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%
110.042977058297228529752792968698296748029721600.14
210.012959086295256429558250.16
单位质量响应值RSD%判断
296031.87295287.210.18数据可信
供试品溶液-20211227批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121727-217270.7320.8312.020.730.8212.10
223606-236060.7950.80
329347-293470.9890.99
426764-267640.9020.90
522658-226580.7630.76
622878-228780.7710.77
10min140742-407421.3721.402.071.371.402.06
240636-406361.3691.37
342736-427361.4401.44
441639-416391.4031.40
542199-421991.4221.42
641003-410031.3811.38
15min144635-446351.5041.491.691.511.491.59
243963-439631.4811.48
345079-450791.5191.52
444466-444661.4981.50
543529-435291.4661.47
643105-431051.4521.46
20min144709-447091.5061.491.971.511.502.09
242941-429411.4471.45
344658-446581.5041.51
445121-451211.5201.53
544836-448361.5101.52
643438-434381.4631.47
30min144087-440871.4851.452.881.491.462.65
242083-420831.4181.43
344388-443881.4951.50
443792-437921.4751.48
543285-432851.4581.47
641192-411921.3881.40
45min142459-424591.4301.403.561.441.413.59
239510-395101.3311.34
342621-426211.4361.45
443150-431501.4541.46
540182-401821.3541.36
641008-410081.3811.39
60min141903-419031.4121.353.581.421.363.47
238522-385221.2981.31
340885-408851.3771.39
439850-398501.3421.35
538200-382001.2871.30
640633-406331.3691.38
极限140336-403361.3591.322.361.371.332.25
238340-383401.2921.31
339836-398361.3421.36
438998-389981.3141.33
537837-378371.2751.29
639126-391261.3181.33
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%
110.042955017294984429391612950991294697229483970.21
210.012956176295331529547460.07
单位质量响应值RSD%判断
293665.04295179.420.37数据可信
供试品溶液-20211227批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124776-247760.8380.7712.630.840.7712.51
220099-200990.6800.68
322266-222660.7530.75
425493-254930.8620.86
524908-249080.8430.84
618563-185630.6280.63
10min139486-394861.3361.343.041.341.342.93
238907-389071.3161.32
341448-414481.4021.40
439913-399131.3501.35
539451-394511.3351.34
637814-378141.2791.28
15min142754-427541.4461.450.971.451.450.92
242789-427891.4481.45
343327-433271.4661.47
442075-420751.4231.43
542705-427051.4451.45
642943-429431.4531.46
20min144045-440451.4901.462.711.501.462.76
244877-448771.5181.52
342994-429941.4541.46
442217-422171.4281.43
542356-423561.4331.44
641903-419031.4181.42
30min143098-430981.4581.406.351.471.406.52
242860-428601.4501.46
342876-428761.4501.46
436248-362481.2261.23
540695-406951.3771.38
641764-417641.4131.42
45min141779-417791.4131.362.241.421.372.14
240761-407611.3791.39
340035-400351.3541.36
439485-394851.3361.35
539338-393381.3311.34
640089-400891.3561.37
60min139522-395221.3371.332.801.351.342.57
240529-405291.3711.38
340253-402531.3621.37
437963-379631.2841.30
537972-379721.2851.30
639098-390981.3231.33
极限139126-391261.3241.302.271.341.322.33
238943-389431.3171.33
339793-397931.3461.36
437527-375271.2701.28
537752-377521.2771.29
638203-382031.2921.31
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%
110.042959449295923529636452961942296315629614850.07
210.012934602294072729376640.15
单位质量响应值RSD%判断
294968.63293472.930.36数据可信
供试品溶液-20211228批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135730-357301.2101.2411.001.211.2410.97
239447-394471.3351.34
336933-369331.2501.25
435853-358531.2141.21
530072-300721.0181.02
641998-419981.4221.42
10min143067-430671.4581.492.131.461.492.07
244954-449541.5221.52
343746-437461.4811.48
443013-430131.4561.46
543464-434641.4711.47
645127-451271.5281.53
15min145375-453751.5361.530.971.541.530.99
244439-444391.5041.51
345251-452511.5321.54
445308-453081.5341.54
545643-456431.5451.55
644833-448331.5181.52
20min145049-450491.5251.531.121.531.541.07
244926-449261.5211.53
345678-456781.5461.55
445503-455031.5401.55
545726-457261.5481.55
644425-444251.5041.51
30min144823-448231.5171.491.911.531.501.95
242847-428471.4501.46
344798-447981.5171.53
444744-447441.5151.52
543443-434431.4711.48
643875-438751.4851.49
45min143416-434161.4701.444.051.481.444.03
239034-390341.3211.33
343490-434901.4721.48
443027-430271.4571.47
543222-432221.4631.47
642341-423411.4331.44
60min142318-423181.4331.412.501.451.422.58
239933-399331.3521.36
342518-425181.4391.45
441687-416871.4111.42
540935-409351.3861.40
642523-425231.4401.45
极限141094-410941.3911.372.561.411.392.56
238912-389121.3171.33
341443-414431.4031.42
441283-412831.3981.41
539592-395921.3401.36
640840-408401.3831.40
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%
110.042958832295887429684022973034297167229661630.24
210.012942578294140229419900.03
单位质量响应值RSD%判断
295434.56293905.090.37数据可信
供试品溶液-20211228批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139209-392091.3251.2210.161.331.2210.07
231965-319651.0801.08
334837-348371.1781.18
431839-318391.0761.08
537583-375831.2701.27
640343-403431.3641.36
10min143947-439471.4851.472.211.491.471.99
241817-418171.4131.42
344469-444691.5031.50
443032-430321.4551.46
544131-441311.4921.49
643556-435561.4721.47
15min145202-452021.5281.511.861.531.512.01
244824-448241.5151.52
345017-450171.5221.53
444478-444781.5031.51
544799-447991.5141.52
642918-429181.4511.45
20min145384-453841.5341.492.001.541.502.10
244352-443521.4991.51
344740-447401.5121.52
443354-433541.4651.47
543653-436531.4761.48
643118-431181.4571.46
30min143823-438231.4811.462.821.491.472.86
244190-441901.4941.50
344294-442941.4971.51
442259-422591.4281.44
543525-435251.4711.48
641231-412311.3941.40
45min142748-427481.4451.412.761.461.422.87
243034-430341.4551.47
341551-415511.4041.42
440401-404011.3661.38
542123-421231.4241.43
640359-403591.3641.37
60min141810-418101.4131.382.521.431.392.56
241606-416061.4061.42
341757-417571.4111.42
440105-401051.3561.37
540471-404711.3681.38
639305-393051.3291.34
极限141240-412401.3941.352.461.411.362.44
240464-404641.3681.38
339536-395361.3361.35
439775-397751.3441.36
539840-398401.3471.36
638298-382981.2951.31
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