CN104257676A - Composition for treating asthenic cold type migraine - Google Patents

Composition for treating asthenic cold type migraine Download PDF

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Publication number
CN104257676A
CN104257676A CN201410545415.7A CN201410545415A CN104257676A CN 104257676 A CN104257676 A CN 104257676A CN 201410545415 A CN201410545415 A CN 201410545415A CN 104257676 A CN104257676 A CN 104257676A
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weight portion
ginsenoside
compositions
cold type
weight
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CN201410545415.7A
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CN104257676B (en
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龚慕辛
许永崧
潘学强
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Capital Medical University
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Capital Medical University
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A61K31/585—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin

Abstract

Composition for treating the asthenic cold type migraine comprises ingredients as follows: 3.0-4.0 parts of ginsenoside Rb1 by weight and 1.0 part of evodiamine (Ev) by weight; preferably, 3.0-4.0 parts of the ginsenoside Rb1 by weight, 1.0 part of the Ev by weight, 0.15-0.60 part of rutaevine (Rv) by weight, 0.50-2.0 parts of limonin(Li) by weight; more preferably, 3.0-4.0 parts of the ginsenoside Rb1 by weight, 1.0 part of the Ev by weight, 0.15-0.60 part of Rv by weight, 0.50-2.0 parts of Li by weight, 0.60-4.0 parts of ginsenoside Rg1 by weight and 0.02-0.25 part of rutaecarpin (Ru). Essential ingredients, namely, the Rb1 and the Ev, which are effective in treating the asthenic cold type migraine, are provided, and main active ingredients, namely, the Rg1, the Rv, the Li and the Ru, are matched and combined on the basis, and the composition which has the optimum curative effect on the asthenic cold type migraine is determined.

Description

One treats the migrainous compositions of asthenic cold type
Technical field
The present invention relates to one and treat the migrainous medicine of asthenic cold type, be specifically related to one and treat the migrainous Chinese medicine active ingredient composition of asthenic cold type.
Background technology
Migraine is a kind of multifactorial primary headache disease, to have a headache for cardinal symptom, is characterized in one-sided, violent throbbing pain.Calendar year 2001, migraine was classified as one of chronic disease disabled most by World Health Organization (WHO).But still undesirable to migrainous Diagnosis and Treat at present, epidemiology " three high and one low " feature of migrainous high incidence, high crippling, high rate of missed diagnosis, low control rate, impels us to be necessary to find more effective migraine treatment medicine.At present, migraine is medicine mainly with opioid drug, triptan medicine, corticosteroids medicine, nonsteroidal antiinflammatory drug or antiepileptic clinically, but the application of these medicines can cause the multiple side effect such as such as drug dependence, and therefore the migrainous research for the treatment of by Chinese herbs receives increasing concern.
Fructus Evodiae decoction begins to be loaded in treatise on Febrile Diseases, full side is made up of Fructus Evodiae, Rhizoma Zingiberis Recens, Radix Ginseng and Fructus Jujubae, it is effective prescription of ancient Chinese medicine doctor treatment " headache due to JUE YIN disorder ", modern clinic is mainly used in treat various headaches, can also treat migraine due to it mainly to hold concurrently disease-vomiting, therefore it treats migrainous effect and mechanism comes into one's own.The further investigation functional component of Fructus Evodiae decoction and optimum proportioning for improving the curative effect of medication of traditional prescription, the migrainous newtype drug of exploitation treatment is significant.
Summary of the invention
Researcher of the present invention is through chemical composition and whole animal pharmacodynamics association study, have found the medicative Effective Component of Chinese Medicine of asthenic cold type migraine, and determine its effective ratio range and optimum proportioning scope, thus provide a kind of compositions comprising properly mixed described effective ingredient.
For achieving the above object, the present invention includes following technical scheme:
One treats the migrainous compositions of asthenic cold type, and it consists of the following composition:
(a) 3.0 ~ 4.0 ginsenoside Rb of weight portion 1; With
(b) 1.0 rutaecarpin of weight portion.
One treats the migrainous compositions of asthenic cold type, and it consists of the following composition:
(a) 3.0 ~ 4.0 ginsenoside Rb of weight portion 1;
(b) 1.0 rutaecarpin of weight portion;
(c) 0.15 ~ 0.60 evodine of weight portion; With
(d) 0.50 ~ 2.0 obaculactone of weight portion.
One treats the migrainous compositions of asthenic cold type, and it consists of the following composition:
(a) 3.0 ~ 4.0 ginsenoside Rb of weight portion 1;
(b) 1.0 rutaecarpin of weight portion;
(c) 0.15 ~ 0.60 evodine of weight portion;
(d) 0.50 ~ 2.0 obaculactone of weight portion;
(e) 0.60 ~ 4.0 ginsenoside Rg of weight portion 1; With
(f) 0.02 ~ 0.25 rutaecarpine of weight portion.
One treats the migrainous medicine of asthenic cold type, and it is made up of compositions as above and pharmaceutic adjuvant.
Medicine as above, preferably, the dosage form of described medicine is tablet, oral cavity disintegration tablet, injection, lyophilized injectable powder, granule, capsule, drop pill, pill, electuary, powder, suspensoid or oral liquid.
Medicine as above, preferably, described dosage form is oral liquid.
On the other hand, the invention provides the application that compositions as above is prevented in preparation or treated in migrainous medicine.
Beneficial effect of the present invention is: the present invention determines Fructus Evodiae decoction preparation to the treatment effective necessary component of asthenic cold type migraine and optimum proportioning, i.e. ginsenoside Rb 1: rutaecarpin=3.0 ~ 4.0: 1.0, most preferably are ginsenoside Rb 1: rutaecarpin: evodine: obaculactone: ginsenoside Rg 1: rutaecarpine=3.0 ~ 4.0: 1.0: 0.15 ~ 0.60: 0.50 ~ 2.0: 0.60 ~ 4.0: 0.02 ~ 0.25, have good effect for the treatment of asthenic cold type migraine disease according to the compositions that said ratio is made.
Detailed description of the invention
Researcher of the present invention conducts in-depth research effective ingredient in Fructus Evodiae decoction compound recipe, treats asthenic cold type migrainous main component ginsenoside Rb in identification Fructus Evodiae decoction preparation 1, rutaecarpin, evodine, obaculactone, ginsenoside Rg 1and rutaecarpine, find neccessary composition ginsenoside Rb further 1with rutaecarpin, compatible combination evodine, obaculactone, ginsenoside Rg on this basis 1the compositions proportioning of optimum curative effect is obtained with rutaecarpine.
Particularly, determine present composition effective ingredient and optimum proportioning process as follows:
(1) by chemical composition and whole animal pharmacodynamics association study, have found and to the medicative Effective Component of Chinese Medicine of asthenic cold type migraine be: ginsenoside Rb 1(Rb 1), rutaecarpin (Ev), evodine (Rv), obaculactone (Li), ginsenoside Rg 1(Rg 1) and rutaecarpine (Ru).
(2) adopt each composition components of uniform Design policy setting, form compositions one to eight (see table 1).
The each component content of table 1 principle active component compositions (μ gmL -1)
(3) carry out pharmacodynamic index detection to each compositions, Modling model is identical with the embodiment of the present invention 1 with detection method, and result is as shown in table 2.
(4) determination of necessary component optimum proportioning
In his-and-hers watches 2 each compositions 7 kinds of pharmacodynamics index data according to Hassan method carry out mathematics conversion ask normalizing value, subsequently the normalizing value of 7 kinds of pharmacodynamics indexs in same compositions is sued for peace, to with open n power (n=pharmacodynamics index number) and namely obtain the corresponding drug effect overall desirability of each compositions, IBM SPSS 19.0 statistical software is adopted to carry out quadratic polynomial stepwise regression analysis, F inspection and variance analysis are carried out to regression equation, level of significance α=0.05, P < 0.05 thinks that equation has significance.Obtain regression equation:
Y＝0.982X 3 2-0.244X 2 2+0.516X 2+0.924
X in formula 2represent ginsenoside Rb 1content, X 3represent the content of rutaecarpin.Correlation coefficient r=0.933 of equation, shows that the fitting effect of equation is better.As calculated: X 2=1.0574, X 3when=0.3125, equation obtains maximum in this test content range, now Y=1.2927.Namely at ginsenoside Rb 1when being 1057.4: 312.5 with the content ratio of rutaecarpin, there is good therapeutic effect to asthenic cold type migraine.
(5) ginsenoside Rb is confirmed through the test of pesticide effectiveness 1when being 1057.4: 312.5 with the content ratio of rutaecarpin, have good therapeutic effect to asthenic cold type migraine, its curative effect is apparently higher than Fructus Evodiae decoction.Experimental result is see the embodiment of the present invention 1.
(6) research of key component optimum proportioning
At control ginsenoside Rb 1: rutaecarpin=3.0 ~ 4.0: on the basis of 1.0, allotment evodine, obaculactone, ginsenoside Rg 1with the content of rutaecarpine, obtain the compositions proportioning that curative effect is better.
Thus, compositions of the present invention is obtained.It contains (a) 3.0 ~ 4.0 ginsenoside Rb of weight portion 1; (b) 1.0 rutaecarpin of weight portion.Preferably: (a) 3.0 ~ 4.0 ginsenoside Rb of weight portion 1; (b) 1.0 rutaecarpin of weight portion; (c) 0.15 ~ 0.60 evodine of weight portion; (d) 0.50 ~ 2.0 obaculactone of weight portion.It is even more preferred that (a) 3.0 ~ 4.0 ginsenoside Rb of weight portion 1; (b) 1.0 rutaecarpin of weight portion; (c) 0.15 ~ 0.60 evodine of weight portion; (d) 0.50 ~ 2.0 obaculactone of weight portion; (e) 0.60 ~ 4.0 ginsenoside Rg of weight portion 1; (f) 0.02 ~ 0.25 rutaecarpine of weight portion.
Below in conjunction with specific embodiment, set forth the present invention further.Should be understood that these embodiments are only not used in for illustration of the present invention to limit the scope of the invention.The test method of unreceipted actual conditions in the following example, usually according to the condition described in medicament book or pharmacopeia, or conveniently condition, unless otherwise indicated, otherwise percentage ratio and number are calculated by weight.
Embodiment 1
(1) the migrainous compositions of preparation treatment asthenic cold type
According to the migrainous compositions one to six of content preparation treatment asthenic cold type of table 3.
The each component raw material of the present composition is all bought by commercial sources or adopts conventional high-performance liquid chromatography separation and Extraction from Radix Ginseng and Fructus Evodiae.In the present embodiment, evodine adopts high performance liquid chromatography to extract from Fructus Evodiae, method is see [Li Li, Jia Ying, Chen Xiaohui, Deng content (English) [J] of evodine and limonin in .HPLC method Simultaneously test Fructus Evodiae. Chinese natural drug, 2003,1 (3): 31-33], all the other each components are commercial sources purchase.
Each component content (μ gmL of each compositions of table 3 -1)
(2) foundation of asthenic cold type Nerve in Migraine Model
Adopt 7 ~ 8 week age, body weight 28 ~ 32g SPF level ICR mice (Beijing experimental animal Technology Co., Ltd. of dimension tonneau China, production permit number: SCXK (capital) 2012-0001).
Grouping: mice, by body weight random packet, comprises Normal group, sham operated rats, model group, positive drug group and each compositions group, often organizes 14.Adaptability raises 4.Each administration group takes the mode of administration preventing to add treatment, by 0.2mL10g -1body weight gavage every day gives relative medicine 1 time, Normal group, sham operated rats, model group group every day with etc. dosage distilled water gavage, positive drug group (Sumatriptan Succinate sheet) only carries out therapeutic administratp, the dosage sumatriptan such as gavage from the 6th day, test totally 20 days.
Modeling: 6-10 day, each administration group mice presses 0.125mgkg -1body weight subcutaneous injection of reserpine once; 11-13 day reserpine dose titration is 0.15mgkg -1; Mice was pressed 450mgkg in 14th -1body weight 3% chloral hydrate anesthesia, cuts off skin of head, brill one hole in 2mm place on the right side of 2mm, sagittal suture under bregma, cut tail and get autoblood, inject 2 μ L autobloods in cerebral cortex from drill hole, degree of depth 1mm, postoperative bone wax hemostasis, penicillin antiinflammatory, sews up wound surface.Sham operated rats is only holed, and does not bury autologous blood clot underground.Gastric infusion on the-20th was the same on 15th.
Draw materials: in the 21st day by mouse anesthesia after, heart extracting blood 0.5-1.0mL, after 4 DEG C of standing 2h, 4 DEG C, 5000rmin -1centrifugal 10min gets serum ,-20 DEG C of preservations, for NO content and NOS vitality test.By mice euthanasia, get full brain, along pin trace place clip front end cerebral tissue ,-80 DEG C of preservations, for NO content and NOS vitality test, residue cerebral tissue is preserved separately, measures for neurotransmitter.
(3) pharmacodynamic index detects
The monoamine neurotransmitters such as 5-HT, DA, NE are detected, by kit measurement NO content and NOS by HPLC-electrochemical process.Results of pharmacodynamic test is in table 4.
(5) pharmacodynamics index general comment normalizing
In his-and-hers watches 4 each compositions 7 kinds of pharmacodynamics index data according to Hassan method carry out mathematics conversion ask normalizing value, for the more obvious pharmacodynamics index of the less improvement result of numerical value press formula (1) calculating d min, formula (2) is pressed for the more obvious pharmacodynamics index of the larger improvement result of numerical value and calculates d max.
d min = Y max - Y i Y max - Y min Formula (1)
d max = Y i - Y min Y max - Y min Formula (2)
Subsequently the normalizing value of 7 kinds of pharmacodynamics indexs in same compositions is sued for peace, to open n power (n=pharmacodynamics index number) and namely obtain the corresponding drug effect overall desirability of each compositions, in table 5.
The pharmacodynamics index overall desirability of table 5 principle active component compositions
(6) result and discussion
Table 4 statistical result showed, after modeling, in model group Mice brain tissues, 5-HT, NE and DA content reduces, cerebral tissue NO content and cerebral tissue and serum NO level S vigor raise, serum NO levels reduces, and These parameters and Normal group are compared difference and all had statistical significance (P < 0.05 or P < 0.01) with sham operated rats.After giving different pharmaceutical treatment, in local administration group Mice brain tissues, 5-HT content significantly raises, and NO content and NOS vigor significantly reduce, and serum NO levels significantly raises.Each administration group NE and DA changes of contents not obvious.Illustrate that each compositions group all has some improvement to the migrainous pharmacodynamics index of asthenic cold type.
Table 5 result shows, the action effect of each compositions is generally better than positive drug sumatriptan and Fructus Evodiae decoction group, and compositions one, two > compositions three, four > compositions five, six, namely after composition proportion, 6 kinds of compositions are better than 4 kinds of compositions, are more better than 2 kinds of compositions.

Claims (7)

1. treat the migrainous compositions of asthenic cold type, it is characterized in that, it consists of the following composition:
(a) 3.0 ~ 4.0 ginsenoside Rb of weight portion 1; With
(b) 1.0 rutaecarpin of weight portion.
2. treat the migrainous compositions of asthenic cold type, it is characterized in that, it consists of the following composition:
(a) 3.0 ~ 4.0 ginsenoside Rb of weight portion 1;
(b) 1.0 rutaecarpin of weight portion;
(c) 0.15 ~ 0.60 evodine of weight portion; With
(d) 0.50 ~ 2.0 obaculactone of weight portion.
3. treat the migrainous compositions of asthenic cold type, it is characterized in that, it consists of the following composition:
(a) 3.0 ~ 4.0 ginsenoside Rb of weight portion 1;
(b) 1.0 rutaecarpin of weight portion;
(c) 0.15 ~ 0.60 evodine of weight portion;
(d) 0.50 ~ 2.0 obaculactone of weight portion;
(e) 0.60 ~ 4.0 ginsenoside Rg of weight portion 1; With
(f) 0.02 ~ 0.25 rutaecarpine of weight portion.
4. treat an asthenic cold type migrainous medicine, it is characterized in that, it is that compositions according to any one of claim 1-3 and pharmaceutic adjuvant are made.
5. medicine as claimed in claim 4, it is characterized in that, the dosage form of described medicine is tablet, oral cavity disintegration tablet, injection, lyophilized injectable powder, granule, capsule, drop pill, pill, electuary, powder, suspensoid or oral liquid.
6. medicine as claimed in claim 5, it is characterized in that, described dosage form is oral liquid.
7. the application that the compositions according to any one of claim 1-3 is prevented in preparation or treated in migrainous medicine.
CN201410545415.7A 2014-10-15 2014-10-15 One kind treats the migrainous compositionss of asthenic cold type Active CN104257676B (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108096511A (en) * 2018-01-24 2018-06-01 刘清 A kind of Chinese medicine preparation and its manufacturing method of rapid recovery antimigraine
CN110049766A (en) * 2016-12-06 2019-07-23 Sg株式会社 It is effective component for preventing or treating the composition of the disease as caused by caffeinism using evodia extract or rutaecarpin

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
潘学强 等: "外翻肠囊吸收成分与药效相关发现吴茱萸汤改善小鼠偏头痛模型指标的有效物质", 《"好医生杯"中药制剂创新与发展论坛论文集（下）》 *
潘学强等: "外翻肠囊吸收成分与药效相关研究吴茱萸汤治疗偏头痛的药效物质", 《中国中药杂志》 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110049766A (en) * 2016-12-06 2019-07-23 Sg株式会社 It is effective component for preventing or treating the composition of the disease as caused by caffeinism using evodia extract or rutaecarpin
CN108096511A (en) * 2018-01-24 2018-06-01 刘清 A kind of Chinese medicine preparation and its manufacturing method of rapid recovery antimigraine

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