CN101879242A - Traditional Chinese medicine composition for treating chronic virus b hepatitis through immunity regulation and control - Google Patents
Traditional Chinese medicine composition for treating chronic virus b hepatitis through immunity regulation and control Download PDFInfo
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- CN101879242A CN101879242A CN 200910057165 CN200910057165A CN101879242A CN 101879242 A CN101879242 A CN 101879242A CN 200910057165 CN200910057165 CN 200910057165 CN 200910057165 A CN200910057165 A CN 200910057165A CN 101879242 A CN101879242 A CN 101879242A
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Abstract
The invention discloses a traditional Chinese medicine composition for treating chronic virus b hepatitis through immunity regulation and control, which is prepared from the following raw medicinal materials in parts by weight: 20-10 parts of glossy privet fruit, 20-10 parts of herba epimedii, 20-10 parts of ternate buttercup root, 20-10 parts of root-bark of tree peony, 10-5 parts of picrorhiza rhizome and 10-5 parts of green tangerine orange peel. Shown by clinical practice, the traditional Chinese medicine composition of the invention has immunoregulation effect similar to that of interferon, and has a certain correction effect on the immunity tolerance induced by hepatitis b virus infection.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, particularly relate to a kind of Chinese medicine composition by immunoregulation treatment chronic viral hepatitis B.
Background technology
(Chronic Viral Hepatitis B CH-B) is a kind of commonly encountered diseases of serious harm human health to chronic viral hepatitis B, and the control of CH-B is a global public health problem, has caused the concern of countries in the world government.China is the district occurred frequently of viral hepatitis, and average attack rate is 120～1,40/,100,000.Be outstanding with hepatitis B (HB) especially wherein.China's hepatitis B virus (HBV) infection rate is up to 57.63%, and promptly the whole nation has at least 600,000,000 people to infect HBV.HBsAg (hepatitis B virus surface antigen) positive rate 9.75% has 1.2 hundred million people approximately, accounts for 1/3, wherein about 1/4 of the whole world and will develop into chronic hepatopathy, and part patient can develop into liver cirrhosis, even develops into hepatocarcinoma.Have at present about existing disease CH-B patient 2,000 ten thousand people.There are every year 23.7 ten thousand people to die from the relevant disease of HB, wherein have 15.6 ten thousand people to die from hepatocarcinoma.
The maximum contribution of western medical treatment primary disease is antiviral, and main medicine has interferon and lamivudine, adefovirdipivoxil, Entecavir, for than nucleoside analogs such as furan are fixed.Interferon, nucleoside analog impel HBV DNA negative conversion rate to have 30% and 85% respectively approximately, and HBeAg (hepatitis B virus e antigen) frequence of seroconversion is about 30%.The complete response rate of antiviral drugs is not high, and has problem such as viral drug resistance, and the Western medicine of clinical practice at present is external imported medicine or imitation medicine.
Chinese medicine is the important means of China's control chronic hepatitis B, no matter the traditional Chinese medical science or doctor trained in Western medicine are all used Chinese medicine or Chinese patent medicine in treatment clinical course, Chinese medicine is the field of the tool originality of China, strengthen the research of Chinese medicine prevention chronic hepatitis B, have crucial meaning improving China's prevention and treatment for chronic hepatitis B ability and level.
Chinese medicine there is no this name of disease, yet the traditional Chinese medical science all has more detailed description to its clinical various symptoms that show, sign, belongs to categories such as " jaundice ", " hypochondriac pain ", " abdominal distention ", " gathering " respectively.With regard to its cause of disease, experience damp and hot or epidemic disease caused by damp-heat pathogen malicious be the primary cause of disease of chronic hepatitis B, positive QI-insufficiency then is the internal condition of morbidity, eating and drinking without temperance, feelings will discord etc. is a risk factor.Tire, baby, preschool period deficiency of kidney-QI, the unit of healthy energy is not enough, is difficult to get rid of evils and goes out, and multiple generate is a chb, and the postoperative infection of growing up is just arrogant because of the kidney qi foot, is enough to by evil, so mostly be acute onset.With regard to its pathogenesis, the heresy of epidemic disease caused by damp-heat pathogen poison is stopped over and is not gone, for a long time sick and kidney; Or because of damp and hot strongly fragrant fire-transformation of a specified duration, the liver-yin of burning, illness of child viscera affecting mother one then for a long time, deficiency of kidney-essence; Or,, undermine kidney yang by spleen and kidney because of liver disease affecting spleen.The symptom of damp and hot delays such as hepatic and renal YIN deficiency performance such as clinical common dizziness and tinnitus, soreness of the waist and knees, two side of body dull pain, two dryness and uneasy feeling of the eye, menoxenia, impotence and seminal emission and dry mouth with bitter taste, yellowish fur is used the kidney invigorating method clinically and has been obtained obvious curative effects for the main treatment chronic hepatopathy.More join with " interior warp ": " pathogen usually intruding into collateral in protracted disease ", hold concurrently with blood circulation promoting and blood stasis dispelling the Therapeutic Method of the heat-clearing and toxic substances removing dampness removing of holding concurrently so establish nourishing the liver and kidney.
Summary of the invention
The technical problem to be solved in the present invention provides a kind of Chinese medicine composition by immunoregulation treatment chronic viral hepatitis B, it is the rule of treatment that said composition adopts with nourishing the liver and kidney, heat-clearing and toxic substances removing dampness removing, removing heat from blood and promoting blood circulation, can treat chronic viral hepatitis B by immunoregulation.
For solving the problems of the technologies described above, Chinese medicine composition by immunoregulation treatment chronic viral hepatitis B of the present invention, be to make: 20～10 parts of Fructus Ligustri Lucidi by following bulk drugs, 20～10 parts of Herba Epimedii, 20～10 parts of Radix Ranunculi Ternatis, 20～10 parts of Cortex Moutans, 10～5 parts of Rhizoma Picrorhizae, 10～5 parts on Pericarpium Citri Reticulatae Viride.
Preferred Chinese medicine composition bulk drugs is: 15 parts of Fructus Ligustri Lucidi, 15 parts of Herba Epimedii, 15 parts of Radix Ranunculi Ternatis, 15 parts of Cortex Moutans, 9 parts of Rhizoma Picrorhizae, 9 parts on Pericarpium Citri Reticulatae Viride.
Raw medicinal material involved in the present invention is recorded Chinese medicine by Chinese Pharmacopoeia one one of version in 2005, and meets the pharmacopeia prescription.Wherein, Fructus Ligustri Lucidi is the dry mature fruit of Oleaceae plant Fructus Ligustri Lucidi Ligustrum lucidum Ait.; Herba Epimedii has another name called " Herba Epimedii " and is Berberidaceae barrenwort Herba Epimedii Epimedium grandiflorum Morr., arrow leaf Herba Epimedii E.sagittatum (Siet.Et Zucc.) Maxim., lobus cardiacus Herba Epimedii E.brevicornum Maxim. and Herba Epimedii E.koreamum Nakai, and the herb of congener; Radix Ranunculi Ternati is the dried root of the little Herba Ranunculi Japonici RanunculusternatusThunb. of ranunculaceae plant; Cortex Moutan is the rough bark of ranunculaceae peony Paeonia suffruticosa Sndr.; Rhizoma Picrorhizae is a Scrophulariaceae herbaceos perennial Rhizoma Picrorhizae Picrorhiza scrophulariiflora pennell rhizome; Pericarpium Citri Reticulatae Viride is the young fruit of rutaceae orange Citrus reticulata Blanco and variety thereof or the peel of immature fruit.
Chinese medicine composition of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into said dosage form on any pharmaceutics, as decoction, pill, granule, tablet, capsule or oral liquid, is preferably decoction.Wherein, the preparation method of decoction is that described bulk drugs is decocted with water, and merges decoction liquor, gets final product.
The The principal indications of Chinese medicine composition of the present invention is a chronic viral hepatitis B, its consumption and the course of treatment can be according to dosage forms, patient's age, the light and heavy degree of disease is done suitably to adjust, but be generally oral 2 times of every day, each 2 (sheet) (bags) (bottle), with 3 months was a course of treatment, can use 6 courses of treatment or longer time continuously, as when being prepared into decoction, be generally 1 dose of (Fructus Ligustri Lucidi 20～10g every day, Herba Epimedii 20～10g, Radix Ranunculi Ternati 20～10g, Cortex Moutan 20～10g, Rhizoma Picrorhizae 10～5g, Pericarpium Citri Reticulatae Viride 10～5g), divide 2 times oral, with 3 months be a course of treatment, can use 6 courses of treatment or longer time continuously.
The theoretical foundation of compositions of the present invention is: Chinese medicine thinks that the primary cause of disease of chronic viral hepatitis B is that impression is damp and hot or epidemic disease caused by damp-heat pathogen is malicious, and positive QI-insufficiency then is the internal condition of morbidity, and eating and drinking without temperance, feelings will discord etc. is a risk factor.Its pathogenesis is mainly: the heresy of epidemic disease caused by damp-heat pathogen poison is stopped over and is not gone, for a long time sick and kidney; Or because of damp and hot strongly fragrant fire-transformation of a specified duration, the liver-yin of burning, illness of child viscera affecting mother one then for a long time, deficiency of kidney-essence; Or,, undermine kidney yang by spleen and kidney because of liver disease affecting spleen.Hold concurrently with blood circulation promoting and blood stasis dispelling the Therapeutic Method of the heat-clearing and toxic substances removing dampness removing of holding concurrently so establish nourishing the liver and kidney.
Chinese medicine composition of the present invention is made up of Fructus Ligustri Lucidi, Herba Epimedii, Radix Ranunculi Ternati, Cortex Moutan, Hu Huang, Pericarpium Citri Reticulatae Viride.Fructus Ligustri Lucidi, Herba Epimedii act as liver and kidney tonifying in the side, and nourishing yin and stopping bleeding is monarch drug.Minister is with Radix Ranunculi Ternati, and assistant is with Cortex Moutan and Radix Arnebiae (Radix Lithospermi).Get Fructus Ligustri Lucidi sweet-bitter flavor cool in nature, return liver, kidney channel, nourishing the kidney and liver.Herba Epimedii is the special medicine of YANG invigorating the kidney warming, goes into the kidney,liver,spleen warp, warming the kidney to invigorate YANG, dispelling cold and dehumidification." element ask the most pure virginity will discuss greatly " has cloud: " sincerely examine the negative and positive place and transfer it, schedule to last with flat." traditional Chinese medical science pays attention to equilibrium between yin and yang, promptly pays attention to the balance of physiological function, " kind healer, regulate yin-yang ".Health is anosis, lean on the balance of immunologic function and physiological function, so-called " flat then anosis ".Imbalance of YIN and YANG influences the human righteousness, and body disease-resistant power is descended, and causes virus to be detained course of disease chronicity.The Fructus Ligustri Lucidi Herba Epimedii is shared, and the nourishing kidney yin kidney yang makes unlikely sun, the unlikely too dry strong impairment of YIN of warming YANG of hindering of YIN nourishing, promptly " schedules to last with flat ".Radix Ranunculi Ternati returns liver, lung meridian, has the effect of clearing up internal heat by using drugs of bitter in taste and cold in nature detoxifcation, blood stasis dispersing and deswelling, belongs to heat-clearing and toxic substances removing in Chinese herbal medicine, blood-activating stasis-removing kind.Pathogen usually intruding into collateral in protracted disease, damp and hot with the passing of time impairment of YIN, hyperactivity of fire caused by deficiency of YIN, so use the Cortex Moutan removing heat from blood and promoting blood circulation, assistant helps Fructus Ligustri Lucidi to support kidney yin, simultaneously the warm property impairment of YIN of assistant system Herba Epimedii.Full side's nourishing the liver and kidney, the heat-clearing and toxic substances removing dampness removing, removing heat from blood and promoting blood circulation, then all diseases alleviate, and noxious dampness gets clearly.
Beneficial effect of the present invention:
Chinese medicine composition clinical practice of the present invention shows it is a kind of Chinese medicine composition for the treatment of chronic viral hepatitis B safely and effectively, it has similar immunoregulation effect to interferon, and hepatitis b virus infected inductive immunologic tolerance is also had certain role of correcting.
The specific embodiment
Embodiment 1
Press following weight weighting raw materials: Fructus Ligustri Lucidi 20g, Herba Epimedii 20g, Radix Ranunculi Ternati 20g, Cortex Moutan 20g, Rhizoma Picrorhizae 10g, Pericarpium Citri Reticulatae Viride 10g adds 2-3 times of decocting and boils 3 times, merges decoction liquor, can be made into decoction.
Embodiment 2
Press following weight weighting raw materials: Fructus Ligustri Lucidi 10g, Herba Epimedii 10g, Radix Ranunculi Ternati 10g, Cortex Moutan 10g, Rhizoma Picrorhizae 5g, Pericarpium Citri Reticulatae Viride 5g, prepared becomes granule routinely.
Embodiment 3
Press following weight weighting raw materials: Fructus Ligustri Lucidi 15g, Herba Epimedii 15g, Radix Ranunculi Ternati 15g, Cortex Moutan 15g, Rhizoma Picrorhizae 7g, Pericarpium Citri Reticulatae Viride 7g, prepared becomes tablet routinely.
Embodiment 4
Press following weight weighting raw materials: Fructus Ligustri Lucidi 12g, Herba Epimedii 18g, Radix Ranunculi Ternati 12g, Cortex Moutan 18g, Rhizoma Picrorhizae 6g, Pericarpium Citri Reticulatae Viride 8g, prepared becomes capsule routinely.
Embodiment 5
Press following weight weighting raw materials: Fructus Ligustri Lucidi 18g, Herba Epimedii 12g, Radix Ranunculi Ternati 18g, Cortex Moutan 12g, Rhizoma Picrorhizae 8g, Pericarpium Citri Reticulatae Viride 6g, prepared becomes oral liquid routinely.
Embodiment 6
Observe the optimum combination of Chinese medicine composition of the present invention: Fructus Ligustri Lucidi 15g, Herba Epimedii 15g, Radix Ranunculi Ternati 15g, Cortex Moutan 15g, Rhizoma Picrorhizae 9g, Pericarpium Citri Reticulatae Viride 9g estimates the clinical efficacy of this optimum Chinese medicine composition.
1 data and method
1.1 case is collected
Case is SHUGUANG HOSPITAL hepatopathy section in June, 2007～2008 outpatient service or the inpatients in year May, totally 32 examples.Wherein male 21 examples, women 11 examples, 22～50 years old age, average 32.4 years old.The course of disease 1～12 year.Prescription group 15 examples wherein of the present invention, interferon group 17 examples, age, sex composition, the equal zero difference of the course of disease between two groups, all case all meets the diagnostic criteria of chronic hepatitis B in 2005.And HBV-DNA positive with the HBeAg positive, Chinese medical discrimination belongs to the deficiency of the liver and kindey damp-heat type of holding concurrently, standard reference " new Chinese medicine clinical research guideline ".
1.2 medicine for treatment
The optimum combination of Chinese medicine composition of the present invention (1 dose): Fructus Ligustri Lucidi 15g, Herba Epimedii 15g, Radix Ranunculi Ternati 15g, Cortex Moutan 15g, Rhizoma Picrorhizae 9g, Pericarpium Citri Reticulatae Viride 9g, after taking by weighing by weight, method is decocted in water for oral dose routinely, 1 dose of every day, obeys 3 months courses of treatment at twice.
The Western medicine interferon: Recombinant Interferon 5,000,000 units, the next day 1 time, subcutaneous injection, 3 months courses of treatment.
1.3 observation index and method
1.3.1 the liver serum biochemistry is learned the detection of index
ALT (glutamate pyruvate transaminase), AST (glutamic oxaloacetic transaminase, GOT), TBIL (total bilirubin) unification are detected by SHUGUANG HOSPITAL clinical laboratory.
1.3.2 the detection of serum HBV virusology sign
HBsAg (hepatitis B virus surface antigen), HBsAb (hepatitis B virus surface antibody), HBeAg (hepatitis B virus e antigen), HBeAb (hepatitis B virus e antibody), HBcAb (hepatitis B virus core antibody), HBV-DNA (Luo Shi fluorescence quantitative PCR method), with treatment March, unified detect before the treatment by SHUGUANG HOSPITAL clinical laboratory.
1.3.3CD4, CD8 part lymphocyte subgroup
The detecting operation step:
1. gather venous blood 1ml, the heparin sodium anticoagulant.
2. get 4 streaming pipes, wherein, add 100～200 μ l vein anticoagulated whole bloods with pipettor respectively behind the 1st～3 pipe labelling, the 4th pipe is labeled as negative control.
3. first pipe adds CD4-PE-Cy5 (MHCD0406-5 of CALTAG company) successively, CD28-FITC (CALTAG MHCD2801-4), each 5 μ l of CD95-R-PE (CALTAG MHCD9504-4) monoclonal antibody, second pipe adds CD4-PE-Cy5 (CALTAG MHCD0406-5), each 5 μ l of CD25-R-PE (CALTAG MHCD2504-5) monoclonal antibody, tee pipe adds CD8-PE-Cy5 (CALTAG MHCD0806-5) successively, CD28-FITC (CALTAG MHCD2801-4), each 5 μ l of CD95-R-PE (CALTAG MHCD9504-4) monoclonal antibody, the 4th pipe adds Mouse IgG1-FITC (CALTAG MG101), Mouse IgG1-R-PE (CALTAG MG104), each 10 μ l of Mouse IgG2a-PE-Cy5 (CALTAG MG2a06) negative control fluorescent labeling monoclonal antibody.
4. every pipe adds erythrocyte cracked liquid (CALTAG GAS-010) 0.5ml, behind the mixing under room temperature lucifuge left standstill 15 minutes.
5. every pipe adds 900 μ l deionized waters, and behind the vibration mixing, lucifuge left standstill 15 minutes under the room temperature.
6. following 1500 rev/mins of every pipe room temperature, centrifugal 5 minutes.
7. abandon supernatant, every pipe adds 2ml PBS (phosphate buffer, concentration 0.01mol/L, pH scope 7.2～7.4), following 1000 rev/mins of room temperature, centrifugal 5 minutes.
8. every pipe adds 500 μ l PBS (concentration 0.01mol/L, pH scope 7.2～7.4), and specimen is put in the flow cytometer, establishes door with lymphocyte count greater than 5000, do the three fluorescence fluidic cell and detect, each every sample lymphocyte count all＞5000.The flow cytometer model is EPICS-XL, U.S. Coulter company product.Reaching treatment before the treatment respectively surveys 1 time 3 months every months.
1.4 statistical analysis
The ratio of cell phenotype CELL Quest Version3.1 statistical analysis, gained The data mean ± standard deviation
Expression.Dna replication dna level, portion C D4
+, CD8
+T lymphocyte subset group percent profile adopts paired data t check to add up; Liver function normalization rate and anti-HBV-DNA effective percentage are used the definite probabilistic method x of four fold table data
2Check; All statistics all adopt two-sided test, and o'clock there is significant difference p＜0.05.
2 results
2.1 two groups of treatment back liver function normalization rates compare (seeing Table 1)
Liver function normalization rate before and after the table 1 liang group treatment
2.2 two groups of treatment back HBV-DNA means compare (seeing Table 2)
HBV-DNA mean level relatively before and after the table 2 liang group treatment
Annotate: with compare #:p＜0.05 before the treatment
2.3 two groups of anti-HBV-DNA effective percentage in treatment back
To treat after 3 months HBV-DNA copy number 2 log that descend serve as effectively, result's demonstration: x
2=1.41, p＞0.05, prescription of the present invention and interferon anti-reflecting virus effect there was no significant difference (seeing Table 3).
The table 3 liang anti-HBV-DNA effective percentage in group treatment back
2.4 treatment front and rear part CD4
+, CD8
+T lymphocyte subset group percent profile
CD4 before and after the treatment
+The no significant change of comparing between two groups of T cell masses, the interferon group is slightly high than prescription group of the present invention.CD8 behind the prescription therapeutic of the present invention
+The T cell mass obviously reduces, the CD4/CD8 ratio that obviously raises, and no significant change (seeing Table 4) before and after the interferon therapy.
The variation of CD4, CD8, CD4/CD8 before and after table 4 treatment
Annotate: with compare #:p＜0.05 before the treatment
Treg cell (regulatory T cells) frequency is the highest before treatment, and Treg cell frequency slightly reduces after treating, behind the interferon therapy Treg cell mass frequency reduce after than prescription therapeutic of the present invention more obvious, but there are no significant between each group difference.Can obviously improve CD8 behind the prescription therapeutic of the present invention
+CD28
+The ratio of cell mass reduces CD8
+CD28
-/ cd8 cell group's ratio changes behind the interferon therapy not obvious (seeing Table 5).
Treg/CD4, CD8 before and after table 5 treatment
+CD28
+/ CD8, CD8
+CD28
-The variation of/CD8
Annotate: with compare #:p＜0.05 before the treatment
To sum up clinical trial shows, Chinese medicine composition of the present invention is safe and effective, and it has similar immunoregulation effect to interferon, and hepatitis b virus infected inductive immunologic tolerance is also had certain role of correcting.
Claims (5)
1. Chinese medicine composition by immunoregulation treatment chronic viral hepatitis B, it is characterized in that: said composition is to be made by following bulk drugs: 20～10 parts of Fructus Ligustri Lucidi, 20～10 parts of Herba Epimedii, 20～10 parts of Radix Ranunculi Ternatis, 20～10 parts of Cortex Moutans, 10～5 parts of Rhizoma Picrorhizae, 10～5 parts on Pericarpium Citri Reticulatae Viride.
2. the Chinese medicine composition by immunoregulation treatment chronic viral hepatitis B as claimed in claim 1, it is characterized in that: described Chinese medicine composition bulk drugs is: 15 parts of Fructus Ligustri Lucidi, 15 parts of Herba Epimedii, 15 parts of Radix Ranunculi Ternatis, 15 parts of Cortex Moutans, 9 parts of Rhizoma Picrorhizae, 9 parts on Pericarpium Citri Reticulatae Viride.
3. the Chinese medicine composition by immunoregulation treatment chronic viral hepatitis B as claimed in claim 1 or 2, it is characterized in that: the dosage form of described Chinese medicine composition is a said dosage form on any pharmaceutics.
4. the Chinese medicine composition by immunoregulation treatment chronic viral hepatitis B as claimed in claim 3, it is characterized in that: the dosage form of described Chinese medicine composition is decoction, pill, granule, tablet, capsule or oral liquid.
5. the Chinese medicine composition by immunoregulation treatment chronic viral hepatitis B as claimed in claim 4, it is characterized in that: the dosage form of described Chinese medicine composition is a decoction.
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Effective date of registration: 20200928 Address after: 300385 E12 1, Si Zhi Dao, Xuefu Industrial Zone, Xiqing District, Tianjin. Patentee after: INCREASE (TIANJIN) INNOVATIVE MEDICINE RESEARCH Co.,Ltd. Address before: 200021 Shanghai city Luwan District Pu Road No. 185 Patentee before: SHUGUANG HOSPITAL AFFILIATED WITH SHANGHAI University OF T C M |