氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.091373661372841374901371871372901373230.09
214.051370461370901370680.03
单位质量响应值RSD%判断
9746.139755.730.07数据可信
供试品溶液-2025011111批-氨氯地平-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%
5min135250-3525023.43821.5124.5823.4421.5124.58
238098-3809825.33125.33
335938-3593823.89523.90
416733-1673311.12611.13
536508-3650824.27424.27
631568-3156820.99020.99
10min177784-7778451.71954.1412.3451.8554.2612.36
293105-9310561.90662.05
382104-8210454.59154.72
465199-6519943.35143.41
590778-9077860.35860.49
679609-7960952.93253.05
15min1107990-10799071.80374.216.4272.2274.636.46
2119122-11912279.20479.69
3110325-11032573.35573.79
4101174-10117467.27167.57
5120283-12028379.97680.45
6110790-11079073.66474.08
20min1121101-12110180.52083.564.5881.3484.404.62
2130860-13086087.00987.93
3122678-12267881.56982.41
4120354-12035480.02480.70
5134537-13453789.45490.37
6124527-12452782.79883.62
30min1130755-13075586.93992.044.4188.2093.344.41
2141492-14149294.07895.49
3133831-13383188.98490.28
4138248-13824891.92193.04
5148224-14822498.55499.97
6137994-13799491.75293.03
45min1138974-13897492.40496.043.2594.1597.853.25
2146281-14628197.26399.19
3139919-13991993.03294.82
4146657-14665797.51399.14
5151530-151530100.753102.71
6143334-14333495.30397.09
60min1140830-14083093.63897.012.7695.9099.352.76
2147971-14797198.386100.86
3142399-14239994.68196.99
4148507-14850798.743100.92
5151321-151321100.614103.13
6144389-14438996.00598.32
极限1144562-14456296.12098.082.6398.90100.962.64
2148684-14868498.860101.88
3142885-14288595.00497.84
4150112-15011299.810102.53
5153258-153258101.902104.98
6145527-14552796.76199.61
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.871329725132837613347651331386133322913314960.20
29.891323472132440713239400.05
单位质量响应值RSD%判断
134903.34133866.530.55数据可信
供试品溶液-2025011111批-厄贝沙坦-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%
5min1398613-39861326.69623.9524.9926.7023.9524.99
2417359-41735927.95227.95
3413477-41347727.69227.69
4185771-18577112.44212.44
5396167-39616726.53226.53
6334615-33461522.41022.41
10min1962882-96288264.48764.1811.4764.6464.3211.49
21082403-108240372.49272.65
31012611-101261167.81767.97
4757065-75706550.70350.77
5992960-99296066.50166.65
6942081-94208163.09463.22
15min11270152-127015285.06684.234.6685.5784.724.72
21324441-132444188.70289.26
31293744-129374486.64687.18
41157750-115775077.53877.89
51273722-127372285.30585.82
61226556-122655682.14682.62
20min11389079-138907993.03092.092.4494.0193.052.50
21420562-142056295.13996.19
31386726-138672692.87393.88
41341047-134104789.81490.60
51382904-138290492.61793.61
61330277-133027789.09290.02
30min11417576-141757694.93997.342.2696.4498.822.22
21484590-148459099.427101.01
31455988-145598897.51299.04
41486516-148651699.556100.84
51465928-146592898.17799.68
61410310-141031094.45295.88
45min11470330-147033098.47299.002.43100.50101.012.36
21493987-1493987100.056102.19
31478931-147893199.048101.12
41532343-1532343102.625104.46
51471708-147170898.564100.62
61421965-142196595.23397.18
60min11470906-147090698.51198.692.78101.08101.252.71
21499804-1499804100.446103.13
31481857-148185799.244101.86
41528797-1528797102.388104.79
51449401-144940197.07099.67
61410734-141073494.48196.96
极限11480341-148034199.14398.732.45102.26101.842.38
21485824-148582499.510102.76
31474509-147450998.752101.92
41527910-1527910102.328105.30
51459549-145954997.750100.89
61417267-141726794.91897.92
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.091370241371321371441370831370581370880.04
214.051368951366071367510.15
单位质量响应值RSD%判断
9729.459733.170.03数据可信
供试品溶液-2025011111批-氨氯地平-0.05molhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1105631-10563170.37662.5615.1870.3862.5615.19
2106373-10637370.87070.87
3106570-10657071.00171.00
489165-8916559.40559.41
581370-8137054.21254.21
674334-7433449.52449.52
10min1152155-152155101.372102.323.17101.76102.663.15
2154432-154432102.889103.28
3146763-14676397.78098.17
4161862-161862107.839108.17
5152889-152889101.861102.16
6153326-153326102.152102.43
15min1158454-158454105.569106.602.41106.52107.522.36
2154443-154443102.896103.86
3157459-157459104.906105.84
4163613-163613109.006109.94
5164218-164218109.409110.28
6161810-161810107.805108.65
20min1157491-157491104.927105.931.49106.47107.441.45
2155370-155370103.514105.05
3158968-158968105.911107.43
4160888-160888107.190108.73
5161943-161943107.893109.37
6159300-159300106.132107.57
30min1154954-154954103.237104.942.53105.36107.032.47
2152289-152289101.461103.57
3154841-154841103.162105.27
4162214-162214108.074110.20
5160434-160434106.888108.96
6160301-160301106.799108.83
45min1156791-156791104.461104.022.03107.16106.702.00
2153022-153022101.950104.63
3153791-153791102.462105.14
4160423-160423106.881109.61
5159211-159211106.073108.74
6153579-153579102.321104.95
60min1154738-154738103.093103.041.49106.37106.301.45
2152237-152237101.427104.67
3151945-151945101.232104.48
4155220-155220103.414106.74
5158085-158085105.323108.58
6155735-155735103.757106.95
极限1151319-151319100.815101.692.23104.67105.522.17
2147938-14793898.563102.37
3150065-15006599.980103.79
4156858-156858104.505108.40
5154915-154915103.211107.05
6154727-154727103.086106.86
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.871323010132311813228211321891132066513223010.08
29.891321915131912213205180.15
单位质量响应值RSD%判断
133971.73133520.530.24数据可信
供试品溶液-2025011111批-厄贝沙坦-0.05molhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1201937-20193713.58912.4822.7313.5912.4822.72
2227223-22722315.29015.29
3217597-21759714.64314.64
4200354-20035413.48213.48
5135802-1358029.1389.14
6129429-1294298.7108.71
10min1442580-44258029.78230.2911.4029.8630.3611.41
2520302-52030235.01235.10
3456918-45691830.74730.83
4492471-49247133.13933.21
5401057-40105726.98827.04
6387532-38753226.07826.13
15min1588350-58835039.59141.056.5939.8341.296.63
2652524-65252443.91044.19
3636632-63663242.84043.09
4647657-64765743.58243.84
5573877-57387738.61738.82
6561403-56140337.77837.97
20min1678959-67895945.68847.225.3746.1547.695.41
2746370-74637050.22550.75
3725474-72547448.81849.31
4733062-73306249.32949.83
5668431-66843144.98045.40
6658024-65802444.28044.68
30min1787844-78784453.01555.193.6853.7355.923.73
2848903-84890357.12457.93
3832406-83240656.01456.78
4858236-85823657.75258.53
5796451-79645153.59554.26
6797458-79745853.66254.31
45min1912717-91271761.41862.353.3062.4363.383.36
2961268-96126864.68665.81
3938949-93894963.18464.26
4954186-95418664.20965.30
5911830-91183061.35962.32
6880297-88029759.23760.18
60min1977279-97727965.76366.761.9967.1168.142.05
21026228-102622869.05770.54
3997420-99742067.11868.54
4995747-99574767.00668.46
5985229-98522966.29867.60
6970742-97074265.32366.60
极限11034648-103464869.62370.981.4471.3472.731.50
21065502-106550271.70073.56
31056584-105658471.10072.90
41077406-107740672.50174.33
51046715-104671570.43572.11
61047643-104764370.49872.14
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.091273151269551267781265171259951267120.40
214.051252811256831254820.23
单位质量响应值RSD%判断
8993.048931.100.49数据可信
供试品溶液-2025011111批-氨氯地平-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137954-3795427.45730.8322.8427.4630.8322.84
244076-4407631.88631.89
341042-4104229.69129.69
433144-3314423.97823.98
538429-3842927.80127.80
661059-6105944.17244.17
10min1113295-11329581.96280.366.7982.1180.536.80
2106219-10621976.84377.02
3107830-10783078.00878.17
4115566-11556683.60583.74
5101206-10120673.21673.37
6122362-12236288.52188.77
15min1136226-13622698.55196.324.3499.1696.934.35
2131716-13171695.28895.89
3132583-13258395.91596.51
4138927-138927100.505101.10
5122707-12270788.77189.33
6136672-13667298.87399.61
20min1140043-140043101.31299.164.38102.47100.314.37
2132802-13280296.07497.21
3137005-13700599.114100.25
4144678-144678104.665105.82
5127815-12781592.46693.52
6140045-140045101.314102.60
30min1143641-143641103.91598.243.01105.6399.942.97
2135072-13507297.71699.38
3134860-13486097.56399.24
4135959-13595998.358100.10
5132368-13236895.76097.33
6132868-13286896.12297.97
45min1124227-12422789.87098.885.4292.17101.135.32
2133146-13314696.32398.53
3137551-13755199.509101.73
4143804-143804104.033106.32
5137271-13727199.307101.41
6144073-144073104.228106.61
60min1140915-140915101.943100.282.14104.74103.082.11
2133478-13347896.56399.31
3137071-13707199.162101.94
4141423-141423102.310105.17
5139987-139987101.272103.92
6138805-138805100.417103.38
极限1140914-140914101.942100.032.49105.30103.392.37
2134430-13443097.252100.53
3136576-13657698.804102.13
4140139-140139101.382104.81
5142685-142685103.223106.44
6134902-13490297.593101.11
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.871337264133811513348471334887133448313359190.13
29.891324655132758113261180.16
单位质量响应值RSD%判断
135351.47134086.750.67数据可信
供试品溶液-2025011111批-厄贝沙坦-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1207697-20769713.87616.8523.5313.8816.8523.52
2255211-25521117.05017.05
3233052-23305215.57015.57
4189045-18904512.63012.63
5272192-27219218.18418.18
6356418-35641823.81123.81
10min1714491-71449147.73351.106.8947.8151.196.90
2723878-72387848.36048.45
3714134-71413447.70947.80
4799362-79936253.40353.47
5825701-82570155.16355.26
6811685-81168554.22654.36
15min1993224-99322466.35470.143.9966.7070.524.00
21031676-103167668.92369.29
31022818-102281868.33268.68
41107607-110760773.99674.36
51081382-108138272.24472.65
61062986-106298671.01571.45
20min11148815-114881576.74979.333.4577.4680.103.45
21162166-116216677.64178.39
31168345-116834578.05478.78
41263538-126353884.41385.19
51184548-118454879.13679.95
61197210-119721079.98280.81
30min11308033-130803387.38686.621.7588.5287.831.69
21328926-132892688.78289.96
31288928-128892886.11087.27
41306885-130688587.30988.56
51281795-128179585.63386.88
61265025-126502584.51385.79
45min11226015-122601581.90793.287.1183.5394.977.02
21403641-140364193.77395.44
31408751-140875194.11595.76
41448840-144884096.79398.52
51366333-136633391.28193.01
61523957-1523957101.811103.55
60min11436750-143675095.98596.161.3098.0698.371.29
21447951-144795196.73398.93
31448449-144844996.76798.93
41449663-144966396.84899.12
51402686-140268693.70995.94
61450855-145085596.92799.24
极限11464184-146418497.81897.300.88100.43100.050.79
21472072-147207298.345101.07
31463374-146337497.764100.47
41454260-145426097.15599.96
51448155-144815596.74799.50
61436988-143698896.00198.85
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.091299371288061287011287841280771288610.53
214.051281121282281281700.07
单位质量响应值RSD%判断
9145.569122.420.18数据可信
供试品溶液-2025011111批-氨氯地平-pH4.5(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145706-4570632.44332.0439.3432.4432.0439.34
237575-3757526.67126.67
341831-4183129.69229.69
419763-1976314.02814.03
552340-5234037.15237.15
673637-7363752.26852.27
10min1113072-11307280.26080.4518.2380.4480.6318.26
2129385-12938591.83991.99
3120207-12020785.32485.49
473705-7370552.31752.39
5114261-11426181.10481.31
6129394-12939491.84592.14
15min1137532-13753297.62297.967.3598.2598.597.42
2147376-147376104.609105.27
3140297-14029799.585100.22
4123540-12354087.69088.06
5129523-12952391.93792.59
6149800-149800106.330107.13
20min1140074-14007499.426100.203.49100.59101.373.57
2146079-146079103.689104.93
3141318-141318100.309101.50
4137495-13749597.59698.45
5134598-13459895.53996.71
6147415-147415104.637106.03
30min1143190-143190101.638102.303.58103.36104.023.66
2150321-150321106.700108.52
3144347-144347102.459104.21
4139456-13945698.988100.39
5137721-13772197.75699.45
6149687-149687106.250108.22
45min1141050-141050100.119102.453.46102.40104.753.55
2149069-149069105.811108.22
3146424-146424103.934106.25
4139580-13958099.076101.02
5139321-13932198.892101.13
6150594-150594106.893109.46
60min1143717-143717102.012102.003.55104.85104.863.62
2150293-150293106.680109.68
3143637-143637101.955104.85
4138788-13878898.513101.01
5137366-13736697.504100.30
6148398-148398105.335108.49
极限1142724-142724101.307100.864.07104.72104.294.14
2148205-148205105.198108.79
3144047-144047102.246105.71
4134686-13468695.60298.65
5135569-13556996.22999.56
6147343-147343104.586108.33
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.871332502133126213312081331204133077913313910.05
29.891331476133057413310250.05
单位质量响应值RSD%判断
134892.71134582.910.17数据可信
供试品溶液-2025011111批-厄贝沙坦-pH4.5(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1155368-15536810.37811.2142.6110.3811.2142.61
2154346-15434610.31010.31
3157618-15761810.52810.53
462015-620154.1424.14
5194985-19498513.02413.02
6282676-28267618.88218.88
10min1561328-56132837.49540.0023.3537.5540.0623.36
2740351-74035149.45349.51
3653072-65307243.62343.68
4343061-34306122.91522.94
5608140-60814040.62240.69
6687348-68734845.91246.02
15min1845071-84507156.44859.8112.0356.7160.1012.08
21037230-103723069.28369.62
3936065-93606562.52662.83
4729459-72945948.72548.88
5859973-85997357.44357.74
6964988-96498864.45864.82
20min11004827-100482767.11970.736.6067.7071.356.67
21167836-116783678.00778.72
31082771-108277172.32572.97
4970921-97092164.85465.28
51038874-103887469.39370.01
61088500-108850072.70873.43
30min11204302-120430280.44383.703.9281.4084.714.00
21337640-133764089.35090.50
31269386-126938684.79185.84
41210733-121073380.87381.65
51233541-123354182.39683.40
61262644-126264484.34085.46
45min11332611-133261189.01493.533.2190.4195.003.27
21468122-146812298.06599.71
31425447-142544795.21596.74
41385562-138556292.55193.78
51394941-139494193.17794.64
61394453-139445393.14594.74
60min11425962-142596295.24997.942.6497.1499.942.66
21535650-1535650102.576104.77
31463655-146365597.76799.82
41475753-147575398.575100.32
51460410-146041097.55099.53
61436198-143619895.93398.04
极限11471602-147160298.29899.661.73100.72102.201.76
21528727-1528727102.114104.87
31516720-1516720101.312103.90
41490097-149009799.533101.83
51481060-148106098.930101.45
61463691-146369197.769100.41
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.091363281365791363071363911365371364280.10
214.051361451360601361020.05
单位质量响应值RSD%判断
9682.619686.980.04数据可信
供试品溶液-2025011211批-氨氯地平-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%
5min129989-2998920.07622.2212.8720.0822.2312.87
238715-3871525.91725.92
336653-3665324.53724.54
428278-2827818.93018.93
530142-3014220.17820.18
635420-3542023.71223.71
10min178185-7818552.34055.057.4352.4555.177.44
284174-8417456.35056.49
390730-9073060.73960.87
472785-7278548.72548.83
583381-8338155.81955.93
684135-8413556.32456.46
15min1119378-11937879.91777.243.8780.3277.673.87
2113285-11328575.83876.29
3122099-12209981.73882.21
4110308-11030873.84574.22
5112643-11264375.40875.83
6114576-11457676.70277.15
20min1133249-13324989.20386.742.5790.0587.602.58
2127934-12793485.64486.52
3133539-13353989.39790.32
4126245-12624584.51485.30
5126143-12614384.44585.29
6130295-13029587.22588.10
30min1136622-13662291.46192.663.2392.8094.003.21
2133681-13368189.49290.85
3144128-14412896.48597.91
4139804-13980493.59194.85
5133687-13368789.49690.81
6142538-14253895.42196.78
45min1148105-14810599.14897.611.69101.0099.471.69
2142333-14233395.28497.14
3148229-14822999.231101.19
4145902-14590297.67399.45
5143393-14339395.99397.80
6146903-14690398.343100.23
60min1150237-150237100.57598.941.93102.98101.341.92
2143026-14302695.74898.13
3150846-150846100.983103.49
4146527-14652798.091100.41
5148636-14863699.503101.84
6147486-14748698.733101.17
极限1141869-14186994.97391.792.3097.9394.742.26
2134772-13477290.22293.13
3136443-13644391.34194.41
4133165-13316589.14692.01
5137029-13702991.73394.63
6139396-13939693.31896.30
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.871326665132742513255971324405132425313256690.11
29.891319223131808613186540.07
单位质量响应值RSD%判断
134312.97133332.050.52数据可信
供试品溶液-2025011211批-厄贝沙坦-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%
5min1323316-32331621.74425.8414.6821.7425.8414.68
2451338-45133830.35430.35
3427321-42732128.73928.74
4312249-31224921.00021.00
5381507-38150725.65825.66
6409692-40969227.55327.55
10min1915218-91521861.55265.926.5061.6766.076.51
21020754-102075468.65068.82
31060307-106030771.31071.47
4896664-89666460.30460.42
5976951-97695165.70465.85
61011388-101138868.02068.17
15min11272490-127249085.58085.972.2586.0486.482.26
21266770-126677085.19685.75
31329911-132991189.44290.00
41269114-126911485.35385.80
51244690-124469083.71184.22
61286371-128637186.51487.04
20min11379585-137958592.78392.421.8593.7293.401.84
21364831-136483191.79192.81
31394416-139441693.78094.83
41384916-138491693.14194.07
51327256-132725689.26390.24
61393847-139384793.74294.75
30min11378329-137832992.69895.453.2394.1596.953.20
21410866-141086694.88796.42
31463570-146357098.431100.00
41474661-147466199.177100.62
51359228-135922891.41492.88
61428524-142852496.07497.61
45min11439597-143959796.81997.502.1098.7999.532.07
21430138-143013896.18398.24
31444920-144492097.17799.30
41484245-148424599.822101.82
51411389-141138994.92296.90
61487638-1487638100.050102.12
60min11448465-144846597.41597.481.6499.92100.051.62
21420552-142055295.53898.13
31456611-145661197.963100.62
41472893-147289399.058101.61
51422622-142262295.67798.18
61475123-147512399.208101.83
极限11443813-144381397.10296.601.44100.1599.711.43
21415474-141547495.19798.32
31442678-144267897.026100.23
41434499-143449996.47699.58
51412758-141275895.01498.05
61468579-146857998.768101.94
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.091368151366631367681369541368341368070.08
214.051350211350851350530.04
单位质量响应值RSD%判断
9709.519612.310.72数据可信
供试品溶液-2025011211批-氨氯地平-0.05molhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161836-6183641.49960.3925.7441.5060.4025.74
2103916-10391669.73969.74
3100459-10045967.41967.42
465347-6534743.85543.86
5121140-12114081.29981.30
687238-8723858.54758.55
10min1149405-149405100.268107.933.80100.50108.263.85
2167536-167536112.436112.82
3163069-163069109.438109.81
4160025-160025107.395107.64
5162134-162134108.810109.26
6162769-162769109.237109.56
15min1167528-167528112.430110.551.69113.22111.491.67
2167376-167376112.328113.34
3166569-166569111.787112.77
4161526-161526108.402109.24
5161711-161711108.527109.58
6163669-163669109.841110.77
20min1168464-168464113.059110.622.45114.47112.182.43
2170857-170857114.665116.30
3163373-163373109.642111.25
4159950-159950107.345108.79
5162922-162922109.339111.00
6163454-163454109.696111.24
30min1169241-169241113.580109.772.36115.62111.932.32
2166613-166613111.816114.09
3163875-163875109.979112.19
4158707-158707106.511108.55
5161901-161901108.654110.92
6161043-161043108.078110.23
45min1168479-168479113.069107.253.27115.74110.023.19
2164062-164062110.104113.00
3157090-157090105.425108.25
4155870-155870104.607107.24
5157192-157192105.494108.36
6156163-156163104.803107.56
60min1164842-164842110.628106.122.78113.93109.492.73
2162069-162069108.767112.27
3157309-157309105.572108.98
4153505-153505103.019106.23
5155872-155872104.608108.06
6155168-155168104.135107.47
极限1163863-163863109.971106.033.04113.88109.992.97
2164057-164057110.101114.21
3154800-154800103.888107.88
4153676-153676103.134106.92
5154199-154199103.485107.52
6157356-157356105.604109.52
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.871323747132505713235001323753132275713237630.07
29.891308377130996313091700.09
单位质量响应值RSD%判断
134119.86132373.100.93数据可信
供试品溶液-2025011211批-厄贝沙坦-0.05molhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min196778-967786.53711.0834.526.5411.0834.50
2202919-20291913.70713.71
3179723-17972312.14012.14
4102250-1022506.9076.91
5240913-24091316.27316.27
6161263-16126310.89310.89
10min1332029-33202922.42829.7914.3822.4629.8514.42
2484555-48455532.73032.81
3465395-46539531.43631.50
4402399-40239927.18127.22
5503915-50391534.03834.13
6457732-45773230.91830.98
15min1513971-51397134.71739.977.7134.8840.207.77
2621889-62188942.00742.26
3610916-61091641.26541.51
4560816-56081637.88138.07
5634667-63466742.87043.15
6608217-60821741.08341.32
20min1614200-61420041.48746.466.5341.8446.916.60
2727960-72796049.17149.66
3693102-69310246.81747.29
4657021-65702144.38044.78
5730295-73029549.32949.85
6704411-70441147.58148.04
30min1746904-74690450.45154.354.2151.0455.064.29
2823126-82312655.60056.36
3818659-81865955.29856.03
4782520-78252052.85753.50
5839382-83938256.69857.49
6817122-81712255.19455.92
45min1856643-85664357.86460.582.6958.7361.592.79
2917658-91765861.98563.06
3897186-89718660.60261.64
4883698-88369859.69160.63
5921769-92176962.26363.37
6904479-90447961.09562.13
60min1914781-91478161.79164.932.6562.9866.272.74
2977855-97785566.05167.47
3972917-97291765.71867.09
4949129-94912964.11165.38
5981657-98165766.30867.76
6971040-97104065.59166.96
极限1981028-98102866.26569.822.8167.7971.532.88
21057342-105734271.42073.20
31032385-103238569.73471.47
41026708-102670869.35170.98
51044626-104462670.56172.38
61060259-106025971.61773.35
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.091263711256411253171245471236891251130.83
214.051237861241001239430.18
单位质量响应值RSD%判断
8879.568821.570.47数据可信
供试品溶液-2025011211批-氨氯地平-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124879-2487918.22534.4428.3218.2334.4428.32
261016-6101644.69744.70
350132-5013236.72436.72
445503-4550333.33333.33
559417-5941743.52643.53
641159-4115930.15130.15
10min165017-6501747.62868.5223.1347.7368.7223.13
2113581-11358183.20483.45
387204-8720463.88164.09
4102959-10295975.42375.61
5118375-11837586.71686.96
674100-7410054.28254.45
15min1121558-12155889.04795.435.4489.4196.005.53
2139954-139954102.523103.23
3124515-12451591.21391.77
4135842-13584299.511100.12
5132778-13277897.26797.99
6127002-12700293.03593.50
20min1133555-13355597.836102.953.6198.70104.063.72
2145959-145959106.922108.20
3136539-136539100.022101.09
4142492-142492104.383105.54
5145786-145786106.796108.06
6138916-138916101.763102.75
30min1141283-141283103.497103.231.19104.90104.911.24
2143686-143686105.257107.13
3139418-139418102.131103.75
4141823-141823103.892105.63
5139486-139486102.180104.04
6139856-139856102.452104.00
45min1142243-142243104.200105.031.74106.18107.271.84
2146318-146318107.185109.64
3142847-142847104.643106.83
4145272-145272106.419108.73
5144227-144227105.653108.08
6139320-139320102.059104.18
60min1140539-140539102.952105.531.42105.51108.361.54
2146456-146456107.286110.34
3143230-143230104.923107.69
4144059-144059105.530108.44
5145251-145251106.404109.42
6144780-144780106.059108.75
极限1145137-145137106.320108.431.23109.45111.851.25
2147925-147925108.362112.01
3150692-150692110.389113.74
4147924-147924108.362111.85
5147541-147541108.081111.68
6148924-148924109.094112.37
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.871329559132763213265871326177132317813266270.18
29.891320884132293613219100.11
单位质量响应值RSD%判断
134410.03133661.270.40数据可信
供试品溶液-2025011211批-厄贝沙坦-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137523-1375239.23419.2732.729.2319.2732.73
2375280-37528025.19925.20
3324001-32400121.75621.76
4263879-26387917.71917.72
5384511-38451125.81925.82
6236730-23673015.89615.90
10min1428783-42878328.79144.2325.3228.8444.3425.33
2809350-80935054.34554.49
3632069-63206942.44142.56
4716907-71690748.13848.24
5852998-85299857.27657.42
6511854-51185434.36934.46
15min1939845-93984563.10870.256.5463.3270.606.64
21117319-111731975.02475.47
31022280-102228068.64369.00
41093448-109344873.42273.79
51097840-109784073.71674.18
61006661-100666167.59467.87
20min11144364-114436476.84081.614.0677.4082.354.16
21248906-124890683.86084.72
31181872-118187279.35980.10
41223921-122392182.18282.96
51284257-128425786.23487.10
61208759-120875981.16481.82
30min11329903-132990389.29988.780.5290.2989.980.48
21315406-131540688.32589.65
31313390-131339088.19089.37
41320198-132019888.64789.88
51327614-132761489.14590.50
61326611-132661189.07890.18
45min11433694-143369496.26894.930.9897.7596.620.96
21421094-142109495.42297.24
31396966-139696693.80295.47
41402798-140279894.19395.92
51421361-142136195.44097.29
61407100-140710094.48296.08
60min11445585-144558597.06696.841.3799.0999.051.31
21426869-142686995.81098.16
31439971-143997196.68998.88
41414346-141434694.96997.21
51458980-145898097.966100.34
61467092-146709298.511100.64
极限11514713-1514713101.708100.711.24104.27103.471.14
21475150-147515099.052101.93
31513733-1513733101.642104.37
41478291-147829199.263102.04
51502291-1502291100.874103.79
61515154-1515154101.738104.41
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.091285031281241280281278361268711278720.48
214.051272121271531271820.04
单位质量响应值RSD%判断
9075.379052.100.19数据可信
供试品溶液-2025011211批-氨氯地平-pH4.5(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163626-6362645.51333.9519.4945.5133.9519.49
252807-5280737.77437.77
338033-3803327.20627.21
444054-4405431.51231.51
543075-4307530.81230.81
643198-4319830.90030.90
10min1120682-12068286.32682.5215.1186.5882.7015.10
2126297-12629790.34290.55
387432-8743262.54162.69
4136926-13692697.94598.12
5104221-10422174.55174.72
6116591-11659183.39983.57
15min1141456-141456101.18699.817.12101.92100.467.14
2140502-140502100.503101.21
3119731-11973185.64586.14
4145486-145486104.068104.79
5145522-145522104.094104.68
6144540-144540103.392104.03
20min1143476-143476102.630103.602.40103.93104.812.45
2143967-143967102.982104.25
3139051-13905199.465100.44
4147725-147725105.670106.97
5148584-148584106.284107.45
6146217-146217104.591105.80
30min1143471-143471102.627105.162.55104.49106.942.54
2143943-143943102.964104.81
3143479-143479102.633104.16
4150457-150457107.624109.51
5151081-151081108.070109.82
6149633-149633107.035108.83
45min1146853-146853105.046105.863.89107.48108.223.91
2148961-148961106.554108.97
3137305-13730598.216100.31
4150156-150156107.409109.89
5154183-154183110.289112.64
6150485-150485107.644110.03
60min1147070-147070105.201106.871.09108.22109.821.13
2150655-150655107.766110.77
3147608-147608105.586108.23
4150287-150287107.502110.58
5150498-150498107.653110.62
6150318-150318107.525110.51
极限1139329-13932999.664103.003.82103.27106.543.76
2148221-148221106.025109.63
3138148-13814898.819102.05
4143210-143210102.440106.12
5152604-152604109.160112.73
6142422-142422101.877105.46
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.871329375132672513265251325399132469013265430.14
29.891323612132453213240720.05
单位质量响应值RSD%判断
134401.52133879.880.28数据可信
供试品溶液-2025011211批-厄贝沙坦-pH4.5(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1274782-27478218.43613.8621.7618.4413.8621.79
2248280-24828016.65816.66
3171157-17115711.48411.48
4199592-19959213.39113.39
5165212-16521211.08511.08
6180225-18022512.09212.09
10min1677537-67753745.45944.8919.7845.5644.9719.77
2785251-78525152.68652.78
3504290-50429033.83533.90
4840697-84069756.40656.48
5537221-53722136.04436.11
6669700-66970044.93345.00
15min1981665-98166565.86466.159.3866.2266.479.41
21057710-105771070.96671.35
3835759-83575956.07456.33
41092109-109210973.27473.66
5932734-93273462.58162.84
61015310-101531068.12168.44
20min11136929-113692976.28177.484.5077.0078.174.57
21202707-120270780.69481.47
31099451-109945173.76774.33
41227171-122717182.33683.13
51104533-110453374.10874.72
61157693-115769377.67478.37
30min11299767-129976787.20789.613.0288.3590.743.06
21332639-133263989.41290.64
31315373-131537388.25489.23
41410209-141020994.61795.87
51309219-130921987.84188.86
61346590-134659090.34891.47
45min11456798-145679897.74297.663.1499.3799.283.18
21478331-147833199.187100.91
31364004-136400491.51692.98
41482161-148216199.444101.22
51476270-147627099.049100.56
61475488-147548898.996100.63
60min11526184-1526184102.398103.020.86104.57105.180.93
21547092-1547092103.801106.08
31536643-1536643103.100105.07
41551405-1551405104.090106.42
51515953-1515953101.711103.77
61535503-1535503103.023105.20
极限11477005-147700599.098101.523.04101.84104.252.97
21568459-1568459105.234108.09
31475722-147572299.012101.56
41483678-148367899.546102.45
51573922-1573922105.601108.23
61499430-1499430100.603103.35
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