非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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500
标示量(mg)20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%
110.151910617190972319079921907010190596319082610.11
210.161944337194456219444500.01
单位质量响应值RSD%判断
188006.01191382.871.26数据可信
长期36月-供试品溶液-2021701批-20mg规格-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%
5min1377732-37773217.92327.7516.9817.9227.7416.98
2683052-68305232.41032.41
3562096-56209626.67126.67
4697994-69799433.11933.12
5597974-59797428.37328.37
6486637-48663723.09023.09
7447222-44722221.22021.22
8672757-67275731.92131.92
9609789-60978928.93428.93
10627994-62799429.79729.80
11630370-63037029.91029.91
12623476-62347629.58329.58
10min11136147-113614753.90860.055.5053.9560.125.51
21313875-131387562.34162.41
31255007-125500759.54859.61
41361088-136108864.58264.66
51289443-128944361.18261.25
61228134-122813458.27358.32
71138889-113888954.03954.09
81330118-133011863.11263.18
91256404-125640459.61459.68
101309254-130925462.12262.19
111285351-128535160.98861.05
121284137-128413760.93061.00
15min11545211-154521173.31875.362.2873.4875.552.29
21616729-161672976.71176.92
31582172-158217275.07275.26
41632182-163218277.44577.66
51581311-158131175.03175.23
61557787-155778773.91574.10
71514525-151452571.86272.03
81639925-163992577.81278.02
91587700-158770075.33475.53
101608002-160800276.29776.50
111602583-160258376.04076.24
121590604-159060475.47275.67
20min11703199-170319980.81482.383.6281.1482.743.61
21726271-172627181.90982.29
31562132-156213274.12174.48
41784478-178447884.67185.06
51758794-175879483.45283.82
61734967-173496782.32282.67
71708064-170806481.04581.37
81809863-180986385.87586.26
91758242-175824283.42683.79
101768577-176857783.91684.29
111765281-176528183.76084.13
121754194-175419483.23483.60
30min11900710-190071090.18691.631.3990.6992.181.40
21899408-189940890.12490.69
31898504-189850490.08190.60
41964103-196410393.19493.77
51935513-193551391.83792.39
61932362-193236291.68892.22
71908234-190823490.54391.05
81984442-198444294.15994.73
91938631-193863191.98592.53
101930202-193020291.58592.15
111949766-194976692.51393.07
121932708-193270891.70492.26
45min12024839-202483996.07696.811.0596.7897.561.06
22013613-201361395.54396.31
32020693-202069395.87996.60
42074235-207423598.41999.20
52058058-205805897.65298.41
62063021-206302197.88798.62
72011001-201100195.41996.13
82066421-206642198.04998.83
92033492-203349296.48697.24
102031145-203114596.37597.14
112047133-204713397.13397.90
122039555-203955596.77497.53
60min12067220-206722098.08699.611.1999.00100.581.19
22051654-205165497.34898.32
32077848-207784898.59199.53
42117154-2117154100.456101.46
52124883-2124883100.822101.79
62102899-210289999.779100.73
72080591-208059198.72199.64
82130504-2130504101.089102.09
92105424-210542499.899100.87
102102894-210289499.779100.76
112123103-2123103100.738101.72
122108676-2108676100.053101.03
极限12103539-210353999.810100.240.92100.94101.430.93
22081486-208148698.76399.96
32094495-209449599.381100.54
42133444-2133444101.229102.46
52139718-2139718101.526102.72
62121378-2121378100.656101.83
72082242-208224298.79999.94
82127812-2127812100.961102.19
92110421-2110421100.136101.33
102108706-2108706100.055101.25
112129675-2129675101.050102.25
122119624-2119624100.573101.77
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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500
标示量(mg)20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%
110.151927754192972019299651929127192887419290880.05
210.161944142194469319444180.03
单位质量响应值RSD%判断
190057.93191379.720.50数据可信
长期36月-供试品溶液-2012702批-20mg规格-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%
5min1630463-63046329.75228.7216.1029.7528.7216.10
2421936-42193619.91119.91
3494796-49479623.35023.35
4674806-67480631.84431.84
5585553-58555327.63327.63
6512054-51205424.16424.16
7713792-71379233.68433.68
8535878-53587825.28825.29
9683682-68368232.26332.26
10638494-63849430.13130.13
11731823-73182334.53534.54
12678953-67895332.04032.04
10min11239843-123984358.50958.015.0458.5758.075.05
21128647-112864753.26153.31
31169241-116924155.17755.23
41244632-124463258.73558.81
51185451-118545155.94256.00
61149960-114996054.26754.32
71230420-123042058.06458.14
81211391-121139157.16657.22
91290261-129026160.88860.96
101285194-128519460.64960.72
111319392-131939262.26362.34
121296717-129671761.19361.26
15min11552027-155202773.24171.862.8473.4472.052.86
21455565-145556568.68968.85
31480367-148036769.85970.03
41508474-150847471.18671.39
51487395-148739570.19170.38
61475962-147596269.65169.83
71511406-151140671.32471.53
81517851-151785171.62871.81
91566244-156624473.91274.12
101562770-156277073.74873.95
111586764-158676474.88075.10
121567099-156709973.95274.16
20min11661698-166169878.41678.782.3678.7879.132.37
21628347-162834776.84277.16
31640172-164017277.40077.73
41663806-166380678.51678.88
51648720-164872077.80478.15
61652519-165251977.98378.31
71664374-166437478.54378.90
81650413-165041377.88478.23
91629177-162917776.88277.25
101724879-172487981.39881.76
111740730-174073082.14682.53
121728209-172820981.55581.93
30min11834834-183483486.58787.781.8487.1288.311.85
21818074-181807485.79686.28
31818356-181835685.80986.31
41834003-183400386.54787.08
51837918-183791886.73287.25
61856203-185620387.59588.10
71845859-184585987.10787.64
81871087-187108788.29788.81
91897392-189739289.53990.08
101896677-189667789.50590.05
111915856-191585690.41090.97
121895810-189581089.46490.02
45min11971670-197167093.04492.783.2693.7793.513.25
21958089-195808992.40393.08
31774180-177418083.72484.42
41961387-196138792.55993.29
51975653-197565393.23293.94
62002829-200282994.51495.21
71951157-195115792.07692.81
81975893-197589393.24393.95
91999452-199945294.35595.10
102006626-200662694.69495.44
112015128-201512895.09595.86
122001910-200191094.47195.22
60min12002800-200280094.51396.271.8095.4597.201.80
22014229-201422995.05295.93
32007108-200710894.71695.59
41983166-198316693.58794.52
52012506-201250694.97195.89
62055935-205593597.02197.93
72025827-202582795.60096.53
82057392-205739297.08998.01
92078708-207870898.09599.05
102087155-208715598.49499.45
112088887-208888798.57699.55
122067798-206779897.58098.54
极限12041565-204156596.34297.251.9097.4898.391.89
22051538-205153896.81397.91
32025785-202578595.59896.69
42036020-203602096.08197.22
52058164-205816497.12698.25
62105754-210575499.371100.49
71971123-197112393.01894.17
82065525-206552597.47398.61
92087166-208716698.49499.66
102097845-209784598.998100.17
112096476-209647698.934100.13
122092791-209279198.76099.94
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