HRP20180783T1 - Farmaceutski pripravak za liječenje glavobolje i postupak njegove pripreme - Google Patents
Farmaceutski pripravak za liječenje glavobolje i postupak njegove pripreme Download PDFInfo
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- HRP20180783T1 HRP20180783T1 HRP20180783TT HRP20180783T HRP20180783T1 HR P20180783 T1 HRP20180783 T1 HR P20180783T1 HR P20180783T T HRP20180783T T HR P20180783TT HR P20180783 T HRP20180783 T HR P20180783T HR P20180783 T1 HRP20180783 T1 HR P20180783T1
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- 238000002360 preparation method Methods 0.000 title claims 32
- 206010019233 Headaches Diseases 0.000 title claims 3
- 231100000869 headache Toxicity 0.000 title claims 3
- 239000008194 pharmaceutical composition Substances 0.000 title claims 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 50
- 239000000284 extract Substances 0.000 claims 34
- 239000000945 filler Substances 0.000 claims 10
- 238000010992 reflux Methods 0.000 claims 8
- 238000005469 granulation Methods 0.000 claims 7
- 230000003179 granulation Effects 0.000 claims 7
- 239000000546 pharmaceutical excipient Substances 0.000 claims 7
- 241000218176 Corydalis Species 0.000 claims 6
- 241000217407 Margaritifera Species 0.000 claims 6
- 241001199012 Usta Species 0.000 claims 6
- 238000000034 method Methods 0.000 claims 6
- VYQNWZOUAUKGHI-UHFFFAOYSA-N monobenzone Chemical compound C1=CC(O)=CC=C1OCC1=CC=CC=C1 VYQNWZOUAUKGHI-UHFFFAOYSA-N 0.000 claims 6
- 210000000582 semen Anatomy 0.000 claims 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 6
- 239000012467 final product Substances 0.000 claims 5
- 239000012535 impurity Substances 0.000 claims 4
- 239000000725 suspension Substances 0.000 claims 4
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 235000019264 food flavour enhancer Nutrition 0.000 claims 3
- 238000009472 formulation Methods 0.000 claims 3
- 238000002156 mixing Methods 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 238000005507 spraying Methods 0.000 claims 3
- 229920001353 Dextrin Polymers 0.000 claims 2
- 239000004375 Dextrin Substances 0.000 claims 2
- 229920002472 Starch Polymers 0.000 claims 2
- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical group O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 claims 2
- 235000019425 dextrin Nutrition 0.000 claims 2
- 238000001035 drying Methods 0.000 claims 2
- 238000010438 heat treatment Methods 0.000 claims 2
- 238000004806 packaging method and process Methods 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- 239000008213 purified water Substances 0.000 claims 2
- 239000008107 starch Substances 0.000 claims 2
- 235000019698 starch Nutrition 0.000 claims 2
- 238000003756 stirring Methods 0.000 claims 2
- 206010001497 Agitation Diseases 0.000 claims 1
- 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 1
- 108010011485 Aspartame Proteins 0.000 claims 1
- 206010022998 Irritability Diseases 0.000 claims 1
- 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 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 206010028813 Nausea Diseases 0.000 claims 1
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 claims 1
- 206010041349 Somnolence Diseases 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- 238000013019 agitation Methods 0.000 claims 1
- 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 1
- 229960003438 aspartame Drugs 0.000 claims 1
- 235000010357 aspartame Nutrition 0.000 claims 1
- 239000000605 aspartame Substances 0.000 claims 1
- 210000003792 cranial nerve Anatomy 0.000 claims 1
- 208000002173 dizziness Diseases 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 206010022437 insomnia Diseases 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 230000008693 nausea Effects 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 208000011580 syndromic disease Diseases 0.000 claims 1
- 230000000472 traumatic effect Effects 0.000 claims 1
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- 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)
- A61K36/74—Rubiaceae (Madder family)
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9068—Zingiber, e.g. garden ginger
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
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- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- 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
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Claims (10)
1. Farmaceutski pripravak za uporabu u liječenju glavobolje koji sadržava 4 do 9 težinskih udjela Radix Angelicae Sinensis, 4 do 9 težinskih udjela Rhizoma Chuanxiong, 2 do 8 težinskih udjela Radix Paeoniae alba, 2 do 8 težinskih udjela Radix Rehmanniae Preparata, 10 do 15 težinskih udjela Ramulus Uncariae cum Uncis, 10 do 15 težinskih udjela Caulis Spatholobi, 10 do 15 težinskih udjela Špica Prunellae, 10 do 15 težinskih udjela Semen Cassiae, 10 do 15 težinskih udjela Concha Margaritifera Usta, 4 do 9 težinskih udjela Rhizoma Corydalis i 0,5 do 2 težinskih udjela Herbe Asari, naznačen time, da se navedeni pripravak priprema sljedećim postupkom:
a). Priprema ekstrakta br. 1: Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Corydalis i Semen de Cassiae se pomiješaju, ekstrahiraju uz refluks i zagrijavanje s etanolom i filtriraju kako bi se uklonili nečistoće; i etanol se izdvaja i koncentrira kako bi se dobio ekstrakt br. 1 za kasniju uporabu;
b). priprema ekstrakta br. 2: Radix Paeoniae alba se ekstrahira uz refluks i zagrijavanje s etanolom i filtrira; i etanol se izdvaja i koncentrira kako bi se dobio ekstrakt br. 2 za kasniju uporabu;
c). Priprema ekstrakta br. 3: Radix Rehmanniae Preparata, Ramulus Uncariae cum Uncis, Caulis Spatholobi, Špica Prunellae, Concha Margaritifera Usta i Herba Asari se pomiješaju, ukuhavaju vodom, filtriraju, koncentriraju, u koje se dodaje etanol, ostavi stajati i filtrira; i etanol se izdvaja i koncentrira da se dobije ekstrakt br. 3 za kasniju uporabu;
d). priprema formulacija: u gore navedena tri ekstrakta dodaje se odgovarajuća količina ekscipijenta, a potom se suše i granuliraju da se dobije konačni produkt.
2. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 1, naznačen time, da se navedeni pripravak pripravlja sljedećim postupkom:
a). Priprema ekstrakta br. 1: Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Corydalis i Semen Cassiae se pomiješaju, ekstrahiraju uz refluks i zagrijavanje s 3 do 6 puta većom količinom 50 do 80 % etanola 2 do 3 puta, prvi put u trajanju 0,5 do 2,5 sati, drugi i / ili treći put u trajanju od 0,5 do 2 sata i filtriraju se kako bi se uklonile nečistoće; i etanol se izdvaja i koncentrira do relativne gustoće 1.250 ~ 1.350 na 70 do 80°C da se dobije ekstrakt br. 1 za kasniju uporabu; b). Priprema ekstrakta br. 2: u Radix Paeoniae alba se dodaje 3 do 6 puta veća količina 50 do 80 % etanola, namoči se, ekstrahira se uz refluks i zagrijavanje 2 do 3 puta, prvi put 0,5 do 2,5 sati, drugi i / ili treći put u trajanju od 0,5 do 2 sata i filtrira; i etanol se izdvaja i koncentrira do relativne gustoće 1,10 ~ 1,35 na 55 do 65 °C da se dobije ekstrakt br. 2 za kasniju uporabu;
c). Priprema ekstrakta br. 3: Radix Rehmanniae Preparata, Ramulus Uncariae cum Uncis, Caulis Spatholobi, Špica Prunellae, Concha Margaritifera Usta i Herba Asari se pomiješaju, ukuhavaju 2 do 3 puta s 4 do 10 puta većom količinom vode, prvi put u trajanju od 0,5 do 3 sata, drugi i / ili treći put u trajanju od 1 do 3 sata, profiltriraju, koncentriraju do relativne gustoće 1,06 ~ 1,1°C na 75 do 85°C u koje se dodaje etanol kako bi se dobila konačna koncentracija etanola od 60% ~ 85%, ostavi stajati 12 do 24 sata i filtrira; izdvaja i koncentrira do relativne gustoće 1.270 ~ 1.350 na 75 do 85°C da se dobije ekstrakt br. 3 za kasniju uporabu;
d). pripremanje pripravaka: u gore navedena tri ekstrakta dodaje se odgovarajuća količina ekscipijenta, a ekstrakti se potom suše i granuliraju da se dobije konačni produkt.
3. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 2, naznačen time, da se navedeni pripravak pripravlja sljedećim postupkom:
a) Priprema ekstrakta br. 1: Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Corydalis i Semen Cassiae se pomiješaju, ekstrahiraju se uz refluks i zagrijavanje s 2 do 4 puta većom količinom 70% etanola, prvi put 2 sata, a drugi put 1 sat, i filtriraju kako bi se uklonile nečistoće; i etanol se izdvaja i koncentrira do relativne gustoće 1.300 ± 1.310 na 74 do 76°C da se dobije ekstrakt br. 1 za kasniju uporabu;
b) Priprema ekstrakta br. 2: u Radix Paeoniae alba se dodaje 4 puta veća količina 60% etanola, namoči se, ekstrahira se uz refluks i zagrijavanje 2 puta, prvi put 2 sata, a drugi put 1 sat, i filtrira; i etanol se izdvaja i koncentrira do relativne gustoće 1,23 do 1,33 na 65°C da se dobije ekstrakt br. 2 za kasniju upotrebu;
c) Priprema ekstrakta br. 3: Radix Rehmanniae Preparata, Ramulus Uncariae cum Uncis, Caulis Spatholobi, Špica Prunellae, Concha Margaritifera Usta i Herba Asari se pomiješaju, 2 puta ukuhavaju s 5 puta većom količinom vode, prvi put tijekom 2 sata i drugi put tijekom 1 sata, filtriraju se, koncentriraju se do relativne gustoće 1,06 do 1,10 na 80°C, a zatim se dodaje etanol da se dobije konačni udio etanola od 65 do 70% i ostavi stajati 12 do 24 sata te filtrira; i etanol se izdvaja i koncentrira do relativne gustoće 1.320 do 1.325 na 79° do 81°C kako bi se dobio ekstrakt br. 3 za kasniju upotrebu;
d) priprema formulacija: u gore navedena tri ekstrakta dodaje se odgovarajuća količina ekscipijenta, suši se i granulira kako bi se dobio konačni produkt.
4. Pripravak namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time, da navedeni ekscipijenti u koraku d) uključuju jednu ili više vrsta punila i sredstva za poboljšanje okusa; ponajprije, navedeno punilo se bira između dekstrina, škroba, topljivog škroba, saharoze, laktoze i mikrokristalne celuloze; navedeno sredstvo za poboljšanje okusa odabrano je između steviosina, aspartama; najpoželjnije, navedeno punilo je dekstrin, a navedeno sredstvo za poboljšanje okusa je steviosin.
5. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 1, naznačen time, da je težinski omjer gore navedenih triju ekstrakata pripravljenih od Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Paeoniae alba, Radix Rehmanniae Preparata, Ramulus Uncariae cum Uncis, Caulis Spatholobi, Špica Prunellae, Semen Cassiae, Concha Margaritifera Usta, Rhizoma Corydalis i Herba Asari u odnosu na ekscipijente je 40:60 do 65:35, poželjno 55:45 do 65:35.
6. Pripravak u skladu s patentnim zahtjevom 5, naznačen time, da je navedeni omjer gore navedenih triju ekstrakata u odnosu na ekscipijente omjer osušenog ekstrakta koji je dobiven iz gore navedenih triju ekstrakata u odnosu na ekscipijente.
7. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 1, naznačen time, da se u koraku d) pripravak pripravlja postupkom granulacije raspršivanjem u fluidiziranom sloju, koji obuhvaća slijedeće korake: uzimanje dijela punila, otapanje s pročišćenom vodom, dodavanje sredstva za poboljšanje okusa koje se otapa snažno miješanje da se dobije gusta otopina; dodavanje dobro pripremljena tri ekstrakta u prethodno navedenu suspenziju korak po korak, miješanje, podešavanje gustoće suspenzije, online filtriranje; stavljanje ostatka punila u granulator; izvođenje granulacije raspršivanjem podešavanjem granulacijskih parametara; sušenje; granuliranje sitom; potpuno miješanje i pakiranje kako bi se dobio konačni proizvod.
8. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 7, naznačen time, da količina dodatka navedenog sredstva za poboljšanje okusa ima 0 ~ 1 % težinskog udjela od ukupnog punila, a težinski omjer između dijela punila koji se prvi dodaju i ostatka punila koje se dodaje kasnije je 1 : 4 do 1,5 : 1.
9. Postupak za pripravu farmaceutskog pripravka za uporabu u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time, da postupak obuhvaća slijedeće korake:
a). Priprema ekstrakta br. 1: Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Corydalis i Semen Cassiae se pomiješaju, ekstrahiraju uz refluks i zagrijavanje s etanolom i filtriraju kako bi se uklonile nečistoće; i etanol se izdvaja i koncentrira kako bi se dobio ekstrakt br. 1 za kasniju uporabu;
b). priprema ekstrakta br. 2: Radix Paeoniae alba se ekstrahira uz refluks i zagrijavanje s etanolom i filtrira; i etanol se izdvaja i koncentrira kako bi se dobio ekstrakt br. 2 za kasniju uporabu;
c). Priprema ekstrakta br. 3: Radix Rehmanniae Preparata, Ramulus Uncariae cum Uncis, Caulis Spatholobi, Špica Prunellae, Concha Margaritifera Usta i Herba Asari se pomiješaju, ukuhavaju s vodom, filtriraju, koncentriraju, u koje se dodaje etanol i ostavi stajati, i filtriraju; i etanol se izdvaja i koncentrira da se dobije ekstrakt br. 3 za kasniju uporabu;
d). priprema formulacija: uzima se dio punila, otopi s pročišćenom vodom, dodaje se sredstvo za poboljšanje okusa koje se otapa uz snažno miješanje da se dobije gusta otopina; dodaju se dobro pripremljena tri ekstrakta u prethodno navedenu suspenziju korak po korak, miješaju, podešava se gustoće suspenzije, online filtrira; ostatak punila stavlja se u granulator; izvodi se granulacija raspršivanjem uz podešavanje granulacijskih parametara; sušenje; granuliranje sitom; potpuno miješanje i pakiranje kako bi se dobio konačni proizvod.
10. Upotreba farmaceutskog pripravka u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačena time, da se koristi za pripravu lijeka za liječenje glavobolje, traumatskog sindroma kranijalnog živca, mučnine i vrtoglavice, uznemirenosti i razdražljivosti, nesanice i pospanosti.
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| CN201210562103 | 2012-12-21 | ||
| PCT/CN2013/089960 WO2014094632A1 (zh) | 2012-12-21 | 2013-12-19 | 一种治疗头痛的药物组合物及其制备方法 |
| EP13864253.3A EP2937094B1 (en) | 2012-12-21 | 2013-12-19 | Pharmaceutical composition for treating headache, and preparation method thereof |
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| CN105120836B (zh) * | 2013-01-08 | 2018-06-05 | 诺娃细胞科技公司 | 具有胶原蛋白合成能力的新型的肽及其用途 |
| CN104688914A (zh) * | 2015-03-04 | 2015-06-10 | 苏州市天灵中药饮片有限公司 | 一种治疗眩晕的中药提取物及其制备方法 |
| CN104840598A (zh) * | 2015-05-27 | 2015-08-19 | 湖南中医药大学 | 一种中草药补血膏及其制备方法 |
| CN107917966B (zh) * | 2016-10-08 | 2022-02-18 | 天士力医药集团股份有限公司 | 一种养血清脑制剂的检测方法 |
| CN107095903A (zh) * | 2017-05-25 | 2017-08-29 | 中国人民解放军第三O二医院 | 一种具有解热功效的中药组合物、其口服液及制备方法 |
| CN108498755B (zh) * | 2018-04-17 | 2021-04-09 | 贾洪章 | 治疗心脑血管疾病的中药组合物及其制备方法和用途 |
| CN108434385A (zh) * | 2018-05-18 | 2018-08-24 | 重庆跃龙生物制药有限公司 | 用于治疗眩晕症的中药组合物及其制备方法 |
| CN108704112A (zh) * | 2018-06-20 | 2018-10-26 | 广西中医药大学第附属医院 | 一种眩晕合剂及其制备方法 |
| CN108837084B (zh) * | 2018-09-26 | 2021-08-10 | 山东鑫谷健康产业有限公司 | 一种中药制剂及其制备方法 |
| CN110327428B (zh) * | 2019-08-19 | 2021-07-20 | 东莞市中医院 | 一种天麻健脑颗粒及其制备方法 |
| CN114848742B (zh) * | 2022-03-30 | 2024-03-15 | 红云制药(昆明)有限公司 | 一种清肺抑火胶囊制备方法 |
| CN115624603B (zh) * | 2022-09-07 | 2023-09-01 | 南阳理工学院 | 一种治疗偏头痛的中药组合物及其制备方法 |
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| CN1047938C (zh) * | 1992-11-14 | 2000-01-05 | 中国人民解放军第二五四医院 | 一种治疗头痛的中药 |
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| JP2004026780A (ja) * | 2002-06-28 | 2004-01-29 | Eisai Co Ltd | 不定愁訴治療用組成物 |
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