CN108186898A - Treat Chinese medicine composition of acute-on-chronic liver failure and its preparation method and application - Google Patents

Treat Chinese medicine composition of acute-on-chronic liver failure and its preparation method and application Download PDF

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CN108186898A
CN108186898A CN201810182809.9A CN201810182809A CN108186898A CN 108186898 A CN108186898 A CN 108186898A CN 201810182809 A CN201810182809 A CN 201810182809A CN 108186898 A CN108186898 A CN 108186898A
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parts
chinese medicine
medicine composition
chronic liver
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李筠
宫嫚
周超
张宁
王立福
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302th Hospital of PLA
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302th Hospital of PLA
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Abstract

This application discloses a kind of Chinese medicine composition for treating acute-on-chronic liver failure, the Chinese medicine composition includes following raw material：1000 2500 parts by weight oriental wormwoods, the 2000 5000 parts by weight radix paeoniae rubrathe, 1,000 2500 parts by weight madders, 1,000 2500 Chong Liang Fen Common St.Paulswort Herbs, 1,000 2500 parts by weight Radix Salviae Miltiorrhizaes, 350 800 parts by weight cape jasmines, 1,000 2500 parts by weight oldenlandia diffusas, 1,000 2500 parts by weight rhizoma atractylodis macrocephalaes and the 500 1500 parts by weight bletilla striatas.Disclosed herein as well is the preparation method and application of the Chinese medicine composition of above-mentioned treatment acute-on-chronic liver failure.The Chinese medicine composition of the treatment acute-on-chronic liver failure of the application can be substantially reduced the case fatality rate and complication rate of acute-on-chronic liver failure patient, improve survival rate, life quality and quality of life.

Description

Treat Chinese medicine composition of acute-on-chronic liver failure and its preparation method and application
Technical field
This application involves but be not limited to a kind of Chinese medicine composition, be particularly, but not limited to a kind of treat slow extra urgaent dispatch liver Chinese medicine composition of failure and its preparation method and application.
Background technology
Acute-on-chronic liver failure (acute-on-chronic liver failure, ACLF) is the master of China's hepatic failure Type is wanted, is one group of clinic for occurring acute hepatic decompensation in a short time by chronic hepatitis or cirrhosis progress Syndrome.The main clinical manifestation of ACLF is for disturbances of blood coagulation, jaundice, hepatic encephalopathy, ascites etc., main pathophysiological Change is that body's immunity changes and liver cell is largely downright bad.
Though for the pathogenesis of ACLF, clinical manifestation, Laboratory behavior and treatment, prognosis etc. research more Generally, but its basic pathogenesis not yet illustrates completely, some problems even have dispute.ACLF clinics are complicated and changeable, and It is more to send out disease, case fatality rate is high, and prognosis is dangerous, has been reported that case fatality rate up to more than 50%, therefore urgently proposes effective therapeutic strategy.
The doctor trained in Western medicine medical treatment of ACLF lacks specific medicament and means at present, take in principle corresponding etiological treatment and Complex treatment measure, and various complication are actively prevented, surgery Liver Transplantation for Treatment is considered when necessary.But no matter internal medicine Synthetic It treats or surgery transplantation of liver, expensive health care expenditures can all cause huge financial burden to patient and family members.Cause This, gives full play to the theory advantage of Traditional Chinese Medicine, finds effective, economy, the traditional medicine of few side effects treatment new method very It is necessary.
Invention content
It is the general introduction of the theme to being described in detail herein below.This general introduction is not the protection in order to limit claim Range.
Traditional Chinese medicine thinks that the etiology and pathogenesis of hepatic failure is extremely complex, and existing liver,spleen,kidney internal organs are damaged weakened body resistance, and have Wet, the malicious, stasis of blood, the reality of heat are evil to be damaged.According to above-mentioned etiology and pathogenesis, seminar obtains four kinds of hepatic failure by further investigation Main syndromes：Hygropyretic jaundice card, stagnant heat jaundice syndrome, deficiency of vital energy jaundice syndrome, deficiency of yang jaundice syndrome, and give clearing heat, detoxicating, dispelling dampness respectively Method, cooling and activating blood removing jaundice method, QI invigorating removing toxic substances stagnation resolvation method, the treatment of warming Yang, enlivening spleen removing jaundice method, have been correspondingly formed with oriental wormwood, the radix paeoniae rubrathe, Huang Stilbene, four kinds of therapies that monkshood is monarch drug in a prescription.
But seminar finds simultaneously, and ACLF syndromes are complicated, simulataneous insufficiency and excessive, and single syndrome is not enough to cover disease to be demonstrate,proved in itself There are stasis syndrome or existing syndrome of qi deficiency in the characteristics of time is mingled with, generally, the usually existing wet card of ACLF patient but also has yang deficiency syndrome not only, i.e., The often combination of a variety of syndromes.Seminar has carried out further further investigation, and is extracted by creative work One of core interpretation of the cause, onset and process of an illness of ACLF --- " damp and hot stasis of blood Huang card ", and the middle treatment of " clearing heat and detoxicating clearing damp stagnation resolvation method " is proposed accordingly Treat prioritization scheme.
Specifically, this application provides a kind of Chinese medicine composition for treating acute-on-chronic liver failure, the Chinese medicine compositions Including following raw material：1000-2500 parts by weight oriental wormwood, the 2000-5000 parts by weight radix paeoniae rubrathe, 1000-2500 parts by weight madder, 1000-2500 Chong Liang Fen Common St.Paulswort Herbs, 1000-2500 parts by weight Radix Salviae Miltiorrhizae, 350-800 parts by weight cape jasmine, 1000-2500 parts by weight Oldenlandia diffusa, 1000-2500 parts by weight rhizoma atractylodis macrocephalae and the 500-1500 parts by weight bletilla striatas.
In some embodiments, the Chinese medicine composition can include following raw material：1500-2000 parts by weight oriental wormwood, The 3000-4000 parts by weight radix paeoniae rubrathe, 1500-2000 parts by weight madder, 1500-2000 Chong Liang Fen pig Xian grass, 1500-2000 weight Part Radix Salviae Miltiorrhizae, 450-700 parts by weight cape jasmine, 1500-2000 parts by weight oldenlandia diffusa, 1500-2000 parts by weight rhizoma atractylodis macrocephalae and The 700-1200 parts by weight bletilla striatas.
In some embodiments, the Chinese medicine composition can include following raw material：1800 parts by weight oriental wormwoods, 3600 The parts by weight radix paeoniae rubrathe, 1800 parts by weight madders, 1800 Chong Liang Fen Common St.Paulswort Herbs, 1800 parts by weight Radix Salviae Miltiorrhizaes, 540 parts by weight cape jasmines, 1800 Parts by weight oldenlandia diffusa, 1800 parts by weight rhizoma atractylodis macrocephalaes and the 900 parts by weight bletilla striatas.
In some embodiments, the Chinese medicine composition can also include pharmaceutically acceptable auxiliary material, as starch, Dextrin, acesulfame potassium, sodium carboxymethyl starch, magnesium stearate or film coating material etc..
The Chinese medicine composition of the application can be made into being suitble to acceptable appropriate in any pharmacy for taking of patient Dosage form, for example, can be the dosage forms such as granule, tablet, capsule, oral administration solution, syrup or injection.The granule Can have sugared granule or sugar free granule.
In addition, present invention also provides a kind of method for preparing Chinese medicine composition as described above, the method includes with Lower step：
(1) each raw material is weighed according to the parts by weight；
(2) oriental wormwood, the radix paeoniae rubrathe, madder, Common St.Paulswort Herb, Radix Salviae Miltiorrhizae, cape jasmine, oldenlandia that step (1) weighed are added water to cook Grass, rhizoma atractylodis macrocephalae and the bletilla striata filter decocting liquid, and filtrate are condensed into the liquid that the relative density at 60 DEG C is 1.10-1.20；
(3) ethyl alcohol is added in into the liquid made from step (2), is sufficiently stirred, stands overnight, filter off sediment, filter Liquid recycles ethyl alcohol and is condensed into the clear cream that the relative density at 60 DEG C is 1.10-1.25, is dried to dry powder, addition pharmaceutically may be used The auxiliary material of receiving, you can obtain the Chinese medicine composition.
In some embodiments, the amount of water described in step (2) can be weighed oriental wormwood, the radix paeoniae rubrathe, madder, pig Xian grass, Radix Salviae Miltiorrhizae, cape jasmine, oldenlandia diffusa, 10 times of rhizoma atractylodis macrocephalae and the total weight of the bletilla striata.
In some embodiments, the number added water to cook in step (2) can be 2 times, and the time of each decoction can Think 1-2 hours.
In some embodiments, it is added in step (3) in the solution obtained after ethyl alcohol, the content of ethyl alcohol can be 40-80 weight %, preferably 70 weight %.
May be used the conventional method of this field by the Chinese medicine composition of the application be prepared into suitable patient take it is any Acceptable appropriate dosage form in pharmacy.
Wherein, the conventional method is at least one of following methods：
(1) after adding in customary adjuvant, granule is made in granulation, dry, whole grain；
(2) after adding in customary adjuvant, tablet is made in granulation, sieving, whole grain, then tabletting；
(3) it after adding in customary adjuvant, pelletizes, dry, whole grain, then capsule is made in capsule charge；
(4) clear cream obtained by the step (3) in preparation method is added into appropriate amount of water, is adjusted with 40 mass % sodium hydroxide solutions PH value refrigerates, filtration, addition sucrose is appropriate, and stirring evenly makes dissolving, adds in essence in right amount and adjusts pH value to 7.0, by agent to 7.0 Amount adds in suitable quantity of water, stands, and filters, and after filling, oral administration solution is made in sterilizing；
(5) proper honey, sucrose are taken, heating is made simple syrup, treats that syrup temp is down to 60 DEG C hereinafter, by preparation method In step (3) obtained by after clear cream and sodium benzoate be mixed in a certain ratio, add in simple syrup, and add appropriate amount of water, stirring is equal It is even, it is distributed into syrup；
(6) dry powder obtained by the step (3) in preparation method is added into injection appropriate amount of water, it is molten with 30 mass % sodium hydroxides Liquid adjusts pH value to 7.4, it is made fully to dissolve, separately takes glucose, meglumine that injection appropriate amount of water is added to dissolve in right amount, mixing is used 30 mass % sodium hydroxide solutions adjust pH value to 7.5, are diluted to required dose concentration with water for injection, stir evenly；Using prior With the filter membrane of water for injection immersion treatment, first with 0.65 μm of filter membrane coarse filtration, then with 0.45 μm of filter membrane refined filtration is carried out；Refined filtration Liquid is rapid filling after clarity test qualification, and 115 DEG C sterilize 20 minutes, and lamp inspection is packaged to be injection.
Present invention also provides the applications of the Chinese medicine composition, are used to prepare the medicine for the treatment of acute-on-chronic liver failure Object.
The combination principle of the Chinese medicine composition of the application and the pharmacological property of each component are as follows：
In formula of the present invention, oriental wormwood bitter, cold nature, there is hardship to let out decline, clear profit for returns spleen, stomach, liver, gallbladder channel The effect of damp and hot, to treat the key medicine of jaundice.Modern research shows that oriental wormwood has hepatic cholagogic, promotes choleresis, increases The effect of cholic acid and bilirubin discharge in bile.Radix paeoniae rubrathe bitter, cold nature, return liver warp.With clearing heat and cooling blood, stasis-dispelling and pain-killing it Effect.《Bencao Jingshu》Speech " wooden Chinese herbaceous peony color is red, and red person master breaks scattered, main tonneau, specially enters liver man blood system promoting circulation of blood cool blood ".Modern medicine Reason Mechanism Study shows that its active constituent Paeoniflorin can be by reducing hepatic tissue malonaldehyde, active oxygen, nitric oxide, NADPH The amount of oxidizing ferment 4 and increase the amount of glutathione and avoid liver oxidative damage, it is horizontal that choline, 5-methyltetrahydrofolate can be raised And play hepatoprotective effect；Total paeony glycoside can removing jaundice drop enzyme, mechanism of action may with increase choleresis, improve liver drug enzyme And the activity of uridine diphosphoglucose acid transferase is related.Therefore oriental wormwood and the radix paeoniae rubrathe are monarch drug in a prescription altogether.
Madder taste bitter and cold, return liver warp have the function of cooling blood and hemostasis, dissolving stasis, promoting menstruation,《Compendium of Materia Medica》Speech：" madder, Qualcomm meridian, promoting circulation of blood of invigorating blood circulation ".Modern pharmacological research shows that one methanolic extract of madder water has protective effect, institute to liver There is stronger anti-inflammatory effect, and the work(of T cell can be influenced to a variety of active chronic inflammation models of animal containing triterpenes components Can, inhibit the breeder reaction of normal human peripheral blood's T lymphocytes of ConA inductions, and cellular immune function can be adjusted.Madder energy The content of interleukins I, II, VI and tumor necrosis factor in serum is reduced, but does not influence the content of cortisol, passes through suppression Organism immune response processed improves local inflammation reaction.Common St.Paulswort Herb, bitter, acrid, cold, Return liver kidney channel, clearing and activating the channels and collaterals is clearing heat and detoxicating, Wind-damp dispelling.Modern pharmacological research is shown, can significantly inhibit and reduce lysosomal enzyme, adenosinetriphosphataes, hyaluronidase etc. Bioactivity, has histamine release caused by immune response a moderate inhibiting effect, and may by inhibit synovial cell IL-1 β, The synthesis of IL-8, and then inhibit the release of other inflammatory mediators such as prostaglandin, capillary permeability is reduced, is played anti-inflammatory Effect.Radix Salviae Miltiorrhizae bitter, cold nature, the thoughts of returning home, pericardium, Liver Channel take its promoting blood circulation, cool blood to disappear carbuncle, the work(of nourishing blood and tranquilization.Cape jasmine Bitter, cold in nature, the thoughts of returning home, lung, stomach, tri-jiao channel, the work(with clearing heat and promoting diuresis, removing pattogenic heat from the blood and toxic material from the body.Oldenlandia diffusa mildly bitter flavor, sweet, property It is cold, enter stomach, large intestine, small intestinl channel, the work(with heat-clearing, dampness removing, removing toxic substances.
Rhizoma atractylodis macrocephalae bitter but sweet flavor, warm-natured, returns spleen, stomach have air making-up and spleen enlivening, the work(for protecting stomach Qi, in case bitter cold flavour of a drug are hindered Taste yang-energy.The bletilla striata, bitter, sweet, puckery, cold nature, return lung, liver, stomach have astringing to arrest bleeding, and detumescence and promoting granulation cares for coke in shield Effect.Modern pharmacological studies have shown that the bletilla striata plays the role of antibacterial bacteriostatic, hemostasis, protection stomach lining, and wound can be promoted to be cured It closes, the activity of Platelet factorⅢ can be enhanced, shorten fibrin ferment generated time, inhibit the activity of plasmase, can also make Cell condensation forms artificial thrombus and stops blooding.Therefore the two is adjuvant altogether.
The effect of making a general survey of full side, playing clearing heat and detoxicating, cooling and activating blood, clearing damp stagnation resolvation altogether, it is kind to control blood stasis blood-head, wet poison internal resistance The acute-on-chronic liver failure of card reaches adjustment immune function, inhibits inflammatory reaction, protects liver cell, promotes the work of Bile metabolism With.
Chinese medicine composition for the treatment of acute-on-chronic liver failure of the application and preparation method thereof is verified and is tied by scientific research It closes clinical experience and refines what is obtained, which is reducing case fatality rate, prevention complication, blocking progression of disease etc. Clear superiority can be embodied, the case fatality rate and complication rate of acute-on-chronic liver failure patient can be substantially reduced, is improved Survival rate, life quality and quality of life.
Other features and advantage will illustrate in the following description, also, partly become from specification It obtains it is clear that being understood by implementing the application.The purpose of the application and other advantages can be by specification, power Specifically noted structure is realized and is obtained in sharp claim.
Specific embodiment
Purpose, technical scheme and advantage to make the application are more clearly understood, hereinafter will be to embodiments herein It is described in detail.It should be noted that in the absence of conflict, the feature in embodiment and embodiment in the application It mutually can arbitrarily combine.
Embodiment 1
The Chinese medicine composition of the present embodiment includes：1800 parts by weight of oriental wormwood, 3600 parts by weight of the radix paeoniae rubrathe, 1800 weight of madder 1800 parts by weight of Fen, Common St.Paulswort Herbs, 1800 parts by weight of Radix Salviae Miltiorrhizae, 540 parts by weight of cape jasmine, 1800 parts by weight of oldenlandia diffusa, rhizoma atractylodis macrocephalae 900 parts by weight of 1800 parts by weight and the bletilla striata.
The Chinese medicine composition of the present embodiment is prepared using following methods：
(1) each raw material is weighed according to the parts by weight；
(2) oriental wormwood, the radix paeoniae rubrathe, madder, Common St.Paulswort Herb, Radix Salviae Miltiorrhizae, cape jasmine, oldenlandia that step (1) weighed are added water to cook Grass, rhizoma atractylodis macrocephalae and the bletilla striata, filter decocting liquid, and by filtrate concentrated by rotary evaporation into the medicine that relative density is 1.10-1.20 at 60 DEG C Liquid；
(3) ethyl alcohol is added in into the liquid made from step (2) so that its alcohol content is 70 weight %, is fully stirred It mixes, stands overnight, filter off sediment, filtrate recycling ethanol and to be condensed at 60 DEG C relative density be the clear of 1.10-1.25 Cream is dried to dry powder.
(4) by granulation, dry, whole grain after the dry powder addition microcrystalline cellulose obtained by step (3), granule is made.
Embodiment 2
The Chinese medicine composition of the present embodiment includes：1200 parts by weight of oriental wormwood, 5000 parts by weight of the radix paeoniae rubrathe, 2500 weight of madder 1000 parts by weight of Fen, Common St.Paulswort Herbs, 1000 parts by weight of Radix Salviae Miltiorrhizae, 600 parts by weight of cape jasmine, 2500 parts by weight of oldenlandia diffusa, rhizoma atractylodis macrocephalae 500 parts by weight of 1200 parts by weight and the bletilla striata.
Preparation method is same as Example 1.
Embodiment 3
The Chinese medicine composition of the present embodiment includes：2500 parts by weight of oriental wormwood, 2000 parts by weight of the radix paeoniae rubrathe, 2000 weight of madder 2000 parts by weight of Fen, Common St.Paulswort Herbs, 1200 parts by weight of Radix Salviae Miltiorrhizae, 800 parts by weight of cape jasmine, 1000 parts by weight of oldenlandia diffusa, rhizoma atractylodis macrocephalae 1200 parts by weight of 1000 parts by weight and the bletilla striata.
Preparation method is same as Example 1.
Embodiment 4
The Chinese medicine composition of the present embodiment includes：1000 parts by weight of oriental wormwood, 3200 parts by weight of the radix paeoniae rubrathe, 1000 weight of madder 2500 parts by weight of Fen, Common St.Paulswort Herbs, 2500 parts by weight of Radix Salviae Miltiorrhizae, 350 parts by weight of cape jasmine, 2100 parts by weight of oldenlandia diffusa, rhizoma atractylodis macrocephalae 1500 parts by weight of 2500 parts by weight and the bletilla striata.
Preparation method is same as Example 1.
Clinical research
1st, case (or for research object) is selected：
1.1 meet the sick credit of Chinese Medical Association's infection in 2006 can hepatic failure and artificial liver group, Chinese Medical Association's hepatopathy Credit can Sever Hepatitis and the formulation of artificial liver group《Hepatic failure practice guidelines》In slow extra urgaent dispatch (subacute) hepatic failure diagnosis The inpatient of standard.Patient age is 16-65 Sui.
1.2 diagnostic criteria
《Hepatic failure practice guidelines》(2006) it is to the definition of slow extra urgaent dispatch (subacute) hepatic failure：In chronic liver disease base On plinth, the main clinical manifestation of acute hepatic decompensation occurs in a short time.
Slow extra urgaent dispatch (subacute) hepatic failure can be divided into early stage, mid-term and late period.
In early days：1. it is extremely weak, and have the severe digestives such as apparent apocleisis, vomiting and abdominal distension road symptom.2. jaundice progressive Deepen (serum total bilirubin >=171 μm ol/L rises >=17.1 μm of ol/L daily).3. there is hemorrhagic tendency, 30% ＜ blood coagulations Proenzyme mobility (prothrombin activity, PTA)≤40%.4. do not occur hepatic encephalopathy or apparent ascites.
Mid-term：On the basis of hepatic failure early stage, the state of an illness further develops, and one two following occurs.1. occur II degree Following hepatic encephalopathy and (or) apparent ascites.2. hemorrhagic tendency is apparent (blutpunkte or ecchymosis), and 20% ＜ PTA≤30%.
Late period：On the basis of hepatic failure mid-term manifestation, the state of an illness is further aggravated, and one three following occurs.It is 1. in distress The property controlled complication, such as hepatorenal syndrome, massive bleeding from upper digestive tract, severe infections and incorrigible electrolyte disturbance etc..② There is III degree or more hepatic encephalopathy.3. there is severe haemorrhage to be inclined to (injection site ecchymosis etc.), PTA≤20%.
2nd, therapeutic scheme
2.1 remedy measures
Control group uses A methods, and test group uses A+B (combination of Chinese tradiational and Western medicine) method.
Wherein：A- Experience of Combined Treatment of Internal Medicine；B- Chinese medicines.
Experience of Combined Treatment of Internal Medicine can hepatic failure and artificial liver group, China with reference to the sick credit of Chinese Medical Association's infection in 2006 Medical association's hepatopathy credit can Sever Hepatitis and the formulation of artificial liver group《Hepatic failure practice guidelines》.
The specific method of 2.2 Chinese medicines
For card type, the patient for damp and hot stasis of blood Huang card is treated using removing pattogenic heat from the blood and toxic material from the body clearing damp stagnation resolvation method.
Primary symptom：1. onset is hurried, yellow skin and eye, yellow urine is unfavorable or certainly sharp；2. pruitus, gastral cavilty feeling of fullness or bitter taste are general It dislikes；3. yellowish fur or purplish tongue, ecchymosis petechia, sublingual arteries and veins thickening extend.
Minor symptom：1. thirsty but drinking-water is few；2. it is uncomfortable or constipated to defecate；3. nose bleeding from the gum blood or the dermal ecchymosis；4. under the side of body Lump in the abdomen；5. tongue or thin white fur of tongue or thin Huang less, veins string or string cunning or chord number.
Dialectical requirement：All to have primary symptom 3 or primary symptom 2 plus minor symptom 2, pulse condition substantially conforms to, and can be set to assertive evidence.
Prescription：Removing pattogenic heat from the blood and toxic material from the body clearing damp Huayu prescription
Usage and dosage：Daily 1 dose, with decocting to 250-300ml, divide 2 times and warmly take.
3rd, observation item
Total bilirubin (TBIL), creatinine (CRE), urea (BUN), leucocyte (WBC), red blood cell (RBC), blood platelet (PLT) etc..
4th, evaluation index
4.1 case fatality rate are in different observing time node statistics patient's case fatality rate.
4.2 complication rates are in different observing time node statistics complication rates.
5th, result of study：
5.1 case fatality rate
Table 1 is in the case fatality rate of different time node
Test group 1 Test group 2 Test group 3 Test group 4 Control group
4 weeks 5.90% 5.94% 5.98% 6.04% 9.64%
8 weeks 11.27% 11.30% 11.28% 11.33% 17.67%
12 weeks 16.05% 16.09% 16.10% 16.13% 19.49%
Note：In the table of the application, the prescription that the Chinese medicine of test group 1-4 uses is respectively embodiment 1-4 Chinese medicine composition.
As it can be seen from table 1 in all timing nodes, the case fatality rate of test group 1-4 is substantially less than the disease of control group Dead rate, the case fatality rate of patient can be significantly reduced by illustrating the Chinese medicine composition of the embodiment of the present application 1-4.
5.2 complication rate
Table 2 is in complication-rate of hepatic encephalopathy of different time node
Test group 1 Test group 2 Test group 3 Test group 4 Control group
4 weeks 20.90% 21.25% 21.36% 21.35% 44.1%
8 weeks 27.42% 28.00% 27.74% 28.10% 50.0%
12 weeks 27.42% 28.00% 27.74% 28.10% 50.0%
Table 3 is in complication-spontaneous bacterial peritonitis incidence of different time node
From table 2, table 3 as can be seen that in all timing nodes, complication occurs for test group --- hepatic encephalopathy and from The incidence of hair property bacterial peritonitis is substantially less than control group rate, illustrates the Chinese medicine composition energy of the embodiment of the present application 1-4 Enough it effectively prevent the generation of hepatic encephalopathy and spontaneous bacterial peritonitis.
Logistic returns prognostic risk factor analysis within 5.3 8 weeks
With the death in 8 weeks for evaluation index, judged by clinical experience and the results of univariate logistic analysis (is with P ＜ 0.10 Boundary), be included in the age, by stages, complication (hepatic encephalopathy, hemorrhage of digestive tract, hepatorenal syndrome etc.), total bilirubin, Chinese medicine controls Variable is included in regression model by the variables such as treatment measure using retrogressing method, and the variable for eventually entering into equation is specifically shown in Table 4.
48 weeks Logistic Regression Analysis Results of table
Logistic model results show that grouping, staging, age, TBIL, complication hepatic encephalopathy, digestion are said Blood and the influence factor that hepatorenal syndrome is acute-on-chronic liver failure patient's prognosis.The regression coefficient (β) of test group is negative, is said It is bright its with death negative correlation, be dead protection factor, the regression coefficient of other six variables is positive value, illustrate and death Positive correlation is dead risk factor, i.e., by stages it is late, older, TBIL values are high, 8 weeks interior generation complication hepatic encephalopathies, disappear 8 weeks prognosis for changing gastrointestinal hemorrhage and patients with hepatorenal syndrome are worse, and damp and hot stasis of blood Huang card group passes through " removing pattogenic heat from the blood and toxic material from the body clearing damp stagnation resolvation 8 weeks prognosis after side " treatment are more preferable (statistically significant for difference with P values ＜ 0.05).
Therefore, the Chinese medicine composition of the embodiment of the present application 1-4 has advantage in terms of patient's prognosis in 8 weeks is improved, using this Chinese medicine composition-removing pattogenic heat from the blood and toxic material from the body clearing damp Huayu Fang " on Treatment of the treatment acute-on-chronic liver failure of application is the guarantor of 8 weeks case fatality rate Shield factor, OR values represent that the mortality risk of application " removing pattogenic heat from the blood and toxic material from the body clearing damp Huayu prescription " treatment is times for not receiving prescription treatment Number, the notable ＜ 1 of OR values of " the removing pattogenic heat from the blood and toxic material from the body clearing damp Huayu prescription " of the Chinese medicine composition of the embodiment of the present application 1-4 illustrate to take this The mortality risk of the Chinese medicine composition of application embodiment 1-4 is significantly less than the multiple for not receiving prescription treatment.
5.4 safety evaluatio
Testing experiment group 1 and the creatinine of control group and urea nitrogen levels, red blood cell, leucocyte and platelet counts, evaluation The safety of the Chinese medicine composition of the embodiment of the present application 1.Statistical result is shown in Table 5-9.
5 two groups of patients of table compare in different time node creatinine
6 two groups of patients of table compare in different time node urea nitrogen
7 two groups of patients of table compare in different time node red blood cell
8 two groups of patients of table compare in different time node leucocyte
9 two groups of patients of table compare in different time node blood platelet
It is equal with control group to can be seen that the red blood cell, leucocyte, platelet counts of test group 1, renal function etc. from table 5-9 No significant difference, and creatinine level of the test group 4 weeks, 12 weeks is substantially reduced compared with control group, embodies the embodiment of the present application 1 Chinese medicine composition have the function of improve renal function, good security.
Although the embodiment disclosed by the application is as above, the content only for ease of understanding the application and use Embodiment, be not limited to the application.Technical staff in any the application fields, is not departing from the application Under the premise of disclosed spirit and scope, any modification and variation, but this can be carried out in the form and details of implementation The scope of patent protection of application, still should be subject to the scope of the claims as defined in the appended claims.

Claims (10)

1. a kind of Chinese medicine composition for treating acute-on-chronic liver failure, the Chinese medicine composition includes following raw material：1000-2500 Parts by weight oriental wormwood, the 2000-5000 parts by weight radix paeoniae rubrathe, 1000-2500 parts by weight madder, 1000-2500 Chong Liang Fen Common St.Paulswort Herbs, 1000-2500 parts by weight Radix Salviae Miltiorrhizae, 350-800 parts by weight cape jasmine, 1000-2500 parts by weight oldenlandia diffusa, 1000-2500 weight Part rhizoma atractylodis macrocephalae and the 500-1500 parts by weight bletilla striatas.
2. Chinese medicine composition according to claim 1, wherein, the Chinese medicine composition includes following raw material：1500-2000 Parts by weight oriental wormwood, the 3000-4000 parts by weight radix paeoniae rubrathe, 1500-2000 parts by weight madder, 1500-2000 Chong Liang Fen Common St.Paulswort Herbs, 1500-2000 parts by weight Radix Salviae Miltiorrhizae, 450-700 parts by weight cape jasmine, 1500-2000 parts by weight oldenlandia diffusa, 1500-2000 weight Part rhizoma atractylodis macrocephalae and the 700-1200 parts by weight bletilla striatas.
3. Chinese medicine composition according to claim 2, wherein, the Chinese medicine composition includes following raw material：1800 weight Part oriental wormwood, the 3600 parts by weight radix paeoniae rubrathe, 1800 parts by weight madders, 1800 Chong Liang Fen Common St.Paulswort Herbs, 1800 parts by weight Radix Salviae Miltiorrhizaes, 540 weight Part cape jasmine, 1800 parts by weight oldenlandia diffusas, 1800 parts by weight rhizoma atractylodis macrocephalaes and the 900 parts by weight bletilla striatas.
4. Chinese medicine composition according to any one of claim 1-3 further includes pharmaceutically acceptable auxiliary material.
5. according to the Chinese medicine composition described in any one of claim 1-4, wherein, the dosage form of the Chinese medicine composition is piece Agent, capsule, granule, oral administration solution, syrup or injection.
6. a kind of method for preparing Chinese medicine composition according to any one of claims 1-5, the method includes following Step：
(1) each raw material is weighed according to the parts by weight；
(2) add water to cook oriental wormwood, the radix paeoniae rubrathe, madder, Common St.Paulswort Herb, Radix Salviae Miltiorrhizae, cape jasmine, oldenlandia diffusa that step (1) weighed, fry it is white Art and the bletilla striata filter decocting liquid, and filtrate are condensed into the liquid that the relative density at 60 DEG C is 1.10-1.20；
(3) ethyl alcohol is added in into the liquid made from step (2), is sufficiently stirred, stands overnight, filter off sediment, filtrate is returned It receives ethyl alcohol and is condensed into the clear cream that the relative density at 60 DEG C is 1.10-1.25, be dried to dry powder, add in pharmaceutically acceptable Auxiliary material, you can obtain the Chinese medicine composition.
7. according to the method described in right 6, wherein, the amount of water described in step (2) is weighed oriental wormwood, the radix paeoniae rubrathe, madder, pig Xian grass, Radix Salviae Miltiorrhizae, cape jasmine, oldenlandia diffusa, 10 times of rhizoma atractylodis macrocephalae and the total weight of the bletilla striata.
8. according to the method described in right 6, wherein, the number added water to cook in step (2) is 2 times, the time of each decoction It is 1-2 hours.
9. according to the method described in right 6, wherein, it is added in step (3) in the solution obtained after ethyl alcohol, the content of ethyl alcohol is 40-80 weight %.
10. Chinese medicine composition according to any one of claim 1-4 is preparing for treating acute-on-chronic liver failure Application in drug.
CN201810182809.9A 2018-03-06 2018-03-06 Treat Chinese medicine composition of acute-on-chronic liver failure and its preparation method and application Pending CN108186898A (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016117705A1 (en) * 2015-01-23 2016-07-28 株式会社ニューロゲン Agent for inducing production of hepatocyte growth factor

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
WO2016117705A1 (en) * 2015-01-23 2016-07-28 株式会社ニューロゲン Agent for inducing production of hepatocyte growth factor

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孙新锋等: "中西医结合治疗乙型肝炎病毒相关慢加急性肝衰竭临床观察", 《北京中医药》 *
李守娟等: "人工肝联合凉血解毒化瘀方治疗重型乙肝疗效观察", 《湖南中医药大学学报》 *
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Application publication date: 20180622