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1000
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%
110.011934181933301935611932391931411933380.09
29.951941611939181940400.09
单位质量响应值RSD%判断
19314.4919501.510.69数据可信
供试品溶液-5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%
5min13193-31931.4811.1289.321.481.1289.29
2-0.0000.00
32673-26731.2401.24
45655-56552.6222.62
52910-29101.3491.35
6-0.0000.00
10min135847-3584716.62412.6528.4416.6312.6528.46
212859-128595.9635.96
330749-3074914.25914.26
426455-2645512.26812.27
527994-2799412.98212.98
629797-2979713.81813.82
15min1112773-11277352.29741.9719.4052.3342.0019.40
259725-5972527.69727.71
399754-9975446.26046.29
492859-9285943.06243.09
589813-8981341.65041.67
688151-8815140.87940.90
20min1167549-16754977.69970.277.5177.8270.367.53
2133863-13386362.07762.13
3159564-15956473.99674.10
4149047-14904769.11969.22
5149163-14916369.17269.27
6149987-14998769.55569.65
30min1204583-20458394.87392.593.3695.1292.803.37
2190147-19014788.17888.34
3196434-19643491.09491.32
4209245-20924597.03597.25
5200400-20040092.93393.14
6197091-19709191.39891.61
45min1213671-21367199.08798.493.4999.4998.853.49
2205705-20570595.39395.70
3205397-20539795.25095.63
4224402-224402104.064104.44
5216660-216660100.473100.84
6208428-20842896.65697.02
60min1218801-218801101.466100.453.54102.04100.983.54
2209936-20993697.35597.82
3209297-20929797.05997.60
4228982-228982106.187106.73
5220659-220659102.328102.86
6211961-21196198.29498.81
120min1220636-220636102.317101.333.57103.06102.033.57
2211439-21143998.05298.68
3211762-21176298.20298.90
4231441-231441107.328108.05
5222070-222070102.982103.68
6213741-21374199.12099.80
240min1220844-220844102.414101.403.47103.32102.273.47
2212555-21255598.57099.36
3212438-21243898.51599.38
4231317-231317107.270108.17
5222022-222022102.960103.83
6212816-21281698.69199.54
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1221047-221047102.508101.923.92103.59102.953.91
2213217-21321798.87799.83
3213298-21329898.91499.94
4234673-234673108.827109.91
5223473-223473103.633104.68
6212921-21292198.73999.75
480min1226147-226147104.873104.383.10106.12105.583.11
2219992-219992102.018103.14
3221874-221874102.891104.08
4237704-237704110.232111.50
5226372-226372104.977106.19
6218400-218400101.280102.46
600min1226203-226203104.899103.323.38106.32104.703.38
2217675-217675100.944102.23
3216487-216487100.393101.76
4235639-235639109.275110.72
5224243-224243103.990105.38
6216567-216567100.430101.78
720min1228421-228421105.927102.724.33107.53104.284.31
2217712-217712100.961102.42
3208081-20808196.49598.03
4234519-234519108.755110.38
5224891-224891104.290105.86
6215458-21545899.916101.43
840min1223223-223223103.517100.727.35105.29102.447.27
2217097-217097100.676102.30
3188436-18843687.38589.08
4235692-235692109.299111.11
5224767-224767104.233105.97
6213933-21393399.209100.89
960min1221306-221306102.62898.2710.12104.58100.169.96
2228005-228005105.734107.53
3180259-18025983.59385.43
4237679-237679110.221112.21
5195327-19532790.58092.49
6208903-20890396.87698.72
极限1220619-220619102.30996.3810.52104.4398.4410.36
2212660-21266098.618100.59
3175435-17543581.35683.33
4238084-238084110.408112.58
5192399-19239989.22391.29
6207848-20784896.38798.39
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%
110.028805058804028803738808758807758805860.03
29.988798058801728799880.03
单位质量响应值RSD%判断
87882.8388175.150.24数据可信
供试品溶液-5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%
5min11447-14470.1480.48193.210.150.48192.74
2-0.0000.00
3638-6380.0650.07
423221-232212.3722.37
53053-30530.3120.31
6-0.0000.00
10min110918-109181.1151.0215.241.121.0215.29
26962-69620.7110.71
310294-102941.0511.05
410276-102761.0501.05
510907-109071.1141.11
610766-107661.1001.10
15min141864-418644.2763.8710.394.283.8810.42
230645-306453.1303.13
337428-374283.8233.82
437940-379403.8753.88
538949-389493.9783.98
640696-406964.1574.16
20min181379-813798.3127.699.838.327.709.82
261522-615226.2846.29
381378-813788.3128.32
474174-741747.5767.59
575024-750247.6637.67
678181-781817.9857.99
30min1144159-14415914.72414.566.1814.7514.586.20
2129114-12911413.18713.20
3143143-14314314.62014.64
4156320-15632015.96615.99
5138940-13894014.19114.21
6143909-14390914.69814.72
45min1207090-20709021.15220.902.4821.2020.952.49
2194822-19482219.89919.94
3206873-20687321.12921.18
4203897-20389720.82520.88
5206310-20631021.07221.12
6208879-20887921.33421.38
60min1258457-25845726.39826.122.1826.4826.202.20
2245277-24527725.05225.12
3257179-25717926.26826.35
4254611-25461126.00526.09
5257844-25784426.33526.42
6261247-26124726.68326.77
120min1396181-39618140.46540.112.1740.5940.232.17
2376688-37668838.47438.59
3393823-39382340.22440.35
4391975-39197540.03540.16
5395667-39566740.41240.54
6401699-40169941.02841.15
240min1572200-57220058.44357.731.7058.6457.921.70
2549150-54915056.08956.27
3568470-56847058.06258.25
4564291-56429157.63557.83
5561152-56115257.31457.51
6576249-57624958.85659.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1692144-69214470.69470.451.7970.9970.741.80
2667442-66744268.17168.44
3689499-68949970.42370.71
4703823-70382371.88672.18
5688287-68828770.30070.59
6697262-69726271.21671.51
480min1793366-79336681.03280.651.3081.4481.051.31
2771444-77144478.79379.18
3795122-79512281.21181.62
4785983-78598380.27880.69
5790346-79034680.72481.13
6801346-80134681.84782.26
600min1853773-85377387.20286.551.2487.7587.091.24
2829028-82902884.67585.19
3850033-85003386.82087.36
4843275-84327586.13086.68
5848708-84870886.68587.22
6859363-85936387.77388.32
720min1894236-89423691.33590.181.7092.0290.871.70
2876380-87638089.51190.17
3858843-85884387.72088.41
4880112-88011289.89290.58
5886514-88651490.54691.23
6901762-90176292.10392.80
840min1918764-91876493.84091.564.9994.6892.404.95
2903804-90380492.31293.12
3806350-80635082.35883.19
4911093-91109393.05693.90
5914810-91481093.43694.27
6924101-92410194.38595.23
960min1928620-92862094.84790.826.2095.8591.816.15
2912254-91225493.17594.14
3790783-79078380.76881.74
4924750-92475094.45195.45
5856630-85663087.49488.48
6922296-92229694.20195.21
极限1928008-92800894.78490.636.5495.9491.776.48
2903157-90315792.24693.36
3784062-78406280.08281.19
4933733-93373395.36996.52
5855131-85513187.34188.48
6919814-91981493.94795.11
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1000
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%
110.012431832431592431712430282430312431140.04
29.952418352420132419240.06
单位质量响应值RSD%判断
24287.1124313.970.08数据可信
供试品溶液-4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%
5min1-0.0000.13244.950.000.13244.95
2-0.0000.00
32046-20460.7580.76
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min127510-2751010.18911.3412.3310.1911.3412.33
238068-3806814.09914.10
328935-2893510.71610.72
429363-2936310.87510.87
530403-3040311.26011.26
629379-2937910.88110.88
15min1105026-10502638.89840.208.7638.9140.228.76
291042-9104233.71933.74
3112435-11243541.64241.66
4114023-11402342.23042.25
5117558-11755843.53943.56
6111141-11114141.16241.18
20min1187923-18792369.60067.829.3669.6867.919.36
2148848-14884855.12855.21
3191266-19126670.83870.93
4192364-19236471.24471.33
5193977-19397771.84271.93
6184350-18435068.27668.36
30min1258095-25809595.58992.584.6295.7992.784.62
2230623-23062385.41485.59
3243681-24368190.25090.46
4249356-24935692.35292.56
5255825-25582594.74894.96
6262231-26223197.12097.32
45min1278580-278580103.17699.943.69103.53100.303.68
2267057-26705798.90899.22
3257131-25713195.23295.59
4263360-26336097.53997.90
5268853-26885399.57399.94
6284141-284141105.235105.60
60min1282362-282362104.576101.474.13105.11101.994.11
2273988-273988101.475101.95
3259032-25903295.93696.45
4265814-26581498.44798.97
5272083-272083100.769101.30
6290541-290541107.605108.14
120min1283605-283605105.037102.004.45105.74102.694.44
2275369-275369101.986102.63
3259929-25992996.26896.94
4266655-26665598.75999.45
5272536-272536100.937101.64
6294353-294353109.017109.73
240min1283178-283178104.878102.024.53105.76102.884.51
2275202-275202101.924102.74
3260244-26024496.38597.22
4266501-26650198.70299.55
5272363-272363100.873101.74
6295342-295342109.384110.28
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1283535-283535105.011102.154.61106.06103.184.59
2275323-275323101.969102.96
3260214-26021496.37397.37
4265513-26551398.33699.35
5274570-274570101.690102.73
6295683-295683109.510110.59
480min1291996-291996108.144104.914.59109.37106.114.58
2280675-280675103.951105.11
3267088-26708898.919100.08
4274914-274914101.818103.00
5280959-280959104.057105.27
6303874-303874112.543113.81
600min1290728-290728107.675104.624.16109.08106.004.15
2279268-279268103.430104.76
3268951-26895199.609100.93
4274441-274441101.643102.99
5280165-280165103.763105.14
6301391-301391111.624113.08
720min1288210-288210106.742104.154.81108.33105.704.79
2278045-278045102.977104.48
3265217-26521798.22699.71
4271971-271971100.728102.25
5279994-279994103.699105.25
6303818-303818112.523114.16
840min1286387-286387106.067103.254.52107.83104.984.50
2276025-276025102.229103.90
3263007-26300797.40899.06
4269543-26954399.829101.52
5279232-279232103.417105.14
6298561-298561110.576112.40
960min1281119-281119104.116101.924.45106.06103.814.43
2272878-272878101.064102.91
3260702-26070296.55498.37
4266649-26664998.757100.61
5274030-274030101.490103.39
6295747-295747109.534111.54
极限1276346-276346102.348101.104.54104.46103.164.52
2270944-270944100.347102.36
3259638-25963896.16098.14
4265043-26504398.162100.18
5270416-270416100.152102.22
6295391-295391109.402111.59
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%
110.028870278876308872298870958873118872580.03
29.988816438822298819360.05
单位质量响应值RSD%判断
88548.7088370.340.15数据可信
供试品溶液-4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%
5min1-0.0000.01244.950.000.02244.95
2-0.0000.00
3850-8500.0860.09
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min17916-79160.8050.8718.310.800.8718.39
210920-109201.1101.11
39542-95420.9700.97
48772-87720.8920.89
57542-75420.7670.77
66515-65150.6620.66
15min133067-330673.3613.578.983.363.579.01
236273-362733.6873.69
336355-363553.6953.70
436971-369713.7583.76
538247-382473.8873.89
629706-297063.0193.02
20min170566-705667.1727.185.447.187.195.46
267164-671646.8276.83
375511-755117.6757.68
473681-736817.4897.50
571747-717477.2927.30
665396-653966.6476.65
30min1139638-13963814.19313.843.9314.2113.863.91
2128450-12845013.05613.08
3141812-14181214.41414.43
4139572-13957214.18614.21
5136839-13683913.90813.93
6130963-13096313.31113.33
45min1207298-20729821.07020.542.2421.1120.582.26
2198279-19827920.15320.19
3207407-20740721.08121.13
4203001-20300120.63320.68
5199741-19974120.30220.34
6197024-19702420.02520.06
60min1259942-25994226.42025.711.7926.5025.781.80
2251097-25109725.52125.60
3256841-25684126.10526.19
4251796-25179625.59225.67
5248274-24827425.23525.31
6249573-24957325.36725.44
120min1399670-39967040.62239.661.6440.7439.781.64
2389320-38932039.57039.69
3394389-39438940.08640.21
4385400-38540039.17239.29
5381662-38166238.79238.91
6390648-39064839.70539.82
240min1573857-57385758.32757.441.2658.5257.621.26
2564000-56400057.32557.51
3570853-57085358.02158.21
4560908-56090857.01157.20
5554213-55421356.33056.51
6566928-56692857.62257.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1689987-68998770.13069.680.8770.4269.960.87
2682439-68243969.36369.64
3693535-69353570.49170.78
4682152-68215269.33469.62
5677429-67742968.85469.13
6687719-68771969.90070.18
480min1802377-80237781.55380.291.2881.9680.691.28
2776288-77628878.90279.30
3799304-79930481.24181.65
4788657-78865780.15980.56
5781367-78136779.41879.81
6791710-79171080.46980.86
600min1862288-86228887.64386.751.3088.1887.281.30
2837511-83751185.12485.65
3867957-86795788.21988.76
4853555-85355586.75587.29
5845398-84539885.92686.45
6854476-85447686.84987.38
720min1900761-90076191.55390.861.0392.2491.531.03
2879027-87902789.34490.01
3904587-90458791.94292.63
4893161-89316190.78191.46
5888743-88874390.33291.00
6897148-89714891.18691.86
840min1924970-92497094.01493.180.9594.8594.010.95
2901805-90180591.65992.48
3925183-92518394.03594.88
4916863-91686393.19094.02
5913319-91331992.83093.65
6918266-91826693.33294.16
960min1926707-92670794.19093.910.9095.1994.890.91
2913918-91391892.89093.86
3936034-93603495.13896.14
4924548-92454893.97194.95
5915061-91506193.00793.98
6927249-92724994.24595.23
极限1918020-91802093.30793.611.0494.4694.751.03
2914585-91458592.95894.08
3934046-93404694.93696.09
4924160-92416093.93195.07
5907655-90765592.25493.38
6927560-92756094.27795.41
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