The related substances in docetaxel injection were identified by LC-MS/MS. Ethyl acetate was used to extract the injection to remove the pharmaceutical excipients. HPLC separation was carried out on a Hedera ODS-2 column (150 mm x 2.1 mm, 5 microm) with a mobile phase consisting of acetonitrile - 0.1% acetate acid aqueous solution (40: 60). Electrospray ionization source was set in the positive mode for the LC-ESI-MS/MS, and the ion monitoring modes were full scan and product ion scan. According to the mass spectra of the related substances, the fragment profiles were explained, and the chemical structures were elucidated. Docetaxel and its main related substances were well separated. Nine related substances in docetaxel injection were detected by LC-MS/MS. Their chemical structures were proposed, and four of them were identified in the docetaxel injection for the first time. The established LC-MS/MS method is effective in the separation and identification of the related substances in docetaxel injection. The test results are useful for its quality control.

Objective:To investigate the efficacy and safety of encephalo-duro-arterio-synangiosis (EDAS) for intracranial atherosclerotic steno-occlusive disease (ICASD).Methods:Patients with symptomatic ICASD received EDAS treatment in the Department of Neurosurgery, the PLA General Hospital from January 2018 to January 2019 were retrospectively included. The baseline information, perioperative complications, primary endpoint events, and changes in modified Rankin Scale (mRS) scores before and after surgery were collected. The primary endpoint event was any stroke/death that occurred within 30 d after enrollment. The secondary endpoint events were any stroke/death, non-stroke bleeding (subdural or epidural bleeding), and clinical functional improvement after 30 d. The clinical functional improvement was defined as a decrease of ≥1 in the mRS score compared to before surgery.Results:A total of 40 patients were included, including 30 males and 10 females, aged 53.9±8.6 years old. The clinical symptoms were mainly limb weakness and dizziness. One case of ischemic stroke and one case of hemorrhagic stroke occurred during the perioperative period. The primary endpoint event incidence was 2.5%. The patients were followed up for 49.75±2.99 months after surgery. One patient died of cerebral hemorrhage 31 months after surgery, and one patient developed acute ischemic stroke 35 months after surgery. The postoperative mRS scores of 34 patients decreased compared to before surgery, and the clinical function improvement rate was 85%. The mRS score increased in 2 cases after surgery compared to before surgery and 4 cases had no change.Conclusion:EDAS can improve the clinical function of patients with symptomatic ICASD and reduce the incidence of long-term stroke.