CN101352449A - 维生素口腔崩解片及其制备方法 - Google Patents
维生素口腔崩解片及其制备方法 Download PDFInfo
- Publication number
- CN101352449A CN101352449A CNA2007100702165A CN200710070216A CN101352449A CN 101352449 A CN101352449 A CN 101352449A CN A2007100702165 A CNA2007100702165 A CN A2007100702165A CN 200710070216 A CN200710070216 A CN 200710070216A CN 101352449 A CN101352449 A CN 101352449A
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- Prior art keywords
- vitamin
- content
- combination
- tablet
- mannitol
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Abstract
Description
实施例No. | 主成分含量(%) | 崩解剂含量(%) | 其他成分含量(%) | 片重(mg) |
1 | 5.23 | 6.54 | 88.2 | 153 |
2 | 7.1 | 6.5 | 86.4 | 154.8 |
3 | 21.7 | 4.34 | 73.96 | 230.3 |
4 | 1.36 | 6.79 | 91.85 | 147.25 |
5 | 0.68 | 6.77 | 92.55 | 147.7 |
6 | 39.5 | 3.95 | 56.55 | 253.4 |
7 | 0.68 | 6.85 | 92.47 | 146.02 |
8 | 56.1 | 4.21 | 39.7 | 356.52 |
9 | 0.68 | 6.85 | 92.47 | 146.05 |
10 | 25.6 | 5.12 | 69.28 | 195.4 |
11 | 39.9 | 5.99 | 54.11 | 250.6 |
12 | 55.9 | 5.59 | 38.51 | 357.5 |
13 | 0.68 | 6.84 | 92.48 | 146.2 |
14 | 10.4 | 7.82 | 81.78 | 191.9 |
15 | 0.67 | 6.65 | 92.68 | 150.3 |
16 | 10.7 | 8.02 | 81.28 | 187 |
17 | 0.07 | 6.87 | 93.06 | 145.6 |
18 | 0.27 | 6.87 | 92.86 | 145.6 |
19 | 0.66 | 6.61 | 92.73 | 151.4 |
20 | 3.32 | 6.64 | 90.04 | 150.6 |
21 | 11.7 | 8.77 | 79.53 | 171.1 |
22 | 0.00007 | 6.87 | 93.13 | 145.4 |
23 | 0.68 | 6.84 | 92.48 | 146.1 |
24 | 0.07 | 6.87 | 93.06 | 145.6 |
25 | 3.21 | 6.43 | 90.36 | 156 |
26 | 6.11 | 6.11 | 87.78 | 163.6 |
27 | 0.07 | 6.86 | 93.07 | 145.7 |
28 | 3.31 | 6.62 | 90.07 | 151 |
29 | 6.41 | 6.41 | 87.18 | 155.9 |
30 | 0.07 | 6.84 | 93.09 | 146.2 |
31 | 3.31 | 6.62 | 90.07 | 151.1 |
32 | 6.41 | 6.41 | 87.18 | 155.9 |
33 | 3.32 | 6.64 | 90.04 | 150.7 |
34 | 61.8 | 7.4 | 30.8 | 485.3 |
35 | 62.9 | 8.22 | 28.88 | 486.4 |
36 | 19.4 | 7.33 | 73.27 | 163.65 |
X1 | 21.5 | 27.8 | 50.7 | 285.8 |
X2 | 20.0 | 26.0 | 54.0 | 307.4 |
实施 | 片剂硬度 | 片剂脆碎度 | 水中崩解时间(秒)n=6 | 口腔内崩解时间(秒)n=3 | 崩解仪测得崩解时间(秒),n=6 |
例No | (N) | (%) | 最小 | 最大 | 平均 | 最小 | 最大 | 平均 | 最小 | 最大 | 平均 |
1 | 20 | 0.21 | 9.1 | 18.3 | 14.8 | 12.1 | 26.7 | 15.9 | 8.6 | 13.5 | 10.9 |
2 | 20 | 0.15 | 11.7 | 17.6 | 15.1 | 14.6 | 22.5 | 17.2 | 9.3 | 16.4 | 12.6 |
3 | 25 | 0.26 | 15.1 | 27.3 | 21.4 | 16.3 | 32.6 | 26.5 | 13.0 | 22.9 | 15.6 |
4 | 25 | 0.12 | 12.7 | 24.6 | 18.3 | 13.5 | 27.8 | 22.8 | 11.6 | 23.1 | 15.9 |
5 | 25 | 0.23 | 10.1 | 23.2 | 15.4 | 13.5 | 29.7 | 19.5 | 11.2 | 20.6 | 14.3 |
6 | 25 | 0.25 | 14.3 | 34.5 | 21.7 | 14.5 | 36.8 | 24.6 | 13.7 | 29.7 | 26.1 |
7 | 30 | 0.32 | 14.5 | 26.7 | 20.8 | 10.2 | 21.9 | 16.2 | 13.6 | 19.7 | 15.3 |
8 | 40 | 0.31 | 16.0 | 31.9 | 24.6 | 18.6 | 37.9 | 27.3 | 14.8 | 21.9 | 17.5 |
9 | 25 | 0.22 | 12.4 | 24.6 | 16.7 | 14.2 | 25.8 | 19.4 | 15.3 | 22.5 | 18.7 |
10 | 30 | 0.43 | 16.5 | 27.6 | 22.1 | 15.8 | 35.2 | 29.7 | 14.8 | 25.7 | 19.8 |
11 | 35 | 0.40 | 20.5 | 36.7 | 30.1 | 26.9 | 39.6 | 33.5 | 17.6 | 29.5 | 24.5 |
12 | 40 | 0.35 | 26.1 | 40.9 | 32.5 | 25.9 | 45.3 | 32.8 | 22.7 | 33.7 | 27.3 |
13 | 25 | 0.44 | 16.1 | 29.3 | 22.5 | 18.6 | 37.2 | 27.3 | 15.1 | 21.9 | 18.6 |
14 | 30 | 0.47 | 18.4 | 33.5 | 25.7 | 20.8 | 38.1 | 32.5 | 15.7 | 26.4 | 23.7 |
15 | 25 | 0.37 | 12.9 | 27.6 | 21.8 | 17.5 | 35.3 | 26.1 | 14.9 | 19.8 | 17.8 |
16 | 30 | 0.28 | 19.6 | 32.8 | 29.7 | 21.7 | 41.3 | 31.6 | 16.7 | 23.3 | 19.6 |
17 | 25 | 0.19 | 12.1 | 20.4 | 15.4 | 11.9 | 25.1 | 16.1 | 11.1 | 15.6 | 12.5 |
18 | 25 | 0.25 | 13.5 | 19.3 | 16.1 | 13.7 | 18.9 | 16.2 | 10.8 | 14.6 | 12.9 |
19 | 25 | 0.20 | 13.3 | 20.4 | 17.2 | 14.7 | 21.9 | 16.8 | 12.7 | 17.6 | 14.8 |
20 | 30 | 0.24 | 14.8 | 22.4 | 19.2 | 15.6 | 25.7 | 22.5 | 15.4 | 20.6 | 17.9 |
21 | 30 | 0.27 | 19.1 | 25.3 | 21.8 | 22.7 | 36.8 | 28.9 | 16.6 | 25.9 | 20.5 |
22 | 25 | 0.24 | 11.2 | 19.4 | 15.6 | 12.1 | 19.9 | 16.7 | 12.1 | 18.6 | 15.2 |
23 | 25 | 0.20 | 12.0 | 17.6 | 14.6 | 14.5 | 21.0 | 17.1 | 11.7 | 18.3 | 15.0 |
24 | 25 | 0.23 | 13.7 | 21.5 | 17.6 | 13.1 | 24.7 | 18.3 | 12.6 | 19.6 | 15.7 |
25 | 30 | 0.37 | 15.2 | 22.6 | 19.4 | 17.8 | 31.0 | 26.5 | 16.1 | 23.1 | 19.4 |
26 | 30 | 0.31 | 14.3 | 20.9 | 16.8 | 16.1 | 27.6 | 22.5 | 14.2 | 20.8 | 17.6 |
27 | 25 | 0.20 | 12.0 | 18.1 | 15.4 | 14.2 | 20.7 | 16.9 | 10.8 | 16.8 | 12.7 |
28 | 25 | 0.27 | 14.7 | 19.3 | 15.7 | 16.6 | 22.8 | 17.6 | 12.0 | 17.4 | 14.9 |
29 | 25 | 0.23 | 13.7 | 19.4 | 16.0 | 15.1 | 23.8 | 17.7 | 13.8 | 17.3 | 14.6 |
30 | 25 | 0.22 | 9.2 | 16.7 | 13.5 | 12.9 | 25.7 | 18.6 | 12.9 | 17.3 | 15.3 |
31 | 25 | 0.20 | 12.3 | 19.6 | 16.1 | 15.1 | 21.6 | 18.3 | 13.0 | 17.6 | 15.7 |
32 | 25 | 0.25 | 12.7 | 20.1 | 16.8 | 14.0 | 22.7 | 17.1 | 12.7 | 18.0 | 15.2 |
33 | 25 | 0.26 | 13.7 | 20.3 | 14.1 | 15.7 | 26.4 | 20.7 | 13.0 | 19.9 | 16.8 |
34 | 40 | 0.39 | 23.0 | 45.7 | 37.1 | 30.1 | 52.6 | 45.6 | 21.2 | 36.1 | 19.1 |
35 | 45 | 0.43 | 28.9 | 50.0 | 40.1 | 36.7 | 56.8 | 48.0 | 26.4 | 36.7 | 32.5 |
36 | 35 | 0.76 | 16.7 | 30.1 | 24.7 | 15.2 | 28.1 | 26.1 | 12.8 | 19.3 | 16.8 |
X1 | 50 | 0.51 | 32.8 | 48.9 | 40.3 | 41.5 | 56.1 | 50.1 | 29.8 | 39.6 | 35.3 |
X2 | 30 | 0.30 | 27.6 | 38.1 | 34.6 | 54.7 | 58.9 | 56.8 | 28.9 | 36.4 | 32.5 |
Y1 | 25 | 不合格 | 21.1 | 42.5 | 28.6 | 17.9 | 39.4 | 28.7 | 11.3 | 21.9 | 15.8 |
Y2 | 20 | 不合格 | 16.3 | 32.5 | 23.6 | 18.4 | 30.5 | 24.3 | 9.6 | 18.8 | 12.5 |
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