To systematically characterize and simultaneous determine 13 chemical components (neochlorogenic acid，chlorogenic acid，cryptochlorogenic acid，luteolin-7-glucuronide，cynaroside，isochlorogenic acid B，isochlorogenic acid A，apigenin-7-glucuronide，isochlorogenic acid C，deoxyelephantopin，isodeoxyelephantopin，isoscabertopin and scabertopin) in Elephantopi Herba based on ultra performance liquid chromatography-quadrupole-time-of-flight tandem mass spectrometry (UPLC-Q TOF MS/MS).

UPLC-Q TOF MS/MS technology combined with sequential window acquisition of all theoretical mass spectra (SWATH) mode was used to collect data of different batches of Elephantopi Herba samples. The separation was performed on a Waters HSS T3 C₁₈(100 mm×2.1 mm，1.8 μm) column with mobile phase consisting of acetonitrile and 0.1% formic acid water solution. The flow rate of gradient elution was 0.4 mL·min^-1，the column temperature was 35 ℃ and the injection volume was 2 μL. The electrospray ionization (ESI) source was employed to collect data under both positive and negative ion modes. With reference to reference substances and relevant literatures，chemical components in Elephantopi Herba were identified. At the same time，the determination method for 13 chemical components in Elephantopi Herba was established and validated.

In this study，the cleavage patterns of different classes of compounds were summarized，and 36 chemical components were initially identified，including 20 organic acids，7 flavonoids，6 sesquiterpene lactones，1 coumarin and 2 other components. All of the analytes showed good linearity (r≥0.999 0) in the tested ranges. The precision，repeatability and stability of the method were good for the 13 components. The average recoveries were in the range of 94.9%-103.5% with relative standard deviations (RSDs) ≤3.8%. The chemical compositions of different batches of Elephantopi Herba were basically similar，but there were certain differences in the contents of 13 components.

In this study，comprehensive characterization of the chemical constituents and relative quantitative analysis of Elephantopi Herba are carried out，and a rapid and efficient qualitative analysis method of Elephantopi Herba is established by UPLC-Q TOF MS/MS，which provides a reference for the screening and rational exploitation of the medicinal substances of Elephantopi Herba，and methodological reference and data support for the quality control and development of Elephantopi Herba.

To establish a low-field and high-field nuclear magnetic resonance (NMR) technique for the determination of pyridoxine hydrochloride. To compare the differences between the results of method validation and sample content.

Using deuterated water as the solvent and maleic acid as the internal standard，method validation of quantitative nuclear magnetic resonance (qNMR) was accomplished with both 80 MHz low-field NMR and 500 MHz high-field NMR instruments. The content of pyridoxine hydrochloride was also determined.

The linearity of pyridoxine hydrochloride was good in the range of 10-30 mg·mL^-1，and the linear correlation coefficients were 0.999 8 and 0.999 6 for the low-field and high-field NMR，respectively. RSDs of the low-field and high-field NMR measurements were 1.4% and 0.040%，respectively. The contents were 100.4% and 100.8%，which were in agreement with the results from the mass balance method (100.0%). And the repeatability RSD was 0.20%. For the same concentration of the sample，the signal-to-noise ratio (S/N) of high-field NMR was about 100 times that of low-field NMR，and the half-peak width was 1/15 of that of low-field NMR.

Both low-field and high-field NMR instruments gave accurate results in the determination of pyridoxine hydrochloride content. However，low-field NMR was only suitable for compounds with simple structures. In the actual content determination，it is necessary to choose the appropriate instrument according to the structure and solubility of the sample to be tested.

To establish an integrated model of biosensing technology for the study of zebrafish，and to study and verify the interaction between cetirizine hydrochloride，fexofenadine hydrochloride，mizolastine，and ebastine，with the key target of allergic rhinitis，macrophage migration inhibitory factor（MIF）.

A MIF-high electron mobility transistor(HEMT) biosensor was constructed using AlGaAs/GaAs HEMT as the sensing element and MIF as the biological element. The interaction strength between cetirizine hydrochloride，fexofenadine hydrochloride，mizolastine，and ebastine and MIF was characterized. Furthermore，a zebrafish immune inflammation model was established. The number of neutrophil migration in the blank control group，model group，positive drug group，and low，medium，and high-dose drug groups were recorded. And the drug inflammation inhibition rate were calculated.

Cetirizine hydrochloride exhibited the strongest binding ability to MIF，with a dissociation constant of 7.05×10^-13 mol·L^-1. The K_D for the interactions between fexofenadine hydrochloride，mizolastine，and ebastine with MIF were 2.34×10^-8 mol·L^-1，1.94×10^-7 mol·L^-1 and 2.44×10^-8 mol·L^-1，respectively. All of them had binding effects with MIF. Further the validation using the zebrafish immune anti-inflammatory model revealed that all four antihistamines significantly reduced the number of neutrophil migrations，among which 100 μmol·L^-1 of cetirizine hydrochloride achieved a neutrophil migration inhibition rate of 68.5%.

This study explores the interaction between antihistamines and the key protein target of AR through the integration of biosensing technology and zebrafish experiments. It was found that MIF is a potential target for antihistamine drugs to exert their pharmacological effects. It provides an important reference for research on drug efficacy and its association with targets.

To analyze the peptide components of bran-fried Bombyx batryticatus decoction and virtually screen anti-epileptic peptides with GAT-1 binding activity.

The peptide compounds in bran-fried Bombyx batryticatus decoction were extensively identified by micro-flow liquid chromatography-tandem mass spectrometry（μLC-MS/MS） technology. Potential anti-epileptic peptides were screened through bioinformatics and in silico simulations，including bioactivity prediction，blood-brain barrier permeability prediction，toxicity prediction，and molecular docking. Finally，molecular dynamics simulations were employed to analyze the interactions between peptides and the target protein.

A total of 384 peptides were identified from bran-fried Bombyx batryticatus decoction，and 19 peptides with higher binding affinities to GAT-1 than that of the control drug were screened as potential anti-epileptic peptides. The FDHFDFDAF exhibited the highest binding affinity，followed by the EHYAWGIK. Two peptides primarily interacted with GAT-1 through hydrogen bonds，hydrophobic，and electrostatic interactions. Molecular dynamics simulations confirmed the binding stability of FDHFDFDAF and EHYAWGIK to GAT-1.

Peptidomics and in silico virtual screening techniques facilitate the rapid discovery of active peptide components in animal-derived traditional Chinese medicine. This study has significant reference value for researching anti-epileptic peptides in bran-fried Bombyx batryticatus decoction，and provides new insights for the study of peptide components in animal-derived traditional Chinese medicine.

To develop a novel and efficient assay for the determination of free formaldehyde content in vaccines，and to compare the results with the method of the Chinese Pharmacopoeia(ChP) 2020 edition.

Vaccine samples were added directly into headspace vials without any pretreatment and tested after mixed with a new derivatization reagent，1% p-toluenesulfonic acid-ethanol solution (1% TsOH-EtOH solution). The concentration of the reagent，the dosage and the optimal derivatization conditions (headspace incubation temperature and time) were tested and confirmed. A DB-624 gas capillary column was used with temperature programming. The detector was a hydrogen-ion flame detector (FID) and the sample was injected in headspace.

The linear range was 0.25-100 μg·mL^-1（r=0.999 5），the detection limit and the quantification limit were 0.10 μg·mL^-1 and 0.25 μg·mL^-1，respectively. The recovery rates of several kinds of vaccines were all over 94%，and the RSDs were all less than 6%，which were in line with the requirements of specificity，precision and durability. There were no significant differences between the results of multiple batches and those determined by ChP 2020 methods.

In this paper，a novel derivatization reagent (1% TsOH-EtOH solution) was developed and validated for the determination of free formaldehyde content in vaccines，which is simple，efficient and can achieve high-throughput detection. The method can just solve the problems in other current detection methods. The method of derivatization headspace gas chromatography for the determination of free formaldehyde content is applicable to vaccines and other biologics，and provide a reference for chemicals，traditional Chinese medicine and excipients.

To establish the first batch of national drug reference standard of L-methionine sulfoxide.

The molecular structure of methionine sulfoxide was confirmed by the methods of IR，NMR and high resolution MS. Moreover，the moisture，residual solvents，residual ignition and related substances of L-methionine sulfoxide were determined，and then，its hygroscopicity，homogeneity and stability were also observed. Finally，mass balance method，HPLC and quantitative NMR were applied to determine and calculate its contents.

The results of experiments showed the structure of L-methionine sulfoxide were confirmed，its contents of moisture，residual ignition，metal elements and related substances were 0.23%，0.20%，10.87 μg·g^-1 and 5.09%. The residual solvents were not detected in the samples. The final content of methionine sulfoxide was 94.5% by mass balance method. The contents of this batch of L-methionine sulfoxide were uniform，and it is stable in short-terms.

The first batch of national drug reference standard of L-methionine sulfoxide was established，and it is used for the inspection for related substances of amino acid drug，which is helpful in normalizing drug quality and guaranteeing drug safety.

To establish an HPLC method for the determination of related substances in olaparib raw materials.

By using YMC-Pack pro C₁₈ AS(150 mm×4.6 mm，3 μm) column，0.05 mol·L^-1 potassium dihydrogen phosphate (pH 3.0 adjusted with dilute phosphoric acid)-methanol-acetonitrile (90:5:5) was as mobile phase A and methanol-acetonitrile-water (45:45:10) was as mobile phase B，in gradient elution，with flow rate of 0.8 mL·min^-1. The column temperature was 30 ℃，the detection wavelength was 210 nm，and the injection volume was 10 μL.

The solvent blank did not interfere with the determination of relevant substances in the test solution，the known impurities Ⅰ-Ⅶ and unknown impurities in the system suitability solution were well separated in the chromatographic system. Olaparib had a good linear relationship with its peak area in the concentration range of 0.083-333.133 μg·mL^-1. The concentrations of impurities Ⅰ-Ⅶ were 0.05-3.0 μg·mL^-1，there were good linear relationships with their peak area，and their r were 0.999 7 or above. The average recoveries of impurities Ⅰ-Ⅶ were all above 92.0%，and RSDs were less than 4.0%.

The HPLC method for the detection of the related substances of olaparib raw materials has strong specificity，high sensitivity，high accuracy and good precision，which can meet the requirements for the detection of related substances of olaparib raw materials.

To establish a method for determination genotoxic impurity furfural in furosemide and its tablets. To analyze and evaluate the measurement results to provide a reference for national drug supervision and ensure drug safety.

The chromatographic column was filled with octadecylsilane bonded silica gel，and the gradient elution was performed with phosphoric acid solution and acetonitrile as the mobile phase. The detection wavelength was 276 nm. The method was validated and used to determine the furfural content in 6 batches of furosemide and 148 batches of furosemide tablets.

The detection limit of furfural was 4 ng·mL^-1 and the quantitation limit was 12 ng·mL^-1. The linearity between 0.012 0-0.602 3 μg·mL^-1 (r=1.000) was good. The average recoveries of furosemide and its tablets were 99.4% (RSD=0.99%) and 101.4% (RSD=1.3%). Furfural was detected in all batches of raw materials and tablet samples. The furfural content in the tablet products，which used the raw materials from company I，was significantly higher than that of the products obtained from company H.

This method has strong specificity，high sensitivity and good accuracy. It can be used for the determination of genotoxic impurity furfural in furosemide and its tablets. By analyzing the measurement results and discussing the sources and control strategies of furfural，quality control of furosemide tablets can be achieved.

To study the whole chain microbial load in the production of a traditional Chinese medicine pill.

A type of traditional Chinese medicine pills prescription was selected as the research object，including the medicinal materials and their purified medicinal materials，intermediates (mixed powder，waiting for inner packaging pills)，and finished products. The microbial limit test method was established according to the 2020 edition of the Chinese Pharmacopoeia（ChP），to detect and analyze the microbial loads of all samples collected throughout the entire chain from medicinal materials to finished products of the traditional Chinese medicine pills.

The microbial content of different medicinal materials varies greatly，and the varieties with higer risk factors for microbial contamination in medicinal materials were Perillae Folium，Pogostemonis Herba，and Angelicae Dahuricae Radix. The production process of Perillae Folium and Pogostemonis Herba needed to be improved and adjusted from “medicinal material to pure medicinal material”. There was a positive correlation between the microbial load of medicinal materials and intermediate and finished products.

The study on the microbial load throughout the entire production chain of traditional Chinese patent medicines can help us to understand the transmission of microorganisms at each stage. This knowledge is crucial for identifying weak links in the production process and the key areas for process control, and has an important guiding significance for traditional Chinese patent medicines manufacturers to improve and explore their production process.

To establish a method for the quantitative detection of bacterial endotoxins in human peripheral blood mononuclear cell (PBMC) suspensions and to validate the feasibility of the detection method.

According to the standards for photometric determination of bacterial endotoxin in General Notice 1143 of Chinese Pharmacopoeia (ChP) part Ⅲ (2020 edition) and 1085 of USP. A preliminary detection method of bacterial endotoxin content in PBMC suspension was established from standard curve reliability verification and primary interferential screening test. Bacterial endotoxins in three batches of PBMC suspensions were quantitatively detected by this method.

In the establishment of standard curve and reliability verification test，the linear regression equation was lgt= 2.910 9-0.300 1lgC，r=-0.999 8，negative control t>3 600 s，repeated reaction tube RSDs were less than 3%，the standard curve was established successfully. The results of the primary interferential screening test showed that the PBMC suspension had interference on limulus test at the dilution ratio of 10 and the recovery rate was close to 100% at the dilution ratio of 80，indicating that 80-fold was the best interference dilution ratio without interference. The results of the three batches of samples showed that the endotoxin contents were all less than 1.0 EU·mL^-1 at the dilution ratio of 80，and the RSDs were less than 10%. The positive recoveries were 80.8%-100.3%，which complied with ChP 2020.

This method can quickly and quantitatively detect the content of endotoxin in PBMC suspension.