ABSTRACT
Objective To establish a quality control method for Lvxintong Rugao. Methods Ketoconazole, Halcinonide and Neomycin sulfate were identified by TLC. The content of Ketoconazole and Halcinonide were determined by HPLC. The chromatographic column of Agilent ZORBAX SB-C18 (4.6 mm×150 mm, 5 μm) column was used. Methanol-phosphate buffer (pH=7.40, 75:25) was applied as the mobile phase. The detection wavelength was 235 nm. The flow rate was 1.0 ml/min and the column temperature was set at room temperature. Neomycin Sulfate was determined by polarimetric analysis. Results The identification and determination methods showed good specificity. Ketoconazole and Halcinonide displayed good linearity within the range of 1.999~39.98 μg (r=0.999 9) and 0.400 8~8.016 μg (r=0.999 9), respectively. The average recoveries were 97.75% (RSD 0.77%) and 97.57% (RSD 0.84%), respectively. For the determination of Neomycin Sulfate, r=0.999 6 (n=6) in the range of 130.4~2 608 U/ml (n=6). The precision and repeatability of RSD were 1.1% and 1.6%, respectively. The solutions were stable in 6 h and the average recovery was 98.8% (RSD 2.6%). Conclusion The method could be used as the quality control method for Lvxintong Rugao.
ABSTRACT
Objective To establish the quality control method for Huoguwan.Methods TLC was applied to detect the component of Danshen,Dihuang,Danggui,Chuanxiong,Sanqi,Tubiechong,and Zhicaowu in this compound preparation. HPLC was used to measure the concentration of Renshenzaogan Rg 1,Rb1and Sanqizaogan R1.Unitary C18analytical column (4.6 mm×250 mm,5 μm)was used with acetonitrile-water as the mobile phase(Flow rate:1.0 ml/min,column temperature:30 ℃,wavelength:203 nm).Results Each component showed distinct spots on TLC without interference.There are good linear relationship for Sanqizhaogan R1in the range of 39.92-399.2 μg/ml,Renshenzhaogan Rb1in 84.28-842.8 μg/ml and Renshenzhaogan Rg1in 135.86-1 358.6 μg/ml.The recovery was 102.35%,103.84% and 102.97% respectively.Conclusion The above described procedure was accurate and reproducible,which can be used as a method for the quality control of Huoguwan.
ABSTRACT
This paper is to study the stability of recombinant human epidermal growth factor (rhEGF) in artificial intestinal juice and gastric juice,providing references for its clinical application in intestinal and stomach injury.RhEGF was added into artificial intestinal juice and gastric juice respectively, and the content of rhEGF was determined with RIA at preset time points. The content of rhEGF in artificial gastric juice (pH 2) and intestinal juice (pH 6.8) had a tendency to decrease as time went by,reaching 43.46% and 21.91% from their baselines 1 h later respectively. But the decrease of rhEGF reached 89.62% and 79.52% 1 h after the presence of peptic enzymes respectively. The rhEGF in the artificial intestinal juice and gastric juice was relatively stable but the process of its inactivation could be greatly expedited in the presence of peptic enzymes.