Improvement of quality standard of Xiaojin capsules
10.12173/j.issn.1008-049X.202305058
- VernacularTitle:小金胶囊的质量标准提升研究
- Author:
Shuang LIU
1
;
Mao-Quan LIN
;
Jing JIN
;
Zhi-Jun HUANG
;
Yang XIANG
;
Gang ZHAO
;
Kai-Li MING
Author Information
1. 国家药品监督管理局食品药品审核查验中心(北京 100044)
- Keywords:
Xiaojin capsules;
Quality standard;
Acetyl-11-keto-β-boswellic acid;
High performance liquid chromatography;
Gas chromatography fingerprint
- From:
China Pharmacist
2023;26(11):332-338
- CountryChina
- Language:Chinese
-
Abstract:
Objective To improve the quality standard of Xiaojin capsules.Methods The agents content of acetyl-11-keto-β-bos wellic acid in Vinegar frankincense was determined by HPLC.According to GC detection patterns of 15 batches of samples,the similarity evaluation was conducted by using the"similarity evaluation system for chromatographic fingerprint of TCM(2012 edition)"of National Pharmacopoeia Committee to confirm common peaks.According to the Chinese Pharmacopoeia method,the contents of Pb,Cd,Cu,As and Hg in samples were detected.Results The linear range of acetyl-11-keto-β-boswellic acid was 13.346-166.824 μg·ml-1(r=0.999 8).The method which possesses high accuracy,and strong specificity,repeatability is good,and the average recovery was 100.76％with an RSD of 1.52％(n=6).The GC fingerprint detection method of Xiaojin capsules was established,and 11 common peaks were identified.The similarity of 15 batches of samples was greater than 0.870,indicating a good similarity.The contents of Pb,Cd,Cu,As and Hg in 15 batches of samples are in accordance with the reference limits in Chinese Pharmacopoeia.Conclusion The GC fingerprint detection method and the HPLC method for the determination of 11-carbonyl-β-acetylboswellic acid,as well as the examination of heavy metals,it can be used as a quality control item for the enhancement of the quality control standards of Xiaojin capsules.
