To explore the safety and efficacy of Inetetamab combined with Pyrotinib in the treatment of HER2-positive breast cancer.

A case of patient was reported with right breast invasive ductal carcinoma with multiple systemic metastases. The patients were found progressing after 3 cycles of docetaxel+Capecitabine+Trastuzumab regimen as the first line therapy for Trastuzumab primary resistance. Second-line therapy combined inetetamab with pyrotinib (inetetamab 8 mg·kg^-1 for the first time, followed by 6 mg·kg^-1, q3w+pyrotinib 400 mg·d^-1, qd+vinorelbine 35 mg day 1, day 8 q3w) for 18 cycles.

The patients achieved partial response (PR) at the first evaluation. During the 18 cycles of treatment, the efficacy was evaluated as continuous PR. The current progress free survival (PFS) was more than 16 months. No grade III or above adverse reactions occurred during the treatment, and the patients were well tolerated.

The combination of inetetamab with pyrotinib is effective and safe in the treatment of metastatic HER2-positive breast cancer.

To explore the construction of clinical trial information management system and its practice in the process management of traditional Chinese medicine clinical trials, so as to improve the management efficiency of drug clinical trials.

In cooperation with Tianjin Abensu Science and Technology Co., Ltd., an information management platform for clinical trial institutions was constructed in the Affiliated Hospital of Chengdu University of traditional Chinese medicine. Through the intranet system, the hospital's original closed systems such as HIS, LIS and RIS were connected. After encrypted transmission, it completed data exchange and docking with the information system running on the internet. The electronic informatization of user management, project management, subject information management, process information management and experimental drug management of clinical trial realized. The security, stability and efficiency of the involved data were analyzed.

The system realized the safety, stability and smooth flow of data in the process of clinical trial management, and greatly improved the efficiency of traditional Chinese medicine (TCM) clinical trial project management.

The introduction of information management system and its integration with internal systems like HIS and LIS is the road which must be taken to realize the modern management of TCM clinical trial institutions, and it is one of the most important ways to practice the innovation of TCM.

To investigate the anti-neuroinflammatory effect of Aucubin extracted from Rehmannia glutinosa in lipopolysaccharide (LPS)-induced neuroinflammation model in vitro.

N9 cells were activated by 10 μg·mL^-1 LPS to establish an in vitro neuroinflammatory model. After treatment with Aucubin for 24 h, NO content was detected by Griess method, cell viability was detected by MTT method, cell morphology was photographed by microscopy, the level of Iba-1 (a specific marker of microglia) was detected by immunofluorescence, CD11b level and CD86/CD206 ratio were determined by flowsight assay, and the levels of IL-6, IL-1β, IL-4 and IL-10 were detected by kits.

Compared with the model group, the aucubin group effectively improved cell morphology, reduced cell supernatant NO level, decreased cell marker CD11b level and CD86/CD206 value, and regulated the release of inflammatory factors.

Aucubin inhibited the activation of microglia to M1 phenotype and promoted the transformation of M2 phenotype. It also regulated the release of inflammatory factors, thus inhibited the activation of N9 microglia and finally suppressed LPS-induced neuroinflammation.

To observe the protective effect of 6-O-methyl-catalpol on fructose-induced NAFLD in mice and its mechanism.

The mice were randomly divided into the control group and fructose-fed groups. After 4 weeks, the fructose-fed mice were further divided to 4 subgroups: model group, silybin group (35 mg·kg^-1), 6-O-methyl-catalpol (30 mg·kg^-1) group, and 6-O-methyl-catalpol (60 mg·kg^-1) group. The drugs were administered by gavage qd for a period of 4 weeks. At the end of the treatment, the levels of ALT, AST, TC, TG, GLU, insulin and leptin were determined. The histopathological changes of liver were evaluated using HE staining. The fatty acid synthetase (FAS) and acetyl CoA carboxylase (ACC) protein expression in liver were measured using Western blot.

Compare with the model group, the elevated levels of AST, ALT, TC, TG, insulin, leptin and HOMA-IR significantly decreased in 6-O-methyl-catalpol groups (P<0.01). HE staining showed that the degree of hepatic steatosis was obviously ameliorated in 6-O-methyl-catalpol treatment groups. The protein expression levels of ACC and FAS were also significantly down-regulated in high 6-O-methyl-catalpol group (P<0.01).

6-O-methyl-catalpol exerts protective effect against NAFLD, which may be related to the improvement of insulin sensitivity and lipid metabolism.

To establish a detection method for exogenous DNA in neomycin sulfate drugs based on the concept of analytical quality by design (AQbD).

The MODDE Pro11 software was used to design the experiment, investigate the key influencing factors and optimize the parameters. Qubit^® DNA detection kit based on fluorescence staining method was employed for the determination of exogenous DNA.

The universal detection method of exogenous DNA in neomycin sulfate was established. The key effect factors are solvent type, solvent concentration and sample concentration. When NaCl was used as solvent, the optimal analysis conditions were solvent concentration at 1.4 mol·L^-1 and sample concentration at 1.8 mg·mL^-1. The linear range of DNA standard was 20~100 ng·mL^-1 (r=0.995 7, n=2). The accuracy was above 81.0%. The recoveries in ruggedness tests were 80%~120%.

The established method is accurate, robust and universal. This study provides reference for the development of determination of exogenous DNA in aminoglycoside antibiotics.

To establish the quality standard of Xianqian Granules.

According to the relevant methods presented in the fourth general rules of Pharmacopoeia of the People's Republic of China (2020), TLC method for identifying 4 Chinese medicinal materials in Xianqian Granules, including Agrimoniae Herba, Rubiae Radix et Rhizoma, Paeoniae Radix Rubra, and Notoginseng Radix et Rhizoma, was established, as well as the HPLC method for determining the index components of purpurin and paeoniflorin in Xianqian Granules.

The TLC method was specific to identify the 4 medicinal materials effectively. In the quantitative analysis method, the mass concentrations of purpurin and paeoniflorin were linear in the ranges of 2.47~53.00 μg·mL^-1 and 18.29~392.0 μg·mL^-1, respectively. The average recoveries were 97.37% (RSD 1.44%) and 99.04% (RSD 0.82%), respectively.

The established methods for quality evaluation of Xianqian Granules are simple, accurate, and specific, which can be used for the quality control for Xianqian Granules.