清咽胶囊质量标准研究  

Study on Quality Standard of Qingyan Capsules

作　　者：卢华[1] 李修善 陈英[1] 郭炎荣[1] 

机构地区：[1]广西壮族自治区人民医院,广西南宁530021 [2]广西万寿堂药业有限公司,广西南宁530219

出　　处：《中国药业》2006年第12期16-18,共3页China Pharmaceuticals

摘　　要：目的建立清咽胶囊的质量标准。方法用薄层色谱法(TLC法)对处方中穿心莲、栀子、墨旱莲等进行定性鉴别;用高效液相色谱法(HPLC法)对处方中穿心莲的有效成分穿心莲内酯和脱水穿心莲内酯进行含量测定,选用ReliesilC18柱(250mm×4.6mm,5μm),流动相为甲醇-水(65∶35),检测波长为250nm。结果该产品定性鉴别薄层色谱特征明显,专属性强;穿心莲内酯含量测定的线性范围为0.084～0.756μg(r=0.9999),平均回收率为97.5%(RSD=2.26%,n=5),脱水穿心莲内酯含量测定的线性范围为0.036～0.324μg(r=0.9998),平均回收率为100.1%(RSD=0.86%,n=5)。结论鉴别和含量测定方法准确可行,重现性好,可有效地控制清咽胶囊的质量。Objective To establish the quality standard of Qingyan capsules. Methods The Andrographis paniculata, Ecliptaprostratal and Fructus Gardeniae were determined by TLC. The quantitative analysis of Andrographis paniculata. Andrographolide and dehydroandrographolide which were effective composition in Andrographis paniculata was made using HPLC. Reliesil C,8 column（250 mm×4. 6 mm, 5μm） was used. The mobile phase consisted of methanol- water（65 ： 35） and the measuring wavelength was 250 nm. Results This method had speciality with TLC. Linear range of andrographolide was 0. 084 -0. 756 μg（ r =0. 999 9）. The average recovery rate was 97.5% , RSD =2.26%. Dehydroandrographolide was 0. 036 - 0. 324 μg（ r = 0. 999 8） by HPLC, The average recovery rate was 100, 1%, RSD = 0. 86%. Conclusion The methods of identification and quantification are accurate, realizable and reproductable. It can be used effectively for the quality control of Qingyan capsules.

关 键 词：清咽胶囊 穿心莲 穿心莲内酯 脱水穿心莲内酯 薄层色谱 高效液相色谱 

分 类 号：R284.1[医药卫生—中药学] R286.0[医药卫生—中医学]