Quality Control

Quality control of Schisandrae Chinensis Fructus in Shihu Yeguang pills

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  • 1. Guangxi Institute for Food and Drug Control, NMPA Key Laboratory for Quality Monitoring and Evaluation of Traditional Chinese Medicine, Chinese Material Medica, Nanning 530021, China;
    2. National Institutes for Food and Drug Control, Beijing 102629, China

Revised date: 2023-03-30

  Online published: 2024-06-25

Abstract

Objective: To establish the Qualitative identification and adulteration inspection methodsof Schisandrae Chinensis Fructus in Shihu Yeguang pills. Methods: TLC was used for qualitative identification of Schisandrae Chinensis Fructus. Cyclohexane-ethyl acetate(3∶2)was used as developing solvent and the plate was detected under ultraviolet lamp(254 nm). LC-MS was used for the qualification of anwuligan and schizandrin. The content ratio of anwuligan and schizandrin as a threshold could be used to discriminate. If the ratio was above 2.0, the Shihu Yeguang pills were added Schisandrae Sphenanthera Fructus. An Agilent Eclipse C18(100 mm×2.1 mm,1.8 μm) column was adopted, and the column temperature was 35 ℃. Injection volume was 1 μL, acetonitrile and 10 mmol·L-1 ammonium acetatesolution was used as the mobile phase for gradient elution, and the flow rate was 0.25 mL·min-1. Results: 91 batches of Shihu Yeguang pills from 19 enterprises were tested, Schisandrae Sphenanthera Fructus was detected from 3 batches of samples. The result of TLC was consistent with the result of LC-MS. 3 batches of samples from an enterprise were detected for addition of Schisandrae Sphenanthera Fructus. Conclusion: The method is accurate and reliable, which can be applied to quality control of Schisandrae Chinensis Fructus in Shihu Yeguang pills.

Cite this article

HE Song-hua, QIN Li-li, LI Li-li, MA Shuang-cheng . Quality control of Schisandrae Chinensis Fructus in Shihu Yeguang pills[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(4) : 685 -692 . DOI: 10.16155/j.0254-1793.2023.04.18

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