CN101491675A - Composite lipid-regulation medicine - Google Patents
Composite lipid-regulation medicine Download PDFInfo
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- CN101491675A CN101491675A CNA2008100043020A CN200810004302A CN101491675A CN 101491675 A CN101491675 A CN 101491675A CN A2008100043020 A CNA2008100043020 A CN A2008100043020A CN 200810004302 A CN200810004302 A CN 200810004302A CN 101491675 A CN101491675 A CN 101491675A
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Abstract
The invention relates to a medicine with lipid-regulating function, in particular to a medicine for treating hyperlipoidemia or atherosclerosis. The medicine comprises a lipid-regulating active ingredient and a synergistic agent, and is characterized in that the lipid-regulating active ingredient is HMG-CoA reductase inhibitor; and the synergistic agent is cane extract. The compound lipid-regulating medicine can reduce dosage of the HMG-CoA reductase inhibitor so as to reduce toxic and side effect of the inhibitor and improve drug effect.
Description
Technical field
The present invention relates to a kind of medicine of transferring the fat effect that has, a kind of medicine for the treatment of hyperlipemia or atherosclerosis especially is provided.Belong to field of medicaments.
Background technology
Hyperlipemia is to cause atherosclerotic arch-criminal, is the main pathology physiological Foundations of cardiovascular and cerebrovascular disease, and preventing and treating atherosclerosis is the important measures of control cardiovascular and cerebrovascular disease, is used to prevent and treat arteriosclerotic medicine and is fat regulation medicine.Lipid-regulation medicine commonly used at present is by adjusting the disorder of blood plasma lipide or lipoprotein, treatment hyperlipemia and the effect of generation arteriosclerosis, wherein the novel and effective medicine is 3-hydroxyl-3-first glutaryl coenzyme A (HMG-CoA) reductase inhibitor, i.e. " Statins " medicine the most.Statins does not have serious adverse reaction when general dosage short-term is used, minority shows slight gastrointestinal reaction, headache or erythra; But prolonged application (more than 4 weeks) is seen hepar damnification more, and myalgia also raises with creatine phosphokinase, and cataract, particularly rhabdomyolysis also renal failure take place, and have higher fatality rate; And for the hyperlipemia patient, the short-term medication is inconceivable, generally all are long-term prescriptions, in addition, the price of statins, be the most expensive in all fat regulation medicines, therefore, seek a kind of drug influence similar to the pharmacokinetics characteristics to Statins but dosage is littler, less adverse effect, be convenient to long-term prescription fat regulation medicine imperative.
Summary of the invention
At above-mentioned prior art defective, main purpose of the present invention provides a kind of HMG-CoA of minimizing reductase inhibitor dosage and then reduces its toxic and side effects and the composite lipid-regulation medicine of raising drug effect.
For this reason, technical solution of the present invention is as follows:
The invention provides a kind of medicine of transferring the fat effect that has, comprise and transfer fat active component and synergist, it is characterized in that described accent fat active component is the HMG-CoA reductase inhibitor, described synergist is a Caulis Sacchari sinensis extract.
The above-mentioned described medicine of transferring the fat effect that has wherein, between described accent fat active component and the synergist, preferably calculates by weight, and described accent fat active component is 1 part, and described synergist is 1/20-25 part, more preferably 1/10-19 part.
The above-mentioned described medicine of transferring the fat effect that has of the present invention wherein, if desired, can also contain acceptable accessories, for example according to dosage form or preparation needs, contains suitable filler, lubricant or diluent etc.
As an embodiment of the present invention, the medicine with the effect of accent fat of the present invention, wherein, in the per unit preparation, described accent fat active component is 1-80mg, described synergist is 1-300mg.For example, described medicine is the compound preparation agent, wherein contains HMG-CoA reductase inhibitor 1-80mg, and Caulis Sacchari sinensis extract is 1-300mg.
The above-mentioned described medicine of transferring the fat effect that has of the present invention, wherein, described HMG-CoA reductase inhibitor is a statins, for example is statinses such as lovastatin, simvastatin, Pitavastatin
The above-mentioned described medicine of transferring the fat effect that has of the present invention, wherein, described Caulis Sacchari sinensis extract, containing compositions such as many arachyl alcohols, Polyphenols polyphenoils, oligomeric xylose or plant sterol, is the Caulis Sacchari sinensis extract that is prepared by extraction, separation, the purification process of sugarcane raw material by this area routine; Wherein, preferred described Caulis Sacchari sinensis extract contains and is not less than many arachyl alcohols of 90%.
Especially, the above-mentioned described composite lipid-regulation medicine of the present invention, wherein said Caulis Sacchari sinensis extract are to make by the method that comprises one of following or a plurality of steps:
(1) extracts many arachyl alcohols;
(2) extract the Polyphenols polyphenoils;
(3) extract plant sterol;
(4) extract oligomeric xylose.
Wherein, the many arachyl alcohols of described extraction can be by conventional from advanced wax or oils and fats (comprising cerosin) many arachyl alcohols of extraction separation technology, for example solvent extraction method and supercritical fluid extraction in this area.
1) solvent extraction method for example can be selected organic solvents commonly used such as acetone, positive butanone, methanol, ethanol, hexane, heptane, chloroform and benzene for use.
2) supercritical extraction method can obtain many arachyl alcohols product (wherein containing octacosanol about 50%), and no solvent residue is in product, and yield is than solvent method height.
In addition, also can select for use methods such as chemical ester exchange process, reducing process and molecular distillation technique to extract high-carbon fatty alcohols such as many arachyl alcohols.
For the analytical method of many arachyl alcohols, can adopt the capillary column gas chromatography method, on the HP-5 post, between octacosanol, triacontanol and other kind high-carbon fatty alcohols and the internal standard substance TPB separating effect is preferably arranged.
Wherein, the extracting method of described Polyphenols polyphenoils can extract polyphenols from peace and quiet sugarcane tip juice by conventional extraction separation method.For example with the following method optional:
1) solvent extraction;
2) ion precipitation method;
3) adsorption column partition method;
4) supercritical carbon dioxide extraction method.
Wherein, the extraction of described phytosterol, the method for extraction phytosterol that can be by this area routine is extracted from Caulis Sacchari sinensis and is obtained.As an example, can obtain phytosterol by the following method.
1) extracts phytosterol from Caulis Sacchari sinensis filter mud sugarcane fat
The Caulis Sacchari sinensis dry filter mud goes out waxy stone with solvent extraction, when with acetone or other suitable solvent refined cane wax, acetone insoluble matter is a cerosin, and another part is a sugarcane fat for the acetone soluble matters, solid-liquid separation gets the extractive lipoid solution of acetone, steams that (recovery reuse) just is sugarcane fat behind the acetone.Have 20%～30% to be sugarcane fat in the waxy stone approximately, sugarcane fat is oils or paste, contain chemical compounds such as glycerolipid, steroid, fatty acid, behind the sugarcane fat alkaline saponification, collect not saponification part, obtain phytosterol, the phytosterol about 20% in the sugarcane fat is stigmasterol (Stigmasterol), and about 80% is α-sitoesterol (α-Sitosterol).
2) from Cortex Sacchari sinensis, extract cupreol
Get Cortex Sacchari sinensis and clean, in water, soak 2～3 days to remove sucrose.Be cut into the fritter of 3～4mm after the drying, take by weighing 200g, respectively with twice of ethanol 700ml, 500ml reflux, extract,, each backflow 8h, with the ethanol extract thin film concentration to syrupy shape, add 10% hydrochloric acid 100ml and in boiling water bath hydrolysis 1.5h, hydrolysate is used ethyl acetate 5OmI respectively, 25mI extracts three times, the pressure reducing and steaming ethyl acetate.Residue carries out low pressure column chromatography with the 40g silica gel H.Wash away the little impurity of polarity with bp6O～90 ℃ petroleum ether, with petroleum ether-ethyl acetate (10: 1) eluting and with thin layer chromatography monitoring eluent, boil off eluent again, the cupreol of collecting is made with extra care with ethanol.
3) from bagasse, extract cupreol
Bagasse is cleaned, and water dumping is soaked three days (changing water three times) and is removed the sucrose after drying, cuts into the fragment about 1cm.Take by weighing bagasse 200g, extract 8h with 95% ethanol 800ml reflux, incline ethanol extract after, add 95% ethanol 700ml reflux again and extract 8h, incline and ethanol extract and merge with above-mentioned ethanol extract, pressure reducing and steaming ethanol. residue is with 10% hydrochloric acid 100ml hydrolysis 2h in boiling water, use ethyl acetate 50ml after the cooling respectively, 25ml, 25ml extracts hydrolyzed solution three times, the combined ethyl acetate extracting solution, using anhydrous sodium sulfate drying, concentrating under reduced pressure to boil off ethyl acetate after washing with water gets the syrupy shape residue, residue is carried out low pressure column chromatography with the 40g silica gel H, with petroleum ether-ethyl acetate (9: 1) eluting, get cupreol.
Wherein, the extraction of described oligomeric xylose, the way that can adopt poly-polysaccharide to degrade.For example can adopt enzyme hydrolysis method.
As an example, can adopt enzymatic isolation method to prepare oligomeric xylose by following link by bagasse: raw material (bagasse), water → xylan extract → make with extra care → refining xylan liquid → enzymatic degradation → thick product → refining concentrating → mill run → further purification → high purity product.Specifically:
1) bagasse pretreatment.
The preprocess method of bagasse has:
(1) physics method: comprise ball milling, compression ball milling, explosion pulverizing, freezing and pulverizing, gamma-radiation, sound wave, electron ray etc. all can make cellulose efflorescence, softening, the cellulosic enzymolysis conversion ratio of raising.
(2) chemical method: process for chemically pretreating has methods such as mineral acid, alkali and organic solvent.Its mechanism mainly is that solvent makes cellulose, hemicellulose and lignin imbibition and destroys its crystallinity, makes bagasse dissolving, degraded, thereby increases digestibility.
(3) physical-chemical method: the strong point of main synthesis logos and chemical method compensates its defect.For example combination of combination, chemical addition agent and the supercritical reaction of chemical addition agent and steam explosion method or the like.
(4) bioanalysis: what be usually used in lignin degrading is white rot fungus, brown rot fungus, soft rot fungus and some antibacterial.
2) extraction of xylan.With bagasse is that raw material can extract xylan by the extracting method of routine, for example can extract xylan, xylan extracted with alkali or acid system and extract xylan by high-temperature cooking process, the perhaps combination of distinct methods, for example the method for wet method steaming and decocting after carrying out sour pretreatment on the basis of high-temperature cooking process improves extraction efficiency.
3) hydrolysis of xylan prepares oligomeric xylose.Can select conventional method for hydrolysis for use, preferably adopt enzymatic isolation method, what for example utilize that endo-xylanase hydrolyzed xylan substrate obtains is the mixture of main component with 1,4-.beta.-Xylobiose, xylotriose.
4) purification of oligomeric xylose.Can obtain high-purity oligomeric xylose by the purification process of routine, for example adopt ion exchange resin and membrane filtration to carry out separation and purification,, can obtain high-purity oligomeric xylose product with the processing of decolouring of activated carbon, kieselguhr.
Accent fat active component HMG-CoA reductase inhibitor of the present invention, statins lovastatin etc. for example, has the effect of potent accent fat, and the octacosanol that contains in the described synergist Caulis Sacchari sinensis extract has stronger effect for reducing blood fat, and polyenoid class and phytosterol also have certain effect for reducing blood fat, in addition, it is auxilliary mutually old mutually to regulate effects such as cardiovascular function, integration metabolic process, control atherosclerosis, complement one another, make the two use in conjunction, the collaborative and synergic effect of performance.
Main is, life-time service HMG-CoA reductase inhibitor, and for example statins such as statins lovastatin can cause extensive untoward reaction.HMG-CoA reductase inhibitor of the present invention, statins such as lovastatin for example is with the compound medicine that Caulis Sacchari sinensis extract is formed, the untoward reaction of can cancelling out each other.After taking, statinses such as lovastatin generally all can cause changes of liver function; showing as the transaminase raises; and the Main Ingredients and Appearance octacosanol in the Caulis Sacchari sinensis extract has direct liver protection; Polyphenols and plant sterol can be eliminated free radical again; have indirect liver protection, thereby can comprehensively prevent the generation of poisoning.
In addition, by with synergist Caulis Sacchari sinensis extract drug combination, the HMG-CoA reductase inhibitor, for example the dosage of statins such as lovastatin is turned down, the serious adverse reaction of its rhabdomyolysis is alleviated, incidence rate reduces, and accomplishes more safe and effectively, is the newtype drug of treatment hyperlipemia or atherosclerosis.
The specific embodiment
Below further explain or illustrate content of the present invention by specific embodiment, but it should not be understood that claim protection domain of the present invention is construed as limiting.
Embodiment one: the Caulis Sacchari sinensis extract preparation
Get sugarcane wax, fusing in advance, in homogeneous phase, use 10 to 20% concentrated sodium hydroxides that account for wax weight, calcium hydroxide or potassium hydroxide solution saponification 3 to 10 hours, use organic solvent (normal hexane for example then, acetone, methyl ethyl ketone, methanol, ethanol, isopropyl alcohol, chloroform, dichloromethane, 1, the 2-dichloroethanes, benzene, toluene or their mixture) in the solid-liquid extraction system, optionally extract alcohol mixture, extracted altogether 15 to 20 hours, recrystallization in above-mentioned solvent or their mixture then, obtain Caulis Sacchari sinensis extract, be a kind of off-white color or the crystallization of yellow powder powder, be many arachyl alcohols of 24 to 34 carbon atoms, account for total extract weight more than 90%, wherein octacosanol content is the highest, is 60%～70%; Tetracosanol is about 2%, and hexacosanol is about 4.52%～10%, and heptacosanol is about 5%, and nonacosanol is about 2%, triacontanol 10%～15%, and n-Dotriacontanol is about 3%～8%, inearnatyl alcohol about 2%.
Example two: spit of fland sugarcane capsule
1, specification: 10mg
2, prescription:
Pitavastatin 1.0g
Caulis Sacchari sinensis extract (containing many arachyl alcohols more than 90%) 9.0g
Lactose 60.0g
Sodium bicarbonate 12.0g
Cross-linking sodium carboxymethyl cellulose 1.5g
2% hypromellose, 30% alcoholic solution is an amount of
Silica 1 .5g
Magnesium stearate 0.4g
Make 1000
3, preparation process
(1) preparation of binding agent: take by weighing hypromellose and in purified water, dissolve, add an amount of ethanol, be diluted to 2% hypromellose, 30% alcoholic solution, standby;
(2) adjuvant is handled: after lactose, cross-linking sodium carboxymethyl cellulose, sodium bicarbonate were crossed 100 mesh sieves respectively, it was standby to take by weighing recipe quantity;
(3) mixing: after Pitavastatin, many arachyl alcohols are crossed 120 mesh sieves, take by weighing recipe quantity, with above-mentioned in add adjuvant with the equivalent method mixing that progressively increases;
(4) system soft material: with 2% hypromellose, 30% alcoholic solution system soft material;
(5) granulate: 20 mesh sieves are granulated;
(6) oven dry: dry under 60 ℃ of conditions;
(7) granulate: 18 mesh sieve granulate;
(8) add silicon dioxide, magnesium stearate mixing;
(9) product detect in the middle of;
(10) capsule fill;
(11) full inspection;
(12) packing, preservation.
4, instructions of taking
One time one, once-a-day.
Example three: spit of fland sugarcane tablet
1, specification: 10mg
2, label prescription:
Pitavastatin 1.0g
Caulis Sacchari sinensis extract (containing many arachyl alcohols more than 90%) 10.0g
Lactose 73.6g
Cross-linking sodium carboxymethyl cellulose 3.2g
Sodium bicarbonate 8.5g
Silica 1 .6g
Pulvis Talci 1.6g
Magnesium stearate 0.5g
2% hypromellose is an amount of
50% alcoholic solution is an amount of
Make 1000
3, preparation process
(1) preparation of binding agent: take by weighing hypromellose and in purified water, dissolve, add an amount of ethanol, be diluted to 2% hypromellose, 50% alcoholic solution, standby;
(2) adjuvant is handled: after lactose, 1/2 cross-linking sodium carboxymethyl cellulose, sodium bicarbonate were crossed 100 mesh sieves respectively, it was standby to take by weighing recipe quantity;
(3) mixing: after Pitavastatin, many arachyl alcohols are crossed 200 mesh sieves, take by weighing recipe quantity, with above-mentioned in add adjuvant with the equivalent method mixing that progressively increases;
(4) system soft material: with 2% hypromellose, 50% alcoholic solution system soft material;
(5) granulate: 20 mesh sieves are granulated
(6) 60 ℃ of forced air dryings;
(7) granulate: 18 mesh sieve granulate;
(8) add recipe quantity magnesium stearate and 1/2 cross-linked carboxymethyl cellulose, mix homogeneously;
(9) product detect in the middle of;
(10) select ф 6mm shallow concave punch for use, regulate pressure, tabletting;
(11) full inspection;
(12) packing, preservation.
4, instructions of taking
One time one, once-a-day.
Embodiment four: the pharmacodynamic studies of spit of fland sugarcane compound preparation
1, experiment is prepared
1.1 normal feedstuff prescription (%) flour 53, rice flour 1918, Semen Maydis powder 718, Testa Tritici 310, yeast 415, casein 110, whole milk powder 415, analysis for soybean powder 310, bone meal 112, cod-liver oil 112, salt 110.
1.2 high lipid food prescription (%) normal feedstuff 79, cholesterol 1, yolk powder 10, Adeps Sus domestica 10.
1.3 Caulis Sacchari sinensis extract mainly obtains according to supercritical fluid extraction in many alkanols preparation method, Main Ingredients and Appearance is 1-octacosanol, 1-n-Dotriacontanol, 1-triacontanol, 1-tetracosanol, 1-inearnatyl alcohol, 1-hexacosanol, 1-heptacosanol and 1-nonacosanol, and many arachyl alcohols calculate the 90.0%-110.0% that should be labelled amount with each pure content sum.According to lovastatin: Caulis Sacchari sinensis extract is to be made into spit of fland sugarcane compound preparation No. 1 at 4: 1, and according to simvastatin: Caulis Sacchari sinensis extract is to be made into spit of fland sugarcane compound preparation No. 2 at 1: 1, and according to Pitavastatin: Caulis Sacchari sinensis extract is to be made into spit of fland sugarcane compound preparation No. 3 at 1: 9.
2, laboratory animal grouping and experiment flow
Choose 60 of SD male rats, body weight 200～230g, the effect of research spit of fland sugarcane compound preparation blood lipid regulation.Animal is divided into 6 groups at random, it is low to be respectively No. 1, spit of fland sugarcane compound preparation, in, high dose group (is equivalent to lovastatin dosage 5mg/kg, 10mg/kg, 15mg/kg), No. 2, spit of fland sugarcane compound preparation is low, in, high dose group (is equivalent to simvastatin dosage 2.5mg/kg, 5mg/kg, 10mg/kg), No. 3, spit of fland sugarcane compound preparation is low, in, high dose group (is equivalent to Pitavastatin dosage 0.5mg/kg, 1mg/kg, 2mg/kg), positive lovastatin matched group (15mg/kg), normal feedstuff group (normal control) and high lipid food pathological model group, each group is all irritated stomach and is given distilled water or relative medicine, experimental session is except that normal physiological saline group is fed with normal diet, and other each groups are all fed with high lipid food.After the administration 21 days, each treated animal is plucked eyeball and is got blood, and separation of serum is measured blood lipid level (TC, TG, HDL-C, LDL-C).
3, date processing carries out the variance analysis statistics with SPSS12.
4, result: see Table 1 and 2.
Table 1 spit of fland sugarcane compound preparation is to the influence of rat blood serum T-CHOL, content of triglyceride
n＝10，mean±SD
Compare with the blank group,
△ △ △P＜0.001; Compare with model control group
* *P＜0.001
Table 2 spit of fland sugarcane compound preparation is to the influence of rat blood serum low-density lipoprotein cholesterol, high density finger protein cholesterol level
n＝10，mean±SD
Compare with the blank group,
△P＜0.05,
△ △ △P＜0.001; Compare with the blank group
*P＜0.05,
* *P＜0.001
By table 1 and table 2 as seen, spit of fland sugarcane compound preparation administration group is compared with model control group, and basic, normal, high dosage group and positive controls all reduce serum TC, TG, LDL-C level, improves the effect of Serum HDL-C, and the highly significant significant difference is arranged.Serum HDL-C can be quickened in the blood plasma cholesterol and triglyceride and transport to liver, thereby reduces cholesterol and content of triglyceride in the blood.The effect of spit of fland sugarcane compound preparation blood lipid regulation has obvious dose dependent, the most obvious with the high dose group effect, action intensity is all above positive controls, thereby the odds ratio list that makes HDL-C/LDL-C greatly increases during with lovastatin, comparatively speaking, and under the synergistic function of synergist Caulis Sacchari sinensis extract, transfer fat active component HMG-CoA reductase inhibitor, for example the statins dosage is turned down, thereby reduces HMG-CoA reductase inhibitor, for example toxic and side effects of statins.
The present invention is described according to preferred embodiment.Should be understood that the description of front and embodiment are just to illustrating the present invention.Under prerequisite without departing from the spirit and scope of the present invention, those skilled in the art can design multiple alternative of the present invention and improvement project, and it all should be understood to be within protection scope of the present invention.
Claims (10)
1, a kind of medicine with the effect of accent fat comprises and transfers fat active component and synergist, it is characterized in that described accent fat active component is the HMG-CoA reductase inhibitor, and described synergist is a Caulis Sacchari sinensis extract.
2, the medicine with the effect of accent fat according to claim 1 wherein calculates by weight, and described accent fat active component is 1 part, and described synergist is 0.05～25 part.
3, the medicine with the effect of accent fat according to claim 2 wherein calculates by weight, and described accent fat active component is 1 part, and described synergist is 0.1～19 part.
4, according to the described medicine of claim 1-3, wherein, if desired, can also contain acceptable accessories with the effect of accent fat.
5, according to the described medicine with the effect of accent fat of claim 1-3, wherein, in the per unit preparation, described accent fat active component is 1～80mg, and described synergist is 1～300mg.
6, according to the described medicine with the effect of accent fat of claim 1-5, wherein, the HMG-CoA reductase inhibitor is a statins.
7, according to the described medicine with the effect of accent fat of claim 1-6, wherein, the HMG-CoA reductase inhibitor is for being selected from statinses such as lovastatin, simvastatin, Pitavastatin.
8, have a medicine of transferring the fat effect according to claim 1-7 is described, wherein said Caulis Sacchari sinensis extract contains compositions such as many arachyl alcohols, Polyphenols, oligomeric xylose or phytosterol, and wherein, preferred described Caulis Sacchari sinensis extract contains and is not less than many arachyl alcohols of 90%.
9, according to the described medicine with the effect of accent fat of claim 1-8, wherein said Caulis Sacchari sinensis extract is to make by the method that comprises following one or more step:
(1) extracts many arachyl alcohols;
(2) extract the Polyphenols polyphenoils;
(3) extract plant sterol;
(4) extract oligomeric xylose.
10, the described application with medicine of transferring the fat effect of claim 1-9 is characterized in that preparing the medicine that is used for the treatment of hyperlipemia or atherosclerosis.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CNA2008100043020A CN101491675A (en) | 2008-01-21 | 2008-01-21 | Composite lipid-regulation medicine |
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| CNA2008100043020A CN101491675A (en) | 2008-01-21 | 2008-01-21 | Composite lipid-regulation medicine |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102351642A (en) * | 2011-08-03 | 2012-02-15 | 中国林业科学研究院资源昆虫研究所 | Refining method of high-grade alkanol |
| WO2021193920A1 (en) * | 2020-03-27 | 2021-09-30 | 東レ株式会社 | Powdered oligosaccharide composition |
-
2008
- 2008-01-21 CN CNA2008100043020A patent/CN101491675A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102351642A (en) * | 2011-08-03 | 2012-02-15 | 中国林业科学研究院资源昆虫研究所 | Refining method of high-grade alkanol |
| WO2021193920A1 (en) * | 2020-03-27 | 2021-09-30 | 東レ株式会社 | Powdered oligosaccharide composition |
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Open date: 20090729 |