塞来昔布胶囊项目信息
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%
19.412785379278641127841932788631278709127863410.07
29.332793527279855127960390.13
单位质量响应值RSD%判断
296104.25299682.640.85数据可信
长期36月-供试品溶液-20211227批-pH6.8(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11058852-105885235.40432.0428.2835.4032.0428.27
21182874-118287439.55139.55
31128531-112853137.73437.73
4801238-80123826.79026.79
51101615-110161536.83436.83
6476402-47640215.92915.93
10min12082726-208272669.63864.5812.5969.6964.6312.60
22008396-200839667.15367.21
32035255-203525568.05168.11
41826933-182693361.08561.13
52148573-214857371.84071.89
61486664-148666449.70849.73
15min12528534-252853484.54479.849.7984.7079.989.80
22463194-246319482.35982.52
32496421-249642183.47083.63
42295911-229591176.76676.90
52587476-258747686.51586.68
61955132-195513265.37265.47
20min12841637-284163795.01389.817.5695.3090.087.58
22739568-273956891.60091.88
32801866-280186693.68393.97
42603041-260304187.03587.28
52819728-281972894.28094.57
62311072-231107277.27377.47
30min13062263-3062263102.39098.494.10102.8298.894.13
23034484-3034484101.461101.88
33035460-3035460101.494101.92
42856148-285614895.49895.88
52926258-292625897.84298.28
62758733-275873392.24192.55
45min13093893-3093893103.447100.665.01104.03101.205.03
23181419-3181419106.374106.95
33130979-3130979104.687105.26
42880934-288093496.32796.85
52977555-297755599.557100.14
62797945-279794593.55294.00
60min13101800-3101800103.712101.054.85104.45101.754.87
23197363-3197363106.907107.64
33142341-3142341105.067105.80
42910586-291058697.31897.98
52957416-295741698.88499.61
62824011-282401194.42495.01
极限13106113-3106113103.856101.294.85104.75102.144.87
23208439-3208439107.277108.17
33150853-3150853105.352106.24
42913119-291311997.40398.21
52960279-296027998.98099.86
62837315-283731594.86895.60
塞来昔布胶囊项目信息
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%
19.412790530279211327897092793647279124527914490.06
29.332796836279436927956020.07
单位质量响应值RSD%判断
296647.08299635.800.71数据可信
长期36月-供试品溶液-20211228批-pH6.8(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1760136-76013625.39423.1812.6325.3923.1812.63
2725886-72588624.25024.25
3684796-68479622.87822.88
4542186-54218618.11318.11
5787925-78792526.32326.32
6662001-66200122.11622.12
10min11856602-185660262.02561.6214.0362.0661.6614.03
21709877-170987757.12357.16
31650179-165017955.12955.16
41603069-160306953.55553.58
52303248-230324876.94676.99
61944810-194481064.97265.01
15min12296141-229614176.70982.3910.3476.8482.5210.33
22236972-223697274.73274.85
32228515-222851574.45074.57
42544268-254426884.99885.11
52856206-285620695.42095.57
62634599-263459988.01688.15
20min12507257-250725783.76293.6310.0684.0193.8910.05
22543138-254313884.96185.19
32615820-261582087.38987.62
42951239-295123998.59498.83
53166873-3166873105.798106.10
63032299-3032299101.302101.57
30min12870924-287092495.911104.035.0496.28104.425.05
22996519-2996519100.107100.47
33134524-3134524104.718105.08
43153302-3153302105.345105.73
53303708-3303708110.370110.83
63224635-3224635107.728108.14
45min12915452-291545297.399106.124.9897.91106.664.98
23105956-3105956103.763104.27
33326062-3326062111.116111.63
43148656-3148656105.190105.73
53338945-3338945111.547112.17
63223950-3223950107.705108.28
60min12920201-292020197.557105.854.8498.22106.564.83
23085921-3085921103.094103.76
33331209-3331209111.288111.97
43149875-3149875105.230105.93
53308571-3308571110.532111.32
63215305-3215305107.416108.15
极限12952452-295245298.635106.894.7399.44107.764.73
23100133-3100133103.569104.39
33350575-3350575111.935112.79
43220212-3220212107.580108.44
53336177-3336177111.454112.41
63238142-3238142108.179109.08
塞来昔布胶囊项目信息
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%
19.412795122279643927963052795609279557527958100.02
29.332793592279790427957480.11
单位质量响应值RSD%判断
297110.52299651.450.61数据可信
长期36月-供试品溶液-20211229批-pH6.8(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1822785-82278527.46529.5214.3727.4729.5214.37
2932970-93297031.14331.14
3866304-86630428.91828.92
4687808-68780822.96022.96
5928831-92883131.00531.01
61067754-106775435.64235.64
10min11875164-187516462.59463.314.5162.6463.364.51
22001552-200155266.81366.86
31939358-193935864.73764.78
41790011-179001159.75259.79
51810902-181090260.44960.50
61963477-196347765.54265.60
15min12329202-232920277.75177.225.8377.8977.365.82
22442469-244246981.53181.68
32394661-239466179.93680.08
42404017-240401780.24880.37
52088520-208852069.71669.85
62221440-222144074.15374.31
20min12672269-267226989.20286.917.2189.4587.177.19
22708716-270871690.41990.69
32696638-269663890.01690.28
42754060-275406091.93392.18
52250614-225061475.12775.37
62539492-253949284.77085.03
30min13035811-3035811101.33895.833.98101.7296.223.97
22827016-282701694.36894.77
32917701-291770197.39597.79
42927602-292760297.72698.11
52707571-270757190.38190.74
62808991-280899193.76694.16
45min13084467-3084467102.96296.584.39103.5097.114.38
22832773-283277394.56095.11
32967750-296775099.06699.61
42927552-292755297.72498.25
52724254-272425490.93891.43
62822309-282230994.21194.74
60min13082973-3082973102.91296.214.31103.6096.884.29
22839359-283935994.78095.47
32905919-290591997.00297.69
42931608-293160897.85998.53
52717114-271711490.69991.33
62815497-281549793.98394.66
极限13104264-3104264103.62396.934.35104.4797.754.33
22836295-283629594.67895.51
32972138-297213899.212100.05
42925730-292573097.66398.49
52744791-274479191.62392.39
62838800-283880094.76195.57
塞来昔布胶囊项目信息
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%
19.412785971279049227885642789994278866627887370.07
29.332788538278836127884500.01
单位质量响应值RSD%判断
296358.87298869.240.60数据可信
长期36月-供试品溶液-DR8010批-pH6.8(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1967238-96723832.37022.4126.7732.3722.4026.77
2791356-79135626.48426.48
3654433-65443321.90221.90
4495943-49594316.59816.60
5559942-55994218.73918.74
6548024-54802418.34118.34
10min12299232-229923276.94870.395.5077.0070.425.51
22163317-216331772.39972.44
32109111-210911170.58570.62
42050892-205089268.63768.66
52002946-200294667.03267.06
61993794-199379466.72666.75
15min12642886-264288688.44985.492.8788.6185.632.88
22581775-258177586.40486.55
32552456-255245685.42285.56
42611261-261126187.39087.52
52452766-245276682.08682.21
62485859-248585983.19483.32
20min12763699-276369992.49290.783.0992.7991.053.09
22752768-275276892.12692.40
32771374-277137492.74993.02
42773091-277309192.80693.07
52580588-258058886.36486.62
62634014-263401488.15288.40
30min12880894-288089496.41495.421.9196.8595.821.91
22877950-287795096.31696.73
32915093-291509397.55997.96
42860149-286014995.72096.12
52770035-277003592.70493.09
62802210-280221093.78194.17
45min12879267-287926796.36096.621.0096.9497.171.01
22900986-290098697.08797.65
32937081-293708198.29598.85
42883278-288327896.49497.04
52862270-286227095.79196.31
62859430-285943095.69696.22
60min12890089-289008996.72296.800.9197.4597.500.92
22892419-289241996.80097.51
32941438-294143898.44099.14
42889694-288969496.70997.40
52876613-287661396.27196.93
62864586-286458695.86896.54
极限12921873-292187397.78697.510.7398.6698.350.75
22917661-291766197.64598.50
32949635-294963598.71599.56
42906395-290639597.26898.10
52892479-289247996.80297.61
62894276-289427696.86297.67
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