Background technology
Icterohepatitis is exactly that hepatocyte is destroyed because hepatitis virus makes, hepatic tissue destroys reconstruct, biliary ductuli blocks, and causes that conjugated bilirubin and unconjugated bilirubin all increase the symptom that caused skin, mucosa and eyeball sclera etc. partly turn to be yellow in the blood.Usually, when the bilirubin concentration of blood was higher than 2-3mg/dL, these the recognizable color of naked eyes partly just can occur.
The factors such as trouble patient and some iatrogenic infections that do not note the diet health, contact this disease all can cause the generation of icterohepatitis disease, main clinical manifestation for feel sick, hepatalgia, inappetence, jaundice, liver function test are unusual etc.As do not control timely and effectively and treat; To produce infringement greatly to liver function; As: liver organization hyperemia, edema take place, ooze out, a series of variations such as hepatocellular degeneration and necrosis; Severe patient causes bilirubin encephalopathy or threat to life, and the clinical onset rate has the trend of continuous rising in recent years.
Clinically icterohepatitis is not still had clear and definite therapeutic scheme, modern medicine often falls flat to clinical a certain symptom treatment, can not find suitable Therapeutic Method.Doctor trained in Western medicine mainly adopts antiviral therapy; But there is shortcoming in various degree separately in antiviral drugs at present commonly used, has unsatisfactory curative effect, side effect is big, the virus sweep rate is low shortcoming like fugitive interferon, although the long-acting interferon curative effect increases; But still can not reach desirable curative effect; Although nucleoside analog such as heptodin, adefovir ester, Entecavir side effect are little, suppress viral good effect, have virus variation and drug withdrawal after the state of an illness wait problem repeatedly.Existing Chinese traditional treatment method mainly is a clearing away heat-damp and promoting diuresis for oral administration, detoxifcation jaundice eliminating decoct, and expense is higher; And untoward reaction is obvious, and the virus sweep rate is not high, and utilization ratio of drug is low; Also exist and use prodrug complex, the trouble of boiling medicine, flavour of a drug are bitter; Take and carry inconvenience, prolonged application stimulating gastrointestinal road, patient is difficult to shortcomings such as acceptance.
Patent of invention CN101785800B discloses a kind of Chinese medicine composition of treating hepatopathy.Its effective ingredient is by Bufo siccus, Herba Portulacae Grandiflorae, Herba Salviae Chinensis, Serissa foetida, compositions such as Herba Artemisiae Scopariae.Cure mainly hepatitis, liver cirrhosis, icterohepatitis, acute hepatitis, infectious hepatitis, liver cirrhosis, hepatic ascites etc.; Blood circulation promoting and blood stasis dispelling is also arranged simultaneously; It is active to promote blood circulation, and anticoagulant and enhancing cerebral blood flow function have specially good effect to the resistance of the brain network stasis of blood, apoplectic hemiplegia, the resistance of the heart arteries and veins stasis of blood, obstruction of qi in the chest and cardialgia, coronary heart disease, angina pectoris and hypertension, hyperlipidemia etc.; But need take medicine for a long time; At least first quarter moon several months at most, bring inconvenience to a certain degree to the patient, and cure rate is merely 80%.
Patent of invention CN101757509A discloses Chinese medicine composition of a kind of new treatment icterohepatitis disease and preparation method thereof; Can significantly improve jaundice that icterohepatitis causes, weak, loss of appetite, nausea and vomiting, liver pain, abdominal distention, constipation or diarrhoea, skin pruritus, the many enlargements of liver, quality is enriched has tenderness, percussion pain; Symptoms such as abnormal liver function; Clinical efficacy is definite, and is evident in efficacy, takes effect rapidly.But the present invention uses prodrug complex; Reach 40 flavor Chinese medicines by Herba Artemisiae Scopariae, Rhizoma Coptidis, Radix Puerariae, Flos Lonicerae, Flos Chrysanthemi, Gypsum Fibrosum, the Rhizoma Anemarrhenae, Radix Bupleuri, Fructus Gardeniae, Radix Isatidis, Folium Isatidis, Herba Houttuyniae, Radix Arnebiae (Radix Lithospermi), Radix Gentianae, Radix Sophorae Flavescentis, Cortex Fraxini, Radix Et Rhizoma Rhei, Cornu Saigae Tataricae, Folium Mori, Poria, Talcum etc. and form, increased prescription compatibility difficulty.
Summary of the invention
The present invention is on the basis of secret prescription handed down in the family from generation to generation; Differential diagnosis of diseases based on Chinese traditional treatment icterohepatitis disease improves with the dialectical principle that combines, and a kind of treating both the principal and secondary aspects of a disease, evident in efficacy, short treating period, instant effect is provided, has been fit to the Chinese medicine composition of oral treatment icterohepatitis.
In order to realize the object of the invention, the technical scheme that the present invention adopts is following:
The present invention treats the Chinese medicine composition of icterohepatitis, and the raw material components weight portion is following: Herba Scutellariae Barbatae 6-18 part, Lignum Aquilariae Resinatum 12-24 part, Bufo siccus 6-12 part, Fructus Arctii 13-26 part, Flos Lonicerae 18-36 part, Radix Scutellariae 18-38 part, Herba Salviae Chinensis 10-18 part.
The present invention treats the Chinese medicine composition of icterohepatitis, and the preferred feedstock ingredients weight parts is following: 8 parts of Herba Scutellariae Barbataes, 14 parts of Lignum Aquilariae Resinatum, 8 parts of Bufo siccuss, 20 parts of Fructus Arctiis, 30 parts of Flos Loniceraes, 30 parts of Radix Scutellariaes, 12 parts of Herba Salviae Chinensiss.
Chinese medicine composition of the present invention adds various conventional adjuvant required when preparing different dosage form; For example disintegrating agent, lubricant, adhesive etc. are prepared into any oral formulations commonly used with the method for Chinese medicinal of routine, for example can be pill, capsule, tablet, powder, granule or oral liquid etc.
Be preferably capsule.
The method for preparing of capsule of the present invention is following:
According to the present invention's prescription, weighting raw materials material Herba Scutellariae Barbatae, Lignum Aquilariae Resinatum, Bufo siccus, Fructus Arctii, Flos Lonicerae, Radix Scutellariae, Herba Salviae Chinensis carry out drying, pulverizing respectively; Cross 200 mesh sieves; The abundant mix homogeneously of medicinal powder after pulverizing after sterilization treatment incapsulates, is promptly got and invents capsule.
Usage and dosage: dosage of the present invention depends on concrete dosage form, factors such as patient age, body weight, health status.Capsule of the present invention: obey the 2-4 grain every day three times at every turn, every content of dispersion 0.5 gram, warm water takes.10 days one courses of treatment.
The present invention treat observe 300 surplus routine icterohepatitis patient, treat 274 examples (91.3%) of fully recovering two courses of treatment, produce effects 21 examples (7%), effective 4 examples (1.4%), invalid 1 example (0.3%), total effective rate can reach 99.7%.
The contribution that the present invention makes prior art:
1, the present invention's medication of writing out a prescription is simplified, and is only processed by seven flavor Chinese crude drugs such as Herba Scutellariae Barbatae, Lignum Aquilariae Resinatum, Bufo siccus, Fructus Arctii, Flos Lonicerae, Radix Scutellariae, Herba Salviae Chinensis, and raw material all is the pure natural medical material, and be simple and easy to, non-stimulated, have no side effect, method for making is simple to operation.This seven flavors Chinese medicine of Clinical Practice proof interacts, and is collaborative each other, has heat-clearing and toxic substances removing, blood stasis-eliminating and stagnation-dissipating, detoxifcation function of gallbladder promoting, antitoxin hepatoprotective, the effect of promoting tissue regeneration by removing blood stasis; This seven flavors drug matching can also be played the effect of clearing away heat-damp and promoting diuresis, detoxifcation jaundice eliminating.
2, the present invention is directed to responding well to treatment soon of icterohepatitis patient; Short treating period, curative effect height; Various crude drug are coordinated each other can play together and are at utmost brought into play drug effect, can effectively improve the self-coordination ability of patient's body, have advantage such as have no side effect, expense is lower.Preparation process of the present invention simply need not to mention alcohol extraction process through water, directly pulverizes mix homogeneously and gets final product by the conventional formulation prepared.
The specific embodiment
Through following FORMULATION EXAMPLE the present invention is described in more detail at present, but does not limit the present invention in any form.
EXAMPLE l: weighting raw materials material Herba Scutellariae Barbatae 6g, Lignum Aquilariae Resinatum 12g, Bufo siccus 6g, Fructus Arctii 13g; Flos Lonicerae 18g, Radix Scutellariae 18g, Herba Salviae Chinensis 12g cleans drying; Pulverize, cross 200 mesh sieves, with the abundant mix homogeneously of medicinal powder after pulverizing after sterilization treatment; The capsule of packing into No. 0 is adorned 0. 5g for every, promptly gets capsule of the present invention.
Embodiment 2: weighting raw materials material Herba Scutellariae Barbatae 18g, Lignum Aquilariae Resinatum 24g, Bufo siccus 12g, Fructus Arctii 20g; Flos Lonicerae 36g, Radix Scutellariae 38g, Herba Salviae Chinensis 18g cleans drying; Pulverize, cross 200 mesh sieves, with the abundant mix homogeneously of medicinal powder after pulverizing after sterilization treatment; The capsule of packing into No. 0 is adorned 0. 5g for every, promptly gets capsule of the present invention.
Embodiment 3: weighting raw materials material Herba Scutellariae Barbatae 8g, Lignum Aquilariae Resinatum 14g, Bufo siccus 8g, Fructus Arctii 20g; Flos Lonicerae 30g, Radix Scutellariae 30g, Herba Salviae Chinensis 12g cleans drying; Pulverize, cross 200 mesh sieves, with the abundant mix homogeneously of medicinal powder after pulverizing after sterilization treatment; The capsule of packing into No. 0 is adorned 0. 5g for every, promptly gets capsule of the present invention.
Embodiment 4: weighting raw materials material Herba Scutellariae Barbatae 10g, Lignum Aquilariae Resinatum 14g, Bufo siccus 10g, Fructus Arctii 15g; Flos Lonicerae 20g, Radix Scutellariae 20g, Herba Salviae Chinensis 15g cleans drying; Pulverize, cross 200 mesh sieves, with the abundant mix homogeneously of medicinal powder after pulverizing after sterilization treatment; The capsule of packing into No. 0 is adorned 0. 5g for every, promptly gets capsule of the present invention.
Embodiment 5: weighting raw materials material Herba Scutellariae Barbatae 6g, Lignum Aquilariae Resinatum 18g, Bufo siccus 10g, Fructus Arctii 18g; Flos Lonicerae 18g, Radix Scutellariae 20g, Herba Salviae Chinensis 12g cleans drying; Pulverize, cross 200 mesh sieves, with the abundant mix homogeneously of medicinal powder after pulverizing after sterilization treatment; The capsule of packing into No. 0 is adorned 0. 5g for every, promptly gets capsule of the present invention.
Embodiment 6: weighting raw materials material Herba Scutellariae Barbatae 16g, Lignum Aquilariae Resinatum 20g, Bufo siccus 8g, Fructus Arctii 20g; Flos Lonicerae 20g, Radix Scutellariae 20g, Herba Salviae Chinensis 10g cleans drying; Pulverize, cross 200 mesh sieves, with the abundant mix homogeneously of medicinal powder after pulverizing after sterilization treatment; The capsule of packing into No. 0 is adorned 0. 5g for every, promptly gets capsule of the present invention.
Pharmacodynamic experiment
1, animal acute toxicity test of the present invention
Medicine: the embodiment of the invention 1 prescription.
Experimental animal: regular grade NIH mice, body weight 18g ± 2g, male and female half and half.
Method and result:
1) medicine preparation: the 10g spice is pulverized, be assigned to the 150g/L suspension with the normal saline that contains 2% Radix Acaciae senegalis:
2) the gastric infusion mode is adopted in experiment.Disposable administration, volume 0.2ml/10g body weight, close observation 8h also notes down, and continues to observe 7d; 3) mice does not have death among the 7d, and behavior is active, and food ration is as usual, and the hair color light does not have loose dirty, and not having faints from fear has a liking for saliva, and eye, mouth, nose, ear and the no abnormal secretions of crissum do not have the mashed toe of docking.Select 5 execution, finding of naked eye: important organs such as the heart, liver, lung, gastric and thymus, no abnormality seen changes, and shows the oral safety of this medicine.
, long-term toxicity test for animals of the present invention
Medicine: the embodiment of the invention 1 prescription.
Animal: regular grade SD rat, body weight 200g ± 10g, male and female half and half.
Method and result:
1) medicine preparation: divide high, medium and low three dose groups, be respectively 300,150,75 times of clinical application amount, mix with the normal saline 1:1 that contains 2% Radix Acaciae senegalis;
2) the gastric infusion mode is adopted in experiment; Successive administration 24d; Promptly more than 3 clinical cycles, observe the animal general toxic reaction and the order of severity, put to death the back by each position of rule of operation inspection; And carry out hematology, the pathological examination of main organs such as ALT, BUN and the heart, liver, spleen, lung, kidney, stomach;
3) long-term oral administration, toxic reaction does not appear in animal.Physically well develop.Naked eyes outward appearance and main organs no abnormality seen.Peripheral hemogram and Serum ALT, BUN and matched group relatively do not have pathologic and change.All not significant changes such as the pathological replacement heart, liver, spleen, lung, kidney, stomach are thought to confirm that through pathology animal is not had poisoning manifestations.
, the 300 routine clinical observations of invention prescription preparation capsule treatment icterohepatitis
The inventor treated 300 examples with capsule of the present invention to icterohepatitis in 2008~2011 years, through clinical observation and statistical procedures, had shown that capsule of the present invention is evident in efficacy.
Clinical data: 300 routine patients are clinic case, minimum 3 years old of age, maximum 68 years old.
Therapeutic Method: usage and dosage, by the capsule of the embodiment of the invention 3 preparations, obey the 2-4 grain at every turn, every day 3 times, warm water delivery service, 10 days is the l course of treatment.
Criterion of therapeutical effect: criterion of therapeutical effect is divided into healing, produce effects, improvement and invalid with reference to " practical combination of Chinese and Western medicine diagnoses and treatment " icterohepatitis criterion of therapeutical effect.
Cure: sign is improved fully, various transference cures, and liver function is normal fully, and each item test rating is normal fully, and the patient does not have any bad sensation, and diet is had a rest normal, and is in high spirits.
Produce effects: sign is significantly improved, and various symptoms disappear basically, and liver function is near normal, and each index of correlation significantly changes, and the patient does not have obvious bad sensation, and diet is had a rest normal basically, in high spirits.
Effectively: sign obviously changes, various doing well,improvings, and the liver function level promotes, and each index of correlation changes, and diet is had a rest and is taken a turn for the better, and spirit is better.
Invalid: sign and symptom do not have improvement, and liver function does not have the improvement sign, and each index of correlation does not have and changes or take a favorable turn and unusual.
Therapeutic outcome: this clinic accept for medical treatment observation 300 surplus routine icterohepatitis patient, treat two courses of treatment after, 274 examples of fully recovering, produce effects 21 examples, effective 4 examples, invalid 1 example, total effective rate can reach more than 99.6%.Show that Chinese medicine composition of the present invention has unique effect aspect the treatment icterohepatitis.
Model case:
Case l: the Wang, the man, 35 years old, certain employee had the icterohepatitis medical history more than 2 years, once used western medicine, but outbreak repeatedly, during lift introduction and also used some traditional Chinese medical science ancient prescriptions, but poor effect.When coming to cure, the people becomes thin, and is tired unable, hepatalgia, and poor appetite, no appetite, it is poor to sleep.Give the capsule preparations for preparing with the embodiment of the invention 3, dosage is each 4, and every day 3 times, sb.'s illness took a favorable turn after 3 days, and appetite increases, after two courses of treatment, and the check through the People's Hospital, city, each item index is normal, the icterohepatitis recovery from illness.Follow up a case by regular visits to half a year and do not have recurrence.
Case 2: Huang, man, 6 years old.Skin, eyeball sclera etc. partly turn to be yellow, yellowish urine such as tea, and 38.2 ℃ of body temperature are with nauseating, hepatalgia, poor appetite, symptoms such as inappetence.Be diagnosed as icterohepatitis on inspection.Give the capsule preparations for preparing with the embodiment of the invention 3, dosage is each 2, and every day 3 times, sb.'s illness took a favorable turn after three days, and body temperature is normal, and appetite increases, after two courses of treatment, and the check through the People's Hospital, city, each item index is normal, the disease recovery from illness.
Case 3: Lee, woman, 56 years old, certain employee.Patient's private prosecution pain in the hepatic region over month, the no appetite of feeling sick is detested greasy, just the abdominal distention pool, urine is like strong tea.The liver function test result: glutamate pyruvate transaminase 490U, icteric index 32U, the quantitative 108 μ mol/L of bilirubin, tongue is white, sclera and yellowing of the skin, urine jaundice.Give the capsule preparations for preparing with the embodiment of the invention 3, dosage is each 4, and every day 3 times, sb.'s illness took a favorable turn after 3 days, and jaundice symptom greatly alleviates, and after 2 courses of treatment, check liver function each item is normal, and the quantitative 16.8 μ mol/L of bilirubin all recover normal.
Case 4: together certain, man, 30 years old.The icterohepatitis medical history was once arranged, take a turn for the better through treatment, over nearly one month, hepatalgia increases the weight of, and jaundice is deepened, and companion's ascites is not though through western medicine, have and take a turn for the better.The jaundice all over of patient's appearance, color are secretly not bright, and xerostomia is desire drink not, oliguria with reddish urine, poor appetite, the next day of stool once, spiritlessness and sparing of words, white and greasy fur, limit point matter is little red, the sliding number of pulse condition.Give the capsule preparations with the embodiment of the invention 3 preparations, dosage is each 4, every day 3 times, takes Chinese medicine composition of the present invention after course of treatment; Hepatalgia disappears, and jaundice alleviates, and takes 1 course of treatment of Chinese medicine composition of the present invention again; Appetite increases, and spirit takes a turn for the better, and liver function is normal basically; Then obey 1 course of treatment of Chinese medicine composition of the present invention again, check: liver function is normal, and symptom all disappears.
Case 5: tall certain, woman, 26 years old.Have a fever 38.0 ℃, malaise, spirit is not good enough, poor appetite, inappetence, bitter taste, yellow fur, epigastrium expands and feels or discomfort, the urine jaundice, sign: sclera is not yellow, hepatomegaly companion dull pain; Lab testing: small three positive accompanied with abnormal hepatic function ALT:668 unit, AST:589 unit, Y – GT:248 unit, DNA (-).Give the capsule preparations for preparing with the embodiment of the invention 3, dosage is each 3, every day 3 times; Take Chinese medicine composition of the present invention after course of treatment; Appetite heightens, and jaundice alleviates, and take 1 check course of treatment of Chinese medicine composition of the present invention again: liver function each item index is normal.