塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.042998945299631329990892998256299402429973250.08
210.013020897302309030219940.06
单位质量响应值RSD%判断
298538.35301897.500.80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%
5min118460-184600.6120.613.840.610.613.74
217375-173750.5760.58
319576-195760.6490.65
418435-184350.6120.61
518166-181660.6030.60
618318-183180.6080.61
10min133491-334911.1111.142.531.111.142.63
234217-342171.1351.14
335708-357081.1851.19
433375-333751.1071.11
534477-344771.1441.15
634717-347171.1521.15
15min139130-391301.2981.282.871.301.282.86
238254-382541.2691.27
338541-385411.2791.28
438257-382571.2691.27
540306-403061.3371.34
636963-369631.2261.23
20min139182-391821.3001.283.131.311.283.22
238794-387941.2871.29
339327-393271.3051.31
438851-388511.2891.29
538572-385721.2801.29
636067-360671.1971.20
30min138570-385701.2801.253.391.291.263.41
237969-379691.2601.27
337848-378481.2561.26
438049-380491.2621.27
537873-378731.2571.27
635010-350101.1621.17
45min136066-360661.1971.212.861.211.222.87
236168-361681.2001.21
338083-380831.2631.27
436820-368201.2221.23
537212-372121.2351.25
635068-350681.1631.17
60min137001-370011.2281.185.601.241.195.56
235854-358541.1901.20
335670-356701.1831.20
435521-355211.1781.19
537598-375981.2471.26
631899-318991.0581.07
极限135653-356531.1831.182.121.201.202.10
235495-354951.1781.19
336041-360411.1961.21
435996-359961.1941.21
536202-362021.2011.22
634152-341521.1331.15
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.043008313300772730074403009640300944430085130.04
210.013017270301642930168500.02
单位质量响应值RSD%判断
299652.69301383.620.41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%
5min116088-160880.5330.5314.550.530.5214.85
215447-154470.5120.51
319553-195530.6480.65
412465-124650.4130.41
516744-167440.5550.55
615125-151250.5010.50
10min133302-333021.1041.104.051.101.104.27
233978-339781.1261.13
334537-345371.1451.15
431399-313991.0411.04
533904-339041.1241.12
631496-314961.0441.04
15min137862-378621.2551.232.911.261.232.97
237240-372401.2341.24
337724-377241.2501.25
437621-376211.2471.25
537064-370641.2281.23
634963-349631.1591.16
20min137484-374841.2421.251.461.251.251.57
238094-380941.2631.27
338059-380591.2611.27
437047-370471.2281.23
538170-381701.2651.27
636964-369641.2251.23
30min136727-367271.2171.206.121.231.215.89
231926-319261.0581.07
336478-364781.2091.22
436179-361791.1991.21
537551-375511.2451.25
638188-381881.2661.27
45min135703-357031.1831.155.521.191.165.46
236373-363731.2061.22
335631-356311.1811.19
431048-310481.0291.04
535392-353921.1731.18
634802-348021.1531.16
60min134917-349171.1571.171.571.171.181.52
234386-343861.1401.15
335182-351821.1661.18
435625-356251.1811.19
535637-356371.1811.19
635872-358721.1891.20
极限134618-346181.1471.151.161.161.161.38
234590-345901.1461.16
334493-344931.1431.16
434099-340991.1301.14
534601-346011.1471.16
635319-353191.1711.19
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.042948608294954529481622948249294390629476940.08
210.012992943299400129934720.03
单位质量响应值RSD%判断
293595.02299048.151.31数据可信
供试品溶液-20211229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%
5min127697-276970.9311.024.890.931.024.94
232071-320711.0781.08
330671-306711.0311.03
429986-299861.0081.01
531020-310201.0431.04
629783-297831.0011.00
10min137114-371141.2481.274.721.251.284.76
238935-389351.3091.31
340651-406511.3661.37
436256-362561.2191.22
538197-381971.2841.29
635899-358991.2071.21
15min138880-388801.3071.335.131.311.335.17
240589-405891.3641.37
343064-430641.4481.45
438667-386671.3001.30
537182-371821.2501.25
639047-390471.3131.32
20min138501-385011.2941.302.191.301.312.09
239369-393691.3231.33
339996-399961.3441.35
438637-386371.2991.31
538978-389781.3101.32
637481-374811.2601.27
30min139461-394611.3261.312.941.341.322.86
239052-390521.3131.32
339389-393891.3241.33
437407-374071.2571.27
540535-405351.3631.37
637890-378901.2741.28
45min136596-365961.2301.242.371.241.262.51
236181-361811.2161.23
338217-382171.2851.30
436558-365581.2291.24
537899-378991.2741.29
636319-363191.2211.23
60min134040-340401.1441.204.901.161.225.02
236034-360341.2111.23
338138-381381.2821.30
434178-341781.1491.16
537186-371861.2501.27
634321-343211.1541.17
极限130701-307011.0321.167.461.051.187.31
235260-352601.1851.20
337202-372021.2511.27
432103-321031.0791.10
536586-365861.2301.25
635273-352731.1861.20
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.042859054285548428591142857586287117528604830.22
210.012854073285438428542280.01
单位质量响应值RSD%判断
284908.67285137.660.06数据可信
供试品溶液-20211229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%
5min129254-292541.0221.032.361.021.022.60
228450-284500.9940.99
328931-289311.0111.01
429549-295491.0331.03
529409-294091.0281.03
630508-305081.0661.07
10min135856-358561.2531.261.841.261.261.62
235541-355411.2421.24
335868-358681.2531.26
436652-366521.2811.28
536995-369951.2931.29
635286-352861.2331.24
15min137196-371961.3001.292.001.301.291.81
235866-358661.2531.26
336788-367881.2861.29
437068-370681.2951.30
538028-380281.3291.33
636431-364311.2731.28
20min138035-380351.3291.311.261.341.321.42
236938-369381.2911.30
337399-373991.3071.31
437076-370761.2961.30
537340-373401.3051.31
638068-380681.3301.34
30min136444-364441.2741.262.431.281.272.43
237071-370711.2951.30
336342-363421.2701.28
434481-344811.2051.21
535733-357331.2491.26
636051-360511.2601.27
45min135325-353251.2341.212.891.251.222.80
233655-336551.1761.19
335749-357491.2491.26
434110-341101.1921.20
535247-352471.2321.24
633340-333401.1651.18
60min134705-347051.2131.182.201.231.192.22
233119-331191.1571.17
334600-346001.2091.22
433223-332231.1611.18
533485-334851.1701.18
633177-331771.1591.17
极限134360-343601.2011.154.441.221.174.50
234594-345941.2091.23
331388-313881.0971.11
431224-312241.0911.11
533362-333621.1661.18
632366-323661.1311.15
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.042866300286416528740712863434287223428680410.17
210.012861249284949028553700.30
单位质量响应值RSD%判断
285661.45285251.750.11数据可信
供试品溶液-20211228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%
5min114333-143330.5000.5317.190.500.5217.07
213226-132260.4610.46
311136-111360.3890.39
417544-175440.6120.61
517207-172070.6000.60
616928-169280.5910.59
10min132507-325071.1341.174.941.141.174.94
231339-313391.0931.09
332824-328241.1451.15
435815-358151.2501.25
533718-337181.1761.18
634939-349391.2191.22
15min134937-349371.2191.282.721.221.292.73
236468-364681.2721.28
337374-373741.3041.31
436876-368761.2871.29
537544-375441.3101.31
637521-375211.3091.31
20min135856-358561.2511.312.431.261.322.30
237671-376711.3141.32
337921-379211.3231.33
438332-383321.3371.34
538172-381721.3321.34
638065-380651.3281.33
30min133688-336881.1751.254.811.181.264.89
237170-371701.2971.31
333496-334961.1691.18
436356-363561.2691.28
537056-370561.2931.30
636879-368791.2871.30
45min147645-476451.6621.3214.381.671.3414.16
240967-409671.4291.44
336603-366031.2771.29
435010-350101.2221.23
534095-340951.1901.20
633385-333851.1651.18
60min137836-378361.3201.234.631.331.244.52
236103-361031.2601.27
335988-359881.2561.27
433825-338251.1801.19
534343-343431.1981.21
633664-336641.1751.19
极限133177-331771.1581.203.831.171.223.73
235042-350421.2231.24
336306-363061.2671.28
432692-326921.1411.16
534666-346661.2101.23
634863-348631.2161.23
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.042874186287050828731252884313289872328801710.41
210.012880534287057228755530.25
单位质量响应值RSD%判断
286869.62287268.030.10数据可信
供试品溶液-20211228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%
5min117509-175090.6070.5918.010.610.5818.06
213937-139370.4840.48
321433-214330.7440.74
418902-189020.6560.66
515996-159960.5550.55
613475-134750.4680.47
10min132623-326231.1321.175.381.131.165.23
232889-328891.1411.14
336404-364041.2631.26
434934-349341.2121.21
533408-334081.1591.16
631328-313281.0871.09
15min135688-356881.2381.292.111.241.292.22
236919-369191.2811.28
337558-375581.3031.31
437372-373721.2971.30
537332-373321.2951.30
637935-379351.3161.32
20min136151-361511.2541.283.951.261.293.84
236312-363121.2601.27
334934-349341.2121.22
438804-388041.3461.35
538199-381991.3251.33
637741-377411.3091.32
30min134354-343541.1921.274.171.201.284.11
236104-361041.2531.26
335608-356081.2351.24
437274-372741.2931.30
538119-381191.3231.33
638190-381901.3251.33
45min132423-324231.1251.234.491.141.244.33
235706-357061.2391.25
334603-346031.2011.21
436225-362251.2571.27
536659-366591.2721.28
636263-362631.2581.27
60min132434-324341.1251.195.121.141.215.09
232231-322311.1181.13
334968-349681.2131.23
434398-343981.1931.21
536125-361251.2531.27
636286-362861.2591.27
极限130571-305711.0611.177.821.081.187.62
230789-307891.0681.08
333674-336741.1681.18
434721-347211.2051.22
535588-355881.2351.25
637141-371411.2891.30
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