复方红景天滴丸的制备工艺研究

Study on the preparation process of compound Rhodiola crenulata dropping pill

关键词:  复方红景天  正交实验  红景天苷  提取工艺

Key words:  Compound Rhodiola  orthogonal test  salidroside  extraction technology

摘要:

[目的] 筛选、优化复方红景天的最佳提取工艺，初步探索该方的滴丸制备方法。[方法] 采用正交实验法，以红景天苷含量及干膏收率为考察指标，对提取时间、乙醇浓度、提取次数、溶剂倍数4个因素进行优化选择。考察冷凝剂、基质的筛选与配比、药物与基质比例，优化成型工艺。[结果] 实结果表明提取时间、提取次数、溶剂倍数对制备工艺有显著性影响。最佳提取工艺条件为10倍量，浓度为60%的乙醇，回流提取2次，每次1.5 h。验证实验中红景天苷平均含量为1.73%，RSD=1.2%，测得干膏收率平均值24.82%，RSD=1.6%（n=3）。滴丸制备选取二甲基硅油作为冷凝剂，PEG4000与PEG6000的最佳比例为2：1，药基比例1∶2.5。[结论] 优选的复方红景天提取及成型工艺合理、稳定、可行。

Abstract:

[Objective] To screen and optimize the best extraction technology of compound Rhodiola. The preparation method of dropping pills of this prescription is preliminarily explored.[Methods] The process was designed by orthogonal experimental method. Taking the content of salidroside and recovery rate of dry ointment as indexes to optimize 4 factors which includes extraction time,ethanol concentration,extraction times and solvent multiple. Studying condensing agent,matrix and its ratio,drugs and matrix proportion and optimize the molding process.[Results] The results of variance analysis showed that the extraction time,extraction times and solvent multiple had significant impact on the preparation.The optimum extraction process was adding 10 fold amount of 60% ethanol,extracting for 1.5h and 2 times. The average content of salidroside in the test was 1.73%,RSD=1.2% and the yield of dry extract was 24.28%,RSD=1.6%(n=3). Dimethyl siliconeoil was selected as condensing agent. The best ratio of PEG4000 and PEG6000 was 2:1. The ratio of drug to matrix was 1:2.5. [Conclusion] The extracting and molding process of the optimized compound Rhodiola is reasonable,stable and feasible.