桂蓉胶囊的质量标准研究  

Study on the quality standard for Guirong Capsules

作　　者：沈怡萱 何悦 肖会敏 邢建峰[1] SHEN Yixuan;HE Yue;XIAO Huimin;XING Jianfeng(School of Pharmacy,Xi′an Jiaotong University,Xi′an 710061,China;Department of Pharmacy,Northwest Women and Children′s Hospital,Xi′an 710061,China;Department of Chinese Materia Medica and Natural Medicines,Air Force Medical University,Xi′an 710032,China)

机构地区：[1]西安交通大学药学院,西安710061 [2]西北妇女儿童医院药剂科,西安710061 [3]空军军医大学中药与天然药物教研室,西安710032

出　　处：《西北药学杂志》2019年第6期719-723,共5页Northwest Pharmaceutical Journal

基　　金：陕西省重点研发计划项目(编号:2017SF-296)

摘　　要：目的建立桂蓉胶囊的质量标准。方法使用TLC法对桂蓉胶囊中的牡丹皮、枸杞、干姜及肉桂进行定性鉴别;使用HPLC法测定桂蓉胶囊中桂皮醛与丹皮酚的含量,使用Kromasil C 18色谱柱(250 mm×4.6 mm,5.0μm);以乙腈-1.0 g·L^-1醋酸溶液(25∶75)为流动相进行梯度洗脱;检测波长为280 nm。结果制剂中肉桂、枸杞、干姜及牡丹皮的TLC鉴别专属性较好。桂皮醛和丹皮酚的线性方程分别为y 1=116144 x 1+47962(r 1=0.9999)和y 2=50036 x 2+3762(r 2=0.9998);桂皮醛和丹皮酚分别在8.42~280.59和2.29~76.23μg·mL^-1范围内线性关系良好。桂皮醛和丹皮酚的平均加样回收率分别为97.78%和98.30%;RSD值分别为1.47%和0.83%。3批制剂中桂皮醛和丹皮酚的平均含量分别为4.66和3.11 mg·g^-1,RSD值分别为0.65%和0.99%。结论建立的标准科学、合理,可用于该制剂的质量控制。Objective To establish and study the quality standard for Guirong Capsules.Methods Paeonia suffruticosa Andr.,Lycium barbarum L.,Zingiber officinale Rose.and Cinnamomum cassia Presl in the preparation were identified by TLC,respectively.And HPLC was used to determine the contents of cinnamaldehyde and paeonol.The analytical column was Kromasil C 18 column(250 mm×4.6 mm,5.0μm).The mobile phase was composed of acetonitrile-1.0 g·L^-1 acetic acid(25∶75)in gradient elution,and the detection wavelength was set at 280 nm.Results The TLC of Paeonia suffruticosa Andr.,Lycium barbarum L.,Zingiber officinale Rose.and Cinnamomum cassia Presl have good specificities,respectively.Cinnamaldehyde regression equation was y 1=116144 x 1+47962(r 1=0.9999)in the concentration range of 8.42-280.59μg·mL^-1,and average recovery was 97.78%,and its RSD was 1.47%.Paeonol regression equation was y 2=50036 x 2+3762(r 2=0.9998)in the concentration range of 2.29-76.23μg·mL^-1,and average recovery was 98.30%,and its RSD was 0.83%.And the cinnamaldehyde and paeonol contents and their RSD values in 3 batchs of preparations were 4.66 mg·g^-1 and 0.65%,3.11 mg·g^-1 and 0.99%,respectively.Conclusion The standard established by the above method is scientific and rational,and can be used as the preparation′quality control method.

关 键 词：桂蓉胶囊 桂皮醛 丹皮酚 质量标准 HPLC法 TLC法 

分 类 号：R282[医药卫生—中药学]