CN105944032A - Traditional Chinese medicine composition for treating intrahepatic cholestatic jaundice diseases and application thereof - Google Patents
Traditional Chinese medicine composition for treating intrahepatic cholestatic jaundice diseases and application thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating intrahepatic cholestatic jaundice diseases. The traditional Chinese medicine composition is prepared from the following pharmaceutical raw materials in parts by weight: 9 parts of radix bupleuri, 30 parts of oriental wormwood, 9-15 parts of gardenia, 9-15 parts of prepared rhubarb, 30 parts of salvia miltiorrhiza, 15 parts of radix curcumae, 30 parts of plantain herb, 60-90 parts of radix paeoniae rubrathe, 30-45 parts of rhizoma atractylodis macrocephalae, 30-60 parts of sculellaria barbata, 60 parts of rhizoma imperatae and 9 parts of liquorice. The invention also provides application of the traditional Chinese medicine composition to the preparation of medicine for treating intrahepatic cholestatic jaundice diseases. The compatibility of the traditional Chinese medicine composition disclosed by the invention meets the principle of assistant and guide, the traditional Chinese medicine compound preparation using common traditional Chinese medicine as raw materials is easy to prepare, low in cost, and effective; through clinical application and pharmacological research for many years, the traditional Chinese medicine composition has obvious curative effect for intrahepatic cholestatic jaundice and has relatively wide market prospect.
Description
Technical field
The present invention relates to Traditional Chinese medicine compound composition technical field, specifically, relate to one and treat hepatic bile
The Chinese medicine composition of cholestatic jaundice disease and application thereof.
Background technology
Intrahepatic cholestasis jaundice is that a variety of causes causes hepatocyte picked-up, transports and drain bilirubin obstacle,
Causing cholate in blood, bilirubin to raise, its clinical manifestation exactly likes with extrahepatic cholestasis jaundice, but its gallbladder
Road is without substantially blocking.
The cause of disease causing intrahepatic cholestasis jaundice is a lot, is divided into primary according to disease pathogenetic reason difference
Property cholestasis and Secondary cases cholestasis.Primary biliary alluvial has referred to that the sudden change of clear and definite Disease-causing gene causes
Cholestasis or have the unknown cause cholestasis of Family inherited inclination, it is possible to be referred to as heritability cholestasis.
Secondary cases cholestasis refer to due to acquired disposition such as hormone, medicine, tumor, block, operation etc. causes
Cholestasis, it is possible to be referred to as acquired cholestasis.The cholestasis no matter which kind of paathogenic factor causes
Cause the retention of the toxicants such as bile acid, cause hepatocyte injury and cholestatic liver disease.Various disease
The intrahepatic cholestasis jaundice caused can with protopathy thus different, but majority of cases has the symptom that comparison is similar,
Fat is caused including jaundice and the proximal small bowel bile acid deficiency after the meal caused due to bilirubin and bile acid alluvial
Bad with fat soluble vitamin absorption.In addition to jaundice, the clinical manifestation bag that cholestatic liver disease is frequently accompanied by
Include: pruritus, fatigue, fat-soluble avitaminosis, osteoporosis, xanthoma, diarrhoea etc..
The cause of disease, Cure the Primary Disease are mainly removed in treatment to primary disease.Phenobarbital can as enzyme induction
Increase hepatic blood flow, bile flow and cholic acid excretion.Glucocorticoid can alleviate bile capillary inflammation,
Improve bile flow, be the common drug for the treatment of cholestatic hepatitis, but jaundice eliminating effective percentage only 56%, effectively
There is also side effect in case big, the problem that jaundice knock-on rate is high, most scholars think that hormone is to silt gallbladder type liver
Inflammation there is no prominent effect, therefore the most gradually trends towards at present being cautious use of or few use.Ursodesoxycholic acid (UDCA) is
The 7-β epimer of chenodeoxycholic acid, more hydrophilic compared with chenodeoxycholic acid and other cholic acid, due to its table
Face activity is weak, and the tendency therefore dividing, dissolving film quality is the most weak, and the liver that can stable be combined by hydrophobicity cholic acid is thin
After birth, its cytotoxicity of antagonism, it is the key agents treating acute and chronic cholestasis at present, can effectively subtract
Slow primary biliary cirrhosis process, alleviates the symptoms such as pruritus, improves patient's biochemical indicator, improves existence
Rate.Cholestyramine, rifampicin, aluminium hydroxide can treat pruritus.Hepatocyte growth-promoting factors, diammonium glycyrrhizinate, paddy
The sweet peptide of Guang, ademetionine etc. can be used to liver protecting therapy.Patient with severe symptoms can use plasmapheresis and liver transplantation to control
Treat.But generally, doctor trained in Western medicine there is no specific active drug, and curative effect is unsatisfactory, and side effect is many, and takes
By costliness.
Intrahepatic cholestasis jaundice belongs to the sick category of the traditional Chinese medical science " jaundice ", and Chinese traditional treatment jaundice has long going through
History, practice over the past thousands of years fully proves, treatment by Chinese herbs jaundice effect is certainly, with the obvious advantage.By clinic
Practice, the etiology and pathogenesis of intrahepatic cholestasis is explored and has been analyzed by modern doctor, it is believed that wet, hot,
The stasis of blood, poison are the Basic disease cause pathogenesis of intrahepatic cholestasis jaundice, owing to damp and hot heresy pents up liver and gall, Yu Jiuxun
Steaming and turn to fire-toxin, consumption hinders nutrient blood, burn blood network and gallbladder network, causes bile excretion obstacle, and seepage is in skin
Send out as Huang.Inventor, under the guidance of this theory, a kind of treats answering of obstructive jaundice to developing
Square preparation.
China is hepatitis big country, effectively and have the Chinese medicine preparation of independent intellectual property right will have wide market,
Its Social and economic benef@is self-evident.
Chinese patent literature CN201410472499.6, discloses a kind for the treatment of in acute icterohepatitis
Medicine and preparation method thereof.Chinese patent literature CN201510040990.6, discloses one and treats icteric
The Chinese medicine preparation of hepatitis and preparation method.But treat in intrahepatic cholestasis jaundice disease about a kind of
Drug composition and application thereof, yet there are no report.
Summary of the invention
It is an object of the invention to for deficiency of the prior art, it is provided that it is yellow that one treats intrahepatic cholestasis
The Chinese medicine composition of subcutaneous ulcer disease.
Another object of the present invention is to provide a kind of Chinese medicine composition treating intrahepatic cholestasis jaundice disease
The purposes of thing.
For achieving the above object, the present invention adopts the technical scheme that: it is yellow that one treats intrahepatic cholestasis
The Chinese medicine composition of subcutaneous ulcer disease, described Chinese medicine composition is made up of the crude drug of following weight portion: Radix Bupleuri 9
Part, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 9-15 part, Radix et Rhizoma Rhei (processed) 9-15 part, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts, Herba Plantaginis
Grass 30 parts, Radix Paeoniae Rubra 60-90 part, Rhizoma Atractylodis Macrocephalae 30-45 part, Herba Scutellariae Barbatae 30-60 part, Rhizoma Imperatae 60 parts, raw
9 parts of Radix Glycyrrhizae.
Described Chinese medicine composition is made up of the crude drug of following weight portion: Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts,
Fructus Gardeniae 15 parts, Radix et Rhizoma Rhei (processed) 15 parts, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts, Herba Plantaginis 30 parts, Radix Paeoniae Rubra 90 parts,
The Rhizoma Atractylodis Macrocephalae 30 parts, Herba Scutellariae Barbatae 30 parts, Rhizoma Imperatae 60 parts, Radix Glycyrrhizae 9 parts.
Described Chinese medicine composition is made up of the crude drug of following weight portion: Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts,
Fructus Gardeniae 9 parts, Radix et Rhizoma Rhei (processed) 9 parts, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts, Herba Plantaginis 30 parts, Radix Paeoniae Rubra 60 parts,
The Rhizoma Atractylodis Macrocephalae 30 parts, Herba Scutellariae Barbatae 30 parts, Rhizoma Imperatae 60 parts, Radix Glycyrrhizae 9 parts.
Described Chinese medicine composition is made up of the crude drug of following weight portion: Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts,
Fructus Gardeniae 9 parts, Radix et Rhizoma Rhei (processed) 9 parts, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts, Herba Plantaginis 30 parts, Radix Paeoniae Rubra 60 parts,
The Rhizoma Atractylodis Macrocephalae 30 parts, Herba Scutellariae Barbatae 60 parts, Rhizoma Imperatae 60 parts, Radix Glycyrrhizae 9 parts.
For realizing above-mentioned second purpose, the present invention adopts the technical scheme that:
Chinese medicine composition application in preparation treatment intrahepatic cholestasis jaundice disease medicament.
Described Chinese medicine composition also includes the adjuvant pharmaceutically allowed.
Described Chinese medicine composition is decoction, tablet, capsule, granule, mixture, oral liquid or syrup
Agent.
The invention has the advantages that: the Chinese medicine composition of the present invention, it is former that its compatibility meets Chinese medicine " monarch "
Then, Chinese medicine compound fixture of the present invention has raw material system conventional Chinese medicine, and simplicity is honest and clean to be tested, through clinical application for many years and medicine
Reason research, has significant curative effect to intrahepatic cholestasis jaundice, has broader market prospect.
Accompanying drawing explanation
Accompanying drawing 1 is normal rats liver histopathology detection figure.
Accompanying drawing 2 is model group rats liver histopathology detection figure.
Accompanying drawing 3 is Western medicine group liver tissues of rats pathology detection figure.
Accompanying drawing 4 is Chinese drug-treated group one liver tissues of rats pathology detection figure.
Detailed description of the invention
The detailed description of the invention provided the present invention below elaborates.
The present invention provides a kind of Chinese medicine composition treating intrahepatic cholestasis jaundice disease, described Chinese medicine
Compositions is made up of the crude drug of following weight portion:
Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 9-15 part, Radix et Rhizoma Rhei (processed) 9-15 part, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae
15 parts, Herba Plantaginis 30 parts, Radix Paeoniae Rubra 60-90 part, Rhizoma Atractylodis Macrocephalae 30-45 part, Herba Scutellariae Barbatae 30-60 part, Rhizoma Imperatae
60 parts, Radix Glycyrrhizae 9 parts.
Embodiment 1
Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 15 parts, Radix et Rhizoma Rhei (processed) 15 parts, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15
Part, Herba Plantaginis 30 parts, Radix Paeoniae Rubra 90 parts, the Rhizoma Atractylodis Macrocephalae 30 parts, Herba Scutellariae Barbatae 30 parts, Rhizoma Imperatae 60 parts, raw
9 parts of Radix Glycyrrhizae.
Embodiment 2
Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 9 parts, Radix et Rhizoma Rhei (processed) 9 parts, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts,
Herba Plantaginis 30 parts, Radix Paeoniae Rubra 60 parts, the Rhizoma Atractylodis Macrocephalae 30 parts, Herba Scutellariae Barbatae 30 parts, Rhizoma Imperatae 60 parts, Radix Glycyrrhizae 9
Part.
Embodiment 3
Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 9 parts, Radix et Rhizoma Rhei (processed) 9 parts, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts,
Herba Plantaginis 30 parts, Radix Paeoniae Rubra 60 parts, the Rhizoma Atractylodis Macrocephalae 30 parts, Herba Scutellariae Barbatae 60 parts, Rhizoma Imperatae 60 parts, Radix Glycyrrhizae 9
Part.
Embodiment 4
Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 12 parts, Radix et Rhizoma Rhei (processed) 12 parts, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15
Part, Herba Plantaginis 30 parts, Radix Paeoniae Rubra 75 parts, the Rhizoma Atractylodis Macrocephalae 40 parts, Herba Scutellariae Barbatae 45 parts, Rhizoma Imperatae 60 parts, raw
9 parts of Radix Glycyrrhizae.
Embodiment 5
Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 15 parts, Radix et Rhizoma Rhei (processed) 15 parts, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15
Part, Herba Plantaginis 30 parts, Radix Paeoniae Rubra 90 parts, the Rhizoma Atractylodis Macrocephalae 45 parts, Herba Scutellariae Barbatae 60 parts, Rhizoma Imperatae 60 parts, raw
9 parts of Radix Glycyrrhizae.
Embodiment 6
Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 9 parts, Radix et Rhizoma Rhei (processed) 9 parts, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts,
Herba Plantaginis 30 parts, Radix Paeoniae Rubra 60 parts, the Rhizoma Atractylodis Macrocephalae 30 parts, Herba Scutellariae Barbatae 30 parts, Rhizoma Imperatae 60 parts, Radix Glycyrrhizae 9
Part.
Embodiment 7
Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 12 parts, Radix et Rhizoma Rhei (processed) 9 parts, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts,
Herba Plantaginis 30 parts, Radix Paeoniae Rubra 75 parts, the Rhizoma Atractylodis Macrocephalae 30 parts, Herba Scutellariae Barbatae 45 parts, Rhizoma Imperatae 60 parts, Radix Glycyrrhizae 9
Part.
Embodiment 8
Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 15 parts, Radix et Rhizoma Rhei (processed) 12 parts, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15
Part, Herba Plantaginis 30 parts, Radix Paeoniae Rubra 90 parts, the Rhizoma Atractylodis Macrocephalae 40 parts, Herba Scutellariae Barbatae 60 parts, Rhizoma Imperatae 60 parts, raw
9 parts of Radix Glycyrrhizae.
Embodiment 9
Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 9 parts, Radix et Rhizoma Rhei (processed) 15 parts, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts,
Herba Plantaginis 30 parts, Radix Paeoniae Rubra 60 parts, the Rhizoma Atractylodis Macrocephalae 45 parts, Herba Scutellariae Barbatae 30 parts, Rhizoma Imperatae 60 parts, Radix Glycyrrhizae 9
Part.
Embodiment 10
Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 9 parts, Radix et Rhizoma Rhei (processed) 12 parts, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts,
Herba Plantaginis 30 parts, Radix Paeoniae Rubra 75 parts, the Rhizoma Atractylodis Macrocephalae 30 parts, Herba Scutellariae Barbatae 45 parts, Rhizoma Imperatae 60 parts, Radix Glycyrrhizae 9
Part.
The preparation of embodiment 11 Chinese medicine composition decoction
According to the arbitrary described proportioning weighting raw materials of embodiment 1-10, add 8 times amount water, soak 1 hour,
Decoct 3 times, each 1 hour, prepare described Chinese medicine composition decoction.
The preparation of embodiment 12 Chinese medicine composition tablets/capsule
According to the arbitrary described proportioning weighting raw materials of embodiment 1-10, add 8 times amount water, soak 1 hour,
Decocting 3 times, each 1 hour, concentrating under reduced pressure obtained extractum, is vacuum dried by extractum, made Chinese medicine leaching
Cream powder, after adding appropriate amount of auxiliary materials, makes granule with dry granulation, is pressed into tablet or fills encapsulated.
The preparation of embodiment 13 Chinese medicinal composition granules
According to the arbitrary described proportioning weighting raw materials of embodiment 1-10, add 8 times amount water, soak 1 hour,
Decocting 3 times, each 1 hour, concentrating under reduced pressure obtained extractum, is vacuum dried by extractum, made Chinese medicine leaching
Cream powder, after adding appropriate amount of auxiliary materials, makes granule with dry granulation.
The preparation of embodiment 14 Chinese medicine composition mixture/oral liquid/syrup
According to the arbitrary described proportioning weighting raw materials of embodiment 1-10, add 8 times amount water, soak 1 hour,
Decoct 3 times, each 1 hour, add suitable pharmaceutical aids (white sugar, Mel, benzene first propanoic acid or ethyl hydroxybenzoate
Deng), make mixture, oral liquid or syrup.
Embodiment 15 present invention impact on Intrahepatic Cholestasis in Rats model
(1) intrahepatic cholestasis animal model
Select healthy male SD rat 160, body weight 150-200g.ANIT 1g is dissolved in 50ml fragrant
2%W/V made by oil (heating), and in addition to normal group, remaining each group disposably gavages 100mg/kg (5ml/kg)
Induction intrahepatic cholestasis animal model.It is divided into 8 groups, often group 20.
(2) experiment packet and Therapeutic Method
1, Normal group
2, intrahepatic cholestasis model control group
3, Western medicine group (ursodesoxycholic acid)
4, Chinese drug-treated group one (embodiment 1) (giving Chinese medicine compound 50mg/kg gavage)
5, Chinese drug-treated group two (embodiment 4) (giving Chinese medicine compound 50mg/kg gavage)
6, Chinese drug-treated group three (embodiment 5) (giving Chinese medicine compound 50mg/kg gavage)
7, Chinese medicine matched group one (30 parts of Herba Artemisiae Scopariae punt-pole, Radix Paeoniae Rubra 90 parts, Radix Bupleuri 10 parts, Radix Salviae Miltiorrhizae 30 parts,
Radix et Rhizoma Rhei (processed) 15 parts, Rhizoma Atractylodis Macrocephalae (parched) 30 parts, Semen Plantaginis 30 parts, Herba Taraxaci 9 parts.) (give Chinese medicine compound 50mg/kg
Gavage)
8, and Chinese medicine matched group two (Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 15 parts, Radix Et Rhizoma Rhei 15 parts, Radix Bupleuri 10 parts, red
Chinese herbaceous peony 90 parts, Herba Taraxaci 9 parts, Semen Plantaginis 30 parts, the Rhizoma Atractylodis Macrocephalae 30 parts.) (give Chinese medicine compound 50mg/kg to fill
Stomach)
Western medicine group gives ursodesoxycholic acid 50mg/kg gavage, and other are respectively organized and press rat body weight conversion same volume physiology
Saline gavage, every day 1 time.Often organize 10 rats of execution in 2d, 4d, 6d, take blood, bile, liver group
Knit specimen, observe the change of following index.
(3) detection project
1. Biochemical Indices In Serum: serum alanine aminotransferase (ALT), serum alkaline phosphatase (ALP), blood
Clear total bilirubin (TBIL), serum direct bilirubin (DBIL), serum tolal bile acid (TBA)；
2. the light microscopic of hepatic tissue, electron microscopic examination.
(4) experimental result
Respectively group rat blood serum biochemical indicator detection
Compared with model group group, Chinese drug-treated group one and Chinese drug-treated group two, Chinese drug-treated group three indices all has decline, and difference has
Statistically significant.
Note: compare with model group, Δ P < 0.05
Respectively group liver tissues of rats pathology detection
Normal rats hepatocyte marshalling, portal area is without obvious pathological changes (see Fig. 1)；Model group rats liver
Lobule destroys, a large amount of inflammatory cell infiltration in portal area, little bile duct proliferation, slight fibroplasia (see Fig. 2)；
Western medicine group rat is similar, the rarely seen a small amount of inflammatory cell infiltration in portal area (see Fig. 3)；Chinese drug-treated group one rat is similar,
The rarely seen a small amount of inflammatory cell infiltration in portal area (see Fig. 4).
Embodiment 16 clinical research of the present invention perspective random controls open trial
(1) research method
Use perspective random controls open trial.
(2) technology path and design
1. case screening
I case is originated: the Changhai hospital department of Chinese medicine, Gastroenterology dept., the inpatient of Infectious Disease.
Ii Western medicine diagnose standard: meet Chinese Medical Association's infectious disease in 2000 and parasitic disease credit meeting, hepatopathy
Branch combines the diagnosis of cholestatic hepatitis in " the viral hepatitis control prece " of revision.
Iii tcm diagnosis standard:
A clinical manifestation is that jaundice is relatively deep, does not moves back through the moon, skin pruritus or have burning sensation, has tiny after grabbing
Petechia and ecchymosis, right flank distending pain, slightly to feel weak, pharyngoxerosis, urine is deep yellow, stool
Color is shallow or greyish white, dimly red tongue, and tongue is few, wiry forceful pulse.
B main symptom: 1. jaundice is relatively deep, does not moves back through the moon, and color and luster is dark stagnant；2. skin pruritus.
C card: 1. dimly red tongue；2. right flank distending pain；3. urine is deep yellow.
The dialectical requirement of d: possess main symptom 1., 2.；Possess the main symptom two persons 1. and in secondary card three.
Iv case inclusive criteria
A meets above Chinese and western medicine diagnostic criteria person；
The men and women patient in b age 20-65 year；
C estimates that life cycle is more than 2 months；
D is without obvious renal insufficiency；
E can adhere to oral Chinese medicine；
Before f treatment, serum total bilirubin is more than 34.21unol/L；
G jaundice continues February more than (before first stage treatment).
V case exclusion standard
A merges intentionally, kidney, lung, endocrine, blood, metabolism and the patient of the serious protopathy of gastrointestinal tract；
B psychotic and anemia of pregnant woman or women breast-feeding their children；
C estimates that life cycle is less than February；
D can not adhere to taking the patient of Chinese medicine；
E imaging examination is found to have in liver, extrahepatic bile ducts obstructor；
F therapeutic process occurs hepatic encephalopathy, upper gastrointestinal hemorrhage, hepatorenal syndrome person.
2. sample size and group technology
All cases derive from the Changhai hospital department of Chinese medicine, Gastroenterology dept., the inpatient of Infectious Disease.Group technology
Using stratified random method, patient is divided into slightly by elder generation according to total bilirubin numerical value, moderate, severe jaundice three layers,
Slightly (total bilirubin 18.0～85.0 μm ol/L), moderate (total bilirubin 85.0～171 μm ol/L), weight
Degree (total bilirubin > 171 μm ol/L).Use table of random number to be grouped again, be divided into Chinese drug-treated group (20 example) with
Western medicine group (20 example).
3. Therapeutic Method
Primary Care: two groups of Primary Care (diammonium glycyrrhizinate injection 30m1, dimension lifes all using 1. the liver protecting and ALT lowering
Element B6Injection 0.2g, vitamin C injection 2.0g, vitamin K120mg intravenous drip, 1 time/d)；
If the cholestatic hepatitis 2. occurred on chronic hepatitis, liver cirrhosis basis, suitably supplement human albumin.
Chinese drug-treated group: embodiment 1 decoction 100ml/ time, 3 times/d, oral, 14d was 1 course for the treatment of, controlled continuously
Treat 2 courses for the treatment of.
Western medicine group: Ursofalk 250mg/ time, 3 times/d, warm water delivery service, 14d was 1 course for the treatment of, controlled continuously
Treat 2 courses for the treatment of.
4. Testing index
(1) change of cardinal symptom；(2) untoward reaction during medication；(3) liver function is checked weekly,
Main detection serum total bilirubin (STB), serum conjugated bilirubin (SCB), serum glutamic pyruvic transminase (ALT),
Serum Aspartic Acid transferring enzyme (AST), alkali phosphatase (ALP), Y-glutamyl transpeptidase (GGT), total
The change of bile acid (TBA).
5 efficacy assessment standards
Formulate with reference to " Shanghai City Chinese medical disease conventional treatment (second edition) jaundice ":
Curing: jaundice disappears, other liver function indexs are normal, transference cure；
Effective: serum total bilirubin fall more than 50%, other liver function indexs improve, and symptom alleviates；
Taking a turn for the better: between serum total bilirubin fall 30%～50%, other liver function indexs take a turn for the better, disease
Shape alleviates；
Do not heal: serum total bilirubin fall less than 30% or rise, other liver function indexs without improve,
Symptom is without taking a turn for the better.
6 tcm syndrome curative effect determinate standard and standards of grading
Primary symptom: show as body icteric sclera dye, skin pruritus in various degree, urine xanthochromia；Companion sees symptom: even
Seeing cold and heat, vomiting and nausea is indigestion and loss of appetite, xerostomia and not polydipsia, constipation, yellowish fur, stringy pulse or cunning and count.Adopt
Use sxemiquantitative integration method, main symptom: without 0 point, light 2 points, in 4 points, weigh 6 points；Secondary card: without 0 point,
Light 1 point, in 2 points, weigh 3 points.More than 16 points is severe, and 11-15 is divided into moderate, 6-10 to be divided into slightly.
Clinical recovery: tcm clinical practice symptom, sign disappear or substantially disappear, syndrome integral reduces >=90%.
Effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces 60%-89%.
Effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces 30%-59%.
Invalid: tcm clinical practice symptom, sign are not obviously improved, and even increase the weight of, syndrome integral is less than 30%.
7 safety evaluatios
Judge according to routine blood test, liver function and biochemical indicator.
8 statistical methods
SPSS12.0 statistical software is used to be analyzed data processing, measurement data mean ± standard deviation
Represent, use t inspection；Enumeration data % represents, uses x2Inspection, the comparison of multisample mean and all
Comparing two-by-two with variance analysis test, the dependency Rank correlation between two factors of number.
Exiting of 9 object of study
Make patient complete whole therapeutic process as far as possible, as following reason occurs, terminate research in advance.
(1) adverse events (including medicine is not resistant to) of stopped treatment is needed；
(2) sb.'s illness took a turn for the worse (such as renal failure, digestive tract hemorrhage, hepatic encephalopathy, severe infections etc.)；
(3) research approach (including poor compliance), person lost to follow-up are run counter to.
10 result of the tests
(1) comprehensive therapeutic effect compares
Western medicine group cure rate is 10%, and obvious effective rate is 35%, and effective percentage is 35%, and inefficiency is 20%,
Total effective rate is 80%；It is 30% that Chinese drug-treated group clinic passes judgment on curative effect cure rate, and obvious effective rate is 55%, effectively
Between two groups of groups, curative effect compares, and P ＜ 0.05 is statistically significant.
Table 1 Patient Global's comparitive study table (%)
Note: compare with Western medicine group,ΔP ＜ 0.05..
(2) tcm symptom comparitive study before and after treatment
Two groups of tcm symptom comparitive study, there was no significant difference (P > 0.05), not statistically significant.
Table 2 tcm symptom comparitive study table (%)
Note: compare with Western medicine group,ΔP>0.05。
(3) before and after treatment, TCM symptom score compares
After Chinese drug-treated group treatment compared with before treatment, compared with Western medicine group, TCM symptom score has and is decreased obviously,
Difference is the most statistically significant.
Table 3 TCM symptom score comparison sheet
Note: compared with Western medicine group,ΔP ＜ 0.05.
(4) before and after treatment, cardinal symptom scale score compares
Before and after Western medicine group and Chinese drug-treated group treatment, symptom score has decline, no significant difference.Chinese drug-treated group
Declining after the treatment of symptom score relatively Western medicine group after treatment, wherein yellow sclera and skin pruritus are marked and Western medicine group
Comparing, difference has statistical significance.
Table 4 cardinal symptom scale score compares
Note: compared with Western medicine group, Δ P ＜ 0.05.
(5) before and after patient treatment, liver function index compares
Before and after treatment, Chinese drug-treated group and the every liver function index of Western medicine group are all decreased obviously, and difference has statistics
Learn meaning.After treatment compared with western medicine group, Chinese drug-treated group ALT, AST, DBIL, TBIL relatively Western medicine group
Decline (P ＜ 0.05).
The detection of table 5 liver function index is compared
Note: compared with Western medicine group, Δ P ＜ 0.05.
Embodiment 17 clinical research of the present invention one
Wu, man, 45 years old, people from Qidong, Jiangsu.The first visit date: on November 3rd, 2011.
Patient is medical because of " skin, urine yellow skin, poor appetite companion paroxysmal abdominal pain February ".Patient before 2 months without substantially
There is fear of cold, heating in inducement, and body temperature is up to 38.7 DEG C, companion's skin pruritus, abdominal distention and pain, without Nausea and vomiting,
Turn white without stool.November 4 is to local hospital inspection.Liver function: TBIL:347.9mmol/L, DBIL:
254.6mmol/L, ALT:55.1U/L, ALP:307.3U/L, every viral hepatitis index is normal.MRI:
Gallbladder Calculus, cholecystitis, calculus of cystic duct, cystic duct expansion, stones in intrahepatic bile duct is slightly expanded.Local
Through the liver protecting and ALT lowering, jaundice eliminating, treatment without being clearly better, jaundice increases the weight of further.November 13 liver function: TBIL:
405.1mmol/L, DBIL:388.7mmol/L, total protein 48.0g/L, albumin 29.0g/L, AST 47.0
U/L, ALP:298.0U/L, TOTAL BILE ACID TBA 212.7mmol/L.Patient and family members thereof institute go to a doctor to me.Inscribe
See: sclera, skin yellow skin, poor appetite, feel sick, eat and i.e. tell, whole skin pruritus, inferior belly gas pain；Little
Just yellow skin, stool is normal；Sleep poor, weak；Without liver palm, spider angioma；Abdominal part is soft, under liver spleen rib not and；
Full abdomen without tenderness, rebound tenderness, abdominal part shifting dullness (-).Tongue is dim ecchymosis, yellow and greasy fur, stringy and rolling pulse.Give
Dampness removing, jaundice eliminating, blood-activating and stasis-removing are treated.Side's medicine: Radix Bupleuri 9g, Herba Artemisiae Scopariae 30g, Fructus Gardeniae 15g, Radix et Rhizoma Rhei (processed)
15g, Radix Salviae Miltiorrhizae 30g, Radix Curcumae 15g, Herba Plantaginis 30g, Radix Paeoniae Rubra 90g, Rhizoma Atractylodis Macrocephalae 30g, Herba Scutellariae Barbatae 30g, Rhizoma Imperatae
60g, Radix Glycyrrhizae 9g.After taking 1 week, jaundice alleviates, and appetite is improved, and nausea is inconspicuous, whole body scabies
Itch and alleviate, defecate dilute, 3 times on the one.Liver function: TBIL:278.1mmol/L, DBIL:224.7mmol/L,
Total protein 49.5g/L, albumin 30.0g/L, ALT 30.0U/LAST 40.0U/L, ALP:198.0U/L,
TOTAL BILE ACID TBA 112.7mmol/L.On the basis of Shang Fang, Radix et Rhizoma Rhei (processed) is kept to 9g, and the Rhizoma Atractylodis Macrocephalae increases to 45g, and Radix Paeoniae Rubra subtracts
It is 60g less.After taking 3 weeks, jaundice continues to improve, and without obvious pruritus, appetite is general, without Nausea and vomiting,
Just matter of defecating is normal, and urine yellow skin improves, and strength increases.Check TBIL:51.1mmol/L, DBIL:
29.7mmol/L.Three examine, and side is adjusted to Rhizoma Atractylodis Macrocephalae 30g.Take TBIL:18.1mmol/L, DBIL after 2 weeks:
6.1mmol/L.Remaining index is normal.Continuing and take 2 weeks, check liver function after half a year, index is normal.
Embodiment 18 clinical research of the present invention two
Lee, man, 52 years old, Shanghai people.In May, 2012 goes to a doctor, first visit.Tell more than 20 years of hepatitis B medical history, carve
Under: skin, yellow sclera, urine yellow skin 2 days.Without obvious inducement, patient occurred that skin, sclera were yellow before 2 days
Dye, urine yellow skin, accompany hypogastric region dull pain, god is clear, spirit can, receive can, dormancy can, do not accompany nausea and vomiting,
Heating, lumbago etc., stool tune, tongue is dim, and tongue is the most greasy, stringy and rolling pulse.I am institute biochemistry detection prompting TBIL:
130.1mmo/L, DBIL:105.8mmol/L.Give dampness removing, jaundice eliminating, blood-activating and stasis-removing treatment.Side's medicine:
Radix Bupleuri 9g, Herba Artemisiae Scopariae 30g, Fructus Gardeniae 9g, Radix et Rhizoma Rhei (processed) 9g, Radix Salviae Miltiorrhizae 30g, Radix Curcumae 15g, Herba Plantaginis 30g, Radix Paeoniae Rubra
60g, Rhizoma Atractylodis Macrocephalae 30g, Herba Scutellariae Barbatae 30g, Rhizoma Imperatae 60g, Radix Glycyrrhizae 9g.After taking medicine 2 weeks, jaundice substantially alleviates,
Urine color is yellowish, still has hypogastric region dull pain uncomfortable, and stool is normal.Top adds Rhizoma Corydalis 15g, continues and takes 2 weeks,
Check bilirubin is down to normally.
Embodiment 19 clinical research of the present invention three
Xiong, man 21 years old, goes to a doctor, has hepatitis B medical history on May 22nd, 2014.Once saw that TBIL rose because of health check-up,
Rear ALT is the highest, once in Nanjing people's hospital admission, Relapse rate.Closely look into TBIL 173mmol/L, receive can,
Just day row 3,4 times (after outer court takes Radix Et Rhizoma Rhei Eupolyphaga seu steleophaga ball), yellowish urine, yellow and thin fur, red tongue, thready pulse.Give dampness removing,
Jaundice eliminating, blood-activating and stasis-removing are treated.Side's medicine: Radix Bupleuri 9g, Herba Artemisiae Scopariae 30g, Fructus Gardeniae 9g, Radix et Rhizoma Rhei (processed) 9g, Radix Salviae Miltiorrhizae
30g, Radix Curcumae 15g, Herba Plantaginis 30g, Radix Paeoniae Rubra 60g, Rhizoma Atractylodis Macrocephalae 30g, Herba Scutellariae Barbatae 60g, Rhizoma Imperatae 60g are raw sweet
Grass 9g.Taking Chinese medicine further consultation after 2 weeks, jaundice substantially alleviates, xerostomia, gives Radix Trichosanthis 15g.After taking 2 weeks
Further consultation, sense right flank is uncomfortable, receive can, yellowish urine, white and thin fur, soft pulse.Check TBIL 18.3mmol/L, ALT46U/L,
AST 32U/L.
The above is only the preferred embodiment of the present invention, it is noted that common for the art
Technical staff, on the premise of without departing from the inventive method, it is also possible to makes some improvement and supplements, these
Improve and supplement and also should be regarded as protection scope of the present invention.
Claims (7)
1. the Chinese medicine composition treating intrahepatic cholestasis jaundice disease, it is characterised in that described
Chinese medicine composition is made up of the crude drug of following weight portion: Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 9-15 part,
Radix et Rhizoma Rhei (processed) 9-15 part, Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts, Herba Plantaginis 30 parts, Radix Paeoniae Rubra 60-90 part, the Rhizoma Atractylodis Macrocephalae
30-45 part, Herba Scutellariae Barbatae 30-60 part, Rhizoma Imperatae 60 parts, Radix Glycyrrhizae 9 parts.
Chinese medicine composition the most according to claim 1, it is characterised in that described Chinese medicine composition by
The crude drug of following weight portion is made: Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 15 parts, Radix et Rhizoma Rhei (processed) 15 parts,
Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts, Herba Plantaginis 30 parts, Radix Paeoniae Rubra 90 parts, the Rhizoma Atractylodis Macrocephalae 30 parts, Herba Scutellariae Barbatae 30 parts,
Rhizoma Imperatae 60 parts, Radix Glycyrrhizae 9 parts.
Chinese medicine composition the most according to claim 1, it is characterised in that described Chinese medicine composition by
The crude drug of following weight portion is made: Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 9 parts, Radix et Rhizoma Rhei (processed) 9 parts,
Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts, Herba Plantaginis 30 parts, Radix Paeoniae Rubra 60 parts, the Rhizoma Atractylodis Macrocephalae 30 parts, Herba Scutellariae Barbatae 30 parts,
Rhizoma Imperatae 60 parts, Radix Glycyrrhizae 9 parts.
Chinese medicine composition the most according to claim 1, it is characterised in that described Chinese medicine composition by
The crude drug of following weight portion is made: Radix Bupleuri 9 parts, Herba Artemisiae Scopariae 30 parts, Fructus Gardeniae 9 parts, Radix et Rhizoma Rhei (processed) 9 parts,
Radix Salviae Miltiorrhizae 30 parts, Radix Curcumae 15 parts, Herba Plantaginis 30 parts, Radix Paeoniae Rubra 60 parts, the Rhizoma Atractylodis Macrocephalae 30 parts, Herba Scutellariae Barbatae 60 parts,
Rhizoma Imperatae 60 parts, Radix Glycyrrhizae 9 parts.
5. yellow at preparation treatment intrahepatic cholestasis according to the arbitrary described Chinese medicine composition of claim 1-4
Application in subcutaneous ulcer disease medicament.
Application the most according to claim 5, it is characterised in that described Chinese medicine composition also includes medicine
The adjuvant allowed on.
Application the most according to claim 5, it is characterised in that described Chinese medicine composition be decoction,
Tablet, capsule, granule, mixture, oral liquid or syrup.
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