板蓝根配方颗粒的质量标准研究  

Study on the Quality Standard of Banlangen Dispensing Granules

作　　者：巩伟[1] 孙旭[1] 赵庆华[1] 李兴东[1] 赵梅[1] 张琨[1] 张欣欣[1] 

机构地区：[1]济南军区联勤部药品仪器检验所,济南250022

出　　处：《中国药房》2015年第18期2541-2544,共4页China Pharmacy

基　　金：军队医疗机构制剂标准提高科研专项课题(No.14ZJZ01-2)

摘　　要：目的：建立板蓝根配方颗粒的质量标准。方法：采用薄层色谱法鉴别板蓝根、亮氨酸和精氨酸,按颗粒剂制剂通则进行检查,测定浸出物,并采用高效液相色谱法测定（R,S）-告依春的含量。色谱柱为Shimadzu VP-ODS C18,流动相为甲醇-0.05%磷酸溶液（7∶93,V/V）,流速为1.0 ml/min,检测波长为245 nm,柱温为室温,进样量为10μl。结果：薄层色谱分离度好,斑点清晰;粒度、水分、溶化性、微生物限度检查均符合规定;浸出物应不少于25.0%;含量测定中,（R,S）-告依春质量浓度在1.565 9~50.109 8μg/ml范围内与其峰面积呈良好的线性关系（r=0.999 9,n=6）,精密度、稳定性、重复性试验的RSD≤1.12%,平均加样回收率为99.25%（RSD=2.08%,n=9）,并初步确定（R,S）-告依春的含量应不得少于0.35 mg/g。结论：建立的质量标准增加了含量测定,控制项目更加全面、合理,可用于板蓝根配方颗粒的质量控制。OBJECTIVE：To establish the quality standard of Banlangen dispensing granules. METHODS：Thin layer chromatography（TLC）was used to identify Isatis indigotica,leucine and arginine,the items according to granules preparations and the extraction were detected. HPLC was conducted to determine the content of（R,S）-goitrin. The Shimadzu VP-ODS C18 column was used with the mobile phase of methanol-0.05% phosphoric acid（7 ∶ 93,V/V）at the flow rate of 1.0 ml/min. The detection wavelength was set at 245 nm,and the column temperature was room temperature. The sample size was 10 μl. RESULTS：TLC showed clear spots and good resolution. Particle size,moisture,dissolubility and microbial limit test were all conformed to the specification. The extraction limit was no less than 25.0%.（R,S）-goitrin showed a good linear relationship in the range of 1.565 9-50.109 8μg/ml（r=0.999 9,n=6）. The average recovery was 99.25%（RSD=2.08%,n=9）;the RSDs of precision,stability and repeatability tests were no more than 1.12%. The content of（R,S）-goitrin was initially determined as 0.35 mg/g. CONCLUSIONS：The established quality standard has increased content determination,and the control programs are more comprehensive and reasonable. It can be used for the quality control of Banlangen dispensing granules.

关 键 词：板蓝根配方颗粒 质量标准 薄层色谱法 高效液相色谱法 (R S)-告依春 

分 类 号：R284.1[医药卫生—中药学] R927.2[医药卫生—中医学]