Summary of the invention
The object of the present invention is to provide the Chinese medicine composition of a kind of compatibility science, determined curative effect, safe, quality controllable treatment hepatitis.
The realization of the object of the invention is based on understanding and the Therapeutic Principle of motherland's medical science to hepatitis mechanism, select for use Rhizoma Picrorhizae, Rhizoma Polygoni Cuspidati, Flos Lonicerae, Rhizoma Osmundae to combine, can make each efficacy of drugs produce synergism these drug regimens, thereby can effectively treat hepatitis.Wherein Rhizoma Picrorhizae has the clearing away damp-heat effect; The effect of Rhizoma Polygoni Cuspidati tool clearing away heat-damp and promoting diuresis, promoting the function of the gallbladder to alleviate jaundice, blood circulation promoting and blood stasis dispelling, Flos Lonicerae, Rhizoma Osmundae have heat-clearing and toxic substances removing, the merit of removing heat from blood, three medicines same usefulness in back helps the Rhizoma Picrorhizae clearing away heat-damp and promoting diuresis eliminating evil.
Above-mentioned Chinese medicine composition mainly is to be made by following bulk drugs: 400~450 parts of Rhizoma Picrorhizae, 50~100 parts of Rhizoma Polygoni Cuspidati, 250~300 parts of Flos Loniceraes, 100~150 parts of Rhizoma Osmundae.Wherein best group becomes 432 parts of Rhizoma Picrorhizae, 86 parts of Rhizoma Polygoni Cuspidati, 133 parts of 266 parts of Flos Loniceraes and Rhizoma Osmundae.The preparation method of said composition is as follows:
A. with the Rhizoma Picrorhizae of described weight proportion with 20%~95% soak with ethanol, percolation extracts, extracting solution is at 50 ℃~70 ℃, vacuum be-0.085~-the 0.1MPa condition, decompression recycling ethanol, and concentrating must concentrated solution 1;
B. with the Flos Lonicerae of described weight proportion, Rhizoma Polygoni Cuspidati, Rhizoma Osmundae with 20%~95% soak with ethanol, reflux, extract,, extracting solution is at 50 ℃~70 ℃, vacuum is-0.085~-the 0.1MPa condition, decompression recycling ethanol, and concentrating, concentrated solution 2;
C. merge 2,50 ℃~70 ℃ vacuum dryings of concentrated solution 1 and concentrated solution, it is ground into powder, make this Chinese medicine composition.
In order to reach better therapeutic, medicine of the present invention also makes up with the Radix Salviae Miltiorrhizae and the Rhizoma Atractylodis Macrocephalae.The Radix Salviae Miltiorrhizae hardship is slightly cold, and the effect of blood circulation promoting and blood stasis dispelling is arranged, in case coagulation of QI-blood; Rhizoma Atractylodis Macrocephalae spleen invigorating QI invigorating, the dampness diuretic has the power of monarch drug damp eliminating, and prevents all medicine bitter cold impairment of the spleens.All medicines are harmonious, the effect of play heat clearing away, dampness removing altogether, detoxify, invigorating blood circulation.
The consumption of drug component of the present invention can also be: 400~450 parts of Rhizoma Picrorhizae, 50~100 parts of Rhizoma Polygoni Cuspidati, 250~300 parts of Flos Loniceraes, 100~150 parts of Rhizoma Osmundae, 50~100 parts of 100~150 parts of the Radix Salviae Miltiorrhizaes and the Rhizoma Atractylodis Macrocephalaes.Wherein best group becomes 432 parts of Rhizoma Picrorhizae, 86 parts of Rhizoma Polygoni Cuspidati, 266 parts of Flos Loniceraes, 133 parts of Rhizoma Osmundae, 86 parts of 106 parts of the Radix Salviae Miltiorrhizaes and the Rhizoma Atractylodis Macrocephalaes.
The preparation method of above-mentioned medicine may further comprise the steps:
A. with the Rhizoma Picrorhizae of described weight proportion and Radix Salviae Miltiorrhizae with 20%~95% soak with ethanol, percolation extracts, extracting solution is at 50 ℃~70 ℃, vacuum be-0.085~-the 0.1MPa condition, decompression recycling ethanol, and concentrating must concentrated solution 1;
B. with the Flos Lonicerae of described weight proportion, Rhizoma Polygoni Cuspidati, Rhizoma Osmundae, the Rhizoma Atractylodis Macrocephalae with 20%~95% soak with ethanol, reflux, extract,, extracting solution is at 50 ℃~70 ℃, vacuum is-0.085~-the 0.1MPa condition, decompression recycling ethanol, and concentrating, concentrated solution 2;
C. merge 2,50 ℃~70 ℃ vacuum dryings of concentrated solution 1 and concentrated solution, it is ground into powder, make this Chinese medicine composition.
The preparation method of medicine of the present invention is the physicochemical property according to a few flavor medical materials in the medicament composing prescription, by positive quadraturing design test, is to investigate index finally to determine with the content of effective.
Rhizoma Picrorhizae is monarch drug in the prescription, and pharmacological research shows that the picrorhiza iridoid glycosides compound has the pharmacologically active of hepatic cholagogic preferably, is the main effective ingredient of Rhizoma Picrorhizae treatment hepatitis.Contain polar functional group in the iridoid glycosides molecular structure of compounds, polarity is bigger, is soluble in hydrophilic solvent, the general solvent method that adopts during extraction.Often select for use water, ethanol as extracting solvent, can adopt the method for percolation or backflow to extract.Water and ethanol are cheap and easy to get, and toxicity is little, are accepted by commercial production easily.Effective component in red sage is salvianolic acid and tanshinone compound, symptom, sign, liver function and the hepatic fibrosis serological index that improves chronic active hepatitis B companion early stage liver cirrhosis person, anti peroxidation of lipid liver damage patient had positive effect, and its effective ingredient also useable solvents method extracts; Effective ingredient of honeysuckle is chlorogenic acid and triterpene saponin constituents, the Rhizoma Polygoni Cuspidati active component is diphenylethylene and anthraquinone analog compound, Rhizoma Atractylodis Macrocephalae effective ingredient is to be the liposoluble constituent of representative with the atractylodes lactone, the Rhizoma Osmundae effective ingredient is the Filixic Acids constituents, all available ethanol extraction, for improving extraction efficiency, adopt ethanol refluxing process to extract.
Pharmaceutical composition of the present invention can be made clinical acceptable peroral dosage form by tradition or modern production technology with acceptable auxiliary on the pharmaceutics, as capsule, tablet, granule, oral liquid etc.Used excipient substance can be: starch, sucrose, lactose, stevioside, micropowder silica gel, microcrystalline Cellulose sodium, gelatin, glycerol, Tween 80, Pulvis Talci etc.Owing to need long-term prescription clinically, make solid preparation store convenient, patient's taking convenience, also meeting the market requirement more.Preferred dosage form is a capsule, and mainly consider: 1. the capsule disintegration rate is fast, can reach effective blood drug concentration rapidly, and bioavailability is higher, can bring into play drug effect rapidly; 2. capsule can be covered the bitterness of medicine itself, and have transportation, carry, characteristics such as taking convenience; 3. capsule preparation technology is simple, and cost is low, and quality is easy to control.
Medicine of the present invention has the liver soothing and the spleen invigorating, and the merit that heat-clearing and toxic substances removing, dampness removing are invigorated blood circulation cures mainly hepatitis, comprises acute or chronic hepatitis B, and hepatitis B is also had better therapeutic effect.
In order further to set forth the therapeutic effect of medicine of the present invention, the Chinese medicine composition that adopts the embodiment of the invention 2 to make carries out following pharmacodynamic experiment, and the present invention is further elaborated, but the present invention is not limited to the content that comprises in the following experiment.
Test example 1 Chinese medicine composition is to carbon tetrachloride (CCl
4) cause the prevention protective effect of chmice acute hepatic injury
Compositions little (1.5g crude drug/kg), in (3.0g crude drug/kg) and big (the 6.0g crude drug/kg) three dosage are irritated the stomach Kunming mouse respectively, 1 time/day, continuous 10 days, the 9th day every group of lumbar injection 0.1%CCl of administration
4Peanut oil solution 0.1ml/10g causes the acute liver damage model, detects the content of every animal serum ALT, AST after 16 hours.Result of the test sees Table 1, table 2.
Table 1 compositions is to mice CCl
4The influence of acute liver damage Serum ALT (x ± s)
Group | Dosage (g/kg) | Number of animals (n) | ALT (U/L) |
Normal control group model matched group positive controls | - - 0.15 | 10 10 10 | 47.64±16.26 226.66±98.46### 88.08±35.93** |
Compositions | The heavy dose of group of dosage group in the small dose group | 1.5 3.0 6.0 | 10 10 10 | 105.50±37.78** 100.07±43.31** 63.96±21.85*** |
Annotate: compare ###P<0.001 with the normal control group; Compare * * P<0.01, * * * P<0.001 with model control group
By last table result as seen, compare with normal group, model group ALT value is rising (P<0.001) obviously; Positive group compares with model group, and the ALT value obviously reduces (P<0.01).Each dosage group of compositions and model group compare, and the ALT value obviously reduces (P<0.01).
Table 2 compositions is to mice CCl
4The influence of acute liver damage serum AST (x ± s)
Group | Dosage (g/kg) | Number of animals (n) | AST (U/L) |
Normal control group model matched group positive controls | - - 0.15 | 10 10 10 | 129.20±22.14 402.98±86.22### 339.38±87.22 |
Compositions | The heavy dose of group of dosage group in the small dose group | 1.5 3.0 6.0 | 10 10 10 | 266.54±72.19** 250.59±78.90*** 245.32±72.99*** |
Annotate: compare ###P<0.001 with the normal control group; Compare * * P<0.01, * * * P<0.001 with model control group
By last table result as seen, compare with normal group, model group AST value is rising (P<0.001) obviously; And positive group compares with model group, though the AST value has reduction, and there was no significant difference (P>0.05); Each dosage group of compositions and model group compare, and the AST value obviously reduces (P<0.01 or P<0.001).
The result shows that the ALT of the large, medium and small dosage group of compositions, AST value relatively have remarkable reduction with model group after modeling.The prompting said composition is to CCl
4The chmice acute hepatic injury of bringing out has certain prevention protective effect.
Test example 2 Chinese medicine compositions are to carbon tetrachloride (CCl
4) cause the therapeutical effect of rat chronic hepatic injury
The Wistar rat, subcutaneous injection 25%CCl
4Peanut oil solution 2ml/kg 2 times weekly, in continuous 8 weeks, causes chronic hepatic injury.Inject CCL in first
4The 2nd day of Oleum Arachidis hypogaeae semen, irritate respectively the capsule for treating gastropathy agent little (1.0g crude drug/kg), in (2.0g crude drug/kg) and big (three dosage of 4.0g crude drug/kg), every day 1 time, continuous 8 weeks, get blood behind administration the 6th, 8 all sockets of the eye, observation group's compound is to the influence of Serum ALT, AST, TP, ALB and liver glycogen and hydroxyproline, and result of the test sees Table 3, table 4, table 5.
Table 3 compositions is to CCl
4Cause the influence (x ± s) of treatment administration 6 all serum AST, the ALT of rat chronic hepatic injury
Group | Dosage (g/kg) | Number of animals (n) | ALT (U/L) | AST (U/L) |
Normal control group model matched group positive controls | - - 0.15 | 11 13 15 | 58.18±7.70 1063.41±125.88### 403.54±209.48*** | 149.86±30.95 975.45±198.58### 843.34±182.12 |
Compositions | The heavy dose of group of dosage group in the small dose group | 1.0 2.0 4.0 | 13 11 13 | 803.87±257.12** 659.26±278.39*** 596.39±378.32*** | 779.04±197.18* 738.92±328.49* 700.49±239.76** |
Annotate: compare ###P<0.001 with the normal control group; Compare * P<0.05, * * P<0.01, * * * P<0.001 with model control group
By last table result as seen, in 6 weeks of administration, model group AST, ALT value obviously raise, and with normal group significant difference (P<0.001) are arranged relatively; Positive group ALT value obviously reduces, and with model group significant difference (P<0.001) is arranged relatively, reduces though the AST value has to a certain degree, compares there was no significant difference (P>0.05) with model group; Each dosage group AST of compositions, ALT value all have to a certain degree reduction, with model group significant difference (P<0.05, P<0.01 or P<0.001) are in various degree arranged relatively.
Table 4 compositions is to CCl
4Cause the influence (x ± s) of treatment administration 8 all serum AST, the ALT of rat chronic hepatic injury
Group | Dosage (g/kg) | Number of animals (n) | ALT (U/L) | AST (U/L) |
Normal control group model matched group positive controls | - - 0.15 | 11 13 13 | 59.29±13.66 971.82±223.50### 220.76±205.28*** | 175.75±26.50 721.98±292.36### 650.46±212.51 |
Compositions | The heavy dose of group of dosage group in the small dose group | 1.0 2.0 4.0 | 13 11 13 | 606.27±337.59** 643.29±173.67*** 562.12±253.08*** | 532.63±204.10 513.18±137.37* 494.74±220.12* |
Annotate: compare ###P<0.001 with the normal control group; Compare * P<0.05, * P<0.01, * * * P<0.001 with model control group
By last table result as seen, in 8 weeks of administration, model group AST, ALT value obviously raise, and with normal group significant difference (P<0.001) are arranged relatively; Positive group ALT value obviously reduces, and with model group significant difference (P<0.001) is arranged relatively, reduces though the AST value has to a certain degree, compares there was no significant difference (P>0.05) with model group; Each dosage group ALT of compositions has to a certain degree reduction, with model group significant difference (P<0.01 or P<0.001) is arranged relatively, and AST has to a certain degree reduction, and wherein compositions big or middle dosage group AST and model group relatively have significant difference (P<0.05).
Table 5 compositions is to CCl
4Cause the influence (x ± s) of treatment administration 6 all serum T P, the ALB of rat chronic hepatic injury
Group | Dosage (g/kg) | Number of animals (n) | TP (g/l) | ALB (g/dl) |
Normal control group model matched group positive controls | - - 0.15 | 11 13 15 | 67.51±4.26 60.71±6.44## 64.82±4.91 | 4.41±0.17 3.81±0.50## 4.02±0.32 |
Compositions | The heavy dose of group of dosage group in the small dose group | 1.0 2.0 4.0 | 13 11 13 | 65.43±5.97 66.08±2.85* 66.75±3.74** | 4.10±0.24 4.37±0.16** 4.26±0.24** |
Annotate: compare ##P<0.01 with the normal control group; Compare * P<0.05, * * P<0.01 with model control group
By last table result as seen, in 6 weeks of administration, model group TP, ALB value obviously reduce, and with normal group significant difference (P<0.01) are arranged relatively; Positive group TP, ALB value have certain rising, but compare there was no significant difference (P>0.05) with model group; Each dosage group TP of compositions, ALB value all have to a certain degree rising, and wherein big or middle dosage group of compositions and model group relatively have significant difference (P<0.05 or P<0.01).
Table 6 compositions is to CCl
4Cause the influence (x ± s) of treatment administration 8 all serum T P, the ALB of rat chronic hepatic injury
Group | Dosage (g/kg) | Number of animals (n) | TP (g/l) | ALB (g/dl) |
Normal control group model matched group positive controls | - - 0.15 | 11 13 13 | 66.63±5.69 56.61±2.19### 60.73±6.00* | 4.44±0.30 3.55±0.37### 3.94±0.44* |
Compositions | The heavy dose of group of dosage group in the small dose group | 1.0 2.0 4.0 | 13 11 13 | 59.60±6.83 60.55±4.25** 60.48±4.23** | 4.02±0.48 4.10±0.56** 4.02±0.36** |
Annotate: compare ###P<0.001 with the normal control group; Compare * P<0.05, * * * P<0.001 with model control group
By last table result as seen, in 8 weeks of administration, model group TP, ALB value obviously reduce, and with normal group significant difference (P<0.001) are arranged relatively; Positive group TP, ALB value have certain rising, with model group significant difference (P<0.05) are arranged relatively; Each dosage group TP of compositions, ALB value all have to a certain degree rising, and wherein big or middle dosage group and model group relatively have significant difference (P<0.01).
Table 7 compositions is to CCl
4Cause the influence (x ± s) of rat chronic hepatic injury serum liver glycogen, hydroxyproline
Group | Dosage (g/kg) | Number of animals (n) | Hepatic glycogen (the mg/g liver is heavy) | Hydroxyproline (ug/kg) |
Normal control group model matched group positive controls | - - 0.15 | 11 13 13 | 19.84±5.09 4.69±1.22### 5.43±1.43 | 166.55±40.66 925.64±244.27### 774.33±146.76 |
Compositions | The heavy dose of group of dosage group in the small dose group | 1.0 2.0 4.0 | 11 13 11 | 6.33±1.86* 8.25±1.23*** 9.35±1.40*** | 590.27±265.25** 425.25±113.32*** 306.69±166.16*** |
Annotate: compare ###P<0.001 with the normal control group; Compare * P<0.05, * * P<0.01, * * * P<0.001 with model control group
By last table result as seen, the model group hepatic glycogen reduces, and with normal group utmost point significant difference (P<0.001) is arranged relatively; Though positive group hepatic glycogen has rising, compares there was no significant difference (P>0.05) with model group; Each dosage group hepatic glycogen of compositions raises, and with model group significant difference (P<0.05 or P<0.001) is arranged relatively.
The model group hydroxyproline obviously raises, and with normal group utmost point significant difference (P<0.001) is arranged relatively; Though positive group hydroxyproline has reduction, compares there was no significant difference (P>0.05) with model group; Each dosage group hydroxyproline of compositions reduces, and with model group significant difference (P<0.01 or P<0.001) is arranged relatively.
Test example 3 Chinese medicine compositions are to the inhibitory action research of DHB
1 age in days Beijing duck, intravenous injection sheldrake DHBV-DNA positive serum, set up the duck hepatitis-B animal model, model group after 7 days (normal saline), positive controls (acyclovir 100mg/kg, be called for short ACV), three dosage of compositions (the continuous oral administration of 10g crude drug/kg, 20g crude drug/kg, 40g crude drug/kg) 10 days, (T before administration
0), the 5th day (T of administration
5), the 10th day (T
10) and drug withdrawal after the 3rd day (P
3) blood sampling, measure the clear middle DHBV-DNA level (OD value) of Sanguis Anas domestica with spot hybridization, and calculate the DHBV-DNA suppression ratio; With S surface antigen (DHBpresAg) level (OD value) before the clear middle DHBV of ELISA method detection Sanguis Anas domestica.This test repeats three batches.Result of the test sees Table 8, table 9, table 10.
The administration of table 8 composition oral is to the influence of the clear DHBV-DNA level of Sanguis Anas domestica
The experiment batch | Group | Dosage g/kg | Number of elements | The clear DHBV-DNA OD of Sanguis Anas domestica value (x ± s) |
T
0 | T
5 | T
10 | P
3 |
1 | Normal saline ACV compositions | -- 0.1 10 20 40 | 10 10 10 10 10 | 0.348±0.311 0.355±0.327 0.31±0.248 0.306±0.373 0.301±0.275 | 0.204±0.173 0.039±0.056* 0.213±0.249 0.212±0.348* 0.149±0.249* | 0.362±0.27 0.044±0.053* 0.346±0.392 0.227±0.308 0.072±0.12* | 0.564±0.434 0.339±0.522 0.586±0.553 0.302±0.385 0.091±0.109* |
2 | Normal saline ACV compositions | -- 0.1 10 20 40 | 8 8 8 8 8 | 0.218±0.136 0.598±0.187 0.439±0.277 0.265±0.092 0.265±0.097 | 0.16±0.073 0.119±0.076*** 0.249±0.122 0.149±0.081** 0.146±0.067** | 0.24±0.11 0.049±0.066*** 0.34±0.326 0.17±0.082*** 0.173±0.058** | 0.395±0.219 0.274±0.312 0.528±0.285 0.264±0.089 0.264±0.06 |
3 | Normal saline ACV compositions | -- 0.1 10 20 40 | 9 9 9 9 9 | 0.217±0.129 0.46±0.085 0.333±0.173 0.316±0.148 0.387±0.312 | 0.194±0.097 0.128±0.067*** 0.202±0.148 0.147±0.091** 0.104±0.08* | 0.227±0.107 0.06±0.059*** 0.273±0.328 0.184±0.134* 0.118±0.089* | 0.412±0.286 0.314±0.324 0.591±0.431 0.198±0.079* 0.166±0.087* |
Annotate: the 5th, 10 days (T of administration group administration
5, T
10) and the 3rd day (P of drug withdrawal
3) the clear DHBV-DNA OD of Sanguis Anas domestica value and the preceding (T of infection
0) comparison of OD value, adopt paired t-test; * p<0.05, * * p<0.01, * * * P<0.001;
As seen from the above table, in three batches of experiments, model group oral normal saline the 5th day, 10 days and withdraw back the 3rd day serum DHBV-DNA level and administration before relatively, there is no significant difference, point out in three batches of experimental model groups whole process 13 days serum DHBV-DNA level steady substantially.
Table 9 compositions is to the suppression ratio of the clear DHBV-DNA of Sanguis Anas domestica
The experiment batch | Group | Dosage g/kg | The duck number of elements | The clear DHBV-DNA suppression ratio of Sanguis Anas domestica (%) |
T
5 | T
10 | P
3 |
1 | Normal saline ACV compositions | -- 0.1 10 20 40 | 10 10 10 10 10 | 41.38 89.01 31.29 30.72 47.18 | -4 87.61 -11.47 33.33 76.08 | -62.07 4.51 -89.03 11.11 69.77 |
2 | Normal saline ACV compositions | -- 0.1 10 20 40 | 8 8 8 8 8 | 26.44 80.13 43.30 43.87 44.81 | -10.34 91.84 22.51 35.85 34.91 | -81.61 54.18 -20.23 0.47 0.47 |
3 | Normal saline ACV | -- 0.1 10 | 9 9 9 | 10.26 72.28 39.33 | -4.77 86.96 18.00 | -90.26 31.64 -77.33 |
Compositions | 20 40 | 9 9 | 53.52 72.99 | 41.55 69.54 | 37.32 57.18 |
By table 9 as seen, each dosage group oral administration of compositions all has in various degree inhibitory action to the clear DHBV-DNA of Sanguis Anas domestica, and certain dose-effect relationship is arranged, heavy dose of group can reach about 70% the suppression ratio of DHBV-DNA, and the clear DHBV-DNA of Sanguis Anas domestica is still had certain inhibitory action in the 3rd day after the drug withdrawal.
The administration of table 10 composition oral is to the influence of the clear DHBpresAg level of Sanguis Anas domestica
The experiment batch | Group | Dosage g/kg | The duck number of elements | The clear DHBpresAg OD of Sanguis Anas domestica value (x ± s) |
T
0 | T
5 | T
10 | P
3 |
1 | Normal saline ACV compositions | 0.1 10 20 40 | 10 10 10 10 10 | 0.562±0.409 0.651±0.317 0.639±0.313 0.406±0.352 0.496±0.305 | 0.418±0.233 0.287±0.267*** 0.464±0.285 0.215±0.273* 0.224±0.314** | 0.422±0.277 0.253±0.244*** 0.646±0.375 0.199±0.152 0.329±0.373* | 0.671±0.437 0.321±0.277* 0.823±0.423 0.236±0.187 0.323±0.383* |
2 | Normal saline ACV compositions | 0.1 10 20 40 | 8 8 8 8 8 | 0.819±0.225 1.425±0.24 0.720±0.447 0.725±0.197 0.73±0.295 | 0.743±0.256 0.92±0.295** 0.557±0.358 0.332±0.197*** 0.555±0.234 | 0.847±0.161 0.768±0.354** 0.705±0.519 0.537±0.274* 0.266±0.139** | 0.965±0.329 0.985±0.454* 1.043±0.539 0.675±0.276 0.486±0.242* |
3 | Normal saline ACV compositions | 0.1 10 20 40 | 9 9 9 9 9 | 0.938±0.457 1.616±0.586 1.009±0.561 0.981±0.23 0.890±0.641 | 0.925±0.459 1.214±0.376* 0.704±0.447 0.474±0.268*** 0.708±0.387 | 0.986±0.367 0.862±0.565** 0.694±0.618 0.69±0.33* 0.351±0.225** | 1.207±0.49 1.151±0.662 1.323±0.589 0.856±0.313 0.623±0.368* |
Annotate: the 5th, 10 days (T of administration group administration
5, T
10) and the 3rd day (P of drug withdrawal
3) the clear DHBpresAg OD of Sanguis Anas domestica value and the preceding (T of infection
0) comparison of OD value, adopt paired t-test; * p<0.05, * * p<0.01, * * * P<0.001
As seen from the above table, in three batches of experiments, model group oral normal saline the 5th day, 10 days and withdraw the 3rd day serum DHBpresAg level and the T in back
0It relatively there is no significant difference, illustrates that three batches of omnidistance 13 days inner model group serum DHBpresAg levels of experiment are steady substantially.
In three batches of experiments, comparing before the 5th, 10 days serum DHBpresAg level of positive administration group administration and the administration all has remarkable decline (P<0.001 or P<0.01 or P<0.05); In first and second batch experiment, compared obvious decline (P<0.05) before the 3rd day serum DHBpresAg level and the administration after the drug withdrawal of positive administration group, but in the 3rd batch of experiment, do not had significant difference.Point out this Chinese medicine composition oral administration that dhbv dna is had to a certain degree inhibitory action.
From above experimental study as seen, Drug therapy hepatitis effect of the present invention is obvious, have protect the liver, the effect of transaminase lowering, inhibition hepatitis B virus, do not have bounce-back, safety range is big, toxic and side effects is little.
Specific embodiment
The present invention further elaborates preparation method and its pharmaceutical preparation of this Chinese medicine composition by following examples, but the invention is not restricted to this scope of embodiments.
The preparation method of embodiment 1 Chinese medicine composition of the present invention
400g is ground into coarse granule with Rhizoma Picrorhizae, with 50% soak with ethanol after 15 hours percolation extract, extracting solution is at 50 ℃~70 ℃, vacuum be-0.085~-the 0.1MPa condition, decompression recycling ethanol, and concentrating must concentrated solution 1; Flos Lonicerae 250g, Rhizoma Polygoni Cuspidati 50g, Rhizoma Osmundae 100g are added 8 times of amount 60% soak with ethanol 1 hour, reflux, extract, 2 times, extracting solution is at 50 ℃~70 ℃, and vacuum be-0.085~-the 0.1MPa condition, decompression recycling ethanol, and concentrating must concentrated solution 2; Merge 2,50 ℃~70 ℃ of concentrated solution 1 and concentrated solutions, vacuum is-0.085~-the 0.1MPa condition under vacuum drying 6 hours, be ground into powder, make this Chinese medicine composition.
The preparation method of embodiment 2 Chinese medicine compositions of the present invention
Rhizoma Picrorhizae 432g, Radix Salviae Miltiorrhizae 106g are ground into coarse granule, with 70% soak with ethanol after 12 hours percolation extract, extracting solution is at 50 ℃~70 ℃, vacuum be-0.085~-the 0.1MPa condition, decompression recycling ethanol, and concentrating must concentrated solution 1; Flos Lonicerae 266g, Rhizoma Polygoni Cuspidati 86g, Rhizoma Atractylodis Macrocephalae 86g, Rhizoma Osmundae 133g are added 8 times of amount 80% soak with ethanol 0.5 hour, reflux, extract, 2 times, extracting solution is at 50 ℃~70 ℃, and vacuum be-0.085~-the 0.1MPa condition, decompression recycling ethanol, and concentrating must concentrated solution 2; Merge 2,50 ℃~70 ℃ of concentrated solution 1 and concentrated solutions, vacuum is-0.085~-the 0.1MPa condition under vacuum drying 6 hours, be ground into powder, make this Chinese medicine composition.
The preparation method of embodiment 3 Chinese medicine compositions of the present invention
Rhizoma Picrorhizae 450g, Radix Salviae Miltiorrhizae 150g are ground into coarse granule, with 95% soak with ethanol after 8 hours percolation extract, extracting solution is at 50 ℃~70 ℃, vacuum be-0.085~-the 0.1MPa condition, decompression recycling ethanol, and concentrating must concentrated solution 1; Flos Lonicerae 300g, Rhizoma Polygoni Cuspidati 100g, Rhizoma Atractylodis Macrocephalae 100g, Rhizoma Osmundae 150g are added 10 times of amount 95% soak with ethanol 0.5 hour, reflux, extract, 2 times, extracting solution is at 50 ℃~70 ℃, vacuum is-0.085~-the 0.1MPa condition, decompression recycling ethanol, and concentrate, concentrated solution 2 got; Merge 2,50 ℃~70 ℃ of concentrated solution 1 and concentrated solutions, vacuum is-0.085~-the 0.1MPa condition under vacuum drying 6 hours, be ground into powder, make this Chinese medicine composition.
The preparation method of embodiment 4 Chinese medicine compositions of the present invention
432g is ground into coarse granule with Rhizoma Picrorhizae, with 40% soak with ethanol after 8 hours percolation extract, extracting solution is at 50 ℃~70 ℃, vacuum be-0.085~-the 0.1MPa condition, decompression recycling ethanol, and concentrating must concentrated solution 1; Flos Lonicerae 280g, Rhizoma Polygoni Cuspidati 90g, Rhizoma Osmundae 120g are added 10 times of amount 30% soak with ethanol 1.5 hours, reflux, extract, 2 times, extracting solution is at 50 ℃~70 ℃, and vacuum be-0.085~-the 0.1MPa condition, decompression recycling ethanol, and concentrating must concentrated solution 2; Merge 2,50 ℃~70 ℃ of concentrated solution 1 and concentrated solutions, vacuum is-0.085~-the 0.1MPa condition under vacuum drying 6 hours, be ground into powder, make this Chinese medicine composition.
The preparation method of embodiment 5 Chinese medicine composition tablets of the present invention
Get the Chinese medicine composition that embodiment 1 makes and sieve, add pregelatinized Starch, mix homogeneously, tabletting, promptly.
The preparation method of embodiment 6 Chinese medicinal composition capsules agent of the present invention
Get the Chinese medicine composition that embodiment 2 makes and sieve, add starch and micropowder silica gel, mix homogeneously divides the capsule of packing into No. 1, promptly.
The preparation method of embodiment 7 Chinese medicinal composition granules of the present invention
Get the Chinese medicine composition that embodiment 3 makes and sieve, add starch, microcrystalline Cellulose sodium etc., mix homogeneously is granulated, promptly.
The preparation method of embodiment 8 Chinese medicine composition oral liquids of the present invention
Get the Chinese medicine composition that embodiment 4 makes and sieve, mix homogeneously adds lactose and an amount of stevioside's flavoring, promptly.