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400
标示量(mg)25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%
110.014837524848774832694841604847694841650.15
29.954832654830324831480.04
单位质量响应值RSD%判断
48368.1348557.590.28数据可信
供试品溶液-2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%
5min17903-79031.4681.1545.821.471.1545.92
25337-53370.9910.99
33834-38340.7120.71
44397-43970.8170.82
511147-111472.0702.07
64440-44400.8250.82
10min1125735-12573523.35018.5322.6523.3518.5322.65
2102035-10203518.94918.95
366460-6646012.34212.34
4122990-12299022.84022.84
595983-9598317.82517.83
685333-8533315.84715.85
15min1309401-30940157.45948.3816.9057.5048.4216.90
2267000-26700049.58549.62
3187062-18706234.73934.76
4293660-29366054.53654.58
5270977-27097750.32350.36
6235069-23506943.65543.68
20min1459612-45961285.35573.0814.8885.4973.2014.89
2397589-39758973.83673.95
3306169-30616956.85956.94
4432221-43222180.26880.40
5424062-42406278.75378.87
6341569-34156963.43363.53
30min1549256-549256102.00292.259.03102.2892.489.05
2479002-47900288.95589.19
3441580-44158082.00682.18
4519428-51942896.46396.73
5536881-53688199.70499.95
6454177-45417784.34584.55
45min1572766-572766106.36897.256.77106.8297.646.79
2496972-49697292.29392.68
3492565-49256591.47491.79
4538225-53822599.954100.38
5552102-552102102.531102.95
6489439-48943990.89491.24
60min1583546-583546108.37098.956.46109.0099.506.49
2508988-50898894.52495.07
3500073-50007392.86993.33
4544080-544080101.041101.63
5558077-558077103.640104.23
6502153-50215393.25593.75
120min1588727-588727109.332100.165.94110.14100.885.97
2517446-51744696.09596.79
3505484-50548493.87394.49
4549675-549675102.080102.84
5559150-559150103.840104.60
6515692-51569295.76996.42
240min1587481-587481109.101100.405.56110.09101.285.59
2521543-52154396.85697.71
3504438-50443893.67994.45
4552245-552245102.557103.49
5554841-554841103.039103.97
6523186-52318697.16197.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1588301-588301109.253101.295.13110.42102.345.17
2526381-52638197.75498.77
3510300-51030094.76895.70
4555811-555811103.220104.32
5559445-559445103.894105.00
6532231-53223198.84199.82
480min1601569-601569111.717102.035.45113.07103.255.46
2534924-53492499.341100.52
3519531-51953196.48297.57
4566204-566204105.150106.42
5531094-53109498.62999.91
6543151-543151100.869102.01
600min1600108-600108111.446101.945.40112.99103.325.42
2533538-53353899.083100.43
3517966-51796696.19197.44
4565056-565056104.937106.38
5531631-53163198.729100.17
6545100-545100101.230102.54
720min1596026-596026110.688101.555.33112.41103.115.35
2530317-53031798.485100.00
3515387-51538795.71297.12
4564466-564466104.827106.45
5531265-53126598.661100.27
6543566-543566100.946102.42
840min1594864-594864110.472101.415.20112.38103.145.21
2530306-53030698.483100.16
3517745-51774596.15097.72
4562733-562733104.505106.30
5529149-52914998.268100.04
6541519-541519100.565102.21
960min1592128-592128109.964100.545.53112.06102.445.54
2519496-51949696.47698.32
3511889-51188995.06396.79
4558479-558479103.715105.69
5525452-52545297.58299.51
6540775-540775100.427102.24
极限1588900-588900109.365100.015.49111.64102.075.49
2517228-51722896.05498.06
3509319-50931994.58696.47
4554789-554789103.030105.17
5522860-52286097.10099.20
6538018-53801899.915101.90
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100664-202507对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.051026909102769410330251033843103031010303560.31
210.101023870102405010239600.02
单位质量响应值RSD%判断
102522.99101382.180.80数据可信
供试品溶液-2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%
5min11098-10980.0970.18116.050.100.18115.21
2960-9600.0850.08
36737-67370.5940.59
4833-8330.0730.07
51444-14440.1270.13
6969-9690.0850.09
10min117308-173081.5261.6017.041.531.6016.96
218530-185301.6341.63
317239-172391.5201.52
416098-160981.4201.42
524172-241722.1322.13
615748-157481.3891.39
15min156111-561114.9484.884.574.954.884.58
258243-582435.1365.14
351205-512054.5164.52
456494-564944.9824.98
556267-562674.9624.97
653418-534184.7114.71
20min1108472-1084729.5668.888.749.588.908.74
299379-993798.7648.78
390802-908028.0088.02
4113714-11371410.02910.04
598785-987858.7128.72
693336-933368.2318.24
30min1166029-16602914.64214.582.0514.6714.602.05
2166491-16649114.68314.71
3160138-16013814.12314.15
4167325-16732514.75714.78
5169380-16938014.93814.96
6162466-16246614.32814.35
45min1237682-23768220.96120.880.9221.0120.930.91
2236834-23683420.88720.94
3236316-23631620.84120.89
4235010-23501020.72620.78
5240310-24031021.19321.24
6234200-23420020.65420.70
60min1293529-29352925.88725.891.3925.9725.971.39
2296418-29641826.14126.23
3293184-29318425.85625.94
4288695-28869525.46025.55
5299577-29957726.42026.51
6289774-28977425.55525.64
120min1449855-44985539.67339.561.1439.8039.681.14
2451132-45113239.78639.91
3450710-45071039.74839.87
4440995-44099538.89239.02
5454633-45463340.09440.23
6443838-44383839.14239.27
240min1647798-64779857.13057.060.8957.3357.260.89
2655271-65527157.78957.98
3648334-64833457.17757.37
4639239-63923956.37556.57
5649795-64979557.30657.50
6641909-64190956.61056.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1784810-78481069.21369.370.5869.5069.650.58
2793606-79360669.98970.28
3788149-78814969.50869.79
4780972-78097268.87569.16
5788607-78860769.54869.84
6783129-78312969.06569.35
480min1905601-90560179.86680.090.2980.2780.490.29
2912401-91240180.46580.87
3905722-90572279.87680.28
4909517-90951780.21180.61
5907191-90719180.00680.41
6908340-90834080.10780.51
600min1978573-97857386.30186.610.2686.8487.150.26
2982493-98249386.64787.19
3979779-97977986.40886.94
4985574-98557486.91987.45
5982812-98281286.67587.22
6983192-98319286.70987.24
720min11020717-102071790.01890.570.5090.7091.250.50
21027133-102713390.58491.27
31026404-102640490.51991.20
41022363-102236390.16390.84
51030360-103036090.86891.56
61034583-103458391.24191.92
840min11046810-104681092.31993.150.5293.1593.990.51
21053852-105385292.94093.78
31060277-106027793.50794.34
41055749-105574993.10793.94
51060039-106003993.48694.32
61060885-106088593.56094.39
960min11064748-106474893.90194.100.6394.8995.090.63
21059538-105953893.44294.43
31067246-106724694.12195.11
41061249-106124993.59294.58
51071744-107174494.51895.51
61077380-107738095.01596.00
极限11061559-106155993.62093.970.8294.7695.120.81
21055062-105506293.04794.20
31065583-106558393.97595.12
41059423-105942393.43194.57
51074497-107449794.76195.91
61077005-107700594.98296.13
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400
标示量(mg)25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%
110.014832504834634835174844254846564838620.14
29.954886054882964884500.05
单位质量响应值RSD%判断
48337.8649090.451.10数据可信
供试品溶液-1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%
5min1311964-31196457.63958.477.4857.6458.467.48
2285094-28509452.67552.67
3357180-35718065.99365.99
4306126-30612656.56156.56
5321796-32179659.45659.46
6316487-31648758.47558.47
10min1455947-45594784.24288.165.0084.3488.265.00
2471736-47173687.15987.25
3520970-52097096.25696.37
4456383-45638384.32284.42
5478911-47891188.48588.58
6478952-47895288.49288.59
15min1490472-49047290.62196.625.4190.8696.865.40
2539573-53957399.69399.93
3566578-566578104.682104.95
4496609-49660991.75591.99
5527560-52756097.47397.72
6516756-51675695.47795.72
20min1498389-49838992.08399.055.2892.4799.465.27
2564165-564165104.236104.64
3571185-571185105.533105.98
4514558-51455895.07195.46
5540567-54056799.876100.29
6527715-52771597.50297.91
30min1504228-50422893.16299.785.8293.70100.355.81
2576138-576138106.449107.02
3574725-574725106.187106.81
4508798-50879894.00794.55
5547090-547090101.082101.66
6529207-52920797.77798.34
45min1504326-50432693.180100.215.4893.88100.945.47
2574342-574342106.117106.87
3572708-572708105.815106.61
4514563-51456395.07295.77
5555059-555059102.554103.30
6533117-53311798.50099.23
60min1514200-51420095.005101.045.2995.86101.945.28
2578751-578751106.931107.86
3577310-577310106.665107.64
4515772-51577295.29596.16
5557365-557365102.980103.89
6537722-53772299.351100.24
120min1514454-51445495.052101.295.2396.06102.365.23
2579241-579241107.022108.13
3577962-577962106.786107.94
4518747-51874795.84596.86
5560435-560435103.547104.63
6538483-53848399.491100.55
240min1512078-51207894.613100.925.3395.78102.165.33
2576442-576442106.505107.79
3576058-576058106.434107.76
4518274-51827495.75796.94
5562725-562725103.970105.23
6531678-53167898.23499.46
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1513501-51350194.876101.314.9796.20102.724.96
2578088-578088106.809108.27
3573531-573531105.967107.47
4525992-52599297.18398.52
5564615-564615104.320105.75
6534176-53417698.696100.08
480min1520705-52070596.207103.455.3497.69105.035.33
2593418-593418109.641111.28
3586384-586384108.342110.03
4533705-53370598.609100.11
5576765-576765106.564108.17
6548443-548443101.332102.88
600min1517816-51781695.673103.135.4197.32104.885.40
2591232-591232109.237111.06
3582960-582960107.709109.57
4532958-53295898.471100.14
5578631-578631106.909108.69
6545354-545354100.761102.48
720min1515090-51509095.169102.375.3296.97104.295.31
2589332-589332108.886110.89
3576514-576514106.518108.56
4530290-53029097.97899.81
5572307-572307105.741107.70
6540834-54083499.926101.82
840min1513270-51327094.833101.865.3096.80103.955.29
2586094-586094108.288110.47
3574847-574847106.210108.43
4528167-52816797.58599.58
5568566-568566105.050107.19
6536717-53671799.165101.22
960min1508997-50899794.043102.635.0496.16104.905.01
2583772-583772107.859110.23
3571169-571169105.530107.93
4569733-569733105.265107.42
5564251-564251104.252106.57
6534986-53498698.845101.07
极限1508207-50820793.897102.575.0796.17105.005.04
2583767-583767107.858110.40
3571861-571861105.658108.23
4567182-567182104.794107.13
5565017-565017104.394106.88
6534889-53488998.827101.21
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100664-202507对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.051022017102210510221301022059102604110228700.18
210.101024659102466710246630.01
单位质量响应值RSD%判断
101778.11101451.780.23数据可信
供试品溶液-1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%
5min118138-181381.6051.576.961.601.577.11
216659-166591.4741.47
319872-198721.7581.76
418280-182801.6171.62
516864-168641.4921.49
616880-168801.4941.49
10min171764-717646.3506.254.696.356.254.65
265602-656025.8055.81
374259-742596.5716.57
473918-739186.5406.54
569014-690146.1066.11
669335-693356.1356.14
15min1116533-11653310.31110.312.9010.3210.322.88
2111695-1116959.8839.90
3120589-12058910.67010.68
4119522-11952210.57510.59
5113773-11377310.06710.08
6117162-11716210.36710.38
20min1150176-15017613.28813.707.6813.3213.737.66
2148568-14856813.14513.17
3154137-15413713.63813.67
4178721-17872115.81315.84
5147749-14774913.07313.10
6149969-14996913.26913.30
30min1205444-20544418.17817.941.1618.2318.001.17
2201853-20185317.86017.91
3205265-20526518.16218.22
4203010-20301017.96318.02
5199252-19925217.63017.68
6201992-20199217.87317.92
45min1261317-26131723.12223.280.6123.2023.360.61
2262942-26294223.26523.35
3265245-26524523.46923.55
4264712-26471223.42223.51
5262971-26297123.26823.35
6261641-26164123.15023.23
60min1318323-31832328.16627.840.9628.2927.960.96
2315375-31537527.90528.02
3317918-31791828.13028.25
4312532-31253227.65327.78
5311025-31102527.52027.64
6312910-31291027.68727.81
120min1464973-46497341.14140.900.8841.3141.070.87
2462634-46263440.93441.10
3465566-46556641.19441.36
4464799-46479941.12641.30
5454940-45494040.25440.42
6460646-46064640.75940.93
240min1660392-66039258.43257.871.1258.6758.111.12
2656320-65632058.07258.31
3663735-66373558.72858.97
4645166-64516657.08557.33
5648071-64807157.34257.57
6650701-65070157.57557.81
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1804990-80499071.22770.061.1571.5670.391.15
2794743-79474370.32070.65
3797130-79713070.53170.87
4784281-78428169.39469.73
5780111-78011169.02569.35
6789350-78935069.84370.17
480min1918397-91839781.26180.211.2681.7180.661.25
2910996-91099680.60681.05
3915922-91592281.04281.50
4895740-89574079.25679.71
5889837-88983778.73479.18
6907917-90791780.33480.78
600min1988596-98859687.47286.591.0488.0687.171.04
2981096-98109686.80987.39
3991414-99141487.72288.31
4968679-96867985.71086.29
5967402-96740285.59786.17
6974602-97460286.23486.81
720min11033211-103321191.42090.320.9092.1591.050.90
21025449-102544990.73391.46
31027192-102719290.88791.62
41010377-101037789.39990.13
51011793-101179389.52590.24
61016975-101697589.98390.71
840min11058079-105807993.62092.700.8494.5193.580.84
21050877-105087792.98393.86
31057048-105704893.52994.42
41038993-103899391.93192.81
51039281-103928191.95792.82
61042136-104213692.21093.08
960min11068686-106868694.55994.100.7895.6095.130.78
21062505-106250594.01295.04
31066945-106694594.40595.45
41074328-107432895.05896.09
51052269-105226993.10694.13
61056115-105611593.44694.47
极限11070059-107005994.68094.230.6495.8895.420.64
21061666-106166693.93895.13
31072527-107252794.89996.10
41070216-107021694.69495.88
51057765-105776593.59294.77
61057645-105764593.58294.77
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