CN110755395A - Preparation method of lipid-lowering tablet with good slow release effect - Google Patents

Preparation method of lipid-lowering tablet with good slow release effect Download PDF

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CN110755395A
CN110755395A CN201911186571.8A CN201911186571A CN110755395A CN 110755395 A CN110755395 A CN 110755395A CN 201911186571 A CN201911186571 A CN 201911186571A CN 110755395 A CN110755395 A CN 110755395A
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parts
solution
chinese medicine
traditional chinese
later use
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郭坤
张海涛
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Fuyang Hengma Food Co Ltd
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Fuyang Hengma Food Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • 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
    • A61K36/488—Pueraria (kudzu)
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537—Salvia (sage)
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2063—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • 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
    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/15—Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
    • 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
    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/19—Preparation or pretreatment of starting material involving fermentation using yeast, bacteria or both; enzymatic treatment
    • 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

Abstract

The invention discloses a preparation method of a lipid-lowering tablet with good slow-release effect, which comprises the following steps: (1) weighing the traditional Chinese medicine raw materials for later use, (2) cleaning, drying and crushing, (3) steam explosion, (4) enzymolysis, (5) preparation of traditional Chinese medicine extract powder, (6) preparation of auxiliary materials, and (7) preparation of finished tablets. The invention provides a preparation method of a special lipid-lowering tablet, which obviously improves the extraction rate of effective components in traditional Chinese medicine components, improves the utilization rate of raw materials, is suitable for large-batch industrial production, has obvious prevention and treatment effects on hyperlipidemia symptoms, has good drug effect, is easy to absorb, and has good slow-release effect.

Description

Preparation method of lipid-lowering tablet with good slow release effect
Technical Field
The invention belongs to the technical field of traditional Chinese medicine extraction and preparation, and particularly relates to a preparation method of a lipid-lowering tablet with a good slow-release effect.
Background
With the continuous acceleration of the life rhythm of people and the excessive accumulation of dietary nutrition, the number of patients with three-high symptoms is continuously increased, the trend of the patients to be younger is obvious, and the health of human beings is seriously harmed. Hyperlipidemia is one of three high symptoms, and refers to the condition of high blood lipid level, which can directly cause some diseases seriously harming human health, such as atherosclerosis, coronary heart disease, pancreatitis, etc. Since lipid metabolism or abnormal operation causes one or more lipids in plasma to be higher than normal, which is called hyperlipidemia, lipids insoluble or slightly soluble in water must be bound to proteins to exist in the form of lipoproteins, and thus, hyperlipidemia is often hyperlipoproteinemia, manifested by hypercholesterolemia, hypertriglyceridemia, and the like.
At present, the lipid-lowering chemical drugs commonly used in clinic have large side effects, and after long-term use, some drugs can cause the consequences of poor absorption of fat-soluble vitamins and the like due to large gastrointestinal reaction. In addition, the individual differences among the population are large, and the curative effect and the response to the medicine are also large. Therefore, with the continuous development of the combination of Chinese and Western medicine and the continuous deepening of the research on Chinese medicine, according to the theory of traditional Chinese medicine, the modern Chinese medicine research result is combined, the dialectical and disease-distinguishing are combined, and the proper compatibility and application of the Chinese medicine are selected, so that the novel natural Chinese medicine compound preparation which is favorable for long-term taking, has small side effect and can adjust the balance of the body functions of the human body has important significance for treating hyperlipoidemia, preventing cardiovascular and cerebrovascular diseases and senile lesion. The active ingredients of various Chinese herbal medicines have proved good prevention and treatment effects on hyperlipidemia, and because of the active ingredients of the Chinese herbal medicines, the Chinese herbal medicines have small side effect on human bodies and can be taken for a long time. The existing literature discloses a blood circulation and lipid lowering granule prescription which is derived from the standard of blood circulation and lipid lowering capsules on page 210 of the heart system book of the national Chinese patent medicine standard compilation, has the functions of lowering lipid, eliminating turbidity, promoting blood circulation and dredging collaterals, and is used for treating hyperlipidemia and preventing and treating atherosclerosis. The extraction method of the contents of the blood circulation promoting and lipid lowering capsule is disclosed as follows: 1) respectively pulverizing 83.2 parts of Notoginseng radix, 100 parts of rhizoma Ligustici Chuanxiong, 25 parts of fructus Zanthoxyli and 83.3 parts of folium Nelumbinis into powder, and separately steaming Notoginseng radix powder for 2 hr; 2) taking 1250 parts of pennisetum sinese roxb and 416.7 parts of lotus leaves, extracting with water, precipitating with ethanol, and concentrating to obtain thick paste; 3) and (3) mixing the raw material powder obtained in the step (1) with the thick paste. The method adopts traditional water extraction and alcohol precipitation method, has low extraction rate, and has no sterilization process and more residual microorganisms.
Sustained release preparation (sustained release preparation) is a preparation which delays the release, absorption, distribution, metabolism, excretion and other processes of a drug in vivo by a proper method so as to achieve the purposes of prolonging the drug action, reducing toxic and side effects and the like. It can avoid the 'peak valley' phenomenon caused by frequent administration of common preparations, and improve the safety, effectiveness and adaptability of the medicine. At present, due to the complexity of the components of the traditional Chinese medicine extract, the traditional Chinese medicine sustained-release preparation has the technical problems of difficult screening of auxiliary materials, poor forming process, unstable medicine release speed and the like in preparation. Although traditional Chinese medicine lipid-lowering medicaments exist in the market at present, the blood concentration of a patient is unstable due to the frequent administration, the pharmacological action of the patient cannot be effectively exerted, and the clinical requirement cannot be met.
Disclosure of Invention
The invention aims to provide a preparation method of a lipid-lowering tablet with good slow-release effect aiming at the existing problems.
The invention is realized by the following technical scheme:
a preparation method of a lipid-lowering tablet with good slow-release effect comprises the following steps:
(1) weighing the traditional Chinese medicine raw materials for later use:
weighing the following traditional Chinese medicine raw materials in parts by weight for later use: 20-25 parts of pseudo-ginseng, 5-8 parts of hawthorn, 3-6 parts of polygonum multiflorum, 2-5 parts of salvia miltiorrhiza and 4-7 parts of kudzu root;
(2) cleaning, drying and crushing:
cleaning the pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae weighed in the step (1) with clear water, drying the cleaned pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae, putting the pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae into a pulverizer together, pulverizing, and taking out to obtain mixed traditional Chinese medicine powder for later use;
(3) and (3) steam explosion treatment:
putting the mixed traditional Chinese medicine powder obtained in the step (2) into a closed tank, introducing steam with the temperature of 100-103 ℃ into the closed tank, increasing the pressure in the closed tank to 0.3-0.35 MPa, carrying out heat preservation and pressure maintaining treatment for 3-4 min, then unloading the closed tank to normal temperature and normal pressure within 20s, and finally taking out the mixed traditional Chinese medicine powder for later use;
(4) and (3) enzymolysis treatment:
a. soaking the mixed traditional Chinese medicine powder treated in the step (3) into the solution A, heating to keep the temperature of the solution A at 35-40 ℃, continuously stirring for 5-10 min, and filtering to obtain filter residue A for later use; the solution A consists of the following substances in parts by weight: 0.5-1 part of chitosan, 1-3 parts of chitosan quaternary ammonium salt and 90-100 parts of water;
b. soaking the filter residue A obtained in the operation a into the solution B, heating to keep the temperature of the solution B at 48-52 ℃, carrying out ultrasonic treatment for 30-35 min, and filtering to obtain filter residue B and filtrate B for later use; the solution B consists of the following substances in parts by weight: 1.8-2.2 parts of cellulase, 0.5-1 part of hemicellulase, 0.1-0.3 part of pectinase and 90-100 parts of water;
c. b, soaking the filter residue B obtained in the operation B into the solution C, heating to keep the temperature of the solution C at 39-43 ℃, carrying out ultrasonic treatment for 35-40 min, and filtering to obtain filter residue C and filtrate C for later use; the solution C comprises the following substances in parts by weight: 1-2 parts of protease, 0.1-0.2 part of tannase and 90-100 parts of water;
(5) preparing traditional Chinese medicine extraction powder:
mixing the filtrate B and the filtrate C obtained in the step (4) together, concentrating the mixture to an extract with the relative density of 1.15-1.25 at the temperature of 60 ℃, adding ethanol until the ethanol content is 75-80%, uniformly stirring, standing for 3-5 hours, taking the supernatant, recovering ethanol, drying and crushing to obtain traditional Chinese medicine extraction powder for later use;
(6) preparing auxiliary materials:
a. firstly, placing talcum powder into a calcining furnace for calcining for 1-2 hours, and then taking out for later use;
b. b, putting the talc powder calcined in the operation a into the solution D, heating to keep the temperature of the solution D at 70-75 ℃, continuously stirring at a high speed for 1-1.5 h, and filtering to obtain modified talc powder for later use; the solution D consists of the following substances in parts by weight: 7-10 parts of citric acid, 2-4 parts of sodium carbonate, 3-5 parts of zinc chloride and 90-100 parts of water; the specific surface area of the calcined talcum powder is obviously improved, when the calcined talcum powder is soaked in the solution D, citric acid is used as an acidic environment condition, and carbonate ions and zinc ions replace magnesium and calcium in the talcum powder, so that the absorption fixed quantity and stability of the talcum powder to effective components in the traditional Chinese medicine extraction powder are enhanced, and the controlled release effect is further improved;
c. weighing the following substances in parts by weight: 5-8 parts of carboxymethyl cellulose, 3-7 parts of xanthan gum, 9-13 parts of calcium bicarbonate, 20-25 parts of pregelatinized starch, 4-6 parts of prolamine, 4-7 parts of polyethylene glycol, 0.1-0.3 part of magnesium stearate and 2-4 parts of modified talcum powder obtained in the operation b;
d. c, mixing all the substances weighed in the operation c uniformly to obtain auxiliary materials for later use;
(7) preparing a finished tablet:
mixing the traditional Chinese medicine extract powder obtained in the step (5) with the auxiliary materials obtained in the step (6) according to a weight ratio of 1: 4-6, then using absolute ethyl alcohol as a wetting agent to prepare a soft material, and finally granulating, drying and tabletting to obtain the finished tablet.
Further, the particle size of the mixed traditional Chinese medicine powder in the step (2) is 80-100 meshes.
Further, the weight ratio of the mixed traditional Chinese medicine powder and the solution A in the operation a in the step (4) is 1: 3-4; the stirring speed of the stirring treatment is 1000-1200 r/min.
Further, the weight ratio of the filter residue A to the solution B in the operation B in the step (4) is 1: 5-6; the ultrasonic treatment frequency is 88-95 kHz.
Further, the weight ratio of the filter residue B to the solution C in the operation C in the step (4) is 1: 6-7; the ultrasonic treatment frequency is 100-110 kHz.
Further, the temperature in the calcining furnace is controlled to be 800-850 ℃ during the calcining treatment in the operation a of the step (6).
Further, the stirring speed of the high-speed stirring treatment in the operation b of the step (6) is 3000-3500 rpm.
The invention improves the traditional Chinese medicine components of the lipid-lowering tablet and the extraction preparation method, and specifically selects five components of pseudo-ginseng, hawthorn, fleece-flower root, salvia miltiorrhiza and kudzuvine root as traditional Chinese medicine extracts, wherein the pseudo-ginseng has the effects of stopping bleeding, removing blood stasis, relieving swelling, alleviating pain, reducing blood pressure and the like; the hawthorn has the effects of reducing blood fat and blood pressure, strengthening heart, resisting arrhythmia and the like, and is also a good medicine for strengthening spleen, stimulating appetite, promoting digestion, removing stagnation, promoting blood circulation and reducing phlegm; the polygonum multiflorum has the effects of soothing the nerves, nourishing blood, activating collaterals, detoxifying, eliminating carbuncles, reducing blood fat and blood pressure and the like; the radix Salviae Miltiorrhizae has effects of promoting blood circulation, dispelling blood stasis, dredging channels, relieving pain, clearing away heart-fire, relieving restlessness, cooling blood, and eliminating carbuncle; radix Puerariae has effects of relieving muscles and fever, promoting eruption, promoting fluid production to quench thirst, invigorating yang and relieving diarrhea, lowering blood pressure and reducing blood lipid; the combined use well ensures the effect of reducing blood fat. In order to improve the extraction content and the use value of the beneficial components of the traditional Chinese medicine, the preparation method is optimized, wherein the mixed traditional Chinese medicine powder is put into a closed tank for steam explosion treatment, the fiber structure of the particles of the mixed traditional Chinese medicine powder is loosened by high temperature and high pressure and temperature and pressure relief treatment, the integral permeability is improved, the foundation is laid for the subsequent extraction, then the enzymolysis treatment is carried out, the mixed traditional Chinese medicine powder is firstly put into the solution A for soaking, the content of tannic acid in the particles of the mixed traditional Chinese medicine powder is reduced and removed by utilizing chitosan and chitosan quaternary ammonium salt in the solution A, the activity inhibition strength of a large amount of tannic acid substances to cellulase and the like is reduced, the enzyme extraction effect of the subsequent solution B is enhanced, when the soaking extraction of the solution B is carried out, the cellulase and hemicellulase carry out enzymolysis to cell wall components, and the pectinase carries out enzymolysis to pectin components between cell walls, the leaching extraction of beneficial ingredients such as flavone and volatile oil in the mixed traditional Chinese medicine powder particles is promoted, then when the solution C is soaked and extracted, protease decomposes and removes proteins between cell walls and cells, the coating effect of partial proteins on certain beneficial ingredients is reduced, the leaching extraction of beneficial ingredients such as alkaloid and isoflavone is promoted, the tannase removes tannin ingredients, the bitter and astringent smell of traditional Chinese medicine substances is reduced, and the edible quality is improved; and finally, auxiliary materials are prepared, the modified talcum powder component is added to serve as a lubricating agent and a sustained-release reinforcing agent, the overall sustained-release effect of the tablet is improved, the added carboxymethylcellulose, xanthan gum, calcium bicarbonate, pregelatinized starch, prolamine, polyethylene glycol and magnesium stearate components ensure the absorption and protection of the beneficial components of the traditional Chinese medicine extract powder, the added prolamine component can be connected and combined with the xanthan gum and the pregelatinized starch through salt bonds and hydrophobic bonds to form stable colloid, the controlled release of the beneficial components of the traditional Chinese medicine extract powder is enhanced, and the sustained-release effect of the tablet is improved by cooperation with the modified talcum powder.
Compared with the prior art, the invention has the following advantages:
the invention provides a preparation method of a special lipid-lowering tablet, which obviously improves the extraction rate of effective components in traditional Chinese medicine components, improves the utilization rate of raw materials, is suitable for large-batch industrial production, has remarkable prevention and treatment effect on hyperlipidemia symptoms, has good drug effect, is easy to absorb, has good slow-release effect, and has great market competitiveness and popularization and use values.
Detailed Description
Example 1
A preparation method of a lipid-lowering tablet with good slow-release effect comprises the following steps:
(1) weighing the traditional Chinese medicine raw materials for later use:
weighing the following traditional Chinese medicine raw materials in parts by weight for later use: 20 parts of pseudo-ginseng, 5 parts of hawthorn, 3 parts of polygonum multiflorum, 2 parts of salvia miltiorrhiza and 4 parts of kudzu root;
(2) cleaning, drying and crushing:
cleaning the pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae weighed in the step (1) with clear water, drying the cleaned pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae, putting the pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae into a pulverizer together, pulverizing, and taking out to obtain mixed traditional Chinese medicine powder for later use;
(3) and (3) steam explosion treatment:
putting the mixed traditional Chinese medicine powder obtained in the step (2) into a closed tank, introducing water vapor with the temperature of 100 ℃ into the closed tank, increasing the pressure in the closed tank to 0.3MPa, carrying out heat preservation and pressure maintaining treatment for 3min, then unloading the closed tank to normal temperature and normal pressure within 20s, and finally taking out the mixed traditional Chinese medicine powder for later use;
(4) and (3) enzymolysis treatment:
a. soaking the mixed traditional Chinese medicine powder treated in the step (3) into the solution A, heating to keep the temperature of the solution A at 35 ℃, continuously stirring for 5min, and filtering to obtain filter residue A for later use; the solution A consists of the following substances in parts by weight: 0.5 part of chitosan, 1 part of chitosan quaternary ammonium salt and 90 parts of water;
b. soaking the filter residue A obtained in the operation a into the solution B, heating to keep the temperature of the solution B at 48 ℃, carrying out ultrasonic treatment for 30min, and filtering to obtain filter residue B and filtrate B for later use; the solution B consists of the following substances in parts by weight: 1.8 parts of cellulase, 0.5 part of hemicellulase, 0.1 part of pectinase and 90 parts of water;
c. b, soaking the filter residue B obtained in the operation B into the solution C, heating to keep the temperature of the solution C at 39 ℃, carrying out ultrasonic treatment for 35min, and filtering to obtain filter residue C and filtrate C for later use; the solution C comprises the following substances in parts by weight: 1 part of protease, 0.1 part of tannase and 90 parts of water;
(5) preparing traditional Chinese medicine extraction powder:
mixing the filtrate B and the filtrate C obtained in the step (4) together, concentrating to obtain an extract with a relative density of 1.15 at 60 ℃, adding ethanol until the ethanol content is 75%, stirring uniformly, standing for 3h, taking the supernatant to recover ethanol, drying and crushing to obtain traditional Chinese medicine extraction powder for later use;
(6) preparing auxiliary materials:
a. firstly, putting talcum powder into a calcining furnace for calcining for 1h, and then taking out the talcum powder for later use;
b. b, putting the talc powder calcined in the operation a into the solution D, heating to keep the temperature of the solution D at 70 ℃, continuously stirring at a high speed for 1 hour, and filtering to obtain modified talc powder for later use; the solution D consists of the following substances in parts by weight: 7 parts of citric acid, 2 parts of sodium carbonate, 3 parts of zinc chloride and 90 parts of water;
c. weighing the following substances in parts by weight: 5 parts of carboxymethyl cellulose, 3 parts of xanthan gum, 9 parts of calcium bicarbonate, 20 parts of pregelatinized starch, 4 parts of prolamine, 4 parts of polyethylene glycol, 0.1 part of magnesium stearate and 2 parts of modified talcum powder obtained in the operation b;
d. c, mixing all the substances weighed in the operation c uniformly to obtain auxiliary materials for later use;
(7) preparing a finished tablet:
mixing the traditional Chinese medicine extract powder obtained in the step (5) and the auxiliary materials obtained in the step (6) according to the weight ratio of 1:4, then using absolute ethyl alcohol as a wetting agent to prepare a soft material, and finally granulating, drying and tabletting to obtain the finished tablet.
Further, the particle size of the mixed traditional Chinese medicine powder in the step (2) is 80-100 meshes.
Further, the weight ratio of the mixed traditional Chinese medicine powder and the solution A in the operation a in the step (4) is 1: 3; the stirring speed of the stirring treatment is 1000 revolutions per minute.
Further, the weight ratio of the filter residue A to the solution B in the operation B in the step (4) is 1: 5; the ultrasonic treatment frequency is 88 kHz.
Further, the weight ratio of the filter residue B to the solution C in the operation C in the step (4) is 1: 6; the ultrasonic treatment frequency is 100 kHz.
Further, the calcination treatment in operation a of step (6) is carried out while controlling the temperature in the calciner to 800 ℃.
Further, the stirring speed of the high-speed stirring treatment in the operation b of the step (6) is 3000 rpm.
Example 2
A preparation method of a lipid-lowering tablet with good slow-release effect comprises the following steps:
(1) weighing the traditional Chinese medicine raw materials for later use:
weighing the following traditional Chinese medicine raw materials in parts by weight for later use: 23 parts of pseudo-ginseng, 7 parts of hawthorn, 5 parts of polygonum multiflorum, 4 parts of salvia miltiorrhiza and 6 parts of kudzu root;
(2) cleaning, drying and crushing:
cleaning the pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae weighed in the step (1) with clear water, drying the cleaned pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae, putting the pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae into a pulverizer together, pulverizing, and taking out to obtain mixed traditional Chinese medicine powder for later use;
(3) and (3) steam explosion treatment:
putting the mixed traditional Chinese medicine powder obtained in the step (2) into a closed tank, introducing water vapor with the temperature of 102 ℃ into the closed tank, increasing the pressure in the closed tank to 0.32MPa, carrying out heat preservation and pressure maintaining treatment for 3.5min, then unloading the closed tank to normal temperature and normal pressure within 15s, and finally taking out the mixed traditional Chinese medicine powder for later use;
(4) and (3) enzymolysis treatment:
a. soaking the mixed traditional Chinese medicine powder treated in the step (3) into the solution A, heating to keep the temperature of the solution A at 38 ℃, continuously stirring for 7min, and filtering to obtain filter residue A for later use; the solution A consists of the following substances in parts by weight: 0.8 part of chitosan, 2 parts of chitosan quaternary ammonium salt and 95 parts of water;
b. soaking the filter residue A obtained in the operation a into the solution B, heating to keep the temperature of the solution B at 50 ℃, carrying out ultrasonic treatment for 33min, and filtering to obtain filter residue B and filtrate B for later use; the solution B consists of the following substances in parts by weight: 2 parts of cellulase, 0.8 part of hemicellulase, 0.2 part of pectinase and 95 parts of water;
c. b, soaking the filter residue B obtained in the operation B into the solution C, heating to keep the temperature of the solution C at 42 ℃, carrying out ultrasonic treatment for 37min, and then filtering to obtain filter residue C and filtrate C for later use; the solution C comprises the following substances in parts by weight: 1.5 parts of protease, 0.15 part of tannase and 95 parts of water;
(5) preparing traditional Chinese medicine extraction powder:
mixing the filtrate B and the filtrate C obtained in the step (4) together, concentrating to obtain an extract with a relative density of 1.20 at 60 ℃, adding ethanol until the ethanol content is 78%, stirring uniformly, standing for 4h, taking the supernatant to recover ethanol, drying and crushing to obtain traditional Chinese medicine extraction powder for later use;
(6) preparing auxiliary materials:
a. firstly, putting talcum powder into a calcining furnace for calcining for 1.5h, and then taking out the talcum powder for later use;
b. b, putting the talc powder calcined in the operation a into the solution D, heating to keep the temperature of the solution D at 73 ℃, continuously stirring at a high speed for 1.2h, and filtering to obtain modified talc powder for later use; the solution D consists of the following substances in parts by weight: 8 parts of citric acid, 3 parts of sodium carbonate, 4 parts of zinc chloride and 95 parts of water;
c. weighing the following substances in parts by weight: 7 parts of carboxymethyl cellulose, 6 parts of xanthan gum, 12 parts of calcium bicarbonate, 23 parts of pregelatinized starch, 5 parts of prolamine, 6 parts of polyethylene glycol, 0.2 part of magnesium stearate and 3 parts of modified talcum powder obtained in the operation b;
d. c, mixing all the substances weighed in the operation c uniformly to obtain auxiliary materials for later use;
(7) preparing a finished tablet:
mixing the traditional Chinese medicine extract powder obtained in the step (5) and the auxiliary materials obtained in the step (6) according to the weight ratio of 1:5, then using absolute ethyl alcohol as a wetting agent to prepare a soft material, and finally granulating, drying and tabletting to obtain the finished tablet.
Further, the particle size of the mixed traditional Chinese medicine powder in the step (2) is 80-100 meshes.
Further, the weight ratio of the mixed traditional Chinese medicine powder and the solution A in the operation a in the step (4) is 1: 3.5; the stirring speed of the stirring treatment is 1100 r/min.
Further, the weight ratio of the filter residue A to the solution B in the operation B in the step (4) is 1: 5.5; the ultrasonic treatment frequency is 92 kHz.
Further, the weight ratio of the filter residue B to the solution C in the operation C in the step (4) is 1: 6.6; the ultrasonic treatment frequency is 106 kHz.
Further, the calcination treatment in operation a of step (6) is carried out while controlling the temperature in the calciner to be 830 ℃.
Further, the stirring speed of the high-speed stirring treatment in the operation b of the step (6) is 3300 rpm.
Example 3
A preparation method of a lipid-lowering tablet with good slow-release effect comprises the following steps:
(1) weighing the traditional Chinese medicine raw materials for later use:
weighing the following traditional Chinese medicine raw materials in parts by weight for later use: 25 parts of pseudo-ginseng, 8 parts of hawthorn, 6 parts of polygonum multiflorum, 5 parts of salvia miltiorrhiza and 7 parts of kudzu root;
(2) cleaning, drying and crushing:
cleaning the pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae weighed in the step (1) with clear water, drying the cleaned pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae, putting the pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae into a pulverizer together, pulverizing, and taking out to obtain mixed traditional Chinese medicine powder for later use;
(3) and (3) steam explosion treatment:
putting the mixed traditional Chinese medicine powder obtained in the step (2) into a closed tank, introducing water vapor with the temperature of 103 ℃ into the closed tank, increasing the pressure in the closed tank to 0.35MPa, carrying out heat preservation and pressure maintaining treatment for 4min, then unloading the closed tank to normal temperature and normal pressure within 20s, and finally taking out the mixed traditional Chinese medicine powder for later use;
(4) and (3) enzymolysis treatment:
a. soaking the mixed traditional Chinese medicine powder treated in the step (3) into the solution A, heating to keep the temperature of the solution A at 40 ℃, continuously stirring for 10min, and filtering to obtain filter residue A for later use; the solution A consists of the following substances in parts by weight: 1 part of chitosan, 3 parts of chitosan quaternary ammonium salt and 100 parts of water;
b. soaking the filter residue A obtained in the operation a into the solution B, heating to keep the temperature of the solution B at 52 ℃, carrying out ultrasonic treatment for 35min, and filtering to obtain filter residue B and filtrate B for later use; the solution B consists of the following substances in parts by weight: 2.2 parts of cellulase, 1 part of hemicellulase, 0.3 part of pectinase and 100 parts of water;
c. b, soaking the filter residue B obtained in the operation B into the solution C, heating to keep the temperature of the solution C at 43 ℃, carrying out ultrasonic treatment for 40min, and filtering to obtain filter residue C and filtrate C for later use; the solution C comprises the following substances in parts by weight: 2 parts of protease, 0.2 part of tannase and 100 parts of water;
(5) preparing traditional Chinese medicine extraction powder:
mixing the filtrate B and the filtrate C obtained in the step (4) together, concentrating to obtain an extract with a relative density of 1.25 at 60 ℃, adding ethanol until the ethanol content is 80%, stirring uniformly, standing for 5h, taking the supernatant to recover ethanol, drying and crushing to obtain traditional Chinese medicine extraction powder for later use;
(6) preparing auxiliary materials:
a. firstly, putting talcum powder into a calcining furnace for calcining treatment for 2 hours, and then taking out the talcum powder for later use;
b. b, putting the talc powder calcined in the operation a into the solution D, heating to keep the temperature of the solution D at 75 ℃, continuously stirring at a high speed for 1.5h, and filtering to obtain modified talc powder for later use; the solution D consists of the following substances in parts by weight: 10 parts of citric acid, 4 parts of sodium carbonate, 5 parts of zinc chloride and 100 parts of water;
c. weighing the following substances in parts by weight: 8 parts of carboxymethyl cellulose, 7 parts of xanthan gum, 13 parts of calcium bicarbonate, 25 parts of pregelatinized starch, 6 parts of prolamine, 7 parts of polyethylene glycol, 0.3 part of magnesium stearate and 4 parts of modified talcum powder obtained in the operation b;
d. c, mixing all the substances weighed in the operation c uniformly to obtain auxiliary materials for later use;
(7) preparing a finished tablet:
mixing the traditional Chinese medicine extract powder obtained in the step (5) and the auxiliary materials obtained in the step (6) according to the weight ratio of 1:6, then using absolute ethyl alcohol as a wetting agent to prepare a soft material, and finally granulating, drying and tabletting to obtain the finished tablet.
Further, the particle size of the mixed traditional Chinese medicine powder in the step (2) is 80-100 meshes.
Further, the weight ratio of the mixed traditional Chinese medicine powder and the solution A in the operation a in the step (4) is 1: 4; the stirring speed of the stirring treatment is 1200 r/min.
Further, the weight ratio of the filter residue A to the solution B in the operation B in the step (4) is 1: 6; the ultrasonic treatment frequency was 95 kHz.
Further, the weight ratio of the filter residue B to the solution C in the operation C in the step (4) is 1: 7; the ultrasonic treatment frequency is 110 kHz.
Further, the calcination treatment in operation a of step (6) is carried out while controlling the temperature in the calciner to be 850 ℃.
Further, the stirring speed of the high-speed stirring treatment in the operation b of the step (6) is 3500 rpm.
Comparative example 1
In comparison with example 2, comparative example 1 omits the treatment of operation a in the enzymatic treatment in step (4), except that the other steps of the method are the same.
Comparative example 2
In this comparative example 2, the treatment of operation c in the enzymatic treatment in the step (4) was omitted as compared with example 2, except that the steps of the other methods were the same.
Comparative example 3
In comparative example 3, compared with example 2, in the operation c of preparing the supplementary material in the step (6), the modified talc powder component obtained in the operation b is replaced by the commercially available talc powder in the same mass part, and the prolamine component is omitted, except that the steps of the method are the same.
Control group
The types and the proportions of the traditional Chinese medicine raw materials are completely the same as the comparison document 2, the extraction method of the traditional Chinese medicine is carried out by adopting a water extraction and alcohol precipitation method corresponding to the standard of the heart system of the national Chinese patent medicine standard compilation medical department, page 210, blood circulation promoting and lipid lowering capsules, and the components of the auxiliary materials are also completely the same as the comparison document 2.
In order to compare the sustained release effect of the sustained release tablet, the tablets prepared in the above example 2 and the comparative example 3 are selected as experimental objects, and an in vitro release degree research test and a rat in vivo release degree research test are respectively carried out, wherein the release medium of the in vitro release degree research test is a release medium simulating the human gastrointestinal tract environment (0.1 mol/L hydrochloric acid before 2h and PBS buffer solution with pH of 6.8 after 2 h), the release degrees of the tablets prepared in each group are respectively examined, and specific comparative data are shown in the following table 1; the rat in-vivo release rate research test is that SD rats are taken, after fasting is carried out for 12 hours, gastric lavage is carried out for administration (100 mg/kg calculated by traditional Chinese medicine extracts), blood is taken from eyeballs for 1 hour, 6 hours, 12 hours and 24 hours respectively, the blood concentration at each time point is determined by HPLC-MS, and specific comparative data are shown in the following table 2.
TABLE 1
Figure DEST_PATH_IMAGE001
As can be seen from Table 1 above, the lipid-lowering tablets of the present invention have a good degree of control of in vitro release.
TABLE 2
Figure 557919DEST_PATH_IMAGE002
As can be seen from Table 2 above, the lipid-lowering tablets of the present invention have a good control of release in rats.
In order to further compare the lipid-lowering using effect of the lipid-lowering tablet of the invention, a drug feeding experiment is carried out, specifically:
(1) establishing an animal model: the formula of the high-fat feed comprises: 78.8% of basal feed, 1% of cholesterol, 10% of egg yolk powder, 10% of lard oil and 0.2% of bile salt. 50 male rats of 3-month-old SD rats are taken, after being fed with high-fat feed for 18 days, tail vein blood is taken, the contents of Triglyceride (TG), cholesterol (TC) and high-density lipoprotein cholesterol (HDL-c) in serum are respectively measured, after a hyperlipemia model is determined to be formed, the hyperlipemia model is randomly divided into 5 groups, 10 rats in each group have no significant difference in TG, TC and HDL-c levels.
(2) Administration treatment: the tablets prepared according to example 2, comparative example 1, comparative example 2, comparative example 3 and control group were administered to 5 groups of rats established in step (1) by gavage with 200mg daily and weighed weekly for 42 days. After the experiment is finished and fasting is carried out for 16h, tail vein blood is taken, and TC, TG and HDL-c levels in serum are respectively measured.
The specific experimental comparison data are shown in table 3 below:
TABLE 3
Figure DEST_PATH_IMAGE003
Note: the average TC content of rats measured before administration was 3.01. + -. 0.18 mmol/L, TG content of 1.78. + -. 0.16 mmol/L, HDL-c content of 0.52. + -. 0.13 mmol/L.
As can be seen from the above table 3, the lipid-lowering tablet prepared by the method of the invention has an obvious improvement effect on hyperlipidemia symptoms, and has great popularization and use values.

Claims (7)

1. A preparation method of a lipid-lowering tablet with good slow release effect is characterized by comprising the following steps:
(1) weighing the traditional Chinese medicine raw materials for later use:
weighing the following traditional Chinese medicine raw materials in parts by weight for later use: 20-25 parts of pseudo-ginseng, 5-8 parts of hawthorn, 3-6 parts of polygonum multiflorum, 2-5 parts of salvia miltiorrhiza and 4-7 parts of kudzu root;
(2) cleaning, drying and crushing:
cleaning the pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae weighed in the step (1) with clear water, drying the cleaned pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae, putting the pseudo-ginseng, the hawthorn, the polygonum multiflorum, the salvia miltiorrhiza and the radix puerariae into a pulverizer together, pulverizing, and taking out to obtain mixed traditional Chinese medicine powder for later use;
(3) and (3) steam explosion treatment:
putting the mixed traditional Chinese medicine powder obtained in the step (2) into a closed tank, introducing steam with the temperature of 100-103 ℃ into the closed tank, increasing the pressure in the closed tank to 0.3-0.35 MPa, carrying out heat preservation and pressure maintaining treatment for 3-4 min, then unloading the closed tank to normal temperature and normal pressure within 20s, and finally taking out the mixed traditional Chinese medicine powder for later use;
(4) and (3) enzymolysis treatment:
a. soaking the mixed traditional Chinese medicine powder treated in the step (3) into the solution A, heating to keep the temperature of the solution A at 35-40 ℃, continuously stirring for 5-10 min, and filtering to obtain filter residue A for later use; the solution A consists of the following substances in parts by weight: 0.5-1 part of chitosan, 1-3 parts of chitosan quaternary ammonium salt and 90-100 parts of water;
b. soaking the filter residue A obtained in the operation a into the solution B, heating to keep the temperature of the solution B at 48-52 ℃, carrying out ultrasonic treatment for 30-35 min, and filtering to obtain filter residue B and filtrate B for later use; the solution B consists of the following substances in parts by weight: 1.8-2.2 parts of cellulase, 0.5-1 part of hemicellulase, 0.1-0.3 part of pectinase and 90-100 parts of water;
c. b, soaking the filter residue B obtained in the operation B into the solution C, heating to keep the temperature of the solution C at 39-43 ℃, carrying out ultrasonic treatment for 35-40 min, and filtering to obtain filter residue C and filtrate C for later use; the solution C comprises the following substances in parts by weight: 1-2 parts of protease, 0.1-0.2 part of tannase and 90-100 parts of water;
(5) preparing traditional Chinese medicine extraction powder:
mixing the filtrate B and the filtrate C obtained in the step (4) together, concentrating the mixture to an extract with the relative density of 1.15-1.25 at the temperature of 60 ℃, adding ethanol until the ethanol content is 75-80%, uniformly stirring, standing for 3-5 hours, taking the supernatant, recovering ethanol, drying and crushing to obtain traditional Chinese medicine extraction powder for later use;
(6) preparing auxiliary materials:
a. firstly, placing talcum powder into a calcining furnace for calcining for 1-2 hours, and then taking out for later use;
b. b, putting the talc powder calcined in the operation a into the solution D, heating to keep the temperature of the solution D at 70-75 ℃, continuously stirring at a high speed for 1-1.5 h, and filtering to obtain modified talc powder for later use; the solution D consists of the following substances in parts by weight: 7-10 parts of citric acid, 2-4 parts of sodium carbonate, 3-5 parts of zinc chloride and 90-100 parts of water;
c. weighing the following substances in parts by weight: 5-8 parts of carboxymethyl cellulose, 3-7 parts of xanthan gum, 9-13 parts of calcium bicarbonate, 20-25 parts of pregelatinized starch, 4-6 parts of prolamine, 4-7 parts of polyethylene glycol, 0.1-0.3 part of magnesium stearate and 2-4 parts of modified talcum powder obtained in the operation b;
d. c, mixing all the substances weighed in the operation c uniformly to obtain auxiliary materials for later use;
(7) preparing a finished tablet:
mixing the traditional Chinese medicine extract powder obtained in the step (5) with the auxiliary materials obtained in the step (6) according to a weight ratio of 1: 4-6, then using absolute ethyl alcohol as a wetting agent to prepare a soft material, and finally granulating, drying and tabletting to obtain the finished tablet.
2. The method for preparing a lipid-lowering tablet with good slow release effect according to claim 1, wherein the particle size of the mixed traditional Chinese medicine powder in the step (2) is 80-100 meshes.
3. The preparation method of a lipid-lowering tablet with good slow release effect according to claim 1, wherein the weight ratio of the mixed traditional Chinese medicine powder and the solution A in the operation a in the step (4) is 1: 3-4; the stirring speed of the stirring treatment is 1000-1200 r/min.
4. The preparation method of the lipid-lowering tablet with good slow release effect according to claim 1, wherein the weight ratio of the filter residue A to the solution B in the operation B in the step (4) is 1: 5-6; the ultrasonic treatment frequency is 88-95 kHz.
5. The preparation method of the lipid-lowering tablet with good slow release effect according to claim 1, wherein the weight ratio of the filter residue B to the solution C in the operation C in the step (4) is 1: 6-7; the ultrasonic treatment frequency is 100-110 kHz.
6. The method for preparing a tablet of good sustained-release lipid-lowering effect according to claim 1, wherein the temperature in the calcination furnace is controlled to be 800 to 850 ℃ during the calcination treatment in operation a of step (6).
7. The method for preparing a lipid-lowering tablet with good slow-release effect according to claim 1, wherein the stirring speed of the high-speed stirring treatment in the operation b of the step (6) is 3000-3500 rpm.
CN201911186571.8A 2019-11-28 2019-11-28 Preparation method of lipid-lowering tablet with good slow release effect Pending CN110755395A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117049927A (en) * 2023-10-13 2023-11-14 中农金瑞肥业有限公司 Biological enzyme added sustained and controlled release fertilizer and preparation method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117049927A (en) * 2023-10-13 2023-11-14 中农金瑞肥业有限公司 Biological enzyme added sustained and controlled release fertilizer and preparation method thereof
CN117049927B (en) * 2023-10-13 2023-12-22 中农金瑞肥业有限公司 Biological enzyme added sustained and controlled release fertilizer and preparation method thereof

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