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%
19.893029593302928830285013023454302805130277770.09
29.943016959300749130122250.23
单位质量响应值RSD%判断
306145.30303040.740.73数据可信
供试品溶液-8149402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%
5min129072-290720.9510.955.460.950.955.21
227678-276780.9050.91
327417-274170.8970.90
427768-277680.9080.91
530197-301970.9870.99
631313-313131.0241.02
10min133199-331991.0861.1210.691.091.1210.65
229132-291320.9530.95
331926-319261.0441.05
434513-345131.1291.13
538189-381891.2491.25
638589-385891.2621.26
15min129893-298930.9781.0812.890.981.0812.92
229038-290380.9500.95
330794-307941.0071.01
432022-320221.0471.05
538997-389971.2751.28
637915-379151.2401.24
20min131065-310651.0161.0611.141.021.0711.12
231083-310831.0161.02
330107-301070.9850.99
428722-287220.9390.94
536796-367961.2031.21
637299-372991.2201.22
30min132067-320671.0491.086.541.051.096.72
231412-314121.0271.03
332354-323541.0581.06
431216-312161.0211.03
535290-352901.1541.16
636346-363461.1891.20
45min131599-315991.0331.057.321.041.067.43
230464-304640.9961.00
331105-311051.0171.02
430119-301190.9850.99
534093-340931.1151.12
636111-361111.1811.19
60min131160-311601.0191.066.501.031.066.35
230505-305050.9981.01
331240-312401.0221.03
431062-310621.0161.02
533756-337561.1041.11
635863-358631.1731.18
极限129932-299320.9791.047.630.991.057.77
228506-285060.9320.94
330898-308981.0101.02
432568-325681.0651.08
533715-337151.1021.11
634951-349511.1431.16
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%
19.893015441301412830165693015499301446930152210.04
29.943010518300551630080170.12
单位质量响应值RSD%判断
304875.73302617.400.53数据可信
供试品溶液-8149402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%
5min130563-305631.0020.985.991.000.985.88
231788-317881.0421.04
330182-301820.9900.99
429771-297710.9760.98
530520-305201.0011.00
626488-264880.8690.87
10min138612-386121.2661.227.841.271.227.87
237914-379141.2431.24
336396-363961.1931.19
438268-382681.2551.26
539895-398951.3081.31
631651-316511.0381.04
15min138669-386691.2681.225.921.271.225.85
238151-381511.2511.25
335320-353201.1581.16
436527-365271.1981.20
540167-401671.3171.32
634295-342951.1251.13
20min135985-359851.1801.164.711.191.174.75
236704-367041.2041.21
333872-338721.1111.12
434645-346451.1361.14
537861-378611.2411.25
633668-336681.1041.11
30min134747-347471.1391.132.301.151.142.22
234904-349041.1451.15
333012-330121.0821.09
434420-344201.1291.14
535251-352511.1561.16
634777-347771.1401.15
45min134084-340841.1181.122.791.131.122.86
234998-349981.1481.16
332362-323621.0611.07
434180-341801.1211.13
534752-347521.1401.15
633638-336381.1031.11
60min133508-335081.0991.112.711.111.122.77
234645-346451.1361.15
334272-342721.1241.13
434126-341261.1191.13
533611-336111.1021.11
632047-320471.0511.06
极限133435-334351.0961.102.381.111.112.28
234846-348461.1431.15
333018-330181.0831.09
432819-328191.0761.09
534130-341301.1191.13
633006-330061.0821.09
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%
19.893011318301711830107403009612301576430129100.12
29.943015579301331530144470.06
单位质量响应值RSD%判断
304642.06303264.290.33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%
5min119185-191850.6290.7720.700.630.7720.44
220664-206640.6770.68
319197-191970.6290.63
427212-272120.8920.89
531233-312331.0231.02
623702-237020.7770.78
10min135224-352241.1541.146.261.161.146.26
236364-363641.1921.19
335349-353491.1581.16
434189-341891.1201.12
536811-368111.2061.21
630763-307631.0081.01
15min131042-310421.0171.0910.051.021.0910.14
230657-306571.0051.01
331445-314451.0301.03
435115-351151.1511.15
539136-391361.2821.29
631624-316241.0361.04
20min135828-358281.1741.205.851.181.205.87
238469-384691.2611.26
334955-349551.1451.15
437081-370811.2151.22
539504-395041.2941.30
633883-338831.1101.11
30min136282-362821.1891.139.241.191.149.07
231941-319411.0471.05
332389-323891.0611.07
435418-354181.1611.17
539893-398931.3071.31
631832-318321.0431.05
45min136959-369591.2111.205.601.221.215.81
236111-361111.1831.19
334067-340671.1161.12
436618-366181.2001.21
540214-402141.3181.33
635597-355971.1661.17
60min136692-366921.2021.0910.631.211.1010.72
230480-304800.9991.01
331298-312981.0261.03
432814-328141.0751.09
538622-386221.2661.28
630034-300340.9840.99
极限137452-374521.2271.165.921.241.176.07
234667-346671.1361.15
332895-328951.0781.09
434510-345101.1311.14
538227-382271.2531.27
633968-339681.1131.12
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%
19.893023553302260830204273023832302397930228800.05
29.943010151300989530100230.01
单位质量响应值RSD%判断
305650.15302819.220.66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%
5min116866-168660.5520.6424.840.550.6425.06
220944-209440.6860.69
314153-141530.4630.46
423607-236070.7730.77
515387-153870.5040.50
626286-262860.8610.86
10min134513-345131.1301.0910.541.131.0910.53
233892-338921.1101.11
329231-292310.9570.96
433470-334701.0961.10
529475-294750.9650.97
638600-386001.2641.27
15min129723-297230.9731.037.090.981.037.13
228463-284630.9320.93
332252-322521.0561.06
432488-324881.0641.07
531118-311181.0191.02
634806-348061.1391.14
20min133227-332271.0881.094.541.091.104.61
231739-317391.0391.04
334489-344891.1291.13
432688-326881.0701.07
532507-325071.0641.07
635904-359041.1751.18
30min133574-335741.0991.133.701.101.133.69
232788-327881.0731.08
336534-365341.1961.20
434713-347131.1361.14
534313-343131.1231.13
634790-347901.1391.15
45min133077-330771.0831.096.701.091.106.57
230980-309801.0141.02
335584-355841.1651.17
430535-305351.0001.01
533759-337591.1051.11
635837-358371.1731.18
60min132984-329841.0801.126.861.091.137.00
231008-310081.0151.02
337520-375201.2281.24
433818-338181.1071.12
533676-336761.1031.11
636326-363261.1891.20
极限131257-312571.0231.056.151.031.066.14
229646-296460.9710.98
334314-343141.1231.13
429977-299770.9810.99
532635-326351.0681.08
633855-338551.1081.12
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