乌芪舒筋通络片的质量控制研究
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摘要
目的研究乌芪舒筋通络片质量控制的可行方法。方法采用薄层色谱法鉴别处方中的细辛、桂枝、牛大力,并采用高效液相色谱法测定处方中续断的川续断皂苷Ⅵ含量。结果细辛、桂枝、牛大力的薄层色谱法鉴别专属性强,阴性无干扰;川续断皂苷Ⅵ的含量在491.7~1966.8 ng(r=0.9996)范围内呈良好线性关系,平均加样回收率为101.25%(n=9),RSD为1.40%。结论定性、定量方法操作简单,重现性好,专属性强,能够有效地控制乌芪舒筋通络片的质量,可为该制剂的检验标准提供科学的依据。
Objective To study the feasible method for quality control of Wuqi Shujin Tongluo Tablets. Methods TLC was used to identify Asarum, Cinnamon Twig and Niu Dali in the prescription, and HPLC was used to determine the content of Dipsacus Aspergillus saponin Ⅵ in the prescription. Results The TLC method of Asarum, Cinnamon Twig cassia and Niu Dali had strong specificity and no negative interference. The content of Dipsacus saponin Ⅵ had a good linear relationship between 491.7 and 1966.8 ng(R=0.9996). The average recovery of sample addition was 101.25%(n=9) and RSD was 1.40%. Conclusion The qualitative and quantitative methods are easily operated and with excellent specificity and reproducibility.They can effectively control the quality of Wuqi Shujin Tongluo Tablets, and provide scientific basis for the test standard of the preparation.
Objective To study the feasible method for quality control of Wuqi Shujin Tongluo Tablets. Methods TLC was used to identify Asarum, Cinnamon Twig and Niu Dali in the prescription, and HPLC was used to determine the content of Dipsacus Aspergillus saponin Ⅵ in the prescription. Results The TLC method of Asarum, Cinnamon Twig cassia and Niu Dali had strong specificity and no negative interference. The content of Dipsacus saponin Ⅵ had a good linear relationship between 491.7 and 1966.8 ng(R=0.9996). The average recovery of sample addition was 101.25%(n=9) and RSD was 1.40%. Conclusion The qualitative and quantitative methods are easily operated and with excellent specificity and reproducibility.They can effectively control the quality of Wuqi Shujin Tongluo Tablets, and provide scientific basis for the test standard of the preparation.
引文
[1]陈震尧,陈金英,姚伟生,等.乌芪舒筋通络片质量标准的研究[J].中国现代应用药学,2017,34(8):1133-1136.
[2]陈震尧,谢锴标,姚伟生.乌芪舒筋通络片微生物限度检查方法学研究[J].中国当代医药,2017,24(18):93-96.
[3]陈震尧,陈金英,姚伟生.乌茂舒筋通络片中乌头碱限量检测方法研究[J].中国药房2015,26(36):5144-5146.
[4]曹国颖,胡欣,孙钊,等.医疗机构制剂生产的风险因素分析与管控[J].中国药事,2018,32(1):30-33.
[5]孙凯英,方宇,彭莉蓉,等.陕西省医疗机构制剂现状与对策分析[J].中国药事,2018,32(1):76-81.
[6]国家药典委员会.中国药典[M].一部.北京:中国医药科技出版社,2015:988-989.
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[8]刘若轩,欧倩雯,吕竹芬,等.牛大力饮片的质量标准研究[J].今日药学,2015,25(1):18-20.
[9]胡少伟,钟昆芮,杨佳,等.薄荷茎、叶中黄酮类成分在不同采收期的含量差异性研究[J].中国中药杂志,2018,43(3):544-550.
[10]罗宇东,谭安蔷,陆施衡,等.壮药藤苦参中强心苷的含量测定及不同产地、采收季节对药材含量的影响[J].中国当代医药,2018,25(12):14-17.
[11]唐广应,文方杰,任一,等.续骨疗伤膏的质量标准研究[J].中国药房,2016,27(9):1233-1235.
[12]杨晓腾,滕统华.祛风止痛胶囊质量标准研究[J].中国药品标准,2016,17(1):24-27.
[13]杜建红,寇新民,王艳丽,等.HPLC测定止痛壮骨散中川续断皂苷Ⅵ的含量[J].中国执业药师,2016,13(11):24-30.
[14]关雪峰,田原,樊晖,等.补正续骨泡腾颗粒质量标准研究[J].辽宁中医药大学学报,2017,19(1):13-15.
[15]黄慧,倪峰,郭丹,等.基于UPLC指纹图谱的青黛提取工艺评价研究[J].中国现代应用药学,2017,34(4):533-537.
[16]张帆,陈越,侯文浩,等.芒果叶中总黄酮提取工艺优选[J].中国药业,2017,26(15):5-10.
[17]江敏瑜,闫丹,陈娇,等.三七跌打软膏的制备及体外透皮特性研究[J].中草药,2017,48(22):4639-4647.
[18]高乐,田宇柔,王鑫国,等.HPLC同时测定续断配方颗粒中4种成分的含量[J].中药材,2017,40(4):884-886.
[19]廖华丽,丁冬梅,李清.防风薄层色谱指纹图谱的建立及其方法学研究[J].山西医科大学学报,2018,49(6):644-650.
[20]崔璐璐.桃花药材薄层色谱鉴别和高效液相色谱指纹图谱研究[J].药物分析杂志,2017,37(2):333-338.
[2]陈震尧,谢锴标,姚伟生.乌芪舒筋通络片微生物限度检查方法学研究[J].中国当代医药,2017,24(18):93-96.
[3]陈震尧,陈金英,姚伟生.乌茂舒筋通络片中乌头碱限量检测方法研究[J].中国药房2015,26(36):5144-5146.
[4]曹国颖,胡欣,孙钊,等.医疗机构制剂生产的风险因素分析与管控[J].中国药事,2018,32(1):30-33.
[5]孙凯英,方宇,彭莉蓉,等.陕西省医疗机构制剂现状与对策分析[J].中国药事,2018,32(1):76-81.
[6]国家药典委员会.中国药典[M].一部.北京:中国医药科技出版社,2015:988-989.
[7]陈秀梅.小儿柴桂退热颗粒薄层色谱鉴别研究[J].襄阳职业技术学院学报,2014,13(5):20-21.
[8]刘若轩,欧倩雯,吕竹芬,等.牛大力饮片的质量标准研究[J].今日药学,2015,25(1):18-20.
[9]胡少伟,钟昆芮,杨佳,等.薄荷茎、叶中黄酮类成分在不同采收期的含量差异性研究[J].中国中药杂志,2018,43(3):544-550.
[10]罗宇东,谭安蔷,陆施衡,等.壮药藤苦参中强心苷的含量测定及不同产地、采收季节对药材含量的影响[J].中国当代医药,2018,25(12):14-17.
[11]唐广应,文方杰,任一,等.续骨疗伤膏的质量标准研究[J].中国药房,2016,27(9):1233-1235.
[12]杨晓腾,滕统华.祛风止痛胶囊质量标准研究[J].中国药品标准,2016,17(1):24-27.
[13]杜建红,寇新民,王艳丽,等.HPLC测定止痛壮骨散中川续断皂苷Ⅵ的含量[J].中国执业药师,2016,13(11):24-30.
[14]关雪峰,田原,樊晖,等.补正续骨泡腾颗粒质量标准研究[J].辽宁中医药大学学报,2017,19(1):13-15.
[15]黄慧,倪峰,郭丹,等.基于UPLC指纹图谱的青黛提取工艺评价研究[J].中国现代应用药学,2017,34(4):533-537.
[16]张帆,陈越,侯文浩,等.芒果叶中总黄酮提取工艺优选[J].中国药业,2017,26(15):5-10.
[17]江敏瑜,闫丹,陈娇,等.三七跌打软膏的制备及体外透皮特性研究[J].中草药,2017,48(22):4639-4647.
[18]高乐,田宇柔,王鑫国,等.HPLC同时测定续断配方颗粒中4种成分的含量[J].中药材,2017,40(4):884-886.
[19]廖华丽,丁冬梅,李清.防风薄层色谱指纹图谱的建立及其方法学研究[J].山西医科大学学报,2018,49(6):644-650.
[20]崔璐璐.桃花药材薄层色谱鉴别和高效液相色谱指纹图谱研究[J].药物分析杂志,2017,37(2):333-338.