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%
110.094161728416275241639744164271415418941613830.10
210.144217388421685542171220.01
单位质量响应值RSD%判断
412426.46415889.740.60数据可信
供试品溶液-YA0011批-二甲双胍-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%
5min1100701-1007012.4322.595.482.432.595.45
2105330-1053302.5432.54
3101403-1014032.4482.45
4114339-1143392.7612.76
5113645-1136452.7442.74
6107817-1078172.6032.60
10min1222987-2229875.3846.159.415.406.169.36
2284504-2845046.8706.88
3233420-2334205.6365.65
4256939-2569396.2046.22
5277273-2772736.6956.71
6252955-2529556.1086.12
15min1364451-3644518.8009.507.388.849.547.36
2420520-42052010.15410.20
3366889-3668898.8598.90
4396016-3960169.5629.61
5434179-43417910.48410.53
6377441-3774419.1149.16
20min1464403-46440311.21312.357.6411.3012.447.64
2556549-55654913.43813.54
3477775-47777511.53611.62
4520059-52005912.55712.65
5554852-55485213.39713.50
6494822-49482211.94812.04
30min1662560-66256015.99817.074.9616.1417.234.97
2750404-75040418.11918.28
3680144-68014416.42316.57
4718340-71834017.34517.50
5740967-74096717.89118.06
6690283-69028316.66716.82
45min1906354-90635421.88523.124.2722.1023.364.30
21007322-100732224.32324.58
3918958-91895822.18922.41
4977369-97736923.59923.84
5991518-99151823.94124.20
6943554-94355422.78323.02
60min11135597-113559727.42028.212.5527.7528.562.58
21204627-120462729.08729.46
31138234-113823427.48427.82
41183385-118338528.57428.93
51194699-119469928.84729.22
61154029-115402927.86528.21
120min11773953-177395342.83343.922.1643.3044.422.19
21882252-188225245.44845.97
31780880-178088043.00143.47
41826517-182651744.10344.61
51831571-183157144.22544.74
61818888-181888843.91844.40
180min12204032-220403253.21855.252.3353.9055.962.34
22345324-234532456.63057.38
32255690-225569054.46555.15
42335722-233572256.39857.12
52307413-230741355.71456.46
62280505-228050555.06555.77
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12573185-257318562.13264.462.4363.0865.462.44
22711654-271165465.47566.51
32616719-261671963.18364.14
42715280-271528065.56366.57
52739525-273952566.14867.17
62662342-266234264.28465.26
360min13124730-312473075.44977.891.7676.7179.201.77
23272767-327276779.02480.38
33206680-320668077.42878.70
43264086-326408678.81480.15
53266352-326635278.86980.22
63219253-321925377.73179.03
480min13515493-351549384.88486.771.4386.5288.471.44
23635796-363579687.78989.54
33565677-356567786.09687.76
43652429-365242988.19189.92
53573567-357356786.28788.03
63619034-361903487.38489.07
600min13745904-374590490.44891.921.7992.5194.061.80
23891102-389110293.95496.15
33742477-374247790.36592.46
43885824-388582493.82695.99
53814303-381430392.09994.28
63762720-376272090.85492.98
720min13862809-386280993.27194.631.6095.7897.231.61
24006636-400663696.74399.41
33861967-386196793.25095.80
43963218-396321895.69598.33
53951324-395132495.40898.04
63869568-386956893.43496.02
极限13865881-386588193.34594.671.4496.3297.741.46
23979457-397945796.08799.24
33861292-386129293.23496.25
43962914-396291495.68898.80
53971988-397198895.90799.02
63883207-388320793.76396.81
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%
110.094232666423605642342854234545423437642343860.03
210.144230927423167442313000.02
单位质量响应值RSD%判断
419661.65417287.970.41数据可信
供试品溶液-YA0011批-二甲双胍-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%
5min1165086-1650863.9453.1213.753.943.1213.65
2135222-1352223.2313.23
3118219-1182192.8252.83
4125562-1255623.0003.00
5119285-1192852.8502.85
6120818-1208182.8872.89
10min1309932-3099327.4067.253.987.437.273.97
2291470-2914706.9656.98
3306093-3060937.3157.33
4318395-3183957.6097.62
5286505-2865056.8466.86
6308097-3080977.3627.38
15min1465827-46582711.13210.673.3511.1910.723.36
2442389-44238910.57210.62
3424741-42474110.15010.20
4452316-45231610.80910.86
5436610-43661010.43310.48
6457546-45754610.93410.98
20min1583962-58396213.95513.652.3014.0713.752.31
2561754-56175413.42413.53
3548951-54895113.11813.22
4578851-57885113.83313.94
5576044-57604413.76513.87
6576891-57689113.78613.89
30min1781315-78131518.67118.271.5118.8518.441.52
2761425-76142518.19518.37
3746249-74624917.83318.00
4765033-76503318.28218.46
5762697-76269718.22618.40
6770085-77008518.40218.58
45min11026930-102693024.54024.292.7724.8224.562.75
21028606-102860624.58024.84
3992879-99287923.72623.98
41025277-102527724.50124.77
5974070-97407023.27723.54
61051934-105193425.13825.40
60min11250440-125044029.88129.632.0030.2830.022.00
21230877-123087729.41429.80
31209805-120980528.91029.28
41245663-124566329.76730.16
51223233-122323329.23129.61
61280422-128042230.59830.99
120min11880304-188030444.93345.341.3745.4845.881.36
21887892-188789245.11445.65
31865096-186509644.56945.09
41908166-190816645.59846.14
51903782-190378245.49446.02
61939257-193925746.34146.89
180min12300958-230095854.98554.671.4055.7655.431.40
22300504-230050454.97455.73
32265735-226573554.14354.89
42282464-228246454.54355.31
52242096-224209653.57854.33
62334371-233437155.78356.56
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12662199-266219963.61762.980.9964.6664.020.98
22667062-266706263.73364.77
32623109-262310962.68363.70
42611253-261125362.40063.44
52606603-260660362.28963.31
62643710-264371063.17564.23
360min13201514-320151476.50576.261.3477.8777.601.33
23204434-320443476.57577.93
33212842-321284276.77678.10
43138529-313852975.00076.35
53141800-314180075.07876.41
63247246-324724677.59878.97
480min13606836-360683686.19185.111.0587.9486.841.04
23598825-359882585.99987.73
33547230-354723084.76686.48
43519877-351987784.11385.84
53524378-352437884.22085.93
63572737-357273785.37687.14
600min13737139-373713989.30589.890.6291.4892.050.61
23790402-379040290.57792.74
33775812-377581290.22992.36
43749508-374950889.60091.75
53738049-373804989.32691.45
63779239-377923990.31192.50
720min13859400-385940092.22692.370.9194.8594.980.90
23882471-388247192.77795.39
33903097-390309793.27095.86
43836837-383683791.68794.28
53814798-381479891.16093.73
63896906-389690693.12295.76
极限13856690-385669092.16193.030.7695.2596.100.74
23897276-389727693.13196.21
33909263-390926393.41896.47
43867572-386757292.42195.48
53888931-388893192.93295.96
63937723-393772394.09897.20
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