地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360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%
1 9.991707927170353716908761708351170655517034490.43
210.041719902169811117090060.91
单位质量响应值RSD%判断
170515.42170219.720.13数据可信
供试品溶液-2025020421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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min12187-21870.0320.036.510.030.0315.50
22121-21210.0310.03
32099-20990.0310.03
42468-24680.0360.04
52408-24080.0350.04
62173-21730.0320.03
15min12860-28600.0420.045.450.040.040.00
22660-26600.0390.04
33040-30400.0450.04
42938-29380.0430.04
52708-27080.0400.04
62697-26970.0400.04
20min13248-32480.0480.0519.580.050.0522.63
23386-33860.0500.05
34318-43180.0630.06
44496-44960.0660.07
52881-28810.0420.04
62917-29170.0430.04
30min13070-30700.0450.043.720.050.0412.18
23053-30530.0450.04
33073-30730.0450.05
43270-32700.0480.05
52983-29830.0440.04
62903-29030.0430.04
45min12947-29470.0430.044.270.040.049.80
23179-31790.0470.05
33023-30230.0440.04
42896-28960.0420.04
52851-28510.0420.04
62981-29810.0440.04
60min12992-29920.0440.046.930.040.0411.92
23340-33400.0490.05
33132-31320.0460.05
42900-29000.0430.04
52715-27150.0400.04
62921-29210.0430.04
90min13083-30830.0450.0515.740.050.0515.58
23352-33520.0490.05
33120-31200.0460.05
42876-28760.0420.04
52884-28840.0420.04
64224-42240.0620.06
120min14264-42640.0630.0519.320.060.0418.60
23589-35890.0530.05
32892-28920.0420.04
42989-29890.0440.04
52677-26770.0390.04
62864-28640.0420.04
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12973-29730.0440.058.920.040.0411.92
23312-33120.0490.05
33022-30220.0440.04
43613-36130.0530.05
52918-29180.0430.04
62943-29430.0430.04
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360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%
1 9.991707064169517016759031690667167392616885460.82
210.041715710172098917183500.22
单位质量响应值RSD%判断
169023.62171150.400.89数据可信
供试品溶液-2025020421批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14662-46620.0680.1234.080.070.1233.46
29308-93080.1370.14
312575-125750.1850.18
45737-57370.0840.08
58730-87300.1280.13
69053-90530.1330.13
10min112628-126280.1850.197.190.190.198.07
214189-141890.2080.21
311559-115590.1700.17
412995-129950.1910.19
511895-118950.1750.17
612865-128650.1890.19
15min114206-142060.2090.206.970.210.206.33
213952-139520.2050.21
314145-141450.2080.21
412696-126960.1860.19
513246-132460.1950.20
611941-119410.1750.18
20min114666-146660.2150.209.010.220.209.64
213524-135240.1990.20
315092-150920.2220.22
414746-147460.2170.22
513246-132460.1950.20
611798-117980.1730.17
30min114689-146890.2160.1913.640.220.2014.05
213040-130400.1910.19
313347-133470.1960.20
415456-154560.2270.23
510591-105910.1560.16
611813-118130.1730.17
45min118664-186640.2740.2019.050.280.2019.94
211851-118510.1740.18
312486-124860.1830.18
414880-148800.2190.22
511725-117250.1720.17
613581-135810.1990.20
60min113419-134190.1970.1912.730.200.2012.03
210752-107520.1580.16
313377-133770.1960.20
415693-156930.2300.23
511847-118470.1740.18
613285-132850.1950.20
90min113612-136120.2000.197.800.200.197.68
212247-122470.1800.18
313587-135870.2000.20
414078-140780.2070.21
512579-125790.1850.19
611409-114090.1680.17
120min112856-128560.1890.188.680.190.188.26
210557-105570.1550.16
312420-124200.1820.18
413247-132470.1950.20
511144-111440.1640.17
611746-117460.1720.17
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限125813-258130.3790.2235.100.380.2334.14
211809-118090.1730.18
312067-120670.1770.18
415440-154400.2270.23
512825-128250.1880.19
613481-134810.1980.20
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360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%
1 9.991722668172092417240531722442172610117232380.12
210.041742833174254817426900.02
单位质量响应值RSD%判断
172496.30173574.700.45数据可信
供试品溶液-2025020421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%
5min1723254-72325410.43910.032.7310.4410.032.73
2688693-6886939.9409.94
3712565-71256510.28510.28
4679585-6795859.8099.81
5690612-6906129.9689.97
6675078-6750789.7449.74
10min1911384-91138413.15513.011.5013.1713.031.51
2898372-89837212.96712.98
3919681-91968113.27413.29
4894937-89493712.91712.93
5904230-90423013.05113.07
6881063-88106312.71712.73
15min11018852-101885214.70614.501.0514.7514.541.06
21003789-100378914.48814.53
31011865-101186514.60514.64
41003969-100396914.49114.53
51003612-100361214.48614.52
6987555-98755514.25414.29
20min11082653-108265315.62715.450.9415.6915.520.95
21072383-107238315.47815.54
31081079-108107915.60415.67
41067028-106702815.40115.46
51063010-106301015.34315.41
61057501-105750115.26415.32
30min11162438-116243816.77816.660.6016.8716.750.61
21156888-115688816.69816.79
31158158-115815816.71616.81
41151689-115168916.62316.71
51152582-115258216.63616.72
61142626-114262616.49216.58
45min11237837-123783717.86617.710.8417.9817.830.84
21229736-122973617.75017.87
31237922-123792217.86817.99
41225525-122552517.68917.80
51221011-122101117.62417.74
61211239-121123917.48317.60
60min11277277-127727718.43618.330.8718.5818.480.86
21276056-127605618.41818.56
31282771-128277118.51518.66
41270266-127026618.33518.48
51261889-126188918.21418.36
61253259-125325918.08918.23
90min11323116-132311619.09719.080.9119.2819.260.90
21323523-132352319.10319.28
31340282-134028219.34519.52
41322367-132236719.08719.26
51321077-132107719.06819.24
61302703-130270318.80318.98
120min11356513-135651319.57919.460.9419.7919.670.94
21343883-134388319.39719.61
31368125-136812519.74719.96
41345440-134544019.42019.63
51342083-134208319.37119.58
61332111-133211119.22719.43
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限11367312-136731219.73519.620.6319.9819.860.64
21367806-136780619.74219.98
31365577-136557719.71019.95
41349464-134946419.47819.72
51356229-135622919.57519.81
61350023-135002319.48619.72
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