冠脉宁片(胶囊)现行薄层鉴别标准比较研究

目的：统一冠脉宁片(胶囊)的薄层鉴别方法。 方法：归纳总结冠脉宁16个现行标准中10项薄层鉴别方法。通过实验比较不同处理方法及薄层展开条件，最终确定适宜方法。 结果：经实验研究，最终统一葛根、丹参、延胡索薄层鉴别项，合并血竭、冰片及何首乌、二苯乙烯薄层鉴别项。 结论：本实验确定的7项薄层鉴别方法为16家生产企业提供了统一、切实可行的薄层执行标准，可有效控制该产品质量，建议取消原儿茶醛鉴别项，可统一增订当归、鸡血藤鉴别项。

Objective: To unify the method of thin-layer chromatography(TLC)for Guanmaining tablets(capsules). Methods: The TLC methods for 10 items in 16 current standards for Guanmaining tablets(capsules)were summarized.The appropriate method was eventually determined through comparison of different processing methods and TLC conditions in experiments. Results: The TLC identification items for Puerariae Radix,Salviae Miltiorrhizae Radix and Corydalis Rhizoma were unified.The items for Draconis Sanguis,borneol and stilbene glycoside,Polygoni Multiflori Radix were consolidated. Conclusion: The TLC methods for seven items determined in this experiment provide a uniformed and practical TLC executive standard for 16 manufacturers,which can effectively control the quality of Guanmaining tablets(capsules).It is suggested to abolish the identification item for protocatechualdehyde and add the identification item for Angelicae Sinensis Radix and Spatholobi Caulis.

[1] LIU Hong-xia(刘红霞),SUN Zhi-po(孙志坡),LIANG Jun(梁军).The TLC research of the Guanmaining soft capsule(冠脉宁软胶囊薄层色谱鉴别研究)[J].Chin Herb Med Form(方药纵横),2007,34(3):343
[2] FU Ying-hua(傅应华),XU Hong-xiang(徐宏祥),JIANG Ning-hua(姜宁华).Studies on the quality control method of Yanluotong granules(眼络通颗粒剂的质量控制项目研究)[J].Chin J Pharm Anal(药物分析杂志),2005,25(8):912
[3] JIA Yan-ning(贾艳宁),WU Li-hong(吴丽红),ZHANG Qing(张庆).Study on extraction condition of the Red Sage Root in compound salvia tablets(复方丹参片中丹参提取工艺研究)[J].Heilongjiang Med J (黑龙江医药),2004,17(5):365
[4] LI Ren-shu(李认书),LI Yong-qiang(李永强).The research progress of salvianolic acid(丹酚酸的研究进展)[J].Lishizhen Med Mater Med Res(时珍国医药),2003,14(6):371
[5] WEI Hui-zhen(魏惠珍),ZHANG Jie(张洁),RAO Yi(饶毅),et al.The pretreatment research of total phenolic acid in Radix Salviae Miltiorrhizae(丹参中总酚酸测定的前处理方法研究)[J].Chin Tradit Herb Drugs(中草药),2008,39(8):1182
[6] FANG Xin-sheng(房信胜),TAN Xiao-mei(谭晓梅).The qualitative analysis and quantitative analysis of purification of salvianolic acids by macroreticular resin(大孔吸附树脂纯化丹参总酚酸的定性定量分析)[J].China J Chin Mater Med(中国中药杂志),2005,17(30):1331
[7] WANG Xiao-ping(王小平),LIU Feng(刘峰),HAN Cui(韩翠).Optimization of extracting technology of total salvianolic acid in Salvia miltiorrhiza(丹参总酚酸提取工艺的优化)[J].J Yunnan Univ Tradit Chin Med (云南中医学院学报),2010,33(2):32
[8] LI Yong-qing(李永庆),CHEN Lei(陈蕾),ZHU Ji-hong(朱霁虹).TLCS determination of tetrahydropalmatine,tetrandrine and demethyltetrandrine in Tonglike injection(描法测定痛立克注射液中THP、粉防己碱和防己诺林碱的含量)[J].Chin J Pharm Anal(药物分析杂志),2001,21(1):28
[9] LI Qing-cui(李青翠),ZHONG Hua-ren(钟化人).Determination of tetrahydropalmatine in Kuntaian capsule by TLCS(薄层扫描法测定坤泰安胶囊中THP的含量)[J].Chin J Pharm Anal(药物分析杂志),1997,17(4):267
[10] YANG Pei-jin(杨培金),LUO Ding-qiang(罗定强),HUANG Yan(黄艳),et al.Study of the unity of quality standards of Guyuling preparation(骨愈灵制剂质量标准统一的研究)[J].Northwest Pharm J(西北药学杂志)[J],2013,28(6):572
[11] LIU Qian(刘倩),WU Xiao-yan(伍小燕),HUANG Quan-fang(黄权芳),et al.Study on the quality standard for Shengfa Wufa oral solution(生发乌发口服液质量标准研究)[J].Northwest Pharm J(西北药学杂志),2013,28(3):235