CN111759991A - 一种治疗慢性肝病的中药复方制剂及其制备方法和应用 - Google Patents
一种治疗慢性肝病的中药复方制剂及其制备方法和应用 Download PDFInfo
- Publication number
- CN111759991A CN111759991A CN202010771209.3A CN202010771209A CN111759991A CN 111759991 A CN111759991 A CN 111759991A CN 202010771209 A CN202010771209 A CN 202010771209A CN 111759991 A CN111759991 A CN 111759991A
- Authority
- CN
- China
- Prior art keywords
- parts
- liver
- preparation
- 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
- 239000003814 drug Substances 0.000 title claims abstract description 60
- 238000002360 preparation method Methods 0.000 title claims abstract description 59
- 150000001875 compounds Chemical class 0.000 title claims abstract description 55
- 208000019423 liver disease Diseases 0.000 title claims abstract description 38
- 238000011282 treatment Methods 0.000 claims description 46
- 208000019425 cirrhosis of liver Diseases 0.000 claims description 24
- 241000270666 Testudines Species 0.000 claims description 19
- 241000512259 Ascophyllum nodosum Species 0.000 claims description 18
- 241001474374 Blennius Species 0.000 claims description 18
- 241000218176 Corydalis Species 0.000 claims description 17
- 244000197580 Poria cocos Species 0.000 claims description 17
- 235000008599 Poria cocos Nutrition 0.000 claims description 17
- 244000038594 Phyllanthus urinaria Species 0.000 claims description 16
- 241000237502 Ostreidae Species 0.000 claims description 15
- 235000020636 oyster Nutrition 0.000 claims description 15
- 238000000034 method Methods 0.000 claims description 14
- 239000000203 mixture Substances 0.000 claims description 14
- 244000131316 Panax pseudoginseng Species 0.000 claims description 13
- 235000003181 Panax pseudoginseng Nutrition 0.000 claims description 13
- 238000009472 formulation Methods 0.000 claims description 13
- 240000009138 Curcuma zedoaria Species 0.000 claims description 12
- 235000003405 Curcuma zedoaria Nutrition 0.000 claims description 12
- 239000001812 curcuma zedoaria berg. rosc. Substances 0.000 claims description 12
- 238000002156 mixing Methods 0.000 claims description 12
- 235000019509 white turmeric Nutrition 0.000 claims description 12
- 239000002994 raw material Substances 0.000 claims description 11
- 235000011135 Salvia miltiorrhiza Nutrition 0.000 claims description 10
- 235000021419 vinegar Nutrition 0.000 claims description 10
- 239000000052 vinegar Substances 0.000 claims description 10
- 239000000463 material Substances 0.000 claims description 9
- 239000006187 pill Substances 0.000 claims description 9
- 241000246044 Sophora flavescens Species 0.000 claims description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 8
- 241000202726 Bupleurum Species 0.000 claims description 7
- 235000001188 Peltandra virginica Nutrition 0.000 claims description 7
- 235000006533 astragalus Nutrition 0.000 claims description 7
- 229940107666 astragalus root Drugs 0.000 claims description 7
- 230000004087 circulation Effects 0.000 claims description 6
- 239000000843 powder Substances 0.000 claims description 6
- 239000009636 Huang Qi Substances 0.000 claims description 5
- 241000045403 Astragalus propinquus Species 0.000 claims description 4
- 235000014375 Curcuma Nutrition 0.000 claims description 4
- 235000003143 Panax notoginseng Nutrition 0.000 claims description 4
- 241000180649 Panax notoginseng Species 0.000 claims description 4
- 239000004480 active ingredient Substances 0.000 claims description 4
- VFLDPWHFBUODDF-FCXRPNKRSA-N curcumin Chemical compound C1=C(O)C(OC)=CC(\C=C\C(=O)CC(=O)\C=C\C=2C=C(OC)C(O)=CC=2)=C1 VFLDPWHFBUODDF-FCXRPNKRSA-N 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 3
- 239000000706 filtrate Substances 0.000 claims description 3
- 238000001914 filtration Methods 0.000 claims description 3
- 238000005498 polishing Methods 0.000 claims description 3
- 238000010298 pulverizing process Methods 0.000 claims description 3
- 238000007873 sieving Methods 0.000 claims description 3
- 241000304195 Salvia miltiorrhiza Species 0.000 claims 2
- 239000008188 pellet Substances 0.000 claims 2
- 244000164480 Curcuma aromatica Species 0.000 claims 1
- 210000004369 blood Anatomy 0.000 abstract description 50
- 239000008280 blood Substances 0.000 abstract description 50
- 230000000694 effects Effects 0.000 abstract description 49
- 206010019668 Hepatic fibrosis Diseases 0.000 abstract description 34
- 230000001737 promoting effect Effects 0.000 abstract description 24
- 206010062717 Increased upper airway secretion Diseases 0.000 abstract description 15
- 208000026435 phlegm Diseases 0.000 abstract description 15
- 230000017531 blood circulation Effects 0.000 abstract description 10
- 231100000331 toxic Toxicity 0.000 abstract description 7
- 230000002588 toxic effect Effects 0.000 abstract description 7
- 238000010521 absorption reaction Methods 0.000 abstract description 6
- 206010067484 Adverse reaction Diseases 0.000 abstract description 4
- 230000006838 adverse reaction Effects 0.000 abstract description 4
- 208000024891 symptom Diseases 0.000 abstract description 4
- 238000012795 verification Methods 0.000 abstract description 3
- 210000004185 liver Anatomy 0.000 description 55
- 210000000952 spleen Anatomy 0.000 description 34
- 238000009825 accumulation Methods 0.000 description 19
- 208000002193 Pain Diseases 0.000 description 15
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 14
- 201000010099 disease Diseases 0.000 description 13
- 230000007812 deficiency Effects 0.000 description 12
- 229940079593 drug Drugs 0.000 description 12
- 230000003908 liver function Effects 0.000 description 12
- 230000001717 pathogenic effect Effects 0.000 description 12
- 208000002672 hepatitis B Diseases 0.000 description 11
- 210000003734 kidney Anatomy 0.000 description 11
- 210000002216 heart Anatomy 0.000 description 10
- 229960000980 entecavir Drugs 0.000 description 9
- YXPVEXCTPGULBZ-WQYNNSOESA-N entecavir hydrate Chemical compound O.C1=NC=2C(=O)NC(N)=NC=2N1[C@H]1C[C@H](O)[C@@H](CO)C1=C YXPVEXCTPGULBZ-WQYNNSOESA-N 0.000 description 9
- 210000000232 gallbladder Anatomy 0.000 description 9
- 244000132619 red sage Species 0.000 description 8
- 238000011160 research Methods 0.000 description 8
- 206010016654 Fibrosis Diseases 0.000 description 7
- 230000008859 change Effects 0.000 description 7
- 235000008216 herbs Nutrition 0.000 description 7
- 210000004072 lung Anatomy 0.000 description 7
- 210000002784 stomach Anatomy 0.000 description 7
- 230000008961 swelling Effects 0.000 description 7
- 210000001015 abdomen Anatomy 0.000 description 6
- 230000009471 action Effects 0.000 description 6
- 230000000840 anti-viral effect Effects 0.000 description 6
- 210000001124 body fluid Anatomy 0.000 description 6
- 239000010839 body fluid Substances 0.000 description 6
- 230000007882 cirrhosis Effects 0.000 description 6
- 235000009508 confectionery Nutrition 0.000 description 6
- 238000011161 development Methods 0.000 description 6
- 230000018109 developmental process Effects 0.000 description 6
- 210000000496 pancreas Anatomy 0.000 description 6
- 208000004998 Abdominal Pain Diseases 0.000 description 5
- 208000032843 Hemorrhage Diseases 0.000 description 5
- 206010061876 Obstruction Diseases 0.000 description 5
- 206010030113 Oedema Diseases 0.000 description 5
- 208000004880 Polyuria Diseases 0.000 description 5
- 208000034158 bleeding Diseases 0.000 description 5
- 230000000740 bleeding effect Effects 0.000 description 5
- 230000023555 blood coagulation Effects 0.000 description 5
- 238000001514 detection method Methods 0.000 description 5
- 230000035619 diuresis Effects 0.000 description 5
- 235000013305 food Nutrition 0.000 description 5
- 230000002401 inhibitory effect Effects 0.000 description 5
- 210000005229 liver cell Anatomy 0.000 description 5
- 230000008506 pathogenesis Effects 0.000 description 5
- 230000000144 pharmacologic effect Effects 0.000 description 5
- 210000002966 serum Anatomy 0.000 description 5
- 208000011580 syndromic disease Diseases 0.000 description 5
- 235000019640 taste Nutrition 0.000 description 5
- 238000002604 ultrasonography Methods 0.000 description 5
- 201000000736 Amenorrhea Diseases 0.000 description 4
- 206010001928 Amenorrhoea Diseases 0.000 description 4
- 206010011224 Cough Diseases 0.000 description 4
- 244000163122 Curcuma domestica Species 0.000 description 4
- 238000013382 DNA quantification Methods 0.000 description 4
- 101710142246 External core antigen Proteins 0.000 description 4
- 206010037660 Pyrexia Diseases 0.000 description 4
- 230000003213 activating effect Effects 0.000 description 4
- 231100000540 amenorrhea Toxicity 0.000 description 4
- 230000036772 blood pressure Effects 0.000 description 4
- 208000002173 dizziness Diseases 0.000 description 4
- 208000013403 hyperactivity Diseases 0.000 description 4
- 208000014674 injury Diseases 0.000 description 4
- 201000007270 liver cancer Diseases 0.000 description 4
- 210000000056 organ Anatomy 0.000 description 4
- 210000003240 portal vein Anatomy 0.000 description 4
- 230000008929 regeneration Effects 0.000 description 4
- 238000011069 regeneration method Methods 0.000 description 4
- 230000001105 regulatory effect Effects 0.000 description 4
- 206010000060 Abdominal distension Diseases 0.000 description 3
- 241001061264 Astragalus Species 0.000 description 3
- 206010012735 Diarrhoea Diseases 0.000 description 3
- 206010018498 Goitre Diseases 0.000 description 3
- 206010067125 Liver injury Diseases 0.000 description 3
- 206010033557 Palpitations Diseases 0.000 description 3
- 240000007164 Salvia officinalis Species 0.000 description 3
- 208000022531 anorexia Diseases 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 3
- 210000000038 chest Anatomy 0.000 description 3
- 230000001684 chronic effect Effects 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 206010061428 decreased appetite Diseases 0.000 description 3
- 238000006731 degradation reaction Methods 0.000 description 3
- 206010012601 diabetes mellitus Diseases 0.000 description 3
- 238000003745 diagnosis Methods 0.000 description 3
- 230000006870 function Effects 0.000 description 3
- 201000003872 goiter Diseases 0.000 description 3
- 230000002440 hepatic effect Effects 0.000 description 3
- 208000006454 hepatitis Diseases 0.000 description 3
- 208000014018 liver neoplasm Diseases 0.000 description 3
- 210000005228 liver tissue Anatomy 0.000 description 3
- 231100000915 pathological change Toxicity 0.000 description 3
- 230000036285 pathological change Effects 0.000 description 3
- 230000001575 pathological effect Effects 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 238000004393 prognosis Methods 0.000 description 3
- 235000005412 red sage Nutrition 0.000 description 3
- 238000005728 strengthening Methods 0.000 description 3
- 210000004233 talus Anatomy 0.000 description 3
- 239000003053 toxin Substances 0.000 description 3
- 231100000765 toxin Toxicity 0.000 description 3
- 230000008736 traumatic injury Effects 0.000 description 3
- GHOKWGTUZJEAQD-ZETCQYMHSA-N (D)-(+)-Pantothenic acid Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCC(O)=O GHOKWGTUZJEAQD-ZETCQYMHSA-N 0.000 description 2
- 206010000077 Abdominal mass Diseases 0.000 description 2
- 208000019901 Anxiety disease Diseases 0.000 description 2
- 208000006820 Arthralgia Diseases 0.000 description 2
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- 206010008909 Chronic Hepatitis Diseases 0.000 description 2
- 208000000059 Dyspnea Diseases 0.000 description 2
- 206010013975 Dyspnoeas Diseases 0.000 description 2
- 241000700721 Hepatitis B virus Species 0.000 description 2
- 208000006083 Hypokinesia Diseases 0.000 description 2
- 206010061245 Internal injury Diseases 0.000 description 2
- 206010027514 Metrorrhagia Diseases 0.000 description 2
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 description 2
- 208000025865 Ulcer Diseases 0.000 description 2
- 206010047513 Vision blurred Diseases 0.000 description 2
- 208000031971 Yin Deficiency Diseases 0.000 description 2
- 230000036506 anxiety Effects 0.000 description 2
- 210000000941 bile Anatomy 0.000 description 2
- 235000019658 bitter taste Nutrition 0.000 description 2
- 230000002950 deficient Effects 0.000 description 2
- 235000005911 diet Nutrition 0.000 description 2
- 230000037213 diet Effects 0.000 description 2
- 239000007919 dispersible tablet Substances 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 210000002683 foot Anatomy 0.000 description 2
- 230000036039 immunity Effects 0.000 description 2
- 230000001939 inductive effect Effects 0.000 description 2
- 206010022437 insomnia Diseases 0.000 description 2
- 210000002429 large intestine Anatomy 0.000 description 2
- 201000004792 malaria Diseases 0.000 description 2
- 239000002398 materia medica Substances 0.000 description 2
- 230000005906 menstruation Effects 0.000 description 2
- 230000004089 microcirculation Effects 0.000 description 2
- 244000052769 pathogen Species 0.000 description 2
- 230000007170 pathology Effects 0.000 description 2
- 230000000149 penetrating effect Effects 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 230000035755 proliferation Effects 0.000 description 2
- 238000003908 quality control method Methods 0.000 description 2
- 230000008439 repair process Effects 0.000 description 2
- 230000002441 reversible effect Effects 0.000 description 2
- 210000000955 splenic vein Anatomy 0.000 description 2
- 208000010110 spontaneous platelet aggregation Diseases 0.000 description 2
- 230000035900 sweating Effects 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 230000002936 tranquilizing effect Effects 0.000 description 2
- 231100000397 ulcer Toxicity 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- ZOOGRGPOEVQQDX-UUOKFMHZSA-N 3',5'-cyclic GMP Chemical compound C([C@H]1O2)OP(O)(=O)O[C@H]1[C@@H](O)[C@@H]2N1C(N=C(NC2=O)N)=C2N=C1 ZOOGRGPOEVQQDX-UUOKFMHZSA-N 0.000 description 1
- XVPBINOPNYFXID-JARXUMMXSA-N 85u4c366qs Chemical compound C([C@@H]1CCC[N@+]2(CCC[C@H]3[C@@H]21)[O-])N1[C@@H]3CCCC1=O XVPBINOPNYFXID-JARXUMMXSA-N 0.000 description 1
- 206010000087 Abdominal pain upper Diseases 0.000 description 1
- 206010000234 Abortion spontaneous Diseases 0.000 description 1
- 208000000044 Amnesia Diseases 0.000 description 1
- 208000031091 Amnestic disease Diseases 0.000 description 1
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- 206010007247 Carbuncle Diseases 0.000 description 1
- GHOKWGTUZJEAQD-UHFFFAOYSA-N Chick antidermatitis factor Natural products OCC(C)(C)C(O)C(=O)NCCC(O)=O GHOKWGTUZJEAQD-UHFFFAOYSA-N 0.000 description 1
- 206010053398 Clonic convulsion Diseases 0.000 description 1
- 206010053567 Coagulopathies Diseases 0.000 description 1
- 241000709687 Coxsackievirus Species 0.000 description 1
- 235000003392 Curcuma domestica Nutrition 0.000 description 1
- 241000721047 Danaus plexippus Species 0.000 description 1
- 208000005171 Dysmenorrhea Diseases 0.000 description 1
- 206010013935 Dysmenorrhoea Diseases 0.000 description 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
- 102000010834 Extracellular Matrix Proteins Human genes 0.000 description 1
- 108010037362 Extracellular Matrix Proteins Proteins 0.000 description 1
- 208000004930 Fatty Liver Diseases 0.000 description 1
- 108010088842 Fibrinolysin Proteins 0.000 description 1
- 206010016807 Fluid retention Diseases 0.000 description 1
- 208000012671 Gastrointestinal haemorrhages Diseases 0.000 description 1
- 229920002527 Glycogen Polymers 0.000 description 1
- 208000034507 Haematemesis Diseases 0.000 description 1
- 208000000616 Hemoptysis Diseases 0.000 description 1
- 241000711549 Hepacivirus C Species 0.000 description 1
- 206010019663 Hepatic failure Diseases 0.000 description 1
- 206010019708 Hepatic steatosis Diseases 0.000 description 1
- 206010019909 Hernia Diseases 0.000 description 1
- 208000008454 Hyperhidrosis Diseases 0.000 description 1
- 206010020850 Hyperthyroidism Diseases 0.000 description 1
- 206010021118 Hypotonia Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- ZSBXGIUJOOQZMP-UHFFFAOYSA-N Isomatrine Natural products C1CCC2CN3C(=O)CCCC3C3C2N1CCC3 ZSBXGIUJOOQZMP-UHFFFAOYSA-N 0.000 description 1
- 206010023126 Jaundice Diseases 0.000 description 1
- ZSBXGIUJOOQZMP-JLNYLFASSA-N Matrine Chemical compound C1CC[C@H]2CN3C(=O)CCC[C@@H]3[C@@H]3[C@H]2N1CCC3 ZSBXGIUJOOQZMP-JLNYLFASSA-N 0.000 description 1
- SEBFKMXJBCUCAI-UHFFFAOYSA-N NSC 227190 Natural products C1=C(O)C(OC)=CC(C2C(OC3=CC=C(C=C3O2)C2C(C(=O)C3=C(O)C=C(O)C=C3O2)O)CO)=C1 SEBFKMXJBCUCAI-UHFFFAOYSA-N 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 240000007594 Oryza sativa Species 0.000 description 1
- 235000007164 Oryza sativa Nutrition 0.000 description 1
- 244000170916 Paeonia officinalis Species 0.000 description 1
- 235000006484 Paeonia officinalis Nutrition 0.000 description 1
- 241001522129 Pinellia Species 0.000 description 1
- 241000037831 Polygonatum sibiricum Species 0.000 description 1
- 206010062519 Poor quality sleep Diseases 0.000 description 1
- 241001619461 Poria <basidiomycete fungus> Species 0.000 description 1
- 208000001431 Psychomotor Agitation Diseases 0.000 description 1
- 208000019155 Radiation injury Diseases 0.000 description 1
- 206010038084 Rectocele Diseases 0.000 description 1
- 206010038743 Restlessness Diseases 0.000 description 1
- 206010039424 Salivary hypersecretion Diseases 0.000 description 1
- 208000032023 Signs and Symptoms Diseases 0.000 description 1
- 241000219784 Sophora Species 0.000 description 1
- 206010041497 Spermatorrhoea Diseases 0.000 description 1
- 206010041519 Spider naevus Diseases 0.000 description 1
- 208000033809 Suppuration Diseases 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 206010053476 Traumatic haemorrhage Diseases 0.000 description 1
- 108090000631 Trypsin Proteins 0.000 description 1
- 102000004142 Trypsin Human genes 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 208000005946 Xerostomia Diseases 0.000 description 1
- NCKJIJSEWKIXAT-DQRAZIAOSA-N [(z)-2-diphenylphosphanylethenyl]-diphenylphosphane Chemical compound C=1C=CC=CC=1P(C=1C=CC=CC=1)/C=C\P(C=1C=CC=CC=1)C1=CC=CC=C1 NCKJIJSEWKIXAT-DQRAZIAOSA-N 0.000 description 1
- 208000019790 abdominal distention Diseases 0.000 description 1
- 208000011279 abdominal lump Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 206010000269 abscess Diseases 0.000 description 1
- 238000007792 addition Methods 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 230000006986 amnesia Effects 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000002300 anti-fibrosis Effects 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 230000010100 anticoagulation Effects 0.000 description 1
- 230000036528 appetite Effects 0.000 description 1
- 235000019789 appetite Nutrition 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 206010003549 asthenia Diseases 0.000 description 1
- 235000019606 astringent taste Nutrition 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 230000001914 calming effect Effects 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000019522 cellular metabolic process Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 208000013116 chronic cough Diseases 0.000 description 1
- 208000019902 chronic diarrheal disease Diseases 0.000 description 1
- 231100000012 chronic liver injury Toxicity 0.000 description 1
- 230000035602 clotting Effects 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 210000002808 connective tissue Anatomy 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 235000003373 curcuma longa Nutrition 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000006735 deficit Effects 0.000 description 1
- 230000001934 delay Effects 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- 230000000994 depressogenic effect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000004069 differentiation Effects 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 230000035622 drinking Effects 0.000 description 1
- 206010013781 dry mouth Diseases 0.000 description 1
- 230000004064 dysfunction Effects 0.000 description 1
- 206010013990 dysuria Diseases 0.000 description 1
- 230000008451 emotion Effects 0.000 description 1
- 206010015037 epilepsy Diseases 0.000 description 1
- 208000001780 epistaxis Diseases 0.000 description 1
- 210000002744 extracellular matrix Anatomy 0.000 description 1
- 210000003414 extremity Anatomy 0.000 description 1
- 230000004438 eyesight Effects 0.000 description 1
- 206010016256 fatigue Diseases 0.000 description 1
- 208000010706 fatty liver disease Diseases 0.000 description 1
- 210000002950 fibroblast Anatomy 0.000 description 1
- 230000004761 fibrosis Effects 0.000 description 1
- 208000017561 flaccidity Diseases 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000019634 flavors Nutrition 0.000 description 1
- 230000027119 gastric acid secretion Effects 0.000 description 1
- 229940096919 glycogen Drugs 0.000 description 1
- 239000008187 granular material Substances 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
- 230000003394 haemopoietic effect Effects 0.000 description 1
- 230000004217 heart function Effects 0.000 description 1
- 208000035861 hematochezia Diseases 0.000 description 1
- 210000003958 hematopoietic stem cell Anatomy 0.000 description 1
- 230000000004 hemodynamic effect Effects 0.000 description 1
- 231100000753 hepatic injury Toxicity 0.000 description 1
- 231100000283 hepatitis Toxicity 0.000 description 1
- 231100000844 hepatocellular carcinoma Toxicity 0.000 description 1
- 206010073071 hepatocellular carcinoma Diseases 0.000 description 1
- 210000003494 hepatocyte Anatomy 0.000 description 1
- 206010019847 hepatosplenomegaly Diseases 0.000 description 1
- 241000411851 herbal medicine Species 0.000 description 1
- 230000036737 immune function Effects 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 210000003127 knee Anatomy 0.000 description 1
- 231100000835 liver failure Toxicity 0.000 description 1
- 208000007903 liver failure Diseases 0.000 description 1
- 230000033001 locomotion Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 201000007227 lymph node tuberculosis Diseases 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 229930014456 matrine Natural products 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 230000007721 medicinal effect Effects 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 244000000010 microbial pathogen Species 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
- 230000036565 night sweats Effects 0.000 description 1
- 206010029410 night sweats Diseases 0.000 description 1
- 230000024121 nodulation Effects 0.000 description 1
- 231100000956 nontoxicity Toxicity 0.000 description 1
- 231100000862 numbness Toxicity 0.000 description 1
- 229930015582 oxymatrine Natural products 0.000 description 1
- 229940055726 pantothenic acid Drugs 0.000 description 1
- 235000019161 pantothenic acid Nutrition 0.000 description 1
- 239000011713 pantothenic acid Substances 0.000 description 1
- 230000036961 partial effect Effects 0.000 description 1
- 230000035790 physiological processes and functions Effects 0.000 description 1
- 229940012957 plasmin Drugs 0.000 description 1
- 231100000614 poison Toxicity 0.000 description 1
- 239000002574 poison Substances 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 230000022558 protein metabolic process Effects 0.000 description 1
- 230000004844 protein turnover Effects 0.000 description 1
- 230000010349 pulsation Effects 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 235000009566 rice Nutrition 0.000 description 1
- 208000026451 salivation Diseases 0.000 description 1
- 235000019643 salty taste Nutrition 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 208000013220 shortness of breath Diseases 0.000 description 1
- SEBFKMXJBCUCAI-HKTJVKLFSA-N silibinin Chemical compound C1=C(O)C(OC)=CC([C@@H]2[C@H](OC3=CC=C(C=C3O2)[C@@H]2[C@H](C(=O)C3=C(O)C=C(O)C=C3O2)O)CO)=C1 SEBFKMXJBCUCAI-HKTJVKLFSA-N 0.000 description 1
- 229960004245 silymarin Drugs 0.000 description 1
- 235000017700 silymarin Nutrition 0.000 description 1
- 208000000995 spontaneous abortion Diseases 0.000 description 1
- 230000002269 spontaneous effect Effects 0.000 description 1
- 239000007858 starting material Substances 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 238000010025 steaming Methods 0.000 description 1
- 231100000240 steatosis hepatitis Toxicity 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 230000008093 supporting effect Effects 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 230000008685 targeting Effects 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 210000001550 testis Anatomy 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 210000000115 thoracic cavity Anatomy 0.000 description 1
- 230000003867 tiredness Effects 0.000 description 1
- 208000016255 tiredness Diseases 0.000 description 1
- 231100000167 toxic agent Toxicity 0.000 description 1
- 239000003440 toxic substance Substances 0.000 description 1
- 230000001131 transforming effect Effects 0.000 description 1
- 238000011269 treatment regimen Methods 0.000 description 1
- 239000012588 trypsin Substances 0.000 description 1
- 235000013976 turmeric Nutrition 0.000 description 1
- 241000701161 unidentified adenovirus Species 0.000 description 1
- 210000003932 urinary bladder Anatomy 0.000 description 1
- 208000019553 vascular disease Diseases 0.000 description 1
- 231100000611 venom Toxicity 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
- 238000010792 warming Methods 0.000 description 1
- 230000029663 wound healing Effects 0.000 description 1
Images
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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/58—Reptiles
- A61K35/586—Turtles; Tortoises, e.g. terrapins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
-
- 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
- A61K36/02—Algae
-
- 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
- A61K36/02—Algae
- A61K36/03—Phaeophycota or phaeophyta (brown algae), e.g. Fucus
-
- 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
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
-
- 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)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
-
- 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)
- A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
-
- 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
- A61K36/489—Sophora, e.g. necklacepod or mamani
-
- 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
-
- 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)
- A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
-
- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/89—Cyperaceae (Sedge family)
- A61K36/8905—Cyperus (flatsedge)
-
- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8969—Polygonatum (Solomon's seal)
-
- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
-
- 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
- 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 or 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
- A61K2236/39—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
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Biotechnology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Alternative & Traditional Medicine (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Zoology (AREA)
- Marine Sciences & Fisheries (AREA)
- Gastroenterology & Hepatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明公开了一种治疗慢性肝病的中药复方制剂及其制备方法和应用，所述中药复方制剂的有效成分的原料包括黄芪、生牡蛎、黄精、海藻、茯苓、丹参、莪术、生鳖甲、昆布、叶下珠、苦参、柴胡、香附、醋延胡、三七。本发明中药复方制剂主要针对慢性肝病肝纤维化，对症下药，具有活血化瘀，祛湿化痰，软坚散结功效，吸收效果好，疗效显著，无毒副作用及临床不良反应，经临床验证对肝纤维化治愈率较高。
Description
技术领域
本发明属于中药制药领域，具体涉及一种治疗慢性肝病的中药复方制剂及其制备方法和应用。尤其涉及一种治疗慢性肝病肝纤维化的中药复方制剂及其制备方法和应用。
背景技术
慢性肝病是指发生在肝脏的病变，以慢性肝炎和肝硬化多见，主要病理改变为肝功损害、肝纤维化。肝纤维化是多种慢性肝病发展过程中的重要病理环节，是慢性肝炎向肝硬化发展的可逆阶段，是机体对各种慢性肝损伤的一种修复反应，是一切慢性肝病共同的病理学基础，肝纤维化可发展为肝硬化、肝衰竭和原发性肝癌，患者最终死于慢性肝病相关的终末期疾病。肝纤维化是肝硬化及肝癌的临床初期阶段，因此对其进行防治可以在很大程度上降低肝硬化及肝癌的发病率及死亡率，提高患者的生活质量。如何抑制肝纤维化，阻止病情进一步发展成肝硬化、肝癌，成为国内外的研究热点。
慢性肝病肝纤维化的基本治疗策略是病因治疗联合抗肝纤维化治疗。由于肝靶向性差，半衰期短，药物在其他组织中积累引起的毒性副作用，导致药物疗效低下，目前，针对肝纤维化的治疗尚无明确可用于临床的抗纤维化化学或生物药物。因此，寻找有效药物阻断、延缓及逆转肝纤维化的发生和发展是急亟解决的问题。
本发明人研究团队长期从事慢性肝病的临床、科学研究工作，临证经验丰富，尤擅于治疗肝纤维化，效如桴鼓。本发明人认为《内经》关于积证病机的描述，与肝纤维化的病理较为吻合。如《灵枢.百病始生篇》认为，病邪侵袭人体，加之内伤忧怒，或饮食起居不节等原因，导致“温气不行，凝血蕴里而不散，津液涩渗，著而不去，而积皆成矣”。凡“湿热疫毒”、“蛊毒”等外邪侵入肝脏，或酒食所伤，经久不愈，渐致肝、脾、肾等功能失调。气、血、津液搏结，使得经脉壅滞不通，以致阳气不能畅行，引起血凝在里不能消散，津液的输注也发生涩滞，终致痰湿、瘀血沉积，肝络瘀阻所致。因此，“痰湿”、“瘀血”是形成肝纤维化病机的关键。基于这一基本病证特点，根据中医辨证理论运用活血化瘀，祛湿化痰，软坚散结的临证方法，制作成一种治疗慢性肝病的中药复方制剂。大部分医家注重于使用活血化瘀药物，但若纯予活血化瘀药多有耗气伤阴之弊，甚至破瘀引起出血。肝体阴而用阳，用药忌刚宜柔，对肝纤维化的治疗消坚反致胀满，因此在使用活血软件散结的药物基础上，应加用益气健脾、养阴柔肝之品。基于此，主要针对慢性肝病肝纤维化患者，特提出了本发明。
发明内容
为了弥补现有技术的不足，本发明提供了一种治疗慢性肝病的中药复方制剂，所述中药复方制剂的有效成分的原料包括黄芪、生牡蛎、黄精、海藻、茯苓、丹参、莪术、生鳖甲、昆布、叶下珠、苦参、柴胡、香附、醋延胡、三七。
优选地，本发明所述中药复方制剂有效成分的原料组成的重量份数为：
黄芪20～40份、生牡蛎20～40份、黄精10～30份、海藻10～30份、
茯苓10～30份、丹参10～30份、莪术10～30份、生鳖甲10～30份、
昆布10～30份、叶下珠10～30份、苦参10～30份、柴胡5～20份、
香附5～20份、醋延胡5～20份、三七5～20份。
优选地，本发明所述的中药复方制剂有效成分的原料组成及重量份数为：
黄芪30份、生牡蛎30份、黄精20份、海藻15份、
茯苓15份、丹参15份、莪术15份、生鳖甲15份、
昆布15份、叶下珠15份、苦参15份、柴胡10份、
香附10份、醋延胡10份、三七10份。
另一方面，本发明还提供了一种制备该中药复方制剂的方法，所述方法包括以下工艺步骤：
(1)按所述重量配比准备15种药材；
(2)把黄芪、丹参、莪术、香附、醋延胡、三七六味药材，经混合用万能碎粉机粉碎成研末，再用槽型混合机混均匀后过100目筛；
(3)把生牡蛎、黄精、海藻、茯苓、生鳖甲、昆布、叶下珠、苦参、柴胡九味药材，加10倍量水煎煮2次，第一次1.5h，第二次1.0h，合并煎液，滤过，滤液浓缩成在60℃时相对密度为1.30～1.35的稠膏；
(4)把步骤(2)所得细粉与步骤(3)所得稠膏用槽型混合机混匀，采用全自动速控中药制丸机制丸，抛光，采用热风循环烘箱干燥后即得，装瓶。
优选地，本发明所述方法制备的中药复方制剂为丸剂。
优选地，本发明所述步骤(4)中制丸时每10丸重0.39g。
优选地，本发明所述步骤(4)中装瓶时为120g/瓶。
再一方面，本发明还提供了一种所述的中药复方制剂在制备治疗慢性肝病中的应用。
优选地，本发明所述的慢性肝病为慢性肝病肝纤维化。
本发明所用中药复方制剂的药性如下：
黄芪：性味甘、微温。归肺、脾、肝、肾经。具有补气健脾，升阳举陷，益卫固表，利尿消肿，养血生津，行滞通痹，敛疮生肌，托毒排脓的作用。主治气虚乏力，中气下陷，久泻脱肛；肺气虚弱，咳喘气短；气血亏虚，疮疡难溃难腐；内热消渴，血虚萎黄；气虚血滞，痹痛麻木等症。现代药理表明黄芪能防止肝糖原减少，实验显示对小白鼠肝炎有保护作用还可能是通过细胞内cAMP，cGMP的调节作用，使细胞的生理代谢增强；还能促进血清和肝脏的蛋白质更新，对蛋白质代谢有促进作用。并且能增强机体的免疫力以及应激能力；改善心功能、降压作用；调节血糖等改善相关血管性病变的血流动力学功能。
生牡蛎：性味咸、微寒。归肝、胆、肾经。具有重镇安神，潜阳补阴，软坚散结，收敛固涩的作用。主治心神不宁，惊悸失眠；肝阳上亢，头晕目眩；瘿瘤，癥瘕，积聚；自汗盗汗，滑精遗精，崩漏带下；胃痛泛酸等症。牡蛎现代药理表示在人体内参与了广泛的代谢过程，具有抗心律失常，保护肝脏细胞，对抗脂肪肝等作用。
黄精：性味甘、平。归脾、肺、肾经。主要功效是益气养阴，润肺益肾，补脾。主治脾胃虚弱，体倦乏力，口干食少，内热消渴，肺虚燥咳，劳嗽久咳，肾虚头晕，腰膝酸软，须发早白内热消渴等症。
海藻：性味苦、咸、寒。归肾、肝、胃经。具有软坚散结，消痰，利水退肿。《本草崇原》：“海藻，其味苦咸，其性寒洁，故主治经脉外内之坚结。”
茯苓：性味甘、淡、平。归心、肺、脾、肾经。具有利水渗湿，健脾，宁心。主治水肿，小便不利；痰饮咳逆，眩悸；脾虚泄泻，食少便溏，呕吐；心悸不安，失眠健忘等症。《药性论》：“忌米醋。”《医学启源》：“如小便利，或数服之，则损人目；如汗多人服之，损元气，夭人寿。”
丹参：性味苦、微寒。归心、肝经。具有活血调经，祛瘀止痛，凉血消痈，除烦安神的作用。《本经》曰“主心腹邪气，肠鸣幽幽如走水，寒热积聚；破症除瘕，止烦满，益气。”《纲目》记载“活血，通心包络。治疝痛。”现代医学研究发现丹参可以提高纤溶酶活性；延长出、凝血时间；抑制血小板聚集；改善血液流变学特性；改善微循环；促进组织的修复与再生作用；抑制纤维母细胞的增生；保肝改善肝微循环。
莪术：性味辛、苦，温。归肝、脾经。具有破血行气、消积止痛的功效。主治血瘀腹痛，肝脾肿大，心腹胀痛；积聚，妇女血瘀经闭，跌打损伤作痛饮食积滞；气滞血瘀之经闭；胸胁痛；腹痛及症瘕肿块；饮食积滞之胃腹胀痛等症。
生鳖甲：性味咸、微寒。归肝、肾经。具有滋阴潜阳、退热除蒸、软坚散结作用。用于阴虚发热，劳热骨蒸，阴虚阳亢，头晕目眩，虚风内动，手足瘛瘲；经闭，癞瘕积聚，久疟疟母。古文记载曰“至于积聚之所治，......如鳖甲丸之于肝积为肥气，干漆丸及半夏散之于心积为伏粱，又鳖甲丸之于脾积为痞气，四方虽各有不同，然总归于入足厥阴、手少阴、足太阴之脏也，以鳖甲阴气之专，入三阴而行其积，固有得于气之相应者矣。”
昆布：性味咸。归肝、胃、肾经。有软坚散结，消痰，利水之功能。用于痰饮水肿；软
坚散结，消痰，利水；瘿瘤、瘰疬、睾丸肿痛、痰饮水肿等症。《别录》：“主十二种水肿，瘿瘤聚结气，痿疮。”现代的药理作用研究表明昆布可以抑制甲状腺机能亢进，并且具有降压作用；降血糖作用；降血脂；抗凝作用；抗放射作用。
叶下珠：性味微苦、甘、凉。归肝、脾经。具有清热利尿，明目，消积功效。现代药理表明叶下珠具有抗乙型肝炎病毒作用；抗肝细胞损伤作用；抗原发性肝细胞癌作用；抗菌作用。
苦参：味苦，性寒，归心、肝、胃、大肠、膀胱经。具有清热燥湿解毒的功效。《神农本草经》：“主心腹气结，癥瘕积聚，黄疸，溺有余沥，逐水，除痈肿。”现代药理研究表明苦参碱、氧化苦参碱对乙型肝炎病毒、丙型肝炎病毒、科萨奇病毒、腺病毒具有较强的抑制作用。
柴胡：性辛苦，微寒。归肝、胆、肺经。主要功效是和疏散退热，疏肝解郁，升举阳气。《神农本草经》注：“气味苦、平，无毒。现代药理研究表明柴胡具有解热，抗炎，促进免疫功能，抗肝损伤，利胆，抗辐射损伤等作用，并且可以降血脂，抑制胃酸分泌，抗溃疡，抑制胰蛋白酶、抗病原微生，抗肿瘤、抗癫痫等作用。
香附：性辛、微苦、微甘、平，归肝、脾三焦经，具有疏肝解郁，理气宽中，调经止痛，安胎的功效，安胎。现代药理学研究表明香附可明显增加胆汁流量，促进胆汁分泌，并对肝细胞有保护作用。
元胡：又名延胡索，性温，味辛苦，入心、脾、肝经，具有活血、行气、止痛的的功效。主治气滞血瘀，胸胁、脘腹疼痛、胸痹心痛、经闭痛经、产后瘀阻、跌扑肿痛等症。
三七：性温，味甘、微苦，归肝、胃经，具有散瘀止血，消肿定痛的功效。主治咯血，吐血，衄血，便血，崩漏，外伤出血，胸腹刺痛，跌扑肿痛。《本草求真》：专入肝胃，兼入心大肠，又名山漆。现代药理研究表明三七能够明显缩短出血和凝血时间，具有抗血小板聚集和溶栓作用；抗肝损伤、抗肿瘤；能够促进多功能造血干细胞的增殖，具有造血作用。
慢性肝病的进程中，肝纤维化是重要阶段，是指肝脏细胞纤维结缔组织过度沉积，是细胞外基质的弥漫性异常分布，肝脏慢性病理改变，是正常肝组织向肝硬化发展过程中的关键步骤，影响慢性肝病预后的重要环节。本发明人累近30年的临床经验，对肝纤维化这一疾病进行了深入探讨及总结，治疗肝纤维化取得良好的效果，延缓患者的病程进展，甚至逆转肝纤维化状态，有效改善慢性肝病患者的预后。
本发明人认为《内经》关于积证病机的描述，与肝纤维化的病理较为吻合。如《灵枢. 百病始生篇》认为，病邪侵袭人体，加之内伤忧怒，或饮食起居不节等原因，导致“温气不行，凝血蕴里而不散，津液涩渗，著而不去，而积皆成矣”。《诸病源候论》“诸脏受邪，初未能为积聚，留滞不去，乃成积聚。”此外《景岳全书》记载：“积者，积垒之谓，由渐而成也。”积聚之病，凡酒食血气风寒情志皆能致之。《济生方》“忧思喜怒之人，人之所不能无者，过则伤乎五脏，……留结而为五积。”该病多为感受疫毒之邪，长期作用于肝脏，又因肝主疏泄，肝脏受邪，影响肝脏的生理机能，致肝络不和，肝病由气及血，气机阻滞，血络不畅，气、血、津液搏结，使得经脉壅滞不通，以致阳气不能畅行，引起血凝在里不能消散，津液的输注也发生涩滞，终致痰湿、瘀血沉积，肝络瘀阻所致。因此，“痰湿”、“瘀血”是形成肝纤维化病机的关键，初期一般为邪毒壅盛，邪正交争，正气尚可抵御邪气，属于实证；积聚的后期病理特点为瘀血作用于肝脏，气阴不足，形成本虚标实之证。
《景岳全书》曰“治积之要，在知攻补之宜，当于孰缓孰急中辨之”。本发明人认为治实当顾虚，补虚勿忘实，疏其血气，令其调达。肝纤维化患者多气血运行不畅，瘀阻脉络，耗伤机体正气，而致气阴亏虚，积伤入络，气血皆瘀，既不能峻攻，又不能缓图，应当疏散肝脏气血，破癥消结，多用辛散活血类药物治之，但辛温药物峻猛多伤阴，应当加入养阴之药物。肝体阴而用阳，用药忌刚宜柔，对肝纤维化的治疗兼以缓剂软坚散结，若纯予活血化瘀药多有耗气伤阴之弊，甚至破瘀引起出血，消坚反致胀满，加用益气健脾、养阴柔肝之品。所谓“阴邪入络，大旨以辛温入血络治之。盖阴主精，不移即主静之根，所以为阴也，……所以必藉体阴而用阳之品，方能出阳，以旋其辛散温通之力也”。因此胡振斌教授根据多年的临床经验提出自己的见解，中医辨证理论运用活血化瘀，祛湿化痰，软坚散结的临证方法，制作成一种治疗慢性肝病的中药复方制剂。因此本发明针对病因下药，方中丹参、三七、莪术为君药活血化瘀。鳖甲、牡蛎为臣药滋阴潜阳，软坚散结，散结而不伤阴。海藻、昆布化痰软坚散结。海藻、昆布、柴胡、香附、延胡索为佐药，气为血之帅，气行则血行，柴胡、香附疏肝理气，延胡索活血气止痛。痰湿郁久而化热，叶下珠、苦参清热解毒，祛外邪；黄芪补中益气；黄精补气养阴，健脾益肾，茯苓健脾渗湿，祛邪而不伤正；叶下珠、苦参、黄芪、黄精、茯苓共为使药。诸药配伍共奏扶正益气，化瘀散结之效。本发明中药复方制剂通过活血通络，益气养阴，疏通肝内血络，清除肝内淤积，化瘀散结，促进肝纤维化的降解与吸收，保护肝脏，促进肝细胞再生，降低门脉血压，具有临床推广价值。
因此，本发明所选用药材的药性相适相辅，针对病因对症下药，诸药配伍共奏扶正益气，化瘀散结之效。通过活血通络，益气养阴，疏通肝内血络，清除肝内淤积，化瘀散结，促进慢性肝病肝纤维化的降解与吸收，保护肝脏，促进肝细胞再生，无毒副作用，疗效佳。
本发明经临床验证对肝纤维化治愈率较高，吸收效果好，疗效显著，无毒副作用及临床不良反应。本发明中药复方制剂可以促进肝纤维化的降解与吸收，保护肝脏，促进肝细胞再生，降低门脉血压，有效改善患者的病情预后，具有临床推广价值。
本发明中药复方制剂主要针对慢性肝病肝纤维化，对症下药，具有扶正益气，化瘀散结、行气止痛功效，吸收效果好，疗效显著，无毒副作用及临床不良反应，经临床验证对肝纤维化治愈率较高。
附图说明
图1中药复方制剂制备模式图。
图2中药复方制剂部分质检图。
图3成品样图。
具体实施方式
以下结合具体实施例进一步阐述本发明。下述实施例中所涉及各种原料，如无特别说明，均为市售。
下面结合附图和实施例对本发明作进一步详细说明。以下实施例仅用于说明本发明而不用于限制本发明的范围。实施例中未注明具体条件的实验方法，通常按照常规条件，或按照制造厂商所建议的条件。
实施例1治疗慢性肝病的中药复方制剂有效成分的原料组成及重量为：
黄芪20～40份、生牡蛎20～40份、黄精10～30份、海藻10～30份、
茯苓10～30份、丹参10～30份、莪术10～30份、生鳖甲10～30份、
昆布10～30份、叶下珠10～30份、苦参10～30份、柴胡5～20份、
香附5～20份、元胡5～20份、三七5～20份。
实施例2治疗慢性肝病的中药复方制剂有效成分的原料组成及重量为：
黄芪20份、生牡蛎20份、黄精10份、海藻10份、
茯苓10份、丹参10份、莪术10份、生鳖甲10份、
昆布10份、叶下珠10份、苦参10份、柴胡5份、
香附5份、元胡5份、三七5份。
实施例3治疗慢性肝病的中药复方制剂有效成分的原料组成及重量为：
黄芪40份、生牡蛎40份、黄精30份、海藻30份、
茯苓30份、丹参30份、莪术30份、生鳖甲30份、
昆布30份、叶下珠30份、苦参30份、柴胡20份、
香附20份、元胡20份、三七20份。
实施例4治疗慢性肝病的中药复方制剂有效成分的原料组成及重量为：
黄芪30份、生牡蛎30份、黄精20份、海藻15份、
茯苓15份、丹参15份、莪术15份、生鳖甲15份、
昆布15份、叶下珠15份、苦参15份、柴胡10份、
香附10份、元胡10份、三七10份。
实施例5实施例1～实施例4中的中药复方制剂的制备方法包括以下工艺步骤：
(1)按所述重量配比准备15种药材；
(2)把黄芪、丹参、莪术、香附、醋延胡、三七六味药材，经混合用万能碎粉机(9FZ-35) 粉碎成研末，再用槽型混合机(CH-50)混均匀后过100目筛；
(3)把生牡蛎、黄精、海藻、茯苓、生鳖甲、昆布、叶下珠、苦参、柴胡九味药材，加10倍量水煎煮2次，第一次1.5h，第二次1.0h，合并煎液，滤过，滤液浓缩成在60℃时相对密度为1.30～1.35的稠膏；
(4)把步骤(2)所得细粉与步骤(3)所得稠膏用槽型混合机(CH-50)混匀，采用全自动速控中药制丸机(YUJ-16B)制丸(每10丸重0.39g)，抛光，采用热风循环烘箱(CTCI) 干燥后即得，装瓶(120g/瓶)。
(5)中药复方制剂制备模式图如图1所示。中药复方制剂部分质检图如图2所示。成品样图如图3所示。
实施例1～实施例4中的中药复方制剂的用法用量为：口服，一次约10g，一日2次，饭后一小时服用。
实施例6治疗案例分析
1、病例选择
选择2016年1月-2018年12月于本院住院和门诊患者200例，诊断：乙肝肝纤维化，随机分为A、B、C、D四组。治疗组A组50例，其中男37例，女13例；平均年龄44.3 岁；病程2-15年。对照组B组50例，其中男40例，女10例；平均年龄43.3岁；病程2.5-13 年。C组50例，其中男41例，女9例；平均年龄42.8岁；病程2-14年。D组50例，其中男39例，女11例；平均年龄44.5岁；病程2.5-15年。4组一般资料比较差异无统计学意义 (P＞0.05)，具有可比性。
2、A，B，C，D 4组均予恩替卡韦抗病毒基础治疗。此外，A组口服本发明中药复方制剂(实施方案4配方)。B组口服水飞蓟素片，2粒/次，3次/天。2组疗程均为1年。C组口服本发明中药复方制剂(实施方案2配方)。D组口服本发明中药复方制剂(实施方案3 配方)。
3、疗效判定：
相关生化检测指标：肝功能、肝纤维化指标、LSM值、肝胆脾胰彩超(肝门静脉内径(Dpv)、脾厚度、脾静脉内径(Dsv)值对比。
4、结果
通过对200例乙肝肝纤维化患者的临床研究发现，A组(使用恩替卡韦联合本发明中药复方制剂(实施例4配方))分别与B组(使用恩替卡韦联合水飞蓟素片)、C组(使用恩替卡韦联合本发明中药复方制剂(实施方案2配方))、D组(使用恩替卡韦联合本发明中药复方制剂(实施方案3配方))治疗后对照比较，在肝功能(ALT、AST)，肝纤指标(HA、PCIII、IV-C、LN)，LSM值、肝胆脾胰彩超(肝门静脉内径(Dpv)、脾厚度、脾静脉内径(Dsv)值方面，A组、C组、D组分别与B组比较有显著性差异(P＜0.05)； A组与C组比较有统计学差异(P＜0.05)，A组与D组治疗后比较无显著性差异(P＞0.05)，恩替卡韦联合本发明中药复方制剂治疗慢性肝病乙肝肝纤维化，不仅可以达到抗病毒的效果，同时还能增强患者机体的免疫力，优于常规护肝治疗，两者发挥协同作用，能够明显缓解患者症状，对慢性肝病长远发展具有重大意义，值得临床推广使用。
(1)4组患者治疗前后肝功能的变化见表1。
表1 4组患者治疗前后肝功能的变化的比较
注：治疗后A组、C组、D组分别与B组比较有显著性差异(*P＜0.05)；A组与C 组比较有统计学差异(#P＜0.05)，A组与D组治疗后比较无显著性差异(ΔP＞0.05)
(2)4组患者治疗前后血清肝纤指标的变化见表2
表2 4组患者治疗前后血清肝纤维化指标的变化的比较
注：治疗后A组、C组、D组分别与B组比较有显著性差异(*P＜0.05)；A组与C 组比较有统计学差异(#P＜0.05)，A组与D组治疗后比较无显著性差异(ΔP＞0.05)
(3)2组患者治疗前后肝硬度值的变化比较见表3。
表3 4组患者治疗前后LSM值得变化比较(
kPa)
注：：治疗后A组、C组、D组分别与B组比较有显著性差异(*P＜0.05)；A组与C 组比较有统计学差异(#P＜0.05)，A组与D组治疗后比较无显著性差异(ΔP＞0.05)
(4)2组患者治疗前后Dpv、脾厚度、Dsv变化情况见表4
表4 4组患者治疗前后Dpv、脾厚度、Dsv变化
注：治疗后A组、C组、D组分别与B组比较有显著性差异(*P＜0.05)；A组与C 组比较有统计学差异(#P＜0.05)，A组与D组治疗后比较无显著性差异(ΔP＞0.05)
典型病例举例：
1、梁某，男，43岁，于2018年2月8日于我院肝病科门诊就诊，自诉2周出现右上腹部刺痛，食欲减退，进食油腻感，体倦乏力，面色晦暗，偶有腹胀，纳寐差，二便调。患有慢性乙型病毒性肝炎病史8年，一直未予抗病毒治疗。期间未就诊及治疗。查体：舌暗红，脉弦细。胸前及后背可见少许散在蜘蛛痣。腹软，右上腹部轻压痛，无反跳痛，移动性浊音(-)。于我院行乙型肝炎两对半检查提示：HBsAg(+)、HBeAg(-)、HBcAb(-)。HBV-DNA 定量：2.36*10∧5。肝功能：ALT：96U/L、AST：73U/L、TBIL：18.5umol/L。肝纤四项：HA： 270Lg/L、PIII：165Lg/L、IV-C：190Lg/L、LN：159Lg/L。肝胆胰脾彩超检查提示：肝内多发结节，早期肝硬化；肝门静脉内径(Dpv)：12.6mm、脾厚度：43.6mm、脾静脉内径(Dsv)：10.3mm。FibroScan系统进行检测提示：10.6kPa。根据患者病史症状体征及辅助检查，诊断：乙肝肝纤维化。治疗上予恩替卡韦分散片抗病毒治疗1片/次，每天1次，以及本发明中药复方制剂(实施例4配方)抗肝纤维化护肝治疗，10g/次，每天2次。3个月随访一次。1年后随访，患者无明显不适，纳寐可，二便调。行乙型肝炎检查提示：HBsAg(+)、 HBeAg(-)、HBcAb(-)。HBV-DNA定量：(-)。肝功能：ALT：32U/L、AST：41U/L、 TBIL：9.5umol/L。肝纤四项：HA：75Lg/L、PIII：63Lg/L、IV-C：52Lg/L、LN：61Lg/L。肝胆胰脾彩超检查提示：肝组织稍回声增粗。肝门静脉内径(Dpv)：7.3mm、脾厚度：28.9mm、脾静脉内径(Dsv)：6.3mm。FibroScan系统进行检测提示：7.3kPa。效果明显。
2、梁某，女，51岁，于2018年6月3日于我院肝病科门诊就诊，自诉近半年来出现乏力，食欲减退。期间未就诊及治疗。于我院行乙型肝炎两对半检查提示：HBsAg(+)、HBeAg(-)、HBcAb(-)。HBV-DNA定量：3.23*10∧3。肝功能：ALT：63U/L、AST：85U/L、 TBIL：19.1umol/L。肝胆胰脾彩超检查提示：肝内多发结节，早期肝硬化。FibroScan系统进行检测提示：10.3kPa。根据患者病史症状体征及辅助检查，西医诊断：乙肝肝纤维化。治疗上予恩替卡韦分散片抗病毒治疗1片/次，每天1次，以及本发明中药复方制剂(实施例4配方)抗肝纤维化护肝治疗，10g/次，每天2次。1年后随访，患者无明显不适，纳寐可，二便调。行乙型肝炎检查提示：HBsAg(+)、HBeAg(-)、HBcAb(-)。HBV-DNA定量：(-)。肝功能：ALT：21U/L、AST：20U/L、TBIL：10.5umol/L。肝胆胰脾彩超检查提示：肝组织稍回声增粗。FibroScan系统进行检测提示：7.6kPa。疗效佳。
实施例7与其他配方的比较试验
治疗慢性肝病的中药复方制剂基础配方有效成分的原料组成及重量为：
黄芪30份、丹参15份、三七10份、莪术15份、
茯苓15份、海藻15份、白芍20份、昆布15份。
病例选择
比较实施实施例4(实施方案4配方)中药复方制剂与实施例7(实施方案7配方)的治疗慢性肝病的中药复方制剂基础配方治疗效果。
选择2016年1月-2018年12月于本院住院和门诊患者50例，E组，诊断：乙肝肝纤维化，其中男37，女13例；平均年龄43.2岁；病程3-15.5年。一般资料比较差异无统计学意义(P＞0.05)，具有可比性。予恩替卡韦抗病毒基础联合口服本发明中药复方制剂基础配方(实施方案7配方)。
(1)2组患者治疗前后肝功能的变化见表5。
表5 2组患者治疗前后肝功能的变化的比较
注：治疗后A组与E组比较有统计学差异(*P＜0.05)
(2)2组患者治疗前后血清肝纤指标的变化见表6
表2 2组患者治疗前后血清肝纤维化指标的变化的比较
注：治疗后A组与E组比较有统计学差异(*P＜0.05)
(3)2组患者治疗前后肝硬度值的变化比较见表7。
表7 2组患者治疗前后LSM值得变化比较(
kPa)
注：治疗后A组与E组比较有统计学差异(*P＜0.05)
(4)2组患者治疗前后Dpv、脾厚度、Dsv变化情况见表7
表7 2组患者治疗前后Dpv、脾厚度、Dsv变化
注：治疗后A组与E组比较有统计学差异(*P＜0.05)
结果：本发明中药复方制剂(实施方案4配方)比中药复方制剂(实施方案7配方)治疗效果好，在肝功能、肝纤指标、LSM值、肝胆脾胰彩超值方面，两组组比较有显著性差异(P＜0.05)。
上述说明并非对发明的限制，本发明也并不限于上述举例。本技术领域的普通技术人员在发明的实质范围内，做出的变化、改型、添加或替换，也应属于本发明的保护范围。
Claims (9)
1.一种治疗慢性肝病的中药复方制剂，其特征在于，所述中药复方制剂的有效成分的原料包括黄芪、生牡蛎、黄精、海藻、茯苓、丹参、莪术、生鳖甲、昆布、叶下珠、苦参、柴胡、香附、醋延胡、三七。
2.根据权利要求1所述的中药复方制剂，其特征在于，所述中药复方制剂的有效成分原料的重量份数为：
黄芪20～40份、生牡蛎20～40份、黄精10～30份、海藻10～30份、
茯苓10～30份、丹参10～30份、莪术10～30份、生鳖甲10～30份、
昆布10～30份、叶下珠10～30份、苦参10～30份、柴胡5～20份、
香附5～20份、醋延胡5～20份、三七5～20份。
3.根据权利要求1所述的中药复方制剂，其特征在于，所述中药复方制剂的有效成分的原料组成及重量份数为：
黄芪30份、生牡蛎30份、黄精20份、海藻15份、
茯苓15份、丹参15份、莪术15份、生鳖甲15份、
昆布15份、叶下珠15份、苦参15份、柴胡10份、
香附10份、醋延胡10份、三七10份。
4.一种制备如权利要求2或3任一权利要求所述的中药复方制剂的方法，其特征在于，所述方法包括以下工艺步骤：
(1)按所述重量配比准备15种药材；
(2)把黄芪、丹参、莪术、香附、醋延胡、三七六味药材，经混合用万能碎粉机粉碎成研末，再用槽型混合机混均匀后过100目筛；
(3)把生牡蛎、黄精、海藻、茯苓、生鳖甲、昆布、叶下珠、苦参、柴胡九味药材，加10倍量水煎煮2次，第一次1.5h，第二次1.0h，合并煎液，滤过，滤液浓缩成在60℃时相对密度为1.30～1.35的稠膏；
(4)把步骤(2)所得细粉与步骤(3)所得稠膏用槽型混合机混匀，采用全自动速控中药制丸机制丸，抛光，采用热风循环烘箱干燥后即得，装瓶。
5.根据权利要求4所述的方法，其特征在于，所述方法制备的中药复方制剂为丸剂。
6.根据权利要求4所述的方法，其特征在于，所述步骤(4)中制丸时每10丸重0.39g。
7.根据权利要求4所述的方法，其特征在于，所述步骤(4)中装瓶时为120g/瓶。
8.一种如权利要求1至3任一权利要求所述的中药复方制剂在制备治疗慢性肝病中的应用。
9.根据权利要求6所述的应用，其特征在于，所述的慢性肝病为慢性肝病肝纤维化。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010771209.3A CN111759991A (zh) | 2020-08-04 | 2020-08-04 | 一种治疗慢性肝病的中药复方制剂及其制备方法和应用 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010771209.3A CN111759991A (zh) | 2020-08-04 | 2020-08-04 | 一种治疗慢性肝病的中药复方制剂及其制备方法和应用 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN111759991A true CN111759991A (zh) | 2020-10-13 |
Family
ID=72729357
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010771209.3A Pending CN111759991A (zh) | 2020-08-04 | 2020-08-04 | 一种治疗慢性肝病的中药复方制剂及其制备方法和应用 |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN111759991A (zh) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101214288A (zh) * | 2008-01-04 | 2008-07-09 | 北京因科瑞斯医药科技有限公司 | 一种治疗肝病的中药组合物及其制备方法 |
-
2020
- 2020-08-04 CN CN202010771209.3A patent/CN111759991A/zh active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101214288A (zh) * | 2008-01-04 | 2008-07-09 | 北京因科瑞斯医药科技有限公司 | 一种治疗肝病的中药组合物及其制备方法 |
Non-Patent Citations (2)
| Title |
|---|
| 吕建林等: "海珠益肝化纤方治疗肝纤维化的临床疗效观察", 《大众科技》 * |
| 胡振斌: "化肝纤冲剂治疗慢性乙型肝炎肝纤维化45例", 《陕西中医》 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN104491755A (zh) | 一种治疗腹胀的中药组合物及其制备方法 | |
| CN107789484B (zh) | 一种治疗月经不调的中药组合物及其制备方法 | |
| TWI840312B (zh) | 一種中藥組合物及其用途 | |
| CN1250275C (zh) | 一种治疗恶性肿瘤的中药制剂及其制备方法 | |
| CN102805844A (zh) | 一种治疗肝癌的药物 | |
| CN102755515B (zh) | 治疗乳腺增生的中药汤剂 | |
| CN104873828A (zh) | 一种治疗放射性皮肤损伤的中药制剂及其制备方法 | |
| CN104257883A (zh) | 一种治疗化疗后白细胞减少症的中药组合物 | |
| CN100579572C (zh) | 一种内服用于治疗偏头痛的中药组合物 | |
| CN111759991A (zh) | 一种治疗慢性肝病的中药复方制剂及其制备方法和应用 | |
| CN105902897A (zh) | 一种治疗胰腺癌的药物制剂及其用途 | |
| CN105106634A (zh) | 一种治疗急性阑尾炎的中药制剂及其应用 | |
| CN105535839A (zh) | 一种治疗结肠癌的中药片剂及其制备方法 | |
| CN111407872A (zh) | 肝癌治疗用中药组合物、治疗肝癌的药物及其制备方法 | |
| CN104258351A (zh) | 一种治疗酒精性心肌病的中药制剂及其制备方法 | |
| CN117815349A (zh) | 一种治疗脑膜瘤的中药组合物及其制备方法 | |
| CN110051812A (zh) | 一种扶正祛邪中药及其制备方法 | |
| CN110960651B (zh) | 一种具有抗乳腺增生作用的中药制剂及其制备方法与应用 | |
| CN108853340A (zh) | 一种滋养肝肾的中药及其制备方法 | |
| CN108938833A (zh) | 一种治疗良性前列腺增生症并膀胱逼尿肌功能障碍的中药 | |
| CN116474058B (zh) | 一种治疗脾大的中药膏 | |
| CN103028028B (zh) | 一种治疗原发性肝癌的中药 | |
| CN106581299A (zh) | 一种改善中老年肾气虚证的中药组合物及其应用 | |
| CN106728828A (zh) | 一种治疗冠心病的中药制剂及其制备工艺 | |
| CN107362296B (zh) | 治疗皮肤良性肿瘤的药物及其制备方法 |
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 |