摘要
目的：研究参芎滴丸的最佳成型工艺及有效成分的含量测定方法。方法以滴丸外观质量、溶散时限、丸质量差异为评价指标,在单因素试验的基础上,采用正交试验对基质组成、药物与基质配比、冷凝剂温度和滴距等进行筛选；采用高效液相色谱法测定滴丸中人参皂苷Rg1、Re的质量分数。结果滴丸最佳成型工艺为：PEG4000-PEG6000（质量比为2∶1）为基质,药物与基质质量比为1∶3,冷凝剂为液体石蜡,冷凝剂温度为8-10℃,滴距为8 cm。人参皂苷Rg1在0.2035~6.105μg、人参皂苷Re在0．2005~6.015μg范围内与峰面积呈良好线性关系（ r=0.9999）；人参皂苷Rg1平均回收率为100.79%,RSD为1．14%（ n=6）；人参皂苷Re平均回收率为99.93%,RSD为1.72%（ n=6）。结论优选得到的参芎滴丸制备工艺合理可行,含量测定方法简便、准确、专属性强,可用于参芎滴丸的制备及质量控制。
Objective To study the preparation of Shenxiong dropping pills and establish a method for the determination of ginsenoside Rg1 , ginsenoside Re. Methods On the basis of preliminary experiment, the formulation technology was selected among sort of the ratio of extractum to matrix, component of matrix, temperature of refrigerant and dropping distance,and all the procedure was evaluated by the appearance quality, disintegration time and weight variance of dropping pills as the evaluation indexes by means of orthogonal experimental method. Ginsenoside Rg1 ,and ginsenoside Re were determined by HPLC. Results The optimized preparation was as follows：PEG4000 to PEG6000（2∶1）was used as matrix with the extractum to matrix at 1∶3, the temperature of refrigerant was 8-10℃ and the dropping distance was 8 cm. The linear range of ginsenoside Rg1 was 0.203 5-6.105 μg,and the linear range of ginsenoside Re was 0.200 5-6.015 μg（r=0. 999 9）. The average recovery of ginsenoside Rg1 was 100. 79%, RSD was 1. 14%（ n=6 ） , and the average recovery of ginsenoside Re was 99.93%,RSD was 1.72%（ n=6） . Conclusion The preparation is reasonable and feasible, and the determination method is sample,accurate and rapid with good reproducibility,which can be used in the preparation and the quality control of Shenxiong dropping pills.
出处
《广东药学院学报》
CAS
2014年第4期395-398,共4页
Academic Journal of Guangdong College of Pharmacy
基金
广东省科技计划项目(2011J4300059)
广东省中医药建设中医药强省重点科研项目(20123012)
