CN111714559A - Pharmaceutical composition for regulating liver lipid metabolism - Google Patents
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Abstract
The invention discloses a pharmaceutical composition for regulating liver lipid metabolism, which comprises baicalein and kadsura longipedunculata lignan which are used as effective medicinal components and auxiliary additive components acceptable in medicaments, wherein the effective medicinal components of the baicalein and the kadsura pedunculata lignan are respectively 1/(0.2-5) in proportion by weight of raw materials of baical skullcap root and kadsura pedunculata for extraction. The invention combines the schisandra sphenanthera and the scutellaria baicalensis, and has better regulation and control effect on liver lipid: when liver lipid is increased, the content of the lipid can be obviously reduced, the immune response is reduced, immune complexes are eliminated, the immunity is regulated and controlled, and the organism can be stimulated to generate interferon to improve the antiviral capability of the organism.
Description
Technical Field
The invention relates to the field of medicine research, in particular to a pharmaceutical composition for regulating liver lipid metabolism.
Background
The liver is a major site for synthesis, catabolism, transformation and productivity of three major substances, i.e., sugar, fat, protein, etc., and plays an important role in synthesis, decomposition of Triglyceride (TG), cholesterol (TC) and secretion of bile acid. Physiologically, Triglyceride (TG) synthesis favors the storage of excess Free Fatty Acids (FFA), TGs can be present in hepatocytes as lipid droplets or secreted into the blood such as low density lipoprotein (VLDL), and although TGs are the predominant form of lipid present in the liver of many fatty liver patients, many epidemiological studies have shown that TG can also exert a protective function, and increased TG synthesis should be an adaptive and beneficial response in the antrum hepaticum, where hepatocytes are exposed to metabolites where TG has a potentially toxic effect.
Epidemiological research finds that a plurality of factors such as drugs, food, obesity and the like can cause liver lipid metabolism disorder, so that the synthesis of TG and TC in the liver is increased, the synthesis is eliminated and reduced, fat drops are formed in liver cells in a light person, and fatty liver is formed in the liver in a heavy person. The mechanism that causes liver lipid accumulation has not been systematically elucidated to date: may be related to the reduction of liver lipid utilization caused by insulin resistance, the reduction of cholesterol excretion caused by the obstruction of bile acid synthesis, and the stimulation of TG, TC synthesis increase and the like by certain factors. It is worth noting that: about 25% of patients with fatty liver will develop further fatty hepatitis for various reasons.
However, the less lipid the liver is, the better, because the liver is also an important organ for the body to utilize TG, TC for energy production and synthesize other important active substances, once TG, TC are stored in the liver too little, many important substances in the body can be deficient, the health of the body is affected by light people, and the life safety of the heavy people can be endangered.
Therefore, the synthesis and metabolism of liver lipid are reasonably regulated and controlled to reach the optimal balance point, and the method has important medical value and social significance for maintaining the health state of the body. However, currently, there are few drugs available. There is therefore a need for a pharmaceutical composition for regulating liver lipid metabolism that effectively addresses the above-mentioned problems.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition for regulating liver lipid metabolism,
in order to achieve the purpose, the technical scheme adopted by the invention is as follows:
the invention takes baicalein and kadsura longipedunculata lignan as effective medicinal components and is combined with auxiliary additive components acceptable in medicaments, and the ratio of the effective medicinal components of the baicalein and the kadsura longepedunculata lignan in parts by weight of raw materials for extracting the effective medicinal components of the baicalein and the kadsura longepedunculata lignan is 1/(0.2-5).
Furthermore, the effective medicinal components of the baicalein and the kadsura longipedunculata lignanoid are 1/1 in parts by weight of the raw materials of the baicalein and the kadsura longepedunculata for extraction respectively.
Further, the preparation method of the effective medicine component baicalein comprises the steps of taking baical skullcap root, adding water, decocting and concentrating, adjusting the pH value to 1.0-2.0 by hydrochloric acid, preserving heat at 80 ℃, standing, filtering, adjusting the pH value to 7.0, adding equal amount of ethanol, stirring to dissolve, adjusting the pH value of filtrate to 1.0-2.0 by hydrochloric acid, preserving heat at 60 ℃, standing, filtering, washing precipitates to the pH value to 7.0 by proper amount of water and ethanol with different concentrations in sequence, and drying under reduced pressure to obtain the baicalein, wherein the content of baicalin is more than or equal to 20.0%.
Further, the preparation method of the active pharmaceutical ingredient kadsura longepedunculata extract comprises the steps of taking kadsura longepedunculata, adding water, decocting, drying and crushing decoction dregs, carrying out reflux extraction for 2 times by using 70% ethanol, combining filtrate every 1.5 hours, recovering ethanol until no ethanol smell exists, adding a proper amount of water, fully stirring, standing overnight, pouring out supernatant, carrying out silica gel column chromatography separation on lower-layer oily precipitate, eluting by using petroleum ether-ethyl acetate (10: 1) to remove impurities, eluting by using petroleum ether-ethyl acetate (10: 4), carrying out thin-layer chromatography inspection, combining lignan-containing parts, and removing a solvent to obtain the schisandra lignan, wherein the total lignan content is more than or equal to 5.0%.
Further, the active pharmaceutical ingredient kadsura longipedunculata lignan is allowed to be replaced by a schisandra extract containing the kadsura longipedunculata lignan.
Further, the pharmaceutical composition is an oral pharmaceutical preparation, and the oral pharmaceutical preparation is a capsule, a pill or a drop.
Compared with the prior art, the invention has the following beneficial effects:
the invention combines the schisandra sphenanthera and the scutellaria baicalensis, and has better regulation and control effect on liver lipid: when liver lipid is increased, the content of the lipid can be obviously reduced, the immune response is reduced, immune complexes are eliminated, the immunity is regulated and controlled, and the organism can be stimulated to generate interferon to improve the antiviral capability of the organism.
Detailed Description
The present invention is further illustrated by the following examples, which are intended to be in a manner including, but not limited to, the following examples.
Example 1
The two types of effective medicinal components or the corresponding extracts thereof can be prepared according to the methods reported in the existing documents. For example, the fructus Schisandrae extract can be prepared by decocting fructus Schisandrae chinensis with water for 1 hr, filtering, removing filtrate, oven drying the residue, pulverizing, extracting with 70% ethanol under reflux for 2 times (each for 1.5 hr), filtering, mixing filtrates, and concentrating as per volume 11 of "Chinese medicinal prescription preparation"; or according to the method in volume 19 of "Chinese medicinal prescription preparation", dried and pulverized fructus Schisandrae chinensis is extracted with 75% ethanol under reflux for three times, 4 times of 75% ethanol is added for the first time, reflux is carried out for 3 hours, 3 times of 75% ethanol is added for the second time, reflux is carried out for 2 hours, 3 times of 75% ethanol is added for the third time, reflux is carried out for 1 hour, extracting solutions are combined, standing is carried out for 48 hours, supernatant fluid is absorbed, ethanol is recovered under reduced pressure, 90% ethanol is added for reflux for 2 hours, filtering is carried out, filtrate is collected, and ethanol is recovered under reduced pressure, so that the Chinese medicinal preparation.
The scutellaria baicalensis extract can be prepared by adding water into scutellaria baicalensis, decocting, combining decoction solutions, concentrating to a proper amount, adjusting the pH value to 1.0-2.0 by hydrochloric acid, keeping the temperature at 80 ℃, standing, filtering, adding a proper amount of water into precipitates, uniformly stirring, adjusting the pH value to 7.0 by 40% of sodium hydroxide, adding an equal amount of ethanol, stirring to dissolve, filtering, adjusting the pH value to 1.0-2.0 by hydrochloric acid, keeping the temperature at 60 ℃, standing, filtering, washing precipitates to the pH value to 7.0 by sequentially using an appropriate amount of water and ethanol with different concentrations, volatilizing the ethanol, and drying under reduced pressure according to a preparation method in the item of scutellaria baicalensis extract, which is the first edition of Chinese pharmacopoeia (2005).
Example 2
Decocting 10kg of scutellaria baicalensis in water, mixing decoctions, concentrating to a proper amount, adjusting the pH value to 1.0-2.0 by using hydrochloric acid, keeping the temperature at 80 ℃, standing, filtering, adding a proper amount of water into precipitates, uniformly stirring, adjusting the pH value to 7.0 by using 40% sodium hydroxide, adding an equal amount of ethanol, stirring to dissolve, filtering, adjusting the pH value of the filtrate to 1.0-2.0 by using hydrochloric acid, keeping the temperature at 60 ℃, standing, filtering, washing the precipitates to a pH value of 7.0 by using a proper amount of water and ethanol with different concentrations in sequence, volatilizing the ethanol, and drying under reduced pressure to obtain the baicalein, wherein the content of baicalin is more than or equal to 90.0%.
Decocting fructus Schisandrae Sphenantherae 10kg in water for 1 hr, filtering, discarding filtrate, oven drying the residue, pulverizing, reflux-extracting with 70% ethanol for 2 times, each for 1.5 hr, filtering, mixing filtrates, recovering ethanol, adding appropriate amount of water, stirring, standing overnight, collecting supernatant, separating the lower oily precipitate by silica gel column chromatography, eluting with petroleum ether-ethyl acetate (10: 1) to remove impurities, eluting with petroleum ether-ethyl acetate (10: 4), checking by thin layer chromatography, mixing the lignan-containing parts, and removing solvent to obtain lignan of fructus Schisandrae, wherein the total lignan content is not less than 95.0%.
Adding the above Scutellariae radix flavone (equivalent to 1kg Scutellariae radix) and fructus Schisandrae Sphenantherae lignanoid (equivalent to 1kg fructus Schisandrae Sphenantherae) into molten polyethylene glycol, stirring, and making into dripping pill to obtain corresponding dripping pill oral medicine.
Example 3
Decocting 10kg of scutellaria baicalensis in water, mixing decoctions, concentrating to a proper amount, adjusting the pH value to 1.0-2.0 by using hydrochloric acid, keeping the temperature at 80 ℃, standing, filtering, and drying precipitates to obtain the scutellaria baicalensis extract, wherein the content of baicalin is more than or equal to 50.0%.
Decocting fructus Schisandrae Sphenantherae 10kg in water for 1 hr, filtering, removing filtrate, oven drying the residue, pulverizing, extracting with 70% ethanol under reflux for 2 times (each for 1.5 hr), filtering, mixing filtrates, and concentrating to obtain fructus Schisandrae extract with total lignanoid content of not less than 10.0%.
Mixing the Scutellariae radix extract (equivalent to 1kg of Scutellariae radix) and fructus Schisandrae Sphenantherae extract (equivalent to 1kg of fructus Schisandrae Sphenantherae), adding appropriate amount of starch, mixing, granulating, and making into capsule 1000 granules to obtain the capsule oral medicine.
Example 4
Taking the scutellaria baicalensis extract (equivalent to 1kg of scutellaria baicalensis) and the kadsura longepedunculata extract (equivalent to 0.2kg of schisandra chinensis) in the above forms, adding a proper amount of auxiliary materials, uniformly mixing, granulating, tabletting and preparing into 1000 tablets to obtain the oral tablet medicine.
Example 5
Taking the baicalein (equivalent to 1kg of baical skullcap root) and the kadsura longipedunculata lignan (equivalent to 5kg of Chinese magnoliavine fruit) in the forms, adding the mixture into the molten polyethylene glycol, stirring uniformly, and preparing into the dropping pill to obtain the oral medicine of the dropping pill.
The following experiments were conducted using pharmaceutical compositions in different ratio compositions, in which the scutellaria baicalensis extract and the kadsura longepedunculata extract were used as the active pharmaceutical ingredients.
1 materials and methods
1.1 test reagents and drugs
Tetracycline: USP Standard, Amresco product, 5 g/bottle, lot 0422, was freshly prepared with normal saline immediately prior to use to prepare the desired solution for use. Cholesterol: AR, chengdu chemical reagent factory, lot number 2006705, lard: purchased from nearby farm markets and refined for use.
1.2 test animals and Environment
Kunming mouse, male, SPF grade, initial weight 20 + -2 g, provided by the Experimental animals center of the institute of traditional Chinese medicine and sciences, Sichuan province, quality certification number: SCXK (Chuan) -2018-19. The experimental animal is hosted in the central barrier system of the experimental animal of the academy of traditional Chinese medicine and pharmacology of Sichuan province, and the qualification number is: SYXK (Chuan) -2018-100, room temperature 22-25 ℃, humidity 50 +/-5%, light and shade each 12 h.
1.3 Biochemical detection kit
1.3.1 semi-automatic detection kit
Cholesterol (TC) assay kit, lot No.: 2019001, respectively; triglyceride (TG) assay kit, lot No.: 2019001, all of which are available from Changchun Hui Living Biol Ltd.
1.4 Main Equipment
A full-automatic biochemical analyzer, Hitachi 7020 type, Nippon plant type Hitachi high new technology; VarioskanFlash full-wavelength scanning multifunctional reading instrument, available from Thermo corporation, USA; electronic balance, BP211D, manufactured by Sartorius; TGL-16 desk type high speed refrigerated centrifuge, Changshan appearance centrifuge instruments Inc.; olympus BX63 all electric intelligent microscope, Japan Olympus company.
1.5 test methods
1.5.1 determination of the optimal ratio of radix Scutellariae to fructus Schisandrae chinensis in regulating and controlling mouse liver lipid
Taking male mice with the weight of 18-22 g, grouping the mice according to the table 1 after adaptive feeding for one day, and performing intragastric administration once a day for 14 continuous days, and meanwhile, except for a control group, performing intragastric administration on 10mL/kg of high fat emulsion (10% lard and 5% cholesterol) once a day for 14 continuous days for other animals in each group; on the 8 th day after the start of administration, animals of the other groups except the control group were intraperitoneally injected with tetracycline 100mg/kg once a day for 7 times continuously, and after 24 hours of the last tetracycline injection and 16 hours of fasting without water prohibition, blood was taken to measure serum TC, the livers of the sacrificed animals were taken to weigh wet and calculate organ indexes thereof, a large piece of liver tissue at the same position was fixed with a 10% formalin solution for pathological histological examination, and the degree of fat accumulation thereof was scored under a microscope according to relevant standards. Liver tissues from the same sites of each animal were simultaneously homogenized with physiological saline at 10% to determine their TG and TC contents.
TABLE 1 Regulation of liver lipids by Scutellaria baicalensis and Schisandra sphenanthera at different ratios (X + -S)
Comparison with model groups: p <0.05, P <0.01, P < 0.001.
As can be seen from Table 1, the contents of TG and TC in liver tissues of mice are remarkably increased after the mice are perfused with the high-fat emulsion for 14 days and injected with tetracycline 100mg/kg7 days, and the difference of the contents compared with a control group has statistical significance; after the kadsura longepedunculata and the scutellaria baicalensis with different proportions are fed by gastric lavage, the TG and TC levels of the mice can be reduced to different degrees, wherein the effect of the ratio of the kadsura longepedunculata to the scutellaria baicalensis in the range of (0.2-1)/(0.2-1) is optimal, and the statistical significance is realized when the difference is compared with a model group.
1.5.2 comparison study of lipid in liver of mice regulated by compatibility of Kadsura japonica, Kadsura japonica and Scutellaria baicalensis
Males were grouped as shown in table 2 and gavaged once daily for 7 consecutive days. On the 4 th day of administration, the animals of the other groups except the control group were injected with dexamethasone 100mg/kg intraperitoneally once a day for 4 consecutive days; after the last dexamethasone injection, each group of animals was gavaged with 0.1ml/10g of 50% ethanol. After 24 hours of the last administration and 16 hours of fasting without water prohibition, blood was taken to measure serum TC, the liver of the sacrificed animal was taken to weigh the wet weight and calculate the organ index, a large block of liver tissue at the same position was fixed with 10% formalin solution for pathological histological examination, and the degree of fat accumulation was scored under a microscope according to relevant standards. Liver tissues from the same sites of each animal were simultaneously homogenized with physiological saline at 10% to determine their TG and TC contents.
TABLE 2 lipid regulation of mouse liver by combination of Kadsura longepedunculata and Kadsura longepedunculata with Scutellaria baicalensis (X + -S)
Comparison with model groups: p <0.05, P <0.01, P < 0.001.
As can be seen from Table 2, after dexamethasone and 50% ethanol are injected into the mice, the TG content of the liver tissues of the mice is increased, the TC content of the mice is obviously reduced, and the difference of the TG content and the TC content of the mice compared with a control group has statistical significance; according to different proportions, the schisandra sphenanthera and the scutellaria baicalensis can reduce the liver TG of the mouse and increase the TC level of the mouse to different degrees, and the difference compared with a model group has statistical significance. However, the effect of reducing mouse liver TG and TC by the compatibility of the schisandra chinensis and the scutellaria baicalensis is weaker, and the difference of the schisandra chinensis and the scutellaria baicalensis compared with a model group has no statistical significance.
1.5.3 Effect of various examples on hepatic lipid deposition in obese mice
Injecting sodium glutamate at the neck part subcutaneously at 4mg/g once a day for 3 days in the first day after birth of Kunming mice; the normal control group was injected subcutaneously with an equal volume of saline. After 20 days of normal feeding, obese mice (male and female) were randomly grouped and gavaged according to table 3 for 1 time per day for 2 consecutive weeks, fasted and forbidden for 16h after the last administration, weighed, sacrificed, the liver medium lobes were fixed in 10% formaldehyde solution, and pathological observation was performed after HE staining. Another liver tissue is taken to be made into liver homogenate to measure the levels of TG and TC according to the steps of the kit.
TABLE 3 Effect of the examples on hepatic lipid metabolism (X. + -. S) in obese mice
Comparison with model groups: p <0.05, P <0.01, P < 0.001.
The mice became very obese more than 40 days after the subcutaneous injection of sodium glutamate. As can be seen from Table 3, the content of TG and TC in the liver is also obviously increased, and the difference compared with the control group has statistical significance; the kadsura longepedunculata and scutellaria baicalensis compositions in different embodiments can reduce the levels of TG and TC of the liver of an obese mouse to different degrees, and have statistical significance compared with a model group.
The above examples show that the combination of kadsura longepedunculata and scutellaria baicalensis has a good regulation and control effect on liver lipid: when liver lipid is increased, the content of the liver lipid can be obviously reduced; when the liver is low in lipid, the content of the liver can be properly increased so as to maintain the normal level.
The above-mentioned embodiment is only one of the preferred embodiments of the present invention, and should not be used to limit the scope of the present invention, but all the insubstantial modifications or changes made within the spirit and scope of the main design of the present invention, which still solve the technical problems consistent with the present invention, should be included in the scope of the present invention.
Claims (6)
1. The pharmaceutical composition for regulating liver lipid metabolism is characterized by comprising effective pharmaceutical ingredients of baicalein and kadsura longipedunculata lignan, and auxiliary additives acceptable in medicines, wherein the ratio of the effective pharmaceutical ingredients of the baicalein and the kadsura longepedunculata lignan to the weight parts of crude drugs of baicalein and kadsura longepedunculata lignan for extraction is 1/(0.2-5).
2. The pharmaceutical composition for regulating liver lipid metabolism according to claim 1, wherein the preferred ratio of the effective pharmaceutical ingredients of scutellaria flavone and kadsura longipedunculata lignan is 1/1 in terms of the weight parts of the raw materials for extraction of scutellaria baicalensis and kadsura longepedunculata lignan.
3. The pharmaceutical composition for regulating liver lipid metabolism according to claim 1 or 2, wherein the preparation method of the effective drug component baicalein comprises decocting Scutellariae radix in water, concentrating, adjusting pH to 1.0-2.0 with hydrochloric acid, keeping at 80 ℃, standing, filtering, adjusting pH to 7.0, adding equal amount of ethanol, stirring for dissolution, adjusting pH of the filtrate to 1.0-2.0 with hydrochloric acid, keeping at 60 ℃, standing, filtering, washing the precipitate with appropriate amount of water and ethanol of different concentrations to pH 7.0, and drying under reduced pressure to obtain baicalein, wherein the content of baicalin is not less than 20.0%.
4. The pharmaceutical composition for regulating liver lipid metabolism according to claim 1 or 2, wherein the preparation method of the effective drug component fructus schisandrae sphenantherae extract comprises the steps of decocting fructus schisandrae sphenantherae in water, drying and crushing the residue, reflux-extracting with 70% ethanol for 2 times, combining the filtrates each time for 1.5 hours, recovering ethanol until no alcohol smell exists, adding a proper amount of water, stirring thoroughly, standing overnight, decanting the supernatant, separating the lower oily precipitate by silica gel column chromatography, eluting with petroleum ether-ethyl acetate (10: 1) to remove impurities, eluting with petroleum ether-ethyl acetate (10: 4), examining by thin layer chromatography, combining the lignan-containing parts, and removing the solvent to obtain fructus schisandrae lignans, wherein the total lignan content is not less than 5.0%.
5. The pharmaceutical composition for regulating liver lipid metabolism according to claim 1 or 2, wherein the active pharmaceutical ingredient kadsura longipedunculata lignan is allowed to be replaced with a schizandra chinensis extract containing the kadsura longipedunculata lignan.
6. The pharmaceutical composition for regulating liver lipid metabolism according to claims 1 to 2, wherein the pharmaceutical composition is an oral pharmaceutical preparation, and the oral pharmaceutical preparation is a capsule, a pill or a drop.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101933973A (en) * | 2009-07-02 | 2011-01-05 | 四川省中医药科学院 | Medicament composition for preventing and treating liver damage |
| CN110179883A (en) * | 2019-06-21 | 2019-08-30 | 四川省中医药科学院 | For preventing and treating the pharmaceutical composition and its application of anti-tubercular drug physical property hepatic injury |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101933973A (en) * | 2009-07-02 | 2011-01-05 | 四川省中医药科学院 | Medicament composition for preventing and treating liver damage |
| CN110179883A (en) * | 2019-06-21 | 2019-08-30 | 四川省中医药科学院 | For preventing and treating the pharmaceutical composition and its application of anti-tubercular drug physical property hepatic injury |
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