依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
111.159475239476169491459484819477629481050.08
211.179443139445649444380.02
单位质量响应值RSD%判断
85031.8484551.300.41数据可信
供试品溶液-1996049批-依折麦布-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156486-564865.9815.1110.335.985.1110.33
243261-432614.5804.58
350885-508855.3885.39
447251-472515.0035.00
543425-434254.5984.60
648083-480835.0915.09
10min166301-663017.0206.712.867.096.762.92
263114-631146.6826.73
364555-645556.8356.89
461900-619006.5546.61
561479-614796.5096.56
662629-626296.6316.69
15min169486-694867.3577.052.437.507.182.48
267260-672607.1217.25
366282-662827.0187.15
464850-648506.8666.99
565615-656156.9477.07
666173-661737.0067.14
20min169323-693237.3407.151.977.577.361.97
268794-687947.2847.49
366694-666947.0617.28
467495-674957.1467.35
566933-669337.0877.29
665808-658086.9687.18
30min170589-705897.4747.212.107.787.502.10
268716-687167.2767.56
366727-667277.0657.36
467569-675697.1547.44
567838-678387.1837.46
666938-669387.0877.37
45min169326-693267.3407.261.577.737.631.56
269067-690677.3137.68
367527-675277.1507.52
469663-696637.3767.74
568912-689127.2967.66
666961-669617.0907.45
60min168437-684377.2467.251.497.727.701.38
269961-699617.4077.85
367887-678877.1887.64
468753-687537.2797.72
568789-687897.2837.72
666910-669107.0847.53
极限169036-690367.3097.312.027.867.841.88
270881-708817.5058.03
367588-675887.1567.69
468289-682897.2307.76
570495-704957.4647.99
667844-678447.1837.70
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180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%
110.162553822544542550162547372551682549510.15
210.192551422545332548380.17
单位质量响应值RSD%判断
25093.6025008.640.24数据可信
供试品溶液-1996049批-贝派度酸-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min171770-7177028.56927.1811.5828.5727.1811.58
259898-5989823.84323.84
379886-7988631.80031.80
465955-6595526.25526.25
559761-5976123.78923.79
672407-7240728.82328.82
10min1122363-12236348.70949.244.8649.0349.544.89
2120573-12057347.99648.26
3132138-13213852.60052.95
4119604-11960447.61047.90
5117384-11738446.72746.99
6130073-13007351.77852.10
15min1152999-15299960.90461.673.8261.7662.523.86
2152025-15202560.51661.31
3164008-16400865.28666.22
4150917-15091760.07560.90
5149162-14916259.37660.16
6160473-16047363.87964.77
20min1171502-17150268.26969.042.9869.8070.573.04
2171008-17100868.07369.54
3181637-18163772.30473.97
4171664-17166468.33469.82
5167334-16733466.61068.05
6177415-17741570.62372.23
30min1195148-19514877.68278.152.4479.9880.452.50
2194661-19466177.48879.72
3204793-20479381.52183.99
4192742-19274276.72478.97
5191895-19189576.38778.57
6198688-19868879.09181.48
45min1211269-21126984.09985.622.5087.2688.792.54
2212392-21239284.54687.63
3225614-22561489.81093.18
4212852-21285284.72987.83
5212630-21263084.64187.67
6215787-21578785.89889.17
60min1215883-21588385.93687.932.7090.0392.062.71
2219670-21967087.44391.47
3232533-23253392.56496.93
4217357-21735786.52390.56
5219352-21935287.31791.29
6220623-22062387.82392.05
极限1225577-22557789.79592.121.9794.8497.222.01
2228071-22807190.78895.79
3237211-23721194.42699.82
4231405-23140592.11597.12
5230097-23009791.59496.54
6236212-23621294.02899.23
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
111.159434909434849440049431229424499433100.07
211.179458509454639456560.03
单位质量响应值RSD%判断
84601.7984660.340.05数据可信
供试品溶液-1996049批-依折麦布-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146885-468854.9734.946.294.974.946.31
246160-461604.8974.90
351806-518065.4955.50
446499-464994.9334.93
544884-448844.7614.76
643067-430674.5684.57
10min161278-612786.5006.632.806.566.692.81
262563-625636.6376.69
365683-656836.9687.03
463030-630306.6866.74
561955-619556.5726.62
660771-607716.4466.50
15min163584-635846.7456.971.946.877.101.96
266194-661947.0227.15
366798-667987.0867.22
467083-670837.1167.25
565375-653756.9357.06
665336-653366.9317.05
20min166426-664267.0467.141.177.257.351.18
267976-679767.2117.42
367710-677107.1837.40
468266-682667.2427.45
566435-664357.0477.25
667322-673227.1417.34
30min166438-664387.0487.170.957.337.450.92
267659-676597.1777.46
367220-672207.1317.43
468133-681337.2277.52
568129-681297.2277.51
667718-677187.1837.46
45min166772-667727.0837.231.287.447.591.22
268510-685107.2677.63
367505-675057.1617.54
468232-682327.2387.61
569268-692687.3487.71
668436-684367.2607.62
60min166148-661487.0177.171.277.457.621.25
268238-682387.2397.69
367332-673327.1427.60
467786-677867.1917.64
568623-686237.2797.72
667498-674987.1607.60
极限168082-680827.2227.251.007.747.780.92
269434-694347.3657.89
368115-681157.2267.76
467523-675237.1637.69
568095-680957.2237.75
668878-688787.3067.83
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180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%
110.162548212542612543022540362544332543710.12
210.192558872553102555980.16
单位质量响应值RSD%判断
25036.5225083.220.14数据可信
供试品溶液-1996049批-贝派度酸-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173433-7343329.22126.7410.0329.2226.7410.03
269462-6946227.64127.64
375689-7568930.11930.12
458430-5843023.25123.25
563255-6325525.17125.17
662895-6289525.02825.03
10min1126570-12657050.36649.643.1550.6949.943.19
2124707-12470749.62449.93
3131423-13142352.29752.63
4120589-12058947.98648.24
5121473-12147348.33748.62
6123725-12372549.23449.51
15min1158253-15825362.97362.561.4763.8663.411.51
2155392-15539261.83562.69
3161219-16121964.15365.07
4157408-15740862.63763.43
5155181-15518161.75162.57
6155803-15580361.99862.82
20min1172933-17293368.81570.281.2070.4071.831.17
2177012-17701270.43871.98
3178984-17898471.22372.85
4177719-17771970.71972.21
5175641-17564169.89271.40
6177469-17746970.62072.13
30min1195826-19582677.92579.602.0180.2781.921.92
2198970-19897079.17681.50
3197779-19777978.70281.12
4202870-20287080.72883.00
5206717-20671782.25884.54
6198010-19801078.79481.09
45min1213739-21373985.05387.741.7488.2790.941.69
2220117-22011787.59190.80
3224966-22496689.52092.81
4222350-22235088.47991.65
5222182-22218288.41291.61
6219537-21953787.36090.53
60min1214739-21473985.45189.012.8589.6193.192.72
2218987-21898787.14191.32
3223545-22354588.95593.24
4229937-22993791.49895.65
5231462-23146292.10596.28
6223362-22336288.88293.03
极限1231600-23160092.16093.811.8997.2798.981.83
2229862-22986291.46896.62
3238912-23891295.070100.35
4240293-24029395.619100.79
5239547-23954795.322100.52
6234282-23428293.22798.36
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
111.159455839452429451189455719462299455490.05
211.179465449457009461220.07
单位质量响应值RSD%判断
84802.6084702.060.09数据可信
供试品溶液-1996049批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158686-586866.2166.115.556.226.115.57
262224-622246.5916.59
352525-525255.5645.56
458939-589396.2436.24
557184-571846.0576.06
656586-565865.9945.99
10min172028-720287.6307.462.137.707.532.15
272158-721587.6437.72
368498-684987.2567.32
470030-700307.4187.49
569113-691137.3217.39
670548-705487.4737.54
15min174758-747587.9197.652.098.077.802.05
272131-721317.6417.80
372921-729217.7247.87
470258-702587.4427.59
571542-715427.5787.73
671958-719587.6227.77
20min174113-741137.8517.681.358.097.921.34
272827-728277.7147.96
372921-729217.7247.95
472038-720387.6317.87
571384-713847.5617.79
671884-718847.6147.85
30min173811-738117.8197.801.738.158.121.69
274310-743107.8718.20
375737-757378.0238.34
472626-726267.6938.01
572364-723647.6657.98
672899-728997.7228.04
45min176756-767568.1307.763.448.558.173.31
272781-727817.7098.13
375368-753687.9838.39
469864-698647.4007.81
571467-714677.5707.97
673179-731797.7528.16
60min173377-733777.7737.641.288.288.141.26
271602-716027.5858.09
372749-727497.7068.20
472602-726027.6908.18
571028-710287.5248.01
671371-713717.5608.05
极限172764-727647.7087.681.308.308.261.26
272827-728277.7148.30
373805-738057.8188.40
472872-728727.7198.29
571073-710737.5298.10
671872-718727.6138.19
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180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%
110.162553122554192558152555082559962556100.12
210.192560892564202562540.10
单位质量响应值RSD%判断
25158.4625147.600.04数据可信
供试品溶液-1996049批-贝派度酸-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13150-31501.2491.4316.311.251.4416.22
24055-40551.6081.61
32694-26941.0681.07
43814-38141.5121.51
53726-37261.4771.48
64270-42701.6931.69
10min16246-62462.4762.716.072.492.736.10
27500-75002.9732.99
36691-66912.6532.66
46821-68212.7042.72
57048-70482.7942.81
66744-67442.6742.69
15min18815-88153.4953.474.733.543.524.63
29010-90103.5723.62
38682-86823.4423.48
48742-87423.4663.51
59238-92383.6623.71
68014-80143.1773.23
20min19725-97253.8564.066.383.944.146.31
210220-102204.0524.14
310117-101174.0114.09
411527-115274.5704.66
59952-99523.9464.03
69901-99013.9254.01
30min110822-108224.2904.615.034.414.745.00
211866-118664.7044.84
312136-121364.8114.94
411961-119614.7424.88
511996-119964.7564.89
610926-109264.3324.46
45min112760-127605.0595.062.685.235.242.59
212685-126855.0295.22
313342-133425.2895.47
412324-123244.8865.07
512859-128595.0985.28
612559-125594.9795.15
60min113101-131015.1945.231.835.425.471.83
213371-133715.3015.54
313231-132315.2455.48
413366-133665.2995.54
513376-133765.3035.54
612763-127635.0605.29
极限113792-137925.4685.492.395.755.792.33
213622-136225.4005.70
314183-141835.6235.92
414317-143175.6765.98
513732-137325.4445.74
613465-134655.3385.63
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
111.159486379483119488019488039481159485330.04
211.179418029416809417410.01
单位质量响应值RSD%判断
85070.2284309.850.64数据可信
供试品溶液-1996049批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151941-519415.5065.646.245.515.646.20
256438-564385.9835.98
356135-561355.9515.95
453210-532105.6415.64
547424-474245.0275.03
654161-541615.7415.74
10min169151-691517.3307.371.457.397.431.48
270746-707467.5007.57
370085-700857.4297.50
469873-698737.4077.47
567820-678207.1897.25
669366-693667.3537.42
15min172457-724577.6817.641.067.827.781.09
272673-726737.7047.85
371754-717547.6067.76
471701-717017.6017.75
570813-708137.5077.64
672830-728307.7207.87
20min172653-726537.7027.691.287.937.921.23
271374-713747.5667.80
374156-741567.8618.09
472786-727867.7167.95
572129-721297.6467.87
672328-723287.6677.90
30min171782-717827.6097.681.517.928.001.50
271821-718217.6137.93
374112-741127.8568.18
473537-735377.7958.11
572302-723027.6647.97
671374-713747.5667.88
45min173965-739657.8417.761.768.248.161.68
272318-723187.6668.07
374093-740937.8548.26
474901-749017.9408.34
571850-718507.6178.01
672032-720327.6368.04
60min173547-735477.7967.681.768.288.171.69
272429-724297.6788.17
371191-711917.5478.04
474478-744787.8958.39
571529-715297.5838.06
671793-717937.6118.10
极限173506-735067.7927.691.658.368.261.56
272132-721327.6468.22
372856-728567.7238.30
473829-738297.8268.40
572365-723657.6718.23
670483-704837.4728.04
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180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%
110.162573152576602567012570302574252572260.15
210.192546672550272548470.10
单位质量响应值RSD%判断
25317.5225009.520.87数据可信
供试品溶液-1996049批-贝派度酸-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13117-31171.2351.4012.381.241.4012.19
23806-38061.5081.51
33767-37671.4931.49
43337-33371.3221.32
54100-41001.6251.62
62997-29971.1881.19
10min17204-72042.8552.597.732.872.607.66
27086-70862.8082.82
36498-64982.5752.59
46010-60102.3822.40
56147-61472.4362.45
66230-62302.4692.48
15min18835-88353.5013.315.933.553.365.95
28891-88913.5243.57
38477-84773.3593.40
47550-75502.9923.03
58205-82053.2523.30
68202-82023.2503.29
20min19897-98973.9223.786.124.013.866.08
210501-105014.1624.25
39433-94333.7383.82
48991-89913.5633.64
58995-89953.5653.65
69355-93553.7073.78
30min111019-110194.3674.313.564.494.443.63
211310-113104.4824.62
311260-112604.4624.59
410343-103434.0994.21
510558-105584.1844.31
610790-107904.2764.39
45min112448-124484.9334.902.195.115.072.15
212376-123764.9055.09
312612-126124.9985.17
412654-126545.0155.17
512146-121464.8134.98
611957-119574.7394.90
60min113203-132035.2325.220.745.465.450.71
213256-132565.2535.49
313015-130155.1585.39
413148-131485.2115.43
513184-131845.2255.45
613293-132935.2685.49
极限113910-139105.5135.511.835.805.801.85
214013-140135.5535.85
314225-142255.6375.92
413453-134535.3315.60
513913-139135.5145.79
613958-139585.5325.81
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