CN105832847B - A kind of Chinese medicine composition and preparation method thereof for treating hypertension - Google Patents

A kind of Chinese medicine composition and preparation method thereof for treating hypertension Download PDF

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CN105832847B
CN105832847B CN201610316369.2A CN201610316369A CN105832847B CN 105832847 B CN105832847 B CN 105832847B CN 201610316369 A CN201610316369 A CN 201610316369A CN 105832847 B CN105832847 B CN 105832847B
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ethyl alcohol
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clear cream
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CN105832847A (en
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刘宏伟
袁莉
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Shaanxi Kai Yuan Pharmaceutical Co Ltd
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/31Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
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    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

The present invention relates to a kind of Chinese medicine compositions and preparation method thereof for treating hypertension.The traditional chinese medicine composition of the invention is prepared by the raw material of following parts by weight: 1000-1800 parts of radish seed, 600-1000 parts of hawthorn, 600-1000 parts of pueraria lobata.The traditional chinese medicine composition of the invention has a good effect in terms for the treatment of II phase of primary hypertension (the turbid hemicrania of phlegm), not only high blood pressure Shi Keyong also can be used when low, therefore can consolidate antihypertensive effect well, prevent blood pressure from rebounding, thus the effect of reaching bidirectional modulation.

Description

A kind of Chinese medicine composition and preparation method thereof for treating hypertension
Technical field
The invention belongs to technical field of traditional Chinese medicines, in particular to a kind of Chinese medicine composition for treating hypertension and its preparation side Method.
Background technique
High blood pressure be it is a kind of with recycle arterial pressure persistently increase based on systemic chronic disease, it is more with the middle-aged and the old See there is that age of onset gradually decreases in recent years.Long-term stress lacks physical exertion, inherent cause, obesity, food The excessive person's disease incidence of salt is higher.According to theory of traditional Chinese medical science, hypertension has the imbalance of yin and yang of liver kidney, phlegm accumulating with stagnant blood more, has because liver-yang is contained partially, Liver-yin is deficient, kidney essence deficiency, caused by kidney yin is weak, has because of eating and drinking without temperance, the spleen damage turbid impatency of phlegm causes, has because feelings will is unsuccessful, liver Yu Huahuo, liver-fire flaming, have because the deficiency of liver-yin and kidney-yin cannot sun processed, liver-yang hyperactivity, the deficiency of the liver-yin then dizzy dizziness, kidney-yin deficiency then soreness of waist ear Ring, the deficiency of Yin and it is interior heat, vexed, feverishness in palms and soles, it is flushing to warm.Laige Granules are the production of Shaanxi Katyuan pharmaceutical Co. Ltd, are used for Treat the Chinese materia medica preparation of II phase of primary hypertension (the turbid hemicrania of phlegm), the approval number of the drug: national drug standard Z20030091.
New drug is become a full member the 72nd (standard No.: WS of standard3- 382 (Z-49) -2006 (Z)) disclosed in Laige Granules be by Radish seed, hawthorn and 3 taste medicine of pueraria lobata are prepared, but undisclosed its prescription proportion, while also not recording the preparation of Laige Granules Method.Preparation process report in relation to Laige Granules is less, and Attached Hospital, Changchun Chinese Medicinal College Rong great Qi is taught in public affairs in 2005 The research of Laige Granules preparation process is reported in " research of Laige Granules treatment high blood pressure " of exploitation table.Research thinks, Lay Monarch drug in a prescription in the side of being Fu, principle active component are sinapines, by screening optimised process are as follows: extract Lay using 80% alcohol reflux Fu, extraction time are 1 time per hour, and about 8 times, extraction is closely colourless to extracting solution, and a small amount of extracting solution is taken from sighting tube, and point exists It on filter paper, sets under ultraviolet lamp (365nm), observation sky blue fluorescence disappears substantially, that is, illustrates that mustard seed alkali carries are most.Ethyl alcohol is recycled, it is dense Contract to obtain clear cream.Hawthorn, pueraria lobata principle active component are flavonoid glycoside compounds, are extracted using decoction alcohol precipitation method, and orthogonal examination is passed through The method of testing filters out optimised process are as follows: decocting time 4h, decocting number is 3 times, alcohol precipitation concentration 65%, and recycling ethyl alcohol obtains clearly Cream.Merge clear cream and add cane sugar powder, kudzu-vine root powder, granulation, dry, whole grain to obtain the final product.
Undisclosed prescription in the studies above report, there is also some defects in preparation process, such as radish seed extraction time mistake More, extraction efficiency is low, and only using sinapine as target component, has ignored flavonoids in radish seed, polysaccharide effective component That extracts considers, therefore the clear cream extracted by this technique, can not play the advantage that Chinese medicine multicomponent multiple target point plays a role;Separately Outside, not only water extract-alcohol precipitation obtains clear cream to pueraria lobata in above-mentioned preparation method, and kudzu-vine root powder is also used as auxiliary material to be added, and is unfavorable for pelletizing, and lead to Pueraria lobota Root usage variance is larger.It has violated Chinese medicine and has selected the Spirit Essence of medicine and the compatibility of Chinese medicine monarch according to organic conception prescription Principle.
Summary of the invention
In order to solve the above-mentioned technical problem, the object of the present invention is to provide a kind of Chinese medicine composition for treating flu and its systems Preparation Method.
The purpose of the present invention is achieved through the following technical solutions:
The present invention provides a kind of Chinese medicine composition for treating hypertension, and the composition is the raw material group by following weight ratio At: 1000-1800 parts of radish seed, 600-1000 parts of hawthorn, 600-1000 parts of pueraria lobata.
Preferably, the composition is made of the raw material of following weight ratio: 1120-1680 parts of radish seed, hawthorn 640- 960 parts, 640-1000 parts of pueraria lobata.
Still more preferably, the composition is made of the raw material of following weight ratio: 1400 parts of radish seed, hawthorn 800 Part, 800 parts of pueraria lobata.
The Chinese medicine composition of any description above, common pharmaceutic adjuvant is added, preparation is made is tablet, pill, capsule Or granule.
Meanwhile the present invention provides the preparation method of above-mentioned preparation, the Chinese materia medica preparation is prepared according to the following steps:
((1) takes radish seed to smash into coarse powder, after adding 60-85% ethyl alcohol to impregnate 12 hours, measures 60-85% ethyl alcohol with 2-8 times Refluxing extraction 5-10 hours, ethyl alcohol is recycled, is placed to room temperature, is refrigerated 15-30 hours, filtration, filtrate is concentrated into relative density For the clear cream of 1.0-1.5;
(2) pueraria lobata and hawthorn add water to cook three times, and decocting time is 1-4 hours, merge decoction liquor, filtration, filtrate concentration It is 1.1-1.35 to relative density, adds ethyl alcohol to make alcohol content up to 50%-80%, stirring, after standing 12 hours, filtration, precipitating is used 50%-80% ethanol washing 1-3 times, washing lotion merges with filtrate, recycles ethyl alcohol, is concentrated into the clear cream that relative density is 1.1-1.8;
(3) clear cream obtained by step (1), step (2) is merged, auxiliary material is added after mixing, preparation is made according to common process.
Preferably, the Chinese materia medica preparation is prepared according to the following steps:
(1) it takes radish seed to smash into coarse powder, after adding 60-85% ethyl alcohol to impregnate 12 hours, measures 60-85% ethyl alcohol with 2-8 times Refluxing extraction 5-10 hours, ethyl alcohol is recycled, is placed to room temperature, is refrigerated 15-30 hours, filtration, filtrate is concentrated into relative density For the clear cream of 1.0-1.5;
(2) pueraria lobata and hawthorn add water to cook three times, and amount of water is followed successively by 8,7,6 times, and decocting time is 1-4 hours, merge Decoction liquor, filtration, it is 1.1-1.35 that filtrate, which is concentrated into relative density, adds ethyl alcohol to make alcohol content up to 50%-80%, stirs, stands After 12 hours, filtration, precipitating is used 50%-80% ethanol washing 1-3 times, and washing lotion merges with filtrate, recycles ethyl alcohol, is concentrated into opposite Density is the clear cream of 1.1-1.8;
(3) clear cream obtained by step (1), step (2) is merged, in clear cream: cane sugar powder and paste is added in the ratio of cane sugar powder 1:2 It is 200-350 parts smart, it is uniformly mixed, pelletizes, dry, granule is made in packing.
Still more preferably, the Chinese materia medica preparation of above-mentioned treatment hypertension is prepared according to the following steps:
(1) it takes radish seed to smash into coarse powder, 75% ethyl alcohol is added to impregnate 12 hours, it is small to extract 8 with 5 times of 75% alcohol refluxs of amount When, ethyl alcohol is recycled, is placed to room temperature, is refrigerated 24 hours, filtration, filtrate is concentrated into the clear cream that relative density is 1.0-1.5;
(2) pueraria lobata and hawthorn add water to cook three times, and amount of water is followed successively by 8,7,6 times, and decocting time is 2 hours, merge and decoct Boil liquid, filtration, it is 1.1-1.35 that filtrate, which is concentrated into relative density, adds ethyl alcohol to make alcohol content up to 65%, stirring stands 12 hours Afterwards, it filters, precipitates with 65% ethanol washing 3 times, washing lotion merges with filtrate, recycles ethyl alcohol, and being concentrated into relative density is 1.1-1.8 Clear cream;
(3) clear cream obtained by step (1), step (2) is merged, in clear cream: cane sugar powder and paste is added in the ratio of cane sugar powder 1:2 280 parts of essence is uniformly mixed, and is pelletized, dry, and granule is made in packing.
Heretofore described radish seed is the drying and ripening kind of crucifer radish Raphanus sativus L. Son.Plant is tapped when summer fruit maturation, is dried, seed is rubbed, removes impurity, then dry.Modern pharmacological research expression, radish Son contains Multiple components, such as volatile oil, fatty acid, antibiotics, alkaloids, flavonoids, polysaccharide and protide.Its Middle fatty acid tool is acted on by relax bowel and defecation toxin expelling;Alkaloids has hypotensive activity, and flavone compound has lipid-loweringing, drop Sugared, anti-oxidant, antithrombotic isoreactivity.Polysaccharide is ideal immunopotentiator, and the function of body immune system can be improved, disease-resistant Malicious, antitumor, anti-aging effects affirmative.
Hawthorn is rosaceous plant large-fruited Chinese hawthorn Crataegus pinnatifida Bge.var.major N.E.Br. or mountain The dry mature fruit of short, bristly hair or beard Crataegus pinnatifida Bge..When the fruit matures in the fall, it is harvested, sliced, and dried.It is modern Studies have shown that hawthorn is containing carbohydrate, protein, fat, vitamin C, carrotene, starch, malic acid, citric acid, calcium and iron etc. Substance has the effects that reducing blood lipid, blood pressure, heart tonifying, arrhythmia, meanwhile, hawthorn is also spleen benefiting and stimulating the appetite, relieving dyspepsia, work The good medicine of blood resolving sputum, to chest diaphragm spleen, the diseases such as full, hernia, blood stasis, amenorrhoea have good curative effect.
Pueraria lobata is the dry root of legume pueraria lobata Pueraria lobata (Willd.) Ohwi, practises and claims elegant jessamine.Autumn, winter The excavation of two seasons, takes advantage of fresh-cut into sheet or fritter;It is dry.Modern research shows that pueraria lobata main component is starch, furthermore containing about 12% flavone compound, including soybean (soya bean) glucoside, daidzein, Puerarin etc. more than 10;And contain Daucosterol, ammonia Base acid, Coumarins etc..The flavones proposed in pueraria lobata can increase brain and coronal vascular flow amount.Water extract has hypoglycemic work With.Decoction is taken orally to rabbit, starts 2 hours blood glucose and rises, decline immediately, decline in the 3rd, 4 hour is minimum, to rabbit adrenal gland Disposition hyperglycemia is allowed to increase instead not only without antagonism, but blood glucose can be promoted to restore normal ahead of time.
Chinese materia medica preparation side of the present invention solves: monarch drug in a prescription radish seed Xin Ganping in side enters spleen and lung, and kind lower gas disappears heap soil or fertilizer over and around the roots except stagnating, and opens strongly fragrant Gas and to transport spleen wet.The sweet temperature of hawthorn acid, enters liver and spleen and walks blood system, is apt to Removing Blood Stasis without hurting new blood, opens strongly fragrant gas without hurting healthy tendency, can help digestion Promoting.Pueraria lobata is sweet pungent and cool, and enter taste makes for assistant, can rise the gas of the clear sun of hair taste, pushes clear positive, compatibility radish seed turbid wet to break One rise and one drop, just together in " spleen preferably rise it is then prompt, stomach preferably drop then and ".Three medicine compatibilities play ascending the clear and descending the turbid altogether, and spleen, eliminating the phlegm stagnation resolvation are transported in rising Yang The effect of promoting, hypertension caused by hemicrania turbid for phlegm have good curative effect.
Beneficial effects of the present invention:
(1) China hypertensive patient number is up to 1.1 hundred million, and current depressor is used when being high blood pressure, stops after lowering With, curative effect is unstable, and with Chinese materia medica preparation of the invention not only high blood pressure Shi Keyong, it also can be used, therefore can consolidate when low well Antihypertensive effect prevents blood pressure from rebounding, thus the effect of reaching bidirectional modulation.As taken for a long time, with stabilizing blood pressure and can have not It is good to react the advantages that less, and there are also effect for reducing blood fat.
(2) the preparation method of Chinese materia medica preparation of the present invention selects the Spirit Essence of medicine in strict accordance with Chinese medicine organic conception prescription And Chinese medicine has done a large amount of experimental study to production technology, new process makes each drug effect according to the combination principle of monarch Ingredient sufficiently extracts, gained finished product preparation quality stable homogeneous, technique more suitable for industrial, teaches disclosed work compared with Rong great Qi Skill is made preparation clinical efficacy and significantly improves.
In order to confirm the marked improvement of process of Chinese material medica preparation of the present invention, we determine respectively is made in specific embodiment 6 Finished particle preparation and the technique that is proposed according to professor Rong great Qi made of content of drug effect components in finished particle preparation, as a result It see the table below 1.
1 finished particle formulation efficacy comparison of ingredients of table
Compared with 6 technique finished product group of embodiment teaches technique finished product group with Rong great Qip<0.01
As seen from the above table, according to sinapine and puerarin content in the finished particle preparation of the preparation process of Rong great Qi professor All it is slightly above the preparation of 6 preparation process of embodiment, therebetween without significant difference, but Rong great Qi teaches flax in technique finished product group Acid, general flavone and organic acid are below 6 technique finished product group of embodiment, there is extremely significant difference therebetween.
Specific embodiment
It is the specific embodiment of the content of present invention below, for illustrating the skill of the technical problem of being solved in present specification Art scheme facilitates those skilled in the art understand that the content of present invention, but the realization of technical solution of the present invention is not limited to these Embodiment.
Embodiment 1
(1) radish seed 1000g is taken to smash into coarse powder, after adding 60% ethyl alcohol to impregnate 12 hours, with 2 times of 60% alcohol refluxs of amount It extracts 5 hours, recycles ethyl alcohol, place to room temperature, refrigerate 15 hours, filtration, it is 1.0-1.5's that filtrate, which is concentrated into relative density, Clear cream;
(2) pueraria lobata 1000g and hawthorn 1000g is taken to add water to cook three times, decocting time is 1 hour, merges decoction liquor, filter It crosses, it is 1.1-1.35 that filtrate, which is concentrated into relative density, and ethyl alcohol is added to make alcohol content up to 50%, and stirring after standing 12 hours, filters, With 50% ethanol washing 1 time, washing lotion merges precipitating with filtrate, recycles ethyl alcohol, is concentrated into the clear cream that relative density is 1.1-1.8;
(3) clear cream obtained by step (1), step (2) is merged, customary adjuvant, dry, granulation is added after mixing, tabletting is .
Embodiment 2
(1) radish seed 1800g is taken to smash into coarse powder, after adding 85% ethyl alcohol to impregnate 12 hours, with 8 times of 85% alcohol refluxs of amount It extracts 10 hours, recycles ethyl alcohol, place to room temperature, refrigerate 30 hours, filtration, filtrate is concentrated into relative density 1.0-1.5's Clear cream;
(2) pueraria lobata 600g and hawthorn 600g is taken to add water to cook three times, decocting time is 4 hours, merges decoction liquor, it filters, It is 1.1-1.35 (80 DEG C) that filtrate, which is concentrated into relative density, adds ethyl alcohol to make alcohol content up to 80%, stirring after standing 12 hours, is filtered It crosses, precipitates with 80% ethanol washing 1-3 times, washing lotion merges with filtrate, recycles ethyl alcohol, and being concentrated into relative density is 1.1-1.8's Clear cream;
(3) clear cream obtained by step (1), step (2) is merged, customary adjuvant is added after mixing, dry, granulation is encapsulated To obtain the final product.
Embodiment 3
(1) radish seed 1120g is taken to smash into coarse powder, after adding 75% ethyl alcohol to impregnate 12 hours, with 5 times of 75% alcohol refluxs of amount It extracts 8 hours, recycles ethyl alcohol, place to room temperature, refrigerate 24 hours, filtration, it is 1.0-1.5's that filtrate, which is concentrated into relative density, Clear cream;
(2) pueraria lobata 960g and hawthorn 960g is taken to add water to cook three times, decocting time is 1-4 hours, merges decoction liquor, filter It crosses, it is 1.1-1.35 that filtrate, which is concentrated into relative density, add ethyl alcohol to make alcohol content up to 50%-80%, stirs, after standing 12 hours, Filtration, precipitating are used 50%-80% ethanol washing 1-3 times, and washing lotion merges with filtrate, recycle ethyl alcohol, being concentrated into relative density is The clear cream of 1.1-1.8;
(3) clear cream obtained by step (1), step (2) is merged, customary adjuvant is added after mixing, pill is made.
Embodiment 4
(1) radish seed 1120g is taken to smash into coarse powder, after adding 60% ethyl alcohol to impregnate 12 hours, with 2 times of 60% alcohol refluxs of amount It extracts 5 hours, recycles ethyl alcohol, place to room temperature, refrigerate 15 hours, filtration, it is 1.0-1.5's that filtrate, which is concentrated into relative density, Clear cream;
(2) pueraria lobata 960g and hawthorn 960g is taken to add water to cook three times, amount of water is followed successively by 8,7,6 times, and decocting time is 1 small When, merge decoction liquor, filtration, it is 1.1-1.35 that filtrate, which is concentrated into relative density, adds ethyl alcohol to make alcohol content up to 50%, stirring is quiet After setting 12 hours, filtration is precipitated with 50% ethanol washing 1-3 times, and washing lotion merges with filtrate, is recycled ethyl alcohol, is concentrated into relatively close Degree is the clear cream of 1.1-1.8;
(3) clear cream obtained by step (1), step (2) is merged, in clear cream: cane sugar powder and paste is added in the ratio of cane sugar powder 1:2 Smart 200g is uniformly mixed, and is pelletized, dry, and granule is made in packing.
Embodiment 5
(1) radish seed 1400g is taken to smash into coarse powder, after adding 85% ethyl alcohol to impregnate 12 hours, with 8 times of 85% alcohol refluxs of amount It extracts 10 hours, recycles ethyl alcohol, place to room temperature, refrigerate 30 hours, filtration, it is 1.0-1.5 that filtrate, which is concentrated into relative density, Clear cream;
(2) pueraria lobata 800g and hawthorn 800g are added water to cook three times, and amount of water is followed successively by 8,7,6 times, and decocting time is 4 small When, merge decoction liquor, filtration, it is 1.1-1.35 that filtrate, which is concentrated into relative density, adds ethyl alcohol to make alcohol content up to 80%, stirring is quiet After setting 12 hours, filtration is precipitated with 80% ethanol washing 3 times, and washing lotion merges with filtrate, is recycled ethyl alcohol, is concentrated into relative density For the clear cream of 1.1-1.8;
(3) clear cream obtained by step (1), step (2) is merged, in clear cream: cane sugar powder and paste is added in the ratio of cane sugar powder 1:2 350 parts of essence is uniformly mixed, and is pelletized, dry, and granule is made in packing.
Embodiment 6
(1) radish seed 1400g is taken to smash into coarse powder, after adding 75% ethyl alcohol to impregnate 12 hours, with 5 times of 75% alcohol refluxs of amount It extracts 8 hours, recycles ethyl alcohol, place to room temperature, refrigerate 24 hours, filtration, it is 1.0-1.5's that filtrate, which is concentrated into relative density, Clear cream;
(2) pueraria lobata 800g and hawthorn 800g are added water to cook three times, and amount of water is followed successively by 8,7,6 times, and decocting time is 2 small When, merge decoction liquor, filtration, it is 1.1-1.35 that filtrate, which is concentrated into relative density, adds ethyl alcohol to make alcohol content up to 65%, stirring is quiet After setting 12 hours, filtration is precipitated with 65% ethanol washing 3 times, and washing lotion merges with filtrate, is recycled ethyl alcohol, is concentrated into relative density For the clear cream of 1.1-1.8;
(3) clear cream obtained by step (1), step (2) is merged, in clear cream: cane sugar powder and paste is added in the ratio of cane sugar powder 1:2 280 parts of essence is uniformly mixed, and is pelletized, dry, and granule is made in packing.
In order to confirm the significant curative effect of Chinese materia medica preparation of the invention in terms for the treatment of II phase hypertension (the turbid hemicrania of phlegm), I Done the test of corresponding clinical comparison, now result is reported as follows:
1. research purpose: the preparation process for comparing granular preparation made from the embodiment of the present invention 6 and Rong great Qi professor is made Granular preparation treatment II phase of primary hypertension (the turbid hemicrania of phlegm) clinical efficacy.
2. research object: choosing the tested case for belonging to hospital in Shaanxi university of TCM in December, -2015 in July, 2013 308, the age between 18-65 years old, using parallel control, random design method, is randomly divided into 2 groups, wherein treatment group is 164;Control group 144.Analyze according to statistics, each group case the age, in terms of there are no significant difference, have comparable Property
3. case selection:
According to Standards of Chinese Medical Syndrome Differentiation: being drafted referring to " new Chinese medicine guideline of clinical investigations ".
The turbid hemicrania of phlegm: primary symptom: dizziness, heavy, headache, fixed pain;And disease: uncomfortable in chest, nauseous, abdominal distension, palpitaition, mistake It sleeps;Tongue vein: purplish tongue, whitish tongue are greasy or yellow greasy, slippery or string are sliding.
Western medicine diagnostic criteria: the standard system formulated referring to the cardiovascular epidemiology in the whole nation in 1979 and crowd prevention and treatment forum It is fixed.Systolic pressure is equal to or higher than 160mmHg (21.3KPa), and diastolic pressure is equal to or higher than 95mmHg (12.7KPa), and the two has one Item is verified, can make a definite diagnosis.
Clinical stages standard: (being drafted referring to the standard that national epidemiology in 1979 and crowd prevention and treatment forum are formulated) II Phase hypertension: blood pressure reaches Definite Hypertension level, and has following 1 person: x-ray, electrocardiogram or echocardiography are shown in have Left ventricular hypertrophy, funduscopy, which is shown in, has Fundus oculi artery universal or part narrows;Albuminuria or creatinine concentration of plasma slightly increase.
It is included in case standard: all to meet II phase of doctor trained in Western medicine hyperpiesia diagnostic criteria, not used depressor within 3 days Object, Chinese medical discrimination category phlegm is turbid to hold stasis of blood person under the arm, can be included in test case.
The case rated age is rejected in under-18s or 70 years old or more person, gestation or breast feeding women, it may be to this medicine mistake Quick person, merge intentionally, liver, kidney and hemopoietic system severe primary disease, diabetes, mental patient, caused by a variety of causes Secondary hypertension, it is all not meet the standard of being included in, not by regulation medication, it can not judge that curative effect or data do not affect the treatment or pacify entirely Full property judgement person;Taking the patients with coronary heart disease that nifepine etc. has antihypertensive effect drug.
4 clinical trial protocols
It tests case to observe using randomized single blind trial, divides patient to the (treatment of 6 groups of the embodiment of the present invention by random digits table Group) and Rong great Qi professor preparation group (control group).Two groups of instructions of taking are that 2 times a day, one bag each time, after meal 30min warm water It takes.
Blood pressure measuring method: each patient at the morning 9 or so, surveys left upper extremity blood pressure every time, it is desirable that uses desk-top blood Pressure meter measures preceding patient and keeps quite, rest 15min, and continuously surveys 3 times and take mean value, the result as this measurement.
Curative effect determinate standard: according to the cardiovascular epidemiology of " new Chinese medicine guideline of clinical investigations " and the whole nation in 1979 And the standard that crowd prevention and treatment forum is formulated determines.
Efficacy of antihypertensive treatment evaluation criteria:
It is effective: 1. diastole drops 10mm Hg or more (including 10mm Hg), and reach normal range (NR);2. though diastolic pressure is not Be down to normally but declined 20mm Hg or more.The above binomial must have one of them.
Effective: 1. diastole drops are not as good as 10mm Hg, but have reached normal range (NR);2. diastolic pressure declines 10- before relatively treating 19mm Hg, but not up to normal range (NR);3. systolic pressure declines 30mm Hg or more before relatively treating.Above three must have wherein 1 .
It is invalid: not up to blood pressure descender after the above standard or a week after taking.
5 test results
Clinical observation on the therapeutic effect: patient's efficacy of antihypertensive treatment is relatively shown in Table 2,3.
2 treatment group of table and control group
Treatment group P < 0.01 * compared with the control group
Pretherapy and post-treatment tcm syndrome curative effect is relatively shown in Table 3
Treatment group P < 0.01 * compared with the control group
Security inspection and adverse reaction result:
It is normal by having carried out the heart, electrograph, liver function, renal function, blood routine, urine to treatment group patient in clinical test Rule and just conventional inspection.There are 3 patients in treatment group, there are 7 patients to treat initial stage in medication 1 hour in control group Have outside slight nausea, restores normal after treatment.Other no abnormality seens.

Claims (3)

1. a kind of Chinese medicine composition for treating hypertension, which is characterized in that the composition is the raw material group by following weight ratio At: 1000-1800 parts of radish seed, 600-1000 parts of hawthorn, 600-1000 parts of pueraria lobata;The composition is made after common auxiliary material is added For at granule, the granule is prepared according to the following steps:
(1) it takes radish seed to smash into coarse powder, 75% ethyl alcohol is added to impregnate 12 hours, extracted 8 hours with 5 times of 75% alcohol refluxs of amount, returned Ethyl alcohol is received, is placed to room temperature, is refrigerated 24 hours, filtration, filtrate is concentrated into the clear cream that relative density is 1.0-1.5;
(2) pueraria lobata and hawthorn add water to cook three times, and amount of water is followed successively by 8,7,6 times, and decocting time is 2 hours, merge decoction liquor, Filtration, it is 1.1-1.35 that filtrate, which is concentrated into relative density, and ethyl alcohol is added to make alcohol content up to 65%, and stirring after standing 12 hours, filters, With 65% ethanol washing 3 times, washing lotion merges precipitating with filtrate, recycles ethyl alcohol, is concentrated into the clear cream that relative density is 1.1-1.8;
(3) clear cream obtained by step (1), step (2) is merged, in clear cream: cane sugar powder and dextrin is added in the ratio of cane sugar powder 1:2 It 280 parts, is uniformly mixed, pelletizes, dry, granule is made in packing.
2. Chinese medicine composition according to claim 1, which is characterized in that the composition is by the raw material of following weight ratio Composition: 1120-1680 parts of radish seed, 640-960 parts of hawthorn, 640-1000 parts of pueraria lobata.
3. Chinese medicine composition according to claim 2, which is characterized in that the composition is by the raw material of following weight ratio Composition: 1400 parts of radish seed, 800 parts of hawthorn, 800 parts of pueraria lobata.
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