恩格列净二甲双胍缓释片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)12.5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%
110.264884884877514901864896064904584892980.24
210.204893544865734879640.41
单位质量响应值RSD%判断
47689.8647839.610.23数据可信
供试品溶液-6032601批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.79161.600.000.79161.56
2-0.0000.00
3-0.0000.00
4-0.0000.00
59478-94781.7861.79
615537-155372.9282.93
10min1200085-20008537.70134.898.5437.7034.898.54
2194885-19488536.72136.72
3183158-18315834.51134.51
4161534-16153430.43730.44
5172042-17204232.41732.42
6199246-19924637.54337.55
15min1417086-41708678.58973.045.6278.6573.105.63
2400399-40039975.44575.51
3377341-37734171.10071.16
4352821-35282166.48066.53
5385932-38593272.71972.78
6392231-39223173.90673.97
20min1541513-541513102.03494.185.06102.2394.365.06
2500145-50014594.23994.43
3481486-48148690.72490.90
4468831-46883188.33988.50
5495420-49542093.34993.53
6511558-51155896.39096.58
30min1616293-616293116.124107.085.54116.49107.425.54
2571971-571971107.773108.12
3541054-541054101.948102.27
4534492-534492100.711101.02
5554223-554223104.429104.76
6591745-591745111.499111.85
45min1639670-639670120.529109.596.15121.09110.106.15
2583990-583990110.038110.56
3554027-554027104.392104.89
4548245-548245103.303103.78
5558033-558033105.147105.65
6605609-605609114.111114.65
60min1645342-645342121.598110.376.16122.36111.066.15
2583546-583546109.954110.66
3560394-560394105.592106.26
4551743-551743103.962104.61
5562879-562879106.060106.74
6610490-610490115.031115.76
120min1648450-648450122.184111.606.18123.14112.486.18
2588549-588549110.897111.79
3558459-558459105.227106.07
4557577-557577105.061105.88
5577476-577476108.810109.67
6623285-623285117.442118.36
240min1656488-656488123.698113.036.62124.86114.106.61
2603478-603478113.710114.78
3565200-565200106.497107.52
4555492-555492104.668105.67
5583859-583859110.013111.05
6634780-634780119.608120.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1647839-647839122.068113.316.07123.44114.576.06
2614294-614294115.748117.01
3565788-565788106.608107.81
4557287-557287105.006106.18
5590262-590262111.220112.44
6632698-632698119.215120.53
480min1670303-670303126.301116.826.15127.88118.276.14
2637991-637991120.213121.67
3583054-583054109.861111.24
4573364-573364108.036109.38
5608418-608418114.641116.05
6646811-646811121.875123.39
600min1667011-667011125.681116.486.16127.47118.126.16
2634145-634145119.488121.15
3580170-580170109.318110.88
4573921-573921108.140109.67
5603882-603882113.786115.39
6649838-649838122.445124.16
720min1659857-659857124.333115.446.43126.33117.276.42
2633531-633531119.372121.23
3571108-571108107.610109.35
4565528-565528106.559108.27
5601418-601418113.322115.11
6644420-644420121.424123.34
840min1657409-657409123.872114.446.22126.07116.466.21
2622676-622676117.327119.38
3568825-568825107.180109.10
4562621-562621106.011107.90
5597179-597179112.523114.50
6635331-635331119.712121.83
960min1649579-649579122.396113.416.28124.80115.636.27
2617560-617560116.363118.61
3563953-563953106.262108.36
4556347-556347104.829106.89
5590875-590875111.335113.50
6633079-633079119.287121.61
极限1649240-649240122.332113.276.05124.94115.686.05
2616554-616554116.174118.62
3565296-565296106.515108.79
4557483-557483105.043107.28
5590063-590063111.182113.53
6628232-628232118.374120.89
恩格列净二甲双胍缓释片项目信息
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%
110.019594319559479591759605819616019593470.23
210.029552979548069550520.04
单位质量响应值RSD%判断
95838.8695314.570.39数据可信
供试品溶液-6032601批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.47158.050.000.47158.03
2-0.0000.00
3-0.0000.00
4-0.0000.00
517334-173341.6321.63
612420-124201.1701.17
10min118133-181331.7081.728.561.711.738.48
218505-185051.7431.74
321339-213392.0092.01
417372-173721.6361.64
517132-171321.6131.62
617423-174231.6411.64
15min162115-621155.8495.995.015.856.005.02
263984-639846.0256.03
369816-698166.5746.58
462857-628575.9195.92
561873-618735.8265.83
661095-610955.7535.76
20min1107296-10729610.10410.222.7110.1210.242.73
2107300-10730010.10410.12
3114487-11448710.78110.80
4108159-10815910.18510.20
5107454-10745410.11910.13
6106686-10668610.04610.06
30min1174849-17484916.46516.472.0116.4916.501.99
2178236-17823616.78416.81
3179171-17917116.87216.90
4174265-17426516.41016.44
5169538-16953815.96516.00
6173113-17311316.30116.33
45min1246941-24694123.25322.942.0423.3123.002.04
2240283-24028322.62622.68
3249753-24975323.51823.58
4245405-24540523.10923.17
5235881-23588122.21222.27
6243485-24348522.92822.99
60min1304805-30480528.70228.582.9228.8028.682.91
2300736-30073628.31928.41
3319466-31946630.08330.18
4303568-30356828.58628.68
5292973-29297327.58827.68
6299590-29959028.21128.31
120min1482687-48268745.45343.982.5045.6044.122.50
2453054-45305442.66242.80
3466168-46616843.89744.05
4478850-47885045.09145.23
5457586-45758643.08943.23
6464025-46402543.69543.84
240min1689350-68935064.91363.751.5865.1363.961.58
2671632-67163263.24563.46
3684403-68440364.44764.67
4670633-67063363.15163.37
5661497-66149762.29062.50
6684288-68428864.43764.65
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1832772-83277278.41977.521.1078.7577.841.11
2826383-82638377.81778.14
3827766-82776677.94778.28
4816581-81658176.89477.22
5808196-80819676.10576.42
6827436-82743677.91678.24
480min1951786-95178689.62688.541.1790.0888.991.17
2951886-95188689.63590.08
3940226-94022688.53789.00
4926688-92668887.26287.71
5928184-92818487.40387.85
6942746-94274688.77589.23
600min11007737-100773794.89493.891.4095.5094.491.40
21002732-100273294.42395.02
31008092-100809294.92895.54
4987868-98786893.02393.62
5972902-97290291.61492.20
61003205-100320594.46895.07
720min11032462-103246297.22396.661.6297.9997.421.61
21047930-104793098.67999.43
31020463-102046396.09396.86
41006765-100676594.80395.56
51010632-101063295.16795.91
61040485-104048597.97898.74
840min11047313-104731398.62197.271.2099.5598.191.19
21042744-104274498.19199.11
31027583-102758396.76397.69
41017851-101785195.84796.76
51021398-102139896.18197.08
61041134-104113498.03998.96
960min11055467-105546799.38998.241.21100.4899.321.21
21050399-105039998.912100.00
31038009-103800997.74598.83
41030560-103056097.04498.11
51028307-102830796.83197.89
61056640-105664099.499100.59
极限11048185-104818598.70397.631.1199.9698.871.11
21039910-103991097.92499.17
31037116-103711697.66198.91
41024341-102434196.45897.69
51022183-102218396.25597.48
61048970-104897098.777100.03
恩格列净二甲双胍缓释片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)12.5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%
110.264866484846984823374822614811164834120.47
210.204903584906454905020.05
单位质量响应值RSD%判断
47116.1848088.431.45数据可信
供试品溶液-6032602批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.15244.950.000.15244.95
2-0.0000.00
34654-46540.8800.88
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1111234-11123421.03326.9516.8421.0326.9416.84
2153115-15311528.95228.95
3120570-12057022.79822.80
4157892-15789229.85529.86
5174813-17481333.05533.05
6137400-13740025.98025.98
15min1322845-32284561.04667.257.5461.0867.307.55
2374895-37489570.88770.94
3353569-35356966.85566.89
4349261-34926166.04066.09
5397223-39722375.10975.16
6336274-33627463.58563.63
20min1520227-52022798.368100.863.8598.50101.023.86
2551412-551412104.264104.43
3541972-541972102.479102.63
4523276-52327698.94499.10
5558532-558532105.611105.79
6505180-50518095.52395.67
30min1724602-724602137.012133.793.46137.31134.123.45
2727512-727512137.562137.90
3698466-698466132.070132.39
4727527-727527137.565137.89
5702030-702030132.744133.10
6665320-665320125.803126.11
45min1784946-784946148.422143.705.25148.95144.255.24
2781908-781908147.848148.42
3756496-756496143.043143.58
4806802-806802152.555153.11
5731778-731778138.369138.95
6697922-697922131.967132.49
60min1788872-788872149.165145.194.79149.94145.984.78
2791164-791164149.598150.41
3755375-755375142.831143.61
4813366-813366153.796154.60
5745873-745873141.034141.84
6712562-712562134.736135.47
120min1797189-797189150.737145.845.01151.76146.884.99
2792968-792968149.939151.00
3759678-759678143.645144.66
4816141-816141154.321155.39
5752222-752222142.235143.28
6709689-709689134.192135.16
240min1792737-792737149.896145.784.83151.17147.054.82
2798954-798954151.071152.39
3756850-756850143.110144.37
4809404-809404153.047154.37
5758924-758924143.502144.78
6708943-708943134.051135.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1797693-797693150.833146.125.12152.36147.635.11
2795959-795959150.505152.07
3761442-761442143.978145.47
4813489-813489153.820155.40
5764440-764440144.545146.06
6703454-703454133.013134.42
480min1817109-817109154.504150.744.97156.28152.504.96
2825068-825068156.009157.83
3782380-782380147.937149.67
4839011-839011158.645160.48
5790539-790539149.480151.24
6729104-729104137.863139.49
600min1807520-807520152.691149.274.81154.73151.294.80
2811476-811476153.439155.52
3775309-775309146.600148.58
4832413-832413157.398159.50
5786179-786179148.656150.67
6723784-723784136.858138.72
720min1781218-781218147.718147.464.63150.01149.724.63
2810158-810158153.190155.52
3766993-766993145.028147.25
4828065-828065156.576158.94
5767283-767283145.083147.34
6725570-725570137.195139.28
840min1715891-715891135.365140.836.39137.90143.336.32
2757518-757518143.236145.82
3769551-769551145.511147.98
4820635-820635155.171157.79
5688810-688810130.244132.74
6716375-716375135.457137.77
960min1687626-687626130.021136.237.99132.78138.977.88
2696355-696355131.671134.50
3760913-760913143.878146.59
4819402-819402154.938157.82
5674799-674799127.595130.31
6683570-683570129.254131.80
极限1669526-669526126.598133.408.77129.58136.378.63
2671840-671840127.036130.08
3757103-757103143.158146.11
4807622-807622152.710155.85
5657865-657865124.393127.32
6669128-669128126.523129.28
恩格列净二甲双胍缓释片项目信息
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%
110.019587169500199470529460269476689498960.55
210.029587269594839591040.06
单位质量响应值RSD%判断
94894.7195718.960.62数据可信
供试品溶液-6032602批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.14244.950.000.14244.95
2-0.0000.00
39134-91340.8630.86
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min11247-12470.1180.1940.570.120.1939.25
21919-19190.1810.18
31010-10100.0950.10
43209-32090.3030.30
52155-21550.2040.20
62541-25410.2400.24
15min115628-156281.4762.3138.821.482.3138.75
221766-217662.0552.06
318125-181251.7121.71
423973-239732.2642.26
542487-424874.0124.01
624748-247482.3372.34
20min153561-535615.0585.797.885.065.797.92
261417-614175.8005.80
360654-606545.7285.73
459513-595135.6205.62
565478-654786.1836.19
667270-672706.3536.36
30min1135554-13555412.80113.295.2612.8113.305.26
2154459-15445914.58614.60
3138396-13839613.06913.08
4133939-13393912.64812.66
5139277-13927713.15213.17
6142747-14274713.48013.49
45min1215722-21572220.37120.451.7420.4020.491.74
2222471-22247121.00921.05
3217312-21731220.52220.56
4215053-21505320.30820.34
5211057-21105719.93119.97
6217791-21779120.56720.60
60min1274220-27422025.89625.750.9725.9625.820.96
2274831-27483125.95326.03
3270887-27088725.58125.65
4273918-27391825.86725.94
5268155-26815525.32325.40
6274184-27418425.89225.96
120min1433992-43399240.98340.511.3241.0940.621.31
2431912-43191240.78740.90
3426612-42661240.28740.40
4425911-42591140.22040.33
5420329-42032939.69339.81
6434980-43498041.07741.19
240min1629869-62986959.48158.781.0959.6658.961.09
2631308-63130859.61759.80
3618343-61834358.39258.57
4614169-61416957.99858.18
5620065-62006558.55558.74
6620647-62064758.61058.79
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1777671-77767173.43872.301.7473.7272.581.73
2782719-78271973.91574.20
3769062-76906272.62572.90
4752823-75282371.09271.37
5761705-76170571.93172.21
6749752-74975270.80271.08
480min1894935-89493584.51283.190.9484.9183.590.93
2885954-88595483.66484.07
3876777-87677782.79783.20
4872897-87289782.43182.82
5875306-87530682.65883.06
6879542-87954283.05883.46
600min1949594-94959489.67489.060.7290.2189.600.72
2951430-95143089.84790.39
3940580-94058088.82289.36
4935338-93533888.32788.86
5945295-94529589.26889.80
6936303-93630388.41888.96
720min1961979-96197990.84391.830.9891.5392.520.98
2987922-98792293.29393.99
3969920-96992091.59392.28
4974906-97490692.06492.74
5963703-96370391.00691.69
6976363-97636392.20192.89
840min1909009-90900985.84190.735.0186.6891.574.96
2961526-96152690.80091.65
31008729-100872995.25896.09
41000130-100013094.44695.28
5895962-89596284.60985.45
6989350-98935093.42894.27
960min1902246-90224685.20289.526.3486.1990.516.28
2900087-90008784.99886.00
31010076-101007695.38596.38
41027688-102768897.04898.04
5889919-88991984.03885.02
6957560-95756090.42691.42
极限1886893-88689383.75388.436.5984.8889.586.52
2884149-88414983.49384.64
31003422-100342294.75795.91
41014441-101444195.79796.95
5880623-88062383.16084.28
6949295-94929589.64590.79
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