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%
19.89 3023871302090230246983015833301941230209430.12
29.943008170301746930128200.22
单位质量响应值RSD%判断
305454.30303100.600.55数据可信
供试品溶液-8145830批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121218-212180.6950.7411.690.690.7411.73
222911-229110.7500.75
322368-223680.7320.73
427172-271720.8890.89
522430-224300.7340.73
619150-191500.6270.63
10min141190-411901.3481.285.111.351.285.14
239137-391371.2811.28
340130-401301.3141.31
440254-402541.3181.32
539302-393021.2871.29
635449-354491.1601.16
15min142435-424351.3891.371.811.391.371.87
242109-421091.3781.38
342723-427231.3981.40
440944-409441.3401.34
542101-421011.3781.38
640928-409281.3401.34
20min142142-421421.3791.372.271.381.382.18
242664-426641.3971.40
342716-427161.3981.40
440186-401861.3151.32
542443-424431.3891.39
641877-418771.3711.38
30min140538-405381.3271.341.981.331.352.05
242128-421281.3791.39
341430-414301.3561.36
439777-397771.3021.31
541344-413441.3531.36
641008-410081.3421.35
45min140375-403751.3221.342.681.331.352.73
241275-412751.3511.36
342543-425431.3931.40
439274-392741.2861.29
540757-407571.3341.34
641383-413831.3551.36
60min140440-404401.3241.322.901.331.332.99
240593-405931.3291.34
341862-418621.3701.38
438283-382831.2531.26
540215-402151.3161.33
640789-407891.3351.35
极限139245-392451.2851.282.791.301.303.01
239482-394821.2921.31
340715-407151.3331.35
437323-373231.2221.23
538981-389811.2761.29
638945-389451.2751.29
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%
19.89 3032303303377530345743033003303469530336700.04
29.943037229303609930366640.03
单位质量响应值RSD%判断
306741.15305499.400.29数据可信
供试品溶液-20211227批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120390-203900.6630.5816.520.660.5816.25
218458-184580.6010.60
312165-121650.3960.40
417961-179610.5840.58
519378-193780.6300.63
619552-195520.6360.64
10min141067-410671.3361.276.111.341.276.26
239157-391571.2741.27
334507-345071.1231.12
438677-386771.2581.26
540351-403511.3131.31
640444-404441.3161.32
15min143957-439571.4301.422.011.431.422.12
243013-430131.3991.40
342461-424611.3821.38
443993-439931.4311.43
544411-444111.4451.45
644816-448161.4581.46
20min144912-449121.4611.461.471.471.471.48
244091-440911.4351.44
344536-445361.4491.45
444649-446491.4531.46
545918-459181.4941.50
645454-454541.4791.48
30min144508-445081.4481.482.481.461.492.52
244492-444921.4481.45
344843-448431.4591.47
446672-466721.5191.53
547076-470761.5321.54
645699-456991.4871.49
45min144421-444211.4451.491.761.451.491.83
245656-456561.4851.49
346772-467721.5221.53
445336-453361.4751.48
546188-461881.5031.51
645732-457321.4881.50
60min144572-445721.4501.491.771.461.501.73
245709-457091.4871.50
346518-465181.5141.52
445189-451891.4701.48
546669-466691.5181.53
645415-454151.4781.49
极限144595-445951.4511.492.131.461.502.17
245433-454331.4781.49
346544-465441.5141.53
445310-453101.4741.49
547242-472421.5371.55
645230-452301.4721.49
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%
19.89 3009035301092630059263007474300733530081390.07
29.943006036300434330051900.04
单位质量响应值RSD%判断
304159.66302333.000.43数据可信
供试品溶液-20211227批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119793-197930.6500.7017.390.650.7017.41
218231-182310.5990.60
325447-254470.8360.84
417090-170900.5610.56
521227-212270.6970.70
625974-259740.8530.85
10min136325-363251.1931.277.401.191.277.27
234574-345741.1361.14
342101-421011.3831.38
439608-396081.3011.30
538882-388821.2771.28
641172-411721.3521.35
15min142284-422841.3891.416.091.391.416.11
244349-443491.4571.46
344752-447521.4701.47
444914-449141.4751.48
542857-428571.4081.41
637984-379841.2481.25
20min143956-439561.4441.472.101.451.472.17
243515-435151.4291.43
345326-453261.4891.49
446064-460641.5131.52
544328-443281.4561.46
644764-447641.4701.48
30min141612-416121.3671.473.701.371.483.78
245552-455521.4961.50
345155-451551.4831.49
446371-463711.5231.53
545414-454141.4921.50
645255-452551.4861.49
45min145794-457941.5041.491.741.511.501.83
245430-454301.4921.50
344782-447821.4711.48
445848-458481.5061.52
545990-459901.5111.52
643954-439541.4441.45
60min145769-457691.5031.473.201.511.483.27
245443-454431.4931.50
344759-447591.4701.48
445887-458871.5071.52
545469-454691.4931.51
642067-420671.3821.39
极限146227-462271.5181.491.401.531.501.36
245537-455371.4961.51
345029-450291.4791.49
445405-454051.4911.51
545255-452551.4861.50
644311-443111.4551.47
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