正交试验优化复方三草滴丸制备工艺

Optimization of Preparation Process of Compound Three Herbs Droplet by Orthogonal Experiment

目的优选复方三草滴丸制备工艺的最佳条件,并测定滴丸中熊果酸的含量。方法以滴丸的硬度、圆整度、拖尾度、黏连为评价指标,采用正交试验设计方法优选滴丸制备工艺;采用HPLC测定滴丸中熊果酸的含量。结果滴丸的最佳制备工艺:药物与基质配比为1∶2,PEG 4000与PEG 6000的配比为2∶1,适宜料温为80℃,滴速为每分钟40滴;HPLC测得滴丸中熊果酸的含量为0.992 5 mg·g^(-1)。结论复方三草滴丸制备工艺简便、可行,得到的滴丸圆整度较高、色泽较亮、成形良好、质量可控。熊果酸含量测定方法稳定、可靠,可用于滴丸的质量控制。

OBJECTIVE To optimize the condition of preparation technique of Compound Three Herbs droplet and determine the content of ursolic acid in the droplet. METHODS Taken the hardness, roundness, trailing degrees and stickiness of the droplets as the index for evaluation, orthogonal experiment was used to optimize preparation technique of the droplet. The content of ursolic acid in the droplet was determined by HPLC. RESULTS The optimal condition of preparation technique was as follows： ratio of drug to matrix was 1∶2, ratio of PEG 4000 to PEG 6000 was 2∶1, temperature of drug was 80 ℃, infusion rate was 40 drops per minute. The content of ursolic acid measured by HPLC was 0.992 5 mg·g（-1）. CONCLUSION The optimal preparation technique in Compound Three Herbs droplet is simple and feasible with good roundness of droplets, bright color, good forming and controllable quality. The method to determine the content of ursolic acid is stable and reliable, which can be used for quality control of droplets.