熊胆丸的质量标准研究  

Study on Quality Standard of Bear Gall Pill

作　　者：邓茂芝 赵常军 彭雪芬 杨建春 

机构地区：[1]江西宜春市食品药品检验所,江西宜春336000 [2]江西宜春市第六人民医院,江西宜春336000

出　　处：《中国药房》2012年第3期253-255,共3页China Pharmacy

摘　　要：目的:建立熊胆丸的质量标准。方法:采用薄层色谱(TLC)法对制剂中熊胆、黄连、龙胆、栀子进行定性鉴别;采用毛细管气相色谱法对样品中冰片、薄荷脑进行定量测定。结果:TLC斑点清晰、分离度好,阴性无干扰;冰片、薄荷脑的检测浓度分别在56.9～683.3(r=0.9987)、56.0～672.0(r=0.9984)μg.mL-1范围内与各自峰面积积分值呈良好线性关系,平均回收率分别为98.68%、99.07%,RSD分别为1.1%、1.0%(n均为9)。结论:所建标准可用于熊胆丸的质量控制。OBJECTIVE： To establish the quality standard of Bear gall pill. METHODS： TLC was used to identify bear gall, Coptidis Rhizoma, Gentianae Radix Et Rhizoma, Gardenia jasminoides qualitatively. Capillary gas chromatography was adopted to determine borneol and menthol quantitatively. RESULTS： TLC spots were clear and well-separated without interference from negative sample; The linear range of borneol was 56.9-683.3 μg. mL^-1 （r=0.998 7） with an average recovery of 98.68% （RSD= 1.1%, n=9）; the linear range of menthol was 56.0-672.0μg. mL^-1（r=0.998 4） with an average recovery of 99.07% （RSD= 1.0% ,n=9）. CONCLUSION：Established standard can be used for the quality control of the drug.

关 键 词：熊胆丸 冰片 薄荷脑 气相色谱法 薄层色谱法 质量标准 

分 类 号：R284.2[医药卫生—中药学] R283.62[医药卫生—中医学]