咳喘停合剂长期稳定性研究  

Studies on the Long-Term Stability of the Kechuanting Oral Compound Solution

作　　者：马梦黎[1] 庄彦[1] 侯跃华[1] 文金隆[1] 孙娇[1] 陈建芬[1] 吴曦[1] MA Mengli ZHUANG Yan HOU Yuehua WEN Jinlong SUN Jiao CHEN Jianfen WU Xi(Yuxi Municipal Hospital of TCM, Yuxi 653100, China)

机构地区：[1]云南省玉溪市中医医院,云南玉溪653100

出　　处：《中国民族民间医药》2017年第2期17-19,共3页Chinese Journal of Ethnomedicine and Ethnopharmacy

摘　　要：目的:根据获批的质量标准和药典规定,对咳喘停合剂进行长期稳定性考察。方法:采用薄层色谱法对咳喘停合剂中主药的有效成分靛玉红、黄芩苷进行薄层定性鉴别,结合pH、相对密度、微生物限度等检测,进行长期稳定性实验。结果:咳喘停合剂在规定时间检测,与对应对照品相应的位置上均显相同颜色的斑点,pH、相对密度、微生物限度等均符合规定。结论:在现有生产工艺控制下,咳喘停合剂保存两年质量稳定。Objective The stability of the Kechuanting oral compound solution in specified temperature was investigated according to the approved quality standard and Chinese pharmacopoeia.Methods The indirubin and baicalin in the main active ingredients of the Kechuanting oral compound solution were detected by layer chromatography （TLC）and the pH value,relative density,microbial limit were measured according to the guidance of China Pharmacopoeia for long-term stability test.Results Within the prescribed time,the spots of the Kechuanting oral compound solution in the chromatogram of the test solution corresponding to the position to the each refer-ence substance had the same color.The pH value,relative density and microbial limit were qualified.Conclusion The quality of the Kechuanting oral compound solution under the existing production process control is stable in two years.

关 键 词：咳喘停合剂 长期稳定性 质量标准 

分 类 号：R283[医药卫生—中药学]