慈航软胶囊质量标准研究

Quality standard for Cihang Soft Capsule

目的:研究制定慈航软胶囊(益母草、当归、川芎等)质量标准。方法:采用薄层色谱法鉴别益母草、当归、川芎、香附药材;用高效液相法测定阿魏酸含量,流动相为甲醇-5%冰醋酸溶液(34∶66);检测波长为320 nm;川芎嗪的流动相为甲醇-水(85∶15);检测波长为292 nm。结果:在TLC图谱中可检出益母草和当归、香附、川芎药材的特征斑点;阿魏酸、川芎嗪含量限度分别为:0.22 mg/mL、3.04 mg/mL。结论:本试验采用的定性、定量方法,以及规定的含量限度标准,可以作为慈航软胶囊的初步质控方法和标准。

AIM： To study and establish the quality standard for Cihang Soft Capsule （Herba Leonuri, Radix Angelical sinensis , Rhizoma Chuanxiong , etc. ）. METHODS ： Herba Leonuri , Radix Angelicae sinensis , Rhizoma Chuanxiong and Rhizoma Cyperi were identified by TLC. Ferulic acid was determined by HPLC with methanol-5% acetic acid（34： 66）as a mobile phase and the detection wavelength was at set 320 nm. Ligustrazine was determined by HPLC with methanol-water（ 85：15 ）as a mobile phase and detection wavelength was set at 292 nm. RESULTS： Herba Leonuri,Radix Angelical sinensis, Rhizome Chuanxiong and Rhizoma Cyperi could be identified. The content limits of ferulic acid and ligustrazine were 0.22 mg/mL, 3.04 mg/mL, respectively. CONCLUSION ： The qualitative and quantitative methods adopted as well as the content limit can be used for the primary quality control of Cihang Soft Capsule.