OBJECTIVE To establish the fingerprint and content determination method of Impatientis Pritzelii Rhizoma to improve the quality control method of Tujia ethnomedicinal herb Impatientis Pritzelii Rhizoma. METHODS The fingerprint was established by UPLC with ACQUITY UPLC BEH C₁₈ column. Phlorizin content assay was performed by HPLC with Eclipse XDB-C₁₈ column. The mobile phases for both methods were composed of acetonitrile and 0.1% formic acid with different gradient elution procedures. The detection wavelength was set at 283 nm. The comparative study was carried out between Impatientis Pritzelii Rhizoma and its adulterants (such as the roots and rhizomes of Impatiens pinfanensis, I. uliginosa, I. siculifer and I. noli-tangere). RESULTS Nine main chromatographic peaks in the fingerprint could be served as the characteristic peaks of Impatientis Pritzelii Rhizoma, four of which were corresponding to catechin, epicatechin, scopolamine and phlorizin, respectively. The established fingerprint could reflect the distribution of the chemical components of Impatientis Pritzelii Rhizoma, which was distinguished from four adulterants. Phlorizin was found and determined in Impatientis Pritzelii Rhizoma for the first time. The contents in 16 batches of Impatientis Pritzelii Rhizoma ranged from 0.007% to 0.085%, while no phloridin was found in the adulterants. CONCLUSION The established methods for the fingerprint and phlorizin content determination of Impatientis Pritzelii Rhizoma are specific, accurate and effective, which could be used for its quality control.

OBJECTIVE To establish a high performance liquid chromatography-refractive index detector method for the determination of main potential carbohydrate residues fructose and sucrose concentration in dextran 40 raw materials from different of production processes, analyze the differences in carbohydrate residues in dextran 40 produced by different manufactures, and provide a reference for the quality evaluation of related drugs and the formulation or edit of national drug standards. METHODS Isocratic elution was performed on a ZORBAX-NH₂ column. Mobile phase consisted of 75% acetonitrile and 25% water at a flow rate of 1.0 mL·min^-1. RID was used as detector. The detector temperature and column temperature was maintained at 40 ℃ and the injection volume was 50 μL. RESULTS Sucrose was not detected in all batches of dextran 40. Fructose residue could only be detected in dextran 40 which using alcohol precipitation production process, and the content was 0.005%-0.14%. No fructose residue was detected in the dextran 40 of manufacturer B using membrane filtration method. CONCLUSION The HPLC-RID method is established to determine the content of fructose and sucrose in dextran 40. The method has strong specificity, high sensitivity, good stability and simple operation. The amount of fructose residual in dextran 40 produced by different processes varies greatly. The fructose residual in the raw material of dextran 40 obtained by membrane filtration is significantly lower than that by alcohol precipitation, it is necessary to control the fructose residue in the quality standard.

OBJECTIVE To discuss the rationality of the current methods for examining viable bacterial count and contaminating bacteria in the standard of Bacillus cereus tablets, and optimize the two methods. METHODS The factors that affect the method for viable bacterial count were compared and analyzed, such as medium, diluent, dilution ratio, and pre-treatment, then the optimal experimental conditions were selected. The microbial limit test in the current standard was replaced with the contaminating bacteria test under the general chapter for probiotic in Chinese Pharmacopoeia part III, and its suitability was studied. RESULTS The optimized method for determination of viable bacterial count could more effectively recover Bacillus cereus in the sample, and the results were significantly higher than the current standard method. The use of a new method for detecting non-pathogenic bacteria can discover potential risks in the sample, and its suitability investigation results basically met the requirements of the Chinese Pharmacopoeia. CONCLUSION The new methods are suitable for the determination of viable bacterial count and detection of contaminating bacteria in Bacillus cereus tablets. The current standards for the determination of viable bacterial count and microbial limit testing cannot effectively monitor product quality risks. It is recommended to revise the methods. This can not only more effectively regulate products, but also better assist manufacturers in improving product quality.

OBJECTIVE To investigate adverse event signals associated with ofatumumab and rituximab in the treatment of multiple sclerosis(MS), provide more evidences for the clinical safe medication based on the U.S. food and drug administration's adverse event reporting system(FAERS) data. METHODS Postmarking adverse event reports of ofatumumab and rituximab were extracted to form an analysis dataset. Disproportionality analysis combined with bayesian confidence propagation neural nework (BCPNN) was conducted for adverse event signal monitoring. Adverse events meeting threshold conditions were selected and summarized for analysis. RESULTS The ofatumumab group collected a total of 72 310 adverse event reports, of which 325 showed positive signals, covering 24 system organ classes (SOCs), involving “infections and infestations” “nervous system disorders” and “musculoskeletal and connective tissue disorders”. The rituximab group collected 23 203 adverse event reports, with 311 showing positive signals, covering 25 SOC, involving “injury, poisoning and procedural complications” “infections and infestations” and “nervous system disorders”. Except for “gastrointestinal disorders” and “eye disorders”, both drugs exhibited significant differences in each SOC. CONCLUSION There are substantial differences in the risk of adverse events between ofatumumab and rituximab in the treatment of MS. Therefore, medication monitoring is required during the treatment. Due to the limitations of real-world studies for quantitative analysis, the above conclusions need to be validated through large-scale cohort studies.

OBJECTIVE To ensure the scientificalness and rationality of proficiency testing and measurement audit projects in the field of authenticity identification of Chinese material medica and decoction pieces, and to provide new ideas for high quality development in this field. METHODS The key technical points were analyzed in the proficiency testing and measurement audit projects of authenticity identification of Chinese material medica and decoction pieces. RESULTS Proficiency testing and measurement audit projects of authenticity identification of Chinese material medica and decoction pieces are insufficient, which cannot meet the needs of market supervision. CONCLUSION Proficiency testing providers should seriously summarize and think about the key technical points in the proficiency testing and measurement audit projects of authenticity identification of Chinese material medica and decoction pieces. By improving capabilities and service, actively organizing proficiency testing projects, and establishing measurement audit sample bank, proficiency testing providers can constantly improve the quality of the proficiency testing and measurement audit projects in the field of authenticity identification of Chinese material medica and decoction pieces, and the shortcomings of external quality control in this field will be complemented which can promote the high quality development of traditional Chinese medicine(TCM) and TCM industry.

Natural drugs have been used in clinic for thousands of years in China, with complete and systematic theories, and are the treasure of the Chinese nation. Among them, flavonoids, polysaccharides, iridoid glycosides, saponins and other natural drugs have been proved to have curative effects on many diseases. Generally, the bioavailability of natural drugs absorbed in the intestine after oral administration is relatively low. As one of the ecosystems regulating the host's adaptation to the environment, the gut microbiota has a two-way effect on the host's internal and external environment, which is usually closely related to the efficacy of natural drugs. In order to understand the mechanism of the effect of drugs that are difficult to absorb, the exploration of targeting the gut microbiota has become a new strategy in recent years. The metabolism of natural drugs is often achieved through the enzymes produced by the gut microbiota, which is closely related to its efficacy and safety. The research of metabolic transformation by the gut microbiota is still limited. So in this review, we mainly discussed the characteristics of major metabolic enzymes derived from gut microbiota and the research progress in the metabolism and transformation of natural drugs, aiming to enrich the information on the metabolism mechanism of natural drugs under the action of gut microbiota and provide evidence for proving that gut microbiota is part of the regulation axis of other organs. It also provides some scientific reference for deepening the understanding and cognition of the metabolism and transformation of natural drugs under the action of intestinal bacteria.

Matricaria chamomilla L. is a herbaceous plant belonging to Asteraceae family. It is frequently used as medicinal herb in the Uygur medicines and is mainly produced in Xinjiang Uygur autonomous region, Europe and other places. Its chemical constituents mainly include flavonoids, phenolic acids, essential oil, coumarins and other compounds. This herb has anti-inflammatory, analgesic, antibacterial, antioxidant, anti-tumor, hypoglycemic, hypolipidemic, hypotensive and pharmacological effects on gastrointestinal and nervous system. Based on the overview of the chemical constituents and pharmacological effects of chamomile, this paper conducts a predictive analysis of its quality markers. It is speculated that flavonoids, phenolic acids and sesquiterpenoids can be used as quality markers of chamomile, providing scientific reference for establishing its quality standards.

OBJECTIVE To observe the inhibitory effect of ritonavir on human T-cell leukemia virus type-1 (HTLV-1) transmission and malignant proliferation of adult T-cell leukemia (ATL) cells, and explore its molecular mechanism. METHODS The proliferation and vitality of ritonavir on various leukemic cells were evaluated by CCK-8 and colony formation assay. The effects of ritonavir on HTLV-1 virus transmission were detected by flow cytometry, dual luciferase reporter gene technique, qPCR and Western blot. The effects of ritonavir on the cell cycle and apoptosis of ATL cells were examined through flow cytometry. RESULTS Ritonavir could inhibit the proliferation of four ATL cell lines and the clonal proliferation of HTLV-1 positive cell lines. The former exhibited a significant dose-effect relationship and had a more pronounced inhibitory effect on HTLV-1 positive cell lines (P<0.05). Additionally, the administration of ritonavir immediately after co-culture of HTLV-1 positive cell lines with JETWT35 cells resulted in a significant down-regulation of red fluorescent protein expression in JETWT35 and inhibited the transmission of HTLV-1 virus into recipient cells (P<0.01). Upon immediate addition of ritonavir to the co-culture system of HTLV-1 positive cell lines and Jurkat cells, there was a notable inhibition of HTLV-1-related gene Tax and other genes mRNA in recipient cells (P<0.01); however, no significant effect was observed when ritonavir was added 12 h after virus transmission. Morever, ritonavir demonstrated a does-dependent inhibition of gp46 expression on the cell membrane of the HTLV-1 positive cell line ATL-T, thereby suppressing the production of HTLV-1 virus (P<0.01). Ritonavir impeded cell progression into G₁ phase and facilitated apoptosis, with the apoptosis rate of HTLV-1 positive cell lines being significantly greater than that of HTLV-1 negative cell lines (P<0.05 or P<0.01). CONCLUSION Ritonavir exerts inhibitory effects on the production and transmission of HTLV-1 virus by diminishing the activity of WT-Luc virus promoter, suppressing the expression of HTLV-1-related virus genes (Tax, HBZ, Gag, Pol, and Env). Additionally, it inhibits the expression of the HTLV-1-positive membrane surface envelope protein subunit gp46. Futhermore, ritonavir induces apoptosis in ATL cells by arresting cell cycle in the G₁ phase, thereby effectively suppressing cell proliferation.

OBJECTIVE To establish an effective identification method for Jiawa and easily mixed species by using DNA barcoding ITS2 sequence. METHODS The total DNA of 72 Jiawa and its similar species samples were extracted by using the plant genomic DNA Extraction kit,PCR amplification and bidirectional sequencing were carried out for the ITS2 fragments, another 30 items of the genus were downloaded from GenBank. MEGA6.0 software was applied to analyze 102 ITS2 sequences, calculate the intraspecific and interspecific K2-P distance, construct neighber-jioning (N-J) phylogenetic tree, and predict the secondary structure of ITS2. RESULTS K2-P genetic distance analysis showed that, in addition to Pleurospermum franchetianum Hemsl. and Pleurospermum wrightianum de Boiss., Pleurospermum hookeri var. thomsonii C.B. Clarke., Sphallerocarpus gracilis (Bess.) K.-Pol., Vicatia thibetica de Boiss., Carum carvi L., Heracleum millefolium Diels., Ligusticum daucoides (Franch.) Franch. and Anthriscus sylvestris subsp. Nemorosa have obvious barcode spacing. N-J tree cluster analysis showed that each species could be clustered into one branch with a bootstrap support rate of >50%, and the monophyleticity was good. The secondary structure analysis of ITS2 showed that the number, size and position of stem-loops in the four helical regions of Jiawa and its miscible were different. CONCLUSION The ITS2 sequence can be used to identify Jiawa and its easily mixed species, which is beneficial to the rational development and utilization of Jiawa resources.

OBJECTIVE To research and evaluate risk of 18 polycyclic aromatic hydrocarbons(PAHs) in seed-fruit herbs based on a SPE-isotope dilution GC-MS/MS method for the determination of the residues. METHODS Using isotope as internal standard, the sample was extracted by n-hexane and purified by molecular imprinting solid phase extraction. GC-MS /MS method was used for the assay. The chromatographic column was DB-17ms(0.25 mm×30 m, 0.25 μm) with temperature programming and MRM detection. The preliminary risk assessment of polycyclic aromatic hydrocarbons (PAHs) in seeds and fruits of traditional Chinese medicine (TCM) was carried out by using toxicity equivalent factor method. RESULTS The calibration curves for the 18 kinds of typical PAHs were linear in the range of 2-50 ng·mL^-1. The average recovery rate was in the range of 77.25%-112.32%, with RSD 2.74%-15.89% (n=3). The LOQs were 0.2-1 μg·kg^-1 According to the risk assessment results, some varieties may have potential cancer risk. CONCLUSION This method is specific, sensitive, and can be used for residue detection of 18 typical kinds of PAHs in seed-fruit herbs. The residual amount of PAHs in some seeds and fruits of traditional Chinese medicine may have a potential cancer risk, which need attention.