保孕丸质量标准研究

目的 完善保孕丸质量控制方法,并建立保孕丸中橙皮苷的含量测定方法.方法 采用薄层色谱法对保孕丸中补骨脂、续断、桑寄生进行定性鉴别;采用HPLC法测定保孕丸中橙皮苷含量,色谱柱为InertSustain C18(4.6mm×250mm,5μm),流动相为甲醇-醋酸-水(35:4:61),流速1.0ml/min.检测波长283nm.结果 保孕丸中补骨脂、续断、桑寄生薄层色谱法中斑点清晰,且阴性对照无干扰.橙皮苷在0.820~4.920μg范围内线性关系良好(r=1.0000),平均回收率为99.85%,RSD为0.21%.结论 建立的方法定性专属性强,定量准确度高,可用于保孕丸的质量控制.

Research on the quality standard of Baoyun pill

Objective To improve the quality standard of Baoyun pill. Methods The natures of Psoralea corylifolia, Radix Dipsaci and Loranthus parasiticus were detected by thin layer chromatography (TLC); the content of Hesperidine were measured by high performance liquid chromatography (HPLC). The operating conditions by HPLC were InertSustain C18 (4.6 mm×250 mm, 5 μm ), the mixture of methanol-acetic acid-water (35:4:61) as mobile phase, 1.0 ml/min as flow speed and wavelength 283 nm. Results The results showed that the TLC spots of Psoralea corylifolia, Radix Dipsaci and Loranthus parasiticus were fairly clear, and the according blank test showed no interference. Hesperidine showed a good linear relationship within the range of 0.820-4.920 μg(r=1.000 0)with an average recovery of 99.85%(RSD=0.21%).Conclusions The TLC and HPLC are handy,safe and accurate for Baoyun pills to determine the quality.