CN100341547C - Medicinal composition for regulating blood fat, prepn. method and use thereof - Google Patents
Medicinal composition for regulating blood fat, prepn. method and use thereof Download PDFInfo
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Abstract
The present invention provides medication composition which performs functions of regulating blood fat and a preparation method thereof. The medication composition is medicament formed by using 4 shares of hawthorn, 3 shares of white atractylodes rhizome, 3 shares of water plantain and 2 shares of red rice as raw materials. The present invention also provides the purpose of the medication composition in medicine for preparing and treating hyperlipemia and fatty liver. The medication preparation has the advantage of scientific and reasonable technology, and products obtained by the preparation method for the medication composition of the present invention have the advantages of small clinic use dosage, low raw material cost, conspicuous clinic curative effects, small toxic side effects, convenient use and stable and controllable quality; thus, the present invention provides a new medication selection for clinic.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and its production and use, relating in particular to a kind of is the pharmaceutical composition and its production and use of feedstock production with the Chinese medicine compound, belongs to the field of Chinese medicines.
Background technology
Raising and aged tendency of population along with people's living standard, (mainly show as serum cholesterol TC, triglyceride TG raises hyperlipemia, HDL-C HDL-C reduction) sickness rate rises year by year, because of the hyperlipemia that lipid metabolic disorder causes, become the important pathogenic factors of commonly encountered diseases such as fatty liver, coronary heart disease and atherosclerosis.
Hyperlipemia belongs to categories such as the traditional Chinese medical science " expectorant is turbid ", " blood stasis ", and it is impaired that pathogenesis mostly is spleen fortuneization function, and the body fluid operation is unfavorable, and it is long-pending to cause wet polyester eventually, and the QI and blood retardance forms.Long-term a large amount of clinical practice shows that it is little that the Chinese medicine hyperlipemia has side effect, eutherapeutic good advantage.
The report of Chinese medicine hyperlipemia is more at present, at different etiology and pathogenesis, and dialectical difference, prescription is also different.Reports such as Yang Jun, blood fat reducing electuary (prescription is made up of Radix Puerariae, Rhizoma Alismatis, Radix Angelicae Sinensis, Radix Polygoni Multiflori, Fructus Crataegi etc.) has remarkable effect for reducing fat to the experimental hyperlipidemia animal pattern, be used for the treatment of various hyperlipemia with its electuary of making and have sure curative effect [Chinese herbal medicine, 1997,28 (4): 225-228]; Reports such as Dong Fuyun, fat reducing liver protecting capsule (prescription Radix Polygoni Multiflori, Fructus Crataegi, Fructus Lycii, Rhizoma Alismatis, Flos Chrysanthemi etc.) can significantly reduce experimental hyperlipidemia animal lipid [time precious traditional Chinese medical science traditional Chinese medicines, 2000,18 (11): 4]; Reports such as Li Kui are fermentation raw material by Oryza glutinosa, and the health care blood fat reducing rice vinegar that adding Rhizoma Alismatis, Fructus Crataegi, dried tangerine peel, Fructus Lycii, Radix Salviae Miltiorrhizae, Rhizoma Zingiberis, Rhizoma Chuanxiong develop has good effect for reducing fat [food industry, 2000, (5): 27-28]; Reports such as Cui Chunli, the clinical treatment that is used for hyperlipemia of compound red leaven capsule (prescription is made up of Monas cuspurpureus Went, Semen Ginkgo, Radix Salviae Miltiorrhizae etc.) has reliable clinical efficacy [Chinese patent medicine, 2002,24 (2): 107-110]; Chinese patent CN1398632 discloses a kind of pharmaceutical composition with blood lipid regulation, is made up of Herb Gynostemmae Pentaphylli total glycosides powder, Monascus ruber mycopowder, Fructus Gardeniae.Chen Wenhui etc. have reported the good fortune be made up of 9 herbal medicines such as the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Radix Notoginseng, Pericarpium Citri Reticulatae Viride, Fructus Crataegi and the liver fat ball clinical treatment fatty liver curative effect obviously [Yunnan University of Traditional Chinese Medicine's journal, 2002,25, (30): 4-6] that disappears; Zhao Ying etc. report oral spleen invigorating removing food stagnancy soup (Rhizoma Atractylodis Macrocephalae 15g, Poria 15g, Rhizoma Alismatis 20g, Fructus Crataegi 30g, Fructus Aurantii 15g, Cortex Magnoliae Officinalis 12g, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 9g, Rhizoma Acori Graminei 6g, Radix Paeoniae Alba 10g, Radix Salviae Miltiorrhizae 15g) clinical treatment fatty liver [journal of shanghai Chinese medicine, 2002, (1): 25] evident in efficacy.2000 editions " the Chinese pharmacopoeia using dosage of having put down in writing Fructus Crataegi is 9～12g, and the using dosage of the Rhizoma Atractylodis Macrocephalae is 6～12g, and the using dosage of Rhizoma Alismatis is 6～9g, does not put down in writing Monas cuspurpureus Went and using dosage thereof.Its " main flavour of a drug are Fructus Crataegi, the Rhizoma Atractylodis Macrocephalae, Monas cuspurpureus Went etc. " disclosed in tcm product-" zhibituo capsule " package insert that Chengdu Diao 9 Wang pharmaceutical factory is produced, promptly this description discloses with present composition raw material and has formed akin prescription, but unexposed its prescription drug using dosage and process for preparing medicine thereof (comprising raw material separation-extraction technology, preparation processing method).What need further specify is that in the herbal mixture prescription, the proportion compatibility of each material medicine and using dosage are very important, are the principal elements of influence and decision herbal mixture curative effect.In other disclosed herbal mixtures, do not see with present composition raw material and form identical or similar herbal mixture.
Summary of the invention
It is the pharmaceutical composition with blood lipid regulation effect of feedstock production with the Chinese medicine compound that technical scheme to be solved by this invention provides a kind of, and the present invention also provides this preparation of drug combination method and purposes.
The invention provides a kind of pharmaceutical composition with blood lipid regulation effect, it is the medicament of being made by following raw materials by weight proportions: 4 parts of Fructus Crataegis, 3 parts of the Rhizoma Atractylodis Macrocephalaes, 3 parts of Rhizoma Alismatis, 2 parts in Monas cuspurpureus Went.
Further, the invention provides a kind of pharmaceutical composition with blood lipid regulation effect, it is the medicament of the clinical consumption of satisfied adult/day of being made by following raw materials by weight proportions: Fructus Crataegi 4g, and Rhizoma Atractylodis Macrocephalae 3g, Rhizoma Alismatis 3g, Monas cuspurpureus Went 2g can divide to orally use for 2～3 times.
Wherein said medicament is an oral formulations, preferably capsule.
Contain ursolic acid in every preparation unit of wherein said medicament and be no less than 2.2mg.Wherein ursolic acid and oleanolic acid are by ursolic acid, and ursolic acid reaches the purpose that whole pharmacy quality is controlled as the index composition by the quality control to ursolic acid.
The present invention also provides this preparation of drug combination method, and its step comprises:
A, to take by weighing the following traditional Chinese medicines material be raw material:
4 parts of Fructus Crataegis, 3 parts of the Rhizoma Atractylodis Macrocephalaes, 3 parts of Rhizoma Alismatis, 2 parts in Monas cuspurpureus Went;
B, usefulness alcohol or the above medical material of aquiferous ethanol co-extracted filter, and get filtrate A;
C, filtrate A reclaim ethanol, and concentrating under reduced pressure gets extractum B;
D, extractum B add suitable quantity of water, leave standstill, and be centrifugal, gets supernatant C and deposit D, with the deposit D drying, as active ingredient I;
E, supernatant C be by the good resin column of pretreatment, is washed to colourlessly, and reuse ethanol is washed till colourless, collects eluent, reclaims ethanol, and concentrate drying gets thick paste E, as active ingredient II;
F, active ingredient I, II add mixing acceptable accessories, make various dosage forms.
In the said method, the used concentration of alcohol of step b is the ethanol of 30-95%, and preferred 80% ethanol, extracting method are heating and refluxing extraction, and extraction time is 1～3 time, and extraction time is 0.5～1.5 hour; The steps d amount of water is 3～7 times; The used concentration of alcohol of step e is 50～80%, preferred 70% ethanol; Among the step f, active ingredient I and II add acceptable accessories after mixing again, make various dosage forms; Or in active ingredient I, add acceptable accessories earlier, again itself and active component II are mixed and made into pharmaceutical preparation.
In order to improve impurities removing efficiency, further reach the purpose that reduces dosage, need to reduce its paste-forming rate, keep its effective ingredient simultaneously to greatest extent.In the relevant Study on extraction of present composition preparation method step b, the inventor has carried out screening study to extracting choice of Solvent, because Fructus Crataegi, the Rhizoma Atractylodis Macrocephalae, Rhizoma Alismatis, the main effective ingredient of Monas cuspurpureus Went four Chinese medicine thing mostly is liposoluble constituent (as ursolic acid, atractylodes lactone, alisol etc.), consider that simultaneously Chinese medicine tradition medication custom is the decocting decoction, so respectively to water, 50% ethanol, 60% ethanol, 70% ethanol, several extraction solvents of 80% ethanol screen, and simultaneously so that ursolic acid and general flavone content are as evaluation index in extractum yield and the extractum, The selection result is as follows:
| Extract solvent | Ursolic acid (mg/g) | Total flavones (mg/g) | Extractum (g/g) |
| Water 50% ethanol 60% ethanol 70% ethanol 80% ethanol | Do not detect 0.290 0.439 0.500 0.540 | 0.525 0.695 0.695 0.705 0.705 | 0.395 0.284 0.264 0.254 0.226 |
According to above The selection result, select ethanol extraction to be better than water extraction, serve as that to extract solvent gained extract content minimum with 80% ethanol, and effective ingredient ursolic acid, content of total flavone are the highest.
The character of the composition that the herbal mixture thing is contained according to the present invention and relevant experimentation, present composition preparation method employing water precipitating-resin adsorption method are carried out the purification remove impurity and (are seen steps d and step e), to improve active constituent content, dwindle the drug administration amount.Discover by experiment, if adopt the remove impurity of conventional filtration method in the steps d, need leave standstill behind the water precipitating 10 hours that wait to precipitate could filter after the complete sedimentation and divide the limit precipitation, the operating time is long, difficulty is big, precipitates to lose greatly.And the employing centrifugal separation only need leave standstill and can carry out centrifugally in 0.5-1 hour, and the operating time is short, and difficulty is little, and precipitation is easily divided and got and lose very little.Extract is divided into precipitation and supernatant two parts after water precipitating is centrifugal, after testing, the master contains ursolic acid and water-insoluble flavones ingredient in the precipitation, mainly contains the water solublity flavone in the supernatant.At water-soluble flavone constituents in the supernatant, adopt macroreticular resin absorbing method to separate again.Macroporous resin separates back gained extractum, after testing, has kept flavones ingredient substantially, has removed micromolecular polysaccharide and monosaccharide impurity.
Said composition preparation method provided by the invention by rational separation-extraction technology and purification impurity removal process, has been removed impurity effectively and has been kept effective ingredient.
The present invention also provides the purposes of each raw material in the medicine of preparation treatment hyperlipemia of weight proportion.
The present invention also provides the purposes of each raw material in the medicine of preparation treatment fatty liver of weight proportion.
The inventor is based on the medication experience of long-term clinical treatment hyperlipemia, and the experimentation and the clinical research of process system, a kind of effective Chinese medicine composition for the treatment of hyperlipemia and fatty liver is provided, the crude drug of this pharmaceutical composition fewer but better (forming) by Fructus Crataegi, the Rhizoma Atractylodis Macrocephalae, Rhizoma Alismatis, Monas cuspurpureus Went four Chinese medicine thing, has the expectorant blood stasis dispelling, the function of invigorating the spleen and regulating the stomach, be used for the treatment of hyperlipemia and fatty liver, the clinical dosage of its every day only is: Fructus Crataegi 4g, Rhizoma Atractylodis Macrocephalae 3g, Rhizoma Alismatis 3g, Monas cuspurpureus Went 2g, can decoct according to a conventional method, divide to orally use for 2～3 times; And by the capsule of the inventive method preparation, then drug effect is better, takes more conveniently, and this dosage be the optimum adult effective dose on the one through long-term clinical application summary.Chinese medicine thinks that the basic pathogenesis of hyperlipemia is a deficiency in origin and excess in superficiality, and deficiency in origin mostly is insufficiency of the spleen or suffers from a deficiency of the kidney, the real turbid and blood stasis of expectorant that mostly is of mark.Be monarch drug with the Fructus Crataegi in the prescription, relieving dyspepsia repercussive, invigorating the spleen and regulating the stomach; The Rhizoma Atractylodis Macrocephalae, Rhizoma Alismatis, Monas cuspurpureus Went are minister, and be auxilliary mutually with Fructus Crataegi, plays invigorating the spleen and regulating the stomach altogether, the merit of expectorant blood stasis dispelling, the traditional Chinese medical science basic pathogenesis of the hyperlipemia of hitting.
Pharmaceutical composition of the present invention has following significant advantage characteristics: one, and the compatibility of drugs science is precise and appropriate, and drug use dosage is little, and cost of material reduces.Full side only is made up of the four Chinese medicine thing, four Chinese medicine thing compatibility, and mutual Synergistic, its using dosage (by oral consumption adult's every day) all is starkly lower than the using dosage in the wherein existing open source literature.Its two, preparation technology is scientific and reasonable, has kept the active component of medicine to greatest extent, has dwindled greatly simultaneously and has taken injection volume, it is reliable to make pharmaceutical preparation reach curative effect, dose is little, taking convenience.Its three, clinical efficacy is remarkable, toxic and side effects is little.Its four, the quality of the pharmaceutical preparations is stable, controlled, reaches the purpose of whole quality of the pharmaceutical preparations control by the quality control to the ursolic acid in the medicament.Using to clinical treatment hyperlipemia and fatty liver of pharmaceutical composition of the present invention provides a kind of new medication to select.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
Embodiment 1: the preparation of medicament composition capsule agent of the present invention:
Fructus Crataegi 2000g Rhizoma Alismatis 1500g Rhizoma Atractylodis Macrocephalae 1500g Monas cuspurpureus Went 1000g
Above four Chinese medicine material adds 6 times of amounts of 80% ethanol, common reflux, extract, three times, each 1.5 hours.Filter, filtrate recycling ethanol to relative density is 1.00～1.03 (60 ℃), and being evaporated to relative density is 1.20～1.25 (60 ℃), adds 4～5 times of water gagings, leaves standstill, centrifugal, divides and gets precipitation, drying.Supernatant is by the good macroporous resin column of pretreatment, is washed to colourlessly, and reuse 70% ethanol is washed till colourless, collects eluent, reclaims ethanol, be condensed into thick paste, drying merges with above-mentioned exsiccant centrifugation, pulverizes, and sieves, it is an amount of to add micropowder silica gel, mixing, and 1000 of capsules are made in packing.Every capsules specification 240mg is equivalent to crude drug in whole 6g, and promptly every gram capsule medicated powder is equivalent to crude drug in whole 25 grams.According to the capsule preparations that this preparation method is made, clinical hyperlipemia or the treatment fatty liver of being used for the treatment of, 2 of every days, each 1 sooner or later, dose is little, taking convenience.
According to above preparation technology, after testing, the ursolic acid rate of transform is 94.5%, the total flavones rate of transform is 99.7%, and the Rhizoma Atractylodis Macrocephalae, Rhizoma Alismatis, Monas cuspurpureus Went liposoluble constituent thin layer chromatogram are strong positive, and paste-forming rate reduces to 3.45% by 27.9%, show that this preparation technology is scientific and reasonable, keep the main effective ingredient of Chinese medicine, significantly reduced the volume of taking medicine simultaneously, reached the purpose of remove impurity.
The assay of embodiment 2 pharmaceutical composition quality control index compositions of the present invention:
Get the content of 10 of this product, mixing is got 0.2g, the accurate title, decide, and puts in the 100ml conical flask, and 20ml adds diethyl ether, supersound process 10 minutes (psychrolusia) filters, with ether washing precipitation secondary, each 20ml, filtrate merges, and evaporate to dryness, residue add dehydrated alcohol to be made dissolving and be transferred in the 10ml measuring bottle, and be diluted to scale, as need testing solution.Other gets the ursolic acid reference substance, adds dehydrated alcohol and makes the solution that every 1ml contains 0.3mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw need testing solution 5 μ l, reference substance solution 5 μ l and 10 μ l, the cross point is on same silica gel g thin-layer plate respectively, (38.5: 1.5: 4) are developing solvent with chloroform-methanol-formic acid, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, 110 ℃ of bakings 5-7 minute, clear to the speckle color, take out, on lamellae, cover onesize glass plate, use immobilization with adhesive tape on every side, scan wavelength X according to thin layer chromatography (an appendix VIB of Chinese Pharmacopoeia version in 2000 thin layer chromatography scanning)
s=537nm, λ
R=700nm measures test sample trap and reference substance trap integrated value, calculates, promptly.
Every of this product contains ursolic acid and oleanolic acid with ursolic acid (C
30H
48O
3) meter, must not be less than 2.2mg.
Below prove beneficial effect of the present invention by pharmacodynamics test, toxicology test.
Test example 1 pharmaceutical composition of the present invention is to the influence of rat food hyperlipemia
The inventor confirms that by the pharmacological testing comparative study to this Chinese medicine compound compositions and single Monas cuspurpureus Went medicine the treatment that said composition is used for hyperlipemia has significant more pharmacologically active.
1, experiment material:
Medicine: Chinese medicine compound composition capsule: press the preparation of embodiment 1 method, hereinafter to be referred as the ZHHW capsule, the 240mg/ grain is equivalent to the 6.0g crude drug in whole, and promptly every gram capsule medicated powder is equivalent to crude drug in whole 25 grams.
Single Monas cuspurpureus Went medicine: with reference to the preparation of embodiment 1 method, hereinafter to be referred as DHQ, every gram capsule medicated powder is equivalent to crude drug in whole 35 grams.
Reagent: serum total cholesterol (TC) test kit; Triglyceride (TG) test kit, HDL-C (HDL-C) test kit is produced by Shanghai Rongsheng Bioisystech Co., Ltd.Low-density lipoprotein cholesterol (LDL-C) test kit is produced by giving birth to biological high-technology company in Beijing.
Animal: the Wistar rat, male, body weight 150-200g is provided instrument by Shandong Province's Experimental Animal Center: 721 type spectrophotometers: Shen, Shanghai instrument automatic control company produces.Centrifugal precipitation mechanism: the LXJ-II type, the Shanghai second analytical tool factory produces.
2, experimental technique
60 of the Wistar rats of hyperlipemia modeling: body weight 150-200g, be divided into general (10 of the groups of raising, male and female half and half) and high fat modeling group (50), giving normal diet and high lipid food (cholesterol 2%, cholate 1%, Adeps Sus domestica 5%, normal feedstuff 92%) respectively raises, continuously, fasting in evening on the 28th, cut tail and get blood morning next day, separation of serum.Enzymatic assays serum TC, TG; The PVS one step sedimentation method are surveyed serum LDL-C; The Polyethylene Glycol method is surveyed Serum HDL-C.
Test of cure: high fat modeling animal is divided at random according to blood fat TC level: the general group of raising, model group, Chinese medicine compound compositions of the present invention is (hereinafter to be referred as ZHHW, being embodiment 1 gained capsule) high dose group is (by crude drug in whole, 4g/kg), middle dosage group is (by crude drug in whole, 2g/kg), low dose group is (by crude drug in whole, 1g/kg), and single Monas cuspurpureus Went medicine group is (hereinafter to be referred as DHQ, by crude drug in whole, 4g/kg), 10 every group, male and female half and half, each group gave 0.5% sodium carboxymethyl cellulose (CMC-Na) simultaneously on 1, ZHHW 4,2,1g/kg, DHQ 4mg/kg.Each medicine all is made into suspension with 0.5%CMC-Na during administration, irritates stomach every day once, and the administration volume is 1ml/100g, continues to give high lipid food simultaneously.The 2nd, 4 weeks got blood and survey every index after administration.
3, result of the test
The results are shown in Table 1-4, meet implication in each table and be expressed as follows:
* compare with model group; ▲ with administration before compare
*P＜0.05 ▲P＜0.05 **P＜0.01 ▲▲P＜0.01
The influence of table 1 pair hyperlipidemia rats serum TC (mmol/L)
| Medicine | Dosage (g/kg) | Before the medicine | Two weeks behind the medicine | Around behind the medicine |
| The general group model group ZHHW group DHQ group of raising | / Veh 1 2 4 4 | 1.929±0.501** 3.994±0.625 3.994±0.671 4.010±0.732 4.055±0.783 4.130±0.916 | 2.080±0.605** 5.148±1.082▲▲ 4.136±0.747*▲▲ 3.339±0.935**▲ 2.675±0.655**▲▲ 3.336±0.856**▲ | 2.033±0.552** 6.045±1.429▲▲ 4.483±1.395*▲ 3.290±0.769**▲ 2.628±0.475**▲▲ 3.148±0.524**▲▲ |
The influence of table 2 couple hyperlipidemia rats serum LDL-C (mmol/L)
| Medicine | Dosage (g/kg) | Before the medicine | Two weeks behind the medicine | Around behind the medicine |
| The general group model group ZHHW group DHQ group of raising | / Veh 1 2 4 4 | 0.849±0.395** 2.769±0.597 2.788±0.653 2.771±0.711 2.832±0.824 2.743±0.653 | 0.823±0.741** 4.201±1.308▲▲ 3.272±0.969* 1.925±0.749**▲▲ 1.302±0.492**▲▲ 2.322±0.661**▲ | 0.793±0.310** 4.031±0.966▲▲ 2.930±0.409** 1.801±0.275**▲▲ 1.101±0.290**▲▲ 2.184±0.253**▲ |
The influence of table 3 pair hyperlipidemia rats Serum HDL-C (mmol/L)
| Medicine | Dosage (g/kg) | Before the medicine | Two weeks behind the medicine | Around behind the medicine |
| The general group model group ZHHW group DHQ group of raising | / Veh 1 2 4 4 | 0.908±0.226** 0.584±0.201 0.565±0.161 0.546±0.138 0.572±0.148 0.549±0.161 | 0.947±0.191** 0.358±0.195▲ 0.518±0.263 0.958±0.205**▲▲ 1.034±0.149**▲▲ 0.742±0.170*▲ | 0.891±0.310** 0.348±0.196▲▲ 0.468±0.113 0.941±0.477**▲▲ 1.138±0.439**▲▲ 0.764±0.365*▲ |
The influence of table 4 pair hyperlipidemia rats serum TG (mmol/L)
| Medicine | Dosage (g/kg) | Before the medicine | Two weeks behind the medicine | Around behind the medicine |
| The general group model group ZHHW group DHQ group of raising | / Veh 1 2 4 4 | 0.786±0.244 1.307±0.588 1.332±0.371 1.303±0.290 1.309±0.439 1.297±0.372 | 0.925±0.260* 1.533±0.321 1.308±0.274 1.073±0.402** 0.926±0.278**▲ 1.421±0.380 | 0.790±0.146** 1.923±0.426▲▲ 1.481±0.451* 1.165±0.324** 0.886±0.330**▲ 1.799±0.439 |
Table 1-4 result show, fed with high 2-4 is after week, and hyperlipemia forms, the modeling success.Each dosage group of Chinese medicine compound composition Z HHW of the present invention (4g/kg, 2g/kf, 1g/kg) is after gastric infusion 2-4 week, rat food hyperlipemia there is the obvious treatment effect, show as the rising that is the high fat moulding of dose-dependent inhibition Serum TC, LDL-C, TG, Serum HDL-C is then had rising or suppresses its continuation reduction effect.Single Monas cuspurpureus Went medicine DHQ group (4g/kg) has the effect that suppresses high fat moulding Serum TC, LDL-C rising, but rat blood serum TG and HDL-G are not had obvious influence.Under identical dosage (all by being equivalent to 4g crude drug in whole/kg), Chinese medicine compound compositions effect for reducing fat of the present invention obviously is better than single Monas cuspurpureus Went medicine, pharmaceutical composition of the present invention is described, mutual compatibility by the different Chinese medicines of four flavors, meet Chinese medical theory, bring into play synergistic function, obtained even more ideal lipid-lowering effect.
The clinical trial of test example 2 treatment fatty livers
Collect (the diagnostic criteria: ultrasound diagnosis Diagnosis of Fatty, reference " practical digestion is sick to be learned " of 20 routine Patients with Fatty Liver; Lab testing is with reference to " new Chinese medicine clinical guidance principle ", triglyceride (TG)＞1.7mmmol/L, cholesterol (TC)＞5.7mmol/L, serum glutamic pyruvic transminase (ALT)＞60IU/L.), take the capsule of embodiment 1, usage be one time 1,2 times on the one, 4 weeks were a course of treatment, treated 3 courses of treatment continuously.
Curative effect determinate standard: formulate standard with reference to " new Chinese medicine clinical guidance principle ", " practical digestion is sick to be learned " and pertinent literature: recovery from illness: subjective symptoms disappearance, TC≤5.7mmol/L, TG≤1.7mmol/L/L, ALT≤60IU/L, B ultrasonic show liver sign liver luminous point, its back court echo recovery normally.Produce effects: symptom is clearly better, TC descends＞and 20%, TG descends＞40%, and ALT descends 〉=50% or normal, and B ultrasonic liver densities of points of light is clearly better, and echo attenuation thereafter obviously alleviates.Effectively: symptom take a favorable turn, TC decline 10%-20%, and TG decline 20%-40%, ALT descend＜50% or normal, the more preceding improvement of B ultrasonic liver sign.Invalid or worsen: subjective symptoms still exists or increases the weight of, TC and (or) TG and (or) ALT and (or) B ultrasonic acoustic inspection no change or increase the weight of.
Therapeutic outcome: treat 20 examples, 3 examples of fully recovering, produce effects 7 examples, effective 6 examples, invalid 4 examples, total effective rate 80%.
The clinical trial explanation, pharmaceutical composition of the present invention has the effect of treatment fatty liver.
The acute toxicity testing of test example 3 medicament composition capsule agent of the present invention
1, experiment material:
Be subjected to reagent thing: embodiment 1 gained capsule, the 240mg/ grain is equivalent to the 6.0g crude drug in whole.
Animal: the NIH mice, body weight 18～22g, Huaxi Medical Univ's Experimental Animal Center provides.
2, experimental technique
Get embodiment 1 gained capsule medicated powder 8g adding distil water 22ml (can just irritate the concentration of stomach), 8g medicine medicated powder of the present invention is equivalent to the 200g crude drug, and every 1ml medicinal liquid is equivalent to the 9.1g crude drug.Get 20 of body weight 20 ± 1g healthy mices, male and female half and half, after stopping eating 8 hours with medicinal liquid by gastric infusion of 0.4ml/10g (being equivalent to crude drug 364g/kg).Conscientiously observe the toxic reaction situation behind the animals administer and write down animal outward appearance, behavioral activity, the mental status, appetite, large and small just its color, had or not situations such as abnormal secretion thing, body weight change and death by hair, skin, breathing, nose, eye, oral cavity etc.If any death, in time perform an autopsy on sb, do pathologic finding if any pathological changes, observed continuously seven days.
3, experimental result
Giving mouse stomach (0.4ml/10g) dosage by the maximum concentration that can irritate stomach (every ml is equivalent to crude drug 9.1g) is 364g/kg, convert 1820 times that are equivalent to adult's (60kg) usual amounts every day by kg body weight, none poisoning and death in 20 mices seven days illustrate that the oral safety of embodiment 1 gained medicine capsule of the present invention is good.
By above-mentioned pharmacodynamics test and toxicological test, prove absolutely that four flavor crude drug of medicine of the present invention are fewer but better, be not to choose at random, but under Chinese medical theory instructs, science compatibility, Synergistic mutually, to the those skilled in the art, be not apparent.Drug combination preparation craft science of the present invention is reasonable, adopts the drug use dosage of preparation of drug combination method gained of the present invention little, and cost of material is low, clinical efficacy is remarkable, and toxic and side effects is little, and is easy to use, steady quality, controlled, provide a kind of new medication to select for clinical.
Claims (8)
1, a kind of pharmaceutical composition with blood lipid regulation effect is characterized in that: it is a kind of medicament, wherein makes this medicament raw materials of effective components medicine and consists of: 4 parts of Fructus Crataegis, 3 parts of the Rhizoma Atractylodis Macrocephalaes, 3 parts of Rhizoma Alismatis, 2 parts in Monas cuspurpureus Went.
2, the pharmaceutical composition with blood lipid regulation effect according to claim 1, it is characterized in that: it is the medicament of the clinical consumption of a kind of satisfied adult/day, wherein makes this medicament raw materials of effective components medicine and consists of: Fructus Crataegi 4g, Rhizoma Atractylodis Macrocephalae 3g, Rhizoma Alismatis 3g, Monas cuspurpureus Went 2g.
3, the pharmaceutical composition with blood lipid regulation effect according to claim 1 and 2, it is characterized in that: described medicament is an oral formulations.
4, according to claim 1,2 or 3 described pharmaceutical compositions with blood lipid regulation effect, it is characterized in that: described oral formulations is a capsule.
5, according to claim 1,2,3 or 4 described pharmaceutical compositions with blood lipid regulation effect is characterized in that: contain ursolic acid in every preparation unit of described medicament and be no less than 2.2mg.
6, the described preparation of drug combination method of claim 1 with blood lipid regulation effect, its step comprises:
A, to take by weighing the following traditional Chinese medicines material be raw material:
4 parts of Fructus Crataegis, 3 parts of the Rhizoma Atractylodis Macrocephalaes, 3 parts of Rhizoma Alismatis, 2 parts in Monas cuspurpureus Went;
B, usefulness alcohol or the above medical material of aquiferous ethanol co-extracted filter, and get filtrate A;
C, filtrate A reclaim ethanol, and concentrating under reduced pressure gets extractum B;
D, extractum B add suitable quantity of water, leave standstill, and be centrifugal, gets supernatant C and deposit D, with the deposit D drying, as active ingredient I;
E, supernatant C be by the good resin column of pretreatment, is washed to colourlessly, and reuse ethanol is washed till colourless, collects eluent, reclaims ethanol, and concentrate drying gets thick paste E, as active ingredient II;
F, active ingredient I, II add mixing acceptable accessories, make pharmaceutical preparation.
7, the purposes of each raw material of the described weight proportion of claim 1 in the medicine of preparation treatment hyperlipemia.
8, the purposes of each raw material of the described weight proportion of claim 1 in the medicine of preparation treatment fatty liver.
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| CN100594924C (en) * | 2006-04-17 | 2010-03-24 | 山西亚宝药业集团股份有限公司 | Traditional Chinese medicine composition for lowering blood-lipid, and method for preparing the same |
| CN102670874B (en) * | 2011-03-14 | 2016-01-06 | 福建省医学科学研究院 | A kind of to medicative compound preparation of fatty liver and preparation method thereof |
| CN103372114B (en) * | 2012-04-20 | 2015-01-21 | 北京北大维信生物科技有限公司 | Red rice and rhizoma alismatis medicinal composition for regulating blood fat and preparation method of composition |
| CN103230482B (en) * | 2013-03-15 | 2015-01-28 | 新疆医科大学第一附属医院 | Extract for reducing blood pressure and adjusting blood fat and its preparation method and use |
| CN103520401B (en) * | 2013-10-21 | 2016-03-02 | 华夏先葆(北京)中药研究院有限公司 | A kind of Traditional Chinese medicine health-preserving preparation with auxiliary lipid-lowering function |
| CN104042801A (en) * | 2014-07-08 | 2014-09-17 | 福建中医药大学 | Preparation process of rhizoma alismatis lipid-lowering condensed pills |
| CN104055966A (en) * | 2014-07-08 | 2014-09-24 | 福建中医药大学 | Rhizoma alismatis lipid-reducing concentrated pill |
| CN114432376A (en) * | 2020-11-05 | 2022-05-06 | 北京中医药大学 | Blood fat regulating pharmaceutical composition and preparation thereof |
| CN113244358A (en) * | 2021-07-02 | 2021-08-13 | 哈尔滨珍宝制药有限公司 | Traditional Chinese medicine composition for treating hyperlipidemia and preparation method and application thereof |
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