龟茸壮骨片质量标准提升研究  

Improvement of Quality for Guirong Zhuanggu Tablets

作　　者：高英鑫 徐伟[1] 张衍旭 王野谌 张雷 祝雨婕 董雪莲[1] Gao Yingxin;Xu Wei;Zhang Yanxu;Whang Yechen;Zhang Lei;Zhu Yujie;Dong Xuelian(Changchun University of Chinese Medicine,Changchun 130117,China;Jilin Zhongyan Pharmaceutical Co.Ltd,Changchun 130062,China)

机构地区：[1]长春中医药大学,吉林长春130117 [2]吉林省中研药业有限公司,吉林长春130062

出　　处：《亚太传统医药》2022年第11期54-58,共5页Asia-Pacific Traditional Medicine

基　　金：吉林省科技发展计划(20190304104YY;20200602034ZP)。

摘　　要：目的:为提升龟茸壮骨片的质量标准提供参考,为中老年人辅助治疗筋骨痿软提供安全保障。方法:按2020版《中国药典》相关药材项下鉴别方法,采用薄层色谱法(TLC)对龟茸壮骨片中续断和补骨脂进行鉴别;采用高效液相色谱法(HPLC-DAD)同时测定补骨脂中的补骨脂素、异补骨脂素和骨碎补中的柚皮苷。结果:在薄层鉴别中供试品与之相对照的药材及成分均在相应的位置上显相同颜色的斑点,专属性好;柚皮苷在0.023 292~0.465 836mg/mL与峰面积呈良好的线性关系(r=0.999 7),平均回收率100.16%,RSD为2.15%,5批含量范围为0.988 5~1.339 5mg/g;补骨脂素在0.004 915~0.108 123mg/mL与峰面积呈良好的线性关系(r=0.999 8),平均回收率98.92%,RSD为2.29%,5批含量范围为0.322 7~0.415 8mg/g;异补骨脂素在0.005 059~0.101 189mg/mL范围内与峰面积呈良好的线性关系(r=0.999 4),平均回收率102.59%,RSD为1.80%,5批含量范围为0.280 6~0.619 3mg/g。结论:所建龟茸壮骨片中续断、补骨脂的薄层鉴别方法和补骨脂素、异补骨脂素、柚皮苷3个成分的含量测定方法,重复性好,薄层方法专属性较高,可用于龟茸壮骨片的质量控制。Objective:It provides a reference for improving the quality standard of Guirong Zhuanggu Tablets,and provides safety guarantee for the auxiliary treatment of muscle and bone atrophy for middle-aged and elderly people.Methods::According to the identification method under the relevant medicinal materials of the Chinese Pharmacopoeia of the2020edition,thin-layer chromatography(TLC)is used to identify the Dipsaci and Psoralen;high-performance liquid chromatography(HPLC)is used to simultaneously determine the content of Psoralen,Isopsoralen in Psoralen And Naringin in Drynaria fortunei.Results:In Guirong Zhuanggu Tablets Dipsacus and Psoralen TLC,the position of response to the reference materials of Dipsacus saponins,Psoralen,Isopsoralen,Dipsacus and Psoralen control medicinal materials Spots with the same color on the top have good specificity;Naringin has a good linear relationship with the peak area at 0.023 292~0.465 836mg/mL(r=0.999 7),the average recovery rate is 100.16%,the RSDis 2.15%,and the content range of 5batches It is 0.988 5~1.339 5mg/g;Psoralen has a good linear relationship between 0.004 915~0.108 123mg/mL and the peak area(r=0.999 8),the average recovery rate is 98.92%,RSDis 2.29%,and the content range of 5batches is 0.322 7~0.415 8mg/g;Isopsoralen in 0.005 059~0.101 189mg/mL has a good linear relationship with the peak area(r=0.999 4),the average recovery rate is 102.59%,the RSDis 1.80%,and the content range of 5batches is 0.280 6~0.619 3mg/g.Conclusion:The thin-layer identification method of Dipsacus and Psoralen in Guirong Zhuanggu Tablets and the determination method of psoralen,isopsoralen and naringin were successfully established,with good repeatability.The thin-layer method is highly specific and can be used for quality control of tortoise and bone-strengthening tablets.

关 键 词：龟茸壮骨片 续断 补骨脂 薄层鉴别 高效液相色谱法 柚皮苷 含量测定 质量标准 提升 

分 类 号：R284.1[医药卫生—中药学]