折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数500
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)A1A2A3A4A5A平均RSD%
110.043397873394823393693395363391133394570.08
210.013398873403113400990.09
单位质量响应值RSD%判断
33810.4633975.920.35数据可信
中间条件18月-供试品溶液-X013576批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1180500-18050053.12351.2619.3953.1251.2619.39
2107879-10787931.75031.75
3185914-18591454.71654.72
4191875-19187556.47056.47
5176190-17619051.85451.85
6202607-20260759.62959.63
10min1287688-28768884.66985.308.6584.8385.458.67
2242222-24222271.28871.38
3307576-30757690.52290.69
4289802-28980285.29185.46
5301471-30147188.72688.88
6310237-31023791.30591.48
15min1303614-30361489.35689.685.4189.7790.105.44
2273348-27334880.44980.76
3315860-31586092.96093.40
4303902-30390289.44189.87
5315652-31565292.89993.32
6315995-31599593.00093.45
20min1305498-30549889.91190.524.4590.5991.204.49
2281413-28141382.82283.37
3315942-31594292.98493.70
4308751-30875190.86891.56
5316678-31667893.20193.90
6317168-31716893.34594.08
30min1305146-30514689.80790.844.0590.7691.794.09
2285300-28530083.96684.77
3316348-31634893.10494.10
4309981-30998191.23092.20
5317229-31722993.36394.34
6317972-31797293.58294.59
45min1304454-30445489.60390.973.6890.8292.193.73
2288126-28812684.79885.85
3315974-31597492.99494.27
4311838-31183891.77793.02
5316155-31615593.04794.31
6317985-31798593.58694.88
60min1304086-30408689.49591.003.5590.9892.493.60
2289066-28906685.07586.38
3315234-31523492.77694.33
4312904-31290492.09093.61
5315983-31598392.99794.54
6317841-31784193.54395.12
极限1326238-32623896.01596.731.6297.7798.501.62
2324889-32488995.61897.18
3330619-33061997.30499.13
4338215-33821599.540101.33
5328413-32841396.65598.47
6323584-32358495.23497.09
折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数500
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)A1A2A3A4A5A平均RSD%
110.043396583394213386313393523397243393570.13
210.013376773391693384230.32
单位质量响应值RSD%判断
33800.5033808.490.02数据可信
长期18月-供试品溶液-X013576批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1199292-19929258.80742.2226.3758.8142.2226.37
2123430-12343036.42236.42
396864-9686428.58328.58
4176809-17680952.17352.17
5130360-13036038.46738.47
6131637-13163738.84338.84
10min1313364-31336492.46780.4814.6092.6480.6114.61
2242524-24252471.56471.67
3208582-20858261.54861.63
4296435-29643587.47287.63
5277116-27711681.77181.89
6298516-29851688.08688.20
15min1321934-32193494.99688.017.5695.4588.387.60
2286542-28654284.55384.88
3259419-25941976.54976.82
4305385-30538590.11390.53
5301415-30141588.94189.30
6314784-31478492.88693.27
20min1324456-32445695.74090.484.6896.4891.124.73
2309619-30961991.36291.94
3281689-28168983.12183.62
4305771-30577190.22790.92
5303329-30332989.50690.13
6314956-31495692.93793.60
30min1322535-32253595.17392.092.5396.2093.002.56
2320171-32017194.47695.33
3305181-30518190.05390.80
4304893-30489389.96890.93
5306166-30616690.34391.24
6313605-31360592.53893.48
45min1322677-32267795.21592.672.7096.5393.852.68
2325112-32511295.93497.07
3313245-31324592.43293.45
4304722-30472289.91791.15
5305442-30544290.13091.30
6313151-31315192.40493.62
60min1322214-32221495.07992.733.1096.6894.193.06
2328147-32814796.82998.25
3314762-31476292.88094.18
4304233-30423389.77391.27
5303635-30363589.59691.03
6312600-31260092.24293.73
极限1331207-33120797.73296.851.1899.6198.581.18
2332966-33296698.25199.96
3326760-32676096.42098.00
4321973-32197395.00896.78
5329236-32923697.15198.86
6327132-32713296.53098.30
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