沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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100309-202205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1000
标示量(mg)12.5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%
113.863538013535513532233530683534173534120.09
214.023533113530853531980.05
单位质量响应值RSD%判断
25498.7025192.440.86数据可信
供试品溶液-25080101批-氢氯噻嗪-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%
5min174841-7484121.26120.5421.6921.2620.5421.70
294582-9458226.86926.87
376342-7634221.68821.69
445848-4584813.02513.02
569134-6913419.64019.64
673097-7309720.76620.77
10min1163066-16306646.32444.9513.3946.3644.9813.38
2166446-16644647.28547.33
3151108-15110842.92742.96
4121423-12142334.49434.52
5185262-18526252.63052.66
6162016-16201646.02646.06
15min1231001-23100165.62462.9111.3065.7463.0211.30
2214491-21449160.93361.06
3211839-21183960.18060.29
4182533-18253351.85551.93
5231575-23157565.78765.91
6257231-25723173.07573.19
20min1272035-27203577.28173.519.0277.5073.729.02
2245496-24549669.74169.97
3253113-25311371.90572.11
4225318-22531864.00964.17
5263246-26324674.78475.01
6293387-29338783.34683.58
30min1286470-28647081.38181.286.7381.7381.626.74
2276387-27638778.51778.86
3288138-28813881.85582.18
4258558-25855873.45273.72
5289785-28978582.32382.68
6317409-31740990.17190.54
45min1287546-28754681.68782.965.6282.1783.435.63
2291155-29115582.71283.18
3293923-29392383.49983.96
4267531-26753176.00176.40
5293225-29322583.30083.79
6318802-31880290.56691.09
60min1286503-28650381.39183.325.1382.0183.935.15
2294112-29411283.55284.16
3294175-29417583.57084.17
4272411-27241177.38877.91
5293847-29384783.47784.11
6318745-31874590.55091.22
极限1290404-29040482.49986.224.1183.2686.974.11
2315220-31522089.54990.30
3298327-29832784.75085.49
4295475-29547583.94084.59
5299158-29915884.98685.76
6322385-32238591.58492.41
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856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(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.605759675756635762535779325790605769750.26
222.795940495944105942300.05
单位质量响应值RSD%判断
25529.8726074.161.50数据可信
供试品溶液-25080101批-缬沙坦-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%
5min1167666-16766613.14112.4721.2513.1412.4721.25
2206711-20671116.20116.20
3167343-16734313.11513.12
4101944-1019447.9907.99
5157219-15721912.32212.32
6153497-15349712.03012.03
10min1368975-36897528.91827.2112.7028.9427.2312.71
2357791-35779128.04228.07
3334953-33495326.25226.27
4276879-27687921.70021.71
5409574-40957432.10032.12
6335128-33512826.26626.29
15min1525274-52527441.16837.959.2641.2438.029.26
2454539-45453935.62435.70
3471940-47194036.98837.05
4415382-41538232.55532.60
5511372-51137240.07940.15
6527104-52710441.31241.38
20min1617950-61795048.43244.178.1248.5744.308.11
2514938-51493840.35840.49
3563308-56330844.14944.28
4504442-50444239.53639.64
5581161-58116145.54845.69
6599898-59989847.01747.15
30min1646262-64626250.65148.495.6850.8748.695.68
2574159-57415945.00045.20
3635630-63563049.81750.02
4573396-57339644.94045.11
5636567-63656749.89150.11
6646152-64615250.64250.85
45min1646886-64688650.70049.353.9451.0049.633.96
2606496-60649647.53447.81
3646427-64642750.66450.95
4590325-59032546.26746.51
5641419-64141950.27150.57
6646088-64608850.63750.93
60min1641981-64198150.31549.522.9650.7049.882.98
2613593-61359348.09048.44
3644650-64465050.52450.89
4602882-60288247.25147.57
5641870-64187050.30650.69
6645927-64592750.62451.00
极限1645798-64579850.61450.580.5851.0951.030.63
2644768-64476850.53450.97
3646848-64684850.69751.15
4638254-63825450.02350.42
5648566-64856650.83151.30
6647865-64786550.77651.24
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856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(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.601067018107049610679981068262107117510689900.17
222.791078458108078610796220.16
单位质量响应值RSD%判断
47300.4447372.620.11数据可信
供试品溶液-25080101批-沙库巴曲-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%
5min1295973-29597311.95411.3022.5911.9511.3022.61
2368091-36809114.86614.87
3295487-29548711.93411.93
4172450-1724506.9656.96
5276787-27678711.17911.18
6269277-26927710.87510.88
10min1669123-66912327.02425.3213.1027.0425.3413.10
2647119-64711926.13526.16
3604689-60468924.42224.44
4495081-49508119.99520.01
5741291-74129129.93929.96
6603731-60373124.38324.40
15min1961560-96156038.83535.629.6338.9035.689.63
2824008-82400833.27933.35
3860536-86053634.75534.82
4751424-75142430.34830.39
5933752-93375237.71237.78
6960142-96014238.77738.84
20min11132113-113211345.72341.628.3645.8541.748.36
2936151-93615137.80937.93
31031524-103152441.66041.78
4921005-92100537.19737.29
51061676-106167642.87843.01
61100165-110016544.43344.56
30min11190679-119067948.08845.806.0548.2945.996.06
21045189-104518942.21242.40
31166740-116674047.12147.31
41047419-104741942.30242.46
51168747-116874747.20247.41
61185578-118557847.88248.08
45min11192221-119222148.15046.534.5348.4446.804.55
21098520-109852044.36644.62
31186607-118660747.92448.19
41073683-107368343.36343.59
51174572-117457247.43847.72
61187678-118767847.96748.24
60min11182035-118203547.73946.583.6548.1146.933.67
21104957-110495744.62644.96
31181659-118165947.72448.07
41094314-109431444.19644.50
51171192-117119247.30147.66
61186106-118610647.90448.26
极限11190132-119013248.06647.890.8948.5148.310.93
21174167-117416747.42147.83
31192863-119286348.17648.60
41170829-117082947.28747.66
51194261-119426148.23348.67
61192845-119284548.17648.61
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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100309-202205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1000
标示量(mg)12.5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%
113.863546233544453547873547543548383546890.05
214.023553343561023557180.16
单位质量响应值RSD%判断
25590.8425372.180.61数据可信
供试品溶液-25080102批-氢氯噻嗪-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%
5min149415-4941513.96317.2012.4013.9617.2012.40
259003-5900316.67216.67
368310-6831019.30219.30
465079-6507918.38918.39
567879-6787919.18019.18
655583-5558315.70615.71
10min1155023-15502343.80442.524.1143.8342.554.10
2140790-14079039.78239.81
3149713-14971342.30342.34
4152118-15211842.98343.01
5146918-14691841.51441.55
6158237-15823744.71244.74
15min1226329-22632963.95261.995.7064.0562.095.69
2205907-20590758.18258.28
3211375-21137559.72759.83
4223489-22348963.15063.25
5210237-21023759.40559.51
6239025-23902567.54067.64
20min1277506-27750678.41373.886.1978.6274.096.18
2239979-23997967.80968.00
3254226-25422671.83572.04
4268334-26833475.82176.03
5249059-24905970.37570.58
6279757-27975779.04979.26
30min1323924-32392491.52984.666.0991.8684.996.08
2277187-27718778.32378.63
3296122-29612283.67384.00
4305377-30537786.28886.62
5281494-28149479.54079.86
6313627-31362788.61988.96
45min1332157-33215793.85588.194.9994.3488.664.98
2294806-29480683.30183.74
3317635-31763589.75290.21
4314832-31483288.96089.44
5292309-29230982.59683.05
6320901-32090190.67591.17
60min1332058-33205893.82789.154.3894.4789.764.38
2300855-30085585.01085.58
3321058-32105890.71991.33
4318560-31856090.01390.64
5296699-29669983.83684.42
6323839-32383991.50592.15
极限1338907-33890795.76395.540.7196.5696.300.70
2341592-34159296.52197.24
3339642-33964295.97096.73
4337368-33736895.32896.10
5335530-33553094.80895.54
6335574-33557494.82195.62
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856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(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.605879585882285878465876185863415875980.13
222.795987135982165984640.06
单位质量响应值RSD%判断
25999.9126259.940.71数据可信
供试品溶液-25080102批-缬沙坦-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%
5min1107409-1074098.31210.2813.108.3110.2813.11
2128077-1280779.9119.91
3150142-15014211.61911.62
4142213-14221311.00511.01
5149527-14952711.57111.57
6119500-1195009.2479.25
10min1317269-31726924.55223.863.6824.5723.883.67
2291327-29132722.54422.56
3306413-30641323.71223.73
4314129-31412924.30924.33
5299778-29977823.19823.22
6321037-32103724.84324.86
15min1450863-45086334.89033.975.4834.9434.025.47
2412574-41257431.92731.98
3424449-42444932.84632.90
4452073-45207334.98335.04
5419157-41915732.43632.49
6474610-47461036.72736.78
20min1545183-54518342.18939.915.9942.3040.025.98
2474122-47412236.69036.80
3501454-50145438.80538.92
4533721-53372141.30241.42
5491673-49167338.04838.16
6548335-54833542.43342.55
30min1628035-62803548.60045.095.9848.7845.275.96
2540675-54067541.84042.01
3575195-57519544.51144.69
4598495-59849546.31446.50
5546244-54624442.27142.45
6607147-60714746.98447.17
45min1639401-63940149.48046.734.7349.7446.994.72
2573536-57353644.38344.62
3611795-61179547.34347.60
4616112-61611247.67847.94
5565271-56527143.74343.99
6617212-61721247.76348.03
60min1636394-63639449.24747.184.0549.5947.524.05
2584507-58450745.23245.54
3617658-61765847.79748.13
4623229-62322948.22848.57
5573887-57388744.41044.73
6622705-62270548.18848.53
极限1639755-63975549.50749.410.9449.9449.820.93
2647887-64788750.13650.52
3637765-63776549.35349.76
4641374-64137449.63250.06
5632556-63255648.95049.34
6631698-63169848.88449.31
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856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(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.601078773107760110777771076855107712810776270.07
222.791089497109094510902210.10
单位质量响应值RSD%判断
47682.6147837.690.23数据可信
供试品溶液-25080102批-沙库巴曲-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%
5min1184469-1844697.3849.2814.017.389.2814.01
2222238-2222388.8968.90
3264339-26433910.58110.58
4249049-2490499.9699.97
5263524-26352410.54910.55
6207779-2077798.3178.32
10min1570012-57001222.81722.243.6922.8322.263.67
2524188-52418820.98321.00
3553296-55329622.14822.17
4565778-56577822.64822.66
5540883-54088321.65121.67
6579519-57951923.19823.21
15min1821374-82137432.87931.915.6232.9331.965.61
2749857-74985730.01630.07
3767992-76799230.74230.80
4819590-81959032.80732.86
5760088-76008830.42630.48
6864002-86400234.58534.64
20min1990852-99085239.66337.616.0839.7737.726.08
2861052-86105234.46734.57
3914052-91405236.58936.69
4972738-97273838.93839.05
5896798-89679835.89836.00
61002239-100223940.11940.23
30min11146720-114672045.90242.556.2046.0742.726.18
2980871-98087139.26339.42
31048386-104838641.96642.13
41094156-109415643.79843.97
5996800-99680039.90140.07
61111460-111146044.49144.67
45min11174057-117405746.99644.055.3747.2444.295.36
21034238-103423841.40041.62
31117713-111771344.74144.98
41121916-112191644.90945.16
51023505-102350540.97041.20
61131413-113141345.28945.54
60min11167817-116781746.74744.284.8447.0744.594.84
21048098-104809841.95442.25
31121094-112109444.87645.19
41129724-112972445.22245.54
51032731-103273141.33941.64
61137535-113753545.53445.86
极限11178854-117885447.18846.831.0347.5947.221.03
21180619-118061947.25947.62
31167206-116720646.72247.11
41179918-117991847.23147.63
51151322-115132246.08646.45
61161892-116189246.50946.91
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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100309-202205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1000
标示量(mg)12.5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%
113.863519423523613529703527603529463525960.13
214.023531063528293529680.06
单位质量响应值RSD%判断
25439.8325176.030.74数据可信
供试品溶液-25080101批-氢氯噻嗪-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%
5min160507-6050717.21417.3114.3917.2117.3014.39
247993-4799313.65413.65
353118-5311815.11215.11
470624-7062420.09320.09
567003-6700319.06319.06
665768-6576818.71118.71
10min1167548-16754847.66844.4711.9747.7044.5011.97
2139697-13969739.74439.77
3180150-18015051.25351.28
4171154-17115448.69448.73
5137776-13777639.19839.23
6141621-14162140.29240.32
15min1255668-25566872.73864.3711.9772.8564.4811.96
2212628-21262860.49360.58
3249870-24987071.08971.20
4242675-24267569.04269.16
5187636-18763653.38353.48
6209123-20912359.49659.59
20min1312438-31243888.89075.9111.7889.1276.1211.77
2264682-26468275.30375.49
3277058-27705878.82479.05
4276273-27627378.60178.83
5217091-21709161.76361.95
6253328-25332872.07372.27
30min1344397-34439797.98284.9210.7098.3685.2610.69
2296627-29662784.39184.71
3298378-29837884.89085.25
4305961-30596187.04787.41
5244457-24445769.54969.84
6301099-30109985.66485.98
45min1347082-34708298.74687.478.8299.2987.958.82
2301646-30164685.81986.28
3304227-30422786.55487.06
4308059-30805987.64488.15
5263825-26382575.05975.46
6319783-31978390.97991.44
60min1347317-34731798.81388.187.9099.5288.807.90
2302907-30290786.17886.78
3304840-30484086.72887.37
4308384-30838487.73688.39
5273226-27322677.73478.26
6322977-32297791.88892.50
极限1351838-351838100.09991.156.36100.9791.926.37
2308810-30881087.85888.60
3314161-31416189.38090.17
4311193-31119388.53689.33
5297931-29793184.76285.42
6338423-33842396.28397.05
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856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(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.605894745905685909425902615899045902300.10
222.795771945777165774550.07
单位质量响应值RSD%判断
26116.3725338.092.14数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-25080101批-缬沙坦-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%
5min1108787-1087878.5529.8614.798.559.8614.78
2109087-1090878.5768.58
3109789-1097898.6318.63
4144391-14439111.35111.35
5148483-14848311.67311.67
6131697-13169710.35310.35
10min1305078-30507823.98325.1611.1724.0025.1811.16
2305443-30544324.01124.03
3367108-36710828.85928.87
4360285-36028528.32328.34
5306441-30644124.09024.11
6276101-27610121.70521.72
15min1465809-46580936.61836.4810.1636.6736.5410.16
2460508-46050836.20136.26
3517653-51765340.69440.76
4515489-51548940.52440.59
5423515-42351533.29333.35
6401476-40147631.56131.61
20min1572066-57206644.97143.018.5345.0943.138.53
2576737-57673745.33845.45
3576711-57671145.33645.47
4583232-58323245.84945.98
5490336-49033638.54638.66
6483993-48399338.04838.15
30min1627517-62751749.33047.616.4349.5247.806.43
2627200-62720049.30549.50
3620848-62084848.80649.01
4643288-64328850.57050.78
5544427-54442742.79842.98
6570657-57065744.86045.03
45min1628394-62839449.39948.863.7349.6749.133.74
2635757-63575749.97850.25
3631868-63186849.67249.96
4644106-64410650.63450.93
5581378-58137845.70345.95
6607439-60743947.75248.00
60min1626308-62630849.23549.162.6149.5949.512.63
2637335-63733550.10250.46
3633125-63312549.77150.14
4642564-64256450.51350.89
5599324-59932447.11447.44
6613146-61314648.20148.52
极限1625476-62547649.17049.961.2849.6150.401.28
2643062-64306250.55250.99
3635121-63512149.92850.38
4641732-64173250.44850.91
5641982-64198250.46750.87
6626035-62603549.21449.62
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856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(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.601075900107584210789541076539107690110768270.12
222.791068609106724510679270.10
单位质量响应值RSD%判断
47647.2146859.461.18数据可信
供试品溶液-25080101批-沙库巴曲-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%
5min1189592-1895927.6718.9116.297.678.9116.27
2187575-1875757.5897.59
3190271-1902717.6997.70
4256886-25688610.39410.39
5265510-26551010.74310.74
6231921-2319219.3849.38
10min1554238-55423822.42523.5811.7022.4423.6011.69
2553310-55331022.38822.40
3674062-67406227.27327.29
4657757-65775726.61426.63
5558158-55815822.58422.60
6499247-49924720.20020.22
15min1853887-85388734.54934.4310.3934.6034.4910.38
2842505-84250534.08934.14
3950842-95084238.47238.53
4949244-94924438.40738.47
5774848-77484831.35131.41
6734585-73458529.72229.77
20min11054050-105405042.64840.688.8242.7640.798.82
21060707-106070742.91743.02
31059884-105988442.88443.01
41074624-107462443.48043.61
5897199-89719936.30236.41
6885318-88531835.82135.92
30min11153033-115303346.65345.026.5646.8345.206.56
21151627-115162746.59646.77
31141875-114187546.20246.40
41184205-118420547.91448.11
5997875-99787540.37540.54
61046923-104692342.36042.52
45min11160684-116068446.96346.283.9547.2246.533.96
21170666-117066647.36647.62
31160274-116027446.94647.22
41189435-118943548.12648.40
51066381-106638143.14743.38
61115457-111545745.13345.36
60min11158607-115860746.87946.592.8047.2146.922.82
21174051-117405147.50347.84
31165307-116530747.15047.50
41184626-118462647.93148.29
51099615-109961544.49244.80
61126409-112640945.57645.88
极限11153195-115319546.66047.441.2647.0747.851.26
21188699-118869948.09648.51
31172831-117283147.45447.88
41182054-118205447.82748.27
51181582-118158247.80848.19
61156072-115607246.77647.16
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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100309-202205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1000
标示量(mg)12.5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%
113.863552293548333553873551773551913551630.06
214.023572313569893571100.05
单位质量响应值RSD%判断
25625.0425471.470.43数据可信
供试品溶液-25080102批-氢氯噻嗪-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%
5min157070-5707016.08417.9918.9816.0817.9918.99
271056-7105620.02520.03
381471-8147122.96022.96
456057-5605715.79815.80
568976-6897619.43919.44
648412-4841213.64413.64
10min1157841-15784144.48343.1310.5444.5143.1610.54
2146037-14603741.15641.19
3164424-16442446.33846.38
4146154-14615441.18941.22
5174785-17478549.25849.29
6129006-12900636.35736.38
15min1225062-22506263.42760.577.0563.5360.677.06
2208120-20812058.65358.75
3234866-23486666.19066.31
4194332-19433254.76754.86
5222812-22281262.79362.91
6204278-20427857.57057.65
20min1277851-27785178.30572.899.1778.5173.109.16
2252073-25207371.04071.24
3294739-29473983.06483.29
4228328-22832864.34864.53
5247593-24759369.77770.00
6251304-25130470.82371.00
30min1324044-32404491.32384.288.3891.6684.608.37
2299778-29977884.48484.80
3330400-33040093.11493.48
4270173-27017376.14176.43
5272810-27281076.88477.22
6297155-29715583.74584.04
45min1335447-33544794.53689.525.1695.0389.985.16
2326616-32661692.04892.51
3333728-33372894.05294.57
4297104-29710483.73184.15
5304083-30408385.69786.16
6308884-30888487.05087.49
60min1336857-33685794.93491.803.1895.5892.413.20
2332797-33279793.79094.40
3334825-33482594.36195.04
4313166-31316688.25788.82
5320715-32071590.38590.99
6315971-31597189.04889.63
极限1339270-33927095.61495.800.8696.4296.570.83
2344081-34408196.97097.74
3337760-33776095.18896.02
4340709-34070996.01996.73
5335991-33599194.69095.45
6341754-34175496.31497.04
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856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(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.605804405811055821125826455822785817160.16
222.795904895902275903580.04
单位质量响应值RSD%判断
25739.6525904.260.46数据可信
供试品溶液-25080102批-缬沙坦-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%
5min1127212-1272129.96210.8017.809.9610.8017.81
2152589-15258911.94911.95
3174326-17432613.65113.65
4121123-1211239.4859.48
5145864-14586411.42211.42
6106160-1061608.3138.31
10min1321603-32160325.18424.3710.0025.2024.3910.01
2297997-29799723.33523.35
3332450-33245026.03326.06
4299138-29913823.42423.44
5352416-35241627.59627.62
6263665-26366520.64720.66
15min1451052-45105235.32033.536.8535.3833.596.85
2413611-41361132.38832.45
3467108-46710836.57836.64
4389496-38949630.50030.55
5440071-44007134.46034.53
6408027-40802731.95132.00
20min1551634-55163443.19639.929.0843.3140.039.07
2494707-49470738.73938.85
3578784-57878445.32245.45
4454199-45419935.56735.67
5483686-48368637.87638.00
6495663-49566338.81438.92
30min1635643-63564349.77545.658.3849.9645.838.36
2583714-58371445.70945.89
3640677-64067750.16950.37
4529114-52911441.43341.60
5529189-52918941.43941.62
6579328-57932845.36545.53
45min1651893-65189351.04748.095.2651.3248.345.27
2631597-63159749.45849.71
3643101-64310150.35950.65
4575871-57587145.09445.33
5583750-58375045.71145.97
6598190-59819046.84247.08
60min1653539-65353951.17649.203.1951.5349.543.21
2640684-64068450.17050.51
3643310-64331050.37550.75
4604774-60477447.35847.67
5615876-61587648.22748.56
6611500-61150047.88448.20
极限1648807-64880750.80650.570.7351.2550.990.71
2649565-64956550.86551.28
3642244-64224450.29250.75
4648532-64853250.78451.17
5637938-63793849.95550.37
6647700-64770050.71951.12
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856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(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.601076419107287910746901077832107407010751780.19
222.791100187109988611000360.02
单位质量响应值RSD%判断
47574.2548268.361.03数据可信
供试品溶液-25080102批-沙库巴曲-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%
5min1224396-2243968.9539.7919.018.959.7819.03
2273822-27382210.92510.92
3314710-31471012.55612.56
4213885-2138858.5338.53
5259721-25972110.36210.36
6185273-1852737.3927.39
10min1583349-58334923.27422.5510.3323.2922.5710.34
2538586-53858621.48821.51
3609349-60934924.31124.33
4541828-54182821.61721.63
5641129-64112925.57925.60
6477176-47717619.03819.05
15min1827506-82750633.01531.296.9333.0731.356.93
2756733-75673330.19130.24
3856279-85627934.16234.22
4713282-71328228.45728.51
5806171-80617132.16332.22
6746297-74629729.77529.82
20min11014067-101406740.45837.309.2440.5737.419.23
2904689-90468936.09436.20
31062189-106218942.37842.50
4830088-83008833.11833.22
5885901-88590135.34435.46
6912547-91254736.40736.50
30min11169042-116904246.64142.728.6446.8242.888.63
21070279-107027942.70042.86
31182131-118213147.16347.35
4970689-97068938.72738.88
5967749-96774938.61038.78
61064378-106437842.46542.62
45min11200272-120027247.88745.015.5648.1445.255.56
21162631-116263146.38546.62
31185898-118589847.31347.58
41053003-105300342.01142.23
51071158-107115842.73542.97
61096687-109668743.75443.98
60min11205146-120514648.08146.113.3548.4146.423.37
21178990-117899047.03747.35
31184999-118499947.27747.62
41110613-111061344.30944.60
51129559-112955945.06545.37
61125407-112540744.90045.20
极限11198039-119803947.79747.550.7748.2147.940.76
21200190-120019047.88348.27
31182515-118251547.17847.60
41196168-119616847.72348.08
51177973-117797346.99747.38
61195562-119556247.69948.07
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