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OBJECTIVE:To establish the quality standard of Ligularia fischeri. METHODS:TLC was used for qualitative identification of samples. The contents of moisture,ash and extract were determined. The content of ferulic acid in samples was determined by HPLC. The determination was performed on Waters SunFire C18column with mobile phase consisted of acetonitrile-0.1% phosphoric acid(13:87,V/V)at the flow rate of 1.0 mL/min. The detection wavelength was set at 319 nm, and column temperature was 30 ℃. The sample size was 10 μL. RESULTS:TLC spots were clear and well-separated without interference from genitive control. The moisture,total ash,acid-insoluble ash and extract of samples were 7.6%-9.4%, 11.7%-19.6%,5.9%-14.1% and 25.4%-37.5%,respectively. The linear range of ferulic acid were 0.021 2-0.636 8 μg(r=0.999 9). limited of quantation was 2.25 ng,the limited of detection was 0.75 ng. RSDs of intermediate precision, reproducibility and stability tests were all lower than 3.0%. The recoveries ranged 97.81%-100.59%(RSD=1.02%,n=9). CONCLUSIONS:The moisture,total ash and acid-insoluble ash of samples are no more than 10.0%,19.0%,12.0%;the extract and the content of ferulic acid are no less than 25.0% and 0.1%. Established standard can provide reference for quality control of L. fischeri.
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Objective To explore a scientific and forward-looking medical materials classification and coding strategy by studying the medical materials classification and coding of extracorporeal circulation and blood purification.Methods From the clinical practice and based on the national standard and the industry standard,the classification coding framework was built through expert consultation and the research of literature and regulation.Results A set of medical devices coding system was proposed determining identifier position,type,name,material,specification and etc,which involved in 7 layers and 14 digits of codes.Each layer was represented by 2 bits of digital Arabia.The coding system fulfilled the requirements for medical facility internal management and centralized purchase bidding.Conclusion The classification and coding system for extracorporeal circulation and blood purification consumables eliminates the deficiencies in naming,promotes consumables information system and lays a foundation for consumables precision management and bidding.
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OBJECTIVE:To analyze the dyeing status of cinnabar and its pieces,and provide reference for its quality clinical safetey appicaton. METHODS:TLC was used for the qualitative identification of amaranth,carmine,erythrosine,acid red 73, 808 udan and indirubin. HPLC-MS was used to detect the 808 udan :HPLC conditions were as follows,column was Acquity UPLC BEH C18 with mobile phase of cetonitrile-0.1% formic acid(70∶30,V/V)at a flow rate of 0.3 ml/min,the detection wave-length was 520 nm;MS conditions were as follows,ion source was electrospray ionization source,scanning mode was positive ion scanning with full scanning tandem mass spectrometry,nebulizer pressure was 30 psi,drying gas was nitrogen,ion spray voltage was 4 000 V,collision energy was 30 V,and the injection volume was 5 μl. The volumetric method was used for content determi-nation of HgS. RESULTS:TLC spots of amaranth,carmine,erythrosine,acid red 73,808 udan and indirubin were clear and well-separated. 4 batches of 808 udan dyeing were included in the 18 batches of samples,6 batches had non-compliance contents (including 3 batches of 808 udan dyeing). CONCLUSIONS:Dyeing-doped and other quality problems exist in the cinnabaris in markets,which should be noticed.
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OBJECTIVE:To establish a method for the content determination of rosin acid in Rheumatoid arthritis tablet. METH-ODS:HPLC was performed on the column of ZORBAX SB-C18 with mobile phase of acetonitrile-0.1% formic acid(82∶18,V/V) at flow rate of 1.0 ml/min ,detection wavelength was 241 nm ,column temperature was 30 ℃ and volume injection was 10 μl. MS/MS column was ZORBAX SB-C18 with mobile phase of acetonitrile-0.1% formic acid(80∶20,V/V)at flow rate of 0.2 ml/min;column temperature was 30 ℃;volume injection was 0.5 μl. Ionization mode was ESI+,atomization gas pressure was 25 psi,gas flow as 8.0 L/min,capillary voltage was 4 000 V,capillary outlet voltage was 120 V,precursor ion was 303 m/z,scan range was 50-500 m/z and the gas temperature was 350 ℃. RESULTS:The linear range of rosin acid was 2.5-100.0 μg/ml. RSDs of preci-sion,stability and reproducibility tests were lower than 2.0%,recoveries was 96.75%-98.11%(RSD=0.53%,n=6). CONCLU-SIONS:The method is simple,accurate and reproducible,and suitable for the content determination of rosin acid in Rheumatoid arthritis tablet.