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OBJECTIVE To provide reference and suggestions for the quality control of this variety, evaluate the quality of xiaojianzhong preparations and preparations analyze the existing problems based on the national drug sampling. METHODS A total of 160 batches of samples were tested according to the statutory standard. In the exploratory study, ochratoxin A and zearalenone residues were detected by liquid chromatography-tandem mass spectrometry; paeoniflorin sulfite in xiaojianzhong preparation was detected by ultra performance liquid chromatography-tandem high resolution mass spectrometry; cinnamaldehyde was determined by high performance liquid chromatography; the overall quality of Xiaojianzhong preparation was evaluated by fingerprint analysis. The pH value of the mixture was investigated. RESULTS The qualified rate of 160 batches of samples was 100% according to statutory standard. Exploratory studies showed that ochratoxin A or zearalenone was detected in 33.1% of the samples, and paeoniflorin sulfite was detected in 83.5% of the samples.The pH value of 9% mixture was beyond the range of benzoic acid inhibitory effect. Cinnamaldehyde in 95.4% of the samples was below the proposed limit. Fingerprint analysis showed that the similarity of 14.6% of samples was lower than the proposed limit. CONCLUSION It is suggested to unify the quality control items of the four dosage forms, increase the pH limit, monitor the quality of the raw materials of licorice and dextrin, standardize the use of cerealose, and strengthen the system specification for the development of ancient classic prescriptions.
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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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