CN108159146B - Traditional Chinese medicine composition for reducing blood fat and preparation method thereof - Google Patents
Traditional Chinese medicine composition for reducing blood fat and preparation method thereof Download PDFInfo
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- CN108159146B CN108159146B CN201810104820.3A CN201810104820A CN108159146B CN 108159146 B CN108159146 B CN 108159146B CN 201810104820 A CN201810104820 A CN 201810104820A CN 108159146 B CN108159146 B CN 108159146B
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/734—Crataegus (hawthorn)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/482—Cassia, e.g. golden shower tree
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/62—Nymphaeaceae (Water-lily family)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Medicinal Chemistry (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
The invention relates to the field of medicines, in particular to a medicine and an extraction process thereof. The extraction process adopts water as solvent, avoids the use of organic solvent in large quantity, and is environment-friendly and safe. In addition, low-temperature high-pressure difference extraction is adopted, so that effective components are extracted to the maximum degree, and the production efficiency is improved. Pharmacological research results show that the traditional Chinese medicine composition prepared by the extraction process provided by the invention can obviously reduce high cholesterol of mice caused by yolk milk, has an obvious improvement effect on experimental hyperlipidaemia rat hemorheology, can reduce whole blood viscosity, and can reduce the contents of cholesterol, triglyceride and low-density lipoprotein in serum, and has an obvious blood fat reducing effect. The traditional Chinese medicine composition has more obvious lipid-lowering effect than the Jiangzhining granules under the same dosage.
Description
Technical Field
The invention relates to the field of medicines, in particular to a traditional Chinese medicine composition for reducing blood fat and a preparation method thereof.
Background
Due to the improvement of the quality of life, hyperglycemia, hyperlipidemia and hypertension gradually become three killers threatening the health of human beings, and the trend of the rejuvenation is presented, so that the quality of life of people is seriously influenced. Most of patients with hyperlipidemia have hypertension symptoms, so stroke and cardiovascular diseases are easy to occur, and the consequences are very serious if the patients cannot be prevented and treated as soon as possible.
Hyperlipidemia can be classified into primary and secondary. Primary hyperlipidemia is associated with both congenital and genetic origin, either due to monogenic or polygenic deficiencies, resulting in abnormalities in the portable, enzymatically active apolipoproteins involved in lipoprotein transport and metabolism, or due to environmental factors (diet, nutrition, drugs) and through unknown mechanisms. The effective genetic factors are as follows: inheritance can cause hyperlipidemia through a variety of mechanisms, some of which may occur at cellular levels, are notoriously characterized as cell surface lipoprotein receptor defects and defects in certain enzymes within the cell (e.g., defects or deficiencies in lipoprotein lipase), may occur on lipoprotein or apolipoprotein molecules, and are mostly due to genetic defects. Capsule wall dietary factors: the examination of the effect of dietary factors is more complicated than that of the permanent abdominal cavity, and a considerable proportion of hyperlipoproteinemia patients are hospitalized and are closely related to the dietary factors. Secondary hyperlipidemia is caused by other intermediate primary diseases, including: diabetes, liver disease, thyroid disease, kidney disease, pancreas, obesity, glycogen storage disease, gout, addison's disease, coxxing syndrome, dysglobulinemia, etc. The traditional Chinese medicine composition has close relation between sugar metabolism and fat metabolism in a human body between the traditional Chinese medicine composition and the hyperlipoproteinemia, and only clinical researches show that about 40 percent of patients with diabetes can secondarily cause hyperlipidemia. Capsule liver disease and hyperlipoproteinemia: modern medical research data confirms that many substances including lipid and lipoprotein, etc. are processed, produced and decomposed in the liver and excreted. Lipid and lipoprotein metabolism must also be disturbed once the liver is medically protected. ⒊ obesity and hyperlipoproteinemia: clinical medical research data show that obesity most often secondarily causes the increase of blood triglyceride level, and part of patients may also have the increase of blood cholesterol level firstly, and too much is mainly manifested as type iv hyperlipoproteinemia and iib hyperlipoproteinemia secondly. Secondary hyperlipidemia may also be associated with other factors such as age, gender, season, alcohol consumption, smoking, diet, physical activity, mental stress, emotional activity, and the like.
The medicaments for reducing blood fat which are commonly used clinically comprise statins, are cholesterol biosynthetic enzyme inhibitors, are lipid-regulating medicaments which are most widely applied clinically at present, are main medicaments for treating hypercholesterolemia at present, have gastrointestinal reaction and headache, and can cause muscle toxicity when being used together with other lipid-reducing medicaments; fibrates are mainly used for mixed type hyperlipidemia with hypertriglyceridemia or triglyceride increase, and the common adverse reactions of the fibrates are gastrointestinal reaction, nausea, diarrhea and liver damage caused by severe cases. Therefore, although these drugs have a certain therapeutic effect, they have a large side effect and are not suitable for people with weak physical fitness.
Compared with western medicines, the traditional Chinese medicine has the advantages of safety, less side effect, no damage to gastrointestinal tracts and less stimulation to liver and kidney, and is more and more concerned by people.
The Jiangzhining granules are composed of four traditional Chinese medicines of hawthorn, prepared fleece flower root, cassia seed and lotus leaf. The functions of the medicine are mainly reducing blood fat and softening blood vessels. Can be used for enhancing coronary blood circulation. Preventing arrhythmia and hyperlipemia. The prescription is currently carried in the ministerial standard WS 3-B-2549-97.
In the existing preparation process, the hawthorn is rich in sugar after being decocted by water, and is not easy to filter and dry after being concentrated, so that repeated moisture absorption is caused, and the production efficiency is influenced. And a large amount of organic solvents are used in the extraction process, and a large amount of waste liquid pollutes the environment and is not beneficial to industrial production.
Disclosure of Invention
In view of the above, the invention provides a traditional Chinese medicine composition for reducing blood fat and a preparation method thereof. The extraction process selects water as a solvent, avoids using a large amount of organic solvents, and is environment-friendly and safe. In addition, low-temperature high-pressure difference extraction is adopted, so that effective components are extracted to the maximum degree, and the production efficiency is improved. Pharmacological research results show that the traditional Chinese medicine composition prepared by the extraction process provided by the invention can obviously reduce high cholesterol of mice caused by yolk milk, has an obvious improvement effect on experimental hyperlipidaemia rat hemorheology, can reduce whole blood viscosity, and can reduce the contents of cholesterol, triglyceride and low-density lipoprotein in serum, and has an obvious blood fat reducing effect. The traditional Chinese medicine composition has more obvious lipid-lowering effect than the Jiangzhining granules under the same dosage.
In order to achieve the above object, the present invention provides the following technical solutions:
the invention discloses a medicine extraction process, which comprises the following steps:
the raw material medicines comprise 500-600 parts by weight of hawthorn, 10-35 parts by weight of prepared fleece-flower root, 10-35 parts by weight of cassia seed and 50-100 parts by weight of lotus leaf;
step 1: pretreating raw materials, and mixing with water;
step 2: extracting at 20-30 Mpa for 30-60 min, and extracting at 40-50 Mpa for 30-60 min;
and step 3: and (3) carrying out solid-liquid separation on the extract obtained in the step (2), and collecting filtrate.
In some embodiments of the invention, the mass ratio of the bulk drug to water is 1: (10-20).
In some embodiments of the invention, the bulk drug is mixed with water for 50-70 min.
In some embodiments of the invention, the temperature of the first extraction is 0 to 10 ℃.
In some embodiments of the invention, the temperature of the second extraction is 0 to 10 ℃.
In some embodiments of the invention, the solid-liquid separation in step 3 is centrifugation or filtration; the rotating speed of the centrifugation is 8000-12000 rpm, and the time of the centrifugation is 10-30 min.
In some embodiments of the present invention, the method further comprises the step of repeating the steps 2 and 3 with the filtrate, wherein the number of the repetition is at least 1.
In some embodiments of the present invention, the step of repeating step 2 and step 3 further comprises the steps of combining the filtrates and filtering; the filtration is microfiltration;
the aperture of the membrane used for microfiltration is 0.45-1.0 μm.
In some embodiments of the invention, the microfiltration is performed by taking the combined filtrate, passing the combined filtrate through a microfiltration membrane, adding water to ensure that the amount of the permeate is not less than 2 times of the volume of the combined filtrate, and filtering until the content of solids in the concentrated solution is not less than 20% (w/w); and (4) washing the microfiltration membrane by using water, collecting a cleaning solution, and mixing the cleaning solution with the concentrated solution.
In some embodiments of the invention, the filtration time is not more than 6 hours and the filtration flow rate reduction is not less than 50%.
In some embodiments of the invention, the solid content in the filtration is 10-20% (w/w), and the relative density measured at 50-80 ℃ is 1.05-1.20.
The invention also provides a medicine prepared by the extraction process.
The extraction process provided by the invention selects water as the solvent, avoids the use of a large amount of organic solvents, and is environment-friendly and safe. In addition, low-temperature high-pressure difference extraction is adopted, so that effective components are extracted to the maximum degree, and the production efficiency is improved. Pharmacological research results show that the traditional Chinese medicine composition prepared by the extraction process provided by the invention can obviously reduce high cholesterol of mice caused by yolk milk, has an obvious improvement effect on experimental hyperlipidaemia rat hemorheology, can reduce whole blood viscosity, and can reduce the contents of cholesterol, triglyceride and low-density lipoprotein in serum, and has an obvious blood fat reducing effect. The traditional Chinese medicine composition has more obvious lipid-lowering effect than the Jiangzhining granules under the same dosage.
Detailed Description
The invention discloses a traditional Chinese medicine composition for reducing blood fat and a preparation method thereof, and a person skilled in the art can appropriately improve process parameters by referring to the content. It is expressly intended that all such similar substitutes and modifications which would be obvious to one skilled in the art are deemed to be included in the invention. While the methods and applications of this invention have been described in terms of preferred embodiments, it will be apparent to those of ordinary skill in the art that variations and modifications in the methods and applications described herein, as well as other suitable variations and combinations, may be made to implement and use the techniques of this invention without departing from the spirit and scope of the invention.
1. Experimental Material
1.1 test article: the traditional Chinese medicine composition provided by the embodiments 1 to 3 of the invention is provided by Jilin correction pharmaceutical drug development Limited.
Control group 1: the composition of comparative example 1;
control group 2: the composition of comparative example 2;
1.2 reagents
Egg yolk emulsion: 75% egg yolk physiological saline suspension; high fat emulsion: 20% cholesterol, 1% propylthiouracil, 40% lard, 20% sodium hyocholate solution (concentration is l 0%), 1% tween, 2% propylene glycol, and distilled water to 100 mL;
atorvastatin calcium: pfeiy pharmaceutical limited, specifications: 20 mg/tablet, batch number: m97466;
total serum cholesterol (TC); triglyceride (TG); high density lipoprotein cholesterol (HDL-cho) and low density lipoprotein cholesterol (LDL-cho) content determination kits, which are purchased from Nanjing institute of bioengineering.
2. Laboratory animal
Wistar rat, male, 240-260 g; ICR mice, male and female halves, 18-22g, certificate number: SCXK (Ji) 2014-. The source is as follows: the national enchance of the Changchun city is a hundred million laboratory animal technology company with license number of laboratory animal production: SCXK (Ji) 2014-. A certificate issuing organ: jilin province scientific and technological hall, quality certification number: 37009200005847.
3. instrument for measuring the position of a moving object
Electronic balance, shanghai national bridge precision scientific instruments ltd, JA 1103N; LBY-N6 full-automatic hemorheometer, Beijing Polycosan instruments Co., Ltd; enzyme-labeling instrument (SMP500-18272-LSIO, Manufactured in China Designed in California USA); LBY-NJ4 platelet aggregation apparatus, teikangtin.
The medicine and the raw materials and reagents used in the extraction process of the medicine provided by the invention can be purchased from the market.
The invention is further illustrated by the following examples:
example 1
The formula is as follows: hawthorn fruit 55kg prepared fleece-flower root 2.5kg cassia seed 1kg lotus leaf 5kg
(1) Crushing the medicinal materials according to the formula amount, and sieving the crushed medicinal materials through a first sieve (10 meshes) to a fourth sieve (65 meshes);
(2) mixing the above powders, adding 10 times of water, stirring and mixing for 60min to thoroughly wet;
(3) extracting for the first time: extracting in a low-temperature high-pressure difference extractor at 5 deg.C for 2 times (30 MPa for the first time) for 60min and 40MPa for 45 min;
(4) solid-liquid separation: centrifuging the extracted slurry at 8000rpm for 20min or filtering to separate solid and liquid, controlling the solid content transferred into the extractive solution not to exceed 20% of the total amount of the medicinal materials, and metering the separated extractive solution for use.
(5) And (3) second extraction: repeating the steps 3-4 on the solid medicine dregs obtained by solid-liquid separation, combining the separated extract with the extract obtained by the first extraction, and entering the step 6;
(6) and (3) microfiltration: filtering the combined extractive solution with 0.45 μm inorganic membrane to clarify; 6.1 when the filtration is close to the minimum circulation of the micro-filter, adding extraction water to dilute and filter filtrate, ensuring that the amount of the permeate liquid is not less than 2 times of the extraction liquid, and continuously filtering until the solid content of the concentrated solution is more than 20 percent. And respectively collecting the filtrate and the concentrated solution.
6.2 circulating water with the minimum circulating amount of the microfilter for 15 minutes to wash the inorganic membrane filter, and combining the cleaning solution with the concentrated solution of 6.1.
6.3 the filtration time per microfilter does not exceed 6 hours or the flow drops by more than 50%.
(7) Concentrating the micro-filtrate to obtain Chinese medicinal extract with solid content of about 15% and relative density of 1.05(70 deg.C).
(8) And adding proper auxiliary materials into the extract for spray drying to obtain the traditional Chinese medicine composition.
The traditional Chinese medicine composition for reducing blood fat can be prepared into any solid dosage form including capsules, tablets, powder or pills and the like by using the existing traditional Chinese medicine preparation technology and process method. In the present example, tablets or granules are prepared, but the dosage form is not limited.
Example 2
The formula is as follows: 50kg of hawthorn, 3.5kg of prepared fleece-flower root, 3.5kg of cassia seed and 10kg of lotus leaf.
(1) Crushing the medicinal materials according to the formula amount, and sieving the crushed medicinal materials through a first sieve (10 meshes) to a fourth sieve (65 meshes);
(2) mixing the above powders, adding 20 times of water, stirring and mixing for 70min to thoroughly wet;
(3) extracting for the first time: extracting in a low-temperature high-pressure difference extractor at 10 deg.C for 2 times (20 MPa for the first time) and 40min for the second time (50 MPa for 30 min);
(4) solid-liquid separation: centrifuging the extracted slurry (rotation speed of 10000rpm, centrifuging time of 15min) or filtering to separate solid and liquid, controlling the content of solid transferred into the extract not to exceed 20% of the total amount of the medicinal materials, and metering the separated extract for later use.
(5) And (3) second extraction: repeating the steps 3-4 on the solid medicine dregs obtained by solid-liquid separation, combining the separated extract with the extract obtained by the first extraction, and entering the step 6;
(6) and (3) microfiltration: filtering the combined extractive solution with 1.0 μm inorganic membrane to clarify;
6.1 when the filtration is close to the minimum circulation of the micro-filter, adding extraction water to dilute and filter filtrate, ensuring that the amount of the permeate liquid is not less than 2 times of the extraction liquid, and continuously filtering until the solid content of the concentrated solution is more than 20 percent. And respectively collecting the filtrate and the concentrated solution.
6.2 circulating water with the minimum circulating amount of the microfilter for 15 minutes to wash the inorganic membrane filter, and combining the cleaning solution with the concentrated solution of 6.1.
6.3 the filtration time per microfilter does not exceed 6 hours or the flow drops by more than 50%.
(7) Concentrating the micro-filtrate to obtain Chinese medicinal extract with solid content of about 20% and relative density of 1.20(50 deg.C).
(8) And adding proper auxiliary materials into the extract for spray drying to obtain the traditional Chinese medicine composition.
The traditional Chinese medicine composition for reducing blood fat can be prepared into any solid dosage form including capsules, tablets, powder or pills and the like by using the existing traditional Chinese medicine preparation technology and process method. In the present example, tablets or granules are prepared, but the dosage form is not limited.
Example 3
The formula is as follows: 60kg of hawthorn, 1kg of prepared fleece-flower root, 2.5kg of cassia seed and 8kg of lotus leaf.
(1) Crushing the medicinal materials according to the formula amount, and sieving the crushed medicinal materials through a first sieve (10 meshes) to a fourth sieve (65 meshes);
(2) mixing the above powders, adding 15 times of water, stirring and mixing for 50min to thoroughly moisten;
(3) extracting for the first time: extracting in a low-temperature high-pressure difference extractor at 0 deg.C for 2 times (25 MPa for the first time) and 30min and 45MPa for the second time for 60 min;
(4) solid-liquid separation: centrifuging the extracted slurry (rotation speed of 12000rpm, centrifuging time of 10min) or filtering to separate solid and liquid, controlling the content of solid transferred into the extractive solution not to exceed 20% of the total amount of the medicinal materials, and metering the separated extractive solution for use.
(5) And (3) second extraction: repeating the steps 3-4 on the solid medicine dregs obtained by solid-liquid separation, combining the separated extract with the extract obtained by the first extraction, and entering the step 6;
(6) and (3) microfiltration: filtering the combined extractive solution with 0.8 μm inorganic membrane to clarify;
6.1 when the filtration is close to the minimum circulation of the micro-filter, adding extraction water to dilute and filter filtrate, ensuring that the amount of the permeate liquid is not less than 2 times of the extraction liquid, and continuously filtering until the solid content of the concentrated solution is more than 20 percent. And respectively collecting the filtrate and the concentrated solution.
6.2 circulating water with the minimum circulating amount of the microfilter for 15 minutes to wash the inorganic membrane filter, and combining the cleaning solution with the concentrated solution of 6.1.
6.3 the filtration time per microfilter does not exceed 6 hours or the flow drops by more than 50%.
(7) Concentrating the micro-filtrate to obtain Chinese medicinal extract with solid content of about 10% and relative density of 1.1(80 deg.C).
(8) And adding proper auxiliary materials into the extract for spray drying to obtain the traditional Chinese medicine composition.
The traditional Chinese medicine composition for reducing blood fat can be prepared into any solid dosage form including capsules, tablets, powder or pills and the like by using the existing traditional Chinese medicine preparation technology and process method. In the present example, tablets or granules are prepared, but the dosage form is not limited.
Comparative example 1
The formula is as follows: 500g of hawthorn (with core removed); 25g of prepared fleece flower root; 25g of cassia seed; 75g of lotus leaves.
(1) Placing raw materials: crushing the raw materials with the formula amount to ensure that the particle size is 180 mu m;
(2) vacuumizing: forming vacuum in a high pressure difference continuous low-temperature extractor at the temperature of-10 ℃ in a reaction system, keeping the vacuum degree at-100 pa, adding water or 70% (v/v) ethanol aqueous solution, and keeping for 5min, wherein the weight ratio of the raw material to the water or 5% (v/v) ethanol aqueous solution is 1: 6;
(3) reducing the vacuum: introducing purified compressed air to increase the pressure in the high pressure difference continuous low temperature extractor to 0Mpa, and maintaining for 1 min;
(4) pressurizing: continuously introducing compressed air to make the pressure in the high pressure difference continuous low temperature extractor reach 8Mpa, and keeping for 20 min;
(5) and (3) reducing pressure: stopping pressurizing, and vacuumizing to reduce the pressure in the high-pressure-difference continuous low-temperature extractor to 0 Mpa;
(6) and (3) circulating extraction: and (5) circulating the steps (2) to (5) for 10 times.
The composition is made into tablet or granule.
Comparative example 2
The formula is as follows: 500g of hawthorn; 25g of prepared fleece flower root; 25g of cassia seed; lotus leaf 60 g.
(1) Placing raw materials: crushing the raw materials with the formula amount to make the particle size 850 mu m;
(2) vacuumizing: forming vacuum in a high-pressure-difference continuous low-temperature extractor at 0 ℃ of a reaction system, keeping the vacuum degree at 20pa, adding water or 5% (v/v) ethanol water solution, and keeping for 30min, wherein the weight ratio of the raw materials to the water or 70% (v/v) ethanol water solution is 1: 20;
(3) reducing the vacuum: introducing purified compressed air to increase the pressure in the high pressure difference continuous low temperature extractor to 0Mpa, and maintaining for 10 min;
(4) pressurizing: continuously introducing compressed air to make the pressure in the high pressure difference continuous low temperature extractor reach 12Mpa, and keeping for 1 min;
(5) and (3) reducing pressure: stopping pressurizing, and vacuumizing to reduce the pressure in the high-pressure-difference continuous low-temperature extractor to 0 Mpa;
(6) and (3) circulating extraction: and (5) circulating the steps (2) to (5) for 10 times.
The composition is made into tablet or granule.
Example 4 Effect on yolk milk-induced hyperlipidemic mice
80 healthy male ICR mice are selected and randomly divided into 8 groups according to body weight, namely a blank control group, a model control group and an atorvastatin calcium group (3 mg.kg)-1) The low, medium and high dose groups of the traditional Chinese medicine composition groups prepared in the embodiments 1 to 3 of the invention are (2, 4, 8 g.kg)-1) Comparative example 1 group (4 g. kg)-1) Comparative example 2 group (4 g. kg)-1). Except for the blank group, the constant volume distilled water is administrated by intragastric administration every day, the egg yolk emulsion is administrated by intragastric administration in the morning in each group by 0.5ml, and the intragastric administration is carried out in the afternoon, and the administration volume is 10 ml/kg-1And 11d in succession. The mice before the last administration are fasted and kept for 12h, and the mice 1h after the last administration are subjected to eyeball extraction and blood sampling (experiment 11d), 3000 r.min-1Centrifuging for 10min, separating serum, and determining serum Triglyceride (TC) and total cholesterol (TG) content according to kit instructions.
The experimental results are as follows:
the serum TG and TC contents of the mice in the model group are obviously increased, the serum TG and TC contents are obviously different from those of a blank control group (p is less than 0.001), the serum TG and TC contents of the mice with hyperlipidemia can be obviously reduced by the atorvastatin calcium group, the low, medium and high dose groups of the traditional Chinese medicine composition prepared in the embodiments 1 to 3 of the invention and the comparative examples 1 and 2, the significant difference (p is less than 0.05, p is less than 0.01, and p is less than 0.001) is obtained compared with the model group, and meanwhile, when the high dose group and the traditional Chinese medicine composition group prepared in the embodiments 1 to 3 of the invention are respectively compared with the comparative examples 1 and 2, the effects of inhibiting the increase of the TG and TC contents are obviously better than those of the comparative examples 1 and 2, the significant difference (p is less than 0.05, p is less than 0.01) is equivalent to that of the atorvastatin calcium group, and the results are shown in Table.
TABLE 1 Effect on serum TC, TG of model mouse with hyperlipidemia induced by yolk milk: (
n＝10)
Comparison with blank control group△△△p<0.001; comparison with model control group<0.05，**p<0.01，
***p<0.001; comparison with comparative example 1★p<0.05，★★p<0.01; comparison with comparative example 2#p<0.05，##p<0.01。
Example 5 Effect on Experimental hyperlipidemic rats
Establishing a model:
and (3) feeding 90 rats with high-fat feed except 10 blank control group common feed, and after feeding for 8 weeks, extracting 5 tail-clipping blood and determining whether the TG content detection model in serum is successful or not. And (3) high-fat feed formula: 78.8% of basal feed, 10% of lard oil, 10% of egg yolk powder, 1% of cholesterol and 0.2% of bile salt. The Yinshi laboratory animal technology, Inc. of Changchun city, stores at low temperature.
Grouping and administration:
70 successfully molded rats were divided into 7 groups: namely a model control group and an atorvastatin calcium group (1 mg. kg)-1) The low, medium and high dose groups of the traditional Chinese medicine composition groups prepared in the embodiments 1 to 3 of the invention (1.5, 3, 6 g.kg)-1) Comparative example 1 group (3g kg)-1) Comparative example 2 group (3g kg)-1). Feeding high fat fodder to other groups except for the blank control group with common fodder, and performing intragastric administration to the blank control group and model control groupDistilled water, the rest groups are administered by intragastric administration, 10ml kg-1And administered for 4 weeks.
Indexes are as follows:
after the last administration, the rats were fasted for 12h and anesthetized with sodium pentobarbital (45 mg. kg)-1) And (3) collecting blood from abdominal aorta, putting the blood into a vacuum blood collection tube containing heparin sodium and sodium citrate anticoagulant, and measuring the specific viscosity and the platelet aggregation rate of the whole blood by using a Beijing pril hematogenesis viscometer and a Tailikang platelet aggregation instrument. Collecting another tube of blood at 3500 r.min-1Centrifuging for 15min to separate serum, measuring total cholesterol (TG), Triglyceride (TC), high density lipoprotein (HDL-C) and low density lipoprotein (LDL-C) levels in serum, measuring superoxide dismutase (SOD) activity, and measuring Malondialdehyde (MDA) content, wherein the specific operation is performed according to kit instructions.
The experimental results are as follows:
effect on rat hemorheology:
the whole blood viscosity of the rat blood in the model control group under different shear rates is obviously increased, and has obvious difference (p is less than 0.05, p is less than 0.01, p is less than 0.001) compared with a blank control group, and the whole blood viscosity under each shear rate can be obviously inhibited by the atorvastatin calcium group, the low, medium and high dose groups of the traditional Chinese medicine composition groups prepared in the embodiments 1-3 of the invention and the comparative examples 1 and 2 groups to have obvious difference (p is less than 0.05, p is less than 0.01, p is less than 0.001;). Meanwhile, the inhibition effect of the middle-high dose group of the traditional Chinese medicine composition prepared in the embodiments 1-3 on the whole blood viscosity of each point is obviously better than that of the comparative examples 1 and 2, and the traditional Chinese medicine composition has obvious advantage (p is less than 0.05 and p is less than 0.01), and the results are shown in a table 2.
TABLE 2 Effect on rat hemorheology: (
n＝10)
Comparison with blank control group△△p<0.01，△△△p<0.001; comparison with model control group<0.05，**p<0.01，***p<0.001; comparison with comparative example 1★p<0.05，★★p<0.01; comparison with comparative example 2#p<0.05，##p<0.01。
Effect on rat erythrocyte and platelet aggregation rates:
the blood erythrocyte aggregation rate and the maximum platelet aggregation rate of rats in the model control group are also obviously increased, and have obvious differences (p <0.05, p <0.01, p <0.001) compared with a blank control group, the atorvastatin calcium group, the low, medium and high dose groups of the traditional Chinese medicine composition groups prepared in the embodiments 1-3 of the invention and the comparative examples 1 and 2 can obviously inhibit the increase of the erythrocyte aggregation rate and the large platelet aggregation rate, and have obvious differences (p <0.05, p <0.01, p < 0.001;) compared with the model control group. Meanwhile, the inhibition effects of the traditional Chinese medicine composition prepared in the embodiments 1-3 on the erythrocyte aggregation rate and the maximum platelet aggregation rate of the high-dose group are obviously better than those of the comparative examples 1 and 2, and the traditional Chinese medicine composition has obvious advantage effects (p is less than 0.05 and p is less than 0.01), and the results are shown in a table 3.
TABLE 3 Effect on rat Red blood cell aggregation Rate and maximum platelet aggregation Rate: (
n＝10)
Comparison with blank control group△△p<0.01，△△△p<0.001; comparison with model control group<0.05，**p<0.01，***p<0.001; comparison with comparative example 1★p<0.05，★★p<0.01; comparison with comparative example 2#p<0.05，##p<0.01。
Effect on rat serum TG, TC, HDL-C, LDL-C:
the contents of TG, TC and LDL-C in the serum of rats in a model control group are obviously increased, the content of HDL-C is obviously reduced, and compared with a blank control group, the contents are obviously different (p is less than 0.001), the contents of TG, TC and LDL-C in the serum of rats can be inhibited to different degrees in the atorvastatin calcium group, the low, medium and high dose groups of the traditional Chinese medicine composition prepared in the embodiments 1 to 3 of the invention and the comparative examples 1 and 2, the HDL-C in the serum of rats is promoted to be released, and compared with the model control group, the contents are obviously different (p is less than 0.05, and p is less than 0.01). Meanwhile, compared with the groups of comparative examples 1 and 2, the traditional Chinese medicine composition of the invention with medium and high doses has obvious effects of reducing TG, TC and LDL-C and remarkably promoting HDL-C increase (p is less than 0.05 and p is less than 0.01), which shows the advantages of the traditional Chinese medicine composition prepared in the embodiments 1-3 and the groups of comparative examples 1 and 2 in reducing blood fat, and the results are shown in Table 4.
TABLE 4 Effect on rat serum TG, TC, HDL-C, LDL-C (II)
n＝10)
Comparison with blank control group△△p<0.01，△△△p<0.001; comparison with model control group<0.05，**p<0.01，***p<0.001; comparison with comparative example 1★p<0.05，★★p<0.01; comparison with comparative example 2#p<0.05，##p<0.01。
Effects on rat serum SOD, MDA:
the rat serum SOD activity of the model control group is reduced, the MDA content is obviously increased, and the rat serum SOD activity has obvious difference (p is less than 0.001) compared with that of a blank control group, the atorvastatin calcium group, the low, medium and high dose groups of the traditional Chinese medicine composition prepared in the embodiment 1-3 of the invention and the comparative examples 1 and 2 can obviously increase the rat serum SOD activity change, inhibit the MDA content release, and have obvious difference (p is less than 0.05, p is less than 0.01, and p is less than 0.001) compared with that of the model control group. Meanwhile, compared with the groups of comparative examples 1 and 2, the middle-high dose group and the high-medium dose group of the traditional Chinese medicine composition prepared in the embodiments 1 to 3 have obvious differences (p is less than 0.05 and p is less than 0.01) in the SOD activity improving effect, and have obvious differences (p is less than 0.05) in the MDA content release inhibiting effect of the middle-high dose group and the high-medium dose group, which shows that the traditional Chinese medicine composition has obvious advantages in improving the anti-oxidation effect and inhibiting the lipid peroxidation reaction of the traditional Chinese medicine composition, and the results are shown in Table.
TABLE 5 Effect on rat serum SOD, MDA: (
n＝10)
Comparison with blank control group△△p<0.01，△△△p<0.001; comparison with model control group<0.05，**p<0.01，***p<0.001; comparison with comparative example 1★p<0.05，★★p<0.01; comparison with comparative example 2#p<0.05，##p<0.01。
Example 6
The tablets prepared from the Chinese medicinal compositions provided in examples 1 to 3 and the tablets prepared in comparative example 1 and comparative example 2 were tested for hardness, disintegration time, friability, active ingredient, etc., and the test results are shown in tables 6 to 8:
TABLE 6 test results of production indices
Note: in comparison with comparative example 1,*shows significant difference (P <0.05),**shows a very significant difference (P < 0.01);
in comparison with the comparative example 2,#show has a remarkable effectThe difference (P <0.05),##shows a very significant difference (P < 0.01).
Extracting volatile oil:
continuously extracting the compositions prepared in examples 1-3 and the compositions prepared in proportion 1 and comparative example 2 for 8 hours according to a method for extracting volatile oil from four parts of the national formulary 2015, dissolving the volatile oil with diethyl ether, and drying the volatile oil with anhydrous sodium sulfate to obtain the volatile oil. The extraction rate is shown in Table 7.
TABLE 7 Effect on volatile oil extraction
| Group of | Extraction ratio of volatile oil (%) |
| Example 1 provides a composition | 30*# |
| Example 2 compositions | 35**## |
| Example 3 compositions | 32*## |
| Comparative example 1 provides a composition | 23 |
| Comparative example 2 provides a composition | 20 |
Note: in comparison with comparative example 1,*shows significant difference (P <0.05),**shows a very significant difference (P < 0.01);
in comparison with the comparative example 2,#shows significant difference (P <0.05),##shows a very significant difference (P < 0.01).
Chromatographic conditions are as follows:
an elastic quartz capillary chromatography column (0.25 mm. times.30M, 0.25 μ M) of the Agilent model 19091M-436; the carrier gas is high-purity helium, the volume flow is 1mL/min, and the split ratio is 50.2: 1; the sample inlet temperature is 280 ℃; temperature programming: 60 deg.C (3min), 10 deg.C/min to 280 deg.C, and maintaining for 12 min. The sample volume is 1 mu L; solvent delay 1.5 min; the temperature of the gasification chamber is 280 ℃; the multiplier voltage 1952.9V.
Mass spectrum conditions:
electron Impact (EI) ion source, ionization voltage 70 eV; the ion source temperature is 230 ℃; the scanning range is 20-500 amu.
Under the above experimental conditions, the GC-MS analysis of the volatile oil components of the product obtained in example 1 revealed 10 peaks. Mass spectrum scanning is carried out on each peak in the total ion flow diagram to obtain a mass spectrogram, the mass spectrogram is automatically searched and checked by an NIST08.L spectrogram library, 10 volatile oil components are identified by combining related standard mass spectrum documents, the relative percentage content of each component of the volatile oil is measured by a peak area normalization method, the identified components account for 100 percent of the total amount of the whole oil, and the result is shown in a table 8.
TABLE 8 chemical composition and relative content of volatile oil identification
The above tests were carried out on the products obtained in examples 2 to 3, and the test results were not significantly different from those of the product obtained in example 1 (P > 0.05). The process provided by the invention adopts low-temperature high-pressure difference extraction, so that the effective components are extracted to the maximum degree, and the production efficiency is improved.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (2)
1. The extraction process of the medicine is characterized by comprising the following steps:
the raw material medicines comprise 500-600 parts by weight of hawthorn, 10-35 parts by weight of prepared fleece-flower root, 10-35 parts by weight of cassia seed and 50-100 parts by weight of lotus leaf;
step 1: pretreating raw materials, and mixing with water;
step 2: extracting at 20-30 Mpa for 30-60 min, and extracting at 40-50 Mpa for 30-60 min;
and step 3: carrying out solid-liquid separation on the extract obtained in the step 2, and collecting filtrate;
the temperature of the first extraction is 0-10 ℃;
the temperature of the second extraction is 0-10 ℃;
the solid-liquid separation in the step 3 is centrifugation or filtration; the rotating speed of the centrifugation is 8000-12000 rpm, and the time of the centrifugation is 10-30 min;
the method also comprises the steps of taking the filtrate and repeating the steps 2 and 3, wherein the repetition frequency is at least 1 time;
the steps of combining the filtrate and filtering are also included after the steps of the step 2 and the step 3 are repeated; the filtration is microfiltration;
the aperture of the membrane used for microfiltration is 0.45-1.0 μm;
the microfiltration specifically comprises the steps of filtering the combined filtrate through a microfiltration membrane, adding water to ensure that the amount of the permeate is not less than 2 times of the volume of the combined filtrate, and filtering until the content of solid in the concentrated solution is not less than 20% (w/w); washing the microfiltration membrane with water, collecting cleaning liquid and mixing the cleaning liquid with the concentrated solution;
the filtering time is not more than 6h, and the reduction amplitude of the filtered flow is not less than 50%;
the content of the solid in the filtration is 10-20% (w/w), and the relative density measured at 50-80 ℃ is 1.05-1.20.
2. The medicament prepared by the extraction process of claim 1.
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| "降脂宁颗粒质量标准的研究";刘超等;《中国实验方剂学杂志》;20021231;第8卷(第6期);第16-18页 * |
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Inventor after: Xu Jian Inventor after: Bai Bing Inventor after: Xu Yun Inventor after: Xu Yanru Inventor after: Zhang Xiantao Inventor after: Li Zhibao Inventor after: Su Yanxia Inventor after: He Fan Inventor after: Chen Defeng Inventor before: Xu Jian Inventor before: Bai Bing Inventor before: Xu Yun Inventor before: Xu Yanru Inventor before: Zhang Xiantao Inventor before: Li Zhibao Inventor before: Xu Yanxia Inventor before: He Fan Inventor before: Chen Defeng |
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Effective date of registration: 20220726 Address after: 130012 No. 1239, Shunda Road, high tech Development Zone, Changchun City, Jilin Province Patentee after: Xiuzheng Pharmaceutical Group Changchun High-new Pharmaceutical Co.,Ltd. Address before: 130012 4-6 / F, amendment building, 1369 Shunda Road, Changchun City, Jilin Province Patentee before: JILIN XIUZHENG PHARMACEUTICAL NEW MEDICINE DEVELOPMENT Co.,Ltd. |