In recent years, continuous manufacturing technology has attracted considerable attention in the pharmaceutical industry. This technology is highly sought after for its significant advantages in cost reduction, increased efficiency, and improved productivity, making it a growing trend in the future of the pharmaceutical industry. Compared to traditional batch production methods, continuous manufacturing technology features real-time control and environmentally friendly intelligence, enabling pharmaceutical companies to produce drugs more efficiently. However, the adoption of continuous manufacturing technology has been slow in the field of traditional Chinese medicine(TCM) pharmaceuticals. On the one hand, there is insufficient research on continuous manufacturing equipment and technology that align with the characteristics of TCM preparations. On the other hand, the scarcity of talent with diverse expertise hampers its development. Therefore, in order to promote the modernization and upgrading of the TCM pharmaceutical industry, this article combined the current development status of the TCM industry to outline the development status and regulatory requirements of continuous manufacturing technology. At the same time, it analyzed the problems with existing TCM manufacturing models and explored the prospects and challenges of applying continuous manufacturing technology in the field of TCM pharmaceuticals. The analysis focused on continuous manufacturing control strategies, technical tools, and pharmaceutical equipment, aiming to provide targeted recommendations to drive the development of the TCM pharmaceutical industry.
Medicine, Chinese Traditional ; Quality Control ; Drug Industry ; Technology, Pharmaceutical/methods* ; Drugs, Chinese Herbal ; Pharmaceutical Preparations

【Objective】 To evaluate and analyze the impact of COVID-19 epidemic on inventory of red blood cells (RBCs)in local and municipal blood stations in China, and to provide reference for the management of public health emergencies. 【Methods】 Relevant data from 2018 to 2021 were collected, and the differences in the volume of qualified RBCs, the usage efficiency of inventory RBCs, the average daily distribution of RBCs,the blood distribution rate of RBCs prepared by 400 mL whole blood, the difference in the average storage days of RBCs at the time of distribution, the average daily inventory of RBCs and the time of the average daily inventory of RBCs to maintain the distribution in 24 local and municipal blood stations in China during the COVID-19 epidemic and non-epidemic periods were retrospectively analyzed. 【Results】 Compared with non-epidemic periods, the volume of qualified RBCs [(117 525.979 ±52 203.175)U] and the average daily distribution of RBCs [( 156. 468 ± 70. 186) U ] increased significantly, but the usage efficiency of inventory RBCs decreased(97.24%±0.51%) significantly (P<0.05).There was no significant difference in the blood distribution rate of RBCs prepared by 400 mL whole blood(73.88%±20.30%), the average storage days of RBCs distribution(13.040 ±3.486), the average daily stock quantity of RBCs[(2 280.542 ±1 446.538) U ] and the time of the average daily inventory of RBCs to maintain the distribution[(15.062 ±7.453) d] (P>0.5). 【Conclusion】 During the COVID-19 epidemic, the inventory management of RBCs operated well, the overall inventory remained relatively stable, the stock composition and storage period showed no significant change.

【Objective】 To analyze the basic characteristics of whole blood donors from blood stations before and after the outbreak of COVID-19. 【Methods】 After excluding invalid data, data related to the basic characteristics of whole blood donors collected from 26 blood stations in China during 2018 to 2021 were statistically analyzed, including the trend of total whole blood donors, the number of repeated blood donors, the frequency of blood donation, the average age of donors and the recruitment of first-time blood donors. 【Results】 Affected by the epidemic, 8 out of 14 indicators were with large variations, accounting for 57%. The overall growth rate of total whole blood donors during the epidemic was higher than before the epidemic (P<0.05).The number of repeated blood donors has shown an increased trend, with a higher number during the epidemic than before (P<0.05). The frequency of blood donation was lower during the epidemic than before(P<0.05).Average ages of blood donors and female blood donors fluctuated widely during the epidemic, both higher than those before the epidemic(P<0.05).The donation rate of first-time blood donors <25 years old and ≥25 years old varied widely and irregularly during the epidemic (both P<0.05). The percentage of first-time blood donors fluctuated irregularly during the epidemic, with overall percentage lower than that before the epidemic(P<0.05). 【Conclusion】 Whole blood donors from 26 blood stations increased after the outbreak of COVID-19, and some indicators in certain areas showed significant fluctuations during the epidemic.

【Objective】 To analyze the hepatitis B virus (HBV) infection data of blood donors from 18 domestic blood stations, so as to investigate the HBV infection situation of blood donors. 【Methods】 The positive rate of HBV and its distribution characteristics of regions, the percentage of HBsAg+ ELISA in first-time vs repeated blood donors, and the percentage of HBsAg-/HBV DNA+ blood donors of 18 domestic blood stations during 2017 to 2020 were collected from the Working Platform for Practice Comparison of Blood Centers, and the HBV infection among blood donors were statistically analyzed. 【Results】 From 2017 to 2020, the positive rate of HBV in blood donors among 18 domestic blood stations was 13.48/10 000-144.02/10 000, with the average HBV positive rate in eastern, central and western region at 26.14/10 000, 51.98/10 000 and 41.00/10 000, respectively. The HBsAg+ rate by ELISA among first-time and repeated blood donors was 14.55/10 000-305.39/10 000 vs 1.04/10 000-87.43/10 000 The HBsAg-/HBV DNA+ yield was 1.80/10 000-35.31/10 000. 【Conclusion】 The distribution of HBV infection in blood donors has regional characteristics, and HBV prevalence was low in repeated blood donors. HBsAg ELISA combined with HBV DNA detection can better ensure blood safety.

Objective:To observe the changes of relevant clinical indicators and ultrasound pre-sentations in rheumatoid arthritis (RA) patients after being treated with tocilizumab for 3 months and explore the efficacy and safety of tocilizumab in the treatment of RA.Methods:Clinical data, laboratory and ultrasound examinations and medications of RA patients who met inclusion criteria in our hospital from Jan-uary 2017 to September 2020 were included and their data were analyzed retrospectively, and the efficacy and safety of tocilizumab and the ultrasound assessment of disease remission were analyzed. Paired sample t test, Wilcoxon signed-rank test, χ2 test or Fisher's exact probability test were used for comparative analysis. Results:① Compared with baseline data, morning stiffness duration of patients treated with tocilizumab for 3 months [60(30, 120) min vs 0(0, 10) min, Z=-6.19, P<0.001], disease activity score of 28 joints-erythrocyte sedimentation rate (DAS28-ESR) [(4.6±1.5) vs (3.2±1.2), t=6.83, P<0.001], disease activity score of 28 joints-C-reactive protein (DAS28-CRP) [(4.2±1.4) vs (2.8±1.1), t=7.14, P<0.001], swollen joint count (SJC) [2(1, 7) vs 0(0, 2), Z=-4.31, P<0.001], tender joints count (TJC) [6(2, 13.5) vs 2(0,4), Z=-5.16, P<0.001], gray scale score (GS) [4.5(2, 6) vs 1(0, 3), Z=-5.86, P<0.001], intra-synovial blood flow energy Doppler (PD) [2(1, 3) vs 0(0, 0), Z=-5.38, P<0.001], white blood cell (WBC) [6.6(4.9, 8.4)×10 9/L vs 5.7(4.9, 7.3)×10 9/L, Z=-2.83, P=0.005], hemoglobin (Hb) [119(104, 131) g/L vs 123(113, 136) g/L, Z=-2.82, P=0.007], ESR [32(14.5, 50) mm/1 h vs 19 (10, 30) mm/1 h, Z=-3.31, P=0.001], CRP [11.40(3.02, 25.80) mg/L vs 3.49(1.30, 11.82) mg/L, Z=-2.78, P=0.004], D-dimer (D-D) [0.93(0.47, 2.07) mg/L vs 0.43(0.21, 0.80) mg/L, Z=-3.77, P<0.001] were significantly improved, and the difference was statistically significant. ② The serum levels of interleukin (IL)-2 [2.08(1.43, 2.76) pg/ml vs 1.21(0.54, 2.08) pg/ml, Z=-2.67, P=0.008], IL-6 [22.40(5.13, 67.27) pg/ml vs 14.63(5.27, 27.71) pg/ml, Z=-2.81, P=0.005], IL-10 [(2.53±0.68) pg/ml vs (1.74±0.74) pg/ml, t=2.60, P=0.017] were significantly changed, while serum levels of IL-4 [1.63(1.08, 3.38) pg/ml vs 1.33(0.97, 2.59) pg/ml, Z=-0.89, P=0.374], tumor necrosis factor (TNF) -α [4.04(1.41, 10.45) pg/ml vs 1.62(0.84, 3.79) pg/ml, Z=-1.92, P=0.056], IL-17 [4.68(1.67, 6.72) pg/ml vs 3.15(1.81, 5.29) pg/ml, Z=-0.53, P=0.594] were not significantly changed from baseline data. ③ There was poor consistency between ultrasonic response and DAS28-ESR response, simplified disease activity Index (SDAI) response and clinical disease activity index (CDAI) response ( Kappa coefficient: 0.142, 0.142, 0.191), but no consistency between ultrasonic response and DAS28-CRP response (Kappa coefficient: -0.015) were found. Receiver operating characteristic (ROC) curve showed that ultrasound was not statistically significantly different in assessing the remission of RA, indicating subclinical synovitis remained in ultrasound examination even though clinically remission could be reached based on the above scoring indexes in RA patients. ④ In terms of adverse reactions, neutrophils (NEU) of patients after 3 months' tocilizumab treatment [4.47(2.77, 5.39)×10 9/L vs 3.76(2.98, 4.74)×10 9/L, Z=-2.77, P=0.006], platelet count (PLT) [(291±84)×10 9/L vs (254±70)×10 9/L, t=4.76, P<0.001] were significantly decreased, high-density lipoprotein-cholesterol (HDL-C) [(1.22±0.27) mmol/L vs (1.39±0.34) mmol/L, t=3.12, P=0.003], low density lipoprotein-cholesterol (LDL-C) [(1.96±0.66) mmol/L vs (2.19±0.84) mmol/L, t=3.15, P=0.003], triglyceride (TG) [0.85(0.68, 1.08) mmol/L vs 0.93(0.71, 1.25) mmol/L, Z=-2.36, P=0.018] and total cholesterol (TC) [(4.18±1.04) mmol/L vs (4.52±1.16) mmol/L, t=3.33, P=0.002] were significantly different from baseline. Among 65 patients, 5 patients (7.7%) had transaminase abnormality, but returned to normal after symptomatic treatment. Conclusion:Tocilizumab treatment can effectively suppress the inflammatory reactions, improve the clinical symptoms and prognosis of patients, however, patients who judged as clinical remission according to the current clinical commonly scores may still have subclinical active disease, ultrasound results should be included as one criteria for disease remission assessment and take into consideration when adjusting treatrnent.

Objective:To explore the effectiveness, safety and cost between urinary follicle stimulating hormone (uFSH) and recombinant follicle stimulating hormone (rFSH) in controlled ovarian stimulation (COS) in China.Methods:Data were collected from 16 reproductive centers in China covering oocytes collection time from May 1, 2015 to June 30, 2018. Eligible patients were over 18 years old, adopting COS with uFSH (uFSH group) or rFSH (rFSH group) as start gonadotropins (Gn), and using in vitro fertilization (IVF) and (or) intracytoplasmic sperm injection for fertilisation, excluding frozen embryo recovery cycle. Generalised estimating equation was used to address the violation of independency assumption between cycles due to multiple IVF cycles for one person and clustering nature of cycles carried out within one center. Controlling variables included age, body mass index, anti-Müllerian hormone level, cause of infertility, ovulation protocol, type of fertilisation, number of embryos transferred, number of days of Gn use.Results:Totally 102 061 cycles met eligibility criteria and were included in the analyses. In terms of effectiveness, after controlling relevant unbalanced baseline characteristics, compared with rFSH group, the high oocyte retrieval (>15 oocytes was considered high retrieval) rate of uFSH group significantly decreased in gonadotropin-releasing hormone agonist protocol ( OR=0.642, P<0.01) and in gonadotropin-releasing hormone antagonist protocol ( OR=0.556, P=0.001), but the clinical pregnancy rate per transfer cycle and the live birth rate per transfer cycle significantly increased ( OR=1.179, OR=1.169, both P<0.01) in both agonist and antagonist protocols. For safety, multiple analysis result demonstrated that in the agonist protocol, compared with rFSH group, the incidence of moderate to severe ovarian hyperstimulation syndrome of uFSH group significantly decreased ( OR=0.644, P=0.002). The differences in ectopic pregnancy rate and multiple pregnancy rate between the uFSH and rFSH groups were not significant ( P=0.890, P=0.470) in all patients. In terms of cost, compared with rFSH group, the uFSH group had lower total Gn costs for each patient ( P<0.01). Conclusion:For patients who underwent COS, uFSH has better safety, and economic profiles over rFSH in China.

【Objective】 To study the annual financial expenditure in blood stations with different scales, and to establish the regression equation between blood collection units and total expenditure. 【Methods】 The annual total expenditure, the per capita cost of serving population, as well as the collection units of whole blood and apheresis platelet of 24 blood stations were collected. The financial expenditure required for collecting 10 000U blood was calculated.The statistical analysis was carried out with SPSS statistical software. 【Results】 From 2017 to 2020, the total annual financial expenditure of 24 blood stations showed an upward trend. The total expenditure among blood stations was different. The per capita cost of servicing population in the areas where the 24 blood stations were located had been increasing year by year. The 24 blood stations were divided into two grades according to the blood collection volume as 50 000 U, and the relationship equation between the blood collection volume and the annual total expenditure had been established. After testing, each equation was effective(P<0.05); There was no difference in the financial expenditure required for collecting 10 000U blood among blood stations with different scales. 【Conclusion】 From 2017 to 2020, the blood stations with an annual collection volume more than 50 000 U demonstrated a higher financial expenditure and the per capita cost of serving population than those <50 000 U. The blood collection volume of blood stations is significantly correlated with the annual total expenditure and the per capita cost of serving population.

To detect the concentration of triptolide in skin and joint after percutaneous administration,an HPLC-MS/MS method and skin and joint micro-dialysis( MD) method of triptolide were established in this study. The separation was achieved on triple quadrupole( AB QTRAP4500) and phenomenex-C18( 4. 6 mm×150 mm,5 μm,luna) column with acetonitrile-water with 0. 1% formic acid( 65 ∶35) as the mobile phase at a flow rate of 0. 7 m L·min-1. An electrospray ionization( ESI) source was applied and operated in the positive multiple reaction monitoring( MRM) mode. The fragment ion for triptolide was m/z 361. 1→145. 0. The effects of different perfusion [Ringer's,PBS( p H 7. 4),30% ethanol saline]drug concentrations and flow rates on the recovery rate,as well as the relationship between the recovery rate and the loss rate were determined by incremental( dialysis) and reduction( retrodialysis) methods.The reduction method was applied in the in vivo study to investigate and determine the stability of the probe recovery rate in 10 h. The results of HPLC-MS/MS detection method conformed to the requirements of biological samples. The perfusion fluid was 30% ethanol saline. The recovery rate of skin and joint probes in vitro of triptolide increased within the flow rate of 0. 5-2. 5 μL·min-1. In order to increase the timeliness of data and the accuracy,the flow rate was determined to be 1 μL·min-1,and the sample interval was determined to be 0. 5 h. The recovery rate of triptolide in skin and joint probes in vitro and the loss rate were stable and equal despite of change of triptolide concentration within 10-200 μg·L-1. This indicated that the effect of drug concentration on the MD probe recovery rate was small,and the recovery rate could be replaced by the loss rate. The loss rate in vivo using MD method was measured at 10 h,indicating that the transfer rate of triptolide was stable within 10 h. The established method of triptolide in MD and HPLC-MS/MS can be applied to investigate the kinetic in skin and joint after percutaneous administration of triptolide.
Chromatography, High Pressure Liquid ; Diterpenes ; pharmacokinetics ; Epoxy Compounds ; pharmacokinetics ; Humans ; Joints ; metabolism ; Phenanthrenes ; pharmacokinetics ; Reproducibility of Results ; Skin ; metabolism ; Tandem Mass Spectrometry

Trauma is the leading cause of death for people under 40 years old in the world. At present, the rescue and treatment system of trauma patients in China is not yet well established, and the mortality of trauma patients is higher than those in the developed countries. Improving the treatment system is the key to reducing the trauma mortality. In order to innovate the service mode of trauma first aid, further promote the establishment of regional trauma first aid system, improve the ability of trauma treatment, reduce the mortality and disability rate of trauma patients in Jiangxi Province, recently Health Commission of Jiangxi Province and the First Affiliated Hospital of Nanchang University have reached a consensus on the establishment of Jiangxi trauma first aid center. In order to provide reference for the construction of trauma treatment system, the author analyzes the following aspects including functional positioning, basic requirements, organization management, and evaluation of core indicators.

The present study carried out a phytochemical investigation of the methanol extract of the branches and leaves of Clausena lansium and afforded nine carbazole alkaloids (compounds 1-9) including two new carbazole alkaloids, claulansiums A and B (compounds 1 and 2). The new compounds were elucidated on the basis of extensive spectroscopic data (MS, NMR, IR, and UV) and the known compounds were identified by comparing spectroscopic data with those reported in literature. All the isolated compounds were tested for their cytotoxic activity against A549 and Hela cancer cell lines. Our results showed that compounds 2-6 exhibited varying degrees of cytotoxicity to cancer cells, with IC values ranging from 8.67 to 98.89 μmol·L.
A549 Cells ; Alkaloids ; chemistry ; isolation & purification ; toxicity ; Antineoplastic Agents ; chemistry ; isolation & purification ; toxicity ; Carbazoles ; chemistry ; isolation & purification ; toxicity ; Cell Line, Tumor ; Cell Survival ; drug effects ; Clausena ; chemistry ; HeLa Cells ; Humans ; Molecular Structure ; Plant Extracts ; chemistry ; toxicity ; Plant Leaves ; chemistry ; Plant Stems ; chemistry ; Plants, Medicinal ; chemistry