依折麦布片项目信息
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
DJ333-221017
对照品来源
自制
对照品使用方法
直接使用
对照品含量(%)
99.67
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)
A
1
A
2
A
3
A
4
A
5
A
平均
RSD%
1
11.08
356958
357204
356960
356954
357022
357020
0.03
2
11.03
361821
362858
362340
0.21
单位质量响应值
RSD%
判断
32222.02
32850.41
1.37
数据可信
供试品溶液-2023122421批-pH1.2(内含0.1%Tween80)
时间
(分钟)
样品
A
1
A
2
A
平均
溶出量(%)
平均(%)
RSD%
累计溶
出量(%)
平均(%)
RSD%
5min
1
232298
-
232298
64.051
51.62
12.90
64.05
51.62
12.90
2
194335
-
194335
53.584
53.58
3
169545
-
169545
46.748
46.75
4
173079
-
173079
47.723
47.72
5
184522
-
184522
50.878
50.88
6
169569
-
169569
46.755
46.75
10min
1
304979
-
304979
84.091
77.13
6.01
84.20
77.22
6.01
2
286720
-
286720
79.057
79.15
3
254387
-
254387
70.142
70.22
4
278763
-
278763
76.863
76.94
5
282332
-
282332
77.847
77.93
6
271169
-
271169
74.769
74.85
15min
1
327943
-
327943
90.423
85.85
4.67
90.67
86.06
4.68
2
319452
-
319452
88.082
88.30
3
285744
-
285744
78.788
78.98
4
313162
-
313162
86.347
86.56
5
316131
-
316131
87.166
87.38
6
305685
-
305685
84.286
84.49
20min
1
337328
-
337328
93.011
89.57
3.97
93.41
89.93
3.98
2
332007
-
332007
91.544
91.91
3
300989
-
300989
82.991
83.32
4
327475
-
327475
90.294
90.65
5
330367
-
330367
91.091
91.45
6
320939
-
320939
88.492
88.83
30min
1
345297
-
345297
95.208
92.82
3.47
95.76
93.33
3.48
2
342954
-
342954
94.562
95.08
3
313967
-
313967
86.569
87.03
4
340400
-
340400
93.858
94.36
5
342502
-
342502
94.437
94.95
6
334737
-
334737
92.296
92.79
45min
1
349031
-
349031
96.238
94.58
3.13
96.95
95.24
3.14
2
349037
-
349037
96.239
96.92
3
321618
-
321618
88.679
89.29
4
346629
-
346629
95.575
96.23
5
348693
-
348693
96.144
96.81
6
343060
-
343060
94.591
95.24
60min
1
351324
-
351324
96.870
95.57
2.98
97.74
96.39
2.99
2
352715
-
352715
97.253
98.09
3
326132
-
326132
89.924
90.68
4
350112
-
350112
96.536
97.35
5
353039
-
353039
97.343
98.17
6
346337
-
346337
95.495
96.30
极限
1
369348
-
369348
101.839
100.94
1.25
102.87
101.92
1.27
2
371437
-
371437
102.415
103.42
3
362218
-
362218
99.874
100.78
4
359172
-
359172
99.034
100.01
5
367523
-
367523
101.336
102.33
6
366868
-
366868
101.156
102.12
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图1 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质<br>溶剂 图2 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质<br>对照品溶液-1-1 图3 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质<br>对照品溶液-1-2 图4 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质<br>对照品溶液-1-3 图5 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质<br>对照品溶液-1-4 图6 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质<br>对照品溶液-1-5 图7 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-5min-片1<br>供试品溶液-1 图8 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-5min-片2<br>供试品溶液-1 图9 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-5min-片3<br>供试品溶液-1 图10 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-5min-片4<br>供试品溶液-1 图11 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-5min-片5<br>供试品溶液-1 图12 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-5min-片6<br>供试品溶液-1 图13 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-10min-片1<br>供试品溶液-1 图14 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-10min-片2<br>供试品溶液-1 图15 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-10min-片3<br>供试品溶液-1 图16 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-10min-片4<br>供试品溶液-1 图17 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-10min-片5<br>供试品溶液-1 图18 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-10min-片6<br>供试品溶液-1 图19 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-15min-片1<br>供试品溶液-1 图20 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-15min-片2<br>供试品溶液-1 图21 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-15min-片3<br>供试品溶液-1 图22 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-15min-片4<br>供试品溶液-1 图23 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-15min-片5<br>供试品溶液-1 图24 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-15min-片6<br>供试品溶液-1 图25 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-20min-片1<br>供试品溶液-1 图26 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-20min-片2<br>供试品溶液-1 图27 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-20min-片3<br>供试品溶液-1 图28 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-20min-片4<br>供试品溶液-1 图29 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-20min-片5<br>供试品溶液-1 图30 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-20min-片6<br>供试品溶液-1 图31 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-30min-片1<br>供试品溶液-1 图32 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-30min-片2<br>供试品溶液-1 图33 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-30min-片3<br>供试品溶液-1 图34 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-30min-片4<br>供试品溶液-1 图35 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-30min-片5<br>供试品溶液-1 图36 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-30min-片6<br>供试品溶液-1 图37 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-45min-片1<br>供试品溶液-1 图38 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-45min-片2<br>供试品溶液-1 图39 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-45min-片3<br>供试品溶液-1 图40 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-45min-片4<br>供试品溶液-1 图41 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-45min-片5<br>供试品溶液-1 图42 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-45min-片6<br>供试品溶液-1 图43 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-60min-片1<br>供试品溶液-1 图44 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-60min-片2<br>供试品溶液-1 图45 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-60min-片3<br>供试品溶液-1 图46 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-60min-片4<br>供试品溶液-1 图47 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-60min-片5<br>供试品溶液-1 图48 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-60min-片6<br>供试品溶液-1 图49 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-极限转速-片1<br>供试品溶液-1 图50 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-极限转速-片2<br>供试品溶液-1 图51 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-极限转速-片3<br>供试品溶液-1 图52 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-极限转速-片4<br>供试品溶液-1 图53 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-极限转速-片5<br>供试品溶液-1 图54 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质-极限转速-片6<br>供试品溶液-1 图55 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质<br>对照品溶液-2-1 图56 依折麦布片溶出曲线测定HPLC图谱<br>自制品-2023122421批-pH1.2(内含0.1%Tween80)介质<br>对照品溶液-2-2
原始图谱
下载图谱
(姜进硙 于 2024-01-26 16:24:40 完成)
生成报告
数据部分
下载报告
( 于 2026-01-02 02:04:35 完成)