舒乐胶囊质量标准的提高研究
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摘要
目的:建立舒乐胶囊的质量标准。方法:采用显微镜对玄参、柴胡进行显微特征性鉴别;采用TLC法对主要成分浙贝母、穿心莲、拳参等进行定性鉴别;采用HPLC法测定丹参中有效成分丹酚酸B的含量。色谱柱:phenomenex synergi 4 hydroRP 80A(250 mm×4.6 mm),流动相:乙腈-甲醇-甲酸-水(10∶30∶59∶1),流速:1.0 ml·min-1,检测波长:286 nm,柱温:20℃,进样量:10μl。结果:显微鉴别具有特征性;薄层色谱斑点清晰,在与对照药材或对照品色谱相应的位置上,显相同颜色的荧光主斑点,阴性样品无干扰;丹参中丹酚酸B在10.001~100.007μg·ml~(-1)浓度范围内线性关系良好(r=1.000 0),平均回收率为99.3%,RSD为1.8%(n=6)。结论:本方法操作简便,专属性高、重复性好,可作为舒乐胶囊的质量控制方法。
Objective: To establish the quality standard for Shule capsules. Methods: The microscopic characteristic identification of Figwort and Radix bupleuri was performed under a microscope. The qualitative identification of fritillary,andrographispaniculata and polygonumbistorta was studied by TLC. The content of salvianolic acid B in Salvia miltiorrhiza was determined by HPLC. The chromatographic separation was carried out by using a phenomenex synergi 4 hydro-RP 80A( 250 mm × 4. 6 mm) column. The mobile phase consisted of acetonitrile-methanol-formic acid-water( 10 ∶ 30 ∶ 59 ∶ 1) with gradient elution at a flow rate of 1. 0 ml·min~(-1),and the injection volume was 10 μl. The detection wavelength and the column temperature was 286 nm and 20 ℃,respectively. Results:The microscopic characteristics were obvious. The spots in TLC were clear without any interference. The linear range was 10. 001-100. 007 μg·ml~(-1)( r = 1. 000 0). The average recovery was 99. 3% with RSD of 1. 8%( n = 6). Conclusion: The method is simple with high specificity and good repeatability,which can be used as the quality control method for Shule capsules.
Objective: To establish the quality standard for Shule capsules. Methods: The microscopic characteristic identification of Figwort and Radix bupleuri was performed under a microscope. The qualitative identification of fritillary,andrographispaniculata and polygonumbistorta was studied by TLC. The content of salvianolic acid B in Salvia miltiorrhiza was determined by HPLC. The chromatographic separation was carried out by using a phenomenex synergi 4 hydro-RP 80A( 250 mm × 4. 6 mm) column. The mobile phase consisted of acetonitrile-methanol-formic acid-water( 10 ∶ 30 ∶ 59 ∶ 1) with gradient elution at a flow rate of 1. 0 ml·min~(-1),and the injection volume was 10 μl. The detection wavelength and the column temperature was 286 nm and 20 ℃,respectively. Results:The microscopic characteristics were obvious. The spots in TLC were clear without any interference. The linear range was 10. 001-100. 007 μg·ml~(-1)( r = 1. 000 0). The average recovery was 99. 3% with RSD of 1. 8%( n = 6). Conclusion: The method is simple with high specificity and good repeatability,which can be used as the quality control method for Shule capsules.
引文
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2 石新华,李原,胡丽娟,等.妇宁丸的显微鉴别与薄层色谱鉴别[J].中国医院药学杂志,2013,33(24):2087-2088
3 郝博,苏建.益胆片质量标准完善研究[J].中国药事,2014,28(7):778-782
4 赵文静,菅原颖,王艳宏,等.仙鹿消癖胶囊中淫羊藿、浙贝母、当归的薄层鉴别研究[J].中医药信息,2011,28(4):62-63
5 崔明超,程斌,陈宏降,等.贝母花的定性鉴别及含量测定研究[J].中医药信息,2014,31(4):20-22
6 陶善斌,汪电雷.穿黄消炎胶囊的质量控制研究[J].安徽医药,2013,6(17):932-934
7 张慧晔,潘雪峰,徐小飞,等.复方穿心莲片的薄层鉴别研究[J].中成药,2015,37(2):460-462
8 彭晓君,何书莲,傅海鸥.速效止泻胶囊的质量标准研究[J].中国伤残医学,2008,16(4):31-32
9 汤杰,宋冰娜,郑盼,等.HPLC测定冠心丹参胶囊中主成分的含量[J].中国现代中药,2015,17(10):1078-1082
10 张爱兵,张珺,程月发,等.高效液相色谱法测定丹参胶囊中8种有效成分的含量[J].中南药学,2015,13(1):80-82