地拉罗司颗粒项目信息
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2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251694487169476916959591697205169867616962190.11
210.311725260172506317251620.01
单位质量响应值RSD%判断
165484.78167329.000.79数据可信
供试品溶液-2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%
5min1459305-45930527.57527.354.8527.5727.354.86
2440448-44044826.44226.44
3475666-47566628.55728.56
4455517-45551727.34727.35
5421641-42164125.31325.31
6480812-48081228.86628.87
15min1679340-67934040.78439.761.6040.8339.801.60
2651960-65196039.14139.18
3665714-66571439.96640.01
4663620-66362039.84139.89
5650178-65017839.03439.08
6662879-66287939.79639.84
30min1800188-80018848.04047.121.1848.1547.241.18
2772507-77250746.37846.49
3784282-78428247.08547.20
4787663-78766347.28847.40
5779428-77942846.79346.90
6785544-78554447.16047.27
45min1864820-86482051.92051.071.0952.1151.261.09
2837297-83729750.26750.45
3848280-84828050.92751.12
4855644-85564451.36951.56
5846779-84677950.83751.02
6850789-85078951.07751.27
60min1906467-90646754.42053.511.0854.7053.791.08
2878984-87898452.77053.04
3886164-88616453.20153.48
4897024-89702453.85354.13
5886920-88692053.24753.52
6892763-89276353.59753.88
90min1961532-96153257.72657.010.8858.1057.380.89
2937844-93784456.30456.66
3948428-94842856.93957.31
4955520-95552057.36557.73
5944145-94414556.68257.04
6950087-95008757.03957.41
120min1995425-99542559.76158.970.9460.2359.440.95
2970858-97085858.28658.74
3982243-98224358.96959.43
4989331-98933159.39559.86
5973843-97384358.46558.92
6982307-98230758.97359.44
极限11010901-101090160.69060.080.7361.2660.640.73
2988614-98861459.35259.90
3999988-99998860.03560.59
41003864-100386460.26760.83
51000230-100023060.04960.60
61000771-100077160.08260.64
地拉罗司颗粒项目信息
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2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251723040172334917211591718164171369117198810.24
210.311711210171073517109720.02
单位质量响应值RSD%判断
167793.27165952.670.78数据可信
供试品溶液-2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%
5min1361118-36111821.61921.161.9621.6221.161.95
2350522-35052220.98520.98
3361295-36129521.63021.63
4343175-34317520.54520.55
5352747-35274721.11821.12
6351704-35170421.05621.06
15min1577468-57746834.57233.991.6534.6134.031.66
2566808-56680833.93433.97
3577883-57788334.59734.63
4555228-55522833.24033.27
5570391-57039134.14834.18
6559026-55902633.46833.50
30min1717627-71762742.96342.611.3443.0642.701.34
2712052-71205242.62942.72
3722830-72283043.27443.37
4700358-70035841.92942.02
5717379-71737942.94843.04
6700299-70029941.92542.02
45min1797637-79763747.75347.391.2047.9247.561.20
2789691-78969147.27747.44
3801382-80138247.97748.14
4780407-78040746.72146.88
5799890-79989047.88848.05
6780803-78080346.74546.91
60min1847584-84758450.74350.271.3350.9950.521.33
2829193-82919349.64249.88
3851827-85182750.99751.24
4829908-82990849.68549.92
5850070-85007050.89251.14
6829907-82990749.68549.92
90min1913504-91350454.68954.610.9655.0254.940.96
2912305-91230554.61854.94
3921812-92181255.18755.52
4902569-90256954.03554.35
5921178-92117855.14955.48
6901801-90180153.98954.31
120min1956955-95695557.29157.200.8957.7157.620.90
2955169-95516957.18457.60
3964702-96470257.75558.18
4947765-94776556.74157.15
5964086-96408657.71858.14
6943798-94379856.50356.91
极限1978562-97856258.58458.430.8059.1058.940.81
2976514-97651458.46258.97
3985912-98591259.02459.54
4966022-96602257.83458.34
5981569-98156958.76459.28
6967672-96767257.93258.44
地拉罗司颗粒项目信息
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2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251701762170248017024151699005169731817005960.14
210.311720848171787617193620.13
单位质量响应值RSD%判断
165911.80166766.440.37数据可信
供试品溶液-2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%
5min1360450-36045021.64821.761.9421.6521.761.94
2369747-36974722.20622.21
3370144-37014422.23022.23
4356817-35681721.43021.43
5363737-36373721.84521.85
6352598-35259821.17621.18
15min1549359-54935932.99433.111.4433.0333.141.44
2562739-56273933.79733.83
3554932-55493233.32833.37
4552640-55264033.19133.23
5549069-54906932.97633.01
6538742-53874232.35632.39
30min1690894-69089441.49441.660.8541.5941.750.85
2701806-70180642.14942.24
3695662-69566241.78041.87
4696761-69676141.84641.94
5691897-69189741.55441.65
6684670-68467041.12041.21
45min1782848-78284847.01746.850.5947.1847.000.59
2784385-78438547.10947.27
3778782-77878246.77246.93
4783725-78372547.06947.23
5777582-77758246.70046.86
6772672-77267246.40546.56
60min1833592-83359250.06449.930.4450.3050.170.43
2830825-83082549.89850.14
3830601-83060149.88550.12
4837114-83711450.27650.51
5829714-82971449.83150.07
6826579-82657949.64349.88
90min1904723-90472354.33654.240.4754.6654.560.48
2909474-90947454.62254.95
3900110-90011054.05954.38
4905189-90518954.36454.69
5900839-90083954.10354.42
6897887-89788753.92654.24
120min1946881-94688156.86856.840.3757.2857.260.37
2951502-95150257.14657.56
3942786-94278656.62257.04
4949531-94953157.02757.44
5944389-94438956.71957.13
6943885-94388556.68857.10
极限1966727-96672758.06058.060.3258.5758.560.32
2971139-97113958.32558.84
3965488-96548857.98658.49
4969140-96914058.20558.71
5964680-96468057.93758.44
6962867-96286757.82858.33
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