Comparative study on composition of dispensing granule decoction, standard decoction, and traditional decoction of Phellodendri Chinensis Cortex prescription / 中草药

ABSTRACT

Objective: Comparing the differences between dispensing granule decoction (DGD), standard decoction (SD) and traditional decoction (TD) of Phellodendri Chinensis Cortex (PCC) prescription to evaluate the quality of commercially available dispensing granule (DG), and establish the relevant standards for SD, TD and evaluative methods for DG. Methods: Fingerprint was established by HPLC. A comprehensive comparative study was conducted on 35 samples of DGD (three batches from each of the five A-E manufacturers), SD (10 batches) and TD (10 batches) in seven categories from five aspects of chemical composition type, representative index component content, fingerprint similarity, total peak area sum and principal component analysis (PCA); Clinically recommended equivalent corrections were performed for DGD. Results: ① Twenty-one common peaks in SD and TD were preserved in the DGD fingerprint. ② The content of magnoflorine in manufacturer A of DGD was 34.3% lower than that of SD (P < 0.05); The content of magnoflorine in manufacturer C was 35.6% lower than SD (P < 0.01), and 37.0% lower than TD (P < 0.05); The content of phellodendrine hydrochloride in D manufacturer was 22.0% lower than SD (P < 0.05), and 27.5% lower than TD (P < 0.05), The content of berberine hydrochloride in D manufacturer was 20.8% lower than SD (P < 0.05), and 23.8% lower than TD (P < 0.05). There were no significant differences between the other manufacturers' components. ③ The average similarity of each DGD and SD was greater than 0.992 6, and the average similarity of each DGD and TD was greater than 0.991 2, with high component similarity. Using the normalization method, the total peak area of the 21 common peaks of SD was 1 unit, and the ratios of the seven types of samples were 0.90, 1.03, 0.69, 0.77, 0.73, 1.00, and 1.06. ⑤ PCA showed that the distance between the B manufacturer and SD and TD was close, and the difference was small. Using the 21 common peak information of SD as the standard, the peak area plus method was used to correct the clinical recommended equivalent of DG. It was recommended that manufacturers A, C, D, and E could be reduced from 1 g equivalent to 12 g of the original decoction pieces to 10.7, 8.3, 9.2, and 8.8 g, respectively. B manufacturer was not needed to be corrected, and still 1 g was equivalent to 10 g of the original decoction pieces. Conclusion: There are differences in the content of components between DGD, SD, and TD in the real world. There is no significant difference in the proportion of components and components. These overall basically consistent differences can be adjusted by correcting the clinical recommended equivalent, thus promoting clinical rational drug use.