CN103372051B - Red rice and kudzuvine root medicinal composition for regulating blood fat and preparation method of the composition - Google Patents

Red rice and kudzuvine root medicinal composition for regulating blood fat and preparation method of the composition Download PDF

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Publication number
CN103372051B
CN103372051B CN201210118280.7A CN201210118280A CN103372051B CN 103372051 B CN103372051 B CN 103372051B CN 201210118280 A CN201210118280 A CN 201210118280A CN 103372051 B CN103372051 B CN 103372051B
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extract
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monas cuspurpureus
cuspurpureus went
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CN103372051A (en
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段震文
郭树仁
刘曦
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Beijing Peking University WBL Biotech Co Ltd
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Beijing Peking University WBL Biotech Co Ltd
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Priority to PCT/CN2013/074534 priority patent/WO2013155995A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06Fungi, e.g. yeasts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/488Pueraria (kudzu)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/60Moraceae (Mulberry family), e.g. breadfruit or fig
    • A61K36/605Morus (mulberry)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps

Abstract

The invention aims to disclose a medicinal composition for regulating blood fat, in particular treating hypertriglyceridemia, and a preparation method of the composition, and discloses pharmaceutical application of the medicinal composition. The medicinal composition is characterized in that red rice and kudzuvine root are compatible and play a synergetic role, has the effects of removing dampness and eliminating phlegm, activating blood circulation to remove stasis, and invigorating spleen to promote digestion, and can be used for reducing cholesterol in blood, increasing high-density lipoprotein, reducing the content of low-density lipoprotein, and in particular achieving the effect of reducing triglyceride prominently, and remarkably treating the hypertriglyceridemia. The preparation process is reasonable, the content of the effective component lovastatin in the red rice can be increased, the active component of each medicament in the prescription can be maintained, and the effect of each medicament can be played sufficiently. According to the preparation, the content of lovastatin is used as the index of quality control, the preparation is stable and controllable in quality.

Description

Monas cuspurpureus Went Radix Puerariae drug regimen of a kind of adjusting blood lipid and preparation method thereof
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, relating in particular to a kind of take Chinese medicine compound as pharmaceutical composition of preparing of raw material and preparation method thereof, belongs to the field of Chinese medicines.
Background technology
The high protein that the life style of modern makes to absorb in the food of people, hypercholesterolemia, high sugar food get more and more, thus cause the sickness rate of hyperlipemia to be obvious ascendant trend.Hyperlipemia is the prerequisite that atherosclerosis is formed, and there is obvious dependency with the sickness rate of cerebrovascular disease.Hyperlipemia is again the key factor of bringing out coronary heart disease, arteriosclerosis, fatty liver, diabetes, obesity.Therefore, prevent and treat hyperlipemia and prevention cardiovascular and cerebrovascular disease is played an important role, research and develop serum regulating drug and health food safely and effectively and be very important.
Hyperlipemia refers to T-CHOL in blood (TC) and/or triglyceride (triglyceride, TG) is too high or HDL-C (HDL-C) is too low.Be divided into clinically: hypercholesterolemia (serum TC rising), hypertriglyceridemia (serum TG rising), combined hyperlipidemia familial (TC, TG all raise), low hdl mass formed by blood stasis (reduction of Serum HDL-C level).
Population of China serum TC level is starkly lower than west coronary heart disease group of people at high risk; By to China 49252 >=18 years old 31 provinces, autonomous regions and municipalities permanent resident population sampling survey: China >=18 year old lipid disorders in residents prevalence 18.6%.Wherein hypercholesterolemia prevalence is 2.9%; Cholesterol marginality rate of rise is 3.9%; Hypertriglyceridemia prevalence is 11.9%; Low hdl mass formed by blood stasis prevalence is 7.4%.Population of China dysbolism of blood fat type based on high triglyceride, low hdl mass formed by blood stasis, this and west crowd with high T-CHOL mass formed by blood stasis for main feature is different.Find a kind of blood lipid-lowering medicine for compatriots' dysbolism of blood fat type to be necessary.
Summary of the invention
The object of the invention is pharmaceutical composition providing a kind of regulating blood lipid action (especially treating hypertriglyceridemia) and preparation method thereof; The object of the invention is also the pharmaceutical applications providing described pharmaceutical composition.
The present invention seeks to be achieved through the following technical solutions:
The crude drug of pharmaceutical composition of the present invention consists of:
Monas cuspurpureus Went 1-5 weight portion Radix Puerariae 1-5 weight portion;
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Monas cuspurpureus Went 2 weight portion Radix Puerariae 4 weight portion;
Monas cuspurpureus Went 4 weight portion Radix Puerariae 2 weight portion;
Monas cuspurpureus Went 1 weight portion Radix Puerariae 4 weight portion;
Monas cuspurpureus Went 4 weight portion Radix Puerariae 1 weight portion;
Pharmaceutical composition of the present invention conventionally, can add customary adjuvant, makes clinical acceptable oral formulations, includes but not limited to pill, powder, tablet, granule, capsule, oral liquid.
The preparation method of pharmaceutical composition of the present invention can also be following method:
Prepare Monas cuspurpureus Went extract I and Radix Puerariae extract II, by extract I and extract II conventionally, add customary adjuvant, make clinical acceptable oral formulations, include but not limited to pill, powder, tablet, granule, capsule, oral liquid;
Described Monas cuspurpureus Went extract I can be prepared by any one method following:.
A, Monas cuspurpureus Went 1 weight portion, add the ethanol of 2 ~ 10 parts by volume 50 ~ 90%, methanol or ethyl acetate at every turn, reflux 1 ~ 3 hour, extracts 2 ~ 3 times; Extracting liquid filtering, merging filtrate, recycling design, is condensed into the thick paste that 55 ~ 60 DEG C are surveyed relative density 0.95 ~ 1.06, obtains extract I;
B, Monas cuspurpureus Went 1 weight portion, add the ethanol of 2 ~ 10 parts by volume 50 ~ 90%, methanol or ethyl acetate reflux 1 ~ 3 hour at every turn, extracts 2 ~ 3 times; Extracting liquid filtering, merging filtrate, recycling design, is concentrated into 55 ~ 60 DEG C and surveys relative density 0.95 ~ 1.06, and add 0.5 ~ 2.0 times of deionized water mixing in concentrated solution, room temperature or cold preservation are placed 2 ~ 12 hours, centrifugal, and collecting precipitation is dry, obtains extract I;
Described Radix Puerariae extract II is prepared by the following method:
Radix Puerariae medical material 1 weight portion, the water or the alcohol heating reflux that add 4 ~ 20 parts by volume extract 1 ~ 3 hour at every turn, and extract 2 ~ 4 times, extracting liquid filtering, merging filtrate, recycling design, is condensed into thick paste; Obtain extract II.
A method described in preparation method of the present invention is preferably: get Monas cuspurpureus Went medical material 1 weight portion, add 3 parts by volume 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue adds 2 parts by volume 75% alcohol reflux 2 hours, and extracting liquid filtering, merges twice filtrate, decompression recycling ethanol, is concentrated into the thick paste that 55 ~ 60 DEG C are surveyed relative density 0.95 ~ 1.06, obtains extract I;
B method described in preparation method of the present invention is preferably: Monas cuspurpureus Went medical material 1 weight portion, adds 3 parts by volume 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue adds 2 parts by volume 75% alcohol reflux 2 hours, and extracting liquid filtering, merges twice filtrate, decompression recycling ethanol, is concentrated into 55 ~ 60 DEG C and surveys relative density 0.95 ~ 1.06, and add 1 times of deionized water mixing in concentrated solution, room temperature or cold preservation place 8 hours.Centrifugal, collecting precipitation, at 80 DEG C, dry 8 lab scales, pulverized 60 mesh sieves, obtained extract I.
Radix Puerariae extract II described in preparation method of the present invention is preferably as follows method preparation: Radix Puerariae medical material 1 weight portion, add the 70% or 40% ethanol heating extraction 1 ~ 3 hour of 12 parts by volume at every turn, extract 2 ~ 3 times, extracting liquid filtering, merging filtrate, recycling design, is concentrated into the thick paste that 55 ~ 60 DEG C are surveyed relative density 0.95 ~ 1.06; Obtain extract II.
The relation of weight portion/parts by volume of the present invention is: grams per milliliter.Monas cuspurpureus Went of the present invention can be common Monas cuspurpureus Went medical material, also can be commercially available functional Monascus or high-load Monas cuspurpureus Went.
Pharmaceutical composition Monas cuspurpureus Went of the present invention and the mutual compatibility of Radix Puerariae, create potentiation.There is dehumidifying eliminate the phlegm, blood circulation promoting and blood stasis dispelling, effect of strengthening the spleen to promote digestion.Pharmaceutical composition of the present invention can reduce blood cholesterol, high density lipoprotein increasing, reduces low density lipoprotein, LDL content, shows the effect reducing triglyceride especially highlightedly, significantly can treat hypertriglyceridemia.Preparation technology of the present invention is reasonable, has both improve the content of effective ingredient lovastatin in Monas cuspurpureus Went, and has remained again the active component of each medicine in prescription, and given full play to the effect of each medicine.Invention formulation is using lovastatin content as quality control index, and the quality of the pharmaceutical preparations is stable, controlled.
Effect of the present invention is proved below by way of pharmacodynamic experiment.
Experimental example 1 pharmaceutical composition of the present invention feeds the impact of model mice hypertriglyceridemia to high lipid food
1, experiment material:
(1), prepare by reagent:
Prepared by Monas cuspurpureus Went extract: method for making is with the method for making of extract I in embodiment 4.
Prepared by Radix Puerariae extract: method for making is with the method for making of extract II in embodiment 4.
Prepared by compound medicines: method for making is shown in embodiment 4.
Each medicine adds 1%CMC all before use and is mixed with 1ml (liquid)/g (crude drug) above.
(2), the preparation of high lipoprotein emulsion: cholesterol 10g, Adeps Sus domestica 40g, sodium cholate 2g, propylthiouracil 1g, tween 80 1ml, propylene glycol 15ml, distilled water add to 100ml
(3), reagent: triglyceride (TG) test kit, Beijing Zhongsheng Beikong Biological Science & Technology Co., Ltd..
(4), animal: ICR mice, male, body weight 25 ~ 30g, buys from Beijing Vital River Experimental Animals Technology Co., Ltd..
(5), instrument: microplate reader (Versa max tunable, Molecular Devices), centrifuge: (Anke LXJ-IIB).
2, method and result
(1), method: get ICR mice 60, raise 5 days, observe after confirming health and mice is divided into 6 groups at random, often organize 10.Blank group, hyperlipidemia model group (ig height lipoprotein emulsion 20ml/kg.d+ water), positive controls (ig height lipoprotein emulsion 20ml/kg.d+ fenofibrate 300mg/kg), Monas cuspurpureus Went group (ig height lipoprotein emulsion 20ml/kg.d+ Monas cuspurpureus Went concentrated solution), Radix Puerariae group (ig height lipoprotein emulsion 20ml/kg.d+ Radix Puerariae concentrated solution), compound recipe group (ig height lipoprotein emulsion 20ml/kg.d+ compound recipe concentrated solution).The morning, 8:30 gave high fat breast and blank solution thereof; Afternoon, 15:30 was by organizing feedwater respectively, positive control drug, being respectively subject to reagent etc.Successive administration 20d, cuts tail at 21d and gets blood respectively.EDTA anticoagulant is adopted to prepare blood plasma.Content of triglyceride is measured by kit method.
(2), the results are shown in Table 1.
Table 1 Traditional Chinese medicine compound composition is on the impact (X ± SD, mg/dl) of high fat mice TG
△ △ represents and to compare (t checks) with blank group, P < 0.01; *, * * represents and to compare (t checks) with hyperlipidemia model group, P < 0.05,0.01
Monas cuspurpureus Went, Radix Puerariae, compound recipe all can reduce the content of TG in high fat breast model mice serum.But in identical dosage situation, Monas cuspurpureus Went group reduces by 31% than model group, and Radix Puerariae group reduces by 29% than model group, and compound recipe group reduces by 38% than model group; The TG of compound recipe group mice reduces amplitude and is greater than Monas cuspurpureus Went group, Radix Puerariae group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
Experimental example 2 pharmaceutical composition of the present invention feeds the impact of model mice hypertriglyceridemia to high lipid food
1, experiment material:
(1), prepare by reagent:
Prepared by Monas cuspurpureus Went extract: method for making is with the method for making of extract I in embodiment 5.
Prepared by Radix Puerariae extract: method for making is with the method for making of extract II in embodiment 5.
Prepared by compound medicines: method for making is shown in embodiment 5.
Each medicine adds 1%CMC all before use and is mixed with 1ml (liquid)/g (crude drug) above.
(2), the preparation of high lipoprotein emulsion: with experimental example 1.
(3), reagent: with experimental example 1.
(4), animal: ICR mice, male, body weight 25 ~ 30g, buys from Beijing Vital River Experimental Animals Technology Co., Ltd..
(5), instrument: with experimental example 1.
2, method and result
(1), method: with experimental example 1.
(2), the results are shown in Table 2.
Table 2 Traditional Chinese medicine compound composition is on the impact (X ± SD, mg/dl) of high fat mice TG
△ △ represents and to compare (t checks) with blank group, P < 0.01; *, * * represents and to compare (t checks) with hyperlipidemia model group, P < 0.05,0.01
Monas cuspurpureus Went, Radix Puerariae, compound recipe all can reduce the content of TG in high fat breast model mice serum.But in identical dosage situation, Monas cuspurpureus Went group reduces by 31% than model group, and Radix Puerariae group reduces by 22% than model group, and compound recipe group reduces by 40% than model group; The TG of compound recipe group mice reduces amplitude and is greater than Monas cuspurpureus Went group, Radix Puerariae group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
Experimental example 3 pharmaceutical composition of the present invention feeds the impact of model mice hypertriglyceridemia to high lipid food
1, experiment material:
(1), prepare by reagent:
Prepared by Monas cuspurpureus Went extract: method for making is with the method for making of extract I in embodiment 6.
Prepared by Radix Puerariae extract: method for making is with the method for making of extract II in embodiment 6.
Prepared by compound medicines: method for making is shown in embodiment 6
Each medicine adds 1%CMC all before use and is mixed with 1ml (liquid)/g (crude drug) above.
(2), the preparation of high lipoprotein emulsion: with experimental example 1.
(3), reagent: with experimental example 1.
(4), animal: ICR mice, male, body weight 25 ~ 30g, buys from Beijing Vital River Experimental Animals Technology Co., Ltd..
(5), instrument: with experimental example 1.
2, method and result
(1), method: with experimental example 1.
(2), the results are shown in Table 3.
Table 3 Traditional Chinese medicine compound composition is on the impact (X ± SD, mg/dl) of high fat mice TG
△ △ represents and to compare (t checks) with blank group, P < 0.01; *, * * represents and to compare (t checks) with hyperlipidemia model group, P < 0.05,0.01
Monas cuspurpureus Went, Radix Puerariae, compound recipe all can reduce the content of TG in high fat breast model mice serum.But in identical dosage situation, Monas cuspurpureus Went group reduces by 29% than model group, and Radix Puerariae group reduces by 23% than model group, and compound recipe group reduces by 42% than model group; The TG of compound recipe group mice reduces amplitude and is greater than Monas cuspurpureus Went group, Radix Puerariae group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
The experimentation of experimental example 4 pharmaceutical composition effect for reducing blood fat of the present invention
1, experiment material:
(1), medicine
Prepared by Monas cuspurpureus Went extract: method for making is with the method for making of extract I in embodiment 4.
Prepared by Radix Puerariae extract: method for making is with the method for making of extract II in embodiment 4.
Prepared by compound medicines: method for making is shown in embodiment 4.
Each medicine adds 1%CMC all before use and is mixed with 1ml (liquid)/g (crude drug) above.
(2), animal: Wistar male rat, body weight 150 ~ 200g.Buy from Beijing Vital River Experimental Animals Technology Co., Ltd..
(3), high lipid food: cholesterol 2%, sodium cholate (pig) 0.5%, Adeps Sus domestica 15% (self-control), propylthiouracil 0.2%, normal feedstuff powder 82.3%.Adeps Sus domestica 40 DEG C of water-baths are melted.Sodium cholate, cholesterol, propylthiouracil pulverizer crushing, stirring evenly, add normal feedstuff mixing, then the Adeps Sus domestica adding fusing is mixed thoroughly.Altogether add 50ml water in 1000g raw material, mix thoroughly.Bulk (cake pressed by the material of every 30g mixing) is pressed into oodle maker.Namely drying and sterilizing obtains high lipid food.
(4), reagent: triglyceride (TG) test kit, Beijing Zhongsheng Beikong Biological Science & Technology Co., Ltd..
(5), instrument: instrument: microplate reader (Versa max tunable, Molecular Devices), centrifuge: (AnkeLXJ-IIB).
2, method and result
(1), hyperlipemia modeling:
Get rat 50, be divided into blank group (10) and high fat modeling group (40), give arm's length basis feedstuff and fed with high respectively, continuous 4 weeks.In fasting in evening on the 28th, morning next day cut tail and gets blood.EDTA anticoagulant is adopted to prepare blood plasma.Content of triglyceride is measured by kit method.The results are shown in Table 2.
(2), method: arm's length basis feedstuff rat will be fed as blank group: continue to feed arm's length basis feedstuff, every day, gavage gave 1%CMC aqueous solution; High fat modeling animal is divided into 5 groups at random according to blood fat TG level, hyperlipidemia model group: feed high lipid food, every day, gavage gave 1%CMC aqueous solution; Monas cuspurpureus Went group: every day, gavage gave Monas cuspurpureus Went extract, dosage is 20g (crude drug)/kg body weight; Radix Puerariae group: every day, gavage gave Radix Puerariae extract, dosage is 20g (crude drug)/kg body weight; Compound recipe group: every day, gavage gave Chinese medicinal compound extract of the present invention, dosage is 20g (crude drug)/kg body weight.Continuous nursing 4 weeks, fasting 12h after last administration, morning next day cuts tail and gets blood.EDTA anticoagulant is adopted to prepare blood plasma.Content of triglyceride is measured by kit method.
(3), the results are shown in Table 4.
Table 4 Traditional Chinese medicine compound composition is on the impact (X ± SD, mg/dl) of lipids contents
△ △ represents and to compare (t checks) with blank group, P < 0.01; *, * * represents and to compare (t checks) with hyperlipidemia model group, P < 0.05,0.01
Result shows: Monas cuspurpureus Went, compound recipe all can reduce the content that high lipid food feeds TG in the high TG rat model serum caused, and are significant difference P < 0.05 and pole significant difference P < 0.01 more respectively with model group.Reduce viewed from percentage rate from TG: under identical dosage situation, Monas cuspurpureus Went group reduces by 22% than model group, and Radix Puerariae group reduces by 18% than model group, and compound recipe group reduces by 39% than model group; The TG of compound recipe group mice reduces amplitude and is greater than Monas cuspurpureus Went group, Radix Puerariae group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
The experimentation of experimental example 5 pharmaceutical composition effect for reducing blood fat of the present invention
1, experiment material:
(1), medicine
Prepared by Monas cuspurpureus Went extract: method for making is with the method for making of extract I in embodiment 5.
Prepared by Radix Puerariae extract: method for making is with the method for making of extract II in embodiment 5.
Prepared by compound medicines: method for making is shown in embodiment 5.
Each medicine adds 1%CMC all before use and is mixed with 1ml (liquid)/g (crude drug) above.
(2), animal: Wistar male rat, body weight 150 ~ 200g.Buy from Beijing Vital River Experimental Animals Technology Co., Ltd..
(3), high lipid food: with experimental example 4.
(4), reagent: with experimental example 4.
(5), instrument: with experimental example 4.
2, method and result
(1), hyperlipemia modeling: with experimental example 4.
(2), experimental technique: with experimental example 4.
(3), the results are shown in Table 5
Table 5 Traditional Chinese medicine compound composition is on the impact (X ± SD, mg/dl) of lipids contents
△ △ represents and to compare (t checks) with blank group, P < 0.01; *, * * represents and to compare (t checks) with hyperlipidemia model group, P < 0.05,0.01
Result shows: Monas cuspurpureus Went, compound recipe all can reduce the content that high lipid food feeds TG in the high TG rat model serum caused, and are significant difference P < 0.05 and pole significant difference P < 0.01 more respectively with model group.In this experiment, Radix Puerariae group has reduction trend, but significant difference is not obvious.Reduce viewed from percentage rate from TG: under identical dosage situation, Monas cuspurpureus Went group reduces by 31% than model group, and Radix Puerariae group reduces by 19% than model group, and compound recipe group reduces by 37% than model group; The TG of compound recipe group mice reduces amplitude and is greater than Monas cuspurpureus Went group, Radix Puerariae group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
The experimentation of experimental example 6 pharmaceutical composition effect for reducing blood fat of the present invention
1, experiment material:
(1), medicine
Prepared by Monas cuspurpureus Went extract: method for making is with the method for making of extract I in embodiment 6.
Prepared by Radix Puerariae extract: method for making is with the method for making of extract II in embodiment 6.
Prepared by compound medicines: method for making is shown in embodiment 6.
Each medicine adds 1%CMC all before use and is mixed with 1ml (liquid)/g (crude drug) above.
(2), animal: Wistar male rat, body weight 150 ~ 200g.Buy from Beijing Vital River Experimental Animals Technology Co., Ltd..
(3), high lipid food: with experimental example 4.
(4), reagent: with experimental example 4.
(5), instrument: with experimental example 4.
2, method and result
(1), hyperlipemia modeling: with experimental example 4.
(2), experimental technique: with experimental example 4.
(3), the results are shown in Table 6
Table 6 Traditional Chinese medicine compound composition is on the impact (X ± SD, mg/dl) of lipids contents
△ △ represents and to compare (t checks) with blank group, P < 0.01; *, * * represents and to compare (t checks) with hyperlipidemia model group, P < 0.05,0.01
Result shows: Monas cuspurpureus Went, Radix Puerariae, compound recipe all can reduce the content that high lipid food feeds TG in the high TG rat model serum caused, and are significant difference P < 0.05 and pole significant difference P < 0.01 more respectively with model group.Reduce viewed from percentage rate from TG: under identical dosage situation, Monas cuspurpureus Went group reduces by 33% than model group, and Radix Puerariae group reduces by 22% than model group, and compound recipe group reduces by 40% than model group; The TG of compound recipe group mice reduces amplitude and is greater than Monas cuspurpureus Went group, Radix Puerariae group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
The experimentation of experimental example 7 pharmaceutical composition effect for reducing blood fat of the present invention
1, experiment material:
(1), medicine
Prepared by Monas cuspurpureus Went extract: get Monas cuspurpureus Went medical material 1 weight portion, add 6 parts by volume 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue adds 6 parts by volume 75% alcohol reflux 2 hours, extracting liquid filtering.Merge twice filtrate, decompression recycling ethanol, be concentrated into 55 ~ 60 DEG C and survey relative density 0.95 ~ 1.06.Spraying dry.
Prepared by Radix Puerariae extract: get Radix Puerariae medical material 1 weight portion, add 6 parts by volume 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue adds 6 parts by volume 75% alcohol reflux 2 hours, extracting liquid filtering.Merge twice filtrate, decompression recycling ethanol, be concentrated into 55 ~ 60 DEG C and survey relative density 0.95 ~ 1.06.Spraying dry.
Prepared by compound medicines: method for making is shown in embodiment 7.
Each medicine adds 1%CMC all before use and is mixed with 1ml (liquid)/g (crude drug) above.
(2), animal: Wistar male rat, body weight 150 ~ 200g.Buy from Beijing Vital River Experimental Animals Technology Co., Ltd..
(3), high lipid food: with experimental example 4.
(4), reagent: with experimental example 4.
(5), instrument: with experimental example 4.
2, method and result
(1), hyperlipemia modeling: with experimental example 4.
(2), experimental technique: with experimental example 4.
(3), the results are shown in Table 7
Table 7 Traditional Chinese medicine compound composition is on the impact (X ± SD, mg/dl) of lipids contents
△ △ represents and to compare (t checks) with blank group, P < 0.01; *, * * represents and to compare (t checks) with hyperlipidemia model group, P < 0.05.
Result shows: Monas cuspurpureus Went, Radix Puerariae, compound recipe all can reduce the content that high lipid food feeds TG in the high TG rat model serum caused, and are significant difference P < 0.05 and pole significant difference P < 0.01 more respectively with model group.Reduce viewed from percentage rate from TG: under identical dosage situation, Monas cuspurpureus Went group reduces by 29% than model group, and Radix Puerariae group reduces by 19% than model group, and compound recipe group reduces by 35% than model group; The TG of compound recipe group mice reduces amplitude and is greater than Monas cuspurpureus Went group, Radix Puerariae group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
Experimental example 8 recipe determination is tested
1, by reagent: screened the water extraction of 25 kinds of medical materials and alcohol extraction position, 2 kinds of monomeric compounds, 4 kinds of effective part extracts, the extract that compared for existing a kind of Chinese medicine preparation and Monas cuspurpureus Went on market be prepared into compound recipe.Refer to table 8.
Wherein, all medical materials have been investigated water extract and Monas cuspurpureus Went extract respectively and are formed compound recipe, ethanol extraction and Monas cuspurpureus Went extract and form compound recipe two kinds of compound recipes.
2, preparation method:
(1), the extract preparation when A is medical material:
● water extracting method: A medical material 100g adds 8 times of water gagings, soaks 30min, keeps micro-30min that boils after being heated to seethe with excitement;
100 mesh screen; Filtering residue adds 5 times of water gagings again, keeps micro-20min that boils after being heated to seethe with excitement; 100 mesh screen;
Filtrate merges, concentrated, dry, obtains medical material water extract.
● alcohol extraction procedure: A medical material 100g adds 8 times amount 75% ethanol, soaks 30min, reflux, extract, 30min; 100 mesh screen; Filtering residue adds 5 times amount 75% ethanol again, reflux, extract, 20min; 100 mesh screen; Filtrate merges, concentrated, dry, obtains medical material ethanol extraction.
(2), B medical material Monas cuspurpureus Went extract preparation: get Monas cuspurpureus Went medical material 100g, add 3 times amount 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue adds 2 times amount 75% alcohol reflux 2 hours, and extracting liquid filtering, merges twice filtrate, decompression recycling ethanol, concentrated, dry, obtains Monas cuspurpureus Went extract.
(3), the preparation method of compound recipe:
The A medical material water extract that the method for 2. (1) is prepared respectively and Monas cuspurpureus Went extract composition compound recipe; Or A medical material ethanol extraction and Monas cuspurpureus Went extract form compound recipe.100ml is mixed with before use with 0.5% sodium carboxymethyl cellulose solution.
(4), the preparation method of tested compound medicine when A is commercially available extract
Get extract 25g, add (extracting method of B medical material, the preparation of compound recipe see above 2) in the extract of B medical material.100ml is mixed with before use with 0.5% sodium carboxymethyl cellulose solution.
(5), the preparation method of tested compound medicine when A is commodity monomers
Get commodity monomers curcumin or matrine 3g (600mg/kg dosage group) or matrine 1g (200mg/kg dosage group), 0.5g (100mg/kg dosage group), add (extracting method of B medical material, the preparation of compound recipe see above 2) in the extract of B medical material.100ml is mixed with before use with 0.5% sodium carboxymethyl cellulose solution.
(6), the preparation method of tested compound medicine when A is commercial preparation
Get Herb Gynostemmae Pentaphylli total glycosides tablet 75 (being equivalent to Herb Gynostemmae Pentaphylli total glycosides 1500mg), add (extracting method of B medical material, the preparation of compound recipe see above 2) in the extract of B medical material.100ml is mixed with before use with 0.5% sodium carboxymethyl cellulose solution.
3, Experimental agents dosage: all by following dosage
(1), the tested compound medicine dosage when A is medical material:
Be 20g medical material/kg body weight (compound concentration is 1g medical material/ml) containing A, B medical material dosage, be equivalent to quantity 10 times;
(2), the dosage of tested compound medicine when A is commercially available extract (such as Radix Salviae Miltiorrhizae, Fructus Hippophae, Folium Ginkgo):
Be 5g extract/kg body weight containing A pharmaceutical quantities, be 20g medical material/kg body weight (compound concentration: contain A extract 0.25g/ml in compound recipe, containing B1g medical material/ml) containing the dosage of B medicine;
(3), the dosage of tested compound medicine when A is commodity monomers (such as curcumin, matrine):
Be 600 ~ 100mg monomer/kg body weight containing A pharmaceutical quantities, be 20g medical material/kg body weight (compound concentration: contain A monomer 30mg/ml ~ 5mg/ml in compound recipe, containing B1g medical material/ml) containing the dosage of B medicine
(4), the dosage of tested compound medicine when A is commercial preparation:
Dosage containing A medicine is 300mg/kg body weight, concentration is 15mg/ml; Dosage containing B medicine is 20g medical material/kg body weight (configuration concentration is 1g medical material/ml).
4, the foundation of model: (1) fructose causes high TG mouse model:
Male ICR mouse, about 30g.Mice administration when non-fasting.Blank group and model group give 1% sodium carboxymethyl cellulose solution with the volume gavage of 20ml/kg, and fenofibrate group (300mg/kg) give fenofibrate according to equal-volume.Successive administration 3 days.Prohibited water 24h at 2nd ~ 3 days, freely drink the fructose soln that drinking-water changes 20% into into 20h, 20h cuts tail and gets blood upon administration respectively.Measure TG.EDTA anticoagulant is adopted to prepare blood plasma (centrifugal 2400rpm × 10min).Measure TG value.
(2) triton WR-1339 causes high TG mice TG model
Triton WR-1339 (Sigma company): be mixed with 50mg/mL concentration with 0.9% sodium chloride solution.According to 250mg/kg dosed administration.
Male ICR mouse, about 30g.Blank group and model group are to 1%CMC solution, and fenofibrate group dosage is 300mg/kg, by reagent according to 20g/kg dosed administration.Continuous i.g. administration measured TG after 2 days.The 3rd day each group get blood, i.g. administration, i.v. modeling (respectively tail vein injection Triton 0.05ml/10g, blank group injecting normal saline), and after modeling, 24h cuts tail and gets blood, measures TG value.
(3) on the impact of TG after normal mouse multiple dosing
Male ICR mouse, about 30g.Mice administration when non-fasting.Blank group gives 1% sodium carboxymethyl cellulose solution with the volume gavage of 20ml/kg, positive drug fenofibrate group (300mg/kg) and respectively give fenofibrate by reagent group according to equal-volume, and successive administration 4 days, cuts tail at 5d and get blood.EDTA anticoagulant is adopted to prepare blood plasma.Measure TG value.
5, administering mode: i.g
6, administration volume: 20ml/kg
7, positive control drug: fenofibrate 300m g/kg body weight
8, mathematical statistics: t checks, and P < 0.05 has significant difference, and P < 0.01 has pole significant difference
9, result: in table 8
Preliminary screening is carried out in the grouping of table 8 medicine
Note:
* represent and compare with model control group, TG has significance to reduce (P < 0.05);
* represents and to compare with model control group, and TG has pole significance to reduce (P < 0.01);
Expression is compared with model control group " to have trend ", and TG value has reduction, but t test statistics difference is remarkable, represents that this medicine has reduction trend.
(1), fructose model: respectively organize and to compare with model control group and to have carried out repetition experimental verification, experimental result is summarized as follows:
*: Radix Salviae Miltiorrhizae, Herb Gynostemmae Pentaphylli, Rhizoma Alismatis, Rhizoma Curcumae, Radix Glycyrrhizae, Fructus Crataegi, Rhizoma Chuanxiong;
*: curcumin, Fructus Hippophae, Radix Oenotherae erythrosepalae oil, Semen Astragali Complanati, Radix Sophorae Flavescentis;
What have trend has: Folium Ginkgo, the Rhizoma Atractylodis Macrocephalae, Herba Sedi
(2), TritonX model: respectively organize and to compare with model control group and to have carried out repetition experimental verification, experimental result is summarized as follows:
*: Rhizoma Curcumae Longae, Radix Sophorae Flavescentis, Rhizoma Alismatis, Rhizoma Curcumae, Radix Curcumae
*: Herb Gynostemmae Pentaphylli, Radix Oenotherae erythrosepalae oil, Radix Puerariae,
What have trend has: after Folium Ginkgo, Radix Et Rhizoma Rhei, Fructus Hippophae, Herba Silybi mariani, Herba Artemisiae Scopariae, Fructus Crataegi, Rhizoma Chuanxiong, Radix Paeoniae Rubra (3), the administration of normal mouse continuous several times, and TG has and extremely significantly reducedly to have: Rhizoma Curcumae
Two, second stage divides into groups to have carried out screening (administering mode, dosage etc. are all with above) (see table 9) to above preferred medicine again
The preferred medicine of table 9 divides into groups to screen again
From above result, different medicaments compounds, the result of the reduction TG demonstrated in various model is different, may be because the different mechanism of action causes.But final result all demonstrates the effect reducing TG preferably.
Detailed description of the invention:
Embodiment 1: the preparation of medicament composition dropping pills agent of the present invention
Get Monas cuspurpureus Went 6kg, add the ethyl acetate reflux 2 hours of 24L80% at every turn, extract 3 times; Extracting liquid filtering, merging filtrate, recycling design, is condensed into thick paste, obtains extract I.
Get Radix Puerariae medical material 1kg: decoct with water 3 times, each volume is respectively 10 times, 8 times, 8 times of its weight, and decocting time is respectively 2h, 1h, 1h.Filter respectively, merging filtrate, concentrating under reduced pressure obtains extract II.
Extract I, II add pharmaceutical adjunct, conveniently technique, make the drop pill of clinical acceptance.
Embodiment 2: the preparation of medicament composition capsule agent of the present invention
Get Monas cuspurpureus Went 4kg, add the alcohol heating reflux 1 hour of 8L90%, filter; Add the alcohol heating reflux 1 hour of 8L90% again, filter; Merging filtrate, recycling design, is condensed into thick paste, obtains extract I.
Get Radix Puerariae medical material 1kg: the 15 times of 90% alcohol reflux 2h adding its weight, filter; Add 10 times of 90% alcohol reflux 1h again, filter; Merging filtrate, concentrated, obtain extract II.
Extract I, II add pharmaceutical adjunct, conveniently technique, make the capsule of clinical acceptance.
Embodiment 3: the preparation of drug composition oral liquid of the present invention
Get Monas cuspurpureus Went medical material 1kg, add 4L50% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue adds 2L50% alcohol reflux 3 hours, extracting liquid filtering.Merge twice filtrate, decompression recycling ethanol, be concentrated into 55 ~ 60 DEG C and survey relative density 0.95 ~ 1.06.Add the deionized water mixing of 2.0 times of volumes in concentrated solution, place 12 hours.Centrifugal, collecting precipitation, obtains Monas cuspurpureus Went extract I.
Get Radix Puerariae medical material 6kg: add its weight 10 times of 20% alcohol reflux 1.5h, filter; Add 10 times of 20% alcohol reflux 1.5h again, filter; Merging filtrate, concentrated, obtain extract II.
Extract I, II add pharmaceutical adjunct, conveniently technique, make the oral liquid of clinical acceptance.
Embodiment 4: the preparation of medicament composition granule agent of the present invention
Get Monas cuspurpureus Went 1kg, add the alcohol heating reflux 2 hours of 4L80% at every turn, extract 2 times; Extracting liquid filtering, merging filtrate, recycling design, is condensed into thick paste, obtains extract I.
Get Radix Puerariae medical material 3kg: 50% alcohol reflux 2 times adding its weight 10 times of volumes, extraction time is 2h.Filter respectively, merging filtrate, concentrating under reduced pressure obtains extract II.
Extract I, II add pharmaceutical adjunct, conveniently technique, make the granule of clinical acceptance.
Embodiment 5: the preparation of medicinal composition tablets of the present invention
Get Monas cuspurpureus Went 2kg, add the alcohol heating reflux 3 hours of 6L70%, filter; Add the alcohol heating reflux 2 hours of 4L75% again, filter; Merging filtrate, recycling design, is condensed into thick paste, obtains extract I.
Get Radix Puerariae medical material 1kg: 75% alcohol reflux 2 times adding its weight 8 times of volumes, extraction time is 1h.Filter respectively, merging filtrate, concentrating under reduced pressure obtains extract II.
Extract I, II add pharmaceutical adjunct, conveniently technique, make the tablet of clinical acceptance.
Embodiment 6: the preparation of medicament composition capsule agent of the present invention
Get Monas cuspurpureus Went medical material 1kg, add 3L75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue adds 2L75% alcohol reflux 2 hours, extracting liquid filtering.Merge twice filtrate, decompression recycling ethanol, be concentrated into 55 ~ 60 DEG C and survey relative density 0.95 ~ 1.06.Add the deionized water mixing of 2.0 times of volumes in concentrated solution, place 8 hours.Centrifugal, collecting precipitation.Obtain extract I.
Get Radix Puerariae medical material 1kg: 75% alcohol reflux 2 times adding its weight 6 times of volumes, extraction time is 1h.Filter respectively, merging filtrate, concentrating under reduced pressure, dry, obtain extract II.
Extract I, II add pharmaceutical adjunct, conveniently technique, make the capsule of clinical acceptance.
Embodiment 7: the preparation of medicament composition capsule agent of the present invention
Get Monas cuspurpureus Went medical material 1kg, Radix Puerariae medical material 1kg adds 6L75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue adds 6 parts by volume 75% alcohol reflux 2 hours, extracting liquid filtering.Merge twice filtrate, decompression recycling ethanol, concentrated, dry.Add pharmaceutical adjunct, conveniently technique, make the capsule of clinical acceptance.
Embodiment 8: the preparation of drug composition oral liquid of the present invention
Get Monas cuspurpureus Went medical material 10kg, Radix Puerariae medical material 10kg, add 75% alcohol reflux 3 hours of 120L, extracting liquid filtering; Filtering residue adds 75% alcohol reflux 2 hours of 120L, extracting liquid filtering.Add pharmaceutical adjunct, conveniently technique, make the oral liquid of clinical acceptance.
Embodiment 9: the preparation of medicinal composition soft capsule agent of the present invention
Get Monas cuspurpureus Went medical material 1kg, add 3L75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue adds 2L75% alcohol reflux 2 hours, extracting liquid filtering.Merge twice filtrate, decompression recycling ethanol, be concentrated into 55 ~ 60 DEG C and survey relative density 0.95 ~ 1.06.Add the deionized water mixing of 2.0 times of volumes in concentrated solution, place 8 hours.Centrifugal, collecting precipitation.Obtain extract I.
Get Radix Puerariae medical material 1kg: 75% alcohol reflux 2 times adding its weight 6 times of volumes, extraction time is 1h.Filter respectively, merging filtrate, concentrating under reduced pressure, dry, obtain extract II.
Extract I, II add pharmaceutical adjunct, conveniently technique, make the soft capsule of clinical acceptance.

Claims (11)

1. there is a pharmaceutical composition for regulating blood lipid action, it is characterized in that the crude drug of this pharmaceutical composition consists of:
Monas cuspurpureus Went 1-5 weight portion Radix Puerariae 1-5 weight portion;
This pharmaceutical composition is made by the following method:
Prepared by step one, Monas cuspurpureus Went extract I
Monas cuspurpureus Went extract I is prepared by any one method following:
A, Monas cuspurpureus Went 1 weight portion, add the ethanol of 2 ~ 10 parts by volume 50 ~ 90%, methanol or ethyl acetate at every turn, reflux 1 ~ 3 hour, extracts 2 ~ 3 times; Extracting liquid filtering, merging filtrate, recycling design, is condensed into the thick paste that 55 ~ 60 DEG C are surveyed relative density 0.95 ~ 1.06, obtains extract I;
B, Monas cuspurpureus Went 1 weight portion, add the ethanol of 2 ~ 10 parts by volume 50 ~ 90%, methanol or ethyl acetate reflux 1 ~ 3 hour at every turn, extracts 2 ~ 3 times; Extracting liquid filtering, merging filtrate, recycling design, is concentrated into 55 ~ 60 DEG C and surveys relative density 0.95 ~ 1.06, and add 0.5 ~ 2.0 times of deionized water mixing in concentrated solution, room temperature or cold preservation are placed 2 ~ 12 hours, centrifugal, and collecting precipitation is dry, obtains extract I;
Prepared by step 2, Radix Puerariae extract II
Radix Puerariae medical material 1 weight portion, the water or the alcohol heating reflux that add 4 ~ 20 parts by volume extract 1 ~ 3 hour at every turn, and extract 2 ~ 4 times, extracting liquid filtering, merging filtrate, recycling design, is condensed into thick paste; Obtain extract II;
Step 3, preparation
By extract I and extract II conventionally, add customary adjuvant, make the pill of clinical acceptance, powder, tablet, granule, capsule or oral liquid.
2. pharmaceutical composition as claimed in claim 1, it is characterized in that the crude drug of this pharmaceutical composition consist of following any one:
3. pharmaceutical composition as claimed in claim 1 or 2, is characterized in that this pharmaceutical composition is made by the following method:
Prepared by step one, Monas cuspurpureus Went extract I
Monas cuspurpureus Went extract I is prepared by any one method following:
A, Monas cuspurpureus Went 1 weight portion, add the ethanol of 2 ~ 10 parts by volume 50 ~ 90%, methanol or ethyl acetate at every turn, reflux 1 ~ 3 hour, extracts 2 ~ 3 times; Extracting liquid filtering, merging filtrate, recycling design, is condensed into the thick paste that 55 ~ 60 DEG C are surveyed relative density 0.95 ~ 1.06, obtains extract I;
B, Monas cuspurpureus Went 1 weight portion, add the ethanol of 2 ~ 10 parts by volume 50 ~ 90%, methanol or ethyl acetate reflux 1 ~ 3 hour at every turn, extracts 2 ~ 3 times; Extracting liquid filtering, merging filtrate, recycling design, is concentrated into 55 ~ 60 DEG C and surveys relative density 0.95 ~ 1.06, and add 0.5 ~ 2.0 times of deionized water mixing in concentrated solution, room temperature or cold preservation are placed 2 ~ 12 hours, centrifugal, and collecting precipitation is dry, obtains extract I;
Prepared by step 2, Radix Puerariae extract II
Radix Puerariae medical material 1 weight portion, the water or the alcohol heating reflux that add 4 ~ 20 parts by volume extract 1 ~ 3 hour at every turn, and extract 2 ~ 4 times, extracting liquid filtering, merging filtrate, recycling design, is condensed into thick paste; Obtain extract II;
Step 3, preparation
By extract I and extract II conventionally, add customary adjuvant, make the pill of clinical acceptance, powder, tablet, granule, capsule or oral liquid.
4. pharmaceutical composition as claimed in claim 3, is characterized in that the A method in described step one is:
Get Monas cuspurpureus Went medical material 1 weight portion, add 3 parts by volume 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue adds 2 parts by volume 75% alcohol reflux 2 hours, and extracting liquid filtering, merges twice filtrate, decompression recycling ethanol, is concentrated into the thick paste that 55 ~ 60 DEG C are surveyed relative density 0.95 ~ 1.06, obtains extract I.
5. pharmaceutical composition as claimed in claim 3, is characterized in that the B method in described step one is:
Monas cuspurpureus Went medical material 1 weight portion, adds 3 parts by volume 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue adds 2 parts by volume 75% alcohol reflux 2 hours, and extracting liquid filtering, merges twice filtrate, decompression recycling ethanol, is concentrated into 55 ~ 60 DEG C and surveys relative density 0.95 ~ 1.06, and add 1 times of deionized water mixing in concentrated solution, room temperature or cold preservation place 8 hours.Centrifugal, collecting precipitation, at 80 DEG C, dry 8 lab scales, pulverized 60 mesh sieves, obtained extract I.
6. pharmaceutical composition as claimed in claim 3, is characterized in that described step 2 is:
Radix Puerariae medical material 1 weight portion, adds the 70% or 40% ethanol heating extraction 1 ~ 3 hour of 12 parts by volume at every turn, extracts 2 ~ 3 times, extracting liquid filtering, merging filtrate, recycling design, is concentrated into the thick paste that 55 ~ 60 DEG C are surveyed relative densities 0.95 ~ 1.06; Obtain extract II.
7. the preparation method of pharmaceutical composition as claimed in claim 1 or 2, is characterized in that the method is:
Prepared by step one, Monas cuspurpureus Went extract I
Monas cuspurpureus Went extract I is prepared by any one method following:
A, Monas cuspurpureus Went 1 weight portion, add the ethanol of 2 ~ 10 parts by volume 50 ~ 90%, methanol or ethyl acetate at every turn, reflux 1 ~ 3 hour, extracts 2 ~ 3 times; Extracting liquid filtering, merging filtrate, recycling design, is condensed into the thick paste that 55 ~ 60 DEG C are surveyed relative density 0.95 ~ 1.06, obtains extract I;
B, Monas cuspurpureus Went 1 weight portion, add the ethanol of 2 ~ 10 parts by volume 50 ~ 90%, methanol or ethyl acetate reflux 1 ~ 3 hour at every turn, extracts 2 ~ 3 times; Extracting liquid filtering, merging filtrate, recycling design, is concentrated into 55 ~ 60 DEG C and surveys relative density 0.95 ~ 1.06, and add 0.5 ~ 2.0 times of deionized water mixing in concentrated solution, room temperature or cold preservation are placed 2 ~ 12 hours, centrifugal, and collecting precipitation is dry, obtains extract I;
Prepared by step 2, Radix Puerariae extract II
Radix Puerariae medical material 1 weight portion, the water or the alcohol heating reflux that add 4 ~ 20 parts by volume extract 1 ~ 3 hour at every turn, and extract 2 ~ 4 times, extracting liquid filtering, merging filtrate, recycling design, is condensed into thick paste; Obtain extract II;
Step 3, preparation
By extract I and extract II conventionally, add customary adjuvant, make the pill of clinical acceptance, powder, tablet, granule, capsule or oral liquid.
8. the preparation method of pharmaceutical composition as claimed in claim 7, is characterized in that in described Monas cuspurpureus Went extract I preparation method, A, B method is respectively:
A method: get Monas cuspurpureus Went medical material 1 weight portion, adds 3 parts by volume 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue adds 2 parts by volume 75% alcohol reflux 2 hours, and extracting liquid filtering, merges twice filtrate, decompression recycling ethanol, is concentrated into the thick paste that 55 ~ 60 DEG C are surveyed relative density 0.95 ~ 1.06, obtains extract I;
B method: Monas cuspurpureus Went medical material 1 weight portion, adds 3 parts by volume 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue adds 2 parts by volume 75% alcohol reflux 2 hours, and extracting liquid filtering, merges twice filtrate, decompression recycling ethanol, is concentrated into 55 ~ 60 DEG C and surveys relative density 0.95 ~ 1.06, and add 1 times of deionized water mixing in concentrated solution, room temperature or cold preservation place 8 hours.Centrifugal, collecting precipitation, at 80 DEG C, dry 8 lab scales, pulverized 60 mesh sieves, obtained extract I.
9. the preparation method of pharmaceutical composition as claimed in claim 7, is characterized in that described Radix Puerariae extract II preparation method is:
Radix Puerariae medical material 1 weight portion, adds the 70% or 40% ethanol heating extraction 1 ~ 3 hour of 12 parts by volume at every turn, extracts 2 ~ 3 times, extracting liquid filtering, merging filtrate, recycling design, is concentrated into the thick paste that 55 ~ 60 DEG C are surveyed relative densities 0.95 ~ 1.06; Obtain extract II.
10. pharmaceutical composition as claimed in claim 1 or 2, is characterized in that this pharmaceutical composition conventionally adds customary adjuvant, makes clinical acceptable pill, powder, tablet, granule, capsule or oral liquid.
11. as the application of the pharmaceutical composition as described in arbitrary in claim 1-6 in the medicine of preparation treatment hypertriglyceridemia.
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