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

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.

Content Determination of Paeoniflorin in Bailing Tablet by HPLC and Its Uncertainty Evaluation / 中国药房

OBJECTIVE:To establish a method to determinate the content of paeoniflorin in Bailing tablet,and to evaluate the uncertainty of results. METHODS:HPLC was performed on the column of Platisil C18 with mobile phase of water- acetonitrile(87:13,V/V) at a flow rate of 1 ml/min,the detection wavelength was 230 nm,the column temperature was 25 ℃ and the injection volume was 10 μl. Quantitative analysis was conducted for the processes and procedures and the uncertainty was evaluated. RESULTS:The linear range of paeoniflorin was 0.100 1-2.502 8 μg;RSDs of precision,stability and reproducibility tests were lower than 2.0%,recovery rate was 98.7%-100.9%(RSD=0.86%,n=6). Reference substance amount,elution produce and the accuracy of method had great effect on the uncertainty. CONCLUSIONS:The established method can be used for the content determination of paeoniflorin in Bailing tablet,and the uncertainty evaluation provides reliability for the method.

Quality Control of Calculus Bovis in Houzao Niuhuang Powder / 中药新药与临床药理

Objective To make a qualitative and a quantitative control on the Calculus Bovis in Houzao Niuhuang Powder.Methods Hyodeoxycholic acid and bilirubin in Calculus Bovis were separately identified by TLC,and the cholic acid content was determined by TLCS with the scan wavelength of ?s=380 nm,?R=650 nm.Results TLC can be used for the identification in-vitro cultured Calculus Bovis and artificial Calulus Bovis,the samples containing cultured Calulus Bovis showed the specific spots of bilirubin but no hyodeoxycholic acid spot while the samples containing artifical Calulus Bovis showed the hyodeoxycholic acid spot but no bilirubin spot.TLC-scanning can be used to measure the quantity of cholic acid,with the linear range being 0.2～1.8 ?g,average recovery rate of 99.5 %,and RSD being 3.3 %(n=6),and the results accorded with the criterion of the cultured Calculus Bovis in Chinese pharmacopoeia.Conclusion The methods can effectively control the quality of Calculus Bovis in Houzao Niuhuang Powder.