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熊胆注射液质量标准的研究 被引量:1

The Study of Bear Gallbladder Injection and Its Quality Control
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摘要 目的制备熊胆注射液,探讨熊胆注射液的质量标准。方法采用高效液相色谱法(HPLC法),以乙腈-甲醇-0.3mol/LNaH2PO4缓冲液(15∶60∶25)为流动相;检测波长205nm,测定熊胆注射液中有效成分熊去氧胆酸(UDCA)的含量。结果UDCA在19.24~96.20μg之间峰面积与其量呈良好的线性关系,平均回收率为99.35%,RSD为0.31%。结论熊胆注射液符合医院制剂规范,质量控制标准方法简便、快捷、准确、可靠。 Objective To study on the method of preparing bear gallbladder injection and to discuss its quality control. Methods The content of effective constitiuent (UDCA) in the bear gallbladder injection was tested by using the HPLC(the buffer solution was 0,3mol/ LNaH2PO4 ; mobile phase was (15:60:25) ; detecdng wavelength was 205nm. Result The peak area and its content of UDCA presented a good linear relation between 19,24-96.20ug and the average recovery rate was 99.35%, RSD was 0,31%. Conclusion The bear gallbladder injection can be used in clinic since it meets the pharmaceutical dosage needs in hospital and the quality control method is simple, quick, accurate and reliable.
出处 《特产研究》 2007年第2期8-9,共2页 Special Wild Economic Animal and Plant Research
关键词 熊胆注射液 制备 质量标准 HPLC UDCA Bear gallbladder injection Preparation Quality control HPLC UDCA
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