非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.651888313188832918862481885568188300618862930.12
29.821926859192774619273020.04
单位质量响应值RSD%判断
195470.78196262.930.29数据可信
供试品溶液-20200718批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1180143-1801438.2786.7939.528.286.7939.55
2180106-1801068.2768.28
3154486-1544867.0997.10
4169161-1691617.7737.77
530133-301331.3851.38
6172253-1722537.9157.91
10min1372151-37215117.10015.1725.9417.1215.1925.95
2377374-37737417.34017.36
3357727-35772716.43716.45
4365103-36510316.77616.79
5156349-1563497.1847.19
6352395-35239516.19216.21
15min1462869-46286921.26920.1813.3921.3320.2413.43
2498393-49839322.90122.96
3447354-44735420.55620.61
4457252-45725221.01121.07
5326074-32607414.98315.00
6443695-44369520.38820.44
20min1520606-52060623.92223.126.1124.0323.216.17
2526675-52667524.20124.31
3516119-51611923.71623.81
4514127-51412723.62423.73
5443708-44370820.38820.44
6497482-49748222.85922.96
30min1588007-58800727.01926.722.2327.1826.872.28
2596053-59605327.38827.55
3586758-58675826.96127.11
4586949-58694926.97027.12
5561647-56164725.80825.91
6570147-57014726.19826.35
45min1647082-64708229.73329.540.9129.9529.740.92
2647567-64756729.75629.98
3644890-64489029.63329.84
4643981-64398129.59129.80
5642099-64209929.50429.66
6631785-63178529.03029.24
60min1676844-67684431.10131.080.9731.3831.350.98
2682714-68271431.37131.66
3681965-68196531.33631.61
4677242-67724231.11931.40
5675415-67541531.03531.26
6664529-66452930.53530.81
90min1713697-71369732.79432.780.9933.1533.120.98
2721841-72184133.16833.53
3715558-71555832.88033.23
4712257-71225732.72833.08
5716275-71627532.91333.20
6700666-70066632.19532.54
120min1733053-73305333.68433.640.6734.1134.050.66
2737476-73747633.88734.32
3734253-73425333.73934.16
4727566-72756633.43133.85
5735236-73523633.78434.15
6724854-72485433.30733.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1732898-73289833.67633.972.0334.1834.452.02
2768557-76855735.31535.82
3735947-73594733.81734.31
4732917-73291733.67734.17
5738500-73850033.93434.37
6726286-72628633.37333.86
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.651905580190593819038691902800190235919041090.09
29.821897029189813918975840.05
单位质量响应值RSD%判断
197316.99193236.661.48数据可信
供试品溶液-20200718批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1166517-1665177.6755.7732.507.685.7732.49
299923-999234.6064.61
3153321-1533217.0677.07
4151010-1510106.9616.96
558543-585432.6982.70
6121321-1213215.5925.59
10min1361616-36161616.66816.5514.9216.6916.5614.93
2299707-29970713.81513.82
3358062-35806216.50416.52
4347494-34749416.01716.03
5329482-32948215.18715.19
6458065-45806521.11421.13
15min1432010-43201019.91320.3510.9519.9720.4010.93
2453050-45305020.88320.92
3443614-44361420.44820.50
4366194-36619416.87916.93
5436594-43659420.12420.16
6517309-51730923.84523.90
20min1503757-50375723.22023.577.9323.3223.667.92
2510724-51072423.54123.63
3502441-50244123.15923.26
4465781-46578121.46921.56
5497553-49755322.93423.02
6587481-58748127.07927.19
30min1584545-58454526.94427.165.3727.0927.305.40
2585538-58553826.98927.13
3571894-57189426.36126.51
4565325-56532526.05826.19
5575880-57588026.54426.68
6651802-65180230.04430.22
45min1644109-64410929.68929.872.8629.9030.082.89
2647719-64771929.85630.06
3634090-63409029.22729.44
4638837-63883729.44629.64
5638692-63869229.44029.63
6684534-68453431.55331.79
60min1682638-68263831.46531.532.6931.7431.802.72
2678124-67812431.25731.52
3669387-66938730.85431.13
4679814-67981431.33531.59
5673759-67375931.05631.32
6720243-72024333.19833.51
90min1716455-71645533.02432.911.7233.3733.261.77
2708747-70874732.66933.00
3705378-70537832.51332.85
4711292-71129232.78633.12
5704923-70492332.49232.82
6737456-73745633.99234.38
120min1741225-74122534.16633.791.0334.5834.201.07
2730617-73061733.67734.08
3725930-72593033.46133.87
4728742-72874233.59033.99
5727974-72797433.55533.96
6743717-74371734.28034.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1738704-73870434.04928.1849.0034.5428.6748.09
2728434-72843433.57634.06
3731728-73172833.72834.22
4737051-73705133.97334.45
5731744-73174433.72934.20
6-0.0000.53
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.651892587189185018934761892209189122718922700.05
29.821960561195938419599720.05
单位质量响应值RSD%判断
196090.16199589.821.26数据可信
供试品溶液-20200721批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1149701-1497016.81111.0118.916.8111.0118.91
2259438-25943811.80311.80
3269322-26932212.25312.25
4250540-25054011.39811.40
5255863-25586311.64011.64
6267232-26723212.15812.16
10min1331111-33111115.06418.258.6015.0818.288.62
2416525-41652518.95018.98
3418451-41845119.03719.06
4409867-40986718.64718.67
5413466-41346618.81118.84
6418036-41803619.01819.05
15min1454508-45450820.67822.183.4520.7322.243.46
2501251-50125122.80422.87
3491200-49120022.34722.42
4497718-49771822.64422.71
5490289-49028922.30622.37
6490041-49004122.29422.36
20min1521098-52109823.70724.642.0423.8024.752.07
2552451-55245125.13425.25
3541817-54181724.65024.77
4547946-54794624.92925.05
5539366-53936624.53824.66
6546494-54649424.86324.98
30min1602661-60266127.41827.450.8827.5727.620.88
2609438-60943827.72627.90
3608431-60843127.68027.85
4604907-60490727.52027.69
5597184-59718427.16927.34
6597300-59730027.17427.35
45min1656813-65681329.88229.880.4330.0930.110.43
2658038-65803829.93730.17
3660124-66012430.03230.27
4658569-65856929.96230.20
5652499-65249929.68529.92
6654768-65476829.78930.02
60min1682981-68298131.07231.031.2131.3531.321.20
2688742-68874231.33431.64
3685991-68599131.20931.51
4686396-68639631.22731.53
5665955-66595530.29830.60
6681650-68165031.01231.31
90min1715909-71590932.57032.380.8932.9132.750.87
2711321-71132132.36132.73
3717233-71723332.63033.00
4716523-71652332.59832.97
5709066-70906632.25932.62
6700774-70077431.88232.25
120min1729442-72944233.18633.190.9533.6033.620.95
2737764-73776433.56434.01
3733913-73391333.38933.83
4733232-73323233.35833.80
5720458-72045832.77733.21
6722014-72201432.84833.29
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1728457-72845733.14133.370.9833.6333.880.98
2742337-74233733.77334.29
3740260-74026033.67834.20
4736186-73618633.49334.01
5729661-72966133.19633.71
6724340-72434032.95433.47
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.651915783191915619173241917550191859419176810.07
29.821930234192868919294620.06
单位质量响应值RSD%判断
198723.42196482.890.81数据可信
供试品溶液-20200721批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1255546-25554611.6399.0045.3211.649.0045.31
274194-741943.3793.38
390821-908214.1374.14
4254809-25480911.60611.61
5245152-24515211.16611.17
6265227-26522712.08012.08
10min1422161-42216119.22816.5623.2519.2516.5823.26
2238870-23887010.88010.89
3272485-27248512.41112.42
4421481-42148119.19719.22
5406440-40644018.51218.54
6420606-42060619.15719.18
15min1505902-50590223.04221.339.6123.1121.389.67
2399308-39930818.18718.22
3424254-42425419.32419.36
4500966-50096622.81822.89
5485447-48544722.11122.18
6493574-49357422.48122.55
20min1559444-55944425.48124.274.4125.6024.374.48
2498505-49850522.70622.78
3510333-51033323.24423.32
4547431-54743124.93425.05
5537013-53701324.45924.57
6544273-54427324.79024.91
30min1617973-61797328.14727.461.3128.3227.621.33
2598521-59852127.26127.38
3602439-60243927.43927.57
4596511-59651127.16927.34
5598236-59823627.24827.42
6604011-60401127.51127.69
45min1671639-67163930.59130.081.2530.8330.301.22
2662546-66254630.17730.36
3665779-66577930.32430.52
4660405-66040530.08030.31
5652414-65241429.71629.95
6649707-64970729.59229.83
60min1694804-69480431.64631.330.7431.9531.610.72
2688656-68865631.36631.62
3690844-69084431.46631.73
4684377-68437731.17231.47
5680345-68034530.98831.28
6687838-68783831.32931.63
90min1723674-72367432.96132.770.9733.3433.130.91
2724446-72444632.99733.32
3727223-72722333.12333.45
4718930-71893032.74533.12
5711431-71143132.40432.77
6711006-71100632.38432.76
120min1736771-73677133.55833.460.4834.0133.880.43
2739066-73906633.66234.06
3736766-73676633.55833.96
4733078-73307833.39033.83
5730756-73075633.28433.72
6730927-73092733.29233.73
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1739470-73947033.68133.580.6634.2134.090.62
2739894-73989433.70034.17
3744243-74424333.89834.38
4734671-73467133.46233.98
5730759-73075933.28433.79
6734898-73489833.47333.99
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