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目的:建立盐酸小檗碱片体外溶出行为的原位、在线分析方法。方法:用自制六通道紫外光纤传感仪与溶出仪联用,在线监测盐酸小檗碱片溶出度。结果:方法的回收率95.8%~101.9%,日内、日间精密度均小于5%。盐酸小檗碱片的溶出参数与中国药典方法对照差异无显著性。结论:本法无需取液、稀释等手工操作,能反映药物溶出全过程,为药物内在质量的检测提供良好的手段。
Objective: To establish an in-situ and on-line analytical method for in vitro dissolution of berberine hydrochloride tablets. Methods: The self-made six-channel UV optical fiber sensor was used in conjunction with the dissolution apparatus to monitor the dissolution of berberine hydrochloride tablets online. Results: The recoveries of the method ranged from 95.8% to 101.9%. The intra-day and inter-day precision were less than 5%. Berberine hydrochloride tablets dissolution parameters and Chinese Pharmacopoeia control method was no significant difference. Conclusion: This method does not need to take liquid, dilution and other manual operations, can reflect the whole process of drug dissolution, provide a good means for the detection of drug intrinsic quality.