CN103566228B - Capsule for treating senile calcific valvular heart disease and preparation method thereof - Google Patents
Capsule for treating senile calcific valvular heart disease and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a capsule for treating senile calcified valvular heart disease and a preparation method thereof, which aim to solve the problem of treatment of calcified valvular heart. The preparation method is characterized by comprising the following steps: (1) distilling still fructus Rubi, fructus Rosae Davuricae, and rhizoma Cyperi with water vapor to extract volatile oil, and collecting residue; (2) pulverizing Gecko and charred fructus Setariae Germinatus into fine powder; (3) mixing cortex kaki, Usnea, fructus Aurantii Immaturus, herba Equiseti hiemalis, herba Moslae chinensis, fructus Akebiae, radix seu caulis Kadsurae Heteroclitae and the residue obtained in step 1, extracting with ethanol for 2 times, mixing the two ethanol extractive solutions, filtering, recovering ethanol, and concentrating under reduced pressure to obtain extract; (4) adding the fine powder obtained in the step 2 into the extract obtained in the step 3, uniformly mixing, drying at 60 ℃, crushing into fine powder, adding polysorbate-80, granulating, drying, finishing granules, spraying the volatile oil obtained in the step 1, uniformly mixing, and encapsulating to obtain the capsule. Clinical experiments prove that: the traditional Chinese medicine composition for treating senile calcified valvular heart disease has the characteristics of good curative effect and higher safety, and is worthy of clinical application and popularization.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to one and treat characteristics of calcific valvular heart disease capsule and preparation method thereof.
Background technology
Characteristics of calcific valvular heart disease (SCHVD) mainly refers to old people with age, cardiac valve connective tissue generation calcification, thus causes the dysfunction of valve or support.Being the common valvular heart disease of old people, is also one of major reason of Aged Heart Failure and sudden death.Open in-heart operation under pulsating checks, for characteristics of calcific valvular heart disease provides reliable diagnostics basis.Along with the prolongation of human longevity, characteristics of calcific valvular heart disease sickness rate increases year by year, and its sickness rate increases with the age and increases, and is more common in the old people of 60 ~ over-65s.This sick pathogeny it be unclear that, and is more common in existing atherosclerotic patient, the most often betides the ventricular side of posterior lobe.The process evolution of this pathological changes mostly is in initiation, severe valvular stenosis have hemodynamic change, causes expectant treatment failure and row valve surgery.
The traditional Chinese medical science is many to be recorded without primary disease, treatment is many and rheumatic heart disease is identical, control from " the rheumatism obstruction of heart-QI " opinion: to the therapeutic scheme of rheumatic heart disease, in the relevant teaching material of national higher institutions of Chinese medicine, list damp and hot resistance network, heart arteries and veins stasis blocking, motive virtual loss, qi depression to blood stasis, heart-yang virtual loss, the heart attacked by pathogenic water penetrate lung 6 type and carry out determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs.Owing to not fully taking into account this pathological factor of calcification, so for improving symptoms of heart failure benefit to some extent, but for preventing narrow or incompetence from aggravating further, reducing cardiovascular event incidence rate and there is no help.
Summary of the invention
Technical assignment of the present invention is for above the deficiencies in the prior art, provides a kind of curative effect certainly and little treatment characteristics of calcific valvular heart disease capsule of side effect and preparation method thereof.
The technical scheme that the present invention solves its technical problem is: a kind of pharmaceutical composition for the treatment of characteristics of calcific valvular heart disease, it is characterized in that being prepared from by the crude drug of following weight proportion: Cortex Kaki 10 ~ 30 parts, rose hip 6 ~ 12 parts, Usnea 3 ~ 10 parts, Cortex Ponciri trifoliatae 6 ~ 12 parts, Cortex Seu Radix Wikstroemiae Micranthae 3 ~ 10 parts, Herba Equiseti Hiemalis 6 ~ 12 parts, go back 6 ~ 12 parts, bobbin, Herba Moslae Chinensis 6 ~ 12 parts, Fructus Akebiae 6 ~ 12 parts, Gecko 1 ~ 5 part, Folium et Ramulus Callicarpae nudiflorae 3 ~ 10 parts, Fructus Setariae Germinatus (parched to brown) 10 ~ 25 parts.
Chinese medicine of the present invention can be prepared from by following method:
(1) bobbin will be gone back, rose hip, Cortex Seu Radix Wikstroemiae Micranthae coarse powder soak separately after 4 hours and extract volatile oil 6 hours with vapor distillation, and mixing for standby use after collecting, medicinal residues are for subsequent use;
(2) Gecko, Fructus Setariae Germinatus (parched to brown) are pulverized 150 mesh sieves, and become fine powder for subsequent use;
(3) by gained medicinal residues mixing in Cortex Kaki, Usnea, Cortex Ponciri trifoliatae, Herba Equiseti Hiemalis, Herba Moslae Chinensis, Fructus Akebiae, Folium et Ramulus Callicarpae nudiflorae and step 1 with 5 times amount 80% ethanol extraction 2 times, each 2 hours, merge twice ethanol extract, filter, reclaiming relative density when ethanol concentrating under reduced pressure become 60 DEG C is the extractum of 1.25 ~ 1.30;
(4) gained fine powder in step 2 is added gained extractum mixing in step 3,60 DEG C of oven dry, are ground into fine powder, add Tween-80 and make granule, and dry, granulate, sprays into gained volatile oil in step 1, and mixing, incapsulates, to obtain final product.
Wherein said: Cortex Kaki is the bark of Ebenaceae plant Fructus Kaki Diospyros kaki Thunb..Nature and flavor are puckery; Property is put down.Merit can heat-clearing and toxic substances removing; Hemostasis.
Rose hip is the fruit of rosaceous plant Rosa bella Rosa davurica Pall..Nature and flavor acid; Bitter; Temperature.Return liver; Spleen; Stomach; Urinary bladder channel.Merit can strengthening the spleen to promote digestion; Promoting blood flow to regulate menstruation; Astringing lung-QI and relieving cough.
Usnea is the thallus (thallus) of Usneaceae Usnea plant USNEA Usnea diffracta (female trailing plants, Herba Cucubali) Usnea diffractaVain. or Usnea Longissima (Scolopendra Usnea, Herba Stellariae Alsines) U. longissima Ach..Nature and flavor are sweet, flat.Merit can heat-clearing and toxic substances removing, and hemostasia and promoting granulation, pain relieving, liver heat removing and eyesight improving, moves back nebula.
Cortex Ponciri trifoliatae is bark bits or the peel bits of rutaceae Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) Poncirus tuifoliata (L.) Raf..Nature and flavor are pungent; Temperature.Return liver; Kidney channel.Merit can endogenous wind stopping relieving convulsion; Eleminating phlegm and freeing channels.
Cortex Seu Radix Wikstroemiae Micranthae is peel of stem and the root of Isolated From Thymelaeaceae Species little Huang structure Wikstroemia micrantha Hemsl..Sweet in the mouth; Property is put down.Return lung meridian.Merit can relieving cough and resolving phlegm; Heat reliving and toxin-eliminating.
Herba Equiseti Hiemalis is the dry aerial parts of Equisetaceae plant Herba Equiseti Hiemalis Equisetum hiemale L..Nature and flavor are sweet, bitter, flat.Return lung, Liver Channel.Merit can be fallen apart wind heat, moves back corneal nebula.
Also bobbin is the fruit of orchid Rhizoma Gastrodiae Gastrodia elata Bl..Sweet in the mouth; Cold in nature.Merit can tonify deficiency subduing the wind syndrome.Main dizzy; Pupil; Wind syndrome of head is had a headache; Weak breath consumption of essence; Early whitening of beard and hair.
Herba Moslae Chinensis is the herb of labiate Mosla chinensis Maxim. Bulbophyllum reptans Lindl..Nature and flavor are worked hard, temperature.Merit can be driven away summer heat, and invigorates blood circulation, and regulates the flow of vital energy, removing dampness.
Fructus Akebiae is the mature fruit of plants of Lardizabalaceae Caulis Akebiae, threeleaf akebia.Property mildly bitter flavor, property put down.Return liver, stomach, urinary bladder channel.Merit can dispersing the stagnated liver-QI for regulating the stomach, promoting blood circulation and stopping pain, hard masses softening and resolving, diuresis.
Gecko is the dry body of Gekkonidae animal Gecko Gekko gecko Linnaeus.Nature and flavor are salty, flat.Return lung, kidney channel.Merit can invigorating the lung and the kidney, improving inspiration by invigorating kidney-QI Dingchuan, supporing yang benefit essence.
Folium et Ramulus Callicarpae nudiflorae is the leaf with twig of Verbenaceae Callicarpa nudiflora Callicarpa nudiflora Hook. Et Arn..Nature and flavor are puckery, micro-pungent, bitter, flat.Return Liver Channel.Merit can be stopped blooding by dissipating blood stasis; Removing toxic substances and promoting subsidence of swelling.
Fructus Setariae Germinatus (parched to brown), for the mature fruit of grass foxtail millet Setaria italica (L.) Beauv. is through drying of germinateing, fries to burnt brown according to frying method.Nature and flavor are sweet, temperature.Return spleen, stomach warp.Merit can help digestion and in, spleen benefiting and stimulating the appetite.
At present, Chinese traditional treatment is not for the medicine typing of heart valve calcification, treatment is many and rheumatic heart disease is identical, control from " the rheumatism obstruction of heart-QI " opinion: to the therapeutic scheme of rheumatic heart disease, in the relevant teaching material of national higher institutions of Chinese medicine, list damp and hot resistance network, heart arteries and veins stasis blocking, motive virtual loss, qi depression to blood stasis, heart-yang virtual loss, the heart attacked by pathogenic water penetrate lung 6 type and carry out determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs.Owing to not fully taking into account this pathological factor of calcification, so for improving symptoms of heart failure benefit to some extent, but preventing narrow or incompetence from aggravating further for reduction, reducing cardiovascular event incidence rate and there is no help.
Compared with prior art, the present invention has following characteristics:
1, set forth one's views unique: controlling from positivism heart valve calcification, is that tangible heresy blocks heart venation, causes heart venation block not all right and his change raw, so get rid of evils as key element.But old people's healthy energy weakness with emaciation, simulataneous insufficiency and excessive, needs strengthening vital QI to eliminate pathogenic factors.
2, with Cortex Kaki, rose hip for monarch: the extract (every 1ml is equivalent to crude drug 0.06g) of Basic pharmacology test confirmation 2% rose hip extractum gavages and rat blood serum lipid peroxide (LPO) content can be made to decline; mouse cardiac muscle lipofuscin is suppressed to be formed; and it is higher containing aluminum, manganese amount in Cortex Kaki; heavy dose of Cortex Kaki (conventional amount used is 5 ~ 6g) energy protecting myocardial cell cell membrane; promote that the foreign body of myocardial cell is got rid of, Cortex Kaki perfusate (1.5g/100ml) strengthens 33.68% to isolated rat cardiac muscular tissue to the tolerance of anoxia.With the Cortex Kaki of dosage ratio disclosed in the present invention, rose hip, effect is improved to this angiosteosis model: with intramuscular injection vitamin D3 and oral nicotine induced rat angiosteosis model, the darkviolet granule that after Cortex Kaki (20g crude drug/kg/d) and rose hip (10g crude drug/kg/d) mixing water decocting liquid gavage 4w, treatment group blood vessel V on Kossa dyes reduces to some extent, aorta vessel calcium content and ALP activity respectively comparatively model group reduce 36.1%(P<0.001) and 21.4%(P<0.05).
3, using Usnea heat clearing away, fall apart wind heat, Herba Moslae Chinensis removing dampness eliminating stagnation of non-bitter cold, Cortex Seu Radix Wikstroemiae Micranthae digestion visible phlegm, Fructus Akebiae hard masses softening and resolving, Cortex Ponciri trifoliatae eleminating phlegm and freeing channels, Herba Equiseti Hiemalis assists monarch drug as ministerial drug: in " accumulation of blood is both of a specified duration; also can turn to expectorant water " (" treatise on blood trouble " rolls up five) heart venation, QI and blood is not all right, then accumulation of phlegm retardance of a specified duration, breath does not reach, so select the visible phlegm in Cortex Seu Radix Wikstroemiae Micranthae, Cortex Ponciri trifoliatae, Fructus Akebiae, Herba Moslae Chinensis removal heart venation, Herba Equiseti Hiemalis increases the ability of medicine walking venation; And medicine of getting rid of evils in we mostly is the flat thing of sweet in the mouth, coordinate rose hip, sour sweet activating QI, is particularly useful for gerontal patient.
4, with Gecko invigorating the lung and the kidney, go back bobbin tonify deficiency subduing the wind syndrome assistant and help rose hip righting, wherein the aminoacid that contains of Gecko and phospholipid composition can reduce the content of malonaldehyde in cell membrane (MDA), play the effect of stabilizing cell membrane.
5, low dose of Folium et Ramulus Callicarpae nudiflorae is corrigent, and resisting dredging collateral medicine in this prescription too much has the anxiety of consumption gas, and the effect of its removing toxic substances and promoting subsidence of swelling also can contribute to getting rid of evils.And silicate contained by Herba Equiseti Hiemalis and tannin have astriction, in loose, there is the meaning of receipts, and under can preventing that heat-clearing and toxic substances removing medicine is cold and cool and rushing down.
6, Fructus Setariae Germinatus (parched to brown) is sweet in flavor and warm in property, returns taste warp, in one cold and cool medicine, get protect sun defend in meaning.
7, institute's thing of getting it filled homogeneous medicine multiple-effect in side, contributes to reducing medicament categories and consumption, does not increase Liver and kidney burden after wound.
8, medicine material consumption of the present invention is groped to sum up to draw through inventor in a large number, and each raw material dosage is for all to have good curative effect in following weight parts scope.
9, because heart valve calcification treatment needs the medication cycle long, so adopt capsule formulation, taking convenience, compliance is good, is convenient to the consolidation of the course for the treatment of.
Detailed description of the invention
Below in conjunction with practical situation, the specific embodiment of the present invention is elaborated.
Embodiment 1, crude drug weight proportion: Cortex Kaki 20 parts, rose hip 10 parts, Usnea 6 parts, Cortex Ponciri trifoliatae 10 parts, Cortex Seu Radix Wikstroemiae Micranthae 6 parts, Herba Equiseti Hiemalis 10 parts, go back 10 parts, bobbin, Herba Moslae Chinensis 10 parts, Fructus Akebiae 10 parts, Gecko 2 parts, Folium et Ramulus Callicarpae nudiflorae 6 parts, Fructus Setariae Germinatus (parched to brown) 20 parts.
The preparation method of embodiment 1 is: by Cortex Kaki, rose hip, Usnea, Cortex Ponciri trifoliatae, Cortex Seu Radix Wikstroemiae Micranthae, Herba Equiseti Hiemalis, go back bobbin, Herba Moslae Chinensis, Fructus Akebiae, Gecko, Folium et Ramulus Callicarpae nudiflorae, the decoction of Fructus Setariae Germinatus (parched to brown) mixing and water adding, filtrate is got after 30 minutes, medicinal residues add water continue decoction get filtrate after 20 minutes, twice filtrate merges, and is divided into two parts of morning and evenings to take.
Embodiment 2, crude drug weight proportion: Cortex Kaki 10 parts, rose hip 6 parts, Usnea 3 parts, Cortex Ponciri trifoliatae 6 parts, Cortex Seu Radix Wikstroemiae Micranthae 3 parts, Herba Equiseti Hiemalis 6 parts, go back 6 parts, bobbin, Herba Moslae Chinensis 6 parts, Fructus Akebiae 6 parts, Gecko 1 part, Folium et Ramulus Callicarpae nudiflorae 3 parts, Fructus Setariae Germinatus (parched to brown) 10 parts.
Embodiment 3, crude drug weight proportion: Cortex Kaki 20 parts, rose hip 10 parts, Usnea 6 parts, Cortex Ponciri trifoliatae 10 parts, Cortex Seu Radix Wikstroemiae Micranthae 6 parts, Herba Equiseti Hiemalis 10 parts, go back 10 parts, bobbin, Herba Moslae Chinensis 10 parts, Fructus Akebiae 10 parts, Gecko 2 parts, Folium et Ramulus Callicarpae nudiflorae 6 parts, Fructus Setariae Germinatus (parched to brown) 20 parts.
Embodiment 4, crude drug weight proportion: Cortex Kaki 30 parts, rose hip 12 parts, Usnea 10 parts, Cortex Ponciri trifoliatae 12 parts, Cortex Seu Radix Wikstroemiae Micranthae 10 parts, Herba Equiseti Hiemalis 12 parts, go back 12 parts, bobbin, Herba Moslae Chinensis 12 parts, Fructus Akebiae 12 parts, Gecko 5 parts, Folium et Ramulus Callicarpae nudiflorae 10 parts, Fructus Setariae Germinatus (parched to brown) 25 parts.
The Chinese medicine of embodiment 2 ~ 4 can be prepared from by following method:
(1) bobbin will be gone back, rose hip, Cortex Seu Radix Wikstroemiae Micranthae coarse powder soak separately after 4 hours and extract volatile oil 6 hours with vapor distillation, and mixing for standby use after collecting, medicinal residues are for subsequent use;
(2) Gecko, Fructus Setariae Germinatus (parched to brown) are pulverized 150 mesh sieves, and become fine powder for subsequent use;
(3) by gained medicinal residues mixing in Cortex Kaki, Usnea, Cortex Ponciri trifoliatae, Herba Equiseti Hiemalis, Herba Moslae Chinensis, Fructus Akebiae, Folium et Ramulus Callicarpae nudiflorae and step 1 with 5 times amount 80% ethanol extraction 2 times, each 2 hours, merge twice ethanol extract, filter, reclaiming relative density when ethanol concentrating under reduced pressure become 60 DEG C is the extractum of 1.25 ~ 1.30;
(4) gained fine powder in step 2 is added gained extractum mixing in step 3,60 DEG C of oven dry, are ground into fine powder, add Tween-80 and make granule, and dry, granulate, sprays into gained volatile oil in step 1, and mixing, incapsulates, to obtain final product.
Can set every capsules is 0.5g.
The efficient combination of said medicine, coordinates mutually, effectively reach the object for the treatment of characteristics of calcific valvular heart disease, and side effect is less.The above results is clinical data sufficient proof, and interrelated data is as follows.
1 object and method
1.1 object
1.1.1 case selection: case is selected from June, 2006 ~ 2011 and is diagnosed as case totally 120 examples that characteristics of calcific valvular heart disease adds up aortic valve year June, wherein male 78 example, women 42 example, 62 ~ 87 years old age, average (73.8 ± 8.1) year.All cases are all clarified a diagnosis through echocardiography.Get rid of severe aortic stenosis or aortic incompetence, seriously hepatorenal disease, hematopathy, malignant tumor.
1.1.2 calcific aortic valve diagnostic criteria: echocardiography has typical cardiac valve and the obvious calcification acoustic image of lobe ring, the mainly fine and close strong echo of limitation, edge is comparatively regular, and mobility declines.The diagnosis of heart failure and relevant disease and cardiac functional grading adopt sick association (NYHA) the cardiac functional grading standard of New York Heart.Aortic stenosis degree criterion: >1.0cm
2for mild stenosis, 0.75 ~ 1.0cm
2for moderate stenosis, <0.75CM
2for severe stenosis.Aortic incompetence degree criterion: aortic regurgitation area <5 cm
2, be slight aortic incompetence; 5 ~ 10 cm
2, be moderate aortic incompetence; >10 cm
2, be severe aortic incompetence.
1.1.3 divide into groups: be divided into three groups at random: matched group 41 example, decoction group 41 example, Capsules group 38 example.Compare in sex, age, the state of an illness, the course of disease, the scoring of ultrasoundcardiogram valve, NYHA classification before three groups of patient treatments, no significant difference (P>0.05), has comparability.
1.2 method.
1.2.1 Therapeutic Method: matched group gives the Primary Cares such as a department woods, beta-blocker, heart tonifying, diuresis and blood vessel dilating medicine; Decoction group and Capsules group add described embodiment 1 gained decoction and described embodiment 3 gained capsule 2g/ time respectively the 4th day on matched group medication basis after treatment, 2 times/d, in order to taking convenience uses embodiment 3 gained capsule instead after decoction group medication 1m, decoction group and Capsules group overall therapeutic time are 12 months.
1.2.2 observation item: after treatment, 3m and the rear 12m for the treatment of measures cardiac function and uses ultrasoundcardiogram to measure aortic stenosis valve orifice area (MVA), calculate aortic regurgitation area, to judge course advancement.
1.2.3 statistical analysis: SPSS 13.0 carries out statistical analysis.Measurement data t checks, enumeration data χ
2inspection.
2 results.
2.1 treatment before, treatment after 3m, treatment after 12m time three groups of patients in severe aortic stenosis or aortic incompetence case distribution see the following form: result show, after treatment, 6m decoction group compares with matched group, and the total case load difference of middle severe aortic valve disease has statistical significance (P<0.05).After treatment, 12m decoction group and Capsules group compare with matched group, and the total case load difference of middle severe aortic valve disease has statistical significance (P<0.05).
| Group | Number of cases | Before treatment | 6m after treatment | 12m after treatment |
| Matched group | 41 | 13 | 27 | 31 |
| Decoction group | 41 | 14 | 18* | 20* |
| Capsules group | 38 | 14 | 17 | 20* |
* compare with same time point matched group, difference has statistical significance (P<0.05).
2.2 3 groups of adverse reactions of patients incidence rates compare: three groups all do not occur obvious adverse reaction record.
3. conclusion.
This result of study shows, after taking decoction of the present invention or capsule, the aortic valve calcification course of disease can be delayed, in minimizing, severe aortic valve disease occurs, and there is not obvious adverse reaction record, illustrate that pharmaceutical composition prepared by the inventive method has the lighter advantage of good effect, untoward reaction in the old calcific aortic for the treatment of is sick.
Claims (1)
1. treat a preparation method for characteristics of calcific valvular heart disease capsule, it is characterized in that: raw material is Cortex Kaki 10 ~ 30 parts, rose hip 6 ~ 12 parts, Usnea 3 ~ 10 parts, Cortex Ponciri trifoliatae 6 ~ 12 parts, Cortex Seu Radix Wikstroemiae Micranthae 3 ~ 10 parts, Herba Equiseti Hiemalis 6 ~ 12 parts, go back 6 ~ 12 parts, bobbin, Herba Moslae Chinensis 6 ~ 12 parts, Fructus Akebiae 6 ~ 12 parts, Gecko 1 ~ 5 part, Folium et Ramulus Callicarpae nudiflorae 3 ~ 10 parts, Fructus Setariae Germinatus (parched to brown) 10 ~ 25 parts; Be made up of following steps:
(1) bobbin will be gone back, rose hip, Cortex Seu Radix Wikstroemiae Micranthae coarse powder soak separately after 4 hours and extract volatile oil 6 hours with vapor distillation, and mixing for standby use after collecting, medicinal residues are for subsequent use;
(2) Gecko, Fructus Setariae Germinatus (parched to brown) are pulverized 150 mesh sieves, and become fine powder for subsequent use;
(3) by gained medicinal residues mixing in Cortex Kaki, Usnea, Cortex Ponciri trifoliatae, Herba Equiseti Hiemalis, Herba Moslae Chinensis, Fructus Akebiae, Folium et Ramulus Callicarpae nudiflorae and step 1 with 5 times amount 80% ethanol extraction 2 times, each 2 hours, merge twice ethanol extract, filter, reclaiming relative density when ethanol concentrating under reduced pressure become 60 DEG C is the extractum of 1.25 ~ 1.30;
(4) gained fine powder in step 2 is added gained extractum mixing in step 3,60 DEG C of oven dry, are ground into fine powder, add Tween-80 and make granule, and dry, granulate, sprays into gained volatile oil in step 1, and mixing, incapsulates, to obtain final product.
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