复方枇杷桔梗膏质量标准研究

Study on Quality Standard of Compound Pipa Jiegeng Ointment

目的建立复方枇杷桔梗膏的质量标准。方法采用薄层色谱（TLC）法对复方枇杷桔梗膏中的枇杷叶、罂粟壳、桔梗和薄荷脑进行定性鉴别，以高效液相色谱（HPLc）法对该制剂中的吗啡进行含量测定。结果复方枇杷桔梗膏中枇杷叶、罂粟壳、桔梗和薄荷脑的TLC中，在与对照药材溶液色谱相应位置上显相同颜色的斑点；吗啡进样量在0．0204～1．023txg范围内与峰面积线性关系良好（r=0．9997），平均回收率为99．09％，RSD为1．40％（n=6）。结论该方法简便、准确、灵敏、重复性好，可用于该制剂的质量控制。

Objective To establish a quality standard for Compound Pipa Jiegeng Ointment. Methods The TLC was used to identify E- riobotrya japonica, Pericarpium Papaveris, Platycodon grandiflorum and menthol. The HPLC method was adopted to detect the morphine content in this preparation. Results Eriobotrya japonica, Pericarpium Papaeris, Platycodon grandiflorum and menthol in TLC showed the same color spots in the corresponding positions of the control herbs; the sample size of morphine in the range of 0. 020 4- 1. 023 μg showed the good linear relation with the peak area（r=0. 999 7）, the mean recovery rate of morphine was 99.09% with RSD of 1.40% （n = 6）. Conclusion The TLC identification method has the good specificity. The HPLC method is simple,accurate and sensitive with good reproducibility and can be applied to control the quality of this product.