To establish a method for determining the absolute contents of candesartan cilexetil and amlodipine besylate in candesartan cilexetil and amlodipine tablets by qNMR.

The chemical shift δ 5.51 of candesartan cilexetil and δ 5.31 of amlodipine besylate were used as the quantitative peaks. δ 6.27 of maleic acid was the quantitative peak of internal standard. DMSO-d₆ was used as the solvent.

The method was highly specific and the solvent peak，water peak and excipient peaks did not interfere with the quantitative peaks. Candesartan cilexetil showed a good linear relationship in the concentration range of 1.580 0- 9.480 2 mg·mL^-1，r=1.000，RSDs of precision，repeatability and stability were 0.070%，1.7% and 0.68%，respectively. The recoveries of low，medium and high concentration spiked were 98.1%-99.2%. The linear range of amlodipine besylate was 0.983 9-5.903 6 mg·mL^-1 (r=0.999 9). The RSDs of precision，repeatability and stability were 0.050%，1.8% and 0.79%，respectively. The recovery of amlodipine besylate was 99.1%-102.0%. This method was used to test two batches of reference preparations and one batch of sample from different sources. The results showed that the content of candesatan cilexetil was between 98.10% to 98.75%, and that of amlldipine besylate was between 98.98% to 99.60%.

This method is rapid and accurate and it is not necessary to use a single component reference substance. This method provides a new method to determine the content to candesartan cilexetil and amlodipine tablets.

To establish a quantitative ¹H-NMR (qHNMR) method for the determination of dexzopiclone tablets content.

Proton signal at δ 6.08 of 1，3，5-trimethoxybenzene and δ 8.54，8.38，8.12，7.78 of dexzopiclone were served as the internal standard and quantitative peaks，respectively. DMSO-d₆ was employed as the solvent. The qHNMR spectra were acquired at 298 K with 10 s relaxation delay and 32 scanning times.

The content of dexzopiclone was estimated to be 2.94% （RSD=0.15%）by qHNMR method，which indicated that 3.00 mg of dexzopiclone was in one tablet. The result was consistent with the description of the label.

qHNMR method can be used to determine the content of dexzopiclone. The method is accurate，simple and efficient.

To establish the ultra high performance liquid chromatography (UPLC) fingerprint of Qiye Shen’an dropping pills，and to determine the contents of 8 index components by quantitative analysis of multi-components by single marker at the same time.

Waters CORTECS^® T3 (150 mm×2.1 mm，1.6 μm) chromatography column was used for gradient elution with acetonitrile -0.1% phosphoric acid as mobile phase，flow rate was 0.40 mL·min^-1，column temperature was 35 ℃，detection wavelength was 203 nm.

The UPLC fingerprint of Qiye Shen’an dropping pills was established，8 common peaks were established，and the similarity of 15 batches of samples was greater than 0.99. Ginsenoside Rb₁，ginsenoside RC，panax notoginseng saponin FC，ginsenoside Rb₂，ginsenoside Rb₃，ginsenoside Rd，panax notoginseng saponin Fe and panax notoginseng saponin Fd were determined by quantitative analysis of multi-components by single marker method. The contents of 8 components in 15 batches were between 7.6-10.0 mg per pill. The average recoveries were 99.8%，100.6%，99.8%，101.2%，102.1%，101.9%，99.7% and 100.2% respectively，and the RSDs were 2.3%，2.2%，2.0%，1.5%，1.7%，1.2%，2.4% and 2.6% respectively.

The UPLC fingerprint of Qiye Shen’an dropping pills and the content determination method of quantitative analysis of multi-components by single marker method established in this study are simple to operation，and have good repeatability，stability and reliability，and can provide a more comprehensive basis for the quality control of Qiye Shen’an dropping pills.

To establish a method and validate its feasibility for quality evaluation of Erycibes Caulis and its processed products，and analyze the effect on the contents of the seven active ingredient before and after processing.

The contents of components were determined by ultra performance liquid chromatography (UPLC). Chlorogenic acid was chosen as the internal reference substances，the relative correction factors (RCFs) of neochlorogenic acid scopolin，scopoletin，isochlorogenic acid B，isochlorogenic acid A，isochlorogenic acid C and to chlorogenic acid were established. The contents of these seven active ingredients were determined by external standard method and quantitative analysis of multi-components by single-marker (QAMS) method. The method was evaluated by comparison of the quantitative results between external standard method and quantitative analysis of multi-components by single-marker (QAMS).

The peaks of neochlorogenic acid，scopolin，chlorogenic acid，scopoletin，isochlorogenic acid B，isochlorogenic acid A and isochlorogenic acid C in the sample showed good linear relationship between 0.028-1.420 μg·μL^-1，0.019-0.956 μg·μL^-1，0.027-1.324 μg·μL^-1，0.014-0.720 μg·μL^-1，0.017-0.824 μg·μL^-1，0.010-0.500 μg·μL^-1 and 0.013-0.672 μg·μL^-1，respectively. The average recoveries of them（n=6）were as follows 98.9%，99.0%，100.6%，101.2%，100.8%，101.7% and 100.5%，with the RSDs of 1.1%，1.7%，1.5%，1.6%，0.55%，1.6% and 1.5%，respectively. It was showed that no significant difference was found in the quantitative results of seven ingredients by external standard method and QAMS method. The content of 5 kinds of organic acids (neochlorogenic acid，chlorogenic acid，isochlorogenic acid B，isochlorogenic acid A and isochlorogenic acid C) in Erycibes Caulis with different processing technology showed the same change trend. The sample of Y₅ (boiled products with licorice sauce and brine) had the highest contents，and the sample of Y₁₀ (dried products Ⅱ soaked in licorice sauce and brine) had the lowest. The content of scopoline was the highest in Y₅(3.53 mg·g^-1)，while the lowest was Y₁₀(0.31 mg·g^-1). The content of scopoletin in Y₇(dried products Ⅰ with licorice sauce) was the highest(1.48 mg·g^-1) and that in Y₃(boiled products Ⅱ with licorice sauce) was the lowest(0.30 mg·g^-1).

The RCFs established in the QAMS methods with chlorogenic acid as the internal reference substances is accurate and feasible. It can be used to control the quality of Erycibes Caulis. Both heating and excipients preparation have a certain effect on the active ingredients in Erycibes Caulis.

To establish a pre-column derivatization high performance liquid chromatography-mass spectrometry to determine biogenic amines in osteopeptide injections and determine the changes of biogenic amines after the stability influence factor test and accelerated test.

The osteopeptide injections were separated by a ZORBAX SB-C₁₈ chromatographic column and gradient elution after derivatization by dansyl chloride. Ten kinds of biogenic amines was determined by mass spectrometry with electrospray ion source and multiple reaction monitoring in positive mode. The osteopeptide injections were placed under high temperature，strong light and accelerated experimental conditions to inspect the stability of biogenic amines.

Method validation showed that the linear relationship of 10 biological amines was good，and the correlation coefficients were higher than 0.990. The detection limits were 0.01-0.10 ng·mL^-1，the quantitation limits were 0.05-0.30 ng·mL^-1. Good accuracy，repeatability and durability were obtained. Under different conditions，the changes of biogenic amines in osteopeptide injections were significant. The accumulation of putrescine increased under high temperature，while spermine and spermidine decreased. The biogenic amines were unstable under strong light and accelerated test.

Method validation shows that the method can be applicable to simultaneous determine 10 biogenic amines in osteopeptide injections. It provided a reference to establish and improve the quality standards of biogenic amines in osteopeptide and other drugs. In addition，the research of the stability of biological amines shows that high temperature and strong light will affect the stability of biogenic amines. Therefore，quality control and supervision should be strengthened during drug production and storage to ensure the stability of drug.

To establish an HPLC analysis method for the determination of diazepam，nordiazepam and oxazepam in hair samples.

The determination of drug content and related substances was performed by high performance liquid chromatography (HPLC). Ultrasonic method combined with liquid-liquid extraction method was used as the pretreatment method. The chromatographic column was Athena C₁₈-WP column (250 mm×4.6 mm，5 μm)；the mobile phase was the mixture of methanol：0.02 mol·L^-1 sodium dihydrogen phosphate (adjusted to pH 3.4 with phosphoric acid)：acetonitrile (30:43:27，v/v/v) in an isometric elution；the column temperature was 50 ℃；the flow rate was 0.7 mL·min^-1；the running time was 30 min；the injection volume was 20 μL. The detection wavelength was 254 nm. The internal standard was clonazepam.

The linearity of all the analytes were good in the concentration range of 0.1 to 25 ng·mg^-1（r>0.995）. The limit of quantitative was 0.1 ng·mg^-1 and the limit of detection was 0.05 ng·mg^-1. The intra-batch accuracies were 88.2%-103.9% (n=6) and the inter-batch accuracies were 88.5%-106.2% with imprecisions ≤9.19%. The recoveries were stable for three anlytes，which met the requirement of methodology. The present method was applied to the authetic hair samples，in which the concentrations of diazepam，norazepam and oxazepam were (0.307±0.016) ng·mg^-1，(0.244±0.012) ng·mg^-1 and (0.478±0.053) ng·mg^-1 respectively. Besides，C_norazepam/C_diazepam was 0.795，which was in consistent with the literature reported.

The established HPLC method is fast and easy to operate，with good reproducibility，applicability，and reliability.

To evaluate the processing ability of identification，tracing and abnormal occurs in drug manufactures by the proficiency testing for microbiological identification and traceability in Shandong Province.

The proficiency test was derived from an event of drug microbial contamination，and samples including contaminated products group and production group were designed to evaluate the testing and tracing competence of 264 participants from those aspects of drug control，identification，genetic comparison and traceability. The contaminated products group was composed of five simulated samples including one positive sample which included Enterobacter cloacae and Staphylococcus aureus，and four negative samples which were sterile. The production group was composed of five simulated samples including four positive samples and one negative sample，but each of the four positive sample included only one strain of Enterobacter cloacae，Staphylococcus aureus，Staphylococous epidemidis and Pseudomons aeruginosa，respectively.

259 participants reported their results. The rate of unqualified，qualified，good and excellent results were 3.5%，49.8%，46.7% and 0，respectively. But four results reported phylogenetic tree based on 16S rRNA gene without genetic comparison at the strain level. The unqualified result indicated inaccurate inspection of positive and negative sample. The qualified result indicated accurate inspection but inaccurate species identification or not. The good result showed accurate species identification without effective tracing analysis.

The ability of most drug manufactures to contaminant microorganisms testing are acceptable. But the ability of microbiological identification and traceability，the precise judgement and the effective measures to an emergency of microbial contamination in drugs remain to be strengthened.

To establish a method for the determination of 22 mycotoxins in pharmaceutical excipients by ultra-high performance liquid chromatography-ion mobility time-of-flight mass spectrometry (UHPLC-IM TOF MS).

The samples were separated on a Waters CORTECS^® UPLC^® C₁₈(100 mm×2.1 mm，1.6 μm) column by gradient elution at a flow rate of 0.25 mL·min^-1 using 0.1% formic acid and a mixture of acetonitrile and methanol (60:40) as the mobile phase. The column temperature was maintained at 35 ℃. MSe data acquisition mode was chosen and electrospray ion source operating in the positive/negative ionization mode for data acquisition was applied. The external standard method was used for quantification.

22 mycotoxins showed good linear relationships within their respective ranges (r>0.998 5). The limits of detection were 0.1-2.0 μg·kg^-1. The recoveries of 22 mycotoxins at three levels were in the range of 80.4%-118.2%，and the RSDs were 0.20%-8.8%. The matrix effect of 22 mycotoxins was not obvious. The method was applied to the detection of 32 batches of corn starch and 167 batches of dextrin. Aflatoxin B1，fumonisins B1 and B2，and zearalenone were detected in some batches.

The method is accurate，efficient and stable. It can be used in quality control of mycotoxins in pharmaceutical excipients，and provides technical supports for the risk assessment of mycotoxins.

To establish a method for determination of 7 mycotoxin contaminants in Jianqu by ultra high performance liquid chromatography-tandem mass spectrometry（UPLC-MS/MS）.

The samples were extracted with acetonitrile aqueous solution (containing 0.1% formic acid) ，and purified by QuEChERS extraction salt bag and Oasis PRiME HLB solid phase extraction column. The column of UPLC was WATERS HSS T3（100 mm×2.1 mm，1.8 μm）. Mobile phase was acetonitrile-5 mmol·L^-1 ammonium formate solution (containing 0.1% formic acid) with gradient elution. Ionization mode was electrospray ionization(ESI) with positive mode. The work mode was multiple-reaction monitoring mode(MRM).

The developed method provided a good linearity for the 7 mycotoxins with their respective linear rangers. The correlation(r) ranged from 0.999 1 to 0.999 9. The average recoveries ranged from 83.5% to 113.8%，RSDs of 2.1% to 5.2%. Among 10 samples were selected for analysis，aflatoxin B1 was detected from 3 samples at concentration of 1.32 μg·kg^-1 to 6.15 μg·kg^-1. The results indicated that there were serious safety risks in the Jianqu products.

This paper establishes a method for the determination of 7 mycotoxins in Jianqu. The residual of mycotoxins in Jianqu can be rapid ly detected by UPLC-MS/MS which is suitable for the risk monitoring of mycotoxins in Jianqu. This article reveals the current situation of mycotoxins contamination in Jianqu，providing a research basis for the safety control of traditional Chinese medicine. It is recommended that the relevant departments should strengthen the corresponding supervision work.

To establish a method for related substances determination in timolol maleate by ultra-high performance liquid chromatography-quadrupole/orbitrap high resolution mass spectrometry（UPLC-Q/Orbitrap HRMS），by which the impurities both in active pharmaceutical ingredients（APIs） and preparations can be recognized and determined.

An ACE Excel3 C₁₈-AR column（150 mm×4.6 mm，3 μm）was used for the separation and a mixture of 0.01 mol·L^-1 ammonium acetate solution with 0.02% formic acid and methanol was employed as the mobile phase by gradient elution，at a flow rate of 0.6 mL·min^-1. The detection wavelength for UV detector was 295 nm，an HESI（heated ESI）ion source was employed in both the positive mode and negative mode. The possible fragmentation patterns prediction was conducted with the help of Mass Frontier 8.0 and Compound Discover 3.3. The related substances could be recognized and determined by means of the forced degradation of the APIs，with the calibration by the correction factors and confirmation by the mass spectrum data from UPLC-Q/Orbitrap HRMS.

The timolol impurity B[3-(tert-butylamino)-2-(4-morpholino-1，2，5-thiadiazol-3-yloxy)propan-1-ol]，timolol impurity D(4-morpholino-1，2，5-thiadiazol-2-ol)，timolol impurity E((S，Z)-4-(｛1-(tert-butylamino)- 3-[(4-morpholino-1，2，5-thiadiazol-3-yl) oxy] propan-2-yl｝oxy)-4-oxobut-2-enoic acid maleate salt) and timolol impurity C[N-(tert-butyl)-2，3-bis (4-morphloline-1，2，5-thiadiazol-3-yloxy) propan-1-amine maleate] were produced from the APIs under selected conditions and separated well in the specified HPLC condition，the limit of quantitation was 0.05 μg·mL^-1 and the limit of detection was 0.015 μg·mL^-1 for HPLC-UV. The contents of individual impurities were between 0.000 4%-0.09% and the results of total impurities were between 0.02%-0.12% for the samples from 4 different manufactures. The probable chemical structures of the 6 unspecified impurities were speculated according to the fragmentation pattern of fragment ions，combined with the fragment information，chemical structure of API and the references.

The system solution can be obtained by the degradation of the API，and be implied in the impurity analysis for the timolol maleate. The results can be used as a reference for the quality control of timolol maletae.

To establish a liquid-liquid extraction method for the determination of genotoxic impurities N-nitrosodimethylamine（NDMA） and N-nitrosodiethylamine（NDEA） in chondroitin sulfate sodium by gas chromatography-mass spectrometry (GC-MS).

The chromatographic column was Thermo TG WAXMS (30 m × 0.25 mm，0.25 μm）. The column temperature was maintained at 40 ℃ for 1 min，increased to 240 ℃ at 25 ℃·min^-1 and maintained for 2 min. The inlet temperature was 220 ℃. The carrier gas was high-purity helium，and the flow rate was 1.0 mL·min^-1. The ion source of mass spectrometry was EI source. The electron energy was 70 eV. The ion source temperature was 280 ℃ and the transmission line temperature was 240 ℃. Injection volume was 1 μL.

The LOD of NDMA was 0.64 ng·mL^-1. Experiment showed a good linear relationship between peak area and concentration in the range of 4-16 ng·mL^-1，and the correlation r was 0.999 3. The LOD of NDEA was 0.176 ng·mL^-1 with a good linear relationship between peak area and concentration within the range of 1.1-4.4 ng·mL^-1. The correlation r was 0.999 6. NDMA and NDEA were not detected in chondroitin sulfate sodium.

The method is simple，specific and can be used to determine the genotoxic impurities NDMA and NDEA in chondroitin sulfate sodium.

To establish an HPLC method for the determination of six related substances in N-fluorenylmethoxycarbonyl-O-tert-butyl-L-threonine.

The analysis was conducted on YMC Triart C₁₈(250 mm×4.6 mm，3μm) column，the mobile phase was consisted with 0.1% trifluoroacetic acid in water（A） and 0.1% trifluoroacetic acid in acetonitrile（B）at the flow rate of 1.0 mL·min^-1. The column temperature was set 30 ℃，the detection wavelength was 265 nm and the injection volume was 10 μL.

N-Fluorenylmethoxycarbonyl-O-tert-butyl-L-threonine had good separation from the adjacent impurity peaks；The resolution of impurity1- 6 was greater than 1.5，and showed a good linear relationship (r≥0.999) in the corresponding mass concentration range，the detection limit of impurity 1-6 was 0.03 μg·mL^-1，and the quantitative limit was 0.06 μg·mL^-1，the average recovery rate (n=9) of impurity 1-6 was in the range of 97.6%-98.8%. The results of the three batches of N-fluorenylmethoxycarbonyl-O-tert-butyl-L-threonine showed that the contents of impurity 2，impurity 4 were <0.2% and <0.1%，respectively，and the other four impurities were not detected，and content of the total impurity was <1%.

This method has good resolution，high sensitivity and strong specificity，and is suitable for the determination of related substances in N-fluorenylmethoxycarbonyl-O-tert-butyl-L-threonine.

To establish a method for determination of gas impurities in medical gases.

The study introduced the principle and measurement system of gas detector tubes，and researched on the accuracy，precision and influence factors. The method was applied to the detection of gas impurities in medicinal gases.

The test results showed that the compressed gas detection tubes produced by manufacturer A and manufacturer B were greatly affected by the pressure. The compressed gas detection tubes produced by manufacturer A and manufacturer C and the ambient gas detection tubes of all manufacturers were greatly affected by the flow rate. All the gas detection tubes were affected by the measurement time. Both ambient temperature and humidity can affect the detection of H₂O detection tube，and ambient humidity also has an impact on the CO₂ ambient gas detection tube produced by manufacturer B. The difference between different manufacturers’ detection tubes was indistinct under the same testing conditions. The compressed gas detection tubes can accurately measure the gas impurity content under the continuous flow measurement system，while some ambient gas detection tubes can not accurately measure. The impurity interference was different for the detection tubes with different principles. It is suggested that the influencing factors should be paid attention to when the gas detection tubes are used，and the appropriate detection tubes and method should be selected.

The gas detector tubes can be used in the detection of medical gases with good accuracy and precision. This study provides references for the detection of impurities in medical gases.

To study the correlation between heavy metal and harmful elements of Jasmine and the geo-authenticity，and to evaluate the risk.

The content difference of heavy metal elements in 43 batches of Jasmine from different production areas was determined by ICP-MS，and cluster analysis was carried out to study the correlation between the content of each element in Jasmine and the geo-authenticity. The dissolution rate of each element after decocting in water was determined，the symbolic elements that might affect the contents of heavy metal and harmful elements was screened，and risk assessment was performed.

The copolymerization of 43 batches of jasmine from different producing areas was divided into 2 types. The contents of heavy metals in powder and dry paste of Jasmine from different producing areas declined in the order of Cu，Cd，Pb ，As and Hg，and the content of Cu in powder and dry paste was higher than other elements. The dissolution rates of heavy metal and harmful elements declined in the order of As，Pb，Hg，Cu and Cd，and Pb，Cd and As were the representative elements that might affect the content of heavy metal and harmful elements in Jasmine. Risk assessment showed that MOE_Pb<1 existed in samples from Hengzhou Town，Hengzhou City，Guangxi Province (batch number：20200810) and Quanzhou City，Fujian Province (batch number：20230705)，and the hazard index and exposure limit values in other producing areas were in line with the limit standards.

This paper provides scientific basis for selection of planting area，artificial breeding and formulation of heavy metal and harmful limit standard.

Based on a sequential analysis method of “physicochemical properties-main component content-fingerprint similarity-anaphylactoid reaction”，the stability and safety of Danhong injection with commonly used clinical solvents 0.9% sodium chloride and 5% glucose injections were evaluated.

According to the clinical application，Danhong injection was mixed with 0.9% sodium chloride injection or 5% glucose injection in the ratios of 20 mL：100 mL，30 mL：100 mL，40 mL：100 mL and 30 mL：250 mL，40 mL：250 mL，respectively. Then，they were placed at room temperature within 10 h. The properties，osmotic pressure，insoluble particles and pH value in the solutions were observed or measured at different time points. The contents of the main components at different time points were determined. The HPLC and ¹H NMR fingerprints at different time points were analyzed by similarity evaluation. The in vitro anaphylactoid reaction assay of RBL-2H3 cell degranulation was used to evaluate the safety of the mixture solutions.

The properties，osmotic pressure，insoluble particles and pH value of solutions were stable within 10 h after mixing，and there was no significant difference in the contents of the main components. The HPLC and ¹H NMR fingerprints showed good similarity，and the mixture solutions didn’t induce obvious degranulation in RBL-2H3 cells.

In this study，the comprehensive evaluation from the physical，chemical and biological perspectives showed that in the concentration range of 30 mL：250-40 mL：100 mL，Danhong injection combined with 0.9% sodium chloride injection or 5% glucose injection had good stability and safety within 10 h，which provides evidences for the clinical practice.

To establish an high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method for the simultaneous determination of 45 additives in oral liquid preparations of traditional Chinese medicine.

The samples were ultrasonically extracted by acetonitrile-methanol (9:1) (containing 0.1% formic acid). The separation was carried out on an Agilent Eclipse Plus C₁₈ chromatographic column (150 mm×3.0 mm，1.8μm) using gradient elution of methanol -5 mmol·L^-1 ammonium acetate. The compounds were scanned and detected simultaneously by electrospray ionization（ESI）ion source in both positive ion and negative ion mode under dynamic multiple reaction monitoring. The retention time and ion ratio were used for qualitative analysis and the external standard method was adopted for quantification.

The good linear relationship of peak area was observed for the 45 additives with correlation coefficients ≥0.992 in the concentration range of 5-2 000 ng·mL^-1，and the limits of quantitation were between 0.2 mg·kg^-1 and 4.0 mg·kg^-1 under the above chromatographic and mass spectrometric conditions. The average recoveries of the blank samples at different added levels ranged from 75.4% to 118.4% with RSDs of 0.70%-9.8%. The method was used to detect 20 batches of oral liquid preparations of traditional Chinese medicines purchased from pharmacies. Benzoic acid was detected in 6 batches with the contents of benzoic acid from 0.13% to 0.27%，and sorbic acid，trans-cinnamic acid，molasses，ethyl 4-hydroxybenzoate，acesulfame potassium，dehydroacetic acid and saccharin sodium were detected in 7 batches of samples respectively.

The established high-throughput detection method is sensitive，simple and fast in pre-treatment，with high accuracy，stable recovery and reduced detection cost effectively. It can be used for the simultaneous rapid screening of multiple additives in oral liquid preparations of traditional Chinese medicine.

To establish the fingerprint of Panax quinquefolius L. from Shandong by UPLC-PDA，and to simultaneously determine the contents of 16 ginsenosides.

The chromatographic column was an Acquity UPLC BEH C₁₈ column(50 mm×2.1 mm，1.7 μm)，which was eluted with water-acetonitrile by gradient at a flow rate of 0.4 mL·min^-1. The detection wavelength was 203 nm，the column temperature was 30 °C，and the injection volume was 2 μL. The Chinese Pharmacopoeia “Chinese Medicine Chromatography Fingerprint Similarity Evaluation System (2012 Edition)” was used for evaluation，and 42 batches of Panax quinquefolius L. from different habitats were compared with cluster analysis and principal component analysis.

The total content 16 ginsenosides in Panax quinquefolius L. from in Shandong were 19.73-58.07 mg·g^-1，and the average value was (34.72±8.22) mg·g^-1. The fingerprints of the ginsenosides in Panax quinquefolius L. from Shandong were established，and the similarities were above 0.90. And 10 common peaks constituted the characteristic peaks of Panax quinquefolius L.. Cluster analysis and principal component analysis showed that the contents of ginsenosides in Panax quinquefolius L. from Shandong were stable.

The fingerprint of Panax quinquefolius L. established is highly characteristic，and the method issimple，which provides data support for the identification and quality control of Panax quinquefolius L..

To establish a UHPLC method for simultaneously determining sinomenine，neochlorogenic acid，magnolflorine，cryptochlorogenic acid，chlorogenic acid，isochlorogenic acid B，isochlorogenic acid A，isochlorogenic acid C，harpagoside，ligustilide and ammonium glycyrrhizate in Jinteng Qingbi granules，and evaluate the quality of Jinteng Qingbi granules combined with principal component analysis.

UHPLC wavelength switching method was employed in the study. The chromatographic separation was performed on a Waters XSelect^® CSH C₁₈ column (150 mm×4.6 mm，2.5 μm) using methanol-acetonitrile (1:1) as mobile phase A and 0.2% phosphoric acid aqueous solution as mobile phase B in a gradient mode at 25 ℃. The flow rate was 1.0 mL·min^-1，and the UV detection wavelength was chosen at 218 nm for sinomenine during 0-17 min，326 nm for neochlorogenic acid，cryptochlorogenic acid，chlorogenic acid，isochlorogenic acid B，isochlorogenic acid A and isochlorogenic acid C during 17-25 min and 34-98nm，263 nm for magnolflorine，harpagoside，ligustilide and ammonium glycyrrhizate during 25-34 min and 98-125nm，respectively. Furthermore，multiple statistical analysis was conducted on the contents of 11 components in 20 batches of Jinteng Qingbi granules using SPSS27.0 software.

Satisfactory linearities of sinomenine，neochlorogenic acid，magnolflorine，cryptochlorogenic acid，chlorogenic acid，isochlorogenic acid B，isochlorogenic acid A，isochlorogenic acid C，harpagoside，ligustilide and ammonium glycyrrhizate were in the ranges of 14.36-143.61 μg·mL^-1 (r=0.999 9)，7.71-77.15 μg·mL^-1 (r=0.999 8)，9.18-91.83 μg·mL^-1 (r=0.999 7)，10.71-107.07 μg·mL^-1 (r=0.999 8)，12.88-128.80 μg·mL^-1 (r=0.999 8)，5.20-51.95 μg·mL^-1 (r=0.999 7)，5.18-51.84 μg·mL^-1 (r=0.999 8)，5.40-53.95 μg·mL^-1 (r=0.999 8)，2.62-26.16 μg·mL^-1 (r=0.999 9)，6.31-63.06 μg·mL^-1 (r=0.999 9) and 11.13-111.26 μg·mL^-1 (r=0.997 6)，respectively. The average recoveries (n=6) were 98.3%，98.3%，98.5%，98.9%，99.2%，101.0%，98.1%，97.1%，96.8%，98.0% and 98.7%，respectively，with RSDs less than 3.0%. The contents ranges of sinomenine and other 10 components of 20 batches of Jinteng Qingbi granules samples were 2.206-2.704，1.071-1.403，2.096-2.487，1.321-1.724，2.241-2.612，0.605-0.749，0.363-0.412，0.835-1.020，0.151-0.191，0.791-1.188 and 1.008-1.363 mg·g^-1，respectively. The results of principal component analysis showed that the quality differences between batches of continuously produced Jinteng Qingbi granules were relatively smaller，and the comprehensive quality of samples S1，S5 and S7 was relatively better.

The established UHPLC method of multi-index component determination is simple，accurate and stable. Combined with principal component analysis，it can be used for quality evaluation of Jinteng Qingbi granules comprehensively.

To establish a quality consistency assessment method to evaluate the consistency of product quality of Liuwei Dihuang concentrated pills (LDCP) among different manufacturers.

Firstly，high performance liquid chromatography (HPLC) was used to determine the content of the six index components in LDCP，and analyze the content differences between different batches of the same manufacturer and the current product quality of different manufacturers. Secondly，quality consistency parameters，i.e.，intra-batch content consistency differences (P_A)，inter-batch content consistency differences (P_B)，and fingerprint similarity (P_C)，were constructed to assess the consistency of product quality among the different manufacturers. And lastly，the consistency parameters were taken as the variables and subjected to the principal component analysis (PCA) to classify the consistency of the LDCP samples of the seven manufacturers to be fitted and differentiated.

The contents of the six index components in thirty-five batches of LDCP samples from seven manufacturers totaled 1.48-2.99 mg per pill，the RSDs of the contents of different components were 4.9%-29.7%，and the consistency parameters of the seven products were 4.2%-15.1% for P_A，26.4%-49.5% for P_B，and 92.9%-98.2% for P_C. There were some differences in the homogeneity of contents in samples from different manufacturers，and the contents of the product varied significantly between batches，with P value of 64.5-75.8，indicating that the difference in the consistency of samples from different manufacturers was relatively small. But under certain conditions，the seven manufacturers can be classified into three categories，with B and J as a category，Z and R as a category，and X，F，and S as a category.

This study provides a simple and effective method for monitoring and distinguishing the quality consistency of commercially available LDCP products，and the experimental results can provide a reference for the sample quality homogeneity of LDCP manufacturers.

To evaluate the quality of the Japanese encephalitis inactivated vaccine strain adapted in human diploid cells (ZFB-3).

The virus strain was identified by identification test to determine whether it was Japanese encephalitis virus strain，the virus titer was tested in mice brain to evaluate the adaptability and proliferation ability of the virus seed on human diploid cells (ZFB-3)，the sterility test，mycoplasma test，and external virus factor test was conducted for any external contamination.

The virus strain was proved as Japanese encephalitis virus and had been well adapted to human diploid cells (ZFB-3) with high virus titer. The virus strain was free from contamination by bacteria，fungi，mycoplasma or exogenous viral factors.

The quality of Japanese encephalitis inactivated vaccine strain adapted in human diploid cells (ZFB-3) meets the requirements and can be applied to vaccine production.

To develop the national standard materials of progesterone in frozen human serum and to evaluate the accuracy and standardization of serum progesterone detection kits.

Low and high concentrations of serum were from normal people and pregnant women individuals respectively，with a clear appearance，no obvious hemolysis，jaundice and lipid blood. After all tests for four infectious diseases were negative，thrombin，anhydrous calcium chloride and anhydrous sodium carbonate were added according to the proportion of 1 kU·L^-1，2.219 6 g·L^-1 and 2.65 g·L^-1 respectively，and centrifuged (4 000 r·min^-1，4 ℃，25 min) after fully mixing. After twice of multiple filtration and sterilization，serum pools were packed in ampoules to prepare candidates Ⅰ and Ⅱand stored at -70 ℃. Single factor variance method and linear regression method were used to evaluate the homogeneity and stability of the candidate. Five labs working together used reference method (isotope dilution liquid chromatography tandem mass spectrometry) to assign value for candidate. The uncertainty was calculated. At the same time，the commutability was evaluated.

Through statistical analysis, the F values of homogeneity for candidate Ⅰ and Ⅱ were 0.570 9 and 1.200 9, respectively, which were all less than F_0.05. Candidate Ⅰ and Ⅱ could be stable at least 8 h at 20-25 ℃. At 2-8 ℃, candidate Ⅰ and Ⅱ could be stable at least 33 d and 7 d respectively. Candidate Ⅰ and Ⅱ cound be stable at least 33 d at -20 ℃. Candidate Ⅰ and Ⅱ remained stable after repeated freeze-thaw cycles for 6 times. The assigned values were：candidate Ⅰ：(4.44±0.24) ng·mL^-1 (k=2), Ⅱ：(16.79±0.82) ng·mL^-1 (k=2). The determination results of candidate Ⅰ and Ⅱ were all within the 95% confidence interval of the fitting regression line established by the determination values of fresh serum samples.

Progesterone candidate had good homogeneity，stability，interoperability. It had accurate and reliable determination value，which could be used as national standard. The establishment of this national standard was of great significance for promoting the consistency and standardization of progesterone testing results.