To establish a method of thin-layer chromatographic identification，HPLC fingerprints and a method of the content determination of 13 chemical constituents (chlorogenic acid，caffeic acid，ferulic acid，senkyunolide I，senkyunolide H，coniferyl ferulate，senkyunolide A，butylphthalide，sedanolide，Z-ligustralactone，butenylylphthalide，levistilide A，and linoleic acid) in Ligusticum sinense Oliv. cv. Chaxiong Mss. and to provide a basis for the quality control of Ligusticum sinense Oliv. cv. Chaxiong Mss.

Thin-layer chromatography was used for the qualitative identification of senkyunolide I，scopoletin，ferulic acid，levistilide A and Z-ligustilide in Ligusticum sinense Oliv. cv. Chaxiong Mss. using n-hexane，ethyl acetate and acetic acid (10：5：0.5) as the mobile phase. The separation was carried out on an Acutfex PA-C₁₈ column (250 mm×4.6 mm，5 μm)，with gradient elution of 0.1% aqueous phosphoric acid solution and acetonitrile at a flow rate of 1 mL·min^-1. The column temperature was 30 ℃，the injection volume was 10 μL，and the detection wavelengths were 210 nm and 285 nm. The fingerprints of 54 batches of Ligusticum sinense Oliv. cv. Chaxiong Mss. were constructed. SPSS and SIMCA software were used for the chemical pattern recognition analysis，and 13 chemical components were determined at the same time.

A thin-layer chromatographic method was established for the identification of senkyunolide I，scopoletin，ferulic acid，levistilide A and Z-ligustilide in Ligusticum sinense Oliv. cv. Chaxiong Mss. The HPLC fingerprints of Ligusticum sinense Oliv. cv. Chaxiong Mss. were established，21 common peaks were found，13 common peaks were identified，and the similarities of all batches of the herbs were above 0.9，except sample S47. The herbs could be roughly divided into four groups according to the collection time and altitude by clustering analysis. OPLS-DA screened out seven differential constituents：peak 17(Z-ligustilide)，peak 13 (senkyunolide A)，peak 12 (coniferyl ferulate)，peak 5 (ferulic acid)，peak 6，peak 16 (sedanolide)，and peak 2 (chlorogenic acid). A method was established for the determination of chlorogenic acid，caffeic acid，ferulic acid，senkyunolide I，senkyunolide H，coniferyl ferulate，senkyunolide A，butylphthalide，sedanolide，Z-ligustralactone，butenylylphthalide，levistilide A and linoleic acid in Ligusticum sinense Oliv. cv. Chaxiong Mss. with good linearity，precision，stability，reproducibility，and spiked recoveries. And the content ranges of the above-mentioned compounds in the herbs were 0.03-3.80 mg·g^-1，0.004-0.055 mg·g^-1，0.17-0.82 mg·g^-1，0.08-0.57 mg·g^-1，0.01-0.19 mg·g^-1，0.04-2.51 mg·g^-1，1.37-11.64 mg·g^-1，0.15-0.58 mg·g^-1，0.18-4.22 mg·g^-1，2.69-9.53 mg·g^-1，0.15-0.59 mg·g^-1，0.07-0.62 mg·g^-1 and 0.31-6.04 mg·g^-1，respectively.

The method of thin-layer chromatography，HPLC fingerprints，and the determination method of the 13 constituents in Ligusticum sinense Oliv. cv. Chaxiong Mss. are simple，accurate and reliable，and can provide a basis for the evaluation of the quality of Ligusticum sinense Oliv. cv. Chaxiong Mss..

To develop a method for the determination of meropenem and vaborbactam for injection by HPLC.

The chromatography was performed on Shimadzu InertSustain C₁₈ (150 mm×4.6 mm，5 μm) column with acetonitrile-0.02 mol·L^-1 sodium dihydrogen phosphate solution (adjust pH to 2.8 with phosphoric acid)(10：90) as a mobile phase，the flow rate was 1.0 mL·min^-1，the detection wavelength was 210 nm，and the sample volume was 10 μL. A method for the determination of meropenem and vaborbactam for injection was established under the chromatographic conditions.

In this method，the linearities of meropenem and vaborbactam were good，and the linearity ranges were 21.40-214.0 μg·mL^-1 and 19.83-198.3 μg·mL^-1. Meropenem and vaborbactam had good precision with RSD of 0.31% and 0.16%，respectively. Within 24 h，meropenem and vaborbactam had good stabilities at 4 ℃，RSDs were 0.31% and 0.16%，respectively. The average recoveries of meropenem and vaborbactam were 101.0% (n=9) and 98.4% (n=9) (RSD<2.0%). The contents of meropenem and vaborbactam were 405.8 mg·g^-1 and 399.1 mg·g^-1，respectively.

The method is accurate，simple and rapid，and can be used for the determination of meropenem and vaborbactam for injection.

To predict the quality marker (Q-Marker) of Shenmai granules by ultra-performance liquid chromatography-ion trap/electrostatic field Orbitrap mass spectrometry (UPLC-LTQ Orbitrap MS) and network pharmacology.

The chromatography was performed on a Shimadzu Shim-pack gist C₁₈ column (100 mm×2.1 mm，2 μm) with acetonitrile-0.1% formic acid water as the mobile phase with gradient elution and the mass spectrometry was scanned in positive and negative ion modes. Databases such as TCMSP，Swiss Target Prediction and GeneCards were used to predict the core targets and construct the “composition-traget” network diagram to explore the Q-Marker of Shenmai granules.

A total of 71 compounds were identified，and 14 active components were screened as Q-Marker candidates for network pharmacological analysis. The results of network pharmacology indicated that ginsenoside Rf，ginsenoside Rg₃，ginsenoside F₂，methylophiopogonanone A，ophiopogonin C，ophiopogonin D，methylophiopogonone A，ophiopogonanone C，methylophiopogonone B，betaine，taraxerone，medicarpin and batatasin I might regulate and control protein activity and function by acting on the PI3K-Akt pathway，regulating protein phosphorylation reactions，thereby achieving the effect of Yangyin Shengjin production.

This study elucidates the chemical composition of Shenmai granules，explores the mechanism of Shenmai granules in Yangyin Shengjin and predicts the Q-Marker through network pharmacology，laying the foundation for the improvement of the pharmacological substance foundation and quality standards of Shenmai granules.

To explore the difference of chemical composition between the bulbus of Lilium lancifolium Thunb. and L. brownii F. E. Brown var. viridulum Baker，the chemical profile of Lilii Bulbus was acquired by ultra-high performance liquid chromatography with quadrupole-time of flight mass spectrometry (UPLC-Q TOF MS)，then the components of all samples was analyzed by chemometrics combined with molecular networking.

The Agilent poroshell 120 EC-C₁₈ column (100 mm×2.1 mm，2.7 μm) was adopt，and the mobile phase was acetonitrile -0.1% formic acid aqueous solution with gradient elution. The flow rate was 0.3 mL·min^-1，the column temperature was 30 ℃ and the injection volume was 1 μL. The mass spectra were acquired in the positive and negative modes in the mass range of m/z 80-1 100. Principal component analysis (PCA)，partial least squares-discriminant analysis (OPLS-DA) and single factor analysis were used for screening the differential components. Then GNPS molecular network was created according to the similarity of MS/MS fragmentation modes. Cytoscape 3.7.2 software was used to screen molecular clusters with similar structures.

Phenolic acid glycerides，alkaloids and steroid saponins were screened as the differential components groups. Among these components，the bulbus of Lilium lancifolium Thunb. was rich in steroid saponins，while the bulbus of L. brownii F. E. Brown var. viridulum Baker was rich in alkaloids. Besides，31 components，including 18 phenolic acid glycerides，7 alkaloids and 6 steroid saponins were identified in the three differential components groups.

This method can provide reference data for the quality control and pharmacodynamic substances of Lilii Bulbus，and provide reference for the rapid qualitative analysis of chemical components of traditional Chinese medicine.

To establish a content determination method for 14 components in pine needles of different varieties and origins simultaneously by ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-QQQ MS/MS).

The UPLC-QQQ MS/MS was adopted. A Waters ACQUITY UPLC BEH HILIC (100 mm×2.1 mm，1.7 μm) chromatographic column was used，with a column temperature of 35 ℃. The mobile phase was a mixture of 0.1% formic acid-acetonitrile solution (A) and 0.1% formic acid-aqueous solution (B) for gradient elution，with a flow rate of 0.2 mL·min^-1. Electrospray ionization was used，and multiple reaction monitoring mode was employed. The monitored ion pairs of each component were m/z 125.0/79.1(gallic acid)，m/z 105.1/77.2(p-hydroxybenzyl alcohol)，m/z 109.1/91.1(protocatechuic acid)，m/z 93.1/65.2(p-hydroxybenzoic acid)，m/z 190.9/85.2(chlorogenic acid)，m/z 151.8/108.2(vanillic acid)，m/z 135.1/89.2(caffeic acid)，m/z 167.0/122.9(syringic acid)，m/z 119.2/93.2(p-coumaric acid)，m/z 208.1/193.0(sinapic acid)，m/z 82.0/77.2(benzoic acid)，m/z 91.3/65.3(phenylacetic acid)，m/z 93.1/65.2(salicylic acid)，and m/z 103.2/77.2(cinnamic acid).

The content ranges of each component in the 12 determined pine needle samples were as follows：gallic acid 0.34-3.42 mg·g^-1，p-hydroxybenzyl alcohol 1.32-9.76 mg·g^-1，protocatechuic acid 0-6.32 mg·g^-1，p-hydroxybenzoic acid 0-19.06 mg·g^-1，chlorogenic acid 0-18.78 mg·g^-1，vanillic acid 0.16-3.81 mg·g^-1，caffeic acid 0-6.68 mg·g^-1，syringic acid 0.09-4.64 mg·g^-1，p-coumaric acid 0.10-9.90 mg·g^-1，sinapic acid 0.98-19.01 mg·g^-1，benzoic acid 1.28-18.21 mg·g^-1，phenylacetic acid 0.95-20.72 mg·g^-1，salicylic acid 0-3.25 mg·g^-1，and cinnamic acid 0-0.27 mg·g^-1. Each component had a good linear relationship within the test range，and the average sample recovery rate was between 98.0% and 101.7%. The quantitative limits of the 14 components were between 0.01 and 0.4 ng.

This method is applicable for the determination of phenolic acids in common pine needles，in which 9 compounds，including p-hydroxybenzyl alcohol，chlorogenic acid，vanillic acid，syringic acid，p-coumaric acid，sinapic acid，benzoic acid，salicylic acid，are determined for the first time in pine needles，which can provide reference for the determination of various phenolic acids in pine needles.

To explore the differences of multiple types of chemical constituents in fresh and white ginseng with different growth years，which provided reference for the quality control and comprehensive exploitation of Panax ginseng.

The saponins in ginseng was determined by HPLC-ELSD；Analytical conditions：a Dimaonsil^® ODS C₁₈ (250 mm×4. 6 mm，5 μm) column was used with (A)-water (B) (gradient elution) as the mobile phase at a flow rate of 1.0 mL·min^-1，the temperature of the drift tube was 100 ℃，the gas flow rate was 2.8 L·min^-1. The UV-Vis spectrophotometric was used to determine the soluble polysaccharides. Glucose and glucuronic acid were used as reference substances of the neutral polysaccharide and acidic polysaccharide with detection wavelengths of 490 nm and 512 nm，respectively. UPLC-T Q MS was used for analyzing amino acids and nucleosides of Panax ginseng. Analytical conditions：an ACQUITY UPLC BEH Amide (100 mm×2.1 mm，1.7 μm) column was used with an aqueous solution containing 5 mmol·L^-1 ammonium formate，5 mmol·L^-1 ammonium acetate，and 0.2% formic acid as mobile phase A，and an acetonitrile solution containing 1 mmol·L^-1 ammonium formate，1 mmol·L^-1 ammonium acetate，and 0.2% formic acid as mobile phase B with gradient elution at the flow rate of 0.40 mL·min^-1. Column temperature was 30 ℃，and injectionvolume was 2 μL. Electrospray ion source was adopted with positive ion modes and multi-reaction monitoring and acquisition.

Under the same growth years，the content of 8 ginsenosides (ginsengside Re，ginsengside Rg₁，ginsengside Rf，ginsengside Rb₁，ginsengside Rc，ginsengside Rb₂，ginsengside Rb₃，ginsengside Rd) and 7 nucleosides (thymine，thymidine，uridine，adenosine，cytidine，guanosine，adenine) in white ginseng were higher than that in fresh ginseng，with the average content of 7.10-12.75 mg·g^-1and 0.195 0-0.878 4 mg·g^-1，respectively. The soluble polysaccharides (neutral polysaccharide，acid polysaccharide) and 15 amino acids (L-leucine，L-phenylalanine，L-tryptophan，gamma-aminobutyric，L-isoleucine，L-valine，L-proline，L-tyrosine，β-alanine，L-threonine，L-glutamine，L-asparagine，L-asparticacid，L-arginine，L-lysine) in fresh ginseng were higher than that in white ginseng，with the average contents of 11.03%-18.29% and 7.61-13.58 mg·g^-1，respectively. Comparison of 3-6 years old with fresh ginseng and white ginseng revealed that the highest average total amounts of soluble polysaccharides，8 ginsenosides，15 amino acids and 7 nucleosides were found in the 6 years old ginseng，which were 18.29%，12.75 mg·g^-1，13.58 mg·g^-1，0.878 4 mg·g^-1.

The contents of multiple types of components in fresh ginseng and white ginseng from different growth years were different. The total amount of soluble polysaccharides，8 ginsenosides，15 amino acids and 7 nucleosides all increased with growth years. The results provide scientific basis for efficacy differences and the quality control of fresh ginseng and white ginseng.

To establish an ion chromatography method suitable for simultaneous determination of acid radical content in chemical reference substances containing methanesulfonic acid，hydrochloric acid，phosphoric acid，sulfuric acid and butadisulfonic acid.

The chromatographic column of Metrosep A Supp 5 250/4.0 (250 mm×4.0 mm，5 μm) was used with 6.4 mmol·L^-1 Na₂CO₃ and 2.0 mmol·L^-1 NaHCO₃ as the eluent with a flow rate of 0.7 mL·min^-1. Column temperature was 30 ℃.

Methanesulfonate (19.1-71.7 μg·mL^-1)，chloride ion (2.6-25.8 μg·mL^-1)，phosphate (7.0-26.3 μg·mL^-1)，sulfate (6.8-51.0 μg·mL^-1)，and succinate (21.3-105.5 μg·mL^-1) had good linear relationships within their respective ranges (r≥0.999 5). Precision (RSD≤2%)，stability (RSD≤2%) and repeatability (RSD≤2%) were good. The average recovery rates (n=9) were 98%-102%. Calculated as salt formation，the content of mesylate in amlodipine mesylate was 23.69%，the content of hydrochloric acid in guanfacine hydrochloride was 12.66%，the content of phosphoric acid in reagliptin phosphate was 17.38%，the content of sulphate in salbutamol sulfate was 16.49%，and the content of butyldisulfonic acid in adenosine butyldisulfonic acid was 45.61%. The deviation between theoretical and measured values was less than 0.50%. The measured values were close to the theoretical values.

The method is suitable for the screen and determination of acid radicals in chemical reference products containing methanesulfonic acid，hydrochloric acid，phosphoric acid，sulfuric acid and butadisulfonic acid.

To screen primary chicken embryo cells adapted strain of live attenuated yellow fever vaccine 17D-204，prepare virus seed banks and perform release tests.

The virus seed of live attenuated yellow fever vaccine 17D-204 was adapted and domesticated on primary chicken embryo cells，and the chicken embryo cells adapted strain was obtained. Establish virus seed banks of live attenuated yellow fever vaccine (primary chicken embryo cells)，and quality control was performed.

The optimum culture temperature of live attenuated yellow fever vaccine 17D-204 in primary chicken embryo cells was 37 ℃，and the optimum MOI(multiplicity of infection) was 0.0048. Three-level seed banks of primary seed bank，master seed bank，working seed bank of live attenuated yellow fever vaccine 17D-204 (primary chicken embryo cells) [17D-204(CEC)] were established. The verification of virus titer，identification test，sterility test，mycoplasma，exogenous virus factor test，Mycobacterium test and other items were in line with the provisions of volume Ⅲ of the Chinese Pharmacopoeia. High throughput sequencing showed that there was no gene mutation and no internal and external virus factor pollution in the gene sequence of the virus seed banks.

The primary chicken embryo cell adapted strain of live attenuated yellow fever vaccine 17D-204(CEC) can be screened out to establish the virus seed banks，with good passage stability and genetic stability. This study laid a firm foundation for the regeneration of live attenuated yellow fever vaccine from chicken yolk sac to chicken embryo cells.

To establish an UPLC-Q Orbitrap MS determination method for multiple residues of exogenous new pollutants，per-and polyfluoroalkyl substances (PFAS)，in Pheretima medicinal materials.

The samples were extracted with acetonitrile (containing 0.2% formic acid) after adding sodium chloride and 27 isotopes labeled internal standard solutions. Ultrasound treatment was performed for 20 min，followed by high-speed oscillation for 10 min. The extraction solution was subjected to freeze centrifugation，and the supernatant was concentrated to about 0.5 mL. Then，5 mL of 40% methanol (containing 0.05% formic acid) was added and mixed well. Further purified by mixed weak anion exchange solid-phase extraction (6 mL，150 mg)， eluted sequentially with 3 mL of methanol and 3 mL of 0.5% ammonia water methanol，and the eluents were collected，respectively. After blowing the eluent nitrogen to near dryness，the residue was redissolved in methanol，and the supernatant was taken for instrumental analysis after freezing and centrifugation. The target and internal PFAS were separated on an ACE EXCEL 2 C₁₈ chromatography column (150 mm×2.1 mm，2 μm)，using 5 mmol·L^-1 ammonium formate solution and acetonitrile were used as the mobile phase for gradient elution. The flow rat e was set to 0.3 mL·min^-1，the column temperature was 35 ℃，and the injection volume was 2 μL. The PFAS were detected by UPLC-Q Orbitrap MS in negative electrospray ionization mode with full scanning monitoring with the scanning range of m/z 100-1 000. Quantification of 43 PFAS using internal standards was performed based on their peak areas in extract ion chromatogram.

The method had good specificity，with a good linear relationship between the 43 tested indicator components and correlation coefficients greater than 0.995. The recovery rate of all indicators for sample addition was 68.3%-121.4%，the repeatability was 3.5%-15.0%. The detection limits and quantification limits were 0.01-0.15 μg·kg^-1 and 0.02-0.5 μg·kg^-1. respectively. A total of 22 kinds of PFAS were detected in 20 batches of Pheretima samples.

The UPLC-Q Orbitrap MS method is sensitive and accurate for simultaneous determination of 43 trace and multiple residual PFAS in Pheretima medicinal materials. It is suitable for daily monitoring of PFAS in Chinese medicinal materials with similar matrices，as well as assessment and control of quality risks.

To establish an ICP-MS method for the detection of elemental impurities in lanthanum oxide and to explore the development of the ICP-MS methodology for high-matrix samples quantitative analysis.

25 mg samples were precisely weighed and placed in a 25 mL flask. 1 mL of nitric acid and 0.25 mL of hydrochloric acid solution were added，shaken，and dissolved for approximately 1 h，then fixed with ultrapure water. Quantitative samples determination were performed using Agilent 7900 ICP-MS in He mode with the standard curve method corrected by internal standard. The atomizing gas flow rate was set at 1.05 L·min^-1，the atomizing chamber temperature was maintained at 2 ℃，the sample aspiration rate was 0.1 r·s^-1，the RF power was 1 550 W，and the sampling depth was 10 mm. The helium flow rate was 5 mL·min^-1，and the energy discrimination was 5.0 V. Based on ICH Q2 (R2) and USP 2023 <233>，a quantitative method for 25 elemental impurities was established by utilizing the recovery rate of the method. The isotope ratio of each element in the sample was investigated，the mass number of the element to be measured was selected，and the method was verified.

Based on the specific outcomes of Se and Ce，82 and 142 were chosen as the detection mass numbers to evade interference. The results demonstrated that the linear relationships of the 24 elemental impurities were excellent，the recoveries ranged from 70% to 150%，the repeatability RSDs were less than 20%，and the method satisfied the quality control requirements. Impurities such as Pb (0.152-0.201 ng·g^-1)，Cd (0.007-0.010 ng·g^-1)，Hg (0.156-0.250 ng·g^-1) were detected in numerous batches of samples，and the contents of each element were lower than the proposed standard.

The method is specific，accurate，simple，and feasible，and can furnish technical support for the elemental impurity control of lanthanum oxide. For complex and high-matrix samples，the recovery rate of standard addition is inadequate to characterize the specificity and accuracy of the method，and the isotope ratio can be utilized as a supplement to the recovery rate of standard addition.

To establish an HPLC method for determination of related substances and purity in pregabalin API.

The analytical column was an Inertsil ODS-3 (150 mm×4.0 mm，3 μm)，the mobile phase A was buffer (7.05 g ammonium dihydrogen phosphate and 1.45 g diammonium hydrogen phosphate dissolved in 1 000 mL water)-methanol-acetonitrile(900：80：20) and the mobile phase B was acetonitrile，the whole carried out by gradient elution at a flow rate of 0.8 mL·min^-1，the detection wavelength was set at 210 nm，the column temperature was 30 ℃ and the injection volume was 50 μL.

Pregabalin was separated completely from the impurities and degradation products (the resolution>2.0). The test solution was stable for at least 48 h. The LOQs of other impurities (verification was performed by using pregabalin)，lactam，4-alkene pregabalin，5-alkene pregabalin，trimer，3-isobutylglutaric acid (PGB-3)，3-isobutyl glutaric acid monoamide (PGB-5)，R-phenethylamine，4-isobutyl-2，6-piperidinedione (PGB-5B)，monoamide phenylethylamine (PGB-5C) and phenylethylamine adipate (PGB-5D) were 0.05%，0.01%，0.01%，0.03%，0.01%，0.05%，0.03%，0.01%，0.01%，0.01% and 0.01%. The linear correlation coefficients of other impurities (verification was performed by using pregabalin)，lactam，4-alkene pregabalin，5-alkene pregabalin，trimer，PGB-3 and PGB-5 were all more than 0.99. The linear ranges were LOQ-150% of impurities’ specification，respectively. The average recoveries (n=9) of lactam，4-alkene pregabalin，5-alkene pregabalin，trimer，PGB-3 and PGB-5 were 100.6% (RSD=0.56%)，100.2% (RSD=0.38%)，100.5% (RSD=0.46%)，101.1% (RSD=1.1%)，100.0% (RSD=0.63%)，100.0% (RSD=0.54%). The repeatability and intermediate precision completely met the requirements. The impurities contents in three batches of pregabalin API 6 months accelerate and 60 months long-term stability test completely met the requirements，respectively.

This method is simple，rapid，sensitive and specific to be used for the determination of related substances and purity in phenethylamine process pregabalin API.

To establish an HPLC method for the ratio of the enantiomer in fluralaner.

The chromatographic separation was performed on chiral chromatography column CHIRALPAK AD-H (250 mm×4.6 mm，5 μm). The mobile phase consisted of n-hexane-anhydrous ethanol (60：40) and the flow rate was 1.0 mL·min^-1. The detection wavelength was 265 nm and the column temperature was room temperature.

Under this chromatographic condition，three batches of samples were determined，the proportions of R-fluralaner and S-fluralaner were 1：1. The calibration curves of R-fluralaner and S-fluralaner good linearities at the range of 80.288-187.338 μg·mL^-1(r=0.999 7) and 81.902-191.104 μg·mL^-1 (r=0.999 9)，respectively. The average recoveries were 100.6% and 100.8%.

The method is accurate，reproducible and can be used for the ratio of enantiomers in fluralaner racemate.

To establish the determination methods for chromatographic fingerprint and multiple constituents，and then evaluate the quality grade of 103 batches of Banlangen granules that were from 55 manufacturers based on the reference drug.

Ultra-high-performance liquid chromatography (UPLC) analysis was used to establish the fingerprint of Banlangen granules and quantitate the contents of 7 components-uridine，adenine，vernine，(R，S)-goitrin，adenosine，syringin and clemastanin B. The test was performed on the Waters ACQUITY UPLC HSS T₃ (100 mm×2.1 mm，1.8 μm) column with gradient elution using methanol-water at a flow rate of 0.2 mL·min^-1. The injection volume was 2 μL，and the column temperature was constant at 30 ℃. Then，the results were detected using adopting a multi-wavelength detection mode. Next，the characteristic peaks and their belonging were clarified by comparing them with the reference drug. The sample fingerprint similarity and determination of contents were finally calculated，and the quality grades of Banlangen granules in each item were evaluated by using the reference drug.

The fingerprint was established，and 10 main characteristic peaks were identified. The similarities of the sample’s fingerprints ranged from 0.541 to 0.993，of which 101 batches were over 0.75 that were reached the second level，and 81 batches were over 0.90 that were reached the first level. The linear ranges of 7 components had good linear relationships within their respective ranges. The average recoveries (n=9) were 97.0%-104.7% with RSDs all below 3%. The precision，stability，and repeatability of methods were all good with RSDs all below 3%. Unified the sample specification to 5 g per bag，the content range of Banlangen granules samples was between 0.189-10.347 mg per bag. As a result，the content of 75 batches of samples reached the second level，and the content of 59 batches of samples reached the first level.

The established methods are simple，accurate and rapid，which can be used for the quality control and grade evaluation of Banlangen granules，as well as the research paradigm of other traditional Chinese medicine preparations.

To develop an ultra-high performance liquid chromatography tandem quadrupole time-of-flight mass spectrometry (UPLC-Q TOF MS) approach to investigate the molecular weight distribution and n value of nonoxynol oligomers，and to study several batches of samples produced domestically or abroad.

The mobile phase was 0.1% trifluoroacetic acid aqueous solution(A)-0.1% trifluoroacetic acid in acetonitrile(B) with linear gradient elution at a flow rate of 0.3 mL·min^-1. The column was Techmate STV SUNSHELL Peptide C₁₈ (100 mm×2.1 mm，2.6 μm，300 Å) and installed in a 60 ℃ column oven. Injection volume was 5 μL. A tandem quadrupole time-of-flight mass spectrometer with Dual ESI as ion source and argon as collision gas were used for detection in positive ion mode with a collection range of m/z 50-3 000. ChemDraw 19.0 software was used to draw the relevant structure，and MassHunter PCDL Manager software was used to build the database and edit the calculation formula.

The weight average molecular weight and number average molecular weight of 6 batches nonoxynol drug substance produced domestically or abroad were determined by the newly established method，and the range of n average value in the structure was obtained. The results showed that the weight average molecular weight and number average molecular weight were different between domestic and foreign products and also between different batches produced by same manufacturer. The n value of structure basis also varies. The weight average molecular weight ranges were 664.6 to 686.8 (n value was about 10)，and number average molecular weight ranges were 677.1 to 715.5 (n value was about 11).

The molecular weight distribution and n value of such oligomer drugs need to be controlled in the production process and quality specifications. The newly established method has high sensitivity，precision and reproducibility，can be qualified for the needs of determining molecular weight distribution and n value of nonoxynol，and provides insight in determination of molecular weight distribution of such oligomers. This study also provides a data supplement for the improvement and revision of the standards of Chinese Pharmacopoeia.

To establish an UPLC-MS/MS method to measure the content of 18 characteristic components in Fengshiantai tablets，and conduct chemometric analysis on the measurement results to provide a basis for quality control.

The components were separated on Waters BEH C₁₈ (100 mm×2.1 mm，1.7 μm) column with methanol and 0.1% formic acid aqueous solution as the mobile phase by gradient elution at a flow rate of 0.2 mL·min^-1. The column temperature was set at 40 ℃. The injection volume was 1 μL. The detection was carried out by electrospray ionization(ESI)，and electron spray ionization source was adopted in positive ion detection with multiple reaction monitoring mode(MRM).

The established methods showed a good linear relationship in a certain range (r≥0.998 3)，whose average recovery rates of samples were 90.2%-101.7% with the RSD of 1.1%-4.9%. The content of ephedrine(calculated as ephedrine hydrochloride)，chlorogenic acid，syringin，strychnine，brucine，berberine(calculated as berberine hydrochloride)，naringin，cinnamaldehyde，ginsenoside Re，ginsenoside Rg₁，epimedin C，icariin，asperosaponin Ⅵ，glycyrrhizic acid(calculated as glycyrrhizic acid ammonium salt)，ginsenoside Rb₁，notopterol，isoimperatorin in 39 batches of samples were 20.23-141.75 μg per tablet，10.50-121.69 μg per tablet，215.24-697.34 μg per tablet，8.46-42.42 μg per tablet，135.24-363.32 μg per tablet，91.29-242.87 μg per tablet，19.65-80.31 μg per tablet，22.57-105.05 μg per tablet，4.69-86.88 μg per tablet，10.32-241.15 μg per tablet，3.36-65.07 μg per tablet，10.79-390.69 μg per tablet，6.51-86.29 μg per tablet，4.10-89.75 μg per tablet，195.55-566.37 μg per tablet，96.98-448.95 μg per tablet，0-132.41 μg per tablet，7.09-232.71 μg per tablet. The results of chemometrics showed that 39 batches of samples from 5 production enterprises were classify into three categories，and there were certain differeces in sample quality among different production enterprises，eight differential markers(naringin，glycyrrhizic acid，isoimperatorin，berberine，syringin，ephedrine，pseudoephedrine，strychnine) that caused quality differences were found.

The established method is simple and feasible，combined with chemometric methods，and can be used for quality evaluation of Fengshiantai tablets.