CN1283308C - Chinese medicime liposome for treating viral hepatitis B and preventing liver cell from fibriform and preparing method thereof - Google Patents
Chinese medicime liposome for treating viral hepatitis B and preventing liver cell from fibriform and preparing method thereof Download PDFInfo
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Abstract
The present invention relates to a traditional Chinese medicine liposome for treating virus hepatitis b and controlling hepatic fibrosis and a preparation method thereof. The traditional Chinese medicine liposome is a polyphase liposome composed of 34 to 48% of active ingredient extracts of traditional Chinese medicine, 66 to 52% of lecithin, and medical auxiliary materials of the proportion by weight, wherein the active ingredients of the traditional Chinese medicine comprise curcuma root, schisandras, white peony root and licorice root. The present invention uses the liposome to embed some kinds of traditional Chinese medicine having the action of hepatic protection and immunoregulation so as to treat virus hepatitis b and control hepatic cell fibrosis, and combines the advantages of the liposome and the characteristics of the traditional Chinese medicine. Therefore, the present invention provides novel medicine having the advantages of exact curative effect and convenient use for treating virus chronic hepatitis b and controlling hepatic cell fibrosis.
Description
Technical field:
The present invention relates to Chinese medicine preparation and preparation method, be specifically related to a kind of treatment Type B viral hepatitis, the Chinese medicine liposome and the preparation method of control hepatic fibrosis.
Background technology:
Diseases such as viral chronic hepatitis B, fat hepatitis and hepatocyte fibrosis are present common frdquently encountered diseases, and hepatitis virus carrier ratio is near 5% among the crowd.The hepatocyte injury that is caused by viral chronic hepatitis B and the generation of hepatocyte fibrosis degeneration constitute a threat to human health.
Modern medicine thinks that hepatitis comes from the invasion and attack of hepatitis virus to human body, in case immunity of organisms is low, then suffers from hepatic disease.Long-term animal migration chronic hepatitis B causes hepatocellular major injury, and the degeneration of hepatocyte fibrosis also develops into the hepatic necrosis degeneration.The means of treatment are also based on hepatitis virus resisting and supporting treatment.The treatment medicine is large in the variety, and clinical need use several medicines simultaneously.Because the physicochemical property of these medicines, bioavailability and the metabolite difference that in human body, produces, easy interference treatment effect and having side effects mutually.Therefore, developmental research a kind ofly have that the treatment specificity is concentrated, determined curative effect, easy to use, side effect is low or the economical medicine that has no side effect is very meaningful.
Motherland's Chinese medicine is learned and is thought, the main pathology machine of hepatopathy is because of being liver " strongly fragrant " and " damp and hot stagnating accumulate " liver spleen, and " dredging " liver, " OK " gas, " softening " liver are taked in treatment, and stagnation of liver-QI must be softened, and damp and hot getting profit tied thinly and stagnate.Thus, the state of an illness is alleviated, and the patient rehabilitates.Long-term next, Chinese medicine subject skilled worker author, the classics prescription and the Chinese patent medicine of foundation and accumulation are very various in the work of treatment clinical liver disease, owing to after taking medicine, are decomposed absorption by gastrointestinal, and be still very big to the treatment influence.Hepatopathies such as B virus chronic hepatitis, fat hepatitis, alcoholic liver injury and hepatocyte fibrosis, the course of disease is long, be easy to recurrence, need long-term medication treatment, except Chinese patent medicine kinds commonly used such as traditional SHUGAN WAN, XIAOYAO POWDER, biejiajian pills, at present, the glycyrrhizin preparations potenlin injection of medical institutions and the supply of medicine shop needs the intravenous injection medication, use inconvenience, and easily produce the infection of doctor source, be difficult for being accepted.And glycyrrhizin tablet oral after, most of decompose and degeneration at gastric, blood drug level is very low, unsatisfactory curative effect.Therefore it is good to need to explore the invention bioavailability, and novel formulation evident in efficacy is very urgent.
Liposomal formulation is one of current scientific and technological forward position project.Natural targeting owing to it makes the organ of reticuloendothelial system and the targeting district that cell becomes the entrapped drug liposome, directionally medicine is transported effectively to arrive in the endothelial system diseased cells to discharge medicine.Liposome can rest in the abundant histiocyte of liver and reticuloendothelial systems such as spleen, lung, it is the good carrier of RE (cell) tissue system disease therapeuticing medicine, when medicine enters cell tissue will be by macrophage phagocytic, the intake of macrophage obviously increases and is activated effectively, strengthens body immunity effectively.Liposome is that present only a few is applied to one of human avirulence immunoactivator.Its lipoid composition is easily biological-degradable in vivo, and non-immunogenicity and toxicity.
Summary of the invention:
Technical problem to be solved by this invention is to learn and modern medical theory according to Chinese medicine, utilizes the characteristics of liposome, provides a kind of compatibility scientific and reasonable, anti-hepatitis B virus evident in efficacy and the Fibrotic Chinese medicine liposome medicine of control hepatocyte.
Treatment Type B viral hepatitis disclosed by the invention and control hepatocyte Fibrotic Chinese medicine liposome are the multiphasic liposomes that 34-48% Chinese medicine active ingredient extract and 66-52% lecithin or other lipid adjuvants and conventional pharmaceutic adjuvant are formed by percentage by weight, and wherein the Chinese medicine active ingredient comprises Radix Curcumae, Fructus Schisandrae Chinensis, the Radix Paeoniae Alba and Radix Glycyrrhizae.
Chinese medicine active ingredient extract of the present invention is to be Radix Curcumae 12-16% by the percentage by weight prescription, Radix Paeoniae Alba 16-22%, active component that Fructus Schisandrae Chinensis 10-14% extract to obtain and 48-62% Radix Glycyrrhizae extract composition, wherein Radix Glycyrrhizae extract is that 1: 1 glycyrrhizin mono-ammonium and monopotassium salt formed by ratio.
Lecithin of the present invention is selected from the lecithin of yolk and Semen sojae atricolor extraction.
Other lipid adjuvants of the present invention are selected from fatty glyceride, sucrose-fatty, sorbitan fatty acid ester, the polyoxyethylene sorbitan fatty acid ester, sodium lauryl sulphate (SLS), polyoxyethylene castor oil, polyoxyethylene-polyoxypropylene copolymer (PoloxamerPluronics), and arabic gum, the tragakanta, fructose fat glue, glyceryl monostearate, Myrj 45, Myrj 52, polyoxyethylene 400 monolaurates, polyoxyethylene 400 monostearates, Brij30, Brij30, and span 20-sorbester p37 or polysorbas20-polysorbate85 etc.
Another technical problem to be solved by this invention is the preparation method that discloses above-mentioned Chinese medicine liposome.
The preparation of treatment Type B viral hepatitis disclosed by the invention, the Fibrotic Chinese medicine liposome of control hepatocyte comprises the following steps:
One, active ingredient extract preparation
(1) by proportioning Fructus Schisandrae Chinensis is put close drying in 78 ℃ of-85 ℃ of baking ovens, cooling; Roll coarser powder, cross 10 mesh sieves, other puts, and is standby;
(2) by proportioning Radix Curcumae is put in 62 ℃ of-75 ℃ of baking ovens close drying, cooling; Add the Radix Paeoniae Alba by proportioning and mix, roll coarser powder, powder is crossed 5 mesh sieves, and other puts, and is standby;
(3) with the coarser powder of step (1) and (2), put the one-level extraction kettle, pressure Mpa8-18; 54 ℃-70 ℃ of temperature; 65%-85% ethanol circulating load 100ml/h-150ml/h; CO
2Flow 900ml/h-1500ml/h; After the 2.5h-4h extraction, decompression 8Mpa-15Mpa; 48 ℃-52 ℃ of temperature flow into detached dowel, enter extraction-container again, be decompressed to normal pressure after, take out extract, other puts clean vessel, and is airtight; Collect medicinal residues, stand-by;
(4) with step (3) medicinal residues, put in the reaction pot that condenser is housed, add 4 times of water gagings, 2 times of water gagings are fried in shallow oil secondary.Collect condenser ethereal oil aqueous mixtures, standby; Waste and even secondary decocting liquid filter, and add oil water mixture in the filtrate, mix, and are evaporated to the 1.0-1.18 thick paste, add step (3) extract, mix, and vacuum drying is ground into 380 orders-450 order impalpable powder to dried mastic, and is standby;
Two, Liposomal formulation preparation
(1) above-mentioned impalpable powder is placed in the container, added distilled water to scale, water-bath keeps temperature for 65 ℃-80 ℃, is stirred to dissolving; Put into glycyrrhizin mono-ammonium and monopotassium salt again, be stirred to dissolving, solution is put in the container with ultrasonic wavelength, output ultrasonic wave is long; With lecithin or other lipid adjuvants and corresponding medicinal adjuvant, put in 65 ℃ of-100 ℃ of water-baths, mix, melt, be the transparent liquor separator that promptly moves; Take advantage of heat to drip/min with 30-45, be instilled in the medicinal liquid of putting the ultrasound wave container, appropriateness is mixed; Instillation finishes, and keeps the ultrasound wave long hair and gives birth to 12-25min, closes generator, and liposome is sucked aseptic canning machine, fill;
(2) the liposome bottle after canned is put into the ultralow temperature drying baker, in-45 ℃--dry freeze 10-15h in 60 ℃, stablize dry 4-6h in 35 ℃ of-45 ℃ of cryostates.Promptly.
Above-mentioned preparation method just provides a kind of preferable embodiment for preparing Chinese medicine liposome preparation of the present invention.Those skilled in the art can be according to description of the invention each parameter to wherein being adopted, and condition and adjuvant carry out suitably changes and improvements, and these variations also all are included in the scope of the present invention.
A technical problem more to be solved by this invention is to disclose the application of above-mentioned Chinese medicine liposome in preparation treatment Type B viral hepatitis, the Fibrotic medicine of control hepatocyte.
Chinese medicine liposome of the present invention can be used for the treatment of viral chronic hepatitis B, chronic active hepatitis, acute hepatitis, fatty hepatitis, alcoholic hepatitis, toxic hepatitis, first cirrhosis.
In the preparation prescription of the present invention:
Fructus Schisandrae Chinensis (Fructus Sehisandiae): the nourishing kidney of astringing the lung, the arresting sweating that promotes the production of body fluid, arresting seminal emission antidiarrheal, mind tranquilizing and the heart calming, heat impairing vital QI the moon.Specially restrain lung qi and grow water, edema with the liver involved gets kidney water and nourishes, and then the damp and hot pathogenic fire of liver is dispeled.
Radix Curcumae (Radix curcumae): promoting blood circulation and stopping pain, promoting QI circulation for relieving depression, removing heat from blood clear away heart-fire, promoting the function of the gallbladder to alleviate jaundice.The soothing the liver circulation of qi promoting of energy is with resolving depression.
The Radix Paeoniae Alba (Radix Paeomiae alba): the yin fluid astringing that nourishes blood, easing the affected liver to relieve pain, suppressing liver-YANG, nourishing blood to suppress the hyperactive liver, relieving spasm to stop pain.Meet Radix Glycyrrhizae, the treating the liver spleen is become estranged, wrist abdomen contraction is anxious has a pain.
This three flavors medicine, equilibrium between yin and yang in compatibility, each is benefited and cites in therapeutic efficiency, has brought into play the advantage of Chinese medicine coordinating effect.
The medical material Radix Glycyrrhizae has the function of " detoxifcation, times strength, slow healthy energy, yin nourishing blood, tonifying the spleen and stomach, clothes are prolonged life for a long time ".Glycyrrhizin (Glycyrrhizin GL) is one of Radix Glycyrrhizae main component, contains monopotassium glycyrrhizunate, mono-ammonium and di-potassium, di-ammonium salts has the protection liver plasma membrane, alleviates hepatic cell fattydegeneration, alleviate hepatic necrosis and between the matter inflammatory reaction, suppress the hepatocyte fibrosis; And the effect of steroid hormone sample is arranged, and do not have the hormonelike side effect.In clinical verification has and hepatitis virus, antiinflammatory, antiallergic action, the jaundice that disappears is improved lipid metabolism, the enhance immunity ability.
Liposome is ideal targeting vector, medicine can be written into target organ or site of action and be detained release, improves the target area medicine effective concentration, and keeps the long period, and medicine is seldom then absorbed at other positions of whole body simultaneously.Not only to make medicine reach target organ, target cell, even cell inner structure.Glycyrrhizin liposome after the biological treatment can improve blood drug level in the liver obviously to the guide effect of liver, thereby increased medicine the specificity of liver is concentrated treatment, has reached the therapeutic effect that other oral glycyrrhizin preparations were difficult to obtain.Be the new results that traditional Chinese medicine combines with the modern biomedical technology.
Carry out clinical trial with preparation of the present invention, adopt multicenter, contrast method at random.Contain monopotassium glycyrrhizunate 75mg and compare group with every in glycyrrhizin tablet (production of Huangshi scud company limited).
Dosage: 150mg (2) once, every day secondary.
Liposome of the present invention: every day secondary, each 15ml.
Two groups 8 weeks of successive administration are a course of treatment respectively.Minimum 18 years old of patient age, the highest 65 years old, male's 28 examples, women's 12 examples.Observe sick the kind: viral chronic hepatitis B, with Serum ALT and AST, serum bilirubin is greater than the upper limits of normal value.Treat in preceding 45 days, used the patient who falls the enzyme medicine, will not observe.Before the treatment and after two weeks of administration, do routine urinalysis ALT, AST, SB, GGT, ALP, A/G, BuN, detection, record clinical symptoms and sign change.
Curative effect judging standard:
Divide produce effects, effective, invalid three grades
Produce effects: 1, subjective symptoms disappears or is clearly better.
2, hepatosplenomegaly is dwindled or is stablized constant.
3, liver function test ALT, AST and SB recover normal.
Effectively: 1, subjective symptoms takes a turn for the better or stablizes constant.
2, hepatosplenomegaly is stablized constant.
3, the more preceding reduction of liver function test ALT, AST and SB 〉=more than 50%.
Invalid: as not have change, do not reach above standard or disease progression person.
As a result, ALT effective percentage 81.4% falls in the liposome group; SB effective percentage 73.3% falls; Rise albumin effective percentage 62.7%; Globulin 48.8% falls; HBeAg negative conversion rate 58.8%; ALT effective percentage 63.2% falls in matched group; SB effective percentage 57.4% falls; Rise albumin effective percentage 28.4%; Globulin 3.8% falls; HBeAg negative conversion rate 27.3%; The average obvious effective rate 65.0% of liposome group; Matched group is 36.0%;
The liposome group: subjective symptoms is clearly better 76.1%; Transference cure 20.1%; Effective 3.8%; The liver spleen dwindles 68.1%; Stablize constant 31.9%;
Matched group: subjective symptoms is clearly better 37.8%; Transference cure 1.8%; Effective 43.7%; Invalid 16.7%.
Bad side reaction all takes place in two groups of patients.
The above results shows: the present invention with liposome embedded some have the viral chronic hepatitis B of treatment by Chinese herbs of hepatoprotective and immunoregulation effect and prevent the hepatocyte fibrosis, the characteristics of advantage of liposome (immunological adjuvant, pharmaceutical carrier, minimizing by the dosage of embedding medicinal, prolong drug at the target organ action effective) and Chinese medicine (determined curative effect, aboundresources, inexpensive, toxic and side effects is few or do not have toxicity) are combined.A kind of determined curative effect, novel drugs easy to use are provided for treating viral chronic hepatitis B and control hepatocyte fibrosis.
The specific embodiment:
Embodiment 1,
Prescription: Fructus Schisandrae Chinensis 11.2Kg
Radix Curcumae 12.5Kg
Radix Paeoniae Alba 19.8Kg
Glycyrrhizin mono-ammonium 28.25Kg
Glycyrrhizin monopotassium salt 28.25Kg
Lecithin (Semen sojae atricolor) 80kg
Glycerol 150kg
Distilled water 750kg
Preparation:
1, Fructus Schisandrae Chinensis is put in 80 ℃ of baking ovens close drying to the heavy-handed not conglomeration degree of being of holding, taken out and be spread out in the clean stainless steel disc, in cleaning ambient, put, roll coarser powder to room temperature, mistake 10 mesh sieves, other puts, and is standby;
2, Radix Curcumae is put in 70 ℃ of baking ovens, close drying to feel drying is promptly taken out, and spreads in the cleaning stainless steel disc, and is airtight to room temperature, adds the Radix Paeoniae Alba and mixes, and rolls coarser powder, and powder is crossed 5 mesh sieves;
3,, put the one-level extraction kettle, pressure 25Mpa with the coarser powder of step 1 and 2; 55 ℃ of temperature; 75% ethanol circulating load 120ml/h; CO
2Flow 1000ml/h; After the 3.5h extraction, decompression 10Mpa; 40 ℃ of temperature flow into detached dowel, enter extraction-container again, be decompressed to normal pressure after, take out extract, other puts clean vessel, and is airtight; Collect medicinal residues, stand-by;
4, with step 3 medicinal residues, put in the reaction pot that condenser is housed, add 4 times of water gagings, 2 times of water gagings are fried in shallow oil secondary.Collect condenser ethereal oil aqueous mixtures, standby; Waste and even secondary decocting liquid filter, and add oil water mixture in the filtrate, mix.Be evaporated to 1.12 thick pastes, add step 3 extract, mix.Vacuum drying is ground into 400 order impalpable powders to dried mastic, and is standby;
5, Liposomal formulation preparation.
Step 4 impalpable powder is placed in the container, added the distillation water purification to scale, water-bath keeps 65 ℃ of-80 ℃ of temperature, is stirred to dissolving, puts into glycyrrhizin mono-ammonium and monopotassium salt again, is stirred to dissolving.Solution is put in the container with ultrasonic wavelength, and output ultrasonic wave is long; With lecithin (big beans) and other corresponding medical accessories, put and put into 90 ℃ of water-baths in the vessel, mix, melt, be the transparent liquor separator that promptly moves, take advantage of heat with 85/min, be instilled into and put in the ultrasound wave container medicinal liquid, appropriateness is mixed, and instillation finishes, keep the ultrasound wave long hair and give birth to 25min, close generator, liposome is sucked the aseptic canning machine, whenever bottled: 15ml, medicinal fourth Jiao Gai with being shaped on the groove bar slightly is pressed on the bottleneck;
6, the liposome bottle that 15ml will be housed is put into clean stainless steel disc, puts into the ultralow temperature drying baker, dry freeze 12h in-60 ℃, and shutdown is stablized dry 4-6h with the freezing bottle on the automatic enclosing cover of fourth Jiao Gai being put in 40 ℃ of cryostates.At this moment, the 15ml Liposomal formulation has become the vitreous humour crystal.Take out vanning.The patient takes preceding 5min, and to the 15ml scale, loam cake is rocked 2-3min, promptly reverts to the liposome consistent with original content, pours in the cuvette, and is oral, gets final product less than 40 ℃ of cleaning sterile water in adding.
Embodiment 2,
Prescription: Fructus Schisandrae Chinensis 14Kg
Radix Curcumae 16Kg
Radix Paeoniae Alba 22Kg
Glycyrrhizin mono-ammonium 24Kg
Glycyrrhizin monopotassium salt 24Kg
Glyceryl monostearate 65kg
Oleic acid 135kg
Distilled water 800kg
1, Fructus Schisandrae Chinensis is put in 80 ℃ of baking ovens close drying to the heavy-handed not conglomeration degree of being of holding, taken out and be spread out in the clean stainless steel disc, in cleaning ambient, put, roll coarser powder to room temperature, mistake 10 mesh sieves, other puts, and is standby;
2, Radix Curcumae is put in 65 ℃ of baking ovens, close drying to feel drying is promptly taken out, and spreads in the cleaning stainless steel disc, and is airtight to room temperature, adds the Radix Paeoniae Alba and mixes, and rolls coarser powder, and powder is crossed 5 mesh sieves;
3,, put the one-level extraction kettle, pressure 26Mpa with the coarser powder of step 1 and 2; 58 ℃ of temperature; 72% ethanol circulating load 110ml/h; CO
2Flow 1100ml/h; After the 4h extraction, decompression 12Mpa; 44 ℃ of temperature flow into detached dowel, enter extraction-container again, be decompressed to normal pressure after, take out extract, other puts clean vessel, and is airtight; Collect medicinal residues, stand-by;
4, with step 3 medicinal residues, put in the reaction pot that condenser is housed, add 4 times of water gagings, 2 times of water gagings are fried in shallow oil secondary.Collect condenser ethereal oil aqueous mixtures, standby; Waste and even secondary decocting liquid filter, and add oil water mixture in the filtrate, mix.Be evaporated to 1.12 thick pastes, add step 3 extract, mix.Vacuum drying is ground into 400 order impalpable powders to dried mastic, and is standby;
5, the step 4 impalpable powder is placed in the container, added the distillation water purification to scale, water-bath keeps 90 ℃ of temperature, is stirred to dissolving, puts into glycyrrhizin mono-ammonium and monopotassium salt again, is stirred to dissolving.Solution is put in the container with ultrasonic wavelength, and output ultrasonic wave is long; With glyceryl monostearate and other corresponding medical accessories, put and put into 92 ℃ of water-baths in the vessel, mix, melt, be the transparent liquor separator that promptly moves, take advantage of heat with 85/min, be instilled into and put in the ultrasound wave container medicinal liquid, appropriateness is mixed, instillation finishes, and keeps the ultrasound wave long hair and gives birth to 25min, closes generator; Liposome is sucked the aseptic canning machine, whenever bottled: 15ml, the medicinal fourth Jiao Gai with being shaped on the groove bar slightly is pressed on the bottleneck;
6, the liposome bottle that 15ml will be housed is put into clean stainless steel disc, puts into the ultralow temperature drying baker, dry freeze 12h in-60 ℃, and shutdown is stablized dry 6h with the freezing bottle on the automatic enclosing cover of fourth Jiao Gai being put in 40 ℃ of cryostates.At this moment, the 15ml Liposomal formulation has become the vitreous humour crystal.Take out vanning.The patient takes preceding 5min, and to the 15ml scale, loam cake is rocked 2-3min, promptly reverts to the liposome consistent with original content, pours in the cuvette, and is oral, gets final product less than 40 ℃ of cleaning sterile water in adding.
Claims (5)
1, a kind of treatment Type B viral hepatitis, control hepatocyte Fibrotic Chinese medicine liposome is characterized in that this liposome is the multiphasic liposomes that 34-48% Chinese medicine active ingredient extract and 66-52% lecithin or lipid adjuvant and conventional pharmaceutic adjuvant are formed by percentage by weight;
Wherein Chinese medicine active ingredient extract is to be Radix Curcumae 12-16% by the percentage by weight proportioning, and extract that Radix Paeoniae Alba 16-22% and Fructus Schisandrae Chinensis 10-14% make and 48-62% are made up of the Radix Glycyrrhizae extract that 1: 1 glycyrrhizin mono-ammonium and monopotassium salt are formed; And described Radix Curcumae, the Radix Paeoniae Alba and Fructus Schisandrae Chinensis extrat are made by following method:
(1) by proportioning Fructus Schisandrae Chinensis is put close drying cooling in 78 ℃ of-85 ℃ of baking ovens, roll coarser powder, cross 10 mesh sieves, standby;
(2) Radix Curcumae is put in 62 ℃ of-75 ℃ of baking ovens, the close drying cooling adds the Radix Paeoniae Alba and mixes, and rolls coarser powder, and powder is crossed 5 mesh sieves, and is standby;
(3) with the coarser powder of step (1) and (2), put the one-level extraction kettle, pressure Mpa8-18; 54 ℃-70 ℃ of temperature; 65%-85% ethanol circulating load 100ml/h-150ml/h; CO
2Flow 900ml/h-1500ml/h; After the 2.5h-4h extraction, decompression 8Mpa-15Mpa; 48 ℃-52 ℃ of temperature flow into detached dowel, enter extraction-container again, be decompressed to normal pressure after, take out extract, other puts clean vessel, and is airtight; Collect medicinal residues, stand-by;
(4) with step (3) medicinal residues, put in the reaction pot that condenser is housed, add 4 times of water gagings, 2 times of water gagings are fried in shallow oil secondary; Collect condenser ethereal oil aqueous mixtures, standby; Waste and even secondary decocting liquid filter, and add oil water mixture in the filtrate, mix, and are evaporated to the 1.0-1.18 thick paste, add step (3) extract, mix, and vacuum drying is ground into 380 orders-450 order impalpable powder, promptly to dried mastic.
2, Chinese medicine liposome according to claim 1 is characterized in that wherein said lecithin is the lecithin that yolk and Semen sojae atricolor are extracted.
3, Chinese medicine liposome according to claim 1, it is characterized in that wherein said lipid adjuvant is meant fatty glyceride, sucrose-fatty, sorbitan fatty acid ester, the polyoxyethylene sorbitan fatty acid ester, sodium lauryl sulphate, polyoxyethylene castor oil, polyoxyethylene-polyoxypropylene copolymer, and arabic gum, the tragakanta, fructose fat glue, glyceryl monostearate, Myrj 45, Myrj 52, polyoxyethylene 400 monolaurates, polyoxyethylene 400 monostearates, Brij30, Brij30, and span 20-sorbester p37 or polysorbas20-polysorbate85.
4, the preparation method of Chinese medicine liposome according to claim 1 is characterized in that the preparation of this Chinese medicine liposome comprises the following steps:
One, active ingredient extract preparation
(1) by proportioning Fructus Schisandrae Chinensis is put close drying cooling in 78 ℃ of-85 ℃ of baking ovens, roll coarser powder, cross 10 mesh sieves, standby;
(2) Radix Curcumae is put in 62 ℃ of-75 ℃ of baking ovens, the close drying cooling adds the Radix Paeoniae Alba and mixes, and rolls coarser powder, and powder is crossed 5 mesh sieves, and is standby;
(3) with the coarser powder of step (1) and (2), put the one-level extraction kettle, pressure Mpa8-18; 54 ℃-70 ℃ of temperature; 65%-85% ethanol circulating load 100ml/h-150ml/h; CO
2Flow 900ml/h-1500ml/h; After the 2.5h-4h extraction, decompression 8Mpa-15Mpa; 48 ℃-52 ℃ of temperature flow into detached dowel, enter extraction-container again, be decompressed to normal pressure after, take out extract, other puts clean vessel, and is airtight; Collect medicinal residues, stand-by;
(4) with step (3) medicinal residues, put in the reaction pot that condenser is housed, add 4 times of water gagings, 2 times of water gagings are fried in shallow oil secondary; Collect condenser ethereal oil aqueous mixtures, standby; Waste and even secondary decocting liquid filter, and add oil water mixture in the filtrate, mix, and are evaporated to the 1.0-1.18 thick paste, add step (3) extract, mix, and vacuum drying is ground into 380 orders-450 order impalpable powder to dried mastic, and is standby;
Two, Liposomal formulation preparation
(1) above-mentioned impalpable powder is placed in the container, added distilled water to scale, water-bath keeps temperature for 65 ℃-80 ℃, is stirred to dissolving; Put into the Radix Glycyrrhizae extract of being made up of 1: 1 glycyrrhizin mono-ammonium and monopotassium salt again, be stirred to dissolving, solution is put in the container with ultrasonic wavelength, output ultrasonic wave is long; With lecithin or other lipid adjuvants and conventional pharmaceutic adjuvant, put in 65 ℃ of-100 ℃ of water-baths, mix, melt, be the transparent liquor separator that promptly moves; Take advantage of heat to drip/min with 30-45, be instilled in the medicinal liquid of putting the ultrasound wave container, appropriateness is mixed; Instillation finishes, and keeps the ultrasound wave long hair and gives birth to 12-25min, closes generator, and liposome is sucked aseptic canning machine, fill;
(2) the liposome bottle after canned is put into the ultralow temperature drying baker, in-45 ℃--dry freeze 10-15h in 60 ℃, stablize dry 4-6h in 35 ℃ of-45 ℃ of cryostates, promptly.
5, the application of Chinese medicine liposome according to claim 1 in preparation treatment Type B viral hepatitis, the Fibrotic medicine of control hepatocyte.
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| CN 02155056 CN1283308C (en) | 2002-12-20 | 2002-12-20 | Chinese medicime liposome for treating viral hepatitis B and preventing liver cell from fibriform and preparing method thereof |
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| CN 02155056 CN1283308C (en) | 2002-12-20 | 2002-12-20 | Chinese medicime liposome for treating viral hepatitis B and preventing liver cell from fibriform and preparing method thereof |
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| CN1283308C true CN1283308C (en) | 2006-11-08 |
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