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%
113.384548144549924559014551104551974552030.10
213.334601764550444576100.80
单位质量响应值RSD%判断
34021.1534329.330.64数据可信
长期6月-供试品溶液-6000597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%
5min119249-192494.2034.6019.734.204.6019.73
220387-203874.4524.45
322428-224284.8974.90
427327-273275.9675.97
522142-221424.8354.84
614728-147283.2163.22
10min161935-6193513.52414.038.1713.5314.048.18
263534-6353413.87413.88
366207-6620714.45714.47
471406-7140615.59315.60
566612-6661214.54614.55
655815-5581512.18812.19
15min1108593-10859323.71323.155.0023.7423.184.99
2102798-10279822.44722.48
3108503-10850323.69323.73
4109677-10967723.95023.99
5109912-10991224.00124.03
696626-9662621.10021.13
20min1145741-14574131.82531.243.7031.8931.303.70
2138217-13821730.18230.25
3145406-14540631.75131.82
4145475-14547531.76731.84
5148580-14858032.44532.52
6134867-13486729.45029.51
30min1206344-20634445.05844.213.5045.1844.333.50
2199057-19905743.46743.59
3207380-20738045.28445.41
4203491-20349144.43544.56
5208619-20861945.55545.68
6189818-18981841.44941.56
45min1267513-26751358.41557.112.7858.6157.302.79
2259942-25994256.76256.95
3267482-26748258.40958.61
4259935-25993556.76156.96
5265789-26578958.03958.24
6248510-24851054.26654.44
60min1305184-30518466.64165.402.1466.9465.692.14
2297367-29736764.93465.22
3306941-30694167.02567.32
4297067-29706764.86965.17
5301067-30106765.74266.04
6289316-28931663.17663.45
极限1349886-34988676.40375.201.9576.8175.601.95
2339541-33954174.14474.54
3355392-35539277.60578.01
4341337-34133774.53674.94
5341490-34149074.56974.98
6338706-33870673.96174.34
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%
113.384561034555844547624549334546824552130.14
213.334522814545714534260.36
单位质量响应值RSD%判断
34021.9034015.450.02数据可信
长期6月-供试品溶液-6000597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%
5min122666-226664.9721.56155.364.971.56155.35
2-0.0000.00
320058-200584.4004.40
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min165127-6512714.2879.3636.8614.299.3636.89
231372-313726.8826.88
357391-5739112.59012.60
443890-438909.6289.63
531839-318396.9846.98
626300-263005.7695.77
15min1103756-10375622.76017.8716.1622.7917.8916.19
273154-7315416.04716.06
389352-8935219.60119.63
481104-8110417.79117.81
572296-7229615.85915.87
669081-6908115.15415.16
20min1139950-13995030.70025.869.6330.7725.909.66
2113081-11308124.80624.84
3117875-11787525.85825.92
4116805-11680525.62325.67
5110043-11004324.14024.18
6109477-10947724.01524.05
30min1194045-19404542.56738.056.7842.6938.146.78
2172308-17230837.79837.88
3160894-16089435.29435.40
4169454-16945437.17237.26
5165430-16543036.29036.37
6178629-17862939.18539.26
45min1247181-24718154.22352.135.5054.4152.285.48
2239229-23922952.47852.62
3218601-21860147.95348.12
4231824-23182450.85451.00
5232882-23288251.08651.22
6256076-25607656.17456.31
60min1291726-29172663.99460.535.8464.2860.775.83
2288208-28820863.22363.45
3257343-25734356.45256.69
4263074-26307457.70957.94
5263887-26388757.88858.11
6291432-29143263.93064.16
极限1331019-33101972.61471.382.9373.0071.722.93
2326380-32638071.59671.93
3311739-31173968.38568.72
4324343-32434371.14971.48
5319370-31937070.05970.38
6339449-33944974.46374.80
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%
113.384544624546564545864547104541604545150.05
213.334539464539524539490.01
单位质量响应值RSD%判断
33969.7334054.690.18数据可信
长期6月-供试品溶液-6000597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%
5min152660-5266011.5547.7054.9911.557.7054.98
255495-5549512.17612.18
338675-386758.4868.49
440399-403998.8648.86
511109-111092.4372.44
612265-122652.6912.69
10min1149357-14935732.77028.6417.8432.7928.6517.86
2153843-15384333.75433.77
3136661-13666129.98430.00
4139015-13901530.50130.52
595574-9557420.97020.97
6108650-10865023.83923.84
15min1222888-22288848.90345.808.2048.9845.868.22
2221321-22132148.55948.64
3216693-21669347.54447.61
4211597-21159746.42646.49
5177176-17717638.87438.91
6202767-20276744.48844.53
20min1275659-27565960.48157.965.8360.6458.105.85
2268215-26821558.84859.01
3273671-27367160.04560.19
4265571-26557158.26858.41
5233707-23370751.27751.38
6268170-26817058.83858.96
30min1339548-33954874.49972.574.5774.7672.804.58
2327528-32752871.86272.12
3341813-34181374.99675.24
4329009-32900972.18772.43
5303079-30307966.49866.69
6343438-34343875.35375.57
45min1388385-38838585.21483.673.8685.5984.033.87
2377216-37721682.76483.14
3392353-39235386.08586.45
4377294-37729482.78183.14
5356083-35608378.12778.43
6396818-39681887.06587.41
60min1412615-41261590.53189.403.7191.0589.893.72
2403596-40359688.55289.06
3419321-41932192.00292.51
4402565-40256588.32688.82
5382138-38213883.84484.27
6424612-42461293.16393.65
极限1436426-43642695.75595.032.9796.4395.672.98
2429472-42947294.22994.89
3443963-44396397.40998.07
4426153-42615393.50194.15
5413604-41360490.74891.32
6449124-44912498.54199.18
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%
113.384539634541074540794542524542244541250.03
213.334531604537854534720.10
单位质量响应值RSD%判断
33940.5834018.900.17数据可信
长期6月-供试品溶液-6000597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%
5min152534-5253411.5379.3339.4311.549.3439.42
210384-103842.2802.28
350164-5016411.01711.02
455209-5520912.12512.12
548371-4837110.62310.62
638373-383738.4278.43
10min1152289-15228933.44531.649.6933.4631.669.70
2118530-11853026.03126.03
3154448-15444833.91933.94
4152238-15223833.43433.45
5149746-14974632.88732.90
6137264-13726430.14530.16
15min1224843-22484349.37948.674.1949.4548.744.20
2206641-20664145.38245.43
3234299-23429951.45651.53
4221991-22199148.75348.83
5225021-22502149.41849.49
6216895-21689547.63447.70
20min1274030-27403060.18160.102.8860.3460.252.89
2263458-26345857.86057.98
3287031-28703163.03763.20
4269323-26932359.14859.30
5275990-27599060.61260.77
6272192-27219259.77859.92
30min1331165-33116572.72973.492.2272.9973.742.22
2326978-32697871.81072.03
3345255-34525575.82476.09
4327077-32707771.83172.09
5337496-33749674.12074.38
6339753-33975374.61574.86
45min1375441-37544182.45383.672.1082.8384.042.10
2374192-37419282.17982.52
3390618-39061885.78686.18
4372481-37248181.80382.18
5384148-38414884.36584.74
6389108-38910885.45585.82
60min1399408-39940887.71789.052.1088.2389.562.10
2398523-39852387.52288.00
3414209-41420990.96791.50
4396138-39613886.99887.51
5409453-40945389.92390.44
6415242-41524291.19491.70
极限1421553-42155392.58093.882.1693.2494.542.16
2419532-41953292.13692.76
3437403-43740396.06196.75
4416793-41679391.53592.19
5432998-43299895.09395.76
6436540-43654095.87196.53
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%
113.384549394546394545674544654546324546480.04
213.334530724534434532580.06
单位质量响应值RSD%判断
33979.6734002.850.05数据可信
长期6月-供试品溶液-6000597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%
5min159337-5933713.02713.4252.6613.0313.4252.66
285893-8589318.85718.86
359333-5933313.02613.03
4-0.0000.00
584748-8474818.60618.61
677336-7733616.97816.98
10min1176105-17610538.66237.0118.0438.6837.0318.06
2193536-19353642.48942.52
3160536-16053635.24435.27
4111690-11169024.52124.52
5192335-19233542.22642.26
6177162-17716238.89438.92
15min1252909-25290955.52453.878.3855.6153.968.41
2260426-26042657.17457.28
3229091-22909150.29550.38
4213597-21359746.89346.93
5268801-26880159.01359.11
6247451-24745154.32654.42
20min1306541-30654167.29965.095.4867.4865.275.50
2307067-30706767.41467.61
3277571-27757160.93861.10
4280080-28008061.48961.61
5317439-31743969.69169.89
6290268-29026863.72663.91
30min1365516-36551680.24677.843.9080.5478.133.91
2362220-36222079.52279.83
3334893-33489373.52373.79
4350332-35033276.91277.13
5370573-37057381.35681.67
6343926-34392675.50675.80
45min1407867-40786789.54487.493.0189.9787.903.01
2404026-40402688.70189.14
3382016-38201683.86884.26
4400940-40094088.02388.37
5410660-41066090.15790.61
6385435-38543584.61985.03
60min1428207-42820794.00992.332.6494.5892.882.64
2423803-42380393.04293.63
3406345-40634589.21089.74
4429661-42966194.32994.82
5428691-42869194.11694.72
6406552-40655289.25589.81
极限1447088-44708898.15497.342.3698.8898.052.34
2444364-44436497.55698.30
3443523-44352397.37298.05
4452672-45267299.380100.03
5449391-44939198.66099.42
6423171-42317192.90493.61
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%
113.384548014550274544604551754543954547720.08
213.334554634544074549350.17
单位质量响应值RSD%判断
33988.9434128.660.30数据可信
长期6月-供试品溶液-6000597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%
5min169590-6959015.24810.8452.7315.2510.8452.73
244185-441859.6819.68
358786-5878612.88012.88
4-0.0000.00
554569-5456911.95611.96
669700-6970015.27215.27
10min1167455-16745536.69133.6616.8736.7233.6716.90
2151277-15127733.14633.16
3164536-16453636.05136.07
4103121-10312122.59522.59
5160595-16059535.18835.21
6174630-17463038.26338.29
15min1239712-23971252.52350.345.7352.6150.425.76
2225109-22510949.32349.39
3234880-23488051.46451.55
4205762-20576245.08445.12
5231551-23155150.73550.81
6241509-24150952.91653.01
20min1286459-28645962.76561.302.7462.9461.462.77
2272726-27272659.75659.91
3285847-28584762.63162.80
4268258-26825858.77758.89
5280067-28006761.36561.53
6285181-28518162.48562.66
30min1341103-34110374.73874.971.6575.0275.231.65
2334358-33435873.26073.51
3351708-35170877.06277.33
4341529-34152974.83175.04
5343588-34358875.28375.55
6340720-34072074.65474.94
45min1383750-38375084.08285.752.1284.4986.142.10
2384907-38490784.33684.71
3403101-40310188.32288.72
4398562-39856287.32887.66
5393571-39357186.23486.63
6384358-38435884.21684.62
60min1407406-40740689.26691.262.2089.8191.792.18
2411822-41182290.23390.75
3427881-42788193.75294.30
4426058-42605893.35293.83
5418851-41885191.77392.31
6407091-40709189.19789.74
极限1431221-43122194.48496.222.4195.1896.902.39
2434653-43465395.23695.90
3453330-45333099.328100.03
4448910-44891098.35999.00
5440811-44081196.58597.27
6425856-42585693.30894.00
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