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基层中药杂志 2000 年第 14 卷第 4 期
— 21 — P rvm ary Jourm al of Chym ese M ateria M edica
·药品质量·
复方苦参注射液的质量标准研究
宋茹袁继民(济南军区药品检验所, 济南 250022)
摘要目的: 建立复方苦参注射液的质量控制标准。方法: 用薄层色谱法对该制剂中当归、苦参进行定性
鉴别; 用 H PL C 法测定该制剂中阿魏酸的含量, 并用 TL C 法测定该制剂中苦参碱的含量。结果: 薄层色谱中
斑点清晰, 易于识别; 阿魏酸在 1. 95~ 9. 76 g· m g- 1范围内呈线性关系, r= 0. 998 0, 平均回收率为 96. 8 ,
R SD = 0. 3 。苦参碱斑点在 2. 16~ 7. 56 g 之间与其吸收度积分值呈线性关系, r= 0. 999 2, 平均回收率为
99. 0 , R SD = 0. 61 。结论: 本法可有效地控制复方苦参注射液的质量。
关键词复方苦参注射液阿魏酸苦参碱 TL C H PL C TL C scanning
Study on Quality Standards pound Injection of Rad ix sop horae f lavescen tis
Song R u, Yuan J iming
( Institu te fo r D rug Con tro l of the J inan M ilitary R egion, J inan 250022)
ABSTRACT OBJECTIVE: To estab lish a quality con tro l standard pound R ad ix sop ha rae
f lavescen tis in jecton. M ETHOD S: T he R ad ix ang elicae sinen sis and R ad ix sop horae f lavescen tis in
compound R ad ix sop h rae f lvescen tis in jection w ere iden tified by TL C. T he con ten t of feru lic acid in the
in jection w as determ ined by H PL C. A lso the con ten t of m atrine in the in jection w as determ ined by TL C-
scann ing. RESULTS: T he spo ts in the TL C w ere clear and distingu ishab le. T he linear ranges of feru lic acid
w as 1. 95- 9. 76 g. m l[- 1 ] , r= 0. 9980. T he average recovery w as 96. 8% , R SD = 0. 3 . T he linear ranges
of m