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 compare the in vitro bioactivity between a generic lactobacillin granules drug and three commercial lactobacillin granules drugs, this study investigated inhibition on pathogenic bacteria, the growth promoting effect on probiotics, and establish a method to evaluate the in vitro bioactivity consistency of drugs that regulate gut microbiota.

Two culture systems were set up to investigate the inhibitory effect on pathogenic bacteria and the growth promoting effect on probiotics by lactobacillin granules. The in vitro bioactivity consistency of four products was evaluated by microbial growth curve and analyzed by two-way analysis of variance with Dunnett-t test.

No significant difference (P>0.05) was observed on inhibition of Staphylococcus aureus and growth promotion of Lactobacillus rhamnosus between the generic lactobacillin granules and the commercial lactobacillin granules.

This method could be used to evaluate the in vitro bioactivity of drugs that regulate gut microbiota, and provided guidance on relevant drug development and quality evaluation.

To determine the polysaccharide hydrolysates from Polygonati Rhizoma under glycoside enzymatic hydrolysis’ HPLC fingerprint. Examine the variations among the polysaccharides produced by the various varieties of Polygonati Rhizoma and provide references for the assessment of the polysaccharide quality.

After the polysaccharide from Polygonati Rhizoma was hydrolyzed by fructose enzymes, its fingerprint was established by HPLC-ELSD. The fingerprint was then analyzed using similarity analysis (SA), hierarchical cluster analysis (HCA), and principal component analysis (PCA) to determine the differences between the polysaccharides from various Polygonati Rhizoma varieties.

Polysaccharides from various strains of Polygonati Rhizoma had different HPLC-ELSD fingerprints, and a total of 17 distinct oligosaccharide fragments were discovered, all of which contained fructose, glucose, and sucrose. Analysis revealed that there are significant intra species differences, minor differences, and high levels of similarity between the three types of Polygonati Rhizoma. The real Polygonati Rhizoma differs significantly from the imitation in several important ways.

Polygonati Rhizoma can be successfully classified according to varieties, using the fingerprint of polysaccharide hydrolysates of the various varieties of Polygonati Rhizoma and its adulterants. The developed HPLC method can be used for the differential analysis of polysaccharides in Polygonati Rhizoma and is straightforward, precise, and repeatable.

To establish an HPLC method for simultaneous determination of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, forsythiaside A, 3，4-O-dicaffeoylquinic acid, 3，5-O-dicaffeoylquinic acid, 4，5-O-dicaffeoylquinic acid, forsythin, andrographalide and dehydroandrographalide in compound Shuanghua tablets.

The samples were extracted with 50% methanol solution under ultrasonic condition, and were performed on Agilent Zoabax SB-C₁₈ column (250 mm×4.6 mm, 5 μm) by gradient elution of acetonitrile -0.15% phosphoric acid solution at a flow rate of 1.0 mL·min^-1. The column temperature was 30 ℃, the injection volume was 10 μL, and the detection wavelength were set at 327 nm (detecting neochlorogenic acid，chlorogenic acid, cryptochlorogenic acid, forsythiaside A，3，4-O-dicaffeoylquinic acid，3，5-O-dicaffeoylquinic acid and 4，5-O-dicaffeoylquinic acid) and 226 nm (detecting forsythin, andrographalide and dehydroandrographalide).

The linear ranges of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid，forsythiaside A，3，4-O-dicaffeoylquinic acid, 3，5-O-dicaffeoylquinic acid, 4，5-O-dicaffeoylquinic acid, forsythin, andrographalide and dehydroandrographalide were 4.071-40.71 μg·mL^-1(r=0.999 9), 20.16-201.6 μg·mL^-1(r=0.999 9), 4.730-47.30 μg·mL^-1(r=0.999 9), 4.536-45.36 μg·mL^-1(r=0.999 8), 1.817-18.17 μg·mL^-1(r=0.999 9), 2.266-22.66 μg·mL^-1(r=0.999 7), 3.321-33.21 μg·mL^-1(r=0.999 9), 3.462-34.62 μg·mL^-1(r=0.999 6), 2.111-21.11 μg·mL^-1(r=0.999 9) and 2.290-22.90 μg·mL^-1(r=0.999 7), respectively. The average recoveries (n=6) were 101.3%(2.1%)，103.0%(1.5%)，100.9%(2.0%)，101.1%(2.0%)，98.4%(1.6%)，102.2%(2.4%)，98.2%(1.3%)，97.8%(2.0%)，99.0%(2.0%) and 96.4%(1.1%), respectively. The contents of the 10 components in 4 bacthes of Fufang Shuanghua tablets were in the range of 1.685-2.649 mg·g^-1, 12.202-13.780 mg·g^-1, 2.415-2.594 mg·g^-1, 1.340-1.919 mg·g^-1, 0.501-0.791 mg·g^-1, 0.891-1.342 mg·g^-1, 1.299-2.105 mg·g^-1, 1.147-1.504 mg·g^-1, 0.654-0.694 mg·g^-1, 0.846-1.151 mg·g^-1, respectively.

This simple accurate reproducible method can be used for the quality control and evaluate of compound Shuanghua tablets.

To establish a method for determining molecular weight and distribution of raw mannatide and its preparation with SEC-RI-MALLS.

Specificity，accuracy, precision and robustness of SEC-RI-MALLS method was verified by performing on a Shodex OHpak SB-804 HQ column with 0.05 mol·L^-1 sodium sulfate buffer as mobile phase at a flow rate of 0.5 mL·min^-1 and a comparison between SEC-RI-MALLS and GPC was studied too.

The tablet excipient starch had no interference to the test. The relative accuracy error between the measured value and the labeled value of dextran standard was less than 3.0%. RSD of precision was 0.40% when the sample concentration was 2 mg·mL^-1 and the RSD of reproducibility and robustness were less than 5.0%. There was no significant difference between Shodex OHpak SB-804 HQ column and TSK-GEL G4000 PW_XL column by comparing the results of 79 batches of samples. Compared with the national standard method (GPC) for molecular weight determination, the molecular weight of SEC-RI-MALLS method was 19 509 Da higher on average, and the molecular weight distribution was more concentrated.

SEC-RI-MALLS method can determine the molecular weight and distribution of mannatide without standard with good accuracy and robustness. Compared with the existing method, SEC-RI-MALLS method is more conducive to the safety and effectiveness control of the variety.

To study the preparation and quality control of 3,5-dihydroxy-7,4’-dimethoxyflavone candidate chemical reference substance from Zhuang medicine Amomum paratsaoko S. Q. Tong & Y. M. Xia.

3,5-dihydroxy-7,4’-dimethoxyflavone was separated and purified consecutively by silica gel, recrystallization as well as preparative HPLC. The structure of 3,5-dihydroxy-7,4’-dimethoxyflavone was identified by IR, UV, NMR and other comprehensive spectrum analytical methods with MS spectrum. Its purity was determined by HPLC and TLC, the ash content was determined by incandescent residue method, and the content of 3,5-dihydroxy-7,4’-dimethoxyflavone was calculated by mass balance method. The method for quality analysis of 3,5-dihydroxy-7,4’-dimethoxyflavone candidate reference materials was investigated by HPLC.

The mean value determined by HPLC of 3,5-dihydroxy-7,4’-dimethoxyflavone was 98.85%, the ash value was 0.02%, and the content of 3,5-dihydroxy-7,4’-dimethoxyflavone calculated by mass balance method was 99.83%. The established analytical method was specific and precise.

3,5-Dihydroxy-7,4’-dimethoxyflavone which was prepared in this study met the quality standard requirements of chemical reference substance, and could be used as a reference substance for quality control of medicinal materials and their preparations such as Amomum paratsaoko S. Q. Tong & Y. M. Xia and others. The analysis method was accurate and reliable, which provided a scientific basis for the research and formulation of quality standard of this reference substance.

To establish an HPLC method for simultaneous determination of seven components(narirutin, naringin, hesperidin, neohesperidin, naringenin, nobiletin and atractylenolide Ⅲ) in Zhizhu granules. And to provide reference for its quality evaluation by using chemometric analysis.

The chromatographic column Waters Symmetry C₁₈(250 mm×4.6 mm，5 μm) was adopted using HPLC-DAD. The mobile phase consisted of acetonitrile (A)-0.1% phosphoric acid (B) in gradient elution with flow rate of 1.0 mL·min^-1, the detection wavelength were 220 nm (atractylenolide Ⅲ), 280 nm (narirutin, naringin, hesperidin, neohesperidin and naringenin) and 332 nm (nobiletin). The column temperature was set at 30℃ and the injection volume was 10 μL. Cluster analysis, principal component analysis and orthogonal partial least squares-discrimination analysis were used to distinguish the content determination results.

The resolution of each component in 24 batches of Zhizhu granules was good, and the linear relationship between concentration and peak area was good (r>0.999 9). The average recoveries were within 87.6%-114.3%. There were some differences in 24 batches of Zhizhu granules, and 4 different components were screened out, which were naringin, hesperidin, neohesperidin and naringin. The contents of narirutin, naringin, hesperidin, neohesperidin, naringenin, nobiletin and atractylenolide Ⅲ in 24 batches of Zhizhu granules samples were 0.378 4-1.380 1 mg·g^-1, 5.125 8-18.137 6 mg·g^-1, 0.283 9-1.195 8 mg·g^-1, 4.490 3-22.585 0 mg·g^-1, 0.022 5-0.349 8 mg·g^-1, 0.063 3-0.211 4 mg·g^-1 and 0.054 7-0.137 5 mg·g^-1, respectively.

The established method is accurate, reliable and reproducible, which can provide reference for the quality control of Zhizhu granules.

To comprehensively evaluate the quality of Poriae Cutis, and to establish a dual wavelength switching HPLC method for comparing the characteristic spectra of Poriae Cutis and studying the content of 11 triterpenoid components, to provide reference for the qualitative and quantitative research of Poriae Cutis.

Agilent 5 HC-C₁₈(2) column(250 mm×4.6 mm, 5 μm) was adopted. Acetonitrile solution (contain 3% tetrahydrofuran) (A) and 0.1% formic acid aqueous solution (B) were used as the mobile phase with gradient elution at a flow rate of 1.0 mL·min^-1. The column temperature was 30 ℃ and the injection volume was 20 μL. The detection wavelengths were 210 and 243 nm.

The feature profiles developed were effective in identifying the 18 shared peaks. RSD for precision, repeatability and stability (48 h) tests were all less than 3.72%(n=6). The 11 chemical components to be measured were well separated, with good linearity in the mass range examined (all r ≥ 0.999 6). The average recovery rate was 95.4%-105.5%, and the RSD was 1.0%-3.1%. The RSDs of precision, repeatability, and stability (48 h) tests were all less than or equal to 3.0%(n=6). The results of similarity analysis showed that most of the origins of Poriae Cutis were very similar to each other. The results of content determination showed that among the 11 triterpenoid constituents, poricoic acid A accounted for the highest percentage in all batches of Poriae Cutis. In addition, the content of five components, poricoic acid A, dehydrotrametenolic acid, poricoic acid B, dehydroeburicoic acid and trametenolic acid, fluctuated relatively more, while the other components fluctuated more gently. No significant geographic variation in samples from different origins.

A method for the determination of Poriae Cutis characteristics and multi-component content was established, which laid the foundation for quality control of Poriae Cutis.

To improve the liquid chromatographic determination method of cefixime granules related substance.

High performance liquid chromatography was used, YMC-Triart C₁₈ column (250 mm×4.6 mm, 5 μm) was selected, 0.05 mol·L^-1 ammonium formate solution (pH 4.7)-methanol was used as mobile phase, flow rate was 1 mL·min^-1, and gradient washing was carried out.The injection volume was 10 μL. The detection wavelength was 254 nm.

This chromatographic condition was applied to the detection of cefixime granules. The differences between this method, the pharmacopeial method and the method of USP PF 2018 were compared, and the systematic methodological verification of specificity, linearity, accuracy, precision and durability were completed. Using pharmacopeial methods, baseline separation of degradation impurities A1~A4 or impurities B1~B4 cannot be reached, and current methods cannot be used to determine polymer B and polymer D. The method proposed in this article can make the resolution between cefixime and each specific impurities meet the requirements (R ≥1.5), and can detect and quantify polymer B and polymer D at the same time, and the resolution was better than the current method.

This method improves the separation between cefixime and impurities, more impurities is detected and can accurate quantify specific impurities. This method has high sensitivity and good repeatability, and is suitable for the quality control of cefixime.