CN1243557C - Medicine against liver fibrillation - Google Patents
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Abstract
The present invention discloses a medicine for preventing hepatic fibrosis, which adopts a traditional Chinese medicine formula that the medicine for preventing hepatic fibrosis is made from Chinese caterpillar fungus mycelium, astragalus root, red sage root, fleece-flower root, mulberry fruit and heterophylly falsestarwort root, and compound traditional Chinese medicine extract is enveloped by liposomes. The preparation can reduce free radicals, so hepatic fibrosis deposition is used, which is favorable to the recovery of chronic hepatitis and the improvement of liver functions. MDA in vivo is reduced by clearing away oxide radicals, so hepatic fibrosis is improved. The present invention is favorable to the inhibition of hepatic fibrosis development, the promotion of the functions of liver cells, the promotion of albumin synthesis, the enhancement of body immune functions and the improvement of the function of the pituitary and the gonad axis. The present invention has the advantage of high safety.
Description
Technical field:
The present invention relates to a kind of medicine for the treatment of hepatopathy, especially a kind of medicine of anti-hepatic fibrosis (trade name: but Bo Li-No. 2).
Background technology:
Treatment by Chinese herbs hepatic fibrosis at present comprises blood circulation promoting and blood stasis dispelling (medicine has Radix Salviae Miltiorrhizae, Semen Persicae, Radix Angelicae Sinensis etc.); Supplementing QI and nourishing YIN (medicine has the Radix Astragali, Radix Glycyrrhizae, Cordyceps etc.); Clearing away heat-damp and promoting diuresis (medicine has Radix Scutellariae, Radix Stephaniae Tetrandrae and Radix Sophorae Flavescentis etc.).Chinese medicine compound is one of valuable feature of Chinese traditional treatment disease.The traditional Chinese medical science think chronic hepatitis can the impairment of the spleen, liver, kidney, cause liver,spleen,kidney void; The chronic inflammatory disease long-term existence causes liver local circulation obstacle on the other hand, and pathological manifestations is arteriolar tortuous.The sinus hepaticus basement membrane thickened causes the mass exchange obstacle, the pathological change complexity, and differential diagnosis in tcm is a polytype, list is difficult to obtain curative effect preferably with a kind of medicine, therefore uses many compound recipes.Wang Baoen etc. at first adopt blood circulation promoting and blood stasis dispelling compound recipe 861 electuaries (compositions such as Radix Salviae Miltiorrhizae, Caulis Spatholobi, the Radix Astragali) to the rat liver fibrosis research that experimentizes, and the result shows that 861 electuaries are to CCI
4And the rat liver fibrosis due to the albumin all has effect, and this can suppress reticular fiber connective tissue proliferation and deposition in the hepatic tissue of two kinds of rat liver fibrosis models, and can alleviate hepatocyte injury.Liu's equality adopts supporting vital QI and dispersing blood stasis No. 319 (compositions such as Radix Salviae Miltiorrhizae, Semen Persicae, Cordyceps mycelium) to the experimental rat fibrosis effect.The result shows that this can be to suppress rat CCL
4The formation of experimental hepatic fibrosis, and promote established hepatic fibrosis to reverse, its mechanism is hepatic fibrosis hepatic tissue collagenase activity, promotes the degraded of collagen in the liver.
The present domestic Chinese prescription that many treatment hepatic fibrosis are arranged.Certain effect of anti hepatic fibrosis is all arranged in zoopery, yet in clinical research, but lack double blind control, less to the mechanism research of Chinese medicine anti-hepatic fibrosis on the other hand, should may have bigger directive function to practice from gene level even back gene level research.
Liposome is that Britain in 1967 at first finds, is 1971 but really be used for clinical, and the seventies, Shenyang Pharmaceutical University succeeded in developing at home first.Liposome is mainly formed double-deck peplos by phospholipid and cholesterol and be should be.Water-soluble substances can be wrapped in the peplos by suitable technology, and liposoluble substance then is wrapped between the bilayer.
The effect characteristics of liposome: (1) targeting is an example with the cancer therapy drug, and behind the liposomal encapsulated medicine, very big in in-house distribution situation change, tissue increases greatly to the ingestion of medicines amount.As after the intravenous injection of cytosine arabinoside liposome 16 hours, the concentration ratio free drug of entrapped drug in tissue was big 68 times.The liposomal encapsulated Cordyceps polysaccharides treatment of humans such as Qiu Dekai chronic hepatitis patient is found, can improve patient's NK cytoactive greatly through liposomal encapsulated Cordyceps polysaccharides treatment chronic hepatitis, INF-r (interferon) compares P＜0.05 or P＜0.01 before cytokine 2 (IL-2) level that the cytokine 2 receptor (MIL-2R) of peripheral blood lymphocyte film is expressed and the treatment.And it is obviously better than the Cordyceps polysaccharides curative effect of not sealing to prove that liposomal encapsulated Cordyceps polysaccharides improves above-mentioned immune indexes.Learn by statistics and handle P＜0.05.Deng Yingjie etc. have studied the preparation and the stability of astragalus polysaccharides liposome, have proved further that with the uniform Design method astragalus polysaccharides liposome has significant more immune effect than astragalus polysaccharides ordinary preparation and blank liposome.Document reports that also liposomal encapsulated medicine can improve 5～10 times of pharmaceutically actives.(2) wrap in the lipid drug disposition by the phagocyte of reticuloendothelial system in the body engulfing as external foreign body.Have plenty of fusion (Fusion), promptly fusion enters in the cell film material of liposome to cell membrane formation thing is similar.All liposomees electrically charged and neutral liquid mainly enter lysosome by endocytosis, and cracking discharges medicine then.Because lysosomal permeability is limited, so the bigger medicine of molecule just can not be discharged into other position of cell, and fusion often is not subjected to this restriction, so the release medicine of liposome is to have optionally.(3) delay release, drug encapsulation prolongs action time after delaying release behind the liposome in vivo.(4) the control medicine distributes in tissue and clearance rate in blood.By changing the area size of liposome, surface charge and composition can change the speed that liposome is eliminated speed and entered the target area at medicine-feeding part.
The material of preparation liposome, the film material of liposome mainly is made of phospholipid and cholesterol, these two kinds of compositions still do not form the bimolecular basic substance of liposome, and itself also has epochmaking physiological function, " artificial membrane " that formed by them often is difficult to get rid of unlike synthetic microcapsule (as artificial nylon microcapsule) in body easily by the body digest and decompose.Liposomal encapsulated Chinese medicine, at present many sealing single medicinal material, as seal Cordyceps polysaccharides, seal astragalus polysaccharides, seal Radix Salviae Miltiorrhizae etc., less for sealing herbal mixture.
Summary of the invention:
The objective of the invention is to develop a kind of medicine for the treatment of hepatic fibrosis, can improve liver function, increase albumin, reduce globulin, hepatic fibrosis is improved.
The technical scheme that the present invention takes is to choose following Chinese prescription to make: Cordyceps mycelium 2～2.5 weight portions, the Radix Astragali 12～15 weight portions, Radix Salviae Miltiorrhizae 12～15 weight portions, the Radix Polygoni Multiflori 4～5 weight portions, Fructus Lycii 5～6 weight portions, Radix Pseudostellariae 5～6 weight portions.Adopt soybean lecithin: the liposomal encapsulated above Chinese medicine extraction liquid of Ovum Gallus domesticus Flavus lecithin=7: 3 ratio system.
Advantage of the present invention or good effect:
But the inventor was since development Bo Li-No. 2 oral liquid in 1997, and cirrhosis patients in decompensation is existing 5 years so far behind the treatment hepatitis B, treat 200 surplus patient behind routine posthepatitic cirrhosis and the 400 many cases chronic hepatitis Bs.Therapeutic outcome shows: (1) can make malonaldehyde (MDA) drop to 19.23 ± 4.75 (μ mol/L) by treatment preceding 32.19 ± 7.74 through oral three months; Hyaluronic acid drops to 398.39 ± 84.81 (mg/mL) from treating preceding 546.12 ± 77.97; Compare P＜0.05 before malonaldehyde (MDA) treatment with after the treatment; Compare P＜0.05 with matched group; Compare P＜0.05 before hyaluronic acid (HA) treatment with after the treatment.Hepatitis B virus causes that the mechanism of hepatic injury is a lot of after invading human body, and one of them is that free radical increases; Chronic hepatitis patient intestinal endotoxin absorbs to increase free radical is increased on the other hand.Free radical damages hepatocyte on the one hand, and hepatocyte is destroyed, and causes inflammation on the other hand, discharge the various kinds of cell factor, thereby fat-storing cell transforms into fibrocyte, increases the weight of hepatic fibrosis.This preparation can reduce free radical and then reduce the hepatic fibrosis deposition, helps chronic hepatitis and recovers, and helps suppressing the development of hepatic fibrosis; (2) help albuminous synthesizing, but taking Bo Li-No. 2 oral liquid makes patient's albumin increase to 32.69 ± 4.64 (g/L) from 28 ± 4.32 after three months, P＜0.01, compare with matched group, P＜0.05, illustrate that but Bo Li-No. 2 oral liquid can promote hepatocellular function, promote albuminous synthetic.(3) enhancing human body immunity function.Soluble interleukin-6 2 receptors (SIL-2R) are apparently higher than the normal person before the treatment, and treatment back obviously descends, and compare P＜0.01 before the treatment; Compare P＜0.05 with matched group.IL-2 is one of critical cytokine of cellular immunization, and IL-2 increases the reflection cellular immune function and strengthens, and IL-2 combines the certain activity of back forfeiture with soluble recepter, so SIL-2R increases and then makes cellular immune function decreased; On the contrary, SIL-2R descends and then reflects the enhancing of immunologic function, and we's treatment was measured patient SIL-2R in 3 months and generally descended.Because of the court's condition restriction, can't measure IL-2.(4) improve hypophysis-gonad axis function.Usually there is hypophysis-gonad axis dysfunction in chronic hepatitis patient, shows as male testical ketone (T) and descends women's estradiol (E
2) increase, the short follicle of hypophysis generates plain decline, can obviously increase after treatment, still among statistics.
Adopt CCL
4Inductive Hepatocirrhosis Model, but inject observation group in contrast with Bo Li-No. 2 oral liquid and interferon then, the result shows: (1) but heavy dose Bo Li-No. 2 oral liquid and interferon can significantly reduce liver hydroxyl dried meat amino acid content (P＜0.05=.Hydroxyl dried meat aminoacid is the distinctive aminoacid of collagen fiber, measures hydroxyl dried meat aminoacid and necessarily reflects degree of hepatic fibrosis on the program, and the higher explanation hepatic fibrosis of hydroxyl dried meat aminoacid is heavier, otherwise more right.(2) hepatopathy is of science checks, compare with the blank group, the model group fibrosis obviously increases (P＜0.01=.Compare with model group, but Bo Li-No. 2 oral liquid and interferon all can reduce degree of hepatic fibrosis (P＜0.01 or P＜0.05=.
This oral liquid has also been cooked toxicological test, by Ministry of Public Health " study of tcm new drug guide " but the toxic reaction of Bo Li-No. 2 oral liquid long term administration is observed in the relevant requirement of Chinese medicine three class toxicitys, the dosage setting is equivalent to 80,40,20 times of clinical consumptions, administration three months.The result, blood biochemical is learned the index inspection and is shown, though but no matter little Bo Li-No. 2 oral liquid is, in, heavy dose of can cause some variations, lower as heavy dose group albumin than blank group, wherein small dose group total serum protein and heavy dose of Histaglobin raise, but the blood urea nitrogen (BUN) of dosage group reduction nothing is closed on pathology sense in Bo Li-No. 2 oral liquid.Other index such as glutamic oxaloacetic transaminase, GOT (AST), T-CHOL (THO), blood glucose (GLU), flesh liver do not have significant change, with blank group there are no significant difference.Histopathologic examination finds that blank group 1 example (1/12) kitchen range fat becomes, and 2 examples (2/12) brain has corpora amylacea; But dosage group 3 examples (3/12) have kitchen range fat to become in Bo Li-No. 2 oral liquid, and 1 example (1/12) brain has corpora amylacea; Heavy dose has 3 examples (3/12) liver to have kitchen range fat to become, and 2 examples (2/12) brain has corpora amylacea.Above-mentioned pathological change intact animal may occur, and administration group and blank group do not have significant difference.The no abnormal discoveries of internal organs histopathologic examination such as other organ such as heart, spleen, kidney, adrenal gland, thymus, stomach, small intestinal, bladder, testis, ovary.Successive administration three months and drug withdrawal two weeks, the organ coefficient inspection is also no abnormal.Long term toxicity test shows, but Bo Li-No. 2 oral liquid does not have the overt toxicity effect, but thereby thinks that by intending with clinical dosage, route of administration and use application course of treatment Bo Li-No. 2 oral liquid be safe.
Description of drawings:
Fig. 1 is a process for producing flow chart of the present invention.
The specific embodiment:
In the treatment of chronic hepatitis, at first should remove the cause of disease, be the key of treatment.Yet it is still undesirable to remove hepatitis virus, only limits to suppress hepatitis virus up to the present.Second should antiinflammatory, eliminates the inflammation in the hepatic tissue, and this is an important ring that prevents hepatic fibrosis.Heavy then to bring out hepatic fibrosis also heavy for inflammation in the hepatic tissue, and both are parallel.Cordyceps mycelium is an immunostimulant.Experiment showed, nourishing class Chinese medicine, the effect of enhance immunity, inflammation-inhibiting is all arranged as the Radix Astragali, Cordyceps etc.Qiu Dekai etc. studies confirm that liposomal encapsulated Cordyceps polysaccharides strengthens cellular immunization as increasing IL-2, IFN, and pathology confirms that also inflammation disappears simultaneously.Chronic hepatopathy is owing to hepatic fibrosis, and blood vessel is tortuous in the liver, and adding epigaster source property endotoxin increases, and makes thrombosis in the sinus hepaticus, increases the weight of blood stasis, so emphasizes blood circulation promoting and blood stasis dispelling in the chronic hepatopathy treatment.Radix Salviae Miltiorrhizae is one of important drugs of clinical treatment blood stasis, not only can microcirculation improvement, and can remove free radical, prevent further hepatic injury, Radix Salviae Miltiorrhizae is one of important drugs of clinical treatment blood stasis, not only can microcirculation improvement, and can remove free radical, prevent further hepatic injury, the Radix Astragali not only can improve immunologic function, and can also improve gastrointestinal function, hepatopathy patients gastrointestinal dysfunction, mycelia imbalance, taking the Radix Astragali can both improve, and Radix Pseudostellariae, Fructus Lycii, the Radix Polygoni Multiflori all have nourish liver and kidney, improve immunologic function, also makes prescription energy equilibrium between yin and yang simultaneously.
The technological process of production is referring to accompanying drawing.
Embodiment:
But with preparation 30000mL Bo Li-No. 2 oral liquid is example.
Take by weighing Radix Astragali 14kg respectively, Radix Salviae Miltiorrhizae 14kg, Fructus Lycii 5.5kg, Radix Polygoni Multiflori 5kg, Radix Pseudostellariae 5kg, Cordyceps mycelium 2.5kg, lecithin 210g, Ovum Gallus domesticus Flavus lecithin 90g, cholesterol 100g, vitamin E 500mg.
1, effective components of Chinese medicinal is extracted
Radix Pseudostellariae is extracted with percolation, and solvent is 95% ethanol 10000mL, and it is standby that percolate recovery ethanol makes medicinal liquid (1), and medicinal residues tool are in addition preserved; Get Radix Salviae Miltiorrhizae and add 95%25000mL reflux, extract, twice, each 2 hours, it is standby that extracting solution recovery ethanol makes medicinal liquid (2), and medicinal residues tool are in addition preserved; Get Fructus Lycii, the Radix Polygoni Multiflori, the Radix Astragali and Radix Pseudostellariae medicinal residues, Radix Salviae Miltiorrhizae decoction dregs and add water 300000mL decoction 3 times, each 2 hours, collecting decoction, concentrate about 3 hours to thick paste shape (relative density about 1.30), adding 95% ethanol makes and contains alcohol amount and reach 60%, placed 24 hours, and got supernatant and reclaim ethanol, it is standby to get medicinal liquid (3).
2, Cordyceps polysaccharides extracts
Get Cordyceps mycelium and add water 15000mL decoction 3 times, each 2 hours, collecting decoction is concentrated into 15000mL, and was standby.
3, liposome membrane material preparation
Get lecithin, Ovum Gallus domesticus Flavus lecithin, cholesterol and place vial, add the dissolving of 400mL chloroform after, add vitamin E, the rotary glass bottle makes the volatilization of chloroform safety, makes the liposome membrane material.
But 4 Bo Li-No. 2 oral liquid preparations
Cordyceps polysaccharides solution, medicinal liquid (1), medicinal liquid (2) and medicinal liquid (3) are added in the liposome membrane material, place after 2 hours, stirred 10 hours, ultrasonic 20 minutes, add phosphate buffer to 30000mL, embedding, sterilization, check, packing is promptly.
But Bo Li-No. 2 oral liquid is sealed situation
But Bo Li-No. 2 oral liquid confirms liposomal encapsulated medicine through Guangxi Agriculture Univ.'s experimental center electron microscope examination, particle diameter 100～200mm, and be evenly distributed.
Entrapment efficiency determination
Adopt dialysis to measure envelop rate, through the check of Pharmacy department of Yulin City of Guangxi Zhuang Autonomous Red Cross Hospital, liposome is between 40%～0% to the envelop rate of Cordyceps polysaccharides.
After adopting supersound process, can make most of multilamelar liposomes become unilamelar liposome.
We adopt liposomal encapsulated Cordyceps polysaccharides, Radix Salviae Miltiorrhizae, the Radix Astragali etc., trade name Bo Li-No. 2 but (CPL-2) treatment posthepatitic cirrhosis 30 examples, the result proves that this medicine is improving liver function, increase albumin, reduce globulin, can make MDA reduction in the body, thereby hepatic fibrosis (HA) is improved by removing oxygen-derived free radicals simultaneously.Zoopery also proves this point.
Claims (1)
1, a kind of medicine of anti-hepatic fibrosis is characterized in that this medicine makes by following technology:
Cordyceps mycelium 2～2.5 weight portions, the Radix Astragali 12～15 weight portions, Radix Salviae Miltiorrhizae 12～15 weight portions, the Radix Polygoni Multiflori 4～5 weight portions, Fructus Lycii 5～6 weight portions and Radix Pseudostellariae 5～6 weight portions are made Chinese medicine extraction liquid, adopt soybean lecithin: the liposomal encapsulated above-mentioned Chinese medicine extraction liquid that Ovum Gallus domesticus Flavus lecithin=7: 3 ratio is made, promptly.
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