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%
19.89 3015057301290630135663013846301299030136730.03
29.943022397302794930251730.13
单位质量响应值RSD%判断
304719.21304343.360.09数据可信
供试品溶液-8149402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%
5min135863-358631.1731.246.281.171.246.33
240566-405661.3271.33
339703-397031.2991.30
434858-348581.1401.14
539270-392701.2841.28
636322-363221.1881.19
10min143361-433611.4181.3615.001.421.3614.84
229226-292260.9560.96
345320-453201.4821.48
442793-427931.4001.40
546246-462461.5131.51
643175-431751.4121.41
15min145019-450191.4721.480.421.481.480.51
245315-453151.4821.49
345099-450991.4751.48
445342-453421.4831.49
544858-448581.4671.47
645203-452031.4781.48
20min143991-439911.4391.435.611.441.435.47
244681-446811.4611.47
343875-438751.4351.44
445645-456451.4931.50
538826-388261.2701.28
644871-448711.4681.47
30min144041-440411.4401.405.431.451.415.31
244480-444801.4551.46
341078-410781.3431.35
444744-447441.4631.47
539084-390841.2781.29
644293-442931.4491.46
45min141683-416831.3631.355.641.371.365.59
243609-436091.4261.44
339608-396081.2951.31
441939-419391.3721.38
537276-372761.2191.23
642721-427211.3971.41
60min139413-394131.2891.315.551.301.325.54
242096-420961.3771.39
338792-387921.2691.28
440700-407001.3311.34
536371-363711.1901.20
642180-421801.3801.39
极限140028-400281.3091.284.201.321.294.06
240682-406821.3311.34
338147-381471.2481.26
439819-398191.3021.32
536200-362001.1841.20
639577-395771.2941.31
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%
19.89 3021328302133630233883021612301934330214010.05
29.943017961301576030168600.06
单位质量响应值RSD%判断
305500.61303507.040.47数据可信
供试品溶液-8149402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%
5min138684-386841.2651.294.681.271.294.53
242482-424821.3901.39
338424-384241.2571.26
439878-398781.3041.30
540417-404171.3221.32
637209-372091.2171.22
10min141027-410271.3421.464.261.341.474.37
246455-464551.5201.52
345362-453621.4841.49
445376-453761.4841.49
544832-448321.4661.47
645502-455021.4881.49
15min140776-407761.3341.464.221.341.464.23
245275-452751.4811.49
345936-459361.5031.51
445282-452821.4811.49
544904-449041.4691.47
645107-451071.4751.48
20min138715-387151.2661.415.391.271.425.33
244892-448921.4681.47
344828-448281.4661.47
442793-427931.4001.41
544272-442721.4481.45
643318-433181.4171.42
30min137651-376511.2321.365.481.241.375.48
243740-437401.4311.44
343068-430681.4091.42
440692-406921.3311.34
543112-431121.4101.42
640892-408921.3381.35
45min134921-349211.1421.316.751.151.326.84
241812-418121.3681.38
342020-420201.3741.39
440005-400051.3091.32
541847-418471.3691.38
639972-399721.3071.32
60min130869-308691.0101.2610.081.021.279.99
241012-410121.3411.35
340631-406311.3291.34
439064-390641.2781.29
540991-409911.3411.35
638661-386611.2651.28
极限138546-385461.2611.270.921.271.291.10
238862-388621.2711.29
339281-392811.2851.30
439489-394891.2921.31
538850-388501.2711.29
638726-387261.2671.28
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%
19.89 3018027301277130107383005516301138630116880.15
29.943008728301359030111590.12
单位质量响应值RSD%判断
304518.50302933.500.37数据可信
供试品溶液-20211229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%
5min139720-397201.3031.355.701.301.355.59
242331-423311.3881.39
340236-402361.3191.32
438054-380541.2481.25
543071-430711.4121.41
644359-443591.4551.45
10min139536-395361.2971.455.861.301.455.84
244246-442461.4511.45
345227-452271.4831.49
442962-429621.4091.41
546560-465601.5271.53
646098-460981.5121.51
15min140796-407961.3381.454.561.341.464.61
244872-448721.4711.48
345862-458621.5041.51
444793-447931.4691.47
543025-430251.4111.42
646159-461591.5141.52
20min138182-381821.2521.456.871.261.456.78
244935-449351.4741.48
344044-440441.4441.45
445280-452801.4851.49
545822-458221.5031.51
646465-464651.5241.53
30min142294-422941.3871.484.451.391.494.53
245121-451211.4801.49
348558-485581.5921.60
445559-455591.4941.50
545012-450121.4761.48
644608-446081.4631.47
45min141677-416771.3671.484.661.381.494.48
245427-454271.4901.50
347659-476591.5631.57
446446-464461.5231.53
543845-438451.4381.45
645690-456901.4981.51
60min141500-415001.3611.484.081.371.494.19
245521-455211.4931.51
346771-467711.5341.55
445407-454071.4891.50
544911-449111.4731.49
646031-460311.5091.52
极限141434-414341.3591.454.841.371.464.93
243476-434761.4261.44
347952-479521.5721.59
444389-443891.4561.47
543416-434161.4241.44
644450-444501.4581.47
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%
19.89 3016029301391630095093017380300926930132210.13
29.943019469301727330183710.06
单位质量响应值RSD%判断
304673.51303659.050.24数据可信
供试品溶液-20211229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%
5min138415-384151.2581.325.921.261.325.77
244027-440271.4421.44
340902-409021.3391.34
442162-421621.3811.38
537733-377331.2361.24
639392-393921.2901.29
10min143757-437571.4331.453.221.431.453.40
245934-459341.5041.51
344874-448741.4691.47
445312-453121.4841.49
542466-424661.3911.39
642678-426781.3981.40
15min144880-448801.4701.472.361.471.472.41
245664-456641.4951.50
344681-446811.4631.47
446144-461441.5111.52
544236-442361.4491.45
643155-431551.4131.42
20min145867-458671.5021.472.771.511.482.67
245750-457501.4981.50
344145-441451.4461.45
446245-462451.5141.52
543350-433501.4201.43
643738-437381.4321.44
30min145894-458941.5031.462.911.511.472.81
245388-453881.4861.50
344774-447741.4661.47
445911-459111.5031.51
543730-437301.4321.44
642674-426741.3971.41
45min146228-462281.5141.453.351.521.463.22
244733-447331.4651.48
344598-445981.4601.47
444872-448721.4691.48
542075-420751.3781.39
643004-430041.4081.42
60min146008-460081.5071.483.291.521.493.22
245482-454821.4891.50
345913-459131.5031.52
446416-464161.5201.53
543764-437641.4331.45
642688-426881.3981.41
极限145347-453471.4851.463.751.501.483.61
246257-462571.5151.53
345411-454111.4871.50
445620-456201.4941.51
542250-422501.3831.40
642785-427851.4011.42
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