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目的:对紫贝胶囊质量标准进行研究。方法:采用显微鉴别法对浙贝母和五味子进行鉴别;薄层色谱法对制剂中的五味子、紫河车进行定性鉴别,并采用高效液相色谱对浙贝母中贝母素甲和贝母素乙进行含量测定,色谱柱为Agilent5-TC-C18(2)(4.6 mm×250 mm,5μm)柱,流动相为乙腈-0.05%二乙胺(65∶35),流速1.0 m L·min-1,柱温25℃,蒸发光散射检测器检测(气体压力:25psi;漂移管温度:60℃;喷雾器:冷却)。结果:显微鉴别可以鉴别出浙贝母和五味子;薄层鉴别能够明显鉴别出五味子、紫河车。贝母素甲0.582 2~5.240 2μg(r=0.999 9)范围内呈良好的线性关系,平均回收率为99.53%(RSD=2.09%)、贝母素乙在0.400 8~3.607 2μg(r=0.999 7)范围内呈良好的线性关系,平均回收率为100.65%(RSD=2.12%)。结论:建立的质量控制方法能更好的控制紫贝胶囊的质量,可作为本制剂的质量标准。
Objective: To study the quality standard of Vitex capsule. Methods: The Fritillaria cirrhosa and Schisandra sphenanthera were identified by microscopic identification method. The schisandra and Placenta carvacrolifera in the preparations were identified by TLC, and the contents of Fritillaria and Fritillaria The column was Agilent5-TC-C18 (2) (4.6 mm × 250 mm, 5μm) with a mobile phase of acetonitrile-0.05% diethylamine (65:35) and a flow rate of 1.0 mL · min-1, column temperature 25 ° C, detection by evaporative light scattering detector (gas pressure: 25 psi; drift tube temperature: 60 ° C; nebulizer: cooling). Results: Micro-identification can identify Fritillaria and Schisandra; TLC identification can clearly identify Schisandra, Placenta. The average recoveries were 99.53% (RSD = 2.09%), and that of peiminine B was 0.400 8 ~ 3.607 2μg (r = 0.999 7) showed a good linear relationship, the average recovery was 100.65% (RSD = 2.12%). Conclusion: The established quality control method can better control the quality of the purple shell capsule, which can be used as the quality standard of the preparation.