CN1424052A - Medicine for treating chronic hepatitis B - Google Patents

Medicine for treating chronic hepatitis B Download PDF

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CN1424052A
CN1424052A CN03100149A CN03100149A CN1424052A CN 1424052 A CN1424052 A CN 1424052A CN 03100149 A CN03100149 A CN 03100149A CN 03100149 A CN03100149 A CN 03100149A CN 1424052 A CN1424052 A CN 1424052A
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cockroach
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preparation
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extractive
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李树楠
胡忠
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Kunming Sinoway Natural Pharmaceuticals Co Ltd
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Kunming Sinoway Natural Pharmaceuticals Co Ltd
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Abstract

A medicine "Ganlong capsule" for treating chronic hepatitis B features that it contains the extract of blattaria. It can greatly increase the transform rate to negative of HbeAg and HBV-DNA.

Description

A kind of treatment chronic hepatitis B medicine
Technical field: the present invention relates to a kind of Chinese medicine preparation for the treatment of chronic hepatitis B, particularly contain the Chinese medicine preparation of cockroach extractive.Said preparation can make chronic hepatitis B patient HbeAg and HBV-DNA infection index negative conversion rate improve greatly.
Background technology: " chronic hepatitis B " is the name of disease of doctor trained in Western medicine.The traditional Chinese medical science does not have this title, but the similar symptom of " chronic hepatitis B " record see respectively TCM Document it " hypochondriac pain ", " liver gastropathy ", " gathering ", " tympanites " and " jaundice " each.At the initial stage of chronic hepatitis B, when finding hypochondriac pain and some gastrointestinal symptoms, the traditional Chinese medical science is commonly referred to as " liver gastropathy ", just the disease of " liver wood subjugates earth ".About the cause of disease of hypochondriac pain, " interior warp " thought aspects such as cold, hot, the stasis of blood, as " Ling Shu Miraculous Pivot or Divine Axis.Five pathogenic factors " piece of writing says: " evil in liver, then in two sides of body bitterly ... the .. stagnant blood is interior ".According to the theory of " general rule is obstructed ", certainly should be in the treatment based on " leading to ".About the cause of disease of hypochondriac pain, " interior warp " thought aspects such as cold, hot, the stasis of blood.Say as " a pain opinion piece of writing is lifted by plain portion ": " the cold visitor is in the arteries and veins of the moon of fainting, the arteries and veins person of the moon of fainting, and hernia and colic lies in liver.The cold visitor is in arteries and veins, and so blood tears swift pulse then is side of body rib and abdomen dragging pain mutually less." " Ling Shu Miraculous Pivot or Divine Axis.Five pathogenic factors " piece of writing says: " evil in liver, then in two sides of body bitterly ... the .. stagnant blood is interior." thereafter, ancient Chinese medicine doctor on the basis of " interior warp ", has progressively had development to the cause of disease of hypochondriac pain again." Jing Yue's complete work.Hypochondriac pain " from clinical practice, the cause of disease is divided into diseases caused by exogenous pathogenic factor and internal injury two big classes, as " hypochondriac pain has debating of internal injury diseases caused by exogenous pathogenic factor ... .. ".In a word, the pathogenesis of hypochondriac pain is that its passages through which vital energy circulates is distributed in two wing because of liver occupies the side of body down, and the gallbladder being attached to the liver, its arteries and veins also follow in the side of body, so the disease of hypochondriac pain, main state blames in liver and gall.As " Jing Yue's complete work. hypochondriac pain " piece of writing says: " this genus of disease liver and gall two warps of hypochondriac pain, all follow with the arteries and veins of two warps and to coerce rib and die also ".Because of liver controlling conveyance and dispersion, property happiness bar reaches again, so disorder of emotion, hepatic depression is clean; Or the stagnation of QI is with the passing of time, qi depression to blood stasis, and blood stasis stops amassing; Or dysfunction of the spleen in transportation, damp and hot interior strongly fragrant, catharsis is unfavorable etc., all can cause hypochondriac pain.Liver property happiness bar reaches, and as depressed rage impairing the liver, irritability is not dredged, then hepatopathy and spleen, and dysfunction of the spleen in transportation is so disease sees that two coerce and have a pain belch, and many tools distension and fullness in the abdomen, discomfort uncomfortable in chest, cards such as loose stool.Liver and other internal organs are closely related, depression of liver-QI, and liver insulting spleen, can cause incoordination between the liver and stomach, incoordination between the liver and spleen.Liver is with the spleen liter, and edema with the liver involved is dredged soil, helps the merit of its fortuneization.Spleen soil battalion is wooden, becomes the usefulness of its catharsis.Stagnation of QI due to depression of the liver, Chang Kecheng insults taste, and taste are unstrong, and normal easily the taking advantage of a weak point in opponent's defence of irritability invaded.In a word, the pathogenesis of depression of liver-QI is a depressed rage impairing the liver, and wood loses bar and reaches, and catharsis is had no right or hyperactive liver-QI attacking the stomach, pain during chest distress, and two side of body distending pains or flee to have a pain, anorexia, or eat and do not change, the abdominal distention loose stool.Cockroach (has another name called: Blatta seu periplaneta) be a kind of Chinese medicine, can treat the symptom that similar chronic hepatitis shows.As Li Shizhen (1518-1593 A.D.) Compendium of Material Medica cloud: " cockroach cures mainly blood stasis disease heavily fortified point, cold and heat, and removing mass is poly-, promoting blood circulation ... ".<BAICAO mirror with controlling " youngster's infantile malnutrition from the beginning of ".So-called " blood stasis disease " summarized the hepatomegaly of chronic hepatitis; " youngster's infantile malnutrition " is the malnutrition of infantile malnutrition, the disease of being off one's feed, and cockroach can be controlled above-mentioned disease.According to theory of Chinese medical science, the method for treatment of chronic hepatitis should be from dispersing liver and promoting blood circulation, the spleen invigorating dehumidifying, and removing toxic substances and promoting subsidence of swelling is started with.In the side only simply with cockroach.Consult the document record, the data of symptoms such as similar chronic hepatitis, hepatomegaly, cirrhotic ascites such as relevant cockroach treatment hypochondriac pain, abdominal distention, lump in the abdomen is more.Cockroach is controlled " infantile malnutrition " and refers to children's's off feed more, and inappetence also often appears in chronic hepatitis patient.<Chinese medicinal animal will〉the hold concurrently chronic hepatitis B of blood stasis disease of cloud " promoting blood circulation to remove blood stasis, inducing diuresis to remove edema " and treatment stagnation of liver-QI with deficiency of the spleen also has close ties.Treat hypochondriac pain in the Dali Dali district with cockroach especially, infantile malnutrition comparatively general.In addition, the hepatitis B detoxifying capsule of LiaoNing, China province Benxi pharmaceutical factory, hepatitis B antipyretic capsule also contain the dry Scorpio of cockroach of un-extracted." eliminating mass the liver benefiting sheet " that Fujian China province Foochow pharmaceutical factory of traditional Chinese medicine produces also used cockroach.At present, as Antihepatitis medicament a lot of reports are arranged with Chinese medicine.Wherein the polysaccharide composition is paid much attention to, and once the someone had studied active ingredients such as ganoderan, polyporusum bellatus, and its preparation has certain therapeutical effect to chronic hepatitis.The how wise youth of Japanese scholar rattan had once done " research of the anti-hepatitis composition of Blatta seu periplaneta " report in Kunming in 1984.Chinese patent 94108943.6 has described also that Blatta seu periplaneta extract is used for the content of hepatitis B but the report that chronic hepatitis B patient HbeAg and HBV-DNA infection index negative conversion rate improved greatly when cockroach of no use or its extract for treating chronic hepatitis B.For the Chinese medicine of treatment chronic hepatitis B, it is very rare that chronic hepatitis B patient HbeAg and HBV-DNA infection index negative conversion rate are reached more than 25%.
Summary of the invention: the present invention has extracted effective site from cockroach, effective through the pharmacological evaluation confirmation to the treatment chronic hepatitis B, when finding with cockroach or its extract for treating chronic hepatitis B unexpectedly simultaneously chronic hepatitis B patient HbeAg and HBV-DNA infection index negative conversion rate are improved greatly.The invention provides a kind of cockroach extractive, the medicine that this extract improves chronic hepatitis B patient HbeAg and HBV-DNA infection index negative conversion rate when can be used for preparing the treatment chronic hepatitis B greatly.The present invention also provides a kind of pharmaceutical preparation, and said preparation is made up of active constituents of medicine cockroach extractive and medicine acceptable carrier.Its effective ingredient of cockroach extractive of the present invention is the mixture of mucopolysaccharide amino acids for sticking sugared propylhomoserin.The content of sticking sugared propylhomoserin is more than 95% in this mixture, and through hydrochloric acid hydrolysis, the sticking sugared propylhomoserin that records is mainly by aminoacid, sulfate radical, glucose, and glucuronic acid, glucosamine is formed.Also having free amino acid in addition, mainly is tyrosine, and nucleoside, mainly is hypoxanthine.Its physicochemical property of cockroach extractive of the present invention is as follows: 1, cockroach extractive is yellowish-brown to khaki powder; The feeble QI raw meat, mildly bitter flavor.2, the soluble in water and methanol of cockroach extractive.The analysis showed that its fat-soluble inequality of mixture of forming sticking sugared propylhomoserin is continuous distribution in the lump.3, the cockroach extractive aqueous solution issues blue-fluorescence near long wave ultraviolet light (340nm), and crest is 440nm.4, the cockroach extractive aqueous solution absorbs in the royal purple district of visible spectrum (500-400nm) and is increased gradually to the shortwave direction by long wave, but does not have feature to receive the peak.Ultraviolet spectra absorbs bigger at shortwave district (200-220nm), the absworption peak of tyrosine is arranged about 275nm, does not have its thick characteristic absorption peak.5, the cockroach behind the purification is made the molecular sieve filtration chromatography by Bio-Gel p-10 (grading range 1500-20000 dalton), as seen the sticking sugared propylhomoserin of the Main Ingredients and Appearance of cockroach is a macromolecule polyalcohol, molecular weight ranges 1000-8000 dalton, be nearly normal distribution, average out to 5000 dalton.This result is with consistent to water dialysis gained result with bag filter.6, the water-soluble acidity (PH 4.5-4.8) that is of cockroach.Result of study shows, the sticking sugared propylhomoserin of the Main Ingredients and Appearance of cockroach and mixture that be nearly continuous distribution different by isoelectric point, IP formed.Chinese medicine preparation of the present invention has following function and cures mainly: dispersing liver and promoting blood circulation, spleen invigorating dehumidifying, removing toxic substances and promoting subsidence of swelling.Have the chronic HBV of inhibition and duplicate, protect the liver, regulate the effect of immunologic function.Cure mainly hypochondriac pain " stagnation of liver-QI with deficiency of the spleen hold concurrently blood stasis symptom " disease and see distending pain over the hypochondrium, the heating installation of feeling sick, spiritlessness and weakness, inappetence, abdominal distention after meal, big loose stool, pale tongue, stringy pulse; Hold concurrently stasis of blood person, still see the thin disease such as puckery of the twinge of side of body rib, hepatosplenomegaly, colour of the tongue purple, pulse condition.Clinical can be used for HbeAg positive the patient of the male chronic hepatitis B of HBV-DNA.Chinese medicine preparation of the present invention, can add the medicine acceptable carrier when being prepared into medicament, described medicine acceptable carrier can be: starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.Chinese medicine preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preparation of the present invention, peroral dosage form preferably, as: capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum etc., more preferably capsule.Preparation of the present invention is determined usage and dosage according to patient's situation in use, but obeys every day three times, each 1-20 agent, as: 1-20 grain or sheet or bag.Chinese medicine preparation of the present invention, can adopt following prescription:
Cockroach extractive 50-300g
Starch 150g
Make 1000 doses described 1000 doses and be meant that this composition can be made into 1000 doses of pharmaceutical preparatioies, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, 1000 bags of granules, oral liquid 1000 peace bottles etc., also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.More than forming when producing and can increase or reduce according to corresponding proportion, can be unit with the kilogram as large-scale production, or is unit with the ton, and small-scale production can be unit with the milligram also, and weight can increase or reduce.Cockroach extractive of the present invention can be prepared as follows: (a) that the cockroach insect soma is dry, coarse pulverization is (b) " with the above-mentioned polypide of alcohol solution dipping; extract effective medicinal components wherein, then filtering residue is separated with filtrate, and filtering residue is extracted repeatedly; (c) filtrate is carried out concentrating under reduced pressure; reclaim ethanol, obtain thick thing, (d) add distilled water in thick thing; filter then; discard upper strata grease and lower floor's residue, concentrating under reduced pressure filtrate obtains water solublity extractum.Chinese medicine preparation of the present invention has been carried out pharmacological testing, and experiment confirm Chinese medicine preparation effect of the present invention is as follows: 1. effect in the antivirus action body: the Inst. of Medicinal Biological Technology, Chinese Academy of Medical Sciences Viral Laboratory carries out the therapeutic test checking with " cockroach " to duck chronic HBV infection duckling.With the suppression ratio of the clear duck chronic HBV of different time Sanguis Anas domestica DNA as curative effect index.With normal saline and positive drug acycloguanosine and phosphorus carboxyl sodium formate is contrast, and the result shows cockroach 0.5,1.5, and the 3g/kg/day group all can suppress duplicating of DHBV infected duck serum DHBV-KNA, and acting duration is longer.Three repeated experiments are unanimity as a result, and statistical significance is arranged, and certain dose-effect relationship is arranged between the various dose group.Interaction in vitro: Inst. of Medicinal Biological Technology, Chinese Academy of Medical Sciences Viral Laboratory report, cockroach secretion to HbeAg in 2215 cells of chronic HBV transfection human liver cell has obvious inhibitory action, its suppression ratio can be respectively when 500 μ ml concentration up to 87.04% and 71.93% at present the clinical Ara-AMP.PFA that is used for the treatment of chronic HBV etc. in 2215 cells, HbeAg expressed and only can suppress about 30%.Three repeated experiments unanimities have statistical significance, and this has certain dose-effect relationship the various dose group.2. the immunoregulation effect institute of Materia Medica,Chinese Academy of Medical Sciences is measured its serum lysozyme activity and the effect of ConA inducing mouse spleen lymphocyte proliferation with the administration of ICR mouse stomach.Experimental result shows, compares with the matched group that gives normal saline, and cockroach 800, organizing 400mg/kg day all has significantly immunological enhancement.(100mg/ time/day, effect ip) is strong than positive control drug polyporusum bellatus in its effect.Three times repeated experiments gets similar result.France " immune genetic and institute of oncology " measures " cockroach " triggers multiple theca cell (pc) oxidative burst effect to phagocytosis result with chemoluminescence method (cL), confirm that " cockroach " to the mouse peritoneal injection or orally all can significantly improve the function that macrophage and NK cell killing are invaded cell outward, therefore has immunomodulatory properties.DaLi Medicine Academy pharmacology teaching and research room guinea pig skin late response, the mouse thymus spleen is weighed, and Turnover of Mouse Peritoneal Macrophages is engulfed three kinds of distinct methods such as chicken red blood cell, confirms that all " cockroach " has enhancing body cellular immunization and humoral immunization effect.3. the hepatoprotective effect DaLi Medicine Academy pharmacology CCl of teaching and research room 4Due to the white mice liver injury model test, the result shows with dosage lumbar injection or the gastric infusion of " cockroach " 200mg/kg, all can resist CCl 4The SGPT value that the e hepatic injury causes raises, and wherein irritating the stomach group has statistical significance.The hepatopathy inspection shows that the hepatic injury of lumbar injection group is lighter.The impaired liver of some mice of also finding " cockroach " treatment when pathomorphism is observed has obvious regeneration to accelerate phenomenon.Application of the present invention, wherein cockroach extractive or the preparation that contains cockroach extractive can make chronic hepatitis B patient HbeAg and HBV-DNA infection index negative conversion rate reach more than 25%.Application of the present invention further can make chronic hepatitis B patient HbeAg and HBV-DNA infection index negative conversion rate reach more than 30%.Application of the present invention further can make chronic hepatitis B patient HbeAg and HBV-DNA infection index negative conversion rate reach more than 35%.Medicine of the present invention has been carried out clinical experiment, the result is as follows: in one group of double blind experiment, observe 203 cases altogether, first group 102 examples wherein, second group 101 examples, chronic hepatitis B patients wherein, first group 66 people, second group 65 people's first groups are used the capsule of the method preparation of the embodiment of the invention 1, the second group is used contrast medicine liver must answer capsule chronic hepatitis B HBV is infected the cloudy influence of changeing of mark to see Table 1, and the influence of liver function is seen Table 2,3, the tcm syndrome curative effect sees Table 4, in the single at random blind expansion control experiment of 5 another groups, observe 301 routine patients altogether, first group 200 people, second group 101 people, wherein chronic hepatitis B patients first group 135 people, second group 71 people infect the cloudy influence of changeing of mark to chronic hepatitis B HBV and see Table 6
The specific embodiment: further specify the present invention by the following examples.Embodiment 1 capsular preparation
Prescription:
Cockroach extractive 150g
Starch 150g is with the raw material mix homogeneously of recipe quantity, and the ethanol of adding 90% is an amount of, and mixing is granulated, and the adding Pulvis Talci is an amount of, incapsulates behind the mixing, makes 1000 capsules.The preparation of embodiment 2 tablets
Prescription:
Cockroach extractive 150g
Starch 150g is with the raw material mix homogeneously of recipe quantity, and the ethanol of adding 90% is an amount of, and mixing is granulated, and the adding Pulvis Talci is an amount of, and tabletting behind the mixing is made 1000 tablets of tablets.The preparation of embodiment 3 oral liquids
Prescription:
Cockroach extractive 150g
Cane sugar powder 150g
Distilled water be added to 10000ml with the material dissolution of recipe quantity in 5000ml water, mix homogeneously filters, filtrate adds distilled water to 10000ml, sterilize behind the mixing, potting in 10ml peace bottle, totally 1000 bottles.
HBV infected to control unusually between unusual negative conversion rate self comparable group in back before mark change flag thing group is controlled and compares HbsAg first group 66 66 0 before and after table 1 chronic hepatitis B was treated
Second group 65 65 0HbeAg first groups 66 42 36.36 P<0.01 (X 2=22.042) ¨ P<0.01 (X 2=11.567) ¨
Second group 64 57 10.93 P<0.05 (X 2=5.143) ¨ HBV-DNA first group 66 40 39.39 P<0.01 (X 2=24.038) ¨ P>0.05 (X 2=3.284)
Second group 65 49 24.62 P<0.01 (X 2=14.063) ¨ HbaAb first group 66 66 0
Second group 65 65 0HbeAb first groups 66 66 0
Difference has highly significant before and after second group 65 65 0 first group HbeAg, the HBV-DNA treatment, difference has significance or highly significant before and after second group HbeAg, the HBV-DNA treatment, and HbsAg, HbsAb, HbeAb treatment back difference there are no significant, the cloudy curative effect of changeing of prompting first group HbeAg is better than the second group.
Unusually control before variation (example) the index group of liver function is controlled before and after table 2 treatment and compare TbiL first group 37 23 0.622 P<0.01 (X between multiple normal normalization rate self comparable group in back 2=21.04) ¨ P>0.05 (X 2=0.575)
Second group 32 17 0.531 P>0.05 (X2=2.56) ALT first group, 60 33 0.55 P<0.01 (X 2=23.36) ¨ P>0.05 (X 2=2.514)
Second group 57 23 0.404 P<0.01 (X 2=13.89) ¨ AST first group 42 27 0.643 P<0.01 (X 2=19.86) ¨ P<0.01 (X 2=8.819)
Second group 41 13 0.317 P<0.05 (X 2=5.06) ¨ A/G first group 35 14 0.364 P>0.05 (X 2=0.04) P>0.05 (X 2=0.028)
Second group 33 12 0.344 P>0.05 (X 2=0.00) SP first group 24 15 0.625 P>0.05 (X 2=0.64) P>0.05 (X 2=0.091)
Second group 24 16 0.667 P>0.05 (X 2=2.04) difference had highly significant before and after first group TbiL, ALT, AST often treated again, difference had highly significant or significance before and after second group ALT, AST often treated again, difference had highly significant after relatively AST often treated again between first and second liang of group groups, and the normal again curative effect of prompting first group AST is better than the second group.
Compare TbiL first group 16.880 ± 12.385 14.979 ± 10.277-1.901 ± 13.847 t=1.377 P>0.05 t=0.088 before the change indicator group of liver function is treated before and after table 3 treatment before and after the difference of treatment back between comparable group
Second group 16.299 ± 8.688 14.876 ± 5.653-1.423 ± 7.388 t=1.926 P>0.05 P>0.05ALT first group 87.30 ± 115.28 51.516 ± 69.318-35.79 ± 115.29 t=3.135 P<0.05 *T=0.604
Second group 94.07 ± 174.30 46.550 ± 45.123-47.52 ± 144.16 t=3.313 P<0.05 *P>0.05AST first group 52.053 ± 66.800 32.895 ± 48.771-19.16 ± 59.635 t=3.245 P<0.05 *T=0.569
Second group 55.186 ± 108.60 29.621 ± 31.132-25.56 ± 91.435 t=2.809 P<0.05 *P>0.05A first group 46.574 ± 4.520 46.230 ± 4.176-0.343 ± 3.486 t=0.995 P>0.05 t=0.703
Second group 46.73 ± 4.718 45.783 ± 4.846-0.947 ± 3.536 t=2.678 P<0.01 *P>0.05G first group 28.997 ± 6.066 28.996 ± 5.471-0.001 ± 5.666 t=0.002 P>0.05 t=0.706
Second group 28.736 ± 5.041 28.498 ± 4.526-0.238 ± 4.240 t=0.563 P>0.05 P>0.05SP first group 75.305 ± 6.437 74.895 ± 6.778-0.411 ± 5.617 t=0.738 P>0.05 t=1.105
Second group 75.332 ± 7.153 73.711 ± 8.406-1.621 ± 7.271 t=2.240 P<0.05 *P>two groups of ALT of 0.05 first, second, difference has significance before and after the AST treatment, but comparing difference does not have significance (P>0.05) between two groups of groups, point out two groups close to the liver function index curative effect.
The total obvious effective rate first of table 4 tcm syndrome curative effect group example number clinic control produce effects enabledisable total effective rate group 85 28 29 18 10 0.882 *0.671 *Compare between 80 9 18 20 33 0.588 0.338 first and second liang of group groups of second group: therapeutic effect of syndrome U=4.901 P<0.01, total effective rate X 2=18.594 P<0.01, total obvious effective rate X2=18.296P<0.01, above results suggest first group is better than the second group to traditional Chinese medical science therapeutic effect of syndrome.
Treat before the treatment of table 5 tcm symptom grading curative effect symptom group between the group of front and back, back self
Heavily there are not relatively pain over the hypochondriac region first group 38 39 23 2 74 26 20 P<0.01 μ=5.216 of light middle anharmonic ratio in not having gently *P>0.05
Second group 53 31 13 4 65 28 71 P>0.05 μ=1.813 μ=1.235 abdominal distention first groups, 39 47 15 1 74 27 10 P<0.01 μ=4.858 *P<0.05
Second group 42 45 12 2 57 43 10 P<0.05 μ=2.477 *μ=2.034 *Nauseating belch first group 56 33 13 0 83 17 20 P<0.01 μ=3.572 *P>0.05
Second group 59 33 90 80 21 00 P<0.05 μ=2.879 *μ=0.231 inappetence first group, 38 44 20 0 78 23 10 P<0.01 μ=5.521 *P<0.05
Second group 37 50 14 0 55 46 00 P<0.05 μ=2.068 *μ=2.74 *Loose stool first group 86 12 31 100 200 P>0.05 μ=1.763 P>0.05
Second group 87 13 10 92 900 P>0.05 μ=0.641 μ=0.886 hepatosplenomegaly first group, 87 14 10 91 10 10 P>0.05 μ=0.496 P>0.05
Compare before and after the second group 83 17 10 86 14 10 P>0.05 μ=0.374 μ=0.513 first group pain over the hypochondriac region, abdominal distention, the belch merit of feeling sick, the inappetence treatment, difference has highly significant, and prompting first group can obviously be improved above-mentioned symptom; Comparing difference has significance before and after second group abdominal distention, the belch of feeling sick, the inappetence treatment, and prompting second group also can be improved above-mentioned symptom; Between abdominal distention, two groups of groups of inappetence relatively treatment back difference significance is arranged, relatively treatment back difference has significance, prompting first group is improved abdominal distention, inappetence symptom curative effect is better than the second group.
Table 6 chronic hepatitis B treatment front and back HBV infects to control unusually before mark variation marker group is controlled and compares HbsAg first group 135 133 1.4 P>0.05 between unusual negative conversion rate self comparable group in back
Second group 71 71 0HbeAg first groups 135 92 31.9 P<0.01 (X 2=41.02) P<0.01 (X 2=7.687)
Second group 71 61 14.1 P<0.01 (X 2=8.10) HBV-DNA first group 135 90 33.3 P<0.01 (X 2=43.02) P<0.05 (X 2=6.277)
Second group 71 59 16.9 P<0.01 (X 2=10.08) HbsAb first group 135 134 0.7 P>0.05
Second group 71 71 0HbeAb first groups 135 128 5.2 P<0.05 (X 2=5.14) P>0.05
Difference has significance before and after second group 71 71 0 first, second group HbeAg, the HBV-DNA treatment, difference had significance or highly significant after relatively HbeAg, HBV-DNA treated between first and second liang of group groups, difference has significance before and after the first group HbeAb treatment, and difference does not have significance before and after the treatment of second group, comparing difference does not have significance between two groups of groups, and prompting first group HbeAg, the cloudy curative effect of changeing of HBV-DNA are better than the second group.

Claims (10)

1. cockroach extractive or the preparation that contains cockroach extractive make application in the medicine that chronic hepatitis B patient HbeAg and HBV-DNA infection index turn out cloudy in preparation.
2. the application of claim 1, wherein the preparation of cockroach extractive is any pharmaceutically useful dosage form.
3. the application of claim 2, wherein the preparation of cockroach extractive is a peroral dosage form.
4. the application of claim 3, wherein the preparation of cockroach extractive is a capsule formulation.
5. the application of claim 4, in the capsule formulation wherein, every capsules contains cockroach extractive 50-300mg.
6. the application of claim 3 wherein contains the medicine acceptable carrier in the preparation of cockroach extractive.
7. the application of claim 1, wherein cockroach extractive prepares as follows:
(a) with cockroach polypide drying, pulverize,
(b) with the above-mentioned polypide of alcohol solution dipping, extract effective medicinal components wherein, then filtering residue separated with filtrate, and filtering residue is extracted repeatedly,
(c) filtrate is carried out concentrating under reduced pressure, reclaims ethanol, obtain thick thing,
(d) in thick thing, add distilled water, filter then, discard upper strata grease and lower floor's residue, concentrating under reduced pressure filtrate.
8. the application of claim 1, wherein cockroach extractive or the preparation that contains cockroach extractive turn out cloudy chronic hepatitis B patient HbeAg and HBV-DNA infection index to reach more than 25%.
9. the application of claim 1, wherein cockroach extractive or the preparation that contains cockroach extractive turn out cloudy chronic hepatitis B patient HbeAg and HBV-DNA infection index to reach more than 30%.
10. the application of claim 1, wherein cockroach extractive or the preparation that contains cockroach extractive turn out cloudy chronic hepatitis B patient HbeAg and HBV-DNA infection index to reach more than 35%.
CN03100149A 2003-01-07 2003-01-07 Medicine for treating chronic hepatitis B Pending CN1424052A (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100361649C (en) * 2003-05-22 2008-01-16 福州金象中药制药有限公司 Prepn process of alive adult roach extract
CN102885858A (en) * 2012-11-10 2013-01-23 昆明赛诺制药有限公司 Method for preparing American cockroach extract for treating hepatitis B
CN102885856A (en) * 2012-11-10 2013-01-23 昆明赛诺制药有限公司 Production method for producing medicine for treating hepatitis B by periplaneta americana extract
CN106619731A (en) * 2016-12-30 2017-05-10 昆明赛诺制药股份有限公司 Medicine for treating hepatitis C
CN106619730A (en) * 2016-12-30 2017-05-10 昆明赛诺制药股份有限公司 Medicament for treating hepatitis A and preparation method thereof

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100361649C (en) * 2003-05-22 2008-01-16 福州金象中药制药有限公司 Prepn process of alive adult roach extract
CN102885858A (en) * 2012-11-10 2013-01-23 昆明赛诺制药有限公司 Method for preparing American cockroach extract for treating hepatitis B
CN102885856A (en) * 2012-11-10 2013-01-23 昆明赛诺制药有限公司 Production method for producing medicine for treating hepatitis B by periplaneta americana extract
CN102885858B (en) * 2012-11-10 2014-02-26 昆明赛诺制药有限公司 Method for preparing American cockroach extract for treating hepatitis B
CN106619731A (en) * 2016-12-30 2017-05-10 昆明赛诺制药股份有限公司 Medicine for treating hepatitis C
CN106619730A (en) * 2016-12-30 2017-05-10 昆明赛诺制药股份有限公司 Medicament for treating hepatitis A and preparation method thereof
CN106619731B (en) * 2016-12-30 2020-06-12 昆明赛诺制药股份有限公司 Medicine for treating hepatitis C
CN106619730B (en) * 2016-12-30 2020-06-16 昆明赛诺制药股份有限公司 Medicine for treating hepatitis A and preparation method thereof

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