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%
110.152985937298823829851192986019298601929862660.04
210.192975167297274929739580.06
单位质量响应值RSD%判断
294213.40291850.640.58数据可信
供试品溶液-8145830批-pH12.0(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%
5min1875348-87534829.75323.6986.1629.7523.6986.16
21506427-150642751.20351.20
3324212-32421211.02011.02
449126-491261.6701.67
5185724-1857246.3136.31
61240548-124054842.16642.17
10min12232497-223249775.88375.4910.0875.9375.5310.09
22585558-258555887.88387.96
32007979-200797968.25168.27
42342438-234243879.61979.62
51988015-198801567.57367.58
62169268-216926873.73373.80
15min12656183-265618390.28491.516.5390.4491.666.54
22863841-286384197.34297.55
32382601-238260180.98581.10
42840901-284090196.56296.68
52654443-265444390.22590.34
62755666-275566693.66593.84
20min12910587-291058798.93199.592.0099.2299.882.03
22939967-293996799.930100.28
32890353-289035398.24398.48
42916485-291648599.13199.40
52880859-288085997.92098.17
63041854-3041854103.393103.71
30min12978367-2978367101.235101.211.75101.68101.651.76
22967137-2967137100.853101.36
32997724-2997724101.893102.28
42926057-292605799.45799.87
52929596-292959699.57799.97
63067059-3067059104.249104.72
45min12980334-2980334101.302101.331.86101.90101.921.87
22977122-2977122101.192101.85
33002698-3002698102.062102.60
42922507-292250799.33699.90
52929642-292964299.579100.12
63074642-3074642104.507105.13
60min12979032-2979032101.257101.191.75102.00101.931.76
22969598-2969598100.937101.74
32998440-2998440101.917102.61
42924691-292469199.410100.12
52926461-292646199.470100.16
63064402-3064402104.159104.94
极限12974789-2974789101.113100.971.83102.01101.861.85
22961122-2961122100.649101.61
32988702-2988702101.586102.43
42914135-291413599.05199.91
52920548-292054899.269100.11
63063535-3063535104.130105.07
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%
110.152978746298144429768462978755298266429796910.08
210.192978876297778829783320.03
单位质量响应值RSD%判断
293565.62292279.880.32数据可信
供试品溶液-8145830批-pH12.0(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%
5min11231234-123123441.86531.6447.4941.8631.6447.48
21564701-156470153.20353.20
3621880-62188021.14521.15
41004032-100403234.13934.14
5843857-84385728.69328.69
6317821-31782110.80710.81
10min12205754-220575475.00171.7015.4075.0671.7515.41
22363251-236325180.35680.44
32055102-205510269.87869.91
42477871-247787184.25384.30
51561580-156158053.09753.14
61989221-198922167.63867.65
15min12586275-258627587.93989.547.7988.1189.697.79
22738460-273846093.11493.31
32425568-242556882.47582.61
42856362-285636297.12397.30
52371447-237144780.63580.76
62821558-282155895.93996.06
20min12907004-290700498.84598.863.6599.1599.153.67
23010143-3010143102.352102.69
32799537-279953795.19195.45
42984129-2984129101.467101.79
52759160-275916093.81894.06
62985331-2985331101.508101.77
30min12996678-2996678101.894101.161.83102.35101.601.86
23041598-3041598103.421103.91
32943310-2943310100.079100.48
42991412-2991412101.715102.19
52884446-288444698.07898.46
62992902-2992902101.766102.18
45min12998544-2998544101.957101.301.74102.57101.891.77
23046323-3046323103.582104.23
32954127-2954127100.447101.00
42992143-2992143101.740102.37
52892205-289220598.34298.87
62992159-2992159101.740102.31
60min12992445-2992445101.750101.091.74102.51101.831.77
23034310-3034310103.174103.98
32943383-2943383100.082100.79
42988803-2988803101.626102.41
52885722-288572298.12198.80
62992987-2992987101.768102.49
极限12982556-2982556101.414100.911.72102.33101.801.75
23033492-3033492103.146104.10
32940043-294004399.968100.82
42983048-2983048101.431102.36
52883391-288339198.04298.87
62984560-2984560101.482102.35
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%
110.152985019298377629820032982946298426229836010.04
210.192980240297970229799710.02
单位质量响应值RSD%判断
293950.84292440.730.37数据可信
供试品溶液-8149401批-pH12.0(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%
5min11159227-115922739.38040.8920.4839.3840.8920.48
21142742-114274238.82038.82
31043682-104368235.45535.45
4915882-91588231.11331.11
51615326-161532654.87454.87
61345549-134554945.70945.71
10min11684628-168462857.22875.8515.0357.2975.9115.02
22021785-202178568.68168.74
32496905-249690584.82284.87
42473814-247381484.03784.08
52189777-218977774.38874.47
62529795-252979585.93986.01
15min12284412-228441277.60390.1611.0877.7590.3311.07
22489546-248954684.57284.73
32964790-2964790100.716100.90
42918347-291834799.13899.31
52408521-240852181.81982.01
62858254-285825497.09797.29
20min12738671-273867193.03598.064.3493.3098.364.34
22820399-282039995.81196.10
33043151-3043151103.378103.71
42981784-2981784101.293101.61
52773766-277376694.22794.54
62961110-2961110100.591100.93
30min12897645-289764598.435100.681.4898.84101.141.50
22949911-2949911100.211100.64
33034160-3034160103.073103.56
42972311-2972311100.971101.44
52963770-2963770100.681101.14
62964522-2964522100.707101.20
45min12902485-290248598.599100.781.4699.15101.391.48
22953662-2953662100.338100.92
33036050-3036050103.137103.78
42975177-2975177101.069101.69
52972977-2972977100.994101.60
62959453-2959453100.535101.18
60min12895475-289547598.361100.681.5299.06101.441.54
22944900-2944900100.040100.77
33032024-3032024103.000103.80
42973333-2973333101.006101.78
52980310-2980310101.243102.00
62956943-2956943100.449101.25
极限12889688-288968898.165100.501.6099.01101.411.62
22947826-2947826100.140101.02
33037574-3037574103.189104.14
42962726-2962726100.646101.57
52957859-2957859100.481101.39
62954333-2954333100.361101.31
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%
110.152977470297977829799302978558298017329791820.04
210.192972819297147129721450.04
单位质量响应值RSD%判断
293515.47291672.720.45数据可信
供试品溶液-8149401批-pH12.0(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%
5min11062767-106276736.17751.8516.2136.1851.8516.20
21597235-159723554.37154.37
31592364-159236454.20554.21
41615109-161510954.97954.98
51791461-179146160.98360.98
61480440-148044050.39550.40
10min12293366-229336678.06883.358.1778.1283.438.17
22464405-246440583.89083.97
32567884-256788487.41287.49
42692448-269244891.65391.74
52532778-253277886.21786.31
62140862-214086272.87672.95
15min12707941-270794192.18095.045.9392.3595.255.93
22885183-288518398.21498.42
32882145-288214598.11098.32
42884688-288468898.19798.42
52903584-290358498.84099.06
62489061-248906184.72984.91
20min12914979-291497999.228100.112.3199.54100.462.32
23001573-3001573102.176102.53
32946480-2946480100.300100.66
42910395-291039599.07299.44
53029572-3029572103.129103.50
62842364-284236496.75697.07
30min12938635-2938635100.033101.862.54100.49102.352.52
22999167-2999167102.094102.60
32948484-2948484100.368100.88
42910754-291075499.08499.60
53042541-3042541103.570104.09
63114121-3114121106.007106.46
45min12937385-293738599.991101.261.71100.60101.911.71
22995728-2995728101.977102.64
32950662-2950662100.443101.10
42910394-291039499.07299.74
53047582-3047582103.742104.42
63006457-3006457102.342102.96
60min12940171-2940171100.085101.141.77100.84101.941.76
22990697-2990697101.805102.62
32944559-2944559100.235101.05
42900493-290049398.73599.55
53045120-3045120103.658104.49
63006414-3006414102.340103.11
极限12928486-292848699.688100.851.82100.60101.801.82
22977195-2977195101.346102.31
32939996-2939996100.079101.04
42890568-289056898.39799.36
53041217-3041217103.525104.52
62998227-2998227102.062102.98
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%
110.152965452296591829654892969266296717329666600.06
210.192982389298176529820770.02
单位质量响应值RSD%判断
292281.77292647.400.09数据可信
供试品溶液-20211227批-pH12.0(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%
5min11397823-139782347.60345.8220.3947.6045.8220.39
21051460-105146035.80835.81
31755538-175553859.78659.79
41459474-145947449.70349.70
51022771-102277134.83134.83
61385500-138550047.18447.18
10min11922033-192203365.45675.0312.5565.5375.1012.54
22259034-225903476.93276.99
32673792-267379291.05791.15
42248975-224897576.59076.66
52187977-218797774.51274.56
61927846-192784665.65465.72
15min12618626-261862689.17892.008.4889.3592.188.48
22687721-268772191.53191.70
33121791-3121791106.314106.54
42689176-268917691.58191.77
52668008-266800890.86091.02
62424131-242413182.55582.72
20min13071788-3071788104.611100.675.42104.91100.995.43
22849756-284975697.05097.36
33226140-3226140109.868110.25
42824523-282452396.19096.52
52847077-284707796.95897.26
62917348-291734899.35299.64
30min13248109-3248109110.616102.865.94111.08103.335.93
22901843-290184398.82399.28
33223394-3223394109.774110.32
42824878-282487896.20296.67
52897376-289737698.67199.12
63025986-3025986103.051103.49
45min13219524-3219524109.642102.555.85110.27103.185.84
22893822-289382298.55099.15
33222932-3222932109.758110.47
42815963-281596395.89996.51
52890846-289084698.44999.04
63024734-3024734103.009103.61
60min13217749-3217749109.582102.465.83110.37103.245.83
22892095-289209598.49299.24
33220482-3220482109.675110.55
42817362-281736295.94696.71
52886636-288663698.30699.05
63016845-3016845102.740103.49
极限13208336-3208336109.261102.355.89110.22103.285.89
22885485-288548598.26699.16
33225246-3225246109.837110.88
42811357-281135795.74296.65
52883715-288371598.20699.10
63017792-3017792102.772103.68
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