CN1651042A - Compound aspirin red yeast extract medicinal preparation and its application - Google Patents
Compound aspirin red yeast extract medicinal preparation and its application Download PDFInfo
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- CN1651042A CN1651042A CN 200410098435 CN200410098435A CN1651042A CN 1651042 A CN1651042 A CN 1651042A CN 200410098435 CN200410098435 CN 200410098435 CN 200410098435 A CN200410098435 A CN 200410098435A CN 1651042 A CN1651042 A CN 1651042A
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- aspirin
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- monas cuspurpureus
- cuspurpureus went
- magnesium carbonate
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Abstract
A compound medicine contains aspirin, extract of red rice, dihydroxyaluminium aminoacetate, heavy magnesium carbonate or magnesium aluminate carbonate, and medical auxiliary. Its application is also disclosed.
Description
Technical field:
The present invention relates to a kind of compound medicament composition, particularly relate to the pharmaceutical composition that contains aspirin 5mg-100mg, Monas cuspurpureus Went extract 10～1000mg, said composition also can contain dihydroxyaluminum aminoacetate 3～24mg, Heavy Magnesium Carbonate 5～44mg or hydrotalcite 15～150mg and an amount of pharmaceutically useful adjuvant.
Background technology:
Low-dosage aspirin can suppress hematoblastic release reaction (release that epinephrine, collagen, thrombin etc. cause) and aggreation (second assembles mutually).Can prolong the bleeding time in vivo, reduce thrombosis.Suppress the cholesterol biosynthesis simultaneously, can reduce low-density lipoprotein cholesterol (LDL-C) level normal and that raise.
Monas cuspurpureus Went records in the Pharmacopoeia of the People's Republic of China as Chinese crude drug, " Chinese medicine voluminous dictionary ".Describe the red song of Monas cuspurpureus Went different name, be inoculated on the rice by monascus and form through fermenting process of preparing.In recent years, relevant scholar deepens continuously to the research of Monas cuspurpureus Went both at home and abroad, has found that the effective ingredient in the Monas cuspurpureus Went mainly contains: cholesterol synthetic inhibitor (lovastatin), unsaturated fatty acids, alcohols and ester type compound, multiple pigment, material for lowering blood pressure (GABA), anti-putrefaction bacteria material (MonacolinK), the Natural antioxidant: as dimemmicac5d and flavone phenol, blood sugar lowering and other biological active substanceies that waits to identify.Wherein lovastatin content is 15～20mg/g; The unsaturated fatty acid total amount reaches more than 80%.
China starts from the eighties in last century in the research to natural Antilipemic monascus, and first has released accent fat new drug---the zhibituo sheet that the Monas cuspurpureus Went that lovastatin is arranged is the single composition buchu drugmaker.Beijing University's dimension believes that having developed with the Monas cuspurpureus Went extract that contains the lovastatin chemical compound again is the medicine of main component---XUEZHIKANG JIAONANG subsequently.
These two kinds of medicine main components are the Monas cuspurpureus Went extract of lovastatin.Have some outstanding characteristics, particularly compare with simple lovastatin, contain that Monas cuspurpureus Went has stronger blood fat reducing comprehensive therapeutic effect under the identical lovastatin dosage situation, and reduced and taken stanin fat-reducing medicament for a long time and issuable toxic and side effects, its potency ratio meets the national conditions of China.
Vast amount of clinical shows that also Monas cuspurpureus Went extract has hypercholesterolemia reducing, reduces low-density lipoprotein cholesterol, reduces serum triglycerides. reduce the remarkable comprehensive therapeutic effect of atherogenic index, high density lipoprotein increasing cholesterol and take safe, side effect is little, and can effectively treat cardiovascular and cerebrovascular diseases such as coronary heart disease, apoplexy and the disease relevant with hyperlipidemia, and as diabetes. the nephrotic syndrome and fatty liver.Be considered to when the promising blood fat reducing material of prospect.
Monas cuspurpureus Went extract has had the Duo Jia pharmaceutical factory to produce as crude drug is domestic at present.
Monas cuspurpureus Went extract is more as the method for preparing raw material of medicine, sale is also arranged on the market, the Monas cuspurpureus Went extract that the present invention uses is that dimension letter biotechnology company of Beijing University extracts the medicine material product that forms from special Chinese medicine Monas cuspurpureus Went and rice fermentation product, and its lovastatin content is 15～20mg/g; The unsaturated fatty acid total amount is more than 80%.
At clinicing aspect, be primarily aimed at simple antithrombotic at present, perhaps simple blood fat reducing, curative effect is very undesirable.Therefore, at above problem, we have developed compound aspirin red yeast extract, and this medicine contains plurality of active ingredients: aspirin and Monas cuspurpureus Went extract and dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate.Can cholesterol reducing, anti-platelet aggregation is alleviated atherosclerosis again, has multiple efficacy of drugs, is an excellent drug prescription.
Summary of the invention:
The invention provides a kind of pharmaceutical composition, contain the aspirin and the Monas cuspurpureus Went extract of effective dose in the said composition, both have synergism.Compositions of the present invention also can add dihydroxyaluminum aminoacetate and Heavy Magnesium Carbonate, or adds hydrotalcite, stimulates for gastrointestinal in order to alleviate aspirin.
Compositions of the present invention can add the appropriate amount of drug acceptable carrier when making pharmaceutical preparation.
Compositions of the present invention, it is formed preferably: aspirin, Monas cuspurpureus Went extract, appropriate amount of drug acceptable carrier.
Compositions of the present invention, it is formed preferably: aspirin, Monas cuspurpureus Went extract, dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, appropriate amount of drug acceptable carrier.
Compositions of the present invention, it is formed preferably: aspirin, Monas cuspurpureus Went extract, hydrotalcite, appropriate amount of drug acceptable carrier.
Compositions of the present invention is that the dosage form with unit dose exists, and is as being mixed with the form through any suitable administration, preferably oral.Alternatively common tablet, capsule, enteric coatel tablets, enteric coated capsule, granule, soft capsule, slow releasing tablet, slow releasing capsule, oral cavity disintegration tablet, controlled release tablet, chewable tablet, controlled release capsule, powder, suspensoid, drop pill, pill, oral liquid, drop etc.
Compositions of the present invention, can contain aspirin 5mg-100mg, Monas cuspurpureus Went extract 10～1000mg in the preparation of unit dose, if what contain dihydroxyaluminum aminoacetate 3～24mg, Heavy Magnesium Carbonate 5～44mg use is hydrotalcite, then add hydrotalcite 15～150mg and an amount of pharmaceutically useful carrier.
Pharmaceutical composition of the present invention preferably can contain the medicine of the Monas cuspurpureus Went extract of the aspirin of 5mg-100mg and 10～1000mg.
Pharmaceutical composition of the present invention preferredly can contain the aspirin of 20mg-80mg and the Monas cuspurpureus Went extract of 100～500mg.
Pharmaceutical composition of the present invention, the preferred aspirin that can contain 20mg-80mg, the Monas cuspurpureus Went extract of 100～500mg contains dihydroxyaluminum aminoacetate 6～12mg, Heavy Magnesium Carbonate 10～22mg.
Pharmaceutical composition of the present invention, the preferred aspirin that can contain 20mg-80mg, the Monas cuspurpureus Went extract of 100～500mg, 30～100mg hydrotalcite.
Dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, hydrotalcite are the medicines of the protection stomach that can buy on the market; add dihydroxyaluminum aminoacetate and Heavy Magnesium Carbonate in the compositions of the present invention or add hydrotalcite; be the effect that utilizes the magnalium chemical compound, can alleviate the aspirin active component stimulates for gastrointestinal.
The present invention also provides the method with aspirin and the medication combined treatment myocardial infarction of Monas cuspurpureus Went extract, angina pectoris and hyperlipidemia.The amount of aspirin and Monas cuspurpureus Went extract drug regimen can be 25mg/200mg, 25mg/250mg, 25mg/300mg, 40mg/200mg, 40mg/250mg, 40mg/300mg.Said composition is administered twice and is used for the treatment of myocardial infarction, angina pectoris, coronary heart disease, cerebral thrombosis, cerebral infarction, cerebral ischemia, hypercholesterolemia, mix type hypercholesterolemia, atherosclerosis, nephrotic syndrome hyperlipemia, diabetes and merges hyperlipemia etc. every day.
The present invention relates to comprise in the pharmaceutic adjuvant: the solid preparation adjuvant that filler, binding agent, disintegrating agent, lubricant etc. are commonly used, wherein filler can be selected: microcrystalline Cellulose, lactose, mannitol, calcium carbonate, starch etc.Preferred lactose.The content of filler is preferably about 5%-20% of compositions gross weight.
Binding agent preferably has the polymer of high-consistency.Can select polyvidone, methylcellulose, hydroxypropyl cellulose, hypromellose, hydroxy methocel, ethyl cellulose, gelatin, guar gum and xanthan gum etc., preferred polyvidone, and hydroxypropyl cellulose.The content of binding agent is preferably about 1-10% of compositions gross weight.
The optional damp polyvinylpolypyrrolidone of the disintegrating agent that comprises in the compositions, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, pre-gelatinized starch and corn starch etc., preferred polyvinylpolypyrrolidone.Disintegrant content is preferably about 0-5% of compositions gross weight.
The lubricant that comprises in the compositions is selected from magnesium stearate, stearic acid, Pulvis Talci, sodium lauryl sulphate and micropowder silica gel etc., preferred magnesium stearate.Lubricant content is preferably about 0.1-5% of compositions gross weight.
Framework material is selected from described in the compositions: hypromellose, acrylic resin II, ethyl cellulose, methylcellulose, sodium alginate, sodium carboxymethyl cellulose.
The present invention also provides preparation of drug combination method of the present invention: comprise aspirin, Monas cuspurpureus Went extract, dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, pharmaceutic adjuvant mix homogeneously, make preparation.Or be that binding agent is granulated with the alcoholic solution of polyvidone, add framework material and mix, further make sustained release pharmaceutical formulation again.Preparation method of the present invention can be operated according to galenic pharmacy routine techniques method.
The Monas cuspurpureus Went extract that the present invention uses is bought the dimension letter bio tech ltd in Beijing University, is the Antilipemic monascus crude drug.
Following data declaration beneficial effect of the present invention by experiment:
Drug synergism
Hematoblastic coagulation, dysbolism of blood fat are that coronary heart disease, angina pectoris, atherosclerosis and various cardiovascular and cerebrovascular disease are closely related.Therefore blood lipid regulation and anticoagulant also are the main targets for the treatment of this class disease at present.At the problems referred to above, we have developed the compound aspirin red yeast extract preparation, stimulate for gastrointestinal in order to alleviate the aspirin active component simultaneously, add to have used the magnalium compound preparation to form compound recipe.New experiment shows that these two kinds of medicine couplings also will be played the effect of prevention and minimizing to reducing thrombosis, blood fat reducing level, alleviation coronary heart disease, angina pectoris being had tangible effect to the cardiovascular and cerebrovascular vessel accident.
One at random, in the clinical trial participated in of double blinding, placebo 122 people, all patients are arteriosclerosis or myocardial infarction, be divided into 3 groups at random, give every day compound aspirin red yeast extract 6 kinds of various dose (25mg/200mg, 25mg/250mg, 25mg/300mg, 40mg/200mg, 40mg/250mg and 40mg/300mg), 2/time, Bid.Independent aspirin group (25 or 40mg), 2/time, Bid.Independent Monas cuspurpureus Went extract group (200,250,300mg), 2/time, Bid.Before treatment, serum TC, TG, LDL-C, high density lipoprotein-cholesterol are looked at 8 weeks, 6 months and 1 year in the treatment back, blood, urine, stool routine and liver, renal function are added up coronary heart disease case fatality rate, apoplexy case fatality rate in following up a case by regular visits to when finishing, and observe the untoward reaction situation.Result such as following table 1:
Table 1: compound aspirin red yeast extract compares with Monas cuspurpureus Went extract group blood fat reducing with single
Example number TC TG LDL-C HDL-C
Before the treatment
Treatment organizes 65 7.2 ± 0.8 2.8 ± 1.0 4.1 ± 0.9 0.83 ± 0.21
Matched group 57 7.1 ± 0.9 2.9 ± 1.1 3.9 ± 0.9 0.89 ± 0.24
Treatment 8 weeks of back
Treatment organizes 63 6.0 ± 0.8 2.0 ± 0.9 2.9 ± 0.9 0.87 ± 0.23
Matched group 56 6.4 ± 0.8 2.7 ± 1.1 3.6 ± 0.9 0.89 ± 0.24
Treat later six months
Treatment organizes 60 5.4 ± 0.8 1.8 ± 0.9 2.7 ± 0.7 0.92 ± 0.21
Matched group 53 6.2 ± 0.8 2.4 ± 1.1 3.4 ± 0.9 0.89 ± 0.25
Decline percentage ratio (%)
Treatment group 56-27-40-42+14
Matched group 49-14-2-2+3
Compare with the treatment group: P＜0.05; Compare between group: P＜0.05.
Follow up a case by regular visits to when finishing, the treatment group is died from coronary heart disease 1 example and is accounted for 2%; Die from apoplexy 3 examples and account for 5%.Matched group is died from coronary heart disease 6 examples and is accounted for 11%, dies from apoplexy 3 examples and accounts for 5%.Credit is analysed by statistics, and two groups coronary heart disease dies of illness to go here and there significant difference (P＜0.05).Liver, renal function before and after three groups of treatments, hematuria, the equal Non Apparent Abnormality of stool routine.
Pharmaceutical composition of the present invention can be used for treating the cardiovascular and cerebrovascular vessel thrombotic disease and comprises: myocardial infarction, angina pectoris, coronary heart disease, cerebral thrombosis, cerebral infarction, cerebral ischemia etc.Hyperlipemia: hypercholesterolemia, mix type hypercholesterolemia, atherosclerosis, nephrotic syndrome hyperlipemia, diabetes merge hyperlipemia etc.
Dosage and administration: adult's usual amounts is oral: starting dose is I, II and V, VI side, reaches therapeutic effect as 2 Zhou Houwei, rises to III, IV, VII and VIII.Every day twice, tuxedo is used.Dosage can be adjusted as required.
Prescription is formed:
Have embodiment:
Embodiment 1: the preparation ordinary tablet
| Composition | Amount % (mg/mg) | Amount/sheet (mg) |
| Aspirin | ????5.0 | ????25.0 |
| Monas cuspurpureus Went extract | ????60.0 | ????300.0 |
| Dihydroxyaluminum aminoacetate | ????1.2 | ????6.0 |
| Heavy Magnesium Carbonate | ????2.2 | ????11.0 |
| Microcrystalline Cellulose | ????23.1 | ????115.5 |
| Hydroxypropyl cellulose | ????4.0 | ????20.0 |
| Carboxymethyl starch sodium | ????3.0 | ????15.0 |
| Pulvis Talci | ????1.5 | ????7.5 |
| Total amount | About 100% | About 500 |
Preparation method: medicine and adjuvant are crossed 80 mesh sieves respectively, with aspirin, Monas cuspurpureus Went extract, dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethyl starch sodium, Pulvis Talci, and mix homogeneously, direct powder compression, promptly.
Embodiment 2: the preparation enteric coatel tablets
According to embodiment 1, prepare 1000 of common APC (Aspirin Phenacetin and Caffeine), add the enteric-coating material coating.
Prescription:
1000 effects
Hydroxypropyl methyl cellulose phthalate 37.5g coating polymer
Ethyl cellulose 6.1g film coating adjuvant
Ethanol 225ml organic solvent
Acetone 225ml organic solvent
Adopt coating pan to carry out coating
Operating condition:
Coating pan rotating speed 6～7r/min
The spraying of nozzle types depletion of QI
Shower nozzle size 0.4mm nozzle (60 ° of angles)
Spray fast 110mL/min
Fluid pressure 60～80kg/cm
2
Aerofluxus flow velocity 140～160m
3/ min
Induction air flow ratio 130～150m
3/ min; 20 ℃
40%～60% relative humidity
Coating time 30min
The coating rear panel heavily increases by 5%.
Embodiment 3:
Preparation aspirin phenacetin caffeine capsule
| Composition | Amount % (mg/mg) | Amount/grain (mg) |
| Aspirin | ????8.0 | ????40.0 |
| Monas cuspurpureus Went extract | ????60.0 | ????300.0 |
| Dihydroxyaluminum aminoacetate | ????1.2 | ????6.0 |
| Heavy Magnesium Carbonate | ????2.2 | ????11.0 |
| Microcrystalline Cellulose | ????23.1 | ????115.5 |
| Polyvidone | ????1.5 | ????7.5 |
| Cross-linked carboxymethyl cellulose | ????4.0 | ????20.0 |
| Total amount | About 100% | About 500mg |
Capsule shells------------
Preparation method: medicine and adjuvant are crossed 80 mesh sieves respectively, with aspirin, Monas cuspurpureus Went extract, dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, microcrystalline Cellulose, cross-linked carboxymethyl cellulose, mix homogeneously, polyvidone 95 alcoholic solution system soft materials with 5% sieve drying, granulate incapsulates shell.
Embodiment 4:
The two-layer slow releasing tablet of preparation aspirin phenacetin caffeine+Monas cuspurpureus Went extract
Prescription:
Slow-released part:
Every consumption
Aspirin (80 order fine powder) 50mg
Monas cuspurpureus Went extract (80 order fine powder) 200mg
Ethyl cellulose 50mg
Acrylic resin II 70mg
Pulvis Talci 6mg
Immediate release section:
Every consumption
Aspirin (80 order fine powder) 30mg
Monas cuspurpureus Went extract (80 order fine powder) 100mg
Dihydroxyaluminum aminoacetate 4mg
Heavy Magnesium Carbonate 8mg
Starch 223mg
12% starch slurry is an amount of
Pulvis Talci 6mg
Preparation method:
1) slow-releasing granules: get ethyl cellulose and acrylic resin II number the fine powder mix homogeneously, with 75% dissolve with ethanol solution, add aspirin and Monas cuspurpureus Went extract fine powder, the system soft material sieves, system wet granular, drying, the granulate that sieves, adding Pulvis Talci mixing.
2) immediate-release granules: get aspirin, Monas cuspurpureus Went extract, starch mixing, add appropriate amount of starch slurry system soft material, sieve, drying, granulate adds the Pulvis Talci mixing.
3) tabletting: immediate-release granules and slow-releasing granules are pressed into double-layer tablet.
Embodiment 5:
Preparation aspirin+Monas cuspurpureus Went extract slow releasing capsule
Prescription:
Slow-released part:
Every consumption
Aspirin (80 order fine powder) 25mg
Monas cuspurpureus Went extract (80 order fine powder) 150mg
Hypromellose 115mg
5% polyvidone, 95% alcoholic solution 3mg
Immediate release section:
Every consumption
Aspirin (80 order fine powder) 15mg
Monas cuspurpureus Went extract (80 order fine powder) 50mg
Dihydroxyaluminum aminoacetate 2mg
Heavy Magnesium Carbonate 4mg
Starch 25mg
10% starch slurry is an amount of
Pulvis Talci 4mg
Preparation method:
1) immediate release section: get aspirin, Monas cuspurpureus Went extract, dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, starch mixing, add appropriate amount of starch slurry system soft material, cross 18 order nylon mesh, the system wet granular, 60～70 ℃ of dryings, granulate sieves.
2) slow-released part: get aspirin, Monas cuspurpureus Went extract, hypromellose mixing, 95% alcoholic solution system soft material with 5% is crossed 18 order nylon mesh, the system wet granular, and drying, granulate sieves.
3) load capsule:, load in capsule shells with the abundant mix homogeneously of immediate-release granules, slow-releasing granules and Pulvis Talci.
Embodiment 6: the preparation ordinary tablet
| Composition | Amount/sheet (mg) |
| Aspirin | ????25.0 |
| Monas cuspurpureus Went extract | ????300.0 |
| Hydrotalcite | ????50.0 |
| Microcrystalline Cellulose | ????115.5 |
| Hydroxypropyl cellulose | ????20.0 |
| Carboxymethyl starch sodium | ????15.0 |
| Pulvis Talci | ????7.5 |
Preparation method: medicine and adjuvant are crossed 80 mesh sieves respectively, with aspirin, Monas cuspurpureus Went extract, hydrotalcite, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethyl starch sodium, Pulvis Talci, and mix homogeneously, direct powder compression, promptly.
Claims (10)
1, a kind of pharmaceutical composition contains the Monas cuspurpureus Went extract and the aspirin of effective dose.
2, the pharmaceutical composition of claim 1 also contains the magnalium chemical compound, and described magnalium chemical compound is selected from dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, hydrotalcite.
3, the pharmaceutical composition of claim 1 is medicinal oral preparation.
4, the pharmaceutical composition of claim 3, described medicinal oral preparation are tablet, capsule, enteric coatel tablets, enteric coated capsule, granule, soft capsule, slow releasing tablet, slow releasing capsule, oral cavity disintegration tablet, controlled release tablet, chewable tablet, controlled release capsule, powder, suspensoid, drop pill, pill, oral liquid or drop.
5, the pharmaceutical composition of claim 3 wherein contains aspirin 5mg-100mg, contains Monas cuspurpureus Went extract 10-1000mg.
6, the pharmaceutical composition of claim 3 also contains dihydroxyaluminum aminoacetate 3～24mg, Heavy Magnesium Carbonate 5～44mg.
7, the pharmaceutical composition of claim 3 wherein contains aspirin 5mg-100mg, contains Monas cuspurpureus Went extract 10-1000mg, contains dihydroxyaluminum aminoacetate 3～24mg, Heavy Magnesium Carbonate 5～44mg.
8, the pharmaceutical composition of claim 7 contains
Aspirin 25.0mg
Monas cuspurpureus Went extract 300.0mg
Dihydroxyaluminum aminoacetate 6.0mg
Heavy Magnesium Carbonate 11.0mg
9, the pharmaceutical composition of claim 7 contains
Aspirin 40.0mg
Monas cuspurpureus Went extract 300.0mg
Dihydroxyaluminum aminoacetate 6.0mg
Heavy Magnesium Carbonate 11.0mg
10, the pharmaceutical composition of claim 7 also contains the medicine acceptable carrier.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410098435 CN1651042A (en) | 2004-12-10 | 2004-12-10 | Compound aspirin red yeast extract medicinal preparation and its application |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410098435 CN1651042A (en) | 2004-12-10 | 2004-12-10 | Compound aspirin red yeast extract medicinal preparation and its application |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1651042A true CN1651042A (en) | 2005-08-10 |
Family
ID=34869495
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410098435 Pending CN1651042A (en) | 2004-12-10 | 2004-12-10 | Compound aspirin red yeast extract medicinal preparation and its application |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1651042A (en) |
-
2004
- 2004-12-10 CN CN 200410098435 patent/CN1651042A/en active Pending
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