CN104826019A - Traditional Chinese medicine composition for treating hepatitis B with hepatic fibrosis - Google Patents
Traditional Chinese medicine composition for treating hepatitis B with hepatic fibrosis Download PDFInfo
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Abstract
The invention belongs to the technical field of medicines and particularly relates to a traditional Chinese medicine composition for treating hepatitis B with hepatic fibrosis. The traditional Chinese medicine composition comprises the following components: 16-18 parts of silybum marianum, 10-12 parts of phyllanthus urinaria, 10-12 parts of manyleaf paris rhizome, 8-10 parts of curcuma aromatica, 6-9 parts of angelica, 8-10 parts of red paeony root, 6-8 parts of rhizoma sparganii, 10-12 parts of kelp, 10-12 parts of atractylodes macrocephala and 8-12 parts of concha arcae. The traditional Chinese medicine composition provided by the invention has the efficacies of activating blood circulation, nourishing liver, dispersing blood stasis, removing toxicity, soothing liver and strengthening spleen, has a remarkable curative effect on treating hepatitis B with hepatic fibrosis, is convenient to take, has no toxic or side effect and is worthy of clinical popularization and application.
Description
Technical field
The invention belongs to medical art, be specifically related to a kind of Chinese medicine composition for the treatment of hepatitis B and hepatic fibrosis.
Background technology
Hepatic fibrosis is that various chronic hepatopathy is not healed for a long time, and healing reaction hindered by the plane of hepatic injury caused by a variety of causes, hepatocyte is inflamed and necrosis, stimulates the synthetics and degradation dysequilibrium of hepatic tissue cell epimatrix, causes the pathological process of fibrous connective tissue abnormal deposition in liver.Hepatic fibrosis sees most of chronic hepatopathys that the reasons such as hepatitis virus, ethanol, medicine, schistosomicide cause, be chronic hepatopathy to cirrhosis progress must through pathological process.The main cause that population of China hepatic fibrosis occurs is viral hepatitis.In recent years, along with constantly increasing of Incidence Rate of Hepatitis B, the sickness rate of hepatic fibrosis is also in the trend risen year by year.The clinical manifestation of patients with liver fibrosis mainly contains poor appetite, weak, abdominal distention, even there will be the danger such as liver blood circulatory disturbance and esophageal veins burst hemorrhage disease, had a strong impact on physical and mental health and the life security of patient time serious.
Although western medical treatment hepatic fibrosis has the effects such as antiviral, anti-hepatic fibrosis, immunomodulating, determine the course for the treatment of, it also has obvious deficiency, and such as not all applicable to all liver fibrosis patients, side effect is obvious, expensive.The traditional Chinese medical science thinks that the major pathogenetic factor of hepatic fibrosis is that the evil of diseases caused by exogenous pathogenic factor epidemic disease poison invades and harasses body and positive QI-insufficiency, visceral dysfunction combined effect.Clinical in TCM Syndrome Type, with benefiting QI for activating blood circulation, blood-activating analgetic, soothing liver and strengthening spleen for method for the treatment of, make the capable then blood of gas, the blood then stasis of blood is removed, and gas is along then stagnation resolvation.And traditional Chinese medical herbal treatment primary disease safety, few side effects, to gastrointestinal tract not damaged, cure the disease and effect a permanent cure, applied widely, there are very outstanding advantage and bright prospects, therefore develop the Chinese medicine preparation for the treatment of hepatic fibrosis safely and effectively necessary.
Summary of the invention
One is the object of the present invention is to provide to have prescription rigorous, compatibility science, evident in efficacy, curative effect of medication can be played to greatest extent, and easy to prepare, patient compliance is good, the Chinese medicine composition of the treatment hepatitis B and hepatic fibrosis had no side effect.For achieving the above object, technical scheme provided by the invention is the Chinese medicine composition of described treatment hepatitis B and hepatic fibrosis, it is characterized in that described Chinese medicine composition is made up of the medicine of following weight: Herba Silybi mariani 16-18 part, Herba Phyllanthi Urinariae 10-12 part, Rhizoma Paridis 10-12 part, Radix Curcumae 8-10 part, Radix Angelicae Sinensis 6-9 part, Radix Paeoniae Rubra 8-10 part, Rhizoma Sparganii 6-8 part, Thallus Laminariae (Thallus Eckloniae) 10-12 part, Rhizoma Atractylodis Macrocephalae 10-12 part, Concha Arcae 8-12 part.
Most preferred technique scheme of the present invention is that Chinese medicine composition of the present invention is obtained by the crude drug of following weight: Herba Silybi mariani 17 parts, Herba Phyllanthi Urinariae 11 parts, Rhizoma Paridis 11 parts, Radix Curcumae 9 parts, Radix Angelicae Sinensis 8 parts, Radix Paeoniae Rubra 9 parts, Rhizoma Sparganii 7 parts, Thallus Laminariae (Thallus Eckloniae) 11 parts, the Rhizoma Atractylodis Macrocephalae 11 parts, Concha Arcae 10 parts.
The dosage form of above-mentioned Chinese medicine composition is oral formulations.
Above-mentioned oral formulations is oral liquid or granule.
Above-mentioned oral formulations is that the preparation method step of oral liquid is as follows: take above Chinese medicine component according to aforesaid ratio and be ground into coarse powder respectively; Add water warm macerating 2 hours, decocts twice, each 3 hours, merges decoction liquor, filters; When filtrate is concentrated into 80 DEG C, relative density is the clear paste of 1.05 ~ 1.10, slowly adds ethanol, make alcohol content reach 75% when being chilled to 40 DEG C, stir, leave standstill 12 hours, filter, reclaim ethanol extremely without alcohol taste, add water appropriate, regulate pH value to 7.0 with 40% sodium hydroxide solution, cold preservation 72 hours, filter, filtrate adds appropriate amount of auxiliary materials, fill sterilizing and get final product.
Above-mentioned oral formulations is that the preparation method of granule has the following steps: take above Chinese medicine component according to aforesaid ratio and be ground into coarse powder respectively; Add water warm macerating 2 hours, decocts twice, each 3 hours, merges decoction liquor, filters; When filtrate is concentrated into 80 DEG C, relative density is the clear paste of 1.05 ~ 1.10, adds appropriate dextrin and sucrose soft material, makes wet granular and cross 16 mesh sieves, and dry, granulate, sieves again, and pack is packed and be get final product.
The present invention relatively and prior art, has following clear superiority:
First, Chinese medicine composition prescription of the present invention mainly develops according to the pathogenic characteristic of hepatitis B and hepatic fibrosis patient, Herba Silybi mariani in side, Herba Phyllanthi Urinariae, Rhizoma Paridis, heat-clearing and toxic substances removing, hepatic cholagogic; Radix Curcumae, Radix Angelicae Sinensis, enriches blood and invigorates blood circulation, promoting QI circulation for relieving depression; Radix Paeoniae Rubra, Rhizoma Sparganii, removing blood stasis circulation of qi promoting, eliminating stasis to stop pain; Thallus Laminariae (Thallus Eckloniae), Concha Arcae, hard masses softening and resolving, expectorant blood stasis dispelling; The Rhizoma Atractylodis Macrocephalae, invigorating the spleen and benefiting QI, dampness diuretic.Full side play altogether enrich blood invigorate blood circulation, the effect of dissolving blood stasis and detoxication, soothing liver and strengthening spleen, have extremely strong specific aim curative effect to hepatitis B and hepatic fibrosis.Through clinical practice checking, its determined curative effect, mild in medicine property and, do not occur toxic and side effects and untoward reaction, safety coefficient is high.Chinese medicine preparation of the present invention adopts advanced extraction equipment and technique, abundant effective component extracting, can be made into and facilitates Chinese medicine preparation that is oral or that carry.
Further, in Chinese medicine composition of the present invention, the function of each crude drug and function cure mainly:
Herba Silybi mariani is bitter, cool.Heat-clearing and toxic substances removing, protects the liver, function of gallbladder promoting, protects brain, anti-X-ray.All there is good efficacy to liver, the scorching diseases of gallbladder such as inflammation around acute or chronic hepatitis, liver cirrhosis, fatty liver, metabolism toxic liver injury, cholelithiasis, cholangitis and hepatic duct, hepatopathy patient subjective symptoms and some biochemical index can be made as serum bilirubin, improvement rapidly such as white Anhui and ball Anhui coefficient, prothrombing, glutamate pyruvate transaminase etc.
Herba Phyllanthi Urinariae, sweetness and bitterness, cool.Calming liver and clearing heat, promoting diuresis to remove toxic substance.Control enteritis, dysentery, infectious hepatitis, oedema due to nephritis, urinary tract infection, infantile malnutrition, acute catarrhal conjunctivitis corneal nebula, aphtha head sore, innominate toxic swelling.
Rhizoma Paridis is bitter; Cold; Liver Channel; Heat-clearing and toxic substances removing; Reducing swelling and alleviating pain; Cool liver arresting convulsion.Main carbuncle sore tumefacting virus; Pharyngeal swelling sore throat; Acute mastitis; Snake bite and insect sting; Traumatic pain; Liver-heat is twitched.
Radix Curcumae, acrid in the mouth; Bitter; The heart cold in nature; Liver; Gallbladder meridian; Promoting blood circulation and stopping pain; Promoting QI circulation for relieving depression; Clear away heart-fire removing heat from blood; Depressed liver-energy dispersing and function of gallbladder promoting.The all pains of main breast abdomen side of body rib; Dysmenorrhes; Amenorrhea; Lump in the abdomen lumps; Calentura coma; Demented; Infantile convulsion; Spit blood; Be defeated in battle standby; Stranguria with blood; Sand Stranguria; Jaundice.
Radix Angelicae Sinensis, sweet, acrid, warm.Return liver, the heart, spleen channel.Enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.For blood deficiency and yellow complexion, dizzy cardiopalmus, menoxenia, amenorrhea dysmenorrhea, asthenia cold abdominalgia, dryness of the intestine constipation, rheumatic arthralgia, injury from falling down, ulcer sores.
Radix Paeoniae Rubra, bitter, be slightly cold.Return Liver Channel.Clearing away heat and cooling blood, eliminating stasis to stop pain.For maculae caused by violent heat pathogen, hematemesis and epistaxis, conjunctival congestion and swelling pain, hypochondriac pain due to stagnation of liverQI, amenorrhea dysmenorrhea ， mass in the abdomen is suffered from abdominal pain, injury from falling down, carbuncle skin infection.
Rhizoma Sparganii, toil, flat.Enter liver.Spleen channel.Removing blood stasis, circulation of qi promoting, removing food stagnancy, pain relieving.Zhi lumps in the chest and abdomen, coagulation of QI-blood, trusted subordinate's pain, the lower swollen pain of the side of body, amenorrhea, postnatal blood stasis is suffered from abdominal pain, traumatic injury.Skin ulcer swells hard.
Thallus Laminariae (Thallus Eckloniae) is salty, cold.Return liver, stomach, kidney channel.Hard masses softening and resolving, expectorant, diuretic.For goiter, scrofula, painful and swollen testis, phlegm retention edema.
The Rhizoma Atractylodis Macrocephalae, bitter in the mouth; Sweet; Warm in nature; Return spleen; Stomach warp; Invigorating the spleen and benefiting QI; Dampness diuretic; Hidroschesis; Antiabortive.Main deficiency-weakness of spleen-QI; Spiritlessness and weakness; The few abdominal distention of lack of appetite; Large loose stool is thin; Fluid-retention stagnating in the interior; Dysuria; Edema; Dizziness due to fluid-retention; Temperature numbness is ached; Spontaneous sweating due to deficiency of QI; Frequent fetal movement.
Concha Arcae is salty, flat.Return lung, stomach, Liver Channel.Expectorant blood stasis dispelling, hard masses softening and resolving, relieving gastric hyperacidity to alleviate stomachache.For the long-pending knot of pertinacious phlegm, sticky difficulty is coughed up, goiter, scrofula ， mass in the abdomen mass in the abdomen, stomachache pantothenic acid.
The present invention also asks the purposes protecting above-mentioned Chinese medicine composition in the medicine of preparation treatment hepatitis B and hepatic fibrosis.In clinical observation process, 60 routine hepatitis B and hepatic fibrosis patients are divided into two groups to treat at random, after two courses for the treatment of terminate, use the treatment group curative effect total effective rate 93.3% of invention formulation treatment, the matched group total effective rate 76.7% of oral Diammonium Glycyrrhizinate enteric coated capsule and compound vitamin B.Treatment group is apparently higher than matched group, and difference has statistical significance (P < 0.05).In treatment group therapeutic process, vital sign steadily and without serious adverse reactions such as allergy, treatment terminates rear lab index routine blood test, electrocardiogram etc. to the routine patient for the treatment of group 30 and carries out statistical procedures, shows no obvious abnormalities.Result shows that the clinical application of we is safely and effectively, is worth studying and applying further.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, but the present invention is not limited only to following specific embodiment.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.
Embodiment 1 oral liquid
The each raw material of the present invention is taken: Herba Silybi mariani 17 parts, Herba Phyllanthi Urinariae 11 parts, Rhizoma Paridis 11 parts, Radix Curcumae 9 parts, Radix Angelicae Sinensis 8 parts, Radix Paeoniae Rubra 9 parts, Rhizoma Sparganii 7 parts, Thallus Laminariae (Thallus Eckloniae) 11 parts, the Rhizoma Atractylodis Macrocephalae 11 parts, Concha Arcae 10 parts by following weight portion.
Preparation technology is as follows:
Take above Chinese medicine component according to aforesaid ratio and be ground into coarse powder respectively; Add water warm macerating 2 hours, decocts twice, each 3 hours, merges decoction liquor, filters; When filtrate is concentrated into 80 DEG C, relative density is the clear paste of 1.05 ~ 1.10, slowly adds ethanol, make alcohol content reach 75% when being chilled to 40 DEG C, stir, leave standstill 12 hours, filter, reclaim ethanol extremely without alcohol taste, add water appropriate, regulate pH value to 7.0 with 40% sodium hydroxide solution, cold preservation 72 hours, filter, filtrate adds appropriate amount of auxiliary materials, and namely fill sterilizing obtains oral liquid of the present invention.
When using traditional Chinese medicine composition for treating hepatitis B and hepatic fibrosis of the present invention, take prepared oral liquid, every bottle of 10ml is containing crude drug amount 5g, every day 3 times, each 1 bottle, bfore meals.
Embodiment 2 granule
The each raw material of the present invention is taken: Herba Silybi mariani 17 parts, Herba Phyllanthi Urinariae 11 parts, Rhizoma Paridis 11 parts, Radix Curcumae 9 parts, Radix Angelicae Sinensis 8 parts, Radix Paeoniae Rubra 9 parts, Rhizoma Sparganii 7 parts, Thallus Laminariae (Thallus Eckloniae) 11 parts, the Rhizoma Atractylodis Macrocephalae 11 parts, Concha Arcae 10 parts by following weight portion.
Preparation technology is as follows:
Take above Chinese medicine component according to aforesaid ratio and be ground into coarse powder respectively; Add water warm macerating 2 hours, decocts twice, each 3 hours, merges decoction liquor, filters; When filtrate is concentrated into 80 DEG C, relative density is the clear paste of 1.05 ~ 1.10, adds appropriate dextrin and sucrose soft material, makes wet granular and cross 16 mesh sieves, and dry, granulate, sieves again, pack packaging both granule of the present invention.
When using traditional Chinese medicine composition for treating hepatitis B and hepatic fibrosis of the present invention, take prepared granule, every bag contains crude drug amount 5g, every day 3 times, each 1 bag, bfore meals.
Embodiment 3
The each raw material of the present invention is taken: Herba Silybi mariani 16 parts, Herba Phyllanthi Urinariae 10 parts, Rhizoma Paridis 10 parts, Radix Curcumae 8 parts, Radix Angelicae Sinensis 6 parts, Radix Paeoniae Rubra 8 parts, Rhizoma Sparganii 6 parts, Thallus Laminariae (Thallus Eckloniae) 10 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, Concha Arcae 8 parts by following weight portion.
Preparation technology is with embodiment 1.
Embodiment 4
The each raw material of the present invention is taken: Herba Silybi mariani 18 parts, Herba Phyllanthi Urinariae 12 parts, Rhizoma Paridis 12 parts, Radix Curcumae 10 parts, Radix Angelicae Sinensis 9 parts, Radix Paeoniae Rubra 10 parts, Rhizoma Sparganii 8 parts, Thallus Laminariae (Thallus Eckloniae) 12 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, Concha Arcae 12 parts by following weight portion.
Preparation technology is with embodiment 1.
The clinical observation of embodiment 5 traditional Chinese medicine composition for treating hepatitis B and hepatic fibrosis of the present invention
1, case physical data: select hospital outpatient and ward to meet hepatitis B and hepatic fibrosis patient 60 example.Be divided into treatment group 30 example and matched group 30 example at random, two groups of patients data comparing difference not statistically significant (P > 0.05) in sex, age and the state of an illness etc., has comparability.In table 1.The inclusion criteria of object of study is: 1. HbsAg testing result is positive patient.2. the patient that all extremely increases of the clinical indices such as hyaluronic acid, Collagen type Ⅳ, type III precollagen and the hepatic fibrosis of IV Collagen Type VI.The exclusion standard of object of study is: 1. merge serious cardiovascular, kidney, endocrine, blood system, nervous system disease and psychiatric patient.2. Alcoholic, Drug, heritability, immunity, other viral hepatopathies.3. anemia of pregnant woman or women breast-feeding their children.
Table 1 case physical data compares
2, Therapeutic Method:
Treatment group: oral liquid prepared by the oral embodiment of the present invention 1, every bottle of 10ml is containing crude drug amount 5g, every day 3 times, each 1 bottle, bfore meals.
Matched group: oral administered compound shell liver softening tablet (being produced by NeiMenggu FuRuiZhong MengYao Science Co., Ltd, the accurate word Z19991011 of traditional Chinese medicines), each 4,3 times on the one.
At medication treatments period, two groups of other any medicines having anti-hepatic fibrosis or protect the liver of all stopping using 3 months were 1 course for the treatment of.Withdrawal after 2 courses for the treatment of, and carry out therapeutic evaluation.
3, Comprehensive Clinical criterion of therapeutical effect
With reference to " hepatic fibrosis combination of Chinese and Western medicine practice guidelines " that hepatopathy Professional Committee of CAIM (Chinese Association Of Integrative Medicine) works out in August, 2006, specific as follows:
(1) effective: gan xian fang (HA, PC-III, IV-C and LN content, lower with) more than two measured values are comparatively treated front decline >=50% or recovered normal; Serum liver functional parameter substantially recovers normal and (or) checks that Liver Fibrosis Stages declined for >=2 phases through liver histopathology, and card Hou Mingxian improves.
(2) effective: gan xian fang has any two measured values comparatively to treat front decline >=25%; Serum liver functional parameter improves and (or) liver histopathology checks that Liver Fibrosis Stages declined for 1 phase before comparatively treating, card Hou Gaishan.
(3) invalid: not reach effective standard person.
4, therapeutic effect:
In clinical observation process, 60 routine patients all complete clinical observation.After 2 courses for the treatment of terminate, improve the comparison (referring to table 2) of situation according to two groups of patient's hepatic fibrosis indexs, treatment group is obviously better than matched group; According to Comprehensive Clinical comparitive study, the routine hepatitis B and hepatic fibrosis clinical patients for the treatment of group 30, effective 16 examples, effective 12 examples, invalid 2 examples, total effective rate reaches 93.3%.Effective 8 examples of the routine patient of matched group 30, effective 15 examples, invalid 7 examples, total effective rate 76.7%.Two groups of therapeutic outcomes compare, treatment group clinical effectiveness in total effective rate more remarkable (referring to table 3).In addition, in treatment group therapeutic process, vital sign is steadily and without serious adverse reactions such as allergy, treatment terminates rear lab index routine blood test, routine urinalysis, electrocardiogram etc. to treatment group patient and carries out statistical procedures, shows no obvious abnormalities.Result shows that the clinical application of we is safely and effectively, is worth studying and applying further.
Table 2 liang group patient hepatic fibrosis index improves the comparison (X ± S) of situation
Table 3 Comprehensive Clinical comparitive study
| Grouping | n | Effective | Effectively | Invalid | Total effective rate |
| Treatment group | 30 | 16 | 12 | 2 | 93.3％ |
| Matched group | 30 | 8 | 15 | 7 | 76.7％ |
Claims (7)
1. treat the Chinese medicine composition of hepatitis B and hepatic fibrosis for one kind, it is characterized in that, its crude drug primarily of following weight portion obtains: Herba Silybi mariani 16-18 part, Herba Phyllanthi Urinariae 10-12 part, Rhizoma Paridis 10-12 part, Radix Curcumae 8-10 part, Radix Angelicae Sinensis 6-9 part, Radix Paeoniae Rubra 8-10 part, Rhizoma Sparganii 6-8 part, Thallus Laminariae (Thallus Eckloniae) 10-12 part, Rhizoma Atractylodis Macrocephalae 10-12 part, Concha Arcae 8-12 part.
2. a kind of Chinese medicine composition for the treatment of hepatitis B and hepatic fibrosis as claimed in claim 1, it is characterized in that, its crude drug primarily of following weight portion obtains: Herba Silybi mariani 17 parts, Herba Phyllanthi Urinariae 11 parts, Rhizoma Paridis 11 parts, Radix Curcumae 9 parts, Radix Angelicae Sinensis 8 parts, Radix Paeoniae Rubra 9 parts, Rhizoma Sparganii 7 parts, Thallus Laminariae (Thallus Eckloniae) 11 parts, the Rhizoma Atractylodis Macrocephalae 11 parts, Concha Arcae 10 parts.
3. a kind of Chinese medicine composition for the treatment of hepatitis B and hepatic fibrosis as described in claim 1,2, it is characterized in that, described Chinese medicine composition is oral formulations.
4. a kind of Chinese medicine composition for the treatment of hepatitis B and hepatic fibrosis as claimed in claim 3, it is characterized in that, described oral formulations is oral liquid or granule.
5. a kind of Chinese medicine composition for the treatment of hepatitis B and hepatic fibrosis as claimed in claim 4, it is characterized in that, above-mentioned oral formulations is that the preparation method step of oral liquid is as follows: take above Chinese medicine component according to aforesaid ratio and be ground into coarse powder respectively; Add water warm macerating 2 hours, decocts twice, each 3 hours, merges decoction liquor, filters; When filtrate is concentrated into 80 DEG C, relative density is the clear paste of 1.05 ~ 1.10, slowly adds ethanol, make alcohol content reach 75% when being chilled to 40 DEG C, stir, leave standstill 12 hours, filter, reclaim ethanol extremely without alcohol taste, add water appropriate, regulate pH value to 7.0 with 40% sodium hydroxide solution, cold preservation 72 hours, filter, filtrate adds appropriate amount of auxiliary materials, fill sterilizing and get final product.
6. a kind of Chinese medicine composition for the treatment of hepatitis B and hepatic fibrosis as claimed in claim 4, it is characterized in that, the preparation method of described granule has the following steps: take above Chinese medicine component according to aforesaid ratio and be ground into coarse powder respectively; Add water warm macerating 2 hours, decocts twice, each 3 hours, merges decoction liquor, filters; When filtrate is concentrated into 80 DEG C, relative density is the clear paste of 1.05 ~ 1.10, adds appropriate dextrin and sucrose soft material, makes wet granular and cross 16 mesh sieves, and dry, granulate, sieves again, and pack is packed and be get final product.
7. the purposes of the medicine as described in claim 1,2 in the medicine of preparation treatment hepatitis B and hepatic fibrosis.
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