Quality stability evaluation of Rukuaixiao preparation using fingerprint chromatography
10.19778/j.chp.2025.03.013
- VernacularTitle:基于指纹图谱的乳块消制剂质量稳定性研究
- Author:
Rong CHEN
1
;
Chao ZHANG
;
Yaqiong WANG
;
Haitao MENG
Author Information
1. 苏州市药品检验检测研究中心,江苏苏州 215104
- Publication Type:Journal Article
- Keywords:
Ruduxiao preparation;
fingerprints;
acceleration stability;
tanshinones;
scutellaria extract powder;
pharmaceutical packaging material
- From:
Drug Standards of China
2025;26(3):332-344
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the quality stability of Ruduxiao preparations from both process stability and for-mulation stability.Methods:HPLC fingerprints of different formulations of Rutuxiaoqi were established.According to the fingerprint screening results,the abnormal content of tansanone in some batches of manufacturer A and the pollution components of manufacturer B for non-medicinal purposes were tracked.Accelerated stability tests were performed on cross-manufacturer samples,and evaluated via multifaceted indicators including description,moisture content and fingerprint profiling.Results:A total of 35 common peaks were identified in the fingerprint,and the reference fingerprints of tablet and granule were close to each other,but the difference was obvious from that of cap-sule.The main difference lies in that some peaks attributed to Salvia Miltiorrhiza in the reference fingerprint of the capsules produced by manufacturer C were partially missing and their contents were relatively low.There were devi-ations in the extraction process of Salvia Miltiorrhiza from tablets of manufacturer A,and the contaminated compo-nent of manufacturer B was confirmed to be scutellaria extract powder by comparison of reference substances and UPLC Q-TOF MS/MS,which may come from collinear pollution.In the accelerated stability test,the granules packaged in the composite film of manufacturer D showed stable performance.The tablets packaged with aluminum-plastic blister were significantly affected by water vapor,and appeared splits,contents overflow,softening,etc.The weight of the tablets increases significantly,and the common peak 1 of fingerprint was significantly degraded,while the tablets and capsules packaged with HDPE plastic bottles were degraded obviously.Conclusion:The established fingerprint method can effectively characterize the overall situation of Ruduxiao preparations,not only can detect the abnormal process changes and non-medicinal component residues,but also can reveal the sensitive conditions that affect the stability of the samples,providing a reference for process verification and upgrading of packaging materials for manufacturers.The peak of common peak 1 can be used as an indicator of the stability of Ruduxiao preparations.
