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%
19.464389824351294355194347684358284360450.39
29.414398674386274392470.20
单位质量响应值RSD%判断
46093.5546678.750.90数据可信
供试品溶液-6041001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%
5min1-0.0000.18244.950.000.18244.95
2-0.0000.00
3-0.0000.00
45673-56731.1011.10
5-0.0000.00
6-0.0000.00
10min146597-465979.0418.3925.609.048.4025.61
229518-295185.7275.73
340929-409297.9427.94
450283-502839.7569.76
559202-5920211.48711.49
633044-330446.4126.41
15min1154629-15462930.00326.8717.7230.0226.8917.73
292989-9298918.04318.05
3152360-15236029.56329.58
4141443-14144327.44427.46
5158929-15892930.83730.86
6130684-13068425.35725.37
20min1262631-26263150.95948.5214.1951.0248.5814.20
2179683-17968334.86434.90
3279022-27902254.13954.20
4259699-25969950.39050.45
5265484-26548451.51251.58
6253994-25399449.28349.34
30min1424674-42467482.40080.277.8782.5580.417.89
2351227-35122768.14968.25
3441345-44134585.63585.79
4432616-43261683.94184.09
5424489-42448982.36482.52
6407686-40768679.10479.24
45min1492550-49255095.57096.673.3295.8696.943.34
2481257-48125793.37993.59
3505624-50562498.10798.40
4527635-527635102.378102.67
5494668-49466895.98196.27
6487508-48750894.59294.86
60min1507971-50797198.562101.093.0899.01101.533.06
2533033-533033103.425103.79
3526261-526261102.111102.57
4543141-543141105.386105.84
5515145-51514599.954100.41
6500588-50058897.13097.55
120min1524259-524259101.723105.573.46102.33106.173.44
2561780-561780109.003109.54
3546109-546109105.962106.59
4569333-569333110.468111.10
5538546-538546104.495105.11
6524414-524414101.753102.34
240min1534490-534490103.708106.392.69104.49107.162.68
2561911-561911109.028109.75
3551651-551651107.037107.84
4568206-568206110.250111.07
5540978-540978104.967105.76
6532516-532516103.325104.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1536251-536251104.049106.262.50105.00107.212.49
2559015-559015108.466109.37
3553720-553720107.439108.42
4565517-565517109.728110.73
5539519-539519104.683105.65
6531781-531781103.182104.11
480min1531445-531445103.117105.582.61104.24106.722.60
2554331-554331107.557108.64
3545893-545893105.920107.08
4566451-566451109.909111.09
5535333-535333103.871105.02
6531448-531448103.117104.22
600min1526569-526569102.171105.002.59103.47106.312.57
2553414-553414107.380108.64
3550140-550140106.744108.08
4557355-557355108.144109.51
5532333-532333103.289104.61
6527216-527216102.296103.57
720min1526003-526003102.061104.402.73103.53105.882.72
2545823-545823105.907107.35
3543917-543917105.537107.05
4560005-560005108.658110.21
5532405-532405103.303104.79
6520113-520113100.918102.36
840min1522180-522180101.319103.732.94102.96105.392.92
2548654-548654106.456108.07
3539149-539149104.612106.31
4555408-555408107.766109.50
5526557-526557102.168103.83
6515669-515669100.056101.67
960min1522425-522425101.367103.462.59103.17105.292.58
2548904-548904106.504108.30
3534719-534719103.752105.62
4549999-549999106.717108.63
5526018-526018102.064103.90
6517243-517243100.361102.14
极限1517362-517362100.384103.072.56102.36105.072.55
2540420-540420104.858106.83
3536220-536220104.043106.08
4550196-550196106.755108.84
5527485-527485102.349104.35
6515540-515540100.031101.98
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%
19.689319249250759251439258399265549269070.31
29.629306189267479286820.30
单位质量响应值RSD%判断
95754.8696536.590.58数据可信
供试品溶液-6041001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%
5min1-0.0000.08244.950.000.08244.95
2-0.0000.00
3-0.0000.00
45287-52870.4950.49
5-0.0000.00
6-0.0000.00
10min18307-83070.7780.9048.440.780.9048.47
26881-68810.6440.64
318841-188411.7641.76
46443-64430.6030.60
59640-96400.9020.90
67598-75980.7110.71
15min137582-375823.5183.4014.903.523.4014.93
230940-309402.8962.90
336833-368333.4483.45
430683-306832.8722.87
545451-454514.2554.26
636295-362953.3983.40
20min174627-746276.9866.909.296.996.909.31
263853-638535.9775.98
376351-763517.1477.16
467459-674596.3156.32
577224-772247.2297.24
682522-825227.7257.73
30min1146735-14673513.73613.638.0913.7513.658.07
2131183-13118312.28012.30
3147428-14742813.80113.82
4140087-14008713.11313.13
5166482-16648215.58415.60
6141863-14186313.28013.30
45min1221029-22102920.69020.472.9320.7320.512.94
2205788-20578819.26419.30
3222580-22258020.83620.88
4221923-22192320.77420.81
5221419-22141920.72720.77
6219084-21908420.50820.55
60min1280595-28059526.26625.861.4326.3425.941.44
2269447-26944725.22325.29
3279081-27908126.12526.20
4274883-27488325.73225.81
5277840-27784026.00826.09
6275756-27575625.81325.89
120min1437156-43715640.92241.120.6141.0441.240.61
2435070-43507040.72740.84
3440490-44049041.23441.36
4442423-44242341.41541.53
5440299-44029941.21641.34
6440013-44001341.18941.31
240min1637957-63795759.71959.670.6659.9159.850.67
2629383-62938358.91659.09
3640305-64030559.93960.13
4637214-63721459.64959.83
5638355-63835559.75659.95
6641084-64108460.01260.20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1780407-78040773.05372.190.9073.3472.480.90
2759483-75948371.09571.37
3774785-77478572.52772.82
4770326-77032672.11072.39
5771957-77195772.26272.56
6770288-77028872.10672.39
480min1871436-87143681.57581.160.8081.9881.570.80
2854474-85447479.98780.38
3869872-86987281.42881.84
4871455-87145581.57681.98
5863535-86353580.83581.25
6871291-87129181.56181.97
600min1935400-93540087.56287.241.2688.1187.781.26
2915440-91544085.69486.22
3951457-95145789.06589.61
4930504-93050487.10487.65
5927305-92730586.80587.35
6931567-93156787.20387.75
720min1978499-97849991.59790.931.1392.2991.621.13
2951518-95151889.07189.74
3978870-97887091.63192.33
4980176-98017691.75492.44
5971987-97198790.98791.68
6967358-96735890.55491.24
840min11004694-100469494.04993.510.9894.8994.350.98
2982070-98207091.93192.75
31006240-100624094.19495.04
41005754-100575494.14894.99
51002888-100288893.88094.72
6992227-99222792.88293.72
960min11016734-101673495.17695.100.3896.1896.100.37
21019606-101960695.44596.42
31012636-101263694.79295.80
41020798-102079895.55696.55
51014532-101453294.97095.97
61011375-101137594.67495.67
极限11013617-101361794.88494.840.7096.0495.990.70
21001444-100144493.74594.88
31017817-101781795.27796.44
41022225-102222595.69096.85
51012616-101261694.79095.95
61010956-101095694.63595.79
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%
19.464408674391664395794371644383484390250.32
29.414382734381384382060.03
单位质量响应值RSD%判断
46408.5646568.120.25数据可信
供试品溶液-6041002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%
5min1-0.0000.69131.540.000.69131.42
23952-39520.7650.77
3-0.0000.00
45620-56201.0881.09
511710-117102.2672.27
6-0.0000.00
10min125436-254364.9246.4515.684.926.4515.70
230708-307085.9455.95
332469-324696.2866.29
440532-405327.8477.85
537127-371277.1887.19
633578-335786.5016.50
15min1103008-10300819.94224.1411.4719.9524.1511.47
2127169-12716924.62024.63
3134586-13458626.05626.07
4141260-14126027.34827.36
5112486-11248621.77721.79
6129478-12947825.06725.08
20min1212751-21275141.18845.739.2741.2345.789.27
2245619-24561947.55147.60
3242062-24206246.86346.92
4261993-26199350.72150.78
5206207-20620739.92139.97
6248710-24871048.15048.20
30min1412160-41216079.79380.495.1479.9080.625.14
2421608-42160881.62281.75
3431210-43121083.48183.61
4432444-43244483.72083.87
5374865-37486572.57372.69
6422336-42233681.76381.90
45min1504366-50436697.64497.871.9597.8998.131.94
2504296-50429697.63097.90
3489607-48960794.78795.06
4512873-51287399.29199.58
5518500-518500100.380100.62
6503549-50354997.48697.75
60min1528401-528401102.297101.114.09102.70101.544.07
2514089-51408999.52699.96
3497450-49745096.30596.73
4522399-522399101.135101.59
5560185-560185108.450108.86
6511207-51120798.96899.40
120min1550340-550340106.544105.283.69107.12105.883.66
2532481-532481103.087103.68
3525827-525827101.799102.39
4545693-545693105.645106.26
5579670-579670112.223112.81
6528905-528905102.395102.99
240min1550268-550268106.531105.473.85107.28106.243.83
2527790-527790102.179102.95
3531423-531423102.882103.64
4556860-556860107.807108.60
5578362-578362111.969112.74
6524153-524153101.475102.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1545685-545685105.643105.864.30106.57106.804.27
2530036-530036102.614103.55
3535988-535988103.766104.70
4556729-556729107.781108.76
5588421-588421113.917114.88
6523845-523845101.415102.35
480min1557247-557247107.882105.563.91108.99106.683.89
2524240-524240101.492102.60
3535157-535157103.605104.71
4554595-554595107.368108.52
5577011-577011111.708112.86
6523243-523243101.299102.40
600min1541136-541136104.763104.333.36106.05105.633.35
2523601-523601101.368102.65
3528303-528303102.278103.55
4550854-550854106.644107.98
5567970-567970109.958111.29
6521634-521634100.987102.26
720min1540265-540265104.594103.963.85106.06105.443.83
2518485-518485100.377101.82
3528096-528096102.238103.68
4550040-550040106.486108.00
5569677-569677110.288111.81
6515530-51553099.805101.25
840min1536300-536300103.826103.403.64105.46105.053.62
2514787-51478799.661101.28
3527235-527235102.071103.69
4546808-546808105.861107.55
5564603-564603109.306111.01
6514973-51497399.697101.31
960min1538048-538048104.165103.623.59105.97105.433.57
2515722-51572299.842101.62
3532260-532260103.044104.83
4546850-546850105.869107.73
5564421-564421109.270111.16
6513957-51395799.501101.28
极限1537410-537410104.041102.753.66106.02104.743.64
2513468-51346899.406101.35
3519109-519109100.498102.46
4544793-544793105.471107.51
5559057-559057108.232110.30
6510570-51057098.845100.79
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%
19.689343899290509300539328109310619314730.23
29.629306589245789276180.47
单位质量响应值RSD%判断
96226.5596425.990.15数据可信
供试品溶液-6041002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%
5min1-0.0000.40112.560.000.40112.56
28114-81140.7580.76
3-0.0000.00
47164-71640.6690.67
510576-105760.9880.99
6-0.0000.00
10min16431-64310.6010.7219.540.600.7219.43
28322-83220.7780.78
37039-70390.6580.66
410474-104740.9790.98
56584-65840.6150.62
67546-75460.7050.71
15min129957-299572.7993.2014.082.803.2014.03
234495-344953.2233.23
341018-410183.8323.83
438599-385993.6063.61
528735-287352.6852.69
632631-326313.0493.05
20min163221-632215.9076.387.885.916.397.90
270875-708756.6226.63
369750-697506.5176.52
473800-738006.8956.90
560216-602165.6265.63
672130-721306.7396.75
30min1144928-14492813.54113.6313.9013.5613.6413.88
2143282-14328213.38713.41
3184246-18424617.21517.23
4140778-14077813.15313.17
5123881-12388111.57511.59
6137880-13788012.88212.90
45min1209376-20937619.56320.422.2719.6020.452.27
2220829-22082920.63320.67
3221523-22152320.69720.74
4222064-22206420.74820.79
5221093-22109320.65720.69
6216121-21612120.19320.23
60min1268198-26819825.05825.171.4825.1325.241.48
2275152-27515225.70825.78
3268560-26856025.09225.17
4272171-27217125.43025.51
5263411-26341124.61124.68
6268953-26895325.12925.20
120min1427487-42748739.94140.261.1040.0540.381.10
2438463-43846340.96741.09
3431548-43154840.32140.44
4433935-43393540.54440.66
5427591-42759139.95140.06
6426330-42633039.83339.95
240min1624328-62432858.33358.590.9458.5158.780.93
2630115-63011558.87359.06
3623332-62333258.24058.43
4635492-63549259.37659.56
5630095-63009558.87159.05
6619370-61937057.86958.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1754788-75478870.52271.481.4670.8071.761.45
2763261-76326171.31371.60
3765202-76520271.49571.78
4774580-77458072.37172.66
5780680-78068072.94173.22
6751871-75187170.24970.53
480min1872916-87291681.55980.810.8681.9581.210.86
2855051-85505179.89080.29
3871386-87138681.41681.82
4867963-86796381.09681.50
5865031-86503180.82281.22
6856908-85690880.06380.46
600min1916531-91653185.63486.290.5186.1686.830.51
2924340-92434086.36386.90
3925503-92550386.47287.01
4930283-93028386.91987.46
5920528-92052886.00786.54
6924375-92437586.36786.89
720min1968165-96816590.45890.310.8091.1390.990.80
2960658-96065889.75790.44
3975510-97551091.14491.83
4969510-96951090.58491.27
5971439-97143990.76491.44
6954502-95450289.18289.85
840min1994702-99470292.93892.740.6393.7693.570.63
2982430-98243091.79192.62
3996120-99612093.07093.91
41000753-100075393.50394.34
5989693-98969392.47093.30
6992068-99206892.69193.51
960min11018212-101821295.13494.520.7096.1195.500.70
21008190-100819094.19895.18
31018099-101809995.12496.12
41013519-101351994.69695.69
51012088-101208894.56295.54
6999489-99948993.38594.36
极限11009487-100948794.31994.030.7095.4695.170.70
21005435-100543593.94095.08
31011691-101169194.52595.68
41011956-101195694.55095.70
51006462-100646294.03695.17
6993132-99313292.79193.92
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2026-04-20 15:33:29 完成)
生成报告数据部分(等待生成报告)
Current page cost:77 ms