CN1290547C - Traditional Chinese medicine for treating and preventing high blood pressure and its preparation technology - Google Patents
Traditional Chinese medicine for treating and preventing high blood pressure and its preparation technology Download PDFInfo
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Abstract
The present invention discloses a traditional Chinese medicine for treating and preventing hypertension and a preparation process thereof. The traditional Chinese medicine is prepared from the raw medicinal materials of 20 to 30 portions of banana peel, 15 to 25 portions of pueraria root and 15 to 25 portions of shepherdspurse herb. The preparation process comprises the steps of extraction through ethanol with the concentration of 70 to 90%, filtration, concentration to obtain extractum, and addition of a proper amount of auxiliary materials to prepare the required traditional Chinese medicine through a conventional process. The traditional Chinese medicine has the advantages of obvious effect on blood pressure reduction and little toxic and side effect. The preparation process has the advantages of simplicity and easy operation.
Description
Technical field
The invention belongs to field of traditional Chinese medicine pharmacy, the Chinese medicine of particularly a kind of treatment and prophylaxis of hypertension the invention still further relates to the preparation technology of this Chinese medicine.
Background technology
Hypertension is the common cardiovascular disease of modern, and critical above hypertension prevalence is 13.58% in the population of China at present, national patients with hypertension nearly 9,000 ten thousand; In last ten years 20th century, China's hypertension prevalence has increased by 25%, is ascendant trend year by year.American-European countries's prevalence is higher, reaches 10～20%.The morbidity of the heart, cerebrovascular disease and death and hypertensive level are closely related, so research and control to hypertension are all paid much attention in countries in the world.The treatment hypertension is based on Western medicine at present, and kind is numerous, but still lacks specific drug, and is difficult to control the development of patient's condition, and long-term prescription often is prone to toxic and side effects.Chinese medicine has particular views to the treatment of hypertension, and the treatment by Chinese herbs hypertension not only has gentleness antihypertensive effect stably, and excellent symptom curative effect is arranged, and has integrally-regulated effect, rare untoward reaction.
Though Chinese medicine does not have the title of hypertension, reality early has understanding, according to its clinical symptoms, mainly is under the jurisdiction of under the Liver Channel disease item, and is in close relations with dizzy, headache, liver-yang, liver-fire, liver-wind etc." card control and converge to mend, dizzy " point out " Ying Yufeng to connect order system on the liver, thus dizzy be liver-wind, so also have because of fiery, because of expectorant, because of empty person." "guide to clinical practice with medical record" Hua Xiuyun: " press through all wind trembling and dizziness of cloud, all belong to liver, head is first of six sun, and the knowledge mouth and nose all are the key that empties, suffer from dizzy person, non-external heresy, be to emit ear on the wind of liver and gall, the anxiety of faintness tumbling down is very then arranged, its disease has folder expectorant, folder fire, middle void, dificiency in lower-JIAO, controls the branch of gallbladder, treating the liver, fire Sheng person ... to let out the heat of part of the body cavity above the diaphragm housing the heart and lungs key network clearly.Abundant expectoration person Bi Liyangming ... the product that relieve dizziness, high fever, infantile convulsions, epilepsy, etc. can add with card." in sum; the clinical manifestation of hypertension is based on the Liver Channel syndrome as can be known; pathology character has multiple pathological changes such as the different wind, fire, expectorant of real partially, inclined to one side void, simulataneous insufficiency and excessive; and the three whenever can transform the folder of holding concurrently mutually; thus provide theoretical direction for the treatment of hypertension; current Chinese medicine is to the clinical research of hypertension: (1). determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs or divide card fixed side, with the card plus-minus; (2). differential diagnosis of diseases is the side surely, in conjunction with dialectical plus-minus; (3). specific prescription and medication or proved recipe, folk prescription; (4). Comprehensive Treatment: Chinese medicine, acupuncture, the qigong, physical training, external treatment etc.But it is ripe that the still difficult standard of determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, treatment according to differentiation of diseases are owed, and folk prescription lacks complex effect again, and decoction uses convenient inadequately.Western medicine treatment hypertension diuretic commonly used such as chlorine plug piperazine, peace are logical for relaxing, furosemide etc.; Adrenergic receptor blocker such as propranolol, Phenoxybenzamine etc.; Nervus centralis and sympathetic inhibitor such as clonidine, methyldopa etc.; Sympathoinhibitor such as reserpine, guanethidine etc. on every side; Vasodilation such as Aiselazine, nifedipine, thin methyl-prop proline etc., but drug side effect is big, and curative effect is stable inadequately, so the suitable effective new Chinese medicine preparation taken for a long time of development safety and low toxicity is the needs of clinical practice.The pure Chinese patent medicine preparation of more existing in the market treatment hypertension, as: Bezoar pill for lowering blood pressure, Bezoar Sedative Pills, silver yellow hypertension pill, NAOLIQING WAN etc.But generally, the Chinese patent medicine of treatment hypertension is also fewer, and the market share is very little, and some curative effect of medication is also undesirable.Therefore, develop pure Chinese medicine hypertension treatment medicine evident in efficacy, that toxic and side effects is little, reduce the mortality rate of various complication, ensureing that people ' s health has great social significance.
Summary of the invention
The purpose of this invention is to provide a kind of evident in efficacy, the treatment that toxic and side effects is little and the Chinese medicine of prophylaxis of hypertension.
A further object of the invention provides the preparation technology of above-mentioned Chinese medicine.
The present invention forms according to the Chinese medical theory prescription.Hypertension belongs to disease categories such as " dizzy ", " headache " more in Chinese medicine, mainly is subordinate under the Liver Channel disease item, and the many and seven emotions pent-up of its cause of disease, drinking and eating irregularly is relevant.Or because of feelings will stimulates, five excessive emotions converting into internal fire; Or eating and drinking without temperance, it is peppery to have a liking for the sweet fertile wine of food; Or it is not normal to live, excess of sexual intercourse, vital essence internal injury; Or natural endowment is contained fat greasiness partially; Or multiple factor such as body constitution is thin partially, the many fire of thin body and interact due to.Many and the overabundant liver-fire of pathogeny, the hepatic and renal YIN deficiency, excessive rising of liver-YANG, liver-wind stirring up internally, liver-yang folder expectorant, blood stasis due to qi deficiency, disarmony between the heart and kidney, imbalance of YIN and YANG is relevant.Its onset of disease yang hyperactivity is in the majority, and the prolonged illness deficiency of YIN is main, even the later stage deficient YIN affecting YANG.The heart, kidney are often involved liver in the main position of pathological changes, fire-transformation is arranged again, give birth to wind, give birth to expectorant, give birth to the stasis of blood, develop each other, transform, and form complicated pathogenesis.Head be the mansion of clear sun, the confluence of all yang-channels, modern overabundant liver-fire, pathogen upward attacking orifices in head and cause dizzy, have a headache.Liver opening at eye, liver-fire upper punch, flushing conjunctival congestion.Liver controlling conveyance and dispersion, depression of liver-QI then catharsis are not normal, and see irritated irritability, and liver and gall fire rises, bile overflow and bitter taste, and fire burns that Tianjin is hindered and xerostomia, constipation, urinates redly, and the red tongue with yellow fur wiry and frequent pulse is the card of overabundant liver-fire.
We are that essential hypertension is set due to the overabundant liver-fire.The raw materials used medical material of we, according to modern pharmacological research, Pericarpium Musae, Radix Puerariae, Herba Capsellae all have hypotensive effect.Pericarpium Musae sweet in the mouth adstringency is cold partially in the side, function heat-clearing and toxic substances removing, diuresis liver heat removing, " national Chinese herbal medicine compilation ", " food Chinese medicine with just side " say that all it can treat hypertension, have good clearing away liver-fire, the effect of blood pressure lowering, at overabundant liver-fire, the main pathogenesis of hypertension, so be monarch drug.The sweet suffering of Radix Puerariae is flat, its light weight is raised, the function expelling pathogenic factors from muscles for reducing heat, promoting the production of body fluid to quench thirst, " pharmacopeia " calls that it cures mainly " stiff nape and back ", " thirsty " reaches " hypertension neck pain ", its extractum sheet (yufeng ningxin tablets, yufeng ningxin pian) " pharmacopeia " is called its " relieving spasm to stop pain strengthens brain and arteria coronaria flow, is used for hypertension, dizziness, headache, neck pain ".Radix Puerariae energy dilating coronary blood vessel and cerebrovascular increase coronary flow and cerebral blood flow, and Radix Puerariae total flavones can reduce myocardial oxygen consumption, increase the oxygen supply, directly blood vessel dilating descends Peripheral resistance, and obvious hypotensive effect is arranged, can better alleviate " item is tight " symptom of hypertensive patient; Puerarin energy anticoagulant; This medicine has beta receptor retardation widely.Select for use this product both can assist monarch drug to strengthen the effect of blood pressure lowering, relieving fainting, pain relieving in the side, can promote the production of body fluid again and moisturize, fire Sheng Tianjin wound is done to alleviate, the merit of dark coloured urine constipation, so be ministerial drug.Herba Capsellae is sweet light cool in nature, the function heat clearing and blood cooling, and suppressing the hyperactive liver blood pressure lowering, diuresis are used for the treatment of the puckery pain of hypertension and conjunctival congestion, pharmacology confirms that certain hypotensive effect is arranged, can help principal drug assistance ignite descending, to strengthen removing heat from the liver to lower the high blood pressure, alleviate overabundant liver-fire, the effect of dizzy, headache, all diseases of conjunctival congestion is so be adjuvant drug.All medicines share, and play the effect of removing heat from the liver to lower the high blood pressure altogether.
The objective of the invention is to realize by following measures:
The Chinese medicine of a kind of treatment and prophylaxis of hypertension, it is to be prepared from by following bulk drugs material:
Pericarpium Musae 20-30 part, Radix Puerariae 15-25 part, Herba Capsellae 15-25 part.
The Chinese medicine of described treatment and prophylaxis of hypertension, it is to be prepared from by following bulk drugs material:
25 parts of Pericarpium Musae, 20 parts of Radix Puerariaes, 20 parts in Herba Capsellae.
The Chinese medicine of described treatment and prophylaxis of hypertension, wherein Radix Puerariae is Pachyrhizua angulatus or Herba Gelsemii Elegantis.
The Chinese medicine of described treatment and prophylaxis of hypertension, its medicament are said dosage forms on any pharmaceutics.
The Chinese medicine of described treatment and prophylaxis of hypertension, its dosage form can be pill, tablet, powder, granule, capsule, drop pill, syrup, medicated wine or oral solutions.
The preparation technology of the Chinese medicine of described treatment and prophylaxis of hypertension may further comprise the steps:
1) get three flavor raw medicinal materials by described prescription, 70-90% ethanol extraction three times, each 1-3 hour, merge extractive liquid, filtered, and relative density 1.15～1.18g/ml when filtrate is concentrated into 60 ℃ gets extractum;
2) add suitable adjuvant in extractum, common process is made required dosage form.
Beneficial effect of the present invention:
The present invention tests used medicine by embodiment 1 preparation, to call fragrant shepherd's purse blood pressure lowering granule in the following text.
One, the pharmacodynamic experiment of medicine of the present invention:
Renal hypertensive rat and spontaneous hypertensive rat (SHR) result of study shows, fragrant shepherd's purse blood pressure lowering granule 80% ethanol extract all has good hypotensive effect to two kinds of hypertension animal models: two kinds of animal models are had good acute hypotensive effect (example: i.g.7.5g (crude drug amount, down together)/kg diastolic pressure maximum reducing amplitude is 9%～15%, the blood pressure lowering time was above 11 hours); The good curing hypotensive effect is also arranged, and (every day, i.g. was administered once, successive administration 15 days), the blood pressure lowering amplitude is big, the blood pressure lowering time is long, also have long-lasting characteristics (example: i.g.7.5g/kg diastolic pressure maximum reducing amplitude is about 22%, drug withdrawal 15 and after 18 days blood pressure just return to level before the administration).Compare with the hypotensive effect of Pericarpium Musae, the particulate efficacy of antihypertensive treatment of fragrant shepherd's purse blood pressure lowering obviously improves: mathematical regression calculates and shows, under equivalent Pericarpium Musae administration situation, the particulate therapeutic hypotensive effect of fragrant shepherd's purse blood pressure lowering is significantly better than the independent medication of Pericarpium Musae, and the blood pressure lowering amplitude obviously increases, the hypotensive effect time of keeping after the drug withdrawal obviously prolongs.The result shows, three flavor Chinese medicines in the fragrant shepherd's purse blood pressure lowering granule prescription have significantly synergism mutually to the hypotensive effect of renal hypertensive rat and SHR, can significantly improve the hypotensive effect curative effect.
1. to experimental hypertension rat hypotensive effect result of the test
Experiment grouping: high dose group (15.0g/kg), middle dosage group (7.5g/kg), low dose group (3.75g/kg), matched group.
Fragrant shepherd's purse blood pressure lowering granule (80% ethanol extraction) has good acute hypotensive effect to renal hypertensive rat, p.o. the relative maximum reducing amplitude of high, medium and low dosage is (X ± SD, %): SAP:15.1 ± 4.5,13.2 ± 3.5,8.5 ± 3.3, DAP:15.4 ± 5.4,14.7 ± 6.2,9.9 ± 3.5 relatively have significant difference (P＜0.01) with matched group.The hypotensive effect persistent period can be above 11 hours.
The high, medium and low dosage of fragrant shepherd's purse blood pressure lowering granule p.o. has good acute hypotensive effect to SHR, the maximum reducing amplitude is (X ± SD relatively, %): SAP:9.0 ± 4.6,7.6 ± 4.4,4.5 ± 2.8, DAP:10.0 ± 3.4,9.5 ± 3.1,5.0 ± 1.3 relatively have significant difference (P＜0.01) with matched group.The hypotensive effect persistent period was above 8 hours.
Every day, p.o. was administered once, 15 days therapeutic result of the test of successive administration shows, fragrant shepherd's purse blood pressure lowering granule has good hypotensive effect to renal hypertensive rat, blood pressure promptly obviously descends after the administration in first day, blood pressure has been reduced to floor level and has been in steady after the administration in the 5th～7 day, the relative maximum reducing amplitude of high, medium and low dosage be respectively (X ± SD, %): SAP:21.6 ± 3.3,19.3 ± 6.9,13.1 ± 3.8; Relatively there is notable difference (P＜0.01) DAP:21.8 ± 5.3,21.6 ± 6.9,13.3 ± 4.4 with matched group.Blood pressure and matched group are still variant after the high dose group drug withdrawal 18 days.
Every day, p.o. was administered once, 15 days therapeutic result of the test of successive administration shows, fragrant shepherd's purse blood pressure lowering granule has good hypotensive effect to SHR, blood pressure promptly obviously descends after the administration in first day, blood pressure has been reduced to floor level and has been in steady after the administration in the 5th～7 day, the relative maximum reducing amplitude of high, medium and low dosage be respectively (X ± SD, %): 22.8 ± 2.4,20.1 ± 4.7,13.4 ± 2.8; Relatively there is notable difference (P＜0.01) DAP:25.1 ± 3.8,22.1 ± 2.4,16.4 ± 4.2 with matched group.Blood pressure and matched group are still variant after the high dose group drug withdrawal 24 days.
Fragrant shepherd's purse blood pressure lowering granule has certain influence to the heart rate of two kinds of animal models, especially SHR is had certain heart rate function of falling, but intensity is less.
Therapeutic test experimental result shows that fragrant shepherd's purse blood pressure lowering granule is about the SAP of SHR, effective dosage of DAP decline 20mmHg: 2.3g/kg days.
Fragrant shepherd's purse blood pressure lowering granule is better than Pericarpium Musae or the independent medication of Herba Capsellae to the therapeutic hypotensive effect of SHR, and Pericarpium Musae is better than Radix Puerariae and Herba Capsellae.
2. anaesthetize hybrid dog hemodynamics result of the test
Experiment grouping: low dose group (1.0g/kg), middle dosage group (2.0g/kg), high dose group (4.0g/kg), matched group.
Each dosage group of the fragrant shepherd's purse blood pressure lowering of hybrid anesthetized dog duodenal administration cardiac hemodynamic result of the test: i.g. granule has the significant effect (compare with matched group p＜0.05, p＜0.01) that reduces SAP, DAP, MAP.After the administration in the 240min, SAP is relative, and the maximum reducing amplitude can reach respectively (high, medium and low dosage group, %): 22.82 ± 7.97,12.03 ± 6.76,8.45 ± 2.74.The result shows that fragrant shepherd's purse blood pressure lowering granule has the hypotensive effect of highly significant to anesthetized dog.
Heart rate (HR) experimental result: high dose group behind medicine 60,240minHR has in short-term and descends (remarkable with the matched group comparing difference), illustrates that fragrant shepherd's purse blood pressure lowering granule has the slight HR effect of falling.
Cardiac output (CO) experimental result: 45minCO obviously increases (compare with matched group p＜0.05) after having only the administration of middle dosage group, illustrates that fragrant shepherd's purse blood pressure lowering granule is little to the CO influence.
Coronary flow (CBF) experimental result: middle dosage group is at 120min, high dose group 45,120min can significantly increase CBF (p＜0.05, p＜0.01), illustrates that fragrant shepherd's purse blood pressure lowering granule has certain increase CBF effect.
Stroke volume (SV), cardiac index (CI), SI (SI) experimental result: high dose group obviously increases CI (P＜0.05), middle dosage group all obviously increases (p＜0.05) to SV, the SI of anesthetized dog, illustrates that fragrant shepherd's purse blood pressure lowering granule has certain influence to SV, CI, SI.
Left indoor pressure (LVSP), left chamber diastasis pressure (LVEDP) experimental result: high dose group can reduce LVSP, the LVEDP (p＜0.05,0.01) of anesthetized dog, illustrates that fragrant shepherd's purse blood pressure lowering granule all has certain influence to LVSP, LVEDP.
The myocardial contraction parameter (+dp/dtmax), (dp/dtmax), left chamber begins to be contracted to left indoor pressure climbing speed Yi value time (t-dp/dtmax) experimental result: fragrant each dosage group of shepherd's purse blood pressure lowering granule does not all have obvious influence to above data to the myocardial relaxation parameter, does not see notable difference (p＞0.05) with matched group
Stroke work index (LVWI), total oxygen consumption index (TII), total peripheral resistance (TPVR) experimental result: high dose group can reduce TPVR, TTI, the LVWI (p＜0.05, p＜0.01) of anesthetized dog, middle dosage group can reduce TPVR (p＜0.01), illustrates that fragrant shepherd's purse blood pressure lowering granule can reduce TPVR, TTI, LVWI.
Partial pressure of oxygen (P in the blood
O2), partial pressure of carbon dioxide (P
CO2) experimental result: high dose group obviously reduces P
CO2(p＜0.05) illustrates that fragrant shepherd's purse blood pressure lowering granule can reduce partial pressure of carbon dioxide in the blood.
Fragrant shepherd's purse blood pressure lowering granule is not seen obvious influence to ECG, compares no significant difference (P.0.05) with matched group.
Fragrant shepherd's purse blood pressure lowering granule shows that to the hemodynamic result of the test of anesthetized dog fragrant shepherd's purse blood pressure lowering granule can improve the hemodynamics of anesthetized dog, points out this medicine that hemodynamics is had the improvement effect.
Two, toxicological experiment of the present invention
1. be subjected to the reagent thing
Title: fragrant shepherd's purse blood pressure lowering granule, 3.0g (crude drug)/1ml (extractum)
The unit of providing: Pharmaceutical Co Ltd, China Univ. of Pharmacy
Lot number: 991115
Solvent: 0.5% sodium carboxymethyl cellulose (CMC)
Compound method: be concentrated into maximum drug level [3.6g (crude drug)/ml] with preceding heating
2. laboratory animal
The SD rat, body weight 120-150g, male and female half and half, totally 20.Supply with by animal housing of China Medicine University (quality certification number: Soviet Union kinoplaszm 97004).
3. test method and result
(1) fragrant shepherd's purse blood pressure lowering granule is tested the anxious poison of rat:
Get 20 of above-mentioned specification rats, behind the empty stomach 12h, gastric infusion (consistent) with the clinical application approach.Dosage is for giving maximum drug level [3.6g (crude drug)/1ml], the maximum body of stomach long-pending (2ml/100g) of irritating, gastric infusion secondary in one day, after the administration, observe activities in rats and death condition every day, observed 7 days continuously altogether, claimed rat body weight, and calculate the body weight gain rate in the 7th day after administration.
The result shows, observes 7 days after the administration, and rat does not occur dead and any poison is paid effect, and body weight increases all to some extent, and male rat body weight gain rate is 18.5%, and the heavy rate of increase of female rats is 18.1% (seeing Table 1).Show that the maximum drug administration amount in the fragrant shepherd's purse blood pressure lowering granule one day is 144g/kg, maximum dosage-feeding is equivalent to 133 times of people's consumption every day.
The fragrant shepherd's purse blood pressure lowering of table 1 granule is to the influence of rat body weight (X ± SD)
| Sex | Mus number (only) | Body weight | Body weight gain rate (%) | |
| Before the administration | After the drug withdrawal | |||
| Male female | 10 10 | 134.0±6.24 134.6±6.60 | 159.2±12.73 159.0±12.08 | 18.5 18.1 |
The fragrant shepherd's purse blood pressure lowering of clinical human granule dosage is 65g every day, that is: 65g/ people/day, body weight for humans is in 60kg, then every kg body weight consumption is 1.083g, rat maximum dosage-feeding every day is 144g/kg, by descending calculating, rat maximum tolerated dose every day is 133 times (144g ÷ 1.083g=133 doubly) of clinical people's consumption.
Conclusion: maximum drug administration amount is 144g (crude drug)/kg in particulate one day of the fragrant shepherd's purse blood pressure lowering of rat p.o., is every day 133 times of clinical people's consumption.
(2) fragrant shepherd's purse blood pressure lowering granule is to the long term toxicity test of rat
Fragrant shepherd's purse blood pressure lowering granule dosage is that 36g/kg, 18g/kg, 9g/kg (are equivalent to 33.2 times of human dosage, 16.6 doubly, 8.3 doubly), gastric infusion (p.o.), every day 1 time, administration is 6 days weekly, and administration is 182 days altogether, general performance, hematological indices, the blood biochemical of measuring rat learns that index, system become celestial, 10 kinds of organ indexs, 18 kinds of main organs histological examinations, and the result shows: fragrant shepherd's purse blood pressure lowering granule is without any side effects to rat.
Three, the hypertensive clinical observation of fragrant shepherd's purse blood pressure lowering granule therapy
Fragrant shepherd's purse blood pressure lowering granule is three class new Chinese medicines, has the effect of suppressing the hyperactive liver to relieve the wind syndrome, is used for the essential hypertension overabundant liver-fire syndrome of (I, II phase), shows as dizzy, dizzy bloated, headache, flushed face due to ascending of fire, the limb fiber crops, tinnitus, brain rings, agitation, dry mouth with bitter taste, constipation, red tongue, yellow and thin fur, wiry and frequent pulse etc.In in April, 2000 to July in out-patient department of Nanjing University of Traditional Chinese Medicine, hospital application fragrant shepherd's purse blood pressure lowering granule therapy essential hypertension (I, II phase) overabundant liver-fire syndrome patient 30 examples in city east, Jintan now are reported as follows clinical observation result:
1. ordinary circumstance
1.1. sex and age male 15 examples, women's 15 examples.The oldest 62 years old, minimum 35 years old, average out to 50.8 years old.
1.2. stadium distribution hypertension I phases 17 example, II phases 13 example.
1.3. cardinal symptom sign distribution situation hypertension 30 examples (accounting for 100%), dizzy 16 examples (accounting for 60%), dizzy 26 examples (accounting for 86.7%) that expand, 14 examples of having a headache (accounting for 46.5%), flushed face due to ascending of fire 18 examples (accounting for 60%), fidgety 18 examples (accounting for 60%), dry mouth with bitter taste 27 examples (accounting for 90%), limb fiber crops 9 examples (accounting for 30%), wiry and frequent pulse 14 examples (accounting for 46.7%), red tongue with yellow fur 29 examples (accounting for 96.7%).
2.. case choice criteria
2.1. diagnostic criteria was with reference to new Chinese medicine clinical research guideline 1993.
2.1.1. doctor trained in Western medicine name of disease diagnostic criteria
Systolic pressure is equal to or higher than 160mmHg (21.3kPa) diastolic pressure and is higher than 95mmHg (12.7kPa), and the two has one through examining, and can make a definite diagnosis.
Should have a rest before the pressure measurement 15 minutes, and generally survey the right side blood pressure,right arm, measure the meansigma methods of pressure value at every turn in continuous measurement 3 times.Hypertension person must time examine in addition on the same day through non-, or in checking for 3 times 2 rising be arranged, or could determine essential hypertension every checking the verifier more than 1 hour on the same day.
2.1.2. clinical stages standard
I phase hypertension: blood pressure reaches the hypertension level of making a definite diagnosis, and clinically is not in the mood for, brain, kidney complication shower.
II phase hypertension: blood pressure reaches makes a definite diagnosis the hypertension level, and a following person is arranged: X line, electrocardiogram or ultrasonic examination are seen left ventricular hypertrophy; Examination of ocular fundus is seen has tremulous pulse general or part in optical fundus to narrow down; Albuminuria or and creatinine concentration of plasma rising.
2.1.3. Chinese medical discrimination, overabundant liver-fire
Primary symptom: dizzy, dizzy expanding, headache, flushed face due to ascending of fire, limb fiber crops, red tongue, yellow and thin fur, wiry and frequent pulse.
Inferior disease: tinnitus, brain rings, agitation, xerostomia hardship.
All have 4 of above primary symptoms, and 2 of inferior diseases are promptly diagnosable.
2.2. test case standard
2.2.1. include the case standard in
Meet I, II type essential hypertension and Chinese medical discrimination and belong to " overabundant liver-fire syndrome ".
The patient of the course of disease more than half a year.
2.2.2. get rid of case standard (comprising incompatibility or rejecting standard)
Age, gestation or nursing women were to this medicine allergy sufferers at under-18s or over-65s.
Be associated with serious primary disease such as Liver and kidney and hemopoietic system, psychotic.
Secondary hyperpietic.
Malignant hypertension (accelerated hypertension).
All standards of including in that do not meet, not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment or safety judgement person.
3. test method
3.1. medication
One time one bag of fragrant shepherd's purse blood pressure lowering granule, 2 times on the one, warm boiled water.
3.2. the course of treatment
14 days is a course of treatment.
3.3. observe
All standard cases of including in that meets are the object of observation, by observing case history and observing form and fill in symptom and sign and relevant check result.
3.4. clinical examination
Each detects once before and after blood, urine, stool for routine, electrocardiogram, liver function (TBIL, ALT), renal function (BUN, the Cr) treatment.
4. criterion of therapeutical effect
With reference to " new Chinese medicine clinical research guideline " first volume (1993, Ministry of Public Health).
4.1. efficacy of antihypertensive treatment evaluation criteria
4.1.1. produce effects
A. more than the diastolic pressure decline 10mmHg (1.3kPa), and reach normal range;
Though b. diastolic pressure is not reduced to normally, descended 20mmHg (2.7kPa) or more than;
C. patient's diastolic pressure this normal range (＜90mmHg), but systolic pressure is greater than or equal to 160mmHg.More than the after-contraction drops of the taking medicine 20mmHg (2.7kPa), and reduce to normal range (＜140mmHg).
More than three need possess wherein one.
4.1.2. effectively
A. diastolic pressure descends not as good as 10mmHg (1.3kPa), but has reached normal range;
Decline 10～19mmHg before b. diastolic pressure is treated (1.3～2.5kPa), but do not reach normal range;
C. systolic pressure is more than the preceding decline 30mmHg (4kPa) of treatment;
More than three need possess wherein one.
4.1.3. it is invalid
Do not reach above standard person.
4.2. symptom efficacy assessment standard
That cardinal symptom comprises is dizzy, dizzyly expand, headache, flushed face due to ascending of fire, a fiber crops, tinnitus, brain sound, dry mouth with bitter taste, fidgety etc.
4.2.1. produce effects
Above-mentioned symptom disappears, or total mark descends more than 80%.
4.2.2. effectively
Above-mentioned symptom alleviates more than 1/2, or total mark descends more than 50%.
4.2.3. it is invalid
Above-mentioned symptom no change or increase the weight of.
5. therapeutic outcome
5.1. efficacy of antihypertensive treatment analysis
The results are shown in Table 2, test case 30 examples, I phase patient 17 examples wherein, II phase patient 13 examples.I phase patient produce effects accounts for 82.4%, effectively accounts for 17.6%, total effective rate 100%; II phase patient produce effects accounts for 61.5%, effectively accounts for 15.4%, invalidly accounts for 23.1%, total effective rate 76.9%.Add up to produce effects to account for 73.3%, effectively account for 16.7%, total effective rate 90.0%.
The fragrant shepherd's purse blood pressure lowering of table 2. granule efficacy of antihypertensive treatment result statistics
| Hypertension | The example number | Produce effects | Effectively | Invalid | Effectively total |
| By stages | The example number | ％ | The example number | ％ | The example number | ％ | Rate (%) | |
| I II | 17 13 | 14 8 | 82.4 61.5 | 3 2 | 17.6 15.4 | 0 3 | 0.0 23.1 | 100 76.9 |
| Add up to | 30 | 22 | 73.3 | 5 | 16.7 | 3 | 10.0 | 90.0 |
5.2. blood pressure lowering amplitude statistics
The results are shown in Table 3, statistical result shows that produce effects person SAP, DAP blood pressure lowering amplitude reach respectively after taking medicine continuously 14 days: 4.08 ± 1.24,2.13 ± 0.72kPa (30.6 ± 9.3,16.0 ± 5.4mmHg); Responder SAP, DAP blood pressure lowering amplitude reach respectively: 3.65 ± 0.65,1.49 ± 0.43kPa (27.4 ± 4.9,11.2 ± 3.2mmHg).
The fragrant shepherd's purse blood pressure lowering of table 3. granule blood pressure lowering amplitude result statistics
Annotate: have 2 routine DAP administrations preceding just in normal range in the produce effects case, just SAP raises, so do not take statistics.
5.3. to I, hypertensive efficacy analysis of II phase
The results are shown in Table 4, I phase patient produce effects accounts for 64.7%, effectively accounts for 29.4%, and is invalid 5.9%, total effective rate 94.1%; II phase patient produce effects accounts for 53.8%, effectively accounts for 23.1%, and is invalid 23.1%, total effective rate 76.9%.Add up to produce effects to account for 60.0%, effectively account for 26.7%, total effective rate 86.7%.
The fragrant shepherd's purse blood pressure lowering of table 4. granule is to I, hypertensive efficacy analysis of II phase
| Hypertension by stages | The example number | Produce effects | Effectively | Invalid | Total effective rate (%) | |||
| The example number | ％ | The example number | ％ | The example number | ％ | |||
| I II | 17 13 | 11 7 | 64.7 53.8 | 5 3 | 29.4 23.1 | 1 3 | 5.9 23.1 | 94.1 76.9 |
| Add up to | 30 | 18 | 60.0 | 8 | 26.7 | 4 | 13.3 | 86.7 |
5.4. symptom Signs curative effect
Symptom Signs curative effect sees Table 5.The result shows that fragrant shepherd's purse blood pressure lowering granule to hypertensive patient's symptom Signs curative effect is: dizzy disappearance rate: 93.75%; Headache disappearance rate: 85.71%; Dizzy disappearance rate: 88.46%; Flushed face due to ascending of fire disappearance rate: 100%; Dry mouth with bitter taste disappearance rate: 81.48%; Fidgety disappearance rate: 55.56%; Limb fiber crops disappearance rate: 77.78%.
The fragrant shepherd's purse blood pressure lowering of table 5. granule symptom Signs efficacy analysis
| Symptom | Treatment precedent number | The routine number in treatment back | Disappearance rate (%) |
| Dizziness and headache | 16 14 | 15 12 | 93.75 85.71 |
| The fidgety limb fiber crops of dizzy flushed face due to ascending of fire dry mouth with bitter taste | 26 18 27 18 9 | 23 18 22 10 7 | 88.46 100 81.48 55.56 77.78 |
5.5. untoward reaction
Clinical observation 30 examples are not seen obvious adverse reaction, and 30 routine patients all do inspections such as blood, urine, stool for routine, electrocardiogram, liver function, renal function, respectively detect 1 time before and after the treatment, all in normal range.
6. discuss
6.1. clinical observation on the therapeutic effect is the result show, fragrant shepherd's purse blood pressure lowering granule has the effect of suppressing the hyperactive liver to relieve the wind syndrome YANG hyperactivity suppressing.Be used for essential hypertension I, the overabundant liver-fire syndrome of II phase has significant curative effect, the total effective rate of blood pressure lowering is 90.0%, obvious effective rate is 73.3%; The efficacy analysis of symptom and sign, total effective rate are 86.7%, and obvious effective rate is 60.0%.
6.2. the drug safety observed result shows that fragrant shepherd's purse blood pressure lowering granule is not seen tangible toxicity.
Brief summary: 30 routine clinical observation on the therapeutic effect results show, fragrant shepherd's purse blood pressure lowering granule is used for essential hypertension I, the overabundant liver-fire syndrome of II phase has significant curative effect, and the total effective rate of hypotensive effect is 90.0%, and obvious effective rate is 73.3%, wherein the total effective rate of I phase is 100%, and obvious effective rate is 82.4%; II phase total effective rate is 76.9%, and obvious effective rate is 61.5%.After taking medicine continuously 14 days, systolic pressure, diastolic pressure blood pressure lowering amplitude are respectively produce effects: 4.08 ± 1.24,2.13 ± 0.72kPa (30.6 ± 9.3,16.0 ± 5.4mmHg); Effectively: 3.65 ± 0.65,1.49 ± 0.43kPa (27.4 ± 4.9,11.2 ± 3.2mmHg).The total effective rate of symptom and sign curative effect is 86.7%, and obvious effective rate is 60.0%, and wherein the total effective rate of I phase is 94.1%, and obvious effective rate is 64.7%; II phase total effective rate is 76.9%, and obvious effective rate is 53.8%.Symptom Signs efficacy result is: dizzy disappearance rate: 93.75%; Headache disappearance rate: 85.71%; Dizzy disappearance rate: 88.46%; Flushed face due to ascending of fire disappearance rate: 100%; Dry mouth with bitter taste disappearance rate: 81.48%; Fidgety disappearance rate: 55.56%; Limb fiber crops disappearance rate: 77.78%.Clinical observation does not see that fragrant shepherd's purse blood pressure lowering granule has tangible toxicity to the patient.
The specific embodiment
The invention will be further elaborated by the following examples.
Embodiment 1
Prescription: Pericarpium Musae 1040g, Herba Capsellae 830g, Radix Puerariae 830g.
Preparation technology: Pericarpium Musae is ground into 1cm
3Coarse grain, Radix Puerariae is cut into 2cm
3Fritter, Herba Capsellae are cut into the 3cm strip, 80% ethanol extraction three times, and each 2 hours, merge extractive liquid, filtered, and relative density 1.15g/ml when filtrate is concentrated into 60 ℃ gets extractum.Get extractum 833g, add lactose 200g, pregelatinized Starch 200g, carboxymethyl starch sodium 88g, micropowder silica gel 96g, stevioside 80g granulates, and drying is made the 1000g granule, and granulate, sieving promptly gets granule.
Embodiment 2
Prescription: Pericarpium Musae 1000g, Herba Capsellae 750g, Radix Puerariae (Pachyrhizua angulatus) 1050g.
Preparation technology: Pericarpium Musae is ground into 1cm
3Coarse grain, Radix Puerariae is cut into 2cm
3Fritter, Herba Capsellae are cut into the 3cm strip, 70% ethanol extraction three times, and each 2 hours, merge extractive liquid, filtered, and relative density 1.15g/ml when filtrate is concentrated into 60 ℃ gets extractum.Add the conventional adjuvant of oral liquid, common process is made oral liquid.
Embodiment 3
Prescription: Pericarpium Musae 1500g, Herba Capsellae 1250g, Radix Puerariae (Herba Gelsemii Elegantis) 1200g.
Preparation technology: Pericarpium Musae is ground into 1cm
3Coarse grain, Radix Puerariae is cut into 2cm
3Fritter, Herba Capsellae are cut into the 3cm strip, 90% ethanol extraction three times, and each 2 hours, merge extractive liquid, filtered, and relative density 1.18g/ml when filtrate is concentrated into 60 ℃ gets extractum.Add the conventional adjuvant of tablet, common process is made tablet.
Embodiment 4
Prescription: Pericarpium Musae 1250g, Herba Capsellae 1000g, Radix Puerariae (Pachyrhizua angulatus) 800g.
Preparation technology: Pericarpium Musae is ground into 1cm
3Coarse grain, Radix Puerariae is cut into 2cm
3Fritter, Herba Capsellae are cut into the 3cm strip, 85% ethanol extraction three times, and each 2 hours, merge extractive liquid, filtered, and relative density 1.17g/ml when filtrate is concentrated into 60 ℃ gets extractum.Add the conventional adjuvant of drop pill, common process is made drop pill.
Claims (5)
1, the Chinese medicine of a kind of treatment and prophylaxis of hypertension is characterized in that it is to be prepared from by following bulk drugs material:
Pericarpium Musae 20-30 part, Radix Puerariae 15-25 part, Herba Capsellae 15-25 part.
2, the Chinese medicine of treatment according to claim 1 and prophylaxis of hypertension is characterized in that it is to be prepared from by following bulk drugs material:
25 parts of Pericarpium Musae, 20 parts of Radix Puerariaes, 20 parts in Herba Capsellae.
3, the Chinese medicine of treatment according to claim 1 and 2 and prophylaxis of hypertension is characterized in that Radix Puerariae is Pachyrhizua angulatus or Herba Gelsemii Elegantis.
4, the Chinese medicine of treatment according to claim 1 and 2 and prophylaxis of hypertension is characterized in that its medicament is pill, tablet, powder, granule, capsule, drop pill, syrup, medicated wine or oral solutions.
5, the preparation technology of the Chinese medicine of treatment as claimed in claim 1 or 2 and prophylaxis of hypertension is characterized in that may further comprise the steps:
1) get three flavor raw medicinal materials by described prescription, 70-90% ethanol extraction three times, each 1-3 hour, merge extractive liquid, filtered, and relative density 1.15～1.18g/ml when filtrate is concentrated into 60 ℃ gets extractum;
2) add suitable adjuvant in extractum, common process is made required dosage form.
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