Objective: To establish the content determination method of Simiao Yongan decoction and Xuanmai Ganjie granules, based on the Scrophulariaceae Radix reference extract(SRRE) and the reference substances of main components in Scrophulariae Radix, so as to explore the feasibility and rationality of the application of traditional Chinese medicine reference extract in the quality control of Chinese formulations in place of monomer reference substance. Methods: The separation was performed by HPLC using a SunFire C18 column(250 mm×4.6 mm, 5 μm) with methanol(A) and 0.05% phosphoric acid aqueous solution(B) as the mobile phase in gradient elution at a flow rate of 1.0 mL·min-1. The detection wavelengths were 210 nm(harpagide), 280 nm(harpagoside) and 330 nm(angoroside C).The column temperature was 35 ℃, and the injection volume was 10 and 20 μL. The HPLC methods were established for the determination of the three components in the two compound preparations by using the three reference standards of harpagide, angoroside C and harpagoside and the SRRE at known contents, and the results were compared by t-test. Results: The contents of the three components in Simiao Yongan decoction were 0.132 9, 0.042 1 and 0.032 5 mg·mL-1, respectively, determined by reference standards, and were 0.133 1, 0.042 0 and 0.032 4 mg·mL-1, respectively, determined by SRRE. The corresponding P values were 0.665, 0.284 and 0.661, respectively. The contents of the three components in Xuanmai Ganjie granules were 0.035 1, 0.012 2 and 0.006 3 mg·mL-1, respectively, determined by reference standards, and were 0.035 3, 0.012 2 and 0.006 4 mg·mL-1, respectively, determined by SRRE. The results of t-test showed that the P-values were all above 0.05 and there was no significant difference between the two methods. Conclusion: The results show that the SRRE can replace the corresponding reference substance to determine the contents in Simiao Yongan decoction and Xuanmai Ganju granules. The results of this study provide a scientific basis for the application of reference extracts in replacement of reference substance in the quality research of traditional Chinese medicine compound preparations, and offer new research ideas for Chinese medicine compound quality control research.
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