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%
113.214474774475714480484487054471324477870.14
213.294471514468894470200.05
单位质量响应值RSD%判断
33897.5833635.820.55数据可信
供试品溶液-5728772批-pH4.5(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141683-416839.2128.5952.349.218.5952.36
24218-42180.9320.93
347454-4745410.48810.49
466653-6665314.73114.73
535171-351717.7737.77
638029-380298.4058.40
10min1148257-14825732.76633.3520.5032.7833.3620.52
296073-9607321.23321.23
3167152-16715236.94136.96
4189603-18960341.90341.93
5153611-15361133.94933.96
6150735-15073533.31333.33
15min1229878-22987850.80451.6612.4350.8751.7312.45
2183074-18307440.46040.50
3247668-24766854.73654.81
4271094-27109459.91360.01
5239942-23994253.02853.10
6230912-23091251.03351.10
20min1288368-28836863.73163.769.2863.8963.929.30
2241709-24170953.41953.52
3303274-30327467.02567.20
4321688-32168871.09571.29
5293743-29374364.91965.08
6282155-28215562.35862.51
30min1356984-35698478.89578.395.8979.1678.655.92
2319301-31930170.56770.76
3371058-37105882.00682.29
4378166-37816683.57783.89
5357583-35758379.02879.29
6345112-34511276.27276.53
45min1405445-40544589.60589.093.8290.0089.483.85
2378384-37838483.62583.94
3417133-41713392.18992.61
4419127-41912792.62993.08
5405850-40585089.69590.09
6392765-39276586.80387.19
60min1430720-43072095.19194.432.8895.7394.972.91
2408194-40819490.21390.66
3439245-43924597.07597.65
4439063-43906397.03597.64
5428744-42874494.75595.30
6417682-41768292.31092.84
极限1451368-45136899.75599.620.96100.45100.321.00
2445012-44501298.35098.95
3457536-457536101.118101.85
4453046-453046100.125100.89
5448738-44873899.17399.88
6448884-44888499.20699.89
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%
113.214491144474834472664466994467654474650.22
213.294475914472914474410.05
单位质量响应值RSD%判断
33873.2033667.490.44数据可信
供试品溶液-5728772批-pH6.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160439-6043913.35615.5517.4813.3615.5517.46
258490-5849012.92512.93
379939-7993917.66517.66
471226-7122615.74015.74
562579-6257913.82913.83
689429-8942919.76219.76
10min1172735-17273538.17140.036.3738.1940.056.37
2176000-17600038.89238.91
3183482-18348240.54640.58
4166673-16667336.83136.86
5190552-19055242.10842.13
6197366-19736643.61443.65
15min1244308-24430853.98755.875.8254.0755.965.82
2247273-24727354.64254.73
3255596-25559656.48256.58
4231890-23189051.24351.33
5271574-27157460.01260.11
6266201-26620158.82558.93
20min1292950-29295064.73666.515.0064.9166.705.00
2295369-29536965.27165.45
3301901-30190166.71466.91
4279974-27997461.86962.04
5321236-32123670.98771.18
6314511-31451169.50169.70
30min1357443-35744378.98879.533.4479.2779.833.45
2352326-35232677.85778.14
3357330-35733078.96379.27
4343802-34380275.97376.25
5377798-37779883.48683.80
6370705-37070581.91882.24
45min1408040-40804090.16989.602.3490.5890.032.35
2396596-39659687.64088.06
3399991-39999188.39088.82
4396184-39618487.54987.95
5419517-41951792.70593.16
6412491-41249191.15291.61
60min1433565-43356595.80994.511.9496.3795.091.94
2418156-41815692.40492.97
3420251-42025192.86793.45
4423265-42326593.53394.08
5438684-43868496.94097.55
6432215-43221595.51196.12
极限1456196-456196100.81099.101.86101.5499.841.85
2441588-44158897.58298.30
3435581-43558196.25596.99
4451396-45139699.749100.45
5456427-456427100.861101.63
6449601-44960199.353100.12
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%
113.214466934479264480054465654457934469960.22
213.294468864488114478480.31
单位质量响应值RSD%判断
33837.7033698.120.30数据可信
供试品溶液-5728772批-pH2.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116507-165073.6482.8877.393.652.8877.43
218782-187824.1514.15
327051-270515.9785.98
43227-32270.7130.71
512572-125722.7782.78
6-0.0000.00
10min171557-7155715.81410.8241.2515.8210.8341.25
259479-5947913.14513.15
355671-5567112.30312.31
417620-176203.8943.90
558103-5810312.84012.85
631402-314026.9406.94
15min1114679-11467925.34320.4616.9325.3820.4816.96
298922-9892221.86121.89
392004-9200420.33220.36
467238-6723814.85914.87
596522-9652221.33121.36
686142-8614219.03719.05
20min1153838-15383833.99728.8411.3434.0728.9011.36
2134943-13494329.82229.89
3121730-12173026.90226.97
4109356-10935624.16724.20
5130180-13018028.76928.83
6133012-13301229.39529.44
30min1217998-21799848.17642.099.0948.3142.209.10
2193894-19389442.85042.96
3172757-17275738.17838.29
4172857-17285738.20038.27
5185773-18577341.05541.16
6199495-19949544.08744.18
45min1276541-27654161.11455.536.8461.3355.706.85
2255893-25589356.55156.74
3228041-22804150.39650.57
4241971-24197153.47453.61
5242883-24288353.67653.85
6262190-26219057.94358.11
60min1313948-31394869.38164.085.9769.6964.345.97
2296961-29696165.62765.91
3264975-26497558.55858.81
4284108-28410862.78663.01
5279569-27956961.78362.05
6300079-30007966.31666.58
极限1355286-35528678.51675.323.4378.9575.703.45
2349475-34947577.23277.62
3323974-32397471.59771.95
4334620-33462073.94974.28
5334663-33466373.95974.33
6346916-34691676.66777.04
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%
113.214452884492084493074485814504674485700.44
213.294475064482184478620.12
单位质量响应值RSD%判断
33956.8533699.170.54数据可信
供试品溶液-5728772批-pH6.8(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103683-10368322.87319.1817.8022.8719.1817.79
267477-6747714.88614.89
3103177-10317722.76122.76
486902-8690219.17119.17
570619-7061915.57915.58
689665-8966519.78019.78
10min1232525-23252551.29648.296.3351.3348.326.34
2203213-20321344.83044.85
3237922-23792252.48752.52
4219645-21964548.45548.49
5208279-20827945.94745.97
6211714-21171446.70546.74
15min1300526-30052666.29761.984.1966.4262.104.20
2271240-27124059.83759.94
3290177-29017764.01464.14
4275443-27544360.76460.88
5272163-27216360.04060.14
6276250-27625060.94261.05
20min1350491-35049177.32072.473.5577.5572.683.56
2320506-32050670.70570.90
3332543-33254373.36073.59
4320377-32037770.67770.89
5323622-32362271.39271.60
6323501-32350171.36671.58
30min1405883-40588389.54084.973.2189.9085.303.21
2379338-37933883.68484.00
3390418-39041886.12886.48
4370370-37037081.70582.04
5386761-38676185.32185.64
6378224-37822483.43883.77
45min1447288-44728898.67494.223.1299.1994.703.12
2427178-42717894.23794.69
3429814-42981494.81995.32
4407966-40796689.99990.47
5432049-43204995.31295.78
6418298-41829892.27892.75
60min1464734-464734102.52298.532.98103.2099.172.97
2450518-45051899.386100.00
3449058-44905899.06499.72
4426679-42667994.12794.75
5452379-45237999.797100.42
6436579-43657996.31196.94
极限1476689-476689105.160101.682.94106.01102.482.94
2469445-469445103.562104.34
3462066-462066101.934102.75
4439451-43945196.94597.72
5466863-466863102.992103.78
6450963-45096399.484100.27
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