表 1 受試者資料
編號 年齡(yr) 身高(cm) 體重(kg) 給藥次序 性別 A
B C D E F G H I J K L
24 23 23 30 21 23 25 29 23 24 24 22
176.6 164.1 159.2 179.9 186.0 178.6 171.3 165.9 172.8 177.7 175.0 172.0
71.4 67.6 54.3 74.6 81.0 70.3 78.3 54.3 68.2 82.1 73.1 66.0
Y L Y L L Y Y L Y L L Y
L Y L Y Y L L Y L Y Y L
Man Man Man Man Man Man Man Man Man Man Man Man Mean
S.D.
24.25 2.67
173.26 7.45
70.1 8.98
*Y: Cephanmycin? (Lot.M001)L: Keflex? (Lot.A0053A)
表 2 血漿中 cephalexin 分析之標準曲線 表 2-1 Cephalexin 分析方法之標準曲線
Spike conc.
(µg/ml)
Peak area of Cephalexin
Peak area of Internal standard
Measure conc.
(µg/ml)
Error (%)
16.0 8.0 4.0 2.0 1.0 0.5 0.05
104119 53717 27815 14322 8104 3870 1298
47977 48783 49235 51135 48266 47379 47185
15.980 8.029 4.041 1.922 1.088 0.447 0.044
-0.125
0.361
1.022
-3.891
8.783
-10.691
-12.741
表 2-2 個別受試者之標準曲線
Calibration curve of subject A Spike conc.
(µg/ml)
Peak area of Cephalexin
Peak area of Internal standard
Measure conc.
(µg/ml)
Error (%)
16.0 8.0 4.0 2.0 1.0 0.5 0.05
128817 66748 33247 17475 9413 5124 1797
61174 62860 59403 62780 62099 61465 60884
15.988 7.975 4.121 1.961 0.988 0.465 0.052
0.077 0.310 -3.021
1.926 1.157 7.033 -3.028
Calibration curve of subject B Spike conc.
(µg/ml)
Peak area of Cephalexin
Peak area of Internal standard
Measure conc.
(µg/ml)
Error (%)
16.0 8.0 4.0 2.0 1.0 0.5 0.05
166728 85515 43103 20663 11602 6146 2369
76824 77560 75156 70436 70774 73512 73766
15.973 8.018 4.076 1.989 1.025 0.426 0.043
0.168
-0.227
-1.908
0.551
-2.464
14.766
14.941
Calibration curve of subject C Spike conc.
(µg/ml)
Peak area of Cephalexin
Peak area of Internal standard
Measure conc.
(µg/ml)
Error (%)
16.0 8.0 4.0 2.0 1.0 0.5 0.05
131961 65417 33918 16433 9679 5127 1726
61789 60844 60930 59360 60428 61308 60246
16.003 7.977 4.053 1.935 1.052 0.473 0.057
-0.020 0.287 -1.324
3.246 -5.215
5.436 -13.470
Calibration curve of subject D Spike conc.
(µg/ml)
Peak area of Cephalexin
Peak area of Internal standard
Measure conc.
(µg/ml)
Error (%)
16.0 8.0 4.0 2.0 1.0 0.5 0.05
126282 65701 34447 17317 9943 5089 1998
58771 59112 60950 59525 61469 60126 58007
15.926 8.137 4.034 1.975 1.005 0.425 0.048
0.460
-1.709
-0.852
1.274
-0.451
14.928
3.195
Calibration curve of subject E Spike conc.
(µg/ml)
Peak area of Cephalexin
Peak area of Internal standard
Measure conc.
(µg/ml)
Error (%)
16.0 8.0 4.0 2.0 1.0 0.5 0.05
128615 64773 34195 16799 9324 5155 1891
61769 61098 61091 61224 60283 62367 60897
15.958 8.028 4.145 1.931 1.002 0.443 0.043
0.262 -0.348 -3.626 3.455 -0.201 11.354 14.353
Calibration curve of subject F Spike conc.
(µg/ml)
Peak area of Cephalexin
Peak area of Internal standard
Measure conc.
(µg/ml)
Error (%)
16.0 8.0 4.0 2.0 1.0 0.5 0.05
131302 64973 31954 17381 9895 5097 1849
61768 60442 58902 59939 60730 59556 59057
16.007 8.002 3.946 2.023 1.055 0.466 0.052
-0.042
-0.029
1.347
-1.127
-5.476
6.895
-4.159
Calibration curve of subject G Spike conc.
(µg/ml)
Peak area of Cephalexin
Peak area of Internal standard
Measure conc.
(µg/ml)
Error (%)
16.0 8.0 4.0 2.0 1.0 0.5 0.05
130989 67610 34945 18183 9876 5493 2194
61430 62731 61729 61081 60895 60885 59797
15.996 7.967 4.072 2.028 0.997 0.449 0.041
0.025 0.408 -1.795 -1.412 0.341 10.255 17.619
Calibration curve of subject H Spike conc.
(µg/ml)
Peak area of Cephalexin
Peak area of Internal standard
Measure conc.
(µg/ml)
Error (%)
16.0 8.0 4.0 2.0 1.0 0.5 0.05
129963 66397 33319 16560 9004 4867 1855
62352 63044 58969 59296 61808 59168 60354
15.970 7.976 4.191 1.976 0.940 0.448 0.049
0.188 0.304 -4.779
1.209 5.994 10.323
2.097
Calibration curve of subject I Spike conc.
(µg/ml)
Peak area of Cephalexin
Peak area of Internal standard
Measure conc.
(µg/ml)
Error (%)
16.0 8.0 4.0 2.0 1.0 0.5 0.05
138844 68791 33254 17087 9011 5013 1154
64873 63891 61384 63581 61281 62756 62896
16.002 8.011 3.991 1.940 1.026 0.521 0.059
-0.010 -0.134 0.216 2.987 -2.587 -4.248 -17.829
Calibration curve of subject J Spike conc.
(µg/ml)
Peak area of Cephalexin
Peak area of Internal standard
Measure conc.
(µg/ml)
Error (%)
16.0 8.0 4.0 2.0 1.0 0.5 0.05
126661 66065 32387 17557 9963 5022 1899
60099 61414 59471 62787 60053 58550 58545
15.978 8.058 3.981 1.948 1.075 0.460 0.050
0.139 -0.727
0.466 2.615 -7.481
8.046
-0.773
Calibration curve of subject K Spike conc.
(µg/ml)
Peak area of Cephalexin
Peak area of Internal standard
Measure conc.
(µg/ml)
Error (%)
16.0 8.0 4.0 2.0 1.0 0.5 0.05
133118 68873 35000 17766 9716 5414 1794
60771 61585 59650 63794 62568 60765 61168
15.947 8.060 4.149 1.882 0.975 0.488 0.049
0.333 -0.747 -3.733 5.918 2.468 2.317 2.516
Calibration curve of subject L Spike conc.
(µg/ml)
Peak area of Cephalexin
Peak area of Internal standard
Measure conc.
(µg/ml)
Error (%)
16.0 8.0 4.0 2.0 1.0 0.5 0.05
132198 67039 34545 17832 10117 5702 1849
59689 60307 60769 61949 58978 59587 59617
16.028 7.957 3.983 1.930 1.079 0.524 0.050
-0.176
0.540
0.432
3.520
-7.859
-4.732
-0.882
表 3 尿液中個別受試者檢品定量之標準曲線
SLOPE INTERCEPT Rsqr
檢量線 A Y＝21.38575X－3.12527 0.998194 檢量線 B Y＝19.30211X－0.38000 0.999631 檢量線 C Y＝19.03623X－0.90281 0.998761 檢量線 D Y＝19.2894X－1.93348 0.999560 檢量線 E Y＝18.68734X－0.96708 0.998690 檢量線 F Y＝18.00425X－0.10201 0.999379 檢量線 G Y＝19.41299X－0.96335 0.999545 檢量線 H Y＝18.67297X－1.04371 0.999665 檢量線 I Y＝18.94671X－0.87631 0.999651 檢量線 J Y＝20.44694X－2.43649 0.999681 檢量線 K Y＝19.84651X－0.61203 0.999604 檢量線 L Y＝20.05948X－0.75072 0.999576
表 4 血漿中 cephalexin 以 HPLC 定量法定量分析之確效性試驗
表 4-1 定量分析之偵測極限及定量極限
Peak High(mm) Cephalexin conc.
(µg/ml) Sample A Sample B Sample C
0.02 10.2 9.9 9.8
0.03 11.8 11.1 11.1
0.04 15 16.2 14
總回歸方程式 △： Y = 255X + 4.4722
取 A、B、C calibration curve 截距之標準偏差σ=1.322 總回歸方程式之斜率 S=255
依 ICH
LOD = 3.3 ×σ / S = 0.0171μg/ml
LOQ = 10 ×σ / S = 0.0518μg/ml → 0.05μg/ml 實驗上以 0.05μg/ml 為撿量線之 LOQ，即可測得 Plasma Sample 最低濃度。
表 4-2 定量分析之同日(Intraday)精密度及準確度試驗
Cephalexin Runs
Conc. 1 2 3
(μ g/ml) 4 5 6 Mean S.D. C.V. (%) Error (%) 16.0 15.890 15.972 16.015
15.973 15.997 15.992 15.973 0.044 0.274 0.168 8.0 8.240 8.070 7.945
8.050 7.999 7.991 8.049 0.104 1.286 -0.615 4.0 3.954 3.984 4.059
4.018 4.022 4.071 4.018 0.044 1.099 -0.450 2.0 1.991 1.965 1.974
1.982 1.978 1.946 1.973 0.016 0.793 1.367 1.0 1.002 1.026 1.022
1.015 1.029 1.034 1.021 0.011 1.121 -2.133 0.5 0.426 0.477 0.486
0.466 0.472 0.470 0.466 0.021 4.472 6.767 0.05 0.047 0.056 0.050
0.047 0.054 0.046 0.050 0.004 8.295 0
表 4-3 定量分析之異日(Interday)精密度及準確度試驗
Cephalexin Days
Conc. 1 2 3
(μ g/ml) 4 5 6 Mean S.D. C.V. (%) Error (%) 16.0 15.839 16.022 15.919
16.010 16.019 15.818 15.938 0.093 0.584 0.389 8.0 8.323 7.908 8.156
7.925 7.987 8.360 8.110 0.200 2.467 -1.373 4.0 3.997 4.110 4.026
4.085 3.951 4.025 4.032 0.058 1.436 -0.808 2.0 1.974 1.953 1.969
2.052 1.953 1.934 1.973 0.041 2.100 1.375 1.0 0.949 1.024 0.996
1.007 1.061 0.913 0.992 0.053 5.358 0.833 0.5 0.425 0.473 0.442
0.429 0.531 0.450 0.458 0.040 8.619 8.333 0.05 0.043 0.052 0.042
0.042 0.048 0.050 0.046 0.004 9.532 7.667
表 4-4 定量分析中之相對回收率試驗(n=3)
Cephalexin conc. Plasma sample Solvent sample Recovery (µg/ml) peak area ratio peak area ratio (%)
16.00 2.1270 2.1859 97.30
8.00 1.0930 1.1083 98.62
4.00 0.5622 0.5793 97.05
2.00 0.2762 0.2926 94.38
1.00 0.1627 0.1673 97.25
0.50 0.0823 0.0864 95.25
0.05 0.0242 0.0267 90.51
Mean 95.77
S.D. 2.71
表 4-5 Cephalexin 標準血漿檢品於 250C 之安定性試驗
Cephalexin Conc. (µg/ml)
Time
(hr) 0.050 2.000 16.000
0.00 3.00 6.00 9.00 12.00 18.00 24.00
0.055 0.052 0.052 0.050 0.046 0.043 0.041
2.058 2.033 2.028 2.014 1.995 1.981 1.965
16.210 16.156 16.093 15.988 15.969 15.857 15.796 Mean
S.D.
C.V.
Error
0.048 0.005 10.720 -3.143
2.011 0.032 1.607 0.529
16.010 0.153 0.953 0.062
表 4-6 Cephalexin 標準血漿檢品於-300C 之安定性試驗
Cephalexin Conc. (µg/ml)
Time
(Day) 0.050 2.000 16.000
0 10 15 30 45 60 90
0.053 0.052 0.049 0.043 0.047 0.045 0.043
2.084 2.076 1.997 1.986 1.875 1.863 1.852
16.131 16.118 16.022 15.982 15.974 15.876 15.778 Mean
S.D.
C.V.
Error
0.047 0.004 8.595 -0.051
1.962 0.099 5.061 -1.907
15.983
0.126
0.788
-0.106
表 4-7 Cephalexin 標準溶液之母液於室溫之安定性試驗
Cephalexin(µg/ml)
Time(hr) 1
Runs
2 3
0 1 2 4 6 168
16.218 16.169 16.256 16.173 16.175 16.198
16.235 16.301 16.217 16.150 16.264 16.189
16.187 16.256 16.263 16.132 16.105 16.204
表 4-8 Cephalexin 血漿標準品連續解凍之安定性試驗
Cephalexin Runs
Conc.(µg/ml) 1 2 3 Mean S.D. C.V.(%) Error(%)
第一次解凍
16.00 16.159 16.296 16.512 16.322 0.178 1.090 2.015 2.00 2.161 2.240 2.137 2.179 0.054 2.473 8.967 0.05 0.056 0.054 0.054 0.055 0.001 2.112 9.333 第二次解凍
16.00 16.567 16.312 16.214 16.364 0.182 1.114 2.277 2.00 2.151 2.154 2.122 2.142 0.018 0.825 7.117 0.05 0.048 0.051 0.051 0.050 0.001 2.966 0.200 第三次解凍
16.00 16.401 16.772 15.956 16.376 0.409 2.495 2.352
2.00 2.187 2.151 2.165 2.168 0.018 0.837 8.383
0.05 0.047 0.049 0.051 0.049 0.002 3.699 2.467
表 4-9 Cephalexin 血漿檢品之品質管制試驗
Subject 16.00（高） 2.00（中） 0.05（低）
（μg/ml） Error（﹪） （μg/ml） Error（﹪） （μg/ml） Error（﹪）
A1 16.284 -1.77 2.268 -13.40 0.0498 0.40 A2 16.819 -5.12 2.113 -5.65 0.0501 -0.20
B1 15.583 2.61 2.106 -5.30 0.0448 10.40 B2 15.052 5.93 2.062 -3.10 0.0450 10.00 C1 16.029 -0.18 1.972 1.40 0.0470 6.00 C2 15.446 3.46 1.983 0.85 0.0464 7.20 D1 15.177 5.14 2.117 -5.85 0.0583 -16.60 D2 15.268 4.58 1.991 0.45 0.0435 13.00
E1 16.238 -1.49 2.120 -6.00 0.0456 8.80 E2 15.805 1.22 2.264 -13.20 0.0486 2.80 F1 15.931 0.43 2.008 -0.40 0.0583 -16.60 F2 14.887 6.96 1.967 1.65 0.0452 9.60 G1 15.810 1.19 1.939 3.05 0.0584 -16.80 G2 16.520 -3.25 2.179 -8.95 0.0506 -1.20 H1 15.816 1.15 2.283 -14.15 0.0496 0.80 H2 15.563 2.73 1.843 7.85 0.0414 17.20
I1 16.242 -1.51 2.231 -11.55 0.0554 -10.80 I2 15.620 2.38 2.177 -8.85 0.0557 -11.40 J1 16.515 -3.22 2.031 -1.55 0.0415 17.00 J2 15.270 4.56 2.112 -5.60 0.0477 4.60 K1 15.993 0.04 2.002 -0.10 0.0427 14.60 K2 15.425 3.59 2.216 -10.80 0.0469 6.20
L1 14.921 6.74 2.003 -0.15 0.0564 -12.80
L2 16.112 -0.70 2.219 -10.95 0.0479 4.20
表 5 尿液中 cephalexin 以 HPLC 定量法定量分析之確效性試驗 表 5-1 尿液定量分析之同日(Intraday)精密度及準確度試驗
Cephalexin Runs
Conc. 1 2 3
(μ g/ml) 4 5 6 Mean S.D. C.V. (%) Error (%) 100.0 100.125 100.157 99.659
99.508 100.263 99.598 99.885 0.332 0.332 -0.115 50.0 49.457 49.327 50.459
50.824 49.187 50.671 49.988 0.741 1.483 -0.025 25.0 25.170 25.174 25.132
25.091 25.004 25.013 25.097 0.075 0.299 0.389 10.0 11.017 11.494 11.060
10.804 11.457 10.861 11.116 0.295 2.652 11.155 5.0 4.938 4.213 4.213
4.285 4.407 4.370 4.404 0.273 6.205 -11.913 2.5 2.204 2.161 2.164
2.175 2.328 2.177 2.202 0.064 2.898 -11.940 1.0 0.959 0.973 0.813
0.813 0.854 0.810 0.870 0.076 8.733 -12.967
表 5-2 尿液定量分析之異日(Interday)精密度及準確度試驗
Cephalexin Days
Conc. 1 2 3
(μ g/ml) 4 5 6 Mean S.D. C.V. (%) Error (%) 100.0 99.356 99.431 100.549
100.711 99.053 99.633 99.789 0.680 0.681 -0.211 50.0 51.188 51.251 47.533
47.408 52.571 50.132 50.014 2.117 4.233 0.028 25.0 24.955 24.618 27.010
26.648 22.814 26.242 25.381 1.572 6.193 1.525 10.0 10.766 10.395 11.036
10.963 10.773 10.110 10.674 0.355 3.322 6.738 5.0 4.315 4.644 4.357
4.320 5.128 4.273 4.506 0.333 7.384 -9.877
表 5-3 尿液定量分析中之定量極限
Cephalexin Runs
Conc. 1 2 3
(μ g/ml) 4 5 6 Mean S.D. C.V. (%) Error (%) 100.0 99.565 100.091 100.893
99.957 100.577 100.559 100.274 0.488 0.487 0.274 50.0 50.753 49.846 47.982
49.939 47.667 48.835 49.170 1.211 2.464 -1.659 25.0 24.817 24.417 24.307
24.742 26.683 24.341 24.885 0.906 3.642 -0.462 10.0 11.267 11.412 12.078
11.559 11.071 11.609 11.499 0.345 3.001 14.993 5.0 4.106 4.335 4.674
4.027 4.245 4.578 4.328 0.257 5.928 -13.450 2.5 2.130 2.223 2.432
2.361 2.386 2.408 2.323 0.120 5.157 -7.067 1.0 0.863 1.176 1.135
0.915 0.872 1.169 1.022 0.153 14.993 2.167
表 5-4 尿液定量分析中之相對回收率試驗(n=3) Cephalexin conc. Urea sample Solvent sample Recovery
(µg/ml) peak area ratio peak area ratio (%)
100.0 5.1644 5.3556 96.43
50.0 2.5788 2.6615 96.89
25.0 1.3394 1.3404 99.93
10.0 0.6258 0.6486 96.50
5.0 0.2444 0.2533 96.48
2.5 0.1358 0.1384 98.14
1.0 0.0850 0.0881 96.49
Mean 97.27
S.D. 1.32
C.V. (%) 1.36
表 5-5 Cephalexin 標準尿液檢品於 250C 之安定性試驗
Cephalexin Conc. (µg/ml)
Time
(hr) 1.000 10.000 100.000
0.00 3.00 6.00 9.00 12.00 18.00 24.00
1.116 1.172 1.063 1.048 1.009 0.993 0.877
11.065 11.019 10.978 10.745 10.395 10.112 10.065
100.712 100.856 100.094 99.992 99.961 99.857 99.510 Mean
S.D.
C.V.
Error
1.040 0.094 9.085 3.971
10.626 0.432 4.062 6.256
100.140 0.478 0.478 0.140
表 5-6 Cephalexin 標準尿液檢品於-300C 之安定性試驗
Cephalexin Conc. (µg/ml)
Time
(Day) 1.000 10.000 100.000
0 10 15 30 45 60 90
1.125 1.056 1.089 1.063 1.017 1.005 0.898
11.084 11.067 10.985 10.941 10.206 10.560 10.052
100.131 100.118 100.022 99.982 99.973 99.855 99.470 Mean
S.D.
1.036 0.073
10.699 0.429
99.936
0.226
表 6 Keflex®與 Cephanmycin®之溶離試驗
表 6-1 Keflex (Eli Lilly,台灣)與 Cephanmycin(永信)膠囊劑於 0.1N HCl 溶離液之溶離試驗
Keflex (Eli Lilly,台灣) 膠囊劑之溶離度
時間(min)
S1 S2 S3 S4 S5 S6 mean S.D. C.V.(%)
0 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 5 10.04 6.01 19.20 11.16 9.20 8.59 10.70 4.51 42.13 10 60.46 53.59 89.01 74.50 76.11 72.17 70.97 12.48 17.58 15 93.21 93.99 97.38 94.20 95.38 100.16 95.72 2.61 2.73 30 96.33 101.40 100.19 98.89 100.48 102.31 99.93 2.11 2.11 45 97.28 102.85 99.86 99.70 102.09 102.64 100.74 2.18 2.16 60 97.85 102.71 99.48 99.74 102.51 102.15 100.74 2.00 1.98 120 98.07 102.43 99.37 99.33 101.85 101.95 100.50 1.80 1.79
Cephanmycin(永信)膠囊劑之溶離度
時間(min)
S1 S2 S3 S4 S5 S6 mean S.D. C.V.(%)
0 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
5 57.34 94.15 64.80 98.15 83.49 84.33 80.38 16.15 20.09 10 102.30 102.75 103.69 102.64 103.18 102.08 102.77 0.59 0.57 15 102.22 102.91 103.81 102.72 103.23 102.56 102.91 0.56 0.54 30 102.56 103.44 104.14 102.85 103.42 102.70 103.19 0.60 0.58 45 102.66 103.35 104.06 102.85 103.43 102.82 103.20 0.52 0.51 60 102.85 103.69 104.27 103.17 103.75 103.12 103.48 0.52 0.50 120 102.85 103.88 104.30 103.27 103.88 103.28 103.58 0.53 0.51
表 6-2 Keflex (Eli Lilly,台灣)與 Cephanmycin(永信)膠囊劑於 pH=4.5 溶離液之溶離試驗
Keflex (Eli Lilly,台灣)膠囊劑之溶離度
時間(min)
S1 S2 S3 S4 S5 S6 mean S.D. C.V.(%)
0 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 5 9.22 5.56 12.12 11.85 7.63 7.90 9.06 2.54 28.00 10 39.71 66.97 56.35 36.70 33.72 29.45 43.82 14.62 33.37 15 77.88 88.93 73.81 71.34 86.12 80.62 79.78 6.86 8.59 30 92.82 96.02 84.39 84.95 95.90 96.77 91.81 5.70 6.20 45 97.23 97.28 90.35 90.27 98.32 100.25 95.62 4.25 4.45 60 99.32 97.85 94.94 93.25 99.23 101.40 97.67 3.04 3.11 120 103.88 99.05 99.96 99.54 101.10 103.73 101.21 2.12 2.10
Cephanmycin(永信)膠囊劑之溶離度
時間(min)
S1 S2 S3 S4 S5 S6 mean S.D. C.V.(%)
0 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
5 18.73 42.00 44.57 37.08 45.17 49.19 39.46 10.91 27.65 10 88.85 89.88 85.21 85.05 87.17 86.99 87.19 1.93 2.21 15 100.50 100.75 95.99 98.19 97.66 96.58 98.28 1.98 2.01 30 103.28 103.41 102.43 102.34 101.71 102.14 102.55 0.66 0.65 45 104.45 103.81 103.06 102.62 101.91 102.41 103.04 0.94 0.91 60 103.61 103.73 103.06 102.56 101.86 102.30 102.85 0.74 0.72 120 104.29 103.83 102.82 102.67 101.84 102.85 103.05 0.88 0.85
表 6-3 Keflex (Eli Lilly,台灣)與 Cephanmycin(永信)膠囊劑於 pH=6.8 溶離液之溶離試驗
Keflex (Eli Lilly,台灣)膠囊劑之溶離度
時間(min)
S1 S2 S3 S4 S5 S6 mean S.D. C.V.(%)
0 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 5 6.22 6.77 6.42 5.82 5.15 8.30 6.45 1.06 16.51 10 20.64 23.81 19.94 21.79 15.21 21.67 20.51 2.91 14.18 15 52.88 67.70 65.42 67.06 53.82 48.03 59.15 8.56 14.47 30 75.11 91.46 90.85 85.23 78.54 79.39 83.43 6.82 8.17 45 82.21 97.26 96.74 92.71 87.74 94.01 91.78 5.80 6.32 60 87.31 100.37 100.11 96.91 92.62 99.46 96.13 5.21 5.42 120 95.67 106.68 105.63 102.61 100.30 107.11 103.00 4.44 4.31
Cephanmycin(永信)膠囊劑之溶離度
時間(min)
S1 S2 S3 S4 S5 S6 mean S.D. C.V.(%)
0 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
5 50.53 38.68 29.12 27.65 60.98 46.25 42.20 12.91 30.60 10 99.14 97.87 97.66 90.24 96.46 91.81 95.53 3.63 3.80 15 101.93 101.53 102.03 98.86 101.76 98.48 100.77 1.64 1.62 30 102.42 102.01 102.29 100.90 101.80 102.64 102.01 0.62 0.61 45 102.58 102.26 102.56 101.04 101.97 102.94 102.23 0.67 0.65 60 103.43 101.01 102.79 101.18 102.09 103.07 102.26 1.01 0.98 120 103.00 102.32 102.62 101.43 102.19 103.49 102.51 0.71 0.69
表 7 十二位受試者個別之血漿中 cephalexin 濃度
