替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.95526955527475520415511295500785517380.21
2112.95569705551595560640.24
单位质量响应值RSD%判断
4930.634925.280.08数据可信
供试品溶液-2410100批-shui(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1140862-14086225.31419.2745.5225.3119.2745.52
248031-480318.6328.63
3105129-10512918.89318.89
454697-546979.8309.83
5121945-12194521.91521.91
6172756-17275631.04631.05
10min1177055-17705531.81827.2222.9031.8627.2522.93
2111313-11131320.00420.02
3159382-15938228.64228.67
4108069-10806919.42119.44
5159779-15977928.71428.75
6193060-19306034.69534.75
15min1180292-18029232.40030.3110.6832.5030.3810.72
2154350-15435027.73827.79
3168122-16812230.21330.29
4153964-15396427.66927.72
5156269-15626928.08328.17
6198810-19881035.72835.84
20min1189624-18962434.07730.948.6934.2331.068.74
2164884-16488429.63129.73
3168738-16873830.32430.45
4156634-15663428.14928.24
5161180-16118028.96629.10
6191809-19180934.47034.64
30min1196506-19650635.31432.288.2135.5232.468.26
2173141-17314131.11531.26
3177736-17773631.94132.12
4163477-16347729.37829.52
5168130-16813030.21530.39
6198667-19866735.70235.93
45min1208096-20809637.39734.347.2837.6634.587.33
2182039-18203932.71432.91
3193774-19377434.82335.06
4176020-17602031.63231.82
5180058-18005832.35832.59
6206581-20658137.12537.41
60min1219151-21915139.38336.816.2639.7137.106.32
2198435-19843535.66135.91
3208623-20862337.49237.78
4189743-18974334.09934.34
5193641-19364134.79935.08
6219231-21923139.39839.75
90min1239174-23917442.98241.075.9643.3741.426.00
2218884-21888439.33639.64
3237054-23705442.60142.95
4215214-21521438.67638.98
5215277-21527738.68739.03
6245666-24566644.14844.56
极限1394178-39417870.83868.534.0671.3068.954.09
2359283-35928364.56764.94
3383215-38321568.86769.29
4378747-37874768.06468.43
5370743-37074366.62667.03
6401825-40182572.21272.70
替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.95522365515325510215524565524435519380.12
2112.95509075516575512820.10
单位质量响应值RSD%判断
4932.424882.920.72数据可信
供试品溶液-2410100批-pH1.2(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1152470-15247027.51427.5410.2027.5127.5410.19
2170363-17036330.74330.74
3163159-16315929.44329.44
4141675-14167525.56625.57
5127934-12793423.08723.09
6160076-16007628.88728.89
10min1237594-23759442.87544.285.3642.9244.325.35
2234422-23442242.30342.35
3253140-25314045.68145.73
4266464-26646448.08548.13
5248206-24820644.79044.83
6232388-23238841.93641.98
15min1271761-27176149.04151.464.6349.1651.584.62
2291275-29127552.56352.68
3288107-28810751.99152.12
4300377-30037754.20554.33
5293033-29303352.88052.99
6266435-26643548.08048.20
20min1293472-29347252.95956.495.4753.1656.695.45
2331244-33124459.77559.98
3317275-31727557.25457.47
4326588-32658858.93559.15
5319048-31904857.57457.78
6290479-29047952.41952.62
30min1331883-33188359.89163.795.6860.1864.105.67
2380519-38051968.66768.98
3355620-35562064.17464.48
4366494-36649466.13666.45
5357990-35799064.60264.90
6328595-32859559.29759.58
45min1364128-36412865.70970.615.9266.1071.015.90
2423235-42323576.37676.80
3394054-39405471.11071.52
4404262-40426272.95273.37
5397235-39723571.68472.09
6364703-36470365.81366.20
60min1389302-38930270.25275.195.9270.7575.715.91
2452873-45287381.72482.27
3416302-41630275.12475.66
4428467-42846777.32077.86
5424233-42423376.55677.08
6388733-38873370.14970.64
90min1421444-42144476.05280.105.0476.6780.755.03
2476483-47648385.98586.67
3448591-44859180.95181.61
4451284-45128481.43782.11
5450203-45020381.24281.89
6415389-41538974.96075.57
极限1500604-50060490.33790.761.3891.0891.541.39
2512602-51260292.50293.33
3503721-50372190.90091.69
4495931-49593189.49490.30
5509081-50908191.86792.65
6495760-49576089.46390.20
替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.95526765534985524345525745529825528330.08
2112.95517375515765516560.03
单位质量响应值RSD%判断
4940.424886.240.78数据可信
供试品溶液-2410100批-pH4.0(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183476-8347615.04724.6528.5115.0524.6528.51
2120887-12088721.79021.79
3162751-16275129.33629.34
4149775-14977526.99727.00
5111805-11180520.15320.15
6191881-19188134.58734.59
10min1163211-16321129.41940.5215.7529.4440.5615.76
2241051-24105143.44943.49
3236338-23633842.60042.65
4206203-20620337.16837.21
5237692-23769242.84442.88
6264264-26426447.63447.69
15min1204769-20476936.91044.8211.9036.9844.9211.92
2263095-26309547.42347.53
3255937-25593746.13346.25
4224081-22408140.39140.50
5256164-25616446.17446.28
6287743-28774351.86652.00
20min1227659-22765941.03648.0210.6741.1748.2010.69
2281459-28145950.73350.92
3268001-26800148.30748.50
4241010-24101043.44243.62
5273846-27384649.36149.54
6306494-30649455.24655.47
30min1260502-26050246.95553.689.6147.1653.949.63
2315426-31542656.85657.13
3296153-29615353.38253.66
4271962-27196249.02149.27
5303830-30383054.76555.03
6338851-33885161.07861.39
45min1297625-29762553.64760.268.6853.9360.618.70
2355636-35563664.10364.47
3328421-32842159.19859.56
4309828-30982855.84656.17
5338031-33803160.93061.29
6376259-37625967.82168.24
60min1332641-33264159.95965.727.8260.3366.177.84
2387337-38733769.81770.29
3354834-35483463.95964.42
4339098-33909861.12261.54
5366979-36697966.14866.60
6406622-40662273.29473.82
90min1377955-37795568.12673.836.9668.6074.396.98
2435892-43589278.56979.16
3398207-39820771.77772.35
4384756-38475669.35269.88
5410819-41081974.05074.62
6449812-44981281.07981.73
极限1519390-51939093.62092.911.7194.2193.601.72
2511383-51138392.17792.90
3501333-50133390.36591.06
4515629-51562992.94293.58
5517277-51727793.23993.93
6527826-52782695.14195.93
替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.95540205537655544025542795527225538380.13
2112.95707645701325704480.08
单位质量响应值RSD%判断
4949.405052.681.47数据可信
供试品溶液-2410100批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1195626-19562634.64630.8513.1034.6530.8613.09
2196237-19623734.75434.75
3182904-18290432.39332.39
4137360-13736024.32724.33
5173940-17394030.80530.81
6159247-15924728.20328.20
10min1217713-21771338.55742.537.0938.6242.587.07
2242426-24242642.93442.99
3255173-25517345.19245.25
4262274-26227446.44946.49
5225327-22532739.90639.96
6237968-23796842.14542.19
15min1239869-23986942.48145.905.8042.6046.025.79
2259589-25958945.97446.10
3273820-27382048.49448.62
4277369-27736949.12349.24
5244666-24466643.33143.45
6259621-25962145.97946.10
20min1260252-26025246.09149.115.4046.2849.315.39
2277775-27777549.19449.40
3291678-29167851.65751.87
4294746-29474652.20052.40
5259692-25969245.99246.18
6279775-27977549.54949.74
30min1293687-29368752.01354.704.8152.2854.984.80
2310293-31029354.95355.24
3320531-32053156.76757.06
4326577-32657757.83758.12
5288828-28882851.15251.42
6313256-31325655.47855.75
45min1333222-33322259.01461.304.2859.3761.674.28
2347885-34788561.61161.99
3355124-35512462.89363.28
4364851-36485164.61665.00
5324488-32448857.46757.82
6351129-35112962.18662.55
60min1362024-36202464.11566.274.0564.5766.754.04
2377179-37717966.79967.28
3379007-37900767.12367.62
4393858-39385869.75370.24
5351395-35139562.23362.68
6381803-38180367.61868.09
90min1400039-40003970.84873.914.1271.4174.504.11
2428182-42818275.83276.43
3414780-41478073.45874.07
4440528-44052878.01878.63
5395956-39595670.12570.68
6424638-42463875.20475.79
极限1522635-52263592.56092.401.6593.2493.101.64
2530289-53028993.91594.64
3509288-50928890.19690.93
4526570-52657093.25793.99
5513243-51324390.89691.56
6528246-52824693.55394.26
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