CN102579637B - Chinese patent drug--herpes virus tablet for treating herpes simplex virus as well as preparation method of same - Google Patents

Chinese patent drug--herpes virus tablet for treating herpes simplex virus as well as preparation method of same Download PDF

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CN102579637B
CN102579637B CN201210069143.9A CN201210069143A CN102579637B CN 102579637 B CN102579637 B CN 102579637B CN 201210069143 A CN201210069143 A CN 201210069143A CN 102579637 B CN102579637 B CN 102579637B
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herpes
radix
sheet
virus
herpesvirus
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CN102579637A (en
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李浪辉
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GUANGXI STRONGLIFE PHARMACEUTICAL GROUP CO Ltd
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GUANGXI STRONGLIFE PHARMACEUTICAL GROUP CO Ltd
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Abstract

The invention relates to a Chinese patent drug--herpes virus tablet for treating herpes simplex virus as well as a preparation method of same. The herpes virus tablet is mainly prepared by finishing scutellaria root, coptis root, gardenia, lithospermum erythrorhizon, panicled swallowwort root and porcine gall powder. The whole formula jointly plays the roles of cooling blood, activating blood circulation, clearing heat and removing toxicity. The herpes virus tablet is a Chinese patent drug--new drug for treating various kinds of herpes simplex viruses, herpes simplex and genital herpes, and has a better therapeutic effect on acute herpes diseases caused by herpes simplex virus or herpes zoster virus. The preparation method is simple, convenient and feasible; the prepared tablet is convenient to take, and has high absorptivity and bioavailability; the herpes virus tablet is smooth, bright and beautiful; and the production process is easy to grasp, the moisture resistance of drugs is good, and the stability of products is high.

Description

A kind of Chinese patent medicine-herpesvirus sheet for the treatment of virus infected herpes and preparation method thereof
One, technical field:
The present invention relates to a kind of Chinese patent medicine and preparation method thereof, particularly a kind of Chinese patent medicine-herpesvirus sheet for the treatment of virus infected herpes and preparation method thereof.
Two, background technology:
Virus infected herpes is a kind of acute herpes disease, and in China, sickness rate is higher, and especially in China's west lags far low developed area, acute herpetic disease ratio is higher.Virus infected herpes is divided into single herpes and herpes zoster, and doctor trained in Western medicine is called virus infected herpes, and the traditional Chinese medical science is called skirt-roof skin ulcer, and being has heat, waste heat clear by the part of the body cavity above the diaphragm housing the heart and lungs, or the sending out in flesh table or the wet fire, outer evil and caused by bringing out by poison of accumulateing of spleen through fire-toxin of liver and gall.
Current doctor trained in Western medicine is mainly treated with antiviral drug, as acyclovir, valaciclovir hydrochlordide, recombinant human interferon alpha 2 b, aescine etc., there is the untoward reaction such as medication is irritated, toxic and side effects is larger in the above Western medicine of clinical middle discovery, makes patient medication select to be subject to certain restrictions in various degree.
Three, summary of the invention:
Object of the present invention, is a kind of drug matching innovation of invention, adopts advanced production technology to extract raw the effective elements of the medicine, improve the availability of crude drug and Chinese patent medicine-herpesvirus sheet of true medicable treatment virus infected herpes and preparation method thereof.
The present invention treats the Chinese patent medicine-herpesvirus sheet of virus infected herpes, primarily of Radix Scutellariae 320-480g, Rhizoma Coptidis 200-300g, Fructus Gardeniae 400-600g, Radix Arnebiae (Radix Lithospermi) 320-480g, Radix Cynanchi Paniculati 80-120g, Pulvis Fellis Suis 20-30g, make the herpesvirus sheet of the every sheet 0.25g of 800-1200 sheet through polish.
The optimum weight preparing each main component during the herpesvirus sheet of 1000 every sheet 0.25g is: Radix Scutellariae 400g, Rhizoma Coptidis 250g, Fructus Gardeniae 500g, Radix Arnebiae (Radix Lithospermi) 400g, Radix Cynanchi Paniculati 100g, Pulvis Fellis Suis 25g.
Chinese patent medicine-herpesvirus sheet that the present invention treats virus infected herpes is pure Chinese medicinal preparation, good effect, have no side effect, it is the Chinese patent medicine new drug for the treatment of various virus infected herpes, herpes simplex and genital herpes, there is heat clearing and damp drying, effect of eliminating fire and detoxication, removing heat from blood, promoting blood circulation and stopping pain, the acute herpetic disease curative effect caused for herpes simplex virus or varicella zoster virus is better.In side, principal agent is Radix Arnebiae (Radix Lithospermi), and sweet in the mouth is cold in nature, GUIXIN Liver Channel, has clearing away heat and cooling blood, invigorates blood circulation, detoxifies, rash effect.Fel Sus domestica sweet in the mouth, cold in nature, return liver, gallbladder, lung, large intestine channel, have clearing heat and moistening dryness, effect of removing toxic substances, auxiliary principal agent clears up liver and gall pyretic toxicity, Rhizoma Coptidis, Radix Scutellariae, and sweet in the mouth is cold in nature, and two medical instruments have clearing heat and moistening dryness, effect of eliminating fire and detoxication.Fructus Gardeniae, GUIXIN lung, stomach tri-jiao channel, have pathogenic fire purging relieving restlessness, clearing away heat and promoting diuresis, removing pathogenic heat from blood and toxic substance from the body effect.Radix Cynanchi Paniculati, acrid in the mouth, warm in nature, return liver, stomach warp, interior dehumidifying of dispelling, promoting flow of QI and blood, antalgesic-antipruritic, removing toxic substances and promoting subsidence of swelling effect.Full side plays removing heat from blood altogether, invigorates blood circulation, heat-clearing toxin-expelling functions.This product is studied through pharmacodynamics test, has antiinflammatory, improves macrophage phagocytic function, improve the immunologic mechanism raising effects such as Serological IgG level, have analgesia and antibacterial action simultaneously.The malicious long poison of urgency of this product is lower.
The present invention treats the preparation method of the Chinese patent medicine-herpesvirus sheet of virus infected herpes, it is characterized in that its key step is:
(1) Radix Cynanchi Paniculati, Pulvis Fellis Suis are ground into fine powder respectively;
(2) four tastes such as Radix Scutellariae, Rhizoma Coptidis, Fructus Gardeniae, Radix Arnebiae (Radix Lithospermi), decoct with water secondary, add water (former dose) 10 times at every turn, each 1.5 hours, filter, collecting decoction, filtrate is concentrated into the clear paste that relative density is 1.08 ~ 1.10 (70 DEG C), adds ethanol after cooling, alcohol content is made to reach 60%, leave standstill 24 hours, get supernatant and filter, filtrate recycling ethanol is also concentrated into the thick paste that relative density is 1.35 ~ 1.38 (70 DEG C);
(3) by fine powder obtained with (1) for thick paste obtained to (2), mixing, dry, pulverize into fine powder, adds enough starch, granulates, and dry, tabletting, coating, must treat the Chinese patent medicine-herpesvirus sheet of virus infected herpes.
Ministerial drug in the Radix Scutellariae side of being in herpesvirus sheet, has heat clearing away, dampness, pathogenic fire purging, removing toxic substances, hemostasis, antiabortive effect.For hygropyrexia, fever disease in summer vomiting and nausea uncomfortable in chest, damp and hot feeling of fullness, dysentery, jaundice, cough due to lung-heat, high hot excessive thirst, heat in blood tells nosebleed, carbuncle sore tumefacting virus, frequent fetal movement.Its main component is baicalin, therefore selects content of baicalin to be that index carries out assay, has worked out the every sheet of this product containing Radix Scutellariae with baicalin (C 21h 18o 11) meter, must not 5.80mg be less than.And Rhizoma Coptidis in the other side, Fructus Gardeniae, Radix Cynanchi Paniculati, Pulvis Fellis Suis have carried out indentification by TLC.Discrimination method favorable reproducibility, negative noiseless.
Applicant is to the quality standard draft of three batch samples by relevant requirements under " Chinese Pharmacopoeia " version in 2000 annex tablet item and this product clinical research medication, accelerated stability test and primary stability test are carried out, result shows, this product temperature be 38 ± 1 DEG C, relative humidity be 75% condition and at ambient temperature place three months, every inspection target all conforms with the regulations, and shows constant product quality.
Pharmacodynamic study shows, herpesvirus sheet has antiinflammatory, improve macrophage phagocytic function, improve the immunologic mechanism raising effect such as Serological IgG level, the EC50 that suppresses herpesvirus HSV-1 is 0.078mg/ml, TI is 5.7, be 0.042mg/ml, TI to the EC50 of herpesvirus HSV-2 be 10.6; To herpesvirus HSV-1 and herpesvirus HSV-2 infecting mouse, there is good protective effect; There are analgesia and antibacterial action simultaneously.Therefore, think that this product can be used for the treatment of viral blister exanthema.
Studies on acute toxicity result, herpesvirus sheet, to mouse stomach 170.7g crude drug/kg/ day, is equivalent to 509 times of clinical daily dose (0.335g/kg), has no dead mouse.Prompting, this product should be safe by clinical plan dosage and route of administration.
Long term toxicity result of study, herpesvirus sheet is with 26.8g, 13.4g and 6.7g medical material/kg/d to rat oral gavage administration, and continuous 6 months, the general status of rat was good, and body weight increases normal; Hematological examination, blood biochemical analysis inspection and organ coefficient inspection, no significant difference between administration group and matched group.The histopathologic examination of main organs, has no the obvious pathological change because drug toxicity causes.Above result prompting herpesvirus sheet by clinical plan dosage, approach and to use the course for the treatment of should be safe.
Herpesvirus sheet production technology is reasonable, and quality standard is more perfect, constant product quality.Pharmacological testing shows that it has antiinflammatory, improves macrophage phagocytic function, improves the immunologic mechanism raising effect such as Serological IgG level, the EC50 that suppresses herpesvirus HSV-1 is 0.078mg/ml, TI is 5.7, be 0.042mg/ml, TI to the EC50 of herpesvirus HSV-2 be 10.6; To herpesvirus HSV-1 and herpesvirus HSV-2 infecting mouse, there is good protective effect; There are analgesia and antibacterial action effect simultaneously; Its toxicity is low, intends being used for the daily dose of clinical research and the course for the treatment of should be safe.
The present invention treats that the Chinese patent medicine-herpesvirus sheet of virus infected herpes is entirely just played removing heat from blood altogether, invigorated blood circulation, heat-clearing toxin-expelling functions.The acute herpetic disease curative effect caused for herpes simplex virus or varicella zoster virus is better.And preparation method is simple and easy to do, makes tablet and conveniently take, have absorb fast, bioavailability is high; Smooth appearance, attractive in appearance; Production technology is easy to grasp and the good product stability advantages of higher of medicine humidity resistance.
Four, detailed description of the invention:
Embodiment 1
Main component: Radix Scutellariae 400g, Rhizoma Coptidis 250g, Fructus Gardeniae 500g, Radix Arnebiae (Radix Lithospermi) 400g, Radix Cynanchi Paniculati 100g, Pulvis Fellis Suis 25g.
(1) Radix Cynanchi Paniculati, Pulvis Fellis Suis are ground into fine powder respectively;
(2) four tastes such as Radix Scutellariae, Rhizoma Coptidis, Fructus Gardeniae, Radix Arnebiae (Radix Lithospermi), decoct with water secondary, add water (former dose) 10 times at every turn, each 1.5 hours, filter, collecting decoction, filtrate is concentrated into the clear paste that relative density is 1.08 ~ 1.10 (70 DEG C), adds ethanol after cooling, alcohol content is made to reach 60%, leave standstill 24 hours, get supernatant and filter, filtrate recycling ethanol is also concentrated into the thick paste that relative density is 1.35 ~ 1.38 (70 DEG C);
(3) by fine powder obtained with (1) for thick paste obtained to (2), mixing, dry, pulverize into fine powder, add enough starch, granulate, dry, tabletting, coating, obtains the Chinese patent medicine-herpesvirus sheet of the treatment virus infected herpes of 1000 every sheet 0.25g.
Embodiment 2
Main component: Radix Scutellariae 320g, Rhizoma Coptidis 200g, Fructus Gardeniae 400g, Radix Arnebiae (Radix Lithospermi) 320g, Radix Cynanchi Paniculati 80g, Pulvis Fellis Suis 20g.
(1) Radix Cynanchi Paniculati, Pulvis Fellis Suis are ground into fine powder respectively;
(2) four tastes such as Radix Scutellariae, Rhizoma Coptidis, Fructus Gardeniae, Radix Arnebiae (Radix Lithospermi), decoct with water secondary, add water (former dose) 10 times at every turn, each 1.5 hours, filter, collecting decoction, filtrate is concentrated into the clear paste that relative density is 1.08 ~ 1.10 (70 DEG C), adds ethanol after cooling, alcohol content is made to reach 60%, leave standstill 24 hours, get supernatant and filter, filtrate recycling ethanol is also concentrated into the thick paste that relative density is 1.35 ~ 1.38 (70 DEG C);
(3) by fine powder obtained with (1) for thick paste obtained to (2), mixing, dry, pulverize into fine powder, add enough starch, granulate, dry, tabletting, coating, obtains the Chinese patent medicine-herpesvirus sheet of the treatment virus infected herpes of 800 every sheet 0.25g.
Embodiment 3
Main component: Radix Scutellariae 480g, Rhizoma Coptidis 300g, Fructus Gardeniae 600g, Radix Arnebiae (Radix Lithospermi) 480g, Radix Cynanchi Paniculati 120g, Pulvis Fellis Suis 30g.
(1) Radix Cynanchi Paniculati, Pulvis Fellis Suis are ground into fine powder respectively;
(2) four tastes such as Radix Scutellariae, Rhizoma Coptidis, Fructus Gardeniae, Radix Arnebiae (Radix Lithospermi), decoct with water secondary, add water (former dose) 10 times at every turn, each 1.5 hours, filter, collecting decoction, filtrate is concentrated into the clear paste that relative density is 1.08 ~ 1.10 (70 DEG C), adds ethanol after cooling, alcohol content is made to reach 60%, leave standstill 24 hours, get supernatant and filter, filtrate recycling ethanol is also concentrated into the thick paste that relative density is 1.35 ~ 1.38 (70 DEG C);
(3) by fine powder obtained with (1) for thick paste obtained to (2), mixing, dry, pulverize into fine powder, add enough starch, granulate, dry, tabletting, coating, obtains the Chinese patent medicine-herpesvirus sheet of the treatment virus infected herpes of 1200 every sheet 0.25g.
During suitability for industrialized production, can by proportioning expanding production.

Claims (2)

1. treat the herpesvirus sheet of virus infected herpes for one kind, it is characterized in that it is by Radix Scutellariae 320-480g, Rhizoma Coptidis 200-300g, Fructus Gardeniae 400-600g, Radix Arnebiae (Radix Lithospermi) 320-480g, Radix Cynanchi Paniculati 80-120g, Pulvis Fellis Suis 20-30g, makes the herpesvirus sheet of the every sheet 0.25g of 800-1200 sheet through polish; Its key step is:
(1) Radix Cynanchi Paniculati, Pulvis Fellis Suis are ground into fine powder respectively;
(2) four tastes such as Radix Scutellariae, Rhizoma Coptidis, Fructus Gardeniae, Radix Arnebiae (Radix Lithospermi), decoct with water secondary, add water former dose 10 times at every turn, each 1.5 hours, filter, collecting decoction, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.08 ~ 1.10, adds ethanol after cooling, alcohol content is made to reach 60%, leave standstill 24 hours, get supernatant and filter, filtrate recycling ethanol and when being concentrated into 70 DEG C relative density be the thick paste of 1.35 ~ 1.38;
(3) by fine powder obtained with (1) for thick paste obtained to (2), mixing, dry, pulverize into fine powder, adds enough starch, granulates, and dry, tabletting, coating, must treat the herpesvirus sheet of virus infected herpes.
2. the herpesvirus sheet for the treatment of virus infected herpes according to claim 1, is characterized in that the weight of each composition during the herpesvirus sheet of the every sheet 0.25g of preparation 1000 is: Radix Scutellariae 400g, Rhizoma Coptidis 250g, Fructus Gardeniae 500g, Radix Arnebiae (Radix Lithospermi) 400g, Radix Cynanchi Paniculati 100g, Pulvis Fellis Suis 25g.
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CN100360160C (en) * 2005-08-31 2008-01-09 赵运荣 Medicine for treating dermatosis and its prepn
CN1895471A (en) * 2006-06-20 2007-01-17 王亚贤 Chinese-medicinal jet embrocation for healing wound and its preparation
CN101513468A (en) * 2008-02-18 2009-08-26 唐远福 Oral medicament for treating herpes zoster
CN101596252B (en) * 2009-07-14 2011-08-10 王婷 Composition for treating herpes zoster and preparation method thereof
US7862838B1 (en) * 2009-08-31 2011-01-04 Qing Si Zeng Composition and regimen for the treatment of herpes simplex and herpes zoster primarily by eliminating their pathogenetic conditions and taking into account both pathogenesis and etiology

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