目的 以茯苓为研究对象，进行其饮片传统汤剂与配方颗粒汤剂化学成分上的对比研究，为茯苓配方颗粒的临床合理应用提供依据。方法 选择15批不同产地或批次的茯苓饮片及5个厂家各3批配方颗粒，基于HPLC法建立二者汤剂指纹图谱，从三萜类化学成分种类、三萜类指标性成分含量、所有峰峰面积总和3个方面进行评价，并使用主成分分析（PCA）法对数据进行统计分析。结果 三萜类化学成分种类：茯苓饮片传统汤剂中未检测到三萜类指标性成分，而多数厂家配方颗粒汤剂中有3个以上的三萜类指标性成分；1个厂家与传统汤剂类似，未检测到上述成分；三萜类指标性成分含量：各厂家茯苓配方颗粒汤剂在三萜类指标性成分含量方面差异较大；A、C、D、E 4个含有指标性成分的配方颗粒厂家产品中，D厂和E厂的多数成分相对较高，A厂各成分相对均衡，而C厂部分指标性成分缺失；所有峰峰面积总和：将D厂配方颗粒汤剂中所有峰峰面积总和定为100%，相较于D厂，传统汤剂为3.90%、A厂12.38%、B厂1.97%、C厂10.47%、E厂8.57%；主成分分析结果表明，同一厂家不同批次间质量不一，C厂最为集中，A厂相对集中，D、E厂3个批次间分布最分散。结论 茯苓饮片传统汤剂与配方颗粒汤剂在三萜类成分种类上具有非常明显的差异，各厂家茯苓配方颗粒汤剂中三萜类成分的种类、含量和批次间稳定性也不尽一致，提示各厂家配方颗粒制备工艺不尽相同，应进一步深入探讨茯苓配方颗粒的制备工艺及其合理应用，同时对茯苓饮片的合理使用也应进一步深入研究。

Objective Taking Poria cocos as the research object and to performs a comparative study on the chemical constituents in its traditional decoction and dispensing granule, so as to provide references for rational clinical application of P. cocos dispensing granule. Methods Fifteen batches of P. cocos decoction pieces from different producing areas or batches and three batches of dispensing granule from five manufacturers were selected. Then the HPLC fingerprints of decoction pieces and dispensing granule were established, which was used to be evaluated from three aspects: the kinds of chemical components of triterpenoid, the content of index components of triterpenoid and the sum of all peak areas. Moreover, the data was statistically analyzed by principal component analysis. Results The kinds of chemical components of triterpenoid: index components of triterpenoid were not detected in traditional decoction of P. cocos decoction pieces while more than three kinds of index components of triterpenoids were found in the decoction of dispensing granule provided by most manufacturers. The above components were not detected in only one manufacturer which has the same situation like the traditional decoction of P. cocos decoction pieces. The content of index components of triterpenoid: in terms of the content of index components of triterpenoid, there are great differences in P. cocos dispensing granule from the four manufacturers, namely, manufacture A, C, D, and E. Among them, manufacturer D and E have higher content in most components; Manufacturer A had relatively balanced content of each ingredient; While some index components were absent in manufacturer C. Sum of all peak areas: The sum of all peak areas of dispensing granule decoction in manufacturer D was set as 100%, compared with it, all the peak areas in traditional decoction were 3.90%, manufacturer A 12.38%, manufacturer B 1.97%, manufacturer C 10.47%, and manufacturer E 8.57%. The results of principal component analysis showed that the quality of different batches in the same manufacturer was different. The extent of quality in the three batches of plant C was mostly concentrated, plant A was relatively concentrated, and plant D and E were the most dispersed. Conclusion There are obvious differences in the types of triterpenoids between the traditional decoction and dispensing granule decoction of P. cocos decoction pieces. The kinds, content and batches stability of triterpenoids are also different among every manufacturer’s P. cocos dispensing granule decoction, which suggests that the preparation process of dispensing granule is not identical in each manufacturer and the researchers should further discuss the preparation process and rational application of P. cocos dispensing granule and P. cocos pieces.

R283.6

国家自然科学基金面上项目（81773892）；河南省首批自然科学基金面上项目（162300410187）；河南省高等学校重点科研项目（16A360021）；河南省中医药科学研究专项课题（2016ZY2055）；河南省中医管理局国家中医临床研究基地科研专项（2018JDZX039）；河南省中医药拔尖人才培养项目资助（2019ZYBJ07）；河南省卫生健康中青年学科带头人专项（HNSWJW-2020014）