的分散片，并在药理实验及化学成分研究的基础上，对妇炎康分散片的制备工艺、质量标准、初步稳定性进行了较详尽的研究，为将中药大复方研制成新颖的分散片提供新的思路。此外，还开展了利用大孔树脂分离纯化丹酚酸B的研究。 本论文主要研究内容和结果如下： 1．首先以抗炎作用实验/(对二甲苯所致小鼠耳肿胀的影响、对角叉菜胶所致的大鼠足肿胀的影响/)为评价指标，确定了处方中各药味的提取工艺路线。以有效成分含量为考察指标，以正交实验法优选了提取工艺条件及精制工艺条件，确定了药物中间体的制备方法：莪术、当归、香附、三棱提取挥发油并将挥发油以研磨法制成β-环糊精包合物，黄柏、延胡索、苦参、丹参以75％乙醇加热回流提取，赤芍、川楝子、芡实、山药、土茯苓5味加水煎煮，减压干燥得干膏粉，以90％乙醇精制制得药物中间体。 2．重点研究了该分散片成型工艺，以分散片所要求的分散均匀度为考察指标，结合中间体性质研究筛选了崩解剂、填充剂的种类、配比、加入方法等，确定了分散片的辅料与药物中间体的配比，并考察了成品的体外溶出行为，对其崩解时限、溶出度进行了控制。 3．以薄层色谱法对处方中莪术、延胡索、黄柏、山药进行了定性鉴别，并采用高效液相色谱法测定了制剂中芍药苷含量。生物学评价实验及初步稳定性实验结果表 Fuyankang dispersible tablets are reformulated Fuyankang tablets which have appeared in the markets for many years for its great beneficial effect in the treatment of patients with gynecological inflammation such as chronic annexitis, pelvic inflammation and so on in clinical applications. However, Fuyankang tablets also have exhibited some disadvantages such as disintegration, slow dissolution kinetics and pharmacodynamics due to its formulation. To overcome these shortcomings, a novel formulation of Fuyankang tablets-dispersible tablets was investigated, the study of preparation process, quality standard and preliminary stabilizing experiments have been carried out in detail on the basis of pharmacology experiments and chemical ingredients, and the results proved that the dispersible tablets could be disinttegrated, dissolved and absorbed quickly, and had higher bioavailability. A novel idea for developing traditional Chinese medicine /(TCM/) compound formulation has been provided. Further more, salvianolic acid B was separated and purified from Radix Salviae miltiorrhizae using macroporous resins.Contents and results of this dissertation are as following: 1.The extraction processes for several prescription medicines have been optimized by diminishing inflammation experiments on mice. Based on an orthogonal frame, the extraction process and refined technique were optimized by investigation the content of effective constituents, and the method for preparation of medicine intermediate was developed. From Rhizoma Curcumae,Radix Angelicae Sinensis,Rhizoma Cyperi,Rhizoma Sparganii, volatile oil were extracted and included byβ-cyclodextrin using trituration method,Cortex Phellodendri Chinensis、Rhizoma Corydalis、Radix Sophorae Flavescentis、Radix Salviae miltiorrhizae were extracted with 75/% alcohol refluxing,Radix Paeoniae Rubra、Fructus Toosendan、Semen Euryales、Rhizoma Dioscoreae、Rhizoma Smilacis Glabrae were extracted with water, then dried under vacuum, the crude powder was purified with 90/% ethanol

关 键 词： 妇炎康分散片 制备工艺 质量评价 丹酚酸

领　　域： [化学工程]