Chinese Medicine Regulatory Office

Bulbus Fritillariae Cirrhosae is one of the precious Chinese Materia Medica. According to the Chinese Pharmacopoeia (edition 2020), the source of Bulbus Fritillariae Cirrhosae is the dried bulb of 6 Fritillaria species mainly Fritillaria cirrhosa D. Don, Fritillaria unibracteata Hsiao et K.C. Hsia, Fritillaria przewalskii Maxim, Fritillaria delavayi Franch, Fritillaria taipaiensis P. Y. Li and Fritillaria unibracteata Hsiao et K. C. Hsia var. wabuensis (S. Y. Tang et S. C. Yue) Z. D. Liu, S. Wang et S. C. Chen. The source of Bulbus Fritillariae Ussuriensis is the dried bulb of Fritillaria ussuriensis Maxim.

Driven by the high profit of Bulbus Fritillariae Cirrhosae, adulteration or substitution with Bulbus Fritillariae Ussuriensis, which is of relatively low market value, has become a concern in the Chinese medicines industry. Although morphological identification can quickly and accurately distinguish the raw medicinal materials, it is difficult to identify the powdered materials due to loss of morphological features. On the other hand, the chemical compositions of closely related species are generally very similar while the contents of the chemical markers are usually at low levels. The use of chemical approach would require complicated analysis and the use of highly specific and sensitive instrumentation.

This research project aims to develop a qualitative real-time polymerase chain reaction method for addressing the difficulty in detection of adulterant commonly found in Bulbus Fritillariae Cirrhosae. The developed DNA-based testing method and quality control system can complement the existing identification approaches and provide scientific basis for Identification of Bulbus Fritillariae Ussuriensis – a common adulterant found in Bulbus Fritillariae Cirrhosae.