Objective: To perform the bacterial endotoxin test of Pulse-Engendering Injection.Methods: The interference actions of the different dilutabilities of injection at the greatest effective diluent range were observed with some sensitivity of TAL. Results: When 0.5EU/ml sensitivity of TAL was used and the dilutability of sample was 1∶8, the injection showed obvious enhancement action, but when 0.25EU/ml senitiity of TAL was used and the dilutability was 1∶16, the enhancement action of injection could be eliminated. Conclusion: The bacterial endoxin test can be carried out with 0.25EU/ml sensitivity of TAL when the dilutability of sample is 1∶16, the limit dose of bacterial endotoxin is controlled thereby.

OBJECTIVE:To optimize the formulation of Dimemorfan phosphate tablets. METHODS:Using 60 min dissolution rate of dimemorfan phosphate as index,L9(34) orthogonal test was used to optimize the amount of starch,microcrystalline cellu-lose,croscarmellose sodium and concentration of HPMC E5 solution. The friability,hardness,60 min dissolution rate and main component were detected. The similarity of dissolution curves of Dimemorfan phosphate tablets was compared with that of imported tablets in 0.1 mol/L hydrochloric acid,pH 6.8 phosphate buffer,water and pH 4.0 acetate buffer. RESULTS:The optimized formu-lation of Dimemorfan phosphate tablet(1 000 tablets)was composed of dimemorfan phosphate 10 g,starch 60 g,microcrystalline cellulose 40 g,10% HPMC E5 solution and croscarmellose sodium 25 g. The friability,hardness,60 min dissolution rate and main component of 3 batches of Dimemorfan phosphate tablets prepared by optimized prescription were 0.42%-0.58%,9.8-10.5 kg,94.89%-96.21% and 99.21%-99.52%,respectively. In 4 dissolution mediums,similar factors f2 of dissolution curves between prepared tablets and imported tablets were above 50. CONCLUSIONS:Dimemorfan phosphate tablets were prepared successfully. The optimized formulation is rational. The dissolution behavior of prepared tablets is similar to that of imported tablets in vitro.

OBJECTIVE:To prepare borneol-puerarin liposomes,and to investigate its brain-targeting. METHODS:Film dis-persion ultrasonic method was used to prepare borneol-puerarin liposomes. The morphology of liposomes was observed by TEM;the particle size and Zeta potential were measured by laser particle size analyzer;the entrapment efficiency were measured by sepha-dex gel filtration method. Compared with Puerarin injection,brain-targeting of borneol-puerarin liposomes and puerarin liposomes via intravenous injection of mice tail was studied with relative intake rate and peak concentration ratio. RESULTS:Borneol-puerarin liposomes were spherical or quasi-circular;its mean particle size,polydispersity index and Zeta potential were 226 nm,0.263 and-21.3 mV respectively. The entrapment efficiency were(65.32±2.13)%. Compared with Puerarin injection,relative intake rate of puerarin liposome and borneol-puerarin liposome were 1.68 and 2.58,and peak concentration ratio were 1.15 and 1.42. CONCLU-SIONS:Brain-targeted borneol-puerarin liposomes are prepared successfully.

Objective:To determine the content of chloroform, ethyl acetate and DMF in dimemorfan phosphate by gas chromatog-raphy (GC). Methods:The capillary gas chromatography was used with a PEG-20M column, programmed temperature, water as the solvent and FID as the detector. Results:The three organic solvents were separated and showed good linear relationship (r>0. 999 0). The detection limit of chloroform, ethyl acetate and DMF was 0. 63,0. 60 and 8. 92μg·ml-1 , respectively. The residues of the organ-ic solvents in three batches of the samples all met with the requirements of ICH. Conclusion: The method is sensitive, accurate and reliable, and can be used in the quality control of dimemorfan phosphate.

Objective:To establish a method for the determination of dichloromethane, methanol and ethanol in fenticonazole ni-trate. Methods:The samples were detected by headspace GC. The column was OV-1301(30 m × 0. 53 mm,3. 0 μm), the detector was FID with nitrogen as the carrier gas, the detector temperature was 250 ℃ and the injector temperature was 200 ℃. Results:The linear range of dichloromethane, methanol and ethanol was 2. 436-21. 924(r=0. 998 8), 12. 268-110. 412(r=0. 999 5) and 20. 052-180. 468 μg·ml-1(r=0. 996 9) with the average recovery of 99. 30% (RSD=2. 36%), 100. 21%(RSD=1. 07%) and 100. 15%(RSD=1. 21%)(n=9), respectively. Conclusion:The detection method is sensitive, accurate and reliable, and can be used in the quality control of fenticonazole nitrate.

Objective To establish a gas chromatograph method for determing Chloroform, ethyl acetate and N, N-dimethyl formamide in butoconazole nitrate. Methods The samples was detected by Headspace Gas Chromatography. Temperature programming method was adpoted and FID was used as detector. The injector temperature was 200 ℃, and the detector temperature was reach 250 ℃. Nitrogen was used as carrier gas in the experiment. Results In the mentioned chromatographic conditions, Chloroform, ethyl acetate and N, N-dimethyl formamide had good linear relationships in the ranges of 0. 066-0. 588,0. 062-0. 556 and 0. 896-8. 061 μg·mL-1 respectively. The average recoveries were 99. 18%,102. 84% and 98. 71%. RSD were 3. 87%,4. 33% and 3. 71%. Conclusion The detection method is sensitive, accurate, reliable, and can be used as a quality control for butoconazole nitrate.

With the continuous progress of tumor treatment methods in recent years, more and more emerging antitumor drugs have been approved to market and put into clinical use. In addition, some treatments that are in clinical trials such as gene therapy are also continuously making new breakthroughs. In this review, we mainly give a brief introduction to the novel antineoplastic therapies that have been clinically used in recent years, as well as the ones with remarkable efficacy and are expected to be approved for marketing.

As an increasing number of emerging anti-tumor drugs are approved and marketed,the imperative for clinical safety monitoring and risk information management has grown significantly.Drug-induced neuropathy associated with these drugs exhibit characteristics such as insidious onset,rapid progression,and challenging treatment,ultimately leading to treatment failures.Therefore,a comprehensive understanding of the risk of neuropathy induced by emerging anti-tumor drugs,coupled with risk surveillance and early warning,as well as management and reporting,can significantly reduce the incidence and severity of drug-related diseases.This paper provides a review of the neuropathy caused by emerging anti-tumor drugs,introduces the pharmacovigilance system and risk information management measures in clinical usage,aiming to provide a reference for guiding the rational clinical use and minimizing the incidence of drug-induced diseases.