To analyze the structure of the maximum impurity in halometasone/triclosan cream and discuss the rationality of the current registered standard for imported drugs.

The related substances in halometasone/triclosan were detected according to JX20080304, and dioxins were determined according to USP. Finally, the possible structures of the maximum impurity were characterized by LC-Q TOF/MS.

The results showed that the maximum unknown impurity(RRT 0.67), calculated according to halometasone was OOS(1.0%) at 2.5%. The peak was related to triclosan through comparing with the chromatography behavior of triclosan in reference substance solution. MS information indicted the process impurities of triclosan.

For compound preparations, to ensure the stability and safety of the product, the impurities relevant to different components should be controlled separately at rational limit based on safety data.

To establish a solid-phase extraction-high performance liquid chromatography(SPE-HPLC) method for the rapid detection of related substances of vitamin D₃, trans vitamin D₃ (impurity A), 7-dehydrocholesterol (impurity B), lumisterol 3 (impurity C), and isotachysterol 3 (impurity D), in vitamin D drops (soft capsules).

The content, which was approximately equivalent to vitamin D₃ 1 548 IU, was taken in about 1.2 g, weighed accurately, put into a test tube, 4 mL of isooctane was added to it, and it was swirled and mixed well. Purification was performed using solid phase extraction columns, with n-hexane-ethyl acetate(85∶15) as the elution agent and anhydrous ethanol as the desorption agent. A Luna Silica(2) 100 Å silica gel column(150 mm×4.6 mm, 3 μm) was used, with n-hexane-n-pentanol (996.5∶3.5) as the mobile phase. The content of vitamin D₃ impurities was calculated using the adding standard calibration factors principal component self-control method.

The separation degree between pre-vitamin D₃ and vegetable oil was greater than 1.5. The linear range of vitamin D₃ was 0.02-0.80 μg·mL^-1, with r=0.999 5. The linear range of impurity A was 0.02 -0.80 μg·mL^-1, with r=0.999 9. The linear range of impurity B was 0.02-0.80 μg·mL^-1, with r=0.999 9. The linear range of impurity C was 0.02-0.80 μg·mL^-1, with r=0.999 9. The linear range of impurity D was 0.02-0.80 μg·mL^-1, with r=0.999 9. The average recovery rate of impurities A-D (n=9) was 93.2%-102.9%. The detection results of 3 batches of vitamin D drops (soft capsules) showed that the content of known impurities and other maximum single impurities were less than 0.5%, and the total content of impurities was less than 1.0%.

The results indicate that the established method is suitable for the detection of vitamin D₃ related substances in vitamin D drops (soft capsules). It has the advantages of being easy to operate, providing rapid and accurate results, and providing technical assurance for the quality control of fat-soluble vitamin D₃ preparations.

To explore the method of pharmacognosic identification of four medicinal seeds, such as Plantaginis Semen from two kinds of original plant，Allii Fistulosi Semen, Allii Tuberosi Semen, and to digitize the identification characteristics.

The seeds of the four medicinal plants were studied by means of type microscope and light microscope, including the appearance(positive view, bottom view, hilum view and surface feature), internal morphology(cross profile and longitudinal profile) and the characters of micromorphology(transverse section, powder). The characteristics of the four medicinal seeds were summarized, and the identification points were characterized by digital method.

The seeds of the four medicinal plants could be identified according to the appearance, internal morphology and the characters of micromorphology.

This study lays a foundation for the variety identification and provides reference for the standard formulation and quality control of the four medicinal seeds. It also provides ideas for digital characterization of seed medicinal materials.

To find out identification characteristics of Baijiangcao from different origins by pharmacognostical study. To discuss the establishment of whole herbs Chinese medicine standard.

Principles of plant taxonomy, macroscopic identification and microscopic identification were used to compare the differences among Baijiangcao from different origins and commercial counterfeit.

The macroscopic characteristics, such as the surface of stem, the cross section of stem, the shape of leaves, hairy on inflorescence and odour. And the microscopic characteristics of transverse section of stem could be used to distinguish Baijiangcao from different origins and commercial counterfeit.

This research establishes the identification method of Baijiangcao from different origins and commercial counterfeit, and provides references for the improvement of quality standard of Baijiangcao from different origins.

To establish an effective method for detecting the components of Lychas mucronatus and investigating instances of adulteration with whole scorpions in Chinese patent medicines.

Thirty Chinese patent medicines containing whole scorpion components, as documented in the Pharmacopoeia of the People’s Republic of China, were collected. DNA was extracted, and differences in the mitochondrial cytochrome C oxidase subunit Ⅰ(COⅠ) gene sequences were compared. Specific primers for the identification of Mesobuthus martensii and Lychas mucronatus DNA were designed. Annealing temperature, cycle number, Taq polymerase, and DNA concentration were optimized to establish the most suitable PCR identification system and conditions. The optimal PCR conditions for distinguishing the sharp-tailed wolf scorpion were finally determined to be an annealing temperature of 52 ℃, 36 cycles, 2×PCR Mix Taq enzyme, and 1 μL of DNA template. The developed method was applied to identify the presence of Centruroides gracilis components in 30 commercially available Chinese patent medicines.

Gel electrophoresis revealed the presence of authentic DNA bands specific to the Mesobuthus martensii in all 30 whole scorpion-containing Chinese patent medicines. Eighteen medicines (60%) showed a single specific DNA band between 100-250 bp, indicative of Lychas mucronatus, while the blank control exhibited no bands. Sequencing of the PCR products containing the identified Lychas mucronatus -specific bands, after TA cloning, revealed sequences with high similarity (92%-98%) to the reference sequences of Lychas mucronatus. Phylogenetic analysis indicated that the obtained sequences belonged to the same lineage as Lychas mucronatus and were distinct from the Mesobuthus martensii. Therefore, the presence of a single band around 120 bp indicates the identification of Lychas mucronatus.

The presence of Lychas mucronatus components mixed with authentic scorpion materials in Chinese patent medicines indicates a need for strengthened supervision. The method established in this study enables the rapid and accurate detection of Lychas mucronatus components in Chinese patent medicines. This is beneficial for improving the quality control of whole scorpion-containing Chinese patent medicines, providing assurance for their clinical applications.

To establish a rapid molecular identification method for DNA fingerprinting-immunocolloidal gold test strips of Chinese herbal medicine human placentophagy genetic markers and to develop an integrated quality control gene detection kit.

Self-developed method and reagents could be for template DNA extraction from human placentophagy. Species-specific primers were designed according to the human mtDNA cytb gene, and the 5’ ends of the primers were labeled with FAM and Biotin, respectively. The optimal annealing temperature and cycle number of PCR were screened to establish a DNA fingerprinting molecular identification method. To develop PCR gene detection reagent premixes, to prepare DNA clones of control herbs using molecular cloning and gene sequencing techniques and to utilize immunocolloidal gold test strips for result detection. Finally, a rapid gene detection kit integrating DNA extraction reagent, PCR gene detection reagent premixes, control herb DNA clone solution, blank control solution and test strips was developed, and evaluated for specificity, reproducibility, sensitivity and stability.

The template DNA extracted by self-developed DNA extraction reagents were all in the concentration of 150-280 ng·μL^-1, the purities were all in the range of 1.8-1.9, and there were no trail in the agarose gel electrophoresis. And the immunocolloidal gold test strips showed two red bands for human placentophagy control herb and authentic product, and one red band for easy-mix product and blank control at annealing temperature of 59 ℃ and 20 cycles for human placentophagy specific primers. The agarose gel electrophoresis was verified to be correct. The DNA sequencing results of the control herbs were 100% homologous with human mtDNA cytb gene. The self-developed integrated rapid gene detection kit was specific, reproducible, stable and sensitive at 0.1 ng·μL^-1.

The DNA fingerprinting-immunocolloidal gold test strip molecular identification method can specifically, accurately, rapidly and visually identify the authenticity of human placentophagy, and the integrated rapid gene detection kit provides a regulated and standardized testing method for quality control of human placentophagy. Therefore, it is more suitable for on-site field testing and universal promotion.

To compare the differences of the volatile oil components of Pimpinella thellungiana Wolff extracted with different methods by GC-MS combined with retention index.

Volatile oil of Pimpinella thellungiana Wolff were extracted using steam distillation, salting-out assisted steam distillation and enzymatic hydrolysis-assisted steam distillation. The chemical components of volatile oil extracted by different methods were analyzed by GC-MS combined with retention index, while the relative contents of volatile oil components were calculated by peak area normalization method.

Among the three extraction methods, the extraction rate of volatile oil was as follows, enzymatic hydrolysis-assisted steam distillation > salting-out assisted steam distillation ≈ steam distillation method. The most comprehensive types of volatile oil were extracted by salting-out assisted steam distillation, followed by enzymatic hydrolysis-assisted steam distillation, and finally by steam distillation. The main types of the volatile oil components of Pimpinella thellungiana Wolff extracted with different methods were basically unchanged, but the relative contents of various compounds were different. A total of 47 compounds were identified from the volatile oil extracted with the three methods, including 35 common compounds. The main chemical structural types of these compounds were terpenes, terpenes, terpenoids, aromatics and aliphatics, among which the higher content compounds were β-bisabolene（17.25%-19.42%）, caryophyllene oxide （12.90%-15.70%）, 1-(3-methyl-2-butenoxy)-4-(1-propenyl) benzene （5.02%-9.36%） and β-pinene （5.31%-6.62%）.

The chemical composition types and relative contents of the volatile oil of Pimpinella thellungiana Wolff extracted with different methods are different, but the differences are not significant. The results can provide reference for the selection of suitable extraction methods and further utilization of volatile oil from Pimpinella thellungiana Wolff.

To establish a method for determination of potential anti-vascular disease active components of Semen raphani based on cell membrane chromatographic (CMC) model of human umbilical vein cell (HUVEC).

The HUVEC cell membrane chromatography coupled with HPLC-ESI IT TOF MS system were used to screen the active components of Semen raphani. The selected active components were further applied to ox-LDL induced HUVEC to verify their protective effects.

Two retained components were selected from Semen raphani by this method. One component was identified as erucinic acid by comparing with the reference material. Compared with the model group, the cell survival rates of the erucinic acid pretreatment groups increased significantly. The amount of ICAM-1 and VCAM-1 decreased in a dose-dependent manner. Bcl-2 protein levels decreased and Bax protein levels increased, with statistical significance (P<0.05).

The method can rapidly obtain active ingredients from complex traditional Chinese medicines. It provides a reference for the application of cell membrane chromatography and the development of Semen raphani.

To establish an HPLC characteristic chromatogram of Xifeng Huoluo capsules, and to determine the contents of gastrodin, amygdalin, strychnine, hydroxysafflower yellow A, brucine, paeoniflorin, ferulic acid, salvianolic acid B, cryptotanshinone, tanshinone Ⅰ, and tanshinone ⅡA.

Extraction of 75% methanol was analyzed by a Venusil MP C₁₈ chromatographic column (250 mm×4.6 mm, 5 μm) using 0.1% phosphoric acid (A) -acetonitrile (B) as the mobile phase with gradient elution at a flow rate of 1.0 mL·min^-1. The column temperature was 30 ℃. The detection wavelengths were variable. The characteristic chromatograms of 10 batches of Xifeng Huoluo capsules were evaluated by similarity evaluation, and the eleven identified index components were quantitatively determined.

There were thirty-one common peaks in the characteristic chromatograms of eleven batches of samples and the similarities were all above 0.99. The common peaks could ascribed to twelve medicinal materials, and eleven of them were identified. Eleven components showed good linearity within their respective ranges (r≥0.999 4), and the average recoveries were 99.3%-103.0% with RSDs of 1.5%-2.4%.

The established method has high sensitivity and strong specificity. The HPLC characteristic chromatogram combined with multi-component quantitative determination can fully reflect its inherent quality and can be used for the quality control of Xifeng Huoluo Capsules.

To establish a hydrogen nuclear magnetic quantitative method which can rapidly determine the contents of linalool and protocatechuate in Homalomena occulta.

Using dimethyl sulfoxide-d₆（DMSO-d₆）as the test solvent and pyrazine -as the internal standard, ¹H-q NMR measurement was performed on a 400 MHz spectrometer. The quantitative resonance peaks of pyrazine, Linalool and protocatechuate were δ 8.66, δ 5.90 and δ 8.60, respectively.

The linear correlation coefficients of linalool and protocatechuate were good with r of 0.999 7 and 0.998 6, respectively. The RSDs of precision were 0.30% and 0.40%, and the recoveries were 98.8%-100.7%（RSD=3.7%） and 99.4%-100.6%（RSD=4.4%）, respectively, which indicated that the established method was accurate, stable and feasible. And the whole detection process was completed in about three minutes. The contents of 2 components in 4 batches of Homalomena occulta were 0.328-0.398 mg·g^-1（linalool）and 0.559-0.630 mg·g^-1 （protocatechuate）, respectively.

The ¹H-q NMR method has the advantages of simple operation, fast analysis speed and specificity, and can be used for the simultaneous determination of two active components in Homalomena occulta, providing a scientific basis for the overall quality evaluation and quality control of Homalomena occulta.