山七降脂通脉胶囊中三七、石菖蒲的显微鉴别及质量评价  

Microscopical Identification and Quality Evaluation of ShanQi JiangZhi TongMai Capsules

作　　者：李旭桂[1] 林晓春[1] 刘萌 郑锦坤[1] 李庆德[1] LI Xu-gui;LIN Xiao-chun;LIU Meng;ZHENG Jin-kun;LI Qing-de(Yuebei People's Hospital,Sha-oguan 512025,China;Shaoguan Institute for Food and Drug Control,Shaoguan 512025,China)

机构地区：[1]粤北人民医院,广东韶关512025 [2]韶关市食品药品检验所,广东韶关512025

出　　处：《海峡药学》2021年第5期52-54,共3页Strait Pharmaceutical Journal

基　　金：2019年广东省中医药局面上科研项目(20191325)。

摘　　要：目的建立山七降脂通脉胶囊处方中三七、石菖蒲的显微鉴别规范并对制剂进行质量评价。方法采用60目药筛过筛山七降脂通脉胶囊内容物,混匀过筛后的粉末、水合氯醛透化,并用稀甘油封藏,放置在显微镜下观察、鉴别;按药典胶囊剂检查项,测定山七降脂通脉胶囊的水分、装量差异、崩解时限。结果显微镜下,可见树脂道碎片含黄色分泌物、梯纹导管、网纹导管及螺旋导管直径15~55μm、草酸钙簇晶等三七显微特征;显微镜下,见纤维束周围细胞中含草酸钙方晶,形成晶纤维。分泌细胞呈圆形或长圆形,胞内充满黄绿色、橙红色或红色分泌物等石菖蒲鉴别特征;制剂质量评价中,三个批次的山七降脂通脉胶囊水分、装量差异、崩解时限符合限定技术要求。结论建立了山七降脂通脉胶囊中三七、石菖蒲的显微鉴别方法,且胶囊检查项符合药典要求。OBJECTIVE To establish microscopical identification standards and evaluate the formula′s quality of San qi and Grassleaf Sweetflag Rhizome in ShanQi JiangZhi TongMai Capsules.METHODS Contents of ShanQi JiangZhi TongMai Capsules are put on 60 mesh sieve.Sieved powders are permeated by chloral hydrate, sealed up with dilute glycerin and observed under microscope.According to Chinese Pharmacopoeia, moisture, packing difference, disintegration time were tested.RESULTS Microscopical identification features of Sanqi including Resin duct cracks with yellow exudation, ladder vessel, venticualte vessel, spiral vessel(15-55 μm) and clusters of calcium oxalate were observed.Microscopical identification features of Grassleaf Sweetflag Rhizome including crystal fiber formed by calcium oxalate square crystal in peripheral cells and secretory cells full of yellow green, orange red or red exudation were observed.During quality evaluation, 3 batchs of ShanQi JiangZhi TongMai Capsules′ moisture, packing difference, disintegration time met the limited technical requirements.CONCLUSION Microscopical identification standards of San qi and Grassleaf Sweetflag Rhizome in ShanQi JiangZhi TongMai Capsules were established and capsules test results were consistent with the requirements of Chinese Pharmacopoeia.

关 键 词：山七降脂通脉胶囊 三七 石菖蒲 显微鉴别 质量评价 

分 类 号：R927[医药卫生—药学]