Study on Quality Standard Improvement for Xiangsha Hezhong Pills / 中国药房

ABSTRACT

OBJECTIVE：To improve the quality standard of Xiangsha hezhong pills. METHODS ：Based on previous quality standard of Xiangsha hezhong pills ，the items of property observation and microscopic identification were revised. TLC identification methods were established for ginger-processed Magnolia officinalis ，Pogostemon cablin and Atractylodes Lancea （stir-fried with earth ）. HPLC methods were adopted for contents determination of hesperidin ，magnolol and honokiol. RESULTS ： The description of the appearance of Xiangsha hezhong pills should be modified to “yellow brown or brown water pill ”. The description of microscopical identification was adjusted slightly. TLC chromatogram of ginger-processed M. officinalis ，P. cablin and Atractylodes Lancea （stir-fried with earth ）all showed the same color spots in the same position as the corresponding substance control or reference medicinal material ，and the negative samples had no interference. The contents determination were performed on Phenomenex Luna C 18 column with mobile phase consisted of methanol-water （40 ∶ 60，V/V，hesperidin）or acetonitrile- 1％ glacial acetic acid （52∶48，V/V，magnolol and honokiol ）at the flow rate of 1.0 mL/min. The column temperature was 30 ℃. The detection wavelengths were set at 284 nm（hesperidin）or 294 nm（magnolol and honokiol ）. The linear ranges of hesperidin ， magnolol and honokiol were 0.201 8-2.018 μg，0.035 7-0.357 4 μg and 0.028 2-0.282 4 μg（all r＝0.999 9）. The detection limits were 2.0，0.72，0.45 ng；the limits of quantitation were 7.0，2.45，1.61 ng. RSDs of precision ，reproducibility，stability and durability tests were all lower than 3％. The average recoveries were 99.92％，100.49％ and 102.08％（all RSD ＜3％）. CONCLUSIONS ：The study verifies the description of character observation and microscopical identification ，adds TLC identification methods for ginger-processed M. officinalis ，P. cablin and Atractylodes Lancea （stir-fried with earth ）based on previous quality standard of Xiangsha hezhong pills. HPLC methods were adopted to determine the contents of hesperidin ，magnolol and honokiol ，and can effectively improve the quality control standard of the preparation.