CN101019841A - Prepn process and application in medicine for treating liver fibrosis of curcumin - Google Patents
Prepn process and application in medicine for treating liver fibrosis of curcumin Download PDFInfo
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- CN101019841A CN101019841A CN 200710020242 CN200710020242A CN101019841A CN 101019841 A CN101019841 A CN 101019841A CN 200710020242 CN200710020242 CN 200710020242 CN 200710020242 A CN200710020242 A CN 200710020242A CN 101019841 A CN101019841 A CN 101019841A
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Abstract
The present invention relates to preparation process and application in medicine for treating liver fibrosis of curcumin. The medicine treating liver fibrosis has curcumin as main effective component and pharmaceutically acceptable carrier, such as excipient, additive and flavoring agent, and may be prepared into different forms, including medicine powder, tablet, micro pill, etc. Curcumin has obvious effect of treating liver fibrosis, no obvious toxic side effect and rich resource.
Description
Technical field
The present invention relates to the application of a kind of curcumin in medicine, specifically is curcumin and preparation thereof the purposes in anti-hepatic fibrosis medicines.
Background technology
Hepatic fibrosis is the common pathological characters of most of chronic hepatopathys, also is the important intermediate link that chronic hepatitis liver cirrhosis etc. further develops, worsens.Mainly be under various impairment factor effects, hepatic stellate cell activator, propagation, the synthetic a large amount of extracellular matrix of justacrine, degraded reduces deposition and increases, and forms hepatic fibrosis.The cause of disease that causes hepatic fibrosis is a lot, and abroad, especially American-European countries occupies the majority (about 50%～80%) with alcoholism, and causing the main cause of hepatic fibrosis in China is to infect hepatitis virus.In HBV the infected, there is 10%～15% patient can develop into chronic HBV infection, wherein 25%～40% case finally develops into liver cirrhosis and even hepatocarcinoma.The easier chronicity that causes of infection with hepatitis C virus person, about 75%～80% acute hepatitis C patient transfers chronic infection to, and chronic HCV infection person 20%～25% develops into hepatic fibrosis, liver cirrhosis.
Existing result of study shows, in the hepatic fibrosis forming process, and various types of hepatic injury, all can activate fat-storing cells of liver, and propagation and change into myofibroblast, and then synthetic a large amount of extracellular matrix, and the degraded relative deficiency, the heavy matter of too much substrate is in liver and form hepatic fibrosis.Recent study confirmed hepatic fibrosis before not entering liver cirrhosis, and the reverse possibility is still arranged, and this brings new hope for effective treatment of hepatic fibrosis, but clinical still shortage is efficient, the medicine of no obvious toxic-side effects.
The focus of current anti-hepatic fibrosis medicines research mainly contains two aspects: (1) is based on modern medical theory, seek anti-hepatic fibrosis medicines at the cause of disease and pathogenetic a certain link, comprise calcium channel blocker verapamil, antiviral drugs gamma interferon, colchicine, vitamin A etc., these anti-hepatic fibrosis medicines great majority are in the experimentation stage, be used for seldom clinical, and curative effect is limited, and prolonged application all has obvious toxic and side effects, thereby very undesirable; (2) characteristics of domestic anti-hepatic fibrosis medicines research are based on motherland's theory of medicine, with methods such as activating blood circulation to dissipate blood stasis, harmonizing the liver and spleens, as FUFANG DANSHEN DIWAN, strong liver softening the hard mass soup etc.The Chinese medicine anti-hepatic fibrosis demonstrates certain potential value and advantage undoubtedly, but because the complexity of the crude drug place of production and composition, so curative effect is owed really, poor reproducibility.
Summary of the invention
The objective of the invention is to develop a kind of anti-hepatic fibrosis medicines of efficient, no obvious toxic-side effects.
For achieving the above object, the invention discloses the application of curcumin in anti-hepatic fibrosis medicines, it is characterized in that: the effective constituent that mainly contains of described anti-hepatic fibrosis medicines is a curcumin, and its structural formula is as follows:
The curcumin anti-hepatic fibrosis medicines can also contain pharmaceutically acceptable carrier, makes various dosage forms as excipient and additive, flavouring agent, comprises powder, tablet, micropill, capsule, microcapsule, granule, liquid preparation.
Advantage of the present invention is: curcumin has stronger effect of anti hepatic fibrosis, and does not have obvious toxic-side effects, has the effect of the hepatic fibrosis symptom that good prevention and treatment cause by various factors.Preparation of the present invention particularly adopts the preparation of slow release formulation, easily makes the preparation of taking every day once, has untoward reaction still less.And Rhizoma Curcumae Longae is abundant in china natural resources, and the extraction of curcumin is simple.
Essence for a better understanding of the present invention will illustrate its application in the preparation anti-hepatic fibrosis medicines with pharmacological testing and the results of pharmacodynamic test that curcumin carries out below.
Description of drawings:
Fig. 1 induces rat liver fibrosis model group picture for adopting DMN;
Fig. 2 is the matched group picture of cutting into slices with curcumin 200mg/kg treatment back lobules of liver.
The specific embodiment
When curcumin is used in anti-hepatic fibrosis medicines, be the effective constituent that mainly contains of pharmaceutical composition with the curcumin, as follows during its structure:
Dosage can be selected suitable dose according to patient's age clinically, body weight and the state of an illness, and oral administration dosage can be: adult 200-2000mg/ days, generally mostly be 300-500mg/ days, and preferred dose is 400mg/ days.
The curcumin anti-hepatic fibrosis medicines can also contain pharmaceutically acceptable carrier, makes various dosage forms as excipient and additive, flavouring agent.Preparation of the present invention can be any dosage form of taking, and these dosage forms comprise: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, syrup, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch, slow releasing preparation, controlled release preparation.Oral formulations preferably, these oral formulations can be tablet, capsule, oral liquid, granule, suspensoid, powder, sustained-release pellet preparation, pill.
Preparation of the present invention, the tablet of its oral administration and capsule are generally a kind of unit dose, and contain excipient commonly used, such as binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can carry out coating to tablet.
The filler that is suitable for comprises cellulose, mannitol, lactose and other similar filler.Suitable disintegrating agent comprises starch, polyvinylpyrrolidone and starch derivatives, for example sodium starch glycollate.Suitable lubricant comprises, for example magnesium stearate.The acceptable wetting agent of appropriate drug comprises sodium lauryl sulphate.
Can fill by mixing, the method that tabletting etc. are commonly used prepares solid oral composition.Mix repeatedly active component is distributed in those compositionss of a large amount of filleies of whole use.
The form of oral liquid for example can be aqueous or oily suspensions, solution, Emulsion, syrup or elixir, perhaps can be a kind of available water before use or other suitable composite dry products of carrier.This liquid preparation can contain conventional additive, such as suspending agent, for example sorbitol, syrup, methylcellulose, gelatin, hydroxyethyl-cellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenation edible fat, emulsifying agent, for example lecithin, anhydro sorbitol monooleate or arabic gum; Non-aqueous carrier (they can comprise edible oil), for example almond oil, fractionated coconut oil, such as oily ester, propylene glycol or the ethanol of the ester of glycerol; Antiseptic, for example para hydroxybenzene methyl ester or propyl p-hydroxybenzoate or sorbic acid, and if desired, can contain conventional flavouring agent or coloring agent.
For injection, the liquid unit dosage forms of preparation contains active component prescription of the present invention and sterile carrier.According to carrier and concentration, this chemical compound can be suspended or dissolving.The preparation of solution is normally by being dissolved in active component in a kind of carrier filter-sterilized before it is packed into a kind of suitable bottle or ampoule, sealing then.For example a kind of local anesthetic of adjuvant, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, can be after the bottle of packing into that this compositions is freezing, and under vacuum, water is removed.
Prepare the parenteral suspension with essentially identical mode,, and before it is suspended in sterile carrier, it is carried out disinfection with oxirane except being is suspended in carrier with reactive compound rather than with its dissolving.Surfactant or wetting agent can be included in this compositions, are beneficial to the uniform distribution of this reactive compound.
Preparation of the present invention, when being prepared into preparation, optionally add suitable medicine acceptable carrier (adjuvant), described medicine acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, the EDTA disodium, EDTA calcium sodium, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, pregelatinized Starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, the phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Pharmaceutical preparation of the present invention can be adopted following method preparation:
Tablet: the curcumin of recipe quantity and medical starch are mixed, the system soft material, the system wet granular, dry 4 hours of 80-100 degree, the cooling back added magnesium stearate, and pregelatinized Starch mixes, granulate, tabletting, the bag film-coat, packing promptly gets tablet.
Slow releasing tablet and slow releasing capsule, so slow releasing preparation can make by slow-release micro-pill, and slow-release micro-pill contains curcumin and makes required sub-chemical compound and the adjuvant of securing satisfactory grades of slow releasing preparation.This slow-release micro-pill can be made capsule, also can make tablet.So, the hepatic fibrosis patient can only obey once or twice every day.
The present invention is pellet preparations preferably, available following method preparation:
Curcumin is crossed the 4# sieve, mix by ratio and starch, (solvent is an ethanol: water=50: 50) be binding agent, rise female and amplification with 0.6% sodium carboxymethyl cellulose.
Rise female: inventory is 400g, and spouting velocity is transferred to 30r/min, is transferred to 20r/min, engine speed: 100～250r/min behind the 1min, air blast 21/min, jet decompression: 0.1Mpa.By the time after initial ball nuclear occurring, stop whitewashing and jet at once, main frame is lift-over 2min again, stops engine speed, takes out ball nuclear, and drying is sieved.The initial ball nuclear of 24～80 purposes is amplified.
Amplify: the particle diameter of preparation is brought amplification respectively at 24～40 orders and the initial ball nuclear of 40～80 purposes, binding agent is that (solvent is an ethanol to 0.6% sodium carboxymethyl cellulose: solution water=50: 50), it is slow that amplification speed is wanted, spouting velocity is about 15r/min, add speed about 25r/min for powder, because material is easy to form particle, so the speed that filler adds will be higher than spouting velocity, but will often observe micropill size, engine speed: 150r/min, air blast: 21/min, jet decompression: 0.1Mpa when the micropill size is similar, stops whitewashing, take out micropill, drying about main frame lift-over 1min.
Micropill coating: with the first weighing of exsiccant micropill (18～24 order); be put in the centrifugal coating pelletizing machine; the amount of pressing ratio weighing chlorphenamine then is (because the amount of binding agent seldom; so temporarily can ignore); engine speed 100r/min; whitewash rotating speed less than 5r/min, air blast about 20, about 37 ℃ of inlet temperature.Coating solution is common stomach dissolution type coating powder, and coating solution concentration 6%, coating process monitor constantly, prevent that whitewashing from too much, causing the micropill adhesion, when sticking together whitewashing are closed, and all the other are constant, wait until after a while and open whitewashing when micropill is dry again.Coating increases weight about 10%.Color even is sieved, with 18～24 order micropill dryings.Fill capsule after the detection level.
Below be pharmaceutical preparation embodiment of the present invention, but scope of the present invention is not limited to embodiment:
Embodiment 1: conventional tablet
Curcumin 400mg
The curcumin of 1000 times of recipe quantities and 500g medical starch are mixed, the system soft material, the system wet granular, dry 4 hours of 80-100 degree, the cooling back added the 50g magnesium stearate, and the 50g pregelatinized Starch mixes, granulate, tabletting, the bag film-coat, packing promptly gets 1000 tablets.
Embodiment 2: the conventional capsule agent
Curcumin 400mg
The curcumin of 1000 times of recipe quantities and 500g medical starch are mixed, the system soft material, the system wet granular, dry 4 hours of 80-100 degree, the cooling back added the 50g magnesium stearate, and the 50g pregelatinized Starch mixes, and granulate is encapsulated, and packing promptly gets 1000 capsules.
Embodiment 3: oral liquid
Curcumin 400mg
The curcumin and the 200g sucrose of 1000 times of recipe quantities are mixed, add cosolvent, antiseptic and water are to 10000ml, and mix homogeneously is filled in the 10ml glass ampoule, sterilization, packing.Obtain 1000 bottles of oral liquids.
Embodiment 4: micropill
Curcumin micropill prescription:
Curcumin 400g
Starch 320g-480g, with 400g for well,
Sodium carboxymethyl cellulose: an amount of
After making the micropill coating, 1000 of cover capsules.
Technology: earlier curcumin is crossed the 4# sieve, mixed by ratio and starch, (solvent is an ethanol: water=50: 50) be binding agent, rise female and amplification with 0.6% sodium carboxymethyl cellulose.
Rise female: inventory is 400g, and spouting velocity is transferred to 30r/min, is transferred to 20r/min, engine speed: 100～250r/min behind the 1min, air blast 21/min, jet decompression: 0.1Mpa.By the time after initial ball nuclear occurring, stop whitewashing and jet at once, main frame is lift-over 2min again, stops engine speed, takes out ball nuclear, and drying is sieved.The initial ball nuclear of 24～80 purposes is amplified.
Amplify: the particle diameter of preparation is brought amplification respectively at 24～40 orders and the initial ball nuclear of 40～80 purposes, binding agent is that (solvent is an ethanol to 0.6% sodium carboxymethyl cellulose: solution water=50: 50), it is slow that amplification speed is wanted, spouting velocity is about 15r/min, add speed about 25r/min for powder, because material is easy to form particle, so the speed that filler adds will be higher than spouting velocity, but will often observe micropill size, engine speed: 150r/min, air blast: 21/min, jet decompression: 0.1Mpa when the micropill size is similar, stops whitewashing, take out micropill, drying about main frame lift-over 1min.
Micropill coating: with the first weighing of exsiccant micropill (18～24 order); be put in the centrifugal coating pelletizing machine; the amount of pressing ratio weighing chlorphenamine then is (because the amount of binding agent seldom; so temporarily can ignore); engine speed 100r/min; whitewash rotating speed less than 5r/min, air blast about 20, about 37 ℃ of inlet temperature.Coating solution is common stomach dissolution type coating powder, and coating solution concentration 6%, coating process monitor constantly, prevent that whitewashing from too much, causing the micropill adhesion, when sticking together whitewashing are closed, and all the other are constant, wait until after a while and open whitewashing when micropill is dry again.Coating increases weight about 10%.Color even is sieved, with 18～24 order micropill dryings.Fill capsule after the detection level.
The curcumin long term toxicity test:
Divide curcumin high and low 2 dosage groups, successive administration 80 days continues after the drug withdrawal of part animal to observe for 2 weeks.Observe and the blood parameters detection through general situation, gross anatomy and pathological observation, the result shows that curcumin high dose group (500mg/kg/ days), low dose group (100mg/kg/ days) every index and normal control group are relatively, all do not have significant difference, pointed out curcumin to have safety preferably.
Curcumin is to CCl
4The therapeutical effect experiment of inductive toxic hepatic fibrosis:
Method: 60 of male SD rats are divided into 6 groups at random: normal control group, negative control group, high, normal, basic 3 dosage curcumin groups and positive drug control group, and remove the normal control group and do not inject CCl
4Outward, all the other respectively organize subcutaneous injection CCl
45ml/kg, back injection 20%CCl
43ml/kg, 2 times/week, totally 12 weeks.Modeling begins administration after 6 weeks, curcumin and positive control drug are carrier with 0.05% carboxymethyl cellulose acid sodium all, normal control group, negative control group are irritated stomach and are given carboxymethyl cellulose acid sodium 10ml/kg/ days, the curcumin group irritates that stomach gives 50,100 respectively, 200mg/kg/ days, and the positive control drug group is irritated stomach and given Malotilate 90mg/kg/ days.After 12 weeks of modeling, get hepatic tissue and do pathological observation, get determination of serum blood NSC 334200 transferring enzyme ALT, millet straw propylhomoserin transfer prunus mume (sieb.) sieb.et zucc. AST content (biological company limited test kit is built up in Nanjing).Experimental result is as follows:
Table 1 curcumin is to CCl
4The ALT of inductive hepatic fibrosis rats, the influence of AST
| Group | Number of animals | Dosage (mg/kg) | ALT (U/L) | AST (U/L) |
| Normal control group negative control group curcumin group | 10 9 8 8 8 | 50 100 200 | 58.5±20.1 811.4±130 629±111.4 * 549.0±132.1 * 235.1±40.5 * | 98.9±19.0 883.6±190.4 740.0±87.1 * 600.7±147.9 * 266.1±64.1 * |
| Positive controls | 9 | 90 | 149.8±45.4 * | 188.1±36.2 * |
* compare P＜0.05 with negative control group
Pathology detect and show the degeneration of negative control group hepatocyte lipid, mainly concentrate on the lobule periphery, and the formation of visible pseudolobuli.The degeneration of curcumin high dose group hepatocyte lipid, the lobules of liver form takes a turn for the better, and the fibrous septum of Xing Chenging obviously alleviates than negative control group on every side, and the visible small amounts of cells in portal area is soaked into.It is not remarkable that low dose group is compared change in the curcumin with negative control group.
The influence experiment that curcumin forms the inductive rat liver fibrosis of N-nitrosodimethylamine (DMN)
Method: hepatic fibrosis is that hepatic injury continues existence, organizes when taking place to repair reaction and synthesize, degrade and the uneven pathological process that causes of deposition because of extracellular matrix, being chronic hepatopathy important pathological feature, also is the main key link that further develops to liver cirrhosis.Selecting the hepatic fibrosis animal model similar to human chronic hepatopathy due to a variety of causes to be not only the pathogenetic important foundation of further investigation hepatic fibrosis, also is the effective means of clinical screening control hepatic fibrosis medicines.The present invention adopts under the abdomen injection N-nitrosodimethylamine 10mg/kg to cause rats'liver infringement and fibrosis model.Adopt N-nitrosodimethylamine to induce rat liver fibrosis, gavage curcumin (50 during this time, 100,200mg/kg) and establish Malotilate group (90mg/kg) and compare, after 4 weeks of administration, measure SOD, MDA in the serum paddy third ammonia transaminase (ALT), alkali phosphatase (AKP), total protein (TP) and albumin (ALB) content and the liver homogenate, GSH-Px content and detect hyaluronic acid (HA), laminin (LN) content with radio immunoassay; Om observation hepatocyte structure and degree of hepatic fibrosis.The result: curcumin prevention administration, obviously reduce hepatic fibrosis rats Serum ALT, AKP activity, SOD, GSH-Px obviously improve than model group in the administration group hepatic tissue, and MDA obviously reduces than model group; Also can obviously reduce serum HA and LN content after the administration.The pathological observation result, curcumin prevention group rat collagen fiber deposition obviously alleviates, and the pseudolobuli structure obviously reduces.
Conclusion: curcumin prevention administration, can suppress the inductive rat liver fibrosis of DMN and form.
Claims (4)
1, the application of curcumin in anti-hepatic fibrosis medicines is characterized in that: the effective constituent that mainly contains of described anti-hepatic fibrosis medicines is a curcumin, and its structural formula is as follows:
Curcumin
2, anti-hepatic fibrosis medicines according to claim 1, it is characterized in that: can also contain pharmaceutically acceptable carrier, make various dosage forms as excipient and additive, flavouring agent, comprise powder, tablet, micropill, capsule, microcapsule, granule, liquid preparation.
3, anti-hepatic fibrosis medicines method for preparing tablet thereof according to claim 2, it is characterized in that may further comprise the steps: the curcumin and the medical starch of recipe quantity are mixed system soft material, system wet granular, at the 80-100 degree dry 4 hours, the cooling back adds magnesium stearate, and pregelatinized Starch mixes, granulate, tabletting, the bag film-coat, packing promptly gets tablet.
4, anti-hepatic fibrosis medicines pellet preparations preparation method according to claim 2, it is characterized in that may further comprise the steps: curcumin is crossed the 4# sieve, by 1: 0.8-1: 1.2 ratios and starch mix, (solvent is an ethanol: water=50: 50) be binding agent with 0.6% sodium carboxymethyl cellulose, rise female and amplification, and then coating and fill capsule.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101502498B (en) * | 2009-03-04 | 2011-05-18 | 陕西科技大学 | Curcumin preparation for percutaneous administration and preparation method thereof |
| CN104548107A (en) * | 2010-12-08 | 2015-04-29 | 江南大学 | Controlled-release medicine auxiliary material for improving stability of main medicine |
| CN105232560A (en) * | 2015-10-13 | 2016-01-13 | 辽宁医学院 | Anti-hepatoma cucurbitacine and curcumin Chinese herbal medicine compound preparation and preparation method |
| CN106220596A (en) * | 2016-07-28 | 2016-12-14 | 西华大学 | Preparation method of gingerpene cyclic element and anti-hepatic fibrosis application |
| CN111166847A (en) * | 2019-12-23 | 2020-05-19 | 成都锦华药业有限责任公司 | Pharmaceutical composition containing turmeric, tablet thereof and preparation method |
-
2007
- 2007-03-07 CN CN 200710020242 patent/CN101019841A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101502498B (en) * | 2009-03-04 | 2011-05-18 | 陕西科技大学 | Curcumin preparation for percutaneous administration and preparation method thereof |
| CN104548107A (en) * | 2010-12-08 | 2015-04-29 | 江南大学 | Controlled-release medicine auxiliary material for improving stability of main medicine |
| CN104548107B (en) * | 2010-12-08 | 2017-06-23 | 江南大学 | A kind of slow controlled release pharmaceutic adjuvant for improving main ingredient stability |
| CN105232560A (en) * | 2015-10-13 | 2016-01-13 | 辽宁医学院 | Anti-hepatoma cucurbitacine and curcumin Chinese herbal medicine compound preparation and preparation method |
| CN106220596A (en) * | 2016-07-28 | 2016-12-14 | 西华大学 | Preparation method of gingerpene cyclic element and anti-hepatic fibrosis application |
| CN106220596B (en) * | 2016-07-28 | 2019-03-26 | 西华大学 | Preparation method of gingerpene cyclic element and anti-hepatic fibrosis application |
| CN111166847A (en) * | 2019-12-23 | 2020-05-19 | 成都锦华药业有限责任公司 | Pharmaceutical composition containing turmeric, tablet thereof and preparation method |
| CN111166847B (en) * | 2019-12-23 | 2021-12-31 | 成都锦华药业有限责任公司 | Pharmaceutical composition containing turmeric, tablet thereof and preparation method |
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Open date: 20070822 |