CN1994403A

CN1994403A - Pharmaceutical composition for promoting blood circulation and preparation method thereof

Info

Publication number: CN1994403A
Application number: CN 200610163849
Authority: CN
Inventors: 梁大府; 李载懿; 郑萍; 史显阳; 郑明�
Original assignee: KUNMING MINGZHU HOSPITAL
Current assignee: KUNMING MINGZHU HOSPITAL
Priority date: 2006-12-26
Filing date: 2006-12-26
Publication date: 2007-07-11
Anticipated expiration: 2026-12-26
Also published as: CN100488539C

Abstract

The invention discloses a pharmaceutical pill composition for treating hyperlipemia, cardiovascular and cerebrovascular sclerosis and coronary disease, as well as the process for preparation, wherein the composition comprises the following constituents: astragalus root 6-8 parts, fleece-flower root 4-6 parts, red sage root 6-8 parts, ganoderma lucidum 3-5 parts, notoginseng 2-4 parts, rhizome of Sichuan lovage 2-4 parts, red peony root 3-5 parts, alisol 3-5 parts, haw 6-8 part, leech 2-4 parts and lotus leaves 2-40 parts.

Description

A kind of pharmaceutical composition for promoting blood circulation and preparation method thereof

Technical field

The present invention relates to a kind of pharmaceutical composition for promoting blood circulation and preparation method thereof, especially treat the pharmaceutical composition for promoting blood circulation of hyperlipemia, cerebrovascular sclerosis, coronary heart disease.

Background technology

Along with economic development, living standards of the people improve, the change of diet structure, fast pace, high efficiency working environment, several big reason that causes cardiovascular and cerebrovascular disease in recent years---hypertension, blood are sticking, blood is thick, fat, diabetes, coronary heart disease etc., obvious ascendant trend occurs in China.

According to epidemiology, sick bed and experimentation confirm that hyperlipidemia is atherosclerotic primary risk factor, with the sickness rate of coronary heart disease, cardiovascular and cerebrovascular disease direct relation are arranged; To human health, civilization forms serious restraining factors to cardiovascular and cerebrovascular disease with its high cause of the death, high disability rate, high mortality and expensive treatment cost.At present in the medicine on the market, Chinese patent medicine is suited the medicine to the illness not clear, drug effect is single, as SHUXUENING pin, fragrant red pin, thromboembolism cleansing pin, TONGXINLUO JIAONANG, Herba Erigerontis tablet, XUESAITONG JIAONANG, Radix Salviae Miltiorrhizae drop pill etc. have the effect of activating blood circulation to dissipate blood stasis, blood pressure lowering coronary dilating, and other effect is very faint: diabetes pill is that the hypoglycemic pcm of representative has blood sugar lowering, improve the symptom of thirsty, polydipsia, polyphagia, and other effect is faint; Current can blood fat reducing, and appropriate of XUEZHIKANG JIAONANG, the blood fat of curative effect certainly have the effect that spleen invigorating removes humidifying fat, and function of promoting blood circulation to disperse blood clots is arranged slightly.In the middle of the Western medicine, depressor such as various diuretic, beta receptor blocker, calcium ion antagonist, vasotonia corotation change enzyme inhibitor etc., but multi-angle produces hypotensive effect, and hypoglycemic medicine mainly contains insulin, minidiab, diamicron, metformin, acarbose etc.Lipid lowerers has lovastatin, simvastatin, gemfibrozil etc., and western medicine not only drug effect is single, and costs an arm and a leg, and side effect is big, as hypoglycemic reaction, the gastrointestinal reaction that depressor causes, and lesions of liver and kidney etc.In a word in the cardiovascular disease in recent years, most of patient all has hypertension, blood fat height, blood glucose height, combination situation that blood viscosity is big, uses present Drug therapy, need various Drug therapy sides to prove effective, and various side effect is full of contradictions.

Summary of the invention

The purpose of this invention is to provide a kind of pharmaceutical composition for promoting blood circulation and preparation method thereof, this pharmaceutical composition pill is a pure Chinese medicinal preparation, has benefiting QI for activating blood circulation, row to stagnate and to promote blood circulation, effects such as blood fat reducing, blood pressure lowering, and curative effect is good, do not increase the gastric burden after taking.

Pharmaceutical composition for promoting blood circulation provided by the present invention is by Radix Astragali 6-8 part, Radix Polygoni Multiflori 4-6 part, Radix Salviae Miltiorrhizae 6-8 part, Ganoderma 3-5 part, Radix Notoginseng 2-4 part, Rhizoma Chuanxiong 2-4 part, Radix Paeoniae Rubra 3-5 part, Rhizoma Alismatis 3-5 part, Fructus Crataegi 6-8 part, Hirudo 2-4 part, Folium Nelumbinis 2-4 part forms pill according to the prepared of traditional water pill.In preparation process, it is standby that the part medical material was directly pulverized No. 6 sieves, and part medical material water decocts and carries 2 times, and each 1 hour, the medicinal liquid of filtration simmer down to relative density d=1.08-1.10 (50 ℃), the two is sticking mutually and become ball promptly.

In preparation process, the Radix Astragali in the above-mentioned prescription, Radix Salviae Miltiorrhizae, Radix Notoginseng, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Rhizoma Alismatis powder can be broken into fine powder, cross sieve No. 6, standby, Radix Polygoni Multiflori, Ganoderma, Hirudo, Fructus Crataegi, Folium Nelumbinis are decocted with water 2 times each 1 hour, filter, merging filtrate is concentrated into relative density 1.08～1.10 (50 ℃), with the general ball of above-mentioned medicated powder, drying, polishing.

Hyperlipemia belongs to the traditional Chinese medical science " expectorant is turbid " " turbid damp " category.Because with the passing of time the foul smell of diet water paddy, stagnation turn to phlegm-damp, the stasis of blood stagnates obstructed and pathogenic.This disease is characteristics with the deficiency in origin and excess in superficiality generally, and deficiency in origin shows as the deficiency of vital energy more, especially based on the spleen deficiency of kidney-QI; Mark is real, then for water wets that cream fat changes that living expectorant is turbid, turbid damp, the stagnation of QI, blood stasis.So control with the dispel method of turbid blood stasis dispelling of benefiting QI for activating blood circulation.

Ten Herba indigoferae Pseudotinctoriae in the prescription of pharmaceutical composition for promoting blood circulation of the present invention:

1, the Radix Astragali mainly contains triterpene saponin (mainly being main component with the astragaloside), flavone compound and polysaccharide.

2, Radix Salviae Miltiorrhizae mainly contains fat-soluble diterpene quinones (TANSHINONES, cryptotanshinone etc.) and water miscible phenolic acids (Radix Salviae Miltiorrhizae acid, danshensu, caffeic acid etc.) composition.In addition, also contain compositions such as flavonoid, triterpenes and sterol.

3, Radix Notoginseng contains ginsenoside, arasaponin, flavonoid glycoside, Radix Notoginseng polysaccharide etc.

4, Rhizoma Chuanxiong mainly contains volatile oil, ferulic acid and crystallization phenolic substance etc.

5, Radix Paeoniae Rubra mainly contains peoniflorin, hydroxyl Radix Paeoniae, glycosides benzoylpaeoniflorin etc.

6, Rhizoma Alismatis contains multiple tetracyclic triterpene keto-alcohol derivant, sesquiterpenoids, cupreol and various trace elements etc.

7, ganoderan, triterpenoid compound, peptide, aminoacid, protein, adenosine, organic acid, alkaloid etc.

8, Radix Polygoni Multiflori contains anthraquinone analog compound (mainly containing emodin, chrysophanol, chrysophanic acid, physcione, physcione-8-O-β-D-glucoside etc.), stilbene glucoside, amide compound, chromone compounds, cachou extract and various trace elements etc.

9, Hirudo mainly contains protein, hirudin, aminoacid, heparin etc.

10, Fructus Crataegi mainly contains organic acid (citric acid, malic acid, succinic acid, ursolic acid, oleanolic acid, chlorogenic acid etc.) and flavone compound (hyperin, Quercetin, rutin etc.).

11, Folium Nelumbinis contains multiple alkaloid, flavonoid, organic acid, cupreol etc.

The Radix Astragali is the key medicine of QI invigorating in the side, and benefiting qi and raising yang is mended all empty deficiencies, makes the prosperous then blood of gas capable, to effect a permanent cure; Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling and battalion promote blood circulation; Two medicines share and contain blood circulation promoting and blood stasis dispelling among tonifications, are monarch drug altogether.The Radix Polygoni Multiflori invigorating the liver and kidney, benefiting essence-blood makes kidney essense vigour prosperous; Ganoderma helps the Radix Astragali, Radix Polygoni Multiflori benefiting QI and nourishing blood, strengthens healthy energy; Radix Notoginseng, Rhizoma Chuanxiong, Radix Paeoniae Rubra help Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain, eliminating stagnation, and five is ministerial drug altogether.The Rhizoma Alismatis promoting diuresis to eliminate damp pathogen, " supporting the five internal organs, physical strength profiting ", its energy of Compendium of Material Medica cloud " eliminating dampness by diuresis heat, row phlegm retention ", " book on Chinese herbal medicine covers an aromatic plant metioned in ancient books " calls its " rush down FUSHUI, going or staying is dirty "; The hawthorn digesting eliminate indigestion, blood circulation promoting and blood stasis dispelling, greasy, the meat stagnation that disappears, Tang Rong river cloud: " blood stasis dispelling blood then expectorant water disappears certainly ", phlegm retention is ruled together; Go into network with Hirudo again and search heresy, the removing blood stasis collateral dredging, the three is adjuvant drug altogether.The Folium Nelumbinis sending up the lucid YANG helps all medicines current and for making.This side's strengthening vital QI to eliminate pathogenic factors: benefiting vital QI and blood and help operation, blood circulation promoting and blood stasis dispelling and promote blood circulation, row stagnates, change turbid, blood fat reducing, full side plays benefiting QI for activating blood circulation altogether, the row turbid merit of dispelling that stagnates.

The modern pharmacological research prompting, the Radix Astragali has the blood vessel dilating blood circulation promoting, reduces effects such as viscosity of blood; Ganoderma can alleviate the formation of aorta wall atherosclerotic plaque, resists myocardial ischemia the merit of blood fat reducing again; Radix Salviae Miltiorrhizae, Radix Notoginseng, Radix Paeoniae Rubra can improve the platelet 26S Proteasome Structure and Function, improve dense, sticking, the poly-state of blood, promote the metabolism of lipid material, the blood vessel dilating blood flow increasing, and microcirculation improvement has antithrombotic, lipid-reducing function; Radix Salviae Miltiorrhizae, Radix Polygoni Multiflori, Fructus Crataegi can promote the metabolism of lipid material and suppress the interior absorption to lipid material of body, reduce the deposition of lipid material in blood vessel wall, reduce lipid material level in the blood; Rhizoma Chuanxiong can reduce TC, TG, LDL-C, rising HDL-C, improves hemorheology, suppresses platelet aggregation, the protection blood vessel wall; Rhizoma Alismatis has blood fat reducing, the formation of atherosclerosis speckle, antithrombotic function; Folium Nelumbinis can reduce triacylglycerol, beta lipoprotein cholesterol and whole blood specific viscosity, the content of rising HDL-C, ApoA; Hirudo can reduce TC, TG, thereby helps recovering the normal of blood lipid metabolism.

Avirulence composition and contemporary toxicology proved deleterious medical material during prescription was formed, and prescription is formed no eighteen incompatible medicaments, nineteen medicaments of mutual restraint incompatibility, and the flavour of a drug consumption does not surpass the drug standard regulation.

Pharmaceutical composition for promoting blood circulation toxicity test of the present invention:

Experimental animal: the ICR mice, body weight 18.5g-20.5g provides licence by zooscopy institute of unming Medical College center: SCXK (Yunnan) 2005-0008

Use medicine:, get 20g behind the porphyrize and add water to the test liquid that the 80ml mixing is 25% (W/V is in crude drug in whole 39%) with pharmaceutical composition for promoting blood circulation of the present invention.

Test method: get 22 of mices, male and female half and half are irritated stomaches three times in the filling stomach volume of the drug level with 25%, 40ml/kg one day and are given a kind of blood vessels beneficial pharmaceutical composition preparation, normally raise after the administration, observe seven days continuously.

The result: 22 mices are all not dead in seven days after administration, and outward appearance, behavioral activity, the mental status, appetite, defecation and color thereof, all normal by hair, the colour of skin, breathing, the also no abnormal secretions in oral cavity, body weight is increased to 25.8+-1.1g by 19.5+_0.5g, this result shows that a kind of pharmaceutical composition for promoting blood circulation irritates stomach and reach 30g/kg (count 46.8g/kg with crude drug in whole, be 120 times with maximal dose 15g/60kg of the clinical day for human beings) for the mice daily dose to irritate stomach and give mice and do not cause that animal acute toxicity reacts.

The composition medicine of said preparation is the medical material that Chinese Pharmacopoeia or Yunnan Province's drug standard are put down in writing, and foundation is safely and effectively arranged.

The specific embodiment

Embodiment 1, Radix Astragali 200g, Radix Salviae Miltiorrhizae 240g, Radix Polygoni Multiflori 180g, Ganoderma 140g, Radix Notoginseng 80g, Rhizoma Chuanxiong 80g, Radix Paeoniae Rubra 160g, Rhizoma Alismatis 120g, Fructus Crataegi 240g, Hirudo 100g, Folium Nelumbinis 80g.

More than ten simply, get the Radix Astragali, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Folium Nelumbinis, Radix Paeoniae Rubra, Radix Notoginseng powder and be broken into fine powder, cross sieve No. 6, standby.Surplus medicine decocts with water 2 times, and each 1 hour, filter, merging filtrate is concentrated into relative density 1.10 (50 ℃), and with the general ball of above-mentioned medicated powder, drying, 1000g is made in polishing, promptly.

Embodiment 2, Radix Astragali 280g, Radix Salviae Miltiorrhizae 240g, Radix Polygoni Multiflori 200g, Ganoderma 120g, Radix Notoginseng 80g, Rhizoma Chuanxiong 80g, Radix Paeoniae Rubra 120g, Rhizoma Alismatis 120g, Fructus Crataegi 240g, Hirudo 80g, Folium Nelumbinis 80g.

More than ten simply, get Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Ganoderma, Radix Notoginseng, Radix Paeoniae Rubra, Rhizoma Alismatis powder and be broken into fine powder, cross sieve No. 6, standby.Surplus medicine decocts with water 2 times, and each 1 hour, filter, merging filtrate is concentrated into relative density 1.10 (50 ℃), and with the general ball of above-mentioned medicated powder, drying, 1000g is made in polishing, promptly.

Embodiment 3, Radix Astragali 240g, Radix Salviae Miltiorrhizae 240g, Radix Polygoni Multiflori 160g, Ganoderma 120g, Radix Notoginseng 80g, Rhizoma Chuanxiong 80g, Radix Paeoniae Rubra 120g, Rhizoma Alismatis 120g, Fructus Crataegi 240g, Hirudo 80g, Folium Nelumbinis 80g.

More than ten simply, get the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Notoginseng, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Rhizoma Alismatis powder and be broken into fine powder, cross sieve No. 6, standby.Surplus medicine decocts with water 2 times, and each 1 hour, filter, merging filtrate is concentrated into relative density 1.08 (50 ℃), and with the general ball of above-mentioned medicated powder, drying, 1000g is made in polishing, promptly.

The clinical research scheme:

Pharmaceutical composition for promoting blood circulation of the present invention is mainly used in the treatment hyperlipemia, is oral pills.According to the requirement of the clinical research guideline of " new Chinese medicine clinical research guideline " relevant hyperlipemia of nineteen ninety-five version, draft its clinical research scheme.

The clinical implementation scheme: this product is the Chinese medicine for oral administration pill, the principle that clinical observation is followed at random, contrasted, and 70 examples are organized in treatment, matched group 50 examples; The contrast medicine is a SHUXIN JIANGZHI JIAONANG; Be 20 days the course of treatment.

Observation index:

(1) safety is observed: general health check-up project; Blood, urine, just conventional; The heart, liver, kidney function test.

(2) health giving quality is observed: symptom: above-mentioned main clinical manifestation; Body weight (once in a week); Check: lipids contents such as cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, LDL are measured.

Curative effect determinate standard

(1) produce effects: clinical symptoms, sign disappear substantially, and lipids detection reaches following any one person, and promptly TC descends 〉=20%, and TG descends 〉=40%, HDL-C rising 〉=0.26mmol/L, and HDL-C/LDL-C descends 〉=20%.

(2) effective: lipids detection reaches following any one person, promptly TC descend 〉=10% but＜20%, TG descend 〉=20% but＜40%, HDL-C risings 〉=0.104mmol/L but＜0.26mmol/L, HDL-C/LDL-C decline 〉=10% but＜20%mmol/L.

(3) invalid: treatment back symptom, sign and lipids detection do not have obvious improver.

Untoward reaction please be recorded faithfully as untoward reaction occurring.

Clinical efficacy is summed up: use a kind of blood vessels beneficial pharmaceutical composition treatment hyperlipemia 56 examples, clinical efficacy is satisfied, is summarized as follows:

With reference to treating the hyperlipemia diagnostic criteria in " new Chinese medicine clinical research guideline ": under the normal diet situation, in 2 weeks as survey for 2 times serum total cholesterols (TC) all 〉=6.0mmol/L or triglyceride (TG) 〉=1.54mmol/L or high density lipoprotein (HDL-C) male≤1.04mmol/L, women≤1.17mmol/L person, can make a definite diagnosis.

Select case 99 examples with reference to " new Chinese medicine clinical research guideline ".Age 28-65 year.Male's 58 examples, women's 41 examples.Deficiency of spleen-YANG and kidneyYANG pattern of syndrome 47 examples, qi depression to blood stasis pattern of syndrome 52 examples; The course of disease the shortest half a year, the longest 8 years.Be divided into treatment at random and organize 56 examples, matched group 43 examples.Learn to handle by statistics (P＞0.05), two groups have comparability at aspects such as age, sex, the courses of disease.

The oral pharmaceutical composition for promoting blood circulation of treatment group according to embodiment 3 preparations, 3 times/d, 5g/ time; The oral SHUXIN JIANGZHI JIAONANG of matched group, 3 times/d, 4/time.20 days is a course of treatment, judges curative effect after 2 courses of treatment.

Observation of curative effect: observation index is the fat 1 time of having a blood test in per 10 days, and result before and after the treatment relatively.

Therapeutic outcome:

After two groups of medications therapeutic outcome see the following form 1, table 2.

Table 1. liang group curative effect relatively

Group	n	Produce effects (%)	Effectively (%)	Invalid (%)	Total effective rate (%)	The P value
Group	n	Produce effects (%)	Effectively (%)	Invalid (%)	Total effective rate (%)	The P value	Treatment group matched group	56 43	36(64.3) 24(55.8)	17(30.3) 11(25.6)	3(5.4) 8(18.6)	94.6 81.4	＜0.05

Blood Lipid before and after table 2. treatment (x ± s)

Group	n		TC	TG	HDL
Group	n		TC	TG	HDL	Treatment group matched group	56 43	After treating before the preceding treatment of the treatment back treatment	6.85±0.23 5.17±0.39* 6.86±0.35 5.72±0.38	2.71±0.36 1.27±0.30* 2.80±0.28 2.46±0.37	1.02±0.29 1.47±0.24* 1.05±0.32 1.23±0.35

*P＜0.01

According to data demonstration as a result, Xuezhikang pharmaceutical composition pill has good effect for reducing fat, can effectively reduce TC, TG, and improve HDL, thereby can treat hyperlipemia, thus the protection cardiovascular and cerebrovascular vessel, an easily rate of slow down arteriosclerotic generation and reduction coronary heart disease.Said preparation is held concurrently with blood circulation promoting and blood stasis dispelling based on QI invigorating, and treating both the principal and the secondary aspects of a disease at the same time so not only obtained short term effect preferably, has also obtained gratifying late result.In the middle of the use, do not find untoward reaction, the clinical expansion applying value is arranged.

Clinical case:

Case 1: Zhang Ping, man, 38 years old, trade, build fat partially (height 1.70m, body weight 78Kg).Nearly March is felt dizzy in readme, and spiritlessness and weakness is ached all over, poor appetite.Look into: light red tongue, tongue are greasy in vain, deep-thready pulse.Lipids detection: TC 7.1mmol/L, TG 1.8mmol/L, HDL 1.02mmol/L.Diagnosis: hyperlipemia, the traditional Chinese medical science belongs to yang deficiency of spleen and stomache.Treatment: oral pharmaceutical composition for promoting blood circulation every day 3 times, each 5g serve on 2 courses of treatment (40 days).Lipids detection: TC 5.6mmol/L, TG1.48mmol/L, HDL 1.11mmol/L is normal value; And above-mentioned symptom disappears.Continue and obey 2 courses of treatment, to consolidate curative effect.Follow up a case by regular visits to after half a year, the lipids detection index is stable, and body weight alleviates (70Kg) to some extent.

Case 2: Zhou Fanghui, woman, 56 years old, teacher.It is dizzy weak that readme is felt closely over the past half year, sensation of oppression over the chest with shortness of breath, sternal rib pain.Look into: the tip of the tongue has petechia, deep and hesitant pulse.Lipids detection: TC 7.6mmol/L, TG 1.62mmol/L, HDL 0.92mmol/L.Diagnosis: hyperlipemia, the traditional Chinese medical science belongs to qi stagnation and blood stasis type.Treatment: oral pharmaceutical composition for promoting blood circulation every day 3 times, each 5g serve on 2 courses of treatment (40 days).Lipids detection: TC 5.8mmol/L, TG 1.49mmol/L, HDL 1.21mmol/L is normal value; And above-mentioned symptom disappears.Continue and obey 2 courses of treatment, to consolidate curative effect.Follow up a case by regular visits to after half a year, the lipids detection index is stable, and conscious health is good.

Claims

1, a kind of pharmaceutical composition for promoting blood circulation, it is characterized in that component: Radix Astragali 6-8 part, Radix Polygoni Multiflori 4-6 part, Radix Salviae Miltiorrhizae 6-8 part by following weight portion, Ganoderma 3-5 part, Radix Notoginseng 2-4 part, Rhizoma Chuanxiong 2-4 part, Radix Paeoniae Rubra 3-5 part, Rhizoma Alismatis 3-5 part, Fructus Crataegi 6-8 part, Hirudo 2-4 part, Folium Nelumbinis 2-4 part forms pill according to the prepared of traditional water pill.

2, a kind of preparation method of pharmaceutical composition for promoting blood circulation, it is characterized in that, it is standby that part medical material in the described component of claim 1 was directly pulverized No. 6 sieves, residue medical material water decocts to be carried 2 times, each 1 hour, filtering the simmer down to relative density is the medicinal liquid of d=1.08-1.10 (50 ℃), and the two sticking mutually and general ball, drying, polishing are promptly.

3, according to the preparation method of the described pharmaceutical composition for promoting blood circulation of claim 2, it is characterized in that, the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Notoginseng, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Rhizoma Alismatis powder in the described component of claim 1 are broken into fine powder, it is standby to cross No. 6 sieves, Radix Polygoni Multiflori, Ganoderma, Hirudo, Fructus Crataegi, Folium Nelumbinis are decocted with water 2 times, each 1 hour, filter merging filtrate, be concentrated into relative density 1.08～1.10 (50 ℃), with the general ball of above-mentioned medicated powder, drying, polishing promptly.