辛苍鼻舒胶囊质量标准研究

Study on Quality Standard of Xincangbishu Capsules

目的建立辛苍鼻舒胶囊的质量控制标准。方法采用薄层色谱法对处方中川芎、苍耳子、辛夷进行定性鉴别;采用毛细管气相色谱法对制剂中的α-蒎烯、β-蒎烯、桉油精进行含量测定,色谱柱采用DB-1毛细管柱(30 m×0.25 mm,0.25μm),进样器温度230℃,FID检测器温度250℃。结果薄层色谱法能定性检出川芎、苍耳子、辛夷,斑点清晰,且阴性对照无干扰;α-蒎烯、β-蒎烯、桉油精的质量浓度分别在0.008～0.091 g/L(r=0.999 8),0.009～0.093 g/L(r=0.999 8),0.060 4～0.604 g/L(r=0.999 7)范围内与峰面积呈良好线性关系,平均回收率分别为92.09%,93.57%,95.82%,RSD分别为1.23%(n=5),1.58%(n=5),2.46%(n=5)。结论方法操作简便,结果准确可靠,重复性好,能有效控制辛苍鼻舒胶囊的质量。

Objective To establish the quality standard for Xincangbishu Capsules.Methods The qualitative identification of Rhizoma Chuanxiong,Fructus Xanthii and Flos Magnoliae in Xincangbishu Capsules were carried out by TLC.The content of α-pinene,β-pinene and cineole in the preparation were determined at the same time by the capillary gas chromatography with sequential increase of temperature programming.The capillary column DB-1（30 m×0.25 mm,0.25 μm） was used with the injector temperature of 230 ℃,the flame ionization detector（FID） temperature of 250 ℃.Results The relevant spots of Rhizoma Chuanxiong,Fructus Xanthii and Flos Magnoliae on TLC plates were clear without the interference of the negative control.The good linearity relationship of α-pinene was during the range of 0.008-0.091 g/L（r=0.999 8）,the average recovery rate was 92.09%with RSD of 1.23%（n=5）;the good linearity relationship of β-pinene was during the range of 0.009-0.093 g/L（r=0.999 8）,the average recovery rate was 93.57%with RSD of 1.58%（n=5）;the good linearity relationship of cineole was during the range of 0.060 4-0.604 g/L（r=0.999 7,the average recovery rate was 95.82%with RSD of 2.46%（n=5）.Conclusion The methods are simple and convenient with accurate and reliable detection results,good reproducibility and the effectively controllable quality of Xincangbishu Capsules.