河车大造胶囊质量标准研究  

Quality Standard of Heche Dazao Capsules

作　　者：汪艳 王荭晖 杜赛 WANG Yan;WANG Honghui;DU Sai(Huangshan Institute of Product Quality Inspection,Huangshan,Anhui,China 245000)

机构地区：[1]安徽省黄山市产品质量检验研究院,安徽黄山245000

出　　处：《中国药业》2023年第7期81-85,共5页China Pharmaceuticals

基　　金：安徽省黄山市2020年度科技计划项目[2020KN-16]。

摘　　要：目的 完善河车大造胶囊的质量标准。方法 采用薄层色谱法定性鉴别制剂中的紫河车、黄柏、熟地黄、龟甲;采用高效液相色谱法测定制剂中盐酸黄柏碱、盐酸药根碱、盐酸巴马汀、盐酸小檗碱的含量,色谱柱为Inertsil ODS-3柱(250 mm×4.6 mm,5μm),流动相为乙腈-1%磷酸二氢钾溶液(梯度洗脱),流速为1.0 mL/min,检测波长为284 nm,柱温为30℃,进样量为5μL。结果 紫河车、黄柏、熟地黄、龟甲的薄层色谱斑点显色清晰,分离度好,且阴性对照无干扰。盐酸黄柏碱、盐酸药根碱、盐酸巴马汀、盐酸小檗碱进样量分别在0.098 7~1.974 9μg、0.011 1~0.221 5μg、0.010 4~0.207 3μg、0.256 5~5.129 1μg范围内与峰面积线性关系良好(r=0.999 9,0.999 9,0.999 9,0.999 8,n=6);精密度、重复性、稳定性试验的RSD均小于2.0%(n=6);平均加样回收率分别为95.01%,97.24%,95.86%,95.05%,RSD分别为0.51%,1.38%,0.33%,0.46%(n=6)。结论 该方法便捷准确,可用于河车大造胶囊的质量控制。Objective To improve the quality standard of Heche Dazao Capsules.Methods Placenta Hominis,Phellodendri Chinensis Cortex,Rehmanniae Radix Praeparata and Testudinis Carapax et Plastrum in the preparation were identified qualitatively by the thin-layer chromatography(TLC)method.The contents of phellodendrine chloride,jatrorrhizine hydrochloride,palmatine hydrochloride and berberine hydrochloride in the preparation were determined by the high-performance liquid chromatography(HPLC)method.The chromatographic column was Inertsil ODS-3 column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-1%potassium dihydrogen phosphate solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 284 nm,the column temperature was 30℃,and the injection volume was 5μL.Results The TLC chromatogram of Placenta Hominis,Phellodendri Chinensis Cortex,Rehmanniae Radix Praeparata and Testudinis Carapax et Plastrum had clear spots and good separation,with no interference from the negative reference.The linear ranges of phellodendrine chloride,jatrorrhizine hydrochloride,palmatine hydrochloride and berberine hydrochloride were 0.0987-1.9749μg,0.0111-0.2215μg,0.0104-0.2073μg and 0.2565-5.1291μg(r=0.9999,0.9999,0.9999,0.9998,n=6)respectively.The RSDs of precision,repeatability and stability tests were lower than 2.0%(n=6).The average recoveries of phellodendrine chloride,jatrorrhizine hydrochloride,palmatine hydrochloride and berberine hydrochloride were 95.01%,97.24%,95.86%and 95.05%respectively,with RSDs of 0. 51%,1. 38%,0. 33% and 0. 46%(n = 6) respectively. Conclusion The method is convenient and accurate,which can beused for the quality control of Heche Dazao Capsules.

关 键 词：河车大造胶囊 薄层色谱法 高效液相色谱法 质量控制 

分 类 号：R932[医药卫生—生药学] R286.0[医药卫生—药学]