立克宁滴丸制备工艺及其质量标准的研究-药剂学专业论文.docxVIP

中文璃要近年来，随游中药剂型的不断发展，滴丸作为一种很有应用 中文璃要 近年来，随游中药剂型的不断发展，滴丸作为一种很有应用 砉蓍景薛中莼毅蘩璧，在中药割裁孛酸皮震越来越雩|人注瓣。与簧 统剂型相比，滴丸具有表面积大、溶出速度快、剂量准确、生物 利用度离、服用方便等特点。以丁香叶为原料的胶囊剂和片剂已 于1983年获准生产，其疗效礁锈，睡床应耀广泛。本实骏爨疆裁 的立克宁滴丸是以丁香叶为原料，按中药新药技术要求设计，经 科学方法提取，滴制而成的现代中药新制剂，具有清热解毒、消 炎止痢之功效。 本文采用正交设计试验，确定了最佳提取工艺、醇沉工艺， 并通过大孔吸附树脂新技术寓集、纯化了有效成分，得到抗菌有 效部爱群；采震豳薅分教技术以聚乙二醇4000佟戈基厦，争基建 油作为冷却剂优化了滴丸成魁工艺。所制得滴丸成品率高，并符合 《中华人民共和阑药典》2000年版一部附录IK滴丸剂项下的有 关翘定；露时采趔薄层色谱法进行定瞧研究，聚惩毙色法移HPLC 法进行定量研究，分别测寇了总酚酸含量和丁香苦营的含量，从 而建立了立克宁滴丸的质量标准。 本醑究为大生产提供了科学依攒，必药材及裂裁酶标准亿奠 定了基獭，为中药现代他的进程提供了可行性参考。 关键词：立毙宁瀵丸 丁香卧 制备工艺 质鬈标准 簇巍渡书疆药大学袋士学经论文■■■■●■■■■■———■■■—●●■■■■■■—■■■■●_I 簇巍渡书疆药大学袋士学经论文 ■■■■●■■■■■———■■■—●●■■■■■■—■■■■●_I lll l■l Abstract Recently，with the development ofTCM preparations，the application of droppills has been paid more and more attention and become a promising TCM preparations．Compared with traditional dosage forms，droppills features larger superficial afe3，faster soluble speed，accu豫ter dosage，easier absorption and more convenient for being taken．The capsule mad tablet made from Folium syringae have been approved since 1983．They have exact curative effects and have been used widely in clinic．Likening droppills is a type of modem TCM preparations extracted from Folium syringae and dripped throu曲scientific method，It has marked antiseptic and antiviral curative effects， We have established氇e best extract condition。alcohol deposition process by orthogonal experiment design．The active principles were gathered and purified through Macroporous艇so施i羲g resins。Droppills was made by solid dispersion technics with the bases of PEG4000 and methyl siliconoil as refrigerant，which has established the optimum moulding technics．It conforms to the standard of the Chinese pharmacopoeia as welt as the hi’馥output rate of droppitls has been attained，The experiment has adopted the TLC approach to take the quality research．Meanwhile we have adopted the colorimetric methods and凇￡C methods to carry out