Objective. The purpose of study is to establish an HPLC-DAD method for determination of the five constituents (deoxyschizandrin, γ-schizandrin, loganin, paeoniflorin, and paeonol) in Maiwei Dihuang Pills. Methods. An Agilent ZORBAX SB-C18 chromatographic column was carried out to determine the five constituents of 50% methanol extract of Maiwei Dihuang Pills. Results. It was found the chromatographic peak resolution of each component in the study sample solution was 1.5 higher than that of other peaks and no peaks appeared in the blank control solution during the same time, suggesting specificity of HPLC-DAD was well established. The linearity test indicated that deoxyschizandrin, γ-schizandrin, loganin, paeoniflorin, and paeonol were 11.6–72.3 μg/mL, 6.4–45.2 μg/mL, 35.2–237.6 μg/mL, 18.1–114.2 μg/mL, and 32.2–215.3 μg/mL, respectively, suggesting each component has a good linear relationship within its own range. Additionally, the precision of HPLC-DAD was confirmed by a precision test; the stability of the study sample solution was confirmed by a stability test; and good reproducibility of HPLC-DAD was proved by a reproducible test. The recovery rate test showed that relative standard deviation (RSD) of recovery rate in deoxyschizandrin, γ-schizandrin, loganin, paeoniflorin, and paeonol was 100.26% (1.80%), 101.39% (1.74%), 101.19% (1.76%), 102.50% (1.65%), and 102.30% (1.58%), respectively. Conclusions. HPLC-DAD used to determine the five constituents in Maiwei Dihuang Pills, and it was easier and faster to operate, showing good condition in repeatability, precision, stability, and recovery, which is a great option for quality control.
Objective. This study attempted to verify the applicability of the microbial limit test (plate culture and membrane filtration) for 10 proprietary Chinese medicines for children. Methods. In this study, we collected 10 proprietary Chinese medicines for children as study objects and performed plate culture and membrane filtration to calculate the colony-forming unit (cfu) of microorganisms in these medicines and verify its applicability in objectionable microorganisms. Results. It was found that the recovery rate of microorganisms including Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger ranged from 70% to 150%. This verification was performed by plate culture or membrane filtration. Inspection for objectionable microorganisms (Escherichia coli, Salmonella paratyphi B, and bile salt-tolerant Gram-negative bacteria) was applicable for most medicines. Conclusion. Microbial limit test is feasible for the determination of microorganisms in 10 proprietary Chinese medicines for children.
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