CN105194355A - Traditional Chinese medicine preparation for treating primary hypertension - Google Patents

Traditional Chinese medicine preparation for treating primary hypertension Download PDF

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CN105194355A
CN105194355A CN201510768253.8A CN201510768253A CN105194355A CN 105194355 A CN105194355 A CN 105194355A CN 201510768253 A CN201510768253 A CN 201510768253A CN 105194355 A CN105194355 A CN 105194355A
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chinese medicine
radix
cortex
traditional chinese
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刘学键
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Qingdao Huazhicao Medical Technology Co Ltd
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Qingdao Huazhicao Medical Technology Co Ltd
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Abstract

The invention discloses a traditional Chinese medicine preparation for treating primary hypertension, belonging to the technical field of traditional Chinese medicines. The traditional Chinese medicine preparation is prepared from the following raw materials: parslane herb, clematis filamentosa Dunn, root of Yunnan glorybower, slender dutchmanspipe root, tall gastrodia tuber, eucommia bark, tree peony bark, ginkgo leaf, baikal skullcap root, silktree albizzia bark and liquorice root. The traditional Chinese medicine preparation is reasonable in medicine composition, has strong synergistic effects, stable effects and small medicine side effects and has obvious curative effects on primary hypertension and obvious clinical popularization value.

Description

A kind of Chinese medicine preparation for the treatment of essential hypertension
Technical field
The invention belongs to technical field of Chinese medicines, particularly relate to a kind of Chinese medicine preparation for the treatment of essential hypertension.
Background technology
By the standard of WHO, the blood pressure of human normal is systolic pressure <140mmHg and (or) diastolic pressure <90mmHg, and exceeding this scope can be diagnosed as 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, be called essential hypertension.Essential hypertension accounts for hyperpietic's more than 90%, normal with organ functional or organic changes such as fat and sugar metabolism disorder and the heart, brain, kidney and retinas, it is the paathogenic factor of apoplexy, coronary heart disease, retinopathy, kidney damage etc., research shows, the M & M of cardiovascular and cerebrovascular disease and blood pressure to increase degree closely related.
Doctor trained in Western medicine is thought, essential hypertension is the result of heredity, environment, anatomical structure, adaptability, nerve, endocrine, the many-sided comprehensive function of body fluid and hemodynamics, is that some congenital hereditary gene a kind of and many pathogenic supercharging factors and physiological reduce pressure factor interaction and the multi-factor disease that causes.Except foreign genetic element, high sodium low potassium meals in life, Bad Eating Habit and overweight, fat, the long-term psychentonia such as to drink, lack motion etc. and all likely bring out hypertension.So the cooperation outside Drug therapy and between non-drug therapy is focused in hypertensive treatment clinically, namely focuses on the cooperation between lifestyle modification and antihypertensive drug therapy.The antihypertensive drugs of the clinical frequent application of doctor trained in Western medicine mainly contains calcium ion antagonist, angiotensin-convertion enzyme inhibitor, β body blocker, this four class of diuretic, secondly C receptor blocking agent, vasodilation etc. are also had, these medicines all can have larger side effect usually, 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 with arteriotony rising with lastingly for disease, also has dizziness in addition, has a headache, neck plate is tight, fatigue, cardio palmus shape.The traditional Chinese medical science belongs to the disease categories such as Chinese medicine is dizzy, headache to hypertensive elaboration, and its pathogenesis is due to negative and positive of qi and blood imbalance, makes brains hollow, and venation is lost and supported, or clear sun is not opened up, or fire is disturbed key clearly and created all diseases of hypertension.After hypertension is formed, internal injury is long-pending damages in 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 further develops, 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 can occur cerebral hemorrhage apoplexy.Damage with the passing of time if internal injury is long-pending, hinder in kidney spleen, make kidney lose folding, board loses vaporization, and retention of water-damp in the body, namely the disease such as edema, renal failure occurs.
Chinese patent application 200710014082.5 discloses the hypertensive Chinese medicine composition of a kind of orally taken for curing, and its raw materials mainly comprises: Ganoderma, Radix Angelicae Sinensis, Cordyceps, Radix Gentianae, Ramulus Uncariae Cum Uncis, Folium Apocyni Veneti, the Cortex Eucommiae, Semen Cassiae, Spica Prunellae, Concha Margaritifera, Radix Glycyrrhizae and Pheretima.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 apply.
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 very important, little and the efficacy stability of Traditional Chinese Medical on Treating Hypertension drug side effect, can long-term safety medication, has a extensive future, but it is not remarkable to there is effect in the hypertensive Chinese medicine of existing prevention and therapy, onset waits not enough slowly, seeks a kind of Be very effective, rapid-action, the Chinese medicine preparation of taking convenience, has great importance to the clinical treatment of essential hypertension.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of Chinese medicine preparation for the treatment of essential hypertension and preparation method thereof, 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 etc., also possess the advantages such as rapid-action, therapeutic effect remarkable, efficacy stability, drug side effect are low simultaneously, can as the hyperpietic long-term prescription for the treatment of, simultaneously low, the taking convenience of Chinese medicine preparation cost of the present invention, is easy to apply.
A kind of Chinese medicine preparation for the treatment of essential hypertension is prepared from by the raw material of following parts by weight:
Herba Portulacae 10-30 part, Clematis filamentosa Dunn 15-30 part, Radix clerodendri yunnanensis 12-28 part, Radix Aristolochiae 10-20 part, Rhizoma Gastrodiae 10-18 part, Cortex Eucommiae 8-16 part, Cortex Moutan 6-14 part, Folium Ginkgo 6-12 part, Radix Scutellariae 4-10 part, Cortex Albiziae 4-14 part and Radix Glycyrrhizae 1-10 part.
Preferably, described Chinese medicine preparation is prepared from by the raw material of following parts by weight:
Herba Portulacae 10 parts, Clematis filamentosa Dunn 15 parts, Radix clerodendri yunnanensis 12 parts, Radix Aristolochiae 10 parts, 10 parts, Rhizoma Gastrodiae, the Cortex Eucommiae 8 parts, Cortex Moutan 6 parts, Folium Ginkgo 6 parts, Radix Scutellariae 4 parts, Cortex Albiziae 4 parts and 1 part, Radix Glycyrrhizae.
Preferably, described Chinese medicine preparation is prepared from by the raw material of following parts by weight:
Herba Portulacae 30 parts, Clematis filamentosa Dunn 30 parts, Radix clerodendri yunnanensis 28 parts, Radix Aristolochiae 20 parts, 18 parts, Rhizoma Gastrodiae, the Cortex Eucommiae 16 parts, Cortex Moutan 14 parts, Folium Ginkgo 12 parts, Radix Scutellariae 10 parts, Cortex Albiziae 14 parts and 10 parts, Radix Glycyrrhizae.
Preferably, described Chinese medicine preparation is prepared from by the raw material of following parts by weight:
Herba Portulacae 20 parts, Clematis filamentosa Dunn 22 parts, Radix clerodendri yunnanensis 20 parts, Radix Aristolochiae 15 parts, 14 parts, Rhizoma Gastrodiae, the Cortex Eucommiae 12 parts, Cortex Moutan 10 parts, Folium Ginkgo 8 parts, Radix Scutellariae 7 parts, Cortex Albiziae 7 parts and 5 parts, Radix Glycyrrhizae.
Accordingly, the present invention also provides the preparation method of described Chinese medicine preparation, and the preparation method of described Chinese medicine preparation comprises the following steps:
(1): get Herba Portulacae, wash away impurity, crushed after being dried, cross 60-80 mesh sieve, adding medical material gross weight 8-10 times amount volume fraction is the ethanol of 60-80%, microwave extraction 8-15 minute, microwave power is 240-300W, and Extracting temperature is 40-60 DEG C, filters and retains Herba Portulacae medicinal residues, the extractum that relative density is 1.20-1.25 is surveyed, obtained Herba portulacae extract at filtrate reduced in volume to 60 DEG C;
(2): get Clematis filamentosa Dunn, Radix clerodendri yunnanensis, Radix Aristolochiae, Rhizoma Gastrodiae, the Cortex Eucommiae, Cortex Moutan, Folium Ginkgo, Radix Scutellariae, Cortex Albiziae and Radix Glycyrrhizae, wash away impurity, crushed after being dried, merge Herba Portulacae medicinal residues, add the water of coarse powder total amount 15-20 times amount, soak 20-30 minute, reflux, extract, 2-3 time, each 1-3 hour, filter, merging filtrate, surveys the extractum that relative density is 1.10-1.20 at filtrate reduced in volume to 60 DEG C, cooling, slowly add ethanol while stirring to alcohol content for reaching 40-60%, 4 DEG C of standing 12-24 hour, filter and retain filtering residue, obtain filtrate A;
(3): the filtering residue obtained in (2) slowly being added while stirring its weight 4-6 times amount volume fraction is the ethanol of 40-60%, 4 DEG C of standing 3-5 hour, filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 2-3 time of 40-60% again, collects and merges cleaning mixture;
(4): merging filtrate A, liquor B and cleaning mixture, survey extractum that relative density be 1.20-1.25 under being evaporated to 60 DEG C of conditions after mixing;
(5): extractum obtained in Herba portulacae extract and (4) is merged mixing, vacuum belt type drying is carried out at 60 DEG C of temperature, drying pressure is-0.08MPa, charging rate is 12L/h, material strip transfer rate is 28cm/min, after drying, dry extract is pulverized, cross 100-200 mesh sieve, obtain Chinese medicine preparation of the present invention.
The dosage form of above-mentioned Chinese medicine preparation is granule, pill, powder, tablet, capsule or oral liquid.
Source, the nature and flavor of Chinese medicine preparation of the present invention Chinese crude drug used, return through and effect:
Herba Portulacae: this product is the dry aerial parts of portulacaceous plant Herba Portulacae.Sour in the mouth, cold in nature; Return liver, large intestine channel; Removing toxic substances, inhibiting bacteria and diminishing inflammation, diuresis dysentery relieving, intestine moistening disappear stagnant, debug, improving eyesight and suppression metrorrhagia.
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.
Radix clerodendri yunnanensis: this product is Verbena officinalis Ke Cheng paulownia platymiscium Radix clerodendri yunnanensis, is used as medicine with root and leaf.Acrid in the mouth, warm in nature; Return lung, urinary bladder channel; Wind-expelling pain-stopping, promoting diuresis to eliminate dampness and promoting QI circulation, blood pressure lowering.
Radix Aristolochiae: this product is the dry root of aristolochiaceae plant Fructus Aristolochiae.Acrid in the mouth, hardship, cold in nature; Attach to the lung and stomach meridians; Promoting the circulation of QI to relieve pain, removing toxic substances and promoting subsidence of swelling, suppressing the hyperactive liver blood pressure lowering.
The Cortex Eucommiae: this product is the dry bark of the Eucommiaceae plant Cortex Eucommiae.Sweet in the mouth, warm in nature; Return liver, kidney channel; Invigorating the liver and kidney, bone and muscle strengthening, antiabortive.
Rhizoma Gastrodiae: this product is the dry tuber of orchid Rhizoma Gastrodiae.Sweet in the mouth, property is put down; Return Liver Channel; Endogenous wind stopping relieving convulsion, suppressing the hyperactive liver sun, dispelling wind and removing obstruction in the collateral.
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.
Folium Ginkgo: this product is the dried leaves of Ginkgoaceae plant Ginkgo biloba.Sweet in the mouth, hardship, puckery, property is put down; GUIXIN, lung meridian; Blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain, astringes the lung and relievings asthma, and changes turbid blood fat reducing.
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.
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 Herba Portulacae, Clematis filamentosa Dunn and Radix clerodendri yunnanensis for monarch drug, blood pressure lowering, clearing away liver-fire, promoting diuresis to eliminate dampness and promoting QI circulation; With Radix Aristolochiae, Rhizoma Gastrodiae and the Cortex Eucommiae for ministerial drug, suppressing the hyperactive liver blood pressure lowering, liver and kidney tonifying, endogenous wind stopping relieving convulsion, dredging collateral, circulation of qi promoting; With Cortex Moutan, Folium Ginkgo, Radix Scutellariae and Cortex Albiziae for adjuvant drug, blood circulation promoting and blood stasis dispelling, resolving stagnation for tranquilization, changes 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, makes all medicines arrange in pairs or groups, synergism, jointly reaches 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, has very significant therapeutic effect to essential hypertension.
The present invention also discloses a kind of purposes of above-mentioned Chinese medicine preparation, i.e. the purposes of above-mentioned Chinese medicine preparation in preparation treatment essential hypertension medicine.Chinese medicine preparation treatment rat primary hypertension model test display of the present invention, Chinese medicine preparation of the present invention is used for the treatment of essential hypertension and has the effect significantly reduced blood pressure, and also has certain effect of slowing down to the heart rate of rat simultaneously; Clinical trial also shows, drug regimen of the present invention is used for the treatment of essential hypertension, Be very effective, clinical symptoms such as dizzy, headache etc. common to essential hypertension also has significant improvement result, the average total effective rate for the treatment of essential hypertension reaches 92.67%, and its therapeutic effect is significantly higher than positive control drug.Chinese medicine preparation therapeutic effect of the present invention is remarkable, and rapid-action, drug side effect is low, and can be used as the drug use for the treatment of essential hypertension, 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, and toxic and side effects is little, and efficacy stability, easy to use, drug compliance is high, is applicable to the long-term treatment of essential hypertension.
(2) pharmacological evaluation display, Chinese medicine preparation of the present invention as treatment essential hypertension drug use time, drug effect is comprehensive, have rapid-action, good effects etc. treat advantage significantly, effectively can reduce the generation of hypertension complication, improve 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 simultaneously, rapid-action, toxic and side effects is low and be easy to advantages such as applying.
Detailed description of the invention
Below by way of specific embodiment, the present invention is described further, it will be understood by those skilled in the art that the present invention also can make other similar changes and obtains similar result and do not depart from content of the present invention and scope except following examples.
embodiment 1
The embodiment of the present invention 1 Chinese medicine granules is prepared from by the raw material of following parts by weight: Herba Portulacae 10 parts, Clematis filamentosa Dunn 15 parts, Radix clerodendri yunnanensis 12 parts, Radix Aristolochiae 10 parts, 10 parts, Rhizoma Gastrodiae, the Cortex Eucommiae 8 parts, Cortex Moutan 6 parts, Folium Ginkgo 6 parts, Radix Scutellariae 4 parts, Cortex Albiziae 4 parts and 1 part, Radix Glycyrrhizae.
Preparation method is as follows:
(1): get Herba Portulacae, wash away impurity, crushed after being dried, cross 60 mesh sieves, adding medical material gross weight 8 times amount volume fraction is the ethanol of 60%, microwave extraction 8 minutes, microwave power is 240W, and Extracting temperature is 40 DEG C, filters and retains Herba Portulacae medicinal residues, the extractum that relative density is 1.20-1.25 is surveyed, obtained Herba portulacae extract at filtrate reduced in volume to 60 DEG C;
(2): get Clematis filamentosa Dunn, Radix clerodendri yunnanensis, Radix Aristolochiae, Rhizoma Gastrodiae, the Cortex Eucommiae, Cortex Moutan, Folium Ginkgo, Radix Scutellariae, Cortex Albiziae and Radix Glycyrrhizae, wash away impurity, crushed after being dried, merge Herba Portulacae medicinal residues, add the water of coarse powder total amount 15 times amount, soak 20 minutes, reflux, extract, 2 times, each 1 hour, filter, merging filtrate, surveys the extractum that relative density is 1.10-1.20 at filtrate reduced in volume to 60 DEG C, cooling, slowly add ethanol while stirring to alcohol content for reaching 40%, 4 DEG C leave standstill 12 hours, filter and retain filtering residue, obtaining filtrate A;
(3): the filtering residue obtained in (2) slowly being added while stirring its weight 4 times amount volume fraction is the ethanol of 40%, 4 DEG C leave standstill 3 hours, filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 2 times of 40% again, collects and merges cleaning mixture;
(4): merging filtrate A, liquor B and cleaning mixture, survey extractum that relative density be 1.20-1.25 under being evaporated to 60 DEG C of conditions after mixing;
(5): extractum obtained in Herba portulacae extract and (4) is merged mixing, vacuum belt type drying is carried out at 60 DEG C of temperature, drying pressure is-0.08MPa, charging rate is 12L/h, material strip transfer rate is 28cm/min, after drying, dry extract is pulverized, cross 100 mesh sieves, obtain Chinese medicine preparation of the present invention;
(6): in above-mentioned Chinese medicine preparation, add the filler Icing Sugar of equivalent, wetting agent distilled water, disintegrating agent hydroxypropyl starch and lubricant Pulvis Talci; mix homogeneously; obtain soft material processed; soft material processed is put into rotary extrusion type granulator; obtain wet granular, dry, cross 20 mesh sieve removing big particles; make uniform particles, obtain Chinese medicinal composition granules of the present invention.
embodiment 2
The embodiment of the present invention 2 Chinese medicinal tablet is prepared from by the raw material of following parts by weight: Herba Portulacae 30 parts, Clematis filamentosa Dunn 30 parts, Radix clerodendri yunnanensis 28 parts, Radix Aristolochiae 20 parts, 18 parts, Rhizoma Gastrodiae, the Cortex Eucommiae 16 parts, Cortex Moutan 14 parts, Folium Ginkgo 12 parts, Radix Scutellariae 10 parts, Cortex Albiziae 14 parts and 10 parts, Radix Glycyrrhizae.
Preparation method is as follows:
(1): get Herba Portulacae, wash away impurity, crushed after being dried, cross 80 mesh sieves, adding medical material gross weight 10 times amount volume fraction is the ethanol of 80%, microwave extraction 15 minutes, microwave power is 300W, and Extracting temperature is 60 DEG C, filters and retains Herba Portulacae medicinal residues, the extractum that relative density is 1.20-1.25 is surveyed, obtained Herba portulacae extract at filtrate reduced in volume to 60 DEG C;
(2): get Clematis filamentosa Dunn, Radix clerodendri yunnanensis, Radix Aristolochiae, Rhizoma Gastrodiae, the Cortex Eucommiae, Cortex Moutan, Folium Ginkgo, Radix Scutellariae, Cortex Albiziae and Radix Glycyrrhizae, wash away impurity, crushed after being dried, merge Herba Portulacae medicinal residues, add the water of coarse powder total amount 20 times amount, soak 30 minutes, reflux, extract, 3 times, each 3 hours, filter, merging filtrate, surveys the extractum that relative density is 1.10-1.20 at filtrate reduced in volume to 60 DEG C, cooling, slowly add ethanol while stirring to alcohol content for reaching 60%, 4 DEG C leave standstill 24 hours, filter and retain filtering residue, obtaining filtrate A;
(3): the filtering residue obtained in (2) slowly being added while stirring its weight 6 times amount volume fraction is the ethanol of 60%, 4 DEG C leave standstill 5 hours, filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 3 times of 60% again, collects and merges cleaning mixture;
(4): merging filtrate A, liquor B and cleaning mixture, survey extractum that relative density be 1.20-1.25 under being evaporated to 60 DEG C of conditions after mixing;
(5): extractum obtained in Herba portulacae extract and (4) is merged mixing, vacuum belt type drying is carried out at 60 DEG C of temperature, drying pressure is-0.08MPa, charging rate is 12L/h, material strip transfer rate is 28cm/min, after drying, dry extract is pulverized, cross 200 mesh sieves, obtain Chinese medicine preparation of the present invention;
(6): in above-mentioned Chinese medicine preparation, add appropriate starch, magnesium stearate as adjuvant, tabletting after granulating, obtains Chinese medicine composition tablet of the present invention.
embodiment 3
The embodiment of the present invention 3 Chinese medicinal tablet is prepared from by the raw material of following parts by weight: Herba Portulacae 20 parts, Clematis filamentosa Dunn 22 parts, Radix clerodendri yunnanensis 20 parts, Radix Aristolochiae 15 parts, 14 parts, Rhizoma Gastrodiae, the Cortex Eucommiae 12 parts, Cortex Moutan 10 parts, Folium Ginkgo 8 parts, Radix Scutellariae 7 parts, Cortex Albiziae 7 parts and 5 parts, Radix Glycyrrhizae.
Preparation method is with embodiment 2.
chinese medicine preparation pharmacodynamic study of the present invention:
test one: the experimentation of Chinese medicine preparation treatment original hypertensive rat of the present invention
1, experimental animal: the Wistar rat of SPF level health 10,10-12 week age, body weight 180-220g, male, be set to Normal group.Original hypertensive rat (SHR) 80, SPF level, 10-12 week age, body weight 200-240g, male, be divided into 8 groups at random, often organize 10.
2, trial drug and dosage regimen:
Drug test group 1 of the present invention: trial drug is the Chinese medicinal tablet of the present invention that the embodiment of the present invention 2 obtains, and grinds rear water into powder and is deployed into the solution that concentration is 0.6g/ml, 0.4g/ml and 0.2g/ml, for subsequent use.Get 3 groups of original hypertensive rats, be labeled as high dose group 1(2.4g/kg), middle dosage group 1(1.6g/kg) and low dose group 1(0.8g/kg), high dose group 1 is the drug solution of 0.6g/ml by concentration, middle dosage group 1 is the drug solution of 0.4g/ml by concentration, low dose group 1 is the drug solution of 0.2g/ml by concentration, according to dosage morning every day, late each gastric infusion are once, successive administration 30d.
Drug test group 2 of the present invention: trial drug is the Chinese medicinal tablet of the present invention that the embodiment of the present invention 3 obtains, and grinds rear water into powder and is deployed into the solution that concentration is 0.6g/ml, 0.4g/ml and 0.2g/ml, for subsequent use.Get 3 groups of original hypertensive rats, be labeled as high dose group 2(2.4g/kg), middle dosage group 2(1.6g/kg) and low dose group 2(0.8g/kg), high dose group 2 is the drug solution of 0.6g/ml by concentration, middle dosage group 2 is the drug solution of 0.4g/ml by concentration, low dose group 2 is the drug solution of 0.2g/ml by concentration, according to dosage morning every day, late each gastric infusion are once, successive administration 30d.
Model control group: get 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 accurate word Z20093153 of traditional Chinese medicines, No. 2 TCM Factory), grind the solution that rear water is deployed into 0.6g/ml into powder, get 1 group of original hypertensive rat, by dosage morning every day of 2.4g/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, survey 3 times continuously during pressure measurement, average as measured value.
4, result of the test: as shown in table 1.
Table 1 respectively group rat tail artery systolic pressure change
Note: compare with Normal group, * p<0.01; Compare with model control group, p<0.05, △ △ p<0.01; Compare with positive controls, # p<0.05, ## p<0.01.
5, conclusion (of pressure testing)
The experimentation display of Chinese medicine preparation of the present invention treatment original hypertensive rat, Chinese medicine preparation of the present invention can significantly reduce essential hypertension rat model blood pressure ( p<0.01), wherein the middle dosage group of Chinese medicine preparation of the present invention and the antihypertensive effect of high dose group be all significantly better than positive controls ( p<0.05).Meanwhile, Chinese medicine preparation of the present invention also possesses the effect of the essential hypertension rat model heart rate that slows down, and the effect of low dose group and middle dosage group and positive controls are suitable, the action effect of high dose group compare with positive controls there is significance difference ( p<0.05).
To sum up, it is obvious that Chinese medicine preparation of the present invention is used for the treatment of essential hypertension antihypertensive effect, and therapeutic effect is remarkable, has very large clinical value.
test two: the clinical trial of Chinese medicine preparation of the present invention
(1) diagnostic criteria and study subject are selected
The content of " diagnosis basis of hypertension " of reference " Chinese 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-3 Measure blood pressures on the same day, systolic pressure >=140mmHg and/or diastolic pressure >=90mmHg, can be diagnosed as essential hypertension.
2, TCM syndrome diagnostic criteria
1) overabundant liver-fire syndrome
Primary symptom: dizzy, 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: dizzy, 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 counting.
3) phlegm-damp stops up Sheng card
Primary symptom: dizzy, 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: dizzy, 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 be thin and delicate.
Meet hypertension Western medicine diagnose standard and TCM syndrome diagnostic criteria, non-medication, or take hypertension drug but drug withdrawal after two weeks, obtained Informed Consent Form person, can include test case between 18 ~ 65 years old the age.
3, get rid of and reject case standard
1) secondary hypertension;
2) age is at 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 are associated with, psychotic;
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 by diagnosis standard screening the clinical volunteers patient that 400 examples meet essential hypertension diagnostic criteria, man 220 example, female 180 example, age 30-65 year, 50 years old mean age.Treatment A group, treatment B group, treatment C group and matched group four groups is divided into by random, double blinding, principle that is parallel, contrast, often organize each 100 examples, two groups of patients the influence factor such as sex, age, sick kind, state of an illness distribution, through statistical procedures, there was no significant difference, meets a point set condition.
2, trial drug and test method
Treatment group: according to the formula of embodiment of the present invention 1-3, 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 2.Therapeutic modality be one time 4, one day three times, be a course for the treatment of with 4 weeks, after 3 courses for the treatment of, evaluate curative effect.
Matched group: control drug is kendir pressure-reducing sheet (the accurate word Z20093153 of traditional Chinese medicines, No. 2 TCM Factory), the same treatment group of therapeutic modality.
3, curative effect determinate standard
Effective: 1) diastolic pressure more than decline 10mmHg, and reach normal range; 2) though diastolic pressure is not down to normally but decline 20mmHg or more.Wherein 1 must be possessed.
Effective: 1) diastolic pressure declines not as good as 10mmHg, but reaches normal range; 2) diastolic pressure comparatively treats front decline 10-19mmHg, but does not reach normal range; 3) systolic pressure comparatively treats front more than decline 30mmHg.Wherein 1 must be possessed.
Invalid: not reach above standard person.
4, therapeutic outcome, as shown in table 3
Table 3 therapeutic effect
5, conclusion (of pressure testing)
Clinical testing data shows, and Chinese medicine preparation of the present invention is remarkable for essential hypertension therapeutic effect, and average obvious effective rate is 67.67%, and average total effective rate is 92.67%, and the total effective rate being significantly higher than contrast medicine is 80%.Treatment C group, the total effective rate that the Chinese medicine preparation of the present invention that namely embodiment 3 prepares treats essential hypertension reaches 95%, is the optimal technical solution of Chinese medicine preparation of the present invention.The clinical symptoms such as clinical observation finds, after taking two courses for the treatment of of Chinese medicine preparation of the present invention, patients' blood obviously declines, dizzy, headache also obviously alleviate, and treatments period has no any untoward reaction.Clinical trial proves, Chinese medicine preparation antihypertensive effect of the present invention is remarkable, and drug safety is high, and can be used as the drug use for the treatment of essential hypertension, clinical generalization value is high.

Claims (5)

1. treat the Chinese medicine preparation of essential hypertension for one kind, it is characterized in that, described Chinese medicine preparation is prepared from by the raw material of following parts by weight: Herba Portulacae 10-30 part, Clematis filamentosa Dunn 15-30 part, Radix clerodendri yunnanensis 12-28 part, Radix Aristolochiae 10-20 part, Rhizoma Gastrodiae 10-18 part, Cortex Eucommiae 8-16 part, Cortex Moutan 6-14 part, Folium Ginkgo 6-12 part, Radix Scutellariae 4-10 part, Cortex Albiziae 4-14 part and Radix Glycyrrhizae 1-10 part.
2. the Chinese medicine preparation for the treatment of essential hypertension as claimed in claim 1, it is characterized in that, described Chinese medicine preparation is prepared from by the raw material of following parts by weight: Herba Portulacae 10 parts, Clematis filamentosa Dunn 15 parts, Radix clerodendri yunnanensis 12 parts, Radix Aristolochiae 10 parts, 10 parts, Rhizoma Gastrodiae, the Cortex Eucommiae 8 parts, Cortex Moutan 6 parts, Folium Ginkgo 6 parts, Radix Scutellariae 4 parts, Cortex Albiziae 4 parts and 1 part, Radix Glycyrrhizae.
3. the Chinese medicine preparation for the treatment of essential hypertension as claimed in claim 1, it is characterized in that, described Chinese medicine preparation is prepared from by the raw material of following parts by weight: Herba Portulacae 30 parts, Clematis filamentosa Dunn 30 parts, Radix clerodendri yunnanensis 28 parts, Radix Aristolochiae 20 parts, 18 parts, Rhizoma Gastrodiae, the Cortex Eucommiae 16 parts, Cortex Moutan 14 parts, Folium Ginkgo 12 parts, Radix Scutellariae 10 parts, Cortex Albiziae 14 parts and 10 parts, Radix Glycyrrhizae.
4. the Chinese medicine preparation for the treatment of essential hypertension as claimed in claim 1, it is characterized in that, described Chinese medicine preparation is prepared from by the raw material of following parts by weight: Herba Portulacae 20 parts, Clematis filamentosa Dunn 22 parts, Radix clerodendri yunnanensis 20 parts, Radix Aristolochiae 15 parts, 14 parts, Rhizoma Gastrodiae, the Cortex Eucommiae 12 parts, Cortex Moutan 10 parts, Folium Ginkgo 8 parts, Radix Scutellariae 7 parts, Cortex Albiziae 7 parts and 5 parts, Radix Glycyrrhizae.
5. the Chinese medicine preparation of the treatment essential hypertension as described in any one of claim 1-4, is characterized in that: the dosage form of described Chinese medicine preparation is granule, pill, powder, tablet, capsule or oral liquid.
CN201510768253.8A 2015-11-12 2015-11-12 Traditional Chinese medicine preparation for treating primary hypertension Withdrawn CN105194355A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108236694A (en) * 2018-04-20 2018-07-03 薛春玲 A kind of Chinese medicine composition for treating essential hypertension
CN108420868A (en) * 2018-06-08 2018-08-21 深圳市中医院 A kind of Chinese herbal medicine foot care formula for treating essential hypertension

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108236694A (en) * 2018-04-20 2018-07-03 薛春玲 A kind of Chinese medicine composition for treating essential hypertension
CN108420868A (en) * 2018-06-08 2018-08-21 深圳市中医院 A kind of Chinese herbal medicine foot care formula for treating essential hypertension
CN108420868B (en) * 2018-06-08 2021-01-12 深圳市中医院 Chinese herbal medicine foot-bath medicine for treating primary hypertension

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Application publication date: 20151230