CN101028319B - Chinese-medicine compound preparation against coronary heart disease and its production - Google Patents

Abstract

A Chinese medicine in the form of dripping pill for preventing and treating coronary heart disease is proportionally prepared from Chuan-xiong rhizome, acanthopanax bark, natural borneol and polyethanediol through extracting from Chuan-xiong rhizome and acanthopanax bark in alcohol, concentrating, mixing with natural borneol and fused polyethanediol, stirring, and shaping.

Description

Prevent and treat the compound Chinese medicinal preparation and the preparation method of coronary heart disease

Technical field

The present invention relates to a kind of pharmaceutical composition of preventing and treating coronary heart disease, specifically be a kind of be the compound Chinese medicinal preparation of preventing and treating coronary heart disease and the preparation method of feedstock production with the Chinese herbal medicine.

Background technology

The coronary heart disease serious threat mankind's life and health is utilized Chinese patent medicine to prevent and treat coronary heart disease and is constantly obtained development and application, and obtains the reliable effect that attracts people's attention.In preventing and treating the compound Chinese medicinal preparation of coronary heart disease, ordinary practice is used as medicine Borneolum Syntheticum as " messenger drug ".The Chinese patent medicine that existing market is sold, all use Borneolum Syntheticum persons substantially adopt synthetic borneol, as market " FUFANG DANSHEN PIAN " salable, " SUXIAO JIUXIN WAN ", " FUFANG DANSHEN DIWAN " and " Subing drop pills " etc.The main chemical compositions of synthetic borneol is " Borneolum Syntheticum " and " isoborneol ", and the two almost respectively accounts for half.Experimental results show that the big (LD of isoborneol toxicity ₅₀Be 830mg/kg); Borneolum Syntheticum is divided into left-handed Borneolum Syntheticum (natural Blumeae preparatum Tabellae, LD ₅₀Be 3720mg/kg) and dextro Borneolum Syntheticum (be called natural Broneolum Syntheticum or borneol, LD ₅₀Be 4960mg/kg).Therefore, external medical administration section (as western countries such as Australia) thinks that " isoborneol " has certain toxicity in the synthetic borneol, does not accept to contain the compound Chinese patent medicine of synthetic borneol.

Chinese patent 85105829 discloses a kind of " SUXIAO JIUXIN WAN manufacturing process ", and it is that Rhizoma Chuanxiong extract and group's medicine are added fused Polyethylene Glycol, regulates dropping liquid and quantitatively splashes in the liquid paraffin, collects the choosing grain and forms.

Chinese patent 1113785 discloses a kind of " Radix Et Caulis Acanthopanacis Senticosi injection lyophilized injectable powder and used Radix Et Caulis Acanthopanacis Senticosi extract production technology ", and it is with the Radix Et Caulis Acanthopanacis Senticosi decocting, concentrates, and uses ethanol precipitation, decolours with absorption with macroporous adsorbent resin.Contain Radix Et Caulis Acanthopanacis Senticosi extract 80-120 milliliter in 1000 milliliters of transfusion liquids, be used for the treatment of cardiovascular disease such as cerebral infarction, coronary heart disease.

Chinese patent 1077125 discloses " a kind of production method for the treatment of the medicine of coronary heart disease ", be with Radix Notoginseng, Radix Ginseng, Sanguis Naemorhedi pulverize, in the medicinal liquid of adding by 13 flavor decocting for Chinese herbal medicine gained such as Semen Cassiae, Radix Polygoni Multiflori, Rhizoma Chuanxiong, Radix Ophiopogonis, Fructus Citri Sarcodactylis, Rhizoma Cyperi (system), the Radix Astragali, Flos Carthami, Radix Puerariae, Sargassum, Radix Salviae Miltiorrhizae, Ganoderma, Pu Huang, granulate oven dry behind the mixing.

That Chinese patent 1498645 discloses is a kind of " treatment cerebral thrombosis and coronary heart disease Chinese medicinal capsule and manufacture method thereof ", and this Chinese medicinal capsule is to make powder by Pheretima, eupolyphage sece steleophaga, Scorpio, Scolopendra, Rhizoma Typhonii, Agkistrodon, Rhizoma Gastrodiae, Ganoderma, Bombyx Batryticatus, Hirudo, system Squama Manis, Moschus, Radix Ginseng Rubra, Radix Curcumae, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Rhizoma Corydalis to incapsulate and form.

Chinese patent 1517122 discloses a kind of " medicine and the preparation method of treatment coronary heart disease ", with Herba Portulacae, Rhizoma Homalomenae, Radix Salviae Miltiorrhizae, Lignum Dalbergiae Odoriferae, and Rhizoma Chuanxiong, Borneolum Syntheticum and Flos Carthami according to the nature and flavor characteristics of each flavor medicine, extract its active ingredient, make the preparation of taking convenience.

These prescriptions, preparation all have certain effect to treatment coronary heart disease, but, their prescription Chinese crude drug kind is a lot, many persons reach more than ten kind near 20 kinds of raw materials, curing the disease to the patient like this makes troubles and economically burden, before 2005 simultaneously, the Borneolum Syntheticum of use is a synthetic borneol, and certain toxicity is arranged.

Summary of the invention

The present invention is exactly in order to solve the problem of preventing and treating of coronary heart disease, and a kind of better preventive and therapeutic effect that has is provided, and adopts the few compound Chinese medicinal preparation of preventing and treating coronary heart disease of medical material kind.

The present invention simultaneously also provides the preparation method of said preparation.

Compound Chinese medicinal preparation of preventing and treating coronary heart disease of the present invention is to be made by following raw materials in weight portion: Rhizoma Chuanxiong 10-100 part, Radix Et Caulis Acanthopanacis Senticosi 100-300 part, natural Broneolum Syntheticum 1-5 part, Polyethylene Glycol 3-17 part.

Described compound Chinese medicinal preparation of preventing and treating coronary heart disease, the weight portion proportioning of its various raw materials are Rhizoma Chuanxiong 20-70 part, Radix Et Caulis Acanthopanacis Senticosi 100-200 part, natural Broneolum Syntheticum 2-4 part, Polyethylene Glycol 6-12 part.

Described compound Chinese medicinal preparation of preventing and treating coronary heart disease, the weight portion proportioning of its various raw materials is: 33 parts of Rhizoma Chuanxiongs, 100 parts of Radix Et Caulis Acanthopanacis Senticosis, 2.2 parts of natural Broneolum Syntheticums, 8 parts of Polyethylene Glycol.

Described compound Chinese medicinal preparation of preventing and treating coronary heart disease, the weight ratio of its various raw materials is: Rhizoma Chuanxiong extract 5-10 part, Radix Et Caulis Acanthopanacis Senticosi extract 5-10 part, natural Broneolum Syntheticum 3-15 part, Polyethylene Glycol 10-50 part.

Described compound Chinese medicinal preparation of preventing and treating coronary heart disease, the weight proportion of its various raw materials is: 5 parts of Rhizoma Chuanxiong extracts, 5 parts of Radix Et Caulis Acanthopanacis Senticosi extracts, 6.6 parts of natural Broneolum Syntheticums, 28 parts of Polyethylene Glycol.

Used Rhizoma Chuanxiong extract is ligustrazine phosphate or synthetic ligustrazine among the present invention; Radix Et Caulis Acanthopanacis Senticosi extract is selected the " extractum that Chinese pharmacopoeia is recorded in 2005 for use; Natural Broneolum Syntheticum (being dextro Borneolum Syntheticum) is selected " kind that Chinese pharmacopoeia is recorded in 2005 for use.

Prevent and treat the preparation method of the compound Chinese medicinal preparation of coronary heart disease, form by following steps:

A. get Rhizoma Chuanxiong 10-100 part, Radix Et Caulis Acanthopanacis Senticosi 100-300 part pulverizing back adding ethanol by prescription, after the reflux, extract,, be condensed into extractum, standby;

B. by recipe quantity extractum, natural Broneolum Syntheticum 1-5 part are joined in the fused Polyethylene Glycol of 3-17 part, fully stir into uniform medicine slurry;

C. the medicine slurry is inserted in the insulation hopper of drop pill machine, make drop pill.

Described preparation method of preventing and treating the compound Chinese medicinal preparation of coronary heart disease, form by following steps:

A. by recipe quantity Rhizoma Chuanxiong extract 5-10 part, Radix Et Caulis Acanthopanacis Senticosi extract 5-10 part, natural Broneolum Syntheticum 3-15 part are joined in the fused Polyethylene Glycol of 10-50 part, fully stir into uniform medicine slurry;

B. the medicine slurry is inserted in the insulation hopper of drop pill machine, make drop pill.

Drop pill machine of the present invention is commercially available machine.

The present invention can also be a percutaneous absorption patch except that drops.

Its consumption of the present invention is adult 1-5 every day gram.

Pharmacodynamics test of the present invention:

Purpose: Model Rats with Acute Myocardial Ischemia due to the employing pituitrin is an index with st section and changes in heart rate, observes the ability that this medicine resists myocardial ischemia.

1. experiment material

1.1 medicine

1.1.1 No. 1 side of sample, colourless transparent liquid, its effective ingredient are single natural Broneolum Syntheticum;

1.1.2 No. 2 sides of sample, milk yellow fluid paste, its effective ingredient are Radix Salviae Miltiorrhizae+Radix Notoginseng+natural Broneolum Syntheticum.

1.1.3 No. 3 sides of sample, colourless transparent liquid, its effective ingredient are single synthetic borneol.

1.1.4 No. 4 sides of sample, shallow ember is thick liquid slightly, and its effective ingredient is Rhizoma Chuanxiong+Radix Et Caulis Acanthopanacis Senticosi+natural Broneolum Syntheticum.

1.1.5 No. 5 sides of sample, thick liquid, its effective ingredient are Rhizoma Chuanxiong+Radix Et Caulis Acanthopanacis Senticosi+synthetic borneol.

1.1.6 SUXIAO JIUXIN WAN is commercially available, is ground into fine powder with mortar during use.

Said medicine requires before the administration to prepare with distilled water all in 5 ℃ of preservations of refrigerator in proportion.

1.1.7 posterior pituitary injection, 6 units/ml, Shanghai No.1 Bio-Chemical Pharmacetical Industry Co., Ltd's product, batch number: 030805.Be mixed with 0.5 unit/ml with normal saline during administration and use liquid.

1.2 experimental apparatus

Japanese photoelectricity SB-613D electrocardiograph.

1.3 laboratory animal

Male SD kind is a rat, and about body weight 280g, two grades, the department of the Chinese Academy of Sciences of Department Of Medicine, Peking University's laboratory animal section provides, the licence numbering: SCXK (capital) 2002-001,

1.4 animal feed

Pellet is kept in the growth of large and small Mus, and Beijing section Austria feed corporation,Ltd that pulls together produces, product license number: (joining) word is raised No. 238 in the capital, and the capital is moving is betrothed to (2000) No. 015.

2. experimental technique

Choose in advance with the responsive qualified rat of posterior pituitary injection intravenous injection screening, be divided into 7 groups at random, every group 13, be myocardial infarction and ischemia model matched group (irritate stomach and give distilled water 10ml/kg), 1-5 number side's group of investigational agent sample (being 1% content), the SUXIAO JIUXIN WAN group (17/kg), rat is parallel tests with each group, every day all with 10ml/kg dosage gastric infusion once, for three days on end, after the last administration 1 hour, use pentobarbital sodium 40mg/kg intraperitoneal injection of anesthesia respectively, dorsal position is fixed, and measures standard I I lead electrocardiogram with electrocardiograph through pin type subintegumental electrode, normal voltage 10mm/mV, chart speed 50mm/s.Subsequently, tail vein constant speed injection posterior pituitary injection 0.5 unit/1ml/kg, to cause Model Rats with Acute Myocardial Ischemia, measure simultaneously behind the quiet notes at once, the electrocardiogram 5,10,15,20,30,40,50,60,90,120,180,240 and 300 seconds the time, organize a t test statistics and handle and a variance analysis causing st section rate of change (%) before and after the myocardial ischemia, heart rate (changing difference %).

3. result of the test and discussion

After the injection posterior pituitary injection, model control group st section is raised very soon, peaks in the time of 5 seconds, reduces gradually subsequently, and is lower than baseline.The st section amplitude of variation of 1-5 number side's group of investigational agent sample and SUXIAO JIUXIN WAN group is all to some extent less than model control group, and the prompting said medicine has function of resisting myocardial ischemia in various degree.Statistical result shows, No. 1, No. 4 and No. 5 medicine sample effects are comparatively outstanding, with matched group relatively, significant difference (p＜0.05) is arranged, see Table 1.Wherein, it is minimum that No. 4 side group st sections are raised, and effect is better than SUXIAO JIUXIN WAN.After causing myocardial ischemia, each organizes heart rate all slowing down gradually in various degree, with model control group relatively, No. 2 are less with No. 5 side's group changes in heart rate, see Table 2.

Each index of analysis-by-synthesis is in the situation of change of different time points, and is comparatively stable with the effect of No. 4 sides.

According to the introduction of related side's science of law, behind the quiet notes lobus posterior hypophyseos injection of rat 5-7 unit/kg, the st section was raised (it is positive to surpass 0.1mV) before this, and the t ripple is low flat subsequently, can have two-way or inversion, simultaneously decreased heart rate.Through trial test and primary dcreening operation, in conjunction with sample single dose group situation, the quiet notes posterior pituitary injection of this test and Selection 5 units/kg, it is unlikely too serious that the st section is raised, and is beneficial to observe more meticulously, quantitatively the drug effect characteristics.To relatively being arranged, specific ischemia index (st section and changes in heart rate) organizes a t check and a variance statistical analysis.

Though the medical material kind by above test the present invention usefulness as can be seen is less, has good curative effect equally, reaches the purpose of curing the disease, if take at premorbid, the outbreak of energy prevention of cardiac.Adopted natural Broneolum Syntheticum simultaneously, reduced toxicity, taken safer.

The specific embodiment

Embodiment 1:

With adding 75% alcohol reflux after 1 kilogram of Rhizoma Chuanxiong, 3 kilograms of pulverizing of Radix Et Caulis Acanthopanacis Senticosi 12 hours, filter, filtrate recycling ethanol is condensed into extractum, and is standby.Get natural Broneolum Syntheticum 66 grams and above-mentioned extractum mix homogeneously, add in the Polyethylene Glycol of fused 250 grams, fully stir into uniform medicine slurry.The medicine that stirs is starched the insulation hopper of putting into the drop pill machine, make drop pill.

Embodiment 2:

Ligustrazine phosphate 500 gram, Radix Et Caulis Acanthopanacis Senticosi 500 grams, natural Broneolum Syntheticum 660 grams are added in the fused 2800 gram Polyethylene Glycol, stir, the medicine slurry that stirs is put into the insulation hopper of drop pill machine, make drop pill.

Claims (7)

1. a compound Chinese medicinal preparation of preventing and treating coronary heart disease is characterized in that it being to be made by following raw materials in weight portion: Rhizoma Chuanxiong 10-100 part, Radix Et Caulis Acanthopanacis Senticosi 100-300 part, natural Broneolum Syntheticum 1-5 part, Polyethylene Glycol 3-17 part.

2. compound Chinese medicinal preparation of preventing and treating coronary heart disease according to claim 1, the weight portion proportioning that it is characterized in that its various raw materials are Rhizoma Chuanxiong 20-70 part, Radix Et Caulis Acanthopanacis Senticosi 100-200 part, natural Broneolum Syntheticum 2-4 part, Polyethylene Glycol 6-12 part.

3. compound Chinese medicinal preparation of preventing and treating coronary heart disease according to claim 1 is characterized in that the weight portion proportioning of its various raw materials is: 33 parts of Rhizoma Chuanxiongs, 100 parts of Radix Et Caulis Acanthopanacis Senticosis, 2.2 parts of natural Broneolum Syntheticums, 8 parts of Polyethylene Glycol.

4. compound Chinese medicinal preparation of preventing and treating coronary heart disease according to claim 1 is characterized in that the weight proportion of its various raw materials is: Rhizoma Chuanxiong extract 5-10 part, Radix Et Caulis Acanthopanacis Senticosi extract 5-10 part, natural Broneolum Syntheticum 3-15 part, Polyethylene Glycol 10-50 part.

5. compound Chinese medicinal preparation of preventing and treating coronary heart disease according to claim 1 is characterized in that the weight proportion of its various raw materials is: 5 parts of Rhizoma Chuanxiong extracts, 5 parts of Radix Et Caulis Acanthopanacis Senticosi extracts, 6.6 parts of natural Broneolum Syntheticums, 28 parts of Polyethylene Glycol.

6. preparation method of preventing and treating the compound Chinese medicinal preparation of coronary heart disease is characterized in that being made up of following steps:

A. get Rhizoma Chuanxiong 10-100 part, Radix Et Caulis Acanthopanacis Senticosi 100-300 part pulverizing back adding ethanol by prescription, after the reflux, extract,, be condensed into extractum, standby;

B. by recipe quantity extractum, natural Broneolum Syntheticum 1-5 part are joined in the fused Polyethylene Glycol of 3-17 part, fully stir into uniform medicine slurry;

C. the medicine slurry is inserted in the insulation hopper of drop pill machine, make drop pill.

7. preparation method of preventing and treating the compound Chinese medicinal preparation of coronary heart disease according to claim 6 is characterized in that being made up of following steps:

A. by recipe quantity Rhizoma Chuanxiong extract 5-10 part, Radix Et Caulis Acanthopanacis Senticosi extract 5-10 part, natural Broneolum Syntheticum 3-15 part are joined in the fused Polyethylene Glycol of 10-50 part, fully stir into uniform medicine slurry;

B. the medicine slurry is inserted in the insulation hopper of drop pill machine, make drop pill.