CN102362993A - Chinese medicinal preparation with effects of protecting intestines and removing toxic materials, and preparation method thereof - Google Patents
Chinese medicinal preparation with effects of protecting intestines and removing toxic materials, and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese medicinal preparation with effects of protecting intestines and removing toxic materials. The Chinese medicinal preparation comprises the following Chinese herbal medicines in part by weight: 6 to 12 parts of rhubarb, 6 to 12 parts of sinkiang arnebia root, 25 to 35 parts of tuckahoe, 25 to 35 parts of coix seed, 10 to 20 parts of common bletilla pseudobulb, 20 to 30 parts of red paeony root, 10 to 20 parts of scutellaria baicalensis, 10 to 15 parts of common andrographis herb, 6 to 12 parts of cutch, and 2 to 5 parts of liquorice. A preparation method comprises the following steps of: weighing Chinese herbal medicines, loading into an extraction bag, adding water in an amount which is 8 to 12 times weight of the Chinese herbal medicines, soaking for 1 to 2 hours, decocting and extracting for 1 to 2 hours, filtering to obtain an extracting solution, concentrating until the relative density is 1.02 to 1.05, and spraying and drying to obtain the Chinese medicinal preparation. The Chinese medicinal preparation has the effects of protecting intestine barriers, removing toxin in intestines, reducing cell factors, and reducing damage of other inflammatory mediators to liver.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation of protecting intestinal detoxicating effect and preparation method thereof that has.
Background technology
China be hepatitis B virus (Hepatitis B Virus HBV) infects high popular area, and hbs antigen (HBsAg) positive rate is 9.09%, about 1.2 hundred million people, wherein chronic hepatitis B patient is about 3,000 ten thousand people.Great mass of data confirms, chronic hepatopathy mostly with intestinal endotoxemia (Intestinal Endotoxemia, IETM).The incidence rate of hepatitis gravis, hepatitis cirrhosis, chronic hepatitis, acute hepatitis patient IETM is respectively 93.3%, 84.3%, 79.0% and 75.0%.The morbidity of chronic virus b hepatopathy and progress, the effect of intestinal endotoxemia is paid much attention to day by day, and the level chain that endotoxin and endotoxin activate the Kupffer Cell inflammatory factor discharges the hepatic injury that is caused, and is " Secondary cases hepatic injury ".With hepatocyte injury that continues and the inflammatory cell infiltration that accompanies, then develop into hepatitis interstitialis chronica even hepatocarcinoma then repeatedly, also can serious hepatic necrosis take place, cause acute and chronic liver failure because of causing excessive inflammatory response.Endotoxin not only increases the weight of hepatic injury, and is the key factor that promotes many organ lesions such as portal hypertension, hepatic energy metabolism obstacle, renal damage, IETM to the development of hepatopathy with lapse to important role and influence.What remove intestinal source property endotoxin, blocking-up intestinal endotoxemia is one of essential measure of treatment hepatopathy.
At present, the endotoxic medicine of multiple treatment intestinal source property is arranged in the prior art, but have defectives such as unsatisfactory curative effect, cost be higher mostly.
Summary of the invention
To above-mentioned prior art, the invention provides and a kind ofly have the Chinese medicine preparation that protects intestinal detoxicating effect, and its preparation method is provided.
The present invention realizes through following technical scheme:
A kind of have a Chinese medicine preparation that protects intestinal detoxicating effect, comprises following bulk drugs: 6～12 parts of Radix Et Rhizoma Rhei, 6～12 parts of Radix Arnebiae (Radix Lithospermi)s; 25～35 parts in Poria, 25～35 parts of Semen Coiciss, 10～20 parts of Pseudobulbus Bletillae (Rhizoma Bletillae); 20～30 parts of Radix Paeoniae Rubra, 10～20 parts of Radix Scutellariaes, 10～15 parts of Herba Andrographis; 6～12 parts in catechu, 2～5 parts in Radix Glycyrrhizae.
Preferably, process: 9 parts of Radix Et Rhizoma Rhei, 9 parts of Radix Arnebiae (Radix Lithospermi)s, 30 parts in Poria, 30 parts of Semen Coiciss, 15 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), 24 parts of Radix Paeoniae Rubra, 15 parts of Radix Scutellariaes, 12 parts of Herba Andrographis, 9 parts in catechu, 3 parts in Radix Glycyrrhizae by following bulk drugs.
A kind of method for preparing with the Chinese medicine preparation that protects intestinal detoxicating effect, for: take by weighing each crude drug, the bag for extracting of packing into; Add 8～12 times of amounts (weight multiple, down together) water logging bubble 1～2h, decoct then and extract 1～2h; Cross and filter extracting solution; Be concentrated into relative density 1.02～1.05, spray drying promptly gets.
Further, after said decoction is extracted, filtered, in medicinal residues, add 8～12 times of water gagings again and decoct and extract 1～2h, repeat this step 1～2 time, merge each extracting solution, be concentrated into relative density 1.02～1.05, spray drying promptly gets.
Preferred manufacturing procedure is: take by weighing each crude drug, the bag for extracting of packing into adds 8 times of water gagings earlier and soaks 1h, decocts then and extracts 3 times, adds 8 times of water gagings at every turn, extracts 2h at every turn, and merge extractive liquid, is concentrated into relative density 1.02～1.05, and spray drying promptly gets.
The method that the present invention also provides other a kind of preparation to protect the Chinese medicine preparation of intestinal detoxicating effect, for: each crude drug is mixed, add 2～5 times of water gagings, be heated to water boiling back slow fire boiling 30 minutes, cross and filter filtrating, promptly get.
Chinese medicine preparation of the present invention is the medicine through nearly 15 years clinical practice replication determined curative effect, has protection intestinal barrier, eliminates intestinal endotoxin, alleviates the effect to the damage of liver of cytokine and other inflammatory mediators.In addition; Though the experiment among the present invention all is to be directed against the hepatopathy intestinal endotoxemia; But those skilled in the art are under the situation of the common practise in who knowledge capital field; Should be able to rationally infer: Chinese medicine preparation of the present invention be not only hepatopathy intestinal endotoxemia patient to be had therapeutic effect, and other disease with intestinal endotoxemia is also had therapeutic effect.
Description of drawings
Figure 1A is the high-efficient liquid phase chromatogram (emodin reference substance) of emodin;
Figure 1B is the high-efficient liquid phase chromatogram (sample) of emodin;
Fig. 1 C is the high-efficient liquid phase chromatogram (sample negative control article) of emodin.
Wherein, a: the peak of emodin.
The specific embodiment
Below in conjunction with embodiment the present invention is further described.
Embodiment 1 has the research of the Chinese medicine preparation dosage form of protecting intestinal detoxicating effect
One, the screening of extraction process
This experiment is on the basis that single factor is investigated; Selection has three factors of appreciable impact to leaching process: extraction time, amount of water, extraction time are as major influence factors; Overall merit with the extraction ratio of main effective ingredient emodin content contained in the monarch drug Radix Et Rhizoma Rhei among the we and this medicine is evaluation index; Adopt orthogonal experimental design method to optimize extraction process, extract the main effective ingredient of medicine to greatest extent, for the preparation of micropill provides fine raw material.
1, instrument and reagent:
1.1 instrument
High performance liquid chromatograph (model: LC-10AT, SPD-10A UV-detector; Serial number: C20974030587CS; Manufacturer: day island proper Tianjin); Performance liquid chromatographic column (model: VP-ODS 3042744; Manufacturer: SHIMADZU); Electronic balance (METTLER PB602-N); Electric jacket (Juancheng, Shandong China Shandong electric heating Instr Ltd.); Water-bath (Jintan City, Jiangsu Province high honour instrument Manufacturing Co., Ltd).
1.2 reagent
Emodin reference substance (lot number: 110756-200110, Nat'l Pharmaceutical & Biological Products Control Institute); Peoniflorin reference substance (lot number: 0736-200117, Nat'l Pharmaceutical & Biological Products Control Institute).What high performance liquid chromatogram was used is other methanol of chromatographically pure level, phosphoric acid, and water is distilled water.Ether, hydrochloric acid, chloroform, petroleum ether, Ethyl formate, formic acid, ethanol, ethyl acetate are analytical pure.
2, prescription and source
We are: Radix Et Rhizoma Rhei, Radix Arnebiae (Radix Lithospermi), Poria, Semen Coicis, Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Paeoniae Rubra, Herba Andrographis, catechu, Radix Glycyrrhizae, Radix Scutellariae.Through clinical verification, has good curative effect.
It is following to test used crude drug source:
Radix Et Rhizoma Rhei is the dry root and rhizome of polygonum rheum palmatum Rheum palmatum L..The place of production: Gansu.
Radix Arnebiae (Radix Lithospermi) is the dry root of comfrey lithospermum euchromum Royle Arnebia euchroma (Royle) Johnst..The place of production: Xinjiang.
Poria is the dry sclerotia of pore fungus Poria Poria cocos (Schow.) Wolf.The place of production: Anhui.
Semen Coicis is the dry mature kernal of grass Semen Coicis Coix lacryma-jobi L.var.mayuen (Roman.) Stapf.The place of production: Guizhou.
Pseudobulbus Bletillae (Rhizoma Bletillae) is the dry tuber of orchid Pseudobulbus Bletillae (Rhizoma Bletillae) Bletilla striata (Thunb.) Reichb.f..The place of production: Guizhou.
Radix Paeoniae Rubra is the dry root of ranunculaceae plant Radix Paeoniae Rubra Paeonia lacti flora Pall..The place of production: Hebei.
Herba Andrographis is the dry aerial parts of acanthaceous plant Herba Andrographis Androgaphis paniculata (Burm.f.) Nees.
Catechu is the peeling branch of leguminous plant catechu Acacia catechu (L.f.) Willd., dried dry soft extracts.
Radix Scutellariae is the dry root of labiate Radix Scutellariae Scutellaria baicalensis Georgi.The place of production: Shanxi.
Radix Glycyrrhizae is the dry root and rhizome of glycyrrhizic legume Glycyrrhiza uralensis Fisch..The place of production: Inner Mongol.
Above crude drug source all meets standards of pharmacopoeia.
3, the screening of Chinese medicine water extraction process
3.1 confirming of test orthogonal test factor level
This experiment is on the basis that single factor is investigated; With the main component emodin content in the side is standard; Selection has three factors of appreciable impact to leaching process: extraction time, amount of water, extraction time are as major influence factors; Overall merit with the extraction ratio of main effective ingredient emodin content contained in the monarch drug Radix Et Rhizoma Rhei among the we and this medicine is evaluation index, adopts orthogonal experimental design method L9 (34) to optimize extraction process, extracts the main effective ingredient of medicine to greatest extent.Like table 1.
Table 1 Chinese medicine water extraction factor level table
3.2 method and result
Get Chinese medicine, and in proportion (9 parts of Radix Et Rhizoma Rhei, 9 parts of Radix Arnebiae (Radix Lithospermi)s, 30 parts in Poria, 30 parts of Semen Coiciss, 15 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), 24 parts of Radix Paeoniae Rubra, 15 parts of Radix Scutellariaes, 12 parts of Herba Andrographis, 9 parts in catechu, 3 parts in Radix Glycyrrhizae, each component is by weight) mix homogeneously, be ground into coarse powder; Get 50g, extract (each orthogonal test scheme is used 50g) by the orthogonal test table contrived experiment.Monarch drug in the Radix Et Rhizoma Rhei side of being, its main effective ingredient is an emodin, is the assay index so select emodin for use.Emodin content is measured has thin layer chromatography scanning, HPLC, and reversed phase high-performance liquid chromatography etc., this research is with the high effective liquid chromatography for measuring emodin content, and emodin and other component separating are good.Comprehensive evaluation index with paste-forming rate and emodin is an index, investigates.
3.2.1 the mensuration of paste-forming rate:
The alcohol extract 25ml that precision is measured each orthogonal test number puts in the evaporating dish that is dried to constant weight, behind evaporate to dryness in the water-bath, in 105 ℃ of dry 3h, puts and cools off 30min in the exsiccator, and precision is weighed rapidly, calculates the rate of extract, and the result sees table 2.
3.2.2 emodin content is measured
3.2.2.1 chromatographic condition
VP-ODSC18 post (4.6 * 150m, 10 μ m), mobile phase methanol-0.1% phosphoric acid solution (85: 15) detects wavelength 254nm, and theoretical cam curve is calculated by emodin and is not less than 1500, column temperature: room temperature.Sensitivity: 0.01 AUFS.
3.2.2.2 the preparation of reference substance solution:
Precision takes by weighing emodin reference substance 5mg, places the 50ml volumetric flask, with dissolve with methanol and release, shake up to scale, the reference substance storing solution.Precision is measured emodin storing solution 1ml, places the 10ml volumetric flask, adds methanol and is diluted to scale, promptly gets emodin standard substance (containing 10 μ g emodins among every 1ml).
3.2.2.3 the preparation of need testing solution:
Get the about 1.00g of dried cream powder (1.0025g), accurate claim surely, place the 25ml volumetric flask,, put coldly, add methanol to scale with methanol 20ml supersound extraction 1h; Shake up, filter, essence is got subsequent filtrate 5ml and is put in the flask, flings to solvent, adds 5molL-1 sulfuric acid solution 10ml, supersound process 5min; Add chloroform 10ml again, reflux 1h, cooling moves in the separatory funnel, uses the minimum of chloroform washing container, and adds in the separatory funnel; Obtain chloroform layer, acid solution layer reuse chloroform extraction 3 times, each 10ml, combined chloroform liquid, reclaim under reduced pressure is to doing; Residue adds dissolve with methanol, is transferred in the 10ml volumetric flask, adds methanol to scale, shakes up, and 0.05 μ m microporous filter membrane filters.Get subsequent filtrate, promptly get need testing solution.Lack the Radix Et Rhizoma Rhei negative controls with the method preparation.
3.2.2.4 algoscopy
Get reference substance solution and will inject HPLC, measure, promptly get according to need testing solution and each 10 μ l of negative controls of orthogonal test gained.
3.2.3 comprehensive evaluation index
Comprehensive evaluation index=[(paste-forming rate actual measurement/paste-forming rate maximum * 50%)+(content actual measurement/content maximum * 50%)] * 100
3.2.4 mensuration result
3.2.4.1 the high-efficient liquid phase chromatogram of emodin is shown in Figure 1A, Figure 1B, Fig. 1 C.
3.2.4.2 orthogonal experiment design result and analysis
According to above-mentioned table 1, this experimental design is 4 factors, 3 horizontal quadrature testing programs, selects L9 (34) orthogonal table to make an experiment, and uses algoscopy to detect, and display result, like table 2.
Table 2L9 (34) orthogonal test table
The result of four kinds of factors is carried out variance analysis (D is an error), as shown in table 3.
Table 3 analysis of variance table
F marginal value: F0.01 (1,2)=99 F0.05 (1,2)=19
The results of analysis of variance shows, each factor is A＞C＞B to the order of emodin extraction efficiency influence, extraction time utmost point significant difference; There were significant differences for extraction time, and amount of water does not make significant difference, and optimum extraction process is A3B1C3; Be that extraction time is 3 times, amount of water is 8 times of water, and extraction time is 2h.
4, discuss
Monarch drug in the side is a Radix Et Rhizoma Rhei, is the assay index so select Radix Et Rhizoma Rhei for use, measures emodin content in the medicine.Experiment shows that Radix Et Rhizoma Rhei is 3 times at extraction time, and amount of water is 8 times of water, and extraction time is that extraction effect is best under the condition of 2h.Consider big production various factors, select to add 8 times of water gagings, extract 3 times, each 2h, it is reasonable to draw this research approach, and data are reliable, credible result, the process stabilizing that preferably obtains is feasible.
After extracting the experiment completion, because this test dose is little, but direct drug injection liquid carries out spray drying, obtains powder.Big production dosage is big, is not suitable for spray drying, available other drying meanss, drying meanss such as vacuum drying, microwave drying.
In the effective component extracting process, because that square Chinese crude drug contains stickum such as tannin is few, so can directly adopt normal pressure to filter when filtering, filtering velocity is very fast.Adopt filtration under diminished pressure, when being filter medium with filter paper, filter paper is if be prone to break, and can use 3 layers of gauze instead is filter medium, and this moment, the rate of filtration was very fast, and the filtrating clarification helps the extraction fully of effective ingredient.
Embodiment 2 preparations have the Chinese medicine preparation that protects intestinal detoxicating effect
Prescription is: Radix Et Rhizoma Rhei 9g, Radix Arnebiae (Radix Lithospermi) 9g, Poria 30g, Semen Coicis 30g, Pseudobulbus Bletillae (Rhizoma Bletillae) 15g, Radix Paeoniae Rubra 24g, Radix Scutellariae 15g, Herba Andrographis 12g, catechu 9g, Radix Glycyrrhizae 3g.
Method for preparing is: take by weighing each crude drug, the bag for extracting of packing into adds 8 times of water gagings earlier and soaks 1h, decocts then and extracts 3 times, adds 8 times of water gagings at every turn, extracts 2h at every turn, and merge extractive liquid, is concentrated into relative density 1.05, and spray drying promptly gets.
Prescription is: Radix Et Rhizoma Rhei 9g, Radix Arnebiae (Radix Lithospermi) 9g, Poria 30g, Semen Coicis 30g, Pseudobulbus Bletillae (Rhizoma Bletillae) 15g, Radix Paeoniae Rubra 24g, Radix Scutellariae 15g, Herba Andrographis 12g, catechu 9g, Radix Glycyrrhizae 3g.
Method for preparing is: each crude drug is mixed, add 4 times of water gagings, be heated to water boiling back slow fire boiling 30 minutes, cross and filter filtrating, promptly get.
Embodiment 4 preparations have the Chinese medicine preparation that protects intestinal detoxicating effect
Prescription is: Radix Et Rhizoma Rhei 6g, Radix Arnebiae (Radix Lithospermi) 12g, Poria 25g, Semen Coicis 35g, Pseudobulbus Bletillae (Rhizoma Bletillae) 10g, Radix Paeoniae Rubra 30g, Radix Scutellariae 10g, Herba Andrographis 15g, catechu 6g, Radix Glycyrrhizae 5g.
Method for preparing is: take by weighing each crude drug, the bag for extracting of packing into adds 8 times of water gagings earlier and soaks 1h, decocts then and extracts 3 times, adds 8 times of water gagings at every turn, extracts 2h at every turn, and merge extractive liquid, is concentrated into relative density 1.05, and spray drying promptly gets.
Embodiment 5 preparations have the Chinese medicine preparation that protects intestinal detoxicating effect
Prescription is: Radix Et Rhizoma Rhei 6g, Radix Arnebiae (Radix Lithospermi) 12g, Poria 25g, Semen Coicis 35g, Pseudobulbus Bletillae (Rhizoma Bletillae) 10g, Radix Paeoniae Rubra 30g, Radix Scutellariae 10g, Herba Andrographis 15g, catechu 6g, Radix Glycyrrhizae 5g.
Method for preparing is: each crude drug is mixed, add 5 times of water gagings, be heated to water boiling back slow fire boiling 30 minutes, cross and filter filtrating, promptly get.
Embodiment 6 preparations have the Chinese medicine preparation that protects intestinal detoxicating effect
Prescription is: Radix Et Rhizoma Rhei 12g, Radix Arnebiae (Radix Lithospermi) 6g, Poria 35g, Semen Coicis 25g, Pseudobulbus Bletillae (Rhizoma Bletillae) 20g, Radix Paeoniae Rubra 20g, Radix Scutellariae 20g, Herba Andrographis 10g, catechu 12g, Radix Glycyrrhizae 2g.
Method for preparing is: take by weighing each crude drug, the bag for extracting of packing into adds 8 times of water gagings earlier and soaks 1h, decocts then and extracts 3 times, adds 8 times of water gagings at every turn, extracts 2h at every turn, and merge extractive liquid, is concentrated into relative density 1.05, and spray drying promptly gets.
Embodiment 7 preparations have the Chinese medicine preparation that protects intestinal detoxicating effect
Prescription is: Radix Et Rhizoma Rhei 12g, Radix Arnebiae (Radix Lithospermi) 6g, Poria 35g, Semen Coicis 25g, Pseudobulbus Bletillae (Rhizoma Bletillae) 20g, Radix Paeoniae Rubra 20g, Radix Scutellariae 20g, Herba Andrographis 10g, catechu 12g, Radix Glycyrrhizae 2g.
Method for preparing is: each crude drug is mixed, add 2 times of water gagings, be heated to water boiling back slow fire boiling 30 minutes, cross and filter filtrating, promptly get.
Clinical data one
1 data and method
1.1 whole patient's 60 examples of physical data; Be inpatient between in March, 2005～2008 year December; Etiological examination is hepatitis B, diagnosis with meet " the viral hepatitis diagnostic criteria " that national infectious disease in 2000 and parasitic disease academic Xi'an meeting are revised by stages.Be divided into two groups according to the random digit method: 30 examples are organized in treatment, male 21 examples, women 9 examples, 27～67 years old age, average 47.03 ± 12.22 years old, average course of disease 14.10 ± 6.92 years.Press hepatitis gravis by stages, early stage 21 examples, mid-terms 6 example, late periods 3, example was sent out patient's 16 examples on the chronic hepatitis B basis, sent out patient's 14 examples (Child-Pugh classification: A level 1 example, B level 6 examples, C level 7 examples) on the hbv-liver cirrhosis basis; Matched group 30 examples, male 20 examples, women 10 examples, 25～64 years old age, average 45.50 ± 11.02 years old, average course of disease 14.80 ± 7.99 years.Press hepatitis gravis by stages, early stage 23 examples, mid-terms 5 example, late periods 2, example was sent out patient's 17 examples on the chronic hepatitis B basis, sent out patient's 13 examples (Child-Pugh classification, A level 2 examples, B level 5 examples, C level 6 examples) on the hbv-liver cirrhosis basis.Two groups of sexes, age, the state of an illness, by stages, classification and Chinese medical discrimination typing (noxious water stagnation type, extreme noxious heat and liver-kidney yin deficiency) etc. be through statistical analysis, difference does not have significance (P＞0.05).
1.2 method all adopts conventional Chinese and western medicine Comprehensive Treatment for two groups; Comprise absolute bed rest; Intravenous drip hepatocyte growth-promoting factors, PGE1, reduced glutathion, blood plasma, albumin are kept electrolyte, acid-base balance and dialectical oral conventional Chinese medicine decoction treatment.The treatment group adds Radix Et Rhizoma Rhei detoxifcation soup (embodiment 3 preparations protect intestinal detoxicating soup) on this basis, is condensed into the 100mL enema, retention enema, every day 1 time, 3 weeks of the course of treatment.Matched group adds retention enema in the 70mL normal saline, every day 1 time, 3 weeks of the course of treatment with lactulose 30mL.
2 observed contents, index
2.1 ordinary circumstance: the cardinal symptom before and after the treatment: weak, hypochondriac pain, abdominal distention, poor appetite, nausea and vomiting, oliguria, mind change, bleeding tendency, loose stool or knot etc.; Sign: jaundice, ascites, hemorrhage levy etc.
2.2 blood biochemistry index: alanine aminotransferase (ALT), aspartate amino transferase (AST), STB (TBil), albumin (Alb), globulin (Glb), thrombinogen mobility (PTA), T-CHOL (TC), blood calcium (Ca), endotoxin (ET).
2.3 hepatitis gravis major complications: hepatic encephalopathy, hemorrhage, infection, hepatorenal syndrome etc.
2.4 the ascites situation relatively before and after two groups of treatments: adopt the B ultrasonic location, special messenger's special plane is measured ascites depth capacity under the flat state that crouches.
3 efficacy determinations quantize integration and fill in the observation of curative effect table respectively at carrying out symptom before and after the treatment.Integration method and efficacy determination are formulated with reference to " traditional Chinese medical science disease diagnosis criterion of therapeutical effect " and " the new Chinese medicine clinical research guideline " of version in 2002 of State Administration of Traditional Chinese Medicine's issue.Produce effects: after treatment finishes, transference cure or obviously alleviate, each item index is reduced to normally; Effectively: after treatment finished, remission was not though each item index is recovered normally level improvement before the treatment; Invalid: treatment does not reach above-mentioned standard or dead person after finishing.
4 statistical method results represent with mean ± standard deviation
.Measurement data adopts t check, the relatively employing x of rate
2Check, ranked data adopt Ridit to analyze.
5 results: two groups of patients are good to this research compliance, all do not have after finishing the course of treatment to come off.
5.1 the main biochemical indicator relatively treatment group of two groups of patient treatments after 3 weeks reduce AST, TBil, Glb, rising PTA,
TC, Ca aspect are superior to matched group, and difference has significance (P＜0.05).See table 4.
The table 4 liang main biochemical indicator of group patient treatment after 3 weeks be
relatively
Relatively preceding with treatment, *, P＜0.05, * *, P＜0.01; Compare △, P＜0.05 with matched group
5.2 be respectively 0.161 ± 0.025EU/mL, 0.016 ± 0.042EU/mL before and after the treatment of relatively treatment group of blood endotoxin blood endotoxin before and after two groups of patient treatments, matched group is respectively 0.159 ± 0.028EU/mL, 0.121 ± 0.031EU/mL.Aspect reduction ET, the treatment group is superior to matched group, and difference has significance (P＜0.05).
5.3 be respectively 24.4 ± 3.69mm, 6.1 ± 1.06mm before and after the treatment of relatively treatment group of the ascites situation ascites degree of depth before and after two groups of treatments, matched group is respectively 24.7 ± 3.49mm, 16.0 ± 2.32mm.The treatment group is being superior to matched group aspect the removing ascites, and difference has significance (P＜0.05).
5.4 relatively treatment group of two groups of clinical comprehensive therapeutic effects of patient produce effects 8 examples, effective 14 examples, invalid 5 examples, total effective rate 83.3%; Matched group produce effects 4 examples, effective 14 examples, invalid 12 examples, total effective rate 60.0%.Total effective rate compares, and the treatment group obviously is superior to matched group (P＜0.05).
5.5 the treatment group to hepatitis gravis each reach by stages Chinese medical discrimination typing curative effect relatively and late period relatively, curative effect is with more remarkable (P＜0.05) in early days.Extreme noxious heat, noxious water stagnation type curative effect are obvious, more remarkable with noxious water stagnation type curative effect especially, with liver-kidney yin deficiency relatively, difference has significance (P＜0.05).See table 5, table 6.
Each the curative effect comparison by stages of table 5 treatment group
Compare *, P＜0.05 with late period
Table 6 treatment group Chinese medical discrimination typing curative effect relatively
Compare *, P＜0.05 with liver-kidney yin deficiency
5.6 major complications improves relatively preventing and treating that the treatment group is superior to matched group aspect the hepatic encephalopathy before and after two groups of treatments, difference has significance (P＜0.05).See table 7.
Table 7 a liang group treatment back major complications is improved relatively
Compare △, P＜0.05 with matched group.
5.7 untoward reaction treatment group the loose stool occurs after 2 routine patient's coloclysis are arranged, transference cure behind the adjustment Radix Et Rhizoma Rhei consumption, and crissum pain appears in 1 routine patient, and doing well,improving after anti symptom treatment is not seen other untoward reaction.
6 discuss
In recent years, the relation of hepatopathy and intestinal endotoxemia (IETM) comes into one's own day by day.Great mass of data confirms that hepatic injury is mostly with IETM, and the incidence rate of hepatitis gravis patient IETM can be up to 93.3%.Endotoxin and endotoxin activate the Secondary cases hepatic injury that Kupffer Cell caused, to the development of hepatitis gravis with lapsed to material impact.Therefore, removing intestinal source property endotoxin, blocking-up intestinal endotoxemia is one of essential measure of treatment hepatitis gravis.To the endotoxic treatment of intestinal source property, modern medicine antiendotoxin preparation majority still is in the experimentation stage, drop into clinical practice particularly compatriots can hold the receptor certain distance is still arranged.At present oral lactulose and few antibiotic of intestinal absorption of adopting more, but because its side effect and be prone to cause alteration of intestinal flora is restricting the ageing of clinical practice.
Hepatitis gravis belongs to categories such as Chinese medicine " fulminant jaundice ", " acute jaundice ", and pathogenesis is mainly damp and hot heap soil or fertilizer over and around the roots and contains, disturbs battalion and go into blood, hot and humid ecchymosis runs through that disease takes place, evolution all the time, thereby treatment is when being the main rule of treatment with heat-clearing and toxic substances removing, cooling blood and removing stasis, invigorating spleen to remove dampness.Protect intestinal detoxifcation soup and form, have spleen invigorating bowel relieving, cooling blood and removing stasis Detoxication by medicines such as Radix Et Rhizoma Rhei, Radix Paeoniae Rubra, Poria, Pseudobulbus Bletillae (Rhizoma Bletillae), catechu, Radix Glycyrrhizaes, be for the side of card.After protecting intestinal detoxifcation soup coloclysis, medicine directly acts on colon, and it has protection intestinal barrier, promotes intestinal endotoxin and antibacterial etc. to excrete, and alleviates the effects such as hepatic injury due to cytokine and other inflammatory mediators.Modern study shows: colon administration; The absorption total amount of its medicine, infiltration rate, bioavailability all obviously improve than oral administration; Simultaneously, colon administration not only makes the effective ingredient of medicine be difficult for being destroyed by Digestive system, and can make the medicine sick institute that goes directly; Be a kind of Therapeutic Method, have vast potential for future development with higher use value; Simultaneously, medicine can absorb the back through colon and get into the body circulation, has both avoided the bitter cold medicine to injure gastric qi, can bring into play the endotoxic effect of whole body of removing again.Through above-mentioned approach, alleviate the damage of endotoxin to liver, reduce the generation of complication.In addition, hepatitis gravis is many with gastrointestinal dysfunction, alteration of intestinal flora, and pathogenic bacterium grow in a large number, are prone to accompanying infection; The inflammatory reaction that excites because of infection can increase the weight of hepatic injury again, forms vicious cycle, becomes the key factor that influences the hepatitis gravis prognosis.The control of many at present conventional application antibiotic is infected, but antibiotic being applied in when killing pathogenic bacterium can cause that endotoxin discharges in a short time in a large number, thus the generation of aggravation hepatic injury, the various complication of promotion.This research confirms to protect intestinal detoxifcation soup coloclysis can directly remove pathogenic bacterium, endotoxin, avoids the untoward reaction of application of antibiotics, control is infected have better curative effect.
This research shows; On the basis of Chinese and western medicine Comprehensive Treatment, give Radix Et Rhizoma Rhei detoxifcation soup coloclysis and can reduce chronic type b hepatitis gravis ET, AST, TBil, Glb significantly; Improve PTA and TC, alleviate the liver inflammatory reaction, promote complex functionality to recover; Thereby reduce the generation of various complication, reduce mortality rate.Based on protect intestinal detoxifcation soup coloclysis curative effect with hepatitis gravis early, mid-term and Chinese medical discrimination belong to the noxious water person of penting up determined curative effect; And satisfied inadequately to late period and liver-kidney yin deficiency, we think when filtering out the best pattern of syndrome patient who is fit to this therapy and intervening in early days to improve curative effect.Because of receive sample size, patient to the compliance of enema treatment and the direct site of action of medicinal liquid limitation etc. influence; Be necessary that from now on further enlarged sample amount, improvement pharmaceutical dosage form and administering mode are to enlarge the drug effect position, to improve patient's compliance, in the hope of further improving clinical efficacy.
Clinical data two colon targeting drug administrations are removed chronic virus b hepatopathy endotoxin clinical research data and method
1, case is selected
1.1 diagnostic criteria:
1.1.1 Western medicine diagnose standard:
Unite the diagnostic criteria of " viral hepatitis is prevented and treated scheme " of revision with reference to Xi'an in 2000 whole nation infectious disease and parasitic disease credit meeting, hepatopathy credit meeting, meet B virus hepatopathy, dynamic turbidimetric plasma endotoxin＞0.03EU/mL person.
1.1.2 tcm diagnosis standard:
With reference to " liver cirrhosis clinical diagnosis, Chinese medical discrimination and the efficacy assessment standard " passed through discussion on the 5th seminar that in May, 2004, China Association of Traditional Chinese Medicine's internal medicine branch held in Luoyang in " the viral hepatitis Chinese medical discrimination standard " of Yichang revision, digestive system disease Professional Committee of CAIM in November, 1993.
1.2 the standard of including in
1.2.1 meet the traditional Chinese medical science and Western medicine diagnose standard, the dynamic turbidimetric plasma endotoxin＞0.03EU/mL and the person that signs the Informed Consent Form.
1.2.2 age>=16 year old ,≤70 years old.
1.3 exclusion standard
1.3.1 do not meet the above-mentioned standard person of including in
1.3.2 by the hepatopathy due to the factors such as drug intoxication, alcoholism.
1.3.3 be associated with serious cardiovascular and cerebrovascular vessel, lung, kidney, endocrine, hemopoietic system protopathy patient, and psychiatric patient
1.3.4. trimester of pregnancy, women breast-feeding their children.
1.4 the rejecting of case and the standard that comes off:
1.4.1 include the case that the standard of including in is found not meet in the back in.
1.4.2 experimenter's compliance is poor, by the regulation medication, can't not judge curative effect, or the not congruent judgement person that affects the treatment of data.
1.4.3 come off, lose visit person naturally in observing.
1.4.4 severely adverse event, complication take place or special physiologicals such as this medicine allergy are changed the person that should not continue the reception test.
1.4.5 bolter etc. voluntarily.
2, research method
2.1 Therapeutic Method
Selection meets chronic virus b hepatopathy intestinal endotoxemia patient 141 examples of including the case standard in, is divided into matched group at random, orally protects intestinal detoxicating micropill group, protects intestinal detoxicating soup colon instillation group, oral lactulose group.Wherein, protecting intestinal detoxicating micropill group and lactulose group is that the double blinding dual analog contrasts grouping at random.
Matched group is taken reduced glutathion (400mg/ time, 3 times/day).
Protect intestinal detoxicating micropill group, lactulose group oral intestinal detoxicating micropill, the lactulose micropill of protecting on the basis of matched group, the two is the design of double blinding dual analog, each 1.5 grams, every day three times.
Protect intestinal detoxicating soup group and on the matched group basis, add and protect the retention enema of intestinal detoxicating soup colon instillation, each I00ml, once a day.
The said intestinal detoxicating micropill that protects prepares through following method:
(1) preparation of medicated powder: be the embodiment 2 prepared medicated powder that obtain.
(2) preparation of calcium pectinate: get low fat pectin 500g, fully grind, slowly add the 2L deionized water, mixing.Other gets 21.71g calcium chloride and is dissolved in the 2L deionized water, slowly pours in the low fat pectin solution, is stirred to mix homogeneously, processes the translucent gels shape.24h is soaked in sealing, and it is fully soaked into.Taking-up is shakeout in 40 ℃ of dry 48h, to doing.The one-tenth quality that obtains is crisp, and first coarse powder takes out micronizing and processes powder, and is subsequent use.
(3) preparation of micropill: medicated powder and microcrystalline Cellulose are pressed mass ratio mix at 1: 2,75% binding agent 55% ethanol (volume fraction) that adds medicated powder and microcrystalline Cellulose gross mass is processed soft material, through extrude-spheronizator extrudes the close slick strip soft material of matter; After high speed is round as a ball the strip soft material is interrupted; Through the piller of long-time round as a ball gained, promptly get fine pellet core after the drying (because of binding agent is 55% ethanol, after the micropill drying; Ethanol is not present in the micropill moisture＜9% through volatilization).
(4) coating preparation: get calcium pectinate (8g) and add water (100ml) porphyrize formation suspension adding EudragitL30D2.5% in colloid mill, phthalic acid ester and sorbester p17 (each 0.5%), mix homogeneously is processed colon coating solution.Stir 24h, to dissolving fully.Fluid bed is preheated to more than 35 ℃, adds fine pellet core (15g), regulates wind speed to all being kept in motion preheating 5min.Open peristaltic pump and spray into coating solution, carry out coating.To coating weightening finish 35%, both got micropill.
Said lactulose micropill obtains through following method for preparing: lactulose and microcrystalline Cellulose are pressed mass ratio mixing in 1: 2; The binding agent (55% ethanol) of adding 75% is processed soft material; Through extrude-spheronizator extrudes the close slick strip soft material of matter, after high speed is round as a ball the strip soft material interrupted, through the piller of long-time round as a ball gained; Promptly get the lactulose micropill after the drying; Do not contain ethanol after the drying, its preparation method is similar with the method for preparing of protecting intestinal detoxicating micropill, and other conventional system micropill method and adjuvant also can use.
Said (embodiment 3 raw materials used survival doses are one day dosage) of protecting intestinal detoxicating soup for embodiment 3 preparations.
Each inspection of index of correlation once is 20 days the course of treatment before and after four groups of treatments.
2.2 observation index
2.2.1 safety indexes: three big routines, electrocardiogram, hepatic and renal function.Each inspection once before and after the treatment.
2.2.2 health giving quality index: plasma endotoxin, liver function (ALT, AST, TBIL, ALB, GLO), TNF-α, IL-6, IL-8, PTA, each inspection once before and after the treatment.
2.3 endotoxin test experience Standard Operating Procedure
Endotoxin adopts dynamic turbidimetric to detect, and detects with BET-24A bacterial endotoxin quantitative analysis instrument, and test kit is available from Zhanjiang Bo Kang marine organisms company limited.
1. 1.0ml vein whole blood+1.0ml I treatment fluid mixes centrifugal 5 minutes (3200 rev/mins, the time, rather few affair was many), processes 2 times of liquid a;
2. the supernatant water bath with thermostatic control among the 0.6ml a 6 minutes (75～80 degree) need not to wait cooling, directly adds 0.6ml II treatment fluid and mixes; Seal with sealing film, outstanding mixing after 15 seconds, centrifugal 6 minutes (4200 rev/mins; Must reach 4200 changes, otherwise albumen is difficult for centrifugally getting off), process 4 times of liquid b;
3. the supernatant among the 0.4ml b+0.4ml endotoxin detects the water mixing, and eddy mixer mixed for 15 seconds, processed 8 times of liquid c;
4. detect with water dissolution TAL (must add immediately after the TAL uncork to detect and use water dissolution, otherwise TAL general inactivation very soon) with the 0.1ml endotoxin, with hand rolling mixing 10 seconds; (amplitude of rocking is not big, does not produce air pocket, otherwise TAL is hung on bottle wall; Liquid level that like this can rising solution in the process at the bottom of it slowly flows to bottle increases the volume of solution, changes the transmittance of solution; Then influence the result) dissolving can leave standstill that to add liquid to be measured about 1 minute better behind the TAL, add behind the water TAL solution not in air standing time surpass 3 minutes, add c liquid 0.2ml (if c liquid is above 1 minute standing time; Suggestion will mix them 3 seconds on blender) rock 10 seconds of mixing with the hands level, the amplitude of rocking is not big, otherwise TAL is hung on bottle wall; Liquid level that like this can rising solution in the process at the bottom of it slowly flows to bottle; Increase the volume of solution, change the transmittance of solution, influence the result then.(will check whether bubble is arranged in the bottle before going up machine, generally speaking, diameter is no more than 1 millimeter bubble and can impact the result; Bubble is bigger, bigger mistake value will occur)
5. go up machine testing.
2.4 retention-enema treatment Standard Operating Procedure
Patient's preparation: treatment forward direction patient specifies the purpose and the necessity of receiving treatment, and obtains patient and cooperates.Advise the preceding emptying defecation of patient's coloclysis, clean crissum, the clinostatism of going down on one's knees on the left of getting, bed hedgehopping buttocks 10cm appears anus.
Operation:
1. the coloclysis time was advisable before sleeping with patient night.Medicinal liquid is heated to 39 ℃～40 ℃ during application.
2. the patient gets disposable polyethylene (PE) plastic glove, gets one of disposable general infusion set, and exhaustor and tube for transfusion are inserted the vial bottle stopper that disinfectant fills the coloclysis medicinal liquid, prevents to come off with the immobilization with adhesive tape bottle stopper.Medicinal liquid is gone out along pipe flow, and vent gas is closed infusion regulator, removes the front end sword-shaped needle, connects a disposal sputum collecting cannula, with about the lubricated sputum aspirator tube front end 20cm of liquid paraffin.
3. advise patient air-breathing deeply, with the soft patient's anus that slowly inserts of sputum aspirator tube, feel without hindrance sense, the about 20cm of insertion depth.
4. open infusion regulator, regulating medicine liquid droplet speed is about 50 droplets/minute.In the drip irrigation process, patient's left lateral position.
5. coloclysis finishes slowly tube drawing of back, with the cleaning gauze gently by rubbing anus 3 minutes, advise the patient get left lateral position at least 30min retain absorption in order to medicine.
6. 1-2 hour effect of medicinal liquid reservation is better after the coloclysis, and it is good to keep a Night Watch.
3, efficacy assessment standard
3.1 comprehensive therapeutic effect
Reference in JIUYUE, 2000 China medical association's infectious disease unites revision " viral hepatitis is prevented and treated scheme " with parasitic disease credit meeting, the Xi'an meeting of hepatopathy association and " the clinical research guideline of Chinese new drug treatment chronic hepatitis " (Ministry of Public Health bureau of drug administration volume) formulated.
1. produce effects: subjective symptoms disappears basically, and tcm syndrome therapeutic index N >=70%, liver function each item abnormal index descend 70% or multiple normal before the treatment.
2. effective: tcm syndrome therapeutic index N >=30%, liver function each item abnormal index descend 30% or multiple normal before the treatment.
3. invalid: do not reach above-mentioned standard person after finishing the course of treatment.
3.2 endotoxin criterion of therapeutical effect
1. produce effects: plasma endotoxin treatment back descends >=70% before the treatment.
2. effective: plasma endotoxin treatment back descends >=30% before the treatment.
3. invalid: after finishing the course of treatment, the index variation does not reach above standard person.
3.3 chronic virus b hepatopathy curative effect determinate standard
1. produce effects: the biochemical abnormal index of each item improves >=70%.
2. effective: the biochemical abnormal index of each item improves >=30%.
3. invalid: the index variation does not reach above standard or sb.'s illness took a turn for the worse and dead person.
3.4 tcm syndrome curative effect determinate standard (formulating) with reference to new Chinese medicine clinical research guideline in 2002
Computational methods: computing formula (nimodipine method): [integration before (integration before the treatment-treatment back integration) * treatment]/100%.
1. produce effects: symptom, sign are obviously improved, and the syndrome integration reduces >=70%.
2. effective: symptom, Signs all take a favorable turn, and the syndrome integration reduces >=30%.
3. invalid: symptom, sign all do not have obvious improvement, even increase the weight of, the syndrome integration reduces less than 30%.
3.5 cardinal symptom curative effect determinate standard
1. produce effects: after treatment finished, symptom integral reduced by 2 minutes or transference cure.
2. effective: after treatment finished, symptom integral reduced 1 fen.
3. invalid: as not reach above-mentioned standard person
4, statistical analysis
With all data input computers, handle through the SPSS13.0 statistical software.Measurement data adopts mean ± standard deviation, the relatively employing variance analysis of many batch totals amount data, and two batch total amount data relatively adopt the t check, the relatively employing X2 check of rate.
(3) experimental result
1, compares before the treatment
Sex, the hepatitis B course of disease, lesion degree, plasma endotoxin, inflammatory cytokine, liver function, the relatively more equal no difference of science of statistics of PTA have comparability before four groups of patient treatments of table 8-table 15 explanation.
Four groups of sex composition ratios of table 8
Annotate: treat preceding four groups and suffer from sex composition, have comparability through statistical procedures there was no significant difference (P＞0.05).
Four groups of hepatitis B courses of disease of table 9 distribute
Annotate: treat preceding four groups of patient's hepatitis B courses of disease and distribute, have comparability through statistical procedures there was no significant difference (P＞0.05).
The state of an illness distributes before four groups of treatments of table 10
Annotate: treat preceding four groups of conditions of patients and distribute, have comparability through statistical procedures there was no significant difference (P＞0.05).
Plasma endotoxin relatively before table 11 treatment
Annotate: treat preceding four groups of patient's plasma endotoxin levels through statistical procedures there was no significant difference (P＞0.05), have comparability.
Inflammatory cytokine relatively before table 12 treatment
Annotate: treat preceding four groups of patient TNF-α, IL-6, IL-8 through statistical procedures there was no significant difference (P＞0.05), have comparability.
Liver function relatively before table 13 treatment
Annotate: treat preceding four groups of patient's liver functions through statistical procedures there was no significant difference (P＞0.05), have comparability.
PTA relatively before table 14 treatment
Annotate: treat preceding four groups of patient PTA statistical procedures there was no significant differences (P＞0.05), have comparability.
2, comprehensive therapeutic effect
2.1 total effective rate
Table 15 total effective rate
Annotate: compare with matched group: ☆ P＜0.05, ☆ ☆ P＜0.01; With protect intestinal detoxicating soup group relatively: △ P＜0.05, △ △ P＜0.01; Compare with the lactulose group: ▲ P＜0.05, ▲ ▲＜0.01;
Table 15 shows that liver function and clinical symptoms are all obviously improved behind four groups of patient treatments.Protect intestinal detoxicating micropill group, protect intestinal detoxicating soup group, lactulose group curative effect all is superior to matched group, P＜0.05.Protect intestinal detoxicating micropill group, protect intestinal detoxicating soup group effective percentage and obvious effective rate is higher than the lactulose group, three groups of curative effects are no difference of science of statistics relatively, P＞0.05.
The effects that all have the effective patient's of improvement liver function and clinical symptoms after four groups of treatments are described, but on the basis of dialectical Chinese medicine compound, add with protect intestinal detoxicating micropill, protect intestinal detoxicating soup, the lactulose treatment curative effect is better.Spleen invigorating transfers intestinal, the treatment of dissolving blood stasis and detoxication method than lactulose treatment certain advantage to be arranged.
2.2 remove the plasma endotoxin curative effect
Table 16 treatment back endotoxin effective percentage
Annotate: compare with matched group: ☆ ☆ P＜0.01; With protect intestinal detoxicating micropill group relatively: △ P＜0.05; With protect intestinal detoxicating soup group comparison ▲ P＜0.05
Each organizes interior plasma endotoxin relatively (EU/mL) before and after table 17 treatment
Annotate: compare in each is organized with before the treatment: ☆ P＜0.05, ☆ ☆ P＜0.01
Plasma endotoxin compares (EU/mL) between the group of table 18 treatment back
Annotate: compare with matched group: ☆ P＜0.05, ☆ ☆ P＜0.01; With protect intestinal detoxicating soup group relatively: △ P＜0.05, △ △ P＜0.01; Compare with the lactulose group: ▲ P＜0.05, ▲ ▲＜0.01;
Last table shows, the horizontal no difference of science of statistics of plasma endotoxin before four groups of patient treatments, and P＞0.05 has comparability.Treatment back matched group plasma endotoxin level descends before the treatment to some extent, but no difference of science of statistics, P＞0.05.Protect intestinal detoxicating micropill group, protect intestinal detoxicating soup group, all obviously decline before the treatment of lactulose group treatment back plasma endotoxin, P＜0.01.Three groups are reduced the plasma endotoxin curative effect and all significantly are superior to matched group, P＜0.01.Protect intestinal detoxicating micropill group, the lactulose group all is superior to protecting intestinal detoxicating soup group, P＜0.01.Protect intestinal detoxicating micropill group curative effect and be superior to the lactulose group, but no difference of science of statistics, P＞0.05.
Explain that it is the effective ways of removing the chb intestinal endotoxemia that intestinal, eliminating damp, detoxifying, activating blood and removing stasis Method colon administration are protected in spleen invigorating.After changing dosage form, realized protecting the high-order segmented intestine targeted disintegrate of intestinal detoxicating micropill and improved the purpose of removing the intestinal endotoxemia clinical efficacy.
2.3 cytokine (TNF-a, IL-6, IL-8) improvement situation
Table 19-table 21 explains that the treatment back matched group preceding inflammatory cytokine of treatment descends to some extent, but not statistically significant.Protect intestinal detoxicating soup group, lactulose group, protect the release that intestinal detoxicating micropill group all can significantly reduce inflammatory cytokine.
The interior TNF-α of each group relatively before and after table 19 treatment
Annotate: compare in each is organized with before the treatment: ☆ P＜0.05, ☆ ☆ P＜0.01.
The interior IL-6 of each group relatively before and after table 20 treatment
Annotate: compare in each is organized with before the treatment: ☆ P＜0.05, ☆ ☆ P＜0.01.
The interior IL-8 of each group relatively before and after table 21 treatment
Annotate: compare in each is organized with before the treatment: ☆ P＜0.05, ☆ ☆ P＜0.01.
TNF-α, IL-6, IL-8 are relatively between the group of table 22 treatment back
Annotate: compare with matched group: ☆ P＜0.05, ☆ ☆ P＜0.01; With protect intestinal detoxicating soup group relatively: △ P＜0.05, △ △ P＜0.01; Compare with the lactulose group: ▲ P＜0.05, ▲ ▲＜0.01;
Table 22 explanation is protected intestinal detoxicating micropill curative effect to the influence of inflammatory factor and all significantly is superior to its excess-three group, and the matched group influence is minimum, no difference of science of statistics.Protect intestinal detoxicating soup group the influence of TNF-α, IL-8 is superior to the lactulose group, and to the two groups of therapeutic equivalences that influence of IL-6.
2.4 liver function is improved situation
The interior ALT of each group, AST are relatively before and after table 23 treatment
Annotate: compare in each is organized with before the treatment: ☆ P＜0.05, ☆ ☆ P＜0.01.
The interior TBIL (umol/l) of each group relatively before and after table 24 treatment
Annotate: compare in each is organized with before the treatment: ☆ P＜0.05, ☆ ☆ P＜0.0
The interior ALB of each group, GLO (g/L) are relatively before and after table 25 treatment
Annotate: compare in each is organized with before the treatment: ☆ P＜0.05, ☆ ☆ P＜0.01.
Explain that protect intestinal detoxicating micropill group after the treatment, protect intestinal detoxicating soup group liver function and significantly improve, control group A ST, ALT obviously descend (P＜0.05), TBIL, ALB, GLO also make moderate progress, but not statistically significant.The lactulose group is to AST, ALT, TBIL, GLO determined curative effect, but not obvious to height ALB effect.
Liver function relatively between the group of table 26 treatment back
Annotate: compare with matched group: ☆ P＜0.05, ☆ ☆ P＜0.01; With protect intestinal detoxicating soup group relatively: △ P＜0.05, △ △ P＜0.01; Compare with the lactulose group: ▲ P＜0.05, ▲ ▲＜0.01;
Explain that protecting intestinal detoxicating micropill group liver function each item index improves and all to be superior to matched group, to protect intestinal detoxicating soup group, but with protect intestinal detoxicating soup group not statistically significant, the curative effect of improving of ALT, GLO, ALB obviously is superior to lactulose group (P＜0.05); Protect intestinal detoxicating soup group ALT fall and be superior to the lactulose group, all the other each item index curative effects are suitable with the lactulose group.
2.5PTA improvement situation
Table 27PTA (%) improvement situation
Annotate: PTA (%)＜80% is unusual.Compare with matched group: ☆ P＜0.05, ☆ ☆ P＜0.01; Compare with the lactulose group: ▲ P＜0.05, ▲ ▲＜0.01;
PTA can reflect the liver complex functionality, is the important indicator of judging the state of an illness and prognosis.Table 27 shows that the treatment back is protected intestinal detoxicating micropill group PTA for four groups and all significantly raise (P＜0.01) than lactulose group, matched group, more also makes moderate progress with protecting intestinal detoxicating soup group, but no difference of science of statistics.Protect intestinal detoxicating soup group and obviously improve, but compare no difference of science of statistics with the lactulose group than matched group, lactulose PTA.
2.6 tcm symptom curative effect
Table 28 tcm symptom integration improves situation
Annotate: each compares 00 P＜0.01 before and after organizing internal therapy; Compare with matched group: ☆ P＜0.05, ☆ ☆ P＜0.01; With protect intestinal detoxicating soup group relatively: △ P＜0.05, △ △ P＜0.01; Compare with the lactulose group: ▲ P＜0.05, ▲ ▲＜0.01;
Table 28 shows, tcm symptom integration no difference of science of statistics before four groups of patient treatments, P＞0.05.The four groups of patient's tcm symptom integrations in treatment back are all than obviously descending P＜0.01 before the treatment.Protect intestinal detoxicating micropill group, protect intestinal detoxicating soup group lactulose group matched group P＜0.01 that is superior to evident in efficacy; Matched group descends than lactulose curative effect integration to some extent, but no difference of science of statistics, P＞0.05.Protect that intestinal detoxicating micropill group is evident in efficacy to be superior to protecting intestinal detoxicating soup group, lactulose group.
Four groups of all obviously improvement of treatment back symptoms are described, but spleen invigorating transfers intestinal, promoting blood circulation and detoxication method can more effectively improve patient's symptom.
Table 29 tcm symptom curative effect
Annotate: with matched group ☆ ☆ P＜0.01 relatively, and protect relatively △ △ P＜0.01 of intestinal detoxicating micropill group, with protect intestinal detoxicating soup group relatively ▲ ▲ P＜0.01.
Last table shows that four groups of patient's symptoms all have clear improvement.Protect intestinal detoxicating micropill group, protect intestinal detoxicating soup group curative effect and be superior to matched group and lactulose group, P＜0.01.Curative effect compares no difference of science of statistics, P＞0.05 between matched group, lactulose group group.Protect intestinal detoxicating micropill group and protect curative effect comparison no difference of science of statistics between intestinal detoxicating soup group group, P＞0.05.
Four groups of all obviously improvement of treatment back symptoms are described, but are cooperated spleen invigorating to transfer intestinal, promoting blood circulation and detoxication method colon administration can more effectively improve patient's symptom.
2.7 cardinal symptom is improved situation before and after the treatment
Table 30 jaundice is improved situation
Annotate: protect intestinal detoxicating micropill group after the treatment, protect intestinal detoxicating soup group, lactulose group and matched group comparison, ☆ P＜0.05.
Last table shows that the four groups of patient's jaundice symptoms in treatment back are all than having clear improvement before the treatment.Protect intestinal detoxicating micropill group, protect intestinal detoxicating soup group, the lactulose group is improved the jaundice symptom curative effect and all is superior to matched group P＜0.05.Protect intestinal detoxicating micropill group, protect curative effect comparison no difference of science of statistics between intestinal detoxicating soup group, lactulose group group, P＞0.05.
Explain that four groups of treatment back jaundice symptoms all obviously improve, but on the basis of dialectical Chinese medicine compound, add with protect intestinal detoxicating micropill, protect intestinal detoxicating soup, the lactulose curative effect is better.
The fidgety irritability of table 31 is improved situation
Annotate: with matched group ☆ P＜0.05 relatively, and protect relatively △ P＜0.05 of intestinal detoxicating micropill group, with clyster group comparison ▲ P＜0.05.
Last table shows that the four groups of fidgety irritability symptoms of patient in treatment back are all than having clear improvement before the treatment.Protect intestinal detoxicating micropill group, protect intestinal detoxicating soup group and improve fidgety irritability symptom curative effect and be superior to matched group, lactulose group (P＜0.05).Curative effect compares no difference of science of statistics (P＞0.05) between matched group and lactulose group group.Protect intestinal detoxicating micropill group and protect curative effect comparison no difference of science of statistics (P＞0.05) between intestinal detoxicating soup group group.
Four groups of all obviously improvement of the fidgety irritability symptoms in treatment back are described, but spleen invigorating transfers intestinal, promoting blood circulation and detoxication method can more effectively improve the fidgety irritability symptom of patient.
Table 32 abdominal distention is improved situation
Annotate: protect intestinal detoxicating micropill group after the treatment, protect intestinal detoxicating soup group, lactulose group and matched group comparison, ☆ ☆ P＜0.05.
Last table shows that the four groups of patient's abdominal distention symptoms in treatment back are all than having clear improvement before the treatment.Protect intestinal detoxicating micropill group, protect intestinal detoxicating soup group, the lactulose group improves abdominal distention symptom curative effect and all is superior to matched group (P＜0.05).Protect intestinal detoxicating micropill group, protect curative effect comparison no difference of science of statistics (P＞0.05) between intestinal detoxicating soup group, lactulose group group.
Explain that four groups of treatment back abdominal distention symptoms all obviously improve, but on the basis of dialectical Chinese medicine compound, add with protect intestinal detoxicating micropill, protect intestinal detoxicating soup, the lactulose curative effect is better.
Table 33 bitter taste is improved situation
Annotate: with matched group ☆ P＜0.05 relatively, and protect intestinal detoxicating micropill group △ P＜0.05, and protect intestinal detoxicating soup group comparison ▲ P＜0.05.
Last table shows that the four groups of patient's bitter taste symptoms in treatment back are all than having clear improvement before the treatment.Protect intestinal detoxicating micropill group, protect intestinal detoxicating soup group and improve the bitter taste curative effect and be superior to matched group, lactulose group (P＜0.05).Curative effect compares no difference of science of statistics (P＞0.05) between matched group and lactulose group group.Protect intestinal detoxicating micropill group and protect curative effect comparison no difference of science of statistics (P＞0.05) between intestinal detoxicating soup group group.
Four groups of all obviously improvement of treatment back bitter taste symptoms are described, but are cooperated spleen invigorating to transfer intestinal, promoting blood circulation and detoxication method colon administration can more effectively improve patient's bitter taste symptom.
Table 34 stool abnormity improves situation
Annotate: treatment back and matched group ☆ ☆ P＜0.01, and protect relatively △ P＜0.05 of intestinal detoxicating micropill group, and protect intestinal detoxicating soup group comparison ▲ P＜0.05.
Last table shows that the four groups of patient's stool abnormities in treatment back are all than having clear improvement before the treatment.Protect intestinal detoxicating micropill group, protect intestinal detoxicating soup group and improve the stool abnormity curative effect and be superior to matched group (P＜0.01), lactulose group (P＜0.05).Curative effect compares no difference of science of statistics, P＞0.05 between matched group and lactulose group group.Protect intestinal detoxicating micropill group and protect curative effect comparison no difference of science of statistics (P＞0.05) between intestinal detoxicating soup group group.
Explain that four groups of treatment back stool abnormities all obviously improve, but cooperate spleen invigorating to transfer intestinal, promoting blood circulation and detoxication method colon administration can more effectively improve patient's stool abnormity symptom.
Table 35 pain over the hypochondriac region is improved situation
Annotate: treatment back and matched group ☆ ☆ P＜0.01, and protect relatively △ P＜0.05 of intestinal detoxicating micropill group, and protect intestinal detoxicating soup group comparison ▲ P＜0.05.
Last table shows that the four groups of patient's pain over the hypochondriac regions in treatment back are all than having clear improvement before the treatment.Protect intestinal detoxicating micropill group, protect intestinal detoxicating soup group and improve pain over the hypochondriac region curative effect and be superior to matched group, lactulose group, P＜0.01, P＜0.05.Curative effect compares no difference of science of statistics, P＞0.05 between matched group and lactulose group group.Protect intestinal detoxicating micropill group and protect curative effect comparison no difference of science of statistics between intestinal detoxicating soup group group, P＞0.05.
Four groups of all obviously improvement of the treatment back pain over the hypochondriac regions are described, but are cooperated spleen invigorating to transfer intestinal, promoting blood circulation and detoxication method colon administration can more effectively improve patient's pain over the hypochondriac region symptom.
The weak improvement situation of table 36
Annotate: treatment back and matched group ☆ P＜0.05, and protect relatively △ P＜0.05 of intestinal detoxicating micropill group, and protect intestinal detoxicating soup group comparison ▲ P＜0.05
Last table shows that the four groups of weak symptoms of patient in treatment back are all than having clear improvement before the treatment.Protect intestinal detoxicating micropill group and protect intestinal detoxicating soup group and improve weak curative effect and be superior to matched group and lactulose group, P＜0.05.Curative effect compares no difference of science of statistics, P＞0.05 between matched group and lactulose group group.Protect intestinal detoxicating micropill group and protect curative effect comparison no difference of science of statistics between intestinal detoxicating soup group group, P＞0.05.
Four groups of all obviously improvement of the weak symptoms in treatment back are described, but are cooperated spleen invigorating to transfer intestinal, promoting blood circulation and detoxication method method colon administration can more effectively improve the weak symptom of patient.
Table 37 poor appetite improves situation
Annotate: with matched group ☆ ☆ P＜0.01, and protect relatively △ P＜0.05 of intestinal detoxicating micropill group, and protect intestinal detoxicating soup group comparison ▲ P＜0.05.
Last table shows that the four groups of patient's poor appetite symptoms in treatment back are all than having clear improvement before the treatment.Protect intestinal detoxicating micropill group, protect intestinal detoxicating soup group and improve curative effect and be superior to matched group, lactulose group, P＜0.01, P＜0.05.Curative effect compares no difference of science of statistics, P＞0.05 between matched group and lactulose group group.Protect intestinal detoxicating micropill group and protect curative effect comparison no difference of science of statistics between intestinal detoxicating soup group group, P＞0.05.
Explain that four groups of treatment back poor appetite symptoms all obviously improve, can more effectively improve patient's poor appetite symptom but cooperate spleen invigorating to protect intestinal, eliminating damp, detoxifying, activating blood and removing stasis Method colon administration.
Claims (10)
1. one kind has the Chinese medicine preparation that protects intestinal detoxicating effect, it is characterized in that: comprise following bulk drugs: 6～12 parts of Radix Et Rhizoma Rhei, 6～12 parts of Radix Arnebiae (Radix Lithospermi)s; 25～35 parts in Poria, 25～35 parts of Semen Coiciss, 10～20 parts of Pseudobulbus Bletillae (Rhizoma Bletillae); 20～30 parts of Radix Paeoniae Rubra, 10～20 parts of Radix Scutellariaes, 10～15 parts of Herba Andrographis; 6～12 parts in catechu, 2～5 parts in Radix Glycyrrhizae.
2. a kind of Chinese medicine preparation that protects intestinal detoxicating effect that has according to claim 1 is characterized in that: processed by following bulk drugs: 9 parts of Radix Et Rhizoma Rhei, 9 parts of Radix Arnebiae (Radix Lithospermi)s; 30 parts in Poria, 30 parts of Semen Coiciss, 15 parts of Pseudobulbus Bletillae (Rhizoma Bletillae); 24 parts of Radix Paeoniae Rubra, 15 parts of Radix Scutellariaes, 12 parts of Herba Andrographis; 9 parts in catechu, 3 parts in Radix Glycyrrhizae.
3. a kind of Chinese medicine preparation that protects intestinal detoxicating effect that has according to claim 1 and 2 is characterized in that: obtain through following method for preparing: take by weighing each crude drug, the bag for extracting of packing into; Add 8～12 times of water gagings and soak 1～2h; Decoct then and extract 1～2h, cross and filter extracting solution, be concentrated into relative density 1.02～1.05; Spray drying promptly gets.
4. a kind of Chinese medicine preparation that protects intestinal detoxicating effect that has according to claim 3; It is characterized in that: after said decoction is extracted, filtered, in medicinal residues, add 8～12 times of water gagings again and decoct and extract 1～2h, repeat this step 1～2 time; Merge each extracting solution; Be concentrated into relative density 1.02～1.05, spray drying promptly gets.
5. a kind of Chinese medicine preparation that protects intestinal detoxicating effect that has according to claim 3 is characterized in that: take by weighing each crude drug, the bag for extracting of packing into; Add 8 times of water gagings earlier and soak 1h, decoct then and extract 3 times, add 8 times of water gagings at every turn; Each 2h that extracts, merge extractive liquid, is concentrated into relative density 1.02～1.05; Spray drying promptly gets.
6. a kind of Chinese medicine preparation that protects intestinal detoxicating effect that has according to claim 1 and 2; It is characterized in that: obtain: each crude drug is mixed, add 2～5 times of water gagings, be heated to water boiling back slow fire boiling 30 minutes through following method for preparing; Cross and filter filtrating, promptly get.
7. claim 1 or 2 described a kind of method for preparinies with the Chinese medicine preparation that protects intestinal detoxicating effect is characterized in that: take by weighing each crude drug, the bag for extracting of packing into; Add 8～12 times of water gagings and soak 1～2h; Decoct then and extract 1～2h, cross and filter extracting solution, be concentrated into relative density 1.02～1.05; Spray drying promptly gets.
8. method for preparing according to claim 7 is characterized in that: after said decoction is extracted, filtered, in medicinal residues, add 8～12 times of water gagings again and decoct extraction 1～2h; Repeat this step 1～2 time, merge each extracting solution, be concentrated into relative density 1.02～1.05; Spray drying promptly gets.
9. method for preparing according to claim 7 is characterized in that: take by weighing each crude drug, the bag for extracting of packing into adds 8 times of water gagings earlier and soaks 1h; Decoct then and extract 3 times, add 8 times of water gagings at every turn, extract 2h, merge extractive liquid, at every turn; Be concentrated into relative density 1.02～1.05, spray drying promptly gets.
10. claim 1 or 2 described a kind of method for preparinies with the Chinese medicine preparation that protects intestinal detoxicating effect is characterized in that:
Each crude drug is mixed, add 2～5 times of water gagings, be heated to water boiling back slow fire boiling 30 minutes, cross and filter filtrating, promptly get.
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