十味百合胶囊制备工艺及质量控制研究

Study on Preparation Technology and Quality Control of Shiwei Baihe Capsules

目的：研究优化十味百合胶囊剂的制备工艺,建立其质量控制方法.方法：以加水量、浸泡时间、煎煮时间为影响因素,以干膏收率为评价指标,采用L9（34）正交试验法进行提取工艺研究;通过辅料种类、辅料配比筛选试验,进行成型工艺研究,并分别采用薄层色谱法和高效液相色谱法对三七和芍药苷含量进行定性和定量鉴别.结果：提取时加水浸泡1h,提取两次,加水量分别为11倍和4倍,煎煮时间分别为1h和1h;干膏粉：糊精：可溶性淀粉为8：1：1;薄层色谱中三七定性鉴别稳定可靠;高效液相色谱中芍药苷线性范围2.112～11.374μg/mL（r=1.000 0,n=5）,平均回收率99.75％（RSD =0.90％,n=5）.结论：制备工艺简单可行、合理有效,质量稳定可控,适用于十味百合胶囊制备.

Objective： To study the formulation and preparation procedure of shiwei baihe capsules and develop a method for the content determination. Methods ： Water volume, soaking time, extraction time were taken for fac tors, L9（34） orthogonal test was used with the dried cream yield as indicators, to choose the best extraction process for capsules. Study the moulding technics by the screening test for the supplementary material types and the ratio of excipients. The TLC （thin layer chromatography） and HPLC（ High Performance Liquid Chromatogra phy） were adopted to identify the contents of Paeoniflorin and Radix Notoginseng on qualitative and quantitative. Results ： The optimal extraction conditions ： The first time used 11 times water, while the second used 4 times wa ter. the time for each extraction was 1 h respectively. The ratio of accessories prescription ： extraction powder： dex trin starch was 8：1 ： 1. Radix Notoginseng could be identified effectively by TLC. Determination method of paeoni florin was linear at range of 2. 112 11. 374 μg/mL（r = 1. 000 0,n =5） ,the average recovery was 99.75% （ RSD = 0.90%, n = 5 ）. Conclusion ： The preparation technology and the method for the content determination are sta ble, feasible and effective, and can be used as the preparation of shiwei baihe capsules.