AIM: To establish a method for the quality standard of Chanfukang Granules (Radix Astragali, Herba Leonuri, Fructus Aurantii, Herba Agrimoniae, Radix Rehmanniae, etc.). METHODS: TLC was used for identification of Herba Leonuri, Fructus Aurantii, Herba Agrimoniae, Radix Rehmanniae. The content of astragaloside Ⅳ was determined by HPLC-ELSD. RESULTS: The TLC identification was highly specific and the spots clear and concentrated. The linear range of astragaloside Ⅳ was 0.336-2.016 ?g, r=0.999 4. The average recovery was 97.13% and RSD was 1.3%. CONCLUSION: The method is simple and accurate. It can be used for quality control of Chanfukang Granules.

Objective To investigate the expression and clinical significance of neutrophil S100A8/A9 in induced sputum in children with bronchial asthma. Methods A total of 108 cases of bronchial asthma patients in the FourthAffiliated Hospital of Nanchang University were involved in the study form October 2014 to October 2015. According to the severity of the disease, the patients were divided into mild group (n=40), moderate group (n=36) and severe group (n=32). Twenty health children were taken as control group at the same period. All the patients were treated with budesonide aerosol for three months, and the control group was received aerosol inhalation for normal saline (NS). The ratio of forced expiratory volume in one second and forced vital capacity (FEV1/FVC, FEV1%) were used to evaluate the pulmonary function in two groups. The asthma control questionnaire (AcQ-5) score was used to estimate the asthma control effects. The expression level of neutrophil S100A8/A9 mRNA in induced sputum was detected by real-time PCR. The correlation of S100A8/A9 mRNA, AcQ-5 score and FEV1%was analyzed. Results Before the treatment, the FEV1%decreased, while the AcQ-5 score and express level of S100A8/A9 mRNA significantly increased with the severity of disease (all P<0.01). Three months after treatment, asthma was completely controlled in 60 patients, partial controlled in 31 cases and uncontrolled in 17 cases. With the improvement of the therapeutic efficacy, the FEV1%significantly decreased, while the express level of S100A8/A9 mRNA significantly increased (all P < 0.01). The express level of S100A8/A9 mRNA in induced sputum neutrophils was negatively correlated with FEV1%(r=-0.327 and-0.406 respectively, P<0.05), which was positively correlated with ACQ-5 score (r=0.704 and 0.817, P<0.05). Conclusion The level of S100A8/A9 expression in induced sputum neutrophil is positively correlated with the severity of asthma, which can be used as clinical indicators of the severity and the efficacy of asthma.

Objective To Pulse oximetry saturation has been wildly used clinically.It has been reported that pulse oximetry plethysmographic waveform (POP) reflected the peripheral tissue perfusion.In this study,we parameterized POP,observed the value of POP parameters in normal adults,and established the normal reference value range.Methods A multi-center prospective descriptive study.Total of 1 019 adult volunteers with normovolemia from 7 cities were enrolled in this study.Sex,age,height,weight and pulse oximetry data in awake and spontaneous breathing under in quiet conditions in the room temperature were collected.POP parameters and perfusion index were analyzed using MATLAB 2012a software.The normal reference value ranges of POP parameters,including the amplitude of POP (Amp) and the area under the curve of POP (AUC),were formulated.Results Statistical differences of POP parameters were detected between men and women in the normal adult.The 95％ confidence reference value of POP parameters in normal population was as follows:Amp (104.8-2298.7) PVA and AUC (3265.8-6028.5) PVPGin total,Amp (129.4-2433.6) PVA and AUC (3319.0-5862.2) PVPG in male;Amp (89.5-2138.2) PVA and AUC (3163.9-5929.9) PVPG in female.Conclusions POP,including the amplitude of POP (Amp) and the area under the curve of POP (AUC),had normal reference value ranges in normal adults.

Objective:To evaluate the immunogenicity, safety, and immune persistence of the sequential booster with the recombinant protein-based COVID-19 vaccine (CHO cell) in healthy people aged 18-84 years.Methods:An open-label, multi-center trial was conducted in October 2021. The eligible healthy individuals, aged 18-84 years who had completed primary immunization with the inactivated COVID-19 vaccine 3 to 9 months before, were recruited from Shangyu district of Shaoxing and Kaihua county of Quzhou, Zhejiang province. All participants were divided into three groups based on the differences in prime-boost intervals: Group A (3-4 months), Group B (5-6 months) and Group C (7-9 months), with 320 persons per group. All participants received the recombinant COVID-19 vaccine (CHO cell). Blood samples were collected before the vaccination and after receiving the booster at 14 days, 30 days, and 180 days for analysis of GMTs, antibody positivity rates, and seroconversion rates. All adverse events were collected within one month and serious adverse events were collected within six months. The incidences of adverse reactions were analyzed after the booster.Results:The age of 960 participants was (52.3±11.5) years old, and 47.4% were males (455). The GMTs of Groups B and C were 65.26 (54.51-78.12) and 60.97 (50.61-73.45) at 14 days after the booster, both higher than Group A′s 44.79 (36.94-54.30) ( P value<0.05). The GMTs of Groups B and C were 23.95 (20.18-28.42) and 27.98 (23.45-33.39) at 30 days after the booster, both higher than Group A′s 15.71 (13.24-18.63) ( P value <0.05). At 14 days after the booster, the antibody positivity rates in Groups A, B, and C were 91.69% (276/301), 94.38% (302/320), and 93.95% (295/314), respectively. The seroconversion rates in the three groups were 90.37% (272/301), 93.75% (300/320), and 93.31% (293/314), respectively. There was no significant difference among these rates in the three groups (all P values >0.05). At 30 days after the booster, antibody positivity rates in Groups A, B, and C were 79.60% (238/299), 87.74% (279/318), and 90.48% (285/315), respectively. The seroconversion rates in the three groups were 76.92% (230/299), 85.85% (273/318), and 88.25% (278/315), respectively. There was a significant difference among these rates in the three groups (all P values <0.001). During the sequential booster immunization, the incidence of adverse events in 960 participants was 15.31% (147/960), with rates of about 14.38% (46/320), 17.50% (56/320), and 14.06% (45/320) in Groups A, B, and C, respectively. The incidence of adverse reactions was 8.02% (77/960), with rates of about 7.50% (24/320), 6.88% (22/320), and 9.69% (31/320) in Groups A, B, and C, respectively. No serious adverse events related to the booster were reported. Conclusion:Healthy individuals aged 18-84 years, who had completed primary immunization with the inactivated COVID-19 vaccine 3 to 9 months before, have good immunogenicity and safety profiles following the sequential booster with the recombinant COVID-19 vaccine (CHO cell).

Bioreactors have been central in monoclonal antibodies and vaccines manufacturing by mammalian cells in suspension culture. Numerical simulation of five impeller combinations in a stirred bioreactor was conducted, and characteristics of velocity vectors, distributions of gas hold-up, distributions of shear rate in the bioreactor using 5 impeller combinations were numerically elucidated. In addition, genetically engineered CHO cells were cultivated in bioreactor installed with 5 different impeller combinations in fed-batch culture mode. The cell growth and antibody level were directly related to the maximum shear rate in the bioreactor, and the highest viable cell density and the peak antibody level were achieved in FBMI3 impeller combination, indicating that CHO cells are sensitive to shear force produced by impeller movement when cells were cultivated in bioreactor at large scale, and the maximum shear rate would play key roles in scaling-up of bioreactor at industrial scale.
Animals ; Batch Cell Culture Techniques ; Bioreactors ; standards ; CHO Cells ; Cell Count ; Computer Simulation ; Cricetinae ; Cricetulus ; Industrial Microbiology ; instrumentation ; methods