奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号T12B-A020-230703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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.48 4559134563654555394547204558114556700.14
213.434530934556004543460.40
单位质量响应值RSD%判断
33803.4133830.680.06数据可信
供试品溶液-3434237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%
5min121642-216424.7763.5028.874.783.5028.95
213688-136883.0213.02
320673-206734.5624.56
411166-111662.4642.46
511305-113052.4952.49
616630-166303.6703.67
10min163752-6375214.06812.3213.2014.1212.3613.24
253929-5392911.90111.93
365606-6560614.47714.53
450981-5098111.25011.28
546755-4675510.31810.35
653943-5394311.90411.94
15min1107604-10760423.74521.509.6823.9521.689.72
297527-9752721.52221.69
3107907-10790723.81224.02
494212-9421220.79020.94
582869-8286918.28718.43
694471-9447120.84721.02
20min1142607-14260731.46929.787.5131.9430.197.57
2135597-13559729.92330.33
3148929-14892932.86533.34
4131769-13176929.07829.46
5119712-11971226.41726.76
6131028-13102828.91429.32
30min1208705-20870546.05644.655.0546.8845.405.13
2202355-20235544.65445.39
3218062-21806248.12048.96
4199250-19925043.96944.68
5188206-18820641.53242.17
6197424-19742443.56644.29
45min1275336-27533660.75960.083.7862.0961.323.83
2274557-27455760.58761.82
3283995-28399562.67064.05
4279793-27979361.74362.94
5257083-25708356.73157.83
6262867-26286758.00859.22
60min1315795-31579569.68769.782.8371.7071.692.86
2309060-30906068.20170.11
3326544-32654472.05974.13
4327703-32770372.31574.20
5307245-30724567.80169.53
6310825-31082568.59170.45
极限1352647-35264777.82077.812.8080.6080.502.84
2350317-35031777.30579.97
3363023-36302380.10982.98
4364497-36449780.43583.12
5338728-33872874.74877.23
6346477-34647776.45879.07
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号T12B-A020-230703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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.48 4532434547634545234544814545454543110.14
213.434552864555144554000.04
单位质量响应值RSD%判断
33702.6033909.160.44数据可信
供试品溶液-3434237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%
5min142707-427079.4277.5417.879.437.5417.89
227728-277286.1216.12
338912-389128.5908.59
433387-333877.3707.37
535019-350197.7307.73
627231-272316.0116.01
10min1132618-13261829.27527.536.6129.3827.616.64
2119420-11942026.36226.43
3134910-13491029.78129.88
4118574-11857426.17526.26
5127775-12777528.20628.29
6114855-11485525.35425.42
15min1208265-20826545.97444.714.3446.4045.104.37
2193640-19364042.74643.11
3215951-21595147.67148.10
4196905-19690543.46643.84
5205187-20518745.29545.69
6195154-19515443.08043.43
20min1260414-26041457.48657.192.5658.4358.082.60
2249752-24975255.13255.97
3267614-26761459.07560.03
4257397-25739756.82057.68
5264808-26480858.45659.36
6254355-25435556.14856.98
30min1331887-33188773.26372.602.8674.8474.122.87
2311588-31158868.78270.23
3339527-33952774.95076.56
4332461-33246173.39074.88
5330514-33051472.96074.51
6327327-32732772.25773.71
45min1386071-38607185.22484.012.6187.6286.332.60
2362682-36268280.06182.27
3386677-38667785.35887.80
4389123-38912385.89888.20
5375650-37565082.92485.29
6383109-38310984.57086.82
60min1409731-40973190.44789.142.3693.7992.402.36
2387576-38757685.55788.66
3408456-40845690.16693.56
4414662-41466291.53694.79
5400807-40080788.47791.76
6401506-40150688.63291.83
极限1427264-42726494.31893.932.0998.6698.182.08
2407923-40792390.04894.10
3426235-42623594.09098.49
4431786-43178695.31699.59
5429114-42911494.72698.99
6430739-43073995.08599.26
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号T12B-A020-230703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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.48 4548854541964541034542114535674541920.11
213.434540534538664539600.03
单位质量响应值RSD%判断
33693.7733801.940.23数据可信
供试品溶液-3434237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%
5min158436-5843612.92214.4611.5612.9214.4611.56
277829-7782917.21017.21
368757-6875715.20415.20
467743-6774314.98014.98
558690-5869012.97812.98
660833-6083313.45213.45
10min1166488-16648836.81538.696.6536.9638.856.67
2197464-19746443.66443.86
3171334-17133437.88638.06
4176910-17691039.11939.29
5167359-16735937.00737.15
6170158-17015837.62637.78
15min1239537-23953752.96854.774.7253.5255.364.75
2268428-26842859.35660.03
3244333-24433354.02854.62
4253015-25301555.94856.55
5235958-23595852.17652.73
6244792-24479254.13054.70
20min1293498-29349864.90065.932.6666.0467.132.71
2313400-31340069.30170.64
3294875-29487565.20466.39
4298955-29895566.10767.33
5296833-29683365.63766.77
6291443-29144364.44665.61
30min1354891-35489178.47679.442.6380.3481.372.68
2376179-37617983.18385.29
3360288-36028879.66981.58
4361298-36129879.89281.85
5353598-35359878.19080.05
6349139-34913977.20479.09
45min1402733-40273389.05588.241.5291.7991.051.54
2403610-40361089.24992.28
3401587-40158788.80191.60
4403207-40320789.15992.00
5393925-39392587.10789.84
6389186-38918686.05988.80
60min1411610-41161091.01891.441.8194.7495.241.81
2415112-41511291.79295.81
3419938-41993892.85996.65
4423560-42356093.66097.50
5405775-40577589.72793.43
6405196-40519689.59993.30
极限1428634-42863494.78293.431.5199.5298.241.51
2425532-42553294.09699.14
3423346-42334693.61398.43
4426941-42694194.40899.28
5419437-41943792.74897.45
6411302-41130290.94995.64
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号T12B-A020-230703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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.48 4544674540134540474544244543064542510.05
213.434510574513214511890.05
单位质量响应值RSD%判断
33698.1533595.610.22数据可信
供试品溶液-3434237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%
5min154009-5400911.97915.3318.7511.9815.3318.75
282250-8225018.24218.24
384078-8407818.64818.65
471359-7135915.82715.83
554657-5465712.12212.12
668363-6836315.16215.16
10min1186703-18670341.40942.516.3841.5442.686.42
2205987-20598745.68645.89
3199021-19902144.14144.35
4201201-20120144.62444.80
5174691-17469138.74538.88
6182468-18246840.46940.64
15min1259866-25986657.63558.434.8958.2359.074.93
2277567-27756761.56162.27
3276066-27606661.22861.93
4266330-26633059.06959.74
5243087-24308753.91454.48
6257698-25769857.15557.77
20min1312220-31222069.24768.973.6970.4870.263.74
2321477-32147771.30072.69
3322817-32281771.59772.98
4313915-31391569.62370.95
5293001-29300164.98466.15
6302494-30249467.09068.34
30min1361712-36171280.22480.993.7582.2383.053.80
2378994-37899484.05786.24
3379696-37969684.21386.39
4367673-36767381.54683.65
5343103-34310376.09777.98
6359801-35980179.80081.80
45min1403480-40348089.48888.852.8592.3891.812.89
2412917-41291791.58194.70
3414601-41460191.95495.06
4393881-39388187.35990.37
5389893-38989386.47489.21
6388969-38896986.26989.15
60min1418404-41840492.79891.992.1096.6995.932.15
2424859-42485994.22998.37
3420002-42000293.15297.28
4415792-41579292.21896.20
5408584-40858490.62094.31
6400825-40082588.89992.74
极限1422026-42202693.60193.672.0498.5298.642.00
2437874-43787497.116102.30
3418007-41800792.70997.88
4414684-41468491.97296.98
5425512-42551294.37499.07
6415901-41590192.24297.07
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号T12B-A020-230703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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.48 4539364543854538814539184540894540420.05
213.434544114539634541870.07
单位质量响应值RSD%判断
33682.6433818.840.29数据可信
供试品溶液-3434237批-pH6.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146940-4694010.3799.7013.5810.389.7013.55
254058-5405811.95311.95
341421-414219.1589.16
441587-415879.1959.20
536705-367058.1168.12
642615-426159.4229.42
10min1134111-13411129.65329.695.5129.7729.805.53
2146152-14615232.31532.45
3135644-13564429.99230.09
4127415-12741528.17228.27
5125540-12554027.75827.85
6136842-13684230.25730.36
15min1204068-20406845.12145.144.3445.5745.584.34
2212091-21209146.89547.39
3211402-21140246.74247.18
4190774-19077442.18142.60
5196369-19636943.41943.82
6210133-21013346.46246.90
20min1249655-24965555.20155.862.9556.1556.802.96
2255351-25535156.46057.47
3261225-26122557.75958.71
4241523-24152353.40254.29
5248629-24862954.97455.85
6259483-25948357.37458.33
30min1311518-31151868.87969.982.7370.4471.542.74
2322683-32268371.34872.99
3326116-32611672.10773.70
4303979-30397967.21268.69
5311955-31195568.97570.47
6322661-32266171.34372.94
45min1361675-36167579.96981.592.0982.2983.932.10
2370902-37090282.00984.44
3379895-37989583.99886.39
4359179-35917979.41781.64
5368659-36865981.51383.77
6373827-37382782.65685.04
60min1390010-39001086.23486.951.5789.4590.191.58
2389496-38949686.12089.46
3404051-40405189.33992.67
4387440-38744085.66688.77
5391804-39180486.63189.79
6396619-39661987.69591.00
极限1408041-40804190.22191.971.4294.3996.181.42
2420235-42023592.91797.22
3424282-42428293.81298.14
4415366-41536691.84095.90
5416599-41659992.11396.24
6411124-41112490.90295.18
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