CN102302549B - Drug composition for treating cardiovascular and cerebrovascular diseases, preparation method and application thereof - Google Patents
Drug composition for treating cardiovascular and cerebrovascular diseases, preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a dan-shen root and ligustrazine drug composition, a preparation method and an application thereof. According to the present invention, a plurality of experimental studies are adopted; the dan-shen root and the szechwan lovage rhizome are extracted through the supercritical fluid extraction method, wherein a weight ratio of the dan-shen root to the szechwan lovage rhizome is 5:1, the propanoid acid, the tanshinone IIA and the ligustrazine are adopted as index components; the experimental results show that: with adopting the preparation method provided by the present invention, the contents of the active ingredients can be significantly improved, the ligustrazine content is more than 100 mug/g; the results of the animal experiments show that: with adopting the preparation method provided by the invention, the significant pharmacologic action of the dan-shen root and ligustrazine drug composition is provided.
Description
Affiliated technical field
The invention belongs to medical technical field, be specifically related to a kind of red-rooted-salvia-root chuanxiong-rhizome azine pharmaceutical composition and its preparation method and application.
Background technology
Change along with growth in the living standard and rhythm of life, the mankind in the always serious threat of " three-hypers disease " (being hypertension, hyperglycemia and hyperlipidemia) that is called as " affluenza ", are the common healthy diseases of middle-aged and elderly people.Even in today of therapeutic treatment means high speed development, still have cerebrovascular accident survivor life over half not take care of oneself fully.It is the first that cardiovascular and cerebrovascular disease occupies the various causes of the death, become the highest No.1 killer of human Death causes, also is " the noiseless demon " of health of people.Cardiovascular and cerebrovascular disease has the characteristics of " sickness rate is high, disability rate is high, mortality rate is high, relapse rate is high and complication many ", therefore cardiovascular and cerebrovascular disease should be prevented trouble before it happens, otherwise in case it is sick to meet with this class, family is heavy financial burden and the mental pressure of back therefore.
The reason of cardiovascular and cerebrovascular disease is that lipid is too much in the diet owing to long-time dietary habit problem, and alcohols is too much.There is not again simultaneously reasonably motion to promote the metabolism of lipid alcohols, cause the interior lipid alcohols material of body to increase gradually, add with age, human secretory antioxidant enzyme ability lowers, and causes the interior free yl level to raise, and is deposited on blood vessel wall after making the ldl cholesterol oxidation in the blood fat, the blood capillary that makes of a specified duration stops up, As time goes on, the free mineral ion combination easily and in the body of lipid alcohols material, formation thrombosis.Thrombosis easily in the corner of blood vessel, perhaps pile up, calcification by bottleneck.Thrombosis is more and more simultaneously, and blood vessel diameter is dwindled.Heart just increases blood pressure in order to keep enough amounts of blood supply, causes high blood pressure disease.If hyperpiesia may cause blood vessel to burst apart, so produce courageous and upright cardiovascular and cerebrovascular disease.If owing to stopping up blood supply insufficiency, be ischemic cardio cerebrovascular diseases.
Every year is died from the number of cardiovascular and cerebrovascular disease up to 1,500 ten thousand people in the whole world, occupies the various causes of the death the first, only just has every year 3000000 people to die from cardiovascular and cerebrovascular disease in China, has the characteristics of repeated drug taking, SM for the patient of cardiovascular and cerebrovascular disease.Chinese medicine plays an important role in the prevention of cardiovascular and cerebrovascular disease and treatment, especially the folk prescription take Radix Salviae Miltiorrhizae as primary raw material or Chinese and Western compound preparation all have definite curative effect, such as Radix Salviae Miltiorrhizae performance Main Function in these preparations such as red-rooted-salvia-root chuanxiong-rhizome azine injecta, FUFANG DANSHEN PIAN, happy amylan capsule.
Red-rooted-salvia-root chuanxiong-rhizome azine injecta, its component are that (chemical name is ligustrazine hydrochloride: the 2，3，5，6-tetramethylpyrazine hydrochlorate); (chemical name is danshensu: β-(3,4-dihydroxy phenyl) lactic acid).Red-rooted-salvia-root chuanxiong-rhizome azine injecta is compound preparation, and it act as blood circulation promoting and blood stasis dispelling, and freeing vessels and nourishing heart has antiplatelet aggregation, coronary artery dilator, and blood viscosity lowering accelerates erythrocytic mobility, improves microcirculation and has the effect that resists myocardial ischemia with myocardial infarction.Ligustrazine is by the effective ingredient of the rhizome extraction of Rhizoma Chuanxiong, has blood circulation promoting and blood stasis dispelling, anti-platelet aggregation, expansion small artery, improves the effects such as microcirculation, antioxidation, antagonism calcium ion and fibrosis; Radix Salviae Miltiorrhizae has blood circulation promoting and blood stasis dispelling, inducing menstruation to relieve menalgia, the relieving restlessness that clears away heart-fire, the effect of removing heat from blood eliminating carbuncle.
Research worker of the present invention is extracted Radix Salviae Miltiorrhizae and Rhizoma Chuanxiong through long-term experimentation with supercritical fluid extraction, take danshensu, Tanshinone I I A and ligustrazine as index components, and CO
2Supercritical fluid extraction extracts has higher danshensu, Tanshinone I I A and three kinds of effective ingredient of ligustrazine, this extracting method carries out at ambient temperature, prevent that some is destroyed to heat-labile composition, use hardly organic solvent in the extraction process, organic solvent-free is residual in the extract, nuisanceless to environment, extraction efficiency is high, energy efficient.
Summary of the invention
Research worker of the present invention is through lot of experiments, Radix Salviae Miltiorrhizae and Rhizoma Chuanxiong are extracted with supercritical fluid extraction, the medical material weight ratio of Radix Salviae Miltiorrhizae and Rhizoma Chuanxiong is 5: 1, take danshensu, tanshinone ⅡA and ligustrazine as index components, experimental result shows that preparation method of the present invention can significantly improve the content of effective ingredient, and the content of ligustrazine is greater than 100 μ g/g.
The object of the present invention is to provide a kind of pharmaceutical composition of red-rooted-salvia-root chuanxiong-rhizome azine.
The object of the invention is to further provide the extracting method of red-rooted-salvia-root chuanxiong-rhizome azine pharmaceutical composition.
The present invention also aims to provide the application of red-rooted-salvia-root chuanxiong-rhizome azine pharmaceutical composition in field of medicaments
The present invention is achieved by the following technical solutions:
The preparation method of red-rooted-salvia-root chuanxiong-rhizome azine:
Get Radix Salviae Miltiorrhizae, Ligusticum chuanxiong Hort, be ground into powder and cross 24 mesh sieves, put into abstraction pool, concentration be 75 ± 5% ethanol as entrainer, CO
2With entrainer respectively by CO
2Pump and entrainer pump are squeezed in the pump housing of each pump, after flow mixer mixes, flow into the manifold in the extractor chamber, after extracting pressure reaches 24-30MPa, and extraction temperature reaches 50 ± 10 ℃, enter and begin extraction in the abstraction pool, after extraction time was 1-2h, the decompression discharging was also collected extract, is concentrated into dried with rotary evaporation, namely get the red-rooted-salvia-root chuanxiong-rhizome azine extract, the content of ligustrazine is greater than 100 μ g/g.
The specific embodiment
Embodiment 1
Get Radix Salviae Miltiorrhizae 100g, Rhizoma Chuanxiong 20g medical material, be ground into powder and cross 24 mesh sieves, put into abstraction pool, concentration be 80% ethanol as entrainer, CO
2With entrainer respectively by CO
2Pump and entrainer pump are squeezed in the pump housing of each pump, after flow mixer mixes, flow into the manifold in the extractor chamber, after extracting pressure reaches 24MPa, and extraction temperature reaches 50 ℃, enter and begin extraction in the abstraction pool, after extraction time was 1h, the decompression discharging was also collected extract, is concentrated into dried with rotary evaporation, namely get the red-rooted-salvia-root chuanxiong-rhizome azine extract, the content of ligustrazine is 105 μ g/g.
Embodiment 2
Get Radix Salviae Miltiorrhizae 50g, Rhizoma Chuanxiong 10g medical material, be ground into powder and cross 24 mesh sieves, put into abstraction pool, concentration be 75% ethanol as entrainer, CO
2With entrainer respectively by CO
2Pump and entrainer pump are squeezed in the pump housing of each pump, after flow mixer mixes, flow into the manifold in the extractor chamber, after extracting pressure reaches 25MPa, and extraction temperature reaches 40 ℃, enter and begin extraction in the abstraction pool, after extraction time was 1.2h, the decompression discharging was also collected extract, is concentrated into dried with rotary evaporation, namely get the red-rooted-salvia-root chuanxiong-rhizome azine extract, the content of ligustrazine is 101 μ g/g.
Embodiment 3
Get Radix Salviae Miltiorrhizae 25g, Rhizoma Chuanxiong 5g medical material, be ground into powder and cross 24 mesh sieves, put into abstraction pool, concentration be 70% ethanol as entrainer, CO
2With entrainer respectively by CO
2Pump and entrainer pump are squeezed in the pump housing of each pump, after flow mixer mixes, flow into the manifold in the extractor chamber, after extracting pressure reaches 26MPa, and extraction temperature reaches 45 ℃, enter and begin extraction in the abstraction pool, after extraction time was 1.5h, the decompression discharging was also collected extract, is concentrated into dried with rotary evaporation, namely get the red-rooted-salvia-root chuanxiong-rhizome azine extract, the content of ligustrazine is 102 μ g/g.
Embodiment 4
Get Radix Salviae Miltiorrhizae 30g, Rhizoma Chuanxiong 6g medical material, be ground into powder and cross 24 mesh sieves, put into abstraction pool, concentration be 80% ethanol as entrainer, CO
2With entrainer respectively by CO
2Pump and entrainer pump are squeezed in the pump housing of each pump, after flow mixer mixes, flow into the manifold in the extractor chamber, after extracting pressure reaches 30MPa, and extraction temperature reaches 60 ℃, enter and begin extraction in the abstraction pool, after extraction time was 2h, the decompression discharging was also collected extract, is concentrated into dried with rotary evaporation, namely get the red-rooted-salvia-root chuanxiong-rhizome azine extract, the content of ligustrazine is 103 μ g/g.
Embodiment 5
Get Radix Salviae Miltiorrhizae 20g, Rhizoma Chuanxiong 4g medical material, be ground into powder and cross 24 mesh sieves, put into abstraction pool, concentration be 75% ethanol as entrainer, CO
2With entrainer respectively by CO
2Pump and entrainer pump are squeezed in the pump housing of each pump, after flow mixer mixes, flow into the manifold in the extractor chamber, after extracting pressure reaches 28MPa, and extraction temperature reaches 55 ℃, enter and begin extraction in the abstraction pool, after extraction time was 1.8h, the decompression discharging was also collected extract, is concentrated into dried with rotary evaporation, namely get the red-rooted-salvia-root chuanxiong-rhizome azine extract, the content of ligustrazine is 101 μ g/g.
Embodiment 6
Get Radix Salviae Miltiorrhizae 35g, Rhizoma Chuanxiong 7g medical material, be ground into powder and cross 24 mesh sieves, put into abstraction pool, concentration be 70% ethanol as entrainer, CO
2With entrainer respectively by CO
2Pump and entrainer pump are squeezed in the pump housing of each pump, after flow mixer mixes, flow into the manifold in the extractor chamber, after extracting pressure reaches 24MPa, and extraction temperature reaches 50 ℃, enter and begin extraction in the abstraction pool, after extraction time was 1h, the decompression discharging was also collected extract, is concentrated into dried with rotary evaporation, namely get the red-rooted-salvia-root chuanxiong-rhizome azine extract, the content of ligustrazine is 100 μ g/g.
The impact that the red-rooted-salvia-root chuanxiong-rhizome azine that obtains with preparation method among the above embodiment changes the nitric oxide in the HIBI tissue (NO), nitricoxide synthase (NOS), the pharmacological action of extracting the red-rooted-salvia-root chuanxiong-rhizome azine that obtains with checking with preparation method of the present invention.
1. materials and methods
1.1 instrument and reagent 752C type ultraviolet spectrophotometer; Red-rooted-salvia-root chuanxiong-rhizome azine (develop with preparation method of the present invention, be mixed with the 1g/L injection with the physiological saline solution dissolving during use); Measure the test kit (bio-engineering research institute is built up in Nanjing) of NO, NOS.
1.2 the grouping: 7 day age the SD rat, male or female, weight 10～15g is divided into 3 groups at random, 10 every group: the blank group; The Hypoxia and ischemia model group; The red-rooted-salvia-root chuanxiong-rhizome azine treatment group.
1.3NO, NOS measures: animal respectively after Hypoxia and ischemia 6,24, the 48h sacrificed by decapitation, get ligation side cerebral tissue and weigh, as the homogenate medium, make 10% tissue homogenate by 1g: 10mL abundant homogenate in ice bath with physiological saline solution, get supernatant after centrifugal, measure NO, NOS.NO adopts nitrate reductase method to measure; NOS uses colorimetric method for determining.
1.4 statistical method: use SAS 8.0 softwares and carry out statistical analysis; Behind the variance test of homogeneity, organize mean more and relatively adopt one factor analysis of variance, relatively adopt in twos the q check between group.
2. result
2.1 red-rooted-salvia-root chuanxiong-rhizome azine is on the impact of neonatal rats brain NO
Neonate rat is after the Hypoxia and ischemia modeling 6,24, and 48h compares with the blank group, and each corresponding time point NO content of model group cerebral tissue raises, and difference has significance (P＜0.05).Time point corresponding to model group compares, and the corresponding time point NO of red-rooted-salvia-root chuanxiong-rhizome azine treatment group content returns and falls, and is certain dose-effect relationship, and difference has significance (P＜0.05).
2.2 red-rooted-salvia-root chuanxiong-rhizome azine is on the impact of neonatal rats brain NOS
Neonate rat is after the Hypoxia and ischemia modeling 6,24, and 48h compares with the blank group, and each time point NOS content of model group cerebral tissue raises, and difference has significance (P＜0.05).Time point corresponding to model group compares, and the corresponding time point NOS of red-rooted-salvia-root chuanxiong-rhizome azine group content returns and falls, and is certain dose-effect relationship, and difference has significance (P＜0.05).
With red-rooted-salvia-root chuanxiong-rhizome azine and glycerol mix homogeneously, add water for injection, with the pH value of hydrochloric acid solution regulator solution, make altogether 1000ml, filtration, embedding 115 ℃, were sterilized in the 5ml ampulla in 30 minutes.Treat coronary heart disease with red-rooted-salvia-root chuanxiong-rhizome azine injecta, clinical observation on the therapeutic effect is as follows:
1. object and method
1.1 object
The 50 routine coronary heart disease inpatients that will meet diagnostic criteria are divided into matched group 25 example and treatment group 25 examples at random, typical clinical manifestation is all arranged or through inspections such as electrocardiogram, ultrasoundcardiogram, coronarographies, all clarify a diagnosis.
1.2 Therapeutic Method
Two groups of cases all take nitrate esters medicine according to the state of an illness or/and calcium antagonist, G-receptor blocking agent, (development of special medicine Co., Ltd is visitd in Guizhou to treatment group at routine treatment basis upper vein instillation red-rooted-salvia-root chuanxiong-rhizome azine injecta, specification 5mI/ props up), 1 times/day, 10mI/ time) in the saline injection, 21 days is 1 course for the treatment of, totally 2 courses for the treatment of.
1.3 observation index
(1) every day the polling symptom, uncomfortable reaction is made routine electrocardiogram before and after the observation index treatment and is detected
(2) observe the inspections such as the variation of the symptoms such as its angina pectoris, attack times, blood pressure, heart rate and blood fat, blood glucose, hemorheology.
1.4 two groups of angina pectoriss improve relatively
The angina pectoris attacks situation all obviously alleviates after two groups of treatments, but treatment group is better than matched group (P＜0.05), and two groups of angina pectoriss improve relatively
Annotate: ★ and matched group compare, P＜0.05.
1.5 compare before and after two groups of electrocardiogram treatments
Two groups of patient's electrocardiograms obviously improve, but treatment group is better than matched group (P＜0.05), and two groups of ECG curative effect relatively
Annotate: ● compare P＜0.01 with matched group.
2. result
The angina pectoris attacks situation all obviously alleviates after two groups of treatments; but treatment group is better than matched group; by this result of study as can be known; the treatment group matched group that is better than evident in efficacy, and can correct preferably hemorheological abnormal change, the prompting red-rooted-salvia-root chuanxiong-rhizome azine injecta can reduce blood viscosity; blood flow rate is accelerated; thereby avoid the generation of micro-embolization and cardiovascular spasm, thereby protect blood vessel endothelium, alleviate the progress of coronary atherosclerosis.
Claims (2)
1. the preparation method of a red-rooted-salvia-root chuanxiong-rhizome azine pharmaceutical composition is characterized in that comprising the steps:
Get weight ratio and be 5: 1 Radix Salviae Miltiorrhizae, Ligusticum chuanxiong Hort, be ground into powder and cross 24 mesh sieves, put into abstraction pool, concentration be 75 ± 5% ethanol as entrainer, CO
2With entrainer respectively by CO
2Pump and entrainer pump are squeezed in the pump housing of each pump, after flow mixer mixes, flow into collection six chambeies in the extractor, after extracting pressure reaches 24-30Mpa, and extraction temperature reaches 50 ± 10 ℃, enter and begin extraction in the abstraction pool, extraction time is 1-2h, and the decompression discharging is also collected extract, is concentrated into dried with rotary evaporation, get the red-rooted-salvia-root chuanxiong-rhizome azine extract, ligustrazine content is greater than 100 μ g/g.
2. according to claim 1 the preparation method of red-rooted-salvia-root chuanxiong-rhizome azine pharmaceutical composition is characterized in that: comprise the steps:
Get weight ratio and be 5: 1 Radix Salviae Miltiorrhizae, Ligusticum chuanxiong Hort, be ground into powder and cross 24 mesh sieves, put into abstraction pool, concentration be 80% ethanol as entrainer, CO
2With entrainer respectively by CO
2Pump and entrainer pump are squeezed in the pump housing of each pump, after flow mixer mixes, flow into collection six chambeies in the extractor, after extracting pressure reaches 24Mpa, and extraction temperature reaches 50 ℃, enter and begin extraction in the abstraction pool, extraction time is 1h, and the decompression discharging is also collected extract, is concentrated into dried with rotary evaporation, get the red-rooted-salvia-root chuanxiong-rhizome azine extract, ligustrazine content is greater than 105 μ g/g.
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