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)60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%
113.834703064698334694334702304694724698550.09
213.794676054706114691080.46
单位质量响应值RSD%判断
33973.6134017.980.10数据可信
供试品溶液-2024102121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%
10min11914-19140.4200.3917.460.420.3917.27
22201-22010.4830.48
31637-16370.3590.36
41884-18840.4140.41
51280-12800.2810.28
61727-17270.3790.38
15min12308-23080.5070.5111.130.510.5111.29
22392-23920.5250.53
32688-26880.5900.59
42204-22040.4840.48
52463-24630.5410.54
61920-19200.4210.42
20min12777-27770.6100.5113.340.610.5213.22
22120-21200.4650.47
32317-23170.5090.51
41949-19490.4280.43
52620-26200.5750.58
62228-22280.4890.49
30min12495-24950.5480.519.540.550.519.68
22434-24340.5340.54
31959-19590.4300.43
42301-23010.5050.51
52147-21470.4710.47
62516-25160.5520.55
45min11960-19600.4300.6154.590.430.6154.90
22099-20990.4610.46
35852-58521.2851.29
42104-21040.4620.46
52399-23990.5270.53
62236-22360.4910.49
60min12239-22390.4910.447.720.500.457.97
22121-21210.4660.47
32094-20940.4600.46
41863-18630.4090.41
51873-18730.4110.42
61915-19150.4200.42
120min11661-16610.3650.378.710.370.388.97
21873-18730.4110.42
31688-16880.3710.38
41528-15280.3350.34
51894-18940.4160.42
61593-15930.3500.35
240min11592-15920.3490.3732.090.360.3831.63
22602-26020.5710.58
31310-13100.2880.29
41059-10590.2320.24
51954-19540.4290.43
61598-15980.3510.36
360min12653-26530.5820.4912.840.590.5012.72
21789-17890.3930.40
32185-21850.4800.49
42430-24300.5330.54
52164-21640.4750.48
62256-22560.4950.50
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12299-22990.5050.5114.490.510.5214.10
22461-24610.5400.55
31744-17440.3830.39
42373-23730.5210.53
52770-27700.6080.61
62240-22400.4920.50
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)60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%
113.834687024699374702274700194686344695040.17
213.794695884713174704520.26
单位质量响应值RSD%判断
33948.2334115.450.35数据可信
供试品溶液-6000597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%
10min11427-14270.3130.3029.810.310.3030.92
21020-10200.2240.22
31250-12500.2740.27
41199-11990.2630.26
52171-21710.4760.48
61191-11910.2610.26
15min12043-20430.4480.467.860.450.467.28
22061-20610.4520.45
32049-20490.4490.45
42155-21550.4730.47
52390-23900.5240.52
61895-18950.4160.42
20min12718-27180.5960.5745.450.600.5745.31
24909-49091.0761.08
31902-19020.4170.42
41809-18090.3970.40
51907-19070.4180.42
62360-23600.5180.52
30min12757-27570.6050.5113.850.610.5114.32
21825-18250.4000.40
32528-25280.5540.56
42379-23790.5220.52
52200-22000.4820.48
62202-22020.4830.48
45min12018-20180.4430.507.540.450.517.46
22147-21470.4710.47
32442-24420.5350.54
42448-24480.5370.54
52346-23460.5140.52
62369-23690.5190.52
60min12629-26290.5760.5110.450.580.5110.29
22214-22140.4850.49
32558-25580.5610.56
41991-19910.4370.44
52386-23860.5230.53
62176-21760.4770.48
120min11964-19640.4310.487.650.440.497.03
22368-23680.5190.52
32199-21990.4820.49
42198-21980.4820.49
52073-20730.4550.46
62407-24070.5280.53
240min11701-17010.3730.4516.730.380.4616.50
21847-18470.4050.41
31914-19140.4200.43
42508-25080.5500.56
51942-19420.4260.43
62496-24960.5470.55
360min12062-20620.4520.4316.800.460.4416.05
21907-19070.4180.42
31503-15030.3300.34
42496-24960.5470.55
52009-20090.4410.45
61777-17770.3900.40
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12002-20020.4390.4722.270.450.4821.99
22067-20670.4530.46
32382-23820.5220.53
42862-28620.6280.63
52276-22760.4990.51
61404-14040.3080.31
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)60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%
113.834713904715934709084732444705104715290.23
213.794692894690464691680.04
单位质量响应值RSD%判断
34094.6534022.340.16数据可信
供试品溶液-6000597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%
10min11277-12770.2800.3317.810.280.3418.57
21671-16710.3660.37
31206-12060.2640.26
41947-19470.4270.43
51575-15750.3450.35
61477-14770.3240.32
15min11823-18230.3990.4414.050.400.4414.16
22121-21210.4650.47
31930-19300.4230.42
42451-24510.5370.54
51629-16290.3570.36
62046-20460.4480.45
20min11668-16680.3650.4421.310.370.4421.18
22161-21610.4730.47
31751-17510.3840.38
42787-27870.6110.61
51859-18590.4070.41
61747-17470.3830.38
30min11624-16240.3560.4529.070.360.4528.78
22078-20780.4550.46
32018-20180.4420.44
43184-31840.6980.70
51870-18700.4100.41
61528-15280.3350.34
45min11871-18710.4100.4527.560.410.4627.27
21841-18410.4030.41
32102-21020.4610.46
43186-31860.6980.70
51677-16770.3670.37
61716-17160.3760.38
60min11979-19790.4340.4623.210.440.4722.99
21625-16250.3560.36
31862-18620.4080.41
43042-30420.6670.67
52187-21870.4790.48
61995-19950.4370.44
120min11811-18110.3970.4430.010.400.4529.91
21928-19280.4220.43
31709-17090.3740.38
43205-32050.7020.71
51999-19990.4380.44
61483-14830.3250.33
240min11536-15360.3370.4038.520.340.4038.85
21452-14520.3180.32
31722-17220.3770.38
43235-32350.7090.72
51455-14550.3190.32
61513-15130.3320.34
360min11429-14290.3130.3651.860.320.3651.13
21283-12830.2810.29
31161-11610.2540.26
43349-33490.7340.74
51343-13430.2940.30
61232-12320.2700.27
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11106-11060.2420.3552.320.250.3651.57
21313-13130.2880.29
31356-13560.2970.30
43307-33070.7250.73
51352-13520.2960.30
61200-12000.2630.27
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