CN116370529B - 一种用于治疗风湿病的外用中药组合物及其制备方法和应用 - Google Patents
一种用于治疗风湿病的外用中药组合物及其制备方法和应用 Download PDFInfo
- Publication number
- CN116370529B CN116370529B CN202310612758.XA CN202310612758A CN116370529B CN 116370529 B CN116370529 B CN 116370529B CN 202310612758 A CN202310612758 A CN 202310612758A CN 116370529 B CN116370529 B CN 116370529B
- Authority
- CN
- China
- Prior art keywords
- parts
- chinese medicine
- traditional chinese
- carbomer
- raw materials
- 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.)
- Active
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 33
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- 230000000699 topical effect Effects 0.000 title claims description 13
- 239000003814 drug Substances 0.000 claims abstract description 66
- 239000002994 raw material Substances 0.000 claims abstract description 29
- 230000008961 swelling Effects 0.000 claims abstract description 20
- 241000903946 Clematidis Species 0.000 claims abstract description 14
- 241000218176 Corydalis Species 0.000 claims abstract description 13
- 210000000582 semen Anatomy 0.000 claims abstract description 12
- 230000003110 anti-inflammatory effect Effects 0.000 claims abstract description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 42
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 32
- 229920002125 Sokalan® Polymers 0.000 claims description 32
- 229960001631 carbomer Drugs 0.000 claims description 32
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 27
- 238000010438 heat treatment Methods 0.000 claims description 23
- 238000003756 stirring Methods 0.000 claims description 21
- 239000011159 matrix material Substances 0.000 claims description 17
- 238000005520 cutting process Methods 0.000 claims description 14
- 238000001914 filtration Methods 0.000 claims description 14
- 239000000843 powder Substances 0.000 claims description 14
- 238000005303 weighing Methods 0.000 claims description 14
- 244000010000 Hovenia dulcis Species 0.000 claims description 13
- 235000008584 Hovenia dulcis Nutrition 0.000 claims description 13
- 240000003146 Lobelia chinensis Species 0.000 claims description 12
- 241001145009 Sophora alopecuroides Species 0.000 claims description 12
- 244000195896 dadap Species 0.000 claims description 12
- 238000000605 extraction Methods 0.000 claims description 12
- AXTGDCSMTYGJND-UHFFFAOYSA-N 1-dodecylazepan-2-one Chemical compound CCCCCCCCCCCCN1CCCCCC1=O AXTGDCSMTYGJND-UHFFFAOYSA-N 0.000 claims description 11
- 241000427159 Achyranthes Species 0.000 claims description 11
- 240000004510 Agastache rugosa Species 0.000 claims description 11
- 241000255789 Bombyx mori Species 0.000 claims description 11
- 235000002566 Capsicum Nutrition 0.000 claims description 11
- 241001506371 Kadsura Species 0.000 claims description 11
- 239000006002 Pepper Substances 0.000 claims description 11
- 235000016761 Piper aduncum Nutrition 0.000 claims description 11
- 235000017804 Piper guineense Nutrition 0.000 claims description 11
- 235000008184 Piper nigrum Nutrition 0.000 claims description 11
- 240000002853 Nelumbo nucifera Species 0.000 claims description 10
- 235000006508 Nelumbo nucifera Nutrition 0.000 claims description 10
- 235000006510 Nelumbo pentapetala Nutrition 0.000 claims description 10
- 239000000463 material Substances 0.000 claims description 10
- 239000000706 filtrate Substances 0.000 claims description 9
- 239000003961 penetration enhancing agent Substances 0.000 claims description 9
- 239000000047 product Substances 0.000 claims description 8
- 238000002791 soaking Methods 0.000 claims description 8
- 239000004698 Polyethylene Substances 0.000 claims description 7
- 239000011248 coating agent Substances 0.000 claims description 7
- 238000000576 coating method Methods 0.000 claims description 7
- 238000000034 method Methods 0.000 claims description 7
- 239000004745 nonwoven fabric Substances 0.000 claims description 7
- 238000004806 packaging method and process Methods 0.000 claims description 7
- -1 polyethylene Polymers 0.000 claims description 7
- 229920000573 polyethylene Polymers 0.000 claims description 7
- 239000008213 purified water Substances 0.000 claims description 7
- 230000001954 sterilising effect Effects 0.000 claims description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 7
- 238000009736 wetting Methods 0.000 claims description 7
- 241000110637 Cuscuta chinensis Species 0.000 claims description 5
- 244000294611 Punica granatum Species 0.000 claims description 5
- 235000014360 Punica granatum Nutrition 0.000 claims description 5
- 241000283690 Bos taurus Species 0.000 claims description 3
- 244000203593 Piper nigrum Species 0.000 claims 3
- 239000002674 ointment Substances 0.000 claims 3
- 206010061218 Inflammation Diseases 0.000 claims 1
- 230000004054 inflammatory process Effects 0.000 claims 1
- 230000000694 effects Effects 0.000 abstract description 24
- 208000002193 Pain Diseases 0.000 abstract description 12
- 241001529821 Agastache Species 0.000 abstract description 4
- 208000025747 Rheumatic disease Diseases 0.000 abstract description 4
- 210000003608 fece Anatomy 0.000 abstract description 3
- 230000000552 rheumatic effect Effects 0.000 abstract description 3
- 230000000202 analgesic effect Effects 0.000 abstract description 2
- 230000007246 mechanism Effects 0.000 abstract description 2
- 230000002195 synergetic effect Effects 0.000 abstract description 2
- 241001604597 Pyrestini Species 0.000 abstract 1
- 241000411851 herbal medicine Species 0.000 abstract 1
- 241000700159 Rattus Species 0.000 description 14
- 210000003371 toe Anatomy 0.000 description 14
- 208000006820 Arthralgia Diseases 0.000 description 8
- CTQNGGLPUBDAKN-UHFFFAOYSA-N O-Xylene Chemical compound CC1=CC=CC=C1C CTQNGGLPUBDAKN-UHFFFAOYSA-N 0.000 description 8
- 241000722363 Piper Species 0.000 description 8
- 241000699670 Mus sp. Species 0.000 description 7
- 206010012735 Diarrhoea Diseases 0.000 description 6
- 239000000679 carrageenan Substances 0.000 description 6
- 229920001525 carrageenan Polymers 0.000 description 6
- 229940113118 carrageenan Drugs 0.000 description 6
- 235000010418 carrageenan Nutrition 0.000 description 6
- 230000001717 pathogenic effect Effects 0.000 description 6
- 230000001737 promoting effect Effects 0.000 description 6
- 210000002966 serum Anatomy 0.000 description 6
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 6
- 210000000988 bone and bone Anatomy 0.000 description 5
- 230000002757 inflammatory effect Effects 0.000 description 5
- 210000003734 kidney Anatomy 0.000 description 5
- 210000002435 tendon Anatomy 0.000 description 5
- 206010047700 Vomiting Diseases 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 230000027939 micturition Effects 0.000 description 4
- 238000010008 shearing Methods 0.000 description 4
- 239000008096 xylene Substances 0.000 description 4
- MZOFCQQQCNRIBI-VMXHOPILSA-N (3s)-4-[[(2s)-1-[[(2s)-1-[[(1s)-1-carboxy-2-hydroxyethyl]amino]-4-methyl-1-oxopentan-2-yl]amino]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]amino]-3-[[2-[[(2s)-2,6-diaminohexanoyl]amino]acetyl]amino]-4-oxobutanoic acid Chemical compound OC[C@@H](C(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCN=C(N)N)NC(=O)[C@H](CC(O)=O)NC(=O)CNC(=O)[C@@H](N)CCCCN MZOFCQQQCNRIBI-VMXHOPILSA-N 0.000 description 3
- 201000000736 Amenorrhea Diseases 0.000 description 3
- 206010001928 Amenorrhoea Diseases 0.000 description 3
- 241000196324 Embryophyta Species 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 3
- 206010027514 Metrorrhagia Diseases 0.000 description 3
- 206010030113 Oedema Diseases 0.000 description 3
- 108060008682 Tumor Necrosis Factor Proteins 0.000 description 3
- 102000000852 Tumor Necrosis Factor-alpha Human genes 0.000 description 3
- 210000001015 abdomen Anatomy 0.000 description 3
- 231100000540 amenorrhea Toxicity 0.000 description 3
- 230000017531 blood circulation Effects 0.000 description 3
- 210000004185 liver Anatomy 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 231100000862 numbness Toxicity 0.000 description 3
- 244000045947 parasite Species 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 208000007848 Alcoholism Diseases 0.000 description 2
- 241000218158 Clematis Species 0.000 description 2
- 201000004624 Dermatitis Diseases 0.000 description 2
- 206010014025 Ear swelling Diseases 0.000 description 2
- 208000010228 Erectile Dysfunction Diseases 0.000 description 2
- 241000220485 Fabaceae Species 0.000 description 2
- 206010017553 Furuncle Diseases 0.000 description 2
- 208000032843 Hemorrhage Diseases 0.000 description 2
- 102000000589 Interleukin-1 Human genes 0.000 description 2
- 108010002352 Interleukin-1 Proteins 0.000 description 2
- 102000003777 Interleukin-1 beta Human genes 0.000 description 2
- 108090000193 Interleukin-1 beta Proteins 0.000 description 2
- 206010023232 Joint swelling Diseases 0.000 description 2
- 235000015512 Liquidambar formosana Nutrition 0.000 description 2
- 241000893545 Liquidambar formosana Species 0.000 description 2
- 208000004880 Polyuria Diseases 0.000 description 2
- 230000003213 activating effect Effects 0.000 description 2
- 201000007930 alcohol dependence Diseases 0.000 description 2
- 238000010171 animal model Methods 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 230000000740 bleeding effect Effects 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 230000035619 diuresis Effects 0.000 description 2
- 208000002173 dizziness Diseases 0.000 description 2
- 229940000406 drug candidate Drugs 0.000 description 2
- 210000005069 ears Anatomy 0.000 description 2
- 239000003777 experimental drug Substances 0.000 description 2
- 210000003414 extremity Anatomy 0.000 description 2
- 201000001881 impotence Diseases 0.000 description 2
- 230000001976 improved effect Effects 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 230000007794 irritation Effects 0.000 description 2
- 210000003127 knee Anatomy 0.000 description 2
- BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 description 2
- 238000010992 reflux Methods 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 208000011580 syndromic disease Diseases 0.000 description 2
- 229940126680 traditional chinese medicines Drugs 0.000 description 2
- 230000008736 traumatic injury Effects 0.000 description 2
- 230000008673 vomiting Effects 0.000 description 2
- 208000004998 Abdominal Pain Diseases 0.000 description 1
- 206010000087 Abdominal pain upper Diseases 0.000 description 1
- 206010000234 Abortion spontaneous Diseases 0.000 description 1
- 240000000031 Achyranthes bidentata Species 0.000 description 1
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 241000219317 Amaranthaceae Species 0.000 description 1
- 208000008710 Amebic Dysentery Diseases 0.000 description 1
- 206010001986 Amoebic dysentery Diseases 0.000 description 1
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 206010003445 Ascites Diseases 0.000 description 1
- 241000208838 Asteraceae Species 0.000 description 1
- 208000004429 Bacillary Dysentery Diseases 0.000 description 1
- 208000008035 Back Pain Diseases 0.000 description 1
- 206010006002 Bone pain Diseases 0.000 description 1
- 241000345998 Calamus manan Species 0.000 description 1
- 241000208671 Campanulaceae Species 0.000 description 1
- 206010007247 Carbuncle Diseases 0.000 description 1
- 241000743683 Carpodacus erythrinus Species 0.000 description 1
- 206010008190 Cerebrovascular accident Diseases 0.000 description 1
- 206010008479 Chest Pain Diseases 0.000 description 1
- 241000207782 Convolvulaceae Species 0.000 description 1
- 241001537328 Corydalis decumbens Species 0.000 description 1
- 206010011224 Cough Diseases 0.000 description 1
- 238000002965 ELISA Methods 0.000 description 1
- 208000004232 Enteritis Diseases 0.000 description 1
- 208000008967 Enuresis Diseases 0.000 description 1
- 206010017915 Gastroenteritis shigella Diseases 0.000 description 1
- 208000012671 Gastrointestinal haemorrhages Diseases 0.000 description 1
- 241000142952 Hamamelidaceae Species 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 206010019468 Hemiplegia Diseases 0.000 description 1
- 208000031361 Hiccup Diseases 0.000 description 1
- 235000008586 Hovenia Nutrition 0.000 description 1
- 241000405398 Hovenia Species 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 208000004044 Hypesthesia Diseases 0.000 description 1
- 208000006877 Insect Bites and Stings Diseases 0.000 description 1
- 208000019395 Lactation disease Diseases 0.000 description 1
- 241000207923 Lamiaceae Species 0.000 description 1
- 208000008930 Low Back Pain Diseases 0.000 description 1
- 208000019255 Menstrual disease Diseases 0.000 description 1
- 208000016285 Movement disease Diseases 0.000 description 1
- 206010062575 Muscle contracture Diseases 0.000 description 1
- 206010052904 Musculoskeletal stiffness Diseases 0.000 description 1
- 208000000112 Myalgia Diseases 0.000 description 1
- 240000001307 Myosotis scorpioides Species 0.000 description 1
- 206010059013 Nocturnal emission Diseases 0.000 description 1
- 206010033799 Paralysis Diseases 0.000 description 1
- 206010034944 Photokeratitis Diseases 0.000 description 1
- 241000534014 Piper kadsura Species 0.000 description 1
- 241000758706 Piperaceae Species 0.000 description 1
- 208000003251 Pruritus Diseases 0.000 description 1
- 208000001431 Psychomotor Agitation Diseases 0.000 description 1
- 241000218201 Ranunculaceae Species 0.000 description 1
- 206010038084 Rectocele Diseases 0.000 description 1
- 206010038743 Restlessness Diseases 0.000 description 1
- 241000219100 Rhamnaceae Species 0.000 description 1
- 241001373816 Saussurea laniceps Species 0.000 description 1
- 208000008765 Sciatica Diseases 0.000 description 1
- 241000270295 Serpentes Species 0.000 description 1
- 241000011945 Sideritis eriocephala Species 0.000 description 1
- 208000004078 Snake Bites Diseases 0.000 description 1
- 241000219784 Sophora Species 0.000 description 1
- 208000005392 Spasm Diseases 0.000 description 1
- 206010041497 Spermatorrhoea Diseases 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 206010042576 Suppressed lactation Diseases 0.000 description 1
- 208000002474 Tinea Diseases 0.000 description 1
- 241000130764 Tinea Species 0.000 description 1
- 206010067197 Tinea manuum Diseases 0.000 description 1
- 208000009205 Tinnitus Diseases 0.000 description 1
- 206010053476 Traumatic haemorrhage Diseases 0.000 description 1
- 241000224526 Trichomonas Species 0.000 description 1
- 206010047642 Vitiligo Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 238000001467 acupuncture Methods 0.000 description 1
- 208000038016 acute inflammation Diseases 0.000 description 1
- 230000006022 acute inflammation Effects 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 230000007815 allergy Effects 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
- 210000000702 aorta abdominal Anatomy 0.000 description 1
- 208000010668 atopic eczema Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 208000019902 chronic diarrheal disease Diseases 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 208000006111 contracture Diseases 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 239000002934 diuretic Substances 0.000 description 1
- 230000001882 diuretic effect Effects 0.000 description 1
- 208000001848 dysentery Diseases 0.000 description 1
- 230000004064 dysfunction Effects 0.000 description 1
- 235000013399 edible fruits Nutrition 0.000 description 1
- 238000001827 electrotherapy Methods 0.000 description 1
- 230000004438 eyesight Effects 0.000 description 1
- 230000001605 fetal effect Effects 0.000 description 1
- 210000002683 foot Anatomy 0.000 description 1
- 238000003306 harvesting Methods 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 208000035861 hematochezia Diseases 0.000 description 1
- 208000034783 hypoesthesia Diseases 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 210000001503 joint Anatomy 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000005906 menstruation Effects 0.000 description 1
- 208000015994 miscarriage Diseases 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 229960005181 morphine Drugs 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 238000010172 mouse model Methods 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 208000013465 muscle pain Diseases 0.000 description 1
- 201000009240 nasopharyngitis Diseases 0.000 description 1
- 230000007383 nerve stimulation Effects 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 238000000554 physical therapy Methods 0.000 description 1
- 206010036067 polydipsia Diseases 0.000 description 1
- 230000035935 pregnancy Effects 0.000 description 1
- 230000001047 pyretic effect Effects 0.000 description 1
- 235000012950 rattan cane Nutrition 0.000 description 1
- 230000002040 relaxant effect Effects 0.000 description 1
- 201000003068 rheumatic fever Diseases 0.000 description 1
- 201000005404 rubella Diseases 0.000 description 1
- 201000004409 schistosomiasis Diseases 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 201000005113 shigellosis Diseases 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 210000000952 spleen Anatomy 0.000 description 1
- 208000000995 spontaneous abortion Diseases 0.000 description 1
- 230000007480 spreading Effects 0.000 description 1
- 238000003892 spreading Methods 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 230000004206 stomach function Effects 0.000 description 1
- 238000005728 strengthening Methods 0.000 description 1
- 238000010254 subcutaneous injection Methods 0.000 description 1
- 239000007929 subcutaneous injection Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 230000008093 supporting effect Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 201000004647 tinea pedis Diseases 0.000 description 1
- 231100000886 tinnitus Toxicity 0.000 description 1
- 208000037816 tissue injury Diseases 0.000 description 1
- 208000004371 toothache Diseases 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- 229920003169 water-soluble polymer Polymers 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)
- A61K36/67—Piperaceae (Pepper family), e.g. Jamaican pepper or kava
-
- 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)
-
- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/285—Aucklandia
-
- 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)
- A61K36/34—Campanulaceae (Bellflower family)
-
- 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)
- A61K36/39—Convolvulaceae (Morning-glory family), e.g. bindweed
-
- 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)
- A61K36/43—Cuscutaceae (Dodder family), e.g. Cuscuta epithymum or greater dodder
-
- 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
-
- 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
- A61K36/532—Agastache, e.g. giant hyssop
-
- 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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/716—Clematis (leather flower)
-
- 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)
- A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
-
- 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
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
-
- 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)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (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)
- Botany (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Dermatology (AREA)
- Insects & Arthropods (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Animal Husbandry (AREA)
- Inorganic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (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
本发明提供一种具有显著治疗风湿病的外用中药组合物及其制备方法和应用。所述的外用中药组合物制备为凝胶膏剂，中药原料由海风藤、路路通、半边莲、夏天无、藿香、牛膝、枳椇、菟丝子、石榴皮、苦豆子、威灵仙、海桐皮、蚕沙、雪莲花组成。本发明采用纯中草药为原料，各组分配伍得当，机理明确，协同增效，治疗风湿性肿胀疼痛效果好，具有显著的镇痛、抗炎作用。
Description
技术领域
本发明属于中药技术领域，具体涉及一种用于治疗风湿病的外用中药组合物及其制备方法和应用。
背景技术
疼痛(pain)通常由组织损伤的伤害性刺激引起的，是复杂的生理心理活动。风湿痹痛为因受风寒湿邪引起的以肢体关节疼痛、酸楚、麻木、重着，以及活动障碍为主的病证。“痛”与“肿”往往相伴而生，风湿痹痛主要的症状为关节疼痛，晨僵，关节肿胀和压痛，关节肿痛和关节畸形和功能障碍。中医认为，血脉“通则不痛，不通则痛”，局部风湿性疼痛综合症因发病部位限于局部，当以局部用药为佳。目前针对痛与肿的治疗现状是，物理疗法如推拿、按摩、热疗、电疗等以及针灸、电刺激神经等疗法，可缓解疼痛，但作用慢。药物治疗如吗啡类药物长期服用会对患者有较大的副作用。
中药凝胶膏剂是将药材提取物溶解、混合于天然或合成水溶性高分子材料基质中，摊涂在背衬材料上，供贴敷于皮肤的外用制剂，经透皮吸收起到全身作用或局部作用。但是有些药物因刺激性、过敏性等不良反应明显，病人依从性差，这些都直接影响了中药在外用治疗风湿病方面的发挥。
发明内容
针对现有技术的不足，本发明的目的在于提供一种外用中药组合物及其制备方法和应用，尤其提供一种用于治疗风湿病的外用中药组合物及其制备方法和应用。
为达到此发明目的，本发明采用以下技术方案：
第一方面，本发明提供一种用于治疗风湿病的外用中药组合物，由以下原料组成：海风藤5-20份、路路通5-20份、半边莲1-15份、夏天无1-15份、藿香1-15份、牛膝1-20份、枳椇1-20份、菟丝子1-15份、石榴皮1-15份、苦豆子1-15份、威灵仙1-20份、海桐皮1-15份、蚕沙1-15份、雪莲花1-15份。
本发明所涉及的各项中药均可从一般中药店购得，其规格符合中国药典标准。
优选地，所述外用中药组合物的制备原料为：海风藤7-15份、路路通7-15份、半边莲3-10份、夏天无3-10份、藿香3-10份、牛膝5-15份、枳椇5-15份、菟丝子3-10份、石榴皮3-10份、苦豆子3-10份、威灵仙5-15份、海桐皮3-12份、蚕沙2-12份、雪莲花2-12份。
更优选地，所述外用中药组合物的制备原料为：海风藤15份、路路通15份、半边莲8份、夏天无8份、藿香7份、牛膝12份、枳椇12份、菟丝子5份、石榴皮5份、苦豆子6份、威灵仙8份、海桐皮8份、蚕沙7份、雪莲花7份。
第二方面，本发明提供一种所述的用于治疗风湿病的外用中药组合物的制备方法，包括以下步骤：
S1.按重量份称取中药原料，将上述中药材粉碎成粗粉，备用；
S2.将步骤S1中得到的中药粗粉置于容器中，加入药材重量8-10倍量的70%乙醇，浸泡6-12h，加热回流提取3-5h，提取温度60-80℃，过滤，滤液备用，滤渣中加入75%乙醇继续加热回流提取2-4h，提取温度60-70℃，过滤，合并两次滤液后减压回收乙醇，再继续浓缩至相对密度为1.12-1.32g/cm3的浸膏，备用；
S3.按卡波姆:浸膏的质量比为5:1-8:1，称取卡波姆，加入卡波姆重量30%的纯净水润湿后，加入卡波姆重量20%-30%的甘油，在 45℃下加热搅拌均匀得到空白基质，备用；
S4.将S2中得到的浸膏加至步骤S3中得到的空白基质中，再加入浸膏量1%-5%的促渗剂氮酮，同方向搅拌15-25min，搅拌均匀后涂布于无纺布上，盖上聚乙烯薄膜，用切割机切割、包装、灭菌，即得。
进一步地，步骤S2中浸泡时间为10h，第一次加热回流时间为4h，第二次加热回流时间为3h，步骤S2中第一次提取温度为70℃，第二次提取温度为65℃。
更进一步地，步骤S3中卡波姆:浸膏的质量比为6:1，甘油加入量为卡波姆重量的20%，步骤S4中氮酮的加入量为2%。
第三方面，本发明提供一种外用中药凝胶膏剂，其由上述制备方法制备得到。
第四方面，本发明提供一种所述的外用中药组合物或是所述的外用中药凝胶膏剂在制备治疗风湿病的药物中的应用。
其中，海风藤为本品为胡椒科植物风藤Piper kadsura （Choisy） Ohwi的干燥藤茎。具有祛风湿，通经络，止痹痛的功效。用于风寒湿痹，肢节疼痛，筋脉拘挛，屈伸不利。
其中，路路通为金缕梅科植物枫香树Liquidambar formosana Hance 的干燥成熟果序。具有祛风活络，利水通经的功效。用于关节痹痛，麻木拘挛，水肿胀满，乳少经闭。
其中，半边莲为桔梗科植物半边莲Lobelia chinensis Lour. 的干燥全草。具有利尿消肿，清热解毒的功效。用于大腹水肿，面足浮肿，痈肿疔疮，蛇虫咬伤；晚期血吸虫病腹水。
其中，夏天无为罂粟科植物伏生紫堇Corydalis decumbens （Thunb.）Pers. 的干燥块茎。具有活血通络，行气止痛的功效。用于中风偏瘫，跌扑损伤，风湿性关节炎，坐骨神经痛。
其中，藿香为唇形科植物广藿香或藿香的全草。具有祛暑解表；化湿和胃的功效。用于夏令感冒，寒热头痛，胸脘痞闷，呕吐泄泻，妊娠呕吐，鼻渊，手、足癣。
其中，牛膝为苋科植物牛膝Achyranthes bidentata Blume. 的干燥根。具有补肝肾，强筋骨，逐瘀通经，引血下行的功效。用于腰膝酸痛，筋骨无力，经闭症瘕，肝阳眩晕。
其中，枳椇为鼠李科枳椇属植物拐枣Hovenia dulcis Thunb.，以树皮与种子入药。具有清热利尿，止咳除烦，解酒毒的功效。用于热病烦渴，呃逆，呕吐，小便不利，酒精中毒。
其中，菟丝子为旋花科植物菟丝子Cuscuta chinensis Lam. 的干燥成熟种子。具有滋补肝肾，固精缩尿，安胎，明目，止泻的功效。用于阳痿遗精，尿有余沥，遗尿尿频，腰膝酸软，目昏耳鸣，肾虚胎漏，胎动不安，脾肾虚泻；外治白癜风。
其中，石榴皮为石榴科植物石榴Punica granatum L. 的干燥果皮。具有涩肠止泻，止血，驱虫的功效。用于久泻，久痢，便血，脱肛，崩漏，白带，虫积腹痛。
其中，苦豆子为豆科槐属植物苦豆子Sophora alopecuroides L.，以全草、根、种子入药。具有清热利湿，止痛，杀虫的功效。用于细菌性痢疾，阿米巴痢疾，胃痛，滴虫性肠炎，白带过多，外用治疮疖，湿疹，顽癣。
其中，威灵仙为毛茛科植物威灵仙ClematischinensisOsbeck.棉团铁线莲C.hexapetalaPall或东北铁线莲C.manshuricaRupr.的根及根茎。具有祛除风湿，治骨鲠的功效。用于风湿痹痛，诸骨鲠喉。
其中，海桐皮为豆科乔木刺桐Erythrina indica Lam.的树皮或根皮。具有祛风湿，舒筋通络的功效。用于风湿麻木，腰腿筋骨疼痛，跌打损伤；外用治各种顽癣。
其中，蚕沙为蚕蛾科动物家蚕蛾幼虫的干燥粪便。具有祛风除湿、和胃化浊、活血通经的功效。用于风湿痹痛，肢体不遂，风疹瘙痒，吐泻转筋，闭经，崩漏。
其中，雪莲花为菊科风毛菊属植物绵头雪莲花Saussurea laniceps Hand.-Mazz.和毛头雪莲花S. eriocephala Franch，以带根全草入药。具有补肾壮阳，调经止血的功效。用于雪盲，牙痛，风湿性关节炎，阳痿，月经不调，崩漏，白带；外用治创伤出血。
本发明的有益效果为：
（1）本发明所涉及的中药组合物，以海风藤、路路通、半边莲、夏天无、藿香、牛膝、枳椇、菟丝子、石榴皮、苦豆子、威灵仙、海桐皮、蚕沙、雪莲花为中药原料，本发明采用纯中草药为原料，各组分配伍得当，机理明确，协同增效，治疗风湿性肿胀疼痛效果好，具有显著的镇痛、抗炎作用。
（2） 制备所述的中药凝胶膏剂工艺简单，可行性高，能够大规模生产，并且对皮肤无刺激和过敏反应，能将处方中的有效成份快速经皮肤吸收直达患处。
（3）原料易得，成本较低，应用人群广泛，具有实用性和社会效益。
实施方式
为了更好地理解本发明，下面结合实施例对本发明的实施方案进行详细描述，但是本领域技术人员将会理解，下列实施例仅用于说明本发明，而不应视为限制本发明的范围。
实施例
一种用于治疗风湿病的外用中药组合物，由以下原料组成：海风藤5份、路路通5份、半边莲2份、夏天无2份、藿香4份、牛膝4份、枳椇9份、菟丝子7份、石榴皮3份、苦豆子4份、威灵仙7份、海桐皮6份、蚕沙4份、雪莲花4份。
一种所述外用中药组合物的制备方法，包括以下步骤：
S1.按重量份称取中药原料，将上述中药材粉碎成粗粉，备用；
S2.将步骤S1中得到的中药粗粉置于容器中，加入药材重量8倍量的70%乙醇，浸泡6h，加热回流提取3h，提取温度60℃，过滤，滤液备用，滤渣中加入75%乙醇继续加热回流提取2h，提取温度60℃，过滤，合并两次滤液后减压回收乙醇，再继续浓缩至相对密度为1.12g/cm3的浸膏，备用；
S3.按卡波姆:浸膏的质量比为5:1，称取卡波姆，加入卡波姆重量30%的纯净水润湿后，加入卡波姆重量24%的甘油，在 45℃下加热搅拌均匀得到空白基质，备用；
S4.将S2中得到的浸膏加至步骤S3中得到的空白基质中，再加入浸膏量1%的促渗剂氮酮，同方向搅拌15min，搅拌均匀后涂布于无纺布上，盖上聚乙烯薄膜，用切割机切割、包装、灭菌，即得。
实施例
一种用于治疗风湿病的外用中药组合物，由以下原料组成：海风藤15份、路路通15份、半边莲10份、夏天无10份、藿香10份、牛膝15份、枳椇15份、菟丝子10份、石榴皮10份、苦豆子10份、威灵仙15份、海桐皮12份、蚕沙12份、雪莲花12份。
一种所述外用中药组合物的制备方法，包括以下步骤：
S1.按重量份称取中药原料，将上述中药材粉碎成粗粉，备用；
S2.将步骤S1中得到的中药粗粉置于容器中，加入药材重量10倍量的70%乙醇，浸泡12h，加热回流提取5h，提取温度80℃，过滤，滤液备用，滤渣中加入75%乙醇继续加热回流提取4h，提取温度70℃，过滤，合并两次滤液后减压回收乙醇，再继续浓缩至相对密度为1.32g/cm3的浸膏，备用；
S3.按卡波姆:浸膏的质量比为8:1，称取卡波姆，加入卡波姆重量30%的纯净水润湿后，加入卡波姆重量30%的甘油，在 45℃下加热搅拌均匀得到空白基质，备用；
S4.将S2中得到的浸膏加至步骤S3中得到的空白基质中，再加入浸膏量5%的促渗剂氮酮，同方向搅拌25min，搅拌均匀后涂布于无纺布上，盖上聚乙烯薄膜，用切割机切割、包装、灭菌，即得。
实施例
一种用于治疗风湿病的外用中药组合物，由以下原料组成：海风藤7份、路路通7份、半边莲3份、夏天无3份、藿香3份、牛膝5份、枳椇5份、菟丝子3份、石榴皮3份、苦豆子3份、威灵仙5份、海桐皮3份、蚕沙2份、雪莲花2份。
一种所述外用中药组合物的制备方法，包括以下步骤：
S1.按重量份称取中药原料，将上述中药材粉碎成粗粉，备用；
S2.将步骤S1中得到的中药粗粉置于容器中，加入药材重量8.5倍量的70%乙醇，浸泡9h，加热回流提取4.5h，提取温度75℃，过滤，滤液备用，滤渣中加入75%乙醇继续加热回流提取3.5h，提取温度66℃，过滤，合并两次滤液后减压回收乙醇，再继续浓缩至相对密度为1.30g/cm3的浸膏，备用；
S3.按卡波姆:浸膏的质量比为6:1，称取卡波姆，加入卡波姆重量30%的纯净水润湿后，加入卡波姆重量25%的甘油，在 45℃下加热搅拌均匀得到空白基质，备用；
S4.将S2中得到的浸膏加至步骤S3中得到的空白基质中，再加入浸膏量4%的促渗剂氮酮，同方向搅拌20min，搅拌均匀后涂布于无纺布上，盖上聚乙烯薄膜，用切割机切割、包装、灭菌，即得。
实施例
一种用于治疗风湿病的外用中药组合物，由以下原料组成：海风藤15份、路路通15份、半边莲8份、夏天无8份、藿香7份、牛膝12份、枳椇12份、菟丝子5份、石榴皮5份、苦豆子6份、威灵仙8份、海桐皮8份、蚕沙7份、雪莲花7份。
一种所述外用中药组合物的制备方法，包括以下步骤：
S1.按重量份称取中药原料，将上述中药材粉碎成粗粉，备用；
S2.将步骤S1中得到的中药粗粉置于容器中，加入药材重量8-10倍量的70%乙醇，浸泡10h，加热回流提取4h，提取温度70℃，过滤，滤液备用，滤渣中加入75%乙醇继续加热回流提取3h，提取温度65℃，过滤，合并两次滤液后减压回收乙醇，再继续浓缩至相对密度为1.28g/cm3的浸膏，备用；
S3.按卡波姆:浸膏的质量比为6:1，称取卡波姆，加入卡波姆重量30%的纯净水润湿后，加入卡波姆重量20%的甘油，在 45℃下加热搅拌均匀得到空白基质，备用；
S4.将S2中得到的浸膏加至步骤S3中得到的空白基质中，再加入浸膏量2%的促渗剂氮酮，同方向搅拌20min，搅拌均匀后涂布于无纺布上，盖上聚乙烯薄膜，用切割机切割、包装、灭菌，即得。
实施例5：本发明外用中药组合物对二甲苯致小鼠耳廓肿胀的影响
（1）实验动物：ICR小鼠（从上海必凯实验动物有限公司购入）
（2）实验药物：取实施例4中制备得到凝胶膏剂，根据0.5 g/kg、1.0 g/kg、2.0 g/kg的给药剂量换算凝胶膏剂所需要的贴敷面积，将其剪切为对应面积的凝胶膏剂，得到低剂量治疗组、中剂量治疗组、高剂量治疗组；同实施例4中步骤S3-S4，取步骤S3中制备的空白基质，再加入相同量的2%的促渗剂氮酮，同样的制备方法制备得到不含有中药浸膏的空白凝胶膏剂，剪切与高剂量治疗组相同面积的空白凝胶膏剂，作为空白凝胶膏剂组。
（3）实验过程：采用在动物耳朵涂二甲苯的方式建立耳廓肿胀模型。取30只ICR小鼠，雌雄各半，腹部脱毛，随机平均分为对照组（空白凝胶膏剂，贴于脱毛处皮肤）、模型组（空白凝胶膏剂，贴于脱毛处皮肤）、低剂量治疗组（0.5 g/kg，贴于脱毛处皮肤）、中剂量治疗组（1.0 g/kg，贴于脱毛处皮肤）和高剂量治疗组（2.0 g/kg，贴于脱毛处皮肤），每组6只。除对照组外，其余各组小鼠右耳双面涂30 μL二甲苯0.5 h建立耳廓肿胀模型。各组每天贴敷6 h，连续用药3 d。最后一次给药6 h后，将小鼠脱臼处死，用直径7 mm打孔器在左右耳对称处取下圆形耳片，称重，以左右耳的重量差作为肿胀程度。
（4）实验结果：结果显示，与对照组相比，涂抹二甲苯后模型组小鼠的耳廓出现明显肿胀。与模型组相比，经过不同剂量组的贴剂治疗后，小鼠耳肿胀得到显著改善，且呈现剂量依赖性。如表1所示。
表1 各组小鼠二甲苯致耳廓肿胀的比较（平均数±标准差，mg）
| 组别 | 只数 | 左右耳重量差（mg） |
| 对照组 | 6 | 0.85 ± 0.17 |
| 模型组 | 6 | 9.40 ± 0.66** |
| 治疗组（低剂量） | 6 | 7.76 ± 0.69## |
| 治疗组（中剂量） | 6 | 6.20 ± 0.36## |
| 治疗组（高剂量） | 6 | 4.38 ± 0.52## |
注：与正常组比较，*P ＜0.05, **P ＜0.01；与模型组比较，#P ＜0.05, ##P ＜0.01(下同)。
实施例6：本发明外用中药组合物对角叉采胶致大鼠足趾肿胀模型的影响
（1）实验动物：SD大鼠（从上海必凯实验动物有限公司购入）
（2）实验药物：取实施例4中制备得到凝胶膏剂，根据0.3 g/kg、0.6 g/kg、1.2 g/kg的给药剂量换算凝胶膏剂所需要的贴敷面积，将其剪切为对应面积的凝胶膏剂，得到低剂量治疗组、中剂量治疗组、高剂量治疗组；同实施例4中步骤S3-S4，取步骤S3中制备的空白基质，再加入相同量的2%的促渗剂氮酮，同样的制备方法制备得到不含有中药浸膏的空白凝胶膏剂，剪切与高剂量治疗组相同面积的空白凝胶膏剂，作为空白凝胶膏剂组。
（3）实验过程：采用在动物足趾皮下注射角叉采胶的方式建立足趾肿胀模型。取30只SD大鼠，雌雄各半，腹部脱毛，随机平均分为对照组（空白凝胶膏剂，贴于脱毛处皮肤）、模型组（空白凝胶膏剂，贴于脱毛处皮肤）、低剂量治疗组（0.3 g/kg，贴于脱毛处皮肤）、中剂量治疗组（0.6 g/kg，贴于脱毛处皮肤）和高剂量治疗组（1.2 g/kg，贴于脱毛处皮肤），每组6只。除对照组外其余各组大鼠右后足趾皮内注射0.1 mL的1%角叉采胶建立足趾肿胀模型。各组每天贴敷6 h，连续用药7 d。游标卡尺测量造模前及最后一次给药6 h后足趾的厚度，以两者的厚度差作为肿胀程度。各组大鼠最后一次给药6 h后，麻醉，腹主动脉取血，采用ELISA测定血清中炎症因子 IL-1β和 TNF-α的含量。
（4）实验结果：
1）对角叉采胶致大鼠足趾肿胀的影响
结果显示，与对照组相比，注射角叉采胶后模型组大鼠的足趾出现明显肿胀。与模型组相比，经过不同剂量组的贴剂治疗后，大鼠的足趾肿胀得到显著改善，且呈现剂量依赖性。如表2所示。
表2 各组大鼠角叉采胶致足趾肿胀的比较（平均数±标准差，mm）
| 组别 | 只数 | 足趾5厚度（mm） |
| 对照组 | 6 | 0.33 ± 0.20 |
| 模型组 | 6 | 3.05 ± 0.25** |
| 治疗组（低剂量） | 6 | 2.71 ± 0.13# |
| 治疗组（中剂量） | 6 | 2.39 ± 0.12## |
| 治疗组（高剂量） | 6 | 2.19 ± 0.11## |
2）对血清中炎症因子 IL-1β和 TNF-α含量的影响
结果显示，与对照组相比，注射角叉采胶后模型组大鼠血清中炎症因子 IL-1β和TNF-α的含量显著升高。与模型组相比，经过不同剂量组的贴剂治疗后，大鼠血清中IL-1β和TNF-α显著降低，且呈现剂量依赖性。如表3所示。
表3 各组大鼠血清中炎症因子含量变化（平均数±标准差，pg/mL）
从实验结果可以看出，本发明外用中药组合物制备的凝胶膏剂低、中、高剂量组均对二甲苯致小鼠耳肿胀及角叉采胶致大鼠足趾肿胀有抑制作用，且均能降低大鼠血清中炎症因子的含量，表明本发明外用中药组合物对急性炎症有确切的抗炎消肿作用，可用于治疗风湿类疾病，且具有显著疗效。
申请人声明，本发明通过上述实施例来说明本发明的一种用于治疗风湿病的外用中药组合物及其制备方法和应用，但本发明并不局限于上述实施例，即不意味着本发明必须依赖上述实施例才能实施。所属技术领域的技术人员应该明了，对本发明的任何改进，对本发明产品各原料的等效替换及辅助成分的添加、具体方式的选择等，均落在本发明的保护范围和公开范围之内。
以上详细描述了本发明的优选实施方式，但是，本发明并不限于上述实施方式中的具体细节，在本发明的技术构思范围内，可以对本发明的技术方案进行多种简单变型，这些简单变型均属于本发明的保护范围。
另外需要说明的是，在上述具体实施方式中所描述的各个具体技术特征，在不矛盾的情况下，可以通过任何合适的方式进行组合，为了避免不必要的重复，本发明对各种可能的组合方式不再另行说明。
Claims (8)
1.一种用于抗炎消肿的外用中药凝胶膏剂，其特征在于，由以下中药原料制成：海风藤5-20份、路路通5-20份、半边莲1-15份、夏天无1-15份、藿香1-15份、牛膝1-20份、枳椇1-20份、菟丝子1-15份、石榴皮1-15份、苦豆子1-15份、威灵仙1-20份、海桐皮1-15份、蚕沙1-15份、雪莲花1-15份；
所述外用中药凝胶膏剂，制备方法包括以下步骤：
S1.按重量份称取中药原料，将上述中药材粉碎成粗粉，备用；
S2.将步骤S1中得到的中药粗粉置于容器中，加入药材重量8-10倍量的70%乙醇，浸泡10h，加热回流提取4h，提取温度70℃，过滤，滤液备用，滤渣中加入75%乙醇继续加热回流提取3h，提取温度65℃，过滤，合并两次滤液后减压回收乙醇，再继续浓缩至相对密度为1.12-1.32g/cm3的浸膏，备用；
S3.按卡波姆:浸膏的质量比为5:1-8:1，称取卡波姆，加入卡波姆重量30%的纯净水润湿后，加入卡波姆重量20%-30%的甘油，在 45℃下加热搅拌均匀得到空白基质，备用；
S4.将S2中得到的浸膏加至步骤S3中得到的空白基质中，再加入浸膏量1%-5%的促渗剂氮酮，同方向搅拌15-25min，搅拌均匀后涂布于无纺布上，盖上聚乙烯薄膜，用切割机切割、包装、灭菌，即得。
2.根据权利要求1所述的外用中药凝胶膏剂，其特征在于，由以下中药原料制成：海风藤7-15份、路路通7-15份、半边莲3-10份、夏天无3-10份、藿香3-10份、牛膝5-15份、枳椇5-15份、菟丝子3-10份、石榴皮3-10份、苦豆子3-10份、威灵仙5-15份、海桐皮3-12份、蚕沙2-12份、雪莲花2-12份。
3.根据权利要求2所述的外用中药凝胶膏剂物，其特征在于，由以下中药原料制成：海风藤15份、路路通15份、半边莲8份、夏天无8份、藿香7份、牛膝12份、枳椇12份、菟丝子5份、石榴皮5份、苦豆子6份、威灵仙8份、海桐皮8份、蚕沙7份、雪莲花7份。
4.一种如权利要求1-3任一项所述的外用中药凝胶膏剂的制备方法，其特征在于，包括以下步骤：
S1.按重量份称取中药原料，将上述中药材粉碎成粗粉，备用；
S2.将步骤S1中得到的中药粗粉置于容器中，加入药材重量8-10倍量的70%乙醇，浸泡10h，加热回流提取4h，提取温度70℃，过滤，滤液备用，滤渣中加入75%乙醇继续加热回流提取3h，提取温度65℃，过滤，合并两次滤液后减压回收乙醇，再继续浓缩至相对密度为1.12-1.32g/cm3的浸膏，备用；
S3.按卡波姆:浸膏的质量比为5:1-8:1，称取卡波姆，加入卡波姆重量30%的纯净水润湿后，加入卡波姆重量20%-30%的甘油，在 45℃下加热搅拌均匀得到空白基质，备用；
S4.将S2中得到的浸膏加至步骤S3中得到的空白基质中，再加入浸膏量1%-5%的促渗剂氮酮，同方向搅拌15-25min，搅拌均匀后涂布于无纺布上，盖上聚乙烯薄膜，用切割机切割、包装、灭菌，即得。
5.如权利要求4所述的外用中药凝胶膏剂的制备方法，其特征在于，步骤S3中卡波姆:浸膏的质量比为6:1，甘油加入量为卡波姆重量的20%。
6.如权利要求4所述的外用中药凝胶膏剂物的制备方法，其特征在于，步骤S4中氮酮的加入量为2%。
7.如权利要求4-6任一项所述的制备方法制备得到的外用中药凝胶膏剂。
8.一种如权利要求1-3任一项所述的中药凝胶膏剂或是权利要求7所述的外用中药凝胶膏剂在制备抗炎消肿的药物中的应用。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310612758.XA CN116370529B (zh) | 2023-05-29 | 2023-05-29 | 一种用于治疗风湿病的外用中药组合物及其制备方法和应用 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310612758.XA CN116370529B (zh) | 2023-05-29 | 2023-05-29 | 一种用于治疗风湿病的外用中药组合物及其制备方法和应用 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN116370529A CN116370529A (zh) | 2023-07-04 |
| CN116370529B true CN116370529B (zh) | 2024-05-31 |
Family
ID=86975412
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202310612758.XA Active CN116370529B (zh) | 2023-05-29 | 2023-05-29 | 一种用于治疗风湿病的外用中药组合物及其制备方法和应用 |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN116370529B (zh) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108066526A (zh) * | 2016-11-14 | 2018-05-25 | 广安市广安区井河镇初级中学校 | 一种治疗风湿病的中药配方 |
-
2023
- 2023-05-29 CN CN202310612758.XA patent/CN116370529B/zh active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108066526A (zh) * | 2016-11-14 | 2018-05-25 | 广安市广安区井河镇初级中学校 | 一种治疗风湿病的中药配方 |
Also Published As
| Publication number | Publication date |
|---|---|
| CN116370529A (zh) | 2023-07-04 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN112717103A (zh) | 一种治疗颈肩腰腿疼痛的植物液 | |
| CN104013929B (zh) | 一种治疗风湿性关节炎和类风湿性关节炎的风湿祛痛药物及制备方法 | |
| CN103611133A (zh) | 活血止痛凝胶及其制备方法 | |
| CN113768975A (zh) | 一种治疗关节疼痛的中药组合物、中药贴剂及其制备方法与使用方法 | |
| CN109432269A (zh) | 一种中药组合物以及制备方法、用途 | |
| CN112843196A (zh) | 一种女性阴道紧致胶囊及其制备工艺 | |
| CN112057585A (zh) | 含有多种精油治疗颈肩腰腿痛的贴剂配方及其制备方法 | |
| CN101856475B (zh) | 一种治疗妇科炎症的中药组合物及其制备方法 | |
| CN116370529B (zh) | 一种用于治疗风湿病的外用中药组合物及其制备方法和应用 | |
| CN110624033A (zh) | 一种接骨续筋中药药物及其制备方法 | |
| CN104940878A (zh) | 一种治疗风湿骨病的中药药膏及其制备方法 | |
| CN114949163A (zh) | 一种调理肩颈腰腿痛的外敷膏药及其制备、使用方法 | |
| CN111991527A (zh) | 足药浴配方及其制备工艺 | |
| CN113318180A (zh) | 一种治疗跌打损伤的中药组合物及其制备方法 | |
| CN102949544B (zh) | 专治偏瘫病人手足肿胀的中药组合物 | |
| CN112121086A (zh) | 一种用于透药治疗的中药酊剂及其制备方法 | |
| CN101954040A (zh) | 治疗骨质增生的外用药及其制备方法 | |
| CN103751467A (zh) | 一种治疗腰背筋膜炎的中药组合物及其制备方法 | |
| CN111084842B (zh) | 治疗肩周炎、颈椎病、腰椎间盘突出、骨性关节炎的外用中药组合物 | |
| CN113230365B (zh) | 一种治疗关节骨病的中药组合物、制剂及其制备方法和应用 | |
| CN113577166B (zh) | 一种药油及其制备方法 | |
| CN116603045A (zh) | 一种用于缓解风湿性腿疼的外用贴膏及其制备方法 | |
| CN116889602A (zh) | 一种治疗滑膜炎、腱鞘炎的外用中药组合物及其制备方法 | |
| CN114869984A (zh) | 一种治疗慢性疼痛的药物及其制备方法 | |
| CN114515325A (zh) | 一种治疗慢性疼痛的苗药拔毒膏及其制备方法 |
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 | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |