CN1513492A - Herbal medicine for treating hypertension disease, and its prepn. method - Google Patents

Herbal medicine for treating hypertension disease, and its prepn. method Download PDF

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CN1513492A
CN1513492A CNA031122515A CN03112251A CN1513492A CN 1513492 A CN1513492 A CN 1513492A CN A031122515 A CNA031122515 A CN A031122515A CN 03112251 A CN03112251 A CN 03112251A CN 1513492 A CN1513492 A CN 1513492A
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extract
concentrated solution
folium helianthi
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凌沛学
张玲
景瑞
吕寒
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A61K36/8994—Coix (Job's tears)
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

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Abstract

A medicine for treating hypertension features that the extract of sunflower leaf is used as its active component. The process for preparing said extract and the process for preparing said medicine in different forms are also disclosed.

Description

Hypertensive medicine of a kind of treatment and preparation method
The invention belongs to field of traditional Chinese, relate to the hypertensive medicine of a kind of treatment, relate to the intermediate Folium Helianthi preparation method of extract for preparing this medicine simultaneously, and the preparation method of the various dosage formulation of Folium Helianthi extract.Its dosage form comprises tablet, capsule, granule, oral liquid, syrup, injection and other dosage forms.
Hypertension is the popular disease the most widely in the world today, is again the key factor that causes apoplexy (being apoplexy), coronary heart disease and renal failure simultaneously.Show according to national hypertension sampling survey result, China more than 15 years old crowd's hypertension prevalence by 5.11% of nineteen fifty-nine rise to 1991 11.88%, estimate that present hyperpietic has reached 100,000,000, be the trend that increases year by year at present along with the raising of people's living standard.On clinical treatment, because many toxicities of Western medicine depressor, therefore using traditional Chinese medical herbal treatment hypertension is important problem in the medical domain.In recent years, Chinese medicine is existing remarkable progress aspect treatment hypertension, becomes one of means of hypertension Comprehensive Treatment.
Folium Helianthi is the dried leaves of feverfew Helianthi Helianthus annuus L., and it is warm in nature, and sweet in the mouth is nontoxic, has the effect of suppressing the hyperactive liver, warm clearly, diffusing stagnate gas, vital energy benefiting and the kidney invigorating.According to the literature, in the leaf of Helianthi, the stem pith, contain organic acid such as a large amount of neochlorogenic acids, isochlorogenic acid, Fumaric acid, its content is 9～12%, there are many acid to exist in addition, also contain glycosides such as alkaloid and oleanolic acid glucosides and echinocystic acid glucosides etc. with the form of salt.Just because of the above-mentioned various compositions that Helianthi itself is had, make them have diversified pharmacological action.According to the literature, sunflower seeds can suppress nitrosamine and brings out the rat precancerous lesion; The root of Helianthi can be controlled gastral cavilty and stagnate bitterly, constipation and anuresis; Medulla Helianthi can be controlled chyluria, urinary obstruction, calculus of urethra; Sunflower plate can be treated urine retention, and the certain herbaceous plants with big flowers dish extracts makes " certain herbaceous plants with big flowers dish hypertension pill ", and clinical efficacy is comparatively desirable.Since Helianthi generally not as Chinese crude drug in clinical practice, therefore only limit to above-mentioned bibliographical information (seeing " Heilungkiang medicine " nineteen ninety-five 8 volumes, 1 phase page 5 for details)." certain herbaceous plants with big flowers dish hypertension pill " reported in the document do not see yet uses clinically and sells.Not appearing in the newspapers up to now, extraction separation effective ingredient and effective site are used for the treatment of hypertension from Folium Helianthi.
The objective of the invention is to clearly propose study a kind of new Chinese medicine preparation with the Folium Helianthi extract, with its as the treatment hypertensive medicine.
Another object of the present invention provides the extraction preparation method of this Folium Helianthi extract.
Another purpose of the present invention provides the preparation method that this Folium Helianthi extract is prepared into various dosage formulation.
Technical scheme of the present invention is: with the Folium Helianthi drying, pulverizes, uses water extraction process, and water extract-alcohol precipitation (30～80% determining alcohol) technology, or 10～80% alcohol extraction processes extract, 1. the water extract directly is condensed into concentrated solution (d=1.16～1.18,60 ℃); 2. the water extract is condensed into precipitate with ethanol (30～80% determining alcohol) behind the concentrated solution, and the alcohol deposit fluid reconcentration becomes concentrated solution (d=1.12～1.14,60 ℃); 3. the alcohol extract decompression recycling ethanol is condensed into concentrated solution (d=1.10～1.12,60 ℃), and the Cryoprecipitation after-filtration removes chlorophyll; The concentrated solution reduced vacuum of above-mentioned three kinds of technologies is dry or be spray dried to extract dry powder, by adding different auxiliary material respectively, can be made into granule, capsule, solid preparations such as tablet; Also can make dissolving, make extraction medicinal liquid of the present invention, make oral liquid and liquid preparations such as syrup, injection by adding adjuvant and antiseptic with adding 200～800ml distilled water in the concentrated solution.The different auxiliary material that adds in the different dosage form of the present invention does not influence clinical effectiveness of the present invention, and these adjuvants comprise starch, microcrystalline Cellulose, magnesium stearate, dextrin, lactose, sucrose, antiseptic etc.Therefore the present invention can satisfy the requirement of numerous hyperpietics to different dosage form.
Using method of the present invention: oral, every day three times, each 2～4 tablets of tablets (or 2～4 capsules; Or 1～2 bag of granule; Or 1～2 oral liquid; Or 10～20ml syrup; Injection once a day, each 1～2), be described in further detail below by the extracting method of specific embodiment the Helianthi leaf extract.
Accompanying drawing is that Folium Helianthi extracts the chlorogenic acid of concentrated solution and the high-efficient liquid phase chromatogram of other organic acid composition.
Embodiment 1:
After Folium Helianthi 20kg pulverizing, put in the extraction pot, it is an amount of to add water, decocts secondary, and each 2 hours, merge extractive liquid, filtered, and filtrate is condensed into the concentrated solution that relative density is 1.16～1.18 (60 ℃); Concentrated solution is continued to be concentrated into the thick paste that relative density is 1.20～1.22 (60 ℃), and the reduced vacuum drying is pulverized, and sieves, and is extract dry powder of the present invention; Or with above-mentioned concentrated solution, add the 200ml distilled water and make dissolving, water precipitating (2～2 ℃) 24 hours filters, and is extraction medicinal liquid of the present invention.
Embodiment 2:
After Folium Helianthi 20kg pulverizing, put in the extraction pot, it is an amount of to add water, decocts secondary, each 1 hour, merge extractive liquid, filters, and filtrate is condensed into the concentrated solution that relative density is 1.12～1.14 (60 ℃), adding ethanol makes and contains the alcohol amount and reach 60%, cold preservation (2～2 ℃) 24 hours filters, and filtrate recycling ethanol also is condensed into the concentrated solution that relative density is 1.12～1.14 (60 ℃); Concentrated solution is spray dried to fine powder, sieves, be extract dry powder of the present invention; Or with above-mentioned concentrated solution, add the 400ml distilled water and make dissolving, water precipitating (2～2 ℃) 24 hours filters, and is extraction medicinal liquid of the present invention.
Embodiment 3:
After Folium Helianthi 20kg pulverizing, put in the extraction pot, add 60% ethanol, the heating and refluxing extraction secondary, 2 hours for the first time, 1 hour for the second time, merge extractive liquid, filtered, and filtrate recycling ethanol also is concentrated into the concentrated solution that relative density is 1.10～1.12 (60 ℃); Cold preservation (2～2 ℃) 24 hours, the filtering chlorophyll is spray dried to fine powder with concentrated solution, sieves, be extract dry powder of the present invention, or, add the 600ml distilled water and make dissolving above-mentioned concentrated solution, water precipitating (2～2 ℃) 24 hours filters, and is extraction medicinal liquid of the present invention.
Embodiment 4:
After Folium Helianthi 20kg pulverizing, put in the extraction pot, add 50% ethanol, heating and refluxing extraction 1 hour decocts with water 1 hour again, and extracting solution filters respectively, alcohol extract reclaims ethanol to the greatest extent, merges with the water extract, and being concentrated into relative density is the concentrated solution of 1.12～1.14 (60 ℃); Concentrated solution is continued to be concentrated into the thick paste that relative density is 1.20～1.22 (60 ℃), and the reduced vacuum drying is pulverized, and sieves, and is extract dry powder of the present invention; Or with above-mentioned concentrated solution, add the 300ml distilled water and make dissolving, water precipitating (2～2 ℃) 24 hours filters, and is extraction medicinal liquid of the present invention.
Embodiment 5: tablet
Any Folium Helianthi extract dry powder in the various embodiments described above is added 200g starch, 10g microcrystalline Cellulose, and mixing is granulated, and oven dry is sieved, and adds the 1.5g magnesium stearate, mixing, and tabletting is tablet of the present invention.
Embodiment 6: capsule
Any Folium Helianthi extract dry powder in the various embodiments described above is added 230g starch, and mixing is granulated, and sieves, and is encapsulated, is capsule of the present invention.
Embodiment 7: granule
Any Folium Helianthi extract dry powder in the various embodiments described above is added lactose 100g, and dextrin 300g granulates, and granulate sieves, and makes granule, granule of the present invention.
Embodiment 8: oral liquid
Will be in the various embodiments described above any Folium Helianthi extracts and adds 0.3% sodium benzoate in the medicinal liquid, the 400ml distilled water, sterilization, oral liquid is made in fill, oral liquid of the present invention.
Embodiment 9: syrup
Will be in the above-mentioned enforcement any Folium Helianthi extracts and adds 0.3% sodium benzoate in the medicinal liquid, adds sucrose, xanthan gum 100g, makes syrup, syrup of the present invention.
Embodiment 10: injection
Any Folium Helianthi in the various embodiments described above is extracted in the medicinal liquid, add the 600ml distilled water, water precipitating (0～-2 ℃) 48 hours, microporous filter membrane filters, and fill is injection of the present invention.
Utilizing the extraction ratio of the Folium Helianthi extract that above-mentioned technology obtains is 5～12%.Its each constituent is as follows after testing:
1. after the Folium Helianthi extract drying, chlorogenic acid content is by " (the 177th page [assay] item of Chinese pharmacopoeia version in 2000 method is down measured, and this product contains chlorogenic acid (C 16H 18O 9) be more than 0.12%.
Figure of description is chlorogenic acid and other organic acid composition high-efficient liquid phase chromatograms.
2. after the Folium Helianthi extract drying, its free organic acids content is more than 0.5% after measured.
3. after the Folium Helianthi extract drying, its total organic acids is more than 9% after measured.
4. after the Folium Helianthi extract drying, after measured, its total alkaloid content is more than 0.2%.
Illustrate drug action of the present invention with pharmacological tests below:
One, the Folium Helianthi extract medicinal liquid of different process extraction is to the normotensive influence of anesthetized dog.
1. test objective
Observe Folium Helianthi extract technology one, technology two, technology three, duodenal administration is to the normotensive influence of anesthetized dog respectively.
2. medicine
The Folium Helianthi extract: three dosage forms are brown viscous liquid, and only viscosity is different.Be mixed with desired concn with normal saline respectively during use.Lot number: 20020718.
3. instrument
RM-6200 type polygraph, Chengdu Instruement Factory.
4. animal
9 of domesticated dogs, body weight 13.7 ± 2.1kg, the male and female dual-purpose is available from the suburb, Jinan.Raised and train for 1 week before the experiment, select that it is normal, healthy, female no pregnant person is for experiment.
5. method and result
Animal is divided into 3 groups at random, one group of 8.33g/kg of Folium Helianthi extract technology, two groups of 8.33g/kg of technology and three groups of 8.33g/kg of technology, 3 every group.Duodenal administration.The administration volume is one group of 5ml/kg of technology, two groups of 10ml/kg of technology, three groups of 8ml/kg of technology.Animal is performed the operation under 2.5% pentobarbital sodium 25mg/kg intravenous anesthesia and separates trachea and common carotid artery, and the common carotid artery intubate links to each other recording blood pressure with polygraph through pressure transducer.Operation separates duodenum and intubate is used in order to administration.
Postoperative is stablized and is traced normal arterial pressure behind the 30min and be worth before as medicine, and duodenal administration then writes down after the administration 15,30,60,120,180 and the blood pressure of 240min respectively.Experimental result compares respectively with before the medicine, carries out statistical analysis and handles.The results are shown in Table 1.
The result shows that 15min systolic pressure and diastolic pressure obviously descend (P＜0.05) after one group of administration of technology, and acting duration can be maintained to 240min behind the medicine; 15～30min systolic pressure obviously descends (P＜0.05) after two groups of administrations of technology, and reduction trend is arranged subsequently, and diastole is pressed with reduction trend, can continue until 240min behind the medicine; 60～180min and 60～120min make anesthetized dog systolic pressure and diastolic pressure obviously descend (P＜0.05) respectively after three groups of administrations of technology.
6. brief summary
6.1 Folium Helianthi extract technology one is pressed by the anesthetized dog normal contraction and diastolic pressure obviously descends (P＜0.05), acting duration can be maintained to 240min behind the medicine.
Descend 6.2 Folium Helianthi extract technology two is pressed obviously the anesthetized dog normal contraction, diastole is pressed with reduction trend.
6.3 Folium Helianthi extract technology three is pressed by the anesthetized dog normal contraction and diastolic pressure obviously descends, but onset time is later, duration of efficacy is shorter.
Table 1 different process Folium Helianthi extract to the normotensive influence of anesthetized dog (X ± SD, n=3)
Measure technology 1 technology 2 technologies 3
Time systolic pressure (mmHg) diastolic pressure (mmHg) systolic pressure (mmHg) diastolic pressure (mmHg) systolic pressure (mmHg) diastolic pressure (mmHg)
Medicine preceding 135.00 ± 32.78 88.33 ± 34.03 116.67 ± 20.82 68.33 ± 14.43 113.33 ± 15.28 70.00 ± 17.32
15′ 116.67±30.14 ** 75.00±35.00 * 98.33±20.21 **?63.33±15.28 95.00±13.23 58.33±22.55
30′ 111.67±33.29 ** 71.67±36.17 * 93.33±22.55 *?58.33±20.21 88.33±20.21 48.33±22.55
60′ 100.00±36.06 ** 65.00±35.00 **?88.33±30.55 51.67±25.17 86.67±11.55 *?48.33±18.93 **
120′ 106.67±35.12 ** 73.33±30.55 * 86.67±33.29 53.33±25.66 81.67±2.86 * 46.67±20.21 **
180′ 110.00±40.00 * 73.33±30.55 * 93.33±37.86 56.67±27.54 78?33±16.07 *?46.67±20.21
240′ 108.33±37.53 * 73.33±30.05 * 90.00±36.06 56.67±27.54 73.33±29.30 43.33±29.30
Annotate: with comparison before the administration, * P＜0.05 * * P＜0.01
Two, Folium Helianthi extract tablet is to the acute blood pressure lowering experimental result of spontaneous hypertensive rat (SHR)
20,10,5g/kg (crude drug amount) the high, medium and low dosage group of Folium Helianthi extract tablet dosage is respectively:, be equivalent to 6 times, 3 times and 1.5 times of one day people's consumption respectively.Measure the situation of change of blood pressure in (gastric infusion) behind the single administration 10 hours during acute drop test, positive drug is chosen the brain-benefiting blood pressure-reducing capsule, dosage 1.8g/kg (be approximately people's every day equivalent consumption 3 times), and result of the test is as follows:
Blood pressure and changes in heart rate percentage rate (%) after preceding blood pressure (kPa) administration of administration (X ± SD)
Time after group heart rate (BPM) administration (hour)
X±SD 2 4 7 10
SAP 25.54±1.95 -4.19±3.72 -6.37±5.23 -8.83±3.59 -5.39±6.65
Contrast
DAP 20.21±2.28 -4.42±6.56 -8.69±6.62 -10.58±4.20 -7.22±8.30
N＝9
HR 431±27 -3.51±5.73 -7.37±5.67 -6.36±6.89 -7.71±5.71
Folium Helianthi tablet SAP 25.58 ± 3.21-7.25 ± 5.76-9.41 ± 6.31-12.52 ± 310 *-12.97 ± 4.29 *
Dosage group DAP 19.87 ± 3.09 11.07 ± 6.83 *-17.24 ± 6.65 *-19.63 ± 5.21 *-18.37 ± 6.62 *
N＝10 HR 425±47 -0.48±6.57 -2.25±8.71 -1.68±7.98 -3.55±4.68
Folium Helianthi tablet SAP 26.7 ± 1.09 8.18 ± 3.35 *-9.72 ± 5.44-13.43 ± 4.64 *-12.39 ± 4.88 *
Middle dosage group DAP 21.31 ± 1.81-7.64 ± 5.84-11.31 ± 4.94-18.94 ± 5.86 *-13.08 ± 9.38
N＝8 HR 435±36 -2.12±4.87 -2.84±5.92 -6.40±7.39 -3.99±7.24
Folium Helianthi tablet SAP 26.20 ± 2.12 9.33 ± 2.70 *-10.12 ± 441-10.57 ± 3.79-10.82 ± 4.22
Low dose group DAP 20.49 ± 2.30-7.15 ± 4.18-7.80 ± 3.36-11.57 ± 4.18-9.81 ± 6.35
N＝8 HR 417±62 -1.98±5.62 -4.30±4.88 -5.57±8.10 -5.26±6.11
Brain-benefiting blood pressure-reducing SAP 26.00 ± 2.08-6.61 ± 5.72-10.87 ± 4.35-10.18 ± 5.57-12.60 ± 7.21 *
Capsule DAP 19.42 ± 2.38-4.20 ± 7.40-10.88 ± 9.11-8.58 ± 9.20-10.67 ± 9.77
N＝10 HR 415±43 -0.69±7.31 -4.83±10.66 -5.60±9.64 -5.78±8.96
Annotate: *: P＜0.05; Compare with matched group *: P＜0.01
Animal blood pressure had the nature fluctuation in one day, the morning, blood pressure was higher, and obviously descend afternoon.This experiment is since 8:00 in the morning.
The result shows that Folium Helianthi extract tablet high dose group and middle dosage group SHR have tangible acute hypotensive effect, and especially the high dose group hypotensive effect clearly.And the hypotensive effect of low dose group is not obvious, when having only after the administration 2 hours SAP is had obvious hypotensive effect.Under the same person dose,equivalent, Folium Helianthi extract tablet is better than brain-benefiting blood pressure-reducing capsule (the capsular consumption of brain-benefiting blood pressure-reducing is equivalent to dosage group in the Folium Helianthi extract tablet in the experiment) to the acute hypotensive effect of SHR.After the administration of Folium Helianthi extract tablet the SHR heart rate there is not obvious influence.
More than two pharmacological tests, adopt the animal difference, but similar result of the test arranged, illustrate that all the Folium Helianthi extract has hypotensive effect preferably.

Claims (5)

1. the hypertensive Chinese medicine preparation of treatment is characterized in that described Chinese medicine preparation is to be prepared from by the Folium Helianthi extract.
2. the preparation method of the described Chinese medicine preparation that is prepared from by the Folium Helianthi extract of claim 1, it is characterized in that this method is with Folium Helianthi drying, pulverizing, extract with water extraction process, the water extract directly is condensed into concentrated solution (d=1.16～1.18,60 ℃), the concentrated solution reduced vacuum is dry or be spray dried to extract dry powder; Or concentrated solution is added 200～800ml distilled water make dissolving, be extraction medicinal liquid of the present invention.
3, the preparation method of the described Chinese medicine preparation that is prepared from by the Folium Helianthi extract of claim 1, it is characterized in that this method is with Folium Helianthi drying, pulverizing, extract with aqueous extraction-alcohol precipitation technology, the water extract is condensed into precipitate with ethanol (30～80% determining alcohol) behind the concentrated solution, the alcohol deposit fluid reconcentration becomes concentrated solution (d=1.12～1.14,60 ℃), the concentrated solution reduced vacuum is dry or be spray dried to extract dry powder; Or concentrated solution is added 200～800ml distilled water make dissolving, be extraction medicinal liquid of the present invention.
4, the preparation method of the described Chinese medicine preparation that is prepared from by the Folium Helianthi extract of claim 1, it is characterized in that this method is with Folium Helianthi drying, pulverizing, extract (10～80% determining alcohol) with alcohol extraction process, the alcohol extract decompression recycling ethanol is condensed into concentrated solution (d=1.10～1.12,60 ℃), the Cryoprecipitation after-filtration removes chlorophyll, and the concentrated solution reduced vacuum is dry or be spray dried to extract dry powder; Or concentrated solution is added 200～800ml distilled water make dissolving, be extraction medicinal liquid of the present invention.
5, the described Folium Helianthi extract of claim 1, it is characterized in that Folium Helianthi extract dry powder and extract medicinal liquid, by adding starch, dextrin, microcrystalline Cellulose, magnesium stearate, lactose, xanthan gum adjuvant, can be made into tablet, capsule, granule, oral liquid, syrup, injection dosage form.
CNA031122515A 2003-05-20 2003-05-20 Herbal medicine for treating hypertension disease, and its prepn. method Pending CN1513492A (en)

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CNA031122515A CN1513492A (en) 2003-05-20 2003-05-20 Herbal medicine for treating hypertension disease, and its prepn. method
AU2003261598A AU2003261598A1 (en) 2003-05-20 2003-09-03 A medicament for treatment of hypertension
PCT/CN2003/000740 WO2004103385A1 (en) 2003-05-20 2003-09-03 A medicament for treatment of hypertension

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011079410A1 (en) * 2009-12-28 2011-07-07 Ling Peixue Medicinal composition including sunflower extract, preparative method and use thereof
CN101816414B (en) * 2009-02-27 2012-05-23 凌沛学 Application of sunflower leaves for preparing foods and health-care foods for reducing blood pressure in auxiliary way

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101816414B (en) * 2009-02-27 2012-05-23 凌沛学 Application of sunflower leaves for preparing foods and health-care foods for reducing blood pressure in auxiliary way
WO2011079410A1 (en) * 2009-12-28 2011-07-07 Ling Peixue Medicinal composition including sunflower extract, preparative method and use thereof

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