CN116688034A - 治疗急性期脱出游离型腰椎间盘突出症的中药制剂及制备方法 - Google Patents
治疗急性期脱出游离型腰椎间盘突出症的中药制剂及制备方法 Download PDFInfo
- Publication number
- CN116688034A CN116688034A CN202310899390.XA CN202310899390A CN116688034A CN 116688034 A CN116688034 A CN 116688034A CN 202310899390 A CN202310899390 A CN 202310899390A CN 116688034 A CN116688034 A CN 116688034A
- Authority
- CN
- China
- Prior art keywords
- root
- taking
- raw
- prepared
- 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 62
- 238000002360 preparation method Methods 0.000 title claims abstract description 38
- 206010050296 Intervertebral disc protrusion Diseases 0.000 title claims abstract description 27
- 239000002994 raw material Substances 0.000 claims abstract description 37
- 235000006484 Paeonia officinalis Nutrition 0.000 claims abstract description 22
- 230000001154 acute effect Effects 0.000 claims abstract description 18
- 244000303040 Glycyrrhiza glabra Species 0.000 claims abstract description 16
- 235000006200 Glycyrrhiza glabra Nutrition 0.000 claims abstract description 16
- 208000003618 Intervertebral Disc Displacement Diseases 0.000 claims abstract description 16
- 241000213006 Angelica dahurica Species 0.000 claims abstract description 13
- 241000255789 Bombyx mori Species 0.000 claims abstract description 13
- 241000131329 Carabidae Species 0.000 claims abstract description 13
- 235000003255 Carthamus tinctorius Nutrition 0.000 claims abstract description 13
- 244000020518 Carthamus tinctorius Species 0.000 claims abstract description 13
- 239000004863 Frankincense Substances 0.000 claims abstract description 13
- 241000361919 Metaphire sieboldi Species 0.000 claims abstract description 13
- 235000006040 Prunus persica var persica Nutrition 0.000 claims abstract description 13
- 241000049624 Alisma plantago-aquatica subsp. orientale Species 0.000 claims abstract description 12
- 244000144730 Amygdalus persica Species 0.000 claims abstract description 12
- 240000007311 Commiphora myrrha Species 0.000 claims abstract description 12
- 235000006965 Commiphora myrrha Nutrition 0.000 claims abstract description 12
- 235000007265 Myrrhis odorata Nutrition 0.000 claims abstract description 12
- 241000227129 Aconitum Species 0.000 claims abstract description 11
- 241000173529 Aconitum napellus Species 0.000 claims abstract description 10
- 235000017965 Asarum canadense Nutrition 0.000 claims abstract description 9
- 235000003717 Boswellia sacra Nutrition 0.000 claims abstract description 9
- 235000012035 Boswellia serrata Nutrition 0.000 claims abstract description 9
- 240000007551 Boswellia serrata Species 0.000 claims abstract description 9
- 235000000385 Costus speciosus Nutrition 0.000 claims abstract description 9
- 241000241550 Cyathula Species 0.000 claims abstract description 9
- 241000212322 Levisticum officinale Species 0.000 claims abstract description 9
- 241000606265 Valeriana jatamansi Species 0.000 claims abstract description 9
- 235000014687 Zingiber zerumbet Nutrition 0.000 claims abstract description 9
- LPLVUJXQOOQHMX-QWBHMCJMSA-N glycyrrhizinic acid Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@@H]1C([C@H]2[C@]([C@@H]3[C@@]([C@@]4(CC[C@@]5(C)CC[C@@](C)(C[C@H]5C4=CC3=O)C(O)=O)C)(C)CC2)(C)CC1)(C)C)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O LPLVUJXQOOQHMX-QWBHMCJMSA-N 0.000 claims abstract description 9
- 239000001645 levisticum officinale Substances 0.000 claims abstract description 9
- 235000011477 liquorice Nutrition 0.000 claims abstract description 9
- 229940107666 astragalus root Drugs 0.000 claims abstract description 7
- 239000000463 material Substances 0.000 claims description 47
- 238000004140 cleaning Methods 0.000 claims description 43
- 238000001035 drying Methods 0.000 claims description 40
- 239000012535 impurity Substances 0.000 claims description 39
- 238000007873 sieving Methods 0.000 claims description 33
- 238000001816 cooling Methods 0.000 claims description 21
- 238000010438 heat treatment Methods 0.000 claims description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 18
- 241001106477 Paeoniaceae Species 0.000 claims description 17
- 238000002791 soaking Methods 0.000 claims description 17
- 239000000843 powder Substances 0.000 claims description 16
- 208000012287 Prolapse Diseases 0.000 claims description 10
- 235000011389 fruit/vegetable juice Nutrition 0.000 claims description 10
- 238000005520 cutting process Methods 0.000 claims description 9
- 235000012907 honey Nutrition 0.000 claims description 9
- 239000000243 solution Substances 0.000 claims description 9
- CBENFWSGALASAD-UHFFFAOYSA-N Ozone Chemical compound [O-][O+]=O CBENFWSGALASAD-UHFFFAOYSA-N 0.000 claims description 8
- 244000236658 Paeonia lactiflora Species 0.000 claims description 8
- 235000008598 Paeonia lactiflora Nutrition 0.000 claims description 8
- 230000001954 sterilising effect Effects 0.000 claims description 8
- 238000009835 boiling Methods 0.000 claims description 6
- 239000003651 drinking water Substances 0.000 claims description 6
- 235000020188 drinking water Nutrition 0.000 claims description 6
- 239000000428 dust Substances 0.000 claims description 6
- 238000001914 filtration Methods 0.000 claims description 6
- 239000007789 gas Substances 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 6
- 238000005507 spraying Methods 0.000 claims description 6
- 238000004659 sterilization and disinfection Methods 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 6
- 238000009736 wetting Methods 0.000 claims description 6
- 239000000284 extract Substances 0.000 claims description 5
- 241000717739 Boswellia sacra Species 0.000 claims description 4
- 235000017443 Hedysarum boreale Nutrition 0.000 claims description 4
- 235000007858 Hedysarum occidentale Nutrition 0.000 claims description 4
- 239000009636 Huang Qi Substances 0.000 claims description 4
- 241000112528 Ligusticum striatum Species 0.000 claims description 4
- 239000001947 glycyrrhiza glabra rhizome/root Substances 0.000 claims description 4
- 241000758794 Asarum Species 0.000 claims description 3
- 241000255791 Bombyx Species 0.000 claims description 3
- 235000001453 Glycyrrhiza echinata Nutrition 0.000 claims description 3
- 235000017382 Glycyrrhiza lepidota Nutrition 0.000 claims description 3
- 240000007594 Oryza sativa Species 0.000 claims description 3
- 235000007164 Oryza sativa Nutrition 0.000 claims description 3
- 241000736199 Paeonia Species 0.000 claims description 3
- 235000014676 Phragmites communis Nutrition 0.000 claims description 3
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims description 3
- 239000002775 capsule Substances 0.000 claims description 3
- 239000000571 coke Substances 0.000 claims description 3
- 238000010790 dilution Methods 0.000 claims description 3
- 239000012895 dilution Substances 0.000 claims description 3
- 229940010454 licorice Drugs 0.000 claims description 3
- 238000002156 mixing Methods 0.000 claims description 3
- 239000001301 oxygen Substances 0.000 claims description 3
- 229910052760 oxygen Inorganic materials 0.000 claims description 3
- 238000004806 packaging method and process Methods 0.000 claims description 3
- 238000003825 pressing Methods 0.000 claims description 3
- 235000009566 rice Nutrition 0.000 claims description 3
- 238000012216 screening Methods 0.000 claims description 3
- 239000000779 smoke Substances 0.000 claims description 3
- 230000000391 smoking effect Effects 0.000 claims description 3
- 239000007787 solid Substances 0.000 claims description 3
- 238000003892 spreading Methods 0.000 claims description 3
- 230000007480 spreading Effects 0.000 claims description 3
- 238000010025 steaming Methods 0.000 claims description 3
- 235000021419 vinegar Nutrition 0.000 claims description 3
- 239000000052 vinegar Substances 0.000 claims description 3
- 230000006837 decompression Effects 0.000 claims description 2
- 239000007788 liquid Substances 0.000 claims description 2
- 239000002245 particle Substances 0.000 claims description 2
- 230000008569 process Effects 0.000 claims description 2
- 238000010298 pulverizing process Methods 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims 3
- 208000002193 Pain Diseases 0.000 abstract description 33
- 230000036407 pain Effects 0.000 abstract description 33
- 230000000694 effects Effects 0.000 abstract description 29
- 239000008280 blood Substances 0.000 abstract description 11
- 210000004369 blood Anatomy 0.000 abstract description 11
- 208000004880 Polyuria Diseases 0.000 abstract description 7
- 230000035619 diuresis Effects 0.000 abstract description 7
- 208000024891 symptom Diseases 0.000 abstract description 7
- 206010030113 Oedema Diseases 0.000 abstract description 5
- 230000003213 activating effect Effects 0.000 abstract description 5
- 230000001939 inductive effect Effects 0.000 abstract description 5
- 208000006820 Arthralgia Diseases 0.000 abstract description 4
- 208000008035 Back Pain Diseases 0.000 abstract description 3
- 208000008930 Low Back Pain Diseases 0.000 abstract description 3
- 244000170916 Paeonia officinalis Species 0.000 abstract 2
- 230000001737 promoting effect Effects 0.000 description 10
- 230000006872 improvement Effects 0.000 description 8
- 238000002203 pretreatment Methods 0.000 description 7
- 230000017531 blood circulation Effects 0.000 description 6
- 241001061264 Astragalus Species 0.000 description 5
- 206010061218 Inflammation Diseases 0.000 description 5
- 235000006533 astragalus Nutrition 0.000 description 5
- 230000004054 inflammatory process Effects 0.000 description 5
- 230000001717 pathogenic effect Effects 0.000 description 5
- 230000008961 swelling Effects 0.000 description 5
- 210000004233 talus Anatomy 0.000 description 5
- 208000005392 Spasm Diseases 0.000 description 4
- 230000027939 micturition Effects 0.000 description 4
- 230000000144 pharmacologic effect Effects 0.000 description 4
- 206010037660 Pyrexia Diseases 0.000 description 3
- 230000003110 anti-inflammatory effect Effects 0.000 description 3
- 230000004064 dysfunction Effects 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 210000005036 nerve Anatomy 0.000 description 3
- 238000011160 research Methods 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 208000011580 syndromic disease Diseases 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- MPDGHEJMBKOTSU-YKLVYJNSSA-N 18beta-glycyrrhetic acid Chemical compound C([C@H]1C2=CC(=O)[C@H]34)[C@@](C)(C(O)=O)CC[C@]1(C)CC[C@@]2(C)[C@]4(C)CC[C@@H]1[C@]3(C)CC[C@H](O)C1(C)C MPDGHEJMBKOTSU-YKLVYJNSSA-N 0.000 description 2
- 206010062717 Increased upper airway secretion Diseases 0.000 description 2
- 206010033425 Pain in extremity Diseases 0.000 description 2
- 230000006978 adaptation Effects 0.000 description 2
- 230000000202 analgesic effect Effects 0.000 description 2
- 230000001760 anti-analgesic effect Effects 0.000 description 2
- 239000003146 anticoagulant agent Substances 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 210000004204 blood vessel Anatomy 0.000 description 2
- 230000001914 calming effect Effects 0.000 description 2
- RZEKVGVHFLEQIL-UHFFFAOYSA-N celecoxib Chemical compound C1=CC(C)=CC=C1C1=CC(C(F)(F)F)=NN1C1=CC=C(S(N)(=O)=O)C=C1 RZEKVGVHFLEQIL-UHFFFAOYSA-N 0.000 description 2
- 229960000590 celecoxib Drugs 0.000 description 2
- 230000000916 dilatatory effect Effects 0.000 description 2
- 230000003467 diminishing effect Effects 0.000 description 2
- 230000002708 enhancing effect Effects 0.000 description 2
- 229930182470 glycoside Natural products 0.000 description 2
- 150000002338 glycosides Chemical class 0.000 description 2
- JYGXADMDTFJGBT-VWUMJDOOSA-N hydrocortisone Chemical compound O=C1CC[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 JYGXADMDTFJGBT-VWUMJDOOSA-N 0.000 description 2
- 230000002757 inflammatory effect Effects 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 238000001990 intravenous administration Methods 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 210000003141 lower extremity Anatomy 0.000 description 2
- 235000012054 meals Nutrition 0.000 description 2
- 230000004089 microcirculation Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 208000026435 phlegm Diseases 0.000 description 2
- 231100000331 toxic Toxicity 0.000 description 2
- 230000002588 toxic effect Effects 0.000 description 2
- 230000000007 visual effect Effects 0.000 description 2
- 238000010792 warming Methods 0.000 description 2
- LPLVUJXQOOQHMX-MOGLOQIBSA-N (2s,3s,4s,5r,6r)-6-[(2r,3r,4s,5s,6s)-2-[[(3s,4ar,6ar,6bs,8as,11s,12ar,14ar,14bs)-11-carboxy-4,4,6a,6b,8a,11,14b-heptamethyl-14-oxo-2,3,4a,5,6,7,8,9,10,12,12a,14a-dodecahydro-1h-picen-3-yl]oxy]-6-carboxy-4,5-dihydroxyoxan-3-yl]oxy-3,4,5-trihydroxyoxane-2-c Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@H]1O[C@@H]1C([C@H]2[C@]([C@@H]3[C@@]([C@@]4(CC[C@@]5(C)CC[C@@](C)(C[C@H]5C4=CC3=O)C(O)=O)C)(C)CC2)(C)CC1)(C)C)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O LPLVUJXQOOQHMX-MOGLOQIBSA-N 0.000 description 1
- SQUNAWUMZGQQJD-UHFFFAOYSA-N 1-(4-ethylphenyl)-2-methyl-3-(piperidin-1-yl)propan-1-one Chemical compound C1=CC(CC)=CC=C1C(=O)C(C)CN1CCCCC1 SQUNAWUMZGQQJD-UHFFFAOYSA-N 0.000 description 1
- 206010002091 Anaesthesia Diseases 0.000 description 1
- 206010010904 Convulsion Diseases 0.000 description 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- LKDRXBCSQODPBY-JDJSBBGDSA-N D-allulose Chemical compound OCC1(O)OC[C@@H](O)[C@@H](O)[C@H]1O LKDRXBCSQODPBY-JDJSBBGDSA-N 0.000 description 1
- 241001489980 Eupolyphaga sinensis Species 0.000 description 1
- MPDGHEJMBKOTSU-UHFFFAOYSA-N Glycyrrhetinsaeure Natural products C12C(=O)C=C3C4CC(C)(C(O)=O)CCC4(C)CCC3(C)C1(C)CCC1C2(C)CCC(O)C1(C)C MPDGHEJMBKOTSU-UHFFFAOYSA-N 0.000 description 1
- 239000004378 Glycyrrhizin Substances 0.000 description 1
- 206010061246 Intervertebral disc degeneration Diseases 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 241001057584 Myrrha Species 0.000 description 1
- 240000005809 Prunus persica Species 0.000 description 1
- 206010059604 Radicular pain Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 229940023019 aconite Drugs 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 229930013930 alkaloid Natural products 0.000 description 1
- 150000003797 alkaloid derivatives Chemical class 0.000 description 1
- 230000037005 anaesthesia Effects 0.000 description 1
- 230000002429 anti-coagulating effect Effects 0.000 description 1
- 230000001773 anti-convulsant effect Effects 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 230000010100 anticoagulation Effects 0.000 description 1
- 239000001961 anticonvulsive agent Substances 0.000 description 1
- 229960003965 antiepileptics Drugs 0.000 description 1
- 230000000975 bioactive effect Effects 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000004663 cell proliferation Effects 0.000 description 1
- 239000000812 cholinergic antagonist Substances 0.000 description 1
- 230000004087 circulation Effects 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000036461 convulsion Effects 0.000 description 1
- 206010061428 decreased appetite Diseases 0.000 description 1
- 230000007850 degeneration Effects 0.000 description 1
- 208000018180 degenerative disc disease Diseases 0.000 description 1
- 229960003957 dexamethasone Drugs 0.000 description 1
- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000010494 dissociation reaction Methods 0.000 description 1
- 230000005593 dissociations Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 229960003720 enoxolone Drugs 0.000 description 1
- 229960002565 eperisone Drugs 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 230000020764 fibrinolysis Effects 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- LPLVUJXQOOQHMX-UHFFFAOYSA-N glycyrrhetinic acid glycoside Natural products C1CC(C2C(C3(CCC4(C)CCC(C)(CC4C3=CC2=O)C(O)=O)C)(C)CC2)(C)C2C(C)(C)C1OC1OC(C(O)=O)C(O)C(O)C1OC1OC(C(O)=O)C(O)C(O)C1O LPLVUJXQOOQHMX-UHFFFAOYSA-N 0.000 description 1
- 229960004949 glycyrrhizic acid Drugs 0.000 description 1
- UYRUBYNTXSDKQT-UHFFFAOYSA-N glycyrrhizic acid Natural products CC1(C)C(CCC2(C)C1CCC3(C)C2C(=O)C=C4C5CC(C)(CCC5(C)CCC34C)C(=O)O)OC6OC(C(O)C(O)C6OC7OC(O)C(O)C(O)C7C(=O)O)C(=O)O UYRUBYNTXSDKQT-UHFFFAOYSA-N 0.000 description 1
- 235000019410 glycyrrhizin Nutrition 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 229960000890 hydrocortisone Drugs 0.000 description 1
- 230000000147 hypnotic effect Effects 0.000 description 1
- 230000036737 immune function Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 208000021600 intervertebral disc degenerative disease Diseases 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 238000002690 local anesthesia Methods 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 230000007721 medicinal effect Effects 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 230000001338 necrotic effect Effects 0.000 description 1
- 231100000862 numbness Toxicity 0.000 description 1
- 230000000399 orthopedic effect Effects 0.000 description 1
- 230000000242 pagocytic effect Effects 0.000 description 1
- 229960002895 phenylbutazone Drugs 0.000 description 1
- VYMDGNCVAMGZFE-UHFFFAOYSA-N phenylbutazonum Chemical compound O=C1C(CCCC)C(=O)N(C=2C=CC=CC=2)N1C1=CC=CC=C1 VYMDGNCVAMGZFE-UHFFFAOYSA-N 0.000 description 1
- 238000000554 physical therapy Methods 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 230000002285 radioactive effect Effects 0.000 description 1
- 230000002040 relaxant effect Effects 0.000 description 1
- 230000003307 reticuloendothelial effect Effects 0.000 description 1
- 239000000932 sedative agent Substances 0.000 description 1
- 230000001624 sedative effect Effects 0.000 description 1
- 230000001568 sexual effect Effects 0.000 description 1
- 238000004088 simulation Methods 0.000 description 1
- 230000002048 spasmolytic effect Effects 0.000 description 1
- 210000000278 spinal cord Anatomy 0.000 description 1
- 210000000273 spinal nerve root Anatomy 0.000 description 1
- 208000010110 spontaneous platelet aggregation Diseases 0.000 description 1
- 230000001502 supplementing effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000002537 thrombolytic effect Effects 0.000 description 1
- 230000002936 tranquilizing effect Effects 0.000 description 1
- 210000003556 vascular endothelial cell Anatomy 0.000 description 1
- 230000006444 vascular growth Effects 0.000 description 1
- 239000000341 volatile oil Substances 0.000 description 1
- 229940126673 western medicines Drugs 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)
- A61K36/48—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
- A61K35/62—Leeches; Worms, e.g. cestodes, tapeworms, nematodes, roundworms, earth worms, ascarids, filarias, hookworms, trichinella or taenia
-
- 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
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
-
- 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)
- A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
-
- 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
- A61K36/232—Angelica
-
- 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
- A61K36/236—Ligusticum (licorice-root)
-
- 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)
- A61K36/26—Aristolochiaceae (Birthwort family), e.g. heartleaf
- A61K36/268—Asarum (wild ginger)
-
- 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
- A61K36/286—Carthamus (distaff thistle)
-
- 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)
- A61K36/32—Burseraceae (Frankincense family)
- A61K36/324—Boswellia, e.g. frankincense
-
- 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)
- A61K36/32—Burseraceae (Frankincense family)
- A61K36/328—Commiphora, e.g. mecca myrrh or balm of Gilead
-
- 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
- A61K36/484—Glycyrrhiza (licorice)
-
- 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)
- A61K36/59—Menispermaceae (Moonseed family), e.g. hyperbaena or coralbead
-
- 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)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
-
- 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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
-
- 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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/714—Aconitum (monkshood)
-
- 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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
-
- 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)
- A61K36/884—Alismataceae (Water-plantain family)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/13—Preparation or pretreatment of starting material involving cleaning, e.g. washing or peeling
-
- 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
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/15—Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
-
- 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
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/17—Preparation or pretreatment of starting material involving drying, e.g. sun-drying or wilting
-
- 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
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Mycology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Insects & Arthropods (AREA)
- General Chemical & Material Sciences (AREA)
- Physical Education & Sports Medicine (AREA)
- Rheumatology (AREA)
- Zoology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Animal Husbandry (AREA)
- Tropical Medicine & Parasitology (AREA)
- Pain & Pain Management (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明提供一种治疗急性期脱出游离型腰椎间盘突出症的中药制剂（腰痹速通方）及制备方法，涉及中药配方技术领域，其中中药组方制剂使用如下重量配比的原料饮片制备而成：生黄芪120‑160克、桃仁10‑12克、红花10‑12克、川芎10‑12克、当归15‑20克、地龙10‑12克、炒赤芍10‑12克、炒白芍10‑12克、乳香10‑12克、没药10‑12克、川牛膝10‑15克、泽泻15‑20克、防己10‑12克、制川乌4‑6克、制草乌4‑6克、细辛3‑4克、僵蚕10‑12克、土鳖虫10‑12克、炙甘草6‑8克。本申请中制备的治疗急性期脱出游离型腰椎间盘突出症的中药组方制剂具有益气活血、利水消肿、蠲痹止痛的功效，能快速缓解脱出游离型腰椎间盘突出症患者急性风暴期的腰腿疼痛症状，治疗周期及起效时限一般均能控制在3周以内。
Description
技术领域
本发明涉及中药配方技术领域，具体涉及一种治疗急性期脱出游离型腰椎间盘突出症的中药制剂（腰痹速通方）及制备方法。
背景技术
腰椎间盘突出症（lumbar disc herniation，LDH）是骨科常见病，指因腰椎间盘退变，外力作用使纤维环破裂，髓核突出刺激或压迫脊髓与神经根导致腰痛及下肢放射性疼痛、麻木为特征的疾病。脱出游离型是腰椎间盘突出症中最为严重的类型，由于髓核突出巨大和神经根受压严重，急性期腰及下肢根性疼痛症状明显，常规的西药、理疗等非手术治疗方法难以有效、持续控制急性风暴期症状，而且副作用明显，患者往往因疼痛难忍而选择手术治疗。手术治疗虽然可以取得短期的疗效，但远期疗效仍不确定，尤其是术后复发、加速腰椎退变、失稳、相邻椎间隙病变等远期并发症给患者带来的痛苦和影响更为严重。研究发现，大部分的腰椎间盘突出症患者经过中医药保守治疗，同样可以获得与手术治疗一样的实质性满意疗效，因此国内外最新指南建议腰椎间盘突出症应首选保守治疗。同时，脱出游离的椎间盘髓核组织会发生自然吸收现象，这为中医药保守治疗脱出游离型腰椎间盘突出症，提供了借鉴和依据。
但椎间盘组织重吸收完成需要2个月到1年以上的时间，整个治疗周期需要患者坚持3-6个月甚至更长的时间，相当一部分患者缺乏耐心和依从性，未等突出椎间盘重吸收就转而选择了手术治疗。而疼痛是急性期脱出游离型LDH患者来院就诊的主要原因，也是患者最不能接受的主要症状。因此，快速有效缓解疼痛是急性期脱出游离型LDH保守治疗的首要目的。
发明内容
本发明的目的是为了快速缓解脱出游离型腰椎间盘突出症患者急性风暴期的腰腿疼痛症状。
为了实现上述目的，本发明采用了如下技术方案：
一种治疗急性期脱出游离型腰椎间盘突出症的中药组方制剂（腰痹速通方），其特征在于：使用如下重量配比的原料饮片制备而成：生黄芪120-160克、桃仁10-12克、红花10-12克、川芎10-12克、当归15-20克、地龙10-12克、炒赤芍10-12克、炒白芍10-12克、乳香10-12克、没药10-12克、川牛膝10-15克、泽泻15-20克、防己10-12克、制川乌4-6克、制草乌4-6克、细辛3-4克、僵蚕10-12克、土鳖虫10-12克、炙甘草6-8克。
优选的，取下述重量配比的主要原料饮片制备而成：生黄芪120克、桃仁10克、红花10克、川芎10克、当归15克、地龙10克、炒赤芍12克、炒白芍12克、乳香10克、没药10克、川牛膝12克、泽泻20克、防己12克、制川乌6克、制草乌6克、细辛4克、僵蚕10克、土鳖虫10克、炙甘草8克。
本申请中采用的上述中药原料具有以下功效：
生黄芪：具有益气活血、利水消肿的功效，现代药理研究表明黄芪能促进血管内皮细胞增殖，有效促成再生神经中的血管生长，改善微循环，促进局部炎性水肿消退；同时黄芪多糖作为黄芪的主要生物活性成分对机体免疫功能有广泛的调节作用，它能增强网状内皮细胞的吞噬能力，利于变性坏死组织的清扫，利于受损神经功能恢复。
桃仁、红花：活血祛瘀，消肿止痛，其煎剂、提取液具有扩张血管、抑制血小板聚集，增强纤维蛋白溶解，降低全血黏度、改善微循环作用；川芎：活血行气，祛风止痛，现代药理具有镇静、解痉、镇痛作用，并能利尿；当归：益气补血、活血通痹；炒赤芍活血散瘀、消肿止痛；炒白芍养血活血，缓急止痛，有效成分白芍总苷具有抗炎镇痛、镇静解痉、扩张血管作用，与川乌配伍抗炎镇痛作用明显增强。
乳香、没药具有活血、止痛、消肿作用，其提取物具有镇痛、消炎作用。
地龙利小便，通经络，除痹痛，地龙煎剂及提取物具有解热镇痛、镇静、抗惊厥、利尿作用；川牛膝：活血通络利关节，祛风除湿止疼痛，引血下行利小便，与泽泻、防己合用加强利水消水肿；防己：利水消肿，祛风止痛，现代药理有镇痛、解热、消炎、肌松、利尿功效。
制川乌、制草乌祛风除湿，温经止痛。生物碱是乌头类药材的主要成分，具有镇痛、抗炎、局麻等药理活性，能显著抑制肿胀，减少炎性渗出，与芍药配伍抗炎镇痛作用明显增强；
细辛祛风散寒、温经止痛、行水化痰，细辛挥发油具有麻醉、解热、抗炎、镇痛、镇静等药理作用。
地鳖虫：破血逐瘀消积，通络消肿止痛。现代药理研究发现，地鳖虫具有抗凝、溶栓、镇痛作用。
僵蚕：祛风解痉止痛，化痰逐瘀散结。现代药理具有抗凝、催眠、抗惊厥作用。
炙甘草：调和药性，解毒止痛。其有效成分甘草甜素和甘草次酸具有保泰松或氢化可的松样的抗炎作用，常与白芍同用，具有缓急止痛功效。
优选的，所述制剂为口服液、药剂颗粒、胶囊中的一种。
本申请还提供了一种治疗急性期脱出游离型腰椎间盘突出症的中药组方制剂（腰痹速通方）的制备方法，包含以下步骤：
S1：制作中药饮片：将权利要求1所述的原料制作成中药饮片；
S2：将S1中所制的中药饮片用凉饮用水浸泡30min，浸泡过程中，水量覆盖药面3-5cm，制川乌、制草乌装入食品级药袋中浸泡；
S3：将S2中制川乌和制草乌以外的药材捞出，用武火先煎15分钟，加入捞出的其余药材武火煮沸，改文火煎煮60分钟，过滤，得第一提取药汁200ml；
S4：将S3中过滤后的药渣加入凉饮用水，水量覆盖药面2-3cm，武火煮沸，改文火煎煮50分钟，过滤，得第二提取药汁200ml；
S5：将S4中过滤后的药渣装入食品级药袋，绞压获得第三提取药汁50ml；
S6：将第一提取药汁、第二提取药汁和第三提取药汁混合，获得治疗脱出游离型腰椎间盘突出症的中药汤剂；
S7：在获得中药汤剂后，将S6中获得的中药汤剂使用柜式减压干燥器进行减压干燥，制得干燥药粉，
S8：用中药超微粉碎机将S7所得药粉进一步粉碎成100目以上的细粉；
S9：对细粉进行臭氧灭菌，最大限度保存药物成分，制成治疗脱出游离型腰椎间盘突出症的中药制剂。
优选的，所述中药饮片的制备方法如下：
生黄芪：取原药材，除去杂质，洗净，润透，切厚片，干燥，生用；
桃仁：取原药材，敲碎，除去杂质及残留的硬壳，筛去灰屑；
红花：净制拣去杂质，筛去灰屑；
川芎：取原药材，除去杂质，大小分开，洗净，用水泡至指甲能掐入外皮为度，取出，润透，切薄片，干燥，筛去碎屑；
当归：取原药材，除去杂质，洗净，稍润，切薄片，晒干或低温干燥，筛去碎屑；
地龙：取原药材，除去杂质，洗净，切段，干燥，加入黄酒拌匀，置锅内，稍闷润，用文火加热，炒至表面呈棕色，取出，放凉；
炒赤芍、炒白芍：取原药材，除去杂质，大小分开，洗净，润透，切薄片，干燥，筛去碎屑，置炒制容器内，用文火加热，炒至颜色加深，取出晾凉，筛去碎屑；
乳香、没药：取原药材，除去杂质，大小分开，置锅内用文火加热，炒至冒烟、表面微熔，喷淋米醋，再炒至表面显油亮光泽时，取出放凉；
川牛膝：取原药材，除去杂质及芦头，洗净，润透，切薄片，干燥，筛去碎屑；
泽泻：取原药材，除去杂质，大小个分开，稍浸，洗净，润透，切厚片，干燥，筛去碎屑；
防己：净制除去杂质，洗净，润透，切厚片，干燥；
制川乌、制草乌：取原药材，洗净，大小分开，用水浸泡至内无干心，加水煮沸4～6小时，或蒸6～8小时，取大个实心切开内无白心者，尝舌微有麻感时，晾至六成干，切薄片，干燥，筛去碎屑；
细辛：取原药材，去除杂质，喷淋洗净，稍润，切段，晾干；用25%炼蜜拌炒至蜜汁吸尽、不粘手，取出放凉。
僵蚕：取原药材，除去杂质及残丝，洗净，晒干；取麸皮撒于热锅内，用武火加热，待冒烟时，加入净僵蚕，炒至表面黄色，取出，筛去麸皮，放凉；
土鳖虫：取原药材，除去杂质，洗净，干燥，于锅内，用文火加热，炒至微焦，筛去灰屑，取出放凉；
炙甘草：取原药材，洗净，润透，带皮切厚片，干燥，筛去碎屑，取炼蜜，加适量开水稀释后，加入净甘草片中拌匀，闷润，于炒制容器内，文火加热，炒至老黄色、不粘手时，取出，晾凉。
优选的，所述S8中细粉要求：100%过100目筛，95%过120目筛。
优选的，所述S9臭氧灭菌环境为：臭氧浓度50g/m3、气流速度40m/s、气源氧气纯度>85%、灭菌温度小于40℃。
本申请中制备的治疗急性期脱出游离型腰椎间盘突出症的中药组方制剂（腰痹速通方）具有益气活血、利水消肿、蠲痹止痛的功效，能快速缓解脱出游离型腰椎间盘突出症患者急性风暴期的腰腿疼痛症状，治疗周期及起效时限一般均能控制在3周以内。
具体实施方式
以下结合具体实施例，对本发明作进一步地详细说明。
实施例1
一种治疗急性期脱出游离型腰椎间盘突出症的中药组方制剂（腰痹速通方）的制备方法，包含以下步骤：
S1：制作中药饮片：
所述中药饮片原药材包括生黄芪、桃仁、红花、川芎、当归、地龙、炒赤芍、炒白芍、乳香、没药、川牛膝、泽泻、防己、制川乌、制草乌、细辛、僵蚕、土鳖虫及炙甘草；
所述原药材制作中药饮片步骤如下：
生黄芪：取原药材，除去杂质，洗净，润透，切厚片，干燥，生用；
桃仁：取原药材，敲碎，除去杂质及残留的硬壳，筛去灰屑；
红花：净制拣去杂质，筛去灰屑；
川芎：取原药材，除去杂质，大小分开，洗净，用水泡至指甲能掐入外皮为度，取出，润透，切薄片，干燥，筛去碎屑；
当归：取原药材，除去杂质，洗净，稍润，切薄片，晒干或低温干燥，筛去碎屑；
地龙：取原药材，除去杂质，洗净，切段，干燥，加入黄酒拌匀，置锅内，稍闷润，用文火加热，炒至表面呈棕色，取出，放凉；
炒赤芍、炒白芍：取原药材，除去杂质，大小分开，洗净，润透，切薄片，干燥，筛去碎屑，置炒制容器内，用文火加热，炒至颜色加深，取出晾凉，筛去碎屑；
乳香、没药：取原药材，除去杂质，大小分开，置锅内用文火加热，炒至冒烟、表面微熔，喷淋米醋，再炒至表面显油亮光泽时，取出放凉；
川牛膝：取原药材，除去杂质及芦头，洗净，润透，切薄片，干燥，筛去碎屑；
泽泻：取原药材，除去杂质，大小个分开，稍浸，洗净，润透，切厚片，干燥，筛去碎屑；
防己：净制除去杂质，洗净，润透，切厚片，干燥；
制川乌、制草乌：取原药材，洗净，大小分开，用水浸泡至内无干心，加水煮沸4～6小时，或蒸6～8小时，取大个实心切开内无白心者，尝舌微有麻感时，晾至六成干，切薄片，干燥，筛去碎屑；
细辛：取原药材，去除杂质，喷淋洗净，稍润，切段，晾干；用25%炼蜜拌炒至蜜汁吸尽、不粘手，取出放凉。
僵蚕：取原药材，除去杂质及残丝，洗净，晒干。取麸皮撒于热锅内，用武火加热，待冒烟时，加入净僵蚕，炒至表面黄色，取出，筛去麸皮，放凉；
土鳖虫：取原药材，除去杂质，洗净，干燥，于锅内，用文火加热，炒至微焦，筛去灰屑，取出放凉；
炙甘草：取原药材，洗净，润透，带皮切厚片，干燥，筛去碎屑，取炼蜜，加适量开水稀释后，加入净甘草片中拌匀，闷润，于炒制容器内，文火加热，炒至老黄色、不粘手时，取出，晾凉。
S2：将S1中所制的中药饮片按照配方量用凉饮用水浸泡30min。
具体的，各药物重量配比分别为：生黄芪120-160克、桃仁10-12克、红花10-12克、川芎10-12克、当归15-20克、地龙10-12克、炒赤芍10-12克、炒白芍10-12克、乳香10-12克、没药10-12克、川牛膝10-15克、泽泻15-20克、防己10-12克、制川乌4-6克、制草乌4-6克、细辛3-4克、僵蚕10-12克、土鳖虫10-12克、炙甘草6-8克。
优选的，取下述重量配比的主要原料饮片制备而成：生黄芪120克、桃仁10克、红花10克、川芎10克、当归15克、地龙10克、炒赤芍12克、炒白芍12克、乳香10克、没药10克、川牛膝12克、泽泻20克、防己12克、制川乌6克、制草乌6克、细辛4克、僵蚕10克、土鳖虫10克、炙甘草8克。
浸泡过程中，水量覆盖药面3-5cm；并且，所述制川乌和所述制草乌装入食品级药袋中浸泡。
S3：将S2中制川乌和制草乌以外的药材捞出，用武火先煎15分钟，加入捞出的其余药材武火煮沸，改文火煎煮60分钟，过滤，得第一提取药汁200ml；
S4：将S3中过滤后的药渣加入凉饮用水，水量覆盖药面2-3cm，武火煮沸，改文火煎煮50分钟，过滤，得第二提取药汁200ml；
S5：将S4中过滤后的药渣装入食品级药袋，绞压获得第三提取药汁，所述第三提取药汁50ml；
S6：将第一提取药汁、第二提取药汁和第三提取药汁混合，获得治疗脱出游离型腰椎间盘突出症的中药汤剂。
S7：将S6中获得的中药汤剂使用柜式减压干燥器进行减压干燥，制得干燥药粉；
S8：研磨药粉
具体的，利用中药超微粉碎机将S7中所得出的药粉进一步粉碎成100目以上的细粉。
具体的，制备完成的细粉要求：100%过100目筛，95%过120目筛。
S9：在臭氧浓度50g/m3、气流速度40m/s、气源氧气纯度>85%、灭菌温度小于40℃条件下对步骤S8所得细粉进行臭氧灭菌，最大限度保存药物成分，制成治疗脱出游离型腰椎间盘突出症的中药制剂。
实施例2
一种治疗急性期脱出游离型腰椎间盘突出症的中药组方制剂（腰痹速通方），使用上述制备方法制备得到。
以下结合实验数据证明本发明制备的中药制剂具有快速缓解疼痛作用，可用于急性期脱出游离型腰椎间盘突出症患者的治疗。
本申请中通过上述配方和方法制备得到的治疗急性期脱出游离型腰椎间盘突出症的中药组方制剂（腰痹速通方），经过大鼠实验证明无毒副作用。
临床实验纳入2019-2022年南通市中医院骨伤科门诊和住院急性期脱出游离型腰椎间盘突出症患者72例，分为实验组和对照组各36例。
评分标准一：疼痛视觉模拟评分（visual analogue scale,VAS):0分，无疼痛；1-3分，轻度疼痛；4-6分，中度疼痛；7-10分，重度疼痛。
评分标准二：Oswestry 功能障碍指数（The Oswestry Disability Index，ODI）:去除性生活评分项，共9个项目，每个项目0-5分，0分表示活动功能正常，5分表示活动功能受限最严重，满分45分,计算总评分占满分的百分比，指数越高表明功能障碍越严重。
评分标准三：JOA下腰痛评分:（Japanese Orthopaedic Association Scores,JOA)总评分为29分，最低0分。分数越低表明功能障碍越明显。改善指数=治疗后评分-治疗前评分；评分改善率=[（治疗后评分-治疗前评分）/ 29-治疗前评分]×100%。通过改善指数可反映患者治疗前后腰椎功能的改善情况；通过改善率可反映临床治疗效果。改善率还可对应于通常采用的疗效判定标准：改善率为100%时为治愈，改善率大于60%为显效，25-60%为有效，小于25%为无效。
两组基线资料比较：患者年龄、性别及治疗前VAS、ODI、JOA评分，见表1。两组比较，P<0.05，差异无统计学意义。
表1 两组基线资料比较表
治疗方法：
基础治疗（两组均使用）
20%甘露醇250ml，静脉滴注，qd×3d；
地塞米松5-10mg，静脉推注，bid×3d；
卧床休息；
（注：由于椎间盘脱出、游离，不建议牵引及手法推拿治疗。）
实验组治疗
生黄芪120克、制川乌先6克、制草乌先6克、桃仁10克、红花10克、川芎10克、当归10克、地龙10克、炒赤芍12克、炒白芍12克、乳香10克、没药10克、川牛膝12克、泽泻20克、防己12克、细辛4克、僵蚕10克、地鳖虫10克、炙甘草8克；
上药根据上述制备煎煮方法统一由南通市中医院全自动煎药机代煎，取汁400ml，早晚各200ml分服，每日一剂。
对照组治疗
塞来昔布胶囊（西乐葆®）（进口药品注册证号：H20140106；H20140107；分包装批准文号：国药准字J20140072；辉瑞制药有限公司）200mg，一日2次，饭后口服，首剂400mg；
乙哌立松（妙纳®）（国药准字H20041061，卫材(中国)药业有限公司）50mg，一日3次，饭后口服。
疗程：1周为1疗程，总治疗时间为3个疗程。
治疗效果对比：
治疗1周，两组VAS、ODI、JOA评分结果（表2.）
表2.治疗1周VAS、ODI、JOA评分结果表（x̅±s）
*：与治疗前比较，P>0.05；＃：两组间比较，P>0.05；表明两组间及治疗前后比较，差异无统计学意义。
治疗2周，两组VAS、ODI、JOA评分结果（表3.）
表3.治疗2周VAS、ODI、JOA评分结果表（x̅±s）
与治疗前比较，*：P<0.05，＃：P>0.05；两组间比较，▲：P<0.05；表明治疗2周后，实验组治疗前后差异有统计学意义，对照组差异无统计学意义；组间比较，差异有统计学意义，说明治疗2周，实验组疗效优于对照组。
治疗3周，两组VAS、ODI、JOA评分结果（表4.）
表4.治疗3周VAS、ODI、JOA评分结果表（x̅±s）
与治疗前比较，*：P<0.01，＃：P<0.05；两组间比较，▲：P<0.05；表明治疗3周后，两组治疗前后差异均有统计学意义；组间比较，差异有统计学意义，说明治疗3周，实验组疗效优于对照组。
临床实验结论：本发明制备的治疗急性期脱出游离型腰椎间盘突出症的中药制剂（腰痹速通方），具有快速缓解疼痛作用，对脱出游离型腰椎间盘突出症疗效显著，其治疗周期及起效时限均缩短到3周以内，且服用安全，无明显毒副作用。
以上所述是本发明的优选实施方式，应当指出，对于本领域的普通技术人员来说，在不脱离本发明所述原理的前提下，还可以作出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
本申请中制备的治疗急性期脱出游离型腰椎间盘突出症的中药组方制剂（腰痹速通方）具有益气活血、利水消肿、蠲痹止痛的功效，能快速缓解脱出游离型腰椎间盘突出症患者急性风暴期的腰腿疼痛症状，治疗周期及起效时限一般均能控制在3周以内。
Claims (7)
1.一种治疗急性期脱出游离型腰椎间盘突出症的中药组方制剂（腰痹速通方），其特征在于：使用如下重量配比的原料饮片制备而成：生黄芪120-160克、桃仁10-12克、红花10-12克、川芎10-12克、当归15-20克、地龙10-12克、炒赤芍10-12克、炒白芍10-12克、乳香10-12克、没药10-12克、川牛膝10-15克、泽泻15-20克、防己10-12克、制川乌4-6克、制草乌4-6克、细辛3-4克、僵蚕10-12克、土鳖虫10-12克、炙甘草6-8克。
2.根据权利要求1所述的一种治疗急性期脱出游离型腰椎间盘突出症的中药组方制剂（腰痹速通方），其特征在于：取下述重量配比的主要原料饮片制备而成：生黄芪120克、桃仁10克、红花10克、川芎10克、当归15克、地龙10克、炒赤芍12克、炒白芍12克、乳香10克、没药10克、川牛膝12克、泽泻20克、防己12克、制川乌6克、制草乌6克、细辛4克、僵蚕10克、土鳖虫10克、炙甘草8克。
3.根据权利要求1所述的治疗急性期脱出游离型腰椎间盘突出症的中药组方制剂（腰痹速通方），其特征在于：所述药剂为口服液、药剂颗粒、胶囊中的一种。
4.一种治疗急性期脱出游离型腰椎间盘突出症的中药组方制剂（腰痹速通方）的制备方法，其特征在于：包含以下步骤：
S1：制作中药饮片：将权利要求1所述的原料制作成中药饮片；
S2：将S1中所制的中药饮片用凉饮用水浸泡30min，浸泡过程中水量覆盖药面3-5cm，制川乌、制草乌装入食品级药袋中浸泡；
S3：将S2中制川乌和制草乌以外的药材捞出，用武火先煎15分钟，加入捞出的其余药材武火煮沸，改文火煎煮60分钟，过滤，得第一提取药汁200ml；
S4：将S3中过滤后的药渣加入凉饮用水，水量覆盖药面2-3cm，武火煮沸，改文火煎煮50分钟，过滤，得第二提取药汁200ml；
S5：将S4中过滤后的药渣装入食品级药袋，绞压获得第三提取药汁50ml；
S6：将第一提取药汁、第二提取药汁和第三提取药汁混合，获得治疗脱出游离型腰椎间盘突出症的中药汤剂；
S7：在获得中药汤剂后，将S6中获得的中药汤剂使用柜式减压干燥器进行减压干燥，制得干燥药粉，
S8：用中药超微粉碎机将S7所得药粉进一步粉碎成100目以上的细粉；
S9：对细粉进行臭氧灭菌，制成治疗脱出游离型腰椎间盘突出症的中药制剂。
5.根据权利要求4所述的制备方法，其特征在于：所述中药饮片的制备方法如下所示：
生黄芪：取原药材，除去杂质，洗净，润透，切厚片，干燥，生用；
桃仁：取原药材，敲碎，除去杂质及残留的硬壳，筛去灰屑；
红花：净制拣去杂质，筛去灰屑；
川芎：取原药材，除去杂质，大小分开，洗净，用水泡至指甲能掐入外皮为度，取出，润透，切薄片，干燥，筛去碎屑；
当归：取原药材，除去杂质，洗净，稍润，切薄片，晒干或低温干燥，筛去碎屑；
地龙：取原药材，除去杂质，洗净，切段，干燥，加入黄酒拌匀，置锅内，稍闷润，用文火加热，炒至表面呈棕色，取出，放凉；
炒赤芍、炒白芍：取原药材，除去杂质，大小分开，洗净，润透，切薄片，干燥，筛去碎屑，置炒制容器内，用文火加热，炒至颜色加深，取出晾凉，筛去碎屑；
乳香、没药：取原药材，除去杂质，大小分开，置锅内用文火加热，炒至冒烟、表面微熔，喷淋米醋，再炒至表面显油亮光泽时，取出放凉；
川牛膝：取原药材，除去杂质及芦头，洗净，润透，切薄片，干燥，筛去碎屑；
泽泻：取原药材，除去杂质，大小个分开，稍浸，洗净，润透，切厚片，干燥，筛去碎屑；
防己：净制除去杂质，洗净，润透，切厚片，干燥；
制川乌、制草乌：取原药材，洗净，大小分开，用水浸泡至内无干心，加水煮沸4～6小时，或蒸6～8小时，取大个实心切开内无白心者，尝舌微有麻感时，晾至六成干，切薄片，干燥，筛去碎屑；
细辛：取原药材，去除杂质，喷淋洗净，稍润，切段，晾干；用25%炼蜜拌炒至蜜汁吸尽、不粘手，取出放凉；
僵蚕：取原药材，除去杂质及残丝，洗净，晒干；取麸皮撒于热锅内，用武火加热，待冒烟时，加入净僵蚕，炒至表面黄色，取出，筛去麸皮，放凉；
土鳖虫：取原药材，除去杂质，洗净，干燥，于锅内，用文火加热，炒至微焦，筛去灰屑，取出放凉；
炙甘草：取原药材，洗净，润透，带皮切厚片，干燥，筛去碎屑，取炼蜜，加适量开水稀释后，加入净甘草片中拌匀，闷润，于炒制容器内，文火加热，炒至老黄色、不粘手时，取出，晾凉。
6.根据权利要求4所述的制备方法，其特征在于：所述S8中细粉要求：100%过100目筛，95%过120目筛。
7.根据权利要求4所述的制备方法，其特征在于：所述S9臭氧灭菌环境为：臭氧浓度50g/m3、气流速度40m/s、气源氧气纯度>85%、灭菌温度小于40℃。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310899390.XA CN116688034A (zh) | 2023-07-21 | 2023-07-21 | 治疗急性期脱出游离型腰椎间盘突出症的中药制剂及制备方法 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310899390.XA CN116688034A (zh) | 2023-07-21 | 2023-07-21 | 治疗急性期脱出游离型腰椎间盘突出症的中药制剂及制备方法 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN116688034A true CN116688034A (zh) | 2023-09-05 |
Family
ID=87834194
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202310899390.XA Pending CN116688034A (zh) | 2023-07-21 | 2023-07-21 | 治疗急性期脱出游离型腰椎间盘突出症的中药制剂及制备方法 |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN116688034A (zh) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105687602A (zh) * | 2014-11-24 | 2016-06-22 | 威海诺达药业集团有限公司 | 一种治疗腰椎间盘突出症的中药 |
-
2023
- 2023-07-21 CN CN202310899390.XA patent/CN116688034A/zh active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105687602A (zh) * | 2014-11-24 | 2016-06-22 | 威海诺达药业集团有限公司 | 一种治疗腰椎间盘突出症的中药 |
Non-Patent Citations (5)
| Title |
|---|
| 张宇;解永利;张清涛;马涛;李林军;: "中药结合射频臭氧介入治疗腰椎间盘突出症28例", 陕西中医学院学报, no. 06, 10 November 2011 (2011-11-10), pages 58 - 59 * |
| 李林;詹红生;陈博;石印玉;: "补阳还五汤在骨伤科中的应用验案举隅", 江苏中医药, no. 04, 5 April 2010 (2010-04-05), pages 45 * |
| 殷文学;: "中药内服并神经阻滞疗法治疗急重型腰椎间盘突出症62例", 中国中医急症, no. 01, 28 January 2007 (2007-01-28), pages 78 * |
| 王强;: "综合疗法治疗腰椎间盘突出症20例", 实用中医内科杂志, no. 01, 25 January 2009 (2009-01-25), pages 49 - 50 * |
| 郑晓红: "中医药治疗腰椎间盘突出症的研究近况", 上海中医药杂志, no. 07, 15 July 2001 (2001-07-15), pages 47 - 49 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102091203B (zh) | 一种治疗难愈性创面的外用中药制剂及其制备方法 | |
| CN104815295A (zh) | 一种治疗颈椎病的中药制剂 | |
| CN102846824B (zh) | 一种治疗寒湿血瘀阻络型糖尿病足的中药组合物及其制备方法 | |
| CN103623280A (zh) | 一种治疗心脑血管疾病的中药制剂 | |
| CN105435197A (zh) | 一种治疗桥本氏病的药物组合物及其制备方法 | |
| CN104721614A (zh) | 一种用于治疗关节脱位的中药制剂及制备方法 | |
| CN116688034A (zh) | 治疗急性期脱出游离型腰椎间盘突出症的中药制剂及制备方法 | |
| CN106511905A (zh) | 一种用于治疗颈椎病的中药制剂及其制备方法 | |
| CN112641917A (zh) | 一种滇南血栓丸的制备方法 | |
| CN102988747B (zh) | 一种三刺降三高的冲剂及其制备方法 | |
| CN104857363A (zh) | 一种降血脂的中药组合制剂及其制备方法 | |
| CN113813324A (zh) | 一种治疗骨质疏松、股骨头坏死的中药组合物及其制备方法 | |
| CN104623304A (zh) | 一种治疗湿热毒蕴型慢性皮肤溃疡的洗剂及其制备方法 | |
| CN104623057A (zh) | 一种治疗糖尿病足的药物组合物及其应用 | |
| CN104225256A (zh) | 一种治疗火毒内陷型烧伤的中药及制备方法 | |
| CN111840497B (zh) | 一种治疗疤痕的药物及其制备方法 | |
| CN115192673B (zh) | 一种治疗结节病的中药组合物及其制备方法 | |
| CN1236804C (zh) | 一种治痔胶囊的制法 | |
| CN114306549B (zh) | 一种改善髋关节置换手术术后关节活动功能和缓解术后疼痛的中药组合物、制剂与应用 | |
| CN105998260A (zh) | 一种治疗膝关节半月板损伤的中药制剂及制备方法 | |
| CN105943639A (zh) | 一种辅助治疗慢性硬脑膜下血肿的中药组合物 | |
| CN105288422A (zh) | 一种用于治疗腹绞痛综合征的中药制剂及制备方法 | |
| CN105853843A (zh) | 一种临床用小儿伤口护理的药物组合物及其制备方法 | |
| CN105920410A (zh) | 一种壮阳补肾的中药丸 | |
| CN113274452A (zh) | 一种治疗腰椎骨质增生的中药组合物 |
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 |