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 3024408302265130218533020425302142330221520.05
29.943029277302918430292300.01
单位质量响应值RSD%判断
305576.54304751.510.20数据可信
供试品溶液-8149401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%
5min140249-402491.3141.2111.221.311.2111.07
235269-352691.1511.15
340115-401151.3091.31
441450-414501.3531.35
530893-308931.0081.01
634565-345651.1281.13
10min146549-465491.5191.485.271.521.485.20
245903-459031.4981.50
347281-472811.5431.55
445733-457331.4931.49
540563-405631.3241.33
645370-453701.4811.48
15min147148-471481.5391.532.121.541.542.31
246218-462181.5081.51
346915-469151.5311.54
447528-475281.5511.56
548474-484741.5821.59
645648-456481.4901.49
20min145729-457291.4931.501.721.501.511.73
245450-454501.4831.49
345990-459901.5011.51
447353-473531.5461.55
546567-465671.5201.53
645266-452661.4771.48
30min143776-437761.4291.472.791.441.482.67
243572-435721.4221.43
344941-449411.4671.48
446015-460151.5021.51
546744-467441.5261.53
644586-445861.4551.46
45min142695-426951.3931.433.121.401.443.16
242216-422161.3781.39
343892-438921.4331.44
444689-446891.4591.47
545837-458371.4961.51
643042-430421.4051.42
60min140624-406241.3261.384.951.341.404.92
240686-406861.3281.34
342377-423771.3831.40
443024-430241.4041.42
546202-462021.5081.52
641382-413821.3511.36
极限140728-407281.3291.331.851.341.341.68
239630-396301.2931.31
341625-416251.3591.37
441225-412251.3461.36
541364-413641.3501.36
640316-403161.3161.33
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%
19.89 3032135303271230324003034130303241730327590.03
29.943033279303490130340900.04
单位质量响应值RSD%判断
306649.04305240.440.33数据可信
供试品溶液-8149401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%
5min134911-349111.1371.148.041.141.147.96
237456-374561.2191.22
337492-374921.2211.22
433418-334181.0881.09
530381-303810.9890.99
636907-369071.2021.20
10min144472-444721.4481.461.921.451.462.04
245548-455481.4831.48
345622-456221.4851.49
444588-445881.4521.45
543373-433731.4121.41
645296-452961.4751.48
15min146638-466381.5181.501.471.521.501.43
246965-469651.5291.53
345053-450531.4671.47
446056-460561.4991.50
545693-456931.4881.49
645978-459781.4971.50
20min146239-462391.5051.472.051.511.482.07
246683-466831.5201.53
344539-445391.4501.46
445025-450251.4661.47
544661-446611.4541.46
644636-446361.4531.46
30min145662-456621.4871.432.991.491.442.90
245452-454521.4801.49
343403-434031.4131.42
443465-434651.4151.42
543355-433551.4111.42
642398-423981.3801.39
45min143361-433611.4121.382.801.421.392.63
243992-439921.4321.44
341059-410591.3371.35
442941-429411.3981.41
541390-413901.3471.36
641709-417091.3581.37
60min141596-415961.3541.322.721.371.342.63
241377-413771.3471.36
339797-397971.2961.31
441380-413801.3471.36
540567-405671.3211.33
638783-387831.2631.28
极限140883-408831.3311.312.581.351.332.50
241332-413321.3461.36
340633-406331.3231.34
440745-407451.3261.34
538490-384901.2531.27
639701-397011.2921.31
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%
19.89 3022582302237530302783026067302840330259410.12
29.943035832303779430368130.05
单位质量响应值RSD%判断
305959.66305514.390.11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%
5min147560-475601.5491.388.581.551.388.63
243855-438551.4291.43
342754-427541.3931.39
442762-427621.3931.39
537104-371041.2091.21
639418-394181.2841.28
10min131600-316001.0291.3712.281.031.3712.31
244306-443061.4431.45
343043-430431.4021.40
443877-438771.4291.43
543797-437971.4271.43
645381-453811.4781.48
15min147568-475681.5501.502.181.551.502.05
246310-463101.5091.51
346432-464321.5131.52
445563-455631.4841.49
545475-454751.4811.49
644704-447041.4561.46
20min146280-462801.5081.521.121.511.531.22
246061-460611.5011.51
346722-467221.5221.53
446759-467591.5231.53
546530-465301.5161.52
647574-475741.5501.56
30min144601-446011.4531.512.891.461.522.83
246289-462891.5081.52
346331-463311.5091.52
445665-456651.4881.50
545812-458121.4921.50
648638-486381.5841.59
45min145103-451031.4691.512.361.481.532.37
245328-453281.4771.49
346553-465531.5171.53
446630-466301.5191.53
547560-475601.5491.56
647720-477201.5551.57
60min144923-449231.4631.523.201.481.533.11
245062-450621.4681.48
346371-463711.5111.52
446254-462541.5071.52
548042-480421.5651.58
648499-484991.5801.59
极限144463-444631.4481.483.481.461.503.61
243742-437421.4251.44
346074-460741.5011.52
444409-444091.4471.46
547586-475861.5501.57
647102-471021.5341.55
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 3032857303270630332523030388303199730322400.04
29.943036222303620030362110.01
单位质量响应值RSD%判断
306596.56305453.820.27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%
5min141532-415321.3521.382.941.351.382.92
241062-410621.3361.34
343629-436291.4201.42
443655-436551.4211.42
543552-435521.4171.42
641470-414701.3501.35
10min145936-459361.4951.462.661.501.462.85
243061-430611.4011.40
346186-461861.5031.51
444665-446651.4541.46
544887-448871.4611.46
643921-439211.4291.43
15min145558-455581.4831.454.561.491.454.58
244090-440901.4351.44
347320-473201.5401.54
444738-447381.4561.46
544119-441191.4361.44
641171-411711.3401.34
20min146741-467411.5211.463.801.531.463.86
245056-450561.4661.47
346094-460941.5001.51
444034-440341.4331.44
545021-450211.4651.47
641924-419241.3641.37
30min147365-473651.5421.483.261.551.483.24
245103-451031.4681.48
346788-467881.5231.53
444907-449071.4621.47
543899-438991.4291.44
643829-438291.4261.43
45min147354-473541.5411.463.381.551.473.38
245030-450301.4661.48
344813-448131.4591.47
444747-447471.4561.47
543987-439871.4321.44
642733-427331.3911.40
60min145235-452351.4721.443.391.491.463.38
246303-463031.5071.52
344741-447411.4561.47
442277-422771.3761.39
544676-446761.4541.47
642907-429071.3961.41
极限146498-464981.5131.462.271.531.472.30
245160-451601.4701.48
345347-453471.4761.49
444023-440231.4331.45
543907-439071.4291.44
644094-440941.4351.45
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