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%
112.954468784406154409064411904414614422100.60
212.954380074413454396760.54
单位质量响应值RSD%判断
34147.4933951.810.41数据可信
长期3月-供试品溶液-2024102121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%
5min161329-6132913.44116.6914.8013.4416.6914.80
273288-7328816.06216.06
378762-7876217.26217.26
471834-7183415.74415.74
576072-7607216.67216.67
695686-9568620.97120.97
10min1172455-17245537.79638.424.7137.8238.454.71
2167364-16736436.68136.71
3173506-17350638.02738.06
4172489-17248937.80437.83
5174730-17473038.29538.32
6191354-19135441.93841.97
15min1228005-22800549.97151.804.2750.0651.894.28
2225552-22555249.43449.52
3232672-23267250.99451.09
4241067-24106752.83452.92
5237419-23741952.03452.13
6253251-25325155.50455.61
20min1273268-27326859.89160.403.4960.0660.583.49
2265882-26588258.27358.44
3280208-28020861.41261.59
4266824-26682458.47958.66
5275498-27549860.38060.56
6291793-29179363.95164.15
30min1330831-33083172.50773.362.7872.7873.632.78
2320014-32001470.13770.40
3335224-33522473.47073.75
4346145-34614575.86476.14
5333187-33318773.02473.30
6342802-34280275.13175.43
45min1379545-37954583.18483.712.2783.5784.122.27
2370926-37092681.29581.68
3381871-38187183.69484.10
4394927-39492786.55586.96
5375948-37594882.39582.80
6388543-38854385.15685.58
60min1404532-40453288.66089.122.2389.1989.662.22
2397819-39781987.18987.71
3406622-40662289.11889.66
4422169-42216992.52693.07
5398188-39818887.27087.81
6410356-41035689.93790.51
极限1426631-42663193.50393.712.0494.1894.402.04
2419065-41906591.84592.51
3429728-42972894.18294.87
4440727-44072796.59397.29
5417263-41726391.45092.13
6432064-43206494.69495.42
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%
112.954487874466854469964419364434714455750.63
212.954400234458374429300.93
单位质量响应值RSD%判断
34407.3434203.090.43数据可信
长期3月-供试品溶液-2024102121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%
5min172597-7259715.79213.9613.0015.7913.9613.00
248789-4878910.61310.61
367246-6724614.62814.63
462205-6220513.53213.53
569277-6927715.07015.07
664976-6497614.13514.13
10min1163153-16315335.49135.347.1735.5235.377.16
2140793-14079330.62730.65
3159324-15932434.65834.68
4170807-17080737.15637.18
5169594-16959436.89336.92
6171211-17121137.24437.27
15min1232301-23230150.53354.008.9250.6254.088.91
2219117-21911747.66647.73
3235611-23561151.25451.34
4261101-26110156.79856.88
5267723-26772358.23958.33
6273534-27353459.50359.59
20min1311892-31189267.84767.783.7968.0267.953.80
2294508-29450864.06664.21
3300547-30054765.37965.55
4317307-31730769.02569.20
5320700-32070069.76369.95
6324510-32451070.59270.78
30min1372176-37217680.96180.932.6481.2481.222.65
2359841-35984178.27878.53
3362855-36285578.93379.21
4377402-37740282.09882.39
5373273-37327381.20081.50
6386786-38678684.13984.44
45min1421409-42140991.67191.381.9592.0991.801.95
2408857-40885788.94089.33
3415696-41569690.42890.84
4426609-42660992.80293.23
5416426-41642690.58791.02
6431456-43145693.85794.30
60min1438931-43893195.48395.621.6596.0596.201.65
2432459-43245994.07594.61
3436572-43657294.96995.53
4450118-45011897.91698.50
5433040-43304094.20194.79
6446379-44637997.10397.70
极限1445104-44510496.82597.021.6397.5697.751.64
2437787-43778795.23495.92
3441310-44131096.00096.72
4450933-45093398.09398.84
5443020-44302096.37297.12
6457796-45779699.586100.35
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%
112.954506254436444438424429874429524448100.74
212.954503404523334513360.32
单位质量响应值RSD%判断
34348.2634852.201.03数据可信
长期3月-供试品溶液-2024102221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%
5min188454-8845419.07915.4216.8419.0815.4216.85
267294-6729414.51514.51
377715-7771516.76216.76
468560-6856014.78814.79
552440-5244011.31111.31
674495-7449516.06816.07
10min1177102-17710238.19935.787.1338.2335.807.14
2152188-15218832.82532.85
3171946-17194637.08737.11
4172126-17212637.12637.15
5149532-14953232.25232.27
6172414-17241437.18837.21
15min1232080-23208050.05748.784.8550.1548.874.85
2208102-20810244.88544.96
3234453-23445350.56950.66
4232803-23280350.21350.30
5217011-21701146.80746.88
6232623-23262350.17450.26
20min1276160-27616059.56559.063.7859.7459.223.79
2254143-25414354.81654.97
3280913-28091360.59060.76
4282608-28260860.95561.13
5271803-27180358.62558.78
6277188-27718859.78659.96
30min1331139-33113971.42371.243.4971.7071.503.49
2308088-30808866.45166.70
3338877-33887773.09273.37
4339616-33961673.25173.52
5332838-33283871.79072.04
6331099-33109971.41471.69
45min1371062-37106280.03480.912.9380.4381.302.93
2356380-35638076.86777.22
3384215-38421582.87183.27
4386420-38642083.34783.74
5379428-37942881.83982.21
6373310-37331080.51980.91
60min1394962-39496285.18986.543.2985.7287.053.28
2380929-38092982.16282.65
3408221-40822188.04988.58
4419919-41991990.57291.10
5404598-40459887.26787.77
6398602-39860285.97486.50
极限1415758-41575889.67591.422.0890.3592.082.08
2413881-41388189.27089.89
3432116-43211693.20393.88
4434207-43420793.65494.34
5428505-42850592.42493.07
6418698-41869890.30990.98
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%
112.954500504458784454294456534453374464690.46
212.954545084483154514120.98
单位质量响应值RSD%判断
34476.3734858.070.78数据可信
长期3月-供试品溶液-2024102221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%
5min166211-6621114.25314.5011.6014.2514.5011.60
260885-6088513.10713.11
380504-8050417.33017.33
458808-5880812.65912.66
571269-7126915.34215.34
666491-6649114.31314.31
10min1151404-15140432.59234.435.5032.6234.455.50
2148387-14838731.94331.96
3166147-16614735.76635.79
4158438-15843834.10734.13
5164330-16433035.37535.40
6170900-17090036.78936.81
15min1213219-21321945.89947.985.3645.9848.065.36
2204901-20490144.10944.18
3232727-23272750.09950.19
4223018-22301848.00948.09
5227222-22722248.91449.00
6236306-23630650.86950.95
20min1257140-25714055.35457.505.2955.5157.665.29
2244970-24497052.73452.88
3276630-27663059.54959.72
4270317-27031758.19058.35
5269219-26921957.95458.12
6284475-28447561.23861.41
30min1310960-31096066.94069.545.1867.1969.805.18
2296874-29687463.90764.14
3333184-33318471.72471.99
4328763-32876370.77271.03
5324637-32463769.88470.15
6343741-34374173.99674.27
45min1355754-35575476.58279.584.8076.9479.964.80
2341958-34195873.61273.96
3379552-37955281.70582.10
4376268-37626880.99881.37
5373754-37375480.45780.84
6390923-39092384.15384.55
60min1382159-38215982.26685.334.5882.7585.834.58
2367886-36788679.19479.66
3407537-40753787.72988.26
4400810-40081086.28186.79
5402234-40223486.58887.10
6417619-41761989.90090.44
极限1412640-41264088.82891.623.2089.4592.263.21
2406733-40673387.55688.15
3435335-43533593.71394.39
4425604-42560491.61992.27
5431148-43114892.81293.47
6442126-44212695.17595.86
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%
112.954493064464394463284465354464904470200.29
212.954479604441094460340.62
单位质量响应值RSD%判断
34518.9234442.780.16数据可信
长期3月-供试品溶液-2024102321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%
5min171440-7144015.46115.9613.8215.4615.9613.82
264773-6477314.01814.02
375430-7543016.32516.32
493086-9308620.14620.15
566748-6674814.44614.45
671032-7103215.37315.37
10min1170339-17033936.86637.366.2036.8937.386.20
2162988-16298835.27535.30
3169730-16973036.73436.76
4193631-19363141.90741.94
5167973-16797336.35436.38
6171026-17102637.01437.04
15min1243860-24386052.77751.574.5252.8651.664.52
2224739-22473948.63948.72
3234199-23419950.68650.77
4256440-25644055.50055.60
5235446-23544650.95651.04
6235130-23513050.88850.98
20min1287585-28758562.24161.163.8662.4261.343.87
2265543-26554357.47057.63
3279431-27943160.47660.65
4298853-29885364.67964.88
5283494-28349461.35561.52
6280679-28067960.74660.92
30min1353458-35345876.49774.043.1176.7874.323.11
2325431-32543170.43170.69
3336135-33613572.74873.02
4352946-35294676.38676.69
5343534-34353474.34974.62
6341210-34121073.84674.12
45min1396022-39602285.70983.772.4186.1284.172.41
2373668-37366880.87181.25
3378995-37899582.02482.42
4394433-39443385.36585.80
5394079-39407985.28885.68
6385232-38523283.37483.77
60min1421777-42177791.28390.382.7091.8390.922.70
2399745-39974586.51587.03
3408057-40805788.31488.85
4426717-42671792.35292.93
5428045-42804592.64093.18
6421219-42121991.16291.70
极限1441332-44133295.51595.441.8096.2296.141.79
2434007-43400793.93094.59
3432214-43221493.54294.22
4438068-43806894.80995.54
5452290-45229097.88798.58
6448084-44808496.97697.66
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%
112.954528934479014472904448324452794476390.72
212.954526794492014509400.55
单位质量响应值RSD%判断
34566.7234821.620.52数据可信
长期3月-供试品溶液-2024102321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%
5min179010-7901016.99517.409.1616.9917.409.15
290191-9019119.40019.40
377810-7781016.73716.74
481437-8143717.51717.52
569402-6940214.92814.93
687369-8736918.79318.79
10min1194987-19498741.94140.655.0541.9740.685.06
2203614-20361443.79743.83
3183602-18360239.49239.52
4189603-18960340.78340.81
5176039-17603937.86537.89
6186103-18610340.03040.06
15min1271987-27198758.50456.814.6458.6056.914.64
2282756-28275660.82060.93
3258503-25850355.60355.70
4263388-26338856.65456.75
5246845-24684553.09653.18
6261223-26122356.18856.29
20min1315826-31582667.93367.193.6368.1367.383.64
2331952-33195271.40271.61
3310013-31001366.68366.87
4309896-30989666.65866.85
5297416-29741663.97364.15
6309092-30909266.48566.68
30min1375027-37502780.66780.162.6980.9880.472.70
2390811-39081184.06284.39
3370391-37039179.67079.97
4369802-36980279.54379.85
5360704-36070477.58677.87
6369342-36934279.44479.75
45min1420978-42097890.55190.211.6490.9990.641.65
2432001-43200192.92293.39
3415340-41534089.33889.77
4416050-41605089.49189.93
5412613-41261388.75289.16
6419316-41931690.19390.63
60min1445269-44526995.77695.331.9596.3795.921.96
2457988-45798898.51299.13
3440065-44006594.65795.24
4444516-44451695.61496.20
5432070-43207092.93793.50
6439365-43936594.50695.09
极限1462067-46206799.38999.681.28100.14100.431.29
2474639-474639102.093102.88
3459994-45999498.94399.68
4462001-46200199.375100.12
5457712-45771298.45299.17
6464246-46424699.858100.60
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