Study on Quality Standard Improvement for Compound Child Antifebrile Suppository / 中国药房

ABSTRACT

OBJECTIVE：To improve the quality standard of Compound child antifebrile suppository. METHODS ：Based on the previous quality standard ，TLC identification methods were established for artificial cow-bezoar and Baphicacanthis Cusiae Rhizoma et Radix. HPLC method was established for content determination of choleic acid （CA），hyodeoxycholic acid （HDCA） and paracetamol. RESULTS ：TLC chromatogram of artificial cow-bezoar and Baphicacanthis Cusiae Rhizoma et Radix all showed the same color spots in the same position as the corresponding substance control or reference medicinal material ，while the negative samples had no interference. HPLC was performed on Welch Xtimate C 18 column（CA，HDCA）or Agilent ZORBAX SB-C 18 column（paracetamol）with mobile phase consisted of acetonitrile-0.5％ formic acetic acid （by gradient elution ，CA and HDCA ）or methanol-water（20∶80，V/V，paracetamol）at the flow rate of 1.0 mL/min. ELSD was used with a nitrogen flow-rate of 2.0 L/min at a drift tube temperature of 105 ℃（CA，HDCA）. The detection wavelength was set at 244 nm（paracetamol）. The linear ranges of CA，HDCA，paracetamol were 0.150 0-4.500 0，0.212 5-6.375 0，0.081 9-1.638 5 μg（all r＞0.999 2）. RSDs of precision ， reproducibility and stability tests were all lower than 3％（n＝6 or n＝7）. The average recoveries were 100.35％，101.39％， 98.81％（all RSD ＜3％，n＝6）. CONCLUSIONS ：Based on previous quality standard of Compound child antifebrile suppository ， TLC method is used to identify artificial cow-bezoar and Baphicacanthis Cusiae Rhizoma et Radix ，and the contents of CA ，HDCA and paracetamol are determined by HPLC ，which can effectively improve the quality control standard of the preparation.