痛得安散质量标准提高研究  

Quality Standard Improvement of Tongdean Powder

作　　者：陈旭[1] 董晖 范寅根[1] 宋洪涛[1] 

机构地区：[1]南京军区福州总医院药学科,福建福州350025 [2]北部战区空军参谋部门诊部,辽宁沈阳110015

出　　处：《解放军药学学报》2016年第2期134-137,共4页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：军队医疗机构制剂标准提高科研专项重点课题;No.14ZJZ17

摘　　要：目的研究痛得安散质量控制方法,以提高其质量标准。方法在原标准的基础上增加了痛得安散中羌活、丹参的TLC鉴别,改进了延胡索、黄芩、苍术的色谱条件;采用HPLC法对苍术素进行含量测定。结果 TLC法鉴别专属性强;HPLC法测得苍术素在2.0~24μg·mL^-1范围内线性关系良好（r=0.9999）,平均回收率为100.81%,RSD为1.67%（n=9）。结论本方法操作简单,结果准确,灵敏度高,重复性好;该质量标准可有效地控制痛得安散的质量。Objective To eatablish a quality control method of Tongdean powder in order to improve the quality standard. Methods TLC indentification of Notopterygii Rhizoma et Radix and Salviae Miltiorrhizae Radix et Rhizoma was added based on the original standard,and the TLC conditions were improved for Corydalis Rhizoma,Scutellariae Radix and Atractylodis Rhizoma. Atractylodin content was determined by HPLC. Results TLC identification was highly specific and the spots were clear. The linear range of atractylodin was 2. 0-24. 0 μg·mL^-1,r =0.9999. The average recovery of atractylodin was 100. 81% with an RSD of 1. 67%（ n =9）. Conclusion This method is easy to operate with accurate results,high sensitivity and good reproducibility. This quality standard can effectively control the quality of Tongdean powder.

关 键 词：痛得安散 质量标准 TLC HPLC 苍术素 

分 类 号：R927[医药卫生—药学]