糖肾康胶囊的质量标准研究
|
摘要
目的:建立糖肾康胶囊的质量标准。方法:采用薄层色谱法(TLC)对制剂中丹参、知母和黄芪进行定性鉴别,采用高效液相色谱法测定制剂中淫羊藿苷的含量,色谱柱为Diamonsil C18(200 mm×4. 6 mm,5μm),流动相为乙腈-水(27∶73),流速为1. 0 ml/min,检测波长为270 nm,柱温为30℃,进样量为10μl。结果:丹参、知母和黄芪的TLC图斑点清晰,分离度好,阴性对照无干扰。淫羊藿苷进样量线性范围为0. 093～0. 464μg(r=0. 999 9);精密度、稳定性、重复性试验的RSD均小于2. 0%;平均加样回收率为99. 18%,RSD为1. 20%(n=9)。结论:所建标准可用于糖肾康胶囊的质量控制。
Objective:To establish the quality standard of tangshenkang capsule. Methods:TLC was used for qualitative identification of Salvia miltiorrhiza,Anemarrhena asphodeloides and Astragalus membranaceus in the preparation. HPLC method was used to determine the content of icariin. The determination was performed on Diamonsil C18 column with mobile phase consisting of acetonitrile-water(27∶ 73) at the flow rate of 1. 0 ml/min. The detection wavelength was set at 270 nm,and the column temperature was 30℃. The sample size was 10 μl. Results:TCL spots of Salvia miltiorrhiza,Anemarrhena asphodeloides and Astragalus membranaceus were clear and well separated without interference from negative control. The linear range of icariin ranged 0. 093 ～0. 464 μg( r = 0. 999 9); the RSDs of precision,stability and repeatability tests were no more than 2. 0%. The average recovery was 99. 18%( RSD was 1. 20%,n = 9). Conclusions:The established standard can be used for the quality control of tangshenkang capsule.
Objective:To establish the quality standard of tangshenkang capsule. Methods:TLC was used for qualitative identification of Salvia miltiorrhiza,Anemarrhena asphodeloides and Astragalus membranaceus in the preparation. HPLC method was used to determine the content of icariin. The determination was performed on Diamonsil C18 column with mobile phase consisting of acetonitrile-water(27∶ 73) at the flow rate of 1. 0 ml/min. The detection wavelength was set at 270 nm,and the column temperature was 30℃. The sample size was 10 μl. Results:TCL spots of Salvia miltiorrhiza,Anemarrhena asphodeloides and Astragalus membranaceus were clear and well separated without interference from negative control. The linear range of icariin ranged 0. 093 ～0. 464 μg( r = 0. 999 9); the RSDs of precision,stability and repeatability tests were no more than 2. 0%. The average recovery was 99. 18%( RSD was 1. 20%,n = 9). Conclusions:The established standard can be used for the quality control of tangshenkang capsule.
引文
1李彦林,李琳,周云丰,等.中药复方防治实验性糖尿病肾病的研究进展[J].中国实验方剂学杂志,2015,21(11):224-227
2 中国药典[S].四部. 2015:57
3 孙冬梅,林晓燕,李素梅,等.复方芪麻胶囊的质量标准研究[J].中国药房,2017,28(18):2553-2556
4 乐佳美,熊筱娟,陆文铨,等.仙人菇口服液的质量标准研究[J].中国药房,2015,26(27):3855-3859
5 盛春帅,周鹃,李海霖.参附益肾胶囊的质量标准研究[J].中国药房,2016,27(33):4735-4738
6 崔思娇,于士龙,薛强,等.通脉丸的质量标准研究[J].中国药房,2016,27(6):821-823
7 唐靖雯,潘梅.抗病毒咀嚼片的质量标准研究[J].中国药房,2015,26(24):3420-3422
8 张晓瑞,王光函,贾冬,等.癫痫清颗粒薄层定性鉴别研究[J].辽宁中医药大学学报,2014,16(9):57-59
9 中国药典[S].一部. 2015:327
10 段丽,张永萍,徐剑,等.精源胶囊的质量标准研究[J].中国药房,2017,28(9):1231-1235
11 张桂林,马慧萍,李兰茹,等. HPLC法测定抗骨质增生片中淫羊藿苷的含量[J].中国药房,2016,27(30):4291-4293
12 陈希,万林春,张文婷.抗骨增生片的质量标准提高研究[J].中国药房,2017,28(6):838-841
2 中国药典[S].四部. 2015:57
3 孙冬梅,林晓燕,李素梅,等.复方芪麻胶囊的质量标准研究[J].中国药房,2017,28(18):2553-2556
4 乐佳美,熊筱娟,陆文铨,等.仙人菇口服液的质量标准研究[J].中国药房,2015,26(27):3855-3859
5 盛春帅,周鹃,李海霖.参附益肾胶囊的质量标准研究[J].中国药房,2016,27(33):4735-4738
6 崔思娇,于士龙,薛强,等.通脉丸的质量标准研究[J].中国药房,2016,27(6):821-823
7 唐靖雯,潘梅.抗病毒咀嚼片的质量标准研究[J].中国药房,2015,26(24):3420-3422
8 张晓瑞,王光函,贾冬,等.癫痫清颗粒薄层定性鉴别研究[J].辽宁中医药大学学报,2014,16(9):57-59
9 中国药典[S].一部. 2015:327
10 段丽,张永萍,徐剑,等.精源胶囊的质量标准研究[J].中国药房,2017,28(9):1231-1235
11 张桂林,马慧萍,李兰茹,等. HPLC法测定抗骨质增生片中淫羊藿苷的含量[J].中国药房,2016,27(30):4291-4293
12 陈希,万林春,张文婷.抗骨增生片的质量标准提高研究[J].中国药房,2017,28(6):838-841