肠可宁微丸质量标准研究
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摘要
目的建立肠可宁微丸的质量标准。方法采用薄层色谱(TLC)法定性鉴别黄芪、黄柏;采用高效液相色谱法测定盐酸小檗碱的含量,色谱柱为YMC-Pack ODS柱(150 mm×4.6 mm,5μm),流动相为乙腈-0.05 mol/L磷酸二氢钾溶液(25∶75,V/V),流速为1.0 m L/min,检测波长为345 nm,柱温为30℃,进样量为10μL。结果黄芪、黄柏的TLC图斑点清晰,分离度好,阴性对照无干扰。精密度、稳定性、重复性试验的RSD均小于3%;盐酸小檗碱质量浓度在10～100μg/m L范围内与峰面积线性关系良好,r=0.999 7(n=5);回收率为99.84%～102.93%,RSD为1.21%(n=6)。结论该方法操作简单,精密度、稳定性、重复性均好,专属性强,可用于肠可宁微丸的质量控制。
Objective To establish the quality standard of Changkening Pellets.Methods TLC method was used for qualitative identification of Astragalus membranaceus and Phellodendron chinense in Changkening Pellets.HPLC method was used for the content determination of berberine hydrochloride in this preparation,the chromatographic column was YMC-Pack ODS column(150 mm × 4.6 mm,5 μm),the mobile phase was acetonitrile-0.05 mol/L potassium dihydrogen phosphate(25 ∶75,V/V),the flow rate was 1.0 m L/min,the detection wavelength was 345 nm,the column temperature was 30 ℃,and the sample size was 10 μL.Results The TLC sports of Astragalus membranaceus and Phellodendron chinense were clear,with good separation and no interference from negative control,and RSDs of precision,stability and repeatability tests were less than 3%.The berberine hydrochloride showed a good linear relationship in the range of 10-100 μg/m L,r = 0.999 7(n = 5).The average recovery was 99.84%-102.93%,RSD was 1.21%(n = 6).Conclusion The method is simple,accurate,stable,reproducible and specific,which can be used for the quality control of Changkening Pellets.
Objective To establish the quality standard of Changkening Pellets.Methods TLC method was used for qualitative identification of Astragalus membranaceus and Phellodendron chinense in Changkening Pellets.HPLC method was used for the content determination of berberine hydrochloride in this preparation,the chromatographic column was YMC-Pack ODS column(150 mm × 4.6 mm,5 μm),the mobile phase was acetonitrile-0.05 mol/L potassium dihydrogen phosphate(25 ∶75,V/V),the flow rate was 1.0 m L/min,the detection wavelength was 345 nm,the column temperature was 30 ℃,and the sample size was 10 μL.Results The TLC sports of Astragalus membranaceus and Phellodendron chinense were clear,with good separation and no interference from negative control,and RSDs of precision,stability and repeatability tests were less than 3%.The berberine hydrochloride showed a good linear relationship in the range of 10-100 μg/m L,r = 0.999 7(n = 5).The average recovery was 99.84%-102.93%,RSD was 1.21%(n = 6).Conclusion The method is simple,accurate,stable,reproducible and specific,which can be used for the quality control of Changkening Pellets.
引文
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[2]朴有为.参苓白术散加减治疗慢性结肠炎34例[J].中医现代药物应用,2013,7(18):122-123.
[3]崔国宁,刘喜平.浅谈黄芪在脾胃病治疗中的用药规律[J].陕西中医药大学学报,2018,41(4):15-17.
[4]朱莉萍.黄芪的药理研究及进展[J].内蒙古中医药,2018,37(3):98-99.
[5]国家药典委员会.中华人民共和国药典(四部)[M].北京:中国医药科技出版社,2015.
[6]韩毅,于艳,吴振起,等.清肺膏的质量标准研究[J].山西医科大学学报,2018,49(1):31-35.
[7]丰长江,范恒.复方苦参灌肠剂的质量标准研究[J].湖北中医药大学学报,2018,20(2):35-38..
[8]袁宏佳,郭洪明,梅娇,等.HPLC法测定痔疮外洗颗粒中盐酸小檗碱的含量[J].实用中医药杂志,2018,34(4):502-503.
[9]侯晓丽,谭朝丹,时扣荣,等.HPLC法测定冬柏通淋合剂中盐酸小檗碱的含量[J].药学实践杂志,2017,35(4):353-378.
[10]吕本强,范积平,张贞良,等.高效液相色谱法测定复方石栗喷雾剂中盐酸小檗碱含量[J].中国药业,2017,26(3):15-17.