CN104547070A - Medical composition resistant to hepatitis b viruses as well as preparation method and application of medical composition - Google Patents
Medical composition resistant to hepatitis b viruses as well as preparation method and application of medical composition Download PDFInfo
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- CN104547070A CN104547070A CN201410829222.4A CN201410829222A CN104547070A CN 104547070 A CN104547070 A CN 104547070A CN 201410829222 A CN201410829222 A CN 201410829222A CN 104547070 A CN104547070 A CN 104547070A
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Abstract
The invention discloses a medical composition resistant to hepatitis viruses. The medical composition is a preparation prepared from the following raw material medicines in parts by weight: 9-15 parts of radix scutellariae, 9-15 parts of Chinese rhubarb, 9-15 parts of Chinese thorowax, 12-18 parts of astragalus membranaceus, 9-15 parts of Chinese magnoliavine fruit, and 6-12 parts of licorice root. The invention further provides a preparation method and application of the medical composition. The medical composition disclosed by the invention has the efficacies of clearing heat, removing dampness, soothing the liver and invigorating the spleen, and is suitable for patients with acute hepatitis b, patients with chronic hepatitis b, asymptomatic hepatitis b virus carriers and inapparent infection patients. According to the invention, the compatibility of the medical composition is precise and appropriate, the curative effects are outstanding, and the medical composition is safe and reliable, and low in cost; t a new selection is provided for clinical medication.
Description
Technical field
The present invention relates to pharmaceutical composition of a kind of anti-hepatitis B virus and its production and use.
Background technology
Hepatitis is the general designation of inflammation.Typically refer to by multiple paathogenic factor--as virus, antibacterial, parasite, chemical toxicant, medicine, ethanol, role of autoimmune factors etc. make liver cell be damaged, the function of liver suffers damage, cause a series of malaise symptoms of health, and the exception of liver function index.Viral, bacillary (as ameba) Drug, Alcoholic, toxic, autoimmunity, non-alcoholic stellato-hepatitis can be divided into according to the cause of disease; Acute hepatitis, chronic hepatitis etc. can be divided into according to course of disease length.
Viral hepatitis is the hepatitis caused by hepatitis virus.Human hepatitis virus have A type, B-mode, non-a, non-b type and fourth type virus point.Hepatitis A virus is spherical in shape, and without peplos, nucleic acid is single stranded RNA; Hepatitis B virus is spherical in shape, has double-layer shell structure, and the peplos of outer quite general virus, nucleic acid is double-stranded DNA, among studying at present non A non B hepatitis virus and hepatitis D virus.
Patent application CN101773655A discloses a kind of pharmaceutical composition, and said composition is by Radix Trichosanthis, Radix Scrophulariae, Rhizoma Coptidis, Radix Scutellariae, Radix Glycyrrhizae, the Radix Astragali, Radix Tripterygii Wilfordii, Poria, Rhizoma Polygoni Cuspidati, Radix Aconiti Lateralis Preparata, Herba Artemisiae Scopariae, Radix Morindae Officinalis, Fructus Schisandrae Chinensis, Endothelium Corneum Gigeriae Galli, the Rhizoma Atractylodis Macrocephalae, Rhizoma Zingiberis Preparatum, Herba Asari, Ramulus Cinnamomi, Rhizoma Atractylodis, Radix Sophorae Tonkinensis, Herba Agrimoniae, Fructus Trichosanthis, the Rhizoma Anemarrhenae, Radix Notoginseng, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Flos Lonicerae, Herba Phyllanthi Urinariae, the Cortex Eucommiae, Rhizoma Sparganii, Rhizoma Curcumae, Rhizoma Curcumae Longae, Cortex Phellodendri, Herba Taxilli, Radix Codonopsis, Herba Ephedrae, Radix Sophorae Flavescentis, Radix Et Rhizoma Rhei, Mylabris, Semen Coicis, Placenta Hominis, Fructus Forsythiae, Ganoderma, Bulbus Fritillariae Uninbracteatae, Spica Prunellae, Fructus Crataegi, Herba Epimedii, Herba Andrographis, Concha Ostreae, Radix Bupleuri, Herba Pogostemonis, Herba Visci, Fructus Luffae, Fructus Mori, Herba Chelidonii, Fructus Tribuli, Rhizoma Chuanxiong, the Rhizoma Pinelliae, Herba Equiseti Hiemalis, Caulis Spatholobi, Herba Hedyotidis Diffusae, Semen Cuscutae, Aloe, Radix Arnebiae (Radix Lithospermi), Herba Astragali Melilotoidis (Herba Astragali Sinici), large-fruited hodgsonia root, Rhizoma Polygonati, Herba Violae, M.macrophylla Gege, Fructus Caricae, Herba Taraxaci, Herb Gynostemmae Pentaphylli, Radix Et Caulis Acanthopanacis Senticosi, Rhizoma Dioscoreae, Eupolyphaga Seu Steleophaga forms, and pulverize and extract dispersion, microwave extracting, the pulverizing of supersonic speed spraying dry, nano-milled, mixing, capsule fill, sterilizing through pretreatment pulverizing, high-frequency ultrasonic and get final product, can be used for Treatment chronic Hepatitis B.
Summary of the invention
The object of the present invention is to provide pharmaceutical composition of a kind of hepatitis virus resisting and its production and use.
The pharmaceutical composition of hepatitis virus resisting of the present invention, it is the preparation that the crude drug comprising following weight proportion is prepared from:
Radix Scutellariae 9-15 part, Radix Et Rhizoma Rhei 9-15 part, Radix Bupleuri 9-15 part, Radix Astragali 12-18 part, Fructus Schisandrae Chinensis 9-15 part, Radix Glycyrrhizae 6-12 part.
Preferably, it is the preparation be prepared from by the crude drug of following weight proportion:
Radix Scutellariae 11-13 part, Radix Et Rhizoma Rhei 11-13 part, Radix Bupleuri 11-13 part, Radix Astragali 14-16 part, Fructus Schisandrae Chinensis 11-13 part, Radix Glycyrrhizae 8-10 part.
Further preferably, it is the preparation be prepared from by the crude drug of following weight proportion:
Radix Scutellariae 12 parts, Radix Et Rhizoma Rhei 12 parts, Radix Bupleuri 12 parts, the Radix Astragali 15 parts, Fructus Schisandrae Chinensis 12 parts, 9 parts, Radix Glycyrrhizae.
Wherein, it is active component by the medicated powder of crude drug or the water of crude drug or ethanol extraction, adds the preparation that pharmaceutically conventional adjuvant or complementary composition are prepared from.
Described preparation is capsule, decoction, powder, granule, tablet, pill, oral liquid.
Present invention also offers the preparation method of aforementioned pharmaceutical compositions, it comprises the steps:
A) each crude drug is taken by weight ratio;
B) get the medicated powder of crude drug or the water of crude drug or ethanol extraction, add that pharmaceutically conventional adjuvant or complementary composition prepare preparation.
Present invention also offers the purposes of aforementioned pharmaceutical compositions in the medicine preparing hepatitis virus resisting.Wherein, the medicine of described hepatitis virus resisting is the medicine of hepatitis virus resisting.
Present invention also offers the purposes of aforementioned pharmaceutical compositions in the medicine of preparation treatment viral hepatitis.Wherein, the medicine of described treatment viral hepatitis is the medicine for the treatment of hepatitis B.
Radix Scutellariae large bitter Great Cold in drug regimen raw material prescription side of the present invention, the power of removing damp-heat is especially high, have the merit of eliminating fire and detoxication concurrently, energy " main all hot jaundice " (Shennong's Herbal), " controlling the damp and hot of spleen " (" Compendium of Materia Medica volume 13 Radix Scutellariaes "), Radix Et Rhizoma Rhei eliminating fire and detoxication and bitter cold sedimentation, heat conduction is descending, is monarch drug altogether with Radix Scutellariae.Radix Bupleuri dispersing the stagnated live-QI to relieve the stagnation of QI, in case liver wood subjugates earth.Sweet and the tepor of the Radix Astragali, QI invigorating diuretic, with spleen invigorating dehumidifying, anti-damp stops gathering.Radix Bupleuri and the Radix Astragali share soothing liver and strengthening spleen diuretic, with principal drug assistance removing damp-heat, are ministerial drug altogether.Help with the nourishing kidney of trimethyl gallic acid temperature, with replenishing the kidney(water)to nourish the liver(wood).Radix Glycyrrhizae replenishing QI to invigorate the spleen first in side, is second in harmonious proportion flavour of a drug.Above-mentioned all medicines, bring out the best in each other, then clear the wetting of heat is removed, and spleen is good for liver and is dredged.
Pharmaceutical composition of the present invention has the merit of removing damp-heat, soothing liver and strengthening spleen, is applicable to acute and chronic hepatitis B, Chronic asymptomatic carrier and inapparent infection person, and its compatibility is precise and appropriate, determined curative effect, and safe and reliable, with low cost, for clinical application provides new selection.
Detailed description of the invention is by the following examples described in further detail foregoing of the present invention.But the scope that should not be construed the above-mentioned theme of the present invention is only limitted to following embodiment.All technology realized based on foregoing of the present invention all belong to scope of the present invention.
Detailed description of the invention
The preparation of embodiment 1 pharmaceutical composition of the present invention
Get Radix Scutellariae 12g, Radix Et Rhizoma Rhei 12g, Radix Bupleuri 12g, Radix Astragali 15g, Fructus Schisandrae Chinensis 12g, Radix Glycyrrhizae 9g, decoct with water, be condensed into extractum, spraying dry, encapsulated, obtain 6g capsule.
The preparation of embodiment 2 pharmaceutical composition of the present invention
Get Radix Scutellariae 13g, Radix Et Rhizoma Rhei 13g, Radix Bupleuri 13g, Radix Astragali 16g, Fructus Schisandrae Chinensis 13g, Radix Glycyrrhizae 10g, decoct with water extraction, concentrated, be prepared into oral liquid.
The preparation of embodiment 3 pharmaceutical composition of the present invention
Get Radix Scutellariae 11g, Radix Et Rhizoma Rhei 11g, Radix Bupleuri 11g, Radix Astragali 14g, Fructus Schisandrae Chinensis 11g, Radix Glycyrrhizae 8g, add 70-80%v/v alcohol reflux, merge extractive liquid, be condensed into extractum, add adjuvant granule, the tablettings such as starch, obtain tablet.
The preparation of embodiment 4 pharmaceutical composition of the present invention
Get Radix Scutellariae 15g, Radix Et Rhizoma Rhei 15g, Radix Bupleuri 15g, Radix Astragali 18g, Fructus Schisandrae Chinensis 15g, Radix Glycyrrhizae 12g, directly beat powder, make powder.
The preparation of embodiment 5 pharmaceutical composition of the present invention
Get Radix Scutellariae 9g, Radix Et Rhizoma Rhei 9g, Radix Bupleuri 9g, Radix Astragali 12g, Fructus Schisandrae Chinensis 9g, Radix Glycyrrhizae 6g, add 70-80%v/v alcohol reflux, merge extractive liquid, be condensed into extractum, add adjuvant granule, the tablettings such as starch, obtain tablet.
Beneficial effect of the present invention is proved below by way of clinical trial.
Test example 1 pharmaceutical composition anti-hepatitis virus experiment of the present invention
1, experimental technique:
1. prepare Contained Serum: choose the new zealand rabbit that body weight is 2.0 ± 0.2kg, be divided at random blank group, acycloguanosine (ACV) group, the basic, normal, high dosage group of pharmaceutical composition of the present invention, male and female half and half.Low, in, high dose group difference gavage 0.125g/kg/ time, 0.25g/kg/ time, 0.5g/kg/ time pharmaceutical composition of the present invention (gets Radix Scutellariae 12g, Radix Et Rhizoma Rhei 12g, Radix Bupleuri 12g, Radix Astragali 15g, Fructus Schisandrae Chinensis 12g, Radix Glycyrrhizae 9g, decoct with water, be condensed into extractum, spraying dry, obtain 6g pharmaceutical composition of the present invention), ACV group gavage 0.083g/kg acycloguanosine, the distilled water of blank group gavage same volume, every day 2 times, sooner or later each 1 time (pharmaceutical composition medicine every day total amount of the present invention is equivalent to 2.5 times of 60kg adult quantity, 5 times, 10 times, acycloguanosine medicine every day total amount is equivalent to 10 times of 60kg adult quantity), continuous 7 days.In last gavage (before gavage, water 12h is can't help in fasting) 2h afterwards, Culling heart blood, aseptic separation of serum, through 56 DEG C of 30min inactivation treatment, degerming with 0.45 μm of filtering with microporous membrane.
2. get containing basic, normal, high dosage pharmaceutical composition serum of the present invention, containing ACV serum, the each 200 μ l of the blank rabbit anteserum of deactivation act on 4h with 50 μ l hepatitis B patient HBsAg positive serums (500 μ g/L HBsAg) respectively at 37 DEG C, then hepatitis B virus surface antigen (HBsAg) and HBeAg (HBeAg) level is detected by enzyme linked immunosorbent assay, hepatitis B virus DNA polymerase activity is detected, by detected by dot blot hybridization hepatitis B virus DNA level by the specific immunity sedimentation method.
2, experimental result
Experimental result is as shown in table 1 ~ table 4:
The inhibitory action that table 1 medicine is expressed HBsAg
Note: compare △ P<0.01 with blank; * P<0.01 is compared with low dosage; With middle dose comparison $ P<0.01; ▲ P>0.05 is compared with ACV.
The inhibitory action that table 2 medicine is expressed HBeAg
Note: compare △ P<0.01 with blank; * P<0.01 is compared with low dosage; With middle dose comparison $ P<0.01; ▲ P>0.05 is compared with ACV.
Table 3 medicine is to the inhibitory action of hepatitis B virus DNA polymerase activity
Note: compare #P<0.01 with blank; * P<0.01 is compared with low dosage; With middle dose comparison $ P<0.01; ▲ P>0.05 is compared with ACV.
Table 4 medicine is to the inhibitory action of hepatitis B virus DNA level
Note: compare #P<0.01 with blank; ▲ P>0.05 is compared with ACV.
As can be seen from table 1 ~ table 4, pharmaceutical composition of the present invention can significantly suppress HBsAg and HBeAg to express, and suppresses hepatitis B virus DNA polymerase activity, suppress hepatitis B virus DNA to copy, and high dose pharmaceutical composition of the present invention action intensity is suitable with ACV.
Experimental result illustrates, pharmaceutical composition of the present invention has anti-HBV effect, can prepare the medicine becoming anti-hepatitis virus.
The zoopery of test example 2 Drug therapy acute hepatitis B of the present invention, chronic hepatitis B or clinical observation on the therapeutic effect experiment
1, clinical data
1.1 diagnostic criterias:
According to the hepatitis B diagnostic criteria (People's Republic of China's health industry standard, WS299-2008) of Ministry of Public Health approval, be specifically divided into acute hepatitis b and chronic viral hepatitis B diagnostic criteria:
1.1.1 acute hepatitis b
1. occur without the explainable weak and symptom of digestive tract of other reasons having yellowish urine, eye Huang and Dermal icterus in the recent period.
2. liver biochemistry inspection is abnormal, and mainly Serum ALT and AST raise, and serum bilirubin can be had to raise.
3. HBsAg is positive.
4. tangible proof is had to show once to detect serum HBsAg feminine gender in 6 months.
5. positive more than the 1:1000 of anti-HBc IgM.
6. liver histological meets acute viral hepatitis change.
7. convalescent serum HBsAg the moon turns, and Anti-HBsAg antibody sun turns.
(1) suspected acute hepatitis B case
Meet that following any one is diagnosable:
A. to meet 1. and 3. simultaneously.
B. to meet 2. and 3. simultaneously.
(2) acute hepatitis b case is made a definite diagnosis
Meet that following any one is diagnosable:
A. 4. suspected case meets simultaneously.
B. 5. suspected case meets simultaneously.
C. 6. suspected case meets simultaneously.
D. 7. suspected case meets simultaneously.
1.1.2 chronic viral hepatitis B
1. still HBsAg was positive or find that the HBsAg positive was more than 6 months more than 6 months for acute HBV infection.
2. the HBsAg positive persistent period is not quite clear, and anti-HBc IgM is negative.
3. the sign of patients with chronic liver is as hepatic facies, liver palm, spider angioma regulating liver-QI, splenomegaly.
4. Serum ALT repeatedly or continue to raise, and plasma albumin can be had to reduce and (or) globulin raises, or bilirubin rising etc.
5. liver pathology has the feature of chronic viral hepatitis.
6. the serum HBeAg positive maybe can detect HBV DNA, and gets rid of other reasons causing ALT to raise.
(1) chronic viral hepatitis B case is made a definite diagnosis
Meet that following any one is diagnosable:
4. and 6. A. to meet 1., simultaneously.
5. and 6. B. to meet 1., simultaneously.
4. and 6. C. to meet 2., simultaneously.
5. and 6. D. to meet 2., simultaneously.
1.2 inclusive criteria
The case meeting 1.1 joint diagnostic criterias is all included in.
2, Therapeutic Method
Experimental group: the medicine giving the embodiment of the present invention 1.
Concrete medication is:
Capsule prepared by the oral embodiment 1 of acute and chronic hepatitis B patient, each 2 grams of capsules, every day 3 times (6 grams of capsules are equivalent to crude drug 72 grams), the course for the treatment of is June.
3, observation of curative effect
3.1 criterions of therapeutical effect: please provide.
Cure: clinical symptom disappearance, HBsAg, HBeAg, HBV DNA and HBV archaeal dna polymerase disappears, normally, serum albumin is normal, and hepatic tissue pathology check result is without exception for serum glutamic pyruvic transminase (ALT), glutamic oxaloacetic transaminase, GOT (AST) activation recovering simultaneously.
Take a turn for the better: clinical symptom disappearance, normally, other liver function test result (as serum albumin, prothrombin time etc.) is all improved for Serum ALT and AST; Or serum HBeAg, HBV DNA and HBV archaeal dna polymerase disappears.
Invalid: clinical symptoms still exists.
3.2 therapeutic outcome
92 routine clinical observation result are as shown in table 1 below:
As shown in table 1:
| Group | Cure | Take a turn for the better | Invalid | Effective percentage (%) |
| Experimental group (92 people) | 8 | 79 | 5 | 94.6 |
As shown in table 1, pharmaceutical composition of the present invention can significantly improve hepatitis B patient clinical symptoms, reduce serum of hepatitis B Patients glutamate pyruvate transaminase (ALT) and glutamic oxaloacetic transaminase, GOT (AST), hepatitis B virus DNA is suppressed to copy, HBsAg and HBeAg of part serum of hepatitis B Patients is turned out cloudy, to hepatitis B, there is good curative effect.
To sum up, pharmaceutical composition of the present invention has the merit of removing damp-heat, soothing liver and strengthening spleen, has the effect of anti-hepatitis virus, effectively can treat hepatitis B, compatibility is precise and appropriate, determined curative effect, and safe and reliable, with low cost, for clinical application provides new selection.
Claims (10)
1. a pharmaceutical composition for hepatitis virus resisting, is characterized in that: it is the preparation that the crude drug comprising following weight proportion is prepared from:
Radix Scutellariae 9-15 part, Radix Et Rhizoma Rhei 9-15 part, Radix Bupleuri 9-15 part, Radix Astragali 12-18 part, Fructus Schisandrae Chinensis 9-15 part, Radix Glycyrrhizae 6-12 part.
2. pharmaceutical composition according to claim 1, is characterized in that: it is the preparation be prepared from by the crude drug of following weight proportion:
Radix Scutellariae 11-13 part, Radix Et Rhizoma Rhei 11-13 part, Radix Bupleuri 11-13 part, Radix Astragali 14-16 part, Fructus Schisandrae Chinensis 11-13 part, Radix Glycyrrhizae 8-10 part.
3. pharmaceutical composition according to claim 2, is characterized in that: it is the preparation be prepared from by the crude drug of following weight proportion:
Radix Scutellariae 12 parts, Radix Et Rhizoma Rhei 12 parts, Radix Bupleuri 12 parts, the Radix Astragali 15 parts, Fructus Schisandrae Chinensis 12 parts, 9 parts, Radix Glycyrrhizae.
4. the pharmaceutical composition according to claim 1-3 any one, is characterized in that: it is active component by the medicated powder of crude drug or the water of crude drug or ethanol extraction, adds the preparation that pharmaceutically conventional adjuvant or complementary composition are prepared from.
5. the pharmaceutical composition according to claim 1-4 any one, is characterized in that: described preparation is capsule, decoction, powder, granule, tablet, pill, oral liquid.
6. the preparation method of pharmaceutical composition described in claim 1-3 any one, is characterized in that: it comprises the steps:
A) each crude drug is taken by weight ratio;
B) get the medicated powder of crude drug or the water of crude drug or ethanol extraction, add that pharmaceutically conventional adjuvant or complementary composition prepare preparation.
7. the purposes of pharmaceutical composition in the medicine preparing hepatitis virus resisting described in Claims 1 to 5 any one.
8. purposes according to claim 7, is characterized in that: described medicine is the medicine of anti-hepatitis B virus.
9. the purposes of pharmaceutical composition described in Claims 1 to 5 any one in the medicine of preparation treatment viral hepatitis.
10. purposes according to claim 9, is characterized in that: described medicine is the medicine for the treatment of hepatitis B.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410829222.4A CN104547070A (en) | 2014-12-25 | 2014-12-25 | Medical composition resistant to hepatitis b viruses as well as preparation method and application of medical composition |
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| CN201410829222.4A CN104547070A (en) | 2014-12-25 | 2014-12-25 | Medical composition resistant to hepatitis b viruses as well as preparation method and application of medical composition |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104888017A (en) * | 2015-06-18 | 2015-09-09 | 王萧 | Medicine for treating hepatitis B |
| CN105770725A (en) * | 2016-02-23 | 2016-07-20 | 李法军 | Pharmaceutical composition for treating hepatitis and preparing method and application thereof |
-
2014
- 2014-12-25 CN CN201410829222.4A patent/CN104547070A/en active Pending
Non-Patent Citations (3)
| Title |
|---|
| HAIBO XU,ET AL: "Study on the antiviral activity of San Huang Yi Gan Capsule against hepatitis B virus with seropharmacological method", 《BMC COMPLEMENTARY & ALTERNATIVE MEDICINE》 * |
| 吴清和等: "三黄乙肝胶囊对HBsAg抑制作用的血清药理学研究", 《中药药理与临床》 * |
| 徐海波: "三黄乙肝胶囊抗乙型肝炎病毒的血清药理学研究", 《中国优秀硕士学位论文全文数据库 医药卫生科技辑》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104888017A (en) * | 2015-06-18 | 2015-09-09 | 王萧 | Medicine for treating hepatitis B |
| CN105770725A (en) * | 2016-02-23 | 2016-07-20 | 李法军 | Pharmaceutical composition for treating hepatitis and preparing method and application thereof |
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