CN1319411A - Traditional Chinese medicine compound preparation for treating chronic hepatitis B and preparation process thereof - Google Patents
Traditional Chinese medicine compound preparation for treating chronic hepatitis B and preparation process thereof Download PDFInfo
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Abstract
The present invention relates to a Chinese medicine compound preparation for curing chronic hepatitis B and its preparation method. Said Chinese meeicine compound preparation contains the Chinese medicinal materials of phyllanthus, sargassum, hedryotis, white mustard seed, zedoary, poria, or also contains the Chinese medicinal materials of salvia root, bushy knotweed root, astragalus root, or also contains the Chinese medicinal materials of smooth greenbrier root, notoginseng and atractylodes root, and its preparation method can includes the following steps: decoction in water, alcohol precipitation, concentration, diacolation, combining leaching liquor, recovering ethyl alcohol, drying, making extract, grinding into powder, making them into capsule, granules preparation and tablet preparation by adding excipient.
Description
The invention belongs to pure compound Chinese medicinal preparation and preparation method, specifically is a kind of prescription and preparation method that contains the treatment chronic hepatitis B of Chinese medicines compositions such as Cacumen Securinegae Suffruticosae, Sargassum, Herba Hedyotidis Diffusae, Semen Sinapis Albae, Rhizoma Curcumae, Poria.
Chronic hepatitis B is a kind of sickness rate height, is difficult for curing, and has a strong impact on healthy disease, has not before still had special effect agent.There is abundant Chinese material medicine resource in China, and the Chinese medicine preparation that the research and development Chinese crude drug is made the treatment chronic hepatitis B is national research of technique problem, and is significant.
The object of the present invention is to provide a kind of compound Chinese medicinal preparation and preparation method for the treatment of chronic hepatitis B, this compound preparation should have the clinical symptoms of improvement and sign, suppresses virus replication; eliminate the cause of disease, regulate immunologic function, the protection hepatocyte; recover liver function; the effect of control hepatic fibrosis, it acts on comprehensively and balance, significantly and lastingly; and the medicine source is extensive; cheap, taking convenience, no obvious toxic-side effects.
To achieve the object of the present invention, according to the etiology and pathogenesis of chronic hepatitis B be because of the evil invasion and attack of damp and hot poison, expectorant stagnate, due to the stasis of blood resistance, adopt detoxify, reduce phlegm, the method for treatment of repercussive filters out through proved recipe, makes capsule, or granule, or tablet.Select monarch drug in the Cacumen Securinegae Suffruticosae side of being for use, Sargassum, Herba Hedyotidis Diffusae, Semen Sinapis Albae, Rhizoma Curcumae, Poria etc. are Fang Zhongchen, adjuvant drug.Cacumen Securinegae Suffruticosae, cool in nature, sweet in the mouth, little hardship are gone into liver, lung meridian, and clearing away heat-damp and promoting diuresis antidotal effect is arranged, and bibliographical information, this medicine be in vivo in (duck hepatitis B animal model), outer (2.215 cell) antivirus test, can obviously suppress the expression of hepatitis B virus and duplicate; In the immunologic function test, the effect of regulating immunologic function is arranged.Sargassum, cold in nature, bitter in the mouth, salty, eliminating phlegm and softening indurated mass, diuretic, with Cacumen Securinegae Suffruticosae mutually 5, principal drug assistance is to separate phlegm-damp and the damp and hot malicious heresy trouble of knot of fighting mutually.Herba Hedyotidis Diffusae, or Rhizoma Smilacis Glabrae, or Rhizoma Polygoni Cuspidati, heat-clearing and toxic substances removing, dampness removing matches with Cacumen Securinegae Suffruticosae, strengthening the effect of heat-clearing and toxic substances removing, more than ministerial drug in a few flavor medicines side of being.All ministers help mutually, more add the detoxifcation clears phlegm.Semen Sinapis Albae, hot, warm, expectorant powder junction, promoting the circulation of QI is harmonious with Sargassum, two medicine using medicines of both cold and hot natures simultaneously, pungent drugs can disperse and bitter drugs can descend removes the persistent ailment of internal organs meridians altogether; Rhizoma Curcumae, or Radix Salviae Miltiorrhizae, or Radix Notoginseng, blood circulation promoting and blood stasis dispelling, with Sargassum, Semen Sinapis Albae mutually 5, removing the fraud of stagnation of phlegm blood stasis, the gluing of the expectorant stasis of blood, Rhizoma Curcumae still can circulation of qi promoting, and circulation of qi promoting both can help reduce phlegm, and can be beneficial to blood stasis dispelling again; Poria, or the Rhizoma Atractylodis Macrocephalae, or the Radix Astragali, invigorating the spleen for eliminating dampness, not only there is the meaning of " see the disease of liver, knowing the liver disease will be transmitted into the spleen is worked as earlier tonifying the spleen " side with Poria, and is the strong fortune of temper, can " give birth to the source of expectorant " clearly, promotes the biochemistry of QI and blood, Gu the foundation of acquired constitution.Go up adjuvant drug in several flavors side of being.The all medicines in full side share, and play detoxifcation altogether, reduce phlegm, the effect of repercussive, make the chronic hepatitis B patient epidemic disease caused by damp-heat pathogen malicious clearly, and phlegm-damp is dissolved, and blood stasis dissipates, thereby the irritability bar reaches, and temper is strong transports, and vital QI recovered after pathogens eliminated is then recovered.
The compound Chinese medicinal preparation of treatment chronic hepatitis B of the present invention is capsule, granule or the tablet that contains Cacumen Securinegae Suffruticosae, Sargassum, Herba Hedyotidis Diffusae, Semen Sinapis Albae, Rhizoma Curcumae, Poria, and the dried raw material weight of its composition is than being Cacumen Securinegae Suffruticosae: Sargassum: Herba Hedyotidis Diffusae: Semen Sinapis Albae: Rhizoma Curcumae: Poria=100: (30-60): (30-90): (10-60): (10-60): (10-60).Corilagin content＞0.3mg/ grain in the preparation,＞the 1.8mg/ bag,＞the 0.2mg/ sheet.The compound Chinese medicinal preparation of this treatment chronic hepatitis B is capsule, granule or the tablet that contains Cacumen Securinegae Suffruticosae, Sargassum, Herba Hedyotidis Diffusae, Semen Sinapis Albae, Rhizoma Curcumae, Poria, Rhizoma Polygoni Cuspidati, Radix Salviae Miltiorrhizae, the Radix Astragali, and the dried raw material weight of its composition is than being Cacumen Securinegae Suffruticosae: Sargassum: Herba Hedyotidis Diffusae: Semen Sinapis Albae: Rhizoma Curcumae: Poria: Rhizoma Polygoni Cuspidati: Radix Salviae Miltiorrhizae: the Radix Astragali=100: (30-60); (30-90): (10-60): (10-60): (10-60): (30-90): (30-90): (30-90), corilagin content＞0.3mg/ grain in the preparation,＞the 1.8mg/ bag,＞the 0.2mg/ sheet.The compound Chinese medicinal preparation of this treatment chronic hepatitis B is capsule, granule or the tablet that contains Cacumen Securinegae Suffruticosae, Sargassum, Herba Hedyotidis Diffusae, Semen Sinapis Albae, Rhizoma Curcumae, Poria, the Rhizoma Atractylodis Macrocephalae, Rhizoma Smilacis Glabrae, Radix Notoginseng, the Radix Astragali, and the dried raw material weight of its composition is than being Cacumen Securinegae Suffruticosae: Sargassum: Herba Hedyotidis Diffusae: Semen Sinapis Albae: Rhizoma Curcumae: Poria: the Rhizoma Atractylodis Macrocephalae: Rhizoma Smilacis Glabrae: Radix Notoginseng: the Radix Astragali=100: (30-60): (30-90): (10-60): (10-60): (10-60): (10-60): (10-60): (10-60): (30-90).Corilagin content＞0.3mg/ grain in the preparation,＞the 1.8mg/ bag,＞the 0.2mg/ sheet.
The preparation method of this compound preparation is by described formula proportion, gets Cacumen Securinegae Suffruticosae to add＞10 times of water that medical material is, and soak time＞0.5 hour, decocting time＞0.5 hour decocts 1-3 time.Decoction liquor 45-75% ethanol precipitate with ethanol, filtering and concentrating, 1. drying under reduced pressure gets dry extract; Get Sargassum, Poria, or add the Radix Astragali, Radix Salviae Miltiorrhizae, or add the Radix Astragali, Radix Notoginseng, the Rhizoma Atractylodis Macrocephalae and decoct with water, decoction liquor is concentrated, with 40-60% ethanol precipitate with ethanol, decompression, concentrate, dry, dry extract 2.; Get Herba Hedyotidis Diffusae, or add Rhizoma Polygoni Cuspidati, or add 50-70% soak with ethanol＞12 hour of 12 times of amounts of Rhizoma Smilacis Glabrae adding＞medical material, with the speed percolation of＞3ml/min, medicinal residues concentrate precipitate with ethanol, and alcohol deposit fluid and percolate merge, and reclaim ethanol, drying under reduced pressure, dry extract 3.; Get co-extracted in the Herba Hedyotidis Diffusae medicinal residues that the Semen Sinapis Albae input boils; Get Rhizoma Curcumae and be ground into fine powder, get the Rhizoma Curcumae powder 4.; 1. the 2. 3. 4. thing mixing moistening granulation of ethanol, drying under reduced pressure, granulate is encapsulated, is sub-packed in the polyethylene bottle through being up to the standards.Or drying under reduced pressure, make granule, pack in the packaging bag of aluminum platinum, be sub-packed in the carton through being up to the standards.Or the adding excipient, break into tablet, be sub-packed in the polyethylene bottle through being up to the standards, or after packing with aluminum platinum plate, be sub-packed in the carton.The corilagin content of above-mentioned three kinds of method products obtained therefroms is respectively＞the 0.3mg/ grain,＞the 1.8mg/ bag,＞the 0.2mg/ sheet.
In this quality of the pharmaceutical preparations control, thin layer chromatography is adopted in the discriminating of Cacumen Securinegae Suffruticosae, Herba Hedyotidis Diffusae, Rhizoma Curcumae, in the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, all show the speckle of same color.
The compound Chinese medicinal preparation of treatment chronic hepatitis B of the present invention cures mainly and called after sea pearl the liver benefiting preparation according to its medicine name, function.
This treatment chronic hepatitis B compound Chinese medicinal preparation, be in the main pharmacodynamics research of extra large pearl the liver benefiting preparation, antivirus test in the duck hepatitis B model body, three batches of experimental result promptings, said preparation can significantly reduce dhbv dna (DHBV) and infect serum DHBV-DNA level, learns by statistics and handles (p＜0.05～0.01).Medicine is to the test of 2.2.15 emiocytosis HBsAg, HBeAg influence, and three batches of experimental results show that extra large pearl the liver benefiting preparation has the obvious suppression effect to 2.2.15 emiocytosis HBeAg, and its suppression ratio is 55%.The acute liver damage test of preparation, select rat D-galactosamine (D-GlaN) acute liver damage model for use, large, medium and small each dosage of medicine all has obvious antagonism serum alanine aminotransferase (ALT), Aspartic Acid aminotransferase (AST) to increase, and the effect that improves liver tissue lesions is arranged.Said preparation has the effect of excellent protection D-GlaN rat acute hepatic injury as a result.The chronic hepatic injury test of preparation, adopt carbon tetrachloride to cause rat chronic liver meeting damage model, medicine can make hepatic injury rat blood serum ALT, alkali phosphatase (AKP) unit of activity descend, serum albumin (ALB), platelet (BPC) level are raise, improving the liver tissues of rats pathological tissue changes, reduce hydroxyprolin levels in the hepatic tissue, significant difference (P＜0.05～0.01) is relatively arranged with the pathological model group.The immunologic liver injury of preparation and immunologic function test thereof, test adopt lyophilized bacillus calmette-guerin vaccine preparation (BCG) to add the low drag of lipopolysaccharide (LPS) induced mice immunologic liver injury model and hydrocortisone or caused by cyclophosphamide immune function of mice.Experimental result shows that extra large pearl the liver benefiting preparation has following influence to immunologic liver injury and immunization thereof.1. medicine has function for protecting liver and reducing enzyme activity to immunologic liver injury.Can reduce Serum ALT, AST unit of activity (P＜0.01), reduce hepatosplenomegaly and organ coefficient (P＜0.01) thereof and alleviate the pathological lesion (P＜0.01) of hepatic tissue.2. medicine has obvious inhibitory action to the immune hyperfunction state of immunologic liver injury mice, and is similar to the effect of immunosuppressant dexamethasone.Sea pearl the liver benefiting preparation can make the phagocytic percentage of peritoneal macrophage and phagocytic index descend (P＜0.05～0.01), and serum hemolysin HC50 reduces (P＜0.01); Can make the OD value decline (P＜0.01) of the inductive spleen T of concanavalin A (ConA) lymphproliferation response.3. medicine has facilitation to the immunologic hypofunction mice, and its effect is similar to levamisole.Sea pearl the liver benefiting preparation can improve mononuclear phagocyte carbon clearance index (P＜0.01), improves the phagocytic percentage and the phagocytic index (P＜0.05～0.01) of peritoneal macrophage, improves serum hemolysin HC
50(P＜0.01) is improved the inductive splenic lymphocytes OD value of ConA (P＜0.01) and is improved the lymphoblastic percentage rate (P＜0.01) that phytohaemagglutinin (PHA) stimulates peripheral blood lymphocyte to transform.
This treatment chronic hepatitis B compound Chinese medicinal preparation, promptly extra large pearl the liver benefiting preparation toxicologic study, the said preparation acute toxicity test is very little because of drug toxicity, and the end records median lethal dose(LD 50) (LD
50).Maximum tolerated dose (MTD) is measured, and the overt toxicity reaction is seen at the end.Recording MTD is 960g/kg, is equivalent to 600 times of clinical consumption, shows that this medicine oral administration administration safety range is big.The long term toxicity test result of said preparation shows that medicine has no adverse effects to the growth promoter of rat, and body weight gain and food ration be no significant difference between administration group and matched group.Rat blood is learned and the hepatic and renal function blood biochemical is learned the detection index, also no significant difference between each administration group and matched group, and the organizational structure of the main organs of histological examination rat is normal substantially, and toxicity damage is seen at the end.Point out this medicine per os long term administration, rat is not had the overt toxicity influence.The mensuration of sea pearl the liver benefiting preparation heavy metal and persticide residue, the utilization atomic absorption spectrophotometer adopts graphite furnace method, chloride genetic method etc. to carry out content of beary metal detections such as extra large pearl the liver benefiting preparation cadmium, female, plumbous, hydrargyrum; The mensuration of persticide residue adopts gas chromatography, has detected the residual quantity of extra large pearl the liver benefiting preparation organochlorine pesticide.Testing result proves that the content of said preparation heavy metal and pesticide remnant amount is all in the scope of safety.
The clinical research of this extra large pearl the liver benefiting preparation shows that said preparation has the clinical symptoms of improvement and sign, suppresses virus replication; eliminate the cause of disease, regulate immunologic function, the protection hepatocyte; recover liver function; the effect of control hepatic fibrosis, it acts on comprehensively and balance, significantly and lastingly; and the medicine source is extensive; cheap, taking convenience, no obvious toxic-side effects.
Embodiment 1:
In the dried raw material weight ratio of medical material is Cacumen Securinegae Suffruticosae: Sargassum: Herba Hedyotidis Diffusae: Semen Sinapis Albae: Rhizoma Curcumae: Poria=100: 30: 90: 10: 10: 60 formula proportion, and to get Cacumen Securinegae Suffruticosae and add the water that 10 times of medical materials are, soak time is after 0.5 hour, decocting time 0.5 hour.Decoction liquor is with 45% ethanol precipitate with ethanol, filtering and concentrating, drying under reduced pressure, dry extract 1.; Get Sargassum, Poria, decoction liquor is concentrated, with 40% ethanol precipitate with ethanol, 2. decompression, concentrated, dry gets dry extract; Get Herba Hedyotidis Diffusae and add 50% soak with ethanol 12 hours of 12 times of medical material amounts, with the speed percolation of 3ml/min, medicinal residues concentrate precipitate with ethanol, and alcohol deposit fluid and percolate merge, and reclaim ethanol, drying under reduced pressure, dry extract 3.; Get co-extracted in the Herba Hedyotidis Diffusae medicinal residues that the Semen Sinapis Albae input boils; Get Rhizoma Curcumae and be ground into fine powder, get the Rhizoma Curcumae powder 4.; 1. the 2. 3. 4. thing mixing moistening granulation of ethanol, drying under reduced pressure is granulated, and is encapsulated, is sub-packed in the polyethylene bottle through being up to the standards.
Embodiment 2:
In the dried raw material weight ratio of medical material is Cacumen Securinegae Suffruticosae: Sargassum: Herba Hedyotidis Diffusae: Semen Sinapis Albae: Rhizoma Curcumae: Poria=100: 60: 30: 60: 60: 10 formula proportion, press the identical process of embodiment 1 then, granulate, encapsulated, be sub-packed in the polyethylene bottle through being up to the standards.
Embodiment 3:
In the dried raw material weight ratio of medical material is Cacumen Securinegae Suffruticosae: Sargassum: Herba Hedyotidis Diffusae: Semen Sinapis Albae: Rhizoma Curcumae: Poria: Radix Salviae Miltiorrhizae: Rhizoma Polygoni Cuspidati: the Radix Astragali=100: 60: 30: 10: 60: 10: 90: 30: 30 formula proportion, get the water that Cacumen Securinegae Suffruticosae adds 15 times of medical material amounts, after the soak time 1 hour, decocting time 1 hour.Decoction liquor is with 55% ethanol precipitate with ethanol, filtering and concentrating, drying under reduced pressure, dry extract 1.; Get Sargassum, Poria, the Radix Astragali, Radix Salviae Miltiorrhizae, decoction liquor is concentrated, with 6 0% ethanol precipitate with ethanol, 2. decompression, concentrated, dry gets dry extract; Get Herba Hedyotidis Diffusae, Rhizoma Polygoni Cuspidati and add 60% soak with ethanol 24 hours of 15 times of medical material amounts, with the speed percolation of 4ml/min, medicinal residues concentrate precipitate with ethanol, and alcohol deposit fluid and percolate merge, and reclaim ethanol, drying under reduced pressure, dry extract 3.; Get co-extracted in the Herba Hedyotidis Diffusae medicinal residues that the Semen Sinapis Albae input boils; Get Rhizoma Curcumae and be ground into fine powder, get the Rhizoma Curcumae powder 4.; 1. the 2. 3. 4. thing mixing moistening granulation of ethanol, drying under reduced pressure is granulated, and is encapsulated, is sub-packed in the polyethylene bottle through being up to the standards.
Embodiment 4:
In the dried raw material weight ratio of medical material is Cacumen Securinegae Suffruticosae: Sargassum: Herba Hedyotidis Diffusae: Semen Sinapis Albae: Rhizoma Curcumae: Poria: Radix Salviae Miltiorrhizae: Rhizoma Polygoni Cuspidati: the Radix Astragali=100: 30: 90: 60: 10: 60: 30: 90: 90 formula proportion, press the identical process of embodiment 3 then, granulate, encapsulated, be sub-packed in the polyethylene bottle through being up to the standards.
Embodiment 5:
Press the dried raw material weight of medical material than being Cacumen Securinegae Suffruticosae: Sargassum: Herba Hedyotidis Diffusae: Semen Sinapis Albae: Rhizoma Curcumae: Poria: the Rhizoma Atractylodis Macrocephalae: Rhizoma Smilacis Glabrae: Radix Notoginseng: the Radix Astragali=100: 60: 30: 10: 60: 60: 10: 10: 60: 90 formula proportion, get Cacumen Securinegae Suffruticosae and add the water that 20 times of medical materials are, after the soak time 1.5 hours, decocting time 1.5 hours decocts 2 times.Decoction liquor is with 60% ethanol precipitate with ethanol, filtering and concentrating, drying under reduced pressure, dry extract 1.; Get Sargassum, Poria, the Radix Astragali, Radix Notoginseng, the Rhizoma Atractylodis Macrocephalae, decoction liquor is concentrated, with 65% ethanol precipitate with ethanol, 2. decompression, concentrated, dry gets dry extract; Get Herba Hedyotidis Diffusae, Rhizoma Smilacis Glabrae and add 65% soak with ethanol 36 hours of 20 times of medical material amounts, with the speed percolation of 5ml/min, medicinal residues concentrate precipitate with ethanol, alcohol deposit fluid and percolate merge, reclaim ethanol, drying under reduced pressure, dry extract 3.: get co-extracted in the Herba Hedyotidis Diffusae medicinal residues that the Semen Sinapis Albae input boils; Get Rhizoma Curcumae and be ground into fine powder, get the Rhizoma Curcumae powder 4.; 1. the 2. 3. 4. thing mixing moistening granulation of ethanol, drying under reduced pressure is granulated, and is encapsulated, is sub-packed in the polyethylene bottle through being up to the standards.
Embodiment 6:
In the dried raw material weight ratio of medical material is Cacumen Securinegae Suffruticosae: Sargassum: Herba Hedyotidis Diffusae: Semen Sinapis Albae: Rhizoma Curcumae: Poria: the Rhizoma Atractylodis Macrocephalae: Rhizoma Smilacis Glabrae: Radix Notoginseng: the Radix Astragali=100: 30: 90: 60: 10: 10: 60: 60: 10: 30 formula proportion, according to the identical process of embodiment 5, granulate, encapsulated, be sub-packed in the polyethylene bottle through being up to the standards.
Embodiment 7:
Press the identical medical material formula proportion of embodiment 5, get Cacumen Securinegae Suffruticosae and add the water that 20 times of medical materials are, soak time is after 1.5 hours, and decocting time 1.5 hours decocts 2 times.Decoction liquor is with 60% ethanol precipitate with ethanol, filtering and concentrating, drying under reduced pressure, dry extract 1.; Get Sargassum, Poria, the Radix Astragali, Radix Notoginseng, the Rhizoma Atractylodis Macrocephalae, decoction liquor is concentrated, with 65% ethanol precipitate with ethanol, 2. decompression, concentrated, dry gets dry extract; Get Herba Hedyotidis Diffusae, Rhizoma Smilacis Glabrae and add 65% soak with ethanol 36 hours of 20 times of medical material amounts, with the speed percolation of 5ml/min, medicinal residues concentrate precipitate with ethanol, and alcohol deposit fluid and percolate merge, and reclaim ethanol, drying under reduced pressure, dry extract 3.; Get co-extracted in the Herba Hedyotidis Diffusae medicinal residues that the Semen Sinapis Albae input boils; Get Rhizoma Curcumae and be ground into fine powder, get the Rhizoma Curcumae powder 4.; 1. the 2. 3. 4. thing mixing moistening granulation of ethanol, drying under reduced pressure is made granule, in the aluminum platinum packaging bag of packing into, is sub-packed in the carton through being up to the standards.
Embodiment 8:
Press the identical medical material formula proportion of embodiment 5, get Cacumen Securinegae Suffruticosae and add the water that 20 times of medical materials are, soak time is after 1.5 hours, and decocting time 1.5 hours decocts 2 times.Decoction liquor is with 60% ethanol precipitate with ethanol, filtering and concentrating, drying under reduced pressure, dry extract 1.; Get Sargassum, Poria, the Radix Astragali, Radix Notoginseng, the Rhizoma Atractylodis Macrocephalae, decoction liquor is concentrated, with 65% ethanol precipitate with ethanol, 2. decompression, concentrated, dry gets dry extract; Get Herba Hedyotidis Diffusae, Rhizoma Smilacis Glabrae and add 65% soak with ethanol 36 hours of 20 times of medical material amounts, with the speed percolation of 5ml/min, medicinal residues concentrate precipitate with ethanol, and alcohol deposit fluid and percolate merge, and reclaim ethanol, drying under reduced pressure, dry extract 3.; Get co-extracted in the Herba Hedyotidis Diffusae medicinal residues that the Semen Sinapis Albae input boils; Get Rhizoma Curcumae and be ground into fine powder, get the Rhizoma Curcumae powder 4.; Will be 1. 2. 3. 4. thing mixing, add excipient, break into tablet, be sub-packed in the polyethylene bottle through being up to the standards.
Embodiment 9:
Press the identical medical material formula proportion of embodiment 5, get Cacumen Securinegae Suffruticosae and add the water that 20 times of medical materials are, soak time is after 1.5 hours, and decocting time 1.5 hours decocts 2 times.Decoction liquor is with 60% ethanol precipitate with ethanol, filtering and concentrating, drying under reduced pressure, dry extract 1.; Get Sargassum, Poria, the Radix Astragali, Radix Notoginseng, the Rhizoma Atractylodis Macrocephalae, decoction liquor is concentrated, with 65% ethanol precipitate with ethanol, 2. decompression, concentrated, dry gets dry extract; Get Herba Hedyotidis Diffusae, Rhizoma Smilacis Glabrae and add 65% soak with ethanol 36 hours of 20 times of medical material amounts, with the speed percolation of 5ml/min, medicinal residues concentrate precipitate with ethanol, and alcohol deposit fluid and percolate merge, and reclaim ethanol, drying under reduced pressure, dry extract 3.; Get co-extracted in the Herba Hedyotidis Diffusae medicinal residues that the Semen Sinapis Albae input boils; Get Rhizoma Curcumae and be ground into fine powder, get the Rhizoma Curcumae powder 4.; Will be 1. 2. 3. 4. thing mixing, add excipient, break into tablet, through being up to the standards, after packing with aluminum platinum plate, be sub-packed in the carton.
Embodiment 10:
In the dried raw material weight ratio of medical material is Cacumen Securinegae Suffruticosae: Sargassum: Herba Hedyotidis Diffusae: Semen Sinapis Albae: Rhizoma Curcumae: Poria: the Rhizoma Atractylodis Macrocephalae: Rhizoma Smilacis Glabrae: Radix Notoginseng: the Radix Astragali=100: 30: 90: 60: 10: 10: 60: 60: 10: 30 formula proportion, according to the identical process of embodiment 5, granulate, encapsulated, through being up to the standards, after packing with aluminum platinum plate, be sub-packed in the carton.
Claims (6)
1, a kind of compound Chinese medicinal preparation for the treatment of chronic hepatitis B, it is characterized in that containing capsule, granule or the tablet of Cacumen Securinegae Suffruticosae, Sargassum, Herba Hedyotidis Diffusae, Semen Sinapis Albae, Rhizoma Curcumae, Poria, the dried raw material weight ratio of its composition is a Cacumen Securinegae Suffruticosae: Sargassum: Herba Hedyotidis Diffusae: Semen Sinapis Albae: Rhizoma Curcumae: Poria=100: (30-60): (30-90): (10-60): (10-60): (10-60), corilagin content＞0.3mg/ grain in the preparation,＞the 1.8mg/ bag,＞the 0.2mg/ sheet.
2, compound Chinese medicinal preparation as claimed in claim 1, it is characterized in that containing Cacumen Securinegae Suffruticosae, Sargassum, Herba Hedyotidis Diffusae, Semen Sinapis Albae, Rhizoma Curcumae, Poria, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati, the capsule of the Radix Astragali, granule or tablet, the dried raw material weight ratio of its composition is a Cacumen Securinegae Suffruticosae: Sargassum: Herba Hedyotidis Diffusae: Semen Sinapis Albae: Rhizoma Curcumae: Poria: Radix Salviae Miltiorrhizae: Rhizoma Polygoni Cuspidati: the Radix Astragali=100: (30-60): (30-90): (10-60): (10-60): (10-60): (30-90): (30-90): (30-90), and corilagin content＞0.3mg/ grain in the preparation,＞1.8mg/ bag,＞0.2mg/ sheet.
3, compound Chinese medicinal preparation as claimed in claim 1, it is characterized in that containing Cacumen Securinegae Suffruticosae, Sargassum, Herba Hedyotidis Diffusae, Semen Sinapis Albae, Rhizoma Curcumae, Poria, the Rhizoma Atractylodis Macrocephalae, Rhizoma Smilacis Glabrae, Radix Notoginseng, the capsule of the Radix Astragali, granule or tablet, the dried raw material weight ratio of its composition is a Cacumen Securinegae Suffruticosae: Sargassum: Herba Hedyotidis Diffusae: Semen Sinapis Albae: Rhizoma Curcumae: Poria: the Rhizoma Atractylodis Macrocephalae: Rhizoma Smilacis Glabrae: Radix Notoginseng: the Radix Astragali=100: (30-60): (30-90): (10-60): (10-60): (10-60): (10-60): (10-60): (30-90), and corilagin content＞0.3mg/ grain in the preparation,＞1.8mg/ bag,＞0.2mg/ sheet.
4, as the preparation method of claim 1 or 2 or 3 described compound Chinese medicinal preparation, its characterization step is to prepare burden by charge ratio according to described medical material, gets Cacumen Securinegae Suffruticosae to add＞water of 10 times of medical material amounts soak time＞0.5 hour, decocting time＞0.5 hour decocts 1-3 time.Decoction liquor 45-75% ethanol precipitate with ethanol, filtering and concentrating, 1. drying under reduced pressure gets dry extract; Get Sargassum, Poria, or add the Radix Astragali, Radix Salviae Miltiorrhizae, or add the Radix Astragali, Radix Notoginseng, the Rhizoma Atractylodis Macrocephalae and decoct with water, decoction liquor is concentrated, with 40-60% ethanol precipitate with ethanol, decompression, concentrate, dry, dry extract 2.; Get Herba Hedyotidis Diffusae, or add Rhizoma Polygoni Cuspidati, or add Rhizoma Smilacis Glabrae, 50-70% soak with ethanol＞12 of 12 times of amounts of adding＞medical material hour, with the speed percolation of＞3ml/min, medicinal residues concentrate precipitate with ethanol, alcohol deposit fluid and percolate merge, and reclaim ethanol, drying under reduced pressure, dry extract 3.; Get co-extracted in the Herba Hedyotidis Diffusae medicinal residues that the Semen Sinapis Albae input boils; Get Rhizoma Curcumae and be ground into fine powder, get the Rhizoma Curcumae powder 4.; 1. the 2. 3. 4. thing mixing moistening granulation of ethanol, drying under reduced pressure, granulate is encapsulated, makes its corilagin content in the scope that requires, and is sub-packed in the polyethylene bottle through being up to the standards.
5, the preparation method of compound Chinese medicinal preparation as claimed in claim 4, its characterization step is with the resulting 1. 2. 3. 4. thing mixing moistening granulation of ethanol, drying under reduced pressure, make granule, pack in the packaging bag of aluminum platinum, make its corilagin content in the scope that requires, be sub-packed in the carton through being up to the standards.
6, the preparation method of the described compound Chinese medicinal preparation of claim 4, its characterization step is with resulting 1. 2. 3. 4. thing mixing, add excipient, break into tablet, make its corilagin content in the scope that requires, be sub-packed in the polyethylene bottle through being up to the standards, or after packing with aluminum platinum plate, be sub-packed in the carton.
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| CN 01106436 CN1128632C (en) | 2001-01-18 | 2001-01-18 | Traditional Chinese medicine compound preparation for treating chronic hepatitis B and preparation process thereof |
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| CN 01106436 CN1128632C (en) | 2001-01-18 | 2001-01-18 | Traditional Chinese medicine compound preparation for treating chronic hepatitis B and preparation process thereof |
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| CN1128632C CN1128632C (en) | 2003-11-26 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1318050C (en) * | 2002-06-10 | 2007-05-30 | 谢邦和<Del/> | Chinese medicine for treating heaptitis B and preparation method thereof and use of charred human hair |
| CN100340286C (en) * | 2005-02-23 | 2007-10-03 | 赵东科 | Medicine for treating hepatitis B and its preparing method |
| CN101375951B (en) * | 2007-08-29 | 2012-03-07 | 北京星昊嘉宇医药科技有限公司 | Medicine composition for treating hepatitis B |
| CN104958660A (en) * | 2015-07-01 | 2015-10-07 | 陈维玉 | Traditional Chinese medicine for treating liver Qi stagnation type chronic hepatitis B and preparation method for traditional Chinese medicine |
| CN109925471A (en) * | 2017-12-19 | 2019-06-25 | 深圳市中医院 | A kind of Chinese medicine composition for treating chronic hepatitis B and precancerous lesion |
-
2001
- 2001-01-18 CN CN 01106436 patent/CN1128632C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1318050C (en) * | 2002-06-10 | 2007-05-30 | 谢邦和<Del/> | Chinese medicine for treating heaptitis B and preparation method thereof and use of charred human hair |
| CN100340286C (en) * | 2005-02-23 | 2007-10-03 | 赵东科 | Medicine for treating hepatitis B and its preparing method |
| CN101375951B (en) * | 2007-08-29 | 2012-03-07 | 北京星昊嘉宇医药科技有限公司 | Medicine composition for treating hepatitis B |
| CN104958660A (en) * | 2015-07-01 | 2015-10-07 | 陈维玉 | Traditional Chinese medicine for treating liver Qi stagnation type chronic hepatitis B and preparation method for traditional Chinese medicine |
| CN109925471A (en) * | 2017-12-19 | 2019-06-25 | 深圳市中医院 | A kind of Chinese medicine composition for treating chronic hepatitis B and precancerous lesion |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1128632C (en) | 2003-11-26 |
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