塞来昔布胶囊项目信息
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%
110.043015179301533930151793015033301198030145420.05
210.013003380300329330033360.01
单位质量响应值RSD%判断
300253.19300033.570.06数据可信
供试品溶液-20211227批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1423202-42320214.04415.3920.2314.0415.3920.24
2364099-36409912.08212.08
3514189-51418917.06317.06
4515245-51524517.09817.10
5367981-36798112.21112.21
6598140-59814019.84919.85
10min11121898-112189837.22934.7918.5537.2634.8218.55
2749380-74938024.86824.89
31024608-102460834.00134.03
41209046-120904640.12140.16
5913722-91372230.32130.35
61271013-127101342.17742.22
15min11715473-171547356.92751.9620.1257.0352.0620.11
21195582-119558239.67439.75
31433448-143344847.56847.67
41926604-192660463.93364.05
51254819-125481941.64041.73
61869291-186929162.03162.15
20min12155350-215535071.52362.1819.0771.7462.3919.06
21528796-152879650.73250.89
31652377-165237754.83355.03
42320457-232045777.00277.24
51494291-149429149.58749.76
62092086-209208669.42469.67
30min12675378-267537888.78077.5410.2789.1477.8610.29
22145480-214548071.19671.45
32077765-207776568.94969.26
42542806-254280684.38184.78
52183430-218343072.45572.72
62394221-239422179.45079.84
45min12847515-284751594.49286.975.5095.0387.455.49
22584138-258413885.75286.15
32443847-244384781.09781.54
42658153-265815388.20988.77
52687761-268776189.19189.60
62503626-250362683.08183.63
60min12878840-287884095.53288.944.9696.2689.604.96
22625954-262595487.14087.71
32545240-254524084.46285.07
42728820-272882090.55491.30
52760283-276028391.59892.19
62542727-254272784.37885.09
极限12944667-294466797.71696.311.4698.6397.141.43
22898180-289818096.17496.92
32952202-295220297.96698.74
42855952-285595294.77295.69
52909692-290969296.55697.33
62852645-285264594.66395.54
塞来昔布胶囊项目信息
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%
110.043005482300600830051343008160300782030065210.05
210.013011873300996430109180.05
单位质量响应值RSD%判断
299454.28300791.010.32数据可信
供试品溶液-20211228批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1705345-70534523.40823.3938.2923.4123.3938.29
2552830-55283018.34718.35
3530024-53002417.59017.59
41237610-123761041.07241.07
5550005-55000518.25318.25
6653412-65341221.68521.68
10min11354369-135436944.94749.9926.8244.9950.0326.83
21129748-112974837.49237.53
31156419-115641938.37838.41
42218944-221894473.63973.72
51529456-152945650.75750.79
61648836-164883654.71954.76
15min11691137-169113756.12363.3119.0856.2663.4619.10
21568919-156891952.06752.18
31550067-155006751.44151.55
42443792-244379281.10181.33
52012436-201243666.78666.92
62180036-218003672.34872.50
20min11992725-199272566.13272.9911.8466.3873.2711.87
21931274-193127464.09264.31
31992236-199223666.11666.33
42556169-255616984.83185.22
52343696-234369677.77978.05
62380869-238086979.01379.31
30min12674294-267429488.75185.165.1789.1385.585.19
22370410-237041078.66679.01
32500277-250027782.97683.32
42670638-267063888.62989.19
52693943-269394389.40389.83
62487274-248727482.54483.00
45min12804836-280483693.08389.053.9993.6489.644.00
22542801-254280184.38784.89
32663566-266356688.39588.91
42729124-272912490.57091.31
52780679-278067992.28192.89
62579555-257955585.60786.23
60min12837613-283761394.17190.713.1694.9291.483.17
22621632-262163287.00387.67
32729752-272975290.59191.28
42760048-276004891.59792.52
52806164-280616493.12793.92
62644549-264454987.76488.56
极限12859279-285927994.89095.401.1695.8296.351.10
22922333-292233396.98297.83
32880327-288032795.58896.46
42848086-284808694.51895.62
52902347-290234796.31997.30
62835658-283565894.10695.07
塞来昔布胶囊项目信息
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%
110.043002875300511330034243008193300693930053090.08
210.012998323300062729994750.06
单位质量响应值RSD%判断
299333.57299647.850.08数据可信
供试品溶液-20211228批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1802284-80228426.68122.5618.9326.6822.5718.93
2531013-53101317.66017.66
3512628-51262817.04817.05
4784111-78411126.07726.08
5760318-76031825.28525.29
6680679-68067922.63722.64
10min12226674-222667474.05151.5924.2974.1051.6324.28
21092387-109238736.32936.36
31605677-160567753.39953.43
41360684-136068445.25245.30
51498355-149835549.83049.88
61523640-152364050.67150.72
15min12592804-259280486.22766.9018.9786.4367.0518.97
21479027-147902749.18749.30
32189940-218994072.83072.97
41781497-178149759.24659.39
51908777-190877763.47963.63
62118206-211820670.44470.59
20min12745835-274583591.31778.2112.2791.6978.4912.29
21942283-194228364.59364.80
32528299-252829984.08284.37
42142900-214290071.26571.53
52283693-228369375.94876.22
62467050-246705082.04582.33
30min12847909-284790994.71191.374.8095.2791.814.83
22653179-265317988.23588.57
32851288-285128894.82495.28
42535387-253538784.31884.72
52740347-274034791.13491.56
62857245-285724595.02295.47
45min12914933-291493396.94094.523.6297.6995.143.64
22860646-286064695.13595.65
32884631-288463195.93396.58
42658004-265800488.39688.97
52795364-279536492.96493.58
62939001-293900197.74198.38
60min12948017-294801798.04195.782.9598.9896.592.97
22924333-292433397.25397.96
32889060-288906096.08096.92
42738277-273827791.06591.81
52823117-282311793.88794.68
62957352-295735298.35199.19
极限12966249-296624998.64797.732.4899.7898.732.46
23039359-3039359101.078101.98
32895818-289581896.30597.33
42846801-284680194.67595.61
52890034-289003496.11297.10
62993316-299331699.547100.58
塞来昔布胶囊项目信息
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%
110.043007017300816330071373003114300512830061120.07
210.013001619300215830018880.02
单位质量响应值RSD%判断
299413.55299888.910.12数据可信
供试品溶液-20211229批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1568900-56890018.90922.3413.3418.9122.3413.33
2666237-66623722.14522.14
3689130-68913022.90622.91
4810611-81061126.94426.94
5582178-58217819.35119.35
6715683-71568323.78823.79
10min11215444-121544440.40045.4619.7240.4445.5019.71
21274059-127405942.34842.39
31458532-145853248.48048.53
41513799-151379950.31750.37
5983464-98346432.68932.73
61760493-176049358.51658.56
15min11605190-160519053.35459.1216.6653.4759.2616.66
21818107-181810760.43160.56
31734873-173487357.66557.81
42002321-200232166.55466.71
51334938-133493844.37244.48
62176484-217648472.34372.51
20min11954225-195422564.95668.9713.8365.1869.2213.84
22170798-217079872.15472.40
31922185-192218563.89164.15
42302705-230270576.53976.83
51655137-165513755.01555.21
62444217-244421781.24381.55
30min12435848-243584880.96481.917.3581.3282.307.37
22602717-260271786.51186.90
32253298-225329874.89775.28
42486893-248689382.66183.10
52284885-228488575.94776.25
62722116-272211690.47990.95
45min12557911-255791185.02287.085.2885.5487.645.30
22758986-275898691.70592.27
32468886-246888682.06282.60
42572367-257236785.50286.11
52539300-253930084.40384.86
62821892-282189293.79694.45
60min12594932-259493286.25288.544.6986.9489.284.72
22784337-278433792.54893.30
32545528-254552884.61085.31
42606811-260681186.64787.42
52596172-259617286.29386.92
62855685-285568594.91995.76
极限12834898-283489894.22894.840.9695.0995.750.94
22829454-282945494.04794.98
32843986-284398694.53095.40
42838095-283809594.33495.28
52897100-289710096.29697.09
62876918-287691895.62596.66
塞来昔布胶囊项目信息
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%
110.043006924300681230086343005237300711830069450.05
210.013000974299887029999220.05
单位质量响应值RSD%判断
299496.51299692.510.05数据可信
供试品溶液-20211229批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1675528-67552822.45819.2537.7222.4619.2637.71
2919213-91921330.55930.56
3537551-53755117.87117.87
4254361-2543618.4568.46
5500115-50011516.62616.63
6588067-58806719.55019.55
10min11566763-156676352.08747.9824.7852.1348.0224.78
21798734-179873459.79959.86
31647772-164777254.78054.82
4810164-81016426.93426.95
51582436-158243652.60852.64
61254312-125431241.70041.74
15min11989796-198979666.15163.6622.5166.3063.7922.52
22383912-238391279.25379.43
32097706-209770669.73869.88
41199551-119955139.87939.95
52190130-219013072.81172.95
61628262-162826254.13154.25
20min12287435-228743576.04674.2516.7276.3374.5216.74
22588363-258836386.05086.39
32370047-237004778.79279.08
41567490-156749052.11152.26
52515447-251544783.62683.91
62072466-207246668.89969.13
30min12456572-245657281.66982.907.5282.1083.317.58
22672510-267251088.84789.36
32515470-251547083.62784.07
42160013-216001371.80972.06
52667570-266757088.68389.13
62490043-249004382.78183.15
45min12549216-254921684.74987.403.9685.3587.984.02
22766178-276617891.96192.65
32578941-257894185.73786.35
42517719-251771983.70184.10
52746680-274668091.31391.94
62614793-261479386.92987.46
60min12596448-259644886.31988.884.1387.0989.644.19
22841346-284134694.46095.33
32616652-261665286.99087.77
42561674-256167485.16385.73
52775613-277561392.27593.09
62649669-264966988.08888.80
极限12774762-277476292.24793.231.1293.1994.161.14
22826279-282627993.95995.02
32853603-285360394.86895.82
42789656-278965692.74293.48
52775146-277514692.26093.26
62806856-280685693.31494.20
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