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%
19.684374264382224376404373454371054375480.10
29.624383364383384383370.01
单位质量响应值RSD%判断
45201.2445565.180.57数据可信
供试品溶液-6041001批-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%
5min160158-6015811.93012.519.3211.9312.519.32
261312-6131212.15912.16
362354-6235412.36612.37
474864-7486414.84714.85
559150-5915011.73011.73
660647-6064712.02712.03
10min1101521-10152120.13320.212.4520.1520.232.45
2102882-10288220.40320.42
3102971-10297120.42120.44
498108-9810819.45619.48
5100603-10060319.95119.97
6105464-10546420.91520.94
15min1132599-13259926.29626.733.0326.3526.783.02
2134480-13448026.66926.72
3135499-13549926.87126.93
4130439-13043925.86825.93
5133352-13335226.44626.50
6142307-14230728.22228.28
20min1159577-15957731.64632.643.0331.7432.733.02
2161688-16168832.06532.16
3172528-17252834.21534.31
4164194-16419432.56232.66
5161064-16106431.94132.04
6168374-16837433.39133.49
30min1203502-20350240.35740.561.0340.5140.711.03
2205652-20565240.78440.94
3206041-20604140.86141.02
4200660-20066039.79439.95
5205315-20531540.71740.87
6205874-20587440.82840.99
45min1256776-25677650.92251.441.5151.1451.661.51
2260988-26098851.75851.98
3259081-25908151.37951.60
4253914-25391450.35550.58
5265429-26542952.63852.86
6260110-26011051.58451.81
60min1301592-30159259.81060.120.7660.1160.420.76
2303654-30365460.21960.53
3303813-30381360.25060.56
4299299-29929959.35559.66
5305055-30505560.49760.80
6305370-30537060.55960.87
120min1440957-44095787.44888.311.0287.8588.721.02
2445014-44501488.25388.66
3446360-44636088.52088.93
4439750-43975087.20987.61
5447776-44777688.80089.21
6452026-45202689.64390.06
240min1617662-617662122.491123.030.39123.04123.580.39
2621204-621204123.194123.75
3623198-623198123.589124.15
4617314-617314122.422122.97
5620740-620740123.102123.66
6622110-622110123.373123.94
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
360min1737410-737410146.239147.280.64146.99148.040.64
2743014-743014147.350148.11
3749262-749262148.589149.35
4738656-738656146.486147.24
5740696-740696146.891147.65
6746984-746984148.138148.91
480min1819670-819670162.552163.910.70163.55164.910.70
2833936-833936165.382166.39
3826266-826266163.860164.87
4819861-819861162.590163.59
5829646-829646164.531165.54
6829594-829594164.520165.53
600min1874517-874517173.429175.380.75174.70176.660.75
2886050-886050175.716177.00
3883721-883721175.255176.54
4893395-893395177.173178.44
5879969-879969174.511175.79
6888606-888606176.223177.51
720min1910342-910342180.534181.101.24182.09182.671.23
2920901-920901182.628184.20
3918201-918201182.093183.67
4914948-914948181.447183.01
5892092-892092176.915178.48
6922684-922684182.982184.56
840min1932553-932553184.939183.213.97186.80185.083.93
2940922-940922186.598188.48
3939087-939087186.234188.11
4936203-936203185.663187.53
5849510-849510168.470170.33
6944608-944608187.329189.22
960min1942304-942304186.872184.455.08189.04186.635.03
2952796-952796188.953191.14
3951030-951030188.603190.79
4947393-947393187.882190.06
5834148-834148165.424167.57
6952940-952940188.982191.18
极限1936494-936494185.720184.385.33188.20186.875.28
2951177-951177188.632191.14
3959760-959760190.334192.84
4950705-950705188.539191.03
5829783-829783164.558166.98
6950505-950505188.499191.01
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