目的 以芍藥甘草湯（Shaoyao Gancao Decoction，SGD）為例，進(jìn)行均一化投料工藝研究，從均一化飲片、湯劑、中成藥三重環(huán)節(jié)，結(jié)合多成分含量、特征圖譜、量值傳遞等數(shù)據(jù)，完成SGD均一化投料工藝全流程，探討并確定SGD均一化投料工藝的質(zhì)量范圍，實(shí)現(xiàn)批間質(zhì)量均一穩(wěn)定。方法 采用UHPLC法對(duì)多批次白芍、炙甘草飲片含量進(jìn)行測(cè)定；選取平均值作為飲片標(biāo)準(zhǔn)質(zhì)量，以此作為均一化標(biāo)準(zhǔn)飲片目標(biāo)質(zhì)量；計(jì)算各批飲片均一化投料比例，完成投料，制備SGD均一化標(biāo)準(zhǔn)湯劑、中成藥；設(shè)定質(zhì)量濃度范圍，建立均一化標(biāo)準(zhǔn)湯劑、中成藥特征圖譜。將飲片分級(jí)后，新制備15批均一化湯劑及中成藥，驗(yàn)證質(zhì)量濃度范圍的合理性，綜合評(píng)價(jià)均一化工藝。結(jié)果 設(shè)置均一化標(biāo)準(zhǔn)飲片中芍藥苷、甘草苷、甘草酸質(zhì)量分?jǐn)?shù)分別為2.236%～2.506%、0.500%～0.680%、1.870%～2.215%；均一化標(biāo)準(zhǔn)湯劑中各成分矯正質(zhì)量濃度分別為芍藥苷2.014～2.522 mg/mL、甘草苷0.170～0.282 mg/mL、甘草酸0.489～0.718 mg/mL；均一化標(biāo)準(zhǔn)中成藥中各成分矯正質(zhì)量濃度分別為芍藥苷1.950～2.391 mg/mL、甘草苷0.159～0.269 mg/mL、甘草酸0.453～0.673 mg/mL；均一化標(biāo)準(zhǔn)湯劑、中成藥特征圖譜中共匹配16個(gè)特征峰，通過對(duì)照品共指認(rèn)出8個(gè)特征峰。新制備的均一化湯劑及中成藥中各成分均在設(shè)置的質(zhì)量濃度范圍內(nèi)；將各組特征圖譜與均一化標(biāo)準(zhǔn)湯劑、中成藥對(duì)照特征圖譜進(jìn)行對(duì)比，相似度均大于0.995。結(jié)論 以飲片標(biāo)準(zhǔn)質(zhì)量為目標(biāo)，通過均一化投料得到質(zhì)量均一的飲片，降低了投料飲片的質(zhì)量波動(dòng)，最終得到批間質(zhì)量均一穩(wěn)定的SGD湯劑及中成藥，為中成藥質(zhì)量一致性工藝研究提供可行性方案。

Objective Taking Shaoyao Gancao Decoction (SGD, 芍藥甘草湯) as an example, the homogenization feeding process was studied. From the triple links of homogenization decoction pieces, decoction and Chinese patent medicine, combined with multi-component content, characteristic spectrum, value transfer and other data, the whole process of homogenization feeding process of SGD was completed, and the quality range of homogenization feeding process of SGD was discussed and determined, so as to achieve uniform and stable quality between batches. Methods UHPLC method was used to determine the content of multiple batches of Baishao (Paeoniae Radix Alba) and Zhigancao (Glycyrrhizae Radix Preparata). The average value was selected as the standard quality of decoction pieces, which was used as the target quality of normalized standard decoction pieces. Calculate the proportion of homogenization of each batch of decoction pieces, complete the feeding, and prepare the SGD homogenization standard decoction and Chinese patent medicine; the mass concentration range was set, and the characteristic chromatograms of normalized standard decoction and Chinese patent medicine were established. After the decoction pieces were graded, 15 batches of homogenized decoctions and Chinese patent medicines were newly prepared to verify the rationality of the mass concentration range and comprehensively evaluate the homogenization process. Results The mass fractions of paeoniflorin, liquiritin and glycyrrhizic acid in normalized standard decoction pieces were 2.236%—2.506%, 0.500%—0.680% and 1.870%—2.215%, respectively. The corrected mass concentrations of each component in the normalized standard decoction were 2.014—2.522 mg/mL for paeoniflorin, 0.170—0.282 mg/mL for liquiritin, and 0.489—0.718 mg/mL for glycyrrhizic acid, respectively. The corrected mass concentrations of each component in the standard Chinese patent medicine were 1.950—2.391 mg/mL for paeoniflorin, 0.159—0.269 mg/mL for liquiritin, and 0.453—0.673 mg/mL for glycyrrhizic acid, respectively. A total of 16 characteristic peaks were matched in the characteristic chromatograms of homogenized standard decoctions and Chinese patent medicines, and eight characteristic peaks were identified by reference substances. The components in the newly prepared homogenized decoction and Chinese patent medicine were within the set mass concentration range. The characteristic chromatograms of each group were compared with the characteristic chromatograms of homogenized standard decoction and Chinese patent medicine, and the similarity was greater than 0.995. Conclusion Taking the standard quality of decoction pieces as the goal, the decoction pieces with uniform quality are obtained by homogenizing the feeding, which reduces the quality fluctuation of the feeding decoction pieces, and finally obtains the SGD and Chinese patent medicine with uniform and stable quality between batches, which provides a feasible scheme for the study of the quality consistency process of Chinese patent medicine.

R283.6

國(guó)家科技重大專項(xiàng)“重大新藥創(chuàng)制”（2018ZX09721005）;中國(guó)中醫(yī)科學(xué)院科技創(chuàng)新工程項(xiàng)目（CI2021A04506）;中國(guó)中醫(yī)科學(xué)院科技創(chuàng)新工程項(xiàng)目（CI2023E001TS）;2023年全國(guó)中藥特色技術(shù)傳承人才培訓(xùn)項(xiàng)目（ZXKT23025）