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To establish the determination methods for chromatographic fingerprint and multiple constituents，and then evaluate the quality grade of 103 batches of Banlangen granules that were from 55 manufacturers based on the reference drug.
Ultra-high-performance liquid chromatography (UPLC) analysis was used to establish the fingerprint of Banlangen granules and quantitate the contents of 7 components-uridine，adenine，vernine，(R，S)-goitrin，adenosine，syringin and clemastanin B. The test was performed on the Waters ACQUITY UPLC HSS T3 (100 mm×2.1 mm，1.8 μm) column with gradient elution using methanol-water at a flow rate of 0.2 mL·min-1. The injection volume was 2 μL，and the column temperature was constant at 30 ℃. Then，the results were detected using adopting a multi-wavelength detection mode. Next，the characteristic peaks and their belonging were clarified by comparing them with the reference drug. The sample fingerprint similarity and determination of contents were finally calculated，and the quality grades of Banlangen granules in each item were evaluated by using the reference drug.
The fingerprint was established，and 10 main characteristic peaks were identified. The similarities of the sample’s fingerprints ranged from 0.541 to 0.993，of which 101 batches were over 0.75 that were reached the second level，and 81 batches were over 0.90 that were reached the first level. The linear ranges of 7 components had good linear relationships within their respective ranges. The average recoveries (n=9) were 97.0%-104.7% with RSDs all below 3%. The precision，stability，and repeatability of methods were all good with RSDs all below 3%. Unified the sample specification to 5 g per bag，the content range of Banlangen granules samples was between 0.189-10.347 mg per bag. As a result，the content of 75 batches of samples reached the second level，and the content of 59 batches of samples reached the first level.
The established methods are simple，accurate and rapid，which can be used for the quality control and grade evaluation of Banlangen granules，as well as the research paradigm of other traditional Chinese medicine preparations.
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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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