Xiangbei Welman Pharmaceutical Co.

Changsha, China

Xiangbei Welman Pharmaceutical Co.

Changsha, China
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Wang T.,Xiangbei Welman Pharmaceutical Co. | Wang T.,China Pharma | Wang G.-J.,China Pharmaceutical University
Chinese Journal of New Drugs | Year: 2010

Ceftriaxone sodium and sulbactam sodium for injection (2:1, CTZ/SBT(2:1) is new anti-drug-resistant antibiotic compound. Pharmacological data in vitro shows that MIC50 and MIC90 of the combination for bacteria with beta-lactamase-producing were reduced significantly than that of CTZ alone. This antimicrobial advantage was also being proved in infected rats. The safety of the compound was demonstrated by toxicity assay using rats and dogs for 30 d system administration. Toleration experiment shows its safety ranges about 5.0 g in health volunteers. Phase I data also displayed that there were no statistical differences in the pharmacokinetic parameters of CTZ and SBT between its administrations alone or simultaneously. The multi-center randomized controlled blinded clinical trials displayed that the compound potency with 88.33%, 90.00% efficiency and 100.00%, 91.67% of the clearance rate and both 100.00% sensitive rate on acute bacterial respiratory and urinary infections, respectively, and with 5.79% adverse effect in full case. In conclusion, the compound was safety and effectively on bacterial infections, especially for the treatment of beta-lactamase-producing bacterial disease in clinical.

Wu N.,China Pharmaceutical University | Wu N.,Xiangbei Welman Pharmaceutical Co. | Wu Q.-Z.,China Pharmaceutical University | Wu Q.-Z.,Xiangbei Welman Pharmaceutical Co. | And 4 more authors.
Chinese Journal of New Drugs | Year: 2010

The third-generation cephalosporin cefotaxime has been widely used in clinic because of its excellent antimicrobial effect and broad antibiotic spectrum. However, most of pathogenic bacteria have developed severe drug-resistance, which is threatening the common use of this antibiotic. Here, we reviewed current data concerning drug-resistance to cefotaxime among several clinical dominating pathogenic bacteria, including their distribution, β-lactamase production as well as its changes.

Wang T.,Xiangbei Welman Pharmaceutical Co. | Zhang C.-H.,Xiangbei Welman Pharmaceutical Co.
Chinese Journal of New Drugs | Year: 2010

Cefotaxime, a third-generation cephalosporin, exerts excellent antimicrobial effect to drug-resistant pathogens when combined with a β-lactamase inhibitor. In this article, recent reports on its analysis methods, antimicrobial effects, pharmacokinetic and adverse reactions were summarized.

Li C.-Q.,Xiangbei Welman Pharmaceutical Co. | Chen W.,Xiangbei Welman Pharmaceutical Co. | Wang T.,Xiangbei Welman Pharmaceutical Co.
Chinese Journal of New Drugs | Year: 2010

Resistance to cefotaxime of clinically isolated Gram-negative bacterial strains is extremely serious, and production of β-lactamases is one of the main mechanisms. Gram-negative bacterial strains mainly express TEM, CTX-M, and SHV type β-lactamases hydrolyzing cefotaxime. These β-lactamases can be effectively inhibited by sulbactam. The inhibition of cefotaxime/sulbactam (1:1, 2:1) is stronger than cefotaxime/sulbactam (4:1, 8:1). The antibacterial activity of cefotaxime/sulbactam (1:1-8:1) increased obviously in the antimicrobial tests in vitro in three regions (Beijing, Sichuan and Xi'an) , and the effect of cefotaxime/sulbactam (1:1, 2:1) was more suitable. The results showed that the cefotaxime/sulbactam combination is highly effective against cefotaxime-resistant Gram-negative bacterial strains, and cefotaxime/sulbactam (2:1) is the reasonable proportion.

Deng G.-X.,Xiangbei Welman Pharmaceutical Co. | Deng G.-X.,Guangzhou Welman Pharmaceutical R and D Co. | Dong W.-X.,Xiangbei Welman Pharmaceutical Co. | Wang T.,Xiangbei Welman Pharmaceutical Co. | Wang T.,Guangzhou Welman Pharmaceutical R and D Co.
Chinese Journal of New Drugs | Year: 2012

Objective: To prepare phentolamine mesylate effervescent tablets, which have advantages of taking conveniently and acting quickly, by a common preparation technique. Methods: The excipients and their proportion in phentolamine mesylate effervescent tablets were optimized by experiments. The quality of preparation was preliminarily evaluated. Results: All the indexes of phentolamine mesylate effervescent tablets, such as disintegration time, tablet weight variation and hardness, accorded with or better than the correlative requirements in the appendix of Chinese Pharmacopoeia (2005 edition). Conclusion: The formula and preparation methods of phentolamine mesylate effervescent tablets are effective and feasible, and the preparation can be developed as a new phentolamine mesylate formulation.

Lu Y.-W.,Guangzhou Welman New Drug R&D Co. | Lu Y.-W.,Xiangbei Welman Pharmaceutical Co. | He Y.-L.,Guangzhou Women and Childrens Medical Center | Cheng G.-H.,Jinan University | And 4 more authors.
Chinese Journal of New Drugs | Year: 2015

Clinical research of pediatric drugs is one of the effective ways to improve children's medication information. In view of the lack of medication information for children, we should improve it gradually according to clinical demand and the priority areas of concern. Thus the prophase of the project is particularly important. Referenced to new founds and achievements in this field of foreign countries and combined some examples, this review focuses on some considerations for the design of pediatric drug trials, such as initiating a project basis, risk and benefit, bridging research, the particularity of different ages, specimen collection and use, the selection of control group, inform and consent, assessment of endpoint, and so on The review maybe offer help for peers. ©, 2015, Chinese Journal of New Drugs Co. Ltd.. All right reserved.

Chen W.,Xiangbei Welman Pharmaceutical Co. | Lu H.-C.,Xiangbei Welman Pharmaceutical Co. | Li C.-Q.,Xiangbei Welman Pharmaceutical Co. | Wang T.,Xiangbei Welman Pharmaceutical Co.
Chinese Journal of New Drugs | Year: 2011

Objective: To analyze the genotype of β-lactamases in cefotaxime-resistant clinical strains, and to determine the hydrolysis rate of cefotaxime/sulbactam (CTX/SBT, 1:1, 2:1, 4:1, 8:1) by β-lactamases. Methods: The minimal inhibitory concentration (MIC) was detected by the agar dilution method. The genotype of β-lactamases was identified by PCR sequencing. β-Lactamases were extracted by ultrasonic treatment and visualization with nitrocefin. The hydrolysis rate and the ability of enzyme inhibitor in protecting cefotaxime from hydrolyzing by β-lactamases were measured by biological method. Results: Among the 544 clinically isolated strains, 331 strains, including Enterobacteriaceae (n=327) and Pseudomonas aeruginosa (n=4), produced β-lactamases catalyzing the hydrolysis of CTX. Three β-lactmases genes (CTX-M, TEM and OXA) were detected. CTX-M-type and TEM-type were the predominant genotypes. The hydrolysis rate of CTX by all β-lactamases was 100% within 24 h. The inhibition rate of β-lactamases of CTX/SBT (1:1, 2:1) was higher than that of CTX/SBT (4:1, 8:1, P<0.05), and all of them were higher than 82%. MIC 90s of CTX against 330 of 331 β-lactamase-producing isolates decreased by more than 2 times, when it was combined with SBT at ratio of 2:1. Conclusion: CTX-M-type and TEM-type β-lactamases, which could catalyze the hydrolysis of CTX and be effectively inhibited by CTX/SBT (1:1~8:1), are predominant genotypes of β-lactamase in CTX-resistant clinical isolates.

Li C.,China Pharmaceutical University | Li C.,Xiangbei Welman Pharmaceutical Co. | Lan G.,Xiangbei Welman Pharmaceutical Co. | Jiang J.,Xiangbei Welman Pharmaceutical Co. | And 2 more authors.
Chromatographia | Year: 2015

A novel stability-indicating high-performance liquid chromatographic (HPLC) method has been developed and validated for the analysis of the impurities A–G in cabazitaxel. Chromatographic separation was achieved on a Welch Xtimate™ C18 (250 × 4.6 mm; 5 μm) column, using the mixture of 0.02 mol L−1 sodium dihydrogen phosphate buffer pH 3.0 (pH value was adjusted with phosphoric acid) and acetonitrile as mobile phase by gradient elution with a flow rate of 1.0 mL min−1, and UV detection was performed at 230 nm. The column temperature was maintained at 40 °C by column oven. The method was validated according to the International Conference on Harmonization (ICH) guidelines. Linearity (r > 0.9990) was observed over the concentration ranges of 25.0–1500.0, 31.5–1518.0, 74.9–1796.8, 65.6–1573.2, 59.4–1425.6, 22.2–1332.0, 1.3–1570.8, 30.8–1476.0 ng mL−1 of cabazitaxel and its impurities A–G, respectively. The RSD value of the recovery for each impurity was <5.0 % (n = 9). The method was found simple and rapid with good specificity and robustness, which can be suitable for the determination of the impurities in cabazitaxel. © 2015, Springer-Verlag Berlin Heidelberg.

Xue X.-L.,East China Normal University | Wang T.,East China Normal University | Wang T.,Xiangbei Welman Pharmaceutical Co. | Meng B.,East China Normal University | And 2 more authors.
Chinese Journal of New Drugs | Year: 2013

Alzheimer's disease (AD) is the most common and serious neurodegenerative disease, whose molecular mechanism is still unclear. So far more and more evidences have shown that the mutation of presenilin1/2 gene is the most important factor in familial AD. Presenilin1 and presenilin 2 conditional double knockout mice (DKO mice), possess most clinical features of AD and exhibit molecular changes, morphology and neuropathology alteration, inflammatory reaction, electrophysiology, cognitive deficits and emotional response in gradually time-dependent mode; furthermore, by environment enrichment(EE), calories restriction(CR), exercise and pharmacology, the deficits of the DKO mice in learning and memory ability, emotional response and neuropathology could be partially improved. All these results suggest that the DKO mice are an ideal AD animal model for exploring the pathologic causes of AD and screening new drugs for prevention and treatment of AD.

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