To investigate the antibacterial effect of acetylkitasamycin dry suspension on Mycoplasma pneumoniae (MP) in vitro.

51 clinical isolates and 2 standard strains of MP from patients with respiratory tract infection stored in our laboratory from 2016 to 2019 were randomly selected for the research. Taking azithromycin and erythromycin as control drugs, the minimum inhibitory concentration (MIC) of acetylkitasamycin dry suspension against MP was determined using broth microdilution method.

Of all the 51 clinical isolates, there were 43 drug-resistant strains that contained the point mutations A2063G in V region of 23S rRNA domain, and there were 8 susceptible strains which had no mutations related to drug resistance. The MIC values of the acetyljithamycin dry suspension were 0.125 mg·L^-1 for the standard MP strains FH and M129; for the clinically resistant MP strains, the MIC was 8~32 mg·L^-1, the MIC₅₀ was 16 mg·L^-1, and the MIC₉₀ was 32 mg·L^-1; for clinically sensitive MP strains, the MIC was 0.063~0.125 mg·L^-1, and both MIC₅₀ and MIC₉₀ were 0.125 mg·L^-1. Erythromycin had a MIC range of 256~1 024 mg·L^-1 for clinically resistant MP strains, the MIC₅₀ was 512 mg·L^-1, and the MIC₉₀ was 1 024 mg·L^-1; azithromycin had a MIC range of 64~512 mg·L^-1 for clinically resistant MP strains, the MIC₅₀ was 256 mg·L^-1, and the MIC₉₀ was 512 mg·L^-1. The MIC values of erythromycin and azithromycin for clinically sensitive MP strains were <0.5 mg·L^-1.

MP showed different degrees of resistance to macrolide antibiotics. Acetylkitasamycin dry suspension had good bacteriostatic activity against sensitive MP strains in vitro, and the MIC value against resistant MP strains was low, and the clinical effect on MP infection need to be further studied.

Drug licensing transactions are constrained by many legal provisions and face many uncertainties, which confuse investors to make decisions. A reasonable risk assessment system for drug licensing transactions will help licensors grasp risks more comprehensively and carry out corresponding prevention and control.

The authors identified the risk factors through expert consultation, case analysis and other methods, and further split the risks of drug licensing transactions using the risk breakdown structure (RBS) method to obtain the risk assessment indicators of drug licensing transactions.

Eight secondary assessment indicators of drug licensing transaction risk, including strategic risk, patent and intellectual property risk, clause negotiation risk, R&D risk, cooperation risk with third parties, policy supervision risk, supply chain risk, and market risk, and 37 tertiary assessment indicators of drug licensing transaction risk were identified, and a diversified drug investment risk assessment system was constructed.

There are many complex risks in the process of drug licensing transactions. The construction of a comprehensive and reasonable drug investment risk assessment system can help investors better identify and evaluate the risks of licensing projects before making decisions.

To explore the feasibility of multivariate data analysis (MVDA) in formulation robustness study of biopharmaceutical drug products by taking an antibody-drug conjugate (ADC) HS630 as example.

A two-level fractional factorial design with five factors was used to investigate the effects of protein content, contents of three excipients and pH on critical quality attributes. After preparation, the samples of each group were exposed to high temperature for 28 d and light for 10 d, respectively. The contents of polymers and free DM1 were detected and analyzed.

Partial least squares (PLS) method was used for model fitting and data analysis, and the model seemed good with an acceptable predictive capability. All the excipients and pH had no significant effect on the contents of polymers and free DM1. Although it was not significant, a higher free DM1 content was noticed with higher protein content and higher pH conditions. Light and high temperature had significant effects on the attributes of drug product with a similar trend but small ranges. The formulation in the studied range was regarded as robust.

Taking MVDA method into formulation robustness study of drug products can analyze the multi-dimensional data obtained under different treatment conditions. The critical components of the formulation can be identified, and the influence of treatment conditions on the critical quality attributes can be investigated.

To evaluate and compare the safety and efficacy of microecological live bacteria preparations Lactasin (Lactasin strain) and Biofermin (Biofermin strain) production strains at the genome level using high-throughput sequencing and bioinformatics technology, thus to provide basis for the quality research and consistency evaluation of strains used in the production of ecological live bacteria products.

Combined with a personalized database, DIAMOND retrieval strategy was used to find target genes and analyze their functions through sequence comparison.

The strains used for Lactasin and Biofermin production were both Enterococcus faecium. The genomes of the 2 strains had good collinearity, but a few of genes had rearrangements such as insertions, deletions, inversions, and translocations. The safety of the Biofermin strain was similar to the Lactasin strain in 6 aspects, including virulence genes, drug resistance genes, bacteriocin genes, biogenic amine genes, prophages and mobile genetic elements. In the evaluation of probiotic function of stress response genes, antimicrobial/antagonistic activity, antioxidant activity genes and adhesion genes, Biofermin strain was better than Lactasin strains.

In this paper, a quality evaluation method of strains for the production of microecological live bacteria products was initially established based on specific gene function analysis, and the quality research and quality evaluation system were also improved and perfected for microecological live bacteria products.

To analyze the clinical medication characteristics of zedoary turmeric oil injection based on real world data, and to provide reference for its clinical rational medication.

Based on the data of 894 cases treated with zedoary turmeric oil injection extracted from the HIS system of 12 hospitals in China, the general data and medication status of the patients were described and analyzed by using frequency analysis method. The visual correlation analysis of the original diseases and combined medication status of 894 patients was carried out by using VOSviewer software and python program.

Among 894 patients who were administered zedoary turmeric oil injection, the frequency of upper respiratory tract infection was the highest, and the overall effective rate of treatment was 99.55%. Among the 894 cases, 11.52% were over the prescribed dropping rate, and 3 cases of adverse reactions were reported. In the aspect of combined use of zedoary turmeric oil injection, the solvent is mainly 5% glucose injection (73.60%), and it is mostly combined with Reduning injection and ambroxol hydrochloride injection.

zedoary turmeric oil injection has important application value in the treatment of respiratory and digestive system-related diseases. However, there are occasional mild adverse events, which may be related to the non-standard infusion operation. The existing data is limited, and the effectiveness and safety of zedoary turmeric oil injection in clinical application still need to be further improved. The reevaluation of the effectiveness and safety of traditional Chinese medicine injection should be strengthened after being listed. Also, higher quality evidence support should be provided for the clinical rational use of traditional Chinese medicine injection such as zedoary turmeric oil injection.

Quercetin enteric nanoparticles were prepared by electrostatic spray technology, and the preparation process was optimized by central composite design-response surface methodology.

The ethanol solution of quercetin/Eudragit L100 (1∶1, w/w) was prepared using Eudragit L100 as an enteric coating material. The effects of solution concentration, electrostatic spray voltage, spraying speed and receiving distance on the particle size were investigated. On the basis of single factor test results, the optimal process parameters were selected by central composite design-response surface methodology. The nanoparticles were evaluated by scanning electron microscope, X-ray powder diffraction and differential thermal analysis. The equilibrium solubility and dissolution of quercetin nanoparticles were determined in the solution of pH 1.2 and pH 6.8.

The optimum preparation conditions are Quercetin/Eudragit L100 concentration of 0.48%, spray voltage of 29.9 kV, spray speed of 0.44 mL·h^-1 and receiving distance of 23.18 cm. The prepared enteric nanoparticles were spherical with an average diameter of (251.1±7.8) nm. The results of X-ray powder diffraction and differential thermal analysis showed that quercetin was amorphous in nanoparticles. The equilibrium solubilities of quercetin enteric nanoparticles were 1.069 and 6.827 μg·mL^-1 in pH 1.2 and pH 6.8 solution, respectively, and the dissolutions of quercetin enteric nanoparticles at 2 h were 15.1% and 83.9% in pH 1.2 and pH 6.8 solution, respectively.

Quercetin enteric nanoparticles prepared by electrostatic spraying had a good enteric effect.