灯盏花素软袋大输液质量标准研究  

Study on Quality Standard of Large Volume Parenteral Infusion of Breviscapine Soft Bag

作　　者：汤秀梅 刘丹 赵娟 张煌 丁江生 TANG Xiu-mei;LIU Dan;ZHAO Juan;ZHANG Huang;DING Jiang-sheng(Yunnan Institute of Materia Medica// Key Laboratory of Yunnan Traditional Chinese Medicine and EthnicMedicine New Drug Creation Enterprise// Innovation and Research Center of Yunnan Baiyao Grou)

机构地区：[1]云南省药物研究所/云南省中药和民族药新药创制企业重点实验室/云南白药集团创新研发中心,云南昆明650100

出　　处：《云南中医中药杂志》2018年第9期65-67,共3页Yunnan Journal of Traditional Chinese Medicine and Materia Medica

基　　金：云南省科技厅项目(NO:2014DA022)

摘　　要：目的建立灯盏素软袋大输液的质量标准。方法高效液相色谱法测定该制剂中野黄芩苷的含量进行质量检查;并测定其PH值,渗透压,不溶性微粒。结果采用以十八烷基硅烷键合硅胶为色谱柱;以乙腈-0. 1%磷酸(18:82)为流动相,流速1. 0 m L/min,检测波长335 nm。野黄芩苷的线性范围为16μg/m L^400μg/m L(r=0. 9999),平均回收率为100. 2%。结论建立的灯盏花素软袋大输液的质量标准,其含量测定方法简便,可控,可用于灯盏花素大输液的质量控制指标。Objective： To establish the quality standard of large volume parenteral infusion of breviscapine soft bag. Methods： High performance liquid chromatography was used to determine the content of wild baicalin in the preparation for quality inspection. The pH value, osmotic pressure and insoluble particles were determined. Results： The octadecylsilane bonded silica gel was used as the column, the mobile phase was acetonitrile -0.1% phosphoric acid （18：82）, the flow rate was 1.0 mL/min, and the detection wavelength was 335 nm. The linear range of wild baicalin was 16 μg/mL to 400 μg/mL （r=0.9999）, and the average recovery was 100.2%. Conclusion： The quality standard of the breviscapine soft bag infusion is established and the method for determining the content is simple and controllable, and can be used for the quality control index of breviscapine large volume parenteral infusion.

关 键 词：灯盏花素软袋大输液 质量标准 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学]