奥利司他胶囊项目信息
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520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)120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%
113.834676934669284694194702874739474696550.59
213.794650204644474647340.09
单位质量响应值RSD%判断
33959.1533700.800.54数据可信
供试品溶液-2024102421批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
120min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
240min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
360min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
奥利司他胶囊项目信息
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520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)120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%
113.834647254644514645854645564648044646240.04
213.794664134660974662550.05
单位质量响应值RSD%判断
33595.3733811.090.46数据可信
供试品溶液-2024102421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%
10min13869-38690.4280.434.940.430.434.77
23987-39870.4410.44
34189-41890.4640.46
43788-37880.4190.42
53645-36450.4040.40
63764-37640.4170.42
15min14759-47590.5270.535.310.530.535.46
24347-43470.4810.48
34567-45670.5060.51
45010-50100.5550.56
54812-48120.5330.53
64970-49700.5500.55
20min15002-50020.5540.543.350.560.543.62
24727-47270.5230.52
35134-51340.5680.57
44769-47690.5280.53
54775-47750.5290.53
64982-49820.5520.55
30min14933-49330.5460.553.170.550.553.15
24705-47050.5210.52
35157-51570.5710.57
45034-50340.5570.56
54833-48330.5350.54
64946-49460.5480.55
45min14732-47320.5240.522.980.530.523.13
24531-45310.5020.50
34858-48580.5380.54
44694-46940.5200.52
54568-45680.5060.51
64869-48690.5390.54
60min14679-46790.5180.495.720.520.495.54
24580-45800.5070.51
34563-45630.5050.51
44193-41930.4640.47
54026-40260.4460.45
64436-44360.4910.50
120min14720-47200.5230.468.490.530.468.90
24059-40590.4490.45
34290-42900.4750.48
43945-39450.4370.44
53692-36920.4090.41
64292-42920.4750.48
240min13835-38350.4250.445.760.430.455.85
24014-40140.4440.45
34425-44250.4900.50
43907-39070.4330.44
54105-41050.4540.46
63791-37910.4200.43
360min13576-35760.3960.4010.480.400.4010.22
23629-36290.4020.41
34224-42240.4680.47
43639-36390.4030.41
53038-30380.3360.34
63568-35680.3950.40
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13837-38370.4250.427.110.430.436.68
23595-35950.3980.41
34182-41820.4630.47
43751-37510.4150.42
53452-34520.3820.39
64029-40290.4460.45
奥利司他胶囊项目信息
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520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)120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%
113.834697354688264669924662524679854679580.30
213.794637134639184638160.04
单位质量响应值RSD%判断
33836.4433634.230.43数据可信
供试品溶液-2024102421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%
10min15433-54330.6010.611.800.600.611.71
25624-56240.6220.62
35529-55290.6120.61
45486-54860.6070.61
55523-55230.6110.61
65331-53310.5900.59
15min16027-60270.6670.682.610.670.682.57
26290-62900.6960.70
36043-60430.6680.67
46022-60220.6660.67
56099-60990.6750.68
66397-63970.7080.71
20min16169-61690.6820.694.160.680.694.45
26113-61130.6760.68
36040-60400.6680.67
46720-67200.7430.75
56106-61060.6750.68
66056-60560.6700.67
30min15843-58430.6460.684.090.650.693.98
26284-62840.6950.70
36176-61760.6830.69
46139-61390.6790.68
56057-60570.6700.67
66601-66010.7300.73
45min16435-64350.7120.676.240.720.686.25
26100-61000.6750.68
36066-60660.6710.68
46383-63830.7060.71
55384-53840.5950.60
66014-60140.6650.67
60min15398-53980.5970.676.160.600.686.29
25940-59400.6570.66
36273-62730.6940.70
46386-63860.7060.71
56359-63590.7030.71
66192-61920.6850.69
120min15826-58260.6440.683.930.650.693.77
26154-61540.6810.69
36053-60530.6690.68
46196-61960.6850.69
56564-65640.7260.73
66129-61290.6780.68
240min15772-57720.6380.644.050.650.653.96
26236-62360.6900.70
35634-56340.6230.63
45825-58250.6440.65
55590-55900.6180.63
65932-59320.6560.66
360min15554-55540.6140.593.910.620.603.58
25457-54570.6040.61
35296-52960.5860.59
45041-50410.5580.57
55183-51830.5730.58
65555-55550.6140.62
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15377-53770.5950.604.180.600.614.44
25778-57780.6390.65
35606-56060.6200.63
45453-54530.6030.61
55100-51000.5640.57
65433-54330.6010.61
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