溶出数据处理

达格列净二甲双胍缓释片项目信息

介质体积(ml)	1000	取样体积(ml)	5	补液体积(ml)	5
对照品批号	100664-202106	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	50
标示量(mg)	1000	供试品稀释倍数	5	系数	1

对照品溶液

序号	称样量(mg)	A₁	A₂	A₃	A₄	A₅	A_平均	RSD%
1	10.09	4289458	4286670	4283285	4283224	4292255	4286978	0.10
2	10.14	4356882	4360324				4358603	0.06

单位质量响应值		RSD%	判断
424873.93	429842.50	0.83	数据可信

供试品溶液-YA0011批-二甲双胍-pH1.2

时间 (分钟)	样品	A₁	A₂	A_平均	溶出量(%)	平均(%)	RSD%	累计溶出量(%)	平均(%)	RSD%
5min	1	122208	-	122208	2.860	2.86	4.84	2.86	2.86	4.82
	2	132871	-	132871	3.109			3.11
	3	117309	-	117309	2.745			2.75
	4	124012	-	124012	2.902			2.90
	5	117659	-	117659	2.753			2.75
	6	118598	-	118598	2.775			2.78
10min	1	283074	-	283074	6.624	7.09	5.09	6.64	7.10	5.08
	2	319745	-	319745	7.482			7.50
	3	320936	-	320936	7.510			7.52
	4	289746	-	289746	6.780			6.79
	5	303407	-	303407	7.100			7.11
	6	299844	-	299844	7.016			7.03
15min	1	431639	-	431639	10.101	10.42	4.27	10.15	10.47	4.25
	2	482397	-	482397	11.288			11.34
	3	439194	-	439194	10.277			10.33
	4	437239	-	437239	10.232			10.28
	5	433651	-	433651	10.148			10.20
	6	446673	-	446673	10.452			10.50
20min	1	549261	-	549261	12.853	13.35	3.84	12.95	13.45	3.83
	2	611191	-	611191	14.302			14.41
	3	561955	-	561955	13.150			13.25
	4	566627	-	566627	13.259			13.36
	5	557505	-	557505	13.046			13.15
	6	575411	-	575411	13.465			13.57
30min	1	762037	-	762037	17.832	18.41	2.98	17.99	18.58	3.00
	2	830173	-	830173	19.426			19.61
	3	780276	-	780276	18.259			18.43
	4	784304	-	784304	18.353			18.52
	5	773029	-	773029	18.089			18.25
	6	790346	-	790346	18.494			18.66
45min	1	1035242	-	1035242	24.225	24.54	2.00	24.48	24.80	2.01
	2	1084145	-	1084145	25.369			25.65
	3	1021337	-	1021337	23.900			24.16
	4	1050201	-	1050201	24.575			24.83
	5	1049017	-	1049017	24.547			24.80
	6	1051501	-	1051501	24.606			24.87
60min	1	1262231	-	1262231	29.537	29.85	1.94	29.91	30.24	1.94
	2	1322538	-	1322538	30.948			31.35
	3	1250251	-	1250251	29.256			29.64
	4	1275632	-	1275632	29.850			30.23
	5	1270388	-	1270388	29.728			30.11
	6	1273669	-	1273669	29.804			30.19
120min	1	1952434	-	1952434	45.688	45.95	2.00	46.21	46.48	2.00
	2	2037210	-	2037210	47.671			48.23
	3	1922589	-	1922589	44.989			45.51
	4	1943290	-	1943290	45.474			46.00
	5	1966380	-	1966380	46.014			46.54
	6	1960891	-	1960891	45.886			46.42
180min	1	2417506	-	2417506	56.571	57.40	1.71	57.32	58.16	1.71
	2	2502637	-	2502637	58.563			59.36
	3	2415872	-	2415872	56.532			57.28
	4	2468104	-	2468104	57.755			58.51
	5	2497990	-	2497990	58.454			59.21
	6	2415737	-	2415737	56.529			57.29

时间 (分钟)	样品	A₁	A₂	A_平均	溶出量(%)	平均(%)	RSD%	累计溶出量(%)	平均(%)	RSD%
240min	1	2855846	-	2855846	66.828	67.32	1.57	67.86	68.37	1.57
	2	2945433	-	2945433	68.924			70.01
	3	2819723	-	2819723	65.983			67.02
	4	2848972	-	2848972	66.667			67.71
	5	2883268	-	2883268	67.470			68.52
	6	2907530	-	2907530	68.037			69.08
360min	1	3479803	-	3479803	81.429	80.91	1.21	82.79	82.30	1.21
	2	3512904	-	3512904	82.203			83.64
	3	3394969	-	3394969	79.444			80.81
	4	3463980	-	3463980	81.058			82.44
	5	3468909	-	3468909	81.174			82.56
	6	3425227	-	3425227	80.152			81.54
480min	1	3822876	-	3822876	89.457	89.20	1.09	91.23	90.99	1.09
	2	3845546	-	3845546	89.987			91.83
	3	3748388	-	3748388	87.714			89.47
	4	3823240	-	3823240	89.465			91.25
	5	3855024	-	3855024	90.209			92.00
	6	3776779	-	3776779	88.378			90.16
600min	1	3989153	-	3989153	93.348	93.86	1.60	95.57	96.10	1.59
	2	4071501	-	4071501	95.275			97.57
	3	3896158	-	3896158	91.172			93.37
	4	4064902	-	4064902	95.120			97.35
	5	4020813	-	4020813	94.088			96.33
	6	4024569	-	4024569	94.176			96.40
720min	1	4069539	-	4069539	95.229	95.70	1.03	97.92	98.41	1.02
	2	4097705	-	4097705	95.888			98.66
	3	4052520	-	4052520	94.830			97.49
	4	4170494	-	4170494	97.591			100.30
	5	4073719	-	4073719	95.327			98.04
	6	4074403	-	4074403	95.343			98.04
极限	1	4043865	-	4043865	94.628	95.73	1.32	97.79	98.91	1.31
	2	4118331	-	4118331	96.370			99.62
	3	4008677	-	4008677	93.805			96.93
	4	4153592	-	4153592	97.196			100.39
	5	4118070	-	4118070	96.364			99.56
	6	4102645	-	4102645	96.003			99.18

达格列净二甲双胍缓释片项目信息

介质体积(ml)	1000	取样体积(ml)	5	补液体积(ml)	5
对照品批号	101568-202301	对照品来源	中检院	对照品使用方法	直接使用
对照品含量(%)	80.4	对照品水分(%)	0	对照品稀释倍数	12500
标示量(mg)	5	供试品稀释倍数	5	系数	1

对照品溶液

序号	称样量(mg)	A₁	A₂	A₃	A₄	A₅	A_平均	RSD%
1	13.00	16788	16705	16709	16667	16699	16714	0.27
2	13.02	16786	16833				16810	0.20

单位质量响应值		RSD%	判断
1285.69	1291.09	0.30	数据可信

供试品溶液-YA0011批-达格列净-pH1.2

时间 (分钟)	样品	A₁	A₂	A_平均	溶出量(%)	平均(%)	RSD%	累计溶出量(%)	平均(%)	RSD%
5min	1	12130	-	12130	60.557	64.86	12.77	60.56	64.86	12.77
	2	15385	-	15385	76.806			76.81
	3	13435	-	13435	67.071			67.07
	4	11952	-	11952	59.668			59.67
	5	10855	-	10855	54.191			54.19
	6	14194	-	14194	70.861			70.86
10min	1	18450	-	18450	92.108	91.34	3.78	92.41	91.67	3.80
	2	19517	-	19517	97.435			97.82
	3	18465	-	18465	92.183			92.52
	4	17768	-	17768	88.703			89.00
	5	17631	-	17631	88.019			88.29
	6	17950	-	17950	89.612			89.97
15min	1	19417	-	19417	96.935	94.44	4.36	97.70	95.22	4.37
	2	20219	-	20219	100.939			101.81
	3	18947	-	18947	94.589			95.39
	4	17975	-	17975	89.736			90.48
	5	18188	-	18188	90.800			91.51
	6	18754	-	18754	93.625			94.43
20min	1	19582	-	19582	97.759	95.26	3.93	99.01	96.51	3.95
	2	20266	-	20266	101.174			102.55
	3	18911	-	18911	94.409			95.68
	4	18477	-	18477	92.243			93.43
	5	18212	-	18212	90.920			92.08
	6	19041	-	19041	95.058			96.33
30min	1	19354	-	19354	96.621	95.28	3.52	98.36	97.01	3.55
	2	20196	-	20196	100.824			102.71
	3	19129	-	19129	95.498			97.24
	4	18545	-	18545	92.582			94.23
	5	18284	-	18284	91.279			92.90
	6	19002	-	19002	94.864			96.61
45min	1	19599	-	19599	97.844	94.98	3.37	100.06	97.18	3.39
	2	19910	-	19910	99.397			101.78
	3	18734	-	18734	93.526			95.74
	4	18451	-	18451	92.113			94.23
	5	18314	-	18314	91.429			93.50
	6	19145	-	19145	95.577			97.80
60min	1	19844	-	19844	99.067	95.80	3.68	101.78	98.48	3.70
	2	20141	-	20141	100.550			103.43
	3	19154	-	19154	95.622			98.31
	4	18612	-	18612	92.917			95.49
	5	18290	-	18290	91.309			93.84
	6	19094	-	19094	95.323			98.02
120min	1	19863	-	19863	99.162	95.09	4.28	102.37	98.25	4.27
	2	20170	-	20170	100.695			104.08
	3	18743	-	18743	93.571			96.74
	4	18157	-	18157	90.645			93.68
	5	18342	-	18342	91.569			94.56
	6	19005	-	19005	94.879			98.05
180min	1	19475	-	19475	97.225	94.07	3.21	100.93	97.70	3.24
	2	19746	-	19746	98.578			102.47
	3	18557	-	18557	92.642			96.27
	4	18402	-	18402	91.868			95.36
	5	18368	-	18368	91.698			95.15
	6	18508	-	18508	92.397			96.05

时间 (分钟)	样品	A₁	A₂	A_平均	溶出量(%)	平均(%)	RSD%	累计溶出量(%)	平均(%)	RSD%
240min	1	19729	-	19729	98.493	93.90	4.20	102.68	98.00	4.18
	2	19878	-	19878	99.237			103.62
	3	18490	-	18490	92.308			96.40
	4	18176	-	18176	90.740			94.69
	5	18093	-	18093	90.326			94.23
	6	18482	-	18482	92.268			96.38
360min	1	19695	-	19695	98.323	93.84	3.51	103.00	98.42	3.51
	2	19545	-	19545	97.574			102.45
	3	18607	-	18607	92.892			97.45
	4	18246	-	18246	91.089			95.50
	5	18178	-	18178	90.750			95.11
	6	18514	-	18514	92.427			97.00
480min	1	19576	-	19576	97.729	92.66	3.61	102.90	97.71	3.59
	2	19230	-	19230	96.002			101.37
	3	18302	-	18302	91.369			96.39
	4	18013	-	18013	89.926			94.79
	5	18081	-	18081	90.266			95.08
	6	18163	-	18163	90.675			95.71
600min	1	19084	-	19084	95.273	91.59	3.24	100.93	97.10	3.25
	2	19128	-	19128	95.493			101.34
	3	18004	-	18004	89.881			95.36
	4	18034	-	18034	90.031			95.34
	5	17838	-	17838	89.053			94.32
	6	17989	-	17989	89.806			95.29
720min	1	19357	-	19357	96.636	91.75	3.51	102.77	97.71	3.51
	2	18948	-	18948	94.594			100.92
	3	18244	-	18244	91.079			97.01
	4	17908	-	17908	89.402			95.16
	5	17670	-	17670	88.214			93.92
	6	18140	-	18140	90.560			96.50
极限	1	18895	-	18895	94.329	91.09	2.88	100.95	97.51	2.93
	2	18808	-	18808	93.895			100.69
	3	18106	-	18106	90.390			96.77
	4	17770	-	17770	88.713			94.92
	5	17623	-	17623	87.979			94.13
	6	18271	-	18271	91.214			97.60

达格列净二甲双胍缓释片项目信息

介质体积(ml)	1000	取样体积(ml)	5	补液体积(ml)	5
对照品批号	100664-202106	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	50
标示量(mg)	1000	供试品稀释倍数	5	系数	1

对照品溶液

序号	称样量(mg)	A₁	A₂	A₃	A₄	A₅	A_平均	RSD%
1	10.09	4355665	4357555	4362954	4356405	4367337	4359983	0.12
2	10.14	4365150	4365800				4365475	0.02

单位质量响应值		RSD%	判断
432109.32	430520.22	0.27	数据可信

供试品溶液-YA0011批-二甲双胍-pH1.2

时间 (分钟)	样品	A₁	A₂	A_平均	溶出量(%)	平均(%)	RSD%	累计溶出量(%)	平均(%)	RSD%
5min	1	115258	-	115258	2.672	2.65	7.35	2.67	2.65	7.37
	2	115462	-	115462	2.677			2.68
	3	108506	-	108506	2.516			2.52
	4	113473	-	113473	2.631			2.63
	5	128511	-	128511	2.980			2.98
	6	103670	-	103670	2.404			2.40
10min	1	278687	-	278687	6.461	6.39	1.65	6.47	6.40	1.63
	2	271172	-	271172	6.287			6.30
	3	280579	-	280579	6.505			6.52
	4	277106	-	277106	6.425			6.44
	5	276906	-	276906	6.420			6.43
	6	268916	-	268916	6.235			6.25
15min	1	421315	-	421315	9.768	9.64	2.60	9.81	9.68	2.56
	2	395572	-	395572	9.171			9.22
	3	420858	-	420858	9.758			9.80
	4	422647	-	422647	9.799			9.84
	5	422281	-	422281	9.791			9.84
	6	410813	-	410813	9.525			9.57
20min	1	528525	-	528525	12.254	12.43	2.49	12.35	12.52	2.49
	2	513418	-	513418	11.904			11.99
	3	545019	-	545019	12.636			12.73
	4	536616	-	536616	12.441			12.54
	5	548932	-	548932	12.727			12.82
	6	544562	-	544562	12.626			12.72
30min	1	750666	-	750666	17.404	17.14	1.59	17.56	17.30	1.58
	2	717055	-	717055	16.625			16.78
	3	741608	-	741608	17.194			17.35
	4	738077	-	738077	17.112			17.27
	5	742964	-	742964	17.226			17.39
	6	745556	-	745556	17.286			17.44
45min	1	1002110	-	1002110	23.234	23.19	1.09	23.48	23.43	1.11
	2	984289	-	984289	22.821			23.05
	3	1002524	-	1002524	23.244			23.49
	4	998840	-	998840	23.158			23.40
	5	1017566	-	1017566	23.592			23.84
	6	995186	-	995186	23.073			23.31
60min	1	1228802	-	1228802	28.490	27.97	1.54	28.85	28.33	1.53
	2	1181929	-	1181929	27.403			27.75
	3	1200815	-	1200815	27.841			28.20
	4	1202017	-	1202017	27.869			28.23
	5	1197378	-	1197378	27.761			28.12
	6	1228316	-	1228316	28.479			28.83
120min	1	1881576	-	1881576	43.624	43.07	1.08	44.13	43.57	1.08
	2	1851941	-	1851941	42.937			43.42
	3	1823336	-	1823336	42.274			42.77
	4	1855012	-	1855012	43.008			43.51
	5	1870612	-	1870612	43.370			43.87
	6	1863877	-	1863877	43.214			43.71
180min	1	2453982	-	2453982	56.896	57.19	1.37	57.62	57.90	1.35
	2	2475861	-	2475861	57.403			58.10
	3	2462500	-	2462500	57.093			57.80
	4	2477149	-	2477149	57.433			58.14
	5	2414009	-	2414009	55.969			56.69
	6	2517177	-	2517177	58.361			59.07

时间 (分钟)	样品	A₁	A₂	A_平均	溶出量(%)	平均(%)	RSD%	累计溶出量(%)	平均(%)	RSD%
240min	1	2839109	-	2839109	65.825	65.93	1.64	66.83	66.93	1.62
	2	2890758	-	2890758	67.022			68.01
	3	2812375	-	2812375	65.205			66.20
	4	2859109	-	2859109	66.288			67.29
	5	2771211	-	2771211	64.251			65.25
	6	2890037	-	2890037	67.006			68.01
360min	1	3472662	-	3472662	80.514	79.56	1.09	81.85	80.89	1.08
	2	3419391	-	3419391	79.279			80.60
	3	3415246	-	3415246	79.182			80.50
	4	3459238	-	3459238	80.202			81.53
	5	3371386	-	3371386	78.166			79.49
	6	3452185	-	3452185	80.039			81.38
480min	1	3827062	-	3827062	88.730	88.54	0.61	90.47	90.26	0.61
	2	3844227	-	3844227	89.128			90.85
	3	3797915	-	3797915	88.055			89.77
	4	3803569	-	3803569	88.186			89.92
	5	3793970	-	3793970	87.963			89.67
	6	3845503	-	3845503	89.158			90.90
600min	1	3996877	-	3996877	92.668	93.35	1.43	94.85	95.52	1.40
	2	4014285	-	4014285	93.071			95.23
	3	4131890	-	4131890	95.798			97.96
	4	3974164	-	3974164	92.141			94.31
	5	3991550	-	3991550	92.544			94.70
	6	4047952	-	4047952	93.852			96.04
720min	1	4019545	-	4019545	93.193	94.51	1.12	95.84	97.14	1.10
	2	4124070	-	4124070	95.617			98.25
	3	4047951	-	4047951	93.852			96.49
	4	4122176	-	4122176	95.573			98.21
	5	4040552	-	4040552	93.680			96.29
	6	4102510	-	4102510	95.117			97.77
极限	1	4067627	-	4067627	94.308	95.09	1.39	97.42	98.20	1.36
	2	4137378	-	4137378	95.925			99.03
	3	4108784	-	4108784	95.262			98.37
	4	4044872	-	4044872	93.780			96.89
	5	4056899	-	4056899	94.059			97.14
	6	4192955	-	4192955	97.214			100.35

达格列净二甲双胍缓释片项目信息

介质体积(ml)	1000	取样体积(ml)	5	补液体积(ml)	5
对照品批号	101568-202301	对照品来源	中检院	对照品使用方法	直接使用
对照品含量(%)	80.4	对照品水分(%)	0	对照品稀释倍数	12500
标示量(mg)	5	供试品稀释倍数	5	系数	1

对照品溶液

序号	称样量(mg)	A₁	A₂	A₃	A₄	A₅	A_平均	RSD%
1	13.00	17017	16746	16873	16987	16859	16896	0.65
2	13.02	16924	16986				16955	0.26

单位质量响应值		RSD%	判断
1299.69	1302.23	0.14	数据可信

供试品溶液-YA0011批-达格列净-pH1.2

时间 (分钟)	样品	A₁	A₂	A_平均	溶出量(%)	平均(%)	RSD%	累计溶出量(%)	平均(%)	RSD%
5min	1	10762	-	10762	53.208	57.49	10.81	53.21	57.49	10.81
	2	9739	-	9739	48.150			48.15
	3	13200	-	13200	65.261			65.26
	4	12519	-	12519	61.895			61.89
	5	12141	-	12141	60.026			60.03
	6	11404	-	11404	56.382			56.38
10min	1	17454	-	17454	86.293	86.92	3.73	86.56	87.21	3.74
	2	16587	-	16587	82.007			82.25
	3	18164	-	18164	89.804			90.13
	4	17202	-	17202	85.047			85.36
	5	17698	-	17698	87.500			87.80
	6	18383	-	18383	90.886			91.17
15min	1	18126	-	18126	89.616	90.64	2.73	90.31	91.36	2.74
	2	17723	-	17723	87.623			88.27
	3	18872	-	18872	93.304			94.08
	4	18133	-	18133	89.650			90.39
	5	18129	-	18129	89.631			90.37
	6	19011	-	19011	93.991			94.73
20min	1	18490	-	18490	91.415	92.08	2.97	92.56	93.26	2.98
	2	17678	-	17678	87.401			88.49
	3	19019	-	19019	94.031			95.27
	4	18723	-	18723	92.567			93.75
	5	18552	-	18552	91.722			92.91
	6	19289	-	19289	95.366			96.57
30min	1	18995	-	18995	93.912	93.06	2.89	95.51	94.69	2.89
	2	17977	-	17977	88.879			90.41
	3	19108	-	19108	94.471			96.18
	4	18885	-	18885	93.368			95.01
	5	18442	-	18442	91.178			92.82
	6	19527	-	19527	96.542			98.23
45min	1	18826	-	18826	93.077	93.29	2.13	95.15	95.39	2.16
	2	18196	-	18196	89.962			91.93
	3	19237	-	19237	95.109			97.29
	4	18923	-	18923	93.556			95.67
	5	18727	-	18727	92.587			94.69
	6	19309	-	19309	95.465			97.63
60min	1	18967	-	18967	93.774	92.99	2.84	96.31	95.56	2.85
	2	17916	-	17916	88.578			91.00
	3	19190	-	19190	94.876			97.54
	4	18865	-	18865	93.269			95.85
	5	18503	-	18503	91.480			94.04
	6	19409	-	19409	95.959			98.60
120min	1	18986	-	18986	93.868	92.93	1.70	96.87	95.96	1.74
	2	18199	-	18199	89.977			92.84
	3	18937	-	18937	93.625			96.76
	4	18808	-	18808	92.988			96.03
	5	18745	-	18745	92.676			95.70
	6	19099	-	19099	94.426			97.55
180min	1	19314	-	19314	95.489	94.17	3.48	98.97	97.67	3.32
	2	19929	-	19929	98.530			101.84
	3	18874	-	18874	93.314			96.92
	4	18882	-	18882	93.353			96.87
	5	17949	-	17949	88.741			92.22
	6	19333	-	19333	95.583			99.18

时间 (分钟)	样品	A₁	A₂	A_平均	溶出量(%)	平均(%)	RSD%	累计溶出量(%)	平均(%)	RSD%
240min	1	19194	-	19194	94.896	93.45	3.39	98.85	97.42	3.23
	2	19555	-	19555	96.681			100.49
	3	18553	-	18553	91.727			95.80
	4	19000	-	19000	93.937			97.92
	5	17794	-	17794	87.974			91.90
	6	19316	-	19316	95.499			99.57
360min	1	19411	-	19411	95.969	93.15	2.99	100.40	97.58	2.83
	2	19319	-	19319	95.514			99.80
	3	18248	-	18248	90.219			94.75
	4	19089	-	19089	94.377			98.83
	5	18063	-	18063	89.304			93.67
	6	18914	-	18914	93.512			98.06
480min	1	19099	-	19099	94.426	93.19	2.56	99.33	98.09	2.43
	2	19459	-	19459	96.206			100.97
	3	18459	-	18459	91.262			96.24
	4	18821	-	18821	93.052			97.97
	5	18140	-	18140	89.685			94.50
	6	19115	-	19115	94.505			99.52
600min	1	18843	-	18843	93.161	92.43	2.53	98.54	97.80	2.41
	2	19245	-	19245	95.148			100.40
	3	18838	-	18838	93.136			98.57
	4	18576	-	18576	91.841			97.23
	5	17839	-	17839	88.197			93.46
	6	18830	-	18830	93.096			98.59
720min	1	18411	-	18411	91.025	91.29	3.35	96.87	97.12	3.17
	2	19188	-	19188	94.866			100.59
	3	18062	-	18062	89.299			95.20
	4	18902	-	18902	93.452			99.30
	5	17489	-	17489	86.466			92.17
	6	18737	-	18737	92.637			98.59
极限	1	18735	-	18735	92.627	91.54	3.08	98.93	97.82	2.93
	2	19161	-	19161	94.733			100.93
	3	18243	-	18243	90.194			96.54
	4	18418	-	18418	91.059			97.37
	5	17576	-	17576	86.897			93.03
	6	18954	-	18954	93.709			100.13

点击查看处理图标(人工保存)

图1　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-溶剂
图2　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-对照品溶液-1-1
图3　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-对照品溶液-1-2
图4　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-对照品溶液-1-3
图5　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-对照品溶液-1-4
图6　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-对照品溶液-1-5
图7　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-5min-片1-供试品溶液-1
图8　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-5min-片2-供试品溶液-1
图9　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-5min-片3-供试品溶液-1
图10　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-5min-片4-供试品溶液-1
图11　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-5min-片5-供试品溶液-1
图12　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-5min-片6-供试品溶液-1
图13　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-10min-片1-供试品溶液-1
图14　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-10min-片2-供试品溶液-1
图15　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-10min-片3-供试品溶液-1
图16　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-10min-片4-供试品溶液-1
图17　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-10min-片5-供试品溶液-1
图18　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-10min-片6-供试品溶液-1
图19　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-15min-片1-供试品溶液-1
图20　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-15min-片2-供试品溶液-1
图21　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-15min-片3-供试品溶液-1
图22　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-15min-片4-供试品溶液-1
图23　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-15min-片5-供试品溶液-1
图24　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-15min-片6-供试品溶液-1
图25　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-20min-片1-供试品溶液-1
图26　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-20min-片2-供试品溶液-1
图27　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-20min-片3-供试品溶液-1
图28　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-20min-片4-供试品溶液-1
图29　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-20min-片5-供试品溶液-1
图30　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-20min-片6-供试品溶液-1
图31　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-30min-片1-供试品溶液-1
图32　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-30min-片2-供试品溶液-1
图33　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-30min-片3-供试品溶液-1
图34　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-30min-片4-供试品溶液-1
图35　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-30min-片5-供试品溶液-1
图36　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-30min-片6-供试品溶液-1
图37　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-45min-片1-供试品溶液-1
图38　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-45min-片2-供试品溶液-1
图39　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-45min-片3-供试品溶液-1
图40　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-45min-片4-供试品溶液-1
图41　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-45min-片5-供试品溶液-1
图42　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-45min-片6-供试品溶液-1
图43　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-60min-片1-供试品溶液-1
图44　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-60min-片2-供试品溶液-1
图45　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-60min-片3-供试品溶液-1
图46　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-60min-片4-供试品溶液-1
图47　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-60min-片5-供试品溶液-1
图48　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-60min-片6-供试品溶液-1
图49　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-120min-片1-供试品溶液-1
图50　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-120min-片2-供试品溶液-1
图51　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-120min-片3-供试品溶液-1
图52　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-120min-片4-供试品溶液-1
图53　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-120min-片5-供试品溶液-1
图54　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-120min-片6-供试品溶液-1
图55　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-180min-片1-供试品溶液-1
图56　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-180min-片2-供试品溶液-1
图57　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-180min-片3-供试品溶液-1
图58　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-180min-片4-供试品溶液-1
图59　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-180min-片5-供试品溶液-1
图60　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-180min-片6-供试品溶液-1
图61　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-240min-片1-供试品溶液-1
图62　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-240min-片2-供试品溶液-1
图63　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-240min-片3-供试品溶液-1
图64　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-240min-片4-供试品溶液-1
图65　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-240min-片5-供试品溶液-1
图66　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-240min-片6-供试品溶液-1
图67　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-360min-片1-供试品溶液-1
图68　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-360min-片2-供试品溶液-1
图69　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-360min-片3-供试品溶液-1
图70　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-360min-片4-供试品溶液-1
图71　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-360min-片5-供试品溶液-1
图72　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-360min-片6-供试品溶液-1
图73　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-480min-片1-供试品溶液-1
图74　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-480min-片2-供试品溶液-1
图75　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-480min-片3-供试品溶液-1
图76　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-480min-片4-供试品溶液-1
图77　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-480min-片5-供试品溶液-1
图78　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-480min-片6-供试品溶液-1
图79　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-600min-片1-供试品溶液-1
图80　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-600min-片2-供试品溶液-1
图81　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-600min-片3-供试品溶液-1
图82　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-600min-片4-供试品溶液-1
图83　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-600min-片5-供试品溶液-1
图84　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-600min-片6-供试品溶液-1
图85　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-720min-片1-供试品溶液-1
图86　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-720min-片2-供试品溶液-1
图87　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-720min-片3-供试品溶液-1
图88　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-720min-片4-供试品溶液-1
图89　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-720min-片5-供试品溶液-1
图90　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-720min-片6-供试品溶液-1
图91　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-极限转速-片1-供试品溶液-1
图92　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-极限转速-片2-供试品溶液-1
图93　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-极限转速-片3-供试品溶液-1
图94　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-极限转速-片4-供试品溶液-1
图95　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-极限转速-片5-供试品溶液-1
图96　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-极限转速-片6-供试品溶液-1
图97　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-对照品溶液-2-1
图98　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性1-pH1.2介质-篮法-100转-对照品溶液-2-2
图99　达格列净二甲双胍缓释片溶出曲线测定HPLC图谱-参比制剂-YA0011批-均一性2-pH1.2介质-篮法-100转-溶剂

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