CN1660321A - Medicinal preparation of extractive from compound aspirin and rice fermentred with red yeast - Google Patents

Medicinal preparation of extractive from compound aspirin and rice fermentred with red yeast Download PDF

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Publication number
CN1660321A
CN1660321A CN2004101040411A CN200410104041A CN1660321A CN 1660321 A CN1660321 A CN 1660321A CN 2004101040411 A CN2004101040411 A CN 2004101040411A CN 200410104041 A CN200410104041 A CN 200410104041A CN 1660321 A CN1660321 A CN 1660321A
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China
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aspirin
monas cuspurpureus
cuspurpureus went
hepatic
capsule
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CN2004101040411A
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Chinese (zh)
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鄂滟
蔡金巧
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Beijing Fukangren Bio Pharm Tech Co Ltd
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Beijing Fukangren Bio Pharm Tech Co Ltd
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Abstract

A medicine contains aspirin, red koji extrat, liver-protecting medicine, dihydroxyaluminium aminoacetate, heavy magnesium carbonate and/or magnesium aluminate carbonate. A packing box is also disclosed, which contains 60 tablets of red koji extract and 60 tablets of aspirin.

Description

Compound aspirin red yeast extract medicinal preparation and application thereof
Technical field:
The present invention relates to a kind of compound medicament composition, particularly relate to and contain aspirin 5mg-100mg, Monas cuspurpureus Went extract 10~500mg, hepatic 5-500mg, said composition and also can contain dihydroxyaluminum aminoacetate 3~33mg, Heavy Magnesium Carbonate 5~44mg or hydrotalcite 15~150mg and an amount of pharmaceutically useful adjuvant.
The invention still further relates to a kind of packing box, in 60 of 60 of 60 of Monas cuspurpureus Went extracts, the aspirin of effective dose and at least a hepatics are arranged.
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, as diabetes.The nephrotic syndrome and fatty liver.Be considered to promising blood fat reducing material.
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 present at clinicing aspect, be primarily aimed at simple antithrombotic, perhaps simple blood fat reducing, curative effect is very undesirable, and adopt the patient of Monas cuspurpureus Went extract treatment to have serum glutamic pyruvic transminase slightly to raise by chance, both ALT/AST surpassed upper limits of normal 3 times (0.06%) and creatine phosphokinase slightly raises (0.12%), can slowly fall the level to the medication after the drug withdrawal after rise.Therefore, the transaminase of active hepatitis or unknown cause rising is the contraindication of such medicine.Excessive drinking and careful such medicine of using of patient of hepatitis history is arranged.From reducing aspects such as low density lipoprotein, LDL, treatment coronary heart disease, prevention cardiovascular event, the medicine that does not still have other classification can replace such medicine at present.
Therefore, at above problem, we have developed compound aspirin red yeast extract, and this medicine contains plurality of active ingredients: aspirin, Monas cuspurpureus Went extract, hepatic and dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate.Can cholesterol reducing, anti-platelet aggregation is alleviated atherosclerosis again, and can liver function protecting, has multiple efficacy of drugs, is an excellent drug prescription.
Summary of the invention:
The invention provides a kind of pharmaceutical composition, the aspirin and Monas cuspurpureus Went extract and at least a hepatic that contain effective dose in the said composition, hepatic is selected from: bifendate, Malotilate, adenosine triphosphate, inosine, glucuronolatone, diisopropylamine dichloroacetate, multivitamin, compositions of the present invention, also can contain dihydroxyaluminum aminoacetate and Heavy Magnesium Carbonate, or hydrotalcite, stimulate for gastrointestinal in order to alleviate aspirin.
Compositions of the present invention, be that dosage form with unit dose exists, exist with unit dosage form, be oral pharmaceutical preparation, be selected from tablet, capsule, enteric coatel tablets, enteric coated capsule, soft capsule, slow releasing tablet, slow releasing capsule, controlled release tablet, controlled release capsule, powder, oral cavity disintegration tablet or drop pill.
Compositions of the present invention, if what can contain in the preparation of unit dose that aspirin 5mg-100mg, Monas cuspurpureus Went extract 10~500mg, hepatic 5-500mg, said composition can contain also that dihydroxyaluminum aminoacetate 3~33mg, 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 aspirin of 25mg-50mg, the Monas cuspurpureus Went extract of 100~400mg, the hepatic of 5-500mg.
Pharmaceutical composition of the present invention preferredly can contain the aspirin of 25mg~50mg, the Monas cuspurpureus Went extract of 100~400mg, the hepatic of 12.5~500mg, 3~33mg dihydroxyaluminum aminoacetate, 5~44mg Heavy Magnesium Carbonate.
Pharmaceutical composition of the present invention preferredly can contain the aspirin of 25mg~40mg and Monas cuspurpureus Went extract, bifendate 12.5~100mg or Malotilate 50~200mg or glucuronolatone 10~500mg or diisopropylamine dichloroacetate 10~100mg or adenosine triphosphate 7.5~50mg or inosine 15~50mg or the vitamin B of 200~300mg 11~100mg, vitamin C 10~500mg, vitamin e1 0~500mg or wherein combination, 6~22mg dihydroxyaluminum aminoacetate, 5~22mg Heavy Magnesium Carbonate of several hepatics.
Dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, hydrotalcite are the medicines of the protection gastric mucosa 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 of the stimulation of aspirin active component for gastrointestinal tract mucosa.
The preparation of unit dose of the present invention refers to the per unit preparation, as every of tablet, and capsular every etc.
The present invention also provides the method with aspirin, Monas cuspurpureus Went extract medicine and hepatic therapeutic alliance myocardial infarction, 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.
In the medicine acceptable auxiliary of the present invention, filler can be selected: microcrystalline Cellulose, lactose, mannitol, calcium carbonate, starch etc.
Binding agent preferably has the polymer of high-consistency.Can select polyvidone, methylcellulose, hydroxypropyl cellulose, hypromellose, hydroxy methocel, ethyl cellulose, starch slurry etc., preferred polyvidone and hydroxypropyl cellulose.
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.
The lubricant that comprises in the compositions is selected from magnesium stearate, stearic acid, Pulvis Talci, sodium lauryl sulphate and micropowder silica gel etc.
Framework material is selected from described in the compositions: hypromellose, acrylic resin II, ethyl cellulose, methylcellulose, sodium alginate, sodium carboxymethyl cellulose.
The enteric coatings material comprises: cellulose acetate phthalate ester, hydroxypropyl methyl cellulose phthalate, enteric solubility acrylic resin I, II, III number etc.
The present invention also provides preparation of drug combination method of the present invention: can adopt direct powder compression can adopt wet granulation again.Enteric coated preparation or slow releasing preparation can make at ordinary tablet or capsule outsourcing film-coat.Slow releasing preparation also can add framework material and adopt common process to make.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.
The present invention also provides a kind of packing box, it is characterized in that, include the Monas cuspurpureus Went extract medicine, aspirin and a kind of hepatic, the Monas cuspurpureus Went extract medicine, aspirin and hepatic are separately packaged, be placed in the described packing box, the Monas cuspurpureus Went extract medicine, aspirin and hepatic exist with unit dosage form, and described unit dosage form is selected from tablet, capsule, enteric coatel tablets, enteric coated capsule, soft capsule, slow releasing tablet, slow releasing capsule, controlled release tablet, controlled release capsule, powder, oral cavity disintegration tablet or drop pill.
Following data declaration beneficial effect of the present invention by experiment:
Drug synergism
The compound aspirin red yeast extract preparation of our exploitation is primarily aimed at platelet aggregation, dysbolism of blood fat problem in coronary heart disease, angina pectoris, atherosclerosis and the various cardiovascular and cerebrovascular disease.The influence that serum transaminase is raise for the component for reducing blood fat of intervening in the Monas cuspurpureus Went extract simultaneously, alleviating the aspirin active component stimulates for gastrointestinal, adds to have used transaminase lowering medicine, magnalium compound preparation to form compound recipe.New experiment shows that this several drugs coupling has tangible effect to minimizing thrombosis, blood fat reducing level, liver function protecting, alleviation coronary heart disease, angina pectoris, also will play the effect of prevention and minimizing to the cardiovascular and cerebrovascular vessel accident.
One at random, in the clinical trial participated in of double blinding, placebo 1200 people, we are example with the aspirin red yeast extract bifendate, illustrate that the several drugs use in conjunction has synergism.All patients are cardiovascular and cerebrovascular vessel thrombotic disease such as arteriosclerosis, coronary heart disease or myocardial infarction, be divided into 3 groups at random, give every day the compound aspirin red yeast extract bifendate 6 kinds of various dose (25/200/25mg, 25/250/25mg, 25/300/25mg, 40/200/25mg, 40/250/25mg and 40/300/25mg), 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, AST/ALT, 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: the compound aspirin red yeast extract bifendate compares with Monas cuspurpureus Went extract group blood fat reducing with single
The example number ????TC ??????TG ????LDL-C ?????HDL-C
Treat 8 all treatment group treatment of control group treatment group later six months control group decline percentage treatment group control groups after the front treatment group treatment of control group ?600 ?600 ? ?592 ?597 ? ?580 ?586 ?(%) ?580 ?580 ?7.5±0.4 ?7.5±0.6 ? ?5.9±0.6 ?6.5±0.7 ? ?5.5±0.9 ?6.3±0.6 ? ?-30 ?-18 ? ?3.2±0.9 ?3.0±0.3 ? ?2.1±0.8 ?2.6±1.3 ? ?1.9±0.7 ?2.5±1.2 ? ?-41 ?-6 ? ??4.4±1.2 ??3.5±0.8 ? ??3.0±0.9 ??3.7±0.6 ? ??2.8±0.9 ??3.3±1.1 ? ??-43 ??-5 ? ?0.86±0.33 ?0.80±0.19 ? ?0.85±0.25 ?0.86±0.22 ? ?0.89±0.26 ?0.88±0.25 ? ?+15 ?+4
Compare with the treatment group: P<0.05; Compare between group: P<0.05.
Follow up a case by regular visits to when finishing, credit is analysed by statistics, three groups on the coronary heart disease case fatality rate, reduce low-density lipoprotein cholesterol, serum total cholesterol, triglyceride, high density lipoprotein increasing etc. relatively, significant difference (P<0.05) is arranged.The compound preparation group relatively has remarkable advantages with respect to independent medication matched group, shows that aspirin and Monas cuspurpureus Went extract two medical instruments have collaborative blood fat reducing effect.And the independent Monas cuspurpureus Went extract group of ratio that serum transaminase raises is for being 2.3%, and the ratio of compound preparation group serum transaminase rising is respectively 0.7%, and both compare has tangible statistical significance (P<0.05).Renal function before and after three groups of treatments, hematuria, the equal Non Apparent Abnormality of stool routine do not have other any untoward reaction yet.Also explanation adding bifendate can reduce serum transaminase in blood fat reducing, and liver function protecting reduces adverse effect.This test proves that fully the compound preparation that hepatic several drugses such as Monas cuspurpureus Went extract, aspirin and bifendate are formed can increase clinical efficacy, has synergism.
For the synergism of several drugs can be described more, we are example with the aspirin red yeast extract Malotilate, another at random, in the clinical trial participated in of double blinding, placebo 1000 people, all patients are cerebral infarction, coronary heart disease or myocardial infarction cardiovascular and cerebrovascular vessel thrombotic disease, be divided into 3 groups at random, give every day the compound aspirin red yeast extract Malotilate 6 kinds of various dose (25/200/100mg, 25/250/100mg, 25/300/100mg, 40/200/100mg, 40/250/100mg and 40/300/100mg), 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, AST/ALT, highdensity 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.Test method is the same, and is concrete
Result such as following table 2:
Table 2: the compound aspirin red yeast extract Malotilate compares with Monas cuspurpureus Went extract group blood fat reducing with single
The example number ?????TC ????TG ????LDL-C ?????HDL-C
Treat 8 all treatment group treatment of control group treatment group later six months control group decline percentage treatment group control groups after the front treatment group treatment of control group ? ?500 ?500 ? ?496 ?492 ? ?480 ?486 (%) ?480 ?480 ? ??7.2±0.5 ??7.0±0.7 ? ??5.8±0.2 ??6.6±0.7 ? ??5.2±0.8 ??6.3±0.6 ? ??-32 ??-16 ? ?3.3±0.8 ?3.2±0.4 ? ? ?2.0±0.5 ?2.8±1.2 ? ?1.7±0.5 ?2.9±1.0 ? ?-44 ?-9 ? ??4.5±1.1 ??3.3±1.2 ? ??3.2±0.8 ??3.6±0.5 ? ??2.4±0.9 ??3.2±1.5 ? ??-40 ??-8 ? ??0.85±0.33 ??0.83±0.20 ? ??0.85±0.25 ??0.90±0.18 ? ??0.83±0.20 ??0.91±0.18 ? ??+17 ??+4
Compare with the treatment group: P<0.05; Compare between group: P<0.05.
Follow up a case by regular visits to when finishing renal function before and after three groups of treatments, hematuria, the equal Non Apparent Abnormality of stool routine.Credit is analysed by statistics, and the compound preparation group relatively aspect reduction low-density lipoprotein cholesterol, serum total cholesterol, the triglyceride, has remarkable advantages (P<0.05) with respect to independent medication matched group.Show that two kinds of medicines of Monas cuspurpureus Went extract and aspirin can increase curative effect each other, have collaborative blood fat reducing effect.And the independent Monas cuspurpureus Went extract group of ratio that serum transaminase raises is 2.6%.And the ratio that compound preparation group serum transaminase raises to be respectively be 0.5%; both compare has tangible statistical significance (P<0.05); be illustrated in hepatics such as adding Malotilate in the compound preparation; can make this compound preparation simultaneously at blood fat reducing; transaminase lowering; liver function protecting is avoided side effects of pharmaceutical drugs.This test proves that again aspirin, Monas cuspurpureus Went extract and hepatic drug combination can increase clinical efficacy, have synergism.
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 IV, V side, reaches therapeutic effect as 2 Zhou Houwei, rises to III and VI.Every day twice, tuxedo is used.Dosage can be adjusted as required.Prescription is formed:
Figure A20041010404100101
Figure A20041010404100102
Figure A20041010404100103
????(mg)
Monas cuspurpureus Went extract (mg) ??200 ??250 ??300 ??200 ??250 ??300
The dihydroxyaluminum aminoacetate Heavy Magnesium Carbonate ??6 ??11 ??6 ??11 ??6 ??11 ??6 ??11 ??6 ??11 ??6 ??11
Malotilate ??100 ??100 ??100 ??100 ??100 ??100
Specific embodiment
Embodiment 1:
Prescription: 1000
Monas cuspurpureus Went extract 300g
Aspirin 20g
Bifendate 25g
Dihydroxyaluminum aminoacetate 6g
Heavy Magnesium Carbonate 11g
Microcrystalline Cellulose 105g
Carboxymethyl starch sodium 20g
Polyvinylpyrrolidone 8g
Micropowder silica gel 4g
Magnesium stearate 2g
Preparation method: medicine and adjuvant are crossed 80 mesh sieves respectively, take by weighing recipe quantity Monas cuspurpureus Went extract, aspirin, bifendate, dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, microcrystalline Cellulose, carboxymethyl starch sodium (2/3), mix homogeneously, polyvinylpyrrolidone aqueous solution system soft material with 10%, cross 16 mesh sieves, dry, granulate adds residue (1/3) carboxymethyl starch sodium, micropowder silica gel, magnesium stearate, and direct compression promptly.
Embodiment 2: preparation Monas cuspurpureus Went extract+aspirin+Malotilate Film coated tablets.
Prescription:
1000
Monas cuspurpureus Went extract 250g
Aspirin 25g
Dihydroxyaluminum aminoacetate 6g
Heavy Magnesium Carbonate 11g
Malotilate 100g
Microcrystalline Cellulose 67.5g
Cross-linking sodium carboxymethyl cellulose 20g
10% starch slurry is an amount of
Micropowder silica gel 5g
Magnesium stearate 2.5g
Preparation method: medicine and adjuvant are crossed 80 mesh sieves respectively, take by weighing recipe quantity Monas cuspurpureus Went extract, aspirin, dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, Malotilate, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose (2/3), mix homogeneously, starch slurry system soft material with 10%, cross 16 mesh sieves, dry, granulate, behind adding residue cross-linking sodium carboxymethyl cellulose, micropowder silica gel, the magnesium stearate mix homogeneously, tabletting.With the tablet bag film-coat that makes promptly.
Embodiment 3: preparation Monas cuspurpureus Went extract+aspirin+adenosine triphosphate disodium salt capsule
Prescription:
1000
Monas cuspurpureus Went extract 200g
Aspirin 40g
Dihydroxyaluminum aminoacetate 6g
Heavy Magnesium Carbonate 11g
Adenosine triphosphate disodium salt 15g
Microcrystalline Cellulose 84g
Polyvinylpyrrolidone 5g
Capsule shells
Preparation method: medicine and adjuvant are crossed 80 mesh sieves respectively, take by weighing recipe quantity Monas cuspurpureus Went extract, aspirin, dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, adenosine triphosphate disodium salt, microcrystalline Cellulose, mix homogeneously, polyvinylpyrrolidone 75% alcoholic solution system soft material with 5%, cross 16 mesh sieves, drying, 14 mesh sieve granulate, in drug particles filling and capsule shells, promptly.
Embodiment 4: preparation Monas cuspurpureus Went extract+aspirin+adenosine triphosphate disodium salt enteric coatel tablets
Prescription:
1000
Monas cuspurpureus Went extract 200g
Aspirin 25g
Dihydroxyaluminum aminoacetate 6g
Heavy Magnesium Carbonate 11g
Adenosine triphosphate disodium salt 20g
Microcrystalline Cellulose 80g
Carboxymethyl starch sodium 14g
Starch slurry is an amount of
Magnesium stearate 2g
Micropowder silica gel 3.6g
Preparation method: medicine and adjuvant are crossed 80 mesh sieves respectively, take by weighing recipe quantity Monas cuspurpureus Went extract, aspirin, dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, adenosine triphosphate disodium salt, microcrystalline Cellulose, carboxymethyl starch sodium (2/3), mix homogeneously, starch slurry system soft material with 8%, sieve drying, granulate, add residue carboxymethyl starch sodium, magnesium stearate, micropowder silica gel, direct compression promptly.Enteric coated.
The configuration of enteric liquid is as follows:
Prescription:
1000 effects
Hydroxypropyl methyl cellulose phthalate 28.7g coating polymer
Ethyl cellulose 5.4g film coating adjuvant
Ethanol 200ml organic solvent
Acetone 200ml 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
Embodiment 5: preparation Monas cuspurpureus Went extract+aspirin+inosine sheet.
Prescription:
1000
Monas cuspurpureus Went extract 200g
Aspirin 25g
Dihydroxyaluminum aminoacetate 6g
Heavy Magnesium Carbonate 11g
Inosine 150g
Microcrystalline Cellulose 110g
Polyvidone 8g
Cross-linking sodium carboxymethyl cellulose 20g
Aspartame 2.5g
Flavoring orange essence 2.5g
Magnesium stearate 2g
Micropowder silica gel 5g
Preparation method: medicine and adjuvant are crossed 80 mesh sieves respectively, take by weighing recipe quantity Monas cuspurpureus Went extract, aspirin, dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, inosine, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose (2/3), aspartame, flavoring orange essence, mixing, polyvidone aqueous solution system soft material with 10%, cross 16 mesh sieves, drying, granulate, add residue cross-linking sodium carboxymethyl cellulose, magnesium stearate, micropowder silica gel, direct powder compression promptly.

Claims (10)

1, a kind of pharmaceutical composition contains Monas cuspurpureus Went extract, aspirin and at least a hepatic of effective dose.
2, the pharmaceutical composition of claim 1, wherein hepatic is selected from: bifendate, Malotilate, adenosine triphosphate disodium salt, inosine, glucuronolatone, diisopropylamine dichloroacetate or vitamin.
3, the pharmaceutical composition of claim 1, described Monas cuspurpureus Went extract are selected from existing national standard medicine " Xuezhikang " or " zhibituo ".
4, 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.
5, the pharmaceutical composition of claim 1, exist with unit dosage form, be oral pharmaceutical preparation, be selected from tablet, capsule, enteric coatel tablets, enteric coated capsule, soft capsule, slow releasing tablet, slow releasing capsule, controlled release tablet, controlled release capsule, powder, oral cavity disintegration tablet or drop pill.
6, the pharmaceutical composition of claim 1, contain the Monas cuspurpureus Went extract of 10~500mg, the aspirin of 5mg~100mg and the hepatic of effective dose, the hepatic of described effective dose, for bifendate is 12.5~300mg, and Malotilate is 50~500mg, and glucuronolatone is 10~500mg, diisopropylamine dichloroacetate is 10~100mg, adenosine triphosphate is 7.5~100mg, and inosine is 7.5~100mg, vitamin B 1Be that 1~100mg, vitamin C are that 10~500mg, vitamin E are 10~500mg.
7, the pharmaceutical composition of claim 5 also contains effective dose dihydroxyaluminum aminoacetate and Heavy Magnesium Carbonate, perhaps contains the effective dose hydrotalcite, and the dihydroxyaluminum aminoacetate of described effective dose is 3~33mg, and Heavy Magnesium Carbonate is 5~44mg, and hydrotalcite is 15~150mg.
8, the pharmaceutical composition of claim 6, in the unit dose, the hepatic that contains Monas cuspurpureus Went extract 100~400mg, aspirin 25~50mg and effective dose, the hepatic of described effective dose is 12.5~75mg for bifendate, Malotilate is 200~500mg, glucuronolatone is 100~500mg, and diisopropylamine dichloroacetate is 100~100mg, and adenosine triphosphate disodium salt is 7.5~50mg, inosine is 15~50mg, vitamin B 1Be that 1~80mg, vitamin C are that 100~500mg, vitamin E are 10~400mg.
9, the pharmaceutical composition of claim 6 also contains dihydroxyaluminum aminoacetate 6~22mg and Heavy Magnesium Carbonate 11~22mg or contains hydrotalcite 15~30mg.
10, a kind of packing box, it is characterized in that, include the Monas cuspurpureus Went extract medicine, aspirin and a kind of hepatic, the Monas cuspurpureus Went extract medicine, aspirin and hepatic are separately packaged, be placed in the described packing box, the Monas cuspurpureus Went extract medicine, aspirin and hepatic exist with unit dosage form, and described unit dosage form is selected from tablet, capsule, enteric coatel tablets, enteric coated capsule, soft capsule, slow releasing tablet, slow releasing capsule, controlled release tablet, controlled release capsule, powder, oral cavity disintegration tablet or drop pill.
CN2004101040411A 2004-12-31 2004-12-31 Medicinal preparation of extractive from compound aspirin and rice fermentred with red yeast Pending CN1660321A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102976962A (en) * 2012-11-20 2013-03-20 万红贵 L-ornithine-aspirin double salt and its preparation method and use

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102976962A (en) * 2012-11-20 2013-03-20 万红贵 L-ornithine-aspirin double salt and its preparation method and use
CN102976962B (en) * 2012-11-20 2015-02-04 南京工业大学 L-ornithine-aspirin double salt and its preparation method and use

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