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CN1565600A - Chinese medicinal composition for treating hypertension - Google Patents

Chinese medicinal composition for treating hypertension Download PDF

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Publication number
CN1565600A
CN1565600A CN 03148091 CN03148091A CN1565600A CN 1565600 A CN1565600 A CN 1565600A CN 03148091 CN03148091 CN 03148091 CN 03148091 A CN03148091 A CN 03148091A CN 1565600 A CN1565600 A CN 1565600A
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Prior art keywords
chinese medicine
weight portion
medicine composition
radix rehmanniae
artemisiae argyi
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CN 03148091
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CN1235611C (en
Inventor
王意忠
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Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co ltd
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BEIJING ZHONGFU TIANHE PHARMA-TECH Co Ltd
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Abstract

The invention discloses a Chinese medicinal composition for treating hypertension, wherein the composition is prepared from rehmannia root, arborvitae tops, Chinese mugwort leafmulberry leaves and lotus leaves. The invention also discloses its preparation process.

Description

The hypertensive Chinese medicine composition of a kind of treatment
Invention field
The present invention relates to a kind of Chinese medicine composition, particularly relate to hypertensive Chinese medicine composition of a kind of treatment and preparation method thereof.
Background technology
Hypertension is by polygenic inheritance and environment and the interactional a kind of systemic disease of multiple risk factor, is a kind of global commonly encountered diseases, frequently-occurring disease, is to cause one of human cardiovascular and cerebrovascular disease main causes of death at present.Sickness rate is the principal disease of harm humans health up to 10-20% in the world wide.China is the country occurred frequently of essential hypertension.91 years according to high altitude hypertension standard generaI investigation, China more than 15 years old the hypertension prevalence be 13.58%.By this sickness rate, China has about 200,000,000 people of hyperpietic now.If press the existing standard diagnosis, the hypertension incidence patient can be more.But phenomenon that China's hypertension is popular to be existed " three Senior Three are low ", that is: hypertensive prevalence height, disability rate height and mortality rate height, awareness is low, the rate of taking medicine low and control rate is low.The heart that hypertension caused, brain, kidney be last target organ damage and the cardiovascular and cerebrovascular vessel incident that causes has seriously influenced quality of life eventually, is referred to as " noiseless killer ".To this, ministry of Health of China proposes the hypertension day of annual October 8 as China, and require the resident more than 35 years old to detect blood pressure every year at least one time, Here it is fundamentally calls national people and all medical personnels clearly to be familiar with hypertensive harm, actively prevents and treats hypertension.
At present modern medicine has 6 classes substantially to hypertensive medicine: 1. diuretic 2. α receptor blocking agents 3. beta-blockers 4. calcium ion antagonists 5. angiotensin converting enzyme inhibitors 6. angiotensin ii receptor antagonist.Along with the progress with the cardiovascular molecular biology research of carrying out of extensive resisting hypertension clinical trial, hypertensive traditional understanding has obtained renewal in recent years, and following disease medical science has become common recognition.Hypertension is not only the hemodynamic abnormalities disease, and follows the bad of target organ such as fat, carbohydrate metabolism disturbance and heart and brain kidney to reinvent.Therefore treatment will improve above-mentioned all metabolism disorders, prevention and the bad of reverse target organ and reinvent in effective controlling blood pressure level.This is to reduce the generation of cardiovascular complication and the key of case fatality rate.Though very much progress is all arranged on theory research and clinical efficacy than before.But because antihypertensive drugs still has arguement to the influence of metabolism and target organ damage, and all exists certain side effect mostly, part has limited its clinical practice.Making hypertensive control can not use up the people is willing to.
Tradition Chinese traditional treatment hypertension lay special stress on organic conception, determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, regulating yin and yang, too many levels conditioning, this has similar to modern medicine to the transformation of hypertension treatment viewpoint and the part of coincideing, and demonstrating Chinese medicine has certain advantage aspect hypertension treatment.And Chinese medicine is inexpensive, toxic and side effects is little, it is little that target organ is influenced.Being worth energetically, develop and spread uses.Therefore, according to hypertension incidence rate height, Western medicine control is not satisfied, and Chinese medicine curative effect height, toxic and side effects are little, inexpensive, does not have the characteristics such as Chinese patent medicine of obvious curative effects on the market again, adds our the effective experience of clinical treatment hypertension in the past.Through verifying repeatedly, testing, inspiring confidence in blood pressure decreasing capsule treatment hypertension in selected is research topic, is intended to our traditional differentiation of tcm, the equilibrated method of regulating YIN and YANG treatment control hypertension, allow vast hyperpietic's income, make motherland's medical radioactive go out more gorgeous radiance.
In sum, the purpose of the selected topic is summarized as follows with foundation:
1, hypertension is commonly encountered diseases, frequently-occurring disease, harm is big, mortality rate is high, is the principal disease of harm humans health, is the problem that is worth very much further investigation.
Though 2, doctor trained in Western medicine can most of control, side effect greatly, cost an arm and a leg, must take medicine for a long time.
3, traditional Chinese medical science organic conception, dialectical opinion control, the compound recipe under the too many levels adjustment, aspect the treatment hypertension very big advantage being arranged, meet the development law of hypertensive etiology and pathogenesis, but lack effective blood pressure lowering Chinese patent medicine at present clinically.
4, prescriptions of Chinese medicine, inexpensive, side effect is little, QI and blood regulating, regulating yin and yang demonstrate remarkable advantages aspect blood pressure lowering, be worth energetically develop and spread to be used.
5, has clinical treatment experience evident in efficacy.In the first phase clinical research, drug withdrawal after greatly hyperpietic's medication 1-2 course of treatment is arranged, blood pressure recovers normally so far, the longest have 3 years surplus.
Summary of the invention
Purpose of the present invention is to provide a kind of new treatment hypertensive Chinese medicine composition; Another object of the present invention is to provide a kind of preparation method of the new hypertensive Chinese medicine composition of treatment.
The present invention seeks to be achieved through the following technical solutions:
The crude drug of pharmaceutical composition of the present invention is formed and proportioning following (by weight):
Radix Rehmanniae 1-10 weight portion Cacumen Platycladi 1-10 weight portion
Folium Artemisiae Argyi 1-10 weight portion Folium Nelumbinis 1-10 weight portion.
Be preferably: Radix Rehmanniae 3-6 weight portion Cacumen Platycladi 3-6 weight portion Folium Artemisiae Argyi 3-6 weight portion Folium Nelumbinis 3-6 weight portion.
Optimum ratio is: Radix Rehmanniae 5 weight portion Cacumen Platycladis 5 weight portion Folium Artemisiae Argyis 5 weight portion Folium Nelumbinis 5 weight portions.
The preferred Radix Rehmanniae of described Radix Rehmanniae; The preferred Biotae orientalise of Cacumen Platycladi; The preferably living Folium Artemisiae Argyi of Folium Artemisiae Argyi; Folium Nelumbinis is preferably given birth to Folium Nelumbinis.
The present composition can be made any clinical acceptable forms, as tablet, and capsule, granule, oral liquid, subcutaneous administration preparation, suppository etc.
Preparation of drug combination method of the present invention is: Radix Rehmanniae, living Folium Nelumbinis add 10-14 times of water gaging respectively and decoct 1-3 time, and each 1-3 hour, collecting decoction filtered; Biotae orientalise, living Folium Artemisiae Argyi adds 8-12 times of water gaging and extracted volatile oil 1-3 hour, volatile oil is standby after with beta-cyclodextrin inclusion compound, the water extract filters, residue adds 8-12 times of water gaging and decocted 1-2 hour, filter, merge, the extractum that to be concentrated into 50-70 ℃ of relative density be 1.10-1.14 with above-mentioned decocting liquid, adding ethanol to determining alcohol is 60-75%, placement is spent the night, and filters decompression filtrate recycling ethanol, be concentrated into 50-70 ℃ of relative density 1.10-1.14, spray drying, medicated powder add volatile oil clathrate compound, through conventional operation directly or add pharmaceutically acceptable excipient and make clinical acceptable forms, as tablet, capsule, granule, oral liquid, the subcutaneous administration preparation, suppository.
Drug combination preparation of the present invention has stronger treatment hypertension effect, and has no side effect.
Following experimental example progress explanation the present invention.
Experimental example 1 pharmacodynamic experiment
Inspire confidence in blood pressure decreasing capsule during drug combination preparation of the present invention (in inspire confidence in blood pressure decreasing capsule) main pharmacodynamics result of study has confirmed and have stronger treatment hypertension effect.
Be subjected to the reagent thing: in inspire confidence in blood pressure decreasing capsule, provide by China Academy Of Traditional Chinese Medicine Traditional Chinese Medicine Research Institute dosage form chamber, contain 4.29g crude drug/g, lot number: 20011015.Laboratory animal spontaneous hypertensive rat (SHR), 3 monthly ages, body weight 210 ± 20g, male and female half and half, available from the department of the Chinese Academy of Sciences of laboratory animal section of Shanghai Second Emdical University, the quality certification number: the moving word of doctor 02-23-6 number; Apoplectic type spontaneous hypertensive rat (SHRsp), 3 monthly ages, body weight 210 ± 20g, male and female half and half are available from Fuwai Hospital, Chinese Academy of Medical Sciences Beijing; Domesticated dog, body weight 15kg ± 2kg, male and female are regardless of, and available from tonneau animal cultivation field, Beijing, the quality certification number: the capital is moving is betrothed to 2000-010 number total 055; The Wister rat, body weight 230 ± 10g, male and female half and half; Kunming mouse, body weight 16 ± 2g, male and female half and half are all available from Chinese Academy of Medical Sciences Animal Experimental Study center, quality certification SCXK11-00-0006.
Will in inspire confidence in blood pressure decreasing capsule with 1.62,3.24,6.42g crude drug/kg/d irritates stomach and gives rat; With 3.3,6.6,13.2g crude drug/kg/d irritates stomach and gives mice; 0.56,1.12,2.24g/kg gives dog, proof by experiment, in inspire confidence in blood pressure decreasing capsule following pharmacological action arranged:
1. to the influence of SHR and SHRsp rat blood pressure: three dosage groups all can obviously stop SHR rat model increased blood pressure, there were significant differences with model control group (P<0.01) from administration the 2nd week beginning, and drug withdrawal relatively still has significance difference (P<0.01) with model control group after 4 weeks.
Dosed administration group big or middle has obvious hypotensive effect to the SHRsp rat model, blood pressure is from begin promptly with model control group significant difference (P<0.01) is arranged relatively in the 1st week of administration, and the heavy dose of group in 4 week of drug withdrawal back relatively still has significance difference (P<0.01) with model control group.
2, to the influence of renal artery stenosis rat blood pressure: three dosed administration groups can obviously stop renal artery stenosis model hypertensive rat blood pressure to rise, from the 1st week of administration the beginning blood pressure and model control group there were significant differences (P<0.01).
3, to the hemodynamic influence of normal dogs: big or middle dosage group after administration 1-2.5 hour, dog are shunk to be pressed with in various degree and are reduced, and its reduction amplitude and matched group relatively have significant difference (P<0.05P<0.01); 1-2.5 hour total peripheral vascular resistance obviously reduces after the administration of heavy dose of group, 1.5 hours diastolic pressures obviously reduce after the administration, and its reduction amplitude and matched group relatively have significant difference (P<0.05).
Three dosage of administration group all do not have obvious influence to dog left indoor pressure, left ventricular end diastolic presssure and mean arterial pressure, heart rate and cardiac output.
4, microcirculation of mouse auricle is influenced: the big or middle dosage of administration group has the arteriolar effect of obvious expansion Mice Auricle, and the changing value and the matched group of tremulous pulse bore relatively have significance difference (P<0.05 P<0.01) before and after its administration; Administration group heavy dose can reduce erythrocytic aggregation in Mice Auricle small artery and the blood capillary, and significance difference (P<0.01) is arranged relatively before the administration; Venule bore and blood flow rate there is not obvious influence.
5, to the influence of renal artery stenosis Hypertensive Rats blood plasma medium vessels active substance, three dosage of administration group have in various degree reduction effect to the nervous plain II of renal artery stenosis Hypertensive Rats blood plasma medium vessels, aldosterone and content of ET; With model control group significance difference (P<0.05P<0.01) is arranged relatively; To atrial natriuretic peptide, fall calcio and do not have obvious influence because of related peptides
6, to the influence of renal hypertensive rat serum intermediate ion: three dosage of administration group have tangible reduction effect to sodium ion in the renal artery stenosis Hypertensive Rats serum, with model control group significance difference (P<0.05 P<0.01) are arranged relatively; To K +, Ca ++There is not obviously influence.
Experimental example 2 toxicity tests
The rat long term toxicity test:
Rat is irritated stomach respectively and inspires confidence in blood pressure decreasing capsule 15,7.5,3.75g crude drug/kg/d (be equivalent to human dosage 50,25 and 12.5 times) in giving, continuous 6 months, continue after the drug withdrawal to observe for 2 weeks, the result shows: ordinary circumstance, body weight, peripheral hemogram to animal do not have obvious influence, every biochemical indicator all fluctuates in normal range, index, macroscopy to important organ there is no significant change, also do not see have because the caused obvious pathomorphology of medicine changes through pathological study.Blood pressure slightly reduces.The chmice acute toxicity test:
With in inspire confidence in blood pressure decreasing capsule (irritate for three times in the dose of 1g medicated powder/ml) a day after stomaches give mice, observed continuously 7 days, the result find no animal dead, and body weight rises appreciably with the maximum volume that can give (0.6ml/ only), Cmax.Total dosage is 387g crude drug/kg/d, is equivalent to 1290 times of people's clinical application amount.
Following examples all can reach the effect of above-mentioned experimental example.
Embodiment 1Capsule
The living Folium Artemisiae Argyi 750g of Radix Rehmanniae 750g Biotae orientalise 750g gives birth to Folium Nelumbinis 750g
Radix Rehmanniae, Folium Nelumbinis add 12 times of water gagings respectively and decoct 2 times, and 1.5 hours for the first time, 1 hour for the second time, collecting decoction filtered; Cacumen Platycladi, Folium Artemisiae Argyi add 10 times of water gagings and extract volatile oil 2h, volatile oil is standby after with beta-cyclodextrin inclusion compound, and the water extract filters, and residue adds 10 times of water gagings and decocted 1 hour, filter, merge with above-mentioned decocting liquid, the extractum that to be concentrated into 60 ℃ of relative densities be 1.10-1.14, adding ethanol to determining alcohol is 70%, placement is spent the night, filter, decompression filtrate recycling ethanol is concentrated into 60 ℃ of relative density 1.10-1.14, spray drying, medicated powder adds volatile oil clathrate compound, dextrin in right amount to 500g, adds magnesium stearate 2g, mixing, cross 80 mesh sieves, dry-pressing is granulated, and is encapsulated, promptly gets 1000.Every 0.5 gram.Every day 2 times, each 3.
Embodiment 2Granule
The living Folium Artemisiae Argyi 400g of Radix Rehmanniae 500g Biotae orientalise 400g gives birth to Folium Nelumbinis 500g
Radix Rehmanniae, Folium Nelumbinis add 12 times of water gagings respectively and decoct 2 times, and 1.5 hours for the first time, 1 hour for the second time, collecting decoction filtered; Cacumen Platycladi, Folium Artemisiae Argyi add 10 times of water gagings and extract volatile oil 2h, and volatile oil is standby after with beta-cyclodextrin inclusion compound, and the water extract filters, residue adds 10 times of water gagings and decocted 1 hour, filters, and merges with above-mentioned decocting liquid, the extractum that to be concentrated into 60 ℃ of relative densities be 1.10-1.14, adding ethanol is 70% to determining alcohol, placement is spent the night, filter, decompression filtrate recycling ethanol is concentrated into 60 ℃ of relative density 1.10-1.14, spray drying, medicated powder adds volatile oil clathrate compound, makes granule 1000 grams through conventional technology.
Embodiment 3Granule
The living Folium Artemisiae Argyi 400g of Radix Rehmanniae 800g Biotae orientalise 700g gives birth to Folium Nelumbinis 500g
Radix Rehmanniae, Folium Nelumbinis add 12 times of water gagings respectively and decoct 2 times, and 1.5 hours for the first time, 1 hour for the second time, collecting decoction filtered; Cacumen Platycladi, Folium Artemisiae Argyi add 10 times of water gagings and extract volatile oil 2h, and volatile oil is standby after with beta-cyclodextrin inclusion compound, and the water extract filters, residue adds 10 times of water gagings and decocted 1 hour, filters, and merges with above-mentioned decocting liquid, the extractum that to be concentrated into 60 ℃ of relative densities be 1.10-1.14, adding ethanol is 70% to determining alcohol, placement is spent the night, filter, decompression filtrate recycling ethanol is concentrated into 60 ℃ of relative density 1.10-1.14, spray drying, medicated powder adds volatile oil clathrate compound, makes granule 1100 grams through conventional technology.
Embodiment 4Tablet
The living Folium Artemisiae Argyi 500g of Radix Rehmanniae 400g Biotae orientalise 600g gives birth to Folium Nelumbinis 600g
Radix Rehmanniae, Folium Nelumbinis add 12 times of water gagings respectively and decoct 2 times, and 1.5 hours for the first time, 1 hour for the second time, collecting decoction filtered; Cacumen Platycladi, Folium Artemisiae Argyi add 10 times of water gagings and extract volatile oil 2h, and volatile oil is standby after with beta-cyclodextrin inclusion compound, and the water extract filters, residue adds 10 times of water gagings and decocted 1 hour, filters, and merges with above-mentioned decocting liquid, the extractum that to be concentrated into 60 ℃ of relative densities be 1.10-1.14, adding ethanol is 70% to determining alcohol, placement is spent the night, filter, decompression filtrate recycling ethanol is concentrated into 60 ℃ of relative density 1.10-1.14, spray drying, medicated powder adds volatile oil clathrate compound, makes 900 in tablet through conventional technology.

Claims (8)

1. hypertensive Chinese medicine composition of treatment is characterized in that this Chinese medicine composition made by following raw material medicaments:
Radix Rehmanniae 1-10 weight portion Cacumen Platycladi 1-10 weight portion
Folium Artemisiae Argyi 1-10 weight portion Folium Nelumbinis 1-10 weight portion.
2. Chinese medicine composition as claimed in claim 1 is characterized in that this Chinese medicine composition made by following raw material medicaments:
Radix Rehmanniae 3-6 weight portion Cacumen Platycladi 3-6 weight portion
Folium Artemisiae Argyi 3-6 weight portion Folium Nelumbinis 3-6 weight portion.
3. Chinese medicine composition as claimed in claim 2 is characterized in that this Chinese medicine composition made by following raw material medicaments:
Radix Rehmanniae 5 weight portion Cacumen Platycladis 5 weight portions
Folium Artemisiae Argyi 5 weight portion Folium Nelumbinis 5 weight portions.
4. as the described Chinese medicine composition of claim 1-3, it is characterized in that the preferred Radix Rehmanniae of Radix Rehmanniae in this Chinese medicine composition; The preferred Biotae orientalise of Cacumen Platycladi; The preferably living Folium Artemisiae Argyi of Folium Artemisiae Argyi; Folium Nelumbinis is preferably given birth to Folium Nelumbinis.
5. Chinese medicine composition as claimed in claim 4, the dosage form that it is characterized in that this Chinese medicine composition can be any in tablet, capsule, granule, oral liquid, subcutaneous administration preparation, the suppository.
6. the preparation method of Chinese medicinal composition preparation as claimed in claim 5 is characterized in that this method is: Radix Rehmanniae, gives birth to Folium Nelumbinis and adds 10-14 times of water gaging respectively and decoct 1-3 time, and each 1-3 hour, collecting decoction, filtration; Biotae orientalise, living Folium Artemisiae Argyi adds 8-12 times of water gaging and extracted volatile oil 1-3 hour, volatile oil is standby after with beta-cyclodextrin inclusion compound, the water extract filters, residue adds 8-12 times of water gaging and decocted 1-2 hour, filter, merge with above-mentioned decocting liquid, the extractum that to be concentrated into 50-70 ℃ of relative density be 1.10-1.14, adding ethanol to determining alcohol is 60-75%, placement is spent the night, filter, decompression filtrate recycling ethanol is concentrated into 50-70 ℃ of relative density 1.10-1.14, spray drying, medicated powder adds volatile oil clathrate compound, through conventional operation directly or add pharmaceutically acceptable excipient and make tablet, capsule, granule, oral liquid, the subcutaneous administration preparation, in the suppository any.
7. the preparation method of Chinese medicinal composition preparation as claimed in claim 6 is characterized in that preparing the capsule method and is: Radix Rehmanniae, give birth to Folium Nelumbinis and add 12 times of water gagings respectively and decoct 2 times, 1.5 hours for the first time, 1 hour for the second time, collecting decoction filtered; Biotae orientalise, living Folium Artemisiae Argyi add 10 times of water gagings and extract volatile oil 2h, volatile oil is standby after with beta-cyclodextrin inclusion compound, and the water extract filters, and residue adds 10 times of water gagings and decocted 1 hour, filter, merge with above-mentioned decocting liquid, the extractum that to be concentrated into 60 ℃ of relative densities be 1.10-1.14, adding ethanol to determining alcohol is 70%, placement is spent the night, filter, decompression filtrate recycling ethanol is concentrated into 60 ℃ of relative density 1.10-1.14, spray drying, medicated powder adds volatile oil clathrate compound, dextrin in right amount to 500g, adds magnesium stearate 2g, mixing, cross 80 mesh sieves, dry-pressing is granulated, and is encapsulated, promptly.
8. the application of Chinese medicine composition as claimed in claim 4 in preparation treatment hypertension disease medicament.
CN 03148091 2003-06-30 2003-06-30 Chinese medicinal composition for treating hypertension Expired - Lifetime CN1235611C (en)

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CN1565600A true CN1565600A (en) 2005-01-19
CN1235611C CN1235611C (en) 2006-01-11

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102283939A (en) * 2011-08-01 2011-12-21 北京阜康仁生物制药科技有限公司 Chinese medicinal preparation for treating hypertension and preparation method thereof
CN104435312A (en) * 2014-11-12 2015-03-25 扬子江药业集团北京海燕药业有限公司 Application of Baiai capsule as intestinal transporter inhibitor
CN107242337A (en) * 2017-07-11 2017-10-13 安徽省葛源农业科技发展有限公司 The processing method that a kind of root of kudzu vine decompression generation makes tea

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102283939A (en) * 2011-08-01 2011-12-21 北京阜康仁生物制药科技有限公司 Chinese medicinal preparation for treating hypertension and preparation method thereof
CN104435312A (en) * 2014-11-12 2015-03-25 扬子江药业集团北京海燕药业有限公司 Application of Baiai capsule as intestinal transporter inhibitor
CN107242337A (en) * 2017-07-11 2017-10-13 安徽省葛源农业科技发展有限公司 The processing method that a kind of root of kudzu vine decompression generation makes tea

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