CN1679871A - 一种复方丹参滴丸质量控制方法 - Google Patents
一种复方丹参滴丸质量控制方法 Download PDFInfo
- Publication number
- CN1679871A CN1679871A CN 200510055262 CN200510055262A CN1679871A CN 1679871 A CN1679871 A CN 1679871A CN 200510055262 CN200510055262 CN 200510055262 CN 200510055262 A CN200510055262 A CN 200510055262A CN 1679871 A CN1679871 A CN 1679871A
- Authority
- CN
- China
- Prior art keywords
- rsd
- fufang danshen
- danshen diwan
- peaks
- peak area
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 244000132619 red sage Species 0.000 title claims abstract description 33
- 238000003908 quality control method Methods 0.000 title claims abstract description 27
- 150000001875 compounds Chemical class 0.000 title claims abstract description 22
- WTPPRJKFRFIQKT-UHFFFAOYSA-N 1,6-dimethyl-8,9-dihydronaphtho[1,2-g][1]benzofuran-10,11-dione;1-methyl-6-methylidene-8,9-dihydro-7h-naphtho[1,2-g][1]benzofuran-10,11-dione Chemical compound O=C1C(=O)C2=C3CCCC(=C)C3=CC=C2C2=C1C(C)=CO2.O=C1C(=O)C2=C3CCC=C(C)C3=CC=C2C2=C1C(C)=CO2 WTPPRJKFRFIQKT-UHFFFAOYSA-N 0.000 title claims abstract description 19
- 238000000034 method Methods 0.000 claims abstract description 38
- 239000013068 control sample Substances 0.000 claims abstract description 19
- 239000008899 fufang danshen Substances 0.000 claims description 141
- 230000014759 maintenance of location Effects 0.000 claims description 86
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims description 66
- 239000007864 aqueous solution Substances 0.000 claims description 52
- 229910019142 PO4 Inorganic materials 0.000 claims description 46
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 46
- 239000010452 phosphate Substances 0.000 claims description 46
- 240000007164 Salvia officinalis Species 0.000 claims description 39
- 238000007639 printing Methods 0.000 claims description 36
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 34
- 238000002360 preparation method Methods 0.000 claims description 31
- 239000000243 solution Substances 0.000 claims description 31
- 235000017276 Salvia Nutrition 0.000 claims description 29
- 239000007788 liquid Substances 0.000 claims description 21
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 17
- 238000004128 high performance liquid chromatography Methods 0.000 claims description 12
- 239000006187 pill Substances 0.000 claims description 12
- 238000005303 weighing Methods 0.000 claims description 9
- 238000010828 elution Methods 0.000 claims description 8
- 239000000945 filler Substances 0.000 claims description 8
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 claims description 8
- 239000000377 silicon dioxide Substances 0.000 claims description 8
- FGDQGIKMWOAFIK-UHFFFAOYSA-N acetonitrile;phosphoric acid Chemical compound CC#N.OP(O)(O)=O FGDQGIKMWOAFIK-UHFFFAOYSA-N 0.000 claims description 5
- 238000005070 sampling Methods 0.000 claims description 5
- 238000004090 dissolution Methods 0.000 claims description 4
- 238000004811 liquid chromatography Methods 0.000 abstract description 8
- 238000010521 absorption reaction Methods 0.000 abstract description 5
- 239000012071 phase Substances 0.000 description 46
- 239000003814 drug Substances 0.000 description 38
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 36
- 239000000047 product Substances 0.000 description 32
- 239000000126 substance Substances 0.000 description 32
- 241000180649 Panax notoginseng Species 0.000 description 30
- 239000000470 constituent Substances 0.000 description 30
- 235000003143 Panax notoginseng Nutrition 0.000 description 29
- 235000011135 Salvia miltiorrhiza Nutrition 0.000 description 14
- 239000000523 sample Substances 0.000 description 13
- 238000003556 assay Methods 0.000 description 10
- 230000000694 effects Effects 0.000 description 10
- 239000000203 mixture Substances 0.000 description 10
- 235000005412 red sage Nutrition 0.000 description 10
- AIGAZQPHXLWMOJ-UHFFFAOYSA-N Tanshinone I Chemical compound C1=CC2=C(C)C=CC=C2C(C(=O)C2=O)=C1C1=C2C(C)=CO1 AIGAZQPHXLWMOJ-UHFFFAOYSA-N 0.000 description 9
- 229940079593 drug Drugs 0.000 description 7
- 239000000463 material Substances 0.000 description 7
- 238000012360 testing method Methods 0.000 description 7
- 239000000706 filtrate Substances 0.000 description 6
- 238000010992 reflux Methods 0.000 description 6
- 238000000926 separation method Methods 0.000 description 6
- 239000006228 supernatant Substances 0.000 description 6
- DTGKSKDOIYIVQL-WEDXCCLWSA-N (+)-borneol Chemical compound C1C[C@@]2(C)[C@@H](O)C[C@@H]1C2(C)C DTGKSKDOIYIVQL-WEDXCCLWSA-N 0.000 description 5
- 208000024172 Cardiovascular disease Diseases 0.000 description 5
- 229930183118 Tanshinone Natural products 0.000 description 5
- 239000002253 acid Substances 0.000 description 5
- 239000004615 ingredient Substances 0.000 description 5
- 239000012567 medical material Substances 0.000 description 5
- 239000012488 sample solution Substances 0.000 description 5
- PAFLSMZLRSPALU-MRVPVSSYSA-N (2R)-3-(3,4-dihydroxyphenyl)lactic acid Chemical compound OC(=O)[C@H](O)CC1=CC=C(O)C(O)=C1 PAFLSMZLRSPALU-MRVPVSSYSA-N 0.000 description 4
- IBGBGRVKPALMCQ-UHFFFAOYSA-N 3,4-dihydroxybenzaldehyde Chemical compound OC1=CC=C(C=O)C=C1O IBGBGRVKPALMCQ-UHFFFAOYSA-N 0.000 description 4
- PAFLSMZLRSPALU-QMMMGPOBSA-N Danshensu Natural products OC(=O)[C@@H](O)CC1=CC=C(O)C(O)=C1 PAFLSMZLRSPALU-QMMMGPOBSA-N 0.000 description 4
- 241000196324 Embryophyta Species 0.000 description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 4
- PAFLSMZLRSPALU-UHFFFAOYSA-N Salvianic acid A Natural products OC(=O)C(O)CC1=CC=C(O)C(O)=C1 PAFLSMZLRSPALU-UHFFFAOYSA-N 0.000 description 4
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 4
- 208000026106 cerebrovascular disease Diseases 0.000 description 4
- 230000002526 effect on cardiovascular system Effects 0.000 description 4
- 239000008187 granular material Substances 0.000 description 4
- 239000007791 liquid phase Substances 0.000 description 4
- 239000013558 reference substance Substances 0.000 description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 239000002131 composite material Substances 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 239000000284 extract Substances 0.000 description 3
- 229930182494 ginsenoside Natural products 0.000 description 3
- 229940089161 ginsenoside Drugs 0.000 description 3
- 235000008216 herbs Nutrition 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 3
- 239000008108 microcrystalline cellulose Substances 0.000 description 3
- 229940016286 microcrystalline cellulose Drugs 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 239000001397 quillaja saponaria molina bark Substances 0.000 description 3
- 229930182490 saponin Natural products 0.000 description 3
- 150000007949 saponins Chemical class 0.000 description 3
- DOUMFZQKYFQNTF-WUTVXBCWSA-N (R)-rosmarinic acid Chemical compound C([C@H](C(=O)O)OC(=O)\C=C\C=1C=C(O)C(O)=CC=1)C1=CC=C(O)C(O)=C1 DOUMFZQKYFQNTF-WUTVXBCWSA-N 0.000 description 2
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 description 2
- SNKFFCBZYFGCQN-UHFFFAOYSA-N 2-[3-[3-[1-carboxy-2-(3,4-dihydroxyphenyl)ethoxy]carbonyl-2-(3,4-dihydroxyphenyl)-7-hydroxy-2,3-dihydro-1-benzofuran-4-yl]prop-2-enoyloxy]-3-(3,4-dihydroxyphenyl)propanoic acid Chemical compound C=1C=C(O)C=2OC(C=3C=C(O)C(O)=CC=3)C(C(=O)OC(CC=3C=C(O)C(O)=CC=3)C(O)=O)C=2C=1C=CC(=O)OC(C(=O)O)CC1=CC=C(O)C(O)=C1 SNKFFCBZYFGCQN-UHFFFAOYSA-N 0.000 description 2
- YMGFTDKNIWPMGF-AGYDPFETSA-N 3-(3,4-dihydroxyphenyl)-2-[(e)-3-[2-[(e)-2-(3,4-dihydroxyphenyl)ethenyl]-3,4-dihydroxyphenyl]prop-2-enoyl]oxypropanoic acid Chemical compound C=1C=C(O)C(O)=C(\C=C\C=2C=C(O)C(O)=CC=2)C=1/C=C/C(=O)OC(C(=O)O)CC1=CC=C(O)C(O)=C1 YMGFTDKNIWPMGF-AGYDPFETSA-N 0.000 description 2
- XYKZSUXWBGUGQV-UHFFFAOYSA-N 4,8-dimethylnaphtho[2,1-f][1]benzofuran-7,11-dione Chemical compound CC1=CC=CC2=C(C(C=3OC=C(C=3C3=O)C)=O)C3=CC=C21 XYKZSUXWBGUGQV-UHFFFAOYSA-N 0.000 description 2
- 241000208340 Araliaceae Species 0.000 description 2
- SMDOOINVMJSDPS-UHFFFAOYSA-N Astragaloside Natural products C1=C(O)C(OC)=CC(C2=C(C(=O)C3=C(O)C=C(O)C=C3O2)OC2C(C(OC3C(C(O)C(O)C(CO)O3)O)C(O)C(CO)O2)O)=C1 SMDOOINVMJSDPS-UHFFFAOYSA-N 0.000 description 2
- 206010013786 Dry skin Diseases 0.000 description 2
- 235000011201 Ginkgo Nutrition 0.000 description 2
- 244000194101 Ginkgo biloba Species 0.000 description 2
- 235000008100 Ginkgo biloba Nutrition 0.000 description 2
- 239000009636 Huang Qi Substances 0.000 description 2
- SNKFFCBZYFGCQN-VWUOOIFGSA-N Lithospermic acid B Natural products C([C@H](C(=O)O)OC(=O)\C=C\C=1C=2[C@H](C(=O)O[C@H](CC=3C=C(O)C(O)=CC=3)C(O)=O)[C@H](OC=2C(O)=CC=1)C=1C=C(O)C(O)=CC=1)C1=CC=C(O)C(O)=C1 SNKFFCBZYFGCQN-VWUOOIFGSA-N 0.000 description 2
- 229920002584 Polyethylene Glycol 6000 Polymers 0.000 description 2
- YMGFTDKNIWPMGF-QHCPKHFHSA-N Salvianolic acid A Natural products OC(=O)[C@H](Cc1ccc(O)c(O)c1)OC(=O)C=Cc2ccc(O)c(O)c2C=Cc3ccc(O)c(O)c3 YMGFTDKNIWPMGF-QHCPKHFHSA-N 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- 230000001476 alcoholic effect Effects 0.000 description 2
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 2
- QMNWISYXSJWHRY-XWJCTJPOSA-N astragaloside Chemical compound O1[C@H](C(C)(O)C)CC[C@]1(C)[C@@H]1[C@@]2(C)CC[C@]34C[C@]4(CC[C@H](O[C@H]4[C@@H]([C@@H](O)[C@H](O)CO4)O)C4(C)C)C4[C@@H](O[C@H]4[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O4)O)CC3[C@]2(C)C[C@@H]1O QMNWISYXSJWHRY-XWJCTJPOSA-N 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- OORMXZNMRWBSTK-LGFJJATJSA-N dammarane Chemical compound C1CCC(C)(C)[C@@H]2CC[C@@]3(C)[C@]4(C)CC[C@H]([C@H](C)CCCC(C)C)[C@H]4CC[C@@H]3[C@]21C OORMXZNMRWBSTK-LGFJJATJSA-N 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 238000000605 extraction Methods 0.000 description 2
- 239000004744 fabric Substances 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 229940093429 polyethylene glycol 6000 Drugs 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 229960003371 protocatechualdehyde Drugs 0.000 description 2
- 238000010298 pulverizing process Methods 0.000 description 2
- 238000000746 purification Methods 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- STCJJTBMWHMRCD-UHFFFAOYSA-N salvianolic acid B Natural products OC(=O)C(Cc1ccc(O)c(O)c1)OC(=O)C=Cc2cc(O)c(O)c3OC(C(C(=O)OC(Cc4ccc(O)c(O)c4)C(=O)O)c23)c5ccc(O)c(O)c5 STCJJTBMWHMRCD-UHFFFAOYSA-N 0.000 description 2
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 2
- 235000017557 sodium bicarbonate Nutrition 0.000 description 2
- 239000007779 soft material Substances 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 238000004809 thin layer chromatography Methods 0.000 description 2
- LJEROUHPDCFEGJ-VVTLTYDVSA-N (1r,3r,4s)-4,7,9-trihydroxy-1,3-dimethyl-3,4-dihydro-1h-benzo[g]isochromene-5,10-dione Chemical compound O=C1C2=CC(O)=CC(O)=C2C(=O)C2=C1[C@H](O)[C@@H](C)O[C@@H]2C LJEROUHPDCFEGJ-VVTLTYDVSA-N 0.000 description 1
- XDUXBBDRILEIEZ-LJQANCHMSA-N (6s)-6-(hydroxymethyl)-1,6-dimethyl-8,9-dihydro-7h-naphtho[1,2-g][1]benzofuran-10,11-dione Chemical compound O=C1C(=O)C2=C3CCC[C@](C)(CO)C3=CC=C2C2=C1C(C)=CO2 XDUXBBDRILEIEZ-LJQANCHMSA-N 0.000 description 1
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- GVKKJJOMQCNPGB-JTQLQIEISA-N Cryptotanshinone Chemical compound O=C1C(=O)C2=C3CCCC(C)(C)C3=CC=C2C2=C1[C@@H](C)CO2 GVKKJJOMQCNPGB-JTQLQIEISA-N 0.000 description 1
- GVKKJJOMQCNPGB-UHFFFAOYSA-N Cryptotanshinone Natural products O=C1C(=O)C2=C3CCCC(C)(C)C3=CC=C2C2=C1C(C)CO2 GVKKJJOMQCNPGB-UHFFFAOYSA-N 0.000 description 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- 206010013709 Drug ineffective Diseases 0.000 description 1
- SHWNNYZBHZIQQV-UHFFFAOYSA-J EDTA monocalcium diisodium salt Chemical compound [Na+].[Na+].[Ca+2].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O SHWNNYZBHZIQQV-UHFFFAOYSA-J 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 244000131316 Panax pseudoginseng Species 0.000 description 1
- 235000003181 Panax pseudoginseng Nutrition 0.000 description 1
- 240000007711 Peperomia pellucida Species 0.000 description 1
- 235000012364 Peperomia pellucida Nutrition 0.000 description 1
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- 235000011158 Prunus mume Nutrition 0.000 description 1
- 244000018795 Prunus mume Species 0.000 description 1
- ZZAFFYPNLYCDEP-HNNXBMFYSA-N Rosmarinsaeure Natural products OC(=O)[C@H](Cc1cccc(O)c1O)OC(=O)C=Cc2ccc(O)c(O)c2 ZZAFFYPNLYCDEP-HNNXBMFYSA-N 0.000 description 1
- GCJWPRRNLSHTRY-UHFFFAOYSA-N Salvianolic acid C Natural products C=1C=C(O)C=2OC(C=3C=C(O)C(O)=CC=3)=CC=2C=1C=CC(=O)OC(C(=O)O)CC1=CC=C(O)C(O)=C1 GCJWPRRNLSHTRY-UHFFFAOYSA-N 0.000 description 1
- GCJWPRRNLSHTRY-VURDRKPISA-N Salvianolic acid C Chemical compound C([C@H](C(=O)O)OC(=O)\C=C\C=1C=2C=C(OC=2C(O)=CC=1)C=1C=C(O)C(O)=CC=1)C1=CC=C(O)C(O)=C1 GCJWPRRNLSHTRY-VURDRKPISA-N 0.000 description 1
- UMPZKDHDIZUVTO-UHFFFAOYSA-N Salvianolic acid D Natural products Cc1ccc(C=CC(=O)OC(Cc2ccc(O)c(O)c2)C(=O)O)c(CC(=O)O)c1O UMPZKDHDIZUVTO-UHFFFAOYSA-N 0.000 description 1
- KFCMFABBVSIHTB-WUTVXBCWSA-N Salvianolic acid D Chemical compound OC(=O)CC1=C(O)C(O)=CC=C1\C=C\C(=O)O[C@@H](C(O)=O)CC1=CC=C(O)C(O)=C1 KFCMFABBVSIHTB-WUTVXBCWSA-N 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 1
- HYXITZLLTYIPOF-UHFFFAOYSA-N Tanshinone II Natural products O=C1C(=O)C2=C3CCCC(C)(C)C3=CC=C2C2=C1C(C)=CO2 HYXITZLLTYIPOF-UHFFFAOYSA-N 0.000 description 1
- XDUXBBDRILEIEZ-UHFFFAOYSA-N Tanshinone IIB Natural products O=C1C(=O)C2=C3CCCC(C)(CO)C3=CC=C2C2=C1C(C)=CO2 XDUXBBDRILEIEZ-UHFFFAOYSA-N 0.000 description 1
- 229930003427 Vitamin E Natural products 0.000 description 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 235000001014 amino acid Nutrition 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 239000002585 base Substances 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 230000004087 circulation Effects 0.000 description 1
- 238000002648 combination therapy Methods 0.000 description 1
- 238000013329 compounding Methods 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 238000007405 data analysis Methods 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000000378 dietary effect Effects 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 150000004141 diterpene derivatives Chemical class 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 230000001815 facial effect Effects 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 208000020694 gallbladder disease Diseases 0.000 description 1
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 description 1
- 238000004817 gas chromatography Methods 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- 230000023597 hemostasis Effects 0.000 description 1
- 241000411851 herbal medicine Species 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 229940057995 liquid paraffin Drugs 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 239000002398 materia medica Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
- 238000004452 microanalysis Methods 0.000 description 1
- 230000004089 microcirculation Effects 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 208000031225 myocardial ischemia Diseases 0.000 description 1
- -1 phenol aldehyde Chemical class 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 229940126532 prescription medicine Drugs 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000013441 quality evaluation Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000000630 rising effect Effects 0.000 description 1
- DOUMFZQKYFQNTF-MRXNPFEDSA-N rosemarinic acid Natural products C([C@H](C(=O)O)OC(=O)C=CC=1C=C(O)C(O)=CC=1)C1=CC=C(O)C(O)=C1 DOUMFZQKYFQNTF-MRXNPFEDSA-N 0.000 description 1
- TVHVQJFBWRLYOD-UHFFFAOYSA-N rosmarinic acid Natural products OC(=O)C(Cc1ccc(O)c(O)c1)OC(=Cc2ccc(O)c(O)c2)C=O TVHVQJFBWRLYOD-UHFFFAOYSA-N 0.000 description 1
- 230000002000 scavenging effect Effects 0.000 description 1
- 229920002545 silicone oil Polymers 0.000 description 1
- KZJWDPNRJALLNS-VJSFXXLFSA-N sitosterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CC[C@@H](CC)C(C)C)[C@@]1(C)CC2 KZJWDPNRJALLNS-VJSFXXLFSA-N 0.000 description 1
- AZEZEAABTDXEHR-UHFFFAOYSA-M sodium;1,6,6-trimethyl-10,11-dioxo-8,9-dihydro-7h-naphtho[1,2-g][1]benzofuran-2-sulfonate Chemical compound [Na+].C12=CC=C(C(CCC3)(C)C)C3=C2C(=O)C(=O)C2=C1OC(S([O-])(=O)=O)=C2C AZEZEAABTDXEHR-UHFFFAOYSA-M 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 238000005556 structure-activity relationship Methods 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 230000009182 swimming Effects 0.000 description 1
- 239000012209 synthetic fiber Substances 0.000 description 1
- 229920002994 synthetic fiber Polymers 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 230000008736 traumatic injury Effects 0.000 description 1
- 229930182493 triterpene saponin Natural products 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
Images
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
保留时间 | 流动相A(v/v) | 流动相B(v/v) |
0min | 90% | 10% |
8min | 78% | 22% |
15min | 74% | 26% |
55min | 48% | 52% |
峰1 | 峰2 | 峰3 | 峰4 |
丹参素 | 原儿茶醛 | 异紫草酸A | 异紫草酸B |
峰5 | 峰6 | 峰7 | 峰8 |
丹酚酸D | 迷迭香酸 | 丹酚酸B | 丹酚酸A |
峰号 | 平均保留时间 | 保留时间RSD% | 平均峰面积 | 峰面积RSD% | 单峰占总峰面积的百分比 |
1 | 6.12 | 0.83 | 2554.60 | 10.68 | 18.19% |
2 | 10.00 | 0.77 | 4438.60 | 14.63 | 31.61% |
3 | 15.96 | 0.58 | 740.16 | 13.18 | 5.27% |
4 | 17.89 | 1.17 | 667.68 | 13.47 | 4.75% |
5 | 20.27 | 2.94 | 654.73 | 15.01 | 4.66% |
6 | 23.83 | 0.88 | 1140.51 | 16.45 | 8.12% |
7 | 27.67 | 0.61 | 880.14 | 11.49 | 6.27% |
8 | 30.93 | 0.47 | 2965.29 | 10.21 | 21.12% |
峰号 | 平均保留时间 | 保留时间RSD% | 平均峰面积 | 峰面积RSD% | 单峰占总峰面积的百分比 |
1 | 6.04 | 0.31 | 1627.92 | 5.91 | 20.80% |
2 | 9.90 | 0.25 | 2575.54 | 13.53 | 32.90% |
3 | 16.89 | 0.61 | 366.89 | 10.92 | 4.69% |
4 | 17.84 | 0.70 | 381.40 | 13.81 | 4.87% |
5 | 20.31 | 0.96 | 186.08 | 12.04 | 2.38% |
6 | 23.74 | 0.76 | 555.35 | 10.48 | 7.09% |
7 | 27.73 | 0.50 | 281.91 | 18.08 | 3.60% |
8 | 31.02 | 1.18 | 1852.33 | 14.84 | 23.66% |
Claims (11)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2005100552629A CN100381817C (zh) | 2004-03-17 | 2005-03-17 | 一种复方丹参滴丸质量控制方法 |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN200410018756.5 | 2004-03-17 | ||
CN200410018756 | 2004-03-17 | ||
CNB2005100552629A CN100381817C (zh) | 2004-03-17 | 2005-03-17 | 一种复方丹参滴丸质量控制方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1679871A true CN1679871A (zh) | 2005-10-12 |
CN100381817C CN100381817C (zh) | 2008-04-16 |
Family
ID=35066877
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB2005100552629A Active CN100381817C (zh) | 2004-03-17 | 2005-03-17 | 一种复方丹参滴丸质量控制方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN100381817C (zh) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101040907B (zh) * | 2007-04-27 | 2011-01-05 | 上海现代中医药技术发展有限公司 | 扶正化瘀植物药中丹参原料指纹图谱质量检测方法 |
CN105277643A (zh) * | 2014-07-17 | 2016-01-27 | 天士力制药集团股份有限公司 | 一种用于复方丹参滴丸的一测多评检测方法 |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1472532A (zh) * | 2002-08-02 | 2004-02-04 | 上海蔡同德堂中药制药厂 | 丹参中丹酚酸b含量的测定方法 |
CN100412545C (zh) * | 2002-12-23 | 2008-08-20 | 北京采瑞医药有限公司 | 一种治疗心脑血管疾病的复方丹参制剂的质量控制方法 |
-
2005
- 2005-03-17 CN CNB2005100552629A patent/CN100381817C/zh active Active
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101040907B (zh) * | 2007-04-27 | 2011-01-05 | 上海现代中医药技术发展有限公司 | 扶正化瘀植物药中丹参原料指纹图谱质量检测方法 |
CN105277643A (zh) * | 2014-07-17 | 2016-01-27 | 天士力制药集团股份有限公司 | 一种用于复方丹参滴丸的一测多评检测方法 |
Also Published As
Publication number | Publication date |
---|---|
CN100381817C (zh) | 2008-04-16 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN1669573A (zh) | 一种治疗心脑血管疾病的中药制剂及其制备方法 | |
CN101036748A (zh) | 一种益气复脉、活血化瘀的益心舒中药制剂的质量控制方法 | |
CN1895617A (zh) | 温肾养心、壮腰安神的中药制剂及制备方法和质量控制方法 | |
CN1670529A (zh) | 复方血栓通制剂hplc指纹图谱的构建方法及其标准指纹图谱 | |
CN1903250A (zh) | 一种丹参药材的提取分离方法 | |
CN1857642A (zh) | 一种解郁安神制剂的质量控制方法 | |
CN101040915A (zh) | 一种双黄连注射液的制备方法及其成分检测方法 | |
CN1785380A (zh) | 一种中药制剂的质量控制方法 | |
CN1903239A (zh) | 一种川芎药材的提取分离方法 | |
CN1843425A (zh) | 脑心通分散片及制备方法和质量控制方法 | |
CN1679870A (zh) | 复方丹参滴丸质量控制方法 | |
CN1843424A (zh) | 桂枝茯苓泡腾片及制备方法和质量控制方法 | |
CN1876089A (zh) | 一种治疗肾气虚证的药物组合物及其制备方法 | |
CN1670524A (zh) | 一种复方丹参滴丸指纹图谱的测定方法 | |
CN101032503A (zh) | 治疗心血管疾病的中药有效成分组合物及质量控制方法 | |
CN1872199A (zh) | 一种中药组合物及其制备方法 | |
CN1679871A (zh) | 一种复方丹参滴丸质量控制方法 | |
CN1785347A (zh) | 一种小儿高热不退的中药制剂质量控制方法 | |
CN100345555C (zh) | 一种止痛巴布膏的制备方法 | |
CN1679811A (zh) | 一种丹参提取物、其制备方法、药物制剂及检测方法 | |
CN1670525A (zh) | 复方丹参滴丸指纹图谱的测定方法 | |
CN1502353A (zh) | 复方芎归总提取物及其制剂和用途 | |
CN1857588A (zh) | 一种仙灵骨葆制剂的质量控制方法 | |
CN1257710C (zh) | 一种丹参药材中有效部位的制剂及其制备方法 | |
CN1903238A (zh) | 一种中药提取物、制剂及其制备方法与用途 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
C56 | Change in the name or address of the patentee |
Owner name: TASLY PHARMACEUTICAL GROUP CO., LTD. Free format text: FORMER NAME: TIANJIN TASLY PHARM. CO., LTD. |
|
CP01 | Change in the name or title of a patent holder |
Address after: 300402 Tianjin Beichen Xinyi white road Liaohe Road No. 1 Patentee after: Tasly Pharmaceutical Group Co., Ltd. Address before: 300402 Tianjin Beichen Xinyi white road Liaohe Road No. 1 Patentee before: Tianjin Tianshili Pharmaceutical Co., Ltd. |
|
CP01 | Change in the name or title of a patent holder | ||
CP01 | Change in the name or title of a patent holder |
Address after: 300402 Tianjin Beichen Xinyi white road Liaohe Road No. 1 Patentee after: Tasly Pharmaceutical Group Limited by Share Ltd Address before: 300402 Tianjin Beichen Xinyi white road Liaohe Road No. 1 Patentee before: Tasly Pharmaceutical Group Co., Ltd. |