Beijing Shijitan Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing, China.
Chongqing Institute for Food and Drug Control, Chongqing, China.
Anal Chim Acta. 2018 Mar 20;1003:56-63. doi: 10.1016/j.aca.2017.11.069. Epub 2017 Dec 12.
Safflower Injection is one kind of injections derived from traditional Chinese medicine. It is widely applied to treat cerebrovascular diseases such as acute cerebral infarction, stroke, coronary heart disease, and angiitis. However, most adverse reactions of Safflower Injection in clinic are caused by its quality problems. In this study, 10 batches of normal and 42 batches of abnormal Safflower Injections were obtained from the clinical practice. Their quality fluctuations were detected by chemical fingerprinting (CF, ultra-performance liquid chromatography tandem mass spectrometry) and bioassays including cell-based biological profile (CBP) assay and enzymatic assay. CF identified 33 compounds in the Safflower Injections, and scutellarin and kaempferol-3-O-rutinoside were identified to be the possible components responsible for clinical adverse reaction. In addition, 59.5% (25/42), 85.7% (36/42) and 38.1% (16/42) of abnormal samples could be identified by CF, CBP assay and enzymatic assay, respectively. Interestingly, further integration of the three methods could entirely identify all the abnormal samples. It indicated that it is advisable to integrate CF, CBP assay and enzymatic assay for developing quality standard of Safflower Injections.
红花注射液是一种源于中药的注射液，广泛应用于治疗脑血管疾病，如急性脑梗死、中风、冠心病和血管炎。然而，临床上红花注射液的大多数不良反应是由其质量问题引起的。在本研究中，从临床实践中获得了 10 批正常批次和 42 批异常批次的红花注射液。通过化学指纹图谱（CF，超高效液相色谱串联质谱）和包括基于细胞的生物特征谱（CBP）测定和酶测定在内的生物测定检测其质量波动。CF 鉴定出红花注射液中的 33 种化合物，研究人员鉴定出野黄芩苷和山奈酚-3-O-芸香糖苷可能是引起临床不良反应的成分。此外，CF、CBP 测定和酶测定分别可以识别 59.5%（25/42）、85.7%（36/42）和 38.1%（16/42）的异常样品。有趣的是，进一步整合这三种方法可以完全识别所有异常样品。这表明，将 CF、CBP 测定和酶测定相结合制定红花注射液质量标准是明智的。
