塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
19.402799571280256928046542802698280208328023150.07
29.332792320280021527962680.20
单位质量响应值RSD%判断
298118.62299707.180.38数据可信
供试品溶液-24081301批-pH6.8(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%
5min1503715-50371516.78416.671.7616.7816.681.77
2505919-50591916.85816.86
3509792-50979216.98716.99
4487637-48763716.24916.25
5504097-50409716.79716.80
6491411-49141116.37416.37
10min11154968-115496838.48538.961.7538.5238.991.74
21190393-119039339.66539.70
31190604-119060439.67239.71
41142689-114268938.07638.11
51179475-117947539.30139.33
61156756-115675638.54438.58
15min11700652-170065256.66757.311.6156.7857.431.61
21733258-173325857.75457.87
31754964-175496458.47758.59
41682022-168202256.04756.16
51741464-174146458.02758.14
61708004-170800456.91257.02
20min12139035-213903571.27571.421.1871.5071.651.17
22173239-217323972.41472.64
32141120-214112071.34471.57
42101833-210183370.03570.26
52165631-216563172.16172.39
62139803-213980371.30071.52
30min12627414-262741487.54887.111.7087.9187.481.69
22655572-265557288.48688.86
32572360-257236085.71486.09
42549376-254937684.94885.31
52657093-265709388.53788.91
62624550-262455087.45387.82
45min12852731-285273195.05694.641.2795.6095.181.27
22890117-289011796.30296.85
32797307-279730793.20993.75
42803360-280336093.41193.94
52864383-286438395.44495.99
62833048-283304894.40094.94
60min12909751-290975196.95696.940.9797.6997.680.97
22944778-294477898.12398.87
32875910-287591095.82896.56
42884278-288427896.10796.82
52939147-293914797.93598.68
62902370-290237096.71097.44
极限12942017-294201798.03197.620.9698.9698.540.96
22974897-297489799.126100.07
32896017-289601796.49897.42
42907179-290717996.87097.78
52934794-293479497.79098.73
62922599-292259997.38498.31
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
19.402779357278257027787052780929278234427807810.07
29.332787753278297427853640.13
单位质量响应值RSD%判断
295827.77298538.480.65数据可信
供试品溶液-24081301批-pH4.5(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%
5min1452494-45249415.16614.144.0415.1714.144.04
2415807-41580713.93613.94
3421770-42177014.13614.14
4424201-42420114.21714.22
5401458-40145813.45513.46
6414780-41478013.90213.90
10min1984197-98419732.98632.691.3533.0232.721.36
2962599-96259932.26232.29
3992698-99269833.27133.30
4973479-97347932.62732.65
5958443-95844332.12332.15
6981264-98126432.88732.92
15min11452758-145275848.69049.390.9348.7949.480.92
21471225-147122549.30949.40
31492401-149240150.01850.11
41466406-146640649.14749.24
51482165-148216549.67549.77
61476578-147657849.48849.58
20min11836166-183616661.54063.021.2261.7363.211.22
21895186-189518663.51863.71
31899777-189977763.67263.87
41888724-188872463.30163.49
51880809-188080963.03663.23
61880630-188063063.03063.22
30min12391724-239172480.16081.621.5380.4881.941.53
22459556-245955682.43382.75
32495669-249566983.64383.97
42433186-243318681.54981.87
52417932-241793281.03881.35
62413201-241320180.87981.20
45min12760320-276032092.51393.410.8992.9993.890.89
22795006-279500693.67694.16
32830480-283048094.86595.35
42787615-278761593.42893.91
52780328-278032893.18493.66
62768466-276846692.78693.27
60min12869974-286997496.18896.800.7296.8597.470.72
22886301-288630196.73597.41
32914695-291469597.68798.37
42891028-289102896.89497.56
52906388-290638897.40998.07
62861034-286103495.88996.55
极限12908012-290801297.46397.800.6298.3298.660.62
22916263-291626397.74098.60
32945808-294580898.73099.60
42925164-292516498.03898.90
52921717-292171797.92298.78
62891903-289190396.92397.78
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
19.402794500278998327901762793873279036527917790.08
29.332781888277787327798800.11
单位质量响应值RSD%判断
296997.77297950.700.23数据可信
供试品溶液-24081301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%
5min1389872-38987213.05413.313.8813.0513.313.87
2408401-40840113.67413.67
3380380-38038012.73612.74
4388202-38820212.99813.00
5396002-39600213.25913.26
6422626-42262614.15014.15
10min1901613-90161330.18831.724.7330.2131.744.73
2919500-91950030.78730.81
3923800-92380030.93130.96
4957200-95720032.04932.07
5953860-95386031.93731.96
61027677-102767734.40934.44
15min11364281-136428145.67947.974.0345.7748.064.03
21390745-139074546.56546.65
31427836-142783647.80747.89
41437562-143756248.13248.22
51443074-144307448.31748.41
61532746-153274651.31951.42
20min11739048-173904858.22760.983.4958.4061.163.49
21777726-177772659.52259.70
31809953-180995360.60160.78
41835871-183587161.46961.65
51839187-183918761.58061.77
61925081-192508164.45664.66
30min12262808-226280875.76378.262.5476.0678.572.55
22292345-229234576.75277.05
32322528-232252877.76378.07
42369944-236994479.35079.66
52346945-234694578.58078.89
62430336-243033681.37281.70
45min12622587-262258787.80990.461.9488.2690.921.94
22651588-265158888.78089.24
32715092-271509290.90791.37
42747145-274714591.98092.45
52728029-272802991.34091.81
62745737-274573791.93392.42
60min12744596-274459691.89594.551.8792.5295.201.87
22771432-277143292.79393.43
32844045-284404595.22495.87
42861553-286155395.81096.46
52870074-287007496.09696.75
62852453-285245395.50696.18
极限12802632-280263293.83896.601.9394.6497.441.93
22830995-283099594.78795.61
32908139-290813997.37098.20
42912093-291209397.50398.35
52947071-294707198.67499.52
62909629-290962997.42098.29
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
19.402764796277376527737952773557277235627716540.14
29.332783658279124427874510.20
单位质量响应值RSD%判断
294856.81298762.170.94数据可信
供试品溶液-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%
5min1282648-2826489.4859.653.279.499.653.26
2277293-2772939.3059.31
3294298-2942989.8769.88
4288390-2883909.6789.68
5302122-30212210.13910.14
6280340-2803409.4089.41
10min1676254-67625422.69423.533.2022.7123.553.20
2672175-67217522.55722.58
3700660-70066023.51323.53
4724425-72442524.31024.33
5713968-71396823.96023.98
6719846-71984624.15724.18
15min11088108-108810836.51537.202.5236.5837.272.52
21070082-107008235.91035.97
31102283-110228336.99137.06
41127106-112710637.82437.89
51115971-111597137.45037.52
61147881-114788138.52138.59
20min11440890-144089048.35448.971.9348.4949.111.94
21414763-141476347.47747.61
31467531-146753149.24849.39
41479365-147936549.64549.79
51459043-145904348.96349.11
61493376-149337650.11550.26
30min11977193-197719366.35167.171.0166.5967.411.01
21978986-197898666.41166.64
31998303-199830367.06067.30
42017282-201728267.69767.94
52012687-201268767.54267.78
62024724-202472467.94668.19
45min12444358-244435882.02983.060.8382.4083.430.83
22456127-245612782.42482.79
32496559-249655983.78084.15
42488201-248820183.50083.88
52487483-248748383.47683.85
62477442-247744283.13983.52
60min12669706-266970689.59190.811.0090.1291.351.00
22688577-268857790.22490.75
32749654-274965492.27492.81
42714410-271441091.09191.64
52709866-270986690.93991.48
62703619-270361990.72991.28
极限12789106-278910693.59894.320.7794.3195.040.77
22798251-279825193.90594.61
32851006-285100695.67596.40
42810822-281082294.32695.05
52812036-281203694.36795.09
62802386-280238694.04394.77
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