CN104491237A

CN104491237A - Use of traditional Chinese medicine preparation in preparing medicines for treating primary hypertension

Info

Publication number: CN104491237A
Application number: CN201410754595.XA
Authority: CN
Inventors: 邓凤桂
Original assignee: GUANGDONG JUZHICHENG TECHNOLOGY Co Ltd
Current assignee: GUANGDONG JUZHICHENG TECHNOLOGY Co Ltd
Priority date: 2014-12-11
Filing date: 2014-12-11
Publication date: 2015-04-08

Abstract

The invention relates to a use of a traditional Chinese medicine preparation in preparing medicines for treating primary hypertension. The traditional Chinese medicine preparation is prepared from such major traditional Chinese medicinal materials as oriental waterplantain rhizome, Szechuan lovage rhizome, milkvetch root, largehead atractylodes rhizome, cassia seed, honeysuckle, hawthorn, Chinese taxillus twig, motherwort herb, earthworm, selfheal, dogbane leaf, danshen, mint, talcum powder and liquorice root; the traditional Chinese medicinal materials are processed to obtain the clinically desired finished product preparation by virtue of a method disclosed by the invention, has the treatment technical advantages such as treatment of both symptoms and root causes, difficulty to recur, no drug dependence and no any toxic and side effects on the primary hypertension, and also has the popularization advantages such as simple and convenient preparation process, stable preparation efficacy, good universal adaptability and easy popularization and application.

Description

The purposes of a kind of Chinese medicine preparation in preparation treatment essential hypertension medicine

Technical field

The present invention relates to the purposes of a kind of Chinese medicine preparation in preparation treatment essential hypertension medicine, belong to the field of Chinese medicines.

Background technology

Doctor trained in Western medicine is thought, based on current medical development level and detection methods, can find the definite cause of disease causing blood pressure to raise, be referred to as secondary hypertension; Otherwise, the definite cause of disease causing blood pressure to raise can not be found, be then called essential hypertension.In Hypertensive Population, majority is essential hypertension, but essential hypertension of clarifying a diagnosis, secondary hypertension except needing first.Think at present, secondary hypertension accounts for 5% ~ 10% of Hypertensive Population, but along with the continuous progress of medical development level and detection methods, the ratio of secondary hypertension will constantly increase, the continuous decline of ratio regular meeting of essential hypertension.

At present, the means of western medical treatment essential hypertension mainly use medicine blood pressure lowering, can only alleviate disease, can not eradicate, and easily cause drug dependence, make the dosage of patient on medication increasing, and effect but worse and worse.

The traditional Chinese medical science is thought, by dialectical Analyses, hypertension is divided into following 6 types:

(1), liver-Yang sthenia type: show to raise with blood pressure and doublely see dizzy, companion's distending pain of the head and eyes, flushed face with red ears, irritable, red tongue with yellow fur, wiry and frequent pulse are dialectical main points.Treatment: the method that suppressing the hyperactive liver and subsiding YANG, nourishing the liver and kidney should be used.

(2), liver-kidney yin deficiency: raise with blood pressure and doublely see dizzy, companioned with headache tinnitus, soreness of the waist and knees, the few tongue of red tongue, thready and rapid pulse are dialectical main points.Treatment: nourishing the liver and kidney, yin nourishing replenishing essence method should be used.

(3), deficiency of both YIN and YANG type: with blood pressure raise double see have a dizzy spell, palpitation and insomnia, lassitude loin and legs, aversion to cold and cold limbs, clear urine in large amounts, light red tongue, deep-thready pulse be dialectical main points.Treatment: Yin-nourishing and Yang-supporting method should be used.

(4), stagnation of turbid phlegm in middle-JIAO type: this card is more common in obesity-related hypertension patient.With blood pressure raise double see dizzy feeling of fullness in the head, heavy as wrapped up in, the heavy numbness of excessive phlegm uncomfortable in chest, limbs, greasy fur, rolling pulse be dialectical main points.Treatment: dispelling phlegm and eliminating dampness, invigorating the spleen and regulating the stomach method should be used.

(5), congestion accumulation type: see that dizziness headache such as thorn, localized pain, chest distress and palpitation symptoms, purplish tongue, thready and hesitant pulse are dialectical main points so that blood pressure rising is double.Treatment: should activating blood circulation to dissipate blood stasis, regulating QI to relieve pain.

(6), Chong and Ren channel disorder type: before and after the common Woman climacteric of assertive evidence, unstable blood pressure is fixed, how to fluctuate with emotion changes.See that dizziness headache, susceptible to lose temper due to restlessness, two side of body distending pains, red tongue, stringy and thready pulse are dialectical main points so that blood pressure rising is double.Treatment: nourishing the liver and kidney should be used, be in harmonious proportion to rush and appoint method.

The present invention just based on above to hypertensive dialectical cognition, in conjunction with self experience of practising medicine and clinical repeatedly grope checking, take into account various typing, again compatibility medical material, form technical scheme of the present invention.

Summary of the invention

The technical problem to be solved in the present invention is, develops the purposes of a kind of Chinese medicine preparation in preparation treatment essential hypertension medicine, requires that Chinese medicine preparation agent has good therapeutic effect to essential hypertension, and be easy to apply.

The scheme that inventor solves the problems of the technologies described above is, according to the traditional Chinese medical science to the dialectical cognition of essential hypertension, in conjunction with self experience of practising medicine for many years and modern clinic Medicinal Trait, again compatibility medical material, invent a new Chinese prescription, this prescription not only has very significant therapeutic effect to essential hypertension, and the special preparation technology that can be utilized as its research and development makes finished product preparation, and can ensure the stability of curative effect and drug effect.This Chinese prescription is expressed as with the weight portion of raw material:

Rhizoma Alismatis 15-33 part, Rhizoma Chuanxiong 12-26 part, Radix Astragali 10-30 part, Rhizoma Atractylodis Macrocephalae 14-30 part, Semen Cassiae 9-25 part, Flos Lonicerae 8-24 part, Fructus Crataegi 9-27 part, Herba Taxilli 7-24 part, Herba Leonuri 17-35 part, Pheretima 7-15 part, Spica Prunellae 7-19 part, Herba Apocyni veneti 4-12 part, Radix Salviae Miltiorrhizae 7-21 part, Herba Menthae 4-11 part, Talcum 6-14 part, Radix Glycyrrhizae 7-15 part.

The proportioning that in practice, preferably out 4 are evident in efficacy is (with parts by weight):

1, Rhizoma Alismatis 24 parts, Rhizoma Chuanxiong 18 parts, the Radix Astragali 20 parts, the Rhizoma Atractylodis Macrocephalae 22 parts, Semen Cassiae 17 parts, Flos Lonicerae 16 parts, Fructus Crataegi 18 parts, Herba Taxilli 15 parts, Herba Leonuri 26 parts, Pheretima 11 parts, Spica Prunellae 13 parts, Herba Apocyni veneti 8 parts, Radix Salviae Miltiorrhizae 14 parts, Herba Menthae 8 parts, 10 parts, Talcum, 11 parts, Radix Glycyrrhizae.

2, Rhizoma Alismatis 26 parts, Rhizoma Chuanxiong 19 parts, the Radix Astragali 23 parts, the Rhizoma Atractylodis Macrocephalae 21 parts, Semen Cassiae 19 parts, Flos Lonicerae 17 parts, Fructus Crataegi 17 parts, Herba Taxilli 14 parts, Herba Leonuri 24 parts, Pheretima 10 parts, Spica Prunellae 14 parts, Herba Apocyni veneti 7 parts, Radix Salviae Miltiorrhizae 15 parts, Herba Menthae 8 parts, 11 parts, Talcum, 12 parts, Radix Glycyrrhizae.

3, Rhizoma Alismatis 25 parts, Rhizoma Chuanxiong 17 parts, the Radix Astragali 21 parts, the Rhizoma Atractylodis Macrocephalae 23 parts, Semen Cassiae 16 parts, Flos Lonicerae 18 parts, Fructus Crataegi 16 parts, Herba Taxilli 17 parts, Herba Leonuri 28 parts, Pheretima 12 parts, Spica Prunellae 14 parts, Herba Apocyni veneti 9 parts, Radix Salviae Miltiorrhizae 16 parts, Herba Menthae 7 parts, 11 parts, Talcum, 13 parts, Radix Glycyrrhizae.

4, Rhizoma Alismatis 26 parts, Rhizoma Chuanxiong 20 parts, the Radix Astragali 22 parts, the Rhizoma Atractylodis Macrocephalae 20 parts, Semen Cassiae 19 parts, Flos Lonicerae 19 parts, Fructus Crataegi 17 parts, Herba Taxilli 18 parts, Herba Leonuri 29 parts, Pheretima 13 parts, Spica Prunellae 15 parts, Herba Apocyni veneti 9 parts, Radix Salviae Miltiorrhizae 13 parts, Herba Menthae 9 parts, 9 parts, Talcum, 12 parts, Radix Glycyrrhizae.

For the preparation technology that above-mentioned Chinese prescription makes finished product preparation and develop is following steps:

(1), each taste Chinese crude drug is taken in Chinese prescription ratio of the present invention;

(2), by Rhizoma Chuanxiong clean, low baking temperature is dried to half-dried, and section, puts into pot, adds 0.3 times of weight yellow wine and mixes thoroughly and blot, and slow fire is fried to dry, takes out, dries grinding, crosses 120 mesh sieves, obtains fine powder a, for subsequent use;

(3), get Rhizoma Alismatis, Flos Lonicerae, Semen Cassiae, Fructus Crataegi, Herba Taxilli, Herba Leonuri, Pheretima, Spica Prunellae, Herba Apocyni veneti, Radix Salviae Miltiorrhizae, Herba Menthae, Talcum put into container, add the purified water of 7-11 times of weight for the first time, soak 8-16 hour, backflow decocts 3-5 hour, filters; Second time adds the purified water of 5-8 times of weight, and backflow decocts 1-3 hour, filters; The purified water that third time adds 3-6 times of weight, refluxes and decocts 0.5-2 hour, filter; Merge three filtrates, concentrating under reduced pressure becomes extractum, continues drying under reduced pressure and becomes dry extract, pulverize grinding, cross 120 mesh sieves, obtain fine powder b, for subsequent use;

(4), get the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae be placed in pot, with slow fire heating, parched with bran, to coke yellow, pulverizes grinding, crosses 120 mesh sieves, obtains fine powder c, for subsequent use;

(5), by fine powder a, b, c mix homogeneously, modern general Chinese medicine preparation technology is utilized to make clinical required dosage form, as tablet, pill, granule, powder or capsule etc.

The source of Chinese medicine preparation raw materials of the present invention, meridian distribution of property and flavor and effect:

Rhizoma Alismatis: this product is the dry tuber of Notes On Alism At Aceae Rhizoma Alismatis.Sweet in the mouth, cold in nature; Return kidney, urinary bladder channel; Diuresis, clearing away damp-heat.

Rhizoma Chuanxiong: this product is the dry rhizome of samphire Rhizoma Chuanxiong.Acrid in the mouth, warm in nature; Return liver, gallbladder, pericardium channel; Blood-activating and qi-promoting, wind-expelling pain-stopping.

The Radix Astragali: this product is the dry root of leguminous plant Radix Astagali or Radix Astragali.Sweet in the mouth, warm in nature; Return lung, spleen channel; Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.

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.

Semen Cassiae: this product is the dry mature seed of leguminous plant Semen Cassiae or little Semen Cassiae.Sweet in the mouth, hardship, salty, cold nature; Return liver, large intestine channel; Clearing away heat to improve acuity of vision, loosening bowel to relieve constipation.

Flos Lonicerae: this product is Caprifoliaceae woodbine Radix Ophiopogonis and congener dry flower sweet in the mouth cold in nature, has effect of heat-clearing and toxic substances removing, removing heat from bloodization silt, cure mainly affection due to external wind and heat, pestilence from the beginning of, skin infection furunculosis, red and swollen heat pain, passing stool with blood and pus.

Fructus Crataegi: this product is the dry mature fruit of rosaceous plant Fructus Pyri Pashiae or Fructus Crataegi.Sour in the mouth, sweet, slightly warm in nature; Return spleen, stomach, Liver Channel; Promoting digestion and invigorating the stomach, circulation of qi promoting dissipating blood stasis.

Herba Taxilli: this product is the dry stem and branch with leaf of Loranthaceae plant Herba Taxilli.Bitter in the mouth, sweet, property is put down; Return liver, kidney channel; Invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit.

Herba Leonuri: this product is the herb of labiate Herba Leonuri.Bitter, pungent, be slightly cold.Return liver, pericardium channel.Promoting blood flow to regulate menstruation, inducing diuresis to remove edema.

Pheretima: this product is the dry body of Ju Yin section animal Pheretima aspergillum, popular Pheretimatschiliensis, power simulation or the blind Pheretimatschiliensis of comb.Salty in the mouth, cold in nature; Return liver, spleen, urinary bladder channel; Heat clearing away is calmed the frightened, and dredging collateral, relievings asthma, diuresis.

Spica Prunellae: this product is the dry fruit ear of labiate Spica Prunellae.Acrid in the mouth, hardship, cold in nature; Return liver, gallbladder meridian; Relieve inflammation or internal heat, improving eyesight, eliminating stagnation, detumescence.

Herba Apocyni veneti: be the herb of apocynaceae plant Herba Apocyni veneti.Sweet-bitter flavor, cool in nature; Relieve inflammation or internal heat, blood pressure lowering, heart tonifying, diuresis.

Radix Salviae Miltiorrhizae: this product is the root of Lamiaceae Salvia platymiscium.Bitter in the mouth, is slightly cold, nontoxic.Enter the heart, Liver Channel.Invigorate blood circulation logical, removing heat from blood is subsided a swelling, and clear away heart-fire relieving restlessness, reinforcing the heart sedate, calming heart and tranquilizing mind.

Herba Menthae: this product is the dry aerial parts of Labiatae mint Herba Menthae.Acrid in the mouth, cool in nature; Return lung, Liver Channel; Dispelling wind-heat, refresh oneself, rash.

Talcum: this product mostly is block aggregation, in irregular bulk.Sweet in the mouth, light, cold in nature; Return bladder, lung, stomach warp; Inducing diuresis for treating stranguria syndrome, clearing away summer-heat, damp eliminating sore.

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 Chinese prescription analysis of Chinese medicine preparation of the present invention:

This prescription is with Rhizoma Alismatis, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Herba Leonuri for monarch drug, heat clearing and damp drying, diuresis poison holding, suppressing the hyperactive liver to relieve the wind syndrome; With Rhizoma Chuanxiong, Semen Cassiae, Herba Taxilli, Herba Apocyni veneti for ministerial drug, blood-activating and qi-promoting, clearing away heat and moistening the bowels, the kidney invigorating bone strengthening, blood pressure lowering heart tonifying; With Flos Lonicerae, Fructus Crataegi, Spica Prunellae, Radix Salviae Miltiorrhizae for adjuvant drug, loose wind heat clearing away, circulation of qi promoting dissipating blood stasis, relieve inflammation or internal heat detumescence, calming heart and tranquilizing mind; With Pheretima, Herba Menthae, Talcum for making medicine, dredging collateral diuresis, heat radiation rash, treating stranguria damp eliminating; With Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, all medicine coordinated, to mutually promote, heat clearing and damp drying, suppressing the hyperactive liver to relieve the wind syndrome, nourishing liver and kidney, diuresis poison holding, effects such as blood stasis dispelling of eliminating the phlegm can be reached, to essential hypertension, there is very significant therapeutic effect.

Compared with prior art, Chinese medicine preparation of the present invention has treating both the principal and secondary aspects of a disease, not easily recur, do not have drug dependence, the treatment technology advantage such as without any side effects, in addition, also have that preparation technology is easy, preparation efficacy stability, general adaptability are good, be easy to promotion advantages such as applying.

Detailed description of the invention

Embodiment one

(1), Rhizoma Alismatis 2400g, Rhizoma Chuanxiong 1800g, Radix Astragali 2000g, Rhizoma Atractylodis Macrocephalae 2200g, Semen Cassiae 1700g, Flos Lonicerae 1600g, Fructus Crataegi 1800g, Herba Taxilli 1500g, Herba Leonuri 2600g, Pheretima 1100g, Spica Prunellae 1300g, Herba Apocyni veneti 800g, Radix Salviae Miltiorrhizae 1400g, Herba Menthae 800g, Talcum 1000g, Radix Glycyrrhizae 1100g is taken in Chinese prescription ratio of the present invention;

(3), get Rhizoma Alismatis, Flos Lonicerae, Semen Cassiae, Fructus Crataegi, Herba Taxilli, Herba Leonuri, Pheretima, Spica Prunellae, Herba Apocyni veneti, Radix Salviae Miltiorrhizae, Herba Menthae, Talcum put into container, first time adds the purified water of 9 times of weight, soaks 12 hours, backflow decoction 4 hours, filtration; Second time adds the purified water of 6 times of weight, and backflow decoction 2 hours, filters; Add the purified water of 4 times of weight for the third time, backflow decoction 1 hour, filters; Merge three filtrates, concentrating under reduced pressure becomes extractum, continues drying under reduced pressure and becomes dry extract, pulverize grinding, cross 120 mesh sieves, obtain fine powder b, for subsequent use;

(5), by fine powder a, b, c mix homogeneously, utilize modern general Chinese medicine preparation technology to make pill, amount to crude drug content and be about 0.48g crude drug/g pill.

Embodiment two

(1), Rhizoma Alismatis 2600g, Rhizoma Chuanxiong 1900g, Radix Astragali 2300g, Rhizoma Atractylodis Macrocephalae 2100g, Semen Cassiae 1900g, Flos Lonicerae 1700g, Fructus Crataegi 1700g, Herba Taxilli 1400g, Herba Leonuri 2400g, Pheretima 1000g, Spica Prunellae 1400g, Herba Apocyni veneti 700g, Radix Salviae Miltiorrhizae 1500g, Herba Menthae 800g, Talcum 1100g, Radix Glycyrrhizae 1200g is taken in Chinese prescription ratio of the present invention;

Embodiment three

(1), Rhizoma Alismatis 2500g, Rhizoma Chuanxiong 1700g, Radix Astragali 2100g, Rhizoma Atractylodis Macrocephalae 2300g, Semen Cassiae 1600g, Flos Lonicerae 1800g, Fructus Crataegi 1600g, Herba Taxilli 1700g, Herba Leonuri 2800g, Pheretima 1200g, Spica Prunellae 1400g, Herba Apocyni veneti 900g, Radix Salviae Miltiorrhizae 1600g, Herba Menthae 700g, Talcum 1100g, Radix Glycyrrhizae 1300g is taken in Chinese prescription ratio of the present invention;

Embodiment four

(1), Rhizoma Alismatis 2600g, Rhizoma Chuanxiong 2000g, Radix Astragali 2200g, Rhizoma Atractylodis Macrocephalae 2000g, Semen Cassiae 1900g, Flos Lonicerae 1900g, Fructus Crataegi 1700g, Herba Taxilli 1800g, Herba Leonuri 2900g, Pheretima 1300g, Spica Prunellae 1500g, Herba Apocyni veneti 900g, Radix Salviae Miltiorrhizae 1300g, Herba Menthae 900g, Talcum 900g, Radix Glycyrrhizae 1200g is taken in Chinese prescription ratio of the present invention;

Embodiment five

(1), Rhizoma Alismatis 1600g, Rhizoma Chuanxiong 1100g, Radix Astragali 1100g, Rhizoma Atractylodis Macrocephalae 1500g, Semen Cassiae 1000g, Flos Lonicerae 900g, Fructus Crataegi 1000g, Herba Taxilli 800g, Herba Leonuri 1800g, Pheretima 800g, Spica Prunellae 800g, Herba Apocyni veneti 500g, Radix Salviae Miltiorrhizae 800g, Herba Menthae 500g, Talcum 700g, Radix Glycyrrhizae 800g is taken in Chinese prescription ratio of the present invention;

Embodiment six

(1), Rhizoma Alismatis 3200g, Rhizoma Chuanxiong 2500g, Radix Astragali 2900g, Rhizoma Atractylodis Macrocephalae 2900g, Semen Cassiae 2400g, Flos Lonicerae 2300g, Fructus Crataegi 2600g, Herba Taxilli 2300g, Herba Leonuri 3400g, Pheretima 1400g, Spica Prunellae 1800g, Herba Apocyni veneti 1100g, Radix Salviae Miltiorrhizae 2000g, Herba Menthae 1000g, Talcum 1300g, Radix Glycyrrhizae 1400g is taken in Chinese prescription ratio of the present invention;

Embodiment seven

(1), Rhizoma Alismatis 1600g, Rhizoma Chuanxiong 2500g, Radix Astragali 2900g, Rhizoma Atractylodis Macrocephalae 1500g, Semen Cassiae 1000g, Flos Lonicerae 2300g, Fructus Crataegi 1000g, Herba Taxilli 2300g, Herba Leonuri 1800g, Pheretima 1400g, Spica Prunellae 800g, Herba Apocyni veneti 1100g, Radix Salviae Miltiorrhizae 800g, Herba Menthae 500g, Talcum 1300g, Radix Glycyrrhizae 800g is taken in Chinese prescription ratio of the present invention;

Embodiment eight

Animal toxicity is tested

(1) test prepares

Test drug: medicine pill obtained by the embodiment of the present invention one to seven, adds purified water by pill and is modulated into scattered paste shape, for subsequent use.

Test animal used: regular grade NIH mice, body weight 22g ± 4g, male and female half and half, female mice is all without pregnant; SD rat, original body mass 220 ± 10g, male and female half and half, female rats is all without pregnant.

(2) acute toxicity test

Application mice carries out acute toxicity testing and shows: mouse stomach Chinese medicine magma of the present invention, under 589.5g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1 hours recovers normal, Continuous Observation 7 days after administration, none dead mouse, and overall health of patients, diet, take the photograph water, urine and body weight increase all normal.Experimental result shows: the maximum dosage-feeding of mouse stomach medicine pill of the present invention is 589.5g crude drug/kg/d(LD ₅₀> 589.5g crude drug/kg).Chinese medicine preparation clinical application every day total amount of the present invention is 0.16g crude drug/kg/d; By weighing machine, the dosis tolerata of mouse stomach Chinese medicine preparation of the present invention is 3684.4 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.

(3), long term toxicity test

Select SD rat, give the Chinese medicine oral liquid of the present invention of Three doses: 28.8g crude drug/kg, 9.6g crude drug/kg, 3.2g crude drug/kg(per weight dosage is by 20 times of calculating of clinical application amount, and clinical application amount is according to Pharmacopoeia of the People's Republic of China version in 2010).Every day gavage once, continuous 90 days, after last administration 24 hours respectively group live and kill 1/2 animal (male and female half and half), all the other 1/2 animals continue that observations are alive after 2 weeks kills.Duration of test observes outward appearance, general behavior, food ration, the body weight change of animal; Within after administration 90 days, within 2 weeks, carry out the index checking such as hematology's (RBC, HB, reticulocyte, PLT, CT, WBC and classification) and blood biochemical (AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, CHOL), urine biochemistry, organ coefficient, histopathology with drug withdrawal.

Result of the test shows: Chinese medicine preparation of the present invention is good at high, medium and low dosage treated animal general state, and outward appearance sign, behavioral activity, food-intake and body weight increase change all without exception; Three dosage groups and matched group hematological examination, blood biochemical analysis, urine biochemical analysis all in normal range, without significant difference between group; Each group of main organs histopathological examination shows no obvious abnormalities.These parameters drug withdrawal also had no change after 2 weeks.This test dosage is respectively 180,60,20 times of clinical medicine dose, according to result of the test: Chinese medicine preparation of the present invention has no significant effect rat in high, medium and low three dosage (28.8g crude drug/kg, 9.6g crude drug/kg, 3.2g crude drug/kg) administration in continuous 90 days, without clear and definite toxicity target organ and sensitive indicator, convalescent period observation also has no retardance toxic reaction, points out the dose safety of Chinese medicine preparation clinical practice of the present invention very high.

Embodiment nine

The clinical trial of Chinese medicine preparation of the present invention

1, experimenter's data

All experimenters provide by certain the People's Hospital of city heart internal medicine, these section office are from May, 2011 to 2013 year December, 480 primary hypertension patients are accepted altogether for medical treatment, the patient that 290 are ready to participate in clinical trial is filtered out from these patients, wherein, man 145, age 36-68 year, female 145, age 37-68 year.

2, experimenter's grouping

The factors such as age-based for experimenter, sex, the course of disease, coincident with severity degree of condition are divided into 5 groups, and often organize 58 people, men and women half and half, and 5 groups are numbered respectively: matched group, test 1, test 2, test 3, test 4.

3, test drug

Contrast medicine: valsartan dispersible tablet, Medisan Pharmaceutical Co., Ltd. Harbin, the accurate word H20061058 of traditional Chinese medicines.

The pill (producing by 4 optimal proportions, specification: amount to crude drug content and be about 0.48g crude drug/g pill) that investigational agent: embodiment of the present invention 1-4 produces.

4, testing program

The oral valsartan dispersible tablet of matched group, each 80mg, every day 1 time.Test 1-4 group is the pill produced of oral embodiment 1-4 respectively, and it is 4.8g/ time that each 10g(amounts to crude drug amount), every day 2 times.Within 4 weeks, be a course for the treatment of, treat 3 courses for the treatment of continuously.The situation such as the change of patient's sign, untoward reaction after recording medicine, and healing person is paid a return visit in drug withdrawal laggard line trace in six months, record recurrent cases.

5, result of the test is passed judgment on

Cure: within blood pressure level returns to normal range, and make a definite diagnosis through doctor and fully recover.

Effective: blood pressure level decreases, but still higher than normotensive value, need to continue medication.

Invalid: blood pressure level does not change, even raise.

Recurrence: healing person recurs hypertension in drug withdrawal in 6 months again.

6, result of the test statistical analysis

(1), patient characteristic's contrast: test group patient is after drug administration, and not only blood pressure level declines, and obviously sensation limbs are spry and light, and vexed insomnia takes a turn for the better, and chest distress and palpitation symptoms excessive phlegm symptom alleviates, and headache tinnitus disappears, and middle gas is full; Contrast medicine is except blood pressure level reduces, and feeling of this type of is not obvious.The matched group headache in various degree that had 8 people to occur, upper respiratory tract infection, diarrhoea, edema, insomnia, unable, backache, stomachache, the untoward reaction symptom such as to feel sick; All there is not untoward reaction in test group 4 group.

(2), test data statistical analysis table:

Group	Case load	Cure (rate)	Effective	Invalid	Total effective rate	Recurrence (rate)
							Matched group	58	18（31.0%）	32	8	86.2%	12（66.7%）
Test 1	58	30（51.7%）	26	2	96.6%	2（6.7%）
							Test 2	58	33（56.9%）	24	1	98.3%	1（3.0%）
Test 3	58	34（58.6%）	21	3	94.8%	4（11.8%）
							Test 4	58	32（55.2%）	26	0	100%	1（3.1%）

7, conclusion

As can be seen from above-mentioned result of the test statistics:

(1), characterize contrast: test group fully presents the advantage that Chinese medicine combines disease treating both the principal and secondary aspects of a disease, medical treatment, remarkable to the conditioning advantage of patient body, matched group just takes stopgap measures; Test group does not have untoward reaction, and matched group has 8 routine untoward reaction, and untoward reaction rate is up to 13.8%.Therefore, test group has significant treatment advantage relative to matched group.

(2), test data contrast: the average cure rate of test group is 55.6%, is 1.8 times of matched group; The average total effective rate of test group is 97.4%, higher than matched group 11.2 percentage points; The average relapse rate of test group is 6.1%, and the relapse rate of matched group is 10.8 times of test group.Therefore, test group has relative to matched group and treats advantage very significantly.

To sum up, compared with prior art, Chinese medicine preparation of the present invention has significant technical advantage in treatment essential hypertension, achieves creationary, to be difficult to expectation technique effect.

Claims

1. the purposes of Chinese medicine preparation in preparation treatment essential hypertension medicine, it is characterized in that, described Chinese medicine preparation is made up of the raw material of following weight portion:

2. purposes as claimed in claim 1, it is characterized in that, described Chinese medicine preparation can also be made up of the raw material of following weight portion:

Rhizoma Alismatis 24 parts, Rhizoma Chuanxiong 18 parts, the Radix Astragali 20 parts, the Rhizoma Atractylodis Macrocephalae 22 parts, Semen Cassiae 17 parts, Flos Lonicerae 16 parts, Fructus Crataegi 18 parts, Herba Taxilli 15 parts, Herba Leonuri 26 parts, Pheretima 11 parts, Spica Prunellae 13 parts, Herba Apocyni veneti 8 parts, Radix Salviae Miltiorrhizae 14 parts, Herba Menthae 8 parts, 10 parts, Talcum, 11 parts, Radix Glycyrrhizae.

3. purposes as claimed in claim 1, it is characterized in that, described Chinese medicine preparation can also be made up of the raw material of following weight portion:

Rhizoma Alismatis 26 parts, Rhizoma Chuanxiong 19 parts, the Radix Astragali 23 parts, the Rhizoma Atractylodis Macrocephalae 21 parts, Semen Cassiae 19 parts, Flos Lonicerae 17 parts, Fructus Crataegi 17 parts, Herba Taxilli 14 parts, Herba Leonuri 24 parts, Pheretima 10 parts, Spica Prunellae 14 parts, Herba Apocyni veneti 7 parts, Radix Salviae Miltiorrhizae 15 parts, Herba Menthae 8 parts, 11 parts, Talcum, 12 parts, Radix Glycyrrhizae.

4. purposes as claimed in claim 1, it is characterized in that, described Chinese medicine preparation can also be made up of the raw material of following weight portion:

Rhizoma Alismatis 25 parts, Rhizoma Chuanxiong 17 parts, the Radix Astragali 21 parts, the Rhizoma Atractylodis Macrocephalae 23 parts, Semen Cassiae 16 parts, Flos Lonicerae 18 parts, Fructus Crataegi 16 parts, Herba Taxilli 17 parts, Herba Leonuri 28 parts, Pheretima 12 parts, Spica Prunellae 14 parts, Herba Apocyni veneti 9 parts, Radix Salviae Miltiorrhizae 16 parts, Herba Menthae 7 parts, 11 parts, Talcum, 13 parts, Radix Glycyrrhizae.

5. purposes as claimed in claim 1, it is characterized in that, described Chinese medicine preparation can also be made up of the raw material of following weight portion:

Rhizoma Alismatis 26 parts, Rhizoma Chuanxiong 20 parts, the Radix Astragali 22 parts, the Rhizoma Atractylodis Macrocephalae 20 parts, Semen Cassiae 19 parts, Flos Lonicerae 19 parts, Fructus Crataegi 17 parts, Herba Taxilli 18 parts, Herba Leonuri 29 parts, Pheretima 13 parts, Spica Prunellae 15 parts, Herba Apocyni veneti 9 parts, Radix Salviae Miltiorrhizae 13 parts, Herba Menthae 9 parts, 9 parts, Talcum, 12 parts, Radix Glycyrrhizae.

6. the purposes as described in claim 1-5, is characterized in that, the preparation technology of described Chinese medicine preparation is following steps:

Step 1, take each taste Chinese crude drug in Chinese prescription ratio of the present invention;

Step 2, cleaned by Rhizoma Chuanxiong, low baking temperature is dried to half-dried, and section, puts into pot, and add 0.3 times of weight yellow wine and mix thoroughly and blot, slow fire is fried to dry, takes out, dries grinding, crosses 120 mesh sieves, obtains fine powder a, for subsequent use;

Step 3, get Rhizoma Alismatis, Flos Lonicerae, Semen Cassiae, Fructus Crataegi, Herba Taxilli, Herba Leonuri, Pheretima, Spica Prunellae, Herba Apocyni veneti, Radix Salviae Miltiorrhizae, Herba Menthae, Talcum put into container, add the purified water of 7-11 times of weight for the first time, soak 8-16 hour, backflow decocts 3-5 hour, filters; Second time adds the purified water of 5-8 times of weight, and backflow decocts 1-3 hour, filters; The purified water that third time adds 3-6 times of weight, refluxes and decocts 0.5-2 hour, filter; Merge three filtrates, concentrating under reduced pressure becomes extractum, continues drying under reduced pressure and becomes dry extract, pulverize grinding, cross 120 mesh sieves, obtain fine powder b, for subsequent use;

Step 4, get the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae be placed in pot, with slow fire heating, parched with bran, to coke yellow, pulverizes grinding, crosses 120 mesh sieves, obtains fine powder c, for subsequent use;

Step 5, by fine powder a, b, c mix homogeneously, modern general Chinese medicine preparation technology is utilized to make clinical required dosage form.

7. the purposes as described in claim 1-5, is characterized in that, described Chinese medicine preparation can make tablet, pill, granule, powder or capsule.