CN103182009B - Hypolipidemic traditional Chinese medicine composition and preparation method and application thereof - Google Patents
Hypolipidemic traditional Chinese medicine composition and preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a hypolipidemic traditional Chinese medicine composition, and a preparation method and an application thereof. The traditional Chinese medicine composition comprises an extract of a mixture of oriental waterplantain tuber and largehead atractylodes rhizome. The composition is characterized in comprising 0.5-2wt% of 23-acetyl alisol B and 0.1-1wt% of atractylenolide B. The invention also provides a preparation method of the traditional Chinese medicine composition, an application of the traditional Chinese medicine composition in preparing hypolipidemic medicines, and medicines comprising the traditional Chinese medicine composition.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition and its preparation method and application, be specifically related to Chinese medicine composition of a kind of blood fat reducing and preparation method thereof, and this Chinese medicine composition medicine of applying and contain this Chinese medicine composition in the medicine for the preparation of blood fat reducing.
Background technology
According to WHO, estimate, cardiovascular and cerebrovascular disease is at present the mankind to be threatened to maximum disease, and cardiovascular and cerebrovascular disease at least causes the whole world 1,200 ten thousand people dead every year, has become the dead enemy of human health.Wherein coronary heart disease, apoplexy person account for 28.8% of the total death toll in the whole world, in noninfectious, rank first.Along with the growth of the average life span,, the variation of the affluence of material conditions and life culture mode, the M & M of cardiovascular and cerebrovascular disease is increasing year by year, and has the trend of rejuvenation.Atherosclerosis is the main pathological basis of cardiovascular and cerebrovascular disease, and hyperlipemia is atherosclerotic important pathogenic factors.Therefore treating hyperlipemia is the key link of preventing and treating atherosclerosis and cardiovascular and cerebrovascular disease.
Hyperlipemia belongs to the category of the phlegm syndrome such as " expectorant is turbid " in motherland's traditional medicine, " the expectorant stasis of blood ", has not only accumulated so far abundant clinical experience, and has formed ripe day by day theory.Treatment for hyperlipemia at present is roughly summarized as three kinds of primary treatment rule for the treatment of such as " removing both phlegm and blood stasis at the same time ", " blood circulation promoting and blood stasis dispelling ", " invigorating the spleen for dissipating phlegm ".Cure the effect that " Rhizoma Alismatis soup " in holy Zhang Zhongjing < < Medical Treasures of the Golden Chamber > > has diuretic damp eliminating, invigorating the spleen and benefiting QI, compatibility is rigorous, treating both the principal and secondary aspects of a disease is the turbid effective prescription that checks type hyperlipemia for the treatment of expectorant.Further investigation and the exploitation of " Rhizoma Alismatis soup ", widening of excavation, development and the application of Shi Dui motherland traditional medicine, is the prominent example for the treatment of different diseases with the same therapeutic principle, has certain Social benefit and economic benefit.
" Rhizoma Alismatis soup " is comprised of Rhizoma Alismatis, the Rhizoma Atractylodis Macrocephalae two medicines, and wherein Rhizoma Alismatis is the dry tuber of Notes On Alism At Aceae Rhizoma Alismatis (Alisma orientalis (Sam.) Junzep.).Nature and flavor are sweet, cold; Return kidney, urinary bladder channel.Have diuresis, the effect of clearing away damp-heat, is usually used in dysuria, edema distension, hyperlipidemia etc.Modern study shows, Rhizoma Alismatis forms by antithrombotic, reduces blood fat, reduces plasma viscosity, suppresses the effect that atheromatous plaque forms, and reaches antiatherogenic object.Simultaneously Rhizoma Alismatis also there is diuresis, spasmolytic, protect the liver, the effect such as antiinflammatory, immunomodulating, blood sugar lowering.The Rhizoma Atractylodis Macrocephalae is the dry rhizome of the feverfew Rhizoma Atractylodis Macrocephalae (Atractylodes macrocephala Koidz.).Nature and flavor are bitter, sweet, temperature.Return spleen, stomach warp.There is invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive effect.For insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, frequent fetal movement etc., main product in Zhejiang, the ground such as Anhui, Jiangxi.The Rhizoma Atractylodis Macrocephalae has diuresis, antitumor, antimicrobial antiphlogistic, the anti-ageing effect of waiting for a long time, and nervous system, digestive tract, uterine smooth muscle are also had to certain effect, also has and regulates immune function.Rhizoma Atractylodis Macrocephalae decoct has the emptying and intestinal propulsion function of obvious promotion Mouse Stomach, and heavy dose of Rhizoma Atractylodis Macrocephalae decoct can promote the intestines and stomach ahead running of mice.
Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae are widely used in adjusting blood fat clinically, and the Rhizoma Alismatis soup of take is that the Chinese medicine compound of basic side all has the effect that regulates hyperlipidemia patient lipid metabolism as Pu short, bristly hair or beard Rhizoma Alismatis soup, Radix Polygoni Multiflori Rhizoma Alismatis soup and Radix Salviae Miltiorrhizae Radix Polygoni Multiflori Rhizoma Alismatis drink.Take Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae is that main compound recipe has good tune blood fat effect to high blood lipid model rat, and can alleviate the experimental atherosclerosis in rats being caused by hyperlipidemia.Yet, at present effective site and the active component of the blood fat reducing of Rhizoma Alismatis soup are still not clear, make its application limited, and the water decoction of multiplex Rhizoma Alismatis soup clinically, carry and use inconvenience, quality standard controllability is poor, is difficult to meet the requirement of Chinese medicine " safe, effective, controlled, stable ".
Summary of the invention
Therefore, the object of the invention is to overcome above-mentioned defect of the prior art, provide a kind of can blood fat reducing, the lipid metabolic disorder diseases such as hyperlipemia, high sticky blood and atherosclerosis are had to definite curative effect, and quality controllable, be easy to Chinese medicine composition of suitability for industrialized production and its preparation method and application.
The invention provides a kind of Chinese medicine composition of blood fat reducing, this Chinese medicine composition comprises the extract of the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae, comprises the Alisol B monoacetate of 0.5～2wt% and the atractylodes lactone B of 0.1～1wt% in described Chinese medicine composition.
Described Rhizoma Alismatis is the dry tuber of Notes On Alism At Aceae Rhizoma Alismatis (Alisma orientalis (Sam.) Juzep.), has diuresis, the effect of clearing away damp-heat, and for dysuria, edema distension, dizziness due to fluid-retention, the puckery pain of pyretic stranguria etc.
The described Rhizoma Atractylodis Macrocephalae is the dry rhizome of the feverfew Rhizoma Atractylodis Macrocephalae (Atractylodes macrocephala Koidz.).The Rhizoma Atractylodis Macrocephalae has invigorating the spleen and benefiting QI, and the effect of dampness diuretic is share pathogenic fluid-retention with Rhizoma Alismatis and must not be stopped poly-and from little urinal from spilling out, the dampness removing that strengthens Rhizoma Alismatis reduces phlegm, the merit of blood circulation promoting and blood stasis dispelling.
Described extract can, directly as Chinese medicine composition of the present invention, also can form Chinese medicine composition of the present invention with other drug composition jointly.
Inventor's discovery, Rhizoma Alismatis has the effect of blood fat reducing to experimental hypercholesterolemicrabbits rabbit and rat, simultaneously not obvious on the blood lipid level impact of normal rabbits.Inventor finds after further study, and the ter penoidses such as acetas of the Alisol A in Rhizoma Alismatis and Alisol A, B, C are main Lipid-lowering activities compositions, wherein finds, particularly evident with the effect for reducing fat of Alisol B monoacetate.The molecular structure of Alisol B monoacetate, as shown in the formula shown in 1, can affect the metabolism of endogenous cholesterol by disturbing the absorption of exogenous cholesterol and triglyceride, accelerates the hydrolysis of triglyceride.
Formula 1 Alisol B monoacetate
Inventor also finds, the Rhizoma Atractylodis Macrocephalae mainly comprises the chemical compositions such as atractylone, atractylol, atractylodes lactone, wherein with atractylodes lactone B, has obvious pharmaceutical active, has the effects such as diuresis, Gastrointestinal motility adjustment, raising immunity.The molecular structure of atractylodes lactone B is as shown in the formula shown in 2.
Formula 2 atractylodes lactone B
In described extract, the content assaying method of Alisol B monoacetate can be:
1) preparation of reference substance solution: the reference substance that takes Alisol B monoacetate is appropriate, accurately weighed, adds acetonitrile and makes every 1ml containing the solution of 20 μ g, obtains.
2) preparation of need testing solution: take the about 0.5g of extract of the present invention, accurately weighed, to put in tool plug conical flask, precision adds acetonitrile 25ml, close plug, weighed weight, supersound process 30 minutes, lets cool, more weighed weight, mends heavy with acetonitrile, shake up, filter, get subsequent filtrate, obtain.
3) chromatographic condition: take octadecylsilane chemically bonded silica as filler; Acetonitrile-water (volume ratio is 70: 30) is mobile phase, detects wavelength 208nm, and number of theoretical plate calculates and should be not less than 3000 by Alisol B monoacetate peak.
4) algoscopy: accurate above-mentioned reference substance solution and each 20 μ l sample introduction under above-mentioned chromatographic system of need testing solution drawn, measure, record peak area, calculate, obtain.
In described extract, the content assaying method of atractylodes lactone B can be:
1) preparation of reference substance solution: precision takes atractylodes lactone B 2.19mg, puts in 50ml measuring bottle, adds dissolve with methanol, and is diluted to scale, shakes up, and obtains.
2) preparation of need testing solution: take the about 2g of extract of the present invention, accurately weighed, add petroleum ether (model is 60-90) 50ml, room temperature magnetic agitation 1 hour, filters, and filtrate is put in 100ml round-bottomed flask, with petroleum ether gradation washing container and residue, washing liquid is incorporated in filtrate, reclaims petroleum ether to dry, add dissolve with methanol residue, solution is put in 10ml measuring bottle, and adds methanol and be diluted to scale, shake up, filter, get subsequent filtrate, obtain.
3) chromatographic condition: be filler with octadecylsilane chemically bonded silica; (volume ratio is 44: 5: 52 to methanol-ether-water-phosphoric acid: be 0.1) mobile phase, detect wavelength 240nm, number of theoretical plate calculates and should be not less than 4500 by atractylodes lactone B peak.
4) algoscopy: accurate above-mentioned reference substance solution and each 20 μ l sample introduction under above-mentioned chromatographic system of need testing solution drawn, measure, record peak area, calculate, obtain.
According to Chinese medicine composition of the present invention, wherein, in the mixture of described Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae, Rhizoma Alismatis can be 1～10 weight portion, and the Rhizoma Atractylodis Macrocephalae can be 0.1～10 weight portion.As preferably, Rhizoma Alismatis can be 5～10 weight portions, and the Rhizoma Atractylodis Macrocephalae can be 2～5 weight portions.As further preferred, Rhizoma Alismatis can be 5～6 weight portions, and the Rhizoma Atractylodis Macrocephalae can be 2～3 weight portions.
The present invention also provides a kind of preparation method of Chinese medicine composition, and this preparation method comprises Amberlyst process and/or supercritical extraction.
Described Amberlyst process can comprise: the mixture water of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae or ethanol water are extracted, and concentrated extracting solution, is used macroporous adsorbent resin to adsorb, and eluting after cleaning is concentrated, dry by eluent, obtains described extract.
Described supercritical extraction can comprise: the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae is pulverized and sieved, be placed in extraction kettle and extract, collect volatile oil, obtain described extract.
Preparation in accordance with the present invention, wherein, described Amberlyst process can comprise: the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae is extracted with the ethanol water of 60～95 volume %, concentrated extracting solution, use macroporous adsorbent resin to adsorb, the ethanol water of water and 20～60 volume % cleans successively, then uses the ethanol water eluting of 60～95 volume %, concentrated, dry to eluent, obtain described extract.
Described supercritical extraction can comprise: the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae is pulverized, crossed 40～80 mesh sieves, be placed in extraction kettle and extract, extraction temperature is 35～75 ℃, and extracting pressure is 15～35MPa, and extraction time is 1～4h, collect volatile oil, obtain described extract.
Preparation in accordance with the present invention, wherein, in described Amberlyst process, can extract with the ethanol water of 80～90 volume %, can preferably extract 1～3 time, and preferably each extraction time is 1～2h.Described macroporous adsorbent resin can be selected from HPD-100 type macroporous adsorbent resin, HPD-300 type macroporous adsorbent resin, D101 type macroporous adsorbent resin and NKA-9 type macroporous adsorbent resin.Can carry out eluting with the ethanol water of 80～90 volume %.
In described supercritical extraction, after pulverizing, can cross 40～60 mesh sieves, extraction temperature can be 40～60 ℃, and extracting pressure can be 20～30MPa, and extraction time can be 1.5～2h.
The present invention also provides Chinese medicine composition of the present invention or the application in the medicine for the preparation of blood fat reducing of the Chinese medicine composition that makes according to method of the present invention.
Application according to the present invention, wherein, described medicine can be for control high sticky blood, hyperlipemia or atherosclerosis.
The present invention also provides a kind of medicine of blood fat reducing, and this medicine comprises treats the Chinese medicine composition of the present invention of effective dose and/or the Chinese medicine composition that method of the present invention makes, and pharmaceutically acceptable adjuvant.
Described pharmaceutically acceptable adjuvant can be excipient, filler, diluent, lubricant, wetting agent, disintegrating agent, surfactant, antiseptic, sweeting agent, aromatic etc.More specifically, described pharmaceutically acceptable adjuvant can be starch, dextrin, lactose, microcrystalline Cellulose, hydroxypropyl methylcellulose, Polyethylene Glycol, magnesium stearate, micropowder silica gel, glucose, mannitol, xylitol, glycine etc.
According to medicine of the present invention, wherein, the preparation of described medicine can be tablet, pill, granule or capsule.Described tablet can be preferably slow releasing tablet, controlled release tablet, dispersible tablet, oral cavity disintegration tablet, chewable tablet or buccal tablet.Described pill can be preferably drop pill.Described capsule can be preferably soft capsule.
The present invention also provides a kind of preparation method of medicine, and this preparation method comprises: described Chinese medicine composition is mixed with described pharmaceutically acceptable adjuvant.
The therapeutic activity of Chinese medicine composition of the present invention is proved by following pharmacodynamics test: designed various dose sample, adopted rat blood fat reducing, the experiment of Carnis Coturnicis japonicae atherosclerosis, observed pharmaceutical composition effect for reducing blood fat and antiatherogenic activity:
1. test material
1.1 medicines and reagent
(1) Chinese medicine composition of the present invention: chocolate brown powder, makes according to the resulting extract of the method in the embodiment of the present invention 7;
(2) positive drug: simvastatin, lot number 08048, Hangzhou Mo Shadong pharmaceutical Co. Ltd product.
1.2 animal
SD rat, male and female dual-purpose, is provided by Tianyin Test Animal Centre.Licence numbering: SCXK (Tianjin) 2010-0002.
Carnis Coturnicis japonicae: male, Chun Le plant provides by Tianjin.
2. test method and result
2.1 impacts on hyperlipemia rat serum lipids
60 of SD rats, are divided into 6 groups at random, and 10 every group, male and female half and half, establish blank group (giving normal diet), the equal feed high lipid food of all the other rats (4% cholesterol, 0.2% methylthiouracil, 10% Adeps Sus domestica, 85.8% normal feedstuff).Three administration group Oral Administration in Rats gavage Chinese medicine composition 2.5g of the present invention, 5.0g and 10.0g/kg; Positive controls is given simvastatin 7.0mg/kg; Volume is 1ml/100g body weight; Blank group and high fat matched group are given respectively equal-volume ordinary water.Every day 1 time, continuous 9 days.The equal fasting of each treated animal rechallenge after 18 hours after last administration.After 90min, each rat eye is got blood, centrifugal, separation of serum, with clinical reagent box, measure serum total cholesterol (TC), triglyceride (TG), low density lipoprotein, LDL (LDL-C) and high density lipoprotein (HDL-C) content, with matched group relatively and carry out statistical procedures, experimental data sees the following form 1:
The impact of the various dose group of table 1 Chinese medicine composition of the present invention on hyperlipemia rat serum lipids
Note:
*compare P < 0.05 with matched group.
Above experimental result shows, model group TC, TG, LDL-C obviously increase, and with the comparison of blank group, all have significant difference.Simvastatin can significantly suppress TC in serum, TG, LDL-C raises.Chinese medicine composition 2.5g/kg of the present invention is above can suppress TC in serum, TG, LDL-C raises, and the Chinese medicine composition 10.0g/kg of the present invention HDL-C in serum that can raise, compares with simvastatin, and the effect that reduces serum LDL-C is stronger
2.2 antiatherogenic effects
48 of male Carnis Coturnicis japonicaes, by body weight, be divided at random 6 groups, every group 8, except blank group is with normal diet, all the other Carnis Coturnicis japonicaes all feed with high lipid food (69% normal feedstuff, 14% Adeps Sus domestica, 6% Oleum Arachidis hypogaeae semen, 6% bone meal, 4% wheat bran, 1% cholesterol, sand 150g/5kg feedstuff), three the oral Chinese medicine composition 2.5g of the present invention of administration group Carnis Coturnicis japonicae, 5.0g and 10.0g/kg; Positive controls is given simvastatin 7.0mg/kg; Volume is 0.5ml/100g body weight; Blank group and high fat matched group are given respectively equal-volume ordinary water.Every day 1 time, continuous 8 weeks.After last administration, the equal overnight fasting of each treated animal, through total arterial blood extracting, with well-established law separation of serum, measures the content of serum TC, TG, LDL-C, HDL-C, and result is checked with t and carried out statistical procedures, in Table 2:
The impact of table 2 Chinese medicine composition various dose of the present invention group on atherosclerosis (AS) Serum of Quail lipid
Note:
*compare P < 0.01 with matched group;
* *compare P < 0.001 with matched group.
Above experimental result shows, model group TC, TG, LDL-C obviously increase, and with the comparison of blank group, all have significant difference.Compare with model group, simvastatin can significantly suppress TC in serum, TG, LDL-C content, HDL-C content in rising serum.Compare with model group, in the above serum that can significantly raise of Chinese medicine composition 2.5g/kg of the present invention, HDL-C raises, and the Chinese medicine composition 10.0g/kg of the present invention HDL-C in serum that can raise, reduces TC, LDL-C content in serum.
3. experiment conclusion
In sum, Chinese medicine composition oral administration of the present invention or gavage all can reduce hyperlipidemia rats serum TC, TG, LDL-C content, rising rat blood serum HDL-C content; Oral administration or gavage all can reduce AS Serum of Quail TC and LDL-C content, and rising HDL-C content, can be used for the control of the lipid metabolic disorder diseases such as hyperlipemia.
Chinese medicine composition provided by the present invention and its preparation method and application has but is not limited to following beneficial effect:
1, Chinese medicine composition of the present invention comprises the extract of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae, and can be around its active component Alisol B monoacetate and atractylodes lactone B, by using different pharmaceutic adjuvants and pharmaceutical technology to be prepared into polytype pharmaceutical preparation, as tablet, pill etc., thereby overcome the defect that the not portable kimonos of traditional water decoction is used, expand range of application, more met the medication demand of modern consumption colony.
2, Chinese medicine composition raw material provided by the present invention is easy to get, and technological process is simple and clear, is easy to realize suitability for industrialized production, for clinical convenient, cheapness and the controlled modern Chinese medicine of quality standard of providing, has great social benefit.
The specific embodiment
Below by specific embodiment, further illustrate the present invention, still, should be understood to, these embodiment are only used for the use specifically describing more in detail, and should not be construed as for limiting in any form the present invention.
General description is carried out to the material and the test method that use in the present invention's test in this part.Although be well known in the art for realizing many materials and the operational approach that the object of the invention used, the present invention still does to describe in detail as far as possible at this.It will be apparent to those skilled in the art that in context, if not specified, material therefor of the present invention and operational approach are well known in the art.
embodiment 1
The present embodiment is used for illustrating Chinese medicine composition of the present invention and its preparation method and application.
Take Rhizoma Alismatis 10kg and Rhizoma Atractylodis Macrocephalae 10kg is mixed, use the ethanol water of 90 volume % of four times of amounts to extract secondary, each 1.5h, merge extractive liquid,, filter, concentrated supernatant is extremely without alcohol taste, and the HPD-100 type macroporous adsorbent resin wet with 10L adsorbs, and the ethanol water 40L of water 40L and 30 volume % cleans successively, then use the ethanol water eluting of 60 volume %, collect eluent concentrated, drying under reduced pressure, obtains the extract of the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae.In above-mentioned concentration operation, can reclaim ethanol simultaneously and re-use.Described extract can, directly as Chinese medicine composition of the present invention, also can form Chinese medicine composition of the present invention with other drug composition jointly.
After testing, in described extract, the content of Alisol B monoacetate is 0.52wt%, and the content of atractylodes lactone B is 0.18wt%.
By the extract obtained fine powder that is ground into, add lactose appropriate, the about 400ml wet granulation of ethanol water with 75 volume %, adds magnesium stearate 5g, Pulvis Talci 3g, tabletting, makes the tablet of medicine of the present invention.
embodiment 2
The present embodiment is used for illustrating Chinese medicine composition of the present invention and its preparation method and application.
Take Rhizoma Alismatis 10kg and Rhizoma Atractylodis Macrocephalae 1kg is mixed, use the ethanol water of 95 volume % of four times of amounts to extract secondary, each 2h, merge extractive liquid,, filter, concentrated supernatant is extremely without alcohol taste, and the HPD-300 type macroporous adsorbent resin wet with 10L adsorbs, and the ethanol water 40L of water 40L and 50 volume % cleans successively, then use the ethanol water eluting of 85 volume %, collect eluent concentrated, drying under reduced pressure, obtains the extract of the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae.In above-mentioned concentration operation, can reclaim ethanol simultaneously and re-use.Described extract can, directly as Chinese medicine composition of the present invention, also can form Chinese medicine composition of the present invention with other drug composition jointly.
After testing, in described extract, the content of Alisol B monoacetate is 1.47wt%, and the content of atractylodes lactone B is 0.65wt%.
By the above-mentioned extract obtained fine powder that is ground into, to mix homogeneously with microcrystalline Cellulose 400g, hyprolose 240g and micropowder silica gel 20g, tabletting, makes the dispersible tablet of medicine of the present invention.
embodiment 3
The present embodiment is used for illustrating Chinese medicine composition of the present invention and its preparation method and application.
Take Rhizoma Alismatis 1kg and Rhizoma Atractylodis Macrocephalae 10kg is mixed, use the ethanol water of 80 volume % of four times of amounts to extract three times, each 1h, merge extractive liquid,, filter, concentrated supernatant is extremely without alcohol taste, and the D101 type macroporous adsorbent resin wet with 10L adsorbs, and the ethanol water 40L of water 40L and 60 volume % cleans successively, then use the ethanol water eluting of 90 volume %, collect eluent concentrated, drying under reduced pressure, obtains the extract of the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae.In above-mentioned concentration operation, can reclaim ethanol simultaneously and re-use.Described extract can, directly as Chinese medicine composition of the present invention, also can form Chinese medicine composition of the present invention with other drug composition jointly.
After testing, in described extract, the content of Alisol B monoacetate is 1.62wt%, and the content of atractylodes lactone B is 0.73wt%.
By the above-mentioned extract obtained fine powder that is ground into, take Polyethylene Glycol (PEG) 6000 appropriate, 85 ℃ of meltings, add above-mentioned powder in the PEG6000 of melting with solid dispersion technology, and the 5 ℃ of liquid paraffin of take are coolant, make the drop pill of medicine of the present invention.
embodiment 4
The present embodiment is used for illustrating Chinese medicine composition of the present invention and its preparation method and application.
Take Rhizoma Alismatis 2kg and Rhizoma Atractylodis Macrocephalae 5kg is mixed, use the ethanol water of 80 volume % of four times of amounts to extract three times, each 1h, merge extractive liquid,, filter, concentrated supernatant is extremely without alcohol taste, and the NKA9 type macroporous adsorbent resin wet with 10L adsorbs, and the ethanol water 40L of water 40L and 40 volume % cleans successively, then use the ethanol water eluting of 80 volume %, collect eluent concentrated, drying under reduced pressure, obtains the extract of the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae.In above-mentioned concentration operation, can reclaim ethanol simultaneously and re-use.Described extract can, directly as Chinese medicine composition of the present invention, also can form Chinese medicine composition of the present invention with other drug composition jointly.
After testing, in described extract, the content of Alisol B monoacetate is 0.69wt%, and the content of atractylodes lactone B is 0.27wt%.
The extract of above-mentioned gained is ground into fine powder, adds dextrin 200g and hyprolose 100g to granulate, make the granule of medicine of the present invention.
embodiment 5
The present embodiment is used for illustrating Chinese medicine composition of the present invention and its preparation method and application.
Take Rhizoma Alismatis 6kg and Rhizoma Atractylodis Macrocephalae 3kg is mixed, use the ethanol water of 60 volume % of quintuple to extract once, each 2h, merge extractive liquid,, filter, concentrated supernatant is extremely without alcohol taste, and the HPD-100 type macroporous adsorbent resin wet with 10L adsorbs, and the ethanol water 40L of water 40L and 20 volume % cleans successively, then use the ethanol water eluting of 60 volume %, collect eluent concentrated, drying under reduced pressure, obtains the extract of the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae.In above-mentioned concentration operation, can reclaim ethanol simultaneously and re-use.Described extract can, directly as Chinese medicine composition of the present invention, also can form Chinese medicine composition of the present invention with other drug composition jointly.
After testing, in described extract, the content of Alisol B monoacetate is 0.5wt%, and the content of atractylodes lactone B is 0.1wt%.
By the extract obtained fine powder that is ground into, add dextrin appropriate, the about 350ml wet granulation of ethanol water with 80 volume %, adds Pulvis Talci 2g, and tabletting makes the tablet of medicine of the present invention.
embodiment 6
The present embodiment is used for illustrating Chinese medicine composition of the present invention and its preparation method and application.
Take Rhizoma Alismatis 10kg and Rhizoma Atractylodis Macrocephalae 6kg is mixed, use the ethanol water of 95 volume % of triplication to extract three times, each 2h, merge extractive liquid,, filter, concentrated supernatant is extremely without alcohol taste, and the HPD-300 type macroporous adsorbent resin wet with 10L adsorbs, and the ethanol water 40L of water 40L and 50 volume % cleans successively, then use the ethanol water eluting of 95 volume %, collect eluent concentrated, drying under reduced pressure, obtains the extract of the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae.In above-mentioned concentration operation, can reclaim ethanol simultaneously and re-use.Described extract can, directly as Chinese medicine composition of the present invention, also can form Chinese medicine composition of the present invention with other drug composition jointly.
After testing, in described extract, the content of Alisol B monoacetate is 2.0wt%, and the content of atractylodes lactone B is 1.0wt%.
By the above-mentioned extract obtained fine powder that is ground into, to mix homogeneously with microcrystalline Cellulose 420g, hyprolose 200g and micropowder silica gel 15g, tabletting, makes the dispersible tablet of medicine of the present invention.
embodiment 7
The present embodiment is used for illustrating Chinese medicine composition of the present invention and its preparation method and application.
Take Rhizoma Alismatis 5kg and Rhizoma Atractylodis Macrocephalae 2kg is mixed, pulverize, cross 60 mesh sieves, be placed in extraction kettle and carry out supercritical extraction, extraction temperature is 50 ℃, and extracting pressure is 25MPa, extraction time is 2h, flash trapping stage pressure is that 7MPa and the second-order separation pressure are 6MPa, collects volatile oil, obtains the extract of the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae.Described extract can, directly as Chinese medicine composition of the present invention, also can form Chinese medicine composition of the present invention with other drug composition jointly.
After testing, in described extract, the content of Alisol B monoacetate is 1.87wt%, and the content of atractylodes lactone B is 0.93wt%.
The extract of above-mentioned gained is ground into fine powder, adds microcrystalline Cellulose 200g, mix, with the ethanol water of 80 volume %, granulate, in incapsulating, make the capsule of medicine of the present invention.
embodiment 8
The present embodiment is used for illustrating Chinese medicine composition of the present invention and its preparation method and application.
Take Rhizoma Alismatis 5kg and Rhizoma Atractylodis Macrocephalae 1kg is mixed, pulverize, cross 70 mesh sieves, be placed in extraction kettle and carry out supercritical extraction, extraction temperature is 35 ℃, and extracting pressure is 15MPa, extraction time is 4h, flash trapping stage pressure is that 7MPa and the second-order separation pressure are 6MPa, collects volatile oil, obtains the extract of the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae.Described extract can, directly as Chinese medicine composition of the present invention, also can form Chinese medicine composition of the present invention with other drug composition jointly.
After testing, in described extract, the content of Alisol B monoacetate is 1.07wt%, and the content of atractylodes lactone B is 0.75wt%.
The extract of above-mentioned gained is ground into fine powder, adds polyvinylpyrrolidone 270g and HPMC (hydroxypropyl emthylcellulose) 100g to mix, granulate, sieve, tabletting, is dried, and makes the slow releasing tablet of medicine of the present invention.
embodiment 9
The present embodiment is used for illustrating Chinese medicine composition of the present invention and its preparation method and application.
Take Rhizoma Alismatis 1kg and Rhizoma Atractylodis Macrocephalae 5kg is mixed, pulverize, cross 80 mesh sieves, be placed in extraction kettle and carry out supercritical extraction, extraction temperature is 75 ℃, and extracting pressure is 35MPa, extraction time is 1h, flash trapping stage pressure is that 7MPa and the second-order separation pressure are 6MPa, collects volatile oil, obtains the extract of the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae.Described extract can, directly as Chinese medicine composition of the present invention, also can form Chinese medicine composition of the present invention with other drug composition jointly.
After testing, in described extract, the content of Alisol B monoacetate is 1.26wt%, and the content of atractylodes lactone B is 0.83wt%.
The extract of above-mentioned gained is ground into fine powder, adds vegetable oil 1000g, mix, adopt gelatin as capsule casing material, be pressed into soft capsule, make the soft capsule preparation of medicine of the present invention.
embodiment 10
The present embodiment is used for illustrating Chinese medicine composition of the present invention and its preparation method and application.
Take Rhizoma Alismatis 5kg and Rhizoma Atractylodis Macrocephalae 3kg is mixed, pulverize, cross 40 mesh sieves, be placed in extraction kettle and carry out supercritical extraction, extraction temperature is 40 ℃, and extracting pressure is 20MPa, extraction time is 1.5h, flash trapping stage pressure is that 7MPa and the second-order separation pressure are 6MPa, collects volatile oil, obtains the extract of the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae.Described extract can, directly as Chinese medicine composition of the present invention, also can form Chinese medicine composition of the present invention with other drug composition jointly.
After testing, in described extract, the content of Alisol B monoacetate is 1.35wt%, and the content of atractylodes lactone B is 0.82wt%.
The extract of above-mentioned gained is ground into fine powder, adds microcrystalline Cellulose 250g, mix, with the ethanol water of 75 volume %, granulate, in incapsulating, make the capsule of medicine of the present invention.
embodiment 11
The present embodiment is used for illustrating Chinese medicine composition of the present invention and its preparation method and application.
Take Rhizoma Alismatis 6kg and Rhizoma Atractylodis Macrocephalae 2kg is mixed, pulverize, cross 50 mesh sieves, be placed in extraction kettle and carry out supercritical extraction, extraction temperature is 60 ℃, and extracting pressure is 30MPa, extraction time is 2h, flash trapping stage pressure is that 7MPa and the second-order separation pressure are 6MPa, collects volatile oil, obtains the extract of the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae.Described extract can, directly as Chinese medicine composition of the present invention, also can form Chinese medicine composition of the present invention with other drug composition jointly.
After testing, in described extract, the content of Alisol B monoacetate is 1.12wt%, and the content of atractylodes lactone B is 0.55wt%.
The extract of above-mentioned gained is ground into fine powder, adds polyvinylpyrrolidone 250g and HPMC (hydroxypropyl emthylcellulose) 150g to mix, granulate, sieve, tabletting, is dried, and makes the slow releasing tablet of medicine of the present invention.
Although the present invention has carried out description to a certain degree, significantly, do not departing under the condition of the spirit and scope of the present invention, can carry out the suitable variation of each condition.Be appreciated that and the invention is not restricted to described embodiment, and be attributed to the scope of claim, it comprises the replacement that is equal to of described each factor.
Claims (15)
1. a Chinese medicine composition for blood fat reducing, this Chinese medicine composition comprises the extract of the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae, it is characterized in that, comprises the Alisol B monoacetate of 0.5～2wt% and the atractylodes lactone B of 0.1～1wt% in described Chinese medicine composition; In the mixture of described Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae, Rhizoma Alismatis is 1～10 weight portion, and the Rhizoma Atractylodis Macrocephalae is 0.1～10 weight portion;
The method of preparing described Chinese medicine composition comprises Amberlyst process or supercritical extraction;
Described Amberlyst process comprises: the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae is extracted with the ethanol water of 60～95 volume %, concentrated extracting solution, use macroporous adsorbent resin to adsorb, the ethanol water of water and 20～60 volume % cleans successively, then use the ethanol water eluting of 60～95 volume %, concentrated, dry to eluent, obtain described extract;
Described supercritical extraction comprises: the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae is pulverized, crossed 40～80 mesh sieves, be placed in extraction kettle and extract, extraction temperature is 35～75 ℃, and extracting pressure is 15～35MPa, and extraction time is 1～4h, collect volatile oil, obtain described extract.
2. Chinese medicine composition according to claim 1, wherein, in the mixture of described Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae, Rhizoma Alismatis is 5～10 weight portions, the Rhizoma Atractylodis Macrocephalae is 2～5 weight portions.
3. Chinese medicine composition according to claim 1, wherein, in the mixture of described Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae, Rhizoma Alismatis is 5～6 weight portions, the Rhizoma Atractylodis Macrocephalae is 2～3 weight portions.
4. the preparation method of the Chinese medicine composition described in any one in claims 1 to 3, this preparation method comprises Amberlyst process or supercritical extraction;
Described Amberlyst process comprises: the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae is extracted with the ethanol water of 60～95 volume %, concentrated extracting solution, use macroporous adsorbent resin to adsorb, the ethanol water of water and 20～60 volume % cleans successively, then use the ethanol water eluting of 60～95 volume %, concentrated, dry to eluent, obtain described extract;
Described supercritical extraction comprises: the mixture of Rhizoma Alismatis and the Rhizoma Atractylodis Macrocephalae is pulverized, crossed 40～80 mesh sieves, be placed in extraction kettle and extract, extraction temperature is 35～75 ℃, and extracting pressure is 15～35MPa, and extraction time is 1～4h, collect volatile oil, obtain described extract.
5. preparation method according to claim 4, wherein, in described Amberlyst process, extracts with the ethanol water of 80～90 volume %; Described macroporous adsorbent resin is selected from HPD-100 type macroporous adsorbent resin, HPD-300 type macroporous adsorbent resin, D101 type macroporous adsorbent resin and NKA-9 type macroporous adsorbent resin; Ethanol water eluting with 80～90 volume %;
In described supercritical extraction, pulverize, cross 40～60 mesh sieves, extraction temperature is 40～60 ℃, and extracting pressure is 20～30MPa, and extraction time is 1.5～2h.
6. preparation method according to claim 5, wherein, extracts 1～3 time with described ethanol water.
7. preparation method according to claim 6, wherein, each extraction time is 1～2h.
8. the application of the Chinese medicine composition described in any one in the medicine for the preparation of blood fat reducing in claims 1 to 3.
9. application according to claim 8, wherein, described medicine is used for preventing and treating high sticky blood, hyperlipemia or atherosclerosis.
10. a medicine for blood fat reducing, this medicine comprises the Chinese medicine composition described in any one in the claims 1 to 3 for the treatment of effective dose, and pharmaceutically acceptable adjuvant.
11. medicines according to claim 10, wherein, the preparation of described medicine is tablet, pill, granule or capsule.
12. medicines according to claim 11, wherein, described tablet is slow releasing tablet, controlled release tablet, dispersible tablet, oral cavity disintegration tablet, chewable tablet or buccal tablet.
13. medicines according to claim 11, wherein, described pill is drop pill.
14. medicines according to claim 11, wherein, described capsule is soft capsule.
The preparation method of the medicine in 15. claim 10 to 14 described in any one, this preparation method comprises: described Chinese medicine composition is mixed with described pharmaceutically acceptable adjuvant.
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| CN104042678B (en) * | 2014-06-13 | 2015-08-12 | 河南中医学院 | A kind of treat hyperlipemia pharmaceutical composition and preparation method and purposes |
| CN104622882B (en) * | 2015-01-12 | 2017-12-05 | 青岛市中心医院 | For treating the medical composition and its use of atherosclerosis |
| CN104622883B (en) * | 2015-01-12 | 2017-12-05 | 青岛市中心医院 | Pharmaceutical preparation for treating atherosclerosis and preparation method thereof |
| CN106596762B (en) * | 2016-12-08 | 2019-08-23 | 正大青春宝药业有限公司 | A method of atractylodes lactone III and Alisol B monoacetate content in detection ZEXIE TANG standard particle |
| CN116898952B (en) * | 2023-07-13 | 2024-03-15 | 上海国创医药股份有限公司 | Alismatis rhizoma soup with effects of invigorating spleen, promoting diuresis, eliminating phlegm and removing water retention, and its preparation method |
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