消疹止痒胶囊的质量标准研究.docVIP

消疹止痒胶囊的质量标准研究 红梅1，王栋2，张勇1*，包丽丽1（010010 呼和浩特，内蒙古自治区人民医院1；内蒙古食品药品检验所2） 【摘要】 目的：建立消疹止痒胶囊的质量标准。方法：采用薄层色谱法（thin layer chromatography,TLC）对方中的诃子、麻黄进行定性鉴别，采用高效液相色谱法（HPLC）测定川芎中的阿魏酸的含量。结果：该鉴别方法专属性强，薄层色谱斑点清晰，阴性对照无干扰；阿魏酸的HPLC色谱峰与其他色谱峰分离良好，进样量在0.0538μg～ 0.3228μg范围内呈良好线性关系（r=0.9999），平均加样回收率为100.30%，RSD=0.96%（n=9）。结论：本方法简便、准确、重现性好，可作为消疹止痒胶囊的质量控制方法。 【关键词】消疹止痒胶囊；阿魏酸；薄层色谱法；高效液相色谱法；质量标准 Studies on the Quality standards of xiaozhenzhiyang Capsules Hong Mei1, Wang Dong2, Zhang Yong1, Bao Lili1 (Department of pharmacy, Mongola Hospital, Mongola for Food and Drug control, Huhhot, 010010, China) [Abstract]Objective: To establish the quality standards of xiaozhenzhiyang capsules. Methods: Thin layer chromatography (TLC) was used for qualitative identification of chebula Fructus, Ephedrae Herbap; The content of Ferulic acid from chuanxiong Rhizoma was determined by HPLC. Results: The identification method was highly specific with clear TLC spots. The negative control did not impose any disturbance. In HPLC, the chromatographic peah of ferulic acid was well isolated from othe peahs. There was a good linear relationship between the sample size and the peak area of piperine in a range of 0.0538μg - 0.3228μg(r=0.9999). The average recovery of ferulic acid was 100.30%(n=9), RSD=0.96%. Conclusion: The method is simple accurade and good reproducibility. lt can be used for the quality control of [基金项目] 内蒙古科技厅计划项目 （ *[通信作者] 张勇，电话：（0471）6620289； Email:zyong69@126.com xiaozhenzhiyang capsules. [Key words]xiaozhezhiyang capsules; Ferulic acid; thin layer chromatography; high performance liquid chromatography; quality standard 急慢性荨麻疹是皮肤出现风团，时隐时现，伴有瘙痒反复发作的一种皮肤病，属于中医风疹块、隐疹等范畴，为过敏性皮肤疾患。随着社会现代化进程的加速，微生物、物理、化学、精神、内分泌失调等致病因素，使本病发病率逐年增加。目前临床用药，西药多采用祛除病因、抗组胺药、皮质激素、钙剂、拟肾上腺素药等治疗，但疗效并不十分理想，并有一定副作用，且易复发[1][2]；中医药通过调节整体功能，提高机体自身免疫力往往能够收到显著疗效[3]，目前国内外运用纯中药制剂治疗此类疾病的药品尚少见。消疹止痒胶囊是由川芎、生地、桑白皮、地骨皮、白鲜皮、麻黄、蝉蜕、诃子等八位中药组成，具有养血疏风、清热止痒之功效。该方为我院名老中医李凤林的经验