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津力糖平片对照品溶液稳定性的研究
引用本文:孙琳琳,王海亮,张静,马艳玲.津力糖平片对照品溶液稳定性的研究[J].中国医院用药评价与分析,2014(10):873-875.
作者姓名:孙琳琳  王海亮  张静  马艳玲
作者单位:石家庄以岭药业股份有限公司,石家庄,050035
基金项目:石家庄市科技支撑计划-津力糖平片治疗2型糖尿病的开发研究
摘    要:目的:探讨津力糖平片检验用葛根素对照品溶液的保存条件和有效期,规范中药检验对照品的管理。方法:按照《中华人民共和国药典:一部》中药的薄层色谱法对葛根素对照品溶液进行薄层成像实验,比较不同时间、不同保存条件下不同质量浓度对照品溶液的成像效果。结果:葛根素溶液最佳保存时间为配制后270d内,高浓度对照品溶液(10mg/ml)成像效果更好,常温和冷藏(2—8℃)保存对实验结果无影响。结论:本研究为中药对照品保存期限设定和标准化管理提供了一定依据,有利于减少葛根素对照品的损耗、节约药品检验成本。

关 键 词:葛根素  对照品  薄层色谱法

Stability of the Reference Solution of Jinlitangping Tablets
SUN Lin-lin,WANG Hai-liang,ZHANG Jing,MA Yan-ling.Stability of the Reference Solution of Jinlitangping Tablets[J].Evaluation and Analysis of Drug-Use in Hospital of China,2014(10):873-875.
Authors:SUN Lin-lin  WANG Hai-liang  ZHANG Jing  MA Yan-ling
Affiliation:SUN Lin-lin;WANG Hai-liang;ZHANG Jing;MA Yan-ling;Shijiazhuang Yiling Pharmaceutical Co.Ltd.;
Abstract:OBJECTIVE : To study the storage and validity of puerarin solution as reference for testing Jinlitangping tablets so as to standardize the management of the reference substance of traditional Chinese medicine. METHODS: The imaging test of puerarin reference solution was performed by thin-layer chromatography (TLC) in accordance with the Pharmacopoeia of People's Republic of China(volume Ⅰ ) with imaging results of the reference solutions stored in different condition at different time and difference mass concentration compared. RESULTS: The optimal storage period of the puerarin reference solution was within 270 days after preparation. The reference solution at high concentration of 10 mg/ml showed better imaging results. Storage under room temperature or cold storage of puerarin solution showed no influence on its test resuhs. CONCLUSIONS: The study serves as reference for the setting of storage life and standardizes management of the reference substance of traditional Chinese medicine, which may help reduce the waste of the puerarin reference solution as well as the cost of drug test.
Keywords:Puerarin  Reference substance  Thin-layer chromatography
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