Recurrent respiratory tract infections (RRTIs) is one of the most common diseases in children and adolescents, especially for preschool children. Tongkang tablet (TKT), a traditional Chinese medical formula consisting of Astragali Radix (AR), Atractylodes Macrocephala (AM), Saposhnikovia Divaricata (SD), Rhizoma Dioscoreae (RD), Concha Ostreae (CO), and Pericarpium Citri Reticulatae (PCR), has been widely used to treat recurrent upper respiratory tract infections of children. To ensure the efficacy and safety of TKT, an integrative and reliable quality control method is urgently needed. The concept of quality marker (Q-marker) is highly helpful but the selection and quantitation of appropriate Q-markers remains challenging, especially for the complex components of Chinese medicinal products. The aim of this article was to identify and quantify Q-markers of TKT for the establishment of a quality control method. First, by a validated UFLC-IT-TOF–MS/MS method, a total of 40 compounds were unambiguously or tentatively identified, including 21 flavonoids, 10 chromones, 3 coumarins, 3 sesquiterpenes, 2 batatasins and 1 saponin. Among them, 10 compounds were further confirmed by reference standards. Then, 10 compounds, including calycosin-7- O -glucoside, prim- O -glucosylcimifugin, cimifugin, naringin, 4′- O - d -glucosyl-5- O -methylvisamminol, hesperidin, ononin, calycosin, sec- O -glucosyhamaudol and formononetin, were selected as Q-markers based on the knowledge of absorption characteristics and bio-activity with the reference literatures. Finally, based on the 10 Q-markers, the fingerprint chromatography was established by HPLC–DAD method, which proved accurate, sensitive and reliable. The presently developed method based on 10 Q-markers is expected to lay a good foundation for the quality control of TKT.

中文翻译：

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UFLC-IT-TOF-MS/MS 和 HPLC-DAD 对通康片中反复呼吸道感染 (RRTIs) 的“质量标志物”进行鉴定和定量

复发性呼吸道感染（RRTIs）是儿童和青少年最常见的疾病之一，尤其是学龄前儿童。通康片 (TKT)，一种中药方剂，由黄芪 (AR)、白术 (AM)、白术 (SD)、薯蓣 (RD)、牡蛎 (CO) 和柑橘皮 (PCR) 组成，已被广泛用于治疗儿童复发性上呼吸道感染。为了确保TKT的有效性和安全性，迫切需要一种综合可靠的质量控制方法。质量标志物（Q-marker）的概念非常有用，但合适的 Q-markers 的选择和定量仍然具有挑战性，尤其是对于中药产品的复杂成分。本文的目的是识别和量化 TKT 的 Q 标记，以建立质量控制方法。首先，通过经过验证的 UFLC-IT-TOF-MS/MS 方法，明确或初步鉴定了总共 40 种化合物，包括 21 种黄酮类化合物、10 种色酮、3 种香豆素、3 种倍半萜、2 种 batatasin 和 1 种皂苷。其中10种化合物通过参考标准进一步确认。然后，10种化合物，包括calycosin-7-O-glucoside、prim-O-glucosylcimifugin、cimifugin、naringin、4'-O-d-glucosyl-5-O-methylvisamminol、橙皮苷、ononin、calycosin、sec-O-glucosyhamaudol根据对吸收特性和生物活性的了解，结合参考文献，选择了芒柄花素和芒柄花素作为 Q 标志物。最后，基于 10 个 Q 标记，采用HPLC-DAD法建立指纹图谱，结果准确、灵敏、可靠。目前开发的基于10个Q-markers的方法有望为TKT的质量控制奠定良好的基础。