CN112057576B - 一种固肾缩尿夜尿穴位贴及其制备方法 - Google Patents
一种固肾缩尿夜尿穴位贴及其制备方法 Download PDFInfo
- Publication number
- CN112057576B CN112057576B CN202011046509.1A CN202011046509A CN112057576B CN 112057576 B CN112057576 B CN 112057576B CN 202011046509 A CN202011046509 A CN 202011046509A CN 112057576 B CN112057576 B CN 112057576B
- Authority
- CN
- China
- Prior art keywords
- parts
- polyisobutylene
- kidney
- seed
- fruit
- 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
- 238000002360 preparation method Methods 0.000 title claims abstract description 21
- 206010029446 nocturia Diseases 0.000 title claims description 33
- 235000013399 edible fruits Nutrition 0.000 claims abstract description 48
- 239000003814 drug Substances 0.000 claims abstract description 40
- 210000003734 kidney Anatomy 0.000 claims abstract description 38
- 239000011505 plaster Substances 0.000 claims abstract description 31
- 210000000582 semen Anatomy 0.000 claims abstract description 30
- 230000027939 micturition Effects 0.000 claims abstract description 25
- 235000008326 Trichosanthes anguina Nutrition 0.000 claims abstract description 23
- 244000078912 Trichosanthes cucumerina Species 0.000 claims abstract description 23
- 239000002674 ointment Substances 0.000 claims abstract description 21
- 235000011274 Benincasa cerifera Nutrition 0.000 claims abstract description 20
- 244000036905 Benincasa cerifera Species 0.000 claims abstract description 20
- 241000572565 Alpinia oxyphylla Species 0.000 claims abstract description 19
- 244000183914 Dianthus superbus Species 0.000 claims abstract description 19
- 235000013535 Dianthus superbus Nutrition 0.000 claims abstract description 19
- 241000893536 Epimedium Species 0.000 claims abstract description 14
- 235000018905 epimedium Nutrition 0.000 claims abstract description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 14
- 235000018645 Allium odorum Nutrition 0.000 claims abstract description 13
- 244000003377 Allium tuberosum Species 0.000 claims abstract description 13
- 235000005338 Allium tuberosum Nutrition 0.000 claims abstract description 13
- 241000258241 Mantis Species 0.000 claims abstract description 13
- 240000005001 Paeonia suffruticosa Species 0.000 claims abstract description 13
- 235000003889 Paeonia suffruticosa Nutrition 0.000 claims abstract description 13
- 244000241463 Cullen corylifolium Species 0.000 claims abstract description 12
- 239000004480 active ingredient Substances 0.000 claims abstract description 11
- 239000002994 raw material Substances 0.000 claims abstract description 10
- 238000001467 acupuncture Methods 0.000 claims abstract description 4
- 229920002367 Polyisobutene Polymers 0.000 claims description 59
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 34
- 239000000341 volatile oil Substances 0.000 claims description 30
- 239000000463 material Substances 0.000 claims description 24
- 240000007371 Cuscuta campestris Species 0.000 claims description 18
- 239000004530 micro-emulsion Substances 0.000 claims description 14
- 235000008671 Calycanthus floridus Nutrition 0.000 claims description 13
- 235000008670 Calycanthus occidentalis Nutrition 0.000 claims description 13
- 244000148992 Lindera benzoin Species 0.000 claims description 13
- 235000004520 Lindera benzoin Nutrition 0.000 claims description 13
- 235000008262 Lindera benzoin var. benzoin Nutrition 0.000 claims description 13
- 239000000284 extract Substances 0.000 claims description 13
- 239000000843 powder Substances 0.000 claims description 13
- GHBFNMLVSPCDGN-UHFFFAOYSA-N rac-1-monooctanoylglycerol Chemical compound CCCCCCCC(=O)OCC(O)CO GHBFNMLVSPCDGN-UHFFFAOYSA-N 0.000 claims description 12
- 238000000605 extraction Methods 0.000 claims description 11
- 239000011159 matrix material Substances 0.000 claims description 11
- 235000019441 ethanol Nutrition 0.000 claims description 9
- 238000005303 weighing Methods 0.000 claims description 8
- 239000011248 coating agent Substances 0.000 claims description 7
- 238000000576 coating method Methods 0.000 claims description 7
- 239000000945 filler Substances 0.000 claims description 7
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 7
- 229920000053 polysorbate 80 Polymers 0.000 claims description 7
- 230000003014 reinforcing effect Effects 0.000 claims description 7
- -1 sucrose fatty acid ester Chemical class 0.000 claims description 7
- 239000012154 double-distilled water Substances 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 6
- 239000003921 oil Substances 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 6
- 229930006000 Sucrose Natural products 0.000 claims description 5
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 5
- 229930195729 fatty acid Natural products 0.000 claims description 5
- 239000000194 fatty acid Substances 0.000 claims description 5
- 238000000034 method Methods 0.000 claims description 5
- 239000005720 sucrose Substances 0.000 claims description 5
- 238000001035 drying Methods 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- 238000010298 pulverizing process Methods 0.000 claims description 4
- 229940087068 glyceryl caprylate Drugs 0.000 claims description 3
- 230000000694 effects Effects 0.000 abstract description 15
- 210000004072 lung Anatomy 0.000 abstract description 12
- 238000010792 warming Methods 0.000 abstract description 12
- 206010067484 Adverse reaction Diseases 0.000 abstract description 9
- 230000006838 adverse reaction Effects 0.000 abstract description 9
- 208000008967 Enuresis Diseases 0.000 abstract description 5
- 230000001737 promoting effect Effects 0.000 abstract description 5
- 210000000952 spleen Anatomy 0.000 abstract description 5
- 208000004880 Polyuria Diseases 0.000 abstract description 4
- 230000036528 appetite Effects 0.000 abstract description 4
- 235000019789 appetite Nutrition 0.000 abstract description 4
- 230000035619 diuresis Effects 0.000 abstract description 4
- 210000004185 liver Anatomy 0.000 abstract description 4
- 208000005346 nocturnal enuresis Diseases 0.000 abstract description 4
- 230000001105 regulatory effect Effects 0.000 abstract description 4
- 230000009471 action Effects 0.000 abstract description 3
- 231100000957 no side effect Toxicity 0.000 abstract description 3
- 230000002269 spontaneous effect Effects 0.000 abstract 2
- 244000001632 Acorus gramineus Species 0.000 abstract 1
- 235000013073 Acorus gramineus Nutrition 0.000 abstract 1
- 241000146029 Lindera aggregata Species 0.000 abstract 1
- 230000004936 stimulating effect Effects 0.000 abstract 1
- 239000000758 substrate Substances 0.000 abstract 1
- 238000011282 treatment Methods 0.000 description 28
- 229940079593 drug Drugs 0.000 description 23
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 17
- 201000010099 disease Diseases 0.000 description 15
- 238000012360 testing method Methods 0.000 description 14
- 210000003128 head Anatomy 0.000 description 10
- 239000008280 blood Substances 0.000 description 7
- 210000004369 blood Anatomy 0.000 description 7
- 230000003860 sleep quality Effects 0.000 description 7
- 230000009466 transformation Effects 0.000 description 6
- 210000002700 urine Anatomy 0.000 description 6
- 235000008216 herbs Nutrition 0.000 description 5
- 208000024891 symptom Diseases 0.000 description 5
- 241000721047 Danaus plexippus Species 0.000 description 4
- 239000002585 base Substances 0.000 description 4
- 210000001124 body fluid Anatomy 0.000 description 4
- 239000010839 body fluid Substances 0.000 description 4
- 235000019198 oils Nutrition 0.000 description 4
- 230000002485 urinary effect Effects 0.000 description 4
- RSWGJHLUYNHPMX-UHFFFAOYSA-N Abietic-Saeure Natural products C12CCC(C(C)C)=CC2=CCC2C1(C)CCCC2(C)C(O)=O RSWGJHLUYNHPMX-UHFFFAOYSA-N 0.000 description 3
- KHPCPRHQVVSZAH-HUOMCSJISA-N Rosin Natural products O(C/C=C/c1ccccc1)[C@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 KHPCPRHQVVSZAH-HUOMCSJISA-N 0.000 description 3
- 210000001015 abdomen Anatomy 0.000 description 3
- 239000000853 adhesive Substances 0.000 description 3
- 230000001070 adhesive effect Effects 0.000 description 3
- 230000007812 deficiency Effects 0.000 description 3
- 238000009826 distribution Methods 0.000 description 3
- 230000006870 function Effects 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 230000009467 reduction Effects 0.000 description 3
- 238000012353 t test Methods 0.000 description 3
- KHPCPRHQVVSZAH-UHFFFAOYSA-N trans-cinnamyl beta-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OCC=CC1=CC=CC=C1 KHPCPRHQVVSZAH-UHFFFAOYSA-N 0.000 description 3
- 210000003708 urethra Anatomy 0.000 description 3
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- 108010000437 Deamino Arginine Vasopressin Proteins 0.000 description 2
- 239000004166 Lanolin Substances 0.000 description 2
- 206010059013 Nocturnal emission Diseases 0.000 description 2
- 206010057071 Rectal tenesmus Diseases 0.000 description 2
- 238000000692 Student's t-test Methods 0.000 description 2
- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical group [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 description 2
- 230000002159 abnormal effect Effects 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 229960004281 desmopressin Drugs 0.000 description 2
- NFLWUMRGJYTJIN-NXBWRCJVSA-N desmopressin Chemical compound C([C@H]1C(=O)N[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@@H](CSSCCC(=O)N[C@@H](CC=2C=CC(O)=CC=2)C(=O)N1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(N)=O)=O)CCC(=O)N)C1=CC=CC=C1 NFLWUMRGJYTJIN-NXBWRCJVSA-N 0.000 description 2
- 238000003745 diagnosis Methods 0.000 description 2
- 208000035475 disorder Diseases 0.000 description 2
- 239000002934 diuretic Substances 0.000 description 2
- 229940030606 diuretics Drugs 0.000 description 2
- 208000002173 dizziness Diseases 0.000 description 2
- 230000004064 dysfunction Effects 0.000 description 2
- 206010016256 fatigue Diseases 0.000 description 2
- 229940039717 lanolin Drugs 0.000 description 2
- 235000019388 lanolin Nutrition 0.000 description 2
- 244000033903 mu dan Species 0.000 description 2
- 235000013045 mu dan Nutrition 0.000 description 2
- 230000000422 nocturnal effect Effects 0.000 description 2
- 231100000252 nontoxic Toxicity 0.000 description 2
- 230000003000 nontoxic effect Effects 0.000 description 2
- 238000002203 pretreatment Methods 0.000 description 2
- 229920005989 resin Polymers 0.000 description 2
- 239000011347 resin Substances 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 208000011580 syndromic disease Diseases 0.000 description 2
- 208000012271 tenesmus Diseases 0.000 description 2
- YYSCJLLOWOUSHH-UHFFFAOYSA-N 4,4'-disulfanyldibutanoic acid Chemical compound OC(=O)CCCSSCCCC(O)=O YYSCJLLOWOUSHH-UHFFFAOYSA-N 0.000 description 1
- 201000004384 Alopecia Diseases 0.000 description 1
- 208000019901 Anxiety disease Diseases 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 206010005003 Bladder cancer Diseases 0.000 description 1
- 108030001720 Bontoxilysin Proteins 0.000 description 1
- 208000031868 Calculus ureteric Diseases 0.000 description 1
- 244000025254 Cannabis sativa Species 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 206010010774 Constipation Diseases 0.000 description 1
- 206010011224 Cough Diseases 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 206010013954 Dysphoria Diseases 0.000 description 1
- 208000004547 Hallucinations Diseases 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 208000006083 Hypokinesia Diseases 0.000 description 1
- 206010021639 Incontinence Diseases 0.000 description 1
- 201000006347 Intellectual Disability Diseases 0.000 description 1
- VQTUBCCKSQIDNK-UHFFFAOYSA-N Isobutene Chemical group CC(C)=C VQTUBCCKSQIDNK-UHFFFAOYSA-N 0.000 description 1
- 206010071289 Lower urinary tract symptoms Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- CTQNGGLPUBDAKN-UHFFFAOYSA-N O-Xylene Chemical compound CC1=CC=CC=C1C CTQNGGLPUBDAKN-UHFFFAOYSA-N 0.000 description 1
- CBENFWSGALASAD-UHFFFAOYSA-N Ozone Chemical compound [O-][O+]=O CBENFWSGALASAD-UHFFFAOYSA-N 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 208000006265 Renal cell carcinoma Diseases 0.000 description 1
- DRHKJLXJIQTDTD-OAHLLOKOSA-N Tamsulosine Chemical compound CCOC1=CC=CC=C1OCCN[C@H](C)CC1=CC=C(OC)C(S(N)(=O)=O)=C1 DRHKJLXJIQTDTD-OAHLLOKOSA-N 0.000 description 1
- 208000009205 Tinnitus Diseases 0.000 description 1
- 230000006750 UV protection Effects 0.000 description 1
- 208000000014 Ureteral Calculi Diseases 0.000 description 1
- 208000007097 Urinary Bladder Neoplasms Diseases 0.000 description 1
- 206010046543 Urinary incontinence Diseases 0.000 description 1
- 208000031975 Yang Deficiency Diseases 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 231100000360 alopecia Toxicity 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000036506 anxiety Effects 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000003542 behavioural effect Effects 0.000 description 1
- 230000008081 blood perfusion Effects 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 229940053031 botulinum toxin Drugs 0.000 description 1
- 229910000019 calcium carbonate Inorganic materials 0.000 description 1
- 210000003169 central nervous system Anatomy 0.000 description 1
- 208000026106 cerebrovascular disease Diseases 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000003920 cognitive function Effects 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000002542 deteriorative effect Effects 0.000 description 1
- 230000004069 differentiation Effects 0.000 description 1
- 230000003292 diminished effect Effects 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 206010013781 dry mouth Diseases 0.000 description 1
- 210000005069 ears Anatomy 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 239000003792 electrolyte Substances 0.000 description 1
- 230000008451 emotion Effects 0.000 description 1
- 208000030172 endocrine system disease Diseases 0.000 description 1
- 238000011841 epidemiological investigation Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 230000029142 excretion Effects 0.000 description 1
- 210000003414 extremity Anatomy 0.000 description 1
- 238000011010 flushing procedure Methods 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000002607 hemopoietic effect Effects 0.000 description 1
- 239000000017 hydrogel Substances 0.000 description 1
- 239000003326 hypnotic agent Substances 0.000 description 1
- 230000000147 hypnotic effect Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 208000017169 kidney disease Diseases 0.000 description 1
- 230000003907 kidney function Effects 0.000 description 1
- 210000003127 knee Anatomy 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 229940057995 liquid paraffin Drugs 0.000 description 1
- 208000019423 liver disease Diseases 0.000 description 1
- 230000003908 liver function Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- YMBXTVYHTMGZDW-UHFFFAOYSA-N loxoprofen Chemical compound C1=CC(C(C(O)=O)C)=CC=C1CC1C(=O)CCC1 YMBXTVYHTMGZDW-UHFFFAOYSA-N 0.000 description 1
- 229960002373 loxoprofen Drugs 0.000 description 1
- 210000004705 lumbosacral region Anatomy 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000005906 menstruation Effects 0.000 description 1
- 201000008383 nephritis Diseases 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 230000008506 pathogenesis Effects 0.000 description 1
- 239000005011 phenolic resin Substances 0.000 description 1
- 229920001568 phenolic resin Polymers 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 208000037920 primary disease Diseases 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000004224 protection Effects 0.000 description 1
- 230000009103 reabsorption Effects 0.000 description 1
- 210000000664 rectum Anatomy 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 208000019116 sleep disease Diseases 0.000 description 1
- 230000004622 sleep time Effects 0.000 description 1
- 230000036578 sleeping time Effects 0.000 description 1
- 235000014347 soups Nutrition 0.000 description 1
- 238000007619 statistical method Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000002636 symptomatic treatment Methods 0.000 description 1
- 229960002613 tamsulosin Drugs 0.000 description 1
- 230000009967 tasteless effect Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 231100000886 tinnitus Toxicity 0.000 description 1
- 229960003553 tolterodine tartrate Drugs 0.000 description 1
- 201000005112 urinary bladder cancer Diseases 0.000 description 1
- 208000014001 urinary system disease Diseases 0.000 description 1
- 229940099259 vaseline Drugs 0.000 description 1
- 235000015112 vegetable and seed oil Nutrition 0.000 description 1
- 239000008158 vegetable oil Substances 0.000 description 1
- 230000002618 waking effect Effects 0.000 description 1
- 229940126673 western medicines Drugs 0.000 description 1
- 239000008096 xylene Substances 0.000 description 1
- 239000011787 zinc oxide Substances 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)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
-
- 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
- A61K35/583—Snakes; Lizards, e.g. chameleons
-
- 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)
- A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
- A61K36/296—Epimedium
-
- 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)
- A61K36/36—Caryophyllaceae (Pink family), e.g. babysbreath or soapwort
-
- 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)
- A61K36/42—Cucurbitaceae (Cucumber 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)
- A61K36/42—Cucurbitaceae (Cucumber family)
- A61K36/428—Trichosanthes
-
- 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
- A61K36/487—Psoralea
-
- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
-
- 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
- A61K36/8962—Allium, e.g. garden onion, leek, garlic or chives
-
- 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)
- A61K36/9062—Alpinia, e.g. red ginger or galangal
-
- 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
- A61K9/70—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
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- 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
- A61K2236/33—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
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)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Botany (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Urology & Nephrology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Insects & Arthropods (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Animal Husbandry (AREA)
- Zoology (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明涉及一种固肾缩尿夜尿穴位贴,其包括药膏,所述药膏包含贴膏剂基质和药效成分,所述药效成分采用包含如下药材的原料制成乌药、益智仁、补骨脂、菟丝子、瓜蒌、瞿麦、桑螵蛸、去头去脚的蛤蚧、石菖蒲、冬瓜子、韭菜子、牡丹皮和淫羊藿。本发明还涉及该中药穴位贴的制备方法。该中药药香具有温肾散寒、暖肾温脾、固精缩尿、润肺行水、宽胸散结、化湿开胃、温肾助阳、补益肝肾、固精缩尿,将其贴于开元、腰眼等穴位可起到温肾缩尿、通调水道的作用。穴位贴可长期使用,无副作用和不良反应,具有“精准、独特、速效、天然”的特点,使用方便,使患者具有很好的依从性。
Description
技术领域
本发明涉及中药穴位贴技术领域,具体涉及一种固肾缩尿夜尿穴位贴及其制备方法。
背景技术
夜尿症(enuresis)指夜间起床排尿,每次排尿之前及之后都处于睡眠状态。它是一种独立的临床疾病,而不是其他疾病中的一个症状或者就把它归类于许多下尿路症状中的一个。夜尿次数增多势必会造成患者睡眠时间和(或)质量下降,导致晨起后依然疲惫乏力,头脑不清醒,记忆力下降等认知功能下降,甚至还会产生焦虑、烦躁等心理情绪,影响白天社会功能,严重影响患者的健康状况和生活质量。流行病学调查显示,美国人群中夜尿症发生率为31%,瑞典62%,韩国48%。
中医学认为,夜尿频多,主要责之膀胱气化无力,肾气虚衰。膀胱为通调水道,储藏津液之腑,小便乃津液经气化后从膀胱排出来。然而仅仅依靠膀胱的气化是不够的,膀胱与肾相表里,膀胱的气化功能又依赖于肾的气化,使清者上升而浊者下降。肾为先天之本,元阴元阳所藏之处,司二阴,膀胧的气化、二焦决渎、津液输布排泄功能均有赖肾气温照气化为动力。因此,研究者认为夜尿症主要是因为肾气不足,元阳衰弱,体内津液得不到温煦气化,从而水道功能失调导致积聚成尿,膀胱缺少肾气的固摄,开阖失常,最终导致夜尿频多。
目前,夜尿症的发病机理较为复杂。但最终都作用在尿的生成、储存两方面。因此将夜尿症分为类:夜间尿量过多,夜间膀胱容量缩小或夜间膀胱活动频繁,混合性夜尿症。西药在减少尿量生成方面采用各种药物,包括促进重吸收的如去氨加压素、降低肾血流灌注的如非留体抗炎药洛索洛芬等;在降低膀胱敏感性方面,药物包括受体阻滞剂如坦索罗辛、受体阻滞剂如酒石酸托特罗定、肉毒杆菌毒素等。西药治疗夜尿症主要是对症治疗,药物选择多样性,对各种症状针对性强,且方便、快捷,疗效准确,但治标不治本,大多数药物长期服用副作用明显,如电解质紊乱、口干、便秘、脸色潮红、头痛和头晕,严重者会影响中枢神经系统,造成意识模糊和产生幻觉等,甚至危及生命安全。因此,探求临床疗效显著,副作用少的治疗方案就成为当前医务工作者努力的重要方向。
发明内容
(一)要解决的技术问题
为了解决现有技术的上述问题,本发明提供一种固肾缩尿夜尿穴位贴及其制备方法,该穴位贴温肾散寒、暖肾温脾、固精缩尿、润肺行水、宽胸散结、化湿开胃、温肾助阳、补益肝肾、固精缩尿,可起到温肾缩尿、通调水道的作用。穴位贴无副作用和不良反应,具有“精准、独特、速效、天然”的特点,使用方便,使患者具有很好的依从性。
(二)技术方案
为了达到上述目的,本发明采用的主要技术方案包括:
一方面,本发明提供一种固肾缩尿夜尿穴位贴,为贴膏剂基质和药效成分组成的药膏,所述药膏包含贴膏剂基质和药效成分,所述药效成分由如下药材的原料制成:
乌药9-12重量份、益智仁10-15重量份、补骨脂5-10重量份、菟丝子5-10重量份、瓜蒌3-6重量份、瞿麦3-6重量份、桑螵蛸5-10重量份、去头去脚的蛤蚧30-40重量份、石菖蒲3-6重量份、冬瓜子3-6重量份、韭菜子5-10重量份、牡丹皮3-6重量份和淫羊藿5-10重量份。
根据本发明较佳实施例,其中,所述原料中,各药材的用量为:乌药12重量份、益智仁15重量份、补骨脂10重量份、菟丝子10重量份、瓜蒌6重量份、瞿麦6重量份、桑螵蛸10重量份、去头去脚的蛤蚧35重量份、石菖蒲6重量份、冬瓜子6重量份、韭菜子10重量份、牡丹皮6重量份、淫羊藿10重量份。
根据本发明较佳实施例,其中,所述原料中,瓜蒌、瞿麦、冬瓜子的质量比为1:1:1;菟丝子与韭菜子的质量比为1:1。瓜蒌、瞿麦、冬瓜子源于经典名方,瓜蒌瞿麦丸和瞿麦汤,瓜蒌为全瓜蒌,质地重,宽胸散结;瞿麦为全草和根,质轻,活血通经;冬瓜子为子实入药,质重,润肺行水。冬瓜子为君药,四居其一;瓜蒌为臣;瞿麦为佐使,均衡用之,瓜蒌、瞿麦、冬瓜子的质量比为1:1:1。菟丝子为下焦臣药,温肾助阳;韭菜子为上焦臣药,养阴润肺,两者均为子实入药,质重,菟丝子与韭菜子的质量比为1:1。
根据本发明较佳实施例,其中,所述贴膏剂基质包括:聚异丁烯10-80%,增粘剂10%,软化剂10-30%,填充剂10%,其中聚异丁烯为小分子量聚异丁烯和大分子量聚异丁烯的混合物;小分子量聚异丁烯占聚异丁烯总重量的20%-50%,大分子量聚异丁烯占聚异丁烯总重量的40%-80%。小分子量聚异丁烯的指常温下呈液态的聚异丁烯,而大分子量聚异丁烯为常温下呈固态的聚异丁烯。
本发明还提供一种固肾缩尿夜尿穴位贴的制备方法,其包括如下步骤:
S1:准备药材
按照以下比例称取药材:乌药9-12重量份、益智仁10-15重量份、补骨脂5-10重量份、菟丝子5-10重量份、瓜蒌3-6重量份、瞿麦3-6重量份、桑螵蛸5-10重量份、去头去脚的蛤蚧30-40重量份、石菖蒲3-6重量份、冬瓜子3-6重量份、韭菜子5-10重量份、牡丹皮3-6重量份和淫羊藿5-10重量份;
S2:制取挥发油
将乌药、瓜蒌、桑螵蛸、石菖蒲、韭菜子、牡丹皮加水润透,使用挥发油智能提取收集分离器的纯蒸汽提取法进行挥发油提取,得混合挥发油A;
S3:制取浸膏粉
将益智仁、补骨脂、菟丝子、瞿麦、淫羊藿、蛤蚧和冬瓜子,加7-12倍质量的75-85%乙醇提取至少2次,浓缩,微波干燥,粉碎,得浸膏粉;
S4:制备微乳液:将混合挥发油A作为油相,按质量比0.8-0.9:0.1-0.3:0.5-0.6:0.6-0.7:17.5-18称取混合挥发油A、吐温80、无水乙醇、单辛酸甘油酯/蔗糖脂肪酸酯、双蒸水,混合、搅拌制成微乳液;
S5:将浸膏粉加水溶解,加入贴膏剂基质及微乳液,搅拌成药膏,涂抹于背衬材料上,制得中药穴位贴。
其中,步骤S5中,水、贴膏剂基质的用量,需要满足达到使药膏可以涂抹并粘着在背衬材料上,且轻微抖动该背衬材料也不会导致药膏脱落或流动的状态。其中步骤S2、S3可颠换顺序或并行,步骤S3、S4可颠换顺序或并行,但步骤S4必须在步骤S2之后。
根据本发明较佳实施例,其中,步骤S3中,加8倍药材质量80%乙醇提取2次,回收乙醇,浓缩,微波干燥,粉碎,得浸膏粉。
根据本发明较佳实施例,其中,步骤S4中,将混合挥发油A作为油相,按质量比0.88:0.22:0.55:0.66:17.75称取混合挥发油A、吐温80、无水乙醇、单辛酸甘油酯/蔗糖脂肪酸酯、双蒸水,混合、搅拌制成微乳液。
根据本发明较佳实施例,其中,步骤S5中,所述贴膏剂基质包括:聚异丁烯10-80%,增粘剂10%,软化剂10-30%,填充剂10%,其中聚异丁烯为小分子量聚异丁烯和大分子量聚异丁烯的混合物;小分子量聚异丁烯占聚异丁烯总重量的20%-50%,大分子量聚异丁烯占聚异丁烯总重量的40%-80%。其中,增粘剂可为天然松香、树胶、松香树脂、烷基酚醛树脂、二甲苯改性树脂。软化剂可为羊毛脂、凡士林、植物油、液状石蜡。填充剂可为氧化锌、碳酸钙、锌钡白等。
分子量在三万以下的聚异丁烯为较低分子量,通常呈液态;在本发明中小分子量聚异丁烯指常温为液态的聚异丁烯,而分子量在三万以上的,为大分子聚异丁烯,材料通常呈固态。
低分子量聚异丁烯(简称低聚异丁烯)为无色、无味、无毒的黏稠物体,低聚异丁烯具有良好的耐热、耐氧、耐臭氧、耐紫外线、耐酸、耐碱等性能,其膨胀系数小,不含电介质、不含任何有害物质。聚异丁烯粘结剂,具有无毒和高透明性,与大分子量聚异丁烯混合使用,可形成能与皮肤直接接触的软膏状粘合剂。
(三)有益效果
(1)本发明的中药穴位贴,其药膏中的药效成分以乌药、益智仁、补骨脂、菟丝子、瓜蒌、瞿麦、桑螵蛸、蛤蚧(去头去脚使用)、石菖蒲、冬瓜子、韭菜子、牡丹皮和淫羊藿药材组合物制成。该组方以乌药、益智仁、蛤蚧、冬瓜子为君药。乌药温肾散寒;益智仁暖肾温脾、固精缩尿;蛤蚧补肺益肾;冬瓜子润肺行水。臣药为瓜蒌、韭菜子、石菖蒲、菟丝子、淫羊藿。由于水道分布于三焦,肺、脾、肾皆相关,上焦配瓜蒌、韭菜子以宽胸散结、养阴润肺;中焦配石菖蒲以化湿开胃;下焦配菟丝子、淫羊藿以温肾助阳、补益肝肾、固精缩尿。佐药为瞿麦、牡丹皮。热药需少佐凉药,故用瞿麦活血通经、用牡丹皮凉血化瘀。使药为补骨脂和桑螵蛸。补骨脂、桑螵蛸转入肾经,走下焦为使药。上述君臣佐使诸药下行,全方合用起到温肾缩尿、通调水道的作用。
(2)本发明的制备方法中,将混合挥发油A用吐温80、无水乙醇等预先搅拌制成微乳液,可有效将混合挥发油A中的各挥发油成分分散均匀,提高药膏成分的均一度,从而有效保证穴位贴的质量和药效的稳定。本发明所制备的固肾缩尿夜尿穴位贴可贴于关元、腰眼等穴位上,具有缓释、长效功能,有效成份可长期作用于患处,有效时间高于常规产品5倍。穴位贴长期使用无副作用和不良反应,具有“精准、独特、速效、天然”的特点,使用方便、可发挥“温肾缩尿、通调水道”的作用、患者依从性好。
附图说明
图1为本发明固肾缩尿夜尿穴位贴的制备方法的流程图。
具体实施方式
为了更好的解释本发明,以便于理解,下面结合附图,通过具体实施方式,对本发明作详细描述。
本发明提供一种固肾缩尿夜尿穴位贴,为贴膏剂基质和药效成分制成的药膏,药效成分采用包含如下药材的原料制成:乌药9-12重量份、益智仁10-15重量份、补骨脂5-10重量份、菟丝子5-10重量份、瓜蒌3-6重量份、瞿麦3-6重量份、桑螵蛸5-10重量份、去头去脚的蛤蚧30-40重量份、石菖蒲3-6重量份、冬瓜子3-6重量份、韭菜子5-10重量份、牡丹皮3-6重量份和淫羊藿5-10重量份。
优选地,所述原料中,各药材的用量为:乌药12重量份、益智仁15重量份、补骨脂10重量份、菟丝子10重量份、瓜蒌6重量份、瞿麦6重量份、桑螵蛸10重量份、去头去脚的蛤蚧35重量份、石菖蒲6重量份、冬瓜子6重量份、韭菜子10重量份、牡丹皮6重量份、淫羊藿10重量份。
优选地,所述原料中,瓜蒌、瞿麦、冬瓜子的质量比为1:1:1;菟丝子与韭菜子的质量比为1:1。
优选地,所述贴膏剂基质包括:聚异丁烯10-80%,增粘剂10%,软化剂10-30%,填充剂10%,其中聚异丁烯为小分子量聚异丁烯和大分子量聚异丁烯的混合物;小分子量聚异丁烯占聚异丁烯总重量的20%-50%,大分子量聚异丁烯占聚异丁烯总重量的40%-80%。贴膏剂基质在穴位贴中主要起到粘接剂的作用,还可将药效成分包裹在贴膏剂基质中,起到密封保护、包被、隔绝水气(防止药效成分变质)的作用。
发明人基于多年对固肾缩尿夜尿的病症研究认为,夜尿增多,关键在肾,肾阳不足,膀胱气化不利,入夜阴盛,阳气更弱,加之肺气不足,水道失调,导致本病发生。
为此,本发明的中药穴位贴设计的处方为:乌药、益智仁、补骨脂、菟丝子、瓜蒌、瞿麦、桑螵蛸、蛤蚧(去头去脚使用)、石菖蒲、冬瓜子、韭菜子、牡丹皮和淫羊藿。
上述组方中,专设四味君药,乌药温肾散寒;益智仁暖肾温脾、固精缩尿;蛤蚧补肺益肾;冬瓜子润肺行水。由于水道分布于三焦,肺、脾、肾皆相关,上焦配瓜蒌、韭菜子以宽胸散结、养阴润肺;中焦配石菖蒲以化湿开胃;下焦配菟丝子、淫羊藿以温肾助阳、补益肝肾、固精缩尿,上述均为臣药。另外,热药需少佐凉药,故用瞿麦活血通经、用牡丹皮凉血化瘀防止患者使用后上火。补骨脂、桑螵蛸转入肾经,走下焦,补骨脂和桑螵蛸为使药,主要为载诸药下行。全方合用起到温肾固肾缩尿、通调水道的作用。
如图1所示,为本发明的固肾缩尿夜尿穴位贴的制备方法,其包括如下步骤:
S1:按照以下比例称取药材:乌药9-12重量份、益智仁10-15重量份、补骨脂5-10重量份、菟丝子5-10重量份、瓜蒌3-6重量份、瞿麦3-6重量份、桑螵蛸5-10重量份、去头去脚的蛤蚧30-40重量份、石菖蒲3-6重量份、冬瓜子3-6重量份、韭菜子5-10重量份、牡丹皮3-6重量份和淫羊藿5-10重量份;
S2:制取挥发油
将乌药、瓜蒌、桑螵蛸、石菖蒲、韭菜子、牡丹皮加水润透,使用挥发油智能提取收集分离器的纯蒸汽提取法进行挥发油提取,得混合挥发油A;
S3:制取浸膏粉
将益智仁、补骨脂、菟丝子、瞿麦、淫羊藿、蛤蚧和冬瓜子,加7-12倍质量的75-85%乙醇提取至少2次,浓缩,微波干燥,粉碎,得浸膏粉;
S4:制备微乳液:将混合挥发油A作为油相,按质量比0.8-0.9:0.1-0.3:0.5-0.6:0.6-0.7:17.5-18称取混合挥发油A、吐温80、无水乙醇、单辛酸甘油酯/蔗糖脂肪酸酯、双蒸水,混合、搅拌制成微乳液;
S5:将浸膏粉加水溶解,加入贴膏剂基质及微乳液,搅拌成药膏,涂抹于背衬材料上,制得中药穴位贴。
以下为本发明的较佳实施例1。
本实施例提供一种固肾缩尿夜尿穴位贴的制备方法,方法过程如下:
(1)按照以下比例称取药材:乌药120克、益智仁150克、补骨脂100克、菟丝子100克、瓜蒌60克、瞿麦60克、桑螵蛸100克、蛤蚧(去头去脚使用)350克、石菖蒲60克、冬瓜子60克、韭菜子100克、牡丹皮60克、淫羊藿100克。
(2)将步骤(1)中的乌药瓜蒌、桑螵蛸、石菖蒲、韭菜子、牡丹皮使用挥发油智能提取收集分离器的纯蒸汽提取法进行挥发油提取,得混合挥发油A。
(3)将益智仁、补骨脂、菟丝子、瞿麦、淫羊藿、蛤蚧、冬瓜子加入提取罐,加8倍药材量80%乙醇提取2次,回收乙醇,浓缩,微波干燥,粉碎,得浸膏粉。
(4)将混合挥发油A作为油相按质量比例0.88:0.22:0.55:0.66:17.75称取混合挥发油A、吐温80、无水乙醇、单辛酸甘油酯、双蒸水,制成微乳液。
(5)将浸膏粉加水溶解后加入贴膏剂基质及挥发油微乳,调拌合成药膏,将其涂抹于背衬材料上。水、贴膏剂基质的用量,需要满足达到使药膏可以涂抹并粘着在背衬材料上,且轻微抖动该背衬材料也不会导致药膏脱落或流动的状态。
穴位贴贴膏剂包括:聚异丁烯50%,增粘剂(天然松香)10%,软化剂(羊毛脂)30%,填充剂(锌钡白)10%,其中聚异丁烯为小分子量和大分子量的聚异丁烯的混合物。小分子量的聚异丁烯占聚异丁烯总重量的50%,大分子量的聚异丁烯占聚异丁烯总重量的50%。
(一)临床用药试验方案
1、一般资料
江西中医药大学附属医院门诊及住院部符合标准的120例夜尿症患者。按照随机数字表法,分为两组,试验组60例。对照组60例。两组年龄、性别、病程、积分等具有可比性。
2、诊断标准
西医诊断标准参照国际尿控学会发布的术语报告及制定:夜晚睡眠中因尿意感而醒来排尿次数次中医辨证标准(参照《24专业105病种中医诊疗方案(试行》
肾气亏虚证:尿频或夜尿频数,尿后有余浙或失禁,腰脊酸痛,腔酸膝软或足跟痛,下腹部或尿道下坠感,耳鸣或耳聲,发脱或齿摇,头晕目弦,舌淡,或边有齿印,苔白,脉沉细弱。
中气下陷证:尿频、尿急,劳累则发,下腹部或尿道下坠感,或直肠坠胀感,纳少,便溏,声低气怯,四肢欠温,神疲乏力,舌淡红,边有齿印,苔薄白,脉细弱。
3、纳入标准:符合诊断标准;年龄在50岁以上,性别不限;患夜尿症月以上者;有尿意且能控制排尿者;自愿参加本临床观察,并且签署知情同意书;能够服从医生的治疗安排,能够配合医生的治疗和随访。
4、排除标准:尿常规或尿细菌培养阳性,且伴有尿急、尿痛等症状、泌尿系感染者;尿失禁或留置尿管者;肾炎、肾细胞癌、输尿管结石、膀胱癌等泌尿系器质性病变者;合并心脑血管、肝、肾、造血系统、内分泌系统等严重原发性疾病及智能障碍患者;手术后、肿瘤、血压、血糖不稳定患者;近周内使用对本研究有干扰因素的药物,如利尿剂等或因夜尿症正在接受药物或非药物治疗者。
5、干预措施
使用本发明实施例1的穴位贴,每天1次/贴(每片含水凝胶贴膏的重量为5g、敷贴半径1.5cm),选择穴位:关元、腰眼。贴敷时间为3h以上。2周为一个疗程。连续贴1个疗程。
对照组患者行为控制和利尿剂、去氨加压素等药物治疗,连服2周。
6、疗效指标
夜尿次数:对比治疗前、后天夜尿次数平均值,计算夜尿次数变化的百分比。
夜尿对生活质量影响的调查问卷(NQOL):量表分为3个部分,分别为精力与睡眠0-28分、困扰与关注0-20分、自评0-4分。总分最高为52分,分数越高代表生活质量越高。
匹兹堡睡眠质量指数量表(PSQI):量表由19个自评和5个他评条目组成,其中第19个自评项目及其下属17个他评条目不参与计分,本课题未予纳入研究。本研究仅介绍参与计分的17个条目。17个计分条目分成7个成分,包括睡眠质量、入睡时间、睡眠时间、睡眠效率、睡眠障碍、催眠药物、日间功能障碍,每个成分按分等级计分,各成分累积得分为匹兹堡睡眠质量量表的总分。最低分为0分,最高分为3分,得分越高,说明睡眠情况越差。
7、统计分析
所有分析经SPSS20.0统计软件进行统计,计量资料采用均数±标准差表示;组间比较采用两独立样本t检验;组内样本采用配对t检验;计数资料采用例数或百分数表示,组间比较用X2检验;等级资料用Ridit分析。P≤0.05作为有显著性统计学意义,以P≤0.01作为有非常显著性统计学意义。
(二)试验结果
1、基线资料比较
如表1,试验组患者中最大年龄81岁,最小年龄52岁,平均61.20±8.50岁。对照组患者中最大年龄80岁,最小年龄50岁,平均62.11±7.45岁。两组平均年龄经t检验显示没有统计学意义(P>0.05)。这说明,两组患者年龄具有可比性。
表1两组年龄分布比较
如表2,试验组患者中最长病程29年,最短病程5年,平均病程12.33±3.12年。对照组患者中最长病程27年,最短病程6年,平均病程11.29±4.19年。两组平均病程经t检验显示没有统计学意义(P>0.05)。这说明,两组患者病程具有可比性。
表2两组病程分布比较
如表3,本次研究纳入患者,男性共44例,女性共76例。表3显示,试验组男性23例,占38.33%;女性37例,占61.67%。对照组男性21例,占35.00%;女性39例,占65.00%。经χ2检验,P>0.05。两组患者性别比例没有统计学意义(P>0.05)。这说明两组患者性别具有可比性。
表3两组患者性别比例比较
如表4,本次研究纳入患者,轻度共53例,中度共30例,重度37例。表4显示,试验组轻度26例,占42.33%;中度14例,占23.33%;重度20例,占33.33%。对照组轻度27例,占45.00%;中度16例,占26.67%;重度17例,占28.33%。经χ2检验,P>0.05。两组患者病情严重程度没有统计学意义(P>0.05)。这说明两组患者病情具有可比性。
表4两组患者病情严重程度比较
2、治疗结果比较
表5显示,与治疗前3.79±1.55比较,治疗后试验组夜尿次数为1.48±0.80有统计学意义(P﹤0.01)。与治疗前3.60±1.22比较,对照组夜尿次数为2.30±0.62有统计学意义(P﹤0.01)。治疗后比较,两组间比较没有统计学意义(P>0.05)。这说明与对照组比较,试验组在减少夜尿次数方面疗效相当。
注:△与治疗前比较P﹤0.05;△△与治疗前比较P﹤0.01;▲与对照组比较P﹤0.05;▲▲与对照组比较P﹤0.01。
表6显示,与治疗前23.15±5.3比较,治疗后试验组生活质量NQOL为32.80±4.38有统计学意义(P﹤0.01)。与治疗前24.20±4.18比较,对照组生活质量NQOL为29.76±3.21有统计学意义(P﹤0.01)。治疗后比较,两组间比较没有统计学意义(P>0.05)。这说明与对照组比较,试验组在改善生活质量方面疗效相当。
注:△与治疗前比较P﹤0.05;△△与治疗前比较P﹤0.01;▲与对照组比较P﹤0.05;▲▲与对照组比较P﹤0.01。
表7显示,与治疗前10.33±2.19比较,治疗后试验组睡眠质量PSQI为7.22±2.18有统计学意义(P﹤0.01)。与治疗前11.31±3.10比较,对照组睡眠质量PSQI为8.21±3.20有统计学意义(P﹤0.01)。治疗后比较,两组间比较没有统计学意义(P>0.05)。这说明与对照组比较,试验组在改善睡眠质量方面疗效相当。
注:△与治疗前比较P﹤0.05;△△与治疗前比较P﹤0.01;▲与对照组比较P﹤0.05;▲▲与对照组比较P﹤0.01。
3、安全性评价
表8两组不良反应率的比较
表9不良反应病例的详细情况
由表8可见,试验过程中,试验组2例出现不良反应,对照组7例出现不良反应,两组不良反应率分别为5%,11.67%,试验组不良反应少于对照组。由表9可见,治疗组、对照组出现的不良反应具体症状及相关处理、结局。
两组患者在治疗前后血、尿、大便常规检查,肝、肾功能、心电图检查以评价药物的安全性。结果:均未发现治疗前正常,治疗后异常的结果,表明该药物安全。
Claims (8)
1.一种固肾缩尿夜尿穴位贴,其特征在于,为贴膏剂基质和药效成分组成的药膏,所述药效成分由如下药材的原料制成:
乌药9-12重量份、益智仁10-15重量份、补骨脂5-10重量份、菟丝子5-10重量份、瓜蒌3-6重量份、瞿麦3-6重量份、桑螵蛸5-10重量份、去头去脚的蛤蚧30-40重量份、石菖蒲3-6重量份、冬瓜子3-6重量份、韭菜子5-10重量份、牡丹皮3-6重量份和淫羊藿5-10重量份;
其中,瓜蒌、瞿麦、冬瓜子的质量比为1:1:1;菟丝子与韭菜子的质量比为1:1。
2.根据权利要求1所述的一种固肾缩尿夜尿穴位贴,其特征在于,所述原料中,各药材的用量为:乌药12重量份、益智仁15重量份、补骨脂10重量份、菟丝子10重量份、瓜蒌6重量份、瞿麦6重量份、桑螵蛸10重量份、去头去脚的蛤蚧35重量份、石菖蒲6重量份、冬瓜子6重量份、韭菜子10重量份、牡丹皮6重量份、淫羊藿10重量份。
3.根据权利要求1所述的一种固肾缩尿夜尿穴位贴,其特征在于,所述贴膏剂基质包括:聚异丁烯50%,增粘剂 10%,软化剂30%,填充剂10%,其中聚异丁烯为小分子量聚异丁烯和大分子量聚异丁烯的混合物;小分子量聚异丁烯占聚异丁烯总重量的50%,大分子量聚异丁烯占聚异丁烯总重量的50%。
4.一种固肾缩尿夜尿穴位贴的制备方法,其包括如下步骤:
S1:准备药材
按照以下比例称取药材:乌药9-12重量份、益智仁10-15重量份、补骨脂5-10重量份、菟丝子5-10重量份、瓜蒌3-6重量份、瞿麦3-6重量份、桑螵蛸5-10重量份、去头去脚的蛤蚧30-40重量份、石菖蒲3-6重量份、冬瓜子3-6重量份、韭菜子5-10重量份、牡丹皮3-6重量份和淫羊藿5-10重量份;其中,瓜蒌、瞿麦、冬瓜子的质量比为1:1:1;菟丝子与韭菜子的质量比为1:1;
S2:制取挥发油
将乌药、瓜蒌、桑螵蛸、石菖蒲、韭菜子、牡丹皮加水润透,使用挥发油智能提取收集分离器的纯蒸汽提取法进行挥发油提取,得混合挥发油A;
S3:制取浸膏粉
将益智仁、补骨脂、菟丝子、瞿麦、淫羊藿、蛤蚧和冬瓜子,加7-12倍质量的75-85%乙醇提取至少2次,浓缩,微波干燥,粉碎,得浸膏粉;
S4:制备微乳液:将混合挥发油A作为油相,按质量比0.8-0.9:0.1-0.3:0.5-0.6:0.6-0.7:17.5-18称取混合挥发油A、吐温80、无水乙醇、单辛酸甘油酯/蔗糖脂肪酸酯、双蒸水,混合、搅拌制成微乳液;
S5: 将浸膏粉加水溶解,加入贴膏剂基质及微乳液,搅拌成药膏,涂抹于背衬材料上,制得中药穴位贴。
5.根据权利要求4所述的制备方法,步骤S5中,水、贴膏剂基质的用量,需要满足达到使药膏可以涂抹并粘着在背衬材料上,且轻微抖动该背衬材料也不会导致药膏脱落或流动的状态。
6.根据权利要求4所述的制备方法,步骤S3中,加8倍药材质量80%乙醇提取2次,回收乙醇,浓缩,微波干燥,粉碎,得浸膏粉。
7.根据权利要求4所述的制备方法,步骤S4中,将混合挥发油A作为油相,按质量比0.88:0.22:0.55:0.66:17.75称取混合挥发油A、吐温80、无水乙醇、单辛酸甘油酯/蔗糖脂肪酸酯、双蒸水,混合、搅拌制成微乳液。
8.根据权利要求4所述的制备方法,步骤S5中,所述贴膏剂基质包括:聚异丁烯50%,增粘剂 10%,软化剂30%,填充剂10%,其中聚异丁烯为小分子量聚异丁烯和大分子量聚异丁烯的混合物;小分子量聚异丁烯占聚异丁烯总重量的50%,大分子量聚异丁烯占聚异丁烯总重量的50%。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202011046509.1A CN112057576B (zh) | 2020-09-29 | 2020-09-29 | 一种固肾缩尿夜尿穴位贴及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202011046509.1A CN112057576B (zh) | 2020-09-29 | 2020-09-29 | 一种固肾缩尿夜尿穴位贴及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN112057576A CN112057576A (zh) | 2020-12-11 |
CN112057576B true CN112057576B (zh) | 2022-04-05 |
Family
ID=73683064
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202011046509.1A Active CN112057576B (zh) | 2020-09-29 | 2020-09-29 | 一种固肾缩尿夜尿穴位贴及其制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN112057576B (zh) |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110624029A (zh) * | 2019-11-19 | 2019-12-31 | 江西中医药大学 | 一种解郁宁心安神中药组合物及外用贴剂的制备方法 |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108619295A (zh) * | 2018-06-23 | 2018-10-09 | 徐州市孕美汇生物科技有限公司 | 一种调理小儿遗尿的保健药贴及其加工方法 |
-
2020
- 2020-09-29 CN CN202011046509.1A patent/CN112057576B/zh active Active
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110624029A (zh) * | 2019-11-19 | 2019-12-31 | 江西中医药大学 | 一种解郁宁心安神中药组合物及外用贴剂的制备方法 |
Non-Patent Citations (2)
Title |
---|
中药治疗小儿功能性遗尿症57例;朱云群等;《现代医药卫生》;20040215(第02期);第126页第2、4节 * |
调理夜尿用乌药?-问答频道-博禾医生;佚名;《http://www.bone.cn/ask/view/103339762.html》;20180913;第1-2页 * |
Also Published As
Publication number | Publication date |
---|---|
CN112057576A (zh) | 2020-12-11 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN103169928B (zh) | 治疗痛经的外用中药组合物及其制备方法和应用 | |
CN102988702B (zh) | 一种前列腺切除术术后敷脐护理剂 | |
CN105055849A (zh) | 滋阴养肾的中药提取物及其制备方法和应用 | |
CN104606347A (zh) | 一种治疗肝肾阴虚型绝经后骨质疏松症的中药制剂 | |
CN1814121A (zh) | 一种治疗椎间盘突出、颈椎病的药物 | |
CN112057576B (zh) | 一种固肾缩尿夜尿穴位贴及其制备方法 | |
CN108815488B (zh) | 治疗痛经的复方精油制剂及其制备方法和使用方法 | |
CN105497537A (zh) | 一种具有美白嫩肤作用的药物组合物及其制备方法 | |
CN102406799A (zh) | 治疗糖尿病高血压并发冠心病的巴布膏及其制备方法 | |
CN101897933A (zh) | 一种治疗白癜风的中成药 | |
CN100515462C (zh) | 治疗心、脑血栓性疾病的中药及制备方法 | |
CN110721229A (zh) | 一种治疗乳腺增生的配方精油 | |
CN105497824A (zh) | 一种治疗跟痛症的中药组合物 | |
CN105232888A (zh) | 一种治疗血液透析后皮肤瘙痒症的中药组合物 | |
CN111658716A (zh) | 一种水凝胶磁疗中药贴膏及其制备方法 | |
CN100998660B (zh) | 治疗椎动脉型颈椎病中药贴及其制备方法 | |
CN1286515C (zh) | 一种治疗囊肿的药物组合物 | |
CN112023015B (zh) | 一种止痛穴位贴及其制备方法 | |
CN117442659B (zh) | 一种补肾理脾舒肝组合物及其制备方法和应用 | |
CN117018158B (zh) | 一种石墨烯暖宫止痛穴位贴及其制备方法和应用 | |
CN101095759B (zh) | 一种抹肚脐治疗便秘的药物 | |
CN100478007C (zh) | 跌打风湿增生膏及其制备方法 | |
CN1130207C (zh) | 骨伤膏及其制作方法 | |
CN105250512A (zh) | 一种治疗剖宫产术后腹部切口硬结的中药软膏 | |
CN118634306A (zh) | 一种用于制备副作用降低的三伏贴的中药组合物及其应用 |
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 |