塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.711465306146471114656881465928146576914654800.04
29.771463967146362114637940.02
单位质量响应值RSD%判断
150924.82149825.380.52数据可信
供试品溶液-2023010711批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1126039-1260398.3488.2011.378.358.2011.35
2120769-1207697.9998.00
3100965-1009656.6876.69
4134712-1347128.9238.92
5118696-1186967.8627.86
6141330-1413309.3619.36
10min1346194-34619422.93022.638.9622.9422.648.96
2329711-32971121.83821.85
3288450-28845019.10619.12
4377367-37736724.99525.01
5346969-34696922.98222.99
6361190-36119023.92423.94
15min1564301-56430137.37737.157.6337.4237.207.63
2543358-54335835.98936.03
3488540-48854032.35932.40
4616710-61671040.84840.90
5577203-57720338.23138.28
6575292-57529238.10538.15
20min1766995-76699550.80250.616.3650.9150.726.36
2742310-74231049.16749.27
3684103-68410345.31245.40
4830037-83003754.97855.09
5783934-78393451.92452.03
6777338-77733851.48751.59
30min11090851-109085172.25372.114.0272.4372.284.02
21080994-108099471.60071.77
31012493-101249367.06367.22
41146444-114644475.93576.13
51105413-110541373.21773.40
61095747-109574772.57772.76
45min11359689-135968990.05990.251.5390.3590.531.54
21365692-136569290.45790.74
31323413-132341387.65787.91
41381206-138120691.48591.79
51377477-137747791.23891.53
61367598-136759890.58390.88
60min11416933-141693393.85194.300.5494.2794.720.54
21425271-142527194.40394.82
31419659-141965994.03194.42
41416487-141648793.82194.27
51436021-143602195.11595.54
61428247-142824794.60095.03
极限11441778-144177895.49795.410.5596.0695.970.55
21444991-144499195.70996.27
31436399-143639995.14095.67
41427677-142767794.56395.15
51451030-145103096.10996.68
61440663-144066395.42395.99
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.711460548145971214585481460266146023114598610.06
29.771463392146289114631420.03
单位质量响应值RSD%判断
150346.14149758.650.28数据可信
供试品溶液-第1批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1143727-1437279.54011.1914.729.5411.1914.70
2169897-16989711.27711.28
3180298-18029811.96811.97
4141282-1412829.3789.38
5168147-16814711.16111.16
6208244-20824413.82313.82
10min1392770-39277026.07129.6211.1926.0929.6311.18
2451845-45184529.99230.01
3465092-46509230.87130.89
4401769-40176926.66826.68
5435037-43503728.87628.89
6530508-53050835.21435.23
15min1633607-63360742.05747.2310.0142.1147.2910.01
2709565-70956547.09947.16
3744590-74459049.42449.49
4662860-66286043.99944.05
5684599-68459945.44245.50
6834301-83430155.37855.45
20min1849667-84966756.39862.388.6356.5162.518.63
2931194-93119461.81061.94
3999761-99976166.36166.50
4887964-88796458.94059.06
5900361-90036159.76359.89
61069340-106934070.98071.14
30min11178445-117844578.22282.273.3378.4282.493.35
21241067-124106782.37882.60
31272766-127276684.48284.72
41223098-122309881.18681.39
51224976-122497681.31081.53
61295900-129590086.01886.28
45min11395633-139563392.63893.520.6692.9693.870.65
21416576-141657694.02894.38
31402674-140267493.10593.47
41418519-141851994.15794.49
51415036-141503693.92694.27
61404956-140495693.25793.65
60min11432239-143223995.06895.450.4595.5395.940.44
21440427-144042795.61196.10
31437281-143728195.40395.91
41447432-144743296.07696.55
51440683-144068395.62896.11
61429484-142948494.88595.42
极限11439476-143947695.54895.830.4596.1596.460.44
21445265-144526595.93296.57
31437468-143746895.41596.06
41452632-145263296.42197.04
51449728-144972896.22996.85
61437943-143794395.44696.12
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.712894312289390428946892895377289666428949890.04
29.772894168289425128942100.01
单位质量响应值RSD%判断
298145.11296234.390.46数据可信
供试品溶液-2023010711批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1334682-33468211.21710.578.7211.2210.578.75
2311185-31118510.42910.43
3353821-35382111.85811.86
4275253-2752539.2259.22
5318879-31887910.68710.69
6298529-29852910.00510.00
10min1807158-80715827.05125.745.7027.0725.765.71
2745197-74519724.97524.99
3829858-82985827.81227.83
4715450-71545023.97823.99
5773036-77303625.90825.92
6737714-73771424.72424.74
15min11242871-124287141.65440.194.8041.7140.244.80
21162819-116281938.97139.02
31284603-128460343.05343.11
41134300-113430038.01538.07
51211399-121139940.59940.65
61158665-115866538.83238.88
20min11616755-161675554.18452.663.3054.3052.773.30
21523474-152347451.05851.17
31638887-163888754.92655.05
41521499-152149950.99251.10
51593584-159358453.40853.52
61532686-153268651.36751.48
30min12174316-217431672.87171.022.3673.0771.212.37
22082474-208247469.79369.98
32169462-216946272.70872.91
42057696-205769668.96269.15
52144524-214452471.87272.07
62085540-208554069.89570.08
45min12582466-258246686.55086.380.8486.8686.680.85
22585888-258588886.66486.96
32600274-260027487.14687.46
42545253-254525385.30285.59
52593435-259343586.91787.22
62556911-255691185.69385.99
60min12796462-279646293.72192.410.8794.1692.840.87
22756413-275641392.37992.80
32755106-275510692.33592.78
42746334-274633492.04192.46
52765785-276578592.69393.13
62724154-272415491.29891.72
极限12808586-280858694.12894.861.5394.7195.431.51
22829087-282908794.81595.38
32810660-281066094.19794.78
42915512-291551297.71198.26
52822253-282225394.58695.16
62796345-279634593.71894.28
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.712893341289233728905142892054289223728920970.04
29.772900882290139629011390.02
单位质量响应值RSD%判断
297847.27296943.600.22数据可信
供试品溶液-第1批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1321741-32174110.77510.375.7410.7810.375.74
2300563-30056310.06610.07
3326140-32614010.92310.92
4327622-32762210.97210.97
5285120-2851209.5499.55
6297224-2972249.9549.95
10min1766146-76614625.65925.702.4825.6825.722.48
2780859-78085926.15226.17
3779867-77986726.11826.13
4785954-78595426.32226.34
5736512-73651224.66624.68
6754662-75466225.27425.29
15min11185318-118531839.69740.232.1639.7540.282.17
21245530-124553041.71441.77
31205700-120570040.38040.44
41210886-121088640.55440.61
51172361-117236139.26339.31
61187359-118735939.76639.82
20min11555028-155502852.07953.021.5652.1953.141.56
21625988-162598854.45654.57
31572539-157253952.66652.78
41578094-157809452.85252.97
51595882-159588253.44753.56
61572078-157207852.65052.76
30min12109627-210962770.65372.021.6870.8572.221.67
22169417-216941772.65672.85
32123207-212320771.10871.30
42174791-217479172.83673.03
52200624-220062473.70173.89
62125836-212583671.19671.39
45min12564784-256478485.89786.390.4686.2086.700.46
22592874-259287486.83887.15
32569501-256950186.05586.36
42578340-257834086.35186.66
52593704-259370486.86587.17
62577960-257796086.33886.64
60min12737637-273763791.68692.320.4692.1192.750.47
22749292-274929292.07692.51
32758704-275870492.39192.82
42773064-277306492.87293.31
52766607-276660792.65693.09
62753544-275354492.21992.65
极限12805262-280526293.95194.350.7194.5294.920.71
22801675-280167593.83094.41
32820486-282048694.46095.03
42842576-284257695.20095.77
52838035-283803595.04895.62
62794760-279476093.59994.16
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