光纤药物溶出仪实时监测不同厂家盐酸多塞平片溶出度 |
| 候海玲 周刚 李旭扬 |
| 内蒙古自治区药品检验研究院，内蒙古呼和浩特，010020 |
| 摘要：目的 采用光纤药物溶出度实时测定仪考察国内9 家不同企业生产的盐酸多塞平片的体外溶出曲线，比较其内在质量差异，分析现行溶出度方法的质量可控性，为进一步加强药品质量控制提供思路，为合理制定溶出度方法与限度提供依据。方法 桨法，测定波长292nm，温度37℃，转速50r·min-1，监测时间90min，分别在不同的溶出介质中，用光程为5mm 光纤探头监测盐酸多塞平片的溶出曲线。结果 经检验9 个厂家溶出度均符合《中国药典》2020 年版规定，但溶出曲线差异很大，可见各厂家生产工艺差距较大。结论 光纤传感药物溶出仪具有实时连续、操作简便等特点，是一种过程分析仪器，可用于评价固体制剂溶出差异。 |
| 关健词：盐酸多塞平片；光纤药物溶出度实时测定仪；溶出度 |
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| Fiberoptic drug dissolution apparatus for real-time monitoring of the dissolution degree of hydrochloride prazosin tablets from different manufacturers |
| Hailing Hou Gang Zhou Xuyang Li |
| Inner Mongolia Institute of Drug Laboratory, Hohhot 010020, China |
| Abstract：Objective To investigate the in vitro dissolution profiles of doxepin hydrochloride tablets produced by 9 different domestic enterprises using a fiber optic real-time dissolution tester, compare their intrinsic quality differences, analyze the quality controllability of the current dissolution method, and provide ideas for further strengthening drug quality control as well as a basis for rationally formulating dissolution methods and limits.Methods The paddle method was adopted, with a detection wavelength of 292 nm, temperature of 37℃, rotation speed of 50 r·min?1, and monitoring time of 90 min. The dissolution profiles of doxepin hydrochloride tablets were monitored using a 5-mm optical path fiber optic probe in different dissolution media.Results The dissolution rates of products from all 9 manufacturers met the requirements specified in the Chinese Pharmacopoeia (2020 edition), but there were significant differences in the dissolution profiles, indicating considerable gaps in production processes among different manufacturers.Conclusion The fiber optic sensing drug dissolution tester, characterized by real-time continuity and simple operation, is a process analysis instrument that can be used to evaluate dissolution differences of solid preparations. |
| Keywords：Doxepin Hydrochloride Tablets; fiber optic real-time dissolution tester; dissolution rate |
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