CN103705594B - Chinese medicine composition for the treatment of hyperlipemia and preparation method thereof - Google Patents
Chinese medicine composition for the treatment of hyperlipemia and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of Chinese medicine composition for the treatment of hyperlipemia, this Chinese medicine composition is prepared from by the Chinese medicine extract comprising following weight proportion: Folium Nelumbinis extract 40-80 part, Radix Salviae Miltiorrhizae extract 10-20 part, Fructus Crataegi extract 30-60 part, Fructus Psoraleae extract or stir-baked SEMEN PSORALEAE with salt solution extract 10-20 part, Folium Sennae extract 1-3 part.The invention also discloses a kind of preparation method of Chinese medicine composition.The good drug efficacy of Chinese medicine composition of the present invention.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition for the treatment of hyperlipemia and preparation method thereof, belong to the field of Chinese medicines.
Background technology:
Hyperlipemia causes atherosclerosis to be cause the main cause of coronary heart disease, hypertension and angiopathy.The situation is tense for population of China dyslipidemia, the health of serious threat our people.China 18 years old and above adult's dyslipidemia total prevalence rate reach 18.6%, and namely patients with dyslipidemia reaches 1.6 hundred million; And the sickness rate of dyslipidemia just tends to rejuvenation, middle age is close with old people's prevalence.Therefore, carry out the early prevention and treatment of dyslipidemia, effective, that toxic and side effects the is little medicine of research adjusting blood lipid is very important.
Clinically, treatment hyperlipidemia, Western medicine generally adopts the treatments such as Statins, bile acid binding resin class, polyenoic fatty acids, fibric acid and nicotinic acid class, although determined curative effect, usually causes diarrhoea, abdominal distention, headache, dizzy, nauseating, erythra; Even cause the untoward reaction such as myositis, smooth muscle dissolving.And clinical research in recent years proves, much Chinese medicine all has the effect reducing blood fat, and as Semen Cassiae, Rhizoma Alismatis, Radix Et Rhizoma Rhei, Radix Polygoni Multiflori, Flos Carthami, Folium Ginkgo etc., antilipemic Chinese herbal medicine has determined curative effect, without the advantage of obvious toxic and side effects.Be principal agent as disclosed a kind of in patent CN02139069.X with Folium Nelumbinis, circulation of qi promoting damp eliminating, coordinate Fructus Crataegi to regulate the flow of vital energy to help digestion, Folium Sennae loosening bowel to relieve constipation and resolving phlegm lowering turbidity, with stir-baked SEMEN PSORALEAE with salt solution temperature compensation Liver and kidney, Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, the Hedan tablet of clinical treatment dyslipidemia.But because of comparatively morning its research and development time, limit by research level at that time, its Chinese crude drug mostly is the semifinished product only slightly carried, have that effective component content is low, dose be large, absorb not exclusively, bioavailability is low, drug effect play comparatively slow, carry the deficiencies such as inconvenient.
Hedan tablet is a kind of Chinese patent medicine produced by Nanchang Jishun Pharmaceutical Co., Ltd., and prescription is Folium Nelumbinis, Radix Salviae Miltiorrhizae, Fructus Crataegi, Folium Sennae, Fructus Psoraleae.Function cures mainly as resolving phlegm lowering turbidity, blood circulation promoting and blood stasis dispelling.Clinical genus for hyperlipemia holds phlegm-turbidity and blood stasis card marquis person under the arm.
What pellet preparation existing is prepared from according to traditional handicraft, dose is large, taste is bitter, the content of drug effect components simultaneously extracted is low, the present invention is through research, pass through Folium Nelumbinis on the basis of existing technology, Radix Salviae Miltiorrhizae, Fructus Crataegi, stir-baked SEMEN PSORALEAE with salt solution, the extracting method of Folium Sennae carries out craft screening, have selected a kind of selected extraction, purification, process for refining, remove most of impurity in medical material and also retain the effective ingredient of each flavour of a drug to greatest extent, make the extract of active constituent content more than 50%, and by further preparation process, be prepared into curative effect excellent, the quality of the pharmaceutical preparations is high, shelf time is long, good stability, the modern Chinese medicine preparation that outward appearance is beautiful, the medication demand of hyperlipidaemic conditions patient can be met better.
Summary of the invention:
The object of the present invention is to provide a kind of Chinese medicine composition for the treatment of hyperlipidemia and preparation method thereof.
The present invention is implemented by following scheme:
Treat a Chinese medicine composition for hyperlipidemia, it is characterized in that, this Chinese medicine composition is made up of the Chinese medicine extract of following weight proportion:
Folium Nelumbinis extract 40-80 part, Radix Salviae Miltiorrhizae extract 10-20 part, Fructus Crataegi extract 30-60 part, Fructus Psoraleae extract 10-20 part, Folium Sennae extract 1-3 part.
Preferably, this Chinese medicine composition is made up of the Chinese medicine extract of following weight proportion:
Folium Nelumbinis extract 50-70 part, Radix Salviae Miltiorrhizae extract 12-18 part, Fructus Crataegi extract 40-50 part, Fructus Psoraleae extract 12-18 part, Folium Sennae extract 1-3 part.
In above extract, wherein in Folium Nelumbinis extract, lotus flavone content is 50-80wt.%, and lotus leaf alkaloid content is 5-15wt.%; In Radix Salviae Miltiorrhizae extract, content of Danshensu is 3 ~ 10wt.%, and Radix Salviae Miltiorrhizae total phenolic acids content is 50 ~ 75wt.%, and content of danshinolic acid B is 20 ~ 45wt.%; The flavone content of hawthorn of Fructus Crataegi extract is 50 ~ 70wt.%; In Fructus Psoraleae extract, psoralen and isopsoralen content sum are that in 50-60wt.%, Folium Sennae extract, Sennoside A and sennoside B sum are 15-35wt.%.
Preferably, in above extract, wherein in Folium Nelumbinis extract, lotus flavone content is 60-70wt.%, and lotus leaf alkaloid content is 8-12wt.%; In Radix Salviae Miltiorrhizae extract, content of Danshensu is 5 ~ 8wt.%, and Radix Salviae Miltiorrhizae total phenolic acids content is 60 ~ 70wt.%, and content of danshinolic acid B is 30 ~ 40wt.%; The flavone content of hawthorn of Fructus Crataegi extract is 60 ~ 65wt.%; In Fructus Psoraleae extract, psoralen and isopsoralen content sum are that in 52-56wt.%, Folium Sennae extract, Sennoside A and sennoside B sum are 20-30wt.%.
More than composition is by weight as proportioning, can increase according to corresponding proportion when producing or reduce, as large-scale production can by kilogram in units of, or in units of ton, small-scale production also can in units of milligram, weight can increase or reduce, but the constant rate of raw medicinal herbs weight proportion between each composition.
Fructus Psoraleae extract described in the present invention can be extracted by Fructus Psoraleae and be prepared from, also can be extracted by the Fructus Psoraleae after concocting and be prepared from, preferred Fructus Psoraleae can be stir-baked SEMEN PSORALEAE with salt solution, mixes thoroughly through Fructus Psoraleae saline, micro-profit, put fry with slow fire in pot obtained to micro-heaving.
Chinese medicine composition of the present invention is pharmaceutical dosage forms, extract as active constituents of medicine, its in the formulation shared percentage by weight can be 0.1-99.9%, all the other are medicine acceptable carrier.Pharmaceutical preparation of the present invention, exists in a unit, and described unit dosage form refers to the unit of preparation, as every sheet of tablet, and every capsules of capsule, every bottle of oral liquid, granule every bag etc.
Chinese medicine preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, capsule, oral liquid, suck agent, granule, pill, powder, unguentum, sublimed preparation, suspensoid, powder, injection, suppository, ointment, plaster, cream, spray, drop, patch, drop pill.Preparation of the present invention, preferably peroral dosage form, as: capsule, tablet, oral liquid, granule etc.
Chinese medicine composition of the present invention, the preparation of its oral administration can containing conventional excipient, and such as binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can carry out coating to tablet if desired.
Raw material of Chinese medicine medicine Folium Nelumbinis, Radix Salviae Miltiorrhizae, Fructus Crataegi, Fructus Psoraleae or stir-baked SEMEN PSORALEAE with salt solution, Folium Sennae are preferably extracted and obtain extract by compositions of the present invention respectively, using five kinds of extracts mixing as active constituents of medicine, are prepared into the pharmaceutical preparation being applicable to taking.
Wherein saidly extract respectively, method is as follows:
Folium Nelumbinis extract preparation method comprises the steps:
(1) Folium Nelumbinis is pulverized, and adds alkali organic solvent, reflux, extract, collects extracting solution for subsequent use;
(2) by gained Folium Nelumbinis medical material residue in (1), add organic solvent, reflux, extract, collect extracting solution for subsequent use;
(3) by extracting solution in (1) through centrifugal, filter after supernatant, after vacuum distillation recovered solvent, then through centrifugal, filter, get supernatant through macroporous resin adsorption afterflush removing impurity, eluting, collects eluent, concentrated, obtain concentrated solution for subsequent use;
(4) by extracting solution in (2) through centrifugal, filter after supernatant, after vacuum distillation recovered solvent, add acidic organic solvent and redissolve, decolouring, centrifugal, filter; Get supernatant, regulate pH >=12.0, after macroporous resin adsorption, rinse removing impurity, eluting, collect eluent, concentrated, obtain concentrated solution for subsequent use;
(5) merge obtained concentrated solution in (3), (4), drying obtains Folium Nelumbinis extract;
Described Radix Salviae Miltiorrhizae extract preparation method comprises the steps:
Radix Salviae Miltiorrhizae is pulverized, and adds organic solvent heating and refluxing extraction, extracting solution, regulates pH 1.5 ~ 4.2 to let cool; centrifugal or filter, get clear liquor or filtrate is adsorbed through macroporous resin column, first rinse with water, water lotion discards; use organic solvent eluting again, eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract;
Described Fructus Crataegi extract preparation method comprises the steps:
Fructus Crataegi is pulverized, and add water warm macerating, heating and refluxing extraction or ultrasonicly to carry, and extracting solution concentrates, centrifugal or filter, and gets clear liquor or filtrate is adsorbed through macroporous resin column, and first rinse with water, then use organic solvent eluting, eluent concentrates, dry, obtains Fructus Crataegi extract;
Described Fructus Psoraleae extract or stir-baked SEMEN PSORALEAE with salt solution method for preparing extractive comprise the steps:
Fructus Psoraleae or stir-baked SEMEN PSORALEAE with salt solution are pulverized, and add organic solvent extraction, and extracting solution concentrates, and coldly put, and filter, collecting precipitation organic solvent dissolution, filter, filtrate concentrates, dry, obtains Fructus Psoraleae extract or stir-baked SEMEN PSORALEAE with salt solution extract;
Described Folium Sennae extract preparation method comprises the steps:
Folium Sennae is pulverized, and with organic solvent extraction (temperature 60-90 DEG C), extracting solution filters, recycling design at 80 DEG C, concentrated after filtering, dry Folium Sennae extract at 40-60 DEG C.
Preferably, describedly to extract respectively, comprise the steps:
Folium Nelumbinis extract preparation method comprises the steps:
(1) Folium Nelumbinis adds the ethanol of 3-5 times of 40%-70% after pulverizing, and adjusts pH9.0-14.0, reflux, extract, 1-3 time at 65 DEG C-85 DEG C, and each extraction 1-3 hour, collects extracting solution for subsequent use;
(2) by gained Folium Nelumbinis medical material residue in (1), add the ethanol of 3-5 times of 60%-95%, adjust pH1.0-6.0, reflux, extract, 2-4 time at 65 DEG C-85 DEG C, each extraction 1-3 hour, collects extracting solution for subsequent use;
(3) by extracting solution in (1) through centrifugal, filter after supernatant, after ethanol is reclaimed in distilling under reduced pressure, regulate pH6.5-7.0, again through centrifugal, filtration, get supernatant and be mixed with 1mg/mL-5mg/mL solution, after macroporous resin adsorption, rinse removing impurity respectively with pure water, 10%-30% ethanol, 50-90% organic solution eluting, collect eluent, in vacuum 0.06Mpa-0.09Mpa, evaporation and concentration at 65 DEG C-85 DEG C, obtain concentrated solution for subsequent use;
(4) by extracting solution in (2) through centrifugal, filter after supernatant, after ethanol is reclaimed in distilling under reduced pressure, add acidic organic solvent and redissolve, decolouring, centrifugal after regulating pH7.0, cross and filter tannin; Get supernatant, regulate pH >=12.0, and be mixed with 0.1mg/mL-2mg/mL solution, after macroporous resin adsorption, rinse removing impurity respectively with pure water, 10%-30% ethanol, 50%-90% organic solution eluting, collect eluent, in vacuum 0.06Mpa-0.09Mpa, evaporation and concentration at 65 DEG C-85 DEG C, obtain concentrated solution for subsequent use;
(5) merge obtained concentrated solution in (3), (4), obtain Folium Nelumbinis extract through vacuum drying;
Described Radix Salviae Miltiorrhizae extract preparation method comprises the steps:
Radix Salviae Miltiorrhizae is pulverized, and adds 2-6 times amount 40% ~ 70% alcohol heating reflux and extracts 2 ~ 4 times, each 0.5 ~ 2 hour; Merge extractive liquid, is 1.5 ~ 4.2 to let cool with acid for adjusting pH, centrifugal or filter, get resin volume on clear liquor or filtrate and be equivalent to the macroporous resin column of crude drug 2 ~ 4 times, first rinse with water, water lotion discards, use 85 ~ 95% ethanol elutions of 2 ~ 4 times of column volumes again, collect eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract;
Described Fructus Crataegi extract preparation method comprises the steps:
Fructus Crataegi is pulverized, and adds 2-6 times amount water temperature leaching 1-3h, heating and refluxing extraction or supersound extraction 2 ~ 4 times, extracting solution concentrating under reduced pressure, centrifugal or filter, and gets clear liquor or the upper macroporous resin column of filtrate, first rinses with water, then use 50% ~ 70% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Fructus Crataegi extract; Described Fructus Psoraleae extract or stir-baked SEMEN PSORALEAE with salt solution method for preparing extractive comprise the steps:
Fructus Psoraleae or stir-baked SEMEN PSORALEAE with salt solution are pulverized, and add 2-4 times amount 50-80% ethanol extraction 1 ~ 3 time, and extracting solution concentrates, and coldly put, and filter, collecting precipitation 80-95% dissolve with ethanol, filter, filtrate concentrates, dry, obtains Fructus Psoraleae extract or stir-baked SEMEN PSORALEAE with salt solution extract;
Described Folium Sennae extract preparation method comprises the steps:
Folium Sennae is pulverized, and adds the ethanol extraction (temperature 60-90 DEG C) 1 ~ 3 time of 1-3 times amount 30%-80%, and extracting solution filters, at 80 DEG C, reclaim ethanol, concentrated after filtering, dry Folium Sennae extract at 40-60 DEG C.
Above-mentioned obtained extract is mixed to scale, adds pharmaceutically acceptable adjuvant or complementary composition, be prepared into tablet, capsule, drop pill, granule, solution, injection and other pharmaceutically acceptable dosage forms.
According to the present invention, in Folium Nelumbinis extract, lotus flavone content is 50%-80%, and lotus leaf alkaloid content is 5%-15%; In Radix Salviae Miltiorrhizae extract, content of Danshensu is 3% ~ 10%, and Radix Salviae Miltiorrhizae total phenolic acids content is 50% ~ 75%, and content of danshinolic acid B is 20% ~ 45%; The flavone content of hawthorn of Fructus Crataegi extract is 50% ~ 70%; In Fructus Psoraleae extract or stir-baked SEMEN PSORALEAE with salt solution, psoralen and isopsoralen content sum are that in 50%-60%, Folium Sennae extract, Sennoside A and sennoside B sum are 15%-35%.
Beneficial effect of the present invention is further illustrated below by way of experimental data.
Drug efficacy study
This experiment is intended to observe the difference between the effects that hyperlipemia in mice model that refining Hedan tablet and Hedan tablet induce TritonWR-1339 and high lipid food cause the blood fat of olive Antihyperlipidemia capsule, provides basis for studying refining Hedan tablet drug action further.
1. materials and methods
1.1 medicines and reagent
TritonWR-1339(Sigma, the U.S.); Refining Hedan tablet (embodiment of the present invention 1 method prepare what red sheet be called refining Hedan tablet), Hedan tablet (what red sheet prepared by prior art is bought from Nanchang Jishun Pharmaceutical Co., Ltd.); TG, TC testing cassete (Bioengineering Research Institute is built up in Nanjing, Nanjing); HDL-C, LDL-C measure test kit (Rong Sheng is biological, Shanghai); Other reagent are analytical pure.
1.2 laboratory animal
ICR mice, 20 ± 2g; SD rat, 200 ± 2g, male and female half and half, are all purchased from Zhejiang Academy of Medical Sciences Experimental Animal Center.Within one week, to adapt to this laboratory condition, sub-cage rearing, animal can freely drink water experimental animal feeding, and picked-up normal diet, the bright-12h of Control release room illumination 12h is dark, and indoor temperature is 24 ± 1 DEG C, and humidity is 55 ± 10%.
1.3 method
1.3.1 the preparation of medicine test solution
Get refining Hedan tablet, being made into concentration is respectively 0.5,1 and 2mgml
-1.Hedan tablet solution concentration is 1mgml
-1, save backup in 4 DEG C.
1.3.2 zoopery
1.3.2.1 acute hyperlipemia mouse model
ICR mice is divided into 6 groups at random: Normal group, model control group, the red experimental group of refining lotus (7.5,15 and 30mgkg
-13 dosage groups) and the red matched group of lotus.Except Normal group, other are group tail vein injection TritonWR-1339(400mgkg respectively respectively
-1) rising of induction blood fat, Normal group injection equal-volume NS.12h after injection TritonWR-1339, by the red medicinal liquid gavage of refining lotus, (dosage is respectively 7.5,15 and 30mgkg to experimental group respectively
-1), the red matched group of lotus is with the red gavage (15mgkg of lotus
-1).12h, 18h and 24h after TritonWR-1339 injection, often organize random selecting 10, go eyeball to take a blood sample, separation of serum ,-38 DEG C of preservations, measure for blood lipids index.
1.3.2.2 olive Antihyperlipidemia capsule
48 SD rats are divided into 6 groups at random: Normal group, feed normal diet; Model control group, feeds high lipid food (high lipid food composition mass fraction is: Adeps Sus domestica 10%, yolk powder 10%, cholesterol 1% and normal feedstuff 79%); The red experimental group of refining lotus of 3 dosage and He Dan matched group also feeding high lipid food, and gavage gives refining He Dan and (is respectively 5,10 and 20mgkg respectively
-1) and He Dan (10mgkg
-1), once a day, continuous 4 weeks.Meanwhile, Normal group and model control group respectively gavage give equal-volume NS.Before and after experiment, tail vein blood respectively, separation of serum ,-38 DEG C of preservations, measure for blood lipids index.
1.3.2.3 blood lipids index measures
Operate by test kit description method, measure the content of T-CHOL (TC), triglyceride (TG), HDL-C (HDL-C) and low-density lipoprotein cholesterol (LDL-C) in Mouse and rat serum respectively, and calculate the ratio of HDL-C/TC and HDL-C/LDL-C.
1.3.2.4 statistical method
Data represent with mean+SD, adopt statistical software (SPSS13.0forWindows) to carry out variance analysis, compare and adopt t inspection between two groups.
2. result
2.1 refining He Dan is on the impact of the hyperlipemia in mice blood lipids index that TritonWR-1339 induces
Compared with Normal group, serum TG, TC and the LDL-C level of the mice of injection TritonWR-1339 increase about 7 times, 5 times and 4 times respectively, HDL-C/TC and HDL-C/LDL-C ratio reduces 40% and 10% respectively, establishes acute hyperlipemia mouse model.And (dosage is respectively 7.5,15 or 30mgkg to give refining He Dan process
-1) the rising of the mice hyperlipemia in mice blood lipid level that obviously suppresses TritonWR-1339 to induce, and with same dosage (15mgkg
-1) He Dan compares, its inhibitory action more obvious (see the following form, be respectively 18h and 24h).
#P<0.01vscontrolgroup.*P<0.05,**P<0.01vsmodelgroup.
#P<0.01vscontrolgroup.*P<0.05,**P<0.01vsmodelgroup.
2.2 refining He Dan are on the impact of hyperlipidemia rats
The each blood lipids index of rat giving refining He Dan protection while feeding high lipid food is clearly better.Dosage is 10 and 20mgkg
-1d
-1tG, TC and LDL-C level of the red experimental group rat of refining lotus maintain 73.2 respectively, 86.4,51.7mg100ml
-1with 67.2,84.0,47.5mg100ml
-1, compare model group and obviously decline.And experimental group (10mgkg red with same dose lotus
-1d
-1) compare, its effect is more obvious, has significant difference.
#P<0.01vscontrolgroup.*P<0.05,**P<0.01vsmodelgroup.
3. discuss
Experimental result shows, refining Hedan tablet significantly can resist hyperlipidemia animal model serum TG, the rising of the indexs such as TC and LDL-C, simultaneously the ratio of elevating HDL-C/TC and HDL-C/LDL-C.The Notes of Key Data is refined Hedan tablet and is had the activity reducing blood lipid level, and under same dose level, it is more obvious that it acts on comparatively Hedan tablet.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in detail.
Embodiment 1
1, (1) Folium Nelumbinis adds the ethanol of 4 times 60% after pulverizing, and adjusts pH12.0, reflux, extract, 2 times at 75 DEG C, and each extraction 2 hours, collects extracting solution for subsequent use;
(2) by gained Folium Nelumbinis medical material residue in (1), add the ethanol of 4 times 85%, adjust pH3.0, reflux, extract, 3 times at 75 DEG C, each extraction 2 hours, collects extracting solution for subsequent use;
(3) by extracting solution in (1) through centrifugal, filter after supernatant, after ethanol is reclaimed in distilling under reduced pressure, regulate pH7.0, again through centrifugal, filtration, get supernatant and be mixed with 3mg/mL solution, pump in AB-8 macroporous resin column and adsorb, applied sample amount is 4BV, after pure water, each 2BV gradient elution of 20% ethanol, use 70% ethanol elution, collect eluent, decompression recycling ethanol, in vacuum 0.06MPa-0.09MPa, evaporation and concentration at 65 DEG C-85 DEG C, obtain concentrated solution for subsequent use;
(4) by extracting solution in (2) through centrifugal, supernatant after filtration, after ethanol is reclaimed in distilling under reduced pressure, add 2% hydrochloric acid solution, after ultrasonic dissolution 1h, divide with normal hexane and extract color element for three times, regulate pH value of solution 7.0, centrifugal, filter, regulate supernatant pH13.0, pump in D101 macroporous resin column and adsorb, applied sample amount is 2BV, with pure water, organic solution each 2BV gradient remove impurity of 30% concentration of alcohol, finally use 4BV volume 50% methanol solution eluting, collect 50% methanol-eluted fractions, at vacuum 0.06Mpa-0.09Mpa, evaporation and concentration at 65 DEG C-85 DEG C, obtain concentrated solution for subsequent use,
(5) obtained concentrated solution in (3), (4) is merged, through concentrating the obtained Folium Nelumbinis extract of final vacuum drying further;
2, get Radix Salviae Miltiorrhizae, pulverize, add medical material weight 4 times amount 60% alcohol heating reflux at every turn and extract 3 times, each 1 hour; Merge extractive liquid, is 2.8 to let cool with acid for adjusting pH, centrifugal, gets the macroporous resin column that resin volume on clear liquor is equivalent to crude drug 3 times, and first rinse with water, water lotion discards, then uses 90% ethanol elution of 2.5 times of column volumes, collects eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract.
3. get the Fructus Crataegi of pulverizing, add medical material weight 4 times amount water temperature leaching 2h, heating and refluxing extraction 3 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal, get macroporous resin column on clear liquor, first rinse with water, then use 60% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Fructus Crataegi extract.
4, get stir-baked SEMEN PSORALEAE with salt solution to pulverize, add 3 times amount 70% ethanol extraction 2 times, extracting solution concentrates, and coldly puts, and filters, collecting precipitation 85% dissolve with ethanol, filters, and filtrate concentrates, and drying, obtains stir-baked SEMEN PSORALEAE with salt solution extract;
5, get Folium Sennae to pulverize, add the ethanol extraction (temperature 80 DEG C) 2 times of 2 times amount 50%, extracting solution filters, at 80 DEG C, reclaim ethanol, concentrated after filtering, dry Folium Sennae extract at 50 DEG C.
6, get that above-mentioned 1-5 walks obtained Folium Nelumbinis extract 120g, Radix Salviae Miltiorrhizae extract 30g, Fructus Crataegi extract 90g, stir-baked SEMEN PSORALEAE with salt solution extract 30g, Folium Sennae extract 4g mix, add the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, make granule, tabletting, coating, makes 1000, to obtain final product.
Embodiment 2
Obtained for the 1-5 of embodiment 1 step Folium Nelumbinis extract 320g, Radix Salviae Miltiorrhizae extract 160g, Fructus Crataegi extract 240g, stir-baked SEMEN PSORALEAE with salt solution extract 160g, Folium Sennae extract 4g are mixed, add Icing Sugar, starch, the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, make granule 1000g.
Embodiment 3
Obtained for the 1-5 of embodiment 1 step Folium Nelumbinis extract 160g, Radix Salviae Miltiorrhizae extract 20g, Fructus Crataegi extract 120g, stir-baked SEMEN PSORALEAE with salt solution extract 20g, Folium Sennae extract 6g are mixed, add starch, the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granule processed, incapsulates 1000.
Embodiment 4
The Folium Nelumbinis extract 40g that Example 1 obtains, Radix Salviae Miltiorrhizae extract 10g, Fructus Crataegi extract 30g, stir-baked SEMEN PSORALEAE with salt solution extract 10g, Folium Sennae extract 1g.Mixing, adds the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, makes granule, tabletting, coating, to obtain final product.
Embodiment 5
The Folium Nelumbinis extract that Example 1 obtains 80 parts, Radix Salviae Miltiorrhizae extract 20 parts, Fructus Crataegi extract 60 parts, stir-baked SEMEN PSORALEAE with salt solution extract 20, Folium Sennae extract 3 parts.Mixing, adds the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, makes granule, tabletting, coating, to obtain final product.
Embodiment 6
The Folium Nelumbinis extract that Example 1 obtains 50 parts, Radix Salviae Miltiorrhizae extract 12 parts, Fructus Crataegi extract 40 parts, stir-baked SEMEN PSORALEAE with salt solution extract 12, Folium Sennae extract 1 part.Mixing, adds the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, makes granule, tabletting, coating, to obtain final product.
Embodiment 7
The Folium Nelumbinis extract that Example 1 obtains 70 parts, Radix Salviae Miltiorrhizae extract 18 parts, Fructus Crataegi extract 50 parts, stir-baked SEMEN PSORALEAE with salt solution extract 18, Folium Sennae extract 3 parts.Mixing, adds the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, makes granule, tabletting, coating, to obtain final product.
Embodiment 7
Wherein Folium Nelumbinis extract, preparation method is as follows:
(1) Folium Nelumbinis adds the ethanol of 3 times 40% after pulverizing, and adjusts pH9.0, reflux, extract, 1 time at 65 DEG C, and each extraction 1 hour, collects extracting solution for subsequent use;
(2) by gained Folium Nelumbinis medical material residue in (1), add the ethanol of 3 times 60%, adjust pH1.0, reflux, extract, 2 times at 65 DEG C, each extraction 1 hour, collects extracting solution for subsequent use;
(3) by extracting solution in (1) through centrifugal, filter after supernatant, after ethanol is reclaimed in distilling under reduced pressure, regulate pH6.5, again through centrifugal, filtration, get supernatant and be mixed with 1mg/mL solution, after macroporous resin adsorption, rinse removing impurity respectively with pure water, 10% ethanol, 50 organic solution eluting, collect eluent, in vacuum 0.06Mpa, evaporation and concentration at 65 DEG C, obtain concentrated solution for subsequent use;
(4) by extracting solution in (2) through centrifugal, filter after supernatant, after ethanol is reclaimed in distilling under reduced pressure, add acidic organic solvent and redissolve, decolouring, centrifugal after regulating pH7.0, cross and filter tannin; Get supernatant, regulate pH >=12.0, and be mixed with 0.1mg/mL solution, after macroporous resin adsorption, rinse removing impurity respectively with pure water, 10% ethanol, 50% organic solution eluting, collect eluent, in vacuum 0.06Mpa, evaporation and concentration at 65 DEG C, obtain concentrated solution for subsequent use;
(5) merge obtained concentrated solution in (3), (4), obtain Folium Nelumbinis extract through vacuum drying;
Wherein said Radix Salviae Miltiorrhizae extract, preparation method is as follows:
Radix Salviae Miltiorrhizae is pulverized, and adds 2 times amount 40% alcohol heating reflux and extracts 2 times, each 0.5 hour; Merge extractive liquid, is 1.5 to let cool with acid for adjusting pH, centrifugal or filter, and get the macroporous resin column that clear liquor or the upper resin volume of filtrate are equivalent to crude drug 2 times, first rinse with water, water lotion discards, then uses 85% ethanol elution of 2 times of column volumes, collects eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract;
Wherein said Fructus Crataegi extract, preparation method is as follows:
Fructus Crataegi is pulverized, and adds 2 times amount water temperatures leaching 1h, heating and refluxing extraction or supersound extraction 2 times, extracting solution concentrating under reduced pressure, centrifugal or filter, and gets clear liquor or the upper macroporous resin column of filtrate, first rinses with water, then use 50% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Fructus Crataegi extract;
Wherein said stir-baked SEMEN PSORALEAE with salt solution extract, preparation method is as follows:
Stir-baked SEMEN PSORALEAE with salt solution is pulverized, and adds 2 times amount 50% ethanol extraction 1 time, and extracting solution concentrates, and coldly puts, and filters, collecting precipitation 80% dissolve with ethanol, filters, and filtrate concentrates, and drying, obtains stir-baked SEMEN PSORALEAE with salt solution extract;
Wherein said Folium Sennae extract, preparation method is as follows:
Folium Sennae is pulverized, and adds the ethanol extraction (temperature 60 C) 1 time of 1 times amount 30%, and extracting solution filters, at 80 DEG C, reclaim ethanol, concentrated after filtering, dry Folium Sennae extract at 40 DEG C.
Embodiment 8
Wherein Folium Nelumbinis extract, preparation method is as follows:
(1) Folium Nelumbinis adds the ethanol of 5 times 70% after pulverizing, and adjusts pH14.0, reflux, extract, 3 times at 85 DEG C, and each extraction 3 hours, collects extracting solution for subsequent use;
(2) by gained Folium Nelumbinis medical material residue in (1), add the ethanol of 5 times 95%, adjust pH6.0, reflux, extract, 4 times at 85 DEG C, each extraction 3 hours, collects extracting solution for subsequent use;
(3) by extracting solution in (1) through centrifugal, filter after supernatant, after ethanol is reclaimed in distilling under reduced pressure, regulate pH7.0, again through centrifugal, filtration, get supernatant and be mixed with 5mg/mL solution, after macroporous resin adsorption, rinse removing impurity respectively with pure water, 30% ethanol, 90% organic solution eluting, collect eluent, in vacuum 0.09Mpa, evaporation and concentration at 85 DEG C, obtain concentrated solution for subsequent use;
(4) by extracting solution in (2) through centrifugal, filter after supernatant, after ethanol is reclaimed in distilling under reduced pressure, add acidic organic solvent and redissolve, decolouring, centrifugal after regulating pH7.0, cross and filter tannin; Get supernatant, regulate pH >=12.0, and be mixed with 2mg/mL solution, after macroporous resin adsorption, rinse removing impurity respectively with pure water, 30% ethanol, 90% organic solution eluting, collect eluent, in vacuum 0.09Mpa, evaporation and concentration at 85 DEG C, obtain concentrated solution for subsequent use;
(5) merge obtained concentrated solution in (3), (4), obtain Folium Nelumbinis extract through vacuum drying;
Wherein said Radix Salviae Miltiorrhizae extract, preparation method is as follows:
Radix Salviae Miltiorrhizae is pulverized, and adds 6 times amount 70% alcohol heating reflux and extracts 4 times, each 2 hours; Merge extractive liquid, is 4.2 to let cool with acid for adjusting pH, centrifugal or filter, and get the macroporous resin column that clear liquor or the upper resin volume of filtrate are equivalent to crude drug 4 times, first rinse with water, water lotion discards, then uses 95% ethanol elution of 4 times of column volumes, collects eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract;
Wherein said Fructus Crataegi extract, preparation method is as follows:
Fructus Crataegi is pulverized, and adds 6 times amount water temperatures leaching 3h, heating and refluxing extraction or supersound extraction 4 times, extracting solution concentrating under reduced pressure, centrifugal or filter, and gets clear liquor or the upper macroporous resin column of filtrate, first rinses with water, then use 70% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Fructus Crataegi extract;
Wherein said stir-baked SEMEN PSORALEAE with salt solution extract, preparation method is as follows:
Stir-baked SEMEN PSORALEAE with salt solution is pulverized, and adds 4 times amount 80% ethanol extraction 3 times, and extracting solution concentrates, and coldly puts, and filters, collecting precipitation 95% dissolve with ethanol, filters, and filtrate concentrates, and drying, obtains stir-baked SEMEN PSORALEAE with salt solution extract;
Wherein said Folium Sennae extract, preparation method is as follows:
Folium Sennae is pulverized, and adds the ethanol extraction (temperature 90 DEG C) 3 times of 3 times amount 80%, and extracting solution filters, at 80 DEG C, reclaim ethanol, concentrated after filtering, dry Folium Sennae extract at 60 DEG C.
Embodiment 9
The detection of extract:
Detect embodiment 1 sample by HPLC method, result is as follows:
Wherein in Folium Nelumbinis extract, lotus flavone content is 65%, and lotus leaf alkaloid content is 10%; In Radix Salviae Miltiorrhizae extract, content of Danshensu is 7%, and Radix Salviae Miltiorrhizae total phenolic acids content is 62%, and content of danshinolic acid B is 32%; The flavone content of hawthorn of Fructus Crataegi extract is 60%; In stir-baked SEMEN PSORALEAE with salt solution extract, psoralen and isopsoralen content sum are 55, Sennoside A and sennoside B sum are 25% in Folium Sennae extract.
Embodiment 10
The detection of extract:
Detect embodiment 7 sample by HPLC method, result is as follows:
Wherein in Folium Nelumbinis extract, lotus flavone content is 50%, and lotus leaf alkaloid content is 5%; In Radix Salviae Miltiorrhizae extract, content of Danshensu is 3%, and Radix Salviae Miltiorrhizae total phenolic acids content is 50%, and content of danshinolic acid B is 20%; The flavone content of hawthorn of Fructus Crataegi extract is 50%; In stir-baked SEMEN PSORALEAE with salt solution extract, psoralen and isopsoralen content sum are 50%, Sennoside A and sennoside B sum are 15% in Folium Sennae extract.
Embodiment 11
The detection of extract:
Detect embodiment 8 sample by HPLC method, result is as follows:
Wherein in Folium Nelumbinis extract, lotus flavone content is 80%, and lotus leaf alkaloid content is 15%; In Radix Salviae Miltiorrhizae extract, content of Danshensu is 10%, and Radix Salviae Miltiorrhizae total phenolic acids content is 75%, and content of danshinolic acid B is 45%; The flavone content of hawthorn of Fructus Crataegi extract is 70%; In stir-baked SEMEN PSORALEAE with salt solution extract, psoralen and isopsoralen content sum are 60%, Sennoside A and sennoside B sum are 35% in Folium Sennae extract.
Embodiment 12
The detection of extract:
Detect embodiment 9 sample by HPLC method, result is as follows:
Wherein in Folium Nelumbinis extract, lotus flavone content is 60%, and lotus leaf alkaloid content is 8%; In Radix Salviae Miltiorrhizae extract, content of Danshensu is 5%, and Radix Salviae Miltiorrhizae total phenolic acids content is 60%, and content of danshinolic acid B is 30%; The flavone content of hawthorn of Fructus Crataegi extract is 60%; In stir-baked SEMEN PSORALEAE with salt solution extract, psoralen and isopsoralen content sum are 52%, Sennoside A and sennoside B sum are 20% in Folium Sennae extract.
Embodiment 13
The detection of extract:
Detect embodiment 1 sample by HPLC method, result is as follows:
Wherein in Folium Nelumbinis extract, lotus flavone content is 70%, and lotus leaf alkaloid content is 12%; In Radix Salviae Miltiorrhizae extract, content of Danshensu is 8%, and Radix Salviae Miltiorrhizae total phenolic acids content is 70%, and content of danshinolic acid B is 40%; The flavone content of hawthorn of Fructus Crataegi extract is 65%; In stir-baked SEMEN PSORALEAE with salt solution extract, psoralen and isopsoralen content sum are 56%, Sennoside A and sennoside B sum are 30% in Folium Sennae extract.
Claims (5)
1. treat the Chinese medicine composition of hyperlipemia for one kind, it is characterized in that, this Chinese medicine composition is prepared from by the Chinese medicine extract of following weight proportion: Folium Nelumbinis extract 40-80 part, Radix Salviae Miltiorrhizae extract 10-20 part, Fructus Crataegi extract 30-60 part, Fructus Psoraleae extract or stir-baked SEMEN PSORALEAE with salt solution extract 10-20 part, Folium Sennae extract 1-3 part;
Wherein Folium Nelumbinis extract, preparation method comprises the steps:
(1) Folium Nelumbinis adds the ethanol of 3-5 times of 40%-70% after pulverizing, and adjusts pH9.0-14.0, reflux, extract, 1-3 time, and each extraction 1-3 hour, collects extracting solution for subsequent use;
(2) by gained Folium Nelumbinis medical material residue in (1), add the ethanol of 3-5 times of 60%-95%, adjust pH1.0-6.0, reflux, extract, 2-4 time, each extraction 1-3 hour, collects extracting solution for subsequent use;
(3) by extracting solution in (1) through centrifugal, filter after supernatant, after reclaiming ethanol, regulate pH6.5-7.0, again through centrifugal, filtration, removing impurity is rinsed respectively with pure water, 10%-30% ethanol after macroporous resin adsorption, 50-90% methanol or ethanol elution, collect eluent, obtains concentrated solution for subsequent use after concentrated;
(4) by extracting solution in (2) through centrifugal, filter after supernatant, after reclaiming ethanol, redissolve, decolouring, centrifugal after regulating pH7.0, cross and filter tannin; Get supernatant, regulate pH >=12.0, after macroporous resin adsorption, rinse removing impurity respectively, 50%-90% methanol or ethanol elution with pure water, 10%-30% ethanol, collect eluent, concentrated to obtain concentrated solution for subsequent use;
(5) merge obtained concentrated solution in (3), (4), obtain Folium Nelumbinis extract through vacuum drying;
Wherein said Radix Salviae Miltiorrhizae extract, preparation method comprises the steps:
Radix Salviae Miltiorrhizae is pulverized, and adds 2-6 times amount 40% ~ 70% alcohol heating reflux and extracts 2 ~ 4 times, each 0.5 ~ 2 hour; Merge extractive liquid, regulates pH to be 1.5 ~ 4.2, centrifugal or filter, and gets the macroporous resin column that the upper resin volume of clear liquor or filtrate is equivalent to crude drug 2 ~ 4 times, first rinses with water, then use 85 ~ 95% ethanol elutions of 2 ~ 4 times of column volumes, collect eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract;
Wherein said Fructus Crataegi extract, preparation method comprises the steps:
Fructus Crataegi is pulverized, and adds 2-6 times amount water temperature leaching 1-3h, heating and refluxing extraction or supersound extraction 2 ~ 4 times, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets clear liquor or the upper macroporous resin column of filtrate, first rinse with water, then use 50% ~ 70% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Fructus Crataegi extract;
Wherein said Fructus Psoraleae extract or stir-baked SEMEN PSORALEAE with salt solution extract, preparation method comprises the steps:
Fructus Psoraleae or stir-baked SEMEN PSORALEAE with salt solution are pulverized, and add 2-4 times amount 50-80% ethanol extraction 1 ~ 3 time, and extracting solution concentrates, and coldly put, and filter, collecting precipitation 80-95% dissolve with ethanol, filter, filtrate concentrates, dry, obtains Fructus Psoraleae extract or stir-baked SEMEN PSORALEAE with salt solution extract;
Wherein said Folium Sennae extract, preparation method comprises the steps:
Folium Sennae is pulverized, and ethanol temperature 60-90 DEG C that adds 1-3 times amount 30%-80% is extracted 1 ~ 3 time, and extracting solution filters, and concentrate drying after filtering, obtains Folium Sennae extract.
2. Chinese medicine composition as claimed in claim 1, it is characterized in that, this Chinese medicine composition is prepared from by the Chinese medicine extract of following weight proportion: Folium Nelumbinis extract 50-70 part, Radix Salviae Miltiorrhizae extract 12-18 part, Fructus Crataegi extract 40-50 part, Fructus Psoraleae extract or stir-baked SEMEN PSORALEAE with salt solution extract 12-18 part, Folium Sennae extract 1-3 part.
3. the Chinese medicine composition as described in as arbitrary in claim 1-2, it is characterized in that, wherein in Folium Nelumbinis extract, lotus flavone content is 50-80wt.%, and lotus leaf alkaloid content is 5-15wt.%; In Radix Salviae Miltiorrhizae extract, content of Danshensu is 3 ~ 10wt.%, and Radix Salviae Miltiorrhizae total phenolic acids content is 50 ~ 75wt.%, and content of danshinolic acid B is 20 ~ 45wt.%; The flavone content of hawthorn of Fructus Crataegi extract is 50 ~ 70wt.%; In Fructus Psoraleae extract or stir-baked SEMEN PSORALEAE with salt solution extract, psoralen and isopsoralen content sum are 50-60wt.%; In Folium Sennae extract, Sennoside A and sennoside B sum are 15-35wt.%.
4. Chinese medicine composition as claimed in claim 3, it is characterized in that, wherein in Folium Nelumbinis extract, lotus flavone content is 60-70wt.%, and lotus leaf alkaloid content is 8-12wt.%; In Radix Salviae Miltiorrhizae extract, content of Danshensu is 5 ~ 8wt.%, and Radix Salviae Miltiorrhizae total phenolic acids content is 60 ~ 70wt.%, and content of danshinolic acid B is 30 ~ 40wt.%; The flavone content of hawthorn of Fructus Crataegi extract is 60 ~ 65wt.%; In Fructus Psoraleae extract or stir-baked SEMEN PSORALEAE with salt solution extract, psoralen and isopsoralen content sum are 52-56wt.%; In Folium Sennae extract, Sennoside A and sennoside B sum are 20-30wt.%.
5. Chinese medicine composition according to claim 1, is characterized in that, described Chinese medicine composition is tablet, capsule, oral liquid, suck agent, granule, pill, powder, sublimed preparation, suspensoid, powder or drop pill.
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| CN105168325A (en) * | 2015-09-30 | 2015-12-23 | 河南行知专利服务有限公司 | Preparation method and application of non-decocted fructus psoraleae preparation |
| CN106110055A (en) * | 2016-07-15 | 2016-11-16 | 安徽元素医学科技有限公司 | A kind of pine Siberian cocklebur grass particle and preparation method thereof |
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| CN108094312A (en) * | 2017-12-15 | 2018-06-01 | 柳州飞升鹏科技有限公司 | A kind of cultural method of laying duck |
| CN112168878B (en) * | 2020-10-20 | 2022-04-01 | 广西壮族自治区中国科学院广西植物研究所 | Radix polygalae fallax hemsl-water lotus lipid-lowering composition and preparation method thereof |
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