首页|骨康胶囊质量标准提高研究

骨康胶囊质量标准提高研究

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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。35µg/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。
Study on Improvement in Quality Standards of Gukang Capsules
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 ℃)-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,5 μm)as the chromatographic column,mobile phaseacetonitrile-0.1%phosphoric acid solution(20∶80),330 nm,30 ℃,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 1.03~51.35 μg/mL(r=0.999 7),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.

Gukang capsulesQuality standardContent determinationTLC

谢二磊、金浩鑫、聂淑华

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江西省药品检查员中心,江西南昌 330029

中药固体制剂制造技术国家工程研究中心,江西南昌 330006

骨康胶囊 质量标准 含量测定 薄层色谱法

2024

药品评价
江西省药学会

药品评价

影响因子:0.672
ISSN:1672-2809
年,卷(期):2024.21(6)