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%
110.042889982288940828780852876420288225428832300.22
210.012883188289019928866940.18
单位质量响应值RSD%判断
287174.30288381.020.30数据可信
供试品溶液-2026010811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%
5min131087-310871.0761.069.351.081.069.33
225887-258870.8960.90
334842-348421.2061.21
431408-314081.0871.09
530760-307601.0651.06
630282-302821.0481.05
10min137118-371181.2851.304.581.291.304.54
236257-362571.2551.26
340462-404621.4001.40
438522-385221.3331.34
536148-361481.2511.25
636284-362841.2561.26
15min137471-374711.2971.322.071.301.332.10
238820-388201.3441.35
339357-393571.3621.37
437994-379941.3151.32
538290-382901.3251.33
637315-373151.2911.30
20min137385-373851.2941.322.331.301.322.32
239429-394291.3651.37
338275-382751.3251.33
438615-386151.3361.34
537475-374751.2971.30
637129-371291.2851.29
30min135876-358761.2421.253.861.251.264.02
237207-372071.2881.30
337401-374011.2941.31
436472-364721.2621.27
535404-354041.2251.24
633643-336431.1641.17
45min134456-344561.1931.195.411.201.205.20
235573-355731.2311.24
335527-355271.2301.24
434755-347551.2031.22
535339-353391.2231.24
630723-307231.0631.08
60min134750-347501.2031.164.261.221.184.12
231920-319201.1051.12
334535-345351.1951.21
434252-342521.1851.20
534295-342951.1871.20
631520-315201.0911.11
极限134226-342261.1851.124.541.201.144.56
233586-335861.1621.18
332809-328091.1361.15
431608-316081.0941.11
530250-302501.0471.06
631625-316251.0951.11
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%
110.042874866288722328739572884465288134328803710.21
210.012873569286326028684140.26
单位质量响应值RSD%判断
286889.54286554.850.09数据可信
供试品溶液-2026010811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%
5min129352-293521.0201.0210.611.021.0210.41
231409-314091.0911.09
332662-326621.1351.13
432011-320111.1121.11
525214-252140.8760.88
626248-262480.9120.91
10min136900-369001.2821.292.951.281.293.01
237626-376261.3071.31
338137-381371.3251.33
437651-376511.3081.31
535073-350731.2181.22
636769-367691.2771.28
15min137544-375441.3041.313.441.311.323.39
235420-354201.2301.24
337914-379141.3171.32
439167-391671.3611.37
537527-375271.3041.31
638621-386211.3421.35
20min138463-384631.3361.332.121.341.332.11
236718-367181.2751.28
338024-380241.3211.33
439075-390751.3571.36
538371-383711.3331.34
638567-385671.3401.35
30min137054-370541.2871.283.251.301.293.24
234620-346201.2031.21
336525-365251.2691.28
438107-381071.3241.33
537236-372361.2931.30
637461-374611.3011.31
45min134963-349631.2151.242.061.231.251.96
234773-347731.2081.22
335627-356271.2381.25
436819-368191.2791.29
535960-359601.2491.26
635735-357351.2411.25
60min134886-348861.2121.278.631.231.298.60
236930-369301.2831.30
342722-427221.4841.50
435990-359901.2501.27
534245-342451.1901.20
634742-347421.2071.22
极限136080-360801.2531.4321.081.271.4520.76
241510-415101.4421.46
357385-573851.9932.01
436530-365301.2691.29
533135-331351.1511.17
643120-431201.4981.52
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%
110.043014511301200230138273014742301868230147530.09
210.012996636299569029961630.03
单位质量响应值RSD%判断
300274.20299316.980.23数据可信
供试品溶液-2026010911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%
5min130946-309461.0281.072.971.031.072.98
233091-330911.0991.10
331445-314451.0451.04
432093-320931.0661.07
533483-334831.1121.11
632391-323911.0761.08
10min139123-391231.3001.292.961.301.292.97
238774-387741.2881.29
336976-369761.2281.23
440546-405461.3471.35
539095-390951.2991.30
638709-387091.2861.29
15min142430-424301.4101.324.761.411.334.69
239679-396791.3181.32
336953-369531.2281.23
440805-408051.3561.36
538650-386501.2841.29
640567-405671.3481.35
20min139082-390821.2981.335.501.311.345.35
238382-383821.2751.28
337267-372671.2381.25
440090-400901.3321.34
542874-428741.4241.43
642244-422441.4031.41
30min136641-366411.2171.222.081.231.232.03
235919-359191.1931.20
337773-377731.2551.26
437553-375531.2481.26
536062-360621.1981.21
636908-369081.2261.24
45min135463-354631.1781.234.471.191.244.46
238708-387081.2861.30
335605-356051.1831.19
439419-394191.3101.32
537263-372631.2381.25
636242-362421.2041.22
60min135162-351621.1681.172.971.181.183.10
235742-357421.1871.20
334781-347811.1561.17
436485-364851.2121.23
535414-354141.1771.19
633393-333931.1091.12
极限134607-346071.1501.184.631.171.204.43
236427-364271.2101.23
334627-346271.1501.17
438051-380511.2641.28
533387-333871.1091.13
635157-351571.1681.19
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%
110.043003823300653630061603008314301346130076590.13
210.012986101298764329868720.04
单位质量响应值RSD%判断
299567.63298388.810.28数据可信
供试品溶液-2026010911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%
5min134823-348231.1601.077.171.161.077.22
232968-329681.0981.10
330213-302131.0071.01
432605-326051.0861.09
533592-335921.1191.12
628576-285760.9520.95
10min138770-387701.2921.281.541.291.281.49
237956-379561.2641.27
338978-389781.2981.30
437795-377951.2591.26
537838-378381.2611.26
639033-390331.3001.30
15min137848-378481.2611.292.381.271.302.29
239743-397431.3241.33
340088-400881.3351.34
438816-388161.2931.30
537890-378901.2621.27
638652-386521.2881.29
20min137581-375811.2521.295.101.261.305.18
238704-387041.2891.30
338646-386461.2871.29
442655-426551.4211.43
537068-370681.2351.24
638333-383331.2771.28
30min140909-409091.3631.286.881.371.296.83
237935-379351.2641.27
342206-422061.4061.42
436599-365991.2191.23
536024-360241.2001.21
636206-362061.2061.22
45min140555-405551.3511.285.051.361.294.91
236430-364301.2141.23
335925-359251.1971.21
438193-381931.2721.28
540054-400541.3341.35
639659-396591.3211.33
60min134523-345231.1501.141.611.171.151.71
233140-331401.1041.12
334463-344631.1481.16
434557-345571.1511.17
534323-343231.1431.16
633893-338931.1291.14
极限133721-337211.1231.2214.731.141.2314.52
234688-346881.1561.17
336221-362211.2071.22
434124-341241.1371.15
547305-473051.5761.59
633138-331381.1041.12
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%
110.042885584288200828939832895317288457928882940.21
210.012871543287318628723640.05
单位质量响应值RSD%判断
287678.69286949.450.18数据可信
供试品溶液-2026011011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%
5min131713-317131.0991.088.791.101.088.73
233544-335441.1631.16
326840-268400.9300.93
431245-312451.0831.08
529109-291091.0091.01
634043-340431.1801.18
10min137123-371231.2871.303.691.291.303.84
237130-371301.2871.29
336131-361311.2531.25
437500-375001.3001.30
536278-362781.2581.26
639962-399621.3851.39
15min137893-378931.3141.311.041.321.320.89
238366-383661.3301.33
337863-378631.3131.32
437258-372581.2921.30
537531-375311.3011.31
638076-380761.3201.33
20min137208-372081.2901.301.771.301.311.64
237924-379241.3151.32
338248-382481.3261.33
436794-367941.2751.28
538278-382781.3271.33
636988-369881.2821.29
30min136754-367541.2741.261.451.281.271.36
235859-358591.2431.25
336751-367511.2741.28
436069-360691.2501.26
537015-370151.2831.29
635787-357871.2411.25
45min138502-385021.3351.244.941.351.264.91
237525-375251.3011.31
334036-340361.1801.19
434858-348581.2081.22
535509-355091.2311.24
634684-346841.2021.22
60min133640-336401.1661.213.051.181.223.09
236160-361601.2541.27
335450-354501.2291.24
434584-345841.1991.21
535516-355161.2311.25
633609-336091.1651.18
极限133267-332671.1531.172.311.171.192.34
233455-334551.1601.18
333042-330421.1451.16
434982-349821.2131.23
534622-346221.2001.22
633956-339561.1771.19
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%
110.042865617285526928650072869629285659128624230.22
210.012875417287430128748590.03
单位质量响应值RSD%判断
285101.89287198.700.52数据可信
供试品溶液-2026011011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%
5min130218-302181.0521.035.501.051.035.42
226976-269760.9390.94
328320-283200.9860.99
429999-299991.0441.04
530267-302671.0541.05
631502-315021.0971.10
10min136512-365121.2711.285.051.271.284.93
235632-356321.2401.24
335348-353481.2301.23
435837-358371.2471.25
536171-361711.2591.26
640298-402981.4031.40
15min138698-386981.3471.324.891.351.334.86
237224-372241.2961.30
341321-413211.4381.44
436716-367161.2781.28
536126-361261.2571.26
637959-379591.3211.33
20min138849-388491.3521.323.351.361.333.32
236843-368431.2821.29
338529-385291.3411.35
436954-369541.2861.29
536866-368661.2831.29
639814-398141.3861.39
30min135173-351731.2241.251.471.231.261.59
236461-364611.2691.28
336071-360711.2561.27
435557-355571.2381.25
536419-364191.2681.28
635555-355551.2381.25
45min135005-350051.2181.3319.491.231.3419.10
237492-374921.3051.32
334941-349411.2161.23
453212-532121.8521.86
534007-340071.1841.20
634597-345971.2041.22
60min133564-335641.1681.2616.131.181.2715.92
233530-335301.1671.18
333863-338631.1791.19
447942-479421.6691.68
534093-340931.1871.20
633498-334981.1661.18
极限132706-327061.1381.198.161.161.218.10
235929-359291.2511.27
332229-322291.1221.14
438986-389861.3571.38
531609-316091.1001.12
633854-338541.1781.20
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