连蒲胶囊的质量标准研究

The Quality Standards Study of Lianpu Capsules

目的建立连蒲胶囊质量控制方法。方法采用薄层色谱法(TLC)对制剂中的苦参碱、冰片、石菖蒲和贯叶连翘进行定性鉴别;采用高效液相色谱法(HPLC)测定制剂中金丝桃苷、苦参碱的含量;采用气相色谱法(GC)测定制剂中冰片的含量;采用原子吸收分光光度法(AAS)、原子荧光法(AFS)和气相色谱法(GC)分别测定连蒲胶囊制剂中重金属及有害元素和有机氯农药残留量。结果薄层色谱显色清晰且阴性对照无干扰。金丝桃苷在0.026～1.037μg范围内线性关系良好(r=1.0000),平均回收率为102.2%,RSD=0.4%(n=6);苦参碱在0.412～6.592μg/ml范围内呈良好的线性关系,回收率103.4%,RSD=1.0%(n=9);冰片在0.01977mg/ml～0.3954mg/ml范围内呈良好的线性关系,回收率97.8%,RSD=1.9%(n=9)。重金属和农药残留检测显示制剂中含有微量铅(Pb)、镉(Cd)、砷(As)、汞(Hg)、铜(Cu)以及有机氯农药六六六(δ-BHC)。结论本方法定性专属性强,定量准确度高、重复性好,可用于连蒲胶囊的质量控制方法。

Objective To develop a method of quality control for Lianpu Capsules. Methods Borneolum Syntheticum, matrine, Hyperici Perforati herba and Acori tatarinowii rhizoma were identified by TLC.HPLC was used for determination of hyperin and matrine. GC was used for determination of Borneolum Syntheticum. AAS, AFS and GC were used for determinations of heavy metals and pesticide residues. Results The chromatographic spots were identified without the interference of negative control. hyperin had a good linearity over the concentration range of 0.026~1.037μg ,the average recovery was 102.2% with RSD of 0.4%. matrine had a good linearity over the concentration range of 0.412~6.592μg/ml ,the average recovery was 103.4% with RSD of 1.0%. Borneolum Syntheticum had a good linearity over the concentration range of 0.01977~0.3954mg/ml ,the average recovery was 97.8%% with RSD of 1.9%.Heavy metals and pesticide residue analysis show a trace of Pb, Cd, As, Hg ,Cu and δ-BHC. Conclusion This method was found to be specific, reliable and accurate .It can be used for the quality of Lianpu Capsules.