Study on Improving Quality Standard of Qiwei Maqianzi Pills
10.6039/j.issn.1001-0408.2018.02.05
- VernacularTitle:七味马钱子丸的质量标准提高研究
- Author:
Yingying FAN
1
;
Mao CAI
;
Fengmei YANG
Author Information
1. 青海省药品检验检测院/青海省中藏药现代化研究重点实验室
- Keywords:
Qiwei maqianzi pills;
Chebulae Fructus;
Aucklandiae Radix;
Hydroxy safflor yellow A;
Brucine;
Strychnine;
TLC;
HPLC;
Quality standard
- From:
China Pharmacy
2018;29(2):163-167
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To improve the quality standard for Qiwei maqianzi pills.METHODS:TLC was used for the qualitative identification of Chebulae Fmctus and Aucklandiae Radix in the preparation.HPLC method was used for the content determination of hydroxy safflor yellow A,brucine and strychnine in preparation.The determination was performed on Phenomenex Prodigy C18 column with mobile phase consisted of methanol-acetonitrile-0.7％ phosphoric acid soulution(26 ∶ 2 ∶ 72,V/V/V,for hydroxy safflor yellow A),acetonitrile-0.01 mol/L sodium heptanesulfonate mixed with same quantity of 0.02 mol/L potassium dihydrogen phosphate (pH adjusted to 2.8 using 10％ phosphoric acid,21 ∶ 79,V/V,for brucine and strychnine) at the flow rate of 1.0 mL/min.The detection wavelengths were 403 nm (for hydroxy safflor yellow A) and 260 nm (for brucine and strychnine).The column temperature was 25 ℃C,and the injection volume was 10 μL.RESULTS:TLC spots of Chebulae Fructus and Aucklandiae Radix were clear and well-separated without interference from negative control.The linear range was 6.29-62.94 μg/mL for hydroxy safflor yellow A(r=0.999 3),1.83-18.30 μg/mL for brucine(r=0.999 4) and 2.11-21.11 μg/mL for strychnine (r=0.999 6).RSDs of precision,stability and reproducibility tests were lower than 2.0％.The recoveries were 101.66％-104.91％(RSD=1.14％,n=6),99.58％-104.55％ (RSD=1.75％,n=6) and 101.22％-104.04％ (RSD=0.99％,n=6),respectively.CONCLUSIONS:Improved standard can be better used for quality control of Qiwei maqianzi pills.
