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)5补液体积(ml)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50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354161728416275241639744164271415418941613830.10
210.384217388421685542171220.01
单位质量响应值RSD%判断
402065.99406273.800.74数据可信
供试品溶液-YA0011批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1100701-1007012.4922.655.482.492.655.47
2105330-1053302.6062.61
3101403-1014032.5092.51
4114339-1143392.8292.83
5113645-1136452.8122.81
6107817-1078172.6682.67
10min1222987-2229875.5176.309.405.536.319.36
2284504-2845047.0397.05
3233420-2334205.7755.79
4256939-2569396.3576.37
5277273-2772736.8606.87
6252955-2529556.2596.27
15min1364451-3644519.0189.737.389.069.777.36
2420520-42052010.40510.45
3366889-3668899.0789.12
4396016-3960169.7999.84
5434179-43417910.74310.79
6377441-3774419.3399.38
20min1464403-46440311.49112.657.6411.5812.757.62
2556549-55654913.77113.87
3477775-47777511.82111.91
4520059-52005912.86812.96
5554852-55485213.72913.83
6494822-49482212.24312.33
30min1662560-66256016.39417.504.9616.5417.654.98
2750404-75040418.56718.74
3680144-68014416.82916.97
4718340-71834017.77417.93
5740967-74096718.33418.50
6690283-69028317.07917.23
45min1906354-90635422.42623.694.2722.6523.944.30
21007322-100732224.92425.19
3918958-91895822.73822.97
4977369-97736924.18324.43
5991518-99151824.53324.80
6943554-94355423.34623.58
60min11135597-113559728.09828.912.5528.4329.272.59
21204627-120462729.80630.19
31138234-113823428.16328.51
41183385-118338529.28029.65
51194699-119469929.56029.95
61154029-115402928.55428.91
120min11773953-177395343.89245.012.1644.3745.522.19
21882252-188225246.57247.11
31780880-178088044.06444.55
41826517-182651745.19345.71
51831571-183157145.31845.85
61818888-181888845.00445.50
180min12204032-220403254.53456.612.3355.2357.352.34
22345324-234532458.03058.80
32255690-225569055.81256.52
42335722-233572257.79258.53
52307413-230741357.09257.85
62280505-228050556.42657.15
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12573185-257318563.66866.062.4364.6467.072.44
22711654-271165467.09468.15
32616719-261671964.74565.73
42715280-271528067.18368.21
52739525-273952567.78368.83
62662342-266234265.87466.88
360min13124730-312473077.31479.811.7678.6081.161.78
23272767-327276780.97782.37
33206680-320668079.34280.65
43264086-326408680.76282.13
53266352-326635280.81982.20
63219253-321925379.65380.99
480min13515493-351549386.98388.921.4388.6690.661.44
23635796-363579689.96091.76
33565677-356567788.22589.93
43652429-365242990.37192.14
53573567-357356788.42090.21
63619034-361903489.54591.28
600min13745904-374590492.68494.201.7994.7996.391.81
23891102-389110296.27798.53
33742477-374247792.59994.74
43885824-388582496.14698.37
53814303-381430394.37696.61
63762720-376272093.10095.28
720min13862809-386280995.57696.971.6098.1599.631.62
24006636-400663699.135101.87
33861967-386196795.55698.16
43963218-396321898.061100.76
53951324-395132497.767100.47
63869568-386956895.74498.39
极限13865881-386588195.65297.011.4498.70100.161.46
23979457-397945798.463101.69
33861292-386129295.53998.63
43962914-396291498.053101.25
53971988-397198898.278101.47
63883207-388320796.08199.21
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)5补液体积(ml)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50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354232666423605642342854234545423437642343860.03
210.384230927423167442313000.02
单位质量响应值RSD%判断
409119.42407639.690.26数据可信
供试品溶液-YA0011批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1165086-1650864.0423.2013.744.043.2013.75
2135222-1352223.3113.31
3118219-1182192.8952.89
4125562-1255623.0753.07
5119285-1192852.9212.92
6120818-1208182.9582.96
10min1309932-3099327.5897.433.977.617.443.98
2291470-2914707.1377.15
3306093-3060937.4957.51
4318395-3183957.7977.81
5286505-2865057.0167.03
6308097-3080977.5447.56
15min1465827-46582711.40710.943.3511.4610.993.35
2442389-44238910.83310.89
3424741-42474110.40110.45
4452316-45231611.07611.13
5436610-43661010.69110.74
6457546-45754611.20411.26
20min1583962-58396214.30013.982.3014.4114.092.29
2561754-56175413.75613.86
3548951-54895113.44213.55
4578851-57885114.17414.28
5576044-57604414.10614.21
6576891-57689114.12614.23
30min1781315-78131519.13218.721.5119.3218.901.53
2761425-76142518.64518.82
3746249-74624918.27318.44
4765033-76503318.73318.91
5762697-76269718.67618.85
6770085-77008518.85719.04
45min11026930-102693025.14724.892.7725.4325.172.75
21028606-102860625.18825.46
3992879-99287924.31324.58
41025277-102527725.10625.38
5974070-97407023.85224.12
61051934-105193425.75926.03
60min11250440-125044030.62030.372.0031.0330.762.00
21230877-123087730.14130.53
31209805-120980529.62530.01
41245663-124566330.50330.90
51223233-122323329.95330.34
61280422-128042231.35431.76
120min11880304-188030446.04346.461.3746.6047.011.37
21887892-188789246.22946.77
31865096-186509645.67146.20
41908166-190816646.72547.28
51903782-190378246.61847.15
61939257-193925747.48748.05
180min12300958-230095856.34456.021.4057.1456.801.41
22300504-230050456.33357.11
32265735-226573555.48156.24
42282464-228246455.89156.68
52242096-224209654.90255.67
62334371-233437157.16257.96
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12662199-266219965.19064.540.9966.2665.600.99
22667062-266706265.30966.37
32623109-262310964.23265.27
42611253-261125363.94265.01
52606603-260660363.82864.87
62643710-264371064.73765.82
360min13201514-320151478.39678.141.3479.7979.521.33
23204434-320443478.46779.85
33212842-321284278.67380.03
43138529-313852976.85378.24
53141800-314180076.93478.30
63247246-324724679.51680.92
480min13606836-360683688.32187.211.0590.1188.991.04
23598825-359882588.12589.90
33547230-354723086.86188.61
43519877-351987786.19287.96
53524378-352437886.30288.05
63572737-357273787.48689.29
600min13737139-373713991.51292.110.6293.7494.320.61
23790402-379040292.81695.03
33775812-377581292.45994.65
43749508-374950891.81594.01
53738049-373804991.53493.71
63779239-377923992.54394.78
720min13859400-385940094.50694.660.9197.2097.330.90
23882471-388247195.07097.75
33903097-390309795.57698.22
43836837-383683793.95396.61
53814798-381479893.41396.05
63896906-389690695.42498.13
极限13856690-385669094.43995.330.7697.6098.470.74
23897276-389727695.43398.59
33909263-390926395.72798.85
43867572-386757294.70697.83
53888931-388893195.22998.33
63937723-393772396.42399.60
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