非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.153917731392072739187093915508391866439182680.05
210.253977862398084739793540.06
单位质量响应值RSD%判断
386036.26388229.660.41数据可信
长期36月-供试品溶液-2011707批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1690332-69033216.04919.1620.2716.0519.1620.27
21021481-102148123.74723.75
3870487-87048720.23720.24
4988924-98892422.99122.99
5598315-59831513.91013.91
6775769-77576918.03518.04
10min12162914-216291450.28351.787.8350.3151.827.84
22414669-241466956.13656.18
32305105-230510553.58953.62
42389427-238942755.54955.59
51960403-196040345.57545.60
62132392-213239249.57449.60
15min12904287-290428767.51967.813.3867.6367.933.40
23002558-300255869.80469.94
32955908-295590868.71968.84
43015573-301557370.10670.24
52750423-275042363.94264.04
62871463-287146366.75666.87
20min13265537-326553775.91775.771.7876.1476.001.79
23310120-331012076.95477.20
33274293-327429376.12176.36
43315594-331559477.08177.33
53160929-316092973.48573.69
63227899-322789975.04275.27
30min13623226-362322684.23384.060.9484.5884.410.96
23643018-364301884.69385.07
33622865-362286584.22484.59
43652348-365234884.91085.29
53561276-356127682.79383.12
63591028-359102883.48483.83
45min13873216-387321690.04589.790.5190.5390.290.52
23848786-384878689.47790.00
33867142-386714289.90390.41
43893252-389325290.51091.03
53839997-383999789.27289.74
63851051-385105189.52990.02
60min14015299-401529993.34892.990.5393.9993.640.54
24001806-400180693.03493.70
34002241-400224193.04493.70
44027638-402763893.63594.30
53980895-398089592.54893.16
63971027-397102792.31892.96
极限14103147-410314795.39094.900.5196.1995.710.52
24081769-408176994.89395.72
34086713-408671395.00895.82
44104091-410409195.41296.24
54064711-406471194.49695.27
64053108-405310894.22795.02
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.153966335396963239693833969490396948139688640.04
210.254017860402068540192720.05
单位质量响应值RSD%判断
391021.08392124.100.20数据可信
长期36月-供试品溶液-2011708批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1994009-99400922.84718.1117.0522.8518.1117.05
2822418-82241818.90318.90
3592083-59208313.60913.61
4822205-82220518.89818.90
5792829-79282918.22318.22
6704539-70453916.19316.19
10min12417647-241764755.56850.667.2355.6150.707.24
22261067-226106751.96952.00
31928038-192803844.31544.34
42203269-220326950.64150.67
52178000-217800050.06050.09
62237666-223766651.43151.46
15min13006430-300643069.10166.213.8169.2366.333.82
22913976-291397666.97667.09
32686888-268688861.75661.85
42897424-289742466.59566.71
52838803-283880365.24865.36
62941575-294157567.61067.72
20min13321644-332164476.34674.432.2476.5974.652.25
23243142-324314274.54174.77
33122374-312237471.76671.97
43253297-325329774.77575.00
53191542-319154273.35573.58
63296742-329674275.77376.00
30min13637869-363786983.61482.751.6983.9983.101.69
23583471-358347182.36482.72
33524561-352456181.01081.33
43609187-360918782.95583.31
53554076-355407681.68882.03
63693338-369333884.88985.24
45min13904420-390442089.74089.001.1390.2589.491.14
23843644-384364488.34388.83
33812022-381202287.61788.07
43862715-386271588.78289.27
53876567-387656789.10089.58
63934297-393429790.42790.92
60min14040847-404084792.87692.031.1893.5492.661.19
23971564-397156491.28491.92
33945327-394532790.68191.28
43989502-398950291.69692.33
54001568-400156891.97392.60
64075089-407508993.66394.31
极限14121035-412103594.71993.641.2795.5494.431.28
24039691-403969192.84993.64
34008076-400807692.12392.87
44063127-406312793.38894.18
54065640-406564093.44694.23
64146879-414687995.31396.11
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.153998523399882439975833993986399421239966260.06
210.254011068400594740085080.10
单位质量响应值RSD%判断
393756.26391073.950.49数据可信
长期36月-供试品溶液-2011709批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11072313-107231324.59421.8313.7824.5921.8313.78
2960653-96065322.03322.03
3991617-99161722.74322.74
4700795-70079516.07316.07
51033939-103393923.71423.71
6951440-95144021.82121.82
10min12419413-241941355.49052.315.0455.5352.345.04
22317122-231712253.14453.18
32236955-223695551.30551.34
42113819-211381948.48148.51
52384598-238459854.69154.73
62211689-221168950.72550.76
15min12950656-295065667.67466.651.7667.8166.781.77
22942083-294208367.47767.60
32888265-288826566.24366.37
42850835-285083565.38465.49
52958666-295866667.85767.99
62846383-284638365.28265.40
20min13234291-323429174.17974.280.9474.4374.520.94
23263943-326394374.85975.10
33243148-324314874.38274.62
43251168-325116874.56674.78
53259715-325971574.76275.01
63181018-318101872.95773.19
30min13566445-356644581.79782.410.8382.1782.770.82
23613727-361372782.88183.24
33605650-360565082.69683.05
43619216-361921683.00783.35
53607584-360758482.74183.11
63546509-354650981.34081.69
45min13822905-382290587.67988.491.0088.1988.990.99
23889072-388907289.19789.70
33893976-389397689.30989.80
43892536-389253689.27689.76
53843819-384381988.15988.66
63808337-380833787.34587.83
60min13956227-395622790.73791.231.1091.3991.871.09
24013470-401347092.05092.70
34013178-401317892.04392.69
44020795-402079592.21892.85
53921308-392130889.93690.59
63940230-394023090.37091.00
极限14035803-403580392.56293.241.1193.3794.041.10
24105721-410572194.16594.97
34099077-409907794.01394.81
44104260-410426094.13294.91
54051083-405108392.91293.72
63996471-399647191.66092.44
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.151941620194036819415061939959194043819407780.04
210.253927889392647339271810.03
单位质量响应值RSD%判断
191209.66383139.6147.26数据不可信!(响应值差异过大,请重新称样测定!)
长期36月-供试品溶液-2011707批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1985682-98568234.77431.0823.7034.7731.0823.70
2984795-98479534.74334.74
3997587-99758735.19435.19
41082000-108200038.17238.17
5662313-66231323.36623.37
6573745-57374520.24120.24
10min12030540-203054071.63678.818.9271.6978.868.91
21939453-193945368.42368.48
32417336-241733685.28285.34
42386789-238678984.20584.27
52314546-231454681.65681.69
62314798-231479881.66581.70
15min12856676-2856676100.782102.854.92100.96103.034.92
22653946-265394693.63093.80
33024622-3024622106.707106.91
43036466-3036466107.125107.33
52974503-2974503104.939105.11
62945135-2945135103.903104.07
20min13225695-3225695113.801115.262.93114.15115.612.94
23106953-3106953109.612109.94
33337598-3337598117.749118.13
43367484-3367484118.803119.19
53319640-3319640117.115117.46
63244305-3244305114.457114.80
30min13591244-3591244126.697127.211.64127.23127.761.65
23544703-3544703125.055125.57
33640422-3640422128.432129.01
43673080-3673080129.584130.16
53653184-3653184128.882129.43
63532092-3532092124.610125.14
45min13835278-3835278135.306135.930.56136.05136.690.58
23825949-3825949134.977135.70
33872096-3872096136.605137.39
43872185-3872185136.609137.41
53871944-3871944136.600137.36
63840880-3840880135.504136.25
60min14001237-4001237141.161142.011.11142.13143.001.11
24021551-4021551141.878142.82
34048292-4048292142.821143.84
44059189-4059189143.206144.23
54070884-4070884143.619144.61
63951115-3951115139.393140.36
极限14056160-4056160143.099143.231.48144.31144.461.48
24064542-4064542143.395144.58
34086021-4086021144.153145.41
44116769-4116769145.237146.50
54090495-4090495144.310145.54
63945783-3945783139.205140.40
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.153946136395008039467033948964394890639481580.05
210.253970494396994239702180.01
单位质量响应值RSD%判断
388981.08387338.340.30数据可信
长期36月-供试品溶液-2011708批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1873757-87375720.25920.3917.9720.2620.3917.97
21022467-102246723.70723.71
31020521-102052123.66223.66
4979384-97938422.70822.71
5654778-65477815.18215.18
6724891-72489116.80816.81
10min12258041-225804152.35651.956.3252.3951.986.32
22388583-238858355.38355.42
32318276-231827653.75353.79
42300560-230056053.34253.38
51983907-198390746.00046.03
62192604-219260450.83950.87
15min12923888-292388867.79567.292.4667.9267.422.47
22989582-298958269.31869.45
32913619-291361967.55667.69
42900501-290050167.25267.38
52771661-277166164.26564.37
62914220-291422067.57067.68
20min13244914-324491475.23875.041.2775.4775.281.28
23286760-328676076.20876.46
33223186-322318674.73474.98
43245406-324540675.24975.49
53164414-316441473.37173.58
63253882-325388275.44675.67
30min13588379-358837983.20283.190.7383.5683.550.74
23616732-361673283.85984.23
33566501-356650182.69483.06
43597298-359729883.40983.77
53548996-354899682.28982.62
63610081-361008183.70584.06
45min13859260-385926089.48289.210.4189.9889.710.42
23856329-385632989.41589.93
33834111-383411188.89989.40
43831887-383188788.84889.35
53835068-383506888.92289.39
63868517-386851789.69790.19
60min13963054-396305491.88991.910.4592.5492.550.45
23972201-397220192.10192.76
33937837-393783791.30491.96
43958191-395819191.77692.43
53959809-395980991.81492.43
63991410-399141092.54793.19
极限14041210-404121093.70193.710.6094.5094.510.60
24049843-404984393.90194.72
33998778-399877892.71793.52
44063715-406371594.22395.03
54033437-403343793.52194.29
64062530-406253094.19694.99
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.153940258394139839341923929850392646839344330.17
210.253905701390551239056060.01
单位质量响应值RSD%判断
387628.87381034.731.22数据可信
长期36月-供试品溶液-2011709批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1972972-97297222.78623.799.9222.7923.799.93
21083802-108380225.38225.38
31148106-114810626.88726.89
4929966-92996621.77921.78
5888337-88833720.80420.80
61072049-107204925.10625.11
10min12300556-230055653.87753.844.6753.9153.884.67
22378876-237887655.71155.75
32319739-231973954.32654.37
42324096-232409654.42854.46
52090221-209022148.95148.99
62379636-237963655.72955.77
15min12885425-288542567.57468.193.0767.7068.323.07
22952567-295256769.14669.28
33000819-300081970.27670.41
42946289-294628968.99969.13
52745798-274579864.30464.42
62938928-293892868.82768.96
20min13185087-318508774.59275.811.9374.8376.051.94
23239292-323929275.86176.11
33329766-332976677.98078.23
43267104-326710476.51276.75
53152340-315234073.82574.05
63248764-324876476.08376.33
30min13530310-353031082.67684.231.4783.0484.601.47
23575468-357546883.73484.11
33685753-368575386.31786.70
43616545-361654584.69685.07
53570776-357077683.62483.97
63601041-360104184.33384.71
45min13788746-378874688.72990.711.7589.2391.221.75
23841794-384179489.97190.49
33993652-399365293.52794.05
43881584-388158490.90391.41
53861636-386163690.43690.92
63873434-387343490.71291.23
60min13926673-392667391.95993.941.7192.6194.601.70
23979541-397954193.19793.86
34133859-413385996.81197.49
44010254-401025493.91694.58
54002235-400223593.72894.36
64015782-401578294.04694.71
极限14003634-400363493.76195.661.7194.5696.481.71
24029403-402940394.36595.19
34205105-420510598.47999.32
44085098-408509895.66996.49
54091823-409182395.82696.62
64093669-409366995.87096.69
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