CN1833657A - Compound preparation for prevention and treatment adiposis and its prepn. method - Google Patents
Compound preparation for prevention and treatment adiposis and its prepn. method Download PDFInfo
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- CN1833657A CN1833657A CN 200510055514 CN200510055514A CN1833657A CN 1833657 A CN1833657 A CN 1833657A CN 200510055514 CN200510055514 CN 200510055514 CN 200510055514 A CN200510055514 A CN 200510055514A CN 1833657 A CN1833657 A CN 1833657A
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Abstract
A compound medicine in the form dispersing tablet, pill, or coated tablet for preventing and treating obesity is proportionally prepared from conjugated magnesium linoleate, selenite, VC and coating material. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to new formulation of a kind of prevention and treatment of obesity and preparation method thereof.
Background technology
At present, the obesity whole world spreads, and the patient has reached 300,000,000, is the 4th killer after the heart disease that now mankind is caused biggest threat, cancer, diabetes.In American-European and some industrial countries, the fat formidable enemy who is considered to health already.The U.S. from 1991 to calendar year 2001, the number of suffering from obesity has risen 74%, and is about 4,400 ten thousand, promptly 20% U.S. adult is diagnosed as obesity.The obesity patient of China has reached more than 7,000 ten thousand.Because living standards of the people improve, the obesity sickness rate sharply increased in recent years.
Fat and overweight meeting causes multiple diseases such as diabetes, hypertension, hyperlipemia and coronary heart disease, and these diseases are to cause the lethal principal element of the people, if develop as one pleases, and will be to the influence of fitness-for-all and damaging property of healthcare system.Show have every year 300000 Americans to die according to U.S.'s investigation because of suffering from fat diseases associated; The relevant expert points out, the probability that serious obesity patient suffers from diabetes is 7 times of the normal people of body weight, and the probability of suffering from hypertension is 6 times of average weight people.Therefore, controlling obesity becomes the human health problem that must pay close attention to just day by day.
Conjugated linoleic acid (Conjugated Linoleic acid, be called for short CLA) be a kind of novel promotion growth, nutrition reallocation agent, has tangible antiobesity action, without any toxic and side effects [(the human feeding trial research of conjugated linoleic acid antiobesity action such as Ma Ning, Shanghai preventive medicine magazine, 2004, the 16th the 4th phase of volume), (conjugated linoleic acid was to the influence of obese rat PPAR bifurcation gene expression and serum leptin level, health research, 2004 for Zhou Xiaorong etc., the 33rd the 3rd phase of volume), stone red flag etc. (conjugated linoleic acid to the research of fat rat model antiobesity action, Chinese marine drug, 2003 the 6th phases)].Conjugated linoleic acid also has many functions according to reports, as strengthen human immunity, reduce body fat, cholesterol and triglyceride and low-density lipoprotein cholesterol, improve HDL-C, atherosclerosis, antitumor, antioxidation, raising skeleton density, prevent and treat multiple important physiological function such as diabetes, increasing scientific research is being carried out relevant research with medical institutions.
Chinese patent application CN1349795 discloses a kind of compound preparation and application thereof that is used for human body weight-losing, described preparation is by conjugated linoleic acid and have the food additive of certain effect of weight reducing formulated, is the compound preparation that the soft capsule of Main Ingredients and Appearance and two kinds of dosage form reprovisions of hard capsule of being made up of L-L-carnitine, chromium picolinate, L-5-oxitriptan etc. form by conjugated linoleic acid specifically.
U.S. Pat 5554646, US5814663 report conjugated linoleic acid can be induced the energy utilization, reduces body weight.The conjugated linoleic acid food supplement, nineteen ninety-five is one of popular additive of U.S. food association recommendation in U.S.'s listing.The quantity of this series products and kind are more and more at present, but the said goods mostly is the acid type preparation of CLA, and user's stomach is had certain stimulation.
The Chinese patent (application number 200410102527.1) of the applicant's application discloses a kind of Magnesium linoleate. and preparation method thereof, conjugated linoleic acid is prepared into magnesium salt, the effect that has not only kept conjugated linoleic acid, also further improved the scope of application of conjugated linoleic acid, can be widely used in medicament, food additive industry, to prepare various health foods, medicine etc., be a kind of rising novel magnesium preparation.
Magnesium is the necessary biological element of human body, accounts for second of intracellular cation.Participate in all energy metabolisms in the human body as a kind of metal coenzyme, activate or 325 kinds of important enzyme systems of catalysis.Participate in the metabolism of glucose, fat, protein and nucleic acid etc., important function is arranged keeping enzyme system.Modern medicine confirms that magnesium has good protective effect to blood circulation, can reduce content of cholesterol in the blood, prevents arteriosclerosis, can also coronary artery dilator, and increase the blood supply of cardiac muscle amount, thereby help prophylaxis of hypertension and myocardial infarction.Modern dissection medical research finds that also coronary heart disease people's cardiac muscle content of magnesium of cardiovascular and cerebrovascular disease patient, particularly heart failure and sudden death is lower, is less than 180mg/kg, illustrates that the generation of cardiovascular and cerebrovascular disease and magnesium deficiency have very confidential relation.In addition, discover that containing magnesium food can prevent diabetes.Therefore, prevent and treat arteriosclerosis, treatment and prevention cardiovascular and cerebrovascular disease, magnesium supplement is extremely important.
Selenium is the nutritional trace element of needed by human, can obviously change lipid metabolism, reduces the mortality rate that causes because of the cardiovascular diseases; Can effectively remove the body harmful free radicals, improve antioxidant ability of organism and immunocompetence, therefore adopt suitable form appropriateness selenium supplement to have the effect of preventing and curing diseases.
Vitamin C is the necessary vitamin of a kind of human body, Wheat Protein, and it can't synthesize in human body, must constantly replenish and take in.Ascorbic major physiological function has: promote the biosynthesis of ossein, be beneficial to the faster healing of tissue injury mouth; The metabolism of tyrosine and tryptophan prolongs the human body life-span in the promotion aminoacid; Improve the utilization of ferrum, calcium and folic acid; Improve fat and the particularly metabolism of cholesterol of lipoid, the prevention cardiovascular diseases; Promote tooth and skeletal growth, prevent that dental bed is hemorrhage; Strengthen the human body anti-stress ability of environment and immunity etc. to external world.
Summary of the invention
The compound preparation that the purpose of this invention is to provide a kind of prevention and treatment of obesity.Compound preparation of the present invention is to be primary raw material with the conjugated linoleic acid magnesium salt, simultaneously according to human body to selenium, ascorbic requirement, in preparation, added a certain amount of selenite and vitamin C, made the Magnesium linoleate. compound preparation.
Concrete, the compound preparation of prevention of the present invention and treatment of obesity, this compound preparation comprises Magnesium linoleate., selenite, vitamin C and coating material; The ratio of weight and number of each component of described compound preparation is: the parts by weight of Magnesium linoleate. are 50-95 part,
The parts by weight of selenite are 0.002-0.02 part,
Ascorbic parts by weight are 1-5 part,
The parts by weight of coating material are 0-45 part.
The dosage form of compound preparation of the present invention is selected from a kind of in powder, pill, tablet and the coated tablet.
In existing health product, the medical technology of preparing, the auxiliary material that are used to prepare various dosage form can be applied to compound preparation of the present invention.As adding a spot of starch as excipient, make it compression molding, obtain plain sheet; Add a spot of Mel, make it to form pill; Select for use as the coating material of thin film or sugar-coat and make thin membrane coated tablet or coated tablet etc.Described excipient also can be selected from one or more of sodium carboxymethyl cellulose, pectin, Radix Acaciae senegalis, lactose, sucrose, stearic acid, hard magnesium or mannitol etc.Described film coating can be natural filmogen, as plant gum or Radix Acaciae senegalis; Also can be product, as methylcellulose etc. through chemical modification.
In a preferred embodiment of the invention, described selenite is a sodium selenite.
In a specific embodiments of the present invention, compound preparation of the present invention is by with described raw material Magnesium linoleate., selenite, vitamin C uniform mixing, makes the described compound preparation of various dosage forms.As through pelletize, tabletting makes plain sheet; Or coated material coating makes coated tablet or coated tablet.
Preferably described raw material Magnesium linoleate., selenite, vitamin C are mixed step by step, be about to the material that amount is few in the raw material and at first follow the mixed with little amount of measuring in the big material, add the big material of a tittle behind the mix homogeneously again and make it mix homogeneously, carry out so repeatedly until with all raw material blendings.
In a preferred embodiment of the invention, preferred described Magnesium linoleate. prepares by the method that may further comprise the steps:
At first, in solution, add magnesium salt then and react, form the conjugated linoleic acid magnesium precipitate, after filtration, drying makes the reactant aqueous solution of conjugated linoleic acid and alkali metal hydroxide, alkali carbonate.
The Chinese patent application of the applicant application numbers 200410102527.1 discloses above-mentioned Magnesium linoleate. and preparation method thereof, and the content of this patent is incorporated herein reference in full.
The preparation method of the compound preparation of prevention of the present invention and treatment of obesity may further comprise the steps:
(1) with conjugated linoleic acid and alkali metal hydroxide or carbonate aqueous solution reaction, adds the magnesium salt precipitation, after filtration, drying makes Magnesium linoleate.;
(2) with described Magnesium linoleate. and selenite, vitamin C uniform mixing in proportion;
(3) make the compound preparation of the present invention of various dosage forms.
The existing technology that is used to prepare various dosage form may be used to prepare compound preparation of the present invention.
The advantage of the compound preparation of prevention of the present invention and treatment of obesity is: sodium selenite, vitamin C that Magnesium linoleate. and human body is necessary are made compound preparation, given full play to the effect of various compositions, various compositions are in conjunction with producing synergism again, increased population effect, both can prevent and treatment of obesity, can replenish necessary magnesium of human body and selenium again, increase immunity.
The effect of existing fat-reducing of compound preparation of the present invention and raising immunity has solved user's stomach discomfort problem again, has also improved the oxidation resistance and the stability of product, has prolonged the shelf-life of product.
Compound preparation of the present invention proves through animal experiment, effect with prevention and treatment of obesity can also improve the HDL-C level useful to body health simultaneously, improves immunity, on health-product market, hold out broad prospects, can produce huge social and economic benefit.
The specific embodiment
To further illustrate the present invention in following examples, these embodiment only are used to the present invention is described and to the present invention without limits.
Embodiment 1
Take by weighing the 93g conjugated linoleic acid in the 930ml distilled water, the sodium hydroxide solution 135ml reaction that adds 10%wt, after forming clear solution, add the Magnesium dichloride hexahydrate solution 474ml of 10%wt again, stir, form the white granular Magnesium linoleate., after filtration, distilled water wash, drying, pulverize, obtain about 97 grams of intermediate products Magnesium linoleate. of the present invention.
Take by weighing 0.01g sodium selenite, 3g vitamin C, 10g Magnesium linoleate., mix homogeneously adds remaining Magnesium linoleate. more several times, mixes step by step, up to total amount; Add a spot of starch again as excipient, mix homogeneously is pressed into tablet.
Embodiment 2
Take by weighing the 95g conjugated linoleic acid in the 950ml distilled water, the sodium hydroxide solution 138ml reaction that adds 10%wt, after forming clear solution, add the Magnesium dichloride hexahydrate solution 485ml of 10%wt again, stir, form the white granular Magnesium linoleate., after filtration, distilled water wash, drying, pulverize, get about 99 grams of intermediate products Magnesium linoleate. of the present invention.
Take by weighing 0.02g sodium selenite, 1g vitamin C, 10g Magnesium linoleate., mix homogeneously adds remaining Magnesium linoleate. more several times, mixes step by step, up to total amount; Be crushed to the 150-200 order again, make powder.
Embodiment 3
Take by weighing the 93g conjugated linoleic acid in the 930ml distilled water, the sodium hydroxide solution 135ml reaction that adds 10%wt, after forming clear solution, add the Magnesium dichloride hexahydrate solution 474ml of 10%wt again, stir, form the white granular Magnesium linoleate., after filtration, distilled water wash, drying, pulverize, get about 97 grams of intermediate products Magnesium linoleate. of the present invention.
Weighing 0.00036g sodium selenite, 2g vitamin C (V again
C), the 10g Magnesium linoleate., mix homogeneously adds remaining Magnesium linoleate. more several times, mixes step by step, up to total amount; Add a spot of excipient carboxymethyl cellulose again, mix homogeneously is pressed into tablet.
Embodiment 4
Take by weighing the 80g conjugated linoleic acid in the 800ml distilled water, the sodium hydroxide solution 116ml reaction that adds 10%wt, after forming clear solution, add the Magnesium dichloride hexahydrate solution 408ml of 10%wt again, stir, form the white granular Magnesium linoleate., after filtration, distilled water wash, drying, pulverize, get about 83.2 grams of intermediate products Magnesium linoleate. of the present invention.
Weighing 0.00022g sodium selenite, 2g vitamin C (V again
C), the 10g Magnesium linoleate., mix homogeneously adds remaining Magnesium linoleate. more several times, mixes step by step, up to total amount; Mix with Mel, make pill.
Embodiment 5
Take by weighing the 90g conjugated linoleic acid in the 900ml distilled water, the sodium hydroxide solution 130ml reaction that adds 10%wt, after forming clear solution, add the Magnesium dichloride hexahydrate solution 460ml of 10%wt again, stir, form the white granular Magnesium linoleate., after filtration, distilled water wash, drying, pulverize, get about 98 grams of intermediate products Magnesium linoleate. of the present invention.
Again with 0.007g sodium selenite and 2g vitamin C (V
C) and Magnesium linoleate., mix homogeneously, through pelletize, tabletting carries out film coating with methylcellulose, makes film coating tablet.
The compound preparation that uses embodiments of the invention 2 to obtain carries out toxicology and function assessment evaluation, 100g compound preparation composed as follows: 0.02 part of sodium selenite, 1.00 parts of vitamin Cs, 98.98 parts of Magnesium linoleate .s.
Toxicological evaluation is the result show, preparation of the present invention is once irritated stomach 20g/kg.bw (body weight) to mice, and mice does not see obvious poisoning symptom in two weeks, and no animal dead is pressed the acute toxicity grading criteria regulation, belongs to nontoxic level, LD
50(median lethal dose(LD 50))＞10000mg/kg; The result is all negative for three genetic toxicity tests (Ames (Salmonella typhimurium/mammal microsomal enzyme test), mouse bone marrow cells are had a liking for many seven micronucleus in erythrocytes tests, mouse sperm deformity test); Feeding trial showed in 30 days, the clinical examination of wistar rat, and hematology, biochemical, organ weights and coefficient and the multiple index of pathological tissue do not have obvious influence, do not find that this medicament has tangible toxicity.
The compound preparation that uses embodiments of the invention 2 to obtain carries out the function assessment evaluation test:
(1) experimental animal: 63 of one-level Kunming mouses, male, body weight 18-21 gram is provided by China Academy of TCM.Animal is divided into five groups at random, 10 of normal control groups, 14 of model control group, each 13 of large, medium and small dosage groups.
(2) test preparation: white powdery, be scattered in 1.5% the cmc soln, divide basic, normal, high three dosage stand-by.
Low dosage: the 3.85g sample, disperse with the carboxymethyl cellulose of 100ml 1.5%, feed 0.2ml/10g body weight (0.77g/kg is equivalent to 7.7 times of equivalents of human body recommended amounts 6g/ day 0.1g/kg);
In dosage: the 19.25g sample disperses with the carboxymethyl cellulose of 100ml 1.5%, feeds 0.2ml/10g body weight (3.85g/kg is equivalent to 57.5 times of equivalents of human body recommended amounts);
High dose: the 35.5g sample disperses with the carboxymethyl cellulose of 100ml 1.5%, feeds 0.2ml/10g body weight (38.5g/kg is equivalent to 574.6 times of equivalents of human body recommended amounts).
(3) nutrient fodder prescription: normal feedstuff 80%, Adeps Sus domestica 10%, yolk powder 10%
(4) test method: experiment beginning certainly, the normal control group gives normal feedstuff, model control group and test group give high lipid food, test group is pressed 0.2ml/10gBW (body weight) per os 4 weeks of gastric infusion simultaneously, and model control group and normal control group give identical 1.5% carboxymethyl cellulose aqueous solution.Every animal of duration of test record give appetite, surplus appetite and berley amount, regularly claim the weight of animals, experiment finished fasting after 18 hours, weigh, eye socket is got blood and is surveyed monoglyceride (TG), HDL-C (HDL-C), T-CHOL (CHO), cut open the belly and get around the testis fat and weigh, calculate fat body index (fat/body than).
(5) test period: 29 days.
(6) result of the test: compare with model control group, fat mass, fat body index extremely obviously reduce around three dosage group animal subject testis, and serum high-density LP obviously improves, and the results are shown in Table 1; Middle dosage group body weight obviously reduces, high dose group extremely obviously reduces, and the results are shown in Table 2; Compare with model control group, the matched group food intake dose obviously reduces, and each dosage group does not have significant change, the results are shown in Table 3.
Table 1 preparation of the present invention is to the influence of experimental animal fat, fat body index and high density lipoprotein
| Project | The normal control group | Model control group | Small dose group | Middle dosage group | Heavy dose of group |
| Fat (g) | 0.5651±0.1631* | 0.9728±0.2235 | 0.7141±0.2012* | 0.1746±0.105* | 0.0482±0.0151* |
| Index | 1.74±0.40* | 2.73±0.51 | 1.93±0.46* | 0.49±0.26* | 0.17±0.05* |
| HDL-C (mg/dL) | 175.68±24.20 | 168.15±35.90 | 191.40±26.67 | 230.63±68.58# | 333.25±146.88# |
# represents to compare with model control group P (T check)＜0.05,
* represent to compare P＜0.001 with model control group
Table 2 experimental animal body weight comparative unit: g
| Week | The normal control group | Model control group | Small dose group | Middle dosage group | Heavy dose of group |
| 0 | 20.1±0.7 | 19.7±0.7 | 19.9±0.8 | 19.9±0.8 | 20.0±0.7 |
| 1 | 27.61±1.61# | 29.36±1.95 | 29.6±2.1 | 29.5±1.8 | 27.12±1.36# |
| 2 | 31.79±2.08 | 33.74±2.29 | 34.62±2.77 | 32.35±4.41 | 27.9±3.11* |
| 3 | 34.5±2.53 | 36.45±2.61 | 36.17±2.69 | 34.52±4.14 | 29.75±3.78* |
| 4 | 35.41±2.77# | 37.94±2.99 | 37.57±3.36 | 34.7±4.19# | 28.25±3.59* |
* expression is compared with model control group, P＜0.01, and # represents to compare P＜0.05 with model control group
Table 3 food intake dose comparative unit: g
| Week | The normal control group | Model control group | Small dose group | Middle dosage group | Heavy dose of group |
| 1 | 5.39 | 6.54 | 6.43 | 5.78 | 6.86 |
| 2 | 6.39 | 6.35 | 7.15 | 9.52 | 9.97 |
| 3 | 4.95 | 9.41 | 7.31 | 7.98 | 4.89 |
| 4 | 5.71 | 8.26 | 9.1 | 9.08 | 8.29 |
| On average | 5.61 | 7.64 | 7.4975 | 8.09 | 7.5025 |
| Standard deviation | 0.6062 | 1.4596 | 1.1348 | 1.6706 | 2.1561 |
| P | 0.0424 | 0.8825 | 0.5788 | 0.6817 |
Data are as can be seen from table:
(1) the fat body index of experimental animal extremely obviously reduces, and sees Table 1,2;
(2) dosage group, high dose group body weight obviously or extremely obviously reduce in, see Table 1,2;
(3) each dosage treated animal food intake dose does not have significant change, sees Table 3;
(4) HDL-C of experimental animal (HDL-C) obviously improves, and sees Table 1;
The above results shows that preparation of the present invention has the function of prevention and treatment of obesity and the effect that improves the HDL-C level.
Claims (6)
1, the compound preparation of a kind of prevention and treatment of obesity is characterized in that this compound preparation comprises Magnesium linoleate., selenite, vitamin C and coating material; The ratio of weight and number of each component of described compound preparation is:
The parts by weight of Magnesium linoleate. are 50-95 part,
The parts by weight of selenite are 0.002-0.02 part,
Ascorbic parts by weight are 1-5 part,
The parts by weight of coating material are 0-45 part.
2, according to the described compound preparation of claim 1, the dosage form that it is characterized in that described compound preparation is selected from a kind of in powder, pill, tablet and the coated tablet.
3,, it is characterized in that described selenite is a sodium selenite according to the described compound preparation of claim 1.
4,, it is characterized in that described raw material Magnesium linoleate., selenite, vitamin C uniform mixing are made the described compound preparation of various dosage forms according to the described compound preparation of claim 1.
5,, it is characterized in that described Magnesium linoleate. prepares by the method that may further comprise the steps according to the described compound preparation of one of claim 1-4:
At first with the reactant aqueous solution of conjugated linoleic acid and alkali metal hydroxide, alkali carbonate, in solution, add magnesium salt then and react and make, form the conjugated linoleic acid magnesium precipitate, after filtration, drying makes.
6, the preparation method of the compound preparation of described prevention of one of claim 1-5 and treatment of obesity may further comprise the steps:
(1) with conjugated linoleic acid and alkali metal hydroxide or carbonate aqueous solution reaction, adds the magnesium salt precipitation, after filtration, drying makes Magnesium linoleate.;
(2) with described Magnesium linoleate. and selenite, vitamin C uniform mixing in proportion;
(3) make the compound preparation of the present invention of various dosage forms.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104027350A (en) * | 2014-05-30 | 2014-09-10 | 西安交通大学 | Application of hydrogen molecule solid carrier in preparation of obesity inhibitory health-care products and medicines |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104027350A (en) * | 2014-05-30 | 2014-09-10 | 西安交通大学 | Application of hydrogen molecule solid carrier in preparation of obesity inhibitory health-care products and medicines |
| CN104027350B (en) * | 2014-05-30 | 2016-05-04 | 西安交通大学 | The application of hydrogen molecule solid-state carrier in preparation inhibition fat health products and medicine |
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