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%
112.448262982611827688290283112828040.26
212.257983479997799160.15
单位质量响应值RSD%判断
6656.276523.761.43数据可信
供试品溶液-WL0116批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182688-8268880.71482.985.6480.7182.985.64
277159-7715975.31775.32
388034-8803485.93285.93
486293-8629384.23284.23
584795-8479582.77082.77
691075-9107588.90088.90
10min193793-9379391.55392.492.9991.6792.613.00
290600-9060088.43788.55
393360-9336091.13191.26
498229-9822995.88396.01
594952-9495292.68592.81
697564-9756495.23495.37
15min197157-9715794.83794.432.9495.1094.692.94
292244-9224490.04190.29
395008-9500892.73993.00
4100375-10037597.97898.25
596978-9697894.66294.93
698667-9866796.31196.59
20min197738-9773895.40495.392.6095.8095.792.60
293917-9391791.67492.06
395892-9589293.60294.01
4101072-10107298.65999.08
598307-9830795.96096.36
699395-9939597.02297.44
30min198896-9889696.53495.572.0997.0896.122.09
294770-9477092.50793.03
396140-9614093.84494.39
4100271-10027197.87798.44
598470-9847096.11996.67
698916-9891696.55497.12
45min199974-9997497.58795.662.0498.2896.362.05
294578-9457892.32092.98
397248-9724894.92695.61
499068-9906896.70297.41
597574-9757495.24495.94
699579-9957997.20197.91
60min199928-9992897.54296.472.6498.3897.302.64
297979-9797995.63996.43
395927-9592793.63694.46
497761-9776195.42796.28
597882-9788295.54596.38
6103480-103480101.009101.87
120min1100251-10025197.85794.283.1198.8495.263.09
294330-9433092.07893.02
396979-9697994.66395.63
494100-9410091.85392.85
593753-9375391.51492.49
6100080-10008097.69098.70
180min1100483-10048398.08492.825.3399.2193.945.28
291776-9177689.58490.66
395992-9599293.70094.81
490425-9042588.26689.40
590276-9027688.12089.24
6101615-10161599.189100.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1101002-10100298.59093.666.0599.8794.925.97
298020-9802095.67996.89
398488-9848896.13697.39
487509-8750985.41986.69
589866-8986687.72088.97
6100793-10079398.38699.69
360min199679-9967997.29990.896.6598.7292.296.57
291539-9153989.35390.71
395931-9593193.64095.04
483877-8387781.87483.27
588752-8875286.63388.01
698887-9888796.52697.98
480min1103728-103728101.25193.046.32102.8294.586.23
296036-9603693.74395.23
399622-9962297.24398.78
487071-8707184.99286.51
590523-9052388.36189.87
694933-9493392.66694.26
600min1103598-103598101.12492.888.18102.8594.568.07
294273-9427392.02293.65
397891-9789195.55397.24
483577-8357781.58183.23
589163-8916387.03488.68
6102439-10243999.993101.73
720min1102612-102612100.16290.467.61102.0392.287.50
292552-9255290.34292.11
396843-9684394.53096.36
482219-8221980.25682.03
588011-8801185.90987.68
693807-9380791.56793.45
960min1100672-10067298.26890.568.10100.2992.517.99
292661-9266190.44892.35
395929-9592993.63895.61
481030-8103079.09580.99
587202-8720285.12087.02
699154-9915496.78698.81
1440min199407-9940797.03388.978.5399.2091.068.41
290508-9050888.34790.39
393839-9383991.59893.71
479169-7916977.27979.29
585597-8559783.55385.58
698343-9834395.99598.16
极限199575-9957597.19789.418.5999.5191.638.47
291019-9101988.84691.02
394894-9489492.62894.87
479495-7949577.59779.72
585709-8570983.66285.82
698891-9889196.53098.84
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%
110.206345236321596329816332996326836331290.14
210.146255676246486251080.11
单位质量响应值RSD%判断
62071.4761647.730.49数据可信
供试品溶液-WL0116批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126692-266924.3154.169.364.314.169.37
223749-237493.8393.84
327225-272254.4014.40
423244-232443.7583.76
524143-241433.9033.90
629364-293644.7474.75
10min157820-578209.3479.056.839.359.066.84
251753-517538.3668.37
358265-582659.4199.43
452009-520098.4088.41
554788-547888.8578.86
661406-614069.9279.93
15min181130-8113013.11512.745.9513.1412.765.96
273019-7301911.80411.82
381892-8189213.23913.26
474078-7407811.97511.99
577652-7765212.55312.57
684931-8493113.73013.75
20min199794-9979416.13315.844.9816.1715.884.97
292137-9213714.89514.93
3101689-10168916.43916.48
492687-9268714.98415.02
597447-9744715.75315.79
6104237-10423716.85116.89
30min1131361-13136121.23620.734.4321.3020.794.43
2121482-12148219.63919.70
3132816-13281621.47121.54
4123050-12305019.89219.95
5125337-12533720.26220.32
6135237-13523721.86221.93
45min1169542-16954227.40826.744.4927.5026.834.50
2156542-15654225.30625.39
3173808-17380828.09828.19
4159140-15914025.72625.81
5160980-16098026.02426.12
6172490-17249027.88427.99
60min1200453-20045332.40532.616.4332.5432.746.43
2201349-20134932.55032.68
3202215-20221532.69032.83
4189440-18944030.62530.75
5191038-19103830.88331.01
6225677-22567736.48336.63
120min1294952-29495247.68146.683.1947.8746.863.20
2279408-27940845.16945.34
3295512-29551247.77247.96
4281136-28113645.44845.62
5281150-28115045.45045.63
6300433-30043348.56748.76
180min1361802-36180258.48857.203.1858.7557.463.19
2340450-34045055.03755.28
3360337-36033758.25158.51
4348565-34856556.34856.59
5343514-34351455.53255.78
6368418-36841859.55859.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1416941-41694167.40266.852.6667.7567.192.66
2418941-41894167.72568.05
3422499-42249968.30068.65
4398559-39855964.43064.76
5400778-40077864.78965.12
6423336-42333668.43668.80
360min1488133-48813378.91178.121.4679.3678.561.47
2476072-47607276.96177.39
3486599-48659978.66379.11
4475957-47595776.94277.36
5479865-47986577.57478.00
6493011-49301179.69980.16
480min1557351-55735190.10089.620.5090.6790.180.51
2550684-55068489.02389.56
3555371-55537189.78090.35
4556715-55671589.99890.54
5551482-55148289.15289.69
6554786-55478689.68690.27
600min1591883-59188395.68394.471.0696.3895.161.07
2581046-58104693.93194.61
3578812-57881293.57094.27
4579682-57968293.71094.38
5582302-58230294.13494.81
6592504-59250495.78396.50
720min1605994-60599497.96496.420.8998.8197.260.90
2593331-59333195.91796.73
3593874-59387496.00596.85
4591074-59107495.55296.37
5596176-59617696.37797.19
6598278-59827896.71797.58
960min1610610-61061098.71098.260.6999.7099.230.69
2611785-61178598.90099.86
3602182-60218297.34898.33
4602979-60297997.47798.43
5608863-60886398.42899.39
6610443-61044398.68399.69
1440min1612491-61249199.01497.960.95100.1599.080.94
2606022-60602297.96899.08
3597448-59744896.58297.72
4602025-60202597.32298.43
5606055-60605597.97499.08
6611610-61161098.872100.02
极限1612601-61260199.03298.380.72100.3299.650.73
2609673-60967398.55999.81
3603035-60303597.48698.76
4604426-60442697.71098.96
5607650-60765098.23299.49
6613940-61394099.248100.55
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%
112.448101480936808868090380955809390.07
212.258083880647807420.17
单位质量响应值RSD%判断
6506.356591.180.92数据可信
供试品溶液-WL0116批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min196972-9697295.24788.645.3395.2588.645.33
284631-8463183.12583.13
394803-9480393.11793.12
486762-8676285.21985.22
587861-8786186.29886.30
690429-9042988.82088.82
10min199886-9988698.10996.862.0898.2596.992.08
296288-9628894.57594.70
3101330-10133099.52799.67
497415-9741595.68295.81
596803-9680395.08195.21
699962-9996298.18498.32
15min1102468-102468100.64598.521.81100.9498.801.82
298310-9831096.56196.83
399284-9928497.51897.81
499971-9997198.19398.46
599175-9917597.41197.68
6102622-102622100.796101.08
20min1102516-102516100.69298.541.12101.1398.961.12
299992-9999298.21398.62
399499-9949997.72998.16
499556-9955697.78598.20
5100194-10019498.41298.83
6100204-10020498.42198.85
30min1102818-102818100.98999.081.73101.5899.661.72
2102521-102521100.697101.26
399912-9991298.13598.72
498132-9813296.38696.95
5100669-10066998.87899.44
6101220-10122099.419100.00
45min1101895-101895100.08298.172.13100.8398.902.12
299134-9913497.37098.08
399829-9982998.05398.78
496214-9621494.50295.21
5100940-10094099.14499.86
6101706-10170699.897100.63
60min1101835-101835100.02398.482.54100.9299.352.53
299705-9970597.93198.79
3101233-10123399.432100.31
495355-9535593.65994.51
5101463-10146399.658100.52
6101983-101983100.169101.05
120min1102685-102685100.85897.794.68101.9098.814.65
2100656-10065698.86599.87
3100302-10030298.51899.54
490219-9021988.61489.61
5101808-10180899.997101.01
6101708-10170899.899100.93
180min1100517-10051798.72996.556.2199.9297.726.15
299832-9983298.05699.21
399281-9928197.51598.69
486093-8609384.56185.69
5101483-10148399.678100.84
6102605-102605100.780101.96
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1100668-10066898.87797.387.48100.2298.697.41
2101549-10154999.743101.04
3100983-10098399.187100.51
484319-8431982.81984.07
5104764-104764102.900104.21
6102591-102591100.766102.10
360min198997-9899797.23696.147.5498.7397.607.47
2102097-102097100.281101.73
399325-9932597.55899.03
483091-8309181.61382.99
5102043-102043100.228101.69
6101757-10175799.947101.43
480min1101766-10176699.95699.277.67101.59100.877.60
2103946-103946102.097103.70
3103629-103629101.786103.40
485550-8555084.02885.53
5105609-105609103.730105.35
6105901-105901104.017105.65
600min1100311-10031198.52797.937.40100.3199.687.33
2101871-101871100.059101.81
3102983-102983101.151102.92
484949-8494983.43885.06
5104424-104424102.566104.34
6103679-103679101.835103.62
720min199321-9932197.55498.706.4499.49100.606.38
2101969-101969100.155102.06
3103908-103908102.060103.98
488095-8809586.52888.28
5105987-105987104.102106.03
6103635-103635101.791103.73
960min198201-9820196.45496.397.7298.5498.447.64
2103580-103580101.737103.79
399811-9981198.035100.11
483193-8319381.71383.59
5102512-102512100.688102.77
6101531-10153199.725101.82
1440min195561-9556193.86193.977.9396.0996.167.84
298775-9877597.01899.22
398279-9827996.53198.75
480622-8062279.18881.19
5100362-10036298.577100.81
6100426-10042698.640100.88
极限196145-9614594.43593.727.7596.8096.047.66
298375-9837596.62598.97
398289-9828996.54198.90
480559-8055979.12681.25
599794-9979498.019100.40
699325-9932597.55899.95
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%
110.206354466355856356786352496352516354420.04
210.146401176388176394670.15
单位质量响应值RSD%判断
62298.2463063.810.87数据可信
供试品溶液-WL0116批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148518-485187.7415.0129.037.745.0129.02
234868-348685.5635.56
328391-283914.5304.53
425955-259554.1414.14
525876-258764.1284.13
624951-249513.9813.98
10min159160-591609.43910.0414.849.4510.0514.82
259918-599189.5609.57
381626-8162613.02313.03
457730-577309.2109.22
556986-569869.0929.10
662154-621549.9169.92
15min183998-8399813.40113.222.1013.4313.242.11
283122-8312213.26213.28
383550-8355013.33013.36
481676-8167613.03113.05
579991-7999112.76212.78
684743-8474313.52013.54
20min1103944-10394416.58416.232.0016.6316.272.02
2103710-10371016.54616.59
3102309-10230916.32316.37
4101659-10165916.21916.26
599193-9919315.82615.86
699485-9948515.87215.91
30min1135883-13588321.67921.756.4121.7521.816.41
2153676-15367624.51824.59
3133487-13348721.29721.37
4133310-13331021.26921.33
5130301-13030120.78920.85
6131137-13113720.92220.99
45min1172760-17276027.56327.191.1427.6727.291.16
2171961-17196127.43527.54
3170412-17041227.18827.29
4171086-17108627.29627.39
5167574-16757426.73526.83
6168848-16884826.93927.03
60min1204529-20452932.63132.381.1032.7832.521.11
2204283-20428332.59232.74
3204427-20442732.61532.76
4204105-20410532.56432.70
5199241-19924131.78831.92
6201228-20122832.10532.24
120min1303581-30358148.43447.371.8148.6347.561.82
2302595-30259548.27748.47
3295122-29512247.08547.28
4297611-29761147.48247.67
5292100-29210046.60346.78
6290521-29052146.35146.54
180min1367528-36752858.63757.641.6758.9057.901.67
2367481-36748158.62958.90
3357877-35787757.09757.36
4364098-36409858.09058.35
5357677-35767757.06557.32
6352842-35284256.29456.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1424113-42411367.66566.741.4968.0267.091.49
2427451-42745168.19768.55
3415031-41503166.21666.56
4418151-41815166.71367.06
5413360-41336065.94966.29
6411977-41197765.72866.07
360min1496174-49617479.16278.231.4479.6278.681.44
2497423-49742379.36179.82
3481722-48172276.85677.30
4496225-49622579.17079.61
5486070-48607077.54977.99
6484349-48434977.27577.71
480min1563691-56369189.93389.211.2690.5189.781.27
2567001-56700190.46291.04
3552928-55292888.21688.78
4565825-56582590.27490.84
5551663-55166388.01488.57
6554014-55401488.39088.94
600min1590551-59055194.21993.621.3094.9394.321.30
2590725-59072594.24794.96
3582419-58241992.92193.62
4598228-59822895.44496.14
5579448-57944892.44793.13
6579389-57938992.43893.12
720min1604615-60461596.46396.261.3697.3197.101.36
2609411-60941197.22898.08
3598954-59895495.55996.39
4615750-61575098.23999.08
5594065-59406594.77995.60
6597386-59738695.30996.13
960min1612386-61238697.70297.742.1198.7098.722.11
2631674-631674100.780101.78
3602913-60291396.19197.17
4624840-62484099.689100.68
5601516-60151695.96896.93
6602382-60238296.10697.07
1440min1605519-60551996.60796.831.1797.7597.961.17
2614580-61458098.05299.20
3602053-60205396.05497.18
4616595-61659598.37499.51
5598910-59891095.55296.66
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