CN101766683A - Salvia dispersible tablet and application thereof - Google Patents
Salvia dispersible tablet and application thereof Download PDFInfo
- Publication number
- CN101766683A CN101766683A CN200810205102A CN200810205102A CN101766683A CN 101766683 A CN101766683 A CN 101766683A CN 200810205102 A CN200810205102 A CN 200810205102A CN 200810205102 A CN200810205102 A CN 200810205102A CN 101766683 A CN101766683 A CN 101766683A
- Authority
- CN
- China
- Prior art keywords
- effective site
- sage root
- red sage
- fat
- soluble effective
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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- 238000002360 preparation method Methods 0.000 claims abstract description 54
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 26
- 239000004375 Dextrin Substances 0.000 claims abstract description 23
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- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 15
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明公开了一种丹参分散片，其含有25～50重量份的丹参有效部位组合物和75～50重量份的辅料；辅料包括崩解剂20％～75％，填充剂24％～79％，润滑剂0.7％～1％；所述的崩解剂包括下述中的一种或多种：交联聚乙烯吡咯烷酮、低取代羟丙甲纤维素、羧甲基淀粉钠、交联羧甲基纤维素钠、羟丙基淀粉和微粉硅胶；所述的填充剂包括下述中的一种或多种：微晶纤维素、乳糖、淀粉、山梨醇和糊精；所述的润滑剂包括下述中的一种或多种：硬脂酸镁、微粉硅胶和滑石粉。本发明还公开了其在制备治疗冠心病和/或心绞痛药物中的应用。本发明的丹参分散片是首次研发制得的丹参单方制剂，且其服用方便、释放速度快、吸收快、生物利用度高、顺应性好。The invention discloses a Danshen dispersible tablet, which contains 25-50 parts by weight of a composition of effective parts of Danshen and 75-50 parts by weight of auxiliary materials; the auxiliary materials include 20%-75% of disintegrants and 24%-79% of fillers , lubricant 0.7% to 1%; the disintegrants include one or more of the following: cross-linked polyvinylpyrrolidone, low-substituted hypromellose, sodium carboxymethyl starch, cross-linked carboxymethyl sodium cellulose, hydroxypropyl starch and micropowder silica gel; the filler includes one or more of the following: microcrystalline cellulose, lactose, starch, sorbitol and dextrin; the lubricant includes the following One or more of the above: magnesium stearate, micronized silica gel and talc. The invention also discloses its application in the preparation of medicines for treating coronary heart disease and/or angina pectoris. The Danshen dispersible tablet of the present invention is a single preparation of Danshen developed for the first time, and has the advantages of convenient administration, fast release, fast absorption, high bioavailability and good compliance.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation and application thereof, be specifically related to a kind of dispersion tablet of red sage root and application thereof.
Background technology
Radix Salviae Miltiorrhizae is a traditional Chinese medical science drug for invigorating blood circulation and eliminating stasis commonly used, has effects such as blood circulation promoting and blood stasis dispelling, menstruction regulating and pain relieving, heat clearing and tranquillizing.Studies show that of modern pharmacology; Radix Salviae Miltiorrhizae has many-sided pharmacological action; as have and increase coronary flow, reduce myocardial excitability and conductivity; myocardial ischemic injury is produced protective effect; also have microcirculation improvement, antiplatelet aggregation and thrombosis, reduce the effect of blood viscosity, and anti-inflammation and antioxidation; improve renal function, improve the learning and memory effect and the protective effect of cerebral tissue ischemical reperfusion injury.
The Radix Salviae Miltiorrhizae chemical constituent mainly comprises diterpene quinone, phenolic acid compound and Radix Salviae Miltiorrhizae lactone and alkaloids etc.Diterpene quinone can be divided into two classes according to structural framework, promptly the tanshinone of o-quinone type and paraquinoid enumerate ketone, what wherein content was higher is Tanshinone I I A, cryptotanshinone, the red ketone I of ginseng, dihydrotanshinone I etc.; Phenolic acid compound comprises danshensu, protocatechualdehyde, protocatechuic acid and salvianolic acid A, B, C, D, E, F, G, H, I, J etc.; wherein salvianolic acid B is the main component of phenolic acid compound in the Radix Salviae Miltiorrhizae, have reduce myocardial oxygen consumption, anticoagulation and antithrombotic, ischemia resisting damage, improve renal function, have the liver injury protection effect, promote fibrinolysis, effect such as control neurotoxicity.It is reported that fat-soluble diterpene quinones composition is antimicrobial effective site, water miscible depside chemical compound is the effective site of Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling.Radix Salviae Miltiorrhizae can be used for treating the thoracic obstruction due to the blood stasis impatency clinically, and disease sees that chest pain, sore spot are fixed, body of the tongue is dark violet; Also can be used for angina pectoris and see above-mentioned patient.
Angina pectoris is a kind of caused by the temporary transient hypoxic-ischemic of cardiac muscle, serves as the clinical syndrome of main performance with ictal chest pain or chest discomfort.Coronary heart disease is because its sickness rate height, the mortality rate height, serious harm human healthy, thereby b referred to as " the first human killer ".The average at home prevalence of coronary heart disease is about 6.49%, and prevalence increases with advancing age, and degree also increases the weight of with the growth at age, and China's Incidence of CHD in recent years obviously raises.There is data to show, from beginning in 40 years old, every increase by 10 years old, prevalence of coronary heart disease increases 1 times.Male 50 years old, women are after 60 years old, and the coronary atherosclerosis development is rapider, and the danger of same myocardial infarction also increases with advancing age, also are the common a kind of cardiovascular disease of old people therefore.World Health Organization (WHO) is classified as follows coronary heart disease: the heart failure in primary cardiac all standing, angina pectoris, myocardial infarction, the ischemic heart desease, arrhythmia; Angina pectoris belongs to Chinese medicine " thoracic obstruction ", " chest pain " category.In the treatment as single imitate not good enoughly with the medication of doctor trained in Western medicine coronary dilating, in recent years aspect such patient of treatment, when finding to give low dose of Western medicine coronary dilating medicine treatment, and, can receive good result based on tcm syndrome differentiation and treatment.
Therefore very necessary at the research of treatment treating coronary heart disease and angina pectoris, be the focus of domestic and international drug research always.
Dispersible tablet (dispersible tablets) claims water dispersion tablet (waterdispersible tablets) again, be meant meet water rapidly disintegrate form the tablet of even stickiness suspension, it has the advantage of solid and liquid preparation concurrently, and overcome both deficiency, compare with common solid preparation, dispersible tablet have meet water rapidly disintegrate form even suspension, the medicine stripping is rapid, absorption is fast, bioavailability is high, take advantages such as easy to carry, can swallow, chew, contain and suck or with taking after the aqueous dispersion, the patient who especially is fit to old, the children and the difficulty of swallowing is oral.Compare with liquid preparation, it is good that dispersible tablet has a medicine stability, packed and transported and preserve advantage easily.Particularly the production technology of dispersible tablet and equipment do not have specific (special) requirements, are a kind of novel troches with DEVELOPMENT PROSPECT, are developed rapidly in recent years.Along with the development of medical industry, the manned various countries of Western medicine dispersible tablet pharmacopeia, " British Pharmacopoeia " began to record 3 kinds of dispersible tablets such as aspirin in 1980, and " The People's Republic of China's pharmacopeia " version in 2000 begins to record dispersible tablet.But dispersible tablets of Chinese medicine is actually rare in various countries' pharmacopeia, especially preparation technology's disunity still, 2005 editions " The People's Republic of China's pharmacopeia " regulation, dispersible tablet requires in the 100ml water of (20 ± 1) ℃, jolting 3min, all disintegrate is also by No. two sieves, and relative and general formulation has improved bioavailability of medicament so greatly.
Radix Salviae Miltiorrhizae Tabellae is 2005 editions Cheng Fang that Pharmacopoeia of People's Republic of China is incorporated into own forces, and its function is a blood circulation promoting and blood stasis dispelling, is used for the thoracic obstruction due to the blood stasis impatency, and disease sees that chest pain, sore spot are fixed, body of the tongue is dark violet; Angina pectoris is seen above-mentioned patient.We carry out patent retrieval to the research of relevant dispersion tablet of red sage root, find that research is less, only relevant for the patent of red sage compound dispersible tablet aspect, and do not retrieve the relevant patent of Radix Salviae Miltiorrhizae folk prescription dispersible tablet.Therefore the research to dispersion tablet of red sage root is very necessary, dispersion tablet of red sage root compare with ordinary tablet have absorb fast, bioavailability is high, takes onset rapidly at acute attack stages such as coronary heart disease, angina pectoriss, effectively disease controlling; Dispersion tablet of red sage root is compared with effervescent tablet to have and is not needed gas-producing disintegrant, do not need the gentle relative humidity in control room, and production cost is low; It is various that dispersion tablet of red sage root and drop pill are compared the mode of taking, and disintegrate is faster, the bioavailability height, and production equipment is identical with conventional tablet; Dispersion tablet of red sage root compare with oral liquid have production, carry, convenient transportation and advantage such as stable.
Summary of the invention
Technical problem to be solved by this invention has provided a kind of brand-new dispersion tablet of red sage root and application thereof, dispersion tablet of red sage root of the present invention is to research and develop the Radix Salviae Miltiorrhizae single preparations of ephedrine that makes first, and its taking convenience, rate of release fast, absorb fast, bioavailability is high, compliance good.
The present invention relates to a kind of dispersion tablet of red sage root, it contains active component of red sage root compositions and adjuvant, and the parts by weight of wherein said active component of red sage root compositions are 25～50 parts; The parts by weight of described adjuvant are 75～50 parts; Adjuvant comprises disintegrating agent 20%～75%, filler 24%～79%, lubricant 0.7%～1%; Preferable, disintegrating agent is 25.5%～50%, filler is 49%～73%; Above-mentioned percentage ratio is each composition shared mass percent in adjuvant;
Described active component of red sage root compositions can be this based composition of this area routine, for comprising the compositions of fat-soluble effective site and water solublity effective site, preferable, fat-soluble effective site is fat-soluble diterpene quinone, water solublity effective site is the water-soluble phenolic acid compounds;
Described disintegrating agent comprises one or more in the following compositions: crospolyvinylpyrrolidone, low-substituted hydroxypropyl methylcellulose, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, hydroxypropyl starch and micropowder silica gel; Better, it comprises in the following compositions one or more: crospolyvinylpyrrolidone, low-substituted hydroxypropyl methylcellulose, carboxymethyl starch sodium and micropowder silica gel;
Described filler comprises one or more in the following compositions: microcrystalline Cellulose, lactose, starch, sorbitol and dextrin; Better, it comprises microcrystalline Cellulose and/or lactose.
Described lubricant comprises one or more in the following compositions: magnesium stearate, micropowder silica gel and Pulvis Talci; Better, it comprises magnesium stearate and/or micropowder silica gel.
Above-mentioned disintegrating agent, filler and lubricant are the interpolation adjuvant in the dispersion tablet of red sage root, and they and active component of red sage root compositions are mixed with together and absorb the Radix Salviae Miltiorrhizae oral dispersable tablet fast, that bioavailability is high.
Among the present invention, some material can have two kinds of functions concurrently, both can serve as disintegrating agent as micropowder silica gel, can serve as lubricant again.
Among the present invention, described active component of red sage root compositions can adopt the extracting method of this area routine to prepare, propose the extracting method preparation that combines as red rooted salvia being carried out alcohol extraction with water, wherein alcohol extraction can be adopted and reflux or percolation, and water is carried can adopt decoction, stir dipping or microwave extraction method.
Take water carried with pure extracting method and combine, can guarantee that fat-soluble diterpene quinone of Radix Salviae Miltiorrhizae and water-soluble phenolic acid compounds all can effectively propose, thereby improve the drug effect of dispersion tablet of red sage root treatment cardiovascular and cerebrovascular disease.
Among the present invention, it is to stir in 80～90 ℃ the solvent to extract that the preferable employing of described stirring infusion process impregnated in temperature with medical material, and the advantage of this extracting method is can guarantee under the prerequisite of abundant effective component extracting, makes macromole impurity proposition such as polysaccharide less; Described microwave extraction method is to utilize microwave energy to improve a kind of new technique of extraction efficiency; its advantage is: because extraction conditions has in short-term, characteristic such as quick; thereby in leaching process, can effectively protect active component; be particularly suitable for the extraction of thermal sensitivity composition; in addition, this technology also has the extraction efficiency height, the active component purity height that obtains, with short production cycle, energy savings, advantage such as reduce cost.
Therefore, active component of red sage root preparation of compositions method of the present invention is preferable comprises the following step: the first step: the extraction of fat-soluble effective site of Radix Salviae Miltiorrhizae and water solublity effective site; Second step: active component of red sage root preparation of compositions: fat-soluble effective site of Radix Salviae Miltiorrhizae and water solublity effective site are mixed and can be made.
Wherein, method in described each step and condition all can be the conventional method and the condition of this area, and preferable methods and condition are as follows:
In the first step, the fat-soluble effective site of described Radix Salviae Miltiorrhizae can be made by following any one method:
(1), ethanol reflux extraction: red rooted salvia is refluxed in ethanol, filters then, with filtrate concentrating get final product the fat-soluble effective site medicinal liquid of Radix Salviae Miltiorrhizae;
(2), the ethanol percolate extraction method: with the red rooted salvia ethanol percolation, dipping is collected percolate, will ly concentrate get final product the fat-soluble effective site medicinal liquid of Radix Salviae Miltiorrhizae;
Described salvia-soluble effective site can be made by following any one method:
(1), decoction is extracted: the medicinal residues after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted decoct with water, and filter, and concentrate, and get salvia-soluble effective site medicinal liquid;
(2), stir dipping and extract: get medicinal residues after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted and add water and stir dipping, filter, concentrate, salvia-soluble effective site medicinal liquid;
(3), microwave extraction: with water is solvent, and the medicinal residues after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted carry out microwave extraction, filter, and concentrate, and get salvia-soluble effective site medicinal liquid;
In second step, described active component of red sage root preparation of compositions method is preferable comprises the following step: fat-soluble effective site medicinal liquid of Radix Salviae Miltiorrhizae and salvia-soluble effective site medicinal liquid that the first step is obtained merge, add conventional diluent, mixing, dry getting final product.
More than each method be existing method, each actual conditions all can be normal condition, preferred especially following concrete grammar of the present invention and condition:
Better as described below of the step of described ethanol reflux extraction:
Get red rooted salvia, use mass concentration 85～95% alcohol refluxs 1～2 time, each consumption is 6～8 times of medical material weight, return time 1～2 hour filters merging filtrate, filtrate recycling ethanol gets the fat-soluble effective site medicinal liquid of Radix Salviae Miltiorrhizae (measure down in 65 ℃, relative density is 1.02～1.08);
Better as described below of the step of described ethanol percolate extraction method:
Get red rooted salvia, with mass concentration 85～95% ethanol percolations, consumption is 10～12 times of medical material weight, floods 12 hours, collects percolate, and medicinal liquid reclaims ethanol and gets the fat-soluble effective site medicinal liquid of Radix Salviae Miltiorrhizae (measure down in 65 ℃, relative density is 1.02～1.08);
Better as described below of the step that described decoction is extracted:
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted decoct with water 1～2 time, each 0.5～1.5 hour, each water consumption is 10～12 times of medical material weight, filters, and being concentrated into relative density is the salvia-soluble effective site medicinal liquid of 1.02～1.08 (measuring down in 65 ℃);
Better as described below of the step that described stirring dipping extracts:
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted add water stirring dipping, water is heated to 80～90 ℃ to be extracted, extract 1～2 time, the each extraction 1～2 hour, the consumption of each water is 10～12 times of medical material weight, filter, being concentrated into relative density is the salvia-soluble effective site medicinal liquid of 1.02～1.08 (measuring down in 65 ℃).
Better as described below of the step of described microwave extraction method:
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted are that solvent adopts microwave extraction with water, pre-soaking 90～120 minutes in water earlier, carry out microwave exposure and extraction 1～2 time then, each exposure time is 8～12 minutes, each water consumption is 10～12 times of medical material weight, microwave output power is 500～650 watts, collects filtrate, and being concentrated into relative density is the salvia-soluble effective site medicinal liquid of 1.02～1.08 (measuring down in 65 ℃);
Better as described below of described active component of red sage root preparation of compositions method:
Fat-soluble effective site medicinal liquid of Radix Salviae Miltiorrhizae that the first step is made and salvia-soluble effective site medicinal liquid merge, and add diluent calcium sulfate and dextrin, mixing, and spray drying again, promptly; Wherein, the ratio of calcium sulfate and dextrin is 2: 1～1.5: 1, and red rooted salvia weight is calcium sulfate and the total consumption of dextrin 18～22 times.
Among the present invention, also can contain some additives of this area routine in the described dispersion tablet of red sage root, as correctives and/or coloring agent.
Among the present invention, described dispersion tablet of red sage root can be prepared by the existing conventional method, carries out tabletting as the granule that adopts active component of red sage root compositions and adjuvant mixture to make, or adopts the mix powder of active component of red sage root compositions and adjuvant to carry out tabletting.Preferable methods and condition are as follows: get 25～50 parts of active component of red sage root compositionss, 75～50 parts of adjuvants, with sieve mixing three times of 100 mesh sieves, the gained mixture is that wetting agent carries out wet granulation with mass concentration 85～95% ethanol with them, 45～50 ℃ of dryings, granulate promptly gets granule.
The invention further relates to the application of above-mentioned dispersion tablet of red sage root in preparation treatment coronary heart disease and/or angina drug.
Among the present invention; the inventor has not only carried out strict quality to the dispersion tablet of red sage root intermediate; measured the characteristic of granule or powder body; but also dispersion tablet of red sage root hardness, dispersing uniformity have been measured; and adopt the HPLC method that water soluble ingredient salvianolic acid B in the dispersible tablet has been carried out assay; effectively control the quality of intermediate and finished product, finally obtained safe, effective, the controlled treating coronary heart disease and angina pectoris that is used for the treatment of.
The present invention is also with particulate flowability, and the dispersing uniformity of tablet and hardness are that index detects dispersion tablet of red sage root of the present invention, and the result shows and meets the requirement of 2005 editions Pharmacopoeias of People's Republic of China to dispersible tablet.
Dispersion tablet of red sage root of the present invention can suitably be selected dosage according to patient age, sex and other condition and symptom.Usually oral clinical recommended dose can be: be equivalent to the active component of red sage root compositions 28.5～75.9mg/kg/ days.
Among the present invention, described relative density is the density of water in 4 ℃ to be used as 1 use, and the density of another kind of material is divided by with it and is obtained.
Except that specified otherwise, raw material that the present invention relates to and reagent are all commercially available to be got.
Positive progressive effect of the present invention is:
(1) dispersion tablet of red sage root of the present invention is to research and develop the Radix Salviae Miltiorrhizae single preparations of ephedrine that makes first, and its taking convenience, rate of release are soon, absorption is fast, bioavailability is high, compliance good.
(2) the preferred active component of red sage root preparation of compositions of the present invention method technology is simple, energy consumption is low, be easy to industrialization.In preparation active component of red sage root compositions process of the present invention, the inventor fully takes into account the comprehensive pharmacological action of effective part group in red sage, made active component composition can embody comprehensively opposed polarity component in the red rooted salvia in conjunction with drug effect.
The specific embodiment
Further specify the present invention with embodiment below, but the present invention is not limited.
Embodiment 1 active component of red sage root preparation of compositions
Get the 1Kg red rooted salvia, use mass concentration 85% alcohol reflux 1 time, consumption is 8 times of medical material weight, and return time 2 hours filters, and filtrate recycling ethanol obtains the fat-soluble effective site of Radix Salviae Miltiorrhizae to the 2.1Kg medicinal liquid, and 65 ℃ are measured relative densities is 1.08.
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted decoct with water 1 time, and 0.5 hour time, water consumption is 12 times of medical material weight, filters, and is concentrated into the 3.2Kg medicinal liquid, gets salvia-soluble effective site, and 65 ℃ are measured relative densities is 1.08.
Fat-soluble effective site of above-mentioned Radix Salviae Miltiorrhizae and salvia-soluble effective site are merged, add calcium sulfate 32g and dextrin 16g mixing, spray drying promptly gets the active component of red sage root compositions.
Embodiment 2 active component of red sage root preparation of compositions
Get the 1Kg red rooted salvia, use mass concentration 95% alcohol reflux 2 times, each consumption is 6 times of medical material weight, and return time 1 hour filters, and filtrate recycling ethanol obtains the fat-soluble effective site of Radix Salviae Miltiorrhizae to the 2.9Kg medicinal liquid, and 65 ℃ are measured relative densities is 1.02.
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted decoct with water 2 times, and each 1.5 hours, each water consumption was 10 times of medical material weight, filters, and is concentrated into the 3.8Kg medicinal liquid, gets salvia-soluble effective site, and 65 ℃ are measured relative densities is 1.02.
Fat-soluble effective site medicinal liquid of above-mentioned Radix Salviae Miltiorrhizae and salvia-soluble effective site filtrate are merged, add calcium sulfate 32g and dextrin 16g mixing, spray drying promptly gets the active component of red sage root compositions.
Embodiment 3 active component of red sage root preparation of compositions
Get the 1Kg red rooted salvia, use mass concentration 90% alcohol reflux 1 time, each consumption is 7 times of medical material weight, and return time 1.5 hours filters, and filtrate recycling ethanol obtains the fat-soluble effective site of Radix Salviae Miltiorrhizae to the 2.2Kg medicinal liquid, and 65 ℃ are measured relative densities is 1.06.
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted decoct with water 1 time, and 1 hour time, water consumption is 11 times of medical material weight, filters, and is concentrated into the 3.2Kg medicinal liquid, gets salvia-soluble effective site, and 65 ℃ are measured relative densities is 1.05.
Fat-soluble effective site medicinal liquid of above-mentioned Radix Salviae Miltiorrhizae and salvia-soluble effective site filtrate are merged, add calcium sulfate 32g and dextrin 16g mixing, spray drying promptly gets the active component of red sage root compositions.
Embodiment 4 active component of red sage root preparation of compositions
Get red rooted salvia 1Kg, with mass concentration 85% ethanol percolation, consumption is 12 times of medical material weight, floods 12 hours, collects percolate, and medicinal liquid reclaims ethanol to the 1.5Kg medicinal liquid, obtains the fat-soluble effective site of Radix Salviae Miltiorrhizae, and 65 ℃ are measured relative density is 1.08.
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted add water stirring dipping 1 time, water is heated to 80 ℃ extracts, and extract 2 hours, water consumption is 10 times of medical material weight, filters, and is concentrated into the 2.5Kg medicinal liquid, get salvia-soluble effective site, 65 ℃ are measured relative densities is 1.04.
Fat-soluble effective site medicinal liquid of above-mentioned Radix Salviae Miltiorrhizae and salvia-soluble effective site filtrate are merged, add calcium sulfate 32g and dextrin 16g mixing, spray drying promptly gets the active component of red sage root compositions.
Embodiment 5 active component of red sage root preparation of compositions
Get red rooted salvia 1Kg, with mass concentration 90% ethanol percolation, consumption is 11 times of medical material weight, floods 12 hours, collects percolate, and medicinal liquid reclaims ethanol to the 1.7Kg medicinal liquid, obtains the fat-soluble effective site of Radix Salviae Miltiorrhizae, and 65 ℃ are measured relative density is 1.08.
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted add water stirring dipping 1 time, water is heated to 85 ℃ extracts, and extract 2 hours, water consumption is 11 times of medical material weight, filters, and is concentrated into the 2.7Kg medicinal liquid, get salvia-soluble effective site, 65 ℃ are measured relative densities is 1.05.
Fat-soluble effective site medicinal liquid of above-mentioned Radix Salviae Miltiorrhizae and salvia-soluble effective site filtrate are merged, add calcium sulfate 32g and dextrin 16g mixing, spray drying promptly gets the active component of red sage root compositions.
Embodiment 6 active component of red sage root preparation of compositions
Get red rooted salvia 1Kg, with mass concentration 95% ethanol percolation, consumption is 10 times of medical material weight, floods 12 hours, collects percolate, and medicinal liquid reclaims ethanol to the 2.4Kg medicinal liquid, obtains the fat-soluble effective site of Radix Salviae Miltiorrhizae, and 65 ℃ are measured relative density is 1.05.
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted add water stirring dipping 2 times, water is heated to 90 ℃ extracts, and extract 1 hour at every turn, water consumption is 12 times of medical material weight, filters, and is concentrated into the 2.7Kg medicinal liquid, get salvia-soluble effective site, 65 ℃ are measured relative densities is 1.05.
Fat-soluble effective site medicinal liquid of above-mentioned Radix Salviae Miltiorrhizae and salvia-soluble effective site filtrate are merged, add calcium sulfate 32g and dextrin 16g mixing, spray drying promptly gets the active component of red sage root compositions.
Embodiment 7 active component of red sage root preparation of compositions
Get red rooted salvia 1Kg, use mass concentration 85% alcohol reflux 1 time, consumption is 8 times of medical material weight, and return time 2 hours filters, and filtrate recycling ethanol obtains the fat-soluble effective site of Radix Salviae Miltiorrhizae to the 2.1Kg medicinal liquid, and 65 ℃ are measured relative densities is 1.07.
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted are that solvent adopts microwave extraction with water, pre-soaking 90 minutes, extract 2 times, each exposure time is 8 minutes, each water consumption is 10 times of medical material weight, and microwave output power is 500 watts, collects filtrate and is concentrated into the 2.5Kg medicinal liquid, get salvia-soluble effective site, 65 ℃ are measured relative densities is 1.03.
Fat-soluble effective site medicinal liquid of above-mentioned Radix Salviae Miltiorrhizae and salvia-soluble effective site filtrate are merged, add calcium sulfate 32g and dextrin 16g mixing, spray drying promptly gets the active component of red sage root compositions.
Embodiment 8 active component of red sage root preparation of compositions
Get red rooted salvia 1Kg, with mass concentration 95% ethanol percolation, consumption is 12 times of medical material weight, floods 12 hours, collects percolate, and medicinal liquid reclaims ethanol to the 2.5Kg medicinal liquid, obtains the fat-soluble effective site of Radix Salviae Miltiorrhizae, and 65 ℃ are measured relative density is 1.05.
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted are that solvent adopts microwave extraction with water, pre-soaking 120 minutes, extract 1 time, each exposure time is 12 minutes, each water consumption is 12 times of medical material weight, and microwave output power is 650 watts, collects filtrate and is concentrated into the 3.5Kg medicinal liquid, get salvia-soluble effective site, 65 ℃ are measured relative densities is 1.02.
Fat-soluble effective site medicinal liquid of above-mentioned Radix Salviae Miltiorrhizae and salvia-soluble effective site filtrate are merged, add calcium sulfate 32g and dextrin 16g mixing, spray drying promptly gets the active component of red sage root compositions.
Embodiment 9 active component of red sage root preparation of compositions
Get red rooted salvia 1Kg, use mass concentration 90% alcohol reflux 1 time, consumption is 6 times of medical material weight, and return time 1 hour filters, and filtrate recycling ethanol obtains the fat-soluble effective site of Radix Salviae Miltiorrhizae to the 2.1Kg medicinal liquid, and 65 ℃ are measured relative densities is 1.07.
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted are that solvent adopts microwave extraction with water, pre-soaking 100 minutes, extract 2 times, each exposure time is 10 minutes, each water consumption is 11 times of medical material weight, and microwave output power is 600 watts, collects filtrate and is concentrated into the 3.3Kg medicinal liquid, get salvia-soluble effective site, 65 ℃ are measured relative densities is 1.03.
Fat-soluble effective site medicinal liquid of above-mentioned Radix Salviae Miltiorrhizae and salvia-soluble effective site filtrate are merged, add calcium sulfate 32g and dextrin 16g mixing, spray drying promptly gets the active component of red sage root compositions.
The preparation of embodiment 10 dispersion tablet of red sage root
Get the active component of red sage root compositions 190g of embodiment 3, add crospolyvinylpyrrolidone 95g, microcrystalline Cellulose 93.1g, magnesium stearate 1.9g, with sieve mixing three times of 100 mesh sieves, direct powder tabletting entirely.
The preparation of embodiment 11 dispersion tablet of red sage root
Get the active component of red sage root compositions 190g of embodiment 3, add crospolyvinylpyrrolidone 95g, microcrystalline Cellulose 45.6g, low-substituted hydroxypropyl methylcellulose 47.5g, magnesium stearate 1.9g, with sieve mixing three times of 100 mesh sieves, direct powder tabletting entirely.
The preparation of embodiment 12 dispersion tablet of red sage root
Get the active component of red sage root compositions 190g of embodiment 4, add crospolyvinylpyrrolidone 38g, microcrystalline Cellulose 74.1g, lactose 76g, magnesium stearate 1.9g is with sieve mixing three times of 100 mesh sieves, is the wetting agent wet granulation with mixture with mass concentration 95% ethanol, 50 ℃ of dryings, granulate promptly gets granule, tabletting behind the mixing.
The preparation of embodiment 13 dispersion tablet of red sage root
Get the active component of red sage root compositions 190g of embodiment 4, add crospolyvinylpyrrolidone 45.6g, microcrystalline Cellulose 51.3g, lactose 68.4g is with sieve mixing three times of 100 mesh sieves, is the wetting agent wet granulation with mixture with mass concentration 85% ethanol, 45 ℃ of dryings, granulate promptly gets granule, adds micropowder silica gel 22.8g, magnesium stearate 1.9g, tabletting behind the mixing.
The preparation of embodiment 14 dispersion tablet of red sage root
Get the active component of red sage root compositions 190g of embodiment 7, add crospolyvinylpyrrolidone 53.2g, microcrystalline Cellulose 58.9g, lactose 53.2g is with sieve mixing three times of 100 mesh sieves, is the wetting agent wet granulation with mixture with mass concentration 90% ethanol, 45 ℃ of dryings, granulate promptly gets granule, adds micropowder silica gel 22.8g, magnesium stearate 1.9g, tabletting behind the mixing.
The preparation of embodiment 15 dispersion tablet of red sage root
Get the active component of red sage root compositions 190g of embodiment 7, add crospolyvinylpyrrolidone 38g, microcrystalline Cellulose 112.1g, with sieve mixing three times of 100 mesh sieves, be the wetting agent wet granulation with mixture with mass concentration 95% ethanol, 45 ℃ of dryings, granulate promptly gets granule, add carboxymethyl starch sodium 38g, magnesium stearate 1.9g, tabletting behind the mixing.
The preparation of embodiment 16 dispersion tablet of red sage root
Get the active component of red sage root compositions 95g of embodiment 7, add crospolyvinylpyrrolidone 38g, microcrystalline Cellulose 112.1g, lactose 95g is with sieve mixing three times of 100 mesh sieves, is the wetting agent wet granulation with mixture with mass concentration 95% ethanol, 45 ℃ of dryings, granulate promptly gets granule, adds carboxymethyl starch sodium 38g, magnesium stearate 1.9g, tabletting behind the mixing.
The preparation of embodiment 17 dispersion tablet of red sage root
Get the active component of red sage root compositions 133g of embodiment 1, add crospolyvinylpyrrolidone 30g, microcrystalline Cellulose 97.1g, lactose 85g is with sieve mixing three times of 100 mesh sieves, is the wetting agent wet granulation with mixture with mass concentration 95% ethanol, 45 ℃ of dryings, granulate promptly gets granule, adds carboxymethyl starch sodium 33g, magnesium stearate 1.9g, tabletting behind the mixing.
The preparation of embodiment 18 dispersion tablet of red sage root
Get the active component of red sage root compositions 133g of embodiment 1, add crospolyvinylpyrrolidone 30g, sorbitol 97.1g, starch 85g is with sieve mixing three times of 100 mesh sieves, is the wetting agent wet granulation with mixture with mass concentration 95% ethanol, 45 ℃ of dryings, granulate promptly gets granule, adds cross-linking sodium carboxymethyl cellulose 33g, Pulvis Talci 1.9g, tabletting behind the mixing.
The preparation of embodiment 19 dispersion tablet of red sage root
Get the active component of red sage root compositions 133g of embodiment 1, add crospolyvinylpyrrolidone 30g, dextrin 97.1g, starch 85g is with sieve mixing three times of 100 mesh sieves, is the wetting agent wet granulation with mixture with mass concentration 95% ethanol, 45 ℃ of dryings, granulate promptly gets granule, adds hydroxypropyl starch 33g, Pulvis Talci 1.9g, tabletting behind the mixing.
Embodiment 20 active component of red sage root preparation of compositions
Get red rooted salvia 1Kg, with mass concentration 95% ethanol percolation, consumption is 12 times of medical material weight, floods 12 hours, collects percolate, and medicinal liquid reclaims ethanol to medicinal liquid, obtains the fat-soluble effective site of Radix Salviae Miltiorrhizae, and 65 ℃ are measured relative density is 1.02.
Get medicinal residues after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted and add water and stir dipping 1 time, water is heated to 80 ℃ extracts, extracted 2 hours, water consumption is 10 times of medical material weight, filters, concentrate, salvia-soluble effective site, 65 ℃ of mensuration relative densities are 1.02.
Fat-soluble effective site thick paste of above-mentioned Radix Salviae Miltiorrhizae and salvia-soluble effective site filtrate are merged, add calcium sulfate 33.3g and dextrin 22.2g mixing, spray drying promptly gets the active component of red sage root compositions.
Embodiment 21 active component of red sage root preparation of compositions
Get red rooted salvia 1Kg, use mass concentration 85% alcohol reflux 1 time, consumption is 8 times of medical material weight, and return time 2 hours filters, and filtrate recycling ethanol obtains the fat-soluble effective site of Radix Salviae Miltiorrhizae to the 2.1Kg medicinal liquid, and 65 ℃ are measured relative densities is 1.07.
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted are that solvent adopts microwave extraction with water, pre-soaking 90 minutes, extract 2 times, each exposure time is 8 minutes, and each water consumption is 10 times of medical material weight, and microwave output power is 500 watts, collect filtrate, concentrate, get salvia-soluble effective site, 65 ℃ are measured relative densities is 1.08.
Fat-soluble effective site medicinal liquid of above-mentioned Radix Salviae Miltiorrhizae and salvia-soluble effective site filtrate are merged, add calcium sulfate 28.6g and dextrin 45.5g mixing, spray drying promptly gets the active component of red sage root compositions.
Embodiment 22 active component of red sage root preparation of compositions
Get red rooted salvia 1Kg, with mass concentration 95% ethanol percolation, consumption is 12 times of medical material weight, floods 12 hours, collects percolate, and medicinal liquid reclaims ethanol to medicinal liquid, obtains the fat-soluble effective site of Radix Salviae Miltiorrhizae, and 65 ℃ are measured relative density is 1.02.
Get medicinal residues after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted and add water and stir dipping 1 time, water is heated to 80 ℃ extracts, extracted 2 hours, water consumption is 10 times of medical material weight, filters, concentrate, salvia-soluble effective site, 65 ℃ of mensuration relative densities are 1.08.
Fat-soluble effective site medicinal liquid of above-mentioned Radix Salviae Miltiorrhizae and salvia-soluble effective site filtrate are merged, add calcium sulfate 33.3g and dextrin 16.7g mixing, spray drying promptly gets the active component of red sage root compositions.
Embodiment 23 active component of red sage root preparation of compositions
Get red rooted salvia 1Kg, use mass concentration 85% alcohol reflux 1 time, consumption is 8 times of medical material weight, and return time 2 hours filters, and filtrate recycling ethanol obtains the fat-soluble effective site of Radix Salviae Miltiorrhizae to the 2.1Kg medicinal liquid, and 65 ℃ are measured relative densities is 1.07.
The medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted are that solvent adopts microwave extraction with water, pre-soaking 90 minutes, extract 2 times, each exposure time is 8 minutes, each water consumption is 10 times of medical material weight, and microwave output power is 500 watts, collects filtrate concentrating, get salvia-soluble effective site, 65 ℃ are measured relative densities is 1.04.
Fat-soluble effective site medicinal liquid of above-mentioned Radix Salviae Miltiorrhizae and salvia-soluble effective site filtrate are merged, add calcium sulfate 28.6g and dextrin 45.5g mixing, spray drying promptly gets the active component of red sage root compositions.
The dispersion tablet of red sage root intermediate that effect embodiment 1 embodiment 10～17 makes and the inspection and the assay of preparation
Below among the present invention, to the inspection and the content assaying method of dispersion tablet of red sage root intermediate and preparation:
Above-mentioned dispersion tablet of red sage root intermediate is granule or mix powder that active component of red sage root compositions and adjuvant mixture are made; Preparation is dispersible tablet.
One, the inspection item of dispersion tablet of red sage root intermediate and preparation is as follows:
1, dispersion tablet of red sage root intermediate (granule or powder) characteristic measurement method
Adopt BT-1000 powder body overall characteristic tester, investigate the characteristic of dispersion tablet of red sage root intermediate (granule or powder) by mensuration dispersion tablet of red sage root intermediate tap density, apparent density, angle of repose, collapse angle, dull and stereotyped angle.
(1) tap density: tap density is meant that powder filling after special container, vibrates container, thereby destroys the space in the powder body, makes the density after powder body is in tight occupied state.Can know data such as the flowability of powder body and voidage by measuring tap density.
(2) apparent density: apparent density is meant the density powder body is in the nature full state in special container after.This index is very important to the design of storage container and packaging bag.
(3) angle of repose: the Free Surface of powder body accumulation horizon is under the static balance state, and the maximum angle that forms with horizontal plane is called angle of repose.It drops on the particular platform powder body naturally by ad hoc fashion and forms.Angle of repose, angle of repose was more little to the flowability affects maximum of split, and the flowability of powder body is good more.Also claim angle of repose such as angle of repose, angle of repose etc.
(4) collapse angle: give the accumulation powder body of measuring angle of repose with certain impact, make the base angle of its collapse back, surface cone be called the collapse angle.
(5) dull and stereotyped angle: the flat board that will be embedded in the powder body is upwards vertically mentioned, powder body the angle between Free Surface on the flat board (inclined-plane) and the flat board be given a shock after the meansigma methods of angle be called dull and stereotyped angle.In the actual measurement process, dull and stereotyped angle is that the meansigma methods of removing the angle of unstable powder body after the angle after mentioning with flat board is impacted with flat board is represented.Dull and stereotyped angle is more little, and the flowability of powder body is strong more.Usually, dull and stereotyped angle is greater than angle of repose.
2, dispersion tablet of red sage root hardness test method
Adopt the crushing strength method, adopt tablet four-function analyzer to measure.Method is as follows: tablet radially is fixed between two cross bars, and movable mast wherein radially pressurizes to tablet by the spring along continuous straight runs, and when tablet was broken, the spring of movable mast stopped pressurization, and the indicated pressure of instrument calibration dish is the hardness of sheet.Measure 6, average.
3, dispersion tablet of red sage root dispersing uniformity
Get 2 of dispersion tablet of red sage root, in 20 ± 1 ℃ the 100ml water, jolting 3 minutes, all disintegrate is also by No. two sieves.
4, the dissolution test of salvianolic acid B (with reference to 2005 editions Pharmacopoeia of People's Republic of China appendix X C dissolution method three therapeutic methods of traditional Chinese medicine) in the dispersion tablet of red sage root
Measure the distilled water 200ml that handles through the degassing, inject in each process container, heating makes solvent temperature remain on 37 ± 0.5 ℃.Get each 6 of test samples, drop into respectively in 6 process containers, start rotation immediately and pick up counting (rotating speed is that per minute 100 changes).The 2ml of sampling at the appointed time after stripping begins (replenishing equivalent isothermal medium simultaneously) filters through 0.45 μ m microporous filter membrane immediately, is sampled to filtration certainly and finishes in 30 seconds.Get filtrate 10 μ l sample introductions.With salvianolic acid B cubage accumulative total stripping percentage rate.
Two, the dispersion tablet of red sage root content assaying method is as follows:
The salvianolic acid B assay:
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica, and the glacial acetic acid of methanol-percent by volume 1% (volume ratio is 45: 55) is a mobile phase, and column temperature is a room temperature, flow velocity 1ml/min, and the detection wavelength is 280nm.Theoretical cam curve is pressed the salvianolic acid B peak and is calculated, and should be not less than 1000.
The preparation precision of reference substance solution takes by weighing the salvianolic acid B reference substance, adds water and makes the solution that every 1ml contains 0.2mg, in contrast product solution.
10 of the preparation dispersion tablet of red sage root of need testing solution grind evenly, get about 0.5g, and accurate the title adds water 40ml supersound extraction 30 minutes in the fixation 50ml measuring bottle, puts to room temperature, adds water to scale, shakes up, and with 0.45 μ m filtering with microporous membrane, promptly gets need testing solution.
Accurate respectively reference substance solution and each the 20 μ l of need testing solution of drawing of algoscopy inject high performance liquid chromatograph, write down 30 minutes chromatograms.
Below be concrete test result:
Embodiment 10:
The powder body overall characteristic of full powder
Annotate: the data of dissolution are the sample time (n=6) of stripping limit more than or equal to labelled amount 70%.
Dispersion tablet of red sage root assay result: salvianolic acid B is the 11.5mg/ sheet.
Embodiment 11:
The powder body overall characteristic of full powder
Annotate: the data of dissolution are the sample time (n=6) of stripping limit more than or equal to labelled amount 70%.
Dispersion tablet of red sage root assay result: salvianolic acid B is the 11.7mg/ sheet.
Embodiment 12:
Particulate overall characteristic
Annotate: the data of dissolution are the sample time (n=6) of stripping limit more than or equal to labelled amount 70%.
Dispersion tablet of red sage root assay result: salvianolic acid B is the 12.1mg/ sheet.
Embodiment 13:
Particulate overall characteristic
Annotate: the data of dissolution are the sample time (n=6) of stripping limit more than or equal to labelled amount 70%.
Dispersion tablet of red sage root assay result: salvianolic acid B is the 11.2mg/ sheet.
Embodiment 14:
Particulate overall characteristic
Annotate: the data of dissolution are the sample time (n=6) of stripping limit more than or equal to labelled amount 70%.
Dispersion tablet of red sage root assay result: salvianolic acid B is the 11.6mg/ sheet.
Embodiment 15:
Particulate overall characteristic
Annotate: the data of dissolution are the sample time (n=6) of stripping limit more than or equal to labelled amount 70%.
Dispersion tablet of red sage root assay result: salvianolic acid B is the 11.3mg/ sheet.
Embodiment 16:
Particulate overall characteristic
Annotate: the data of dissolution are the sample time of stripping limit more than or equal to labelled amount 70%.
Dispersion tablet of red sage root assay result: salvianolic acid B is the 5.6mg/ sheet.
Embodiment 17:
Particulate overall characteristic
Annotate: the data of dissolution are that the stripping limit does not measure for 70% sample time more than or equal to mark.
Dispersion tablet of red sage root assay result: salvianolic acid B is the 7.9mg/ sheet.
Conclusion: dispersion tablet of red sage root taking convenience of the present invention, rate of release are soon, absorption is fast, bioavailability is high, compliance good.
The effect of the dispersion tablet of red sage root that dispersion tablet of red sage root that effect embodiment 2 the present invention make and patent 200610039611.2 " a kind of dispersion tablet of red sage root for coronary artery and preparation method thereof " embodiment make relatively
Wherein, patent 1 refers to fully EXAMPLE l, 2, the 3 prepared dispersible tablets according to patent 200610039611.2 " a kind of dispersion tablet of red sage root for coronary artery and preparation method thereof "; Patent 2 is meant, principal agent is substituted by the active component of red sage root compositions that embodiments of the invention 3 make, all the other each compositions are same as described in patent 200610039611.2 " a kind of dispersion tablet of red sage root for coronary artery and preparation method thereof " embodiment 1,2,3, the dispersible tablet for preparing.
Above-mentioned data show that dispersible tablet prescription of the present invention is better than the dispersible tablet prescription of patent " a kind of dispersion tablet of red sage root for coronary artery and preparation method thereof ".
Claims (10)
1. dispersion tablet of red sage root, it is characterized in that: it contains active component of red sage root compositions and adjuvant, and the parts by weight of wherein said active component of red sage root compositions are 25～50 parts; The parts by weight of described adjuvant are 75～50 parts; Described adjuvant comprises disintegrating agent 20%～75%, and filler 24%～79%, lubricant 0.7%～1%, above-mentioned percentage ratio are each composition shared mass percent in adjuvant; Described active component of red sage root compositions is the compositions that comprises fat-soluble effective site and water solublity effective site; Described disintegrating agent comprises one or more in the following compositions: crospolyvinylpyrrolidone, low-substituted hydroxypropyl methylcellulose, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, hydroxypropyl starch and micropowder silica gel; Described filler comprises one or more in the following compositions: microcrystalline Cellulose, lactose, starch, sorbitol and dextrin; Described lubricant comprises one or more in the following compositions: magnesium stearate, micropowder silica gel and Pulvis Talci.
2. dispersion tablet of red sage root as claimed in claim 1 is characterized in that: the mass percent that described disintegrating agent accounts for adjuvant is 25.5%～50%, and the mass percent that described filler accounts for adjuvant is 49%～73%.
3. dispersion tablet of red sage root as claimed in claim 1 is characterized in that: described fat-soluble effective site is fat-soluble diterpene quinone; Described water solublity effective site is the water-soluble phenolic acid compounds.
4. dispersion tablet of red sage root as claimed in claim 1 is characterized in that: described disintegrating agent comprises one or more in the following compositions: crospolyvinylpyrrolidone, low-substituted hydroxypropyl methylcellulose, carboxymethyl starch sodium and micropowder silica gel.
5. dispersion tablet of red sage root as claimed in claim 1 is characterized in that: described filler comprises microcrystalline Cellulose and/or lactose.
6. dispersion tablet of red sage root as claimed in claim 1 is characterized in that: described lubricant comprises magnesium stearate and/or micropowder silica gel.
7. dispersion tablet of red sage root as claimed in claim 1 is characterized in that: described active component of red sage root compositions is made by following method: the first step: the extraction of fat-soluble effective site of Radix Salviae Miltiorrhizae and water solublity effective site; Second step: active component of red sage root preparation of compositions: fat-soluble effective site of Radix Salviae Miltiorrhizae and water solublity effective site are mixed, can make.
8. dispersion tablet of red sage root as claimed in claim 7 is characterized in that:
In the first step, the fat-soluble effective site of described Radix Salviae Miltiorrhizae is made by following any one method:
(1), ethanol reflux extraction: red rooted salvia is refluxed in ethanol, filters then, with filtrate concentrate the fat-soluble effective site medicinal liquid of Radix Salviae Miltiorrhizae;
(2), ethanol percolate extraction method: with the red rooted salvia ethanol percolation, dipping is collected percolate, will it concentrated fat-soluble effective site medicinal liquid of Radix Salviae Miltiorrhizae;
Described salvia-soluble effective site is made by following any one method:
(1), decoction is extracted: the medicinal residues after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted decoct with water, and filter, and concentrate, and get salvia-soluble effective site medicinal liquid;
(2), stir dipping and extract: get medicinal residues after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted and add water and stir dipping, filter, concentrate, salvia-soluble effective site medicinal liquid;
(3), microwave extraction: with water is solvent, and the medicinal residues after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted carry out microwave extraction, filter, and concentrate, and get salvia-soluble effective site medicinal liquid;
In second step, described active component of red sage root preparation of compositions method comprises the following step: fat-soluble effective site medicinal liquid of Radix Salviae Miltiorrhizae and salvia-soluble effective site medicinal liquid that the first step is obtained merge, and add conventional diluent, mixing, dry getting final product.
9. dispersion tablet of red sage root as claimed in claim 8 is characterized in that:
The step of described ethanol reflux extraction is as described below: get red rooted salvia, with mass concentration 85～95% alcohol refluxs 1～2 time, each consumption is 6～8 times of medical material weight, return time 1～2 hour, filter, merging filtrate, filtrate recycling ethanol get the fat-soluble effective site medicinal liquid of Radix Salviae Miltiorrhizae, this medicinal liquid is measured down in 65 ℃, and relative density is 1.02～1.08;
The step of described ethanol percolate extraction method is as described below: get red rooted salvia, with mass concentration 85～95% ethanol percolations, consumption is 10～12 times of medical material weight, flooded 12 hours, collect percolate, medicinal liquid reclaims ethanol and gets the fat-soluble effective site medicinal liquid of Radix Salviae Miltiorrhizae, and this medicinal liquid is measured down in 65 ℃, and relative density is 1.02～1.08;
The step that described decoction is extracted is as described below: the medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted decoct with water 1～2 time, each 0.5～1.5 hour, each water consumption is 10～12 times of medical material weight, filter, filtrate is concentrated, get salvia-soluble effective site medicinal liquid, this medicinal liquid is measured down in 65 ℃, and relative density is 1.02～1.08;
The step that described stirring dipping extracts is as described below: the medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted add water stirring dipping, water is heated to 80～90 ℃ to be extracted, extract 1～2 time, the each extraction 1～2 hour, the consumption of each water are 10～12 times of medical material weight, filter, filtrate is concentrated, get salvia-soluble effective site medicinal liquid, this medicinal liquid is measured down in 65 ℃, and relative density is 1.02～1.08;
The step of described microwave extraction method is as described below: the medicinal residues of getting after the fat-soluble effective site of Radix Salviae Miltiorrhizae is extracted are that solvent adopts microwave extraction with water, pre-soaking 90～120 minutes in water earlier, carry out microwave exposure and extraction 1～2 time then, each exposure time is 8～12 minutes, each water consumption is 10～12 times of medical material weight, microwave output power is 500～650 watts, collect filtrate, filtrate is concentrated, get salvia-soluble effective site medicinal liquid, this medicinal liquid is measured down in 65 ℃, and relative density is 1.02～1.08;
Described active component of red sage root preparation of compositions method is as described below: fat-soluble effective site medicinal liquid of Radix Salviae Miltiorrhizae that the first step is made and salvia-soluble effective site medicinal liquid merge, and add diluent calcium sulfate and dextrin, mixing, and spray drying again, promptly; Wherein, the ratio of calcium sulfate and dextrin is 2: 1～1.5: 1, and red rooted salvia weight is calcium sulfate and dextrin gross weight 18～22 times.
10. as the application of each described dispersion tablet of red sage root of claim 1～9 in preparation treatment coronary heart disease and/or angina drug.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103735690A (en) * | 2014-01-22 | 2014-04-23 | 李晓斌 | Traditional Chinese medicine for treating gastrohelcosis and preparation method thereof |
| CN109223728A (en) * | 2018-10-22 | 2019-01-18 | 海南赛立克药业有限公司 | Capsule of red sage root and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN100509000C (en) * | 2006-04-18 | 2009-07-08 | 张国清 | Dispersion tablet of red sage root for coronary artery and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103735690A (en) * | 2014-01-22 | 2014-04-23 | 李晓斌 | Traditional Chinese medicine for treating gastrohelcosis and preparation method thereof |
| CN109223728A (en) * | 2018-10-22 | 2019-01-18 | 海南赛立克药业有限公司 | Capsule of red sage root and preparation method thereof |
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