Objective To optimize the RP-HPLC procedure for the determination of aristolochic acid. Method Different extraction solvents and methods have been screened to get the most efficient way for sample preparation. The influence of different mobile systems on quantitation were compared to choose an approprate mobile system for determination. Besides,the minimum limits of different detecting waves were measured to give the method to detect trace amount of aristolochic acid. Result Refluxing with 70% methanol was better than other ways in sample preparation. Both methanol-1% acetic acid (70∶30) solution and 0.3% ammonium carbonate solution (pH=7.5)-acetonitrile (75∶25) with wavelength of 250 nm and 319 nm can be used for quantitation while 0.3% ammonium carbonate solution (pH=7.5)-acetonitrile (75∶25) with wavelength of 224 nm for trace detection. The minimum detectable amount was 0.02 ng. Conclusion The method established can be applied to determinate aristolochic acid and detect trace amout exactly.

Objective To investigate the effect of FCGR3A polymorphisms on NK cell function. Methods Peripheral blood samples from can?cer patients were collected and FCGR3A polymorphisms were confirmed by PCR. In vitro proliferation rates,ADCC activity,and expression of NK cell activating receptors were compared under trastumab stimulation. Results This study showed that the wild?type FCGR3A exhibited a higher affinity to trastumab along with better NK cell proliferation and ADCC activity than the mutant type. Compared to the patients with wild?type FC?GR3A,the proliferation rates of NK cells in patients with the mutant type were reduced by approximately 8?fold. In addition,the expression of NK cell activating receptors in patients with wild?type FCGR3A was higher than in patients with the mutant type. Conclusion Mutations in FC?GR3Areduce NK cell function,causing a poor reaction to monoclonal antibody.

This paper is to report the investigation on the metabolic behavior of Staphylococcus aureus (S. aureus) after given Qingkailing injection, and with the aim of seeking for a new quality control method based on biological assessment. The growth thermogenic curves of S. aureus were determined by microcalorimetry and analyzed by computer. The results showed that in the concentration range of (0-5.00%), the growth thermogenic curves of S. aureus were declined and removed back with increasing dosage of Qingkailing injection; the main parameters (T1, T2, k1, P1, P2 and I) and the dosage of Qingkailing injection have good correlation. The 50% inhibiting dosage is 3.26 %, and the optimal inhibiting dosage is 5.47%. Difference could be detected among the Qingkailing injection samples from different factories and different batches. It is proved that Qingkailing injection could inhibit the metabolic behavior of S. aureus, and microcalorimetry might be applied in the quality assessment of Qingkailing injection.

ObjectiveTo establish a new,rapid,and reliable reversed-phase ultra performance liquid chromatography (RP-UPLC) method for the simultaneous determination of six quaternary ammonium alkaloids (QAAs) in Coptidis Rhizoma.MethodsThe effect of different experimental parameters on the analysis of QAAs by RP-UPLC was evaluatcd.ResultsOptimal resolution was achieved with an Acquity UPLC BEH C18 column using a gradient elution profile and a mobile phase consisting of water spiked with 10 mmol/L ammonium bicarbonate (A,pH adjusted to 10.0 by ammonia water) and acetonitrile (B),at a flow rate of 0.30 rnL/min and wavelength of 345 nm.The column temperature was set at 30 ℃.The proposed method was found to be reproducible,precise,and rapid according to the method validation.Conclusion The proposed method,which is compatible with MS analysis and the preparation of QAA,provides some helpful insights into the quality control of Coptidis Rhizoma.

At present,the various levels of safety evaluations of traditional Chinese medical (TCM) injections were in force in post-marketing clinical researches,while the process quality is guaranteed with difficulty.Therefore,it is requisite to call for technical guidance.By drawing lessons from the international experience of drug marketing safety evaluation and the related methods,we proposed the key techniques of quality control for clinical safety evaluation of TCM injections from the three aspects:preparation,implementation and summarization of researches,combining with the characteristics of TCM injections.The key techniques contained some scientific problems,ethics,publicity,data management,statistical analysis,specification report,etc.This paper comprehensively introduced the requisite technologies and methods over research quality,laying a foundation for the studies of post-marketing clinical safety evaluation of TCM injections.

Objective To analyze the influence of a dental caries phototherapy device using neodymium-yttrium-aluminum-garnet (Nd:YAG) laser on the temperature of tooth pulp chamber of different sites and morphologies under different irradiation duration and power. Methods Fifty intact isolated teeth were collected and randomly divided into middle incisor group, upper right first premolar group, upper right second molar group, upper left first premolar group, and upper left second molar group. Each experimental group was irradiated according to the laser power 1.5, 1.6, 1.7, 1.8, 1.9 and 2.0 W, and the irradiation duration 30, 60, 90 s. The temperature rise of the pulp chamber was recorded with a thermocouple thermometer. Results After the laser irradiation, the temperature of the tooth pulp chamber increased, and the temperature rise was less than 5.5℃, i.e. the threshold leading to the dental pulp necrosis. Conclusions The use of laser to prevent dental caries will increase the temperature of the tooth pulp chamber, but the temperature rise in the range of 5.5 ° C is relatively safe and will not cause irreversible damage to the pulp tissue.

Decoction is one of the most commonly used dosage forms of traditional Chinese medicine. The stability of chemical constituents in decoction is closely related to the clinical efficacy and safety. There were few reports about the influence of metal ions in the stability of chemical constituents in traditional Chinese medicine. However, there is no evidence that metal ions in decoction water need to be controlled. In this study, 2,3,5,4'-tetrahydroxy stilbene-2-O-β-D-glucoside (THSG), one of the main constituents in Polygoni Multiflori Radix was studied. Ordinary tap water, deionized water, and water containing different metal ions were used to investigate and compare the influence on THSG. The results showed that after storage in a dark place at the room temperature for 10 days, the degradation of THSG was 7% in deionized water, while undetectable in tap water. The content of THSG could be decreased by different kinds of metal ions, and the effect was concentration-dependent. Moreover, Fe3+ and Fe2+ showed the greatest influence at the same concentration; and our study has shown that THSG decreased more than 98% in Fe and Fe2+ solutions at 500 ppm concentration. In the same time we found out p-hydroxybenzaldehyde (molecular weight: 122.036 7) and 2,3,5-trihydroxybenzaldehyde-2-O-glycoside (molecular weight: 316.079 4) were the main degradation products of THSG in tap water and water containing Cu2+, Ca2+, Zn2+, Mg2+ and Al3+. The product of THSG dimer with a water molecule was found in water containing Fe3+ and Fe2+. The above results showed that the metal ions in water could significantly influence the stability of THSG in water, indicating that the clinical efficacy and safety of decoction would be affected if the metal ions in water were not under control. It's suggested that deionized water should be used in the preparation of decoction containing Polygoni Multiflori Radix in the clinic to avoid degradation of THSG. Meanwhile, decoction prepared by tap water should be taken by patients in a short time. Our investigation provides important information and reference about the influence of metal ions on the stability of decoctions in other traditional Chinese medicine that have unstable groups such as hydroxyls and unsaturated bonds, etc.

The liver injury induced by Polygonum multiflorum Thunb. (PM) was investigated based on idiosyncratic hepatotoxicity model co-treated with lipopolysaccharide (LPS) at a non-hepatotoxic dose. Sprague-Dawley (SD) rats were intragastrically administered with three doses (18.9, 37.8, 75.6 g crude drug per kg body weight) of 50% alcohol extracts of PM alone or co-treated with non-toxic dose of LPS (2.8 mg·kg(-1)) via tail vein injection. The plasma alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities were assayed and the isolated livers were evaluated for histopathological changes. The dose-toxicity relationships of single treatment of PM or co-treatment of LPS were investigated comparatively to elucidate the idiosyncratic hepatotoxicity of PM. The results showed that no significant alterations of plasma ALT and AST activities were observed in the groups of solo-administration of LPS (2.8 mg·kg(-1), i.v.) or different dosage (18.9, 37.8 and 75.6 g·kg(-1), i.g.) of PM, compared to normal control group (P > 0.05); while significant elevations were observed in the co-administration groups of PM and LPS. Treatment with LPS alone caused slight infiltration of inflammatory cells in portal area but no evident hepatocytes injury. Co-treatment with LPS and PM (75.6 g·kg(-1), i.g.) caused hepatocyte focal necrosis, loss of central vein intima and a large number of inflammatory cell infiltration in portal areas. When further reduce the dosage of PM, significant increases of plasma ALT and AST activities (P < 0.05) were still observed in co-administration groups of LPS and PM (1.08 or 2.16 g·kg(-1)), but not in LPS or PM solo-administration groups. Nevertheless, the co-treatment of low dosage of PM (0.54 g·kg(-1)) with LPS did not induce any alteration of plasma ALT and AST. In conclusion, intragastric administration with 75.6 g·kg(-1) of PM did not induce liver injury in normal rats model; while the 2 folds of clinical equivalent dose of PM (1.08 g·kg(-1)) could result in liver injury in the LPS-based idiosyncratic hepatotoxicity model, which could be used to evaluate the idiosyncratic hepatotoxicity of PM.

To enhance the scientific and fair evaluation about proprietary Chinese medicines containing toxic herbs during the switch process of non-prescription drugs, and to ensure those medicines to be used safely by the public in their self-medication. Combined with current research status of toxic herbs, the experience and knowledge accumulated in the practical work of selection and switch of OTC Chinese medicines for years, thinking about the feasible standards about evaluation and management of proprietary Chinese medicines containing toxic herbs at this stage. Initially established ideas and methods about evaluation of proprietary Chinese medicines containing toxic herbs during the switch process of non-prescription drugs. Basically solved the main problem currently faced by toxic herbs during the OTC switch process of proprietary Chinese medicines, effectively promoted the work on OTC switch, and had the important significance in making consumers use non-prescription drugs conveniently and safely.
Humans ; Medicine, Chinese Traditional ; adverse effects ; methods ; Nonprescription Drugs ; adverse effects ; classification ; Plants, Toxic ; adverse effects ; classification ; Quality Control ; Research ; statistics & numerical data

Hypertension is one of the main factors leading to cardiovascular death.The number of cardiovascular patients were about 330 million in China,and 245 million among them were suffering from hypertensive in 2021.The rates of treatment and control of hypertension were less than 45.8%from 1991 to 2018.Therefore,it is of great clinical significance and social value to carry out hypertension related research.Animal models of hypertension are important tools to explore the pathogenesis of hypertension and evaluate the development of antihypertensive agents.At present,there are many ways to establish animal models of hypertension,by consulting and sorting out the relevant papers of animal models of hypertension at home and abroad,the author summarized and discussed the replication methods,principles,features and applications of commonly used animal models from four aspects,such as genetics,surgical induction,environmental induction and pharmaceuticals induction,in order to provide a reference for the selection and establishment of more scientific animal models of hypertension and lay the foundation for the combined treatment of hypertension with Chinese and Western medicine.