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%
112.701638741647501648001637091644971643260.31
212.781654211657431655820.14
单位质量响应值RSD%判断
12939.0612956.340.10数据可信
供试品溶液-25041501批-达格列净-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%
5min1178197-17819788.52390.276.5388.5290.276.53
2189614-18961494.19494.19
3194263-19426396.50496.50
4172794-17279485.83985.84
5164309-16430981.62381.62
6191127-19112794.94694.95
10min1194349-19434996.54697.582.1696.6897.722.16
2199114-19911498.91399.05
3199548-19954899.12999.27
4193658-19365896.20396.33
5190492-19049294.63094.75
6201439-201439100.068100.21
15min1196609-19660997.66998.461.4397.9598.741.44
2199531-19953199.12199.41
3200320-20032099.51399.81
4196772-19677297.75098.02
5194197-19419796.47196.74
6201792-201792100.244100.54
20min1197278-19727898.00198.661.1698.4399.091.17
2199629-19962999.16999.61
3199986-19998699.34799.79
4197653-19765398.18898.61
5195306-19530697.02297.43
6201751-201751100.223100.67
30min1198100-19810098.41099.200.9198.9899.780.92
2199979-19997999.34399.93
3201473-201473100.085100.68
4198316-19831698.51799.08
5198120-19812098.42098.97
6202210-202210100.451101.04
45min1198984-19898498.84999.390.6299.57100.120.63
2200513-20051399.608100.34
3200813-20081399.757100.50
4198941-19894198.82899.54
5199227-19922798.97099.67
6201968-201968100.331101.08
60min1198781-19878198.74899.530.6799.62100.400.68
2200234-20023499.470100.36
3200866-20086699.784100.68
4201839-201839100.267101.13
5198770-19877098.74399.59
6201587-201587100.142101.04
120min1205618-205618102.144102.610.44103.16103.640.44
2206316-206316102.491103.53
3206458-206458102.562103.60
4206058-206058102.363103.38
5206691-206691102.677103.68
6208246-208246103.450104.49
180min1205268-205268101.971102.370.50103.14103.550.50
2204892-204892101.784102.97
3207457-207457103.058104.25
4205680-205680102.175103.34
5206043-206043102.356103.51
6207108-207108102.885104.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1204604-204604101.641102.030.46102.96103.360.47
2204427-204427101.553102.89
3205621-205621102.146103.50
4205355-205355102.014103.33
5205225-205225101.949103.26
6207067-207067102.864104.22
360min1203287-203287100.987101.160.37102.46102.640.36
2202987-202987100.837102.33
3203096-203096100.892102.39
4203293-203293100.989102.46
5204687-204687101.682103.14
6204484-204484101.581103.09
480min1201860-201860100.278100.460.43101.90102.100.42
2201739-201739100.218101.86
3201056-20105699.878101.53
4202369-202369100.530102.16
5203473-203473101.079102.69
6202906-202906100.797102.46
600min1201156-20115699.92899.900.48101.70101.680.46
2201505-201505100.101101.90
3199893-19989399.300101.10
4200171-20017199.439101.21
5202499-202499100.595102.36
6201339-201339100.019101.83
720min1198374-19837498.54699.040.73100.47100.970.71
2199472-19947299.091101.04
3197278-19727898.00199.95
4199407-19940799.059100.98
5201510-201510100.104102.02
6200139-20013999.423101.38
极限1198580-19858098.64899.080.58100.72101.170.57
2200700-20070099.701101.80
3197966-19796698.343100.44
4199078-19907898.896100.97
5200823-20082399.762101.83
6199580-19958099.145101.26
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%
19.991086587109427510936421086199109275710906920.37
29.961099079110211911005990.20
单位质量响应值RSD%判断
109178.38110501.910.86数据可信
供试品溶液-25041501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%
5min150014-500144.5544.453.544.554.453.56
248867-488674.4494.45
351733-517334.7104.71
447445-474454.3204.32
547174-471744.2954.29
648155-481554.3844.38
10min1109491-1094919.96910.023.779.9810.033.77
2112832-11283210.27310.28
3115815-11581510.54410.55
4106457-1064579.6929.70
5104529-1045299.5179.52
6111158-11115810.12010.13
15min1156602-15660214.25814.293.1914.2814.313.19
2160802-16080214.64014.66
3162977-16297714.83814.86
4154038-15403814.02414.05
5148973-14897313.56313.58
6158226-15822614.40614.43
20min1197074-19707417.94317.793.0117.9917.843.02
2199090-19909018.12618.17
3202339-20233918.42218.47
4191331-19133117.42017.46
5185945-18594516.92916.97
6196755-19675517.91417.96
30min1259198-25919823.59923.462.6423.6723.532.65
2261525-26152523.81023.88
3265757-26575724.19624.27
4253334-25333423.06523.13
5246496-24649622.44222.51
6259878-25987823.66123.73
45min1334513-33451330.45630.212.0230.5630.312.03
2335006-33500630.50130.61
3338641-33864130.83130.94
4327714-32771429.83729.94
5320164-32016429.14929.25
6334588-33458830.46230.57
60min1395773-39577336.03335.802.1536.1835.962.15
2397975-39797536.23436.39
3400475-40047536.46136.62
4396262-39626236.07836.23
5377034-37703434.32734.47
6392032-39203235.69235.84
120min1593303-59330354.01753.221.4754.2253.421.47
2586147-58614753.36653.57
3589822-58982253.70053.91
4588613-58861353.59053.79
5569799-56979951.87752.07
6579547-57954752.76552.97
180min1712897-71289764.90564.391.2265.1964.681.23
2708653-70865364.51964.81
3718823-71882365.44565.74
4706713-70671364.34264.62
5693686-69368663.15663.43
6702815-70281563.98864.27
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1805858-80585873.36972.820.7273.7573.200.72
2800525-80052572.88473.27
3804855-80485573.27873.67
4801873-80187373.00673.38
5791575-79157572.06972.44
6794428-79442872.32872.71
360min1933558-93355884.99684.590.5585.4985.080.54
2925992-92599284.30784.80
3933673-93367385.00685.50
4932297-93229784.88185.37
5928195-92819584.50784.98
6921057-92105783.85784.35
480min11008806-100880691.84691.710.5392.4792.330.53
21006096-100609691.60092.22
31007224-100722491.70292.33
41012143-101214392.15092.77
51012042-101204292.14192.74
6997725-99772590.83891.45
600min11049130-104913095.51895.420.5096.2896.170.50
21049871-104987195.58596.34
31043518-104351895.00795.77
41050697-105069795.66096.41
51054738-105473896.02896.77
61040291-104029194.71395.46
720min11055551-105555196.10296.580.6897.0097.480.67
21060515-106051596.55497.45
31055759-105575996.12197.03
41066525-106652597.10198.00
51072255-107225597.62398.51
61054248-105424895.98496.88
极限11059179-105917996.43396.750.6597.4897.790.64
21063827-106382796.85697.90
31058582-105858296.37897.43
41066676-106667697.11598.16
51073502-107350297.73798.77
61054123-105412395.97297.01
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%
112.701666781658111645631654111653121655550.47
212.781645671649261647460.16
单位质量响应值RSD%判断
13035.8312890.920.80数据可信
供试品溶液-25041502批-达格列净-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%
5min1156303-15630377.55573.799.6477.5573.799.64
2120728-12072859.90359.90
3161637-16163780.20180.20
4151154-15115475.00075.00
5151438-15143875.14175.14
6151090-15109074.96874.97
10min1190362-19036294.45493.262.2494.5793.372.25
2180496-18049689.55989.65
3192221-19222195.37795.50
4190539-19053994.54294.65
5187427-18742792.99893.11
6186667-18666792.62192.73
15min1192954-19295495.74094.812.1196.0095.062.12
2183450-18345091.02591.25
3194430-19443096.47396.74
4193578-19357896.05096.30
5190111-19011194.33094.58
6191896-19189695.21595.47
20min1193664-19366496.09394.841.7496.4995.231.75
2186080-18608092.33092.69
3194971-19497196.74197.15
4192880-19288095.70496.10
5190282-19028294.41594.81
6188984-18898493.77194.16
30min1193338-19333895.93194.851.7896.4895.381.78
2185975-18597592.27892.78
3194831-19483196.67297.22
4192703-19270395.61696.16
5191955-19195595.24595.78
6188126-18812693.34593.88
45min1193168-19316895.84794.871.4896.5495.541.49
2186797-18679792.68593.32
3194459-19445996.48797.19
4192745-19274595.63796.32
5190506-19050694.52695.20
6189480-18948094.01794.69
60min1192667-19266795.59894.651.7296.4395.471.73
2186756-18675692.66593.44
3194994-19499496.75397.60
4192137-19213795.33596.16
5190951-19095194.74795.57
6187011-18701192.79293.61
120min1198519-19851998.50297.971.3499.4898.931.35
2193575-19357596.04996.96
3200994-20099499.730100.72
4199104-19910498.79299.76
5196447-19644797.47498.44
6196000-19600097.25298.21
180min1198515-19851598.50097.321.3999.6298.431.40
2192248-19224895.39096.45
3198644-19864498.56499.70
4197871-19787198.18099.30
5195998-19599897.25198.36
6193554-19355496.03897.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1197818-19781898.15497.151.2799.4398.401.29
2192096-19209695.31596.52
3197946-19794698.21799.50
4197931-19793198.21099.48
5194938-19493896.72597.98
6194006-19400696.26297.51
360min1196166-19616697.33496.361.3398.7597.761.34
2190482-19048294.51495.86
3196931-19693197.71499.15
4196104-19610497.30398.72
5192419-19241995.47596.87
6193066-19306695.79697.19
480min1195500-19550097.00495.721.5098.5797.271.51
2188705-18870593.63295.12
3195929-19592997.21798.80
4194657-19465796.58598.15
5191797-19179795.16696.71
6190935-19093594.73996.27
600min1193968-19396896.24494.891.5697.9596.581.57
2186731-18673192.65394.28
3194617-19461796.56698.29
4192393-19239395.46297.17
5189978-18997894.26495.95
6189783-18978394.16795.84
720min1192007-19200795.27194.521.2997.1396.351.30
2186544-18654492.56094.33
3193727-19372796.12497.99
4191085-19108594.81396.66
5190032-19003294.29196.12
6189550-18955094.05195.87
极限1191771-19177195.15394.171.4097.1596.141.41
2186593-18659392.58494.49
3193140-19314095.83397.85
4190960-19096094.75196.74
5189238-18923893.89795.86
6186997-18699792.78594.74
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%
19.991099451109301010899961091631109321310934600.33
29.961088078109194210900100.26
单位质量响应值RSD%判断
109455.46109438.760.02数据可信
供试品溶液-25041502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%
5min143354-433543.9614.3022.633.964.3022.56
238048-380483.4763.48
343949-439494.0164.02
442859-428593.9163.92
568118-681186.2246.22
646050-460504.2084.21
10min1109221-1092219.9799.825.009.999.835.01
298233-982338.9758.98
3110087-11008710.05810.06
4104837-1048379.5799.58
5113769-11376910.39510.40
6109053-1090539.9649.97
15min1157938-15793814.43114.666.5514.4514.686.56
2145923-14592313.33313.35
3159384-15938414.56314.58
4155933-15593314.24714.27
5166559-16655915.21815.24
6177026-17702616.17516.20
20min1213198-21319819.48018.264.6019.5218.304.61
2187104-18710417.09517.13
3198539-19853918.14018.18
4195015-19501517.81817.86
5207186-20718618.93018.98
6198228-19822818.11218.16
30min1259946-25994623.75124.186.3623.8224.256.36
2250715-25071522.90722.97
3261865-26186523.92624.00
4257415-25741523.52023.59
5298032-29803227.23127.31
6260028-26002823.75823.83
45min1336213-33621330.71930.812.1630.8330.912.17
2327791-32779129.95030.05
3337747-33774730.85930.97
4334783-33478330.58930.69
5350162-35016231.99432.11
6336285-33628530.72630.83
60min1395324-39532436.12036.492.2536.2736.652.25
2390086-39008635.64235.79
3403131-40313136.83336.99
4394871-39487136.07936.23
5415507-41550737.96438.13
6397543-39754336.32336.48
120min1594636-59463654.33154.681.6954.5454.881.70
2588445-58844553.76553.96
3605844-60584455.35555.56
4593573-59357354.23454.44
5615252-61525256.21556.44
6592817-59281754.16554.37
180min1719172-71917265.71066.121.3566.0066.411.35
2717234-71723465.53265.81
3721423-72142365.91566.21
4720827-72082765.86166.15
5743333-74333367.91768.22
6720116-72011665.79666.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1812400-81240074.22874.741.3874.6275.131.39
2811623-81162374.15774.53
3815653-81565374.52574.91
4819148-81914874.84475.23
5839937-83993776.74477.15
6809363-80936373.95074.34
360min1936883-93688385.60186.861.1386.1087.371.13
2950807-95080786.87487.36
3951532-95153286.94087.44
4952851-95285187.06087.56
5968646-96864688.50489.03
6943559-94355986.21186.71
480min11020376-102037693.23094.391.1493.8695.031.15
21026303-102630393.77294.39
31038621-103862194.89795.53
41035516-103551694.61395.24
51052677-105267796.18196.84
61025183-102518393.66994.30
600min11063635-106363597.18398.411.0497.9599.181.04
21071636-107163697.91498.67
31081542-108154298.81999.59
41077711-107771198.46999.24
51096132-1096132100.152100.95
61071665-107166597.91698.69
720min11076922-107692298.397100.191.2699.31101.111.26
21094569-1094569100.009100.91
31102119-1102119100.699101.62
41094792-1094792100.029100.95
51118831-1118831102.226103.18
61092012-109201299.775100.69
极限11081055-108105598.774100.191.2299.83101.261.22
21095473-1095473100.092101.15
31100497-1100497100.551101.62
41094454-109445499.998101.06
51119884-1119884102.322103.43
61087917-108791799.401100.47
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