骨康胶囊质量标准提高研究  

Study on Improvement in Quality Standards of Gukang Capsules

作　　者：谢二磊 金浩鑫[2] 聂淑华 XIE Erlei;JIN Haoxin;NIE Shuhua(Jiangxi Drug Inspection Center,Nanchang Jiangxi 330029,China;National Pharmaceutical Engineering Center for Solid Preparation in Chinese Herbal Medicine,Nanchang Jiangxi 330006,China)

机构地区：[1]江西省药品检查员中心,江西南昌330029 [2]中药固体制剂制造技术国家工程研究中心,江西南昌330006

出　　处：《药品评价》2024年第6期681-683,共3页Drug Evaluation

摘　　要：目的 对骨康胶囊进行含量测定和薄层色谱鉴别研究,提高其质量标准。方法 薄层色谱法(TLC),以芭蕉根为对照药材,以石油醚(60~90 ℃)-乙酸乙酯(20∶1)为展开剂;高效液相色谱法(HPLC),色谱柱为迪马C18柱(250 mm×4.6 mm,5 μm),流动相为乙腈-0.1%磷酸溶液(20∶80),检测波长为330 nm,柱温为30 ℃,流速为1.0 mL/min。结果 建立的芭蕉根薄层色谱鉴别,分离效果较好,斑点清晰;HPLC法测定刺槐素-6-C-β-D-葡萄糖苷在1.03~51.35 μg/mL范围内线性关系良好(r=0.999 7),稳定性、精密度、重复性RSD均小于1.00%;回收率为104.68%,RSD=0.74%。结论 建立的方法简便可行,能有效地控制骨康胶囊的质量。Objective To study the thin layer identification and content determination of gukang capsules,and improve its quality standards.Methods TLC was used with banana root as the reference material and petroleum ether(60-90°C)-ethyl acetate(20∶1)as the developing agent.HPLC method was established to determine the content of acacetin-6-C-β-D-glucopyranoside,using Diamonsil C18 column(250 mm×4.6 mm,5μm)as the chromatographic column,mobile phaseacetonitrile-0.1%phosphoric acid solution(20∶80),330 nm,30°C,1.0 mL/min.Results The established TLC identification method had clear spots and good separation effect.The linear relationship between acacetin-6-C-β-D-glucopyranoside and its concentration was good within the range of 1.03~51.35μg/mL(r=0.9997),RSD less than 1.00%.Recovery rate was 104.68%,RSD 0.74%.Conclusion The method is simple and feasible and can effectively control the quality of gukang capsules.

关 键 词：骨康胶囊 质量标准 含量测定 薄层色谱法 

分 类 号：R286.0[医药卫生—中药学]