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%
1111.95437695535165429765436825391105446110.98
2112.95487975491155489560.05
单位质量响应值RSD%判断
4866.944862.320.07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%
5min1104646-10464619.05116.5127.5319.0516.5127.54
288888-8888816.18216.18
395366-9536617.36117.36
445439-454398.2728.27
5119812-11981221.81221.81
689981-8998116.38116.38
10min1175967-17596732.03527.1821.4532.0727.2121.47
2139791-13979125.44925.48
3132458-13245824.11424.14
4104311-10431118.99019.00
5194228-19422835.35935.40
6149167-14916727.15627.18
15min1188811-18881134.37330.3416.5034.4630.4216.50
2152524-15252427.76727.84
3164465-16446529.94130.01
4128715-12871523.43223.48
5206477-20647737.58937.68
6159102-15910228.96429.04
20min1195265-19526535.54831.7314.7435.6931.8514.75
2166311-16631130.27730.39
3186007-18600733.86233.98
4132793-13279324.17524.26
5202612-20261236.88537.04
6162793-16279329.63629.76
30min1201924-20192436.76032.9912.7736.9633.1712.79
2178310-17831032.46132.63
3189651-18965134.52634.70
4143059-14305926.04426.17
5205050-20505037.32937.55
6169322-16932230.82531.00
45min1218861-21886139.84335.4411.9340.1135.6711.96
2195741-19574135.63435.85
3199041-19904136.23536.47
4157141-15714128.60728.78
5216653-21665339.44139.72
6180622-18062232.88233.10
60min1232809-23280942.38338.0010.5042.7138.2910.53
2212673-21267338.71739.00
3211479-21147938.49938.79
4173474-17347431.58131.80
5227475-22747541.41241.76
6194546-19454635.41735.69
90min1260607-26060747.44342.579.3347.8442.929.36
2240194-24019443.72744.07
3232089-23208942.25242.61
4201858-20185836.74837.02
5251275-25127545.74446.16
6216864-21686439.48039.82
极限1399155-39915572.66667.647.0373.1468.067.04
2385388-38538870.15970.58
3332232-33223260.48260.91
4358268-35826865.22265.55
5395348-39534871.97372.47
6358819-35881965.32365.72
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%
1111.95543085530545531105526255528305531850.12
2112.95578795582885580840.06
单位质量响应值RSD%判断
4943.574943.170.01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%
5min1107253-10725319.21426.8951.3619.2126.8951.37
2133560-13356023.92723.93
3168204-16820430.13430.13
468937-6893712.35012.35
5130113-13011323.31023.31
6292522-29252252.40552.41
10min1256122-25612245.88443.824.5045.9243.874.52
2247816-24781644.39644.44
3246368-24636844.13744.19
4224700-22470040.25540.28
5241041-24104143.18243.22
6251666-25166645.08645.17
15min1301888-30188854.08350.485.6954.1950.605.70
2290622-29062252.06552.18
3279460-27946050.06550.19
4254740-25474045.63645.72
5276332-27633249.50549.62
6287639-28763951.53051.69
20min1330855-33085559.27255.065.3659.4755.265.37
2307463-30746355.08255.28
3305167-30516754.67054.88
4280078-28007850.17650.34
5305746-30574654.77454.97
6314598-31459856.36056.61
30min1372512-37251266.73562.015.2967.0362.305.30
2342308-34230861.32461.62
3346444-34644462.06562.36
4315771-31577156.57056.82
5347160-34716062.19362.48
6352567-35256763.16263.50
45min1414798-41479874.31169.025.0274.7269.425.02
2375446-37544667.26167.66
3386343-38634369.21369.61
4356142-35614263.80364.14
5387128-38712869.35469.74
6391800-39180070.19170.64
60min1438244-43824478.51173.544.7779.0474.044.77
2395563-39556370.86571.37
3413777-41377774.12874.64
4382220-38222068.47468.92
5412395-41239573.88074.38
6420636-42063675.35775.92
90min1460229-46022982.45078.774.4283.1179.404.44
2423368-42336875.84676.47
3445473-44547379.80680.45
4411164-41116473.66074.22
5439405-43940578.71979.35
6458442-45844282.12982.82
极限1505594-50559490.57790.071.8491.3890.841.87
2497536-49753689.13389.88
3513684-51368492.02692.80
4487886-48788687.40488.09
5502178-50217889.96590.72
6509753-50975391.32292.15
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%
1111.95494095490675498485502305505245498160.11
2112.95521665525285523470.05
单位质量响应值RSD%判断
4913.464892.360.31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%
5min1166235-16623530.02729.2322.5730.0329.2322.56
2112981-11298120.40820.41
3186069-18606933.60933.61
4200736-20073636.25936.26
5120952-12095221.84721.85
6183871-18387133.21233.21
10min1228649-22864941.30042.308.5441.3542.358.55
2213720-21372038.60438.64
3253344-25334445.76145.82
4239790-23979043.31343.37
5210887-21088738.09238.13
6258795-25879546.74646.80
15min1248219-24821944.83545.698.7844.9545.818.79
2234293-23429342.32042.42
3274833-27483349.64349.77
4257949-25794946.59346.73
5223101-22310140.29840.40
6279416-27941650.47050.60
20min1265978-26597848.04348.828.1748.2449.028.18
2250501-25050145.24845.42
3292375-29237552.81153.03
4274537-27453749.58949.80
5241571-24157143.63543.80
6296655-29665553.58453.80
30min1295013-29501353.28854.197.4553.5654.477.47
2277460-27746050.11750.36
3324746-32474658.65858.96
4304971-30497155.08655.38
5273288-27328849.36449.60
6324730-32473058.65558.96
45min1333348-33334860.21260.706.3260.5761.066.34
2311276-31127656.22556.55
3360364-36036465.09265.49
4342662-34266261.89462.28
5312023-31202356.36056.68
6356506-35650664.39564.80
60min1364495-36449565.83865.725.3566.3066.195.37
2337675-33767560.99461.42
3384200-38420069.39769.91
4371390-37139067.08467.57
5343519-34351962.04962.47
6381720-38172068.94969.46
90min1411785-41178574.38073.614.3474.9574.194.37
2379120-37912068.48069.00
3421286-42128676.09676.72
4416056-41605675.15275.75
5393136-39313671.01271.53
6423906-42390676.56977.20
极限1511884-51188492.46193.340.7993.1694.040.80
2515790-51579093.16693.80
3513034-51303492.66893.42
4522228-52222894.32995.05
5517084-51708493.40094.04
6520567-52056794.02994.78
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%
1111.95532175523815515465522075517345522170.12
2112.95539275555735547500.21
单位质量响应值RSD%判断
4934.924913.640.31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%
5min1184609-18460933.20127.6015.8933.2027.6015.89
2143645-14364525.83425.83
3168152-16815230.24130.24
4168444-16844430.29430.29
5118835-11883521.37221.37
6137116-13711624.66024.66
10min1242122-24212243.54442.038.0943.6042.088.09
2223633-22363340.21940.26
3255481-25548145.94746.00
4252842-25284245.47245.52
5215376-21537638.73438.77
6212840-21284038.27838.32
15min1263353-26335347.36345.396.8647.4945.516.87
2246211-24621144.28044.39
3274327-27432749.33649.46
4263799-26379947.44347.57
5234612-23461242.19442.29
6232074-23207441.73741.84
20min1284488-28448851.16448.637.2751.3748.827.27
2260567-26056746.86247.05
3295275-29527553.10453.31
4282718-28271850.84551.05
5249301-24930144.83545.01
6250003-25000344.96245.14
30min1318414-31841457.26554.546.5757.5654.816.58
2289022-28902251.97952.24
3330297-33029759.40259.70
4313088-31308856.30756.60
5282589-28258950.82251.07
6286080-28608051.45051.70
45min1360819-36081964.89161.096.8565.2861.456.85
2324766-32476658.40758.76
3369355-36935566.42666.82
4349015-34901562.76863.15
5312528-31252856.20656.54
6321547-32154757.82858.16
60min1388743-38874369.91366.176.3770.4166.646.38
2349847-34984762.91863.36
3399531-39953171.85372.36
4374979-37497967.43867.93
5340952-34095261.31861.74
6353506-35350663.57664.01
90min1435951-43595178.40374.225.8979.0274.805.91
2388445-38844569.86070.41
3443941-44394179.84080.47
4418980-41898075.35175.95
5386010-38601069.42269.95
6402810-40281072.44372.98
极限1525679-52567994.54094.111.0595.2894.811.08
2522997-52299794.05894.73
3526202-52620294.63595.39
4527229-52722994.81995.55
5512558-51255892.18192.82
6525205-52520594.45595.11
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