Summary of the invention
The object of the invention is to provide a kind of Chinese medicine composition for the treatment of hepatitis.
Another object of the present invention is to provide a kind of preparation method of Chinese medicine composition for the treatment of hepatitis.
Another object of the present invention be to provide a kind of Chinese medicine composition for the treatment of hepatitis new purposes.
The present invention is achieved through the following technical solutions:
The crude drug of Chinese medicine composition of the present invention consists of:
Thallus Laminariae (Thallus Eckloniae) extract 1.5-4.5 weight portion Extraction of Eucheuma gelatinae 0.5-1.5 weight portion
Semen Trigonellae 25-75 weight portion Herba Erodii 15-45 weight portion.
The crude drug composition of Chinese medicine composition of the present invention is preferably:
Thallus Laminariae (Thallus Eckloniae) extract 3 weight portion Extraction of Eucheuma gelatinae 1 weight portions
Semen Trigonellae 50 weight portion Herba Erodii 30 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably:
Thallus Laminariae (Thallus Eckloniae) extract 1.7 weight portion Extraction of Eucheuma gelatinae 1.3 weight portions
Semen Trigonellae 70 weight portion Herba Erodii 17 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably:
Thallus Laminariae (Thallus Eckloniae) extract 4.3 weight portion Extraction of Eucheuma gelatinae 0.7 weight portions
Semen Trigonellae 30 weight portion Herba Erodii 17 weight portions.
Chinese medicine composition of the present invention adds conventional adjuvant to make the tablet of clinical acceptance, capsule, granule, pill or oral liquid according to common process.
In Chinese medicine composition of the present invention, Thallus Laminariae (Thallus Eckloniae) extract is commercially available, as Xi'an Si Nuote Bioisystech Co., Ltd sells; Extraction of Eucheuma gelatinae is commercially available, and medical company limited as luxuriant in Anhui Province's generation sells.
Chinese medicine composition preparation method of the present invention is: Semen Trigonellae and the Herba Erodii 10-20 that adds water is doubly measured, soak 24-48 hour; With slow fire boiling 1-3 time, decoct 1-3 hour at every turn, medicinal liquid is leached, collect for subsequent use; Filtrate is concentrated into the thick paste that relative density is 1:1.25-1.35, and by thick paste low-temperature bake 5-15 hour, the powder that gets dry extract, mixes dried cream powder and Thallus Laminariae (Thallus Eckloniae) extract and Extraction of Eucheuma gelatinae; Add conventional adjuvant pharmaceutically to make tablet, capsule, granule, oral liquid, injection or pill.
The preferred preparation method of Chinese medicine composition of the present invention is: Semen Trigonellae and Herba Erodii are added water 15 times and measured, soak 36 hours; With slow fire boiling 2 times, decoct for the first time 2 hours, medicinal liquid is leached stand-by, add for the second time 10 times of water gagings, with slow fire boiling 1 hour, medicinal liquid is leached stand-by; Merge secondary medical filtration, collect filtrate; Filtrate is concentrated into the thick paste that relative density is 1:1.25-1.35, by thick paste low-temperature bake 10 hours, the powder that gets dry extract, dried cream powder and Thallus Laminariae (Thallus Eckloniae) extract and Extraction of Eucheuma gelatinae is mixed; The weight ratio that is 1:0.5 with starch adds adjuvant, granulates, and after granulate, is sub-packed in capsule.
Chinese medicine composition of the present invention has soothing liver-QI, hepatoprotective and hepatoprotective effect, has good therapeutical effect to treating acute hepatitis A, acute hepatitis b, chronic persistent hepatitis and chronic active hepatitis etc., and effect is remarkable, has no side effect.
Experimental example is used for further illustrating the present invention below, but is not limited to the present invention.
Experimental example one:
The object of observation and method
One, case selection
(1) etiological diagnosis
A type: possess any 1 person in following 4:
1, the anti-HAVIgM positive of acute stage hepatitis serum;
2, acute stage and the anti-HAVIgG of convalescent period paired sera tire and are 4 times and increase above;
3, the anti-HAV immunoelectronmicroscopy of acute early stage feces is to HAV granule;
4, in acute early stage feces, find HAAg.
B-mode: in following 4, to possess any 1 person:
1, the serum HbsAg positive, or the HbeAg positive;
2, the serum HbsAg positive, but the anti-HbcIgM positive, or anti-HBs or the anti-HBc positive;
3, serum HBV-DNA or the DNA polymerase positive, or HbeAg or the anti-Hbe positive;
4, HBV infection index is not obvious or only have the anti-HBc1 item index positive, and HbcAg, HbsAg or the HBV-DNA positive in liver.
(2) Clinical typing
1, acute icterohepatitis:
(1) Acute onset.
(2) there is hepatitis symptom, sign in various degree and chemically examine abnormal.
(3) serum total bilirubin (TBIL) > 17.1 μ mol/L, the urine bilirubin positive.
(4) can get rid of the jaundice that other reasons causes.
2, acute anicteric hepatitis:
(1) epidemiologic data:
Close contact history: refer to be diagnosed as viral hepatitis (particularly acute stage) with eating, live together, with life or often contact hepatitis virus pollutant (as blood, feces) and do not take safeguard procedures person;
Injection history: refer to once accept in half a year blood transfusion, blood products and sterilize undemanding Chinese medicine injection, immunity inoculation, acupuncture treatment etc.
(2) symptom: refer to occur at no distant date, continue several days symptoms above, that explain without other reasons, as weak, loss of appetite, feel sick, detest greasy, abdominal distention, loose stool, pain in the hepatic region etc.
(3) sign: refer to that hepatomegaly and dynamic change and have a tenderness.Part patient can have splenomegaly.
(4) chemical examination: mainly refer to that ALT vigor increases.
In 4 of all epidemiologic datas, symptom, sign, chemical examination 3 obviously positive (should comprise that chemical examination is positive), or chemical examination and sign, or chemical examination and symptom all obviously positive, and person can make a definite diagnosis to get rid of other diseases.
All ALT of individual event at no distant date increase, or only have symptom, sign, or only have epidemiological history and (2), in (3) two 1, be suspicious person.As positive in etiological diagnosis, and get rid of other diseases, can make a definite diagnosis.
3, chronic persistent hepatitis: have and make a definite diagnosis or suspicious acute hepatitis medical history (sometimes indefinite), the course of disease exceedes not yet fully recovers half a year, and the state of an illness is lighter, can have pain in the hepatic region and weak, can there is ALT to raise or slight liver function injury, and inadequate diagnosing chronic active hepatitis person.
4, chronic active hepatitis:
(1) symptom: previously have hepatitis history (sometimes indefinite), have at present obvious hepatitis symptom, as weak, appetite is poor, abdominal distention, loose stool etc.
(2) sign: hepatomegaly, more than quality medium hardness, can jaundice, spider angioma, hepatic facies, liver palm or splenomegaly, and get rid of other reasons person.
(3) lab testing: repeatedly or continue to raise, or plasma albumin obviously reduces ALT vigor, or white/globulin ratio is obviously abnormal, or gamma globulin obviously increases, or SB is prolonged and repeated increases.
(4) the outer organ performance of liver: as arthritis, nephritis, vasculitis, erythra or dry syndrome etc., wherein more common with nephritis.In above 4, have 3 positive, or (2), (3) two positive, all diagnosable is chronic active hepatitis.
(3) damp and hot stifling card Standards of Chinese Medical Syndrome Differentiation
The appearance whole body is all yellow, presents orange, and dysphoria with smothery sensation gastral cavity is vexed, indigestion and loss of appetite vomiting, bitter taste and dryness in the mouth, hypochondriac pain abdominal distention, lassitude, or skin pruritus, yellowish or reddish urine, constipation or half congealed, yellowish fur, stringy and rolling pulse number.
(4) liver function injury diagnostic criteria: meet following one of them person
1, glutamate pyruvate transaminase (ALT) > 40u (Reitman method).
2, serum total bilirubin (TBIL) > 17.1 μ mol/L.
3, the direct red matter of gallbladder (DBIL) > 3.42 μ mol/L.
Two, include case standard in
1, inclusive criteria: meet following standard person and can include the object of observation in:
(1) lab testing performance liver function has infringement, glutamate pyruvate transaminase (ALT) > 40u (Reitman method).
(2) the acute and chronic diagnosis of hepatitis b standard of Western medicine diagnose.
(3) tcm diagnosis meets damp and hot stifling card.
2, exclusion standard:
(1) confirm on inspection, ethylism poisoning by Chinese medicine or the caused liver function injury person of malignant tumor.
(2) age is at under-18s or over-65s, gestation or women breast-feeding their children, those who are allergic to this drug.
(3) be associated with the serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, psychotic.
(4) do not meet inclusive criteria, end is medication in accordance with regulations, cannot judge that curative effect or data are not congruent to affect the treatment or safety judgement person.
Three, clinical observation
Treatment group 1 anthology invention capsule (according to embodiment 1 method preparation) is treated acute hepatitis A, acute hepatitis b, chronic persistent hepatitis and chronic active hepatitis patient and is amounted to 200 examples, wherein male's 100 examples, women's 100 examples.Acute hepatitis A 50 examples, acute hepatitis b 50 examples, chronic persistent hepatitis 50 examples and chronic active hepatitis 50 examples.
Treatment group 2 anthology invention tablets (according to embodiment 2 method preparations) are treated acute hepatitis A, acute hepatitis b, chronic persistent hepatitis and chronic active hepatitis patient and are amounted to 200 examples, wherein male's 100 examples, women's 100 examples.Acute hepatitis A 50 examples, acute hepatitis b 50 examples, chronic persistent hepatitis 50 examples and chronic active hepatitis 50 examples.
Treatment group 3 anthology invention granules (according to embodiment 3 method preparations) are treated acute hepatitis A, acute hepatitis b, chronic persistent hepatitis and chronic active hepatitis patient and are amounted to 200 examples, wherein male's 100 examples, women's 100 examples.Acute hepatitis A 50 examples, acute hepatitis b 50 examples, chronic persistent hepatitis 50 examples and chronic active hepatitis 50 examples.
Matched group is selected extra large Qi Shugan Capsules, is produced by Qingdao ZhengDa HaiEr Pharmaceutical Co., Ltd, treats acute hepatitis A, acute hepatitis b, chronic persistent hepatitis and chronic active hepatitis patient and amounts to 200 examples, wherein male's 100 examples, women's 100 examples.Acute hepatitis A 50 examples, acute hepatitis b 50 examples, chronic persistent hepatitis 50 examples and chronic active hepatitis 50 examples.
Four, usage and dosage
Treatment group 1: take capsule of the present invention (according to embodiment 1 method preparation), treat two courses for the treatment of (10 days courses for the treatment of), 0.2g/ grain, one day 3 times, one time 1.
Treatment group 2 is taken tablet of the present invention (according to embodiment 2 methods preparations), treats two courses for the treatment of (10 days courses for the treatment of), 0.3g/ grain, one day 3 times, one time 1.
Treatment group 3 is taken granule of the present invention (according to embodiment 3 methods preparations), treats two courses for the treatment of (10 days courses for the treatment of), 8g/ grain, one day 3 times, one time 1 bag.
Matched group: extra large Qi Shugan Capsules, produced by Qingdao ZhengDa HaiEr Pharmaceutical Co., Ltd, treat two courses for the treatment of (10 days courses for the treatment of), 0.2g/ grain, 3 times on the one, one time 1.
Five, observation index:
1, security inspection:
(1) general health check-up project.
(2) blood, urine, feces routine examination.
(3) heart, kidney function test.
2, health giving quality observation:
(1) relevant symptoms and sign.
(2) change of liver function.
Six, short term effect evaluation criteria
1, acute hepatitis:
(1) effective: main syndrome disappears; Hepatosplenomegaly disappears or retraction, and hepatic region is without obvious tenderness and kowtow pain; Liver function test is normal.See that disease integration reduces more than 70%.
(2) invalid: not reach effective standard.
2, chronic hepatitis:
(1) effective: main syndrome disappears or substantially disappears; Hepatosplenomegaly is stablized constant, and without obvious tenderness and kowtow pain; Normal or the initial value of liver function test declines more than 50%.See that disease integration reduces more than 70%.
(2) invalid: not reach effective standard.
Seven, therapeutic outcome
Table 1 treatment group 1 Clinical Laboratory efficacy evaluation (n=200) of the present invention
Table 2 treatment group 2 Clinical Laboratory efficacy evaluations (n=200) of the present invention
Table 3 treatment group 3 Clinical Laboratory efficacy evaluations (n=200) of the present invention
Table 4 matched group Clinical Laboratory efficacy evaluation (n=200)
Eight, conclusion
Treatment group 1, treatment group 2, treatment group 3 and matched group are treated respectively two courses for the treatment of (10 days each courses for the treatment of), therapeutic outcome shows, treatment group 1 effective percentage 97% of the present invention, treatment group 2 effective percentage 95%, treatment group 3 effective percentage 93.5%, matched group effective percentage 81.5%.Treatment group 1 best results of the present invention, treatment group 1 of the present invention, treatment group 2 and treatment group 3 are obviously better than matched group.
Nine, discuss
In Chinese medicine composition of the present invention, Thallus Laminariae (Thallus Eckloniae) extract is commercially available, and by Xi'an, Si Nuote Bioisystech Co., Ltd provides; Extraction of Eucheuma gelatinae is commercially available, and by Anhui Province's generation, luxuriant medical company limited provides.Semen Trigonellae is pulse family annual herb plant, warming the kidney to activate YANG, and dispersing cold for relieving pain, for kidney cold caused by deficiency, cold and pain in the lower abdomen, inguinal hernia, the disturbance of lower legs due to pathogenic cold and dampness.Herba Erodii is MangNiu Er Seedling section plant Mang cattle Seedling, energy wind-damp dispelling, the meridian dredging, antidiarrheal profit.For rheumatic arthralgia, numbness contracture, muscles and bones is ached, dysentery.The all medicine merging of crude drug of the present invention have soothing liver-QI, hepatoprotective and hepatoprotective effect, have good therapeutical effect to treating acute hepatitis A, acute hepatitis b, chronic persistent hepatitis and chronic active hepatitis etc., and effect is remarkable, has no side effect.
Experimental example two: pharmacodynamic experiment
The impact of test example 1 on hepatic injury due to carbon tetrachloride (CCL4)
Test material:
Dosage of drug I group of the present invention (according to embodiment 1 method preparation); Dosage of drug II group of the present invention (according to embodiment 2 method preparations); Dosage of drug III group of the present invention (according to embodiment 3 method preparations); Matched group: select extra large Qi Shugan Capsules, produced by Qingdao ZhengDa HaiEr Pharmaceutical Co., Ltd.
Test method:
Choosing NIH is 60 of healthy mices, and body weight is 22-25 gram, is divided at random normal group, blank model group, and three groups such as matched group and Chinese medicine I of the present invention, II, III, all by 20ml/kg body weight gastric infusion, normal group and the blank group of distilled water to equivalent.
First gastric infusion two days before experiment, once a day, the second afternoon lumbar injection 0.1% (CCL4) Oleum Arachidis hypogaeae semen 10ml/kg body weight once, normal group gives equivalent Oleum Arachidis hypogaeae semen, within the 3rd day, continues administration, and the upper and lower noon respectively once, fasting is got blood with capillary glass tube from eye socket rear vein beard after 12 hours and is surveyed serum paddy transaminase (SGPT, reitman-frankel method), and get liver paraffin section routinely, and do histopathologic examination, check result represents the degree of pathological change with "+"."-" represents that liver is normal; "+" represents that hepatocyte only has a small amount of degeneration and spotty necrosis or a small amount of cell infiltration; " +++ " shows that most of degeneration necrosis and the neutrophilic infiltration filling the air appear in hepatocyte; " ++ " shown and is positioned between the two, and the analysis of result is with integration method, and "-" is 0 point, and "+" is 1 point, and " ++ " is that 2 points " +++ " is 3 points.
The impact (X ± SD) of table 1 on hepatic injury mice SGPT due to CCL4
Group |
Dosage (mg/kg) |
Number of animals (only) |
SGPT(υ/100ml) |
Normally |
- |
10 |
40±23 |
Blank |
- |
10 |
160±47 |
Matched group |
250 |
10 |
98±59* |
Chinese medicine I group of the present invention |
250 |
10 |
42±26** |
Chinese medicine II group of the present invention |
250 |
10 |
53±25** |
Chinese medicine III group of the present invention |
250 |
10 |
56±23** |
The experimental result of table 1 shows: three groups of Chinese medicine composition of the present invention, all can reduce the serum glutamic pyruvic transminase SGPT of hepatic injury mice due to CCL4, and with the comparison of blank group, difference significance, with matched group comparison, difference has significance.
The impact (X ± SD) of table 2 on hepatic injury mouse liver pathological change due to CCL4
Table 2, due to CCL4 hepatic necrosis degeneration obvious, especially cell infiltration is extensive, hepatic necrosis is serious; Matched group hepatic pathology improves not obvious, and indices compares with blank group, no significant difference.Chinese medicine I group of the present invention, II group, III group, relatively there were significant differences for hepatic necrosis and cell infiltration and blank group and matched group, and organizational structure has approached normal.
Following embodiment all can realize the effect of above-mentioned experimental example.