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%
19.893043586304374430435583043201304272030433620.02
29.943029047302892930289880.01
单位质量响应值RSD%判断
307721.13304727.160.70数据可信
供试品溶液-8149401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%
5min131644-316441.0291.007.311.031.007.26
233479-334791.0891.09
330710-307100.9991.00
432996-329961.0731.07
528191-281910.9170.92
628353-283530.9220.92
10min136183-361831.1771.185.501.181.185.39
238470-384701.2511.25
334348-343481.1171.12
438828-388281.2631.26
535555-355551.1561.16
634208-342081.1131.11
15min136168-361681.1761.128.441.181.128.55
238586-385861.2551.26
331525-315251.0251.03
434773-347731.1311.13
534386-343861.1181.12
630795-307951.0021.00
20min133742-337421.0971.068.561.101.078.59
237309-373091.2141.22
329952-299520.9740.98
432067-320671.0431.05
533000-330001.0731.08
629792-297920.9690.97
30min133741-337411.0971.094.271.101.104.15
235824-358241.1651.17
332029-320291.0421.05
434111-341111.1091.12
533277-332771.0821.09
632019-320191.0411.05
45min132846-328461.0681.085.421.081.085.35
236136-361361.1751.18
332042-320421.0421.05
433954-339541.1041.11
532719-327191.0641.07
630895-308951.0051.01
60min132906-329061.0701.085.991.081.096.12
234788-347881.1321.14
331438-314381.0231.03
436525-365251.1881.20
531524-315241.0251.03
632630-326301.0611.07
极限137611-376111.2231.107.141.231.116.86
235044-350441.1401.15
331886-318861.0371.05
432316-323161.0511.06
534255-342551.1141.13
631189-311891.0141.03
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%
19.893035991303651830378003039401303780430375030.05
29.943039847303845430391500.04
单位质量响应值RSD%判断
307128.72305749.500.32数据可信
供试品溶液-8149401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%
5min131401-314011.0211.125.701.021.125.79
235661-356611.1591.16
332764-327641.0651.06
436140-361401.1751.17
535863-358631.1661.17
635457-354571.1521.15
10min129611-296110.9621.1912.200.961.1912.27
240396-403961.3131.31
332616-326161.0601.06
439277-392771.2771.28
539638-396381.2881.29
638715-387151.2581.26
15min131346-313461.0191.2010.551.021.2010.68
239902-399021.2971.30
332653-326531.0611.06
439870-398701.2961.30
539493-394931.2841.29
638415-384151.2491.25
20min133629-336291.0931.198.771.101.208.65
238522-385221.2521.26
333102-331021.0761.08
439958-399581.2991.30
540129-401291.3041.31
634790-347901.1311.14
30min133390-333901.0851.187.871.091.188.03
237581-375811.2211.23
334092-340921.1081.11
438588-385881.2541.26
539956-399561.2991.31
633670-336701.0941.10
45min133160-331601.0781.146.951.091.156.96
236840-368401.1971.21
333407-334071.0861.09
436139-361391.1751.18
538511-385111.2521.26
632403-324031.0531.06
60min133509-335091.0891.156.411.101.166.34
236679-366791.1921.20
333930-339301.1031.11
436901-369011.1991.21
538851-388511.2631.27
633296-332961.0821.09
极限134169-341691.1111.146.921.121.167.05
236986-369861.2021.22
333619-336191.0931.10
435445-354451.1521.17
538860-388601.2631.28
632113-321131.0441.06
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%
19.893038532303746730393473038876303942730387300.03
29.943044686303551630401010.22
单位质量响应值RSD%判断
307252.78305845.170.33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%
5min121082-210820.6850.7320.330.680.7220.16
217464-174640.5670.57
329046-290460.9440.94
425845-258450.8400.84
522926-229260.7450.74
617849-178490.5800.58
10min132156-321561.0451.104.091.051.103.99
235732-357321.1611.16
334675-346751.1271.13
433940-339401.1031.10
533476-334761.0881.09
632324-323241.0501.05
15min135663-356631.1591.049.891.161.049.90
232343-323431.0511.05
335199-351991.1441.15
431444-314441.0221.02
527275-272750.8860.89
630136-301360.9790.98
20min138514-385141.2511.128.011.261.128.23
236517-365171.1861.19
334241-342411.1131.12
433494-334941.0881.09
531017-310171.0081.01
632328-323281.0501.05
30min139670-396701.2891.139.131.301.149.27
236752-367521.1941.20
335760-357601.1621.17
433110-331101.0761.08
530630-306300.9951.00
633395-333951.0851.09
45min139259-392591.2761.175.571.281.185.53
237833-378331.2291.24
336028-360281.1711.18
434522-345221.1221.13
534274-342741.1141.12
634908-349081.1341.14
60min138997-389971.2671.1510.331.281.1610.36
238823-388231.2611.27
335898-358981.1661.18
432288-322881.0491.06
529959-299590.9730.98
637163-371631.2071.22
极限135086-350861.1401.134.151.151.154.19
237698-376981.2251.24
333775-337751.0971.11
434205-342051.1111.12
534724-347241.1281.14
634054-340541.1061.12
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%
19.893036607303781330362993036045303621430365960.03
29.943028609302905430288320.02
单位质量响应值RSD%判断
307037.01304711.470.54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%
5min121998-219980.7160.6726.130.720.6725.82
218642-186420.6070.61
325360-253600.8260.83
423407-234070.7620.76
510607-106070.3450.35
623435-234350.7630.76
10min134176-341761.1131.078.711.111.078.81
232319-323191.0521.05
337367-373671.2171.22
432221-322211.0491.05
532792-327921.0681.07
628579-285790.9310.93
15min127178-271780.8851.017.840.891.027.74
230809-308091.0031.01
331030-310301.0101.01
430305-303050.9870.99
533533-335331.0921.09
633858-338581.1031.11
20min137563-375631.2231.177.311.231.177.38
234013-340131.1081.11
339803-398031.2961.30
432477-324771.0581.06
534848-348481.1351.14
636212-362121.1791.18
30min132496-324961.0581.104.021.061.114.11
234021-340211.1081.11
334806-348061.1331.14
431961-319611.0411.05
534808-348081.1331.14
635293-352931.1491.16
45min136123-361231.1761.145.301.181.155.34
235074-350741.1421.15
336458-364581.1871.20
431408-314081.0231.03
535451-354511.1541.16
635941-359411.1701.18
60min130563-305630.9951.126.891.001.127.03
236852-368521.2001.21
333837-338371.1021.11
432661-326611.0641.07
535705-357051.1631.17
635857-358571.1681.18
极限135014-350141.1401.134.391.151.144.34
234701-347011.1301.14
335284-352841.1491.16
431855-318551.0371.05
534705-347051.1301.14
636427-364271.1861.20
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