恩格列净二甲双胍缓释片项目信息
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101566-202301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400
标示量(mg)25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%
111934181933301935611932391931411933380.09
211941611939181940400.09
单位质量响应值RSD%判断
193338.00194040.000.26数据可信
供试品溶液-5批-恩格列净-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%
5min13193-31930.1480.1189.430.150.1188.91
2-0.0000.00
32673-26730.1240.12
45655-56550.2630.26
52910-29100.1350.14
6-0.0000.00
10min135847-358471.6661.2728.431.671.2728.41
212859-128590.5980.60
330749-307491.4291.43
426455-264551.2291.23
527994-279941.3011.30
629797-297971.3851.38
15min1112773-1127735.2404.2119.405.244.2119.35
259725-597252.7752.78
399754-997544.6354.64
492859-928594.3154.32
589813-898134.1734.18
688151-881514.0964.10
20min1167549-1675497.7857.047.517.807.057.51
2133863-1338636.2206.23
3159564-1595647.4147.42
4149047-1490476.9266.94
5149163-1491636.9316.94
6149987-1499876.9696.98
30min1204583-2045839.5069.283.369.539.303.36
2190147-1901478.8358.85
3196434-1964349.1289.15
4209245-2092459.7239.74
5200400-2004009.3129.33
6197091-1970919.1589.18
45min1213671-2136719.9299.873.499.979.903.47
2205705-2057059.5589.59
3205397-2053979.5449.58
4224402-22440210.42710.46
5216660-21666010.06710.10
6208428-2084289.6859.72
60min1218801-21880110.16710.063.5410.2210.123.53
2209936-2099369.7559.80
3209297-2092979.7259.78
4228982-22898210.64010.69
5220659-22065910.25310.31
6211961-2119619.8499.90
120min1220636-22063610.25210.153.5610.3310.223.58
2211439-2114399.8259.89
3211762-2117629.8409.91
4231441-23144110.75410.83
5222070-22207010.31910.39
6213741-2137419.93210.00
240min1220844-22084410.26210.163.4610.3510.253.46
2212555-2125559.8779.96
3212438-2124389.8719.96
4231317-23131710.74810.84
5222022-22202210.31710.40
6212816-2128169.8899.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1221047-22104710.27110.213.9110.3810.323.91
2213217-2132179.90710.00
3213298-2132989.91110.01
4234673-23467310.90411.01
5223473-22347310.38410.49
6212921-2129219.89410.00
480min1226147-22614710.50810.463.1010.6310.583.10
2219992-21999210.22210.33
3221874-22187410.31010.43
4237704-23770411.04511.17
5226372-22637210.51910.64
6218400-21840010.14810.27
600min1226203-22620310.51110.353.3810.6510.493.37
2217675-21767510.11510.24
3216487-21648710.05910.20
4235639-23563910.94911.09
5224243-22424310.42010.56
6216567-21656710.06310.20
720min1228421-22842110.61410.294.3310.7710.454.32
2217712-21771210.11610.26
3208081-2080819.6699.82
4234519-23451910.89711.06
5224891-22489110.45010.61
6215458-21545810.01210.16
840min1223223-22322310.37210.097.3510.5510.267.25
2217097-21709710.08810.25
3188436-1884368.7568.93
4235692-23569210.95211.13
5224767-22476710.44410.62
6213933-2139339.94110.11
960min1221306-22130610.2839.8510.1210.4810.049.94
2228005-22800510.59510.77
3180259-1802598.3768.56
4237679-23767911.04411.24
5195327-1953279.0769.27
6208903-2089039.7079.89
极限1220619-22061910.2519.6610.5210.469.8610.35
2212660-2126609.88210.08
3175435-1754358.1528.35
4238084-23808411.06311.28
5192399-1923998.9409.15
6207848-2078489.6589.86
恩格列净二甲双胍缓释片项目信息
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100664-202507对照品来源中检院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10
标示量(mg)1000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%
118805058804028803738808758807758805860.03
218798058801728799880.03
单位质量响应值RSD%判断
880586.00879988.000.05数据可信
供试品溶液-5批-二甲双胍-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%
5min11447-14470.0150.05192.740.010.05195.59
2-0.0000.00
3638-6380.0070.01
423221-232210.2370.24
53053-30530.0310.03
6-0.0000.00
10min110918-109180.1120.1015.290.110.1015.81
26962-69620.0710.07
310294-102940.1050.11
410276-102760.1050.11
510907-109070.1110.11
610766-107660.1100.11
15min141864-418640.4280.3910.420.430.3910.98
230645-306450.3130.31
337428-374280.3820.38
437940-379400.3880.39
538949-389490.3980.40
640696-406960.4160.42
20min181379-813790.8310.779.840.830.779.69
261522-615220.6280.63
381378-813780.8310.83
474174-741740.7580.76
575024-750240.7660.77
678181-781810.7990.80
30min1144159-1441591.4721.466.181.471.466.22
2129114-1291141.3191.32
3143143-1431431.4621.46
4156320-1563201.5971.60
5138940-1389401.4191.42
6143909-1439091.4701.47
45min1207090-2070902.1152.092.482.122.102.58
2194822-1948221.9901.99
3206873-2068732.1132.12
4203897-2038972.0832.09
5206310-2063102.1072.11
6208879-2088792.1332.14
60min1258457-2584572.6402.612.182.652.622.24
2245277-2452772.5052.51
3257179-2571792.6272.63
4254611-2546112.6012.61
5257844-2578442.6342.64
6261247-2612472.6682.68
120min1396181-3961814.0464.012.174.064.022.18
2376688-3766883.8473.86
3393823-3938234.0224.03
4391975-3919754.0044.02
5395667-3956674.0414.05
6401699-4016994.1034.12
240min1572200-5722005.8445.771.705.865.791.70
2549150-5491505.6095.63
3568470-5684705.8065.83
4564291-5642915.7645.78
5561152-5611525.7315.75
6576249-5762495.8865.91
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1692144-6921447.0697.041.797.107.071.82
2667442-6674426.8176.84
3689499-6894997.0427.07
4703823-7038237.1897.22
5688287-6882877.0307.06
6697262-6972627.1227.15
480min1793366-7933668.1038.061.318.148.101.30
2771444-7714447.8797.92
3795122-7951228.1218.16
4785983-7859838.0288.07
5790346-7903468.0728.11
6801346-8013468.1858.23
600min1853773-8537738.7208.651.248.778.711.23
2829028-8290288.4678.52
3850033-8500338.6828.74
4843275-8432758.6138.67
5848708-8487088.6688.72
6859363-8593638.7778.83
720min1894236-8942369.1339.021.709.209.091.69
2876380-8763808.9519.02
3858843-8588438.7728.84
4880112-8801128.9899.06
5886514-8865149.0559.12
6901762-9017629.2109.28
840min1918764-9187649.3849.164.999.479.244.94
2903804-9038049.2319.31
3806350-8063508.2368.32
4911093-9110939.3069.39
5914810-9148109.3449.43
6924101-9241019.4399.52
960min1928620-9286209.4859.086.209.589.186.14
2912254-9122549.3189.41
3790783-7907838.0778.17
4924750-9247509.4459.54
5856630-8566308.7498.85
6922296-9222969.4209.52
极限1928008-9280089.4789.066.549.599.186.46
2903157-9031579.2259.34
3784062-7840628.0088.12
4933733-9337339.5379.65
5855131-8551318.7348.85
6919814-9198149.3959.51
恩格列净二甲双胍缓释片项目信息
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101566-202301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400
标示量(mg)25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%
112431832431592431712430282430312431140.04
212418352420132419240.06
单位质量响应值RSD%判断
243114.00241924.000.35数据可信
供试品溶液-4批-恩格列净-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%
5min1-0.0000.01244.950.000.01244.95
2-0.0000.00
32046-20460.0760.08
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min127510-275101.0211.1412.331.021.1412.29
238068-380681.4131.41
328935-289351.0741.07
429363-293631.0901.09
530403-304031.1281.13
629379-293791.0901.09
15min1105026-1050263.8984.038.763.904.038.73
291042-910423.3793.38
3112435-1124354.1734.17
4114023-1140234.2314.23
5117558-1175584.3634.36
6111141-1111414.1254.13
20min1187923-1879236.9746.809.366.986.809.38
2148848-1488485.5245.53
3191266-1912667.0987.11
4192364-1923647.1397.15
5193977-1939777.1997.21
6184350-1843506.8416.85
30min1258095-2580959.5789.284.629.609.304.60
2230623-2306238.5598.58
3243681-2436819.0439.06
4249356-2493569.2549.27
5255825-2558259.4949.51
6262231-2622319.7329.75
45min1278580-27858010.33810.013.6910.3710.053.66
2267057-2670579.9119.94
3257131-2571319.5429.58
4263360-2633609.7739.81
5268853-2688539.97710.01
6284141-28414110.54510.58
60min1282362-28236210.47910.174.1310.5310.224.13
2273988-27398810.16810.22
3259032-2590329.6139.66
4265814-2658149.8659.92
5272083-27208310.09710.15
6290541-29054110.78210.84
120min1283605-28360510.52510.224.4610.6010.294.48
2275369-27536910.21910.28
3259929-2599299.6469.71
4266655-2666559.8969.96
5272536-27253610.11410.18
6294353-29435310.92411.00
240min1283178-28317810.50910.224.5310.6010.314.51
2275202-27520210.21310.29
3260244-2602449.6589.74
4266501-2665019.8909.98
5272363-27236310.10810.19
6295342-29534210.96011.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1283535-28353510.52210.244.6110.6310.344.57
2275323-27532310.21710.32
3260214-2602149.6579.76
4265513-2655139.8539.96
5274570-27457010.18910.29
6295683-29568310.97311.08
480min1291996-29199610.83610.514.5910.9610.634.56
2280675-28067510.41610.53
3267088-2670889.91210.03
4274914-27491410.20210.32
5280959-28095910.42710.55
6303874-30387411.27711.40
600min1290728-29072810.78910.484.1610.9310.624.15
2279268-27926810.36410.50
3268951-2689519.98110.11
4274441-27444110.18510.32
5280165-28016510.39710.54
6301391-30139111.18511.33
720min1288210-28821010.69610.444.8110.8510.594.79
2278045-27804510.31810.47
3265217-2652179.8429.99
4271971-27197110.09310.25
5279994-27999410.39110.55
6303818-30381811.27511.44
840min1286387-28638710.62810.354.5210.8010.524.48
2276025-27602510.24310.41
3263007-2630079.7609.93
4269543-26954310.00310.17
5279232-27923210.36210.54
6298561-29856111.08011.26
960min1281119-28111910.43310.214.4510.6310.404.44
2272878-27287810.12710.31
3260702-2607029.6759.86
4266649-2666499.89610.08
5274030-27403010.16910.36
6295747-29574710.97511.18
极限1276346-27634610.25510.134.5410.4710.344.52
2270944-27094410.05510.26
3259638-2596389.6359.83
4265043-2650439.83610.04
5270416-27041610.03510.24
6295391-29539110.96211.18
恩格列净二甲双胍缓释片项目信息
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100664-202507对照品来源中检院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10
标示量(mg)1000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%
118870278876308872298870958873118872580.03
218816438822298819360.05
单位质量响应值RSD%判断
887258.00881936.000.43数据可信
供试品溶液-4批-二甲双胍-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%
5min1-0.0000.00244.950.000.00244.95
2-0.0000.00
3850-8500.0090.01
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min17916-79160.0800.0918.390.080.0916.67
210920-109200.1110.11
39542-95420.0970.10
48772-87720.0890.09
57542-75420.0770.08
66515-65150.0660.07
15min133067-330670.3360.369.010.340.369.25
236273-362730.3690.37
336355-363550.3700.37
436971-369710.3760.38
538247-382470.3890.39
629706-297060.3020.30
20min170566-705660.7170.725.400.720.725.42
267164-671640.6830.68
375511-755110.7670.77
473681-736810.7490.75
571747-717470.7290.73
665396-653960.6650.67
30min1139638-1396381.4191.383.911.421.383.85
2128450-1284501.3061.31
3141812-1418121.4411.44
4139572-1395721.4191.42
5136839-1368391.3911.39
6130963-1309631.3311.33
45min1207298-2072982.1072.052.242.112.062.19
2198279-1982792.0152.02
3207407-2074072.1082.11
4203001-2030012.0632.07
5199741-1997412.0302.03
6197024-1970242.0032.01
60min1259942-2599422.6422.571.802.652.581.83
2251097-2510972.5522.56
3256841-2568412.6112.62
4251796-2517962.5592.57
5248274-2482742.5232.53
6249573-2495732.5372.54
120min1399670-3996704.0623.971.644.073.981.61
2389320-3893203.9573.97
3394389-3943894.0094.02
4385400-3854003.9173.93
5381662-3816623.8793.89
6390648-3906483.9713.98
240min1573857-5738575.8335.741.265.855.761.25
2564000-5640005.7335.75
3570853-5708535.8025.82
4560908-5609085.7015.72
5554213-5542135.6335.65
6566928-5669285.7625.78
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1689987-6899877.0136.970.877.047.000.90
2682439-6824396.9366.96
3693535-6935357.0497.08
4682152-6821526.9336.96
5677429-6774296.8856.91
6687719-6877196.9907.02
480min1802377-8023778.1558.031.288.208.071.28
2776288-7762887.8907.93
3799304-7993048.1248.16
4788657-7886578.0168.06
5781367-7813677.9427.98
6791710-7917108.0478.09
600min1862288-8622888.7648.681.308.828.731.29
2837511-8375118.5128.57
3867957-8679578.8228.88
4853555-8535558.6768.73
5845398-8453988.5938.65
6854476-8544768.6858.74
720min1900761-9007619.1559.091.039.229.151.02
2879027-8790278.9349.00
3904587-9045879.1949.26
4893161-8931619.0789.15
5888743-8887439.0339.10
6897148-8971489.1199.19
840min1924970-9249709.4019.320.959.499.400.96
2901805-9018059.1669.25
3925183-9251839.4049.49
4916863-9168639.3199.40
5913319-9133199.2839.36
6918266-9182669.3339.42
960min1926707-9267079.4199.390.909.529.490.88
2913918-9139189.2899.39
3936034-9360349.5149.61
4924548-9245489.3979.50
5915061-9150619.3019.40
6927249-9272499.4259.52
极限1918020-9180209.3319.361.049.459.481.03
2914585-9145859.2969.41
3934046-9340469.4949.61
4924160-9241609.3939.51
5907655-9076559.2259.34
6927560-9275609.4289.54
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