CN104510854A - 一种治疗妇女痛经的中药组合物及其用途 - Google Patents
一种治疗妇女痛经的中药组合物及其用途 Download PDFInfo
- Publication number
- CN104510854A CN104510854A CN201410782657.8A CN201410782657A CN104510854A CN 104510854 A CN104510854 A CN 104510854A CN 201410782657 A CN201410782657 A CN 201410782657A CN 104510854 A CN104510854 A CN 104510854A
- Authority
- CN
- China
- Prior art keywords
- traditional chinese
- chinese medicinal
- parts
- medicinal composition
- chinese medicine
- 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.)
- Granted
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 38
- 206010013935 Dysmenorrhoea Diseases 0.000 title abstract description 11
- 208000005171 Dysmenorrhea Diseases 0.000 title abstract description 8
- 239000003814 drug Substances 0.000 claims abstract description 49
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 24
- 238000002360 preparation method Methods 0.000 claims abstract description 24
- 239000012141 concentrate Substances 0.000 claims abstract description 8
- 239000007788 liquid Substances 0.000 claims abstract description 6
- 241000218176 Corydalis Species 0.000 claims abstract description 4
- 239000003480 eluent Substances 0.000 claims abstract description 4
- 239000011347 resin Substances 0.000 claims abstract description 4
- 229920005989 resin Polymers 0.000 claims abstract description 4
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 9
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 8
- 239000002671 adjuvant Substances 0.000 claims description 7
- 229920002472 Starch Polymers 0.000 claims description 6
- 238000009472 formulation Methods 0.000 claims description 6
- 239000008107 starch Substances 0.000 claims description 6
- 235000019698 starch Nutrition 0.000 claims description 6
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 5
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 5
- 239000000284 extract Substances 0.000 claims description 5
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 5
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 5
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 5
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 5
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 5
- 239000002202 Polyethylene glycol Substances 0.000 claims description 4
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 4
- 235000019359 magnesium stearate Nutrition 0.000 claims description 4
- 229920001223 polyethylene glycol Polymers 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- 229920000881 Modified starch Polymers 0.000 claims description 3
- 230000000274 adsorptive effect Effects 0.000 claims description 3
- 229940126678 chinese medicines Drugs 0.000 claims description 3
- 238000004132 cross linking Methods 0.000 claims description 3
- 238000010828 elution Methods 0.000 claims description 3
- 239000012567 medical material Substances 0.000 claims description 3
- 239000000843 powder Substances 0.000 claims description 3
- 238000001556 precipitation Methods 0.000 claims description 3
- 238000004064 recycling Methods 0.000 claims description 3
- 238000000926 separation method Methods 0.000 claims description 3
- 239000002002 slurry Substances 0.000 claims description 3
- 239000006228 supernatant Substances 0.000 claims description 3
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 2
- 108010011485 Aspartame Proteins 0.000 claims description 2
- 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 claims description 2
- 239000001856 Ethyl cellulose Substances 0.000 claims description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 2
- 229930195725 Mannitol Natural products 0.000 claims description 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 2
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims description 2
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 2
- 239000004141 Sodium laurylsulphate Substances 0.000 claims description 2
- 229920002125 Sokalan® Polymers 0.000 claims description 2
- 239000000605 aspartame Substances 0.000 claims description 2
- 235000010357 aspartame Nutrition 0.000 claims description 2
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 2
- 229960003438 aspartame Drugs 0.000 claims description 2
- 229960001631 carbomer Drugs 0.000 claims description 2
- 229940084030 carboxymethylcellulose calcium Drugs 0.000 claims description 2
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 2
- 239000002702 enteric coating Substances 0.000 claims description 2
- 238000009505 enteric coating Methods 0.000 claims description 2
- 229920001249 ethyl cellulose Polymers 0.000 claims description 2
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 2
- -1 hydroxypropyl Chemical group 0.000 claims description 2
- 239000008101 lactose Substances 0.000 claims description 2
- XMGQYMWWDOXHJM-UHFFFAOYSA-N limonene Chemical compound CC(=C)C1CCC(C)=CC1 XMGQYMWWDOXHJM-UHFFFAOYSA-N 0.000 claims description 2
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 2
- 239000000594 mannitol Substances 0.000 claims description 2
- 235000010355 mannitol Nutrition 0.000 claims description 2
- 229920000609 methyl cellulose Polymers 0.000 claims description 2
- 239000001923 methylcellulose Substances 0.000 claims description 2
- 235000010981 methylcellulose Nutrition 0.000 claims description 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 2
- 239000007968 orange flavor Substances 0.000 claims description 2
- 239000000741 silica gel Substances 0.000 claims description 2
- 229910002027 silica gel Inorganic materials 0.000 claims description 2
- 229910000029 sodium carbonate Inorganic materials 0.000 claims description 2
- 235000017550 sodium carbonate Nutrition 0.000 claims description 2
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 12
- 239000013543 active substance Substances 0.000 abstract description 3
- 239000000463 material Substances 0.000 abstract description 2
- 235000017276 Salvia Nutrition 0.000 abstract 1
- 240000007164 Salvia officinalis Species 0.000 abstract 1
- 241000301400 Trogopterus Species 0.000 abstract 1
- 240000001398 Typha domingensis Species 0.000 abstract 1
- 238000010521 absorption reaction Methods 0.000 abstract 1
- 210000003608 fece Anatomy 0.000 abstract 1
- 239000000178 monomer Substances 0.000 abstract 1
- 230000001376 precipitating effect Effects 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
- 229940079593 drug Drugs 0.000 description 9
- 239000008187 granular material Substances 0.000 description 7
- 230000000052 comparative effect Effects 0.000 description 6
- 239000000243 solution Substances 0.000 description 5
- 241000700159 Rattus Species 0.000 description 4
- 230000005180 public health Effects 0.000 description 4
- 210000004291 uterus Anatomy 0.000 description 4
- 208000036029 Uterine contractions during pregnancy Diseases 0.000 description 3
- 239000002775 capsule Substances 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 230000003203 everyday effect Effects 0.000 description 3
- 238000003304 gavage Methods 0.000 description 3
- 239000006187 pill Substances 0.000 description 3
- 239000003826 tablet Substances 0.000 description 3
- PAFLSMZLRSPALU-MRVPVSSYSA-N (2R)-3-(3,4-dihydroxyphenyl)lactic acid Chemical compound OC(=O)[C@H](O)CC1=CC=C(O)C(O)=C1 PAFLSMZLRSPALU-MRVPVSSYSA-N 0.000 description 2
- WCGUUGGRBIKTOS-GPOJBZKASA-N (3beta)-3-hydroxyurs-12-en-28-oic acid Chemical compound C1C[C@H](O)C(C)(C)[C@@H]2CC[C@@]3(C)[C@]4(C)CC[C@@]5(C(O)=O)CC[C@@H](C)[C@H](C)[C@H]5C4=CC[C@@H]3[C@]21C WCGUUGGRBIKTOS-GPOJBZKASA-N 0.000 description 2
- VOXZDWNPVJITMN-ZBRFXRBCSA-N 17β-estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 VOXZDWNPVJITMN-ZBRFXRBCSA-N 0.000 description 2
- PAFLSMZLRSPALU-QMMMGPOBSA-N Danshensu Natural products OC(=O)[C@@H](O)CC1=CC=C(O)C(O)=C1 PAFLSMZLRSPALU-QMMMGPOBSA-N 0.000 description 2
- QHLKSZBFIJJREC-SPSUIZEHSA-N Isorhamnetin-3-O-nehesperidine Chemical compound C1=C(O)C(OC)=CC(C2=C(C(=O)C3=C(O)C=C(O)C=C3O2)O[C@H]2[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O2)O[C@H]2[C@@H]([C@H](O)[C@@H](O)[C@H](C)O2)O)=C1 QHLKSZBFIJJREC-SPSUIZEHSA-N 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 241000699670 Mus sp. Species 0.000 description 2
- 208000002193 Pain Diseases 0.000 description 2
- PAFLSMZLRSPALU-UHFFFAOYSA-N Salvianic acid A Natural products OC(=O)C(O)CC1=CC=C(O)C(O)=C1 PAFLSMZLRSPALU-UHFFFAOYSA-N 0.000 description 2
- AEQDJSLRWYMAQI-UHFFFAOYSA-N Tetrahydropalmatine Natural products C1CN2CC(C(=C(OC)C=C3)OC)=C3CC2C2=C1C=C(OC)C(OC)=C2 AEQDJSLRWYMAQI-UHFFFAOYSA-N 0.000 description 2
- 230000037396 body weight Effects 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 229960005309 estradiol Drugs 0.000 description 2
- 229930182833 estradiol Natural products 0.000 description 2
- 238000011049 filling Methods 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 230000036407 pain Effects 0.000 description 2
- 230000003285 pharmacodynamic effect Effects 0.000 description 2
- 150000003180 prostaglandins Chemical class 0.000 description 2
- 239000007779 soft material Substances 0.000 description 2
- 230000001629 suppression Effects 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- AEQDJSLRWYMAQI-KRWDZBQOSA-N tetrahydropalmatine Chemical compound C1CN2CC(C(=C(OC)C=C3)OC)=C3C[C@H]2C2=C1C=C(OC)C(OC)=C2 AEQDJSLRWYMAQI-KRWDZBQOSA-N 0.000 description 2
- 229940096998 ursolic acid Drugs 0.000 description 2
- PLSAJKYPRJGMHO-UHFFFAOYSA-N ursolic acid Natural products CC1CCC2(CCC3(C)C(C=CC4C5(C)CCC(O)C(C)(C)C5CCC34C)C2C1C)C(=O)O PLSAJKYPRJGMHO-UHFFFAOYSA-N 0.000 description 2
- 206010002091 Anaesthesia Diseases 0.000 description 1
- 206010009866 Cold sweat Diseases 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 206010028813 Nausea Diseases 0.000 description 1
- XNOPRXBHLZRZKH-UHFFFAOYSA-N Oxytocin Natural products N1C(=O)C(N)CSSCC(C(=O)N2C(CCC2)C(=O)NC(CC(C)C)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(CCC(N)=O)NC(=O)C(C(C)CC)NC(=O)C1CC1=CC=C(O)C=C1 XNOPRXBHLZRZKH-UHFFFAOYSA-N 0.000 description 1
- 101800000989 Oxytocin Proteins 0.000 description 1
- 102100031951 Oxytocin-neurophysin 1 Human genes 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 210000001015 abdomen Anatomy 0.000 description 1
- 230000037005 anaesthesia Effects 0.000 description 1
- 230000008827 biological function Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000000812 cholinergic antagonist Substances 0.000 description 1
- 210000002808 connective tissue Anatomy 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 239000007919 dispersible tablet Substances 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000002357 endometrial effect Effects 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 210000004392 genitalia Anatomy 0.000 description 1
- 239000000745 gonadal hormone Substances 0.000 description 1
- 235000008216 herbs Nutrition 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000000366 juvenile effect Effects 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 230000003821 menstrual periods Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000008693 nausea Effects 0.000 description 1
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 description 1
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- XNOPRXBHLZRZKH-DSZYJQQASA-N oxytocin Chemical compound C([C@H]1C(=O)N[C@H](C(N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CSSC[C@H](N)C(=O)N1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)=O)[C@@H](C)CC)C1=CC=C(O)C=C1 XNOPRXBHLZRZKH-DSZYJQQASA-N 0.000 description 1
- 229960001723 oxytocin Drugs 0.000 description 1
- 230000003950 pathogenic mechanism Effects 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 239000002089 prostaglandin antagonist Substances 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 230000011664 signaling Effects 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 230000002048 spasmolytic effect Effects 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 238000010254 subcutaneous injection Methods 0.000 description 1
- 239000007929 subcutaneous injection Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 230000003191 uterotonic effect Effects 0.000 description 1
- 230000008673 vomiting Effects 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)
- A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
-
- 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
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/24—Mucus; Mucous glands; Bursa; Synovial fluid; Arthral fluid; Excreta; Spinal fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
-
- 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
- A61K2236/55—Liquid-liquid separation; Phase separation
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Alternative & Traditional Medicine (AREA)
- Biomedical Technology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Neurology (AREA)
- Cell Biology (AREA)
- Developmental Biology & Embryology (AREA)
- Immunology (AREA)
- Virology (AREA)
- Zoology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
Abstract
本发明涉及一种治疗妇女原发性痛经的中药组合物及其用途。其由10份的延胡索、10份的丹参、10份的五灵脂和10份的蒲黄制成,其制备方法如下:(1)取上述四味中药粉碎,加入总药材10倍量的水80℃提取二次,合并提取液减压浓缩得浓缩液;(2)取步骤(1)得到的浓缩液加入乙醇,使乙醇的浓度达到90%,放置沉淀,分离上清液,浓缩,得浓缩物;(3)取步骤(2)得到的浓缩物上大孔吸附树脂柱D101,用浓度50%的乙醇梯度洗脱,洗脱液回收溶剂,得中药组合物。本发明的中药有效部位组合物具有有效物质明确、疗效确切,副作用小、服用方便等优点。
Description
技术领域
本发明属于中药领域,具体涉及一种治疗妇女原发性痛经的中药组合物及其用途。
背景技术
痛经是指女性在经期或其前后出现周期性下腹疼痛为主证,伴有其它不适,以致影响工作及生活的妇科疾病。我国女性痛经发病率为33.19%,为妇科的常见病和多发病。痛经分为原发性和继发性两类,原发性痛经是指生殖器无器质性病变的痛经,多发于青少年期。其病理机制可能与子宫内膜的前列腺素有关,痛经患者子宫内膜及血中前列腺素含量高于正常妇女。痛经时常伴发恶心、呕吐、腹泻、头晕、乏力等症状,严重者可有面色苍白、出冷汗,严重影响了患者的工作和生活质量,必须积极治疗。但目前对原发性痛经的治疗,多采用非甾体抗炎镇痛药、性激素、止痛解痉药、前列腺素抑制剂治疗,临床效果不明显,对患者有一定的毒副作用。但用中药治疗往往会收到良好的效果。
妇女痛经丸为《中华人民共和国卫生部药品标准》中药成方制剂第一册收载,药物组成为延胡索、五灵脂、丹参和蒲黄,功效活血行气,调经止痛,要少而力专,疗效肯定。但本品为浓缩丸,服用剂量偏大,一次需服用50粒。专利CN1548125公开了一种妇女痛经丸的改进剂型,其通过将丸剂改制成颗粒剂,一定程度上减少了用药量,提高了疗效。但目前治疗妇科疾病的复方药物多存在使用不便、用药量大、成分复杂、有效部位不明确,复方中起疗效的物质基础不清楚,并存在一定的不良反应等问题,因此很有必要在中医药理论的指导下开发出一种有效物质明确、疗效确切,副作用小、服用方便的治疗妇科疾病的药物。
发明内容
本发明的一个目的是提供一种治疗妇女痛经的中药组合物,其由10份的延胡索、10份的的丹参、10份的的五灵脂和10份的的蒲黄制成,其制备方法如下:
(1)取上述四味中药粉碎,加入总药材10倍量的水80℃提取二次,合并提取液减压浓缩得浓缩液;
(2)取步骤(1)得到的浓缩液加入乙醇,使乙醇的浓度达到90%,放置沉淀,分离上清液,浓缩,得浓缩物;
(3)取步骤(2)得到的浓缩物上大孔吸附树脂柱D101,用浓度50%的乙醇梯度洗脱,洗脱液回收溶剂,得中药组合物。
所述的中药组合物中包含有不低于5.5%的丹参素;5.5%的异鼠李素-3-O-新橙皮苷;2.5%的延胡索乙素;2.5%的熊果酸。
本发明的另一个目的是提供一种含有所述中药组合物的药物制剂,本发明中药组合物可以根据需要和药学上可接受的辅料制备成合适的药物制剂用于妇女痛经的治疗,如口服制剂、注射制剂等。
所述药物制剂优选为口服制剂,所述口服制剂选自片剂、胶囊、缓释片剂、丸剂、颗粒剂、分散片、散剂。所述口服制剂所选用的辅料选自淀粉、预胶化淀粉、淀粉浆、β-环糊精、卡波姆、微晶纤维素、羟丙基甲基纤维素、低取代羟丙基纤维素、羧甲基纤维素钙、聚乙二醇(PEG)、羧甲基纤维素钠、甲基纤维素、乙基纤维素、甘露醇、十二烷基硫酸钠、交联羧甲基纤维素钠、乳糖、聚乙烯吡咯烷酮(PVP)、交联聚乙烯吡咯烷酮、硬脂酸镁、滑石粉、微粉硅胶、阿斯巴甜、甜橙香精、碳酸氢钠、碳酸钠、肠溶包衣粉中的一种或几种。上述制剂的所用辅料及制备方法均可采用其常规的辅料和制备方法制得。
本发明还提供所述中药组合物的用途,即该中药组合物在制备治疗妇女痛经中的应用。所述的医药用途中,根据动物病情以及用药部位可以将上述药物组合物制备成合适的药物制剂以方便用药,这在本领域技术人员掌握的技术范围之内。例如,将对小鼠痛经的治疗方案应用于人身上,所有药物对人的有效剂量可以通过该药物对小鼠的有效剂量进行换算,这对于本领域的普通技术人员来说是显而易见的。
采用上述技术方案后,本发明的中药组合物具有有效物质明确、疗效确切,副作用小、服用方便等优点。
具体实施方式
下面将进一步的详细说明来举例说明本发明。需要指出的是,以下说明仅仅是对本发明要求保护的技术方案的举例说明,并非对这些技术方案的任何限制。本发明的保护范围以所附权利要求书记载的内容为准。
实施例1中药组合物的制备
(1)取上述四味中药各100g粉碎,加入总药材10倍量的水80℃提取二次,合并提取液减压浓缩得浓缩液;
(2)取步骤(1)得到的浓缩液加入乙醇,使乙醇的浓度达到90%,放置沉淀,分离上清液,浓缩,得浓缩物;
(3)取步骤(2)得到的浓缩物上大孔吸附树脂柱D101,用浓度50%的乙醇梯度洗脱,洗脱液回收溶剂,得中药组合物33.7g(得率8.4%)。
经HPLC检测,获得的中药组合物中含有7.9%的丹参素;6.2%的异鼠李素-3-O-新橙皮苷;3.1%的延胡索乙素;5.5%的熊果酸。
实施例2实施例1制备的中药组合物的药效学试验(1)
取未孕雌性SD大鼠,麻醉后剖腹取出子宫,剥离子宫壁上的脂肪和结缔组织后,将子宫置于盛有Loke’s液的离体器官仪中(通5%O2,95%CO2),一端固定,另一端固定在张力换能器上,通过生物机能信号系统记录收缩曲线,稳定后加入终浓度1μM/L的PGF2α引起子宫收缩,稳定后,加入不同浓度药物(对照组加入等量Loke’s液),记录子宫的舒张情况(子宫收缩抑制率)。
子宫收缩抑制率=(给药前收缩幅度-给药后收缩幅度)/给药前收缩幅度×100%
对比例1:药物为妇女痛经丸,制备方法参见《中华人民共和国卫生部药品标准》中药成方制剂第一册。
对比例2:药物为妇女痛经颗粒,制备方法参见专利CN1548125。
具体结果如下:
各组组合物在不同终浓度抑制子宫收缩的情况(n=8)
实施例3实施例1制备的中药组合物的药效学试验(2)
取SD雌性大白鼠,体重200-250g,按体重分层,然后按完全随机分组,每组12只。除正常组外,其余各组大鼠连续皮下注射雌二醇10d(第1天,第10天两天皮下给予0.5mg/(只·d),余者均予0.2mg/(只·d))。各组均从第10天给雌二醇当日开始给药(实施例2-6的剂量为100mg/kg,以生药量计约为12g/kg),每天灌胃1次,连续3d。除正常组、病理模型组每天灌予相应体积冷开水外,其余各组每天灌胃相应药物。给药第3天,各组大鼠最后1次灌胃45min后,每只动物腹腔注射催产素2U/只。
对比例1:药物为妇女痛经丸,制备方法参见《中华人民共和国卫生部药品标准》中药 成方制剂第一册,剂量为100mg/kg。
对比例2:药物为妇女痛经颗粒,制备方法参见专利CN1548125,剂量为100mg/kg。
对比例3:药物为妇女痛经丸,制备方法参见《中华人民共和国卫生部药品标准》中药成方制剂第一册,剂量以生药量计为12g/kg。
对比例4:药物为妇女痛经颗粒,制备方法参见专利CN1548125,剂量以生药量计为12g/kg。
具体结果如下:
实施例4片剂
处方
制备工艺:将四种中药提取物混合均匀,与预胶化淀粉和交联羧甲基纤维钠充分混合,10%淀粉浆制软材,18目筛制粒,60℃下干燥,16目筛整粒,加入硬脂酸镁,混匀,压片。
实施例5胶囊剂
处方
制备工艺:将四种中药提取物和辅料分别过80目筛,与淀粉和交联羧甲基纤维素钠充分混合,7%PVP溶液制软材,18目筛制粒,60℃下干燥,16目筛整粒,加入硬脂酸镁,混匀,灌胶囊。
本发明内容仅仅举例说明了要求保护的一些具体实施方案,其中一个或更多个技术方案中所记载的技术特征可以与任意的一个或多个技术方案相组合,这些经组合而得到的技术方案也在本申请保护范围内,就像这些经组合而得到的技术方案已经在本发明公开内容中具体记载一样。
Claims (5)
1.一种治疗妇女痛经的中药组合物,其特征在于,其由10份的延胡索、10份的的丹参、10份的的五灵脂和10份的的蒲黄制成,其制备方法如下:
(1)取上述四味中药粉碎,加入总药材10倍量的水80℃提取二次,合并提取液减压浓缩得浓缩液;
(2)取步骤(1)得到的浓缩液加入乙醇,使乙醇的浓度达到90%,放置沉淀,分离上清液,浓缩,得浓缩物;
(3)取步骤(2)得到的浓缩物上大孔吸附树脂柱D101,用浓度50%的乙醇梯度洗脱,洗脱液回收溶剂,得中药组合物。
2.一种含有权利要求1所述的中药组合物的药物制剂,其特征在于,所述组合物可以根据需要和药学上可接受的辅料制备成合适的药物制剂。
3.根据权利要求2所述的药物制剂,其特征在于,所述药物制剂优选为口服制剂。
4.根据权利要求4所述的药物制剂,其特征在于,所述口服制剂所选用的辅料选自淀粉、预胶化淀粉、淀粉浆、β-环糊精、卡波姆、微晶纤维素、羟丙基甲基纤维素、低取代羟丙基纤维素、羧甲基纤维素钙、聚乙二醇(PEG)、羧甲基纤维素钠、甲基纤维素、乙基纤维素、甘露醇、十二烷基硫酸钠、交联羧甲基纤维素钠、乳糖、聚乙烯吡咯烷酮(PVP)、交联聚乙烯吡咯烷酮、硬脂酸镁、滑石粉、微粉硅胶、阿斯巴甜、甜橙香精、碳酸氢钠、碳酸钠、肠溶包衣粉中的一种或几种。
5.权利要求1所述的中药组合物在在制备治疗妇女痛经中的应用。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410782657.8A CN104510854B (zh) | 2014-12-16 | 2014-12-16 | 一种治疗妇女痛经的中药组合物及其用途 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410782657.8A CN104510854B (zh) | 2014-12-16 | 2014-12-16 | 一种治疗妇女痛经的中药组合物及其用途 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN104510854A true CN104510854A (zh) | 2015-04-15 |
CN104510854B CN104510854B (zh) | 2016-04-13 |
Family
ID=52787092
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201410782657.8A Active CN104510854B (zh) | 2014-12-16 | 2014-12-16 | 一种治疗妇女痛经的中药组合物及其用途 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN104510854B (zh) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105832922A (zh) * | 2016-06-10 | 2016-08-10 | 普正药业股份有限公司 | 妇女痛经颗粒在改善血液流变学药物中的应用 |
CN106620514A (zh) * | 2016-12-01 | 2017-05-10 | 湖北硅金凝节能减排科技有限公司 | 一种治疗痛经的中药亲水凝胶贴剂及其制备方法 |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1548125A (zh) * | 2003-05-11 | 2004-11-24 | 山东绿因药业有限公司 | 一种妇女痛经颗粒及其制备工艺 |
-
2014
- 2014-12-16 CN CN201410782657.8A patent/CN104510854B/zh active Active
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1548125A (zh) * | 2003-05-11 | 2004-11-24 | 山东绿因药业有限公司 | 一种妇女痛经颗粒及其制备工艺 |
Non-Patent Citations (1)
Title |
---|
中华人民共和国卫生部药典委员会编: "妇女痛经丸", 《卫生部颁药品标准(中药成方制剂第一册)》 * |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105832922A (zh) * | 2016-06-10 | 2016-08-10 | 普正药业股份有限公司 | 妇女痛经颗粒在改善血液流变学药物中的应用 |
CN106620514A (zh) * | 2016-12-01 | 2017-05-10 | 湖北硅金凝节能减排科技有限公司 | 一种治疗痛经的中药亲水凝胶贴剂及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
CN104510854B (zh) | 2016-04-13 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN101933991B (zh) | 一种镇痛抗炎药物及其制备方法 | |
CN104510853B (zh) | 一种治疗妇女痛经的中药有效部位组合物及其用途 | |
CN104225006A (zh) | 一种益气通便的中药组合物 | |
CN104510854B (zh) | 一种治疗妇女痛经的中药组合物及其用途 | |
WO2022160520A1 (zh) | 一种治疗颈椎间盘突出的药物组合物及其制备方法和应用 | |
CN101474192A (zh) | 糠酸氟替卡松药物制剂及制备方法 | |
CN1985918A (zh) | 一种用于风湿类风湿关节炎、脊椎病等疾病的中药组合物 | |
CN104435435B (zh) | 一种治疗妇女痛经的中药颗粒及其制备方法 | |
CN103169831A (zh) | 一种治疗痛经的中药组合物及其制备方法 | |
CN102526214B (zh) | 一种治疗血管神经性头痛、偏头痛的中药制剂 | |
CN109289009A (zh) | 一种中药组合物及其制备方法和应用 | |
CN104707075B (zh) | 一种治疗痛经和月经不调的苗药组合物及制备方法 | |
CN1977900A (zh) | 一种用于银屑病等皮肤疾病的中药组合物 | |
CN102068511A (zh) | 一种治疗腰椎间盘突出的外用药 | |
CN108524775A (zh) | 中药在制备治疗重症肌无力合并胸腺瘤的药物制剂中的应用 | |
CN102512557B (zh) | 一种用于创伤中后期恢复的中药 | |
CN106620070A (zh) | 一种治疗骨关节病变的药物组合物及其制备方法和用途 | |
CN101579481B (zh) | 一种治疗高血压的药物组合物 | |
CN102512481B (zh) | 雷公藤胶囊剂及其应用 | |
CN104173481B (zh) | 一种抗前列腺炎症的中药组合物及其制备方法和应用 | |
CN1977904A (zh) | 一种用于盆腔炎、附件炎等妇科炎症的中药组合物 | |
CN104510751B (zh) | 一种治疗妇女痛经的中药单体组合物及其用途 | |
CN104740236B (zh) | 一种乌鸡白凤分散片 | |
CN103330929B (zh) | 一种治疗女子不孕症的药物及其制备方法 | |
CN102940656A (zh) | 治疗前列腺增生的药物组合物 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
TR01 | Transfer of patent right | ||
TR01 | Transfer of patent right |
Effective date of registration: 20220728 Address after: 278 Chuangxin Avenue, Jinggangshan economic and Technological Development Zone, Ji'an City, Jiangxi Province Patentee after: Jiangxi Puzheng Pharmaceutical Co.,Ltd. Address before: 276600 Shandong Linyi high tech Zone Industrial third road and Qiyang Road intersection shandongjing Yutang National Medicine Co.,Ltd. Patentee before: JINGYUTANG PHARMACEUTICAL CO.,LTD. |