达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10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%
112.511588551588591589381586161587321588000.08
212.571596051596151596100.01
单位质量响应值RSD%判断
12693.8412697.690.03数据可信
供试品溶液-TL3539批-达格列净-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%
5min165756-6575633.31445.4224.9233.3145.4224.92
258854-5885429.81729.82
393998-9399847.62247.62
4105613-10561353.50653.51
5114232-11423257.87357.87
699505-9950550.41250.41
10min1111371-11137156.42376.2822.1656.4776.3522.17
2104824-10482453.10753.15
3175920-17592089.12689.20
4178029-17802990.19490.27
5163142-16314282.65282.74
6170111-17011186.18386.26
15min1128917-12891765.31384.0318.7365.4584.2218.74
2123632-12363262.63562.76
3189866-18986696.19196.40
4190006-19000696.26296.48
5177145-17714589.74689.96
6185633-18563394.04694.25
20min1141990-14199071.93687.2015.3472.1787.5115.36
2135032-13503268.41168.63
3192159-19215997.35397.70
4192226-19222697.38797.75
5181924-18192492.16792.51
6189362-18936295.93696.28
30min1153764-15376477.90190.4711.8478.2490.9111.88
2149489-14948975.73576.06
3193397-19339797.98098.48
4193478-19347898.02198.53
5186138-18613894.30294.79
6195137-19513798.86199.35
45min1167796-16779685.01093.108.1085.4793.678.16
2161852-16185281.99882.43
3194200-19420098.38799.03
4193917-19391798.24398.90
5190109-19010996.31496.94
6194684-19468498.63299.27
60min1174595-17459588.45494.696.0189.0495.406.08
2170584-17058486.42286.98
3194340-19434098.45899.25
4194812-19481298.69799.50
5191846-19184697.19497.96
6195203-19520398.89599.68
120min1185550-18555094.00497.072.5694.7297.932.66
2185285-18528593.87094.56
3194753-19475398.66799.60
4195308-19530898.94899.90
5192977-19297797.76798.68
6195782-19578299.188100.12
180min1188336-18833695.41697.831.8196.2798.831.92
2189099-18909995.80296.63
3195717-19571799.155100.24
4195273-19527398.930100.03
5193898-19389898.23499.30
6196255-19625599.428100.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1189923-18992396.22098.161.4397.2299.311.53
2190854-19085496.69297.66
3195563-19556399.077100.31
4195217-19521798.902100.15
5194158-19415898.36599.57
6196793-19679399.700100.93
360min1193356-19335697.95998.840.7499.11100.140.85
2193625-19362598.09599.21
3195692-19569299.143100.53
4195800-19580099.197100.59
5194938-19493898.761100.12
6197175-19717599.894101.28
480min1195886-19588699.241100.970.95100.53102.411.03
2199139-199139100.889102.15
3200429-200429101.542103.07
4199938-199938101.294102.84
5199038-199038100.838102.34
6201345-201345102.007103.54
600min1195797-19579799.196100.710.90100.64102.300.97
2198923-198923100.779102.19
3199605-199605101.125102.81
4198957-198957100.797102.49
5198200-198200100.413102.07
6201222-201222101.944103.63
720min1195244-19524498.916100.581.15100.51102.331.19
2199310-199310100.976102.54
3201191-201191101.928103.76
4198091-198091100.358102.20
5196806-19680699.707101.51
6200571-200571101.614103.45
960min1194648-19464898.61499.710.62100.35101.610.68
2197297-19729799.956101.67
3197296-19729699.955101.94
4197130-19713099.871101.87
5196366-19636699.484101.44
6198139-198139100.382102.37
1440min1192062-19206297.30498.620.7799.19100.670.81
2195900-19590099.248101.12
3195035-19503598.810100.95
4195048-19504898.816100.96
5193920-19392098.245100.35
6196050-19605099.324101.46
极限1191968-19196897.25698.470.7299.29100.660.76
2195491-19549199.041101.06
3194436-19443698.506100.79
4194540-19454098.559100.85
5193831-19383198.200100.45
6195867-19586799.231101.52
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.069593749619519625799646939577859612760.29
210.049553549561989557760.07
单位质量响应值RSD%判断
95554.2795196.810.27数据可信
供试品溶液-TL3539批-二甲双胍-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%
5min132508-325083.4082.8611.433.412.8611.47
227540-275402.8882.89
323672-236722.4822.48
428652-286523.0043.00
526260-262602.7532.75
624996-249962.6212.62
10min157263-572636.0046.255.026.016.265.05
255226-552265.7905.79
359156-591566.2026.21
460714-607146.3666.37
562897-628976.5956.60
662399-623996.5426.55
15min183140-831408.7179.588.128.739.608.10
280913-809138.4848.50
393658-936589.8209.83
496279-9627910.09510.11
596313-9631310.09810.11
698016-9801610.27710.29
20min1110612-11061211.59812.578.2811.6212.608.29
2104296-10429610.93510.96
3123968-12396812.99813.03
4127223-12722313.33913.37
5125309-12530913.13913.17
6127829-12782913.40313.43
30min1152106-15210615.94818.1213.2715.9918.1713.24
2147481-14748115.46315.51
3174678-17467818.31518.36
4176436-17643618.49918.55
5174315-17431518.27718.33
6212065-21206522.23522.28
45min1216854-21685422.73723.946.5722.8124.016.57
2202956-20295621.28021.35
3235648-23564824.70724.78
4238742-23874225.03225.11
5235720-23572024.71524.79
6239811-23981125.14425.23
60min1258987-25898727.15529.136.2327.2629.246.23
2252641-25264126.48926.59
3286087-28608729.99630.11
4291826-29182630.59830.71
5286314-28631430.02030.13
6290853-29085330.49630.62
120min1408540-40854042.83544.944.2842.9845.094.30
2402455-40245542.19742.33
3437779-43777945.90146.06
4439047-43904746.03446.19
5436917-43691745.81045.97
6446862-44686246.85347.02
180min1522697-52269754.80456.763.3155.0156.983.32
2515364-51536454.03554.24
3550162-55016257.68457.91
4549035-54903557.56657.80
5551336-55133657.80758.03
6559726-55972658.68758.92
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1611858-61185864.15365.922.6464.4466.232.66
2605071-60507163.44163.72
3635206-63520666.60166.91
4634026-63402666.47766.79
5638576-63857666.95467.27
6647769-64776967.91868.24
360min1746325-74632578.25179.551.8678.6479.961.87
2739526-73952677.53977.92
3761284-76128479.82080.23
4758092-75809279.48579.90
5770290-77029080.76481.18
6776889-77688981.45681.88
480min1851510-85151089.28090.291.4089.7890.811.41
2847600-84760088.87089.36
3860662-86066290.24090.77
4856090-85609089.76090.29
5872983-87298391.53192.07
6877868-87786892.04492.59
600min1902204-90220494.59595.551.3295.2396.211.33
2900697-90069794.43795.06
3908236-90823695.22895.89
4904040-90404094.78895.46
5924110-92411096.89297.56
6928480-92848097.35098.04
720min1931859-93185997.70598.491.0798.4899.291.08
2933563-93356397.88398.65
3936216-93621698.16198.97
4931163-93116397.63298.44
5948181-94818199.416100.23
6955279-955279100.160100.99
960min1952911-95291199.912100.260.96100.84101.210.97
2949455-94945599.549100.46
3952053-95205399.822100.78
4947434-94743499.338100.30
5966824-966824101.371102.34
6968729-968729101.570102.55
1440min1950318-95031899.640100.161.00100.72101.261.01
2949618-94961899.567100.63
3950848-95084899.696100.80
4946203-94620399.208100.32
5966747-966747101.363102.48
6968075-968075101.502102.64
极限1952287-95228799.846100.111.00101.07101.361.01
2949210-94921099.524100.74
3948871-94887199.488100.74
4945086-94508699.091100.35
5966058-966058101.290102.56
6967383-967383101.429102.72
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10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%
112.511588491588301589341588581591361589210.08
212.571604871602431603650.11
单位质量响应值RSD%判断
12703.5212757.760.31数据可信
供试品溶液-TL3539批-达格列净-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%
5min145471-4547122.97444.6428.9022.9744.6428.90
2109700-10970055.42555.42
3101945-10194551.50751.51
468618-6861834.66934.67
5103997-10399752.54352.54
6100409-10040950.73150.73
10min1100288-10028850.67073.3718.0550.7073.4418.06
2166541-16654184.14384.23
3153400-15340077.50477.58
4127952-12795264.64664.70
5166997-16699784.37484.45
6156180-15618078.90878.98
15min1122279-12227961.78081.1713.8661.8981.3513.88
2175889-17588988.86689.08
3166856-16685684.30284.50
4145759-14575973.64373.79
5178319-17831990.09490.30
6174843-17484388.33888.53
20min1134604-13460468.00784.5911.1568.2184.8911.17
2177672-17767289.76790.11
3174516-17451688.17288.49
4155740-15574078.68678.95
5181972-18197291.94092.28
6180063-18006390.97591.30
30min1151122-15112276.35388.237.2576.6688.657.29
2179230-17923090.55491.03
3179533-17953390.70791.16
4169803-16980385.79186.17
5185108-18510893.52494.00
6182956-18295692.43792.90
45min1165261-16526183.49691.264.4383.9291.824.47
2180860-18086091.37891.99
3183365-18336592.64393.23
4180882-18088291.38991.90
5187338-18733894.65195.27
6186103-18610394.02794.63
60min1173538-17353887.67892.472.9288.2293.162.97
2181241-18124191.57092.32
3182289-18228992.10092.83
4186119-18611994.03594.68
5187799-18779994.88495.64
6187094-18709494.52795.27
120min1186553-18655394.25494.831.8294.9395.661.80
2181736-18173691.82092.71
3187529-18752994.74795.61
4191719-19171996.86497.65
5188971-18897195.47696.38
6189610-18961095.79996.68
180min1190631-19063196.31495.502.1497.1396.482.08
2181715-18171591.81092.84
3188401-18840195.18896.20
4193942-19394297.98798.92
5189820-18982095.90596.95
6189600-18960095.79496.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1191672-19167296.84095.802.4797.8096.922.40
2181919-18191991.91393.08
3188593-18859395.28596.44
4196322-19632299.190100.27
5189415-18941595.70096.89
6189740-18974095.86497.04
360min1193190-19319097.60796.022.2598.7197.282.18
2182707-18270792.31193.61
3188975-18897595.47896.77
4195165-19516598.60599.83
5189775-18977595.88297.22
6190458-19045896.22797.54
480min1200252-200252101.17598.682.33102.43100.092.24
2188458-18845895.21796.66
3193948-19394897.99099.43
4200494-200494101.298102.67
5193676-19367697.85399.33
6195029-19502998.536100.00
600min1198504-198504100.29298.022.48101.7099.582.39
2186340-18634094.14695.73
3192907-19290797.46499.05
4199817-199817100.956102.48
5193149-19314997.58799.21
6193356-19335697.69199.30
720min1200853-200853101.47997.992.84103.0499.692.74
2185200-18520093.57095.29
3192480-19248097.24998.98
4198804-198804100.444102.12
5193262-19326297.64499.41
6193050-19305097.53799.29
960min1196414-19641499.23697.072.58100.9498.922.50
2183869-18386992.89894.76
3190763-19076396.38198.26
4197944-197944100.009101.84
5191699-19169996.85498.77
6192065-19206597.03998.94
1440min1194930-19493098.48695.972.60100.3497.962.51
2181991-18199191.94993.95
3188400-18840095.18797.21
4195460-19546098.754100.73
5189016-18901695.49897.56
6189926-18992695.95898.00
极限1194471-19447198.25595.602.71100.2697.742.61
2180993-18099391.44593.59
3187595-18759594.78196.94
4194875-19487598.459100.58
5188493-18849395.23497.44
6188837-18883795.40897.60
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.069552759552949556319543429560199553120.07
210.049548089559439553760.09
单位质量响应值RSD%判断
94961.4395156.970.15数据可信
供试品溶液-TL3539批-二甲双胍-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%
5min124437-244372.5712.625.532.572.625.56
225369-253692.6692.67
322845-228452.4032.40
424370-243702.5642.56
526923-269232.8322.83
625580-255802.6912.69
10min152806-528065.5556.509.355.566.509.32
263253-632536.6546.66
358319-583196.1356.14
469783-697837.3417.34
564571-645716.7936.80
661739-617396.4956.50
15min178025-780258.2089.7310.248.229.7410.22
2100780-10078010.60210.62
391246-912469.5999.61
484990-849908.9418.96
598707-9870710.38410.40
6101048-10104810.63010.64
20min1101758-10175810.70512.619.1410.7312.649.13
2129461-12946113.61913.65
3121330-12133012.76412.79
4112030-11203011.78511.81
5128721-12872113.54113.57
6126000-12600013.25513.28
30min1144335-14433515.18417.627.9815.2217.677.98
2179286-17928618.86018.91
3170014-17001417.88517.93
4159728-15972816.80316.85
5178175-17817518.74418.79
6173454-17345418.24718.30
45min1199970-19997021.03623.936.7221.1024.006.73
2240960-24096025.34825.43
3230663-23066324.26524.34
4220454-22045423.19123.26
5238668-23866825.10725.19
6234116-23411624.62824.71
60min1247699-24769926.05729.225.9526.1529.335.95
2293207-29320730.84530.96
3281083-28108329.56929.68
4271350-27135028.54528.65
5288932-28893230.39530.51
6284321-28432129.91030.02
120min1395088-39508841.56245.234.3841.7045.384.39
2447980-44798047.12647.29
3434352-43435245.69345.85
4424181-42418144.62344.77
5441720-44172046.46846.63
6436259-43625945.89346.05
180min1507849-50784953.42557.053.4453.6257.273.45
2560749-56074958.99059.22
3547515-54751557.59757.82
4536886-53688656.47956.69
5553791-55379158.25858.49
6546877-54687757.53057.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1596636-59663662.76566.412.8163.0466.722.82
2647547-64754768.12068.44
3634640-63464066.76367.07
4636755-63675566.98567.29
5638689-63868967.18967.51
6633313-63331366.62366.94
360min1729758-72975876.76979.842.1577.1480.252.16
2777654-77765481.80782.23
3762725-76272580.23780.65
4753448-75344879.26179.66
5765363-76536380.51480.93
6764946-76494680.47180.88
480min1839816-83981688.34790.771.7488.8391.291.75
2886030-88603093.20893.76
3865962-86596291.09791.63
4856566-85656690.10990.63
5864027-86402790.89491.43
6864559-86455990.95091.48
600min1893047-89304793.94795.931.2694.5696.591.28
2928679-92867997.69598.38
3913029-91302996.04996.71
4908910-90891095.61596.27
5915475-91547596.30696.98
6912154-91215495.95796.63
720min1924164-92416497.22098.770.9997.9899.581.00
2952387-952387100.189101.02
3939946-93994698.88099.69
4937626-93762698.63699.43
5943135-94313599.216100.04
6936399-93639998.50799.32
960min1941835-94183599.079100.660.9599.98101.620.97
2970102-970102102.053103.04
3955626-955626100.530101.49
4957421-957421100.718101.66
5959610-959610100.949101.92
6956830-956830100.656101.62
1440min1944698-94469899.380100.600.78100.43101.700.80
2967644-967644101.794102.93
3953227-953227100.277101.39
4958190-958190100.799101.90
5956700-956700100.643101.76
6957157-957157100.691101.80
极限1942272-94227299.125100.340.72100.33101.600.73
2962565-962565101.260102.55
3950827-950827100.025101.28
4955960-955960100.565101.81
5955950-955950100.564101.84
6955398-955398100.506101.77
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