维药马奶子葡萄干的质量标准研究

Study on Quality Standard of Uygur Drug Manaizi Raisin

目的:建立马奶子葡萄干的质量标准,为药用植物资源的开发利用提供科学依据。方法:对马奶子葡萄干原植物进行鉴定;对其粉末进行显微鉴别;以齐墩果酸为对照品,建立其薄层色谱(TLC)鉴别方法;按药典法测定10批马奶子葡萄干的杂质、水分、总灰分、酸不溶性灰分、重金属及有害元素、有机氯农药残留量;采用高效液相色谱法对马奶子葡萄干中齐墩果酸的含量进行测定。结果:供试品的TLC中,在与齐墩果酸对照品色谱相应的位置上,显相同颜色的斑点;暂定了马奶子葡萄干中各项检查指标限度。齐墩果酸的质量浓度在0.06～0.48mg·mL-1范围内与峰面积积分值呈良好的线性关系(r=0.9999);平均加样回收率为99.17%,RSD=1.76%(n=6);并根据样品含量测定结果暂定本品含齐墩果酸不得少于0.18mg·g-1。结论:本试验完善了马奶子葡萄干的质量标准,为保证其临床应用的安全性和可控性奠定了基础。

OBJECTIVE：To set up the quality standard of Manaizi raisin,and to provide scientific basis for the utilization and development of medicinal plant resources.METHODS：Original plant of Manaizi raisin was identified;microscopic identification was conducted for powder;using oleanolic acid as control,TLC of it had been established;the residual quantity of impurity,moisture,total ash,sour insoluble ash,heavy metal,harmful elements and organic chlorine pesticide in 10 batches of Manaizi raisin were determined according to Chinese Pharmacopeia.The content of oleanolic acid in Manaizi raisin was analyzed by HPLC.RESULTS：TLC of test sample showed same color spot to that of oleanolic acid control at the same position.The limits of detection index were determined for Manaizi raisins provisionally.The linear range of oleanolic acid was 0.06～0.48 mg·mL-1（r=0.999 9） with an average recovery of 99.17% （RSD=1.76%,n=6）.According to results of content determination,the content of oleanolic acid would be no less than 0.18 mg·g-1.CONCLUSION：The established quality standard lays foundation for the safety and controllability of clinical use of Manaizi raisin.