Revision and Improvement of Quality Standard for Rosae Davuricae Radix Et Rhizoma / 中国药师

ABSTRACT

Objective: To revise the quality standard and provide scientific basis for the quality conctrol and utilization and devel-opment of Rosae Davuricae Radix Et Rhizoma. Methods: The historical evolution and resource distribution of Rosae Davuricae Radix Et Rhizoma were studied by herbalogical study and textual research. Macroscopic and microscopic identification were used to identify the transverse section and the powder. TLC was used to identify Rosae Davuricae Radix Et Rhizoma. The contents of moisture, total ash, acid insoluble ash and alcohol soluble extract were determined to make out the corresponding limits. An HPLC method was used to de-termine the content of ursolic acid with the following conditions an Diamonsil C18column (250 mm×4. 6 mm, 5 μm) was eluted with the mobile phase of methanol-0. 5% phosphoric acid ( 87 13), the column temperature was 30℃, the flow rate was 1. 0 ml·min-1 and the detection wavelength was 210 nm. Results: The samples showed good macroscopic and microscopic characteristics. TLC showed that the spots were clear with good resolution. According to the measurement results, the content of moisture, total ash, acid in-soluble ash and alcohol soluble extract from the samples was 5. 6%-7. 3% , 1. 5%-3. 2% , 0. 2%-1. 1% and 15. 8%-28. 1% , respec-tively. The linear range of ursolic acid was 0. 10-1. 99 μg (r=0. 999 9), the average recovery was 97. 5% with the RSD of 1. 3% (n=9). The content of ursolic acid in the samples were 0. 1320-0. 5730 mg·g-1. Conclusion: The established methods are suitable for the quality control of Rosae Davuricae Radix Et Rhizoma.