Full
Outline
To evaluate the stability of the component-based Chinese medicine Yuanqin capsules in different batches.
High-performance liquid chromatography (HPLC) fingerprint for Yuanqin capsules was established, and the similarities of flavonoids components was assessed using the chromatographic fingerprint similarity evaluation system for traditional Chinese medicines, with retention time and peak area relative deviation as evaluation indices. Additionally, the contents of key flavonoids were determined and compared batches.
A total of 27 common peaks were identified, of which 14 were attributed to Iris tectorum Maxim., and 13 to Scutellaria baicalensis Georgi. Eleven chemical components were confirmed, including tectoridin, iristectorin B, iristectorin A, iridin, baicalin, glychionide A, oroxyloside, tectorigenin, wogonoside, baicalein, wogonin. The fingerprint and content determination methods showed good precision, stability, and repeatability. For the six key components (tectoridin, iristectorin B, iristectorin A, baicalin, tectorigenin, and wogonoside), the injection amounts exhibited linear relationships with peak areas within the ranges of 0.027 6~0.552, 0.006 2~0.124, 0.012 3~0.146, 0.063~1.26, 0.015 2~0.304, and 0.017 1~0.342 μg. The average recoveries rates (n=6) were 99.67% (relative standard deviation, RSD=0.87%), 100.19% (RSD=1.83%), 100.26% (RSD=0.97%), 99.74% (RSD=0.49%), 100.39% (RSD=1.78%), and 99.64% (RSD=0.96%), all meeting the testing requirements. The similarity between the 15 batches of Yuanqin capsules and the reference fingerprint ranged from 0.948 to 0.989, indicating small batch-to-batch variations in component contents and stable quality.
Yuanqin capsules exhibit good quality consistency. The established HPLC fingerprint and content determination method can provide a basis for the quality control of Yuanqin capsules.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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