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%
19.893025098302194930186003023122302258830222710.08
29.943018486300717430128300.27
单位质量响应值RSD%判断
305588.57303101.610.58数据可信
供试品溶液-8145830批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130368-303680.9940.944.650.990.944.48
229273-292730.9580.96
327704-277040.9070.91
426564-265640.8690.87
528531-285310.9340.93
629083-290830.9520.95
10min130597-305971.0011.096.441.001.096.59
233744-337441.1041.11
332615-326151.0671.07
434902-349021.1421.14
531825-318251.0421.04
636518-365181.1951.20
15min128539-285390.9341.017.450.941.027.42
231422-314221.0281.03
329685-296850.9710.97
429486-294860.9650.97
531264-312641.0231.03
635005-350051.1461.15
20min129976-299760.9811.026.180.991.036.05
232437-324371.0621.07
330018-300180.9820.99
430539-305390.9991.00
530011-300110.9820.99
634718-347181.1361.14
30min129989-299890.9811.054.820.991.064.63
231539-315391.0321.04
331984-319841.0471.05
431826-318261.0421.05
533412-334121.0931.10
634446-344461.1271.13
45min131660-316601.0361.073.291.041.083.50
232323-323231.0581.07
333332-333321.0911.10
431318-313181.0251.03
533955-339551.1111.12
633533-335331.0971.11
60min130532-305320.9991.075.551.011.085.44
231023-310231.0151.02
333681-336811.1021.11
432579-325791.0661.08
535297-352971.1551.16
633880-338801.1091.12
极限132512-325121.0641.104.881.071.115.07
231824-318241.0411.05
335073-350731.1481.16
432458-324581.0621.07
535895-358951.1751.19
633137-331371.0841.10
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%
19.893021007300686730181593014202301012930140730.20
29.943013912302497530194440.26
单位质量响应值RSD%判断
304759.66303767.000.24数据可信
供试品溶液-8145830批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132099-320991.0510.994.081.050.994.11
228731-287310.9410.94
330498-304980.9981.00
430977-309771.0141.01
529116-291160.9530.95
630586-305861.0011.00
10min137913-379131.2411.166.521.241.166.43
233238-332381.0881.09
333009-330091.0811.08
436076-360761.1811.18
534048-340481.1151.12
638188-381881.2501.25
15min134985-349851.1451.135.671.151.135.72
235122-351221.1501.15
331900-319001.0441.05
434871-348711.1411.14
532622-326221.0681.07
637335-373351.2221.23
20min130219-302190.9891.065.500.991.075.73
233957-339571.1121.12
330859-308591.0101.01
434656-346561.1341.14
531876-318761.0431.05
633408-334081.0941.10
30min131250-312501.0231.054.291.031.064.32
233174-331741.0861.09
330788-307881.0081.01
434376-343761.1251.13
531689-316891.0371.04
631328-313281.0261.03
45min131912-319121.0451.053.621.051.063.35
233071-330711.0831.09
331454-314541.0301.04
433144-331441.0851.09
532753-327531.0721.08
630152-301520.9871.00
60min131644-316441.0361.053.831.051.064.03
231999-319991.0471.06
330968-309681.0141.02
434383-343831.1261.14
531823-318231.0421.05
631239-312391.0231.03
极限131554-315541.0331.032.861.041.042.89
231848-318481.0431.05
331264-312641.0231.03
433131-331311.0851.10
531384-313841.0271.04
630406-304060.9951.01
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%
19.893007934300637330120683025201301475030132650.25
29.943009948301177730108620.05
单位质量响应值RSD%判断
304677.96302903.620.42数据可信
供试品溶液-20211227批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128716-287160.9410.966.400.940.966.40
231267-312671.0251.03
325864-258640.8480.85
428936-289360.9490.95
530272-302720.9920.99
629938-299380.9820.98
10min129435-294350.9651.2010.580.971.2010.43
237943-379431.2441.25
336465-364651.1961.20
436354-363541.1921.19
540625-406251.3321.33
638984-389841.2781.28
15min132123-321231.0531.2510.151.061.2510.16
240003-400031.3121.31
339584-395841.2981.30
434503-345031.1311.13
541549-415491.3621.37
640952-409521.3431.35
20min136179-361791.1861.268.761.191.268.68
238089-380891.2491.25
340673-406731.3341.34
433008-330081.0821.09
541253-412531.3531.36
641376-413761.3571.36
30min136737-367371.2041.285.911.211.295.93
238071-380711.2481.26
340663-406631.3331.34
436359-363591.1921.20
541250-412501.3521.36
641421-414211.3581.37
45min136783-367831.2061.275.641.211.285.64
237296-372961.2231.23
341081-410811.3471.36
436503-365031.1971.21
540998-409981.3441.35
640357-403571.3231.33
60min136904-369041.2101.264.931.221.285.06
236805-368051.2071.22
340472-404721.3271.34
436648-366481.2021.21
540366-403661.3231.34
639858-398581.3071.32
极限137282-372821.2221.254.211.231.264.44
235398-353981.1611.17
339139-391391.2831.30
437880-378801.2421.25
539400-394001.2921.31
639547-395471.2971.31
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%
19.893002859300669130001413008799301546730067910.20
29.943001856298805729949560.33
单位质量响应值RSD%判断
304023.36301303.420.64数据可信
供试品溶液-20211227批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128866-288660.9500.924.590.950.924.48
226993-269930.8880.89
330093-300930.9900.99
426893-268930.8850.89
528264-282640.9300.93
627068-270680.8910.89
10min133216-332161.0931.1010.671.091.1010.61
231092-310921.0231.02
338646-386461.2721.27
429379-293790.9670.97
536788-367881.2111.21
631678-316781.0421.04
15min136949-369491.2161.205.221.221.205.49
237339-373391.2291.23
338337-383371.2621.27
433731-337311.1101.11
537741-377411.2421.25
634358-343581.1311.13
20min137114-371141.2211.215.401.231.225.39
237058-370581.2201.22
339759-397591.3081.31
434325-343251.1301.13
538174-381741.2561.26
635027-350271.1531.16
30min137259-372591.2261.243.201.231.253.15
238086-380861.2531.26
339616-396161.3041.31
436684-366841.2071.21
538483-384831.2661.27
636439-364391.1991.21
45min138643-386431.2721.243.331.281.253.28
238227-382271.2581.27
337975-379751.2501.26
435844-358441.1801.19
538716-387161.2741.28
636231-362311.1921.20
60min137599-375991.2371.212.531.251.222.67
237865-378651.2461.26
336926-369261.2151.23
436358-363581.1961.21
536316-363161.1951.21
635331-353311.1631.17
极限137837-378371.2451.215.131.261.225.10
237523-375231.2351.25
337175-371751.2231.24
436146-361461.1901.20
538011-380111.2511.26
633032-330321.0871.10
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