CN103372040B - Monas cuspurpureus Went Rhizoma Chuanxiong drug regimen of a kind of adjusting blood lipid and preparation method thereof - Google Patents
Monas cuspurpureus Went Rhizoma Chuanxiong drug regimen of a kind of adjusting blood lipid and preparation method thereof Download PDFInfo
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- CN103372040B CN103372040B CN201210119116.8A CN201210119116A CN103372040B CN 103372040 B CN103372040 B CN 103372040B CN 201210119116 A CN201210119116 A CN 201210119116A CN 103372040 B CN103372040 B CN 103372040B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/236—Ligusticum (licorice-root)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation 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
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/19—Preparation or pretreatment of starting material involving fermentation using yeast, bacteria or both; enzymatic treatment
Abstract
The object of the invention is pharmaceutical composition of open a kind of regulating blood lipid action (especially treating hypertriglyceridemia) and preparation method thereof; The object of the invention is also the pharmaceutical applications of openly described pharmaceutical composition.In pharmaceutical composition of the present invention, Monas cuspurpureus Went and the mutual compatibility of Rhizoma Chuanxiong, create potentiation.There is dehumidifying eliminate the phlegm, blood circulation promoting and blood stasis dispelling, effect of strengthening the spleen to promote digestion; Blood cholesterol, high density lipoprotein increasing can be reduced, reduce low density lipoprotein, LDL content, show 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.
Description
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 Rhizoma Chuanxiong 1-5 weight portion;
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Monas cuspurpureus Went 2 weight portion Rhizoma Chuanxiong 4 weight portion;
Monas cuspurpureus Went 4 weight portion Rhizoma Chuanxiong 2 weight portion;
Monas cuspurpureus Went 1 weight portion Rhizoma Chuanxiong 4 weight portion;
Monas cuspurpureus Went 4 weight portion Rhizoma Chuanxiong 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 Rhizoma Chuanxiong 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 Rhizoma Chuanxiong extract II is prepared by the following method:
Ligusticum chuanxiong Hort 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.
Rhizoma Chuanxiong extract II described in preparation method of the present invention is preferably as follows method preparation:: Ligusticum chuanxiong Hort 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 Rhizoma Chuanxiong, 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 pharmacodynamics test.
Test 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 Rhizoma Chuanxiong 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 0.75g (crude drug)/ml (liquid) 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 (Versamaxtunable, MolecularDevices), centrifuge: (AnkeLXJ-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), Rhizoma Chuanxiong group (ig height lipoprotein emulsion 20ml/kg.d+ Rhizoma Chuanxiong 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, Rhizoma Chuanxiong, 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 34% than model group, and Rhizoma Chuanxiong group reduces by 26% 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, Rhizoma Chuanxiong group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
Test 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 Rhizoma Chuanxiong 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 0.75g (crude drug)/ml (liquid) 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, Rhizoma Chuanxiong, 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 37% than model group, and Rhizoma Chuanxiong group reduces by 30% 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, Rhizoma Chuanxiong group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
Test 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 Rhizoma Chuanxiong 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 0.75g (crude drug)/ml (liquid) 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, Rhizoma Chuanxiong, 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 38% than model group, and Rhizoma Chuanxiong group reduces by 34% than model group, and compound recipe group reduces by 45% than model group; The TG of compound recipe group mice reduces amplitude and is greater than Monas cuspurpureus Went group, Rhizoma Chuanxiong group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
The experimentation of test 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 Rhizoma Chuanxiong 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 0.75g (crude drug)/ml (liquid) 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 (Versamaxtunable, MolecularDevices), 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; Rhizoma Chuanxiong group: every day, gavage gave Rhizoma Chuanxiong 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 tests) 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 16% than model group, and Rhizoma Chuanxiong group and model group be not than reducing, and compound recipe group reduces by 25% than model group; The TG of compound recipe group mice reduces amplitude and is greater than Monas cuspurpureus Went group, Rhizoma Chuanxiong group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
The experimentation of test 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 Rhizoma Chuanxiong 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 0.75g (crude drug)/ml (liquid) 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.Reduce viewed from percentage rate from TG: under identical dosage situation, Monas cuspurpureus Went group reduces by 29% than model group, and Rhizoma Chuanxiong group reduces by 6% 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, Rhizoma Chuanxiong group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
The experimentation of test 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 Rhizoma Chuanxiong 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 0.75g (crude drug)/ml (liquid) 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, 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.Rhizoma Chuanxiong 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 Rhizoma Chuanxiong group reduces by 9% 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, Rhizoma Chuanxiong group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
The experimentation of test 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 10kg, adds 75% alcohol reflux 3 hours of 60L, extracting liquid filtering; Filtering residue adds 75% alcohol reflux 2 hours of 120L, extracting liquid filtering.Merge twice filtrate, decompression recycling ethanol, be concentrated into 55 ~ 60 DEG C and survey relative density 0.95 ~ 1.06, dry.
Prepared by Rhizoma Chuanxiong extract: get Ligusticum chuanxiong Hort 10kg, adds 75% alcohol reflux 3 hours of 60L, extracting liquid filtering; Filtering residue adds 75% alcohol reflux 2 hours of 120L, extracting liquid filtering.Merge twice filtrate, decompression recycling ethanol, be concentrated into 55 ~ 60 DEG C and survey relative density 0.95 ~ 1.06, 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 0.75g (crude drug)/ml (liquid) 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, compound recipe all obviously can reduce the content that high lipid food feeds TG in the high TG rat model serum caused; Rhizoma Chuanxiong 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 32% 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, Rhizoma Chuanxiong group.Show that Traditional Chinese medicine compound composition has the effect more obviously reducing TG in blood.
Experimental example 8 formulation screening test
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): containing A pharmaceutical quantities be 5g extract/kg body weight, containing the dosage of B medicine be 20g medical material/kg body weight (compound concentration: in compound recipe containing A extract 0.25g/ml, containing B1g medical material/ml);
(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) tritonWR-1339 causes high TG mice TG model
TritonWR-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 Triton0.05ml/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 300mg/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: Folium Ginkgo, Radix Et Rhizoma Rhei, Fructus Hippophae, Herba Silybi mariani, Herba Artemisiae Scopariae, Fructus Crataegi, Rhizoma Chuanxiong, Radix Paeoniae Rubra
(3), after the administration of normal mouse continuous several times, 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 medicinal composition tablets 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 Ligusticum chuanxiong Hort 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 tablet of clinical acceptance.
Embodiment 2: the preparation of medicament composition granule 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 Ligusticum chuanxiong Hort 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 granule 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 Ligusticum chuanxiong Hort 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 Ligusticum chuanxiong Hort 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 pharmaceutical composition 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 Ligusticum chuanxiong Hort 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 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 Ligusticum chuanxiong Hort 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 10kg, Ligusticum chuanxiong Hort 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 capsule of clinical acceptance.
Embodiment 8: 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 Ligusticum chuanxiong Hort 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 (9)
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 Rhizoma Chuanxiong 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, Rhizoma Chuanxiong extract II
Ligusticum chuanxiong Hort 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 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.
4. pharmaceutical composition as claimed in claim 1 or 2, 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, extracting liquid filtering, merges twice filtrate, decompression recycling ethanol, be concentrated into 55 ~ 60 DEG C and survey relative density 0.95 ~ 1.06, 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, drying 8 hours, pulverized 60 mesh sieves, obtained extract I.
5. pharmaceutical composition as claimed in claim 1 or 2, is characterized in that described step 2 is:
Ligusticum chuanxiong Hort 1 weight portion, 70% or 40% alcohol heating reflux at every turn adding 12 parts by volume extracts 1 ~ 3 hour, 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 density 0.95 ~ 1.06; Obtain extract II.
6. 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, Rhizoma Chuanxiong extract II
Ligusticum chuanxiong Hort 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,
By extract I and extract II conventionally, add customary adjuvant, make the pill of clinical acceptance, powder, tablet, granule, capsule or oral liquid.
7. the preparation method of pharmaceutical composition as claimed in claim 6, is characterized in that in described Monas cuspurpureus Went extract I preparation method, A, B method is respectively:
A 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 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, extracting liquid filtering, merges twice filtrate, decompression recycling ethanol, be concentrated into 55 ~ 60 DEG C and survey relative density 0.95 ~ 1.06, 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, drying 8 hours, pulverized 60 mesh sieves, obtained extract I.
8. the preparation method of pharmaceutical composition as claimed in claim 6, is characterized in that described Rhizoma Chuanxiong extract II preparation method is:
Ligusticum chuanxiong Hort 1 weight portion, 70% or 40% alcohol heating reflux at every turn adding 12 parts by volume extracts 1 ~ 3 hour, 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 density 0.95 ~ 1.06; Obtain extract II.
9. as the application of the pharmaceutical composition as described in arbitrary in claim 1-5 in the medicine of preparation treatment hypertriglyceridemia.
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| PCT/CN2013/074536 WO2013155997A1 (en) | 2012-04-20 | 2013-04-22 | Blood lipid-regulating red yeast ligusticum chuanxiong pharmaceutical composition and preparation method therefor |
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