CN113694095A - A Chinese medicinal composition for treating acute and chronic hepatitis and liver cirrhosis, and its preparation method and quality control method - Google Patents
A Chinese medicinal composition for treating acute and chronic hepatitis and liver cirrhosis, and its preparation method and quality control method Download PDFInfo
- Publication number
- CN113694095A CN113694095A CN202111164408.9A CN202111164408A CN113694095A CN 113694095 A CN113694095 A CN 113694095A CN 202111164408 A CN202111164408 A CN 202111164408A CN 113694095 A CN113694095 A CN 113694095A
- Authority
- CN
- China
- Prior art keywords
- parts
- solution
- methanol
- chinese medicine
- traditional chinese
- 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.)
- Pending
Links
- 208000006454 hepatitis Diseases 0.000 title claims abstract description 108
- 230000001154 acute effect Effects 0.000 title claims abstract description 49
- 206010008909 Chronic Hepatitis Diseases 0.000 title claims abstract description 48
- 239000000203 mixture Substances 0.000 title claims abstract description 48
- 208000019425 cirrhosis of liver Diseases 0.000 title claims abstract description 46
- 238000002360 preparation method Methods 0.000 title claims abstract description 45
- 238000003908 quality control method Methods 0.000 title description 2
- 239000003814 drug Substances 0.000 claims abstract description 83
- 238000001035 drying Methods 0.000 claims abstract description 48
- 238000002156 mixing Methods 0.000 claims abstract description 43
- 238000000034 method Methods 0.000 claims abstract description 26
- 235000009051 Ambrosia paniculata var. peruviana Nutrition 0.000 claims abstract description 24
- 235000003097 Artemisia absinthium Nutrition 0.000 claims abstract description 24
- 240000001851 Artemisia dracunculus Species 0.000 claims abstract description 24
- 235000017731 Artemisia dracunculus ssp. dracunculus Nutrition 0.000 claims abstract description 24
- 235000003261 Artemisia vulgaris Nutrition 0.000 claims abstract description 24
- 239000001138 artemisia absinthium Substances 0.000 claims abstract description 24
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims abstract description 24
- IPQKDIRUZHOIOM-UHFFFAOYSA-N Oroxin A Natural products OC1C(O)C(O)C(CO)OC1OC(C(=C1O)O)=CC2=C1C(=O)C=C(C=1C=CC=CC=1)O2 IPQKDIRUZHOIOM-UHFFFAOYSA-N 0.000 claims abstract description 23
- IKIIZLYTISPENI-ZFORQUDYSA-N baicalin Chemical compound O1[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1OC(C(=C1O)O)=CC2=C1C(=O)C=C(C=1C=CC=CC=1)O2 IKIIZLYTISPENI-ZFORQUDYSA-N 0.000 claims abstract description 23
- 229960003321 baicalin Drugs 0.000 claims abstract description 23
- AQHDANHUMGXSJZ-UHFFFAOYSA-N baicalin Natural products OC1C(O)C(C(O)CO)OC1OC(C(=C1O)O)=CC2=C1C(=O)C=C(C=1C=CC=CC=1)O2 AQHDANHUMGXSJZ-UHFFFAOYSA-N 0.000 claims abstract description 23
- 238000007873 sieving Methods 0.000 claims abstract description 13
- 238000010298 pulverizing process Methods 0.000 claims abstract description 12
- 238000001514 detection method Methods 0.000 claims abstract description 6
- 238000012545 processing Methods 0.000 claims abstract description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 124
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 60
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 55
- 238000001914 filtration Methods 0.000 claims description 50
- 241001071917 Lithospermum Species 0.000 claims description 37
- 239000000706 filtrate Substances 0.000 claims description 36
- 239000000284 extract Substances 0.000 claims description 33
- 239000000243 solution Substances 0.000 claims description 33
- 235000005187 Taraxacum officinale ssp. officinale Nutrition 0.000 claims description 26
- 241000245665 Taraxacum Species 0.000 claims description 25
- 241000526704 Berberis thunbergii Species 0.000 claims description 24
- 239000000287 crude extract Substances 0.000 claims description 23
- 239000012088 reference solution Substances 0.000 claims description 22
- 239000012085 test solution Substances 0.000 claims description 22
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 21
- 240000004534 Scutellaria baicalensis Species 0.000 claims description 20
- 235000017089 Scutellaria baicalensis Nutrition 0.000 claims description 20
- 229920002472 Starch Polymers 0.000 claims description 20
- 239000008107 starch Substances 0.000 claims description 20
- 235000019698 starch Nutrition 0.000 claims description 20
- 239000000463 material Substances 0.000 claims description 18
- 238000005303 weighing Methods 0.000 claims description 17
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims description 15
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 15
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 15
- 229930013930 alkaloid Natural products 0.000 claims description 15
- 230000001376 precipitating effect Effects 0.000 claims description 14
- 239000008187 granular material Substances 0.000 claims description 12
- 238000005498 polishing Methods 0.000 claims description 12
- 239000013558 reference substance Substances 0.000 claims description 12
- NEZONWMXZKDMKF-JTQLQIEISA-N Alkannin Chemical compound C1=CC(O)=C2C(=O)C([C@@H](O)CC=C(C)C)=CC(=O)C2=C1O NEZONWMXZKDMKF-JTQLQIEISA-N 0.000 claims description 11
- 239000004229 Alkannin Substances 0.000 claims description 11
- UNNKKUDWEASWDN-UHFFFAOYSA-N alkannin Natural products CC(=CCC(O)c1cc(O)c2C(=O)C=CC(=O)c2c1O)C UNNKKUDWEASWDN-UHFFFAOYSA-N 0.000 claims description 11
- 235000019232 alkannin Nutrition 0.000 claims description 11
- 238000000227 grinding Methods 0.000 claims description 11
- 230000007935 neutral effect Effects 0.000 claims description 11
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 10
- 239000003795 chemical substances by application Substances 0.000 claims description 10
- 238000001816 cooling Methods 0.000 claims description 10
- 238000001704 evaporation Methods 0.000 claims description 10
- 239000012488 sample solution Substances 0.000 claims description 10
- 238000001291 vacuum drying Methods 0.000 claims description 10
- 238000011049 filling Methods 0.000 claims description 9
- 238000010438 heat treatment Methods 0.000 claims description 9
- 238000012360 testing method Methods 0.000 claims description 8
- VKJGBAJNNALVAV-UHFFFAOYSA-M Berberine chloride (TN) Chemical compound [Cl-].C1=C2CC[N+]3=CC4=C(OC)C(OC)=CC=C4C=C3C2=CC2=C1OCO2 VKJGBAJNNALVAV-UHFFFAOYSA-M 0.000 claims description 7
- 238000000605 extraction Methods 0.000 claims description 7
- 239000007788 liquid Substances 0.000 claims description 7
- 239000011259 mixed solution Substances 0.000 claims description 7
- 239000002244 precipitate Substances 0.000 claims description 7
- 238000005406 washing Methods 0.000 claims description 7
- 238000007605 air drying Methods 0.000 claims description 6
- 238000009835 boiling Methods 0.000 claims description 6
- 239000003480 eluent Substances 0.000 claims description 6
- 239000011812 mixed powder Substances 0.000 claims description 6
- 238000010992 reflux Methods 0.000 claims description 6
- 239000006228 supernatant Substances 0.000 claims description 6
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 5
- FUKUFMFMCZIRNT-UHFFFAOYSA-N hydron;methanol;chloride Chemical compound Cl.OC FUKUFMFMCZIRNT-UHFFFAOYSA-N 0.000 claims description 5
- 238000005259 measurement Methods 0.000 claims description 5
- 230000001502 supplementing effect Effects 0.000 claims description 5
- 238000009210 therapy by ultrasound Methods 0.000 claims description 5
- PNEYBMLMFCGWSK-UHFFFAOYSA-N aluminium oxide Inorganic materials [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 claims description 4
- 239000007864 aqueous solution Substances 0.000 claims description 4
- 238000007689 inspection Methods 0.000 claims description 4
- 239000000843 powder Substances 0.000 claims description 4
- 239000000523 sample Substances 0.000 claims description 4
- 230000004580 weight loss Effects 0.000 claims description 4
- 241000092668 Artemisia capillaris Species 0.000 claims description 3
- 235000008658 Artemisia capillaris Nutrition 0.000 claims description 3
- PQLVXDKIJBQVDF-UHFFFAOYSA-N acetic acid;hydrate Chemical compound O.CC(O)=O PQLVXDKIJBQVDF-UHFFFAOYSA-N 0.000 claims description 3
- KIBLEPZGKRYXBB-UHFFFAOYSA-N butan-2-one ethyl acetate formic acid hydrate Chemical compound O.OC=O.CCC(C)=O.CCOC(C)=O KIBLEPZGKRYXBB-UHFFFAOYSA-N 0.000 claims description 3
- 239000000945 filler Substances 0.000 claims description 3
- RBTARNINKXHZNM-UHFFFAOYSA-K iron trichloride Chemical compound Cl[Fe](Cl)Cl RBTARNINKXHZNM-UHFFFAOYSA-K 0.000 claims description 3
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 claims description 3
- 239000003208 petroleum Substances 0.000 claims description 3
- 239000000377 silicon dioxide Substances 0.000 claims description 3
- 238000005507 spraying Methods 0.000 claims description 3
- 238000003756 stirring Methods 0.000 claims description 3
- 239000013068 control sample Substances 0.000 claims description 2
- 238000004128 high performance liquid chromatography Methods 0.000 claims description 2
- 239000012925 reference material Substances 0.000 claims description 2
- 239000013074 reference sample Substances 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 31
- 229940079593 drug Drugs 0.000 abstract description 19
- 206010067125 Liver injury Diseases 0.000 abstract description 10
- 231100000753 hepatic injury Toxicity 0.000 abstract description 9
- 206010016654 Fibrosis Diseases 0.000 abstract description 6
- 230000007882 cirrhosis Effects 0.000 abstract description 6
- 206010030113 Oedema Diseases 0.000 abstract description 5
- 241000050051 Chelone glabra Species 0.000 abstract 1
- 210000004185 liver Anatomy 0.000 description 51
- 239000000047 product Substances 0.000 description 36
- 239000008280 blood Substances 0.000 description 19
- 210000004369 blood Anatomy 0.000 description 19
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 16
- 201000010099 disease Diseases 0.000 description 15
- 230000001737 promoting effect Effects 0.000 description 13
- 230000006870 function Effects 0.000 description 12
- 230000001717 pathogenic effect Effects 0.000 description 12
- 206010023126 Jaundice Diseases 0.000 description 11
- 150000003797 alkaloid derivatives Chemical class 0.000 description 11
- 231100000283 hepatitis Toxicity 0.000 description 11
- 229930002356 pyrrolizidine alkaloid Natural products 0.000 description 11
- 239000002994 raw material Substances 0.000 description 10
- 230000001105 regulatory effect Effects 0.000 description 10
- 241000202726 Bupleurum Species 0.000 description 9
- 208000024891 symptom Diseases 0.000 description 9
- 231100000354 acute hepatitis Toxicity 0.000 description 8
- 210000000232 gallbladder Anatomy 0.000 description 7
- 208000015181 infectious disease Diseases 0.000 description 7
- 210000005229 liver cell Anatomy 0.000 description 7
- 230000008569 process Effects 0.000 description 7
- 238000011160 research Methods 0.000 description 7
- 241001083847 Berberis Species 0.000 description 6
- 230000017531 blood circulation Effects 0.000 description 6
- 239000002775 capsule Substances 0.000 description 6
- 239000000796 flavoring agent Substances 0.000 description 6
- 235000019634 flavors Nutrition 0.000 description 6
- 208000002672 hepatitis B Diseases 0.000 description 6
- 230000003908 liver function Effects 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 6
- 231100000614 poison Toxicity 0.000 description 6
- VZGDMQKNWNREIO-UHFFFAOYSA-N tetrachloromethane Chemical compound ClC(Cl)(Cl)Cl VZGDMQKNWNREIO-UHFFFAOYSA-N 0.000 description 6
- 231100000331 toxic Toxicity 0.000 description 6
- 230000002588 toxic effect Effects 0.000 description 6
- 230000001988 toxicity Effects 0.000 description 6
- 231100000419 toxicity Toxicity 0.000 description 6
- 208000008964 Chemical and Drug Induced Liver Injury Diseases 0.000 description 5
- 208000004930 Fatty Liver Diseases 0.000 description 5
- 208000004880 Polyuria Diseases 0.000 description 5
- 241000207929 Scutellaria Species 0.000 description 5
- 210000004027 cell Anatomy 0.000 description 5
- 235000009508 confectionery Nutrition 0.000 description 5
- 230000035619 diuresis Effects 0.000 description 5
- 238000005265 energy consumption Methods 0.000 description 5
- 238000001727 in vivo Methods 0.000 description 5
- 238000010926 purge Methods 0.000 description 5
- ADRDEXBBJTUCND-UHFFFAOYSA-N pyrrolizidine Chemical class C1CCN2CCCC21 ADRDEXBBJTUCND-UHFFFAOYSA-N 0.000 description 5
- 239000000341 volatile oil Substances 0.000 description 5
- 241000700721 Hepatitis B virus Species 0.000 description 4
- 241000700605 Viruses Species 0.000 description 4
- 230000003213 activating effect Effects 0.000 description 4
- 230000006378 damage Effects 0.000 description 4
- 230000001976 improved effect Effects 0.000 description 4
- 238000002347 injection Methods 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 244000052769 pathogen Species 0.000 description 4
- 230000000144 pharmacologic effect Effects 0.000 description 4
- 210000000952 spleen Anatomy 0.000 description 4
- 210000002784 stomach Anatomy 0.000 description 4
- 208000011580 syndromic disease Diseases 0.000 description 4
- 239000003440 toxic substance Substances 0.000 description 4
- 241000130784 Arnebia euchroma Species 0.000 description 3
- 208000000419 Chronic Hepatitis B Diseases 0.000 description 3
- 206010019728 Hepatitis alcoholic Diseases 0.000 description 3
- 206010061218 Inflammation Diseases 0.000 description 3
- 206010037660 Pyrexia Diseases 0.000 description 3
- 230000002159 abnormal effect Effects 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 3
- 208000002353 alcoholic hepatitis Diseases 0.000 description 3
- 229940093265 berberine Drugs 0.000 description 3
- QISXPYZVZJBNDM-UHFFFAOYSA-N berberine Natural products COc1ccc2C=C3N(Cc2c1OC)C=Cc4cc5OCOc5cc34 QISXPYZVZJBNDM-UHFFFAOYSA-N 0.000 description 3
- 230000004087 circulation Effects 0.000 description 3
- 230000004054 inflammatory process Effects 0.000 description 3
- 230000007774 longterm Effects 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 238000004809 thin layer chromatography Methods 0.000 description 3
- 239000003053 toxin Substances 0.000 description 3
- 231100000765 toxin Toxicity 0.000 description 3
- 108700012359 toxins Proteins 0.000 description 3
- 239000011782 vitamin Substances 0.000 description 3
- 235000013343 vitamin Nutrition 0.000 description 3
- 229930003231 vitamin Natural products 0.000 description 3
- 229940088594 vitamin Drugs 0.000 description 3
- 208000016261 weight loss Diseases 0.000 description 3
- BAHMQESJBKGPTE-UHFFFAOYSA-N 1,5,8-trimethyl-3a,4-dihydroazuleno[6,5-b]furan-2,6-dione Chemical compound C1C2OC(=O)C(C)=C2C=C2C(C)=CC(=O)C2=C1C BAHMQESJBKGPTE-UHFFFAOYSA-N 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 2
- FXNFHKRTJBSTCS-UHFFFAOYSA-N Baicalein Natural products C=1C(=O)C=2C(O)=C(O)C(O)=CC=2OC=1C1=CC=CC=C1 FXNFHKRTJBSTCS-UHFFFAOYSA-N 0.000 description 2
- 241001072256 Boraginaceae Species 0.000 description 2
- 241000721047 Danaus plexippus Species 0.000 description 2
- 206010012735 Diarrhoea Diseases 0.000 description 2
- 206010072268 Drug-induced liver injury Diseases 0.000 description 2
- 206010019233 Headaches Diseases 0.000 description 2
- 206010019668 Hepatic fibrosis Diseases 0.000 description 2
- 206010019799 Hepatitis viral Diseases 0.000 description 2
- 102000014150 Interferons Human genes 0.000 description 2
- 108010050904 Interferons Proteins 0.000 description 2
- 241000699670 Mus sp. Species 0.000 description 2
- 206010028813 Nausea Diseases 0.000 description 2
- 206010029350 Neurotoxicity Diseases 0.000 description 2
- 208000002193 Pain Diseases 0.000 description 2
- 206010061924 Pulmonary toxicity Diseases 0.000 description 2
- 206010044221 Toxic encephalopathy Diseases 0.000 description 2
- NIJJYAXOARWZEE-UHFFFAOYSA-N Valproic acid Chemical compound CCCC(C(O)=O)CCC NIJJYAXOARWZEE-UHFFFAOYSA-N 0.000 description 2
- 206010047700 Vomiting Diseases 0.000 description 2
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- UDFLTIRFTXWNJO-UHFFFAOYSA-N baicalein Chemical compound O1C2=CC(=O)C(O)=C(O)C2=C(O)C=C1C1=CC=CC=C1 UDFLTIRFTXWNJO-UHFFFAOYSA-N 0.000 description 2
- 229940015301 baicalein Drugs 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- YBHILYKTIRIUTE-UHFFFAOYSA-N berberine Chemical compound C1=C2CC[N+]3=CC4=C(OC)C(OC)=CC=C4C=C3C2=CC2=C1OCO2 YBHILYKTIRIUTE-UHFFFAOYSA-N 0.000 description 2
- 210000000941 bile Anatomy 0.000 description 2
- 230000033228 biological regulation Effects 0.000 description 2
- 230000000740 bleeding effect Effects 0.000 description 2
- 230000005587 bubbling Effects 0.000 description 2
- 230000001684 chronic effect Effects 0.000 description 2
- 206010061428 decreased appetite Diseases 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 238000004821 distillation Methods 0.000 description 2
- 208000002173 dizziness Diseases 0.000 description 2
- 201000008865 drug-induced hepatitis Diseases 0.000 description 2
- 230000001779 embryotoxic effect Effects 0.000 description 2
- 231100000238 embryotoxicity Toxicity 0.000 description 2
- 235000020774 essential nutrients Nutrition 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 230000037406 food intake Effects 0.000 description 2
- 230000007674 genetic toxicity Effects 0.000 description 2
- 231100000025 genetic toxicology Toxicity 0.000 description 2
- 231100000869 headache Toxicity 0.000 description 2
- 230000002440 hepatic effect Effects 0.000 description 2
- 230000002443 hepatoprotective effect Effects 0.000 description 2
- 229910052500 inorganic mineral Inorganic materials 0.000 description 2
- 229940079322 interferon Drugs 0.000 description 2
- 210000003734 kidney Anatomy 0.000 description 2
- 230000003859 lipid peroxidation Effects 0.000 description 2
- 208000019423 liver disease Diseases 0.000 description 2
- 210000005228 liver tissue Anatomy 0.000 description 2
- 210000004072 lung Anatomy 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
- 239000002398 materia medica Substances 0.000 description 2
- 210000004379 membrane Anatomy 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 239000011707 mineral Substances 0.000 description 2
- 230000008693 nausea Effects 0.000 description 2
- 231100000228 neurotoxicity Toxicity 0.000 description 2
- 230000007135 neurotoxicity Effects 0.000 description 2
- ZXERDUOLZKYMJM-ZWECCWDJSA-N obeticholic acid Chemical compound C([C@@]12C)C[C@@H](O)C[C@H]1[C@@H](CC)[C@@H](O)[C@@H]1[C@@H]2CC[C@]2(C)[C@@H]([C@H](C)CCC(O)=O)CC[C@H]21 ZXERDUOLZKYMJM-ZWECCWDJSA-N 0.000 description 2
- 229960001601 obeticholic acid Drugs 0.000 description 2
- 230000003647 oxidation Effects 0.000 description 2
- 238000007254 oxidation reaction Methods 0.000 description 2
- 239000012071 phase Substances 0.000 description 2
- 231100000374 pneumotoxicity Toxicity 0.000 description 2
- 239000002574 poison Substances 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 230000007047 pulmonary toxicity Effects 0.000 description 2
- 230000002829 reductive effect Effects 0.000 description 2
- -1 saponin compounds Chemical class 0.000 description 2
- 229930000044 secondary metabolite Natural products 0.000 description 2
- 210000000813 small intestine Anatomy 0.000 description 2
- 230000008961 swelling Effects 0.000 description 2
- 201000001862 viral hepatitis Diseases 0.000 description 2
- 230000008673 vomiting Effects 0.000 description 2
- XWMMEBCFHUKHEX-MRTCRTFGSA-N (+)-Taraxasterol Chemical compound C([C@@]12C)C[C@H](O)C(C)(C)[C@@H]1CC[C@]1(C)[C@@H]2CC[C@H]2[C@@H]3[C@H](C)C(=C)CC[C@]3(C)CC[C@]21C XWMMEBCFHUKHEX-MRTCRTFGSA-N 0.000 description 1
- YKFCISHFRZHKHY-NGQGLHOPSA-N (2s)-2-amino-3-(3,4-dihydroxyphenyl)-2-methylpropanoic acid;trihydrate Chemical compound O.O.O.OC(=O)[C@](N)(C)CC1=CC=C(O)C(O)=C1.OC(=O)[C@](N)(C)CC1=CC=C(O)C(O)=C1 YKFCISHFRZHKHY-NGQGLHOPSA-N 0.000 description 1
- QMKPCZNFLUQTJZ-UHFFFAOYSA-N (4aR)-10c-Hydroxy-1t.2c.4ar.6at.6bc.9.9.12ac-octamethyl-(8atH.12btH.14acH.14btH)-docosahydro-picen Natural products CC1CCC2(C)CCC3(C)C(CCC4C5(C)CCC(O)C(C)(C)C5CCC34C)C2C1C QMKPCZNFLUQTJZ-UHFFFAOYSA-N 0.000 description 1
- MSWZFWKMSRAUBD-GASJEMHNSA-N 2-amino-2-deoxy-D-galactopyranose Chemical compound N[C@H]1C(O)O[C@H](CO)[C@H](O)[C@@H]1O MSWZFWKMSRAUBD-GASJEMHNSA-N 0.000 description 1
- 208000004998 Abdominal Pain Diseases 0.000 description 1
- 206010000234 Abortion spontaneous Diseases 0.000 description 1
- 206010059193 Acute hepatitis B Diseases 0.000 description 1
- 206010065051 Acute hepatitis C Diseases 0.000 description 1
- 208000022309 Alcoholic Liver disease Diseases 0.000 description 1
- 208000024827 Alzheimer disease Diseases 0.000 description 1
- 208000006400 Arbovirus Encephalitis Diseases 0.000 description 1
- 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 1
- 241000045403 Astragalus propinquus Species 0.000 description 1
- 208000035143 Bacterial infection Diseases 0.000 description 1
- NEZONWMXZKDMKF-UHFFFAOYSA-N C.I. Natural Red 20 Chemical compound C1=CC(O)=C2C(=O)C(C(O)CC=C(C)C)=CC(=O)C2=C1O NEZONWMXZKDMKF-UHFFFAOYSA-N 0.000 description 1
- 206010007247 Carbuncle Diseases 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 206010008616 Cholecystitis and cholelithiasis Diseases 0.000 description 1
- 108020004638 Circular DNA Proteins 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 206010010741 Conjunctivitis Diseases 0.000 description 1
- 206010010774 Constipation Diseases 0.000 description 1
- 206010061818 Disease progression Diseases 0.000 description 1
- 206010052369 Encephalitis lethargica Diseases 0.000 description 1
- 208000004232 Enteritis Diseases 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- IAJILQKETJEXLJ-UHFFFAOYSA-N Galacturonsaeure Natural products O=CC(O)C(O)C(O)C(O)C(O)=O IAJILQKETJEXLJ-UHFFFAOYSA-N 0.000 description 1
- 102000053187 Glucuronidase Human genes 0.000 description 1
- 108010060309 Glucuronidase Proteins 0.000 description 1
- 206010019705 Hepatic pain Diseases 0.000 description 1
- 206010019708 Hepatic steatosis Diseases 0.000 description 1
- 208000005176 Hepatitis C Diseases 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 208000006083 Hypokinesia Diseases 0.000 description 1
- 206010062717 Increased upper airway secretion Diseases 0.000 description 1
- 241000334160 Isatis Species 0.000 description 1
- 240000004035 Lithospermum officinale Species 0.000 description 1
- 235000011030 Lithospermum officinale Nutrition 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 208000001132 Osteoporosis Diseases 0.000 description 1
- CXOFVDLJLONNDW-UHFFFAOYSA-N Phenytoin Chemical compound N1C(=O)NC(=O)C1(C=1C=CC=CC=1)C1=CC=CC=C1 CXOFVDLJLONNDW-UHFFFAOYSA-N 0.000 description 1
- 206010057190 Respiratory tract infections Diseases 0.000 description 1
- 244000299790 Rheum rhabarbarum Species 0.000 description 1
- 235000009411 Rheum rhabarbarum Nutrition 0.000 description 1
- KYWSCMDFVARMPN-LCSVLAELSA-N Saikosaponin D Chemical compound O([C@@H]1[C@@H](O)[C@H](O[C@@H]2[C@@]([C@H]3[C@]([C@@H]4[C@@]([C@@]5(C[C@@H](O)[C@]67CO[C@]5([C@@H]6CC(C)(C)CC7)C=C4)C)(C)CC3)(C)CC2)(C)CO)O[C@@H]([C@@H]1O)C)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O KYWSCMDFVARMPN-LCSVLAELSA-N 0.000 description 1
- 206010040047 Sepsis Diseases 0.000 description 1
- 241000219784 Sophora Species 0.000 description 1
- 208000005392 Spasm Diseases 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 241000194017 Streptococcus Species 0.000 description 1
- 240000001949 Taraxacum officinale Species 0.000 description 1
- 102000003929 Transaminases Human genes 0.000 description 1
- 108090000340 Transaminases Proteins 0.000 description 1
- 208000037386 Typhoid Diseases 0.000 description 1
- 206010046306 Upper respiratory tract infection Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 206010048245 Yellow skin Diseases 0.000 description 1
- KVPNBBUKZBDNBJ-OIXVRUHCSA-N [(7S,9E,11S,12R,13S,14R,15R,16R,17S,18S,19E,21Z)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-26-[(E)-(4-methylpiperazin-1-yl)iminomethyl]-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] acetate pyrazine-2-carboxamide pyridine-4-carbohydrazide Chemical compound NC(=O)c1cnccn1.NNC(=O)c1ccncc1.CO[C@H]1\C=C\O[C@@]2(C)Oc3c(C2=O)c2c(O)c(\C=N\N4CCN(C)CC4)c(NC(=O)\C(C)=C/C=C/[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@@H]1C)c(O)c2c(O)c3C KVPNBBUKZBDNBJ-OIXVRUHCSA-N 0.000 description 1
- 206010000269 abscess Diseases 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 208000037628 acute hepatitis B virus infection Diseases 0.000 description 1
- 208000037621 acute hepatitis C virus infection Diseases 0.000 description 1
- 231100000439 acute liver injury Toxicity 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 230000001476 alcoholic effect Effects 0.000 description 1
- IAJILQKETJEXLJ-QTBDOELSSA-N aldehydo-D-glucuronic acid Chemical compound O=C[C@H](O)[C@@H](O)[C@H](O)[C@H](O)C(O)=O IAJILQKETJEXLJ-QTBDOELSSA-N 0.000 description 1
- 208000030961 allergic reaction Diseases 0.000 description 1
- 208000022531 anorexia Diseases 0.000 description 1
- 230000002605 anti-dotal effect Effects 0.000 description 1
- 230000002924 anti-infective effect Effects 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000001754 anti-pyretic effect Effects 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 230000000840 anti-viral effect Effects 0.000 description 1
- 239000002221 antipyretic Substances 0.000 description 1
- 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 1
- 235000006533 astragalus Nutrition 0.000 description 1
- 229940107666 astragalus root Drugs 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 150000003836 berberines Chemical group 0.000 description 1
- MSWZFWKMSRAUBD-UHFFFAOYSA-N beta-D-galactosamine Natural products NC1C(O)OC(CO)C(O)C1O MSWZFWKMSRAUBD-UHFFFAOYSA-N 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 210000005252 bulbus oculi Anatomy 0.000 description 1
- 229940083181 centrally acting adntiadrenergic agent methyldopa Drugs 0.000 description 1
- 230000002490 cerebral effect Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000001989 choleretic effect Effects 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 239000006071 cream Substances 0.000 description 1
- 230000034994 death Effects 0.000 description 1
- 231100000517 death Toxicity 0.000 description 1
- 230000013872 defecation Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000006735 deficit Effects 0.000 description 1
- 238000001784 detoxification Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 230000005750 disease progression Effects 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000035622 drinking Effects 0.000 description 1
- 206010013781 dry mouth Diseases 0.000 description 1
- 208000001848 dysentery Diseases 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- 239000000469 ethanolic extract Substances 0.000 description 1
- 230000008020 evaporation Effects 0.000 description 1
- 208000010706 fatty liver disease Diseases 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 229930003935 flavonoid Natural products 0.000 description 1
- 235000017173 flavonoids Nutrition 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 229940097043 glucuronic acid Drugs 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 238000009499 grossing Methods 0.000 description 1
- BCQZXOMGPXTTIC-UHFFFAOYSA-N halothane Chemical compound FC(F)(F)C(Cl)Br BCQZXOMGPXTTIC-UHFFFAOYSA-N 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000002949 hemolytic effect Effects 0.000 description 1
- 230000002439 hemostatic effect Effects 0.000 description 1
- 208000005252 hepatitis A Diseases 0.000 description 1
- 201000010284 hepatitis E Diseases 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000002452 interceptive effect Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 208000037906 ischaemic injury Diseases 0.000 description 1
- 210000002429 large intestine Anatomy 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 239000007791 liquid phase Substances 0.000 description 1
- 231100000832 liver cell necrosis Toxicity 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 230000003211 malignant effect Effects 0.000 description 1
- 230000005906 menstruation Effects 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 239000002207 metabolite Substances 0.000 description 1
- 244000000010 microbial pathogen Species 0.000 description 1
- 230000004089 microcirculation Effects 0.000 description 1
- 230000027939 micturition Effects 0.000 description 1
- 208000015994 miscarriage Diseases 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000010172 mouse model Methods 0.000 description 1
- 230000017074 necrotic cell death Effects 0.000 description 1
- 239000002773 nucleotide Substances 0.000 description 1
- 125000003729 nucleotide group Chemical group 0.000 description 1
- 210000004940 nucleus Anatomy 0.000 description 1
- 210000003463 organelle Anatomy 0.000 description 1
- 244000045947 parasite Species 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 210000003516 pericardium Anatomy 0.000 description 1
- 229960002036 phenytoin Drugs 0.000 description 1
- 208000026435 phlegm Diseases 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- NGFFRJBGMSPDMS-UHFFFAOYSA-N psi-Taraxasterol Natural products CC12CCC(O)C(C)(C)C1CCC1(C)C2CCC2C3C(C)C(C)=CCC3(C)CCC21C NGFFRJBGMSPDMS-UHFFFAOYSA-N 0.000 description 1
- 208000020016 psychiatric disease Diseases 0.000 description 1
- 239000001397 quillaja saponaria molina bark Substances 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000008929 regeneration Effects 0.000 description 1
- 238000011069 regeneration method Methods 0.000 description 1
- 230000000241 respiratory effect Effects 0.000 description 1
- 208000020029 respiratory tract infectious disease Diseases 0.000 description 1
- 230000000284 resting effect Effects 0.000 description 1
- 238000010079 rubber tapping Methods 0.000 description 1
- 229930192014 saikosaponin Natural products 0.000 description 1
- 229930182490 saponin Natural products 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 208000000995 spontaneous abortion Diseases 0.000 description 1
- 238000001256 steam distillation Methods 0.000 description 1
- 231100000240 steatosis hepatitis Toxicity 0.000 description 1
- 238000002636 symptomatic treatment Methods 0.000 description 1
- HUTYZQWCTWWXND-NCTFTGAASA-N taraxasterol Natural products C[C@H]1[C@H]2C3=CC[C@@H]4[C@@]5(C)CC[C@H](O)C(C)(C)[C@@H]5CC[C@@]4(C)[C@]3(C)C[C@H](O)[C@@]2(C)CCC1=C HUTYZQWCTWWXND-NCTFTGAASA-N 0.000 description 1
- 229940126585 therapeutic drug Drugs 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- 201000008297 typhoid fever Diseases 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- 229960000604 valproic acid Drugs 0.000 description 1
- 201000002498 viral encephalitis Diseases 0.000 description 1
- 230000009385 viral infection Effects 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
- 239000008215 water for injection Substances 0.000 description 1
- 239000008767 xiaochaihu Substances 0.000 description 1
- 239000008539 xiaoyao Substances 0.000 description 1
- 238000004383 yellowing Methods 0.000 description 1
- HBOMLICNUCNMMY-XLPZGREQSA-N zidovudine Chemical compound O=C1NC(=O)C(C)=CN1[C@@H]1O[C@H](CO)[C@@H](N=[N+]=[N-])C1 HBOMLICNUCNMMY-XLPZGREQSA-N 0.000 description 1
- 229960002555 zidovudine Drugs 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/282—Artemisia, e.g. wormwood or sagebrush
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/233—Bupleurum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/288—Taraxacum (dandelion)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/30—Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/10—Antioedematous agents; Diuretics
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
- G01N30/14—Preparation by elimination of some components
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/90—Plate chromatography, e.g. thin layer or paper chromatography
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/90—Plate chromatography, e.g. thin layer or paper chromatography
- G01N30/95—Detectors specially adapted therefor; Signal analysis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Medical Informatics (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Microbiology (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Biochemistry (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Immunology (AREA)
- Analytical Chemistry (AREA)
- Physics & Mathematics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Gastroenterology & Hepatology (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention relates to a Chinese medicinal composition for treating acute and chronic hepatitis and liver cirrhosis, and a preparation method and a quality detection method thereof, and relates to the field of medicines. Processing radix Arnebiae, extracting radix Berberidis Amurensis, herba Artemisiae Scopariae, bupleuri radix, Scutellariae radix and herba Taraxaci, concentrating, mixing, drying, pulverizing, sieving, and granulating. The invention measures the content of baicalin in the traditional Chinese medicine composition. And provides a method for identifying the traditional Chinese medicine preparation of the oriental wormwood and the baical skullcap root. The invention has good curative effect on treating acute and chronic hepatitis, early cirrhosis, edema, liver injury and the like. The invention is applied to the field of medicines.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to a traditional Chinese medicine composition for treating acute and chronic hepatitis and liver cirrhosis and a preparation method thereof.
Background
Hepatitis, generally, refers to the liver affected by various pathogenic factors, such as virus, bacteria, parasite, chemical poison, drug, poison, alcohol, etc., so that the cells of the liver are destroyed, the function of the liver is damaged, and a series of uncomfortable symptoms of the body and abnormal liver function index are caused. Hepatitis refers to the necrosis of liver cells and abnormal liver function caused by various reasons, and can be divided into acute hepatitis and chronic hepatitis, and the main difference is the pathogenic cause.
Acute hepatitis refers to liver disease caused by infection of hepatitis virus, and the disease course does not exceed 6 months generally. The acute hepatitis is mainly classified into acute viral hepatitis, alcoholic hepatitis, drug hepatitis and infectious toxic hepatitis according to the etiology. Acute viral hepatitis, at present, five kinds of hepatitis viruses which can cause diseases, namely A, B, C, D and E, are determined, and are one of infectious diseases which are widely spread in the world and are harmful to the world; there may be no obvious symptoms in early stage of alcoholic hepatitis, but the liver has already been pathologically changed. The acute hepatitis can be caused by drinking a large amount of wine within 2 weeks, and the symptoms of obvious weight loss, inappetence, nausea, vomiting, general malaise and hypodynamia, fever, abdominal pain, diarrhea and the like are shown; drug-induced hepatitis, many drugs can cause hepatitis. Such as trifluorobromochloroethane, methyldopa, isoniazid, rifampicin and pyrazinamide, zinc phenytoin and valproic acid, zidovudine, and the like; toxic hepatitis of infection, a toxic lesion in the liver secondary to bacterial infection. Severe infections such as sepsis, typhoid fever and fulminant epidemic encephalitis can cause toxic hepatitis. The acute hepatitis can be divided into acute icteric hepatitis and acute icteric hepatitis according to the condition that the patient has jaundice: acute icterohepatitis, acute onset of disease, rapid disease progression, and different degrees of yellow skin and eyeball infection. The course of the disease is about 2-3 months, and hepatitis A and hepatitis E are common; acute anicteric hepatitis, with predominant hepatitis B, is characterized by hepatitis C in part. Most are slow onset. The most prominent manifestations are anorexia, general weakness and liver pain. Some patients have nausea, vomiting, dizziness, headache, fever and upper respiratory symptoms. In most cases, the liver is swollen and painful, and the patient is attacked by tapping. Liver function impairment is not as pronounced as jaundice. Most of the cases recovered from the disease within 3-6 months, but some cases had prolonged disease and became chronic.
Chronic hepatitis is mostly formed by acute hepatitis b and acute hepatitis c, which have evolved over half a year. In addition, chronic hepatitis also includes those patients who are not caused by virus, but have clinical manifestations of chronic hepatitis, including fatty liver patients, drug-induced hepatitis patients, etc. Chronic hepatitis b is one of the most important health burdens worldwide, resulting in over 80 million hepatitis b virus-related deaths each year. For chronic Hepatitis B Virus (HBV) infected patients, since HBV infection cannot be completely cured at present, antiviral therapeutic drugs approved for chronic hepatitis b CHB in various countries are classified into two major categories: one is long-acting interferon (PEG-IFN), the other is orally taken Nucleotide (NAs), the specific medication strategy comprises single medicine or combined medicine, and the combined medicine also comprises sequential medicine. Due to the existence of covalent, closed and circular DNA in the liver cell nucleus, no method is available for eliminating hepatitis B virus in infected cells, thereby achieving the aim of complete cure. Steatohepatitis is one of the more common chronic hepatitis in modern people. The fat of human body accounts for more than 50 percent of the liver cells, the function of organelles in the liver cells is influenced, and the liver area can be stuffy and uncomfortable. Chronic steatohepatitis also causes severe liver function damage, lasting more than two thirty years, and may progress to cirrhosis.
The treatment of acute hepatitis is based on resting, and the drug treatment is required to be reduced as much as possible to relieve the liver burden of the acute hepatitis caused by drug reasons; liver function can be restored to normal by itself in most patients; if the liver function is obviously abnormal, patients with over-high transaminase or jaundice symptoms need to take liver protection medicines; in combination with the etiology, hormone drugs can be suitably used for anti-inflammatory treatment; appropriate amount of vitamins can be supplemented for patients with alcoholic hepatitis according to the condition of the patient.
Various hepatitis diseases have complex etiology, long course of disease, no specific medicine, poor western medicine treatment effect and many toxic and side effects. Although various western medicine preparations have obvious effects in a short period, the preparations are expensive and need to be taken for a long time to maintain treatment, and the economic pressure of patients is high. For example, some interferon drugs have obvious effect on short-term symptom relief when used for treating hepatitis, but have side effects of reducing the anti-infection capacity of the organism and the like after long-term administration, can not prevent relapse and are easy to rebound. The traditional Chinese medicine formulas and dosage forms which are commonly used at present are not ideal although having certain curative effect.
In the aspect of treatment of traditional Chinese medicine, acute hepatitis mainly comprises the functions of soothing liver and regulating spleen, clearing heat and promoting diuresis, and detoxifying and activating blood circulation, and is used for relieving constipation, so that damp turbidity and epidemic toxin are discharged from stool and urine. Chronic hepatitis mainly soothing liver and regulating qi, and activating blood and dissolving stasis, so as to achieve the purposes of smoothing qi movement, leading blood to channel and nourishing liver. Liver cirrhosis is mainly characterized by promoting the circulation of qi, removing food retention, expelling water and removing blood stasis. During the whole treatment process, the liver-soothing and qi-regulating functions and the blood circulation-promoting and blood stasis-removing functions are the first to play the roles of soothing the liver, regulating the qi movement of the liver, and moistening and nourishing the liver by leading blood to the channels and ensuring that the liver is full of blood when blood stasis is removed, so that the liver disease can be cured.
Patent publication No. CN 103301197a, title of the invention: a Chinese medicine preparation for treating chronic hepatitis and early cirrhosis and a preparation method thereof disclose that the Chinese medicine preparation is prepared from the following raw material medicines in parts by weight: oriental wormwood 350-; bupleurum 200-300; berberis 350-450; 100 and 270 of scutellaria; dandelion 150-280; 10-30 of lithospermum, and the pharmaceutically acceptable capsules are prepared by extracting, distilling, decocting, filtering, concentrating, drying, crushing, granulating, filling and the like. The herba artemisiae scopariae and the radix bupleuri are added with 10 times of water and decocted for 2 hours to extract volatile oil, and decoction dregs and other raw materials are decocted and extracted, so that the production process is complex, and the production cost is high. The raw material formula of the invention is as follows: oriental wormwood 350-; bupleurum 200-300; berberis 350-450; 100 and 270 of scutellaria; dandelion 150-280; 10-30 parts of lithospermum erythrorhizon, and 10000 granules (0.4g) are prepared. It is administered orally 3 granules at a time, 3 times daily. Wherein the dosage of the raw materials is as follows: herba Artemisiae Scopariae 0.315-0.405 g/day; 0.18-0.27 g/day of radix bupleuri; berberis root 0.315-0.405 g/day; 0.09-0.243 g/day of radix scutellariae; 0.135-0.252g dandelion/day; radix Arnebiae is 0.009-0.027 g/day. The invention lacks quality inspection methods such as product identification and content determination. In the invention, the raw material lithospermum is decocted, extracted, concentrated and filled, and toxic substances in the lithospermum are not treated.
Patent publication No. CN 104415111 a, title of the invention: a Kuhuang injection and a preparation method thereof, which discloses: is prepared from oriental wormwood, bupleurum root, flavescent sophora root, rhubarb, isatis leaf, HS-15 and water for injection. The preparation method of the kuh-seng injection comprises the following steps: extracting volatile oil from herba Artemisiae Scopariae and bupleuri radix by steam distillation, and collecting volatile oil; decocting the water solution obtained by distillation and the residue after distillation, radix Sophorae Flavescentis and folium Isatidis in water, concentrating the decoction, adding ethanol, and recovering the extract; decocting radix et rhizoma Rhei in water, concentrating the decoction, adding ethanol, recovering the extract liquid, mixing the extractive solution with the volatile oil, adding HS-15, mixing, adjusting pH, filtering, and bottling. In the invention, the preparation is a traditional Chinese medicine injection, and has higher requirements on production equipment and process conditions and higher cost. The bitter yellow injection can only cure yellow, is used as a support therapy and symptomatic treatment, treats both symptoms and root causes, and has the advantages of long treatment period, high cost, great side effect and low cure rate.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating acute and chronic hepatitis and liver cirrhosis, a preparation method and a quality detection method thereof. The invention is a medicine composition which is developed by taking oriental wormwood, berberis thunbergii, radix bupleuri, dandelion, astragalus mongholicus and lithospermum as raw materials, has the functions of clearing liver and promoting diuresis, and is used for treating acute and chronic hepatitis, early cirrhosis and edema.
The invention relates to a traditional Chinese medicine composition for treating acute and chronic hepatitis and liver cirrhosis, which comprises, by weight, 20-200 parts of oriental wormwood, 20-200 parts of berberis thunbergii, 10-100 parts of radix bupleuri, 10-100 parts of dandelion, 5-50 parts of scutellaria baicalensis, 1-10 parts of lithospermum and 1-10 parts of starch.
Furthermore, the traditional Chinese medicine composition comprises 50-100 parts by weight of oriental wormwood, 50-100 parts by weight of berberis thunbergii, 30-60 parts by weight of radix bupleuri, 30-60 parts by weight of dandelion, 15-30 parts by weight of scutellaria baicalensis, 3.5-7 parts by weight of lithospermum and 1-10 parts by weight of starch.
Furthermore, the traditional Chinese medicine composition comprises, by weight, 60-80 parts of oriental wormwood, 60-80 parts of berberis thunbergii, 30-60 parts of radix bupleuri, 30-60 parts of dandelion, 15-30 parts of scutellaria baicalensis, 3.5-7 parts of lithospermum and 1-10 parts of starch.
Furthermore, the traditional Chinese medicine composition comprises 50-70 parts by weight of oriental wormwood, 50-70 parts by weight of berberis thunbergii, 30-60 parts by weight of radix bupleuri, 30-60 parts by weight of dandelion, 15-25 parts by weight of scutellaria baicalensis, 3.5-6 parts by weight of lithospermum and 1-10 parts by weight of starch.
The invention relates to a preparation method of a traditional Chinese medicine composition for treating acute and chronic hepatitis and liver cirrhosis, which is carried out according to the following steps:
step one, weighing and batching: weighing 20-200 parts of oriental wormwood, 20-200 parts of berberis thunbergii, 10-100 parts of radix bupleuri, 10-100 parts of dandelion, 5-50 parts of scutellaria baicalensis, 1-10 parts of lithospermum and 1-10 parts of starch for later use;
step two, processing the lithospermum: pulverizing radix Arnebiae, and ultrasonic-assisted extracting with ethanol at volume percentage of 60-80% at 30-50 deg.C for 0.5-1 hr at 5-10 times of material-liquid ratio and ultrasonic frequency of 20-50 kHz; extracting, filtering, reserving dregs, recovering ethanol from filtrate, concentrating, adding 2% NaOH solution by mass, filtering, collecting filtrate, precipitating, concentrating and drying to obtain crude extract of total alkaloids, and removing the crude extract of total alkaloids; adding concentrated hydrochloric acid into the filtrate until no precipitate is generated, filtering, precipitating, and washing with water to neutral to obtain alkannin crude extract;
step three, extraction and concentration: adding 7-9 times of water into berberis thunbergii root, decocting for 2h, then adding herba artemisiae capillaris, radix bupleuri, radix scutellariae and dandelion, supplementing water to 9-11 times of total medicinal materials, heating and boiling, then adding radix lithospermi dregs, decocting for two times, adding 9-11 times of water for decocting for 3h for the first time, adding 7-9 times of water for decocting for 2h for the second time, filtering the decoction in times, combining the decoctions, and standing for 12 h; discarding the residue, filtering the supernatant, vacuum concentrating to obtain extract with relative density of 1.30, adding the crude extract of alkannin obtained in step two, and collecting the extract;
step four, mixing, drying, crushing and sieving: uniformly mixing starch and the extract obtained in the third step, drying by adopting pulse vacuum, crushing, sieving by using a 100-mesh sieve, and mixing for later use;
step five, granulating, finishing granules and mixing: adding 75% ethanol into the total mixed powder by volume percentage, granulating, drying, grading, and mixing for later use;
step five, filling and polishing: encapsulating, making into 1000 granules, and polishing to obtain the Chinese medicinal composition for treating acute and chronic hepatitis and liver cirrhosis.
Further, the vacuum concentration temperature in the third step is 50-60 ℃, and the vacuum degree is-0.07 +/-0.01 MPa.
Further, the temperature of the extract in the third step is 60 ℃.
Furthermore, the temperature of pulse vacuum drying in the fourth step is 55-65 ℃, the drying time is 15-30min, and the vacuum degree is-0.08 +/-0.02 Mpa.
The invention relates to a content determination method of a traditional Chinese medicine composition for treating acute and chronic hepatitis and liver cirrhosis, which determines the content of baicalin by high performance liquid chromatography, and comprises the following specific steps:
(1) preparation of control solutions
Drying baicalin at 105 deg.C to constant weight as control sample, adding methanol, and shaking; wherein, the mass volume ratio of the baicalin to the methanol is 50 ug: 1 mL;
(2) preparation of control solutions
Grinding the Chinese medicinal composition of claim 1, adding methanol into the powder, performing ultrasonic treatment at a frequency of 40kHz and a power of 250W for 30min, cooling to room temperature, weighing, adding methanol to make up for the weight loss, shaking, filtering, and collecting the filtrate; wherein the mass volume ratio of the traditional Chinese medicine composition to the methanol is 0.5 g: 50 mL;
(3) respectively taking 10uL of each of the reference solution and the test solution, and injecting the reference solution and the test solution into a liquid chromatograph for measurement, wherein the measurement conditions are as follows: octadecylsilane chemically bonded silica is used as a filling agent, and methanol-0.4% phosphoric acid aqueous solution is used as a mobile phase; wherein the volume ratio of the methanol to the 0.4% phosphoric acid aqueous solution is 1: 1; the detection wavelength is 278nm, and the theoretical plate number is more than 2500 calculated according to baicalin peak.
The invention relates to a method for identifying berberis thunbergii, scutellaria baicalensis and oriental wormwood in a traditional Chinese medicine composition for treating acute and chronic hepatitis and liver cirrhosis, which is carried out according to the following steps:
step one, grinding the traditional Chinese medicine composition of claim 1, adding a hydrochloric acid-methanol mixed solution, carrying out ultrasonic treatment for 30min, filtering, concentrating a filtrate to 16-17% of the volume of the original mixed solution, adding the filtrate to a neutral alumina column, eluting with methanol until the eluent is colorless, collecting the eluent, evaporating to dryness, and dissolving residues with methanol to obtain a sample solution; taking berberine hydrochloride reference substance, adding methanol to obtain berberine hydrochloride methanol solution as reference substance solution; respectively taking 5uL of a test solution and 2uL of a reference solution, placing on the same silica gel G thin-layer plate, developing with n-butanol-glacial acetic acid-water as a developing agent, taking out, air drying, and inspecting under an ultraviolet lamp;
wherein, the mass volume ratio of the traditional Chinese medicine composition of claim 1 to the hydrochloric acid-methanol mixed solution is 1g:15 mL; the mass volume ratio of the berberine hydrochloride to the methanol is 0.5mg to 1 mL;
step two, grinding the traditional Chinese medicine composition of claim 1, adding water for mixing, heating and refluxing for 30min, filtering, adding ethyl acetate into filtrate, shaking once for extraction, extracting for three times, combining extracting solutions, evaporating to dryness in a water bath, and dissolving residues with methanol to obtain a test solution; preparing herba Artemisiae Scopariae reference material into reference solution according to the manner of test solution; respectively placing 10uL of test solution and 5uL of reference solution on the same silica gel G thin layer plate, developing with petroleum ether-ethyl acetate-acetone as developing agent, taking out, air drying, and inspecting under ultraviolet lamp; wherein the mass-volume ratio of the traditional Chinese medicine composition of claim 1 to water is 1g:10 mL; the mass volume ratio of the herba artemisiae scopariae reference medicinal material to water is 1g:10 mL;
step three, grinding the traditional Chinese medicine composition of claim 1, adding methanol for mixing, heating and refluxing for 30min, cooling, filtering, evaporating filtrate in water bath, adding water into residues, stirring and dissolving to obtain a test solution; taking baicalin as reference medicinal material, adding methanol to obtain solution as reference solution; respectively taking 5uL of a test solution and 5uL of a reference solution, placing the test solution and the reference solution on the same silica gel G thin-layer plate, developing by taking ethyl acetate-butanone-formic acid-water as a developing agent, taking out, drying in the air, spraying a ferric trichloride ethanol solution with the mass percentage of 5%, and placing the sample solution and the reference solution under an ultraviolet lamp for inspection; wherein the mass-volume ratio of the traditional Chinese medicine composition of claim 1 to the methanol is 1g:15 mL; the mass-volume ratio of the baicalin reference medicinal material to the methanol is 1mg:1 mL;
and (3) inspecting the chromatogram of the test sample under the ultraviolet lamp, and displaying fluorescent spots with the same color on the positions corresponding to the chromatogram of the reference sample, so as to determine that the test sample is respectively berberis thunbergii, scutellaria baicalensis and oriental wormwood.
The Chinese medicine preparation for treating acute and chronic hepatitis and liver cirrhosis is prepared with capillary artemisia, berberis root, bupleurum root, dandelion, astragalus root and gromwell as material, and has bitter, pungent and slightly cold taste. It is entered into spleen, stomach, liver and gallbladder meridians. Has the effects of removing dampness and heat, promoting gallbladder function and eliminating jaundice, and is mainly used for treating pathogenic factors of wind, dampness, cold and heat, jaundice due to heat accumulation, and body weight reducing, qi invigorating and aging resisting; the "Ben Cao Zheng Yi" (the book of materia medica Zheng Yi) is a special product for removing dampness and clearing heat, which is a main drug for treating damp-heat and yellowing; the records of Western medicine of Zhongzhao: it is good at clearing heat from liver and gallbladder, regulating stagnation of liver and gallbladder, eliminating stagnation of heat, and has no obstruction of bile passage into small intestine. Herba Artemisiae Scopariae can be used as single Chinese medicinal material or prescription for treating acute icterohepatitis and liver cirrhosis. Modern researches show that the oriental wormwood can protect liver cell membranes, prevent liver cell necrosis, promote liver cell regeneration, improve liver microcirculation and inhibit activity of glucuronidase, can accelerate clearance rate of ethanol and metabolites thereof by directly acting on a liver metabolic enzyme system, relieve lipid peroxidation damage reaction of alcohol in liver tissues of mice with acute liver injury caused by carbon tetrachloride (CCl4) to livers, improve oxidation resistance, stabilize liver cell membrane structures and achieve liver detoxification functions.
Bupleurum root, radix bupleuri, pungent and bitter in flavor, slightly cold in nature. It enters liver, gallbladder and lung meridians. Has effects of dispelling pathogenic heat, relieving liver qi stagnation, and invigorating yang. It can be used for eliminating pathogenic factors, relieving exterior syndrome, clearing away heat, and relieving half exterior and half interior pathogenic factors of shaoyang. The diseases treated by the radix bupleuri prescription are mostly in liver meridian: bupleurum root in Xiaochaihu decoction and Dachaihu decoction are all used as monarch drugs, and the efficacy of clearing away pathogenic factors of shaoyang and dispelling qi movement due to stasis is mainly applied to treat shaoyang syndrome; the Chai Ge Jie Tang is mainly used to treat wind-cold syndrome due to external contraction and heat transformation due to depression, because it can penetrate the exterior of the body and clear the interior of the body. The Xiaoyao powder takes the bupleurum as a monarch drug, has the efficacies of soothing the liver and relieving the depression and regulating the liver qi, and is used for treating the syndromes of liver depression, spleen deficiency and blood weakness caused by headache, dizziness, dry mouth and throat, and pain in both hypochondriac regions. About 60 saponin compounds, hundreds of volatile oil compounds and polysaccharide components have been isolated and identified from bupleurum root so far. Modern pharmacological research shows that the bupleurum has the effects of relieving fever, resisting inflammation, protecting liver, resisting oxidation and the like. The liver protection effect is mainly embodied in the aspects of liver injury resistance and liver fibrosis resistance. Goldi and other researches find that the saikosaponin can inhibit the damage of lipid peroxidation induced by alcohol to liver tissues and has obvious protective effect on alcoholic liver damage.
Dandelion, bitter, sweet and cold in flavor. It enters liver and stomach meridians. Clearing away heat and toxic material, dispersing swelling and dissipating stagnation, inducing diuresis and treating stranguria. Can be used for treating jaundice due to damp-heat pathogen, stranguria due to heat pathogen, and pain. It can be used for treating jaundice due to damp-heat pathogen by combining with bupleuri radix and Scutellariae radix. Shen nong Ben Cao Jing Shu (Shen nong Ben Cao Jing Shu): dandelion is sweet and mild in flavor and has five toxins. It is the essential herb for entering liver and stomach, clearing heat and cooling blood. Mammary abscess pertains to liver meridian, and women have major actions on liver meridian after menstruation, so the good property of producing phlegm is indicated for women with swollen carbuncle and mammary toxicity. ". Modern pharmacological research shows that dandelion contains taraxasterol, taraxacin and the like, and has stronger inhibiting effect on staphylococcus aureus and hemolytic streptococcus; it also has the functions of promoting bile flow, protecting liver, promoting urination, invigorating stomach and reducing diarrhea, and has obvious curative effect on treating pyocutaneous disease and pyogenic infection surgical diseases and clearing away heat and toxic of internal organs.
Baical skullcap root, radix Scutellariae is bitter in flavor and cold in nature. It enters lung, gallbladder, spleen, large intestine and small intestine meridians. Has the functions of clearing away heat, eliminating dampness, purging fire, detoxicating, stopping bleeding and preventing miscarriage. It is combined with Yin Chen. Fructus Gardeniae can be used for treating jaundice due to damp-heat pathogen. It is usually indicated for cholecystitis and cholelithiasis, and is often combined with Zhi Qiao, Yu jin and jin Qian Cao. Shen nong Ben Cao Jing: bitter and neutral in taste. Mainly has damp-heat jaundice, intestinal qi-flowing, purgation, retention of water, bleeding obstruction and treatment of malignant boil. Modern pharmaceutical research shows that the scutellaria has the functions of benefiting gallbladder, protecting liver and relieving spasm. Baicalin and baicalein. The ethanol extract of Scutellariae radix has choleretic effect. Baicalin as a main active ingredient has wide pharmacological actions of purging fire for removing toxin, clearing heat and drying dampness, protecting liver and the like. Astragaloside can be hydrolyzed in vivo to baicalein and glucuronic acid, the latter being known as antidotal and hepatoprotective agents.
Berberis root is bitter and cold in taste, and has the effects of clearing heat, eliminating dampness, purging pathogenic fire and removing toxicity. Can be used for treating dysentery, enteritis, jaundice, upper respiratory infection, conjunctivitis, etc. Each part of the whole berberis thunbergii plant contains alkaloid, wherein the main component is berberine, and most of the berberine is distributed in the root bark. Contains coumarin, flavonoid, etc. besides alkaloid. Researches of a plurality of scholars find that the berberine and the derivatives thereof have better pharmacological activity in the aspects of treating diabetes, cardiovascular diseases, tumors, blood fat reduction, inflammation, bacteria and virus infection, osteoporosis, Alzheimer disease, mental diseases, cerebral ischemic injury and the like.
Zi Cao is sweet, salty and cold in flavor. It enters heart and liver meridians. Has the effects of clearing heat, cooling blood, promoting blood circulation and removing toxic substances. The compendium of materia medica states that "Zi Cao is sweet and salty in flavor and cold in qi enters pericardium and liver blood system, and it is indicated for cooling blood, activating blood circulation and facilitating defecation. Modern researches show that the lithospermum has the functions of resisting pathogenic microorganisms, resisting inflammation and resisting allergic reaction. Antipyretic, antitumor, hepatoprotective, and hemostatic effects. The different solvent extracts of arnebia euchroma (Royle) Johnst are used for gastric lavage to treat immune liver injury model mice, and biochemical index detection is carried out to find that arnebia euchroma (Royle) Johnst can improve pathological injury of liver to different degrees; many researchers find that the water extract and the alcohol extract of arnebia euchroma have a certain protection effect on the alcoholic liver injury of mice and the liver injury cells caused by D-galactosamine and carbon tetrachloride.
Radix bupleuri, radix bupleuri, radix bupleuri, radix bupleuri, radix cortex bupleuri, radix cortex bupleuri, radix bupleuri, radix cortex bupleuri, radix cortex bupleuri, radix cortex bupleuri, radix cortex bupleuri; herba artemisiae scopariae has effects of clearing heat, promoting diuresis and removing jaundice, herba taraxaci has effects of clearing heat, removing toxicity, relieving swelling, resolving hard mass, radix scutellariae has effects of clearing heat, eliminating dampness, purging fire and removing toxicity, and the three are used as ministerial drugs; berberis root, radix Berberidis Amurensis is bitter and slightly cold in taste, is used as an adjuvant drug for clearing heat, eliminating dampness, purging fire and removing toxicity, is sweet and salty in taste, is cold in qi, enters heart and liver channels, is used for clearing heat, cooling blood, activating blood and removing toxicity, and is also used as an adjuvant drug for combining the whole formula. The six medicinal materials are combined to treat both symptoms and root causes, has the effects of soothing liver, regulating qi, promoting blood circulation, removing blood stasis and clearing away heat and toxic materials, and can radically treat diseases so as to achieve the aim of healing.
The invention has the beneficial effects that:
1. the invention is mainly prepared by the processes of extraction, concentration, drying, crushing, granulation, filling and the like. The process is simple to operate, short in production period and low in cost, and is suitable for industrial mass production. The preparation form is capsule, the eating method is simple, and the carrying is convenient.
2. The dosage of the formula raw materials in the invention is as follows: herba Artemisiae Scopariae 3.6-36 g/day; 3.6-36 g/day of berberis thunbergii, 1.8-18 g/day of radix bupleuri, 1.8-18 g/day of dandelion, 0.9-9 g/day of scutellaria baicalensis and 0.18-1.8 g/day of lithospermum, the daily dosage of raw materials of a product formula is about 10 times of that of the prior art, the content of active ingredients is far higher than that of the prior art, and the invention has great advantages in terms of product efficacy.
3. The product of the invention has the efficacy of clearing liver and promoting diuresis, is used for treating acute and chronic hepatitis, early cirrhosis, edema and other symptoms, has no toxic or side effect, and is beneficial to popularization and application.
4. The prior art is a method for detecting scutellaria baicalensis in granules, and is not suitable for the product. Therefore, the invention establishes a complete high-performance liquid phase content measuring method, can effectively, quickly and accurately measure the baicalin content in the product, and ensures the quality and the effectiveness of the product.
5. The invention establishes a product identification method, which eliminates interfering substances and furthest reserves substances to be detected. The product identification can be rapidly and effectively carried out, the method is simple, and the specificity is strong. The method fills the gap of the prior art for identifying the oriental wormwood and the baical skullcap root. The invention can identify the capillary artemisia and the baicalin in the product, improves the quality standard, and has the advantages of simple and quick operation, strong specificity and good durability.
6. The invention adopts the pulse vacuum dryer to dry the extract, solves the defects of low vacuum drying efficiency and high energy consumption in the traditional process aiming at the characteristics of high sugar content, low temperature, easy overflow, easy bubbling and the like of the traditional Chinese medicine extract, improves the drying efficiency by more than 200 percent and greatly shortens the drying time; compared with a hot air circulation oven, the energy consumption is saved by more than 80%, the operation is simple, and the cleaning is easy. The extract after pulse vacuum drying is loose and porous, has uniform quality, is easy to crush, has less loss of effective components of the product, and has higher baicalin content compared with the traditional drying process, thereby ensuring the quality and stability of the product.
7. Pyrrolizidine Alkaloids (PAs) are a class of secondary metabolites commonly owned by Boraginaceae plants, and a large number of experimental studies and clinical cases show that long-term and large-amount ingestion of PAs can cause hepatic giant cell disease and hepatic fibrosis to induce HSOS. In addition, PAs may also have pulmonary toxicity, genetic toxicity, neurotoxicity and embryotoxicity. In the prior art, the lithospermum serving as a raw material is decocted, extracted, concentrated and filled, and toxic substances in the lithospermum are not treated. The invention extracts and decocts the alkaloid in the lithospermum after extracting and separating, reduces the potential safety hazard brought by pyrrolizidine alkaloid, and greatly reduces the side effect of the product. The application value and the biological activity of the product are improved.
8. The traditional Chinese medicine preparation for treating acute and chronic hepatitis and liver cirrhosis is mainly used, and other products (such as Huoluoshu liver capsule, Zhenge capsule, Obeticholic acid tablet and in vivo fat regulation product) are added in an auxiliary way, so that the traditional Chinese medicine preparation has good curative effects on acute and chronic hepatitis, early liver cirrhosis, edema, liver injury and the like. The cure scheme has the effects of soothing liver, regulating qi, clearing away damp-heat, promoting blood circulation, removing blood stasis, nourishing liver and kidney, supplementing essential nutrients such as protein, vitamins and minerals, regulating fat in vivo, and reducing liver injury, and is especially suitable for treating diseases such as viral hepatitis B and steatohepatitis.
9. The traditional Chinese medicine preparation for treating acute and chronic hepatitis and liver cirrhosis is mainly used, and other products (such as Huoluoshu liver capsule, Zhenge capsule, Obeticholic acid tablet and in vivo fat regulation product) are added in an auxiliary way, so that the traditional Chinese medicine preparation has good curative effects on acute and chronic hepatitis, early liver cirrhosis, edema, liver injury and the like. The cure scheme has the effects of soothing liver, regulating qi, clearing away damp-heat, promoting blood circulation, removing blood stasis, nourishing liver and kidney, supplementing essential nutrients such as protein, vitamins and minerals, regulating fat in vivo, and reducing liver injury, and is especially suitable for treating diseases such as viral hepatitis B and steatohepatitis. The invention has obvious effect in treating acute and chronic hepatitis and early cirrhosis.
Detailed Description
For the purpose of promoting a clear understanding of the objects, aspects and advantages of the embodiments of the invention, reference will now be made in detail to the embodiments of the present disclosure, and it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the disclosure.
The exemplary embodiments of the present invention and the description thereof are provided to explain the present invention and not to limit the present invention.
Detailed description of the preferred embodiment 1
The embodiment provides a prescription of a traditional Chinese medicine preparation for treating acute and chronic hepatitis and liver cirrhosis. The composition comprises the following components in parts by weight: 100 parts of oriental wormwood, 60 parts of berberis thunbergii, 50 parts of radix bupleuri, 50 parts of dandelion, 20 parts of scutellaria baicalensis, 5 parts of lithospermum and 5 parts of starch.
The preparation method of the traditional Chinese medicine preparation for treating acute and chronic hepatitis and liver cirrhosis comprises the following steps:
1. weighing and batching: weighing the medicinal slices according to the formula ratio for later use.
2. Treating lithospermum: 2. treating lithospermum: pulverizing radix Arnebiae, ultrasonic-assisted extracting with 60-80% ethanol at 30-50 deg.C for 0.5-1 hr at 5-10 times of material-liquid ratio and ultrasonic frequency of 20-50kHz, filtering, collecting residue, recovering ethanol from filtrate, concentrating, adding 2% NaOH, filtering, precipitating, concentrating, and drying to obtain total alkaloid crude extract. Adding concentrated hydrochloric acid into the filtrate until no precipitate is generated, filtering, precipitating, and washing with water to neutral to obtain alkannin crude extract for use. The filtrate was treated and discarded.
3. Extracting and concentrating: adding 7-9 times of water into berberis thunbergii root, decocting for 2 hours, then adding herba artemisiae capillaris, radix bupleuri, radix scutellariae and dandelion, supplementing water to 9-11 times of total medicinal materials, heating and boiling, then adding lithospermum dregs, decocting for two times, adding 9-11 times of water for decocting for 3 hours for the first time, adding 7-9 times of water for decocting for 2 hours for the second time, filtering the decoction in times, combining the decoctions, and standing for 12 hours. Discarding the residue, filtering the supernatant, vacuum concentrating (at 50-60 deg.C and vacuum degree of-0.07 + -0.01 Mpa) to obtain extract with relative density of 1.30(60 deg.C), adding the above crude extract, and collecting the extract.
4. Mixing, drying, crushing and sieving: mixing starch and extract uniformly, drying under pulse vacuum (55-65 deg.C, drying for 15-30min, vacuum degree of-0.08 + -0.02 Mpa), pulverizing, sieving with 100 mesh sieve, and mixing.
5. Granulating, finishing and totally mixing: adding 75% ethanol into the total mixed powder, granulating, drying, grading, and mixing.
6. Filling and polishing: encapsulating, making into 1000 granules, and polishing.
Specific example 2
The embodiment provides a prescription of a traditional Chinese medicine preparation for treating acute and chronic hepatitis and liver cirrhosis. The composition comprises the following components in parts by weight: 150 parts of oriental wormwood, 20 parts of berberis thunbergii, 30 parts of radix bupleuri, 50 parts of dandelion, 20 parts of scutellaria baicalensis, 5 parts of lithospermum and 5 parts of starch.
The preparation method of the traditional Chinese medicine preparation for treating acute and chronic hepatitis and liver cirrhosis comprises the following steps:
1. weighing and batching: weighing the medicinal slices according to the formula ratio for later use.
2. Treating lithospermum: pulverizing radix Arnebiae, ultrasonic-assisted extracting with ethanol 80% at 30 deg.C and ultrasonic frequency of 20kHz for 0.5 hr to obtain extract 5 times of ethanol, filtering, collecting residue, recovering ethanol from filtrate, concentrating, adding 2% NaOH, filtering, precipitating, concentrating, and drying to obtain total alkaloid crude extract. Adding concentrated hydrochloric acid into the filtrate until no precipitate is generated, filtering, precipitating, and washing with water to neutral to obtain alkannin crude extract for use. The filtrate was treated and discarded.
3. Extracting and concentrating: decocting radix Berberidis Amurensis with 7 times of water for 2 hr, adding herba Artemisiae Scopariae, bupleuri radix, Scutellariae radix and herba Taraxaci, adding water to 9 times of the total amount of the medicinal materials, boiling, adding radix Arnebiae residue, decocting twice, adding 9 times of water for 3 hr for the first time, adding 7 times of water for decocting for 2 hr for the second time, filtering the decoctions, mixing the decoctions, and standing for 12 hr. Discarding the residue, filtering the supernatant, vacuum concentrating (at 50-60 deg.C and vacuum degree of-0.07 + -0.01 Mpa) to obtain extract with relative density of 1.30(60 deg.C), adding the above crude extract, and collecting the extract.
4. Mixing, drying, crushing and sieving: mixing starch and extract uniformly, drying under pulse vacuum (55 deg.C, 15min, vacuum degree of-0.08 + -0.02 Mpa), pulverizing, sieving with 100 mesh sieve, and mixing.
5. Granulating, finishing and totally mixing: adding 75% ethanol into the total mixed powder, granulating, drying, grading, and mixing.
6. Filling and polishing: encapsulating, making into 1000 granules, and polishing.
Specific example 3
The embodiment provides a prescription of a traditional Chinese medicine preparation for treating acute and chronic hepatitis and liver cirrhosis. The composition comprises the following components in parts by weight: 80 parts of oriental wormwood, 80 parts of berberis thunbergii, 50 parts of radix bupleuri, 40 parts of dandelion, 25 parts of scutellaria baicalensis, 6 parts of lithospermum and 5 parts of starch.
The preparation method of the traditional Chinese medicine preparation for treating acute and chronic hepatitis and liver cirrhosis comprises the following steps:
1. weighing and batching: weighing the medicinal slices according to the formula ratio for later use.
2. Treating lithospermum: pulverizing radix Arnebiae, ultrasonic-assisted extracting with ethanol at 70% concentration for 40min at 40 deg.C and ultrasonic frequency of 30kHz for 8 times, filtering, collecting residue, recovering ethanol from filtrate, concentrating, adding 2% NaOH, filtering, precipitating, concentrating, and drying to obtain total alkaloid crude extract. Adding concentrated hydrochloric acid into the filtrate until no precipitate is generated, filtering, precipitating, and washing with water to neutral to obtain alkannin crude extract for use. The filtrate was treated and discarded.
3. Extracting and concentrating: decocting radix Berberidis Amurensis with 8 times of water for 2 hr, adding herba Artemisiae Scopariae, bupleuri radix, Scutellariae radix and herba Taraxaci, adding water to 10 times of the total amount of the medicinal materials, boiling, adding radix Arnebiae residue, decocting twice, adding 10 times of water for the first time, decocting for 3 hr, adding 8 times of water for the second time, decocting for 2 hr, filtering the decoctions, mixing the decoctions, and standing for 12 hr. Discarding the residue, filtering the supernatant, vacuum concentrating (at 50-60 deg.C and vacuum degree of-0.07 + -0.01 Mpa) to obtain extract with relative density of 1.30(60 deg.C), adding the above crude extract, and collecting the extract.
4. Mixing, drying, crushing and sieving: mixing starch and extract uniformly, drying under pulsed vacuum (65 deg.C, drying for 15min, vacuum degree of-0.08 + -0.02 Mpa), pulverizing, sieving with 100 mesh sieve, and mixing.
5. Granulating, finishing and totally mixing: adding 75% ethanol into the total mixed powder, granulating, drying, grading, and mixing.
6. Filling and polishing: encapsulating, making into 1000 granules, and polishing.
Specific example 4
The embodiment provides a prescription of a traditional Chinese medicine preparation for treating acute and chronic hepatitis and liver cirrhosis. The composition comprises the following components in parts by weight: 120 parts of oriental wormwood, 60 parts of berberis thunbergii, 45 parts of radix bupleuri, 35 parts of dandelion, 24 parts of scutellaria baicalensis, 6 parts of lithospermum and 5 parts of starch.
The preparation method of the traditional Chinese medicine preparation for treating acute and chronic hepatitis and liver cirrhosis comprises the following steps:
1. weighing and batching: weighing the medicinal slices according to the formula ratio for later use.
2. Treating lithospermum: pulverizing radix Arnebiae, ultrasonic-assisted extracting with 60% ethanol at 50 deg.C for 0.5 hr at ultrasonic frequency of 40kHz for 10 times, filtering, collecting residue, recovering ethanol from filtrate, concentrating, adding 2% NaOH, filtering, precipitating, concentrating, and drying to obtain total alkaloid crude extract. Adding concentrated hydrochloric acid into the filtrate until no precipitate is generated, filtering, precipitating, and washing with water to neutral to obtain alkannin crude extract for use. The filtrate was treated and discarded.
3. Extracting and concentrating: decocting radix Berberidis Amurensis with 7 times of water for 2 hr, adding herba Artemisiae Scopariae, bupleuri radix, Scutellariae radix and herba Taraxaci, adding water to 9 times of the total amount of the medicinal materials, boiling, adding radix Arnebiae residue, decocting twice, adding 9 times of water for 3 hr for the first time, adding 7 times of water for decocting for 2 hr for the second time, filtering the decoctions, mixing the decoctions, and standing for 12 hr. Discarding the residue, filtering the supernatant, vacuum concentrating (at 50-60 deg.C and vacuum degree of-0.07 + -0.01 Mpa) to obtain extract with relative density of 1.30(60 deg.C), adding the above crude extract, and collecting the extract.
4. Mixing, drying, crushing and sieving: mixing starch and extract uniformly, drying under pulse vacuum (60 deg.C, drying for 20min, vacuum degree of-0.08 + -0.02 Mpa), pulverizing, sieving with 100 mesh sieve, and mixing.
5. Granulating, finishing and totally mixing: adding 75% ethanol into the total mixed powder, granulating, drying, grading, and mixing.
6. Filling and polishing: encapsulating, making into 1000 granules, and polishing.
Specific example 5
1. Alkannin separation
Pyrrolizidine Alkaloids (PAs) are a class of secondary metabolites commonly owned by Boraginaceae plants, and a large number of experimental studies and clinical cases show that long-term and large-amount ingestion of PAs can cause hepatic giant cell disease and hepatic fibrosis to induce HSOS. In addition, PAs may also have pulmonary toxicity, genetic toxicity, neurotoxicity and embryotoxicity. In the prior art, the raw material lithospermum is decocted, extracted, concentrated and filled, and toxic substances in the lithospermum are not treated. The invention extracts and decocts the alkaloid in the lithospermum after extracting and separating, reduces the potential safety hazard brought by pyrrolizidine alkaloid, and greatly reduces the side effect of the product.
Control group: decocting radix Arnebiae twice, adding 8 times of water for decocting for 3 hr for the first time, adding 8 times of water for decocting for 2 hr for the second time, filtering decoctions, mixing decoctions, and concentrating. Measurement of
Experimental groups: pulverizing radix Arnebiae, ultrasonic-assisted extracting with ethanol at 70% concentration for 40min at 40 deg.C and ultrasonic frequency of 30kHz for 8 times, filtering, collecting residue, recovering ethanol from filtrate, concentrating, adding 2% NaOH, filtering, precipitating, concentrating, and drying to obtain total alkaloid crude extract. Adding concentrated hydrochloric acid into the filtrate until no precipitate is generated, filtering, precipitating, and washing with water to neutral to obtain alkannin crude extract for use. The filtrate was treated and discarded. Decocting the radix Arnebiae residue twice, adding 8 times of water for decocting for 3 hr for the first time, adding 8 times of water for decocting for 2 hr for the second time, filtering decoctions, mixing decoctions, concentrating, mixing with the crude extract of alkannin, and determining.
TABLE 1 Experimental results of different extraction processes
The experimental results show that the content of the lithospermum in the production process is improved by about 4 times by extracting and separating the alkaloid in the lithospermum and then decocting and extracting, meanwhile, the content of the alkaloid is reduced to 1/5, and the cream yield of the product is improved. The experimental group process reduces the potential safety hazard caused by pyrrolizidine alkaloid, greatly reduces the side effect of the product, and improves the product quality.
2. Effect of pulsed vacuum drying on products
The pulse vacuum drier is a vacuum box type drying device, is designed aiming at the characteristics of high sugar content, low temperature, easy overflow, easy bubbling and the like of the traditional Chinese medicine extract, and has the advantages of high drying efficiency and low energy consumption. The invention determines the influence of the pulse vacuum drying equipment on the product drying process through experiments, and the experimental method and the results are as follows:
TABLE 3 drying Process test results
The invention adopts pulse vacuum drying, solves the defects of low vacuum drying efficiency and high energy consumption in the traditional process, improves the drying efficiency by more than 200 percent, and greatly shortens the drying time; compared with a hot air circulation oven, the energy consumption is saved by more than 80%. The drying efficiency is greatly improved. From the appearance of the product, the extract after pulse vacuum drying is loose and porous, has uniform quality and is easy to crush. Under other drying conditions, the product is slightly dark in color, hard in texture and not easy to crush. From the content of the functional components of the product, the loss of the functional components of the product is minimum under the condition of pulse vacuum drying, the content of baicalin is high, and the quality and the stability of the product are ensured.
Specific example 6
A content determination method of a Chinese medicinal preparation for treating acute and chronic hepatitis and liver cirrhosis comprises the following chromatographic conditions:
octadecylsilane chemically bonded silica is used as a filling agent in chromatographic condition and system adaptability tests; methanol-0.4% phosphoric acid water solution (50:50) is used as a mobile phase; the detection wavelength is 278nm, and the theoretical plate number is not less than 2500 calculated according to baicalin peak.
Preparation of reference solution A proper amount of baicalin dried at 105 deg.C to constant weight is precisely weighed, and methanol is added to make into solution containing 50ug per 1mL, and shaken well to obtain the final product.
Preparation of a test solution: taking the content of the product with different filling amounts, grinding, taking 0.5g of powder, precisely weighing, placing in a conical flask with a plug, precisely adding 50mL of methanol, sealing the plug, weighing, ultrasonically treating (with the power of 250W and the frequency of 40kHz) for 30 minutes, cooling to room temperature, weighing again, complementing the weight loss by using the methanol, shaking uniformly, filtering, and taking the subsequent filtrate to obtain the product.
The determination method comprises precisely sucking 10uL of each of the reference solution and the sample solution, injecting into a liquid chromatograph, and determining.
Each granule of the product contains baicalin (C) extracted from Scutellariae radix21H18O11) Calculated, the content of the active ingredient should not be less than 1.0 mg.
Specific example 7
Identification of Chinese medicinal preparation for treating acute and chronic hepatitis and liver cirrhosis
A method for identifying a traditional Chinese medicine preparation for treating acute and chronic hepatitis and liver cirrhosis comprises the following steps:
a. taking 2G of the content of the product, grinding, adding 30mL of hydrochloric acid-methanol (1:100) mixed solution, carrying out ultrasonic treatment for 30 minutes, filtering, concentrating the filtrate to 5mL, adding onto a neutral alumina column (120 meshes, 15G of alumina, and the inner diameter of about 2cm), adding methanol for elution until the eluent is colorless, collecting the eluent, evaporating to dryness, dissolving the residue with 1mL of methanol to obtain a sample solution, taking a proper amount of berberine hydrochloride as a reference substance, adding methanol to prepare a solution containing 0.5mg per 1mL of the solution, taking a reference substance solution as a reference substance solution, carrying out a thin layer chromatography test, taking 5ul of the sample solution and 2ul of the reference substance solution, respectively dropping on the same silica gel G thin layer plate, taking n-butanol-glacial acetic acid-water (2:0.5:1) as a developing agent, developing, taking out, airing, and placing under an ultraviolet lamp (365nm) for inspection. In the chromatogram of the test solution, fluorescent spots with the same color appear at the corresponding positions of the chromatogram of the control solution.
b. 4g of content of the product is ground, 40mL of water is added, heating reflux is carried out for 30 minutes, filtration is carried out, ethyl acetate is added into filtrate for shaking extraction for three times, 20mL of each time, extracting solutions are combined, water bath evaporation is carried out, and 1mL of methanol is added into residues for dissolution to obtain a test solution. Preparing 2g of herba Artemisiae Scopariae control material, and making into control solution by the same method. Performing thin layer chromatography, sucking 10uL of sample solution and 5uL of reference solution, respectively dropping on the same silica gel G thin layer plate, developing with petroleum ether-ethyl acetate-acetone (6:3:0.5) as developing agent, taking out, air drying, and inspecting under ultraviolet lamp (365 nm). The same color of the main fluorescent spot appears at the position corresponding to the color spectrum of the reference substance.
c. Grinding the content of the product 2g, adding 30mL of methanol, heating and refluxing for 30 minutes, cooling, filtering, evaporating the filtrate in water bath, adding 15mL of water into the residue, stirring to dissolve, filtering, adding diluted hydrochloric acid into the filtrate to adjust the pH value to 1-2, shaking and extracting with ethyl acetate for 2 times, 20mL each time, combining the ethyl acetate solutions, evaporating to dryness, and adding 1mL of methanol into the residue to dissolve to obtain a sample solution. Taking baicalin reference substance, adding methanol to obtain solution containing 1mg per 1mL, taking as reference substance solution, performing thin layer chromatography test, sucking sample solution and reference substance solution each 5ul, respectively dropping on the same silica gel G thin layer plate, developing with ethyl acetate-butanone-formic acid-water (5:3:1:1) as developing agent, taking out, air drying, and spraying with 5% ferric trichloride ethanol solution. The main fluorescent spot with the same color appears on the chromatogram of the test solution at the position corresponding to the chromatogram of the reference solution.
Claims (10)
1. A traditional Chinese medicine composition for treating acute and chronic hepatitis and liver cirrhosis is characterized by comprising, by weight, 20-200 parts of oriental wormwood, 20-200 parts of berberis thunbergii, 10-100 parts of radix bupleuri, 10-100 parts of dandelion, 5-50 parts of scutellaria baicalensis, 1-10 parts of lithospermum and 1-10 parts of starch.
2. The traditional Chinese medicine composition for treating acute and chronic hepatitis and liver cirrhosis according to claim 1, wherein the traditional Chinese medicine composition comprises 50-100 parts by weight of oriental wormwood, 50-100 parts by weight of berberis thunbergii, 30-60 parts by weight of radix bupleuri, 30-60 parts by weight of dandelion, 15-30 parts by weight of scutellaria baicalensis, 3.5-7 parts by weight of lithospermum and 1-10 parts by weight of starch.
3. The traditional Chinese medicine composition for treating acute and chronic hepatitis and liver cirrhosis according to claim 1, wherein the traditional Chinese medicine composition comprises, by weight, 60-80 parts of oriental wormwood, 60-80 parts of berberis thunbergii, 30-60 parts of radix bupleuri, 30-60 parts of dandelion, 15-30 parts of scutellaria baicalensis, 3.5-7 parts of lithospermum and 1-10 parts of starch.
4. The traditional Chinese medicine composition for treating acute and chronic hepatitis and liver cirrhosis according to claim 1, which is characterized by comprising 50-70 parts by weight of oriental wormwood, 50-70 parts by weight of berberis thunbergii, 30-60 parts by weight of radix bupleuri, 30-60 parts by weight of dandelion, 15-25 parts by weight of scutellaria baicalensis, 3.5-6 parts by weight of lithospermum and 1-10 parts by weight of starch.
5. The preparation method of the traditional Chinese medicine composition for treating acute and chronic hepatitis and liver cirrhosis according to claim 1 is characterized by comprising the following steps:
step one, weighing and batching: weighing 20-200 parts of oriental wormwood, 20-200 parts of berberis thunbergii, 10-100 parts of radix bupleuri, 10-100 parts of dandelion, 5-50 parts of scutellaria baicalensis, 1-10 parts of lithospermum and 1-10 parts of starch for later use;
step two, processing the lithospermum: pulverizing radix Arnebiae, and ultrasonic-assisted extracting with ethanol at volume percentage of 60-80% at 30-50 deg.C for 0.5-1 hr at 5-10 times of material-liquid ratio and ultrasonic frequency of 20-50 kHz; extracting, filtering, reserving dregs, recovering ethanol from filtrate, concentrating, adding 2% NaOH solution by mass, filtering, collecting filtrate, precipitating, concentrating and drying to obtain crude extract of total alkaloids, and removing the crude extract of total alkaloids; adding concentrated hydrochloric acid into the filtrate until no precipitate is generated, filtering, precipitating, and washing with water to neutral to obtain alkannin crude extract;
step three, extraction and concentration: adding 7-9 times of water into berberis thunbergii root, decocting for 2h, then adding herba artemisiae capillaris, radix bupleuri, radix scutellariae and dandelion, supplementing water to 9-11 times of total medicinal materials, heating and boiling, then adding radix lithospermi dregs, decocting for two times, adding 9-11 times of water for decocting for 3h for the first time, adding 7-9 times of water for decocting for 2h for the second time, filtering the decoction in times, combining the decoctions, and standing for 12 h; discarding the residue, filtering the supernatant, vacuum concentrating to obtain extract with relative density of 1.30, adding the crude extract of alkannin obtained in step two, and collecting the extract;
step four, mixing, drying, crushing and sieving: uniformly mixing starch and the extract obtained in the third step, drying by adopting pulse vacuum, crushing, sieving by using a 100-mesh sieve, and mixing for later use;
step five, granulating, finishing granules and mixing: adding 75% ethanol into the total mixed powder by volume percentage, granulating, drying, grading, and mixing for later use;
step five, filling and polishing: encapsulating, making into 1000 granules, and polishing to obtain the Chinese medicinal composition for treating acute and chronic hepatitis and liver cirrhosis.
6. The preparation method of the Chinese medicinal composition for treating acute and chronic hepatitis and liver cirrhosis according to claim 1, wherein the vacuum concentration temperature in the third step is 50-60 ℃ and the vacuum degree is-0.07 +/-0.01 Mpa.
7. The method for preparing a Chinese medicinal composition for treating acute and chronic hepatitis and liver cirrhosis according to claim 1, wherein the temperature for measuring the extract in the third step is 60 ℃.
8. The preparation method of a Chinese medicinal composition for treating acute and chronic hepatitis and liver cirrhosis according to claim 1, wherein the pulse vacuum drying in the fourth step is performed at 55-65 deg.C for 15-30min under-0.08 ± 0.02 Mpa.
9. The method for measuring the content of the traditional Chinese medicine composition for treating acute and chronic hepatitis and liver cirrhosis as claimed in claim 1, wherein the content of baicalin is measured by high performance liquid chromatography, and the specific method is as follows:
(1) preparation of control solutions
Drying baicalin at 105 deg.C to constant weight as control sample, adding methanol, and shaking; wherein, the mass volume ratio of the baicalin to the methanol is 50 ug: 1 mL;
(2) preparation of control solutions
Grinding the Chinese medicinal composition of claim 1, adding methanol into the powder, performing ultrasonic treatment at a frequency of 40kHz and a power of 250W for 30min, cooling to room temperature, weighing, adding methanol to make up for the weight loss, shaking, filtering, and collecting the filtrate; wherein the mass volume ratio of the traditional Chinese medicine composition to the methanol is 0.5 g: 50 mL;
(3) respectively taking 10uL of each of the reference solution and the test solution, and injecting the reference solution and the test solution into a liquid chromatograph for measurement, wherein the measurement conditions are as follows: octadecylsilane chemically bonded silica is used as a filling agent, and methanol-0.4% phosphoric acid aqueous solution is used as a mobile phase; wherein the volume ratio of the methanol to the 0.4% phosphoric acid aqueous solution is 1: 1; the detection wavelength is 278nm, and the theoretical plate number is more than 2500 calculated according to baicalin peak.
10. The method for identifying berberis thunbergii, scutellaria baicalensis and artemisia capillaris in the traditional Chinese medicine composition for treating acute and chronic hepatitis and liver cirrhosis as claimed in claim 1, which is characterized by comprising the following steps:
step one, grinding the traditional Chinese medicine composition of claim 1, adding a hydrochloric acid-methanol mixed solution, carrying out ultrasonic treatment for 30min, filtering, concentrating a filtrate to 16-17% of the volume of the original mixed solution, adding the filtrate to a neutral alumina column, eluting with methanol until the eluent is colorless, collecting the eluent, evaporating to dryness, and dissolving residues with methanol to obtain a sample solution; taking berberine hydrochloride reference substance, adding methanol to obtain berberine hydrochloride methanol solution as reference substance solution; respectively taking 5uL of a test solution and 2uL of a reference solution, placing on the same silica gel G thin-layer plate, developing with n-butanol-glacial acetic acid-water as a developing agent, taking out, air drying, and inspecting under an ultraviolet lamp;
wherein, the mass volume ratio of the traditional Chinese medicine composition of claim 1 to the hydrochloric acid-methanol mixed solution is 1g:15 mL; the mass volume ratio of the berberine hydrochloride to the methanol is 0.5mg to 1 mL;
step two, grinding the traditional Chinese medicine composition of claim 1, adding water for mixing, heating and refluxing for 30min, filtering, adding ethyl acetate into filtrate, shaking once for extraction, extracting for three times, combining extracting solutions, evaporating to dryness in a water bath, and dissolving residues with methanol to obtain a test solution; preparing herba Artemisiae Scopariae reference material into reference solution according to the manner of test solution; respectively placing 10uL of test solution and 5uL of reference solution on the same silica gel G thin layer plate, developing with petroleum ether-ethyl acetate-acetone as developing agent, taking out, air drying, and inspecting under ultraviolet lamp; wherein the mass-volume ratio of the traditional Chinese medicine composition of claim 1 to water is 1g:10 mL; the mass volume ratio of the herba artemisiae scopariae reference medicinal material to water is 1g:10 mL;
step three, grinding the traditional Chinese medicine composition of claim 1, adding methanol for mixing, heating and refluxing for 30min, cooling, filtering, evaporating filtrate in water bath, adding water into residues, stirring and dissolving to obtain a test solution; taking baicalin as reference medicinal material, adding methanol to obtain solution as reference solution; respectively taking 5uL of a test solution and 5uL of a reference solution, placing the test solution and the reference solution on the same silica gel G thin-layer plate, developing by taking ethyl acetate-butanone-formic acid-water as a developing agent, taking out, drying in the air, spraying a ferric trichloride ethanol solution with the mass percentage of 5%, and placing the sample solution and the reference solution under an ultraviolet lamp for inspection; wherein the mass-volume ratio of the traditional Chinese medicine composition of claim 1 to the methanol is 1g:15 mL; the mass-volume ratio of the baicalin reference medicinal material to the methanol is 1mg:1 mL;
and (3) inspecting the chromatogram of the test sample under the ultraviolet lamp, and displaying fluorescent spots with the same color on the positions corresponding to the chromatogram of the reference sample, so as to determine that the test sample is respectively berberis thunbergii, scutellaria baicalensis and oriental wormwood.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111164408.9A CN113694095A (en) | 2021-09-30 | 2021-09-30 | A Chinese medicinal composition for treating acute and chronic hepatitis and liver cirrhosis, and its preparation method and quality control method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111164408.9A CN113694095A (en) | 2021-09-30 | 2021-09-30 | A Chinese medicinal composition for treating acute and chronic hepatitis and liver cirrhosis, and its preparation method and quality control method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113694095A true CN113694095A (en) | 2021-11-26 |
Family
ID=78662553
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202111164408.9A Pending CN113694095A (en) | 2021-09-30 | 2021-09-30 | A Chinese medicinal composition for treating acute and chronic hepatitis and liver cirrhosis, and its preparation method and quality control method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113694095A (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1712052A (en) * | 2005-06-02 | 2005-12-28 | 孙鲜玲 | Medicinal preparation for treating hepatitis its production and quality control |
| CN1876040A (en) * | 2005-06-02 | 2006-12-13 | 贵阳云岩西创药物科技开发有限公司 | Pharmaceutical composition for treating hepatitis, its preparation process and quality control method |
| CN102972848A (en) * | 2012-12-12 | 2013-03-20 | 江南大学 | Intermediate wave infrared and pulse vacuum draying integrated device of granulate prepared food and using method thereof |
| CN106377575A (en) * | 2016-09-20 | 2017-02-08 | 辽宁可济药业有限公司 | Preparation method and application of Yuganlong granules for treating hepatitis |
-
2021
- 2021-09-30 CN CN202111164408.9A patent/CN113694095A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1712052A (en) * | 2005-06-02 | 2005-12-28 | 孙鲜玲 | Medicinal preparation for treating hepatitis its production and quality control |
| CN1876040A (en) * | 2005-06-02 | 2006-12-13 | 贵阳云岩西创药物科技开发有限公司 | Pharmaceutical composition for treating hepatitis, its preparation process and quality control method |
| CN102972848A (en) * | 2012-12-12 | 2013-03-20 | 江南大学 | Intermediate wave infrared and pulse vacuum draying integrated device of granulate prepared food and using method thereof |
| CN106377575A (en) * | 2016-09-20 | 2017-02-08 | 辽宁可济药业有限公司 | Preparation method and application of Yuganlong granules for treating hepatitis |
Non-Patent Citations (1)
| Title |
|---|
| 汤俊等: "紫草中的吡咯里西啶类成分及其代谢毒性研究进展", 《药学学报》 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN111407877A (en) | Traditional Chinese medicine composition for treating novel coronavirus pneumonia, preparation method, detection method and application thereof | |
| KR20120123064A (en) | Pharmaceutical composition including sunflower extract, preparative method and use thereof | |
| CN109172635B (en) | Preparation method of traditional Chinese medicine composition containing cassia twig | |
| CN105535439A (en) | Traditional Chinese medicinal composition for treating pharyngitis and preparation method thereof | |
| AU2002241544B9 (en) | Herbal pharmaceutical compositions for treating immunological disorders | |
| CN1977889A (en) | Medicinal composition of astragalus, salvia miltrorrhiza and oxymatrine, and its preparing method | |
| CN101933973B (en) | Medicament composition for preventing and treating liver damage | |
| CN113521232A (en) | Traditional Chinese medicine composition containing bighead atractylodes rhizome | |
| Zou et al. | A review of the research progress on Pinellia ternata (Thunb.) Breit.: Botany, traditional uses, phytochemistry, pharmacology, toxicity and quality control | |
| CN109239239B (en) | Traditional Chinese medicine composition for clearing lung, eliminating phlegm, relieving cough and asthma and preparation method and application thereof | |
| CN104840695A (en) | Medicine combination for treating white scour of piglet and preparation method thereof | |
| CN101940642A (en) | Chinese medicinal composition and application thereof | |
| CN104435977B (en) | It is a kind of to be used to treat medicine of hepatic injury and preparation method thereof | |
| CN116115673A (en) | Traditional Chinese medicine formula for clearing heat and freeing nose and preparation process | |
| CN103006781B (en) | Compound Dai medicine extract with liver-protecting effect and preparation method thereof | |
| CN107569528B (en) | Pharmaceutical composition for treating hepatitis, pharmaceutical preparation, application and preparation method | |
| CN113694095A (en) | A Chinese medicinal composition for treating acute and chronic hepatitis and liver cirrhosis, and its preparation method and quality control method | |
| CN110448651B (en) | Preparation method of Tibetan traditional Chinese medicine composition for treating liver diseases, composition and granules containing composition | |
| CN114344358A (en) | Eucommia ulmoides composition containing aucubin and geniposide, preparation and application | |
| CN112546085A (en) | Sambucus chinensis extract for treating gout and preparation method thereof | |
| CN111558008A (en) | Lotus-atractylodes-rhizome fat-reducing navel patch, preparation method and application | |
| CN105106634A (en) | Traditional Chinese medicine preparation for treating acute appendicitis and application thereof | |
| CN115414435B (en) | Chinese herbal compound Ge Houdan poria cocos granule and preparation method and application thereof | |
| CN103735906A (en) | Chinese herb preparation for treating dry bronchiectasis and preparation method thereof | |
| CN115844973B (en) | Xuan Bai Shuang sound compound extract and preparation method and application thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20211126 |