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抗口腔溃疡炎膜剂的制备及质量控制
引用本文:何心,王帆,杨大伟,孙照英,张闯.抗口腔溃疡炎膜剂的制备及质量控制[J].中国药房,2010(17):1582-1583.
作者姓名:何心  王帆  杨大伟  孙照英  张闯
作者单位:[1]黑龙江省医院药学部,哈尔滨市150036 [2]黑龙江中医药大学,哈尔滨市150040
基金项目:哈尔滨市科技创新人才研究专项基金资助项目(2008RFXQS035)
摘    要:目的:制备抗口腔溃疡炎膜剂并建立其质量标准。方法:先制备含药胶浆和空白胶浆再制备成复合膜剂;应用高效液相色谱法对制剂中靛玉红进行定量分析。结果:制备的膜剂外观均一性良好,各项检测指标符合《中国药典》相关规定;靛玉红检测浓度线性范围为0.8~6.4μg·mL-(1r=0.9998);平均回收率为100.65%(RSD=1.07%,n=6)。结论:所制膜剂处方合理、制备方法简单可行,含量测定方法准确可靠。

关 键 词:抗口腔溃疡炎膜剂  靛玉红  制备  质量控制  高效液相色谱法

Preparation and Quality Control of Anti-inflammatory Dental Ulcer Film
HE XinDept. of Pharmacy,Heilongjiang Provincial Hospital,Harbin,China WANG Fan,YANG Da-wei,SUN Zhao-ying,ZHANG Chuang.Preparation and Quality Control of Anti-inflammatory Dental Ulcer Film[J].China Pharmacy,2010(17):1582-1583.
Authors:HE XinDept of Pharmacy  Heilongjiang Provincial Hospital  Harbin  China WANG Fan  YANG Da-wei  SUN Zhao-ying  ZHANG Chuang
Institution:(Heilongjiang University of Traditional Chinese Medicine, Harbin 150040, China)
Abstract:OBJECTIVE: To prepare anti-inflammatory dental ulcer film and establish its quality standard. METHODS: Drug-containing mortar and blank mortar were prepared to prepare compound film agent. HPLC was used to the quantitative analysis of indirubin. RESULTS: The preparation had well appearance and its detection of index was up to the standard stated in Chinese Pharmacopeia. The linear range of indirubin was 0.8~6.4 μg·mL-1 (r=0.999 8) with an average recovery rate of 100.65% (RSD=1.07%,n=6). CONCLUSION: The formula of preparation is reasonable, the preparation method is simple and applicable and determination method is accurate and reliable.
Keywords:Anti-inflammatory dental ulcer film  Indirubin  Preparation  Quality Control  HPLC method
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