心复康口服液质量的评价

Appraising the quality of Xinfukang oral liquid （心复康口服液）

目的建立心复康口服液的质量评价方法。方法采用薄层色谱法对心复康口服液中的主要药味黄芪、人参、丹参、淫羊藿进行定性鉴别，并对其中的有毒药味附子进行乌头碱的限量检查；在此基础上，采用高效液相色谱法对方中君药人参的指标成分人参皂苷Rg1进行线性关系考察和稳定性、精密度、重现性、回收率试验，并测定批号为20080406、20080527、20080618共3批心复康口服液中人参皂苷Rg1的含量。结果薄层色谱法显示，心复康口服液中含有黄芪、人参、丹参、淫羊藿；有毒物质限量检查可知乌头碱在规定的剂量范围。人参皂苷Rg1在194．4～5832．0ng范围内呈良好的线性关系；同一批供试品8h内峰面积的相对标准偏差（RSD）为1．58％，表明药物基本稳定；同一份人参皂苷Rg1峰面积的RSD为0．41％，表明精密度良好；同一批样品人参皂苷Rg1峰面积的RSD为0．07％，表明本法重现性良好；人参皂苷Rg1的平均加样回收率为98．70％，RSD为1．71％。批号为20080406、20080527、20080618心复康口服液人参皂苷Rg1的含量分别为61．37、57．60、42．27μg／m1，RSD为0．90％、1．40％、1．90％。结论本研究中建立的质量评价系统能够有效反映心复康口服液的质量，可作为评价心复康口服液质量的有效手段。

Objective To establish a method of appraising the quality of Xinfukang oral liquid （心复康口服液）. Methods The main ingredients in this preparation： Radix astragali （黄芪）, Radix et rhizoma ginseng （人参）, Radix et rhizoma salviae miltiorrhizae （丹参）, Herba epimedii （淫羊藿） were qualitatively differentiated by thin layer chromatography （TLC）, and the quantitatively limited examination was carried out for aconitine in its toxic ingredient of Radix aconiti lateralis praeparata （附子）. Based on these examinations, the index component, ginsenoside Rgl, in the monarchy ingredient, Radix et rhizoma ginseng, was determined by high-performance liquid chromatography （HPLC） to carry out the verification of linearity, tests of stability, precision, reproducibility and recovery rate, and the content of ginsenoside Rgl in the three batches of Xinfukang oral liquid （NO. 20080406, 20080527, 20080618） was also measured. Results The TLC revealed that Xinfukang oral liquid contained Radix astragali, Radix et rhizoma ginseng, Radix et rhizoma salviae miltiorrhizae and Herba epimedii. The quantitatively limited examination showed that the content of aconitine, a toxic substance, was in the safe range. Ginsenoside Rgl in the range of 194.4 - 5 832.0 ng had good linearity. Relative standard deviation （RSD） of the peak areas of the same sample in 8 hours was 1.58%, indicating the basic stability of this method. The RSD of ginsenoside Rgl peak area of the same sample was 0. 41%, revealing that the precision was good, while that was 0.07%, showing the reproducibility of the method was nice. The mean recovery rate of ginsenoside Rgl was 98.70% in samples with addition of it, and the RSD was 1.71%. The content of ginsenoside Rgl in the three batches of Xinfukang oral liquid with NO. 20080406, 20080527 and 20080618 was 61.37, 57.60 and 42.27 心复康口服液g/ml respectively, and the RSD, 0. 90%, 1.40%, 1.90% respectively. Conclusion This method can validly reflect the quality of Xinfukang oral liquid, and it can be an effective measure to assess the quality of the liquid.