Improvement and Optimization of Quality Standard for Qiangli Pipa Distillate Formula / 中国药师

ABSTRACT

Objective: To improve the quality standard for Qiangli Pipa distillate formula. Methods: The chemical reactions for i-dentification in the old standard were deleted. TLC methods were established to identify Papaveris pericarpium, Eriobotryae folium and Platycodonis radix. The contents of morphine and codeine phosphate from Papaveris pericarpium were determined by HPLC. The chro-matographic conditions for morphine content determination were as follows an Inertsil ODS-3 chromatographic column (250 mm × 4. 6 mm, 5 μ m ) was used, the mobile phase was acetonitrile-the mixture of 0. 01 mol·L-1sodium heptane sulfonate and 0. 02 mol ·L-1potassium dihydrogen phosphate with equal amount (10% phosphoric acid was used to adjust pH to 2. 8) ( 13 87 ), the detec-tion wavelength was 220 nm ,the column temperature was 30 ℃, and the flow rate was 1. 0 ml·min-1. The chromatographic condi-tions for codeine phosphate content determination were as follows an Inertsil ODS-3 chromatographic column (250 mm×4. 6 mm, 5 μ m ) was used, the mobile phase was acetonitrile-the mixture of 0. 01 mol·L-1sodium heptane sulfonate and 0. 02 mol·L-1s potas-sium dihydrogen phosphate with equal amount (10% phosphoric acid was used to adjust pH to 2. 8) ( 15 85 ), the detection wave-length was 220 nm, the column temperature was 30 ℃, and the flow rate was 1. 0 ml·min-1. Results: TLC had obvious characteris-tics with clear and well-separated spots. Morphine showed a good linear relationship within the range of 3. 14-62. 8 μg·ml-1( r=1. 000 0) with the average recovery of 96. 69% (RSD=2. 41% , n=9). Codeine phosphate showed a good linear relationship within the range of 3. 52-87. 94 μg·ml-1(r=1. 000 0) with the average recovery of 95. 68% (RSD=2. 64% , n=9). Conclusion: The quality standard for Qiangli Pipa distillate formula is improved. The methods are easy-operated and accurate with good specificity, which are suitable for the quality control of Qiangli Pipa distillate formula.