膝可保胶囊质量标准分析与研究

Quality standard analysis and research for Xikebao capsules

目的：建立膝可保胶囊的质量标准。方法：采用薄层色谱法对膝可保胶囊中秦皮、龙血竭药材进行鉴别;采用高效液相色谱法对膝可保胶囊中芍药苷、秦皮甲素、秦皮乙素进行含量测定。结果：薄层色谱专属性强,分离度高,阴性对照无干扰;高效液相色谱法测得秦皮甲素、秦皮乙素、芍药苷分别在0.123 6~0.865 2μg（r=0.999 6）,0.075 9~0.531 3μg（r=0.999 6）,0.060 6~1.515 0μg（r=0.9995）范围内进样量与峰面积呈良好的线性关系,平均加样回收率分别为98.85%,98.41%,99.59%,RSD分别为1.89%,1.91%,1.28%。结论：所建立的定性、定量方法操作简便,结果准确,重现性好,能够有效控制膝可保胶囊的质量。

OBJECTIVE To establish quality standard of Xikebao capsules. METHODS Contents of Fraxinus rhynchophylla Hance and Resina draconis in Xikebao capsules were identified by TLC method, and comprehensive contents of paeoniflorin, aesculin and aesculetin in capsules were determined by HPLC method. RESULTS TLC methods established had high specificity and high degree of separation,without interference by negative control. Aesculin, aesculetin and paeoniflorin had good linearity within range of 0.1236 - 0. 8652μg （r = 0.9996）,0.0759- 0.531 3μg （r= 0.9996） and 0.0606 - 1.515μg （r = 0. 999 5） ,respectively. Average recovery and RSD were 98. 85% （RSD= 1.89%） ,98. 41%（ RSD= 1.91%） and 99. 59%（ RSD = 1.28%）, respectively. CONCLUSION Established qualitative and quantitative methods are simple, accurate and reproduci- ble,which can be used for quality control of Xikebao capsules.