CN103372073A - Red rice and hawthorn medicinal composition for regulating blood fat and preparation method of composition - Google Patents
Red rice and hawthorn medicinal composition for regulating blood fat and preparation method of composition Download PDFInfo
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- CN103372073A CN103372073A CN201210119095XA CN201210119095A CN103372073A CN 103372073 A CN103372073 A CN 103372073A CN 201210119095X A CN201210119095X A CN 201210119095XA CN 201210119095 A CN201210119095 A CN 201210119095A CN 103372073 A CN103372073 A CN 103372073A
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Abstract
The invention aims to provide a medicinal composition for regulating blood fat, in particular treating hypertriglyceridemia, and a preparation method of the composition, and provides pharmaceutical application of the medicinal composition. The red rice and hawthorn in the medicinal composition are compatible, and play a synergetic effect. The medicinal composition 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
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, relate in particular to pharmaceutical composition of a kind of preparation take Chinese medicine compound as raw material and preparation method thereof, belong to the field of Chinese medicines.
Background technology
Modern's life style is so that the high protein that absorbs in people's the food, hypercholesterolemia, high sugar food are more and more, thereby causes the sickness rate of hyperlipemia to be obvious ascendant trend.Hyperlipemia is the prerequisite that atherosclerosis forms, and has 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 the prevention cardiovascular and cerebrovascular disease is played an important role, researching and developing safely and effectively, serum regulating drug and health food are very important.
Hyperlipemia refers to T-CHOL in the blood (TC) and/or triglyceride (triglyceride, TG) is too high or HDL-C (HDL-C) is excessively 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 49252 〉=18 years old 31 permanent resident population of provinces, autonomous regions and municipalities of China sampling survey: China 〉=18 years old lipid disorders in residents prevalence 18.6%.Wherein the hypercholesterolemia prevalence is 2.9%; Cholesterol marginality rate of rise is 3.9%; The hypertriglyceridemia prevalence is 11.9%; Low hdl mass formed by blood stasis prevalence is 7.4%.Population of China dysbolism of blood fat type is take high triglyceride, low hdl mass formed by blood stasis as main, and this and west crowd are different take high T-CHOL mass formed by blood stasis as main feature.Seeking a kind of blood lipid-lowering medicine for compatriots' dysbolism of blood fat type is necessary.
Summary of the invention
Pharmaceutical composition that provides a kind of regulating blood lipid action (especially treating hypertriglyceridemia) and preparation method thereof is provided the object of the invention; The object of the invention also is to provide the pharmaceutical applications of 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 Fructus Crataegi 1-5 weight portion;
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Monas cuspurpureus Went 2 weight portion Fructus Crataegis 4 weight portions;
Monas cuspurpureus Went 4 weight portion Fructus Crataegis 2 weight portions;
Monas cuspurpureus Went 1 weight portion Fructus Crataegi 4 weight portions;
Monas cuspurpureus Went 4 weight portion Fructus Crataegis 1 weight portion;
Pharmaceutical composition of the present invention can add conventional adjuvant according to conventional method, 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:
Preparation Monas cuspurpureus Went extract I and Fructus Crataegi extract II, with extract I and extract II according to conventional method, add conventional 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 following any one method:.
A, Monas cuspurpureus Went 1 weight portion add ethanol, methanol or the ethyl acetate of 2～10 parts by volume 50～90% at every turn, and reflux 1～3 hour is extracted 2～3 times; Extracting liquid filtering, merging filtrate reclaims solvent, is condensed into 55～60 ℃ of thick pastes of surveying relative density 0.95～1.06, gets extract I;
B, Monas cuspurpureus Went 1 weight portion added the ethanol, methanol of 2～10 parts by volume 50～90% or ethyl acetate reflux 1～3 hour at every turn, extracted 2～3 times; Extracting liquid filtering, merging filtrate reclaims solvent, is concentrated into 55～60 ℃ and surveys relative density 0.95～1.06, adds 0.5～2.0 times of deionized water mixing in the concentrated solution, and room temperature or cold preservation were placed 2～12 hours, and is centrifugal, collecting precipitation, drying obtains extract I;
Described Fructus Crataegi extract II prepares by the following method:
Fructus Crataegi medical material 1 weight portion, the water or the alcohol heating reflux that add 4～20 parts by volume extracted 1～3 hour at every turn, extract 2～4 times, extracting liquid filtering, merging filtrate reclaims solvent, is condensed into thick paste; Get extract II.
A method described in the preparation method of the present invention is preferably: get Monas cuspurpureus Went medical material 1 weight portion, added 3 parts by volume, 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue added 2 parts by volume, 75% alcohol reflux 2 hours, and extracting liquid filtering merges filtrate twice, and decompression recycling ethanol is concentrated into 55～60 ℃ of thick pastes of surveying relative density 0.95～1.06, gets extract I;
B method described in the preparation method of the present invention is preferably: Monas cuspurpureus Went medical material 1 weight portion added 3 parts by volume, 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue added 2 parts by volume, 75% alcohol reflux 2 hours, and extracting liquid filtering merges filtrate twice, and decompression recycling ethanol is concentrated into 55～60 ℃ and surveys relative density 0.95～1.06, adds 1 times of deionized water mixing in the concentrated solution, and room temperature or cold preservation were placed 8 hours.Centrifugal, collecting precipitation, 80 ℃ of lower dry 8 lab scales were pulverized 60 mesh sieves, obtained extract I.
Fructus Crataegi extract II described in the preparation method of the present invention is preferably as follows the method preparation: Fructus Crataegi medical material 1 weight portion, 70% or the 40% ethanol heating extraction 1～3 hour that at every turn adds 12 parts by volume, extract 2～3 times, extracting liquid filtering, merging filtrate, reclaim solvent, be concentrated into 55～60 ℃ of thick pastes of surveying relative density 0.95～1.06; Get 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 Fructus Crataegi have produced potentiation.Have dehumidifying and eliminate the phlegm blood circulation promoting and blood stasis dispelling, the 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, and hypertriglyceridemia can be significantly treated in the effect that shows especially highlightedly triglyceride reducing.Preparation technology of the present invention is reasonable, has both improved the content of effective ingredient lovastatin in the Monas cuspurpureus Went, has kept again the active component of each medicine in the prescription, has given full play to the effect of each medicine.As quality control index, the quality of the pharmaceutical preparations is stable, controlled with lovastatin content for preparation of the present invention.
Below prove effect of the present invention by pharmacodynamics test.
Test example 1 pharmaceutical composition of the present invention is fed the impact of model mice hypertriglyceridemia on high lipid food
1, experiment material:
(1), prepared by reagent:
The Monas cuspurpureus Went extract preparation: method for making is with the method for making of extract I among the embodiment 4.
The Fructus Crataegi extract preparation: method for making is with the method for making of extract II among the embodiment 4.
The compound medicines preparation: method for making is seen embodiment 4.
More than each medicine all add before use 1%CMC and be mixed with 1ml (liquid)/g (crude drug).
(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: the 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 60 of ICR mices, raised 5 days, observe confirming mice to be divided into 6 groups at random, 10 every group after the health.Blank group, hyperlipidemia model group (the high lipoprotein emulsion 20ml/kg.d+ of ig water), positive controls (the high lipoprotein emulsion 20ml/kg.d+ of ig fenofibrate 300mg/kg), Monas cuspurpureus Went group (the high lipoprotein emulsion 20ml/kg.d+ of ig Monas cuspurpureus Went concentrated solution), Fructus Crataegi group (the high lipoprotein emulsion 20ml/kg.d+ of ig Fructus Crataegi concentrated solution), compound recipe group (the high lipoprotein emulsion 20ml/kg.d+ of ig compound recipe concentrated solution).The morning, 8:30 gave high fat breast and blank solution thereof; Afternoon, 15:30 was by organizing respectively feedwater, positive control drug, respectively being subjected to reagent etc.Successive administration 20d cuts tail at 21d and gets blood respectively.Adopt the EDTA anticoagulant to prepare blood plasma.Press kit method and measure content of triglyceride.
(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 to compare (t check), P＜0.01 with the blank group; *, * * represents to compare (t check), P＜0.05,0.01 with the hyperlipidemia model group
Monas cuspurpureus Went, Fructus Crataegi, compound recipe all can reduce the content of TG in the high fat breast model mice serum.But in identical dosage situation, the Monas cuspurpureus Went group reduces by 31% than model group, and the Fructus Crataegi group reduces by 34% than model group, and the compound recipe group reduces by 42% than model group; The TG of compound recipe group mice reduces amplitude greater than Monas cuspurpureus Went group, Fructus Crataegi group.Show that Traditional Chinese medicine compound composition has the effect of TG in the more obvious reduction blood.
Test example 2 pharmaceutical compositions of the present invention are fed the impact of model mice hypertriglyceridemia on high lipid food
1, experiment material:
(1), prepared by reagent:
The Monas cuspurpureus Went extract preparation: method for making is with the method for making of extract I among the embodiment 5.
The Fructus Crataegi extract preparation: method for making is with the method for making of extract II among the embodiment 5.
The compound medicines preparation: method for making is seen embodiment 5.
More than each medicine all add before use 1%CMC and be mixed with 1ml (liquid)/g (crude drug).
(2), the preparation of high lipoprotein emulsion: with experimental example 1.
(3), reagent: with experimental example 1.
(4), animal: the 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 to compare (t check), P＜0.01 with the blank group; *, * * represents to compare (t check), P＜0.05,0.01 with the hyperlipidemia model group
Monas cuspurpureus Went, Fructus Crataegi, compound recipe all can reduce the content of TG in the high fat breast model mice serum.But in identical dosage situation, the Monas cuspurpureus Went group reduces by 34% than model group, and the Fructus Crataegi group reduces by 30% than model group, and the compound recipe group reduces by 45% than model group; The TG of compound recipe group mice reduces amplitude greater than Monas cuspurpureus Went group, Fructus Crataegi group.Show that Traditional Chinese medicine compound composition has the effect of TG in the more obvious reduction blood.
Test example 3 pharmaceutical compositions of the present invention are fed the impact of model mice hypertriglyceridemia on high lipid food
1, experiment material:
(1), prepared by reagent:
The Monas cuspurpureus Went extract preparation: method for making is with the method for making of extract I among the embodiment 6.
The Fructus Crataegi extract preparation: method for making is with the method for making of extract II among the embodiment 6.
The compound medicines preparation: method for making is seen embodiment 6
More than each medicine all add before use 1%CMC and be mixed with 1ml (liquid)/g (crude drug).
(2), the preparation of high lipoprotein emulsion: with experimental example 1.
(3), reagent: with experimental example 1.
(4), animal: the 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 to compare (t check), P＜0.01 with the blank group; *, * * represents to compare (t check), P＜0.05,0.01 with the hyperlipidemia model group
Monas cuspurpureus Went, Fructus Crataegi, compound recipe all can reduce the content of TG in the high fat breast model mice serum.But in identical dosage situation, the Monas cuspurpureus Went group reduces by 37% than model group, and the Fructus Crataegi group reduces by 31% than model group, and the compound recipe group reduces by 48% than model group; The TG of compound recipe group mice reduces amplitude greater than Monas cuspurpureus Went group, Fructus Crataegi group.Show that Traditional Chinese medicine compound composition has the effect of TG in the more obvious reduction blood.
The experimentation of test example 4 pharmaceutical composition effect for reducing blood fat of the present invention
1, experiment material:
(1), medicine
The Monas cuspurpureus Went extract preparation: method for making is with the method for making of extract I among the embodiment 4.
The Fructus Crataegi extract preparation: method for making is with the method for making of extract II among the embodiment 4.
The compound medicines preparation: method for making is seen embodiment 4.
More than each medicine all add before use 1%CMC and be mixed with 1ml (liquid)/g (crude drug).
(2), animal: Wistar male rat, body weight 150～200g.Purchase is 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 is melted with 40 ℃ of water-baths.Sodium cholate, cholesterol, propylthiouracil with the pulverizer crushing, stirring evenly, add the normal feedstuff mixing, the Adeps Sus domestica that adds again fusing is mixed thoroughly.Altogether add 50ml water in the 1000g raw material, mix thoroughly.Be pressed into bulk (material that every 30g mixes is pressed a cake) with oodle maker.Drying and sterilizing namely gets 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: (Anke LXJ-IIB).
2, method and result
(1), hyperlipemia modeling:
Get 50 of rats, be divided into blank group (10) and high fat modeling group (40), give respectively arm's length basis feedstuff and fed with high, continuous 4 weeks.In fasting in evening on the 28th, cut tail and get blood morning next day.Adopt the EDTA anticoagulant to prepare blood plasma.Press kit method and measure content of triglyceride.The results are shown in Table 2.
(2), method: will feed arm's length basis feedstuff rat as the blank group: continue to feed the arm's length basis feedstuff, every day, gavage gave the 1%CMC aqueous solution; High fat modeling animal is divided into 5 groups at random according to blood fat TG level, the hyperlipidemia model group: feed high lipid food, every day, gavage gave the 1%CMC aqueous solution; The Monas cuspurpureus Went group: every day, gavage gave Monas cuspurpureus Went extract, and dosage is 20g (crude drug)/kg body weight; The Fructus Crataegi group: every day, gavage gave Fructus Crataegi extract, and dosage is 20g (crude drug)/kg body weight; The compound recipe group: every day, gavage gave Chinese medicinal compound extract of the present invention, and dosage is 20g (crude drug)/kg body weight.Fed for 4 weeks continuously, fasting 12h after the last administration, cut tail and get blood morning next day.Adopt the EDTA anticoagulant to prepare blood plasma.Press kit method and measure content of triglyceride.
(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 to compare (t check), P＜0.01 with the blank group; *, * * represents to compare (t check), P＜0.05,0.01 with the hyperlipidemia model group
The result shows: Monas cuspurpureus Went, Fructus Crataegi, compound recipe all can reduce the content that high lipid food is fed TG in the high TG rat model serum cause, with model group be more respectively significant difference P＜0.05 and utmost point significant difference P＜0.01.Reduce percentage rate from TG: in identical dosage situation, the Monas cuspurpureus Went group reduces by 30% than model group, and the Fructus Crataegi group reduces by 18% than model group, and the compound recipe group reduces by 35% than model group; The TG of compound recipe group mice reduces amplitude greater than Monas cuspurpureus Went group, Fructus Crataegi group.Show that Traditional Chinese medicine compound composition has the effect of TG in the more obvious reduction blood.
The experimentation of test example 5 pharmaceutical composition effect for reducing blood fat of the present invention
1, experiment material:
(1), medicine
The Monas cuspurpureus Went extract preparation: method for making is with the method for making of extract I among the embodiment 5.
The Fructus Crataegi extract preparation: method for making is with the method for making of extract II among the embodiment 5.
The compound medicines preparation: method for making is seen embodiment 5.
More than each medicine all add before use 1%CMC and be mixed with 1ml (liquid)/g (crude drug).
(2), animal: Wistar male rat, body weight 150～200g.Purchase is 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 to compare (t check), P＜0.01 with the blank group; *, * * represents to compare (t check), P＜0.05,0.01 with the hyperlipidemia model group
The result shows: Monas cuspurpureus Went, Fructus Crataegi, compound recipe all can reduce the content that high lipid food is fed TG in the high TG rat model serum cause, with model group be more respectively significant difference P＜0.05 and utmost point significant difference P＜0.01.Reduce percentage rate from TG: in identical dosage situation, the Monas cuspurpureus Went group reduces by 33% than model group, and the Fructus Crataegi group reduces by 22% than model group, and the compound recipe group reduces by 38% than model group; The TG of compound recipe group mice reduces amplitude greater than Monas cuspurpureus Went group, Fructus Crataegi group.Show that Traditional Chinese medicine compound composition has the effect of TG in the more obvious reduction blood.
The experimentation of test example 6 pharmaceutical composition effect for reducing blood fat of the present invention
1, experiment material:
(1), medicine
The Monas cuspurpureus Went extract preparation: method for making is with the method for making of extract I among the embodiment 6.
The Fructus Crataegi extract preparation: method for making is with the method for making of extract II among the embodiment 6.
The compound medicines preparation: method for making is seen embodiment 6.
More than each medicine all add before use 1%CMC and be mixed with 1ml (liquid)/g (crude drug).
(2), animal: Wistar male rat, body weight 150～200g.Purchase is 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 to compare (t check), P＜0.01 with the blank group; *, * * represents to compare (t check), P＜0.05,0.01 with the hyperlipidemia model group
The result shows: Monas cuspurpureus Went, Fructus Crataegi, compound recipe all can reduce the content that high lipid food is fed TG in the high TG rat model serum cause, with model group be more respectively significant difference P＜0.05 and utmost point significant difference P＜0.01.Reduce percentage rate from TG: in identical dosage situation, the Monas cuspurpureus Went group reduces by 36% than model group, and the Fructus Crataegi group reduces by 19% than model group, and the compound recipe group reduces by 40% than model group; The TG of compound recipe group mice reduces amplitude greater than Monas cuspurpureus Went group, Fructus Crataegi group.Show that Traditional Chinese medicine compound composition has the effect of TG in the more obvious reduction blood.
The experimentation of test example 7 pharmaceutical composition effect for reducing blood fat of the present invention
1, experiment material:
(1), medicine
Monas cuspurpureus Went extract preparation: get Monas cuspurpureus Went medical material 1 weight portion, added 6 parts by volume, 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue added 6 parts by volume, 75% alcohol reflux 2 hours, extracting liquid filtering.Merge filtrate twice, decompression recycling ethanol is concentrated into 55～60 ℃ and surveys relative density 0.95～1.06.Dry.
Fructus Crataegi extract preparation: get Fructus Crataegi medical material 1 weight portion, added 6 parts by volume, 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue added 6 parts by volume, 75% alcohol reflux 2 hours, extracting liquid filtering.Merge filtrate twice, decompression recycling ethanol is concentrated into 55～60 ℃ and surveys relative density 0.95～1.06.Dry.
The compound medicines preparation: method for making is seen embodiment 7.
More than each medicine all add before use 1%CMC and be mixed with 1ml (liquid)/g (crude drug).
(2), animal: Wistar male rat, body weight 150～200g.Purchase is 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 to compare (t check), P＜0.01 with the blank group; *, * * represents to compare (t check), P＜0.05 with the hyperlipidemia model group.
The result shows: Monas cuspurpureus Went, Fructus Crataegi, compound recipe all can reduce the content that high lipid food is fed TG in the high TG rat model serum cause, with model group be more respectively significant difference P＜0.05 and utmost point significant difference P＜0.01.Reduce percentage rate from TG: in identical dosage situation, the Monas cuspurpureus Went group reduces by 32% than model group, and the Fructus Crataegi group reduces by 26% than model group, and the compound recipe group reduces by 40% than model group; The TG of compound recipe group mice reduces amplitude greater than Monas cuspurpureus Went group, Fructus Crataegi group.Show that Traditional Chinese medicine compound composition has the effect of TG in the more obvious reduction blood.
Experimental example 8 formulation screening tests
1, is subjected to 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, contrasted that the extract of existing a kind of Chinese medicine preparation and Monas cuspurpureus Went is prepared into compound recipe on the market.See table 8 for details.Wherein, all medical materials have been investigated water extract and Monas cuspurpureus Went extract composition compound recipe, ethanol extraction and two kinds of compound recipes of Monas cuspurpureus Went extract composition compound recipe respectively.
2, preparation method:
(1), extract preparation when A is medical material:
● water extracting method: A medical material 100g adds 8 times of water gagings, soaks 30min, is heated to the rear little 30min of boiling of maintenance of boiling; 100 mesh sieves filter; Filtering residue adds 5 times of water gagings again, is heated to the rear little 20min of boiling of maintenance of boiling; 100 mesh sieves filter; Filtrate merges, and concentrated, drying gets the medical material water extract.
● the ethanol extraction method: A medical material 100g adds 8 times of amount 75% ethanol, soaks 30min, reflux, extract, 30min; 100 mesh sieves filter; Filtering residue adds 5 times of amount 75% ethanol, reflux, extract, 20min again; 100 mesh sieves filter; Filtrate merges, and concentrated, drying gets the medical material ethanol extraction.
(2), B medical material Monas cuspurpureus Went extract preparation: get Monas cuspurpureus Went medical material 100g, added 3 times of amount 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue added 2 times of amount 75% alcohol reflux 2 hours, and extracting liquid filtering merges filtrate twice, decompression recycling ethanol, and concentrated, drying gets Monas cuspurpureus Went extract.
(3), the preparation method of compound recipe:
The A medical material water extract that method with 2. (1) prepares respectively and Monas cuspurpureus Went extract form compound recipe; Perhaps A medical material ethanol extraction and Monas cuspurpureus Went extract form compound recipe.Be mixed with 100ml with 0.5% sodium carboxymethyl cellulose solution before use.
(4), the preparation method of tested compound medicine when A is commercially available extract
Get extract 25g, in the extract of adding B medical material (extracting method of B medical material, the preparation of compound recipe see above 2).Be mixed with 100ml with 0.5% sodium carboxymethyl cellulose solution before use.
(5), the preparation method of tested compound medicine when A is commercially available monomer
Get commercially available monomer curcumin or matrine 3g (600mg/kg dosage group) or matrine 1g (200mg/kg dosage group), 0.5g (100mg/kg dosage group), in the extract of adding B medical material (extracting method of B medical material, the preparation of compound recipe see above 2).Be mixed with 100ml with 0.5% sodium carboxymethyl cellulose solution before use.
(6), the preparation method of tested compound medicine when A is the commercial preparation
Get 75 of Herb Gynostemmae Pentaphylli total glycosides tablets (being equivalent to Herb Gynostemmae Pentaphylli total glycosides 1500mg), in the extract of adding B medical material (extracting method of B medical material, the preparation of compound recipe see above 2).Be mixed with 100ml with 0.5% sodium carboxymethyl cellulose solution before use.
3, Experimental agents dosage: all by following dosage
(1), tested compound medicine dosage when A is medical material:
Containing A, B medical material dosage is 20g medical material/kg body weight (compound concentration is 1g medical material/ml), be equivalent to 10 times of quantities;
(2), the dosage of tested compound medicine when A is commercially available extract (for example Radix Salviae Miltiorrhizae, Fructus Hippophae, Folium Ginkgo):
The dosage that to contain the A pharmaceutical quantities be 5g extract/kg body weight, contain the B medicine is 20g medical material/kg body weight (compound concentration: contain A extract 0.25g/ml in the compound recipe, contain the B1g medical material/ml);
(3), the dosage of tested compound medicine when A is commercially available monomer (for example curcumin, matrine):
The dosage that to contain the A pharmaceutical quantities be 600～100mg monomer/kg body weight, contain the B medicine is 20g medical material/kg body weight (compound concentration: contain A monomer 30mg/ml～5mg/ml in the compound recipe, contain the B1g medical material/ml)
(4), the dosage of tested compound medicine when A is the commercial preparation:
The dosage that contains the A medicine is that 300mg/kg body weight, concentration are 15mg/ml; The dosage that contains the B medicine is that (configuration concentration is 1g medical material/ml) to 20g medical material/kg body weight.
4, the foundation of model: (1) fructose causes high TG mouse model:
Male ICR mouse is about 30g.Mice administration in the situation of non-fasting.Blank group and model group give 1% sodium carboxymethyl cellulose solution with the volume gavage of 20ml/kg, and the fenofibrate group (300mg/kg) give fenofibrate according to equal-volume.Successive administration 3 days.Prohibited water 24h at the 2nd～3 day, drinking-water is changed into 20% fructose soln and freely drink into 20h, 20h cuts tail and gets blood after administration respectively.Measure TG.Adopt the EDTA anticoagulant to prepare blood plasma (centrifugal 2400rpm * 10min).Measure the 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 the 250mg/kg dosed administration.
Male ICR mouse is about 30g.Blank group and model group are to 1%CMC solution, and fenofibrate group dosage is 300mg/kg, is subjected to reagent according to the 20g/kg dosed administration.The i.g. administration was measured TG after 2 days continuously.Get blood, i.g. administration, i.v. modeling (respectively tail vein injection Triton 0.05ml/10g, blank group injecting normal saline) the 3rd day each group, and 24h cuts tail and gets blood after modeling, measures the TG value.
(3) on the impact of TG behind the normal mouse multiple dosing
Male ICR mouse is about 30g.Mice administration in the situation of non-fasting.The blank group gives 1% sodium carboxymethyl cellulose solution with the volume gavage of 20ml/kg, positive drug fenofibrate group (300mg/kg) and respectively be subjected to the reagent group to give fenofibrate according to equal-volume, and successive administration 4 days is cut tail at 5d and is got blood.Adopt the EDTA anticoagulant to prepare blood plasma.Measure the 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 check, there is significant difference P＜0.05, and there is the utmost point significant difference P＜0.01
9, result: see Table 8
Preliminary screening is carried out in the grouping of table 8 medicine
Annotate:
* expression is compared with model control group, and TG has significance to reduce (P＜0.05);
* represents to compare with model control group, and TG has utmost point significance to reduce (P＜0.01);
The expression that " trend arranged " is compared with model control group, and the TG value has reduction, but t test statistics difference is not remarkable, represents that this medicine has reduction trend.
(1), fructose model: each group is with the model control group comparison and carried out the repeated experiments checking, and 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 trend was arranged has: Folium Ginkgo, the Rhizoma Atractylodis Macrocephalae, Herba Sedi
(2), TritonX model: each group is with the model control group comparison and carried out the repeated experiments checking, and 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 trend was arranged 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 has: Rhizoma Curcumae
Two, second stage divides into groups to have carried out screening (administering mode, dosage etc. all with above) (seeing Table 9) again to above preferred medicine
The preferred medicine of table 9 divides into groups to screen again
From above result as seen, different medicaments compounds, the result of the reduction TG that demonstrates in various models is different, may be because the different mechanism of action causes.But final result all demonstrates the effect that reduces preferably TG.
The specific embodiment:
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 reclaims solvent, is condensed into thick paste, gets extract I.
Get Fructus Crataegi 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 gets extract II.
Extract I, II add pharmaceutical adjunct, according to common process, 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, the alcohol heating reflux of adding 8L90% 1 hour filters; The alcohol heating reflux 1 hour that adds again 8L90% filters; Merging filtrate reclaims solvent, is condensed into thick paste, gets extract I.
Get Fructus Crataegi medical material 1kg: add 15 times of 90% alcohol reflux 2h of its weight, filter; Add again 10 times of 90% alcohol reflux 1h, filter; Merging filtrate, concentrated, get extract II.
Extract I, II add pharmaceutical adjunct, according to common process, 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, added the 4L50% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue added the 2L50% alcohol reflux 3 hours, extracting liquid filtering.Merge filtrate twice, decompression recycling ethanol is concentrated into 55～60 ℃ and surveys relative density 0.95～1.06.The deionized water mixing that adds 2.0 times of volumes in the concentrated solution was placed 12 hours.Centrifugal, collecting precipitation obtains Monas cuspurpureus Went extract I.
Get Fructus Crataegi medical material 6kg: add 10 times of 20% alcohol reflux 1.5h of its weight, filter; Add again 10 times of 20% alcohol reflux 1.5h, filter; Merging filtrate, concentrated, get extract II.
Extract I, II add pharmaceutical adjunct, according to common process, 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 reclaims solvent, is condensed into thick paste, gets extract I.
Get Fructus Crataegi medical material 3kg: add 50% alcohol reflux 2 times of 10 times of volumes of its weight, extraction time is 2h.Filter respectively, merging filtrate, concentrating under reduced pressure gets extract II.
Extract I, II add pharmaceutical adjunct, according to common process, make the granule of clinical acceptance.
Embodiment 5: the preparation of medicinal composition tablets of the present invention
Get Monas cuspurpureus Went 2kg, the alcohol heating reflux of adding 6L70% 3 hours filters; The alcohol heating reflux 2 hours that adds again 4L75% filters; Merging filtrate reclaims solvent, is condensed into thick paste, gets extract I.
Get Fructus Crataegi medical material 1kg: add 75% alcohol reflux 2 times of 8 times of volumes of its weight, extraction time is 1h.Filter respectively, merging filtrate, concentrating under reduced pressure gets extract II.
Extract I, II add pharmaceutical adjunct, according to common process, 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, added the 3L75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue added the 2L75% alcohol reflux 2 hours, extracting liquid filtering.Merge filtrate twice, decompression recycling ethanol is concentrated into 55～60 ℃ and surveys relative density 0.95～1.06.The deionized water mixing that adds 2.0 times of volumes in the concentrated solution was placed 8 hours.Centrifugal, collecting precipitation.Get extract I.
Get Fructus Crataegi medical material 1kg: add 75% alcohol reflux 2 times of 6 times of volumes of its weight, extraction time is 1h.Filter respectively, merging filtrate, concentrating under reduced pressure, drying gets extract II.
Extract I, II add pharmaceutical adjunct, according to common process, make the capsule of clinical acceptance.
Embodiment 7: the preparation of pharmaceutical composition of the present invention
Get Monas cuspurpureus Went medical material 1kg, Fructus Crataegi medical material 1kg and added the 6L75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue added 6 parts by volume, 75% alcohol reflux 2 hours, extracting liquid filtering.Merge filtrate twice, decompression recycling ethanol, concentrated, drying.Add pharmaceutical adjunct, according to common process, 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, Fructus Crataegi medical material 10kg, 75% alcohol reflux of adding 120L 3 hours, extracting liquid filtering; 75% alcohol reflux of filtering residue adding 120L 2 hours, extracting liquid filtering.Add pharmaceutical adjunct, according to common process, 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, added the 3L75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue added the 2L75% alcohol reflux 2 hours, extracting liquid filtering.Merge filtrate twice, decompression recycling ethanol is concentrated into 55～60 ℃ and surveys relative density 0.95～1.06.The deionized water mixing that adds 2.0 times of volumes in the concentrated solution was placed 8 hours.Centrifugal, collecting precipitation.Get extract I.
Get Fructus Crataegi medical material 1kg: add 75% alcohol reflux 2 times of 6 times of volumes of its weight, extraction time is 1h.Filter respectively, merging filtrate, concentrating under reduced pressure, drying gets extract II.
Extract I, II add pharmaceutical adjunct, according to common process, make the soft capsule of clinical acceptance.
Claims (11)
1. pharmaceutical composition with regulating blood lipid action is characterized in that the crude drug of this pharmaceutical composition consists of:
Monas cuspurpureus Went 1-5 weight portion Fructus Crataegi 1-5 weight portion.
2. pharmaceutical composition as claimed in claim 1, the crude drug that it is characterized in that this pharmaceutical composition consist of following any one:
Monas cuspurpureus Went 2 weight portion Fructus Crataegis 4 weight portions;
Monas cuspurpureus Went 4 weight portion Fructus Crataegis 2 weight portions;
Monas cuspurpureus Went 1 weight portion Fructus Crataegi 4 weight portions;
Monas cuspurpureus Went 4 weight portion Fructus Crataegis 1 weight portion.
3. pharmaceutical composition as claimed in claim 1 or 2 is characterized in that this pharmaceutical composition makes by the following method:
Step 1, Monas cuspurpureus Went extract I preparation
Monas cuspurpureus Went extract I is prepared by following any one method:
A, Monas cuspurpureus Went 1 weight portion add ethanol, methanol or the ethyl acetate of 2～10 parts by volume 50～90% at every turn, and reflux 1～3 hour is extracted 2～3 times; Extracting liquid filtering, merging filtrate reclaims solvent, is condensed into 55～60 ℃ of thick pastes of surveying relative density 0.95～1.06, gets extract I;
B, Monas cuspurpureus Went 1 weight portion added the ethanol, methanol of 2～10 parts by volume 50～90% or ethyl acetate reflux 1～3 hour at every turn, extracted 2～3 times; Extracting liquid filtering, merging filtrate reclaims solvent, is concentrated into 55～60 ℃ and surveys relative density 0.95～1.06, adds 0.5～2.0 times of deionized water mixing in the concentrated solution, and room temperature or cold preservation were placed 2～12 hours, and is centrifugal, collecting precipitation, drying obtains extract I;
Step 2, Fructus Crataegi extract II preparation
Fructus Crataegi medical material 1 weight portion, the water or the alcohol heating reflux that add 4～20 parts by volume extracted 1～3 hour at every turn, extract 2～4 times, extracting liquid filtering, merging filtrate reclaims solvent, is condensed into thick paste; Get extract II;
Step 3, preparation
Extract I and extract II according to conventional method, are added conventional adjuvant, make pill, powder, tablet, granule, capsule or the oral liquid of clinical acceptance.
4. pharmaceutical composition as claimed in claim 3 is characterized in that the A method in the described step 1 is:
Get Monas cuspurpureus Went medical material 1 weight portion, added 3 parts by volume, 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue added 2 parts by volume, 75% alcohol reflux 2 hours, and extracting liquid filtering merges filtrate twice, and decompression recycling ethanol is concentrated into 55～60 ℃ of thick pastes of surveying relative density 0.95～1.06, gets extract I.
5. pharmaceutical composition as claimed in claim 3 is characterized in that the B method in the described step 1 is:
Monas cuspurpureus Went medical material 1 weight portion added 3 parts by volume, 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue added 2 parts by volume, 75% alcohol reflux 2 hours, and extracting liquid filtering merges filtrate twice, and decompression recycling ethanol is concentrated into 55～60 ℃ and surveys relative density 0.95～1.06, adds 1 times of deionized water mixing in the concentrated solution, and room temperature or cold preservation were placed 8 hours.Centrifugal, collecting precipitation, 80 ℃ of lower dry 8 lab scales were pulverized 60 mesh sieves, obtained extract I.
6. pharmaceutical composition as claimed in claim 3 is characterized in that described step 2 is:
Fructus Crataegi 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, and extracting liquid filtering, merging filtrate reclaims solvent, is concentrated into 55～60 ℃ of thick pastes of surveying relative densities 0.95～1.06; Get extract II.
7. the preparation method of pharmaceutical composition as claimed in claim 1 or 2 is characterized in that the method is:
Step 1, Monas cuspurpureus Went extract I preparation
Monas cuspurpureus Went extract I is prepared by following any one method:
A, Monas cuspurpureus Went 1 weight portion add ethanol, methanol or the ethyl acetate of 2～10 parts by volume 50～90% at every turn, and reflux 1～3 hour is extracted 2～3 times; Extracting liquid filtering, merging filtrate reclaims solvent, is condensed into 55～60 ℃ of thick pastes of surveying relative density 0.95～1.06, gets extract I;
B, Monas cuspurpureus Went 1 weight portion added the ethanol, methanol of 2～10 parts by volume 50～90% or ethyl acetate reflux 1～3 hour at every turn, extracted 2～3 times; Extracting liquid filtering, merging filtrate reclaims solvent, is concentrated into 55～60 ℃ and surveys relative density 0.95～1.06, adds 0.5～2.0 times of deionized water mixing in the concentrated solution, and room temperature or cold preservation were placed 2～12 hours, and is centrifugal, collecting precipitation, drying obtains extract I;
Step 2, Fructus Crataegi extract II preparation
Fructus Crataegi medical material 1 weight portion, the water or the alcohol heating reflux that add 4～20 parts by volume extracted 1～3 hour at every turn, extract 2～4 times, extracting liquid filtering, merging filtrate reclaims solvent, is condensed into thick paste; Get extract II;
Step 3, preparation
Extract I and extract II according to conventional method, are added conventional adjuvant, make pill, powder, tablet, granule, capsule or the oral liquid of clinical acceptance.
8. the preparation method of pharmaceutical composition as claimed in claim 7 is characterized in that A, B method are respectively in the described Monas cuspurpureus Went extract I preparation method:
The A method: Monas cuspurpureus Went medical material 1 weight portion added 3 parts by volume, 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue added 2 parts by volume, 75% alcohol reflux 2 hours, and extracting liquid filtering merges filtrate twice, and decompression recycling ethanol is concentrated into 55～60 ℃ of thick pastes of surveying relative density 0.95～1.06, gets extract I;
The B method: Monas cuspurpureus Went medical material 1 weight portion added 3 parts by volume, 75% alcohol reflux 3 hours, extracting liquid filtering; Filtering residue added 2 parts by volume, 75% alcohol reflux 2 hours, and extracting liquid filtering merges filtrate twice, and decompression recycling ethanol is concentrated into 55～60 ℃ and surveys relative density 0.95～1.06, adds 1 times of deionized water mixing in the concentrated solution, and room temperature or cold preservation were placed 8 hours.Centrifugal, collecting precipitation, 80 ℃ of lower dry 8 lab scales were pulverized 60 mesh sieves, obtained extract I.
9. the preparation method of pharmaceutical composition as claimed in claim 7 is characterized in that described Fructus Crataegi extract II preparation method is:
Fructus Crataegi 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, and extracting liquid filtering, merging filtrate reclaims solvent, is concentrated into 55～60 ℃ of thick pastes of surveying relative densities 0.95～1.06; Get extract II.
10. pharmaceutical composition as claimed in claim 1 or 2 is characterized in that this pharmaceutical composition adds conventional adjuvant according to conventional method, makes clinical acceptable pill, powder, tablet, granule, capsule or oral liquid.
11. such as the application of arbitrary described pharmaceutical composition among the claim 1-6 in the medicine of preparation treatment hypertriglyceridemia.
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| CN111084304A (en) * | 2019-12-17 | 2020-05-01 | 众心同创(厦门)电子商务有限公司 | Beverage capable of reducing blood cholesterol and preparation process thereof |
| CN112335881A (en) * | 2020-11-26 | 2021-02-09 | 北京理工亘舒科技有限公司 | Digestion-promoting medicated diet vegetarian product and preparation method and application thereof |
| CN115137770A (en) * | 2022-07-18 | 2022-10-04 | 劲牌持正堂药业有限公司 | Preparation method of traditional Chinese medicine product with efficacy of reducing blood fat and blood pressure |
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Application publication date: 20131030 |