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USP盐酸米诺环素溶出度测定 已有1人参与
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如题，对于USP盐酸米诺环素溶出度项下计算想跟各位同仁讨论一下。 药典原文涉及计算部分的摘录如下： Standard stock solution: 0.11 mg/mL of USP Minocycline Hydrochloride RS in Medium Standard solutions: Dilute the Standard stock solution with Medium to obtain solutions with final concentrations of 0.088 mg/mL, 0.0528 mg/mL, 0.0352 mg/mL, 0.022 mg/mL, and 0.0176 mg/mL. Sample solution: dissolution solution Injection size: 20 μL for the 4 and 24 h time points; 50 μL for the 48 and 72 h time points Analysis: Construct a calibration curve for each sampling interval by plotting the concentration of the Standard solutions versus peak area. Calculate the slopes and y-intercepts using linear regression analysis. Calculate the release rate of minocycline: Resulti = [(rUi − yi)/Si] × 10/( i × W × A) i =sampling time, 4, 24, 48, 72 h rUi=peak response from each of the Standard solutions at time i yi =y-intercept of the calibration curve at sampling time i Si =slope of the calibration curve at sampling time i W =weight of the sample (mg) A =amount of minocycline in the sample (mg/mg of sample) as determined in the Assay 说明：溶出介质体积10ml， Tolerances Time (h) Release Rate (μg/h) Average of 6 Measurements 0–4 NLT 25 4–24 NLT 1.0 24–48 NLT 0.2 48–72 NLT 0.05 具体溶出内容与计算相关性不大，未摘录，如有需要可以提供。 问题：1 按照说明，计算公式与i时间的溶出液没有关系吗？（溶出的样品溶液，Sample solution没参与计算）； 2 如果公示中rUi写错，实为Sample solution的峰面积，这个计算最后的单位也无法得到ug/h? 3 不同时间进样体积不一致，这种不一致也未在计算公式中体现出来。 本人非常困惑，还请广大同仁指点指点，谢谢。 |
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2楼2021-08-11 14:44:27
