Standard Deliberation

Study on the improvement of the quality standard of imported medicinal materials scammony resin*

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  • Xinjiang Uyghur Autonomous Region Institute for Drug Control, NMPA Key Laboratory for Quality Control of Traditional Chinese, Uighur Medicine, Urumqi 830054, China

Received date: 2021-03-23

  Online published: 2024-06-24

Abstract

Objective: To improve the quality standard of scammony resin from Convolvulus scammonia L.. Methods: 23 batches of scammony resin samples were collected and their moisture,total ash,95% ethanol extract,volatile ether extract,the heavy metals and harmful elements,pesticide residues were determined by the methods of the 2020 edition of Chinese Pharmacopoeia. The macroscopic character of the samples was described. and the qualitative identification was carried out by UV and TLC. The fingerprint of the samples was determined by HPLC, the chromatographic separation was performed on an Agilent ODS-AQ(4.6 mm×250 mm, 5 μm) column with methanol as A, 0.4%phosphoric acid as B for mobile phase with gradient elution system(0-5 min, 30%A;5-10 min, 30%A→40%A;10-15 min, 40%A;15-20 min, 40%A→55%A;20-30 min, 55%A→70%A; 30-32 min, 70%A→95%A;32-45 min, 90%A;45-55 min, 100%A; 55-60 min, 100%A→30%A; 60-70 min, 30%A), the flow rate was 1.0 mL·min-1, column temperature was set as 35 ℃, and the detection wavelength was set at 254 nm. Results: The results showed that water content should limited as≤3.5%, total ash content≤2.0%, 95% ethanol extract≥95.0%, volatile ether extract≤3.0% and the heavy metals and harmful elements and the pesticide residues were not detected. There were 5 common peaks in different samples in HPLC fingerprint, and the similarity was all over 0.99, and the RSD range of retention times for different samples of 5 common peaks determined by HPLC was 0.32%-0.45%. The results showed that the reproducibility of common components in different batches of samples was good. Conclusion: The established quality standard can be used for the quality standard and evaluation of scammony resin products.

Cite this article

SULEYMAN Halik, BAI Yu, ELIQEM Tursun . Study on the improvement of the quality standard of imported medicinal materials scammony resin*[J]. Chinese Journal of Pharmaceutical Analysis, 2022 , 42(2) : 352 -360 . DOI: 10.16155/j.0254-1793.2022.02.22

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