CN105770353A - Traditional Chinese medicinal preparation for treating primary hypertension and preparation method of traditional Chinese medicinal preparation - Google Patents

Traditional Chinese medicinal preparation for treating primary hypertension and preparation method of traditional Chinese medicinal preparation Download PDF

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CN105770353A
CN105770353A CN201511007265.5A CN201511007265A CN105770353A CN 105770353 A CN105770353 A CN 105770353A CN 201511007265 A CN201511007265 A CN 201511007265A CN 105770353 A CN105770353 A CN 105770353A
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chinese medicine
radix
medicine preparation
preparation
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邓凤桂
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GUANGDONG JUZHICHENG TECHNOLOGY Co Ltd
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GUANGDONG JUZHICHENG TECHNOLOGY Co Ltd
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Abstract

The invention belongs to the field of traditional Chinese medicine, and relates to a traditional Chinese medicinal preparation for treating primary hypertension and a preparation method of the traditional Chinese medicinal preparation. The traditional Chinese medicinal preparation is mainly prepared from the following raw materials in parts by weight: 20-30 parts of folium ciematis, 20-28 parts of vitex negundo var. cannabifolia, 25-35 parts of root of Yunnan glorybower, 12-18 parts of radix aucklandiae, 15-23 parts of bulbus allii macrostemi, 15-20 parts of white atractylodes rhizome, 15-25 parts of rhizoma dioscoreae, 8-12 parts of cortex moutan, 8-15 parts of radix scutellariae, 7-13 parts of cortex albiziae, 8-15 parts of semen ziziphi spinosae and 5-13 parts of liquorice root. The traditional Chinese medicinal preparation disclosed by the invention is reasonable in medicine prescription and strong in synergistic effect; and the traditional Chinese medicinal preparation, on treating the primary hypertension, is significant in curative effect, stable in efficacy, low in side effects of medicines and obvious in clinical popularization value.

Description

Chinese medicine preparation for the treatment of essential hypertension and preparation method thereof
Technical field
The invention belongs to the field of Chinese medicines, particularly relate to Chinese medicine preparation for the treatment of essential hypertension and preparation method thereof.
Background technology
By the standard of WHO, the blood pressure of human normal, for shrinking pressure less than 140mmHg and (or) diastolic pressure less than 90mmHg, exceedes this scope and diagnosable for hypertension.Hypertension is common cardiovascular disease, and it is defined as body and follows bad arterial pressure persistence and increase.The hypertension being secondary to kidney, endocrine and nervous system disease is called that secondary hypertension is sick, accounts for the 5% ~ 10% of hyperpietic；And not yet illustrate the hypertension of its reason so far, it is called essential hypertension.Essential hypertension accounts for more than the 90% of hyperpietic, it is often accompanied by organ functional or the organic change such as fat and sugar metabolism disorder and the heart, brain, kidney and retina, it it is the paathogenic factor of apoplexy (cerebral infarction and cerebral hemorrhage), coronary heart disease, retinopathy, kidney damage (glomerule infraction, renal failure), research shows, the M & M of cardiovascular and cerebrovascular disease and blood pressure to increase degree closely related.
The current research of doctor trained in Western medicine is thought, essential hypertension is the result of heredity, environment, anatomical structure, adaptability, nerve, endocrine, body fluid and hemodynamics many-side comprehensive function, is some congenital hereditary gene a kind of and many pathogenic supercharging factors and physiological decompression factor interaction and the multi-factor disease that causes.Except foreign genetic element, high sodium low potassium meals in life, Bad Eating Habit and the psychentonia overweight, fat, long-term such as drink, lack motion etc. and all likely bring out hypertension.So, the cooperation outside Drug therapy and between non-drug therapy is focused in the treatment of hypertension clinically, namely focuses on the cooperation between lifestyle modification and antihypertensive drug therapy.The antihypertensive drugs of the clinical often application of doctor trained in Western medicine mainly has calcium ion antagonist (CaA), angiotensin-convertion enzyme inhibitor (ACEI), β body blocker, this four class of diuretic, secondly also have C receptor blocking agent, vasodilation etc., these medicines generally all can have bigger side effect, also costly, toleration and the compliance of Drug safety and patient have much room for improvement price.
The most onset of hypertension is slow, progressive, as long as raising with arteriotony and persistently for disease, and, fatigue, cardio palmus shape tight in addition with dizzy, headache, neck plate.The elaboration of hypertension is belonged to the disease categories such as Chinese medicine dizziness, headache by the traditional Chinese medical science, and its pathogenesis is owing to negative and positive of qi and blood is lacked of proper care, and makes brains hollow, and venation is lost and supported, or clear sun is not opened up, or fire is disturbed clear key and created all diseases of hypertension.After hypertension is formed, internal injury is long-pending damages at stagnation of phlegm-damp in middle-JIAO, deficiency of qi and blood, deficiency of kidney yin, and the existence of intermediary's pathogenesis such as hyperactivity of YANG due to deficiency of YIN develops further, if qi and blood stagnation is in brain, then can become cerebral thrombosis and apoplexy, or stasis blocking in the heart be then the thoracic obstruction, angina pectoris.If QI and blood superinverse, hold expectorant under the arm and hold fire under the arm in clear key, then may occur in which cerebral hemorrhage apoplexy.Damaging with the passing of time if internal injury is long-pending, hinder in kidney spleen, make kidney lose folding, board loses vaporization, retention of water-damp in the body, and namely the disease such as edema, renal failure occurs.
Chinese patent application 200710014082.5 discloses the Chinese medicine composition of a kind of orally taken for curing hypertension, the crude drug of its effective ingredient specifically includes that Ganoderma 6～9 grams, Radix Angelicae Sinensis 6～12 grams, Cordyceps 5～10 grams, Radix Gentianae 3～6 grams, Ramulus Uncariae Cum Uncis 3～12 grams, Folium Apocyni Veneti 6～12 grams, the Cortex Eucommiae 3～6 grams, Semen Cassiae 10～15 grams, Spica Prunellae 9～15 grams, Concha Margaritifera 10～20 grams, 4～8 grams of Radix Glycyrrhizae and Pheretima 5～10 grams.This traditional Chinese medicine composition for treating hypertension has determined curative effect, the advantage of non-relapse after healing, but crude drug cost is high, and drug price is expensive, is not easy to popularization and application.
Current medical circle is thought, essential hypertension is a lifelong participation disease, and not yet report has any medicine thoroughly to cure hypertension at present, and patient needs long-term taking anti-hypertension treatment.Antihypertensive drugs needs to apply for a long time or all the life, the toleration of Drug safety and patient is particularly significant, Traditional Chinese Medical on Treating Hypertension drug side effect is little and efficacy stability, can long-term safety medication, have a extensive future, but it is not notable to there is effect in the Chinese medicine of existing prevention and treatment hypertension, onset waits deficiency slowly, seeks a kind of effect significantly, rapid-action, the Chinese medicine preparation of taking convenience, has great importance to the clinical treatment of essential hypertension.
Summary of the invention
In order to make up the deficiencies in the prior art, first purpose of the present invention is to provide a kind of Chinese medicine preparation treating essential hypertension, this Chinese medicine preparation has effect of suppressing the hyperactive liver blood pressure lowering, blood circulation promoting and blood stasis dispelling, resolving stagnation for tranquilization, vital energy benefiting and the kidney invigorating, also possess the advantages such as rapid-action, therapeutic effect notable, efficacy stability, drug side effect are low simultaneously, can as treating hyperpietic initial medication or long term maintenance medication, simultaneously Chinese medicine preparation cost of the present invention is low, taking convenience, it is easy to popularization and application.
Chinese medicine preparation of the present invention is mainly prepared from by the raw material of following parts by weight:
Clematis filamentosa Dunn 20 ~ 30 parts, Herba Viticis Cannabifoliae 20 ~ 28 parts, Radix clerodendri yunnanensis 25 ~ 35 parts, the Radix Aucklandiae 12 ~ 18 parts, Bulbus Allii Macrostemonis 15 ~ 23 parts, the Rhizoma Atractylodis Macrocephalae 15 ~ 20 parts, Rhizoma Dioscoreae 15 ~ 25 parts, Cortex Moutan 8 ~ 12 parts, Radix Scutellariae 8 ~ 15 parts, Cortex Albiziae 7 ~ 13 parts, Semen Ziziphi Spinosae 8 ~ 15 parts and 5 ~ 13 parts of Radix Glycyrrhizae.
Preferably, described Chinese medicine preparation is mainly prepared from by the raw material of following parts by weight: Clematis filamentosa Dunn 20 parts, Herba Viticis Cannabifoliae 20 parts, Radix clerodendri yunnanensis 25 parts, the Radix Aucklandiae 12 parts, Bulbus Allii Macrostemonis 15 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, Rhizoma Dioscoreae 15 parts, Cortex Moutan 8 parts, Radix Scutellariae 8 parts, Cortex Albiziae 7 parts, Semen Ziziphi Spinosae 8 parts and 5 parts of Radix Glycyrrhizae.
Preferably, described Chinese medicine preparation is mainly prepared from by the raw material of following parts by weight: Clematis filamentosa Dunn 30 parts, Herba Viticis Cannabifoliae 28 parts, Radix clerodendri yunnanensis 35 parts, the Radix Aucklandiae 18 parts, Bulbus Allii Macrostemonis 23 parts, the Rhizoma Atractylodis Macrocephalae 20 parts, Rhizoma Dioscoreae 25 parts, Cortex Moutan 12 parts, Radix Scutellariae 15 parts, Cortex Albiziae 13 parts, Semen Ziziphi Spinosae 15 parts and 13 parts of Radix Glycyrrhizae.
Preferably, described Chinese medicine preparation is mainly prepared from by the raw material of following parts by weight: Clematis filamentosa Dunn 25 parts, Herba Viticis Cannabifoliae 23 parts, Radix clerodendri yunnanensis 30 parts, the Radix Aucklandiae 15 parts, Bulbus Allii Macrostemonis 18 parts, the Rhizoma Atractylodis Macrocephalae 17 parts, Rhizoma Dioscoreae 20 parts, Cortex Moutan 10 parts, Radix Scutellariae 12 parts, Cortex Albiziae 10 parts, Semen Ziziphi Spinosae 12 parts and 9 parts of Radix Glycyrrhizae.
The source of Chinese crude drug, nature and flavor used by Chinese medicine preparation of the present invention, return through and effect:
Clematis filamentosa Dunn: this product is Ranunculaceae Clematis filamentosa Dunn, is used as medicine with leaf.Sweet in the mouth, slightly cool in nature；GUIXIN, Liver Channel；Clearing away liver-fire, mind calming god, blood pressure lowering, removing obstruction in the collateral to relieve pain.
Herba Viticis Cannabifoliae: this product is the dried leaves of Verbenaceae Herba Viticis Cannabifoliae.Mildly bitter flavor, pungent, property is put down.Return lung meridian.Expelling pathogenic wind from the body surface, eliminating phlegm and relieving asthma, removing toxic substances, dehumidifying, parasite killing, pain relieving.
Radix clerodendri yunnanensis: this product is Verenaceae paulownia platymiscium Radix clerodendri yunnanensis, is used as medicine with root and leaf.Acrid in the mouth, warm in nature；Return lung, bladder warp；Wind-expelling pain-stopping, promoting diuresis to eliminate dampness and promoting QI circulation, blood pressure lowering.
The Radix Aucklandiae: this product is the dry root of the feverfew Radix Aucklandiae.Acrid in the mouth, hardship, warm in nature；Return spleen, stomach, large intestine, three burnt, gallbladder meridians；Promoting the circulation of QI to relieve pain, warming middle-JIAO for easing the stomach.
Bulbus Allii Macrostemonis: this product is the dry bulb of liliaceous plant Allium macrostemon or Chinese onion.Acrid in the mouth, hardship；Warm in nature.Return lung, stomach, large intestine channel.Activating YANG and eliminating stagnation, circulation of qi promoting intestinal stasis relieving, the chest stuffiness relieving of regulating the flow of vital energy.
The Rhizoma Atractylodis Macrocephalae: this product is the dry rhizome of the feverfew Rhizoma Atractylodis Macrocephalae.Bitter in the mouth, sweet, warm in nature；Return spleen, stomach warp；Invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.
Rhizoma Dioscoreae: this product is the dry rhizome of Dioscoreaceae plant Rhizoma Dioscoreae.Sweet in the mouth, property is put down；Return spleen, lung, kidney channel；Spleen reinforcing nourishing the stomach, promote the production of body fluid lung benefiting, the kidney invigorating arresting seminal emission.
Cortex Moutan: this product is the dry root bark of ranunculaceae peony.Bitter in the mouth, pungent, cold nature；GUIXIN, liver, kidney channel；Clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling.
Cortex Albiziae: this product is the dry bark of leguminous plant Herba Albiziae.Sweet in the mouth, property is put down；GUIXIN, liver, lung meridian；Resolving stagnation for tranquilization, promoting blood circulation and detumescence.
Semen Ziziphi Spinosae: this product is the dry mature seed of Rhamnaceae plant Ziziphi Spinosae.Sweet in the mouth, acid, property is put down；Return liver, gallbladder, heart channel；Tonifying liver, mind calming, arresting sweating, promotes the production of body fluid.
Radix Scutellariae: this product is the dry root of labiate Radix Scutellariae.Bitter in the mouth, cold in nature；Return lung, gallbladder, spleen, large intestine, small intestine meridian；Heat clearing and damp drying, eliminating fire and detoxication, hemostasis, antiabortive.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L..Sweet in the mouth, property is put down；GUIXIN, lung, spleen, stomach warp；Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
The prescription analysis of medicament composing prescription of the present invention:
Medicament composing prescription of the present invention with Clematis filamentosa Dunn, Herba Viticis Cannabifoliae and Radix clerodendri yunnanensis for monarch drug, blood pressure lowering, clearing away liver-fire, promoting diuresis to eliminate dampness and promoting QI circulation, expelling pathogenic wind from the body surface；With the Radix Aucklandiae, Bulbus Allii Macrostemonis, the Rhizoma Atractylodis Macrocephalae and Rhizoma Dioscoreae for ministerial drug, activating YANG and eliminating stagnation, circulation of qi promoting intestinal stasis relieving, the chest stuffiness relieving of regulating the flow of vital energy, liver and kidney tonifying, invigorating the spleen and benefiting QI；With Cortex Moutan, Radix Scutellariae, Cortex Albiziae and Semen Ziziphi Spinosae for adjuvant drug, blood circulation promoting and blood stasis dispelling, resolving stagnation for tranquilization, change turbid blood fat reducing；With Radix Glycyrrhizae for making medicine, relieving spasm to stop pain, heat-clearing and toxic substances removing, coordinating the actions of various ingredients in a prescription, make all medicines arrange in pairs or groups, synergism, jointly reach suppressing the hyperactive liver blood pressure lowering, blood circulation promoting and blood stasis dispelling, resolving stagnation for tranquilization, effect of vital energy benefiting and the kidney invigorating, essential hypertension is had very significant therapeutic effect.
Second purpose of the present invention is to provide corresponding manufacturing process and is made and facilitate easy-to-use finished product preparation under the premise ensureing curative effect by this Chinese medicine.
The preparation method of described Chinese medicine preparation mainly comprises the steps that
S1: take Herba Viticis Cannabifoliae, crushed after being dried, cross 60-100 mesh sieve, be placed in supercritical carbon dioxide extraction apparatus, add the ethanol that 30-45% volume fraction is 60-85% of coarse powder weight, regulation and control carbon dioxide flow is 15 ~ 20L/h, extracting pressure is 15 ~ 20MPa, and extraction temperature is 40 ~ 60 DEG C, and extraction time is 1.5 ~ 2h, decompression separation prepares Herba Viticis Cannabifoliae extract, retains Herba Viticis Cannabifoliae residue；
S2: take Clematis filamentosa Dunn, Radix clerodendri yunnanensis, the Radix Aucklandiae, Bulbus Allii Macrostemonis, the Rhizoma Atractylodis Macrocephalae, Rhizoma Dioscoreae, Cortex Moutan, Radix Scutellariae, Cortex Albiziae, Semen Ziziphi Spinosae and Radix Glycyrrhizae, pulverizes, and merges the Herba Viticis Cannabifoliae residue described in S1, adds the water soaking 2 ~ 4h of medical material gross weight 7 ~ 10 times amount, decocts 2 ~ 3h, filters；Filtering residue adds the soak by water 1 ~ 2h of medical material gross weight 4 ~ 6 times amount, filters；Merging twice filtrate, being evaporated under 60 ~ 65 DEG C of environment relative density is the extractum of 1.05 ~ 1.25, and adding ethanol to alcohol content is 60-90%(v/v), stand 12 ~ 36h, taking supernatant, reclaim ethanol, being evaporated under 60 ~ 65 DEG C of environment relative density is the extractum of 1.20 ~ 1.25；
S3: the Herba Viticis Cannabifoliae extract described in S1 and the extractum described in S2 are merged mixing, vacuum belt type drying is carried out at 60 DEG C of temperature, drying pressure is-0.09MPa, charging rate is 15L/h, material strip transfer rate is 26cm/min, dried by dry extract pulverizing, cross 100-200 mesh sieve, obtain Chinese medicine composition of the present invention.
Utilizing modern general Chinese medicine preparation technology, Chinese medicine preparation of the present invention can be made into the finished product preparation of clinical needs, such as dosage forms such as granule, pill, powder, tablet, capsule or oral liquids.
Invention additionally discloses a kind of purposes of above-mentioned Chinese medicine preparation, i.e. above-mentioned Chinese medicine preparation purposes in preparation treatment essential hypertension medicine.Chinese medicine preparation of the present invention treatment rat primary hypertension model test display, Chinese medicine preparation of the present invention has, for treating essential hypertension, the effect significantly reducing blood pressure, and the heart rate of rat also has certain effect of slowing down simultaneously；Clinical trial displays that, drug regimen of the present invention is used for treating essential hypertension, effect is notable, clinical symptoms such as dizziness, headache etc. that essential hypertension is common also have significant improvement result, the average total effective rate for the treatment of essential hypertension reaches 92.08%, and its therapeutic effect is significantly higher than positive control drug.Chinese medicine preparation therapeutic effect of the present invention is notable, and rapid-action, drug side effect is low, can as treatment essential hypertension drug use, and clinical generalization value is high.
Compared with prior art, Chinese medicine preparation of the present invention has following technical advantage:
(1) compared with the Therapeutic Method of current essential hypertension, Chinese medicine preparation of the present invention is natural pure Chinese medicinal preparation, toxic and side effects is little, long-term taking is also avoided that or reduces the untoward reaction of medicine, and Chinese medicine preparation efficacy stability of the present invention, easy to use, drug compliance is high, it is adaptable to the long-term treatment of essential hypertension.
(2) pharmacological evaluation shows, when Chinese medicine preparation of the present invention is as the drug use for the treatment of essential hypertension, medicine effect is comprehensive, has rapid-action, and good effect etc. treats advantage significantly, can effectively reduce the generation of hypertension complication, improves the quality of life of patient.
(3) Chinese medicine preparation preparation technology of the present invention is simple, and raw material is easy to get, and also has efficacy stability, rapid-action, toxic and side effects is low and the advantage such as application easy to spread simultaneously.
Detailed description of the invention
Below will by specific embodiment, the present invention is described further, it will be understood by those skilled in the art that the present invention it may also be made that except following example other similar changes obtain similar result without deviating from present disclosure and scope.
Embodiment 1
The embodiment of the present invention 1 Chinese medicine preparation is mainly prepared from by the raw material of following parts by weight:
Clematis filamentosa Dunn 20 parts, Herba Viticis Cannabifoliae 20 parts, Radix clerodendri yunnanensis 25 parts, the Radix Aucklandiae 12 parts, Bulbus Allii Macrostemonis 15 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, Rhizoma Dioscoreae 15 parts, Cortex Moutan 8 parts, Radix Scutellariae 8 parts, Cortex Albiziae 7 parts, Semen Ziziphi Spinosae 8 parts and 5 parts of Radix Glycyrrhizae.
Preparation method is as follows:
S1: take Herba Viticis Cannabifoliae, crushed after being dried, cross 60 mesh sieves, be placed in supercritical carbon dioxide extraction apparatus, add the ethanol that 45% volume fraction is 75% of coarse powder weight, regulation and control carbon dioxide flow is 18L/h, extracting pressure is 18MPa, and extraction temperature is 50 DEG C, and extraction time is 1.5h, decompression separation prepares Herba Viticis Cannabifoliae extract, retains Herba Viticis Cannabifoliae residue；
S2: take Clematis filamentosa Dunn, Radix clerodendri yunnanensis, the Radix Aucklandiae, Bulbus Allii Macrostemonis, the Rhizoma Atractylodis Macrocephalae, Rhizoma Dioscoreae, Cortex Moutan, Radix Scutellariae, Cortex Albiziae, Semen Ziziphi Spinosae and Radix Glycyrrhizae, pulverizes, and merges the Herba Viticis Cannabifoliae residue described in S1, adds the water soaking 2h of medical material gross weight 10 times amount, decocts 2h, filters；Filtering residue adds the soak by water 2h of medical material gross weight 6 times amount, filters；Merging twice filtrate, being evaporated under 60 DEG C of environment relative density is the extractum of 1.25, and adding ethanol to alcohol content is 60%(v/v), stand 12h, take supernatant, reclaim ethanol, being evaporated under 60 DEG C of environment relative density is the extractum of 1.25；
S3: the Herba Viticis Cannabifoliae extract described in S1 and the extractum described in S2 are merged mixing, vacuum belt type drying is carried out at 60 DEG C of temperature, drying pressure is-0.09MPa, charging rate is 15L/h, material strip transfer rate is 26cm/min, dried by dry extract pulverizing, cross 100 mesh sieves, obtain Chinese medicine composition of the present invention；
S4: take the Chinese medicine composition 1 part described in S3, sucrose 2 parts, 1.3 parts of dextrin, soft material made by the ethanol adding appropriate 60%, crosses 16 mesh sieve granules, dry, every bag of 10g, and namely subpackage obtains Chinese medicine granules of the present invention.
Embodiment 2
The embodiment of the present invention 2 Chinese medicine preparation is mainly prepared from by the raw material of following parts by weight:
Clematis filamentosa Dunn 30 parts, Herba Viticis Cannabifoliae 28 parts, Radix clerodendri yunnanensis 35 parts, the Radix Aucklandiae 18 parts, Bulbus Allii Macrostemonis 23 parts, the Rhizoma Atractylodis Macrocephalae 20 parts, Rhizoma Dioscoreae 25 parts, Cortex Moutan 12 parts, Radix Scutellariae 15 parts, Cortex Albiziae 13 parts, Semen Ziziphi Spinosae 15 parts and 13 parts of Radix Glycyrrhizae.
Preparation method is with embodiment 1.
Embodiment 3
The embodiment of the present invention 3 Chinese medicine preparation is mainly prepared from by the raw material of following parts by weight:
Clematis filamentosa Dunn 25 parts, Herba Viticis Cannabifoliae 23 parts, Radix clerodendri yunnanensis 30 parts, the Radix Aucklandiae 15 parts, Bulbus Allii Macrostemonis 18 parts, the Rhizoma Atractylodis Macrocephalae 17 parts, Rhizoma Dioscoreae 20 parts, Cortex Moutan 10 parts, Radix Scutellariae 12 parts, Cortex Albiziae 10 parts, Semen Ziziphi Spinosae 12 parts and 9 parts of Radix Glycyrrhizae.
Preparation method is as follows:
S1: take Herba Viticis Cannabifoliae, crushed after being dried, cross 60 mesh sieves, be placed in supercritical carbon dioxide extraction apparatus, add the ethanol that 40% volume fraction is 75% of coarse powder weight, regulation and control carbon dioxide flow is 15L/h, extracting pressure is 18MPa, and extraction temperature is 45 DEG C, and extraction time is 2h, decompression separation prepares Herba Viticis Cannabifoliae extract, retains Herba Viticis Cannabifoliae residue；
S2: take Clematis filamentosa Dunn, Radix clerodendri yunnanensis, the Radix Aucklandiae, Bulbus Allii Macrostemonis, the Rhizoma Atractylodis Macrocephalae, Rhizoma Dioscoreae, Cortex Moutan, Radix Scutellariae, Cortex Albiziae, Semen Ziziphi Spinosae and Radix Glycyrrhizae, pulverizes, and merges the Herba Viticis Cannabifoliae residue described in S1, adds the water soaking 3h of medical material gross weight 10 times amount, decocts 3h, filters；Filtering residue adds the soak by water 2h of medical material gross weight 6 times amount, filters；Merging twice filtrate, being evaporated under 60 DEG C of environment relative density is the extractum of 1.25, and adding ethanol to alcohol content is 75%(v/v), stand 24h, take supernatant, reclaim ethanol, being evaporated under 60 DEG C of environment relative density is the extractum of 1.25；
S3: the Herba Viticis Cannabifoliae extract described in S1 and the extractum described in S2 are merged mixing, vacuum belt type drying is carried out at 60 DEG C of temperature, drying pressure is-0.09MPa, charging rate is 15L/h, material strip transfer rate is 26cm/min, dried by dry extract pulverizing, cross 100 mesh sieves, obtain Chinese medicine composition of the present invention；
S4: take the Chinese medicine composition described in S3 and add starch dilution, mix homogeneously in the ratio of 4:1, obtain mixing fine powders, standby；
S5: take mixing fine powders 60% ethanol described in S4 by nebulization moistening, soft material processed, crosses 14 mesh sieves and must wet grain, and wet grain is 60 DEG C of drying, dry granular crosses 14 mesh sieve granulate, adds the magnesium stearate mixing of dry granular gross weight 0.5%, tabletting, every tablet weight 0.25g, coating, obtain Chinese medicinal tablet of the present invention.
Embodiment 4
The embodiment of the present invention 4 Chinese medicine preparation is mainly prepared from by the raw material of following parts by weight:
Clematis filamentosa Dunn 28 parts, Herba Viticis Cannabifoliae 22 parts, Radix clerodendri yunnanensis 32 parts, the Radix Aucklandiae 15 parts, Bulbus Allii Macrostemonis 18 parts, the Rhizoma Atractylodis Macrocephalae 20 parts, Rhizoma Dioscoreae 23 parts, Cortex Moutan 12 parts, Radix Scutellariae 10 parts, Cortex Albiziae 9 parts, Semen Ziziphi Spinosae 12 parts and 13 parts of Radix Glycyrrhizae.
Preparation method is with embodiment 3.
Chinese medicine preparation pharmacodynamic study of the present invention:
Test one: the experimentation of Chinese medicine preparation of the present invention treatment original hypertensive rat
1, experimental animal: the Wistar rat 8 that SPF level is healthy, 9 ~ 11 week old, body weight 170 ~ 210g, male, it is set to Normal group.Original hypertensive rat (SHR) 40, SPF level, 10 ~ 12 week old, body weight 180 ~ 220g, male, it is randomly divided into 5 groups, often group 8.
2, trial drug and dosage regimen:
Drug test group of the present invention: trial drug is the Chinese medicinal tablet of the present invention that the embodiment of the present invention 3 prepares, and is deployed into, with water, the solution that concentration is 1.2g/ml, 0.8g/ml and 0.4g/ml after grinding into powder, standby.Take 3 groups of original hypertensive rats, it is labeled as high dose group (2.4g/kg), middle dosage group (1.6g/kg) and low dose group (0.8g/kg), high dose group concentration is the drug solution of 1.2g/ml, middle dosage group concentration is the drug solution of 0.8g/ml, low dose group concentration is the drug solution of 0.4g/ml, according to dosage every day early, late each gastric infusion once, successive administration 30d.
Model control group: take 1 group of original hypertensive rat, isometric(al) normal saline every day early, late each gavage once, continuous gavage 30d.
Positive controls: positive control drug is kendir pressure-reducing sheet (the quasi-word Z20093153 of traditional Chinese medicines, No. 2 TCM Factory), it is deployed into the solution of 1.2g/ml after grinding into powder with water, takes 1 group of original hypertensive rat, by dosage morning every day of 1.2g/kg, late each gastric infusion once, successive administration 30d.
Normal group: isometric(al) normal saline every day early, late each gavage once, continuous gavage 30d.
3, the mensuration of blood pressure, heart rate: before first gastric infusion after 2h and last administration 2h, measure tail systolic arterial pressure and the heart rate of each group of rat.Before pressure measurement, rat is put into (37 ± 1) DEG C electrothermostat preheating 15min, surveys continuously during pressure measurement 3 times, average as measured value.
4, result of the test: as shown in table 1.
Table 1 is respectively organized rat tail artery and is shunk buckling
Group Number of cases Tail systolic arterial pressure (mmHg) Heart rate (secondary/min)
Normal group 8 106.46±10.24 394±22
Model control group 8 179.62±15.66** 458±34**
Positive controls 8 146.22±11.48△ 416±28△
Low dose group 8 132.80±10.42△△ 412±24△
Middle dosage group 8 124.18±8.94△△# 404±20△
High dose group 8 112.86±10.58△△## 396±16△△#
Note: compare with Normal group,**P0.01；Compare with model control group,△P0.05,△△P0.01；Compare with positive controls,#P0.05,##P0.01。
5, conclusion (of pressure testing)
The experimentation of Chinese medicine preparation of the present invention treatment original hypertensive rat shows, Chinese medicine preparation of the present invention can significantly reduce the blood pressure (P0.01) of essential hypertension rat model, and wherein the middle dosage group of Chinese medicine preparation of the present invention and the antihypertensive effect of high dose group are all significantly better than positive controls (P0.05).Simultaneously, Chinese medicine preparation of the present invention is also equipped with slowing down the effect of essential hypertension rat model heart rate, low dose group is suitable with positive controls with the effect of middle dosage group, and the action effect of high dose group compares the difference (P0.05) with significance with positive controls.
To sum up, Chinese medicine preparation of the present invention is used for treating essential hypertension antihypertensive effect substantially, and therapeutic effect is notable, has very big clinical value.
Test two: the clinical trial of Chinese medicine preparation of the present invention
(1) diagnostic criteria and study subject select
Content with reference to " diagnosis basis of hypertension " of " China's hypertension prevention and control guide " (revised edition in 2010) and " new Chinese medicine guideline of clinical investigations " is drafted.
1, Western medicine diagnose standard, in Table 2.
The definition of table 2 blood pressure level and classification
When not using antihypertensive drugs, non-blood pressure of measuring for 3 times on the same day, contraction pressure >=140mmHg and/or diastolic pressure >=90mmHg, namely diagnosable for essential hypertension.
2, TCM syndrome diagnostic criteria
1) overabundant liver-fire syndrome
Primary symptom: dizziness, headache, being irritable and getting angry easily.
Secondary disease: flushing, conjunctival congestion, xerostomia, bitter taste, constipation, urinate red, red tongue with yellow fur, wiry and frequent pulse.
2) syndrome of hyperactivity of yang due to yin deficiency
Primary symptom: dizziness, headache, the soreness of waist, knee joint are soft, dysphoria with feverish sensation in the chest palms and soles.
Secondary disease: cardiopalmus, insomnia, tinnitus, the few tongue of forgetful, red tongue, stringy and thready pulse and count.
3) phlegm-damp stops up Sheng card
Primary symptom: dizziness, headache, head as wrapped up in, uncomfortable in chest, vomiting expectorant birth.
Secondary disease: cardiopalmus, insomnia, tastelessness, lack of appetite, enlarged tongue greasy fur, rolling pulse.
4) deficiency syndrome of both YIN and YANG
Primary symptom: dizziness, headache, the soreness of waist, knee joint are soft, aversion to cold and cold limbs.
Secondary disease: tinnitus, cardiopalmus, breathe hard, nocturia frequency, pale tongue with white fur, deep pulse thin and delicate.
Meet hypertension Western medicine diagnose standard and TCM syndrome diagnostic criteria, the age between 18 ~ 65 years old, non-medication, or take hypertension drug but after drug withdrawal two weeks, it is thus achieved that Informed Consent Form person, test case can be included in.
3, get rid of and reject case standard
1) secondary hypertension；
2) age is under-18s or over-65s, trimester of pregnancy or women breast-feeding their children, or those who are allergic to this drug；
3) the severe primary diseases such as cardiovascular and cerebrovascular vessel, Liver and kidney and hemopoietic system, psychotic it are associated with；
4) do not meet inclusive criteria, not by regulation medication, cannot judge that curative effect or data do not affect the treatment or safety judgement person entirely.
(2) clinical trial protocol
1, physical data
Obtain 320 examples by diagnosis standard screening and meet the clinical volunteers patient of essential hypertension diagnostic criteria, male 178 examples, female 142 example, 32 ~ 68 years old age, 54 years old mean age.It is divided into treatment A group, treatment B group, treatment C group and matched group four groups by random, double blinding, principle parallel, comparison, often organizing each 80 examples, two groups of patients are the influence factor such as sex, age, sick kind, state of an illness distribution, through statistical procedures, there was no significant difference, meet packet condition.
2, trial drug and test method
Treatment group: the formula of 1 ~ 3 according to embodiments of the present invention, prepares Chinese medicinal tablet of the present invention, and respectively as the trial drug for the treatment of A, B, C group, preparation method is with embodiment 3.Therapeutic modality be one time 2, one day three times, with 4 weeks for a course for the treatment of, after 3 courses for the treatment of evaluate curative effect.
Matched group: control drug is kendir pressure-reducing sheet (the quasi-word Z20093153 of traditional Chinese medicines, No. 2 TCM Factory), therapeutic modality be one time 4, one day three times, with 4 weeks for a course for the treatment of, after 3 courses for the treatment of evaluate curative effect.
3, curative effect determinate standard
Effective: 1) diastolic pressure more than decline 10mmHg, and reach normal range；2) though diastolic pressure do not drop to normally decline 20mmHg or more than.Must possess wherein 1.
Effective: 1) diastolic pressure decline is not as good as 10mmHg, but reached normal range；2) diastolic pressure relatively treats the front 10 ~ 19mmHg that declines, but not up to normal range；3) pressure front more than the decline 30mmHg of relatively treatment is shunk.Must possess wherein 1.
Invalid: not reach above standard person.
4, therapeutic outcome, as shown in table 3
Table 3 therapeutic effect
Group Number of cases Effective (rate) Effectively Invalid Total effective rate
Matched group 80 49(61.25%) 13 18 77.5%
Treatment A group 80 59(73.75%) 12 9 88.75%
Treatment B group 80 61(76.25%) 13 6 92.5%
Treatment C group 80 63(78.75%) 13 4 95%
5, conclusion (of pressure testing)
Clinical testing data shows, Chinese medicine preparation of the present invention is notable for essential hypertension therapeutic effect, and average obvious effective rate is 76.25%, and average total effective rate is 92.08%, and the total effective rate being significantly higher than comparison medicine is 80%.Treatment C group, the total effective rate of the Chinese medicine preparation of the present invention treatment essential hypertension that namely embodiment 3 prepares reaches 95%, for the optimal technical solution of Chinese medicine preparation of the present invention.Clinical observation finds, after taking two courses for the treatment of of Chinese medicine preparation of the present invention, patients' blood is decreased obviously, and the clinical symptoms such as dizziness, headache also substantially alleviates, and has no any untoward reaction during treatment.Clinical trial proves, Chinese medicine preparation antihypertensive effect of the present invention is notable, and drug safety is high, can as treatment essential hypertension drug use, and clinical generalization value is high.

Claims (7)

1. treat the Chinese medicine preparation of essential hypertension, it is characterised in that described Chinese medicine preparation is mainly prepared from by the raw material of following parts by weight:
Clematis filamentosa Dunn 20 ~ 30 parts, Herba Viticis Cannabifoliae 20 ~ 28 parts, Radix clerodendri yunnanensis 25 ~ 35 parts, the Radix Aucklandiae 12 ~ 18 parts, Bulbus Allii Macrostemonis 15 ~ 23 parts, the Rhizoma Atractylodis Macrocephalae 15 ~ 20 parts, Rhizoma Dioscoreae 15 ~ 25 parts, Cortex Moutan 8 ~ 12 parts, Radix Scutellariae 8 ~ 15 parts, Cortex Albiziae 7 ~ 13 parts, Semen Ziziphi Spinosae 8 ~ 15 parts and 5 ~ 13 parts of Radix Glycyrrhizae.
2. Chinese medicine preparation as claimed in claim 1, it is characterised in that described Chinese medicine preparation is mainly prepared from by the raw material of following parts by weight:
Clematis filamentosa Dunn 20 parts, Herba Viticis Cannabifoliae 20 parts, Radix clerodendri yunnanensis 25 parts, the Radix Aucklandiae 12 parts, Bulbus Allii Macrostemonis 15 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, Rhizoma Dioscoreae 15 parts, Cortex Moutan 8 parts, Radix Scutellariae 8 parts, Cortex Albiziae 7 parts, Semen Ziziphi Spinosae 8 parts and 5 parts of Radix Glycyrrhizae.
3. Chinese medicine preparation as claimed in claim 1, it is characterised in that described Chinese medicine preparation is mainly prepared from by the raw material of following parts by weight:
Clematis filamentosa Dunn 30 parts, Herba Viticis Cannabifoliae 28 parts, Radix clerodendri yunnanensis 35 parts, the Radix Aucklandiae 18 parts, Bulbus Allii Macrostemonis 23 parts, the Rhizoma Atractylodis Macrocephalae 20 parts, Rhizoma Dioscoreae 25 parts, Cortex Moutan 12 parts, Radix Scutellariae 15 parts, Cortex Albiziae 13 parts, Semen Ziziphi Spinosae 15 parts and 13 parts of Radix Glycyrrhizae.
4. Chinese medicine preparation as claimed in claim 1, it is characterised in that described Chinese medicine preparation is mainly prepared from by the raw material of following parts by weight:
Clematis filamentosa Dunn 25 parts, Herba Viticis Cannabifoliae 23 parts, Radix clerodendri yunnanensis 30 parts, the Radix Aucklandiae 15 parts, Bulbus Allii Macrostemonis 18 parts, the Rhizoma Atractylodis Macrocephalae 17 parts, Rhizoma Dioscoreae 20 parts, Cortex Moutan 10 parts, Radix Scutellariae 12 parts, Cortex Albiziae 10 parts, Semen Ziziphi Spinosae 12 parts and 9 parts of Radix Glycyrrhizae.
5. the Chinese medicine preparation as described in as arbitrary in claim 1-4, it is characterised in that described Chinese medicine preparation is granule, pill, powder, tablet, capsule or oral liquid.
6. the preparation method of the Chinese medicine preparation as described in as arbitrary in claim 1-4, it is characterised in that described preparation method comprises the following steps:
S1: take Herba Viticis Cannabifoliae, crushed after being dried, cross 60-100 mesh sieve, be placed in supercritical carbon dioxide extraction apparatus, add the ethanol that 30-45% volume fraction is 60-85% of coarse powder weight, regulation and control carbon dioxide flow is 15 ~ 20L/h, extracting pressure is 15 ~ 20MPa, and extraction temperature is 40 ~ 60 DEG C, and extraction time is 1.5 ~ 2h, decompression separation prepares Herba Viticis Cannabifoliae extract, retains Herba Viticis Cannabifoliae residue；
S2: take Clematis filamentosa Dunn, Radix clerodendri yunnanensis, the Radix Aucklandiae, Bulbus Allii Macrostemonis, the Rhizoma Atractylodis Macrocephalae, Rhizoma Dioscoreae, Cortex Moutan, Radix Scutellariae, Cortex Albiziae, Semen Ziziphi Spinosae and Radix Glycyrrhizae, pulverizes, and merges the Herba Viticis Cannabifoliae residue described in S1, adds the water soaking 2 ~ 4h of medical material gross weight 7 ~ 10 times amount, decocts 2 ~ 3h, filters；Filtering residue adds the soak by water 1 ~ 2h of medical material gross weight 4 ~ 6 times amount, filters；Merging twice filtrate, being evaporated under 60 ~ 65 DEG C of environment relative density is the extractum of 1.05 ~ 1.25, and adding ethanol to alcohol content is 60-90%(v/v), stand 12 ~ 36h, taking supernatant, reclaim ethanol, being evaporated under 60 ~ 65 DEG C of environment relative density is the extractum of 1.20 ~ 1.25；
S3: the Herba Viticis Cannabifoliae extract described in S1 and the extractum described in S2 are merged mixing, vacuum belt type drying is carried out at 60 DEG C of temperature, drying pressure is-0.09MPa, charging rate is 15L/h, material strip transfer rate is 26cm/min, dried by dry extract pulverizing, cross 100-200 mesh sieve, obtain Chinese medicine composition of the present invention.
7. the Chinese medicine preparation as claimed in claim 1 purposes in preparation treatment essential hypertension medicine.
CN201511007265.5A 2015-12-30 2015-12-30 Traditional Chinese medicinal preparation for treating primary hypertension and preparation method of traditional Chinese medicinal preparation Withdrawn CN105770353A (en)

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Application publication date: 20160720