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Evaluating the quality consistency of compound Liangmianzhen
buccal tablets during accessories replacement by HPLC/UV
related with its active profiling and UV dissolution profiles
Yue Yu, Hanxiao Chi, Guoxiang Sun, Fangliang Yang, Wanyang Sun, Jiayue Hu, Yanhua Zhang
2020 (1):
8-23.
摘要
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341 )
PDF(2255KB)
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2052
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Compound Liangmianzhen buccal tablet is a drug that exhibits notable effect on cough and diphtheria. Since the accessory
has been changed, along with the difficulties in traditional Chinese drug-evaluation, it is imperative to set up a reliable method
to evaluate the drug and ensure the quality consistency. First, the content of the Compound Liangmianzhen buccal tablets
reflected by fingerprints were evaluated by the comprehensive linearly quantified fingerprint method and systematic quantified
fingerprint method, in which thirteen fingerprint peaks was selected and gallic acid was chosen as the reference peak. The results
of the two methods showed all batches in grades 1–3 of above good level with the qualitative similarities of Sl and Sm above 0.90,
and the quantitative ones of Pl% and Pm% from 80%–120%, indicating all samples far qualified. Second, the measurement of
antioxidant effect based on DPPH free radical clearance test has demonstrated the consistency between the old prescription
group and the new ones and further dug up the major antioxidant compositions. Third, dissolution profiles at 190 to 400 nm
that evaluate the curative effect consistency were evaluated by f2 and the correlation of the dissolution curve. In conclusion, the
combination of 3 kinds of analysis methods can comprehensively assess the quality of the traditional Chinese drug and be served
as a routine procedure to evaluate the herbal medicine consistency.
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