【目的】 对过岗龙糖衣片进行剂型改良，考察过岗龙片新旧剂型间的化学等量性和药效等效性。【方法】 以硬度、分 散均匀性等指标通过单因素考察筛选制剂工艺，运用薄层色谱鉴别、高效液相色谱（HPLC）含量测定和特征图谱建立质量标 准，以超高效液相色谱-串联四极杆飞行时间质谱（UPLC-Q-TOF-MS）技术分析入血成分，通过炎性疼痛模型小鼠抗炎实验 和镇痛实验评价药效学。【结果】 确定过岗龙分散片成型工艺。建立了薄层色谱鉴别方法。以HPLC法建立了过龙岗片的含 量测定方法和特征图谱，辨识共有峰15个，新旧剂型的相似度均 > 0.9。共鉴定入血成分12个。过岗龙片可减轻炎性疼痛小 鼠足趾肿胀程度，降低血清中白细胞介素6（IL-6）含量，改善脾脏指数，提高小鼠的热痛阈和醋酸扭体次数。【结论】 过岗龙分 散片的处方工艺稳定，质量标准可行，新旧剂型的化学组成和药理作用基本一致，在个别指标上过岗龙分散片优于糖衣片。

Objective To modify the dosage form of Guoganglong Sugar-Coated Tablets， and to investigate the chemical equivalence and pharmacodynamic equivalence between the new and old dosage forms of Guoganglong Tablets. Methods The preparation technology was screened by single-factor exploration with the indexes of hardness and dispersion uniformity，the quality standard was established by thin layer chromatography identification， high performance liquid chromatography（HPLC）content determination and charactertistics chromatograms， the constituents absorbed into blood were analyzed by ultra-high performance liquid chromatography quadrupole time of flight mass spectrometry（UHPLC-Q-TOF-MS），and the pharmacodynamics was evaluated by anti-inflammatory experiment and analgesic experiment in mice model with inflammatory pain. Results The molding process of Guoganglong Dispersible Tablets was determined. A thin layer chromatographic identification method was established. A method for detecting the content of Guoganglong Tablets and the charactertistic chromatograms was established by HPLC，and a total of 15 common peaks were identified，with the similarity of the new-old dosage forms being greater than 0.9. A total of 12 constituents absorbed into blood were identified. Guoganglong Tablets could alleviate swelling degree of toes in mice with inflammatory pain，reduce the levels of interleukin 6（IL-6）in serum，improve spleen index，and increase the thermal pain threshold and acetic acid twisting frequency in mice. Conclusion The prescription process of Guoganglong Dispersible Tablets is stable，the quality standard is feasible， the chemical composition and pharmacological actions between the new and old dosage forms are basically the same，and in terms of certain indexes，Dispersible Tablets of Guoganglong are superior to Sugar-Coated Tablets .

R282.5

国家自然科学基金资助项目（编号：82174257）；广东省妇科中药企业重点实验室（编号：2020B121202004）