CN100400074C - Chinese medicinal preparation for freating coronary heart disease, brain arteriosclerosis and its preparation method - Google Patents
Chinese medicinal preparation for freating coronary heart disease, brain arteriosclerosis and its preparation method Download PDFInfo
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Abstract
The present invention discloses a Chinese medical preparation for treating coronary heart disease and cerebral arteriosclerosis and a preparing method thereof. The Chinese medical preparation is prepared from 400g of ginkgo leaf, 400g of foliolean boxtree, 400g of red sage root, 400 g of Litsea pungens, 400 g of longstamen onion bulb, and a right amount of supplementary materials. Each medicine in the prescription of the Chinese medical preparation is singly extracted, and modern medicine separation and purification technologies such as a super critical extraction technology, a macroporous resin separation technology, etc. are used; effective components of medicinal materials can be furthest extracted to be used in the preparation; the bioavailability of the preparation is higher than that of capsules, and the purity of the preparation is enhanced when the content of the effective components is increased. Because most plant pigment and plant fibers are discarded, the preparation is refined and purified, and the substance of non-medicine components and non-pharmacological activity is greatly reduced; consequently, the absorption rate and the bioavailability of the medicine in vivo are greatly improved, and the effecting time of the medicine is shortened in a certain degree.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation and preparation method thereof, particularly a kind of Chinese medicine preparation for the treatment of coronary heart disease, cerebral arteriosclerosis and preparation method thereof.
Background technology
Coronary heart disease, cerebral arteriosclerosis are a kind of commonly encountered diseases, and it is having a strong impact on the healthy of people.And existing treatment coronary heart disease, cerebral arteriosclerosis medicine are also a lot, but most of curative effect is not satisfactory.For reaching the purpose of treatment, a large amount of research has been done by many inventors and medicine enterprise, and the product of some treatments also is provided; Be called " heart and brain curing capsule and preparation technology thereof " as ZL02127973.X, name and develop, through secular clinical practice proof determined curative effect for treating this type of disease.But, in the research that continues, find because the defective of extract drugs technology, make bioavailability of medicament, medicine stability undesirable, and the dosage form kind is abundant inadequately, is suitable for crowd's narrow range.Pharmaceutical dosage form is the application form of Drug therapy disease, and under the prerequisite that guarantees curative effect, the multiformity of dosage form has greatly satisfied the different medication demand of vast sufferer.In influencing numerous factors of curative effect of medication, except the character of medicine itself, also have other several factors, for example: the race, age, or sex of sufferer, inherited genetic factors, physiologic factor etc.In view of such circumstances, the extracting method of improvement medicine, raising drug bioavailability and dosage changing form just become the thing that people are badly in need of solving.
Summary of the invention
The objective of the invention is to: a kind of Chinese medicine preparation for the treatment of coronary heart disease, cerebral arteriosclerosis and preparation method thereof is provided, at prior art, extract drugs method and dosage form are improved, to improve bioavailability, be suitable for more extensive crowd, satisfy the medication demand of different sufferers to greatest extent, give full play to the therapeutic effect of medicine, overcome the deficiencies in the prior art.
The present invention is achieved in that by weight it is with Folium Ginkgo 400g, little leaf boxwood 400g, Radix Salviae Miltiorrhizae 400g, Fructus cinnamomi camphorae 400g, Bulbus Allii Macrostemonis 400g, adds appropriate amount of auxiliary materials and makes.
Described Chinese medicine preparation comprises drop pill, tablet.
Its preparation method comprises the following steps:
(1) gets Folium Ginkgo, pulverize, use Diluted Alcohol heating and refluxing extraction three times, merge extractive liquid,, recovery ethanol also is concentrated in right amount, is added on the macroporous adsorptive resins of having handled well, and 5%～70% alcoholic solution eluting is collected corresponding eluent successively, reclaim ethanol, spray drying, promptly;
(2) get Radix Salviae Miltiorrhizae, pulverize, adopt supercritical CO
2Extraction, the 5L supercritical CO
2Extraction equipment is separated with a detached dowel by two extraction-containers, and extraction temperature is 40 ℃～60 ℃, pressure 400 * 10
5Pa, CO
2Flow 1.2L/min, water and ethanol are made entrainer, keep constant temperature, constant voltage, carry out cycling extraction, extract 3 hours;
(3) get little leaf boxwood with 80% acid alcohol percolation, recovered alcohol, extractum are waved near and are done, and with 5% acetum dissolution filter, it is 9 that filtrate is transferred pH with ammonia, and precipitation is separated out, and filters, and the filter cake decompression is dried, promptly;
(4) get Fructus cinnamomi camphorae water distillating extracting oil, get Fructus cinnamomi camphorae oil;
(5) get the alcohol reflux twice of Bulbus Allii Macrostemonis with 5 times of amounts 90%, 1 hour for the first time, 0.5 hour for the second time, merge extractive liquid, reclaimed ethanol, is concentrated into extractum, the decompression oven dry, promptly;
(6) add appropriate amount of auxiliary materials, make different preparations.
The method for preparing drop pill is: get the said extracted thing, add Polyethylene Glycol 6000175g, 80～85 ℃ of water-bath melting mixing, mixed 30 minutes, add Fructus cinnamomi camphorae oil again, mix homogeneously drips and makes ball.
The method for preparing tablet is: gets the said extracted thing, adds lactose 200g, and Pulvis Talci 50g, mix homogeneously mixed 30 minutes, added Fructus cinnamomi camphorae oil again, mix homogeneously, compacting is in flakes.
The present invention compared with prior art, the medicine of respectively distinguishing the flavor of in owing to will write out a prescription extracts separately, and modern medicines separating and purifying technologies such as supercritical extraction technique and macroporous resin isolation technics have been used, effective ingredient in the medical material can be extracted in the preparation to greatest extent, medicine has higher bioavailability than capsule, and the purity of preparation had also improved when active constituent content increased.Most plant pigment, Plant fiber are discarded, and make preparation obtain refining and purification, and the material of non-ingredient and parmacodynamics-less activity significantly reduces.Thereby medicine absorption in vivo speed and bioavailability are improved greatly, shortened the onset time of medicine to a certain extent.
Below be the relevant parameter and the test data of optimal process:
1, gets the rate test
2. adjuvant is selected
The present invention is a pure Chinese medicinal preparation, and in order to select the adjuvant that is fit to characteristics of prescriptions and formulation characteristic, it is preferred to have carried out adjuvant.
2.1 the selection of drop pill substrate, condensing agent
"+" for meeting optimum condition, "-" do not meet optimum condition."---" abandon testing.Drug release rate is fusion time limit of comprehensive substrate and dissolubility and the conclusion that draws.So suitable substrate, the condensing agent of drop pill is: PEG6000, methyl-silicone oil are decided to be about 175g according to the amount of the preparation amount of making PEG6000.
2.2 the selection of additive of tablet
Tablet is a regular dosage form, and each flavour of a drug that are characterized in taking on the extraction process to write out a prescription extract separately, concentrate refining, the selection of its adjuvant such as following table:
| Filler | Binding agent | Agent is separated in spring | Lubricant | According to the moulding process of tablet,, determine that by parallel test and cross matching the adjuvant of tablet is: lactose 200g, Pulvis Talci 50g in conjunction with the characteristics of this pharmaceutical preparation. |
| Starch | Distilled water | Starch | Pulvis Talci | |
| Dextrin | Ethanol | Tween 80 | Magnesium stearate | |
| Icing Sugar | Starch slurry | Sodium laurylsulfate | PEG4000 | |
| Lactose | Dextrin | Calcium carbonate | Boric acid | |
| Calcium carbonate | Syrup | Tartaric acid | Paraffin | |
| Kaolin | Refined honey | CMC-Na | Micropowder silica gel | |
| Magnesium carbonate | Cellulose family | Magnesium stearate | Sodium benzoate |
Pharmacodynamics test
Test objective
Observe the influence that oxygen consumption that preparation of the present invention causes real tentative myocardial ischemia, normobaric hypoxia and isoproterenol increases, and a little less than the strong drug action of contrast different dosage form, for clinical application provides test basis.
Two, test material
(1) medicine
(1) is subjected to the reagent thing
Capsule: this product content is a chocolate brown powder.Provide by Antai Pharmaceutical Co., Ltd., Guizhou Prov..
Drop pill: this product content is the dark brown piller.Provide by Antai Pharmaceutical Co., Ltd., Guizhou Prov..
Tablet: this product circular piece.Provide by Antai Pharmaceutical Co., Ltd., Guizhou Prov..
(2) positive drug
Aspirin: produce by Shijiazhuang Pharmaceutical Group Co Ltd.
Buxine Tablet: produce by Chinese Wuhu Zhang Hengchun pharmaceutical Co. Ltd.
(2), experimental animal
Kunming mouse is some, and the SD rat is some, is provided by Guiyang Medical College zoopery center.
Test method and result
(1), to the influence of myocardial ischemia due to the ligation rat coronary artery
Get 50 of female sd inbred rats, body weight 254 ± 16.75g is divided into 5 groups immediately: blank group, positive controls (Buxine 0.015g/kg) drop pill group (0.3g/kg), tablet group (0.3g/kg), Capsules group (0.3g/kg).Ligation coronary artery preceding every day of gastric infusion 1 time, the blank group is irritated the NS that stomach is given equivalent, successive administration 4 days, after the last administration 1 hour with 10% urethane (1g/kg) intraperitoneal anesthesia, be fixed in the Mus plate, behind the recording ecg, connect artificial respirator before opening the thoracic cavity, after the ligation anterior descending coronary, close the thoracic cavity rapidly, recover autonomous respiration, 5 minutes, 60 minutes, 120 minutes, 180 minutes electrocardiograms after the record ligation calculate each time ST section and are offset mv number (ε ST) up and down.Put to death animal in 180 minutes, and took out heart rapidly, with NS flushing, excision atrium and right ventricle.Stay left ventricle, left ventricle is cut into the thick myocardium sheet of 0.1cm, put into 0.3% nitro tetrazole orchid (NBT dyestuff) dyeing 10 minutes, unnecessary dyestuff is removed in water flushing immediately after the dyeing, and infarct is not painted, and non-infarct is dyed blueness by NBT.After left ventricle weighed, cut infarct and weigh, multiply by a hundred per cent with the heavy ratio with left ventricle weight of infarct is the myocardial ischemia percentage rate.The results are shown in following table 1.
Table 1 preparation of the present invention is to the influence of myocardial ischemia due to the ligation rat coronary artery
Annotate: preparation of the present invention and blank group are relatively
★P＞0.05,
★ ★P＜0.01, wherein drop pill group curative effect is better, and the tablet group is taken second place good than Capsules group.
(2), to the influence of mice normobaric hypoxia
Get 50 of mices, male and female half and half, body weight 20.20 ± 1.15g is divided into 5 groups immediately: blank group, positive controls (Buxine 0.015g/kg) drop pill group (0.6g/kg), agent group (0.6g/kg), Capsules group (0.6g/kg).Every day, gastric infusion was 1 time, and the blank group is irritated the NS that stomach is given equivalent, and successive administration 4 days after 1 hour is put into mice after the last administration the tight bottle stopper of 15g sodica calx wide mouthed bottle inner cap is housed, and writes down every Mus respiratory arrest time, is every Mus time-to-live.The results are shown in Table 2.
Table 2 preparation of the present invention is to mice normobaric hypoxia (X ± S)
Annotate: preparation of the present invention and blank group are relatively
★P＞0.05,
★ ★P＜0.01, wherein drop pill group curative effect is better, and the tablet group is taken second place good than Capsules group, all can prolong the time-to-live of mice.
(3), isoproterenol is caused the influence of oxygen consumption increase effect
Get 50 of mices, male and female half and half, body weight 20.56 ± 1.03g is divided into 5 groups immediately: blank group, positive controls (Buxine 0.015g/kg) drop pill group (0.6g/kg), tablet group (0.6g/kg), Capsules group (0.6g/kg).Every day, gastric infusion was 1 time, and the blank group is irritated the NS that stomach is given equivalent, successive administration 4 days, and after the last administration 50 minutes, lumbar injection isoproterenol 2mg/kg put into the tight bottle stopper of wide mouthed bottle inner cap after 10 minutes, the record mice time-to-live.The results are shown in Table 3.
Table 3 preparation of the present invention causes the influence of oxygen consumption increase effect to isoproterenol
| Group | Animal (only) | Dosage (g/kg) | Time-to-live (branch) | The P value |
| Blank group | 10 | - | 23.70±5.12 | |
| Positive group | 10 | 0.015 | 37.50±5.58 | ＜0.01 |
| XINNAONING drop pill group | 10 | 0.6 | 33.20±5.57 | ＜0.01 |
| XINNAONING tablet group | 10 | 0.6 | 29.90±4.46 | ＜0.01 |
| The XINNAONING JIAONANG group | 10 | 0.6 | 28.10±4.79 | ＜0.05 |
Annotate: preparation of the present invention and blank group are relatively
★P＞0.05,
★ ★P＜0.01, wherein drop pill group curative effect is better, and the tablet group is taken second place good than Capsules group, all can prolong the time-to-live of mice.
(4) influence pain caused to glacial acetic acid
Get 50 of mices, male and female half and half, body weight 20.63 ± 1.12g is divided into 5 groups immediately: blank group, positive controls (aspirin 0.2g/kg) drop pill group (0.6g/kg), tablet group (0.6g/kg), Capsules group (0.6g/kg).Before the ligation coronary artery every day gastric infusion 1 time, the blank group is irritated the NS that stomach is given equivalent, successive administration 3 days, after the last administration 1 hour, lumbar injection 0.6% glacial acetic acid caused pain, write down every Mus and turned round and turn round body incubation period and 10 minutes the body number of times.The results are shown in Table 4.
The influence that table 4 preparation of the present invention is pain caused to glacial acetic acid
Annotate: preparation of the present invention and blank group are relatively
★P＞0.05,
★ ★P＜0.01, wherein drop pill group curative effect is better, and the tablet group is taken second place good than Capsules group, and it is pain caused all to weaken glacial acetic acid.
Conclusion
Preparation of the present invention is to ligation rat left coronary artery, and the myocardial ischemia that anterior descending branch causes has the improvement effect, can reverse the ischemic change of electrocardiogram (ECG), and the percentage rate in myocardial ischemia district is reduced; Can also obviously prolong the time-to-live of normal pressure ischemia mice, the antagonism isoproterenol causes oxygen consumption increase effect, the pain caused effect of antagonism glacial acetic acid.Wherein the drop pill effect is stronger, and tablet takes second place, and capsule is not as the above two strong drug action.
The specific embodiment
Embodiments of the invention 1: produce drop pill
Produce by following technical process with Folium Ginkgo 400g, little leaf boxwood 400g, Radix Salviae Miltiorrhizae 400g, Fructus cinnamomi camphorae 400g, Bulbus Allii Macrostemonis 400g:
(1) gets Folium Ginkgo, pulverize, use Diluted Alcohol heating and refluxing extraction three times, merge extractive liquid,, recovery ethanol also is concentrated in right amount, is added on the macroporous adsorptive resins of having handled well, and 5%～70% alcoholic solution eluting is collected corresponding eluent successively, reclaim ethanol, spray drying, promptly.This technology extract is compared with the XINNAONING JIAONANG extract, the active constituent content height, and impurity is few, and is quality controllable.
(2) get Radix Salviae Miltiorrhizae, pulverize, adopt supercritical CO
2Extraction.The 5L supercritical CO
2Extraction equipment (HA-9508) is separated with a detached dowel by two extraction-containers, and extraction temperature is 40 ℃～60 ℃, pressure 400 * 10
5Pa, CO
2Flow 1.2L/min, water and ethanol are made entrainer.Keep constant temperature, constant voltage, carry out cycling extraction, extracted 3 hours.
(3) get little leaf boxwood with 80% acid alcohol percolation, recovered alcohol, extractum are waved near and are done, and with 5% acetum dissolution filter, it is 9 that filtrate is transferred pH with ammonia, and precipitation is separated out, and filters, and the filter cake decompression is dried, promptly.
(4) get Fructus cinnamomi camphorae water distillating extracting oil, get Fructus cinnamomi camphorae oil.
(5) get the alcohol reflux twice of Bulbus Allii Macrostemonis with 5 times of amounts 90%, 1 hour for the first time, 0.5 hour for the second time, merge extractive liquid, reclaimed ethanol, is concentrated into extractum, the decompression oven dry.
(6) get the said extracted thing, add Polyethylene Glycol 6000 about 175g, 80～85 ℃ of water-bath melting mixing, mixed 30 minutes, add Fructus cinnamomi camphorae oil again, mix homogeneously drips and makes ball, and the heavy 45mg of every ball makes 5000 of drop pill, promptly.
Embodiments of the invention 2: produce tablet
Produce by following technical process with Folium Ginkgo 400g, little leaf boxwood 400g, Radix Salviae Miltiorrhizae 400g, Fructus cinnamomi camphorae 400g, Bulbus Allii Macrostemonis 400g:
(1) gets Folium Ginkgo, pulverize, use Diluted Alcohol heating and refluxing extraction three times, merge extractive liquid,, recovery ethanol also is concentrated in right amount, is added on the macroporous adsorptive resins of having handled well, and 5%～70% alcoholic solution eluting is collected corresponding eluent successively, reclaim ethanol, spray drying, promptly.This technology extract is compared with the XINNAONING JIAONANG extract, the active constituent content height, and impurity is few, and is quality controllable.
(2) get Radix Salviae Miltiorrhizae, pulverize, adopt supercritical CO
2Extraction.The 5L supercritical CO
2Extraction equipment (HA-9508) is separated with a detached dowel by two extraction-containers, and extraction temperature is 40 ℃～60 ℃, pressure 400 * 10
5Pa, CO
2Flow 1.2L/min, water and ethanol are made entrainer.Keep constant temperature, constant voltage, carry out cycling extraction, extracted 3 hours.
(3) get little leaf boxwood with 80% acid alcohol percolation, recovered alcohol, extractum are waved near and are done, and with 5% acetum dissolution filter, it is 9 that filtrate is transferred pH with ammonia, and precipitation is separated out, and filters, and the filter cake decompression is dried, promptly.
(4) get Fructus cinnamomi camphorae water distillating extracting oil, get Fructus cinnamomi camphorae oil.
(5) get the alcohol reflux twice of Bulbus Allii Macrostemonis with 5 times of amounts 90%, 1 hour for the first time, 0.5 hour for the second time, merge extractive liquid, reclaimed ethanol, is concentrated into extractum, the decompression oven dry.
(6) get the said extracted thing, add lactose 200g, Pulvis Talci 50g, mix homogeneously mixed 30 minutes, added Fructus cinnamomi camphorae oil again, mix homogeneously, compacting is in blocks, and every heavy 0.3g makes 1000, promptly.
Claims (4)
1. Chinese medicine preparation for the treatment of coronary heart disease, cerebral arteriosclerosis is characterized in that: by weight, it is with Folium Ginkgo 400g, little leaf boxwood 400g, Radix Salviae Miltiorrhizae 400g, Fructus cinnamomi camphorae 400g, Bulbus Allii Macrostemonis 400g, adds appropriate amount of auxiliary materials and makes; Its preparation method comprises the following steps:
(1) gets Folium Ginkgo, pulverize, use Diluted Alcohol heating and refluxing extraction three times, merge extractive liquid,, recovery ethanol also is concentrated in right amount, is added on the macroporous adsorptive resins of having handled well, and 5%～70% alcoholic solution eluting is collected corresponding eluent successively, reclaim ethanol, spray drying, promptly;
(2) get Radix Salviae Miltiorrhizae, pulverize, adopt supercritical CO
2Extraction, the 5L supercritical CO
2Extraction equipment is separated with a detached dowel by two extraction-containers, and extraction temperature is 40 ℃～60 ℃, pressure 400 * 10
5Pa, CO
2Flow 1.2L/min, water and ethanol are made entrainer, keep constant temperature, constant voltage, carry out cycling extraction, extract 3 hours;
(3) get little leaf boxwood with 80% acid alcohol percolation, recovered alcohol, extractum are waved near and are done, and with 5% acetum dissolution filter, it is 9 that filtrate is transferred pH with ammonia, and precipitation is separated out, and filters, and the filter cake decompression is dried, promptly;
(4) get Fructus cinnamomi camphorae water distillating extracting oil, get Fructus cinnamomi camphorae oil;
(5) get the alcohol reflux twice of Bulbus Allii Macrostemonis with 5 times of amounts 90%, 1 hour for the first time, 0.5 hour for the second time, merge extractive liquid, reclaimed ethanol, is concentrated into extractum, the decompression oven dry, promptly;
(6) add appropriate amount of auxiliary materials, make different preparations.
2. the Chinese medicine preparation of treatment coronary heart disease according to claim 1, cerebral arteriosclerosis is characterized in that: described Chinese medicine preparation is drop pill or tablet.
3. the Chinese medicine preparation of treatment coronary heart disease according to claim 1, cerebral arteriosclerosis, it is characterized in that: the method for preparing drop pill is: get the said extracted thing, add Polyethylene Glycol 6000 175g, 80～85 ℃ of water-bath melting mixing, mixed 30 minutes, add Fructus cinnamomi camphorae oil again, mix homogeneously drips and makes ball.
4. the Chinese medicine preparation of treatment coronary heart disease according to claim 1, cerebral arteriosclerosis is characterized in that: the method for preparing tablet is: get the said extracted thing, add lactose 200g, Pulvis Talci 50g, mix homogeneously mixed 30 minutes, add Fructus cinnamomi camphorae oil again, mix homogeneously, compacting is in flakes.
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| CNB2005102006592A CN100400074C (en) | 2005-10-31 | 2005-10-31 | Chinese medicinal preparation for freating coronary heart disease, brain arteriosclerosis and its preparation method |
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| CN100400074C true CN100400074C (en) | 2008-07-09 |
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| CN1973858B (en) * | 2006-12-20 | 2010-11-03 | 贵阳中医学院 | Large-fruit pungent litse fruit oil emulsion and its preparation process |
| CN103800635A (en) * | 2014-03-12 | 2014-05-21 | 邹琳 | Medicinal and edible two-purpose composition for preventing and treating coronary heart disease and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1418653A (en) * | 2002-11-28 | 2003-05-21 | 贵州安泰药业有限公司 | Xin-nao-ning capsule for treating cardio-vascular and cerebral vascular disease |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1418653A (en) * | 2002-11-28 | 2003-05-21 | 贵州安泰药业有限公司 | Xin-nao-ning capsule for treating cardio-vascular and cerebral vascular disease |
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