CN101385823B - Medicine for treating heavy acute pancreatitis and preparation method thereof - Google Patents
Medicine for treating heavy acute pancreatitis and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a drug for treating severe acute pancreatitis. The drug is made from bupleurum, corydalis tuber, oriental wormwood, fermented soybean, immature orange fruit, white atractylodes rhizome, oriental water plantain and Chinese aloe according to a certain weight proportion. The drug has protective effect on the intestinal barrier function under the condition of the severe acute pancreatitis, can lower intestinal tract permeability, lighten endotoxemia and inflammatory reaction, and has greater influence on outcome of diseases.
Description
Technical field
The present invention relates to a kind of medicine for the treatment of Severe Acute Pancreatitis SAP and preparation method thereof, belong to the field of Chinese medicines.
Background technology
Severe Acute Pancreatitis SAP is that the state of an illness is dangerous by the disease of multifactorly bringing out, a plurality of internal organs are impaired, development rapidly, clinical characters is high complication, high mortality.Though treatment and the monitoring to this disease obtained some progress in recent years, its mortality rate is still very high, can reach 10-40%.Severe Acute Pancreatitis SAP plays a few hours after being ill, and the perfusion of intestinal and pancreas obviously reduces.Because the liquid that " third space " that serious pancreas inflammation causes lost in a large number causes visceral vessel and shrinks that cause the intestinal mucosa ischemia, the reperfusion injury behind the liquid resuscitation has destruction to intestinal barrier function.Regulate the gastrointestinal polypeptide and the hormone secretion disorder of intestinal power, small intestine power obviously descends, and power abnormality causes bacterial overgrowth, and attaches to intestinal wall, discharges a large amount of toxin.In addition, cytokine excessively generates, somatomedin lacks and factors such as the excessive apoptosis of intestinal epithelial cell cause the intestinal mucosal barrier damage jointly, and intestinal depletion takes place.Intestinal depletion makes intestinal permeability increase, antibacterial in the enteric cavity is displaced to the pancreatic necrosis tissue and causes infecting, after intestinal bacteria and endotoxin enter the body circulation, stimulate activatory monokaryon and macrophage, stimulate the generation of tumor necrosis factor-alpha, interleukin-6, interleukin-8 etc., cause cytokinemia for the first time, activate neutrophilic granulocyte, be gathered in organs such as lung, liver.This fashion is unlikely to cause serious organ injury, if complication such as antibacterial displacement, infection take place, then can stimulate macrophage to produce and cause inflammatory cytokine, cause in the circulation cytokine peak for the second time, thereby excessive activation neutrophilic granulocyte, internal organs such as pancreas are constituted " second strike ", cause multiple organ injury then, be developed to multiple organ dysfunction syndrome at last.Intestinal source property bacterial infection is a factor that influences the Severe Acute Pancreatitis SAP survival rate, and the generation of intestinal depletion is to stoping advancing of disease when therefore controlling Severe Acute Pancreatitis SAP, and the prognosis that improves the Severe Acute Pancreatitis SAP patient seems most important.
It is the importance of Severe Acute Pancreatitis SAP Comprehensive Treatment that the selectivity digestive tract depollutes, and depollutes by intestinal and prevents bacterial translocation, prevents the generation of intestinal depletion.The generation and the death in course of disease later stage (greater than two weeks) that the selectivity digestive tract depollutes and can reduce Severe Acute Pancreatitis SAP patient pyemia reduce downright bad pancreatic tissue gram positive bacterial infection, reduce the average time of patient's row abdominal.Studies show that: clear pancreas soup, dahuang fuzi decoction, DACHENGQI TANG etc. have the protection pancreatic acinar cell and regulate the effect of cytokine secretion; can alleviate the multiple pathophysiological change that acute necrotizing pancreatitis causes; can obviously reduce the chance of occurrence of bacterial translocation and infection, intestinal mucosal barrier is had protective effect.The Tongli that the Chinese medicine of being studied at present mostly is Radix Et Rhizoma Rhei and effective ingredient thereof or contains Radix Et Rhizoma Rhei is captured compound recipe, and other Chinese medicines intestinal bacterial translocation and very few to the influence and the Study on Mechanism report of intestinal barrier function when suppressing Severe Acute Pancreatitis SAPs.
Summary of the invention
The inventor is through research and clinical verification repeatedly; eight flavor Chinese medicine compositions such as discovery Radix Bupleuri have protective effect to intestinal barrier function under the Severe Acute Pancreatitis SAP state; can reduce intestinal permeability, alleviate endotoxemia and inflammatory reaction, prognosis of disease is had considerable influence.
The technical issues that need to address of the present invention just provide a kind of Chinese medicine composition of effective treatment Severe Acute Pancreatitis SAP.
Another technical problem that the present invention need solve provides the preparation method of this Chinese medicine composition.
Traditional Chinese medicinal composition raw materials thing of the present invention selects Radix Bupleuri, Rhizoma Corydalis, Herba Artemisiae Scopariae, tasteless preserved soybean, Fructus Aurantii Immaturus, the Rhizoma Atractylodis Macrocephalae, Rhizoma Alismatis, Aloe to make up.The Radix Bupleuri depressed liver-energy dispersing and QI regulating, Rhizoma Corydalis blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain, two medicines share, and QI and blood is ruled together.The Radix Bupleuri dispersing the stagnated live-QI to relieve the stagnation of QI, the Herba Artemisiae Scopariae eliminating damp-heat, promoting the function of the gallbladder to alleviate jaundice share, and treats damp and hot in liver and gall and the not easypro side of body distending pain of stagnation of liver-QI.The tasteless preserved soybean depressed liver-energy dispersing and function of gallbladder promoting is with Herba Artemisiae Scopariae, Fructus Aurantii Immaturus, the Aloe alcoholic jaundice of dispelling.Radix Bupleuri, Fructus Aurantii Immaturus share, one rise and one drop, altogether long memorial stagnation of liver-QI and taste, the machine of regulating the flow of vital energy, activating yang reaches Yu Zhigong, in the treatment burnt retardance, liver stomach become estranged, disorder of QI movement.Rhizoma Alismatis eliminating dampness and diuresis the turbid descending the moon, Rhizoma Atractylodis Macrocephalae invigorating the spleen and replenishing QI, the spleen strengthening and damp drying, sending up the lucid YANG, two medicines share, and are burnt in the strong fortune, ascending the clear and descending the turbid, regulating fluid apssage.Fructus Aurantii Immaturus rushes down long-pending intestinal stasis relieving, and the painful abdominal mass that disappears pain relieving is walked and do not kept, and Rhizoma Atractylodis Macrocephalae invigorating the spleen and benefiting QI is share, and mends double the executing that disappear, and treats weakness of the spleen and stomach, and mechanism of qi is obstructed.The Aloe relieving accumulation of pathogens by purgation share with Fructus Aurantii Immaturus, and the painful abdominal mass that disappears of purging heat waits all tangible invisible stagnant but admittance QI and blood expectorant food stagnation is stagnant.
The modern pharmacology data: the functional component of Radix Bupleuri mainly is a saponin component, has effects such as antiinflammatory, analgesia, function of gallbladder promoting; The functional component of Rhizoma Corydalis is an alkaloids, has analgesic effect; The functional component of Herba Artemisiae Scopariae mainly is compositions such as volatile oil, flavonoid, Coumarins, chromogen ketone, has function of gallbladder promoting, protects the liver, effect such as antiinflammatory, analgesia, diuresis, blood pressure lowering; The functional component of the Rhizoma Atractylodis Macrocephalae mainly is a volatile oil, has effects such as antitumor, antiinflammatory; The functional component of Rhizoma Alismatis mainly is a terpenoid, effect such as have diuresis, antiinflammatory, protect the liver; The functional component of Fructus Aurantii Immaturus is flavonoid glycoside, alkaloids, volatile oil, has effects such as antiinflammatory, diuresis; Aloetic functional component is an anthraquinone analog compound, have rush down down, treatment wound, effect such as antibacterial.
Each constituent content of Chinese medicine composition of the present invention has better curative effect in the following weight parts scope:
2～5 parts of Radix Bupleuri, 2～5 parts of Rhizoma Corydalis, 2～4 parts of Herba Artemisiae Scopariaes, 3～8 parts of tasteless preserved soybeans, 2～4 parts of Fructus Aurantii Immaturuss, 3～8 parts of the Rhizoma Atractylodis Macrocephalaes, 2～5 parts of Rhizoma Alismatis, 0.5～1.5 part of Aloe.
Be preferably: 4.5 parts of Radix Bupleuri, 4.5 parts of Rhizoma Corydalis, 3 parts of Herba Artemisiae Scopariaes, 6 parts of tasteless preserved soybeans, 3 parts of Fructus Aurantii Immaturuss, 6 parts of the Rhizoma Atractylodis Macrocephalaes, 4.5 parts of Rhizoma Alismatis, 1 part of Aloe.
The preparation method of Chinese medicine composition of the present invention is as follows:
With Radix Bupleuri, Rhizoma Corydalis, Herba Artemisiae Scopariae, tasteless preserved soybean, Fructus Aurantii Immaturus, the Rhizoma Atractylodis Macrocephalae, Rhizoma Alismatis, the Aloe 8 flavor medicines of described weight proportion, except that Aloe, all the other 7 flavor decoctings, decoct 2 times, each 1.5 hours, add 12 times in water for the first time, add for the second time 10 times in water, twice filtrate merging, concentrated, dry adds Aloe, an amount of dextrin, mixing is beaten powder, crosses sieve No. 5,70% alcohol granulation is crossed sieve No. 2, drying, granulate, mixing, packing is promptly.
The specific embodiment
Below further set forth the beneficial effect of Chinese medicine composition of the present invention, but do not limit the scope of the invention by the test example.
The clinical observation of Drug therapy Severe Acute Pancreatitis SAP of the present invention
1, physical data
Choose routine Severe Acute Pancreatitis SAP patient in year June 60 in January, 2006 to 2007, be divided into treatment and organize 30 examples, male's 14 examples wherein, women's 16 examples, the mean age is 61.3 ± 14.4 years old; Matched group 30 examples, male's 15 examples wherein, women's 15 examples, the mean age is 63.4 ± 11.9 years old, two groups at sex and zero difference on the age (P〉0.05).Pathogenic factor and inducement: have tangible diet inducement 7 examples (11.67%), mostly be eating and drinking too much at one meal, feed irritable food or the back outbreak of drinking, there are 36 examples (60.00%) that cholecystitis or Biliary Calculi are arranged, there is 14 examples (23.33%) patient to be hyperlipemia, other 3 examples (5.00%) patient etiology unknown.
2, diagnostic criteria
Case meets the diagnostic criteria that the world, Bangkok in 2002 gastrointestinal disease conference pancreatitis working group proposes Severe Acute Pancreatitis SAP, and is admitted to hospital in back 48 hours in morbidity; Age was less than 65 years old; Surgical operation therapy wouldn't be gone in two weeks in the back of being admitted to hospital.
3, Therapeutic Method
Two groups of patients all give the general treatments such as supporting, suppress pancreatin of suiting the medicine to the illness under the homeostasis situation, the treatment group adds Chinese medicine composition of the present invention, and each 5g, took for three weeks at every day 3 times.
4, observation of curative effect and evaluation criteria:
Observe patient's ordinary circumstance, abdominal symptoms and sign; The capable APACHE-II scoring in the 7th, 14 day of selected back, and detection serum amylase, change of serum C RP, tumor necrosis factor (TNF-α), interleukin-1 β, plasma endotoxin, plasma D-lactic acid, plasma D AO, urine lactulose/mannitol ratio, intestinal microbial population changes; Observe the generation of complication and the variation of indexs such as hospital stays, expense.
Clinical recovery: symptom, sign are alleviated in 3 days, disappear within 14～21 days, and blood, amylase in urine recover normal.
Produce effects: symptom, sign significantly take a turn for the better in 7 days, and blood, amylase in urine recover normal.
Effectively: symptom, sign alleviate in 7 days, and blood, amylase in urine have downward trend.
Invalid: symptom does not alleviate or worsens in 7 days, and blood, amylase in urine do not reduce.
5 therapeutic outcomes
(1) every cardinal symptom improvement situation compares (seeing Table 1)
The table 1 liang every cardinal symptom improvement of group patient situation relatively
(2) two groups of patients go into group APACHE-II scoring in the 1st day zero difference, and two groups of APACHE-II scorings are with the length of stay increase trend that all tapers off, and treatment group APACHE-II scoring is lower than matched group (P＜0.05) (seeing Table 2).
Table 2 liang group APACHEII scoring relatively
*Compare P＜0.05 with matched group,
☆Compared P＜0.05 with the 1st day,
★Compared P＜0.05 with the 7th day
(3) serum amylase (seeing Table 3)
Serum amylase changes relatively before and after the table 3 liang group treatment
Annotate: compare in the group
*P＜0.05,
*P＜0.01.
Compare ⊙ P＜0.05 between group.
Table 3 is as seen: before the treatment, two groups of serum amylases similar (P〉0.05), the treatment back all obviously descends (P＜0.01) than treatment is preceding for two groups, and treatment back treatment group and matched group also have difference (P＜0.05), illustrate that treatment group serum amylase recovery situation is better than matched group.
(4) change of serum C RP changes (seeing Table 4)
Change of serum C RP changes relatively before and after the table 4 liang group patient treatment
Annotate: compare in the group
*P＜0.05,
*P＜0.01.
Compare ⊙ P＜0.05 between group.
Table 4 is as seen: change of serum C RP level similar (P〉0.05) before two groups of patient treatments, treatment back CRP level is the preceding difference very remarkable (P＜0.01) of treatment, treatment back two group differences are also had a statistical significance (P＜0.05), show that Chinese medicine composition of the present invention can obviously reduce the level of acute critical pancreatitis patient CRP.
(5) tumor necrosis factor changes (seeing Table 5)
Tumor necrosis factor (TNF-α) changes relatively before and after the table 5 liang group patient treatment
Annotate: compare in the group
*P＜0.05,
*P＜0.01.
Compare ⊙ P＜0.05 between group.
Table 5 is as seen: TNF-alpha levels similar (P〉0.05) before two groups of patient treatments, treatment back treatment is organized the 7th, 14 day all than obviously descend before the treatment (P＜0.05), and matched group the 14th day, just obviously descend (P＜0.05), two groups TNF-alpha levels also had notable difference (P＜0.05) in the 14th day, showed that Chinese medicine composition of the present invention can obviously reduce acute critical pancreatitis patient's tumor necrosis factor level.
(6) interleukin-1 β changes (seeing Table 6)
Interleukin-1 β changes relatively before and after the table 6 liang group patient treatment
Annotate: compare in the group
*P＜0.05,
*P＜0.01.
Compare ⊙ P＜0.05 between group.
Table 7 is as seen: treat preceding two groups of patient's interleukin-1 β levels similar (P〉0.05), treatment back two groups (the 7th, the 14th days) all are lower than interleukin-1 β level before the treatment, but equal not statistically significants (P〉0.05).
(7) variation of plasma endotoxin (seeing Table 7)
The variation of plasma endotoxin relatively before and after the table 7 liang group patient treatment
Annotate: compare in the group
*P＜0.05,
*P＜0.01.
Compare ⊙ P＜0.05 between group.
Table 8 is as seen: it is similar to treat preceding two groups of plasma endotoxin levels, treatment back the 7th, 14 day, before treatment group level is lower than treatment, before matched group was lower than treatment on the 14th day, two groups of the 14th day difference tool statistical significances show that Chinese medicine composition of the present invention can obviously reduce acute critical pancreatitis patient plasma endotoxin.
(9) plasma D-lactic acid changes (seeing Table 9)
Plasma D-lactic acid changes relatively before and after the table 9 liang group patient treatment
Annotate: compare in the group
*P＜0.05,
*P＜0.01.
Compare ⊙ P＜0.05 between group.
Table 9 is as seen: plasma D-lactate level similar (P〉0.05) before two groups of patient treatments, before treatment group treatment back all was lower than treatment on the the 7th, 14 day (P＜0.05,＜0.01), the 14th level also is lower than the preceding level (P＜0.05) of treatment after the treatment of control group, the 14th day different tool statistical significance of level error (P＜0.05) in two groups of treatment backs shows that Chinese medicine composition of the present invention can obviously reduce acute critical pancreatitis patient plasma D-lactic acid.
(10) plasma D AO changes (seeing Table 10)
Plasma D AO changes relatively before and after the table 10 liang group patient treatment
Annotate: compare in the group
*P＜0.05,
*P＜0.01.
Compare ⊙ P＜0.05 between group.
Table 10 is as seen: treat preceding two groups of patient's plasma D AO levels similar (P〉0.05), before the two groups of patient's plasma D AO in treatment back all are starkly lower than treatment, and the decline of treatment group DAO level is more obvious, shows that Chinese medicine composition of the present invention can obviously reduce acute critical pancreatitis patient plasma D AO level.
(11) variation of urine lactulose/mannitol (seeing Table 11)
Urine lactulose/mannitol changes before and after the table 11 liang group patient treatment
Annotate: compare in the group
*P＜0.05,
*P＜0.01.
Compare ⊙ P＜0.05 between group.
Table 11 is as seen: treat preceding two groups of patient's urine lactulose/mannitol similar (P〉0.05), treatment group treatment back all was starkly lower than treatment preceding (P＜0.05) on the the 7th, 14 day, before being lower than treatment on the 14th day after the treatment of control group, compared difference tool statistical significance on the 7th, 14 day for two groups, show that Chinese medicine composition of the present invention can obviously reduce the acute critical pancreatitis patient and urinate lactulose/mannitol.
(12) intestinal microbial population changes: intestinal microbial population adopts enterobacteria gene redundancy concensus sequence-PCR (ERIC-PCR) fingerprint image to analyze.Two groups of ERIC bands are mostly greater than 500bp, and matched group is obviously different in the 1st, 7 day advantage ERIC band number of treatment, structure distribution, and the 1st, 7,14 day advantage ERIC band number, structure distribution are organized in treatment does not have significant change.
(13) infect complication: the incidence rate that Chinese medicine composition multiple organ dysfunction syndrome of the present invention, acute lung injury/adult respiratory distress syndrome, pancreatic cyst form is respectively 23.33%, 6.67% and 0%, lower than matched group (matched group is respectively 26.67%, 20.00% and 16.67%), P＜0.05.
The hospital stays of (14) treatment group and matched group was respectively 20.0 ± 5.7 days and 34.5 ± 12.94 days, and the treatment group hospital stays is than matched group short (P＜0.05).
The hospitalization cost of (15) treatment group and matched group is respectively 2.59 ± 1.42 ten thousand yuan and 4.68 ± 4.03 ten thousand yuan, and the treatment group is lower than matched group (P＜0.05).
(16) general curative effect (seeing Table 12)
Table 12 treatment group and matched group clinical efficacy are relatively
Table 12 shows: compare for two groups, the curative effect of treatment group is better than matched group, shows that difference learns processing by statistics, has remarkable meaning (P＜0.05).
Further illustrate the preparation method of medicine of the present invention by the following examples
Embodiment 1: Radix Bupleuri 622.3g, Rhizoma Corydalis 622.3g, Herba Artemisiae Scopariae 414.9g, Semen Sojae Preparatum 829.7g, Fructus Aurantii Immaturus 414.9g, Rhizoma Atractylodis Macrocephalae 829.7g, Rhizoma Alismatis 622.3g, Aloe 138.9g.
Preparation method: above 8 flavors, except that Aloe, all the other 7 flavor decoctings decoct 2 times, each 1.5 hours, add 12 times in water for the first time, add 10 times in water for the second time, twice filtrate merging, concentrated, dry adds Aloe, an amount of dextrin, mixing, beat powder, cross sieve No. 5,70% alcohol granulation, cross sieve No. 2, drying, granulate, mixing, packing, promptly.
Embodiment 2: Radix Bupleuri 240g, Rhizoma Corydalis 480g, Herba Artemisiae Scopariae 260g, Semen Sojae Preparatum 600g, Fructus Aurantii Immaturus 240g, Rhizoma Atractylodis Macrocephalae 480g, Rhizoma Alismatis 360g, Aloe 60g.
Preparation method: above 8 flavors, except that Aloe, all the other 7 flavor decoctings decoct 2 times, each 1.5 hours, add 12 times in water for the first time, add 10 times in water for the second time, twice filtrate merging, concentrated, dry adds Aloe, an amount of dextrin, mixing, beat powder, cross sieve No. 5,70% alcohol granulation, cross sieve No. 2, drying, granulate, mixing, packing, promptly.
Claims (3)
1. a medicine for the treatment of Severe Acute Pancreatitis SAP is characterized in that the active part of this medicine is made up of the raw material of following weight portion: 2～5 parts of Radix Bupleuri, 2～5 parts of Rhizoma Corydalis, 2～4 parts of Herba Artemisiae Scopariaes, 3～8 parts of tasteless preserved soybeans, 2～4 parts of Fructus Aurantii Immaturuss, 3～8 parts of the Rhizoma Atractylodis Macrocephalaes, 2～5 parts of Rhizoma Alismatis, 0.5～1.5 part of Aloe.
2. a kind of medicine for the treatment of Severe Acute Pancreatitis SAP according to claim 1, it is characterized in that the consumption of each crude drug of the active part of this medicine is: 4.5 parts of Radix Bupleuri, 4.5 parts of Rhizoma Corydalis, 3 parts of Herba Artemisiae Scopariaes, 6 parts of tasteless preserved soybeans, 3 parts of Fructus Aurantii Immaturuss, 6 parts of the Rhizoma Atractylodis Macrocephalaes, 4.5 parts of Rhizoma Alismatis, 1 part of Aloe.
3. according to the preparation method of claim 1 or 2 described medicines, may further comprise the steps: with Radix Bupleuri, Rhizoma Corydalis, Herba Artemisiae Scopariae, tasteless preserved soybean, Fructus Aurantii Immaturus, the Rhizoma Atractylodis Macrocephalae, Rhizoma Alismatis, the Aloe 8 flavor medicines of described weight proportion, except that Aloe, all the other 7 flavor decoctings decoct 2 times, each 1.5 hours, add for the first time 12 times in water, add 10 times in water for the second time, twice filtrate merging, concentrated, dry, add Aloe, an amount of dextrin, mixing is beaten powder, crosses sieve No. 5,70% alcohol granulation, cross sieve No. 2, drying, granulate, mixing, packing promptly.
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| CN104906525A (en) * | 2015-07-06 | 2015-09-16 | 苗怡文 | Traditional Chinese medicine composition for treating acute edematous pancreatitis |
| CN105233135B (en) * | 2015-10-20 | 2019-03-29 | 河南中医学院第一附属医院 | The drug and preparation method thereof for treating Pancreatic Psoudocyst after Severe Acute Pancreatitis SAP |
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