目的 對比黃柏配方顆粒湯劑（DGD）與標(biāo)準(zhǔn)湯劑（SD）、傳統(tǒng)湯劑（TD）的差異，對市售配方顆粒（DG）的質(zhì)量進(jìn)行評價，并建立SD、TD的相關(guān)標(biāo)準(zhǔn)及DG的評價方法。方法 采用HPLC建立指紋圖譜，從化學(xué)成分種類、代表性指標(biāo)成分含量、指紋圖譜相似度、共有峰峰面積總和、主成分分析（PCA）5個方面對DGD（A～E 5個廠家各3批）與SD（10批）、TD（10批）共7類35個供試品進(jìn)行全面對比研究；對DGD進(jìn)行臨床建議當(dāng)量校正。結(jié)果 ①SD和TD中的21個共有峰均在DGD指紋圖譜中得到保留。②DGD中A廠木蘭花堿含量比SD低34.3%（P<0.05）；C廠木蘭花堿含量比SD低35.6%（P<0.01），比TD低37.0%（P<0.05）；D廠鹽酸黃柏堿含量比SD低22.0%（P<0.05），比TD低27.5%（P<0.05）；D廠鹽酸小檗堿的含量比SD低20.8%（P<0.05），比TD低23.8%（P<0.05）；其他廠家各成分與SD、TD無顯著性差異（P>0.05）。③各DGD與SD平均圖譜相似度均大于0.992 6，與TD平均圖譜相似度均大于0.991 2，成分相似度較高。④采用歸一化法以SD的21個共有峰的總峰面積值為1個單位，7類供試品比值分別為0.90、1.03、0.69、0.77、0.73、1.00、1.06。⑤PCA顯示B廠與SD、TD距離接近，差異小。以SD的21個共有峰信息為標(biāo)準(zhǔn)，采用峰面積加和法對DG的臨床建議當(dāng)量進(jìn)行校正，建議A、C、D、E廠家由1 g相當(dāng)于原飲片12 g分別降低至10.7、8.3、9.2、8.8 g，B廠家無需校正，仍為1 g相當(dāng)于原飲片10 g。結(jié)論 真實(shí)世界中多數(shù)黃柏DGD與SD、TD間存在成分含量上的差異，并無成分種類和成分種類間比例的明顯差異；這些整體基本一致的差異可通過對臨床建議當(dāng)量進(jìn)行校正加以調(diào)整，從而促進(jìn)臨床合理用藥。

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. ④ 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.

國家自然科學(xué)基金面上項(xiàng)目（81773892）；河南省首批自然科學(xué)基金面上項(xiàng)目（162300410187）；河南省高等學(xué)校重點(diǎn)科研項(xiàng)目（16A360021）；河南省中醫(yī)藥科學(xué)研究專項(xiàng)課題（2016ZY2055）；河南省中醫(yī)管理局國家中醫(yī)臨床研究基地科研專項(xiàng)（2018JDZX039）；河南省中醫(yī)藥拔尖人才培養(yǎng)項(xiàng)目資助（2019ZYBJ07）