三七破壁饮片质量分析
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摘要
目的建立三七破壁饮片的质量控制方法。方法参考2015年版《中华人民共和国药典》相关检测方法,对10批三七破壁饮片的性状、显微特征、薄层鉴别、指纹图谱及其水分、灰分、浸出物、重金属、粒径分布以及人参皂苷Rb1、人参皂苷Rg1、三七皂苷R1的含量等进行检测,建立三七破壁饮片的质量控制方法。结果三七破壁饮片为灰褐色至灰黄色的颗粒,气微,味苦回甜。显微镜下可见淀粉粒甚多,单粒圆形、半圆形或圆多角形,直径4～30μm,脂道碎片含黄色分泌物,导管碎片较少。薄层鉴别显示,10批样品在与对照品色谱相应的位置上,均显示相同颜色的斑点。水分范围为5.05%～9.82%,总灰分范围为2.96%～3.20%,酸不溶性灰分范围为0.52%～1.19%,浸出物含量范围为21.03%～27.78%,每0.01g样品中未破壁细胞数为46～81。指纹图谱显示,各批次三七破壁饮片的色谱图相似度为0.879～0.996。粒径分析显示,各样品D90为34.09～38.93μm。10批样品中人参皂苷Rg1、人参皂苷Rb1、三七皂苷R1总含量为6.9%～8.3%。结论建立的方法可用于三七破壁饮片的质量控制。
Objective To establish the quality control method for Panax notoginseng ultrafine decoction pieces.Methods With reference to related methods in the 2015 edition of Pharmacopoeia of The Peoples Republic of China,10 batches of Panaxnotoginseng ultrafine decoction pieces were analyzed in terms of properties,microscopic features,thin-layer chromatography(TLC)identification,fingerprint,water content,ash content,extract,heavy metals,particle size distribution,and content of ginsenoside Rb1,ginsenoside Rg1,and notoginsenoside R1,so as to establish the quality control method for Panax notoginseng ultrafine decoction pieces.Results Panax notoginseng ultrafine decoction pieces were taupe to grayyellow particles with a touch of smell,a bitter taste,and a sweet aftertaste.Microscopic observation showed a large number of starch grains with a round,semi-circular,or polygonal shape and a diameter of4-30μm,yellow secretions in lipid debris,and a small amount of ductal debris.TLC identification showed that the 10 batches of samples and the reference samples had spots with the same color at the corresponding position of the chromatograph.The ranges of water content,total ash,acid-insoluble ash,and extract were 5.05%-9.82%,2.96%-3.20%,0.52%-1.19%,and 21.03%-27.78%,respectively.The number of unbroken cells in each 0.01 g sample ranged from 46 to 81.The fingerprint analysis showed a similarity of0.879-0.996 between the 10 batches of Panax notoginsengultrafine decoction pieces.Particle size analysis showed that D90 of these samples ranged from 34.09 to 38.93μm.The total content of ginsenoside Rg1,ginsenoside Rb1,and notoginsenoside R1 in the 10 batches of samples ranged from 6.9% to 8.3%.Conclusion The method established in this study can be used for the quality control of Panax notoginseng ultrafine decoction pieces.
Objective To establish the quality control method for Panax notoginseng ultrafine decoction pieces.Methods With reference to related methods in the 2015 edition of Pharmacopoeia of The Peoples Republic of China,10 batches of Panaxnotoginseng ultrafine decoction pieces were analyzed in terms of properties,microscopic features,thin-layer chromatography(TLC)identification,fingerprint,water content,ash content,extract,heavy metals,particle size distribution,and content of ginsenoside Rb1,ginsenoside Rg1,and notoginsenoside R1,so as to establish the quality control method for Panax notoginseng ultrafine decoction pieces.Results Panax notoginseng ultrafine decoction pieces were taupe to grayyellow particles with a touch of smell,a bitter taste,and a sweet aftertaste.Microscopic observation showed a large number of starch grains with a round,semi-circular,or polygonal shape and a diameter of4-30μm,yellow secretions in lipid debris,and a small amount of ductal debris.TLC identification showed that the 10 batches of samples and the reference samples had spots with the same color at the corresponding position of the chromatograph.The ranges of water content,total ash,acid-insoluble ash,and extract were 5.05%-9.82%,2.96%-3.20%,0.52%-1.19%,and 21.03%-27.78%,respectively.The number of unbroken cells in each 0.01 g sample ranged from 46 to 81.The fingerprint analysis showed a similarity of0.879-0.996 between the 10 batches of Panax notoginsengultrafine decoction pieces.Particle size analysis showed that D90 of these samples ranged from 34.09 to 38.93μm.The total content of ginsenoside Rg1,ginsenoside Rb1,and notoginsenoside R1 in the 10 batches of samples ranged from 6.9% to 8.3%.Conclusion The method established in this study can be used for the quality control of Panax notoginseng ultrafine decoction pieces.
引文
[1]国家药典委员会.中华人民共和国药典:一部[M].北京:中国医药科技出版社,2015:11.
[2]李时珍.本草纲目:上册[M].刘衡如,点校.北京:人民卫生出版社,2005.
[3]王肯堂.证治准绳[M].北京:中国中医药出版社,1997.
[4]刘颖,苏桂云,芦海生,等.不同部位三七粉显微特征及质量标准[J].中国实验方剂学杂志,2017,23(23):34-39.
[5]韩丽丽,孙俊英,马全龙.三七粉及其一种伪品的鉴别检验研究[J].时珍国医国药,2016,27(12):2932-2933.
[6]张迅杰,赫军,柳芳,等.人参和三七HPLC特征图谱研究[J].山东中医药大学学报,2017,41(4):372-376.
[7]陈炜璇,刘敏,严萍,等.三七破壁饮片指纹图谱研究[J].中药材,2012,35(7):1056-1061.
[8]吴小明,梁少瑜,程文胜,等.三七普通细粉与超微粉中三七皂苷R1、人参皂苷Rb1及人参皂苷Rg1体外溶出行为的比较研究[J].中草药,2013,44(24):3489-3492.
[9]张传辉,贾成友,李微,等.三七接骨凝胶膏剂的制备及体外透皮特性研究[J].中草药,2015,46(5):654-664.
[10]任韡,李欣,白林,等.HPLC法测定保元丹中三七皂苷R1的含量[J].中国药物应用与监测,2017,14(2):81-83.
[11]常翠,陈思思,王娟,等.HPLC法测定大鼠皮肤中三七皂苷R1和人参皂苷Rb1[J].中成药,2017,39(9):1885-1888.
[12]于霞,刘佳,王一男,等.HPLC法同时测定疏通散中三七皂苷R1、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1的含量[J].沈阳药科大学学报,2016,33(7):537-541.
[13]董鹏鹏,梅全喜.中药破壁饮片的质量控制与评价方法研究进展[J].中药材,2015,38(9):1999-2002.
[14]陈斌,许慧琳,贾晓斌.三七炮制的研究进展与研究思路[J].中草药,2013,44(4):482-487.
[2]李时珍.本草纲目:上册[M].刘衡如,点校.北京:人民卫生出版社,2005.
[3]王肯堂.证治准绳[M].北京:中国中医药出版社,1997.
[4]刘颖,苏桂云,芦海生,等.不同部位三七粉显微特征及质量标准[J].中国实验方剂学杂志,2017,23(23):34-39.
[5]韩丽丽,孙俊英,马全龙.三七粉及其一种伪品的鉴别检验研究[J].时珍国医国药,2016,27(12):2932-2933.
[6]张迅杰,赫军,柳芳,等.人参和三七HPLC特征图谱研究[J].山东中医药大学学报,2017,41(4):372-376.
[7]陈炜璇,刘敏,严萍,等.三七破壁饮片指纹图谱研究[J].中药材,2012,35(7):1056-1061.
[8]吴小明,梁少瑜,程文胜,等.三七普通细粉与超微粉中三七皂苷R1、人参皂苷Rb1及人参皂苷Rg1体外溶出行为的比较研究[J].中草药,2013,44(24):3489-3492.
[9]张传辉,贾成友,李微,等.三七接骨凝胶膏剂的制备及体外透皮特性研究[J].中草药,2015,46(5):654-664.
[10]任韡,李欣,白林,等.HPLC法测定保元丹中三七皂苷R1的含量[J].中国药物应用与监测,2017,14(2):81-83.
[11]常翠,陈思思,王娟,等.HPLC法测定大鼠皮肤中三七皂苷R1和人参皂苷Rb1[J].中成药,2017,39(9):1885-1888.
[12]于霞,刘佳,王一男,等.HPLC法同时测定疏通散中三七皂苷R1、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1的含量[J].沈阳药科大学学报,2016,33(7):537-541.
[13]董鹏鹏,梅全喜.中药破壁饮片的质量控制与评价方法研究进展[J].中药材,2015,38(9):1999-2002.
[14]陈斌,许慧琳,贾晓斌.三七炮制的研究进展与研究思路[J].中草药,2013,44(4):482-487.