调中生血胶囊制备和质量标准研究.docVIP

调中生血胶囊制备和质量标准研究 　　?摘 要 目的：制备调中生血胶囊，建立调中生血胶囊（陈皮、降矾）的质量控制标准，并考察制剂的稳定性。方法：将处方中的生药进行处理后制成硬胶囊剂。采用化学方法鉴别降矾，TLC法鉴别陈皮，HPLC法测定陈皮中有效成分橙皮苷的含量，并进行初步稳定性考察。结果：降矾和陈皮鉴别方法，专属性强，重现性好，空白无干扰。橙皮苷含量测定方法，在0.119 75～3.097 5 μg进样量范围内，线性关系良好，r＝0.999 9；平均回收率为100.04％，RSD＝0.29％（n＝6）。考察3个月，稳定性良好。结论：本研究中建立的定性定量方法操作简便，专属性强，准确可靠，可以有效控制调中生血胶囊质量。? 　　关键词 陈皮 降矾 橙皮苷 HPLC 初步稳定性 ? 　　中图分类号：R917 文献标识码：B 文章编号：1006-1533(2007)09-0419-03? 　　Study on the preparation and quality standard control of Tiaozhong Shengxue Capsule? 　　Xu Lingling, Wang Ling, Guo Taoying, He Xianping? 　　(Department of Pharmacy, Yueyang Hospital of Chinese Integrative Medicine, ?Shanghai University of Traditional Chinese Medicine, Shanghai,200437) 　　? 　　ABSTRACT Objective: 　　To prepare Tiaozhong Shengxue Capsule and establish the quality control standard for Tiaozhong Shengxue Capsule (Pericarpium Citri Reticulatae and Jiangfan) and investigate the stability of the preparation. Methods: The crude drugs in the prescription was made into hard gelatin capsule. Jiangfan was identified by chemical method. Pericarpium Citri Reticulata was identified by TLC method. The content of hesperidin, an active component of Pericarpium Citri Reticulata, was determined by HPLC method. The primary stability of the preparation was investigated. Results: The method for identification of Pericarpium Citri Reticulatae and Jiangfan had good specificity and repeatability. There was no interference in blank control. The hesperidin determination method had good linearity from 0.119 75 to 3.097 5 μg (r=0.999 9) when the quantity in sampling was at the mug level. The mean recovery rate was 100.04% and the relative standard deviation (RSD) was 0.29% (n=6). The results of the 3 months investigation showed that primary stability was satisfactory.Conclusion: The qualitative and quantitative method is simple, specific, accurate and reliable. It can be used to effectively control the quality of Tiaozhong Shengxue Capsule.? 　　KEY WORDSPericarpium Citri Reticulatae