均匀设计法优选制备复方天麻滴丸最佳工艺.docVIP

均匀设计法优选制备复方天麻滴丸最佳工艺摘要：目的研究制备复方天麻滴丸的最佳工艺。方法选用U9(94)进行均匀设计优选滴丸的制备工艺。以硬度、拖尾、粘连及综合结果为指标，考察基质与药物之比、PEG 4000与PEG 6000之比、料温（溶解药物基质的温度）及滴距（滴管口与冷却液面之间的距离）对制备滴丸的影响。结果最佳的工艺条件为：基质与药物的比例为7∶1，PEG 4000与PEG 6000之比为1∶5，料温96 ℃，滴距5 cm。结论均匀设计法是优化复方天麻滴丸制备工艺的有利工具。 关键词：均匀设计；滴丸；制备工艺 中图分类号：R282.71文献标识码：A文章编号：1672-979X(2009)01-0018-03 Optimization of Preparation Procedure of Compound Tall Gastrodia Tuber Drop Pill by Uniform Design CHENG Ji, JI Yu-bin, LI Wen-lan, HU Zheng-ting, XU Dong (1. Center of Research on Life Sciences and Environmental Sciences, Harbin 150076, China; 2. Engineering Research Center of Natural Anticancer Drugs, Ministry of Education, Harbin University of Commerce, Harbin 150076, China) Abstract：Objective To study the optimum preparation procedure of compound tall gastrodia tuber drop pill. Methods The optimization of preparation procedure of compound tall gastrodia tuber drop pill was performed by U9(94) uniform design method. With hardness, tailing, adhesion and comprehensive result as investigative indexes, the influences of ratio of base to drug, ratio of PEG 4000 to PEG 6000, material temperature and dropping distance on the preparation of drop pill were studied. Results The optimum preparation procedure was as follows: ratio of base to drug of 7∶1, ratio of PEG 4000 to PEG 6000 of 1∶5, material temperature of 96 ℃ and dropping distance of 5cm. Conclusion The uniform design is a good method for the optimization of preparation procedure of compound tall gastrodia tuber drop. Key words：uniform design; drop pill; preparation procedure 滴丸是将固体或液体溶解，乳化或混悬于适宜熔融基质中，通过滴管滴入另一与之不相混融的冷凝剂中，由于表面张力作用使液滴成球状冷却凝固而成丸。由于丸与冷凝剂的比重不同，凝固形成的滴丸徐徐沉于容器底或浮于冷凝剂表面，取出洗去冷凝剂，干燥即得[1，2]。 复方天麻滴丸是按照中医药理论组方、临床使用多年的传统中药方剂，提取纯化有效使用制成的中药滴丸制剂。它比传统剂型剂量小、起效快且疗效高。 均匀设计作为一种以少量实验处理多因素多水平的方法，近年被广泛应用。本实验用均匀设计法安排实验，选取基质与药物之比、聚乙二醇（PEG）4000与PEG 6000之比、料温及滴距4个因素，优选出了合理的提取工艺，并对结论进行了验证，为选择生产工艺参数提供了实验数据。 1实验材料 DPS统计软件（北京中农博思科技发展公司）；DWI-12滴丸机（任丘津任金属柜厂）。 川芎、天麻购自哈药集团世一堂中药饮片厂。经鉴定，川芎为伞形科