再造丸质量标准研究  

Study on Quality Standard of Zaizao Pills

作　　者：程似锦[1] 李恒 Cheng Sijin;Li Heng(Department of Biological Medicine, Changjiang Professional College, Wuhan, Hubei, China 430064;Wuhan Institute for Drug and Medical Device Control, Wuhan, Hubei, China 430075)

机构地区：[1]长江职业学院生物医药学院,湖北武汉430064 [2]武汉药品医疗器械检验所,湖北武汉430075

出　　处：《中国药业》2018年第10期16-18,共3页China Pharmaceuticals

摘　　要：目的建立再造丸的质量标准。方法采用薄层色谱法定性鉴别处方中的秦艽、续断;采用高效液相色谱(HPLC)法测定秦艽中龙胆苦苷的含量,流动相为甲醇-水(30∶70),检测波长为275 nm,流速为1.0 mL/min,柱温为30℃。结果薄层色谱分离度良好。龙胆苦苷进样量在0.019 74~1.974 1μg范围内与峰面积积分值线性关系良好,r=0.999 9(n=7);平均回收率为98.11%,RSD为0.44%(n=6)。结论该方法有效,结果准确、可靠,可用于本制剂的质量控制。Objective To establish the quality standard for Zaizao Pills. Methods The Gentianae Macrophyllae Radix and Dipsaci Radix in the prescription were identified by TLC. The content of gentiopicrin of Gentianae Macrophyllae Radix was determined by HPLC,the mobile phase was methanol-water（ 30 ∶ 70）,the detection wavelength was 275 nm,the flow rate was 1. 0 mL/min,and the column temperature was 30 ℃. Results The TLC bands were separated well. The gentiopicrin showed a good linear relationship in the rang of0. 019 74-1. 974 1 μg,r = 0. 999 9（ n = 7）,the average recovery was 98. 11%,and RSD was 0. 44%（ n = 6）. Conclusion The methods are effective,accurate and reliable,which can be used for the quality control of Zaizao Pills.

关 键 词：再造丸 秦艽 续断 薄层色谱法 高效液相色谱法 质量标准 

分 类 号：R284.1[医药卫生—中药学] R286.0[医药卫生—中医学]