CN105853759A - Traditional Chinese medicine composition, its extract product, its preparation, preparation method and application thereof - Google Patents
Traditional Chinese medicine composition, its extract product, its preparation, preparation method and application thereof Download PDFInfo
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- CN105853759A CN105853759A CN201510028323.6A CN201510028323A CN105853759A CN 105853759 A CN105853759 A CN 105853759A CN 201510028323 A CN201510028323 A CN 201510028323A CN 105853759 A CN105853759 A CN 105853759A
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Abstract
The invention discloses a traditional Chinese medicine composition, an extract product, its preparation, a preparation method and an application thereof. The provided traditional Chinese medicine composition comprises the following components in parts by weight: 10-60 parts of radix astragali preparata, 10-30 parts of Codonopsis pilosula, 10-15 parts of root of kudzu vine, 3-10 parts of rhizoma cimicifugae, 3-10 parts of honey-fried licorice root, 3-10 parts of gastrodia elata, 5-20 parts of red sage root, 5-10 parts of grass-leaved sweetflag rhizome and 5-30 parts of rhizoma alismatis. The traditional Chinese medicine composition has good treatment effect for vertebrobasilar insufficiency with high efficiency.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, its extract, its preparation, its preparation method and application.
Background technology
Vertebro-basilar artery insufficiency is clinical common ischemic cerebrovascular, and it mainly shows themselves in that dizzy
Dizzy, shakiness of walking, Nausea and vomiting, horizontal nystagmus, depending on thing can not, vascular dementia, tinnitus ear
Deaf etc..Patient is mostly middle-older patient, is associated with arteriosclerosis, hypertension, hyperlipidemia etc. chronic more
Disease, hemorheology is abnormal.Vertebro-basilar artery insufficiency onset is anxious, and symptom is many, weight, and sign is few, faces
Bed diagnosis has certain difficulty, TCD,transcranial Doppler Doppler (TCD) to can detect that the Hemodynamic environment of Vertebral-basilar artery
Degree, spectrum morphology, pulsatility index etc..
This disease of western medical treatment is broadly divided into following three broad aspect at present: various risk factors are controlled by (1)
Treat, such as hypertension, diabetes, hyperlipidemia etc.；(2) blood supply of brain and brain cell are improved
Metabolism, as prevented platelet aggregation, reduces viscosity of blood；Selectivity expansion of cerebral vascular, increases brain blood
Flow；Improve brain cell metabolism；(3) verification treatment during outbreak.Clinical observation finds, uses simple west
It is single that medicine treatment improves symptom, and relapse rate is high.
In prior art, (the taste treatment Vertebral-basilar artery blood supply of yiqi clever Tonga is or not yiqi clever Tonga taste
Foot dizziness clinical observation, " tcm clinical magazine " 2011,23 (11): 962～964) by Radix Astragali Preparata, party
Ginseng, Radix Puerariae, Fructus Viticis, the Radix Paeoniae Alba, Cortex Phellodendri, Rhizoma Cimicifugae, Radix Glycyrrhizae Preparata, Rhizoma Gastrodiae, Radix Salviae Miltiorrhizae, Rhizoma Acori Graminei and pool
Rushing down composition, when it is used for treating vertebro-basilar artery insufficiency, effective percentage is only 88%.
For more effectively alleviating the misery of patient, this area is needed one badly and is treated vertebro-basilar artery insufficiency
The higher Chinese medicine composition of effective percentage.
Summary of the invention
Problem to be solved by this invention is existing for treating Vertebral-basilar artery blood supply not in order to overcome
The defects such as the effective percentage of the yiqi clever Tonga taste of foot is low, therapeutic effect is poor, and provide a kind of Chinese medicine
Compositions, its extract, its preparation, its preparation method and application.The Chinese medicine composition of the present invention is used for
During treatment vertebro-basilar artery insufficiency, effective percentage is high, therapeutic effect is more preferable.
The invention provides a kind of Chinese medicine composition, in parts by weight, its by 10～60 parts of Radix Astragali Preparatas,
10～30 parts of Radix Codonopsis, 10～15 parts of Radix Puerariaes, 3～10 parts of Rhizoma Cimicifugaes, 3～10 parts of Radix Glycyrrhizae Preparatas, 3～10 parts of Rhizoma Gastrodiaes,
5～20 parts of Radix Salviae Miltiorrhizaes, 5～10 parts of Rhizoma Acori Graminei and 5～30 parts of Rhizoma Alismatis compositions.
In the present invention, described Radix Astragali Preparata is the Preparation process product of the Radix Astragali, and concocting method is specifically shown in " China
People's republic's pharmacopeia " 2010 years versions one；The described Radix Astragali be product be leguminous plant Radix Astagali
(Astragalus membranaceus (Fisch.) bge.var.mongholicus (bge.) Hsiao) or film pod are yellow
The dry root of stilbene (ArtragaZas membranaceus (Fisch.) Bge.).
In the present invention, described Radix Codonopsis is Campanulaceae Radix Codonopsis (Codonopsis piLosula (Franch.)
Nannf.), element flower Radix Codonopsis (Codonopsis pilosula Nannf.var.modesta (Nannf.) L.T.Shen)
Or the dry root of radix codonpsis tangshen (Codonopsis tangshen Oliv.).
In the present invention, described Radix Puerariae is legume pueraria lobata (Pueraria lobata (Willd) Ohwi)
Dry root.
In the present invention, described Rhizoma Cimicifugae is cohosh C.heracleifolia (Cimicifuga
Heracleifolia Kom.), Cimicifuga Dahurica (Cimicifuga dahurica (Turcz.) Maxim.) or Rhizoma Cimicifugae
The dry rhizome of (Cimicifuga foetida L.).
In the present invention, described Radix Glycyrrhizae Preparata is the Preparation process product of Radix Glycyrrhizae, and concocting method is specifically shown in " China
People's republic's pharmacopeia " 2010 years versions one；Described Radix Glycyrrhizae is glycyrrhizic legume (Glycyrrhiza
Uralensis Fisch.), Glycyrrhiza inflata Bat. (Glycyrrhiza inflata Bat.) or Glycyrrhiza glabra L. (Glycyrrhiza
Glabra L.) dry root and rhizome.
In the present invention, described Rhizoma Gastrodiae is being dried of orchid Rhizoma Gastrodiae (Gastrocdia edata Bl.)
Tuber.
In the present invention, described Radix Salviae Miltiorrhizae is labiate Radix Salviae Miltiorrhizae (Salvia miltiorrhiza Bge.)
Dry root and rhizome.
In the present invention, described Rhizoma Acori Graminei is acorus gramineus araceae plant (Acorus tatarinowii
Schott) dry rhizome.
In the present invention, described Rhizoma Alismatis is Notes On Alism At Aceae Rhizoma Alismatis (Alisma orientalis
(Sam.) Juzep.) dry tuber.
Above-mentioned Chinese medicine composition is preferably by Radix Astragali Preparata 15 parts, Radix Codonopsis 15 parts, Radix Puerariae 15 parts, liter
Fiber crops 6 parts, Radix Glycyrrhizae Preparata 6 parts, 10 parts of Rhizoma Gastrodiae, Radix Salviae Miltiorrhizae 20 parts, Rhizoma Acori Graminei 10 parts and 20 parts of groups of Rhizoma Alismatis
Become.
Above-mentioned Chinese medicine composition can be finely disintegrated Chinese medicine composition.
Present invention also offers the preparation method of a kind of above-mentioned Chinese medicine composition: by described Chinese medicine composition
Each component mixing of thing, or pulverize as fine powder.
Present invention also offers the preparation method of a kind of Chinese medicine extract: each by described Chinese medicine composition
Component boiling, filters, takes filtrate, to obtain final product.
In the preparation method of described Chinese medicine extract, the most also include after described " taking filtrate "
" concentrate " step.
Present invention also offers a kind of Chinese medicine extract, it is according to the preparation method of above-mentioned Chinese medicine extract
Prepare.
Present invention also offers above-mentioned Chinese medicine composition or above-mentioned Chinese medicine extract at preparation treatment vertebra
Application in the medicine of basilar artery insufficiency；The common sympton of described vertebro-basilar artery insufficiency
Have dizziness, walk shakiness, Nausea and vomiting, horizontal nystagmus, depending on thing can not, Hiccough and deaf, blood vessel
Property dull-witted etc..
Present invention also offers a kind of Chinese medicine preparation, it include above-mentioned Chinese medicine composition and/or above-mentioned in
Medicament extract, and one or more pharmaceutically acceptable adjuvants.
Described pharmaceutically acceptable adjuvant refers to the pharmaceutic adjuvant that pharmaceutical field is conventional, is for solving system
The mouldability of agent, effectiveness, stability, safety add in prescription except the present invention Chinese medicine composition or
The conventional medicinal material of all beyond Chinese medicine extract, such as diluent (such as carboxymethylstach sodium etc.), bonding
Agent (such as polyvidone etc.), disintegrating agent (such as microcrystalline Cellulose etc.), lubricant are (such as magnesium stearate, micropowder
Silica gel etc.) and other adjuvant.As required, optional above-mentioned adjuvant, by this area routine side
Method, makes described Chinese medicine preparation by Chinese medicine composition or the Chinese medicine extract of the present invention；Described Chinese medicine
Preparation is the various regular dosage form in this area, especially clinical conventional oral solid formulation, as tablet, powder,
Pill, capsule, granule, oral liquid, dry suspension or drop pill etc..
Without prejudice to the field on the basis of common sense, above-mentioned each optimum condition, can combination in any, obtain this
Invent each preferred embodiments.
Agents useful for same of the present invention and raw material are the most commercially.
The most progressive effect of the present invention is: the Chinese medicine composition of the present invention is used for treating Vertebral-basilar artery
During blood supply insufficiency, effective percentage is high, therapeutic effect is more preferable.
Detailed description of the invention
Further illustrate the present invention below by the mode of embodiment, but the most therefore limit the present invention to
Among described scope of embodiments.The experimental technique of unreceipted actual conditions in the following example, according to often
Rule method and condition, or select according to catalogue.
Embodiment 1
Radix Astragali Preparata 15g, Radix Codonopsis 15g, Radix Puerariae 15g, Rhizoma Cimicifugae 6g, Radix Glycyrrhizae Preparata 6g, Rhizoma Gastrodiae 10g, red
Ginseng 20g, Rhizoma Acori Graminei 10g, Rhizoma Alismatis 20g.
Embodiment 2
By Radix Astragali Preparata 10g, Radix Codonopsis 10g, Radix Puerariae 15g, Rhizoma Cimicifugae 3g, Radix Glycyrrhizae Preparata 3g, Rhizoma Gastrodiae 10g,
Radix Salviae Miltiorrhizae 20g, Rhizoma Acori Graminei 5g, Rhizoma Alismatis 30g.Said composition lays particular emphasis on improves vertebro-basilar artery insufficiency
The vertigo symptoms caused.
Embodiment 3
By Radix Astragali Preparata 60g, Radix Codonopsis 30g, Radix Puerariae 10g, Rhizoma Cimicifugae 10g, Radix Glycyrrhizae Preparata 6g, Rhizoma Gastrodiae 3g,
Radix Salviae Miltiorrhizae 10g, Rhizoma Acori Graminei 5g, Rhizoma Alismatis 5g.Said composition stresses to improve vertebro-basilar artery insufficiency and causes
Can not symptom depending on thing.
Embodiment 4
By Radix Astragali Preparata 10g, Radix Codonopsis 15g, Radix Puerariae 12g, Rhizoma Cimicifugae 3g, Radix Glycyrrhizae Preparata 3g, Rhizoma Gastrodiae 6g, pellet
Ginseng 20g, Rhizoma Acori Graminei 10g, Rhizoma Alismatis 30g.Said composition stresses to improve vertebro-basilar artery insufficiency and causes
Vascular dementia symptom.
Embodiment 5
By Radix Astragali Preparata 30g, Radix Codonopsis 15g, Radix Puerariae 12g, Rhizoma Cimicifugae 5g, Radix Glycyrrhizae Preparata 10g, Rhizoma Gastrodiae 9g,
Radix Salviae Miltiorrhizae 5g, Rhizoma Acori Graminei 5g, Rhizoma Alismatis 20g.Said composition lays particular emphasis on to be improved vertebro-basilar artery insufficiency and draws
Play deaf symptom.
Embodiment 6
By Radix Astragali Preparata 10g, Radix Codonopsis 10g, Radix Puerariae 15g, Rhizoma Cimicifugae 3g, Radix Glycyrrhizae Preparata 3g, Rhizoma Gastrodiae 10g,
Radix Salviae Miltiorrhizae 20g, Rhizoma Acori Graminei 5g, Rhizoma Alismatis 30g are sufficiently mixed uniformly, add magnesium stearate 1g, silicon dioxide
1.5g, starch 7.5g, mix homogeneously, fill capsule, every 0.65g, obtain capsule.This capsule
Lay particular emphasis on and improve the vertigo symptoms that vertebro-basilar artery insufficiency causes.
Embodiment 7
By Radix Astragali Preparata 60g, Radix Codonopsis 30g, Radix Puerariae 10g, Rhizoma Cimicifugae 10g, Radix Glycyrrhizae Preparata 6g, Rhizoma Gastrodiae 3g,
Radix Salviae Miltiorrhizae 10g, Rhizoma Acori Graminei 5g, Rhizoma Alismatis 5g are sufficiently mixed uniformly, add magnesium stearate 1.5g, titanium dioxide
Silicon 2.25g, starch 11.5g, wet granulation, fill capsule, every 0.65g, obtain capsule.Should
Capsule stress to improve vertebro-basilar artery insufficiency causes can not symptom depending on thing.
Embodiment 8
By Radix Astragali Preparata 10g, Radix Codonopsis 15g, Radix Puerariae 12g, Rhizoma Cimicifugae 3g, Radix Glycyrrhizae Preparata 3g, Rhizoma Gastrodiae 6g, pellet
Ginseng 20g, Rhizoma Acori Graminei 10g, Rhizoma Alismatis 30g are sufficiently mixed uniformly, add magnesium stearate 1g, silicon dioxide
1.5g, starch 7.5g, wet granulation, tabletting, coating, obtain tablet.This tablet stresses to improve vertebra base
End cerebral arterial insufficiency causes vascular dementia symptom.
Embodiment 9
By Radix Astragali Preparata 30g, Radix Codonopsis 15g, Radix Puerariae 12g, Rhizoma Cimicifugae 5g, Radix Glycyrrhizae Preparata 10g, Rhizoma Gastrodiae 9g,
Radix Salviae Miltiorrhizae 5g, Rhizoma Acori Graminei 5g, Rhizoma Alismatis 20g are sufficiently mixed uniformly, add magnesium stearate 1.2g, titanium dioxide
Silicon 1.8g, starch 9g, add in oneself melted polyethylene glycol 6000 of 260g, stir evenly, instilled by medicinal liquid
In methyl-silicone oil, take out drop pill and absorb coolant, be dried, obtain drop pill.This drop pill lays particular emphasis on and changes
Kind vertebro-basilar artery insufficiency causes deaf symptom.
Comparative example 1
Radix Astragali Preparata 15g, Radix Codonopsis 15g, Radix Puerariae 15g, Fructus Viticis 10g, Radix Paeoniae Alba 15g, Cortex Phellodendri 10g,
Rhizoma Cimicifugae 6g, Radix Glycyrrhizae Preparata 6g, Rhizoma Gastrodiae 10g, Radix Salviae Miltiorrhizae 20g, Rhizoma Acori Graminei 10g, Rhizoma Alismatis 20g.
Effect example 1
1 case collects standard
1.1 Western medicine diagnose standards are with reference to " neurological " (Wang Weizhi, " neurological " the 1st edition, people
People health publishing house, 2006:205): 1. there is dizziness, for sense of rotation or regard thing and shake dynamic or unstable sense；
2. dizziness the most still has other symptoms of a kind of vertebrobasilar ischemia simultaneously, as eye symptom (nystagmus,
Amaurosis, flash of light, metamorphopsia, diplopia etc.)；3. the cause of disease is clear and definite.
1.2 Syndrome in TCM marquis's diagnostic criterias: State Administration of Traditional Chinese Medicine issued with reference on June 28th, 1994
People's Republic of China's traditional Chinese medicine industry standard " Chinese medical disease Standardization of diagnosis and curative effect " (country Chinese medicine
Management board, " Chinese medical disease Standardization of diagnosis and curative effect ", publishing house of Nanjing University, 1994:23) to dizziness
Diagnosis and classifying method.
1.3TCD diagnostic criteria (high mountain, Huang Jiaxing, " the diagnosis skill of transcranial Doppler sonography (TCD)
Art and clinical practice " the 1st edition, publishing house of China Concord Medical Science University, 2004:121): (1) TCD
Spectral image shrinks peak rust circle, the peak that S1 and S2 permelting synthesis one circle is blunt, and S2 peak is more than S1 peak；
(2) TCD is high resistant waveform, and main peak point is high and steep, and S2 peak disappears, relaxing period and blood flow speed at the end of vasodilation
Substantially slowing down, blood flow speed at the end of vasodilation is almost 0 sometimes；(3) pulsatility index, drag index, receive
Contracting peak speed exceedes normal range with diastole peak speed ratio value.Possesses in above 3 any 1.
1.4 inclusive criterias: 1. meet above-mentioned diagnostic criteria 1.1 and 1.2；2. TCD checks prompting vertebra substrate
Cerebral arterial insufficiency person；3. the age is more than 35 years old, less than 70 years old；Use without system in the nearlyest 2 weeks
Corticosteroid and antihistamine drug history, without this type of pharmacohistory of external in 1 week；5. signed informed consent
Book person.
2 Therapeutic Method
The Chinese medicine composition of embodiment 1, instructions about how to take medicine: potion on the one, take two bags, decoction being taken warmly sooner or later, the course for the treatment of
3 weeks.
The Chinese medicine composition of comparative example 1, instructions about how to take medicine: potion on the one, take two bags, decoction being taken warmly sooner or later, the course for the treatment of
It it is 3 weeks.
3 observation items and criterion of therapeutical effect
3.1 doctor trained in Western medicine criterions of therapeutical effect
Vertebra base tremulous pulse blood supply situation uses to be examined through cranium color Doppler (FD-T98 type TCD) conventional method
Look into.Observe the masters such as treatment before and after look left vertebral artery (LVA), right vertebral artery (RVA), basilar artery BA
Want the change of tremulous pulse vertebra base arterial contraction phase peak veloity,PV (Vs).
3.2 Efficacy of Traditional Chinese Medicine standards
Formulate with reference to relevant criterion in " Chinese medical disease Standardization of diagnosis and curative effect ".
Recovery from illness: dizziness, the symptoms such as shakiness, Nausea and vomiting, horizontal nystagmus of walking, sign disappear,
TCD prompting Vertebral-basilar artery blood supply recovers normal, within more than 2 weeks, does not shows effect.
Take a turn for the better: sings and symptoms and TCD check and improve substantially.
Invalid: sings and symptoms is not improved or increases the weight of, TCD checks without changing.
With cure rate and improvement rate sum as effective percentage.
4 statistical analysis
Using SPSS 10.0 statistical software, before and after treatment, measurement data paired samples t checks, relevant
Property inspection use Bivariate analysis.Quantitative data F checks, and qualitative data Ridit checks.
5 results of study
5.1 clinical efficacies (are shown in Table 1)
1 liang of table group comparitive study
| Group | Total number of cases | Recovery from illness example (rate) | Improvement example (rate) | Invalid example (rate) | Total effective rate (%) |
| Embodiment 1 | 60 | 31(51.7) | 27(45.0) | 2(3.3) | 96.7 |
| Comparative example 1 | 60 | 24(40.0) | 29(48.3) | 7(11.7) | 88.3 |
Note: two groups of effective percentage compare, χ2=7.769, P=0.047 ＜ 0.05；As can be seen here, the present invention
Chinese medicine composition effective percentage is high.
5.2TCD checks result (being shown in Table 2)
Before and after the group treatment of 2 liang of table, TCD checks result
Note: 1t=-8.622, P ＜ 0.01；2t=-36.534, P ＜ 0.01；3t=-8.364, P ＜ 0.01；4t=-10.682,
P ＜ 0.01；5t=-8.563, P ＜ 0.01；6t=-7.539, P ＜ 0.01；As can be seen here, in the present invention
Drug composition therapeutic effect is good, and vertebra base arterial contraction phase Peak Flow Rate significantly improves.
Effect example 2
Observing 8 example vertebro-basilar artery insufficiency case patients, the Chinese medicine composition of Application Example 2 enters
Row treatment, potion on the one, take two bags, decoction being taken warmly sooner or later, 30 days is a course for the treatment of.Improve dizziness, especially
The symptom effect being dizziness headache companion's nausea and vomiting is notable, and criterion of therapeutical effect is with reference to " Chinese medical disease diagnosis curative effect
Standard " in relevant criterion formulate.
Effect example 3
Observing 6 example vertebro-basilar artery insufficiency case patients, the Chinese medicine composition of Application Example 3 enters
Row treatment, potion on the one, take two bags, decoction being taken warmly sooner or later, 30 days is a course for the treatment of.Can not depending on thing to patient
And nystagmus effect is notable, criterion of therapeutical effect is with reference to mark relevant in " Chinese medical disease Standardization of diagnosis and curative effect "
Quasi-formulation.
Effect example 4
Observing 3 example vertebro-basilar artery insufficiency case patients, the Chinese medicine composition of Application Example 4 enters
Row treatment, potion on the one, take two bags, decoction being taken warmly sooner or later, 30 days is a course for the treatment of.It is crazy about improving vascular
Slow-witted patient's memory and cognitive impairment aspect effect are preferable, and criterion of therapeutical effect is with reference to Mini-Mental scale (MMSE)
Formulate with relevant criterion in Chinese edition Montreal Cognitive Assessment (MOCA).
Effect example 5
Observing 5 example vertebro-basilar artery insufficiency case patients, the Chinese medicine composition of Application Example 5 enters
Row treatment, potion on the one, take two bags, decoction being taken warmly sooner or later, 30 days is a course for the treatment of.Move improving vertebra substrate
The Hiccough and deaf effect that arteries and veins blood supply insufficiency causes becomes apparent from, and criterion of therapeutical effect is with reference to " Chinese medical disease diagnosis curative effect
Standard " in relevant criterion formulate.
Claims (10)
1. a Chinese medicine composition, it is characterised in that in parts by weight, by 10～60 parts of Radix Astragali Preparatas,
10～30 parts of Radix Codonopsis, 10～15 parts of Radix Puerariaes, 3～10 parts of Rhizoma Cimicifugaes, 3～10 parts of Radix Glycyrrhizae Preparatas, 3～10 parts of Rhizoma Gastrodiaes,
5～20 parts of Radix Salviae Miltiorrhizaes, 5～10 parts of Rhizoma Acori Graminei and 5～30 parts of Rhizoma Alismatis compositions.
2. Chinese medicine composition as claimed in claim 1, it is characterised in that its by Radix Astragali Preparata 15 parts,
Radix Codonopsis 15 parts, Radix Puerariae 15 parts, Rhizoma Cimicifugae 6 parts, Radix Glycyrrhizae Preparata 6 parts, 10 parts of Rhizoma Gastrodiae, Radix Salviae Miltiorrhizae 20 parts,
Rhizoma Acori Graminei 10 parts and Rhizoma Alismatis 20 parts composition.
3. one kind such as claim 1 or the preparation method of Chinese medicine composition of 2: the Chinese drug-treated group as described in by
Each component of compound, mixes or pulverizes as fine powder.
4. Chinese medicine composition as claimed in claim 1 or 2 is in preparation treatment Vertebral-basilar artery blood supply not
Application in the medicine of foot.
5. a Chinese medicine preparation, it includes Chinese medicine composition as claimed in claim 1 or 2 and one
Or multiple pharmaceutically acceptable adjuvant.
6. a preparation method for Chinese medicine extract, it comprises the steps: such as claim 1 or 2
Each component boiling of described Chinese medicine composition, filters, takes filtrate, to obtain final product.
7. the preparation method of Chinese medicine extract as claimed in claim 6, it is characterised in that described
Also include after taking filtrate concentrating.
8. a Chinese medicine extract, it is according to the system of Chinese medicine extract as claimed in claims 6 or 7
Preparation Method prepares.
9. Chinese medicine extract as claimed in claim 8 is at preparation treatment vertebro-basilar artery insufficiency
Application in medicine.
10. a Chinese medicine preparation, it includes Chinese medicine extract as claimed in claim 8 and one or many
Plant pharmaceutically acceptable adjuvant.
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