苋黄洗剂的质量控制

Quality Control of Xianhuang Lotion

目的:建立苋黄洗剂的质量标准。方法:选用薄层色谱法(TLC法)对苦参、黄柏进行定性鉴别;选用高效液相色谱法(HPLC法)同时测定苋黄洗剂中苦参碱和盐酸小檗碱含量。色谱柱:ZORBAX EXTEND-C_(18)(2.1 mm×150 mm),5μm;流动相:乙腈-磷酸盐缓冲液(pH6.8,v/v=45∶55);流速:1.0 mL·min-1;检测波长:225 nm;柱温:30℃;进样量:20μL。结果:薄层色谱分离度好,无干扰。苦参碱浓度在11.6~174μg·mL^(-1)、盐酸小檗碱浓度在10.6~159μg·mL^(-1)范围内与峰面积有良好线性关系。平均加样回收率分别为98.66%和98.09%,RSD为1.16%和1.10%。结论:本试验方法准确、有效、可靠,节约了时间,简化了试验步骤,可用于该制剂的质量控制。

Objective Establishment of quality standard for Xianhuang Lotion.Methods TLC was used for qualitative identification of Sophora flavescens and Phellodendron amarense.HPLC method was used for simultaneous determination of matrine and berberine hydrochloride in Xianhuang lotion.Chromatographic column:ZORBAX EXTEND-C_(18)(2.1 mm×150 mm),5μm;Mobile phase:acetonitrile phosphate buffer solution(pH6.8,v/v=45∶55);Flow velocity:1 mL·min-1;Detection of wavelength:225 nm;Column temperature:30℃;Sampling quantity:20μL.Results TLC with good separation and no interference.Matrine concentration had a good linear relationship with the peak area in the range of 11.6-174μg·mL^(-1) and berberine hydrochloride in the range of 10.6-159μg·mL^(-1).The average recoveries were 98.66%and 98.09%,RSD 1.16%and 1.10%respectively.Conclusion The method is accurate,effective,reliable,saves time and simplifies the test procedure,and can be used for the quality control of the preparation.