CN102362993B - 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
- Publication number
- CN102362993B CN102362993B CN 201110382533 CN201110382533A CN102362993B CN 102362993 B CN102362993 B CN 102362993B CN 201110382533 CN201110382533 CN 201110382533 CN 201110382533 A CN201110382533 A CN 201110382533A CN 102362993 B CN102362993 B CN 102362993B
- Authority
- CN
- China
- Prior art keywords
- group
- intestinal
- parts
- treatment
- radix
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Images
Landscapes
- Medicines Containing Plant Substances (AREA)
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 is that hepatitis B virus (Hepatitis B Virus, HBV) infects high Prevalent district, and hbs antigen (HBsAg) positive rate is 9.09%, about 1.2 hundred million people, and wherein chronic hepatitis B patient is about 3,000 ten thousand people.The great mass of data confirmation, chronic hepatopathy is 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 of endotoxin and Kupffer cell activation by lipopolysaccharide inflammatory factor discharges the hepatic injury that causes, and is " Secondary cases hepatic injury ".Repeatedly with the hepatocyte injury that continues and the inflammatory cell infiltration that accompanies, then develop into even hepatocarcinoma of hepatitis interstitialis chronica, also can serious hepatic necrosis occur because causing excessive inflammatory response, cause acute and chronic liver failure.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 for the treatment of hepatopathy.
At present, the endotoxic medicine of multiple treatment intestinal source property is arranged in prior art, but mostly have the defectives such as unsatisfactory curative effect, high expensive.
Summary of the invention
For 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 is achieved by the following technical solutions:
A kind of have a Chinese medicine preparation that protects intestinal detoxicating effect, the crude drug that comprises following weight portion: 6～12 parts of Radix Et Rhizoma Rhei, 6～12 parts of Radix Arnebiae (Radix Lithospermi)s, 25～35 parts, 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, catechu, 2～5 parts, Radix Glycyrrhizae.
Preferably, be to be made by the crude drug of following weight portion: 9 parts of Radix Et Rhizoma Rhei, 9 parts of Radix Arnebiae (Radix Lithospermi)s, 30 parts, 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, catechu, 3 parts, Radix Glycyrrhizae.
A kind of preparation method with the Chinese medicine preparation that protects intestinal detoxicating effect, for: take each crude drug, the bag for extracting of packing into, add 8～12 times of amounts (weight multiple, lower same) water soaking 1～2h, then decoct and extract 1～2h, filter to get extracting solution, be concentrated into relative density 1.02～1.05, spray drying, and get final product.
Further, after described decoction is extracted, filtered, add again 8～12 times of water gagings to decoct in the medicinal residues 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, and get final product.
Preferred preparation method is: take each crude drug, the bag for extracting of packing into first adds 8 times of water gagings to soak 1h, then decocts 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, spray drying, and get final product.
The method that the present invention also provides another 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 the rear slow fire boiling of water boiling 30 minutes, filter to get filtrate, and get final product.
Chinese medicine preparation of the present invention is the medicine through the clinical practice replication determined curative effect of nearly 15 years, has protection intestinal barrier, eliminates intestinal endotoxin, alleviates cytokine and other inflammatory mediators to the effect of the damage of liver.In addition, although the experiment in the present invention is all for the hepatopathy intestinal endotoxemia, but those skilled in the art are in the situation that who knows the common practise of this area, 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 product) of emodin.
Wherein, a: the peak of emodin.
The specific embodiment
The present invention is further illustrated below in conjunction with embodiment.
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 on leaching process: extraction time, amount of water, extraction time are as major influence factors, in the we in the monarch drug Radix Et Rhizoma Rhei overall merit of the extraction ratio of the content of contained main active ingredient emodin and this medicine as evaluation index, adopt the orthogonal experimental design method Optimized Extraction Process, extract to greatest extent the main effective ingredient of medicine, the raw material of high-quality is provided for the preparation of micropill.
1, instrument and reagent:
1.1 instrument
High performance liquid chromatograph (model: LC-10AT, SPD-10A UV-detector; Serial number: C20974030587CS; Manufacturer: Japanese Shimadzu); 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 company limited).
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.
Test crude drug source used as follows:
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 determining of test orthogonal test factor level
This experiment is on the basis that single factor is investigated, main component emodin content in the side is as standard, selection has three factors of appreciable impact on leaching process: extraction time, amount of water, extraction time are as major influence factors, in the we in the monarch drug Radix Et Rhizoma Rhei overall merit of the extraction ratio of the content of contained main active ingredient emodin and this medicine as evaluation index, adopt orthogonal experimental design method L9 (34) Optimized Extraction Process, extract to greatest extent the main effective ingredient of medicine.As 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, 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, catechu, 3 parts, Radix Glycyrrhizae, each component is by weight) mix homogeneously, be ground into coarse powder; Get 50g, extract (each orthogonal test scheme 50g) by the orthogonal test table contrived experiment.Monarch drug in the Radix Et Rhizoma Rhei side of being, its main effective ingredient is emodin, is the assay index therefore select emodin.The assay of emodin has thin layer chromatography scanning, high performance liquid chromatography, and reversed phase high-performance liquid chromatography etc., this research is with the content of high effective liquid chromatography for measuring emodin, and emodin and other component separating are good.Take the comprehensive evaluation index of paste-forming rate and emodin as index, investigate.
3.2.1 the mensuration of paste-forming rate:
The alcohol extract 25ml that precision measures each orthogonal test number puts in the evaporating dish that is dried to constant weight, after evaporate to dryness in water-bath, in 105 ℃ of dry 3h, puts cooling 30min in exsiccator, and precise weighing, calculate the rate of extract rapidly, the results are shown in Table 2.
3.2.2 the assay of emodin
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 emodin reference substance 5mg, is placed in the 50ml volumetric flask, with dissolve with methanol and release to scale, shakes up, and gets the reference substance storing solution.Precision measures emodin storing solution 1ml, is placed in the 10ml volumetric flask, adds methanol and is diluted to scale, namely gets emodin standard substance (containing 10 μ g emodins in every 1ml).
3.2.2.3 the preparation of need testing solution:
get approximately 1.00g (1.0025g) of dried cream powder, accurately weighed, be placed in the 25ml volumetric flask, with methanol 20ml supersound extraction 1h, let cool, add methanol to scale, shake up, filter, essence is got subsequent filtrate 5ml and is put in flask, fling to solvent, add 5molL-1 sulfuric acid solution 10ml, supersound process 5min, add again chloroform 10ml, reflux 1h, cooling, move in separatory funnel, with a small amount of chloroform washing container, and add in separatory funnel, divide and get chloroform layer, the acid solution layer is used chloroform extraction 3 times again, each 10ml, combined chloroform liquid, reclaim under reduced pressure is to doing, residue adds dissolve with methanol, be transferred in the 10ml volumetric flask, add methanol to scale, shake up, 0.05 μ m microporous filter membrane filters.Get subsequent filtrate, namely get need testing solution.With the standby Radix Et Rhizoma Rhei negative controls that lacks of legal system.
3.2.2.4 algoscopy
Get reference substance solution and will inject HPLC according to need testing solution and each 10 μ l of negative controls of orthogonal test gained, measuring, and get final product.
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 measurement result
3.2.4.1 the high-efficient liquid phase chromatogram of emodin is as shown in Figure 1A, Figure 1B, Fig. 1 C.
3.2.4.2 orthogonal result and analysis
According to above-mentioned table 1, this experimental design is 4 factor 3 horizontal quadrature testing programs, selects L9 (34) orthogonal table to test, and uses algoscopy to detect, and shows result, as table 2.
Table 2L9 (34) orthogonal test table
The result of four factors is carried out variance analysis (D is 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 on the order of emodin extraction efficiency impact, 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 Radix Et Rhizoma Rhei, is the assay index therefore select Radix Et Rhizoma Rhei, measures the content of emodin in medicine.Experiment shows, Radix Et Rhizoma Rhei is 3 times at extraction time, and amount of water is 8 times of water, and extraction time is that under the condition of 2h, extraction effect is best.Consider large production various factors, select to add 8 times of water gagings, extract 3 times, each 2h can draw this research approach reasonable, and data are reliable, credible result, and the process stabilizing that preferably obtains is feasible.
After the extraction experiment was completed, because this test dose is little, but direct drug injection liquid carried out spray drying, obtains powder.Large production dosage is large, is not suitable for spray drying, available other drying meanss, the drying meanss such as vacuum drying, microwave drying.
In the effective component extracting process, contain the stickum such as tannin due to square Chinese crude drug few, so can directly adopt normal pressure to filter when filtering, filtering velocity is very fast.Adopt filtration under diminished pressure, during take filter paper as filter medium, if filter paper is easily broken, can use 3 layers of gauze instead is filter medium, and this moment, the rate of filtration was very fast, and the filtrate clarification is conducive to the extraction fully of effective ingredient.
Embodiment 2 preparations have the Chinese medicine preparation that protects intestinal detoxicating effect
Formula 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.
Preparation method is: take each crude drug, the bag for extracting of packing into first adds 8 times of water gagings to soak 1h, then decocts 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, spray drying, and get final product.
Embodiment 3 preparations have the Chinese medicine preparation that protects intestinal detoxicating effect
Formula 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.
Preparation method is: each crude drug is mixed, add 4 times of water gagings, be heated to the rear slow fire boiling of water boiling 30 minutes, filter to get filtrate, and get final product.
Embodiment 4 preparations have the Chinese medicine preparation that protects intestinal detoxicating effect
Formula 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.
Preparation method is: take each crude drug, the bag for extracting of packing into first adds 8 times of water gagings to soak 1h, then decocts 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, spray drying, and get final product.
Embodiment 5 preparations have the Chinese medicine preparation that protects intestinal detoxicating effect
Formula 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.
Preparation method is: each crude drug is mixed, add 5 times of water gagings, be heated to the rear slow fire boiling of water boiling 30 minutes, filter to get filtrate, and get final product.
Formula 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.
Preparation method is: take each crude drug, the bag for extracting of packing into first adds 8 times of water gagings to soak 1h, then decocts 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, spray drying, and get final product.
Formula 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.
Preparation method is: each crude drug is mixed, add 2 times of water gagings, be heated to the rear slow fire boiling of water boiling 30 minutes, filter to get filtrate, and get final product.
Clinical data one
1 data and method
1.1 physical data all patients 60 examples, be inpatient between in March, 2005～2008 year December, etiological examination is hepatitis B, diagnosis and " the Diagnosis of Viral Hapatitis standard " that meet national infectious disease in 2000 and parasitic disease academic Xi'an meeting by stages and revise.Be divided into two groups according to the random digit method: treatment group 30 examples, male 21 examples, female's 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, sent out patient's 16 examples on the chronic hepatitis B basis, hbv-liver cirrhosis is sent out patient's 14 examples (Child-Pugh classification: A level 1 example, B level 6 examples, C level 7 examples) on the basis; Matched group 30 examples, male 20 examples, female's 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, sent out patient's 17 examples on the chronic hepatitis B basis, hbv-liver cirrhosis is sent out patient's 13 examples (Child-Pugh classification, A level 2 examples, B level 5 examples, C level 6 examples) on the basis.Two groups of sexes, age, the state of an illness, by stages, the Epidemiological Analysis by statistics such as classification and Syndrome Differentiation of Traditional Chinese Medicine (noxious water stagnation type, extreme noxious heat and liver-kidney yin deficiency), no significant difference (P＞0.05).
1.2 two groups of methods all adopt conventional Chinese and western medicine Comprehensive Treatment, 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.Treatment group adds Radix Et Rhizoma Rhei Detoxication Decoction (embodiment 3 preparation protect intestinal detoxicating soup) on this basis, is condensed into the 100mL enema, retention enema, every day 1 time, 3 weeks of the course for the treatment of.Matched group adds retention enema in the 70mL normal saline with lactulose 30mL, every day 1 time, 3 weeks of the course for the treatment of.
2 observed contents, index
2.1 ordinary circumstance: the cardinal symptom before and after 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), total bilirubin (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 before and after two groups of treatments, the ascites situation relatively: adopt B ultrasonic to locate, special messenger's special plane is measured ascites depth capacity under flat sleeping state.
3 efficacy determinations quantize integration and fill in the observation of curative effect table respectively at carrying out symptom before and after treatment.Integration method and efficacy determination are formulated with reference to " traditional Chinese medical science disease Standardization of diagnosis and curative effect " of State Administration of Traditional Chinese Medicine's issue and " the new Chinese medicine guideline of clinical investigations " of version in 2002.Produce effects: after treatment finishes, transference cure or obviously alleviate, indices is down to normally; Effectively: after treatment finished, remission though indices does not recover normally, was treated front level improvement; Invalid: treatment does not reach above-mentioned standard or died after finishing.
4 statistical method results are with mean ± standard deviation
Expression.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, finish the course for the treatment of rear all without coming off.
5.1 two groups of patient treatments Main Biochemical after 3 weeks relatively treatment group reduce AST, TBil, Glb, rising PTA,
TC, Ca aspect is better than matched group, and difference has significance (P＜0.05).See Table 4.
The table 4 liang Main Biochemical of group patient treatment after 3 weeks relatively
Relatively front 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 blood endotoxin comparison treatment group 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, treatment group is better than 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 the ascites situation comparison treatment group ascites degree of depth before and after two groups of treatments, matched group is respectively 24.7 ± 3.49mm, 16.0 ± 2.32mm.Treatment group is being better than matched group aspect removing ascites, and difference has significance (P＜0.05).
5.4 two groups of patient clinical comprehensive therapeutic effects compare treatment group 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 treatment group obviously is better than matched group (P＜0.05).
5.5 treatment group to hepatitis gravis each reach the Syndrome Differentiation of Traditional Chinese Medicine curative effect relatively by stages 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, especially more remarkable with noxious water stagnation type curative effect, with liver-kidney yin deficiency relatively, difference has significance (P＜0.05).See Table 5, table 6.
Each curative effect comparison by stages of table 5 treatment group
Compare *, P＜0.05 with late period
Table 6 treatment group Syndrome Differentiation of Traditional Chinese Medicine curative effect relatively
Compare *, P＜0.05 with liver-kidney yin deficiency
5.6 before and after two groups of treatments, major complications improves relatively preventing and treating that treatment group is better than matched group aspect hepatic encephalopathy, difference has significance (P＜0.05).See Table 7.
After table 7 liang group treatment, major complications is improved relatively
Compare △, P＜0.05 with matched group.
5.7 the untoward reaction treatment group loose stool occurs after 2 routine patient's coloclysis are arranged, transference cure after adjustment Radix Et Rhizoma Rhei consumption, and crissum pain appears in 1 routine patient, and doing well,improving after anti symptom treatment has no other untoward reaction.
6 discuss
In recent years, the relation of hepatopathy and intestinal endotoxemia (IETM) comes into one's own day by day.The great mass of data confirmation, hepatic injury is mostly with IETM, and the incidence rate of severe viral hepatitis IETM can be up to 93.3%.The Secondary cases hepatic injury that endotoxin and Kupffer cell activation by lipopolysaccharide cause, to the development of hepatitis gravis with lapse to important.Therefore, removing intestinal source property endotoxin, blocking-up intestinal endotoxemia is one of essential measure for the treatment of 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 adopt oral lactulose and the few antibiotic of intestinal absorption more, but due to its side effect and easily cause alteration of intestinal flora, restricting the ageing of clinical practice.
Hepatitis gravis belongs to the 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 and seek blood, and hot and humid ecchymosis runs through disease generation, evolution all the time, thereby treatment is worked as take heat-clearing and toxic substances removing, cooling blood and removing stasis, invigorating spleen to remove dampness as the main rule for the treatment of.Protect the intestinal Detoxication Decoction by ingredients such as Radix Et Rhizoma Rhei, Radix Paeoniae Rubra, Poria, Pseudobulbus Bletillae (Rhizoma Bletillae), catechu, Radix Glycyrrhizaes, have spleen invigorating bowel relieving, cooling blood and removing stasis Detoxication, be for the side of card.After protecting intestinal Detoxication Decoction 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 digested liquid and destroys, and can make the medicine sick institute that goes directly, be a kind of Therapeutic Method with higher use value, have vast potential for future development; Simultaneously, enter the body circulation after medicine can absorb by colon, both avoided the bitter cold medicine to injure gastric qi, can bring into play again the endotoxic effect of whole body of removing.By above-mentioned approach, alleviate endotoxin to the damage of liver, 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, easily 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 affects the hepatitis gravis prognosis.Many conventional application antibiotic control is at present infected, but Antibiotic use can cause that endotoxin discharges in a short time in a large number when killing pathogenic bacterium, thus the generation of aggravation hepatic injury, the various complication of promotion.Originally studies confirm that protecting intestinal Detoxication Decoction coloclysis can directly remove pathogenic bacterium, endotoxin, the untoward reaction of avoiding antibiotic to use has good therapeutic effect to the control infection.
Originally studies show that, give Radix Et Rhizoma Rhei Detoxication Decoction coloclysis and can reduce significantly chronic severe hepatitis B ET, AST, TBil, Glb on the basis of Chinese and western medicine Comprehensive Treatment, improve PTA and TC, alleviate the inflammation reaction, promote complex functionality to recover, thereby reduce the generation of various complication, reduce mortality rate.Based on protect intestinal Detoxication Decoction 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 not 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.Affect because the compliance of enema treatment and medicinal liquid direct effect position are limited to etc. by sample size, patient, be necessary from now on further enlarged sample amount, improve pharmaceutical dosage form and administering mode to enlarge the drug effect position, to improve patient compliance, to 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 the whole nation, Xi'an in 2000 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 Standards of Chinese Medical Syndrome Differentiation " of Yichang revision, CAIM (Chinese Association Of Integrative Medicine) digestive system disease Professional Committee in November, 1993.
1.2 inclusive criteria
1.2.1 meet the traditional Chinese medical science and Western medicine diagnose standard, 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 above-mentioned inclusive criteria person
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 rear discovery does not meet inclusive criteria in.
1.4.2 experimenter's compliance is poor, not medication in accordance with regulations can't judge curative effect, or the not congruent judgement person that affects the treatment of data.
1.4.3 naturally come off in observing, person lost to follow-up.
1.4.4 severely adverse event, complication occur or the 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 at random matched group, orally protects intestinal detoxifying micro pellets group, protects intestinal detoxicating soup colon instillation group, oral lactulose group.Wherein, protecting intestinal detoxifying micro pellets group and lactulose group is that Double-blind double-dummy contrasts grouping at random.
Matched group is taken reduced glutathion (400mg/ time, 3 times/days).
Protect intestinal detoxifying micro pellets group, lactulose group oral intestinal detoxifying micro pellets, the lactulose micropill of protecting on the basis of matched group, both for Double-blind double-dummy designs, each 1.5 grams, every day three times.
Protect intestinal detoxicating soup group and add on the matched group basis and protect the retention enema of intestinal detoxicating soup colon instillation, each I00ml, once a day.
The described intestinal detoxifying micro pellets that protects prepares by the following method:
(1) preparation of medicated powder: be the preparation-obtained medicated powder of embodiment 2.
(2) preparation of calcium pectinate: get low fat pectin 500g, fully grind, slowly add the 2L deionized water, mixing.Separately get 21.71g calcium chloride and be dissolved in the 2L deionized water, slowly pour in low fat pectin solution, be stirred to mix homogeneously, make the translucent gels shape.Sealing infiltrates 24h, and it is fully infiltrated.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 makes powder, and is standby.
(3) preparation of micropill: medicated powder and microcrystalline Cellulose are mixed in mass ratio at 1: 2, add 75% binding agent 55% ethanol (volume fraction) of medicated powder and microcrystalline Cellulose gross mass to make soft material, through extrude-spheronizator extrudes the close smooth strip soft material of matter, after high speed is round as a ball, the strip soft material is interrupted, piller through long-time round as a ball gained, namely get fine pellet core after drying (because binding agent is 55% ethanol, after the micropill drying, ethanol is not present in micropill through volatilization, moisture＜9%).
(4) coating preparation: get calcium pectinate (8g) and add water (100ml) porphyrize in colloid mill and form suspension and add EudragitL30D2.5%, phthalic acid ester and sorbester p17 (each 0.5%), mix homogeneously is made colon coating solution.Stir 24h, to dissolving fully.Fluid bed is preheated to more than 35 ℃, adds fine pellet core (15g), regulates wind speed and extremely all is kept in motion, preheating 5min.Open peristaltic pump and spray into coating solution, carry out coating.To coating weightening finish 35%, both got micropill.
Described lactulose micropill obtains by following preparation method: lactulose and microcrystalline Cellulose are mixed in mass ratio at 1: 2, add 75% binding agent (55% ethanol) to make soft material, through extrude-spheronizator extrudes the close smooth strip soft material of matter, after high speed is round as a ball, the strip soft material is interrupted, piller through long-time round as a ball gained, namely get the lactulose micropill after drying, do not contain ethanol after drying, its preparation method is similar with the preparation method of protecting the intestinal detoxifying micro pellets, and other conventional micropill method processed and adjuvant also can use.
The described intestinal detoxicating soup that protects is (the raw materials used survival dose of embodiment 3 is the dosage of one day) that embodiment 3 prepares.
Before and after four groups of treatments, each inspection of index of correlation once, is 20 days the course for the treatment of.
2.2 observation index
2.2.1 safety indexes: three large routines, electrocardiogram, hepatic and renal function.Before and after treatment, each checks once.
2.2.2 health giving quality index: plasma endotoxin, liver function (ALT, AST, TBIL, ALB, GLO), TNF-α, IL-6, IL-8, PTA, before and after treatment, each checks once.
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 business was many), makes 2 times of liquid a;
2. the supernatant water bath with thermostatic control in 0.6ml a 6 minutes (75～80 degree), need not etc. cooling, directly adding 0.6ml II treatment fluid mixes, seal with sealed membrane, outstanding mixed after 15 seconds, (4200 rev/mins must reach 4200 and turn in centrifugal 6 minutes, otherwise albumen is difficult for centrifugally getting off), make 4 times of liquid b;
3. the supernatant in 0.4ml b+0.4ml endotoxin detects the water mixing, and eddy mixer mixed for 15 seconds, made 8 times of liquid c;
4. detect with the water dissolution tachypleus amebocyte lysate with the 0.1ml endotoxin and (must add immediately after the tachypleus amebocyte lysate uncork to detect and use water dissolution, otherwise tachypleus amebocyte lysate is with very fast inactivation), with hand rolling mixing 10 seconds, (amplitude of rocking is not large, do not produce air pocket, otherwise tachypleus amebocyte lysate 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, then affecting result) can to add liquid to be measured in standing about 1 minute after tachypleus amebocyte lysate better again in dissolving, add after water tachypleus amebocyte lysate solution not in air standing time over 3 minutes, add c liquid 0.2ml (if c liquid is over 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 large, otherwise tachypleus amebocyte lysate 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, then affect result.(will check whether bubble is arranged in bottle before upper machine, generally, diameter is no more than the bubble of 1 millimeter and can impact result; Bubble is larger, larger mistake value will occur)
5. go up machine testing.
2.4 retention-enema treatment Standard Operating Procedure
Patient's preparation: treatment forward direction patient describes purpose and the necessity of receiving treatment in detail, obtains patient and coordinates.Advise the front emptying defecation of patient's coloclysis, clean crissum, the clinostatism of going down on one's knees on the left of getting, padded buttocks 10cm appears anus.
Operation:
1. the coloclysis time is advisable before falling asleep with patient at night.During application, medicinal liquid is heated to 39 ℃～40 ℃.
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 glass stopper that fills the coloclysis medicinal liquid of having sterilized, and prevents from coming 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 the lubricated sputum aspirator tube front end 20cm of paraffin oil left and right.
3. advise patient deeply air-breathing, with the soft patient's anus that slowly inserts of sputum aspirator tube, feel without hindrance sense, insertion depth is 20cm approximately.
4. open infusion regulator, regulating drop speed is about 50 droplets/minute.In the drip irrigation process, patient's left lateral position.
5. slow tube drawing after coloclysis finishes rubbed anus 3 minutes gently with the cleaning gauze, advise the patient get left lateral position at least 30min retain absorption in order to medicine.
6. after coloclysis, 1-2 hour effect of medicinal liquid reservation is better, can keep a Night Watch good.
3, efficacy assessment standard
3.1 comprehensive therapeutic effect
Unite revision " viral hepatitis is prevented and treated scheme " and " guideline of clinical investigations of Chinese Drugs in Therapy chronic hepatitis " (Ministry of Public Health bureau of drug administration volume) formulation with reference in JIUYUE, 2000 China medical association's infectious disease and parasitic disease credit meeting, the Xi'an meeting of hepatopathy association.
1. produce effects: subjective symptoms disappears substantially, and tcm syndrome therapeutic index N 〉=70%, the every abnormal index of liver function are treated front decline 70% or multiple normal.
2. effective: tcm syndrome therapeutic index N 〉=30%, the every abnormal index of liver function are treated front decline 30% or multiple normal.
3. invalid: do not reach above-mentioned standard person after finishing the course for the treatment of.
3.2 endotoxin criterion of therapeutical effect
1. produce effects: descend 〉=70% before treatment after the plasma endotoxin treatment.
2. effective: as to descend 〉=30% before treatment after the plasma endotoxin treatment.
3. invalid: after finishing the course for the treatment of, the index variation does not reach above standard person.
3.3 chronic virus b hepatopathy curative effect determinate standard
1. produce effects: every biochemical abnormal index improves 〉=70%.
2. effective: every biochemical abnormal index improves 〉=30%.
3. invalid: the index variation does not reach above standard or sb.'s illness took a turn for the worse and died.
3.4 tcm syndrome curative effect determinate standard (formulating with reference to new Chinese medicine guideline of clinical investigations in 2002)
Computational methods: computing formula (nimodipine method): [integration before (integration after integration before treatment-treatment) * 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: all without obviously improving, even increase the weight of, the syndrome integration reduces less than 30% for symptom, sign.
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 minute.
3. invalid: as not reach above-mentioned standard person
4, statistical analysis
With all data input computer, process through the SPSS13.0 statistical software.Measurement data adopts mean ± standard deviation, the relatively employing variance analysis of many Sets of Measurement Datas, and two Sets of Measurement Datas relatively adopt the t check, the relatively employing X2 check of rate.
(3) experimental result
1, compare before the treatment
Before four groups of patient treatments of table 8-table 15 explanation, sex, the hepatitis B course of disease, lesion degree, plasma endotoxin, inflammatory cytokine, liver function, the more equal no difference of science of statistics of PTA, have comparability.
Four groups of sex composition ratios of table 8
Annotate: treat front four groups of trouble sex compositioies and learn by statistics processing there was no significant difference (P＞0.05), have comparability.
Four groups of hepatitis B courses of disease of table 9 distribute
Annotate: treat front four groups of patient's hepatitis B courses of disease distribution and learn by statistics processing there was no significant difference (P＞0.05), have comparability.
Before four groups of treatments of table 10, the state of an illness distributes
Annotate: treat front four groups of conditions of patients distribution and learn by statistics processing there was no significant difference (P＞0.05), have comparability.
Before table 11 treatment, plasma endotoxin relatively
Annotate: treat front four groups of patient's Endotoxin Levels and learn by statistics processing there was no significant difference (P＞0.05), have comparability.
Before table 12 treatment, inflammatory cytokine relatively
Annotate: treat front four groups of patient TNF-α, IL-6, IL-8 and learn by statistics processing there was no significant difference (P＞0.05), have comparability.
Before table 13 treatment, liver function relatively
Annotate: treat front four groups of patient's liver functions and learn by statistics processing there was no significant difference (P＞0.05), have comparability.
Before table 14 treatment, PTA relatively
Annotate: treat front 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, all obviously improvement of liver function and clinical symptoms after four groups of patient treatments.Protect intestinal detoxifying micro pellets group, protect intestinal detoxicating soup group, lactulose group curative effect all is better than matched group, P＜0.05.Protect intestinal detoxifying micro pellets group, protect intestinal detoxicating soup group effective percentage and obvious effective rate 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 add on the basis of dialectical Chinese medicine compound with protect the intestinal detoxifying micro pellets, 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, some superiority to be arranged.
2.2 remove the plasma endotoxin curative effect
Endotoxin effective percentage after table 16 treatment
Annotate: compare with matched group: ☆ ☆ P＜0.01; With protect intestinal detoxifying micro pellets group relatively: △ P＜0.05; With protect intestinal detoxicating soup group comparison ▲ P＜0.05
Before and after table 17 treatment, each organizes interior plasma endotoxin relatively (EU/mL)
Annotate: compare in each is organized with before treatment: ☆ P＜0.05, ☆ ☆ P＜0.01
Between organizing after table 18 treatment, plasma endotoxin compares (EU/mL)
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;
Upper table shows, Endotoxin Levels no difference of science of statistics before four groups of patient treatments, and P＞0.05 has comparability.Descend to some extent before after treatment, the matched group Endotoxin Levels is treated, but no difference of science of statistics, P＞0.05.Protect intestinal detoxifying micro pellets group, protect intestinal detoxicating soup group, plasma endotoxin all obviously descends before treatment after the treatment of lactulose group, P＜0.01.Three groups are reduced the plasma endotoxin curative effect and all significantly are better than matched group, P＜0.01.Protect intestinal detoxifying micro pellets group, the lactulose group all is better than protecting intestinal detoxicating soup group, P＜0.01.Protect intestinal detoxifying micro pellets group curative effect and be better than the lactulose group, but no difference of science of statistics, P＞0.05.
Illustrate 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 detoxifying micro pellets and improved the purpose of removing the intestinal endotoxemia clinical efficacy.
2.3 cytokine (TNF-a, IL-6, IL-8) improvement situation
The explanation of table 19-table 21, the rear matched group for the treatment of is treated front inflammatory cytokine and is descended to some extent, but not statistically significant.Protect intestinal detoxicating soup group, lactulose group, protect intestinal detoxifying micro pellets group and all can significantly reduce the release of inflammatory cytokine.
Before and after table 19 treatment, the interior TNF-α of each group relatively
Annotate: compare in each is organized with before treatment: ☆ P＜0.05, ☆ ☆ P＜0.01.
Before and after table 20 treatment, the interior IL-6 of each group relatively
Annotate: compare in each is organized with before treatment: ☆ P＜0.05, ☆ ☆ P＜0.01.
Before and after table 21 treatment, the interior IL-8 of each group relatively
Annotate: compare in each is organized with before treatment: ☆ P＜0.05, ☆ ☆ P＜0.01.
Between organizing after table 22 treatment, TNF-α, IL-6, IL-8 are relatively
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 detoxifying micro pellets curative effect to the impact of inflammatory factor and all significantly is better than its excess-three group, and the matched group impact is minimum, no difference of science of statistics.Protect intestinal detoxicating soup group the impact of TNF-α, IL-8 is better than the lactulose group, and on the two groups of therapeutic equivalences that affect of IL-6.
2.4 Hepatic function improvement situation
Before and after table 23 treatment, interior ALT, AST of each group relatively
Annotate: compare in each is organized with before treatment: ☆ P＜0.05, ☆ ☆ P＜0.01.
Before and after table 24 treatment, the interior TBIL (umol/l) of each group relatively
Annotate: compare in each is organized with before treatment: ☆ P＜0.05, ☆ ☆ P＜0.0
Before and after table 25 treatment, interior ALB, GLO (g/L) of each group relatively
Annotate: compare in each is organized with before treatment: ☆ P＜0.05, ☆ ☆ P＜0.01.
Illustrate, protect intestinal detoxifying micro pellets group after treatment, protect intestinal detoxicating soup group liver function and significantly improve, control group A ST, ALT obviously descend (P＜0.05), and 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.
Between organizing after table 26 treatment, liver function relatively
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;
Illustrate that protecting intestinal detoxifying micro pellets group liver function indices improves and all to be better than 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 better than lactulose group (P＜0.05); Protect intestinal detoxicating soup group ALT fall and be better than the lactulose group, all the other indices curative effects are suitable with the lactulose group.
2.5PTA improvement situation
Table 27PTA (%) improvement situation
Annotate: PTA (%)＜80% is abnormal.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 the judgement state of an illness and prognosis.Table 27 shows, treats rear four groups and protects intestinal detoxifying micro pellets group PTA than all significantly risings (P＜0.01) of lactulose group, matched group, more also make moderate progress with protecting intestinal detoxicating soup group, but no difference of science of statistics.Protect intestinal detoxicating soup group and obviously improve than matched group, lactulose PTA, but compare no difference of science of statistics with the lactulose group.
2.6 tcm symptom curative effect
Table 28 TCM symptom score 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 score no difference of science of statistics before four groups of patient treatments, P＞0.05.After treatment, four groups of patient's TCM symptom scores all obviously descend before treatment, P＜0.01.Protect intestinal detoxifying micro pellets group, protect intestinal detoxicating soup group lactulose group matched group P＜0.01 that is better than evident in efficacy; Matched group descends to some extent than lactulose curative effect integration, but no difference of science of statistics, P＞0.05.Protect that intestinal detoxifying micro pellets group is evident in efficacy is better than protecting intestinal detoxicating soup group, lactulose group.
After four groups of treatments are described, symptom is all obviously improved, 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 intestinal detoxifying micro pellets group relatively △ △ P＜0.01, with protect intestinal detoxicating soup group relatively ▲ ▲ P＜0.01.
Upper table shows that four groups of patient's symptoms all have clear improvement.Protect intestinal detoxifying micro pellets group, protect intestinal detoxicating soup group curative effect and be better than matched group and lactulose group, P＜0.01.Between matched group, lactulose group group, curative effect compares no difference of science of statistics, P＞0.05.Protect intestinal detoxifying micro pellets group and protect curative effect comparison no difference of science of statistics between intestinal detoxicating soup group group, P＞0.05.
After four groups of treatments are described, symptom is all obviously improved, but coordinates spleen invigorating to transfer intestinal, promoting blood circulation and detoxication method colon administration can more effectively improve patient's symptom.
2.7 before and after treatment, cardinal symptom is improved situation
Table 30 jaundice is improved situation
Annotate: protect intestinal detoxifying micro pellets group after treatment, protect intestinal detoxicating soup group, lactulose group and matched group comparison, ☆ P＜0.05.
Upper table shows, has clear improvement before after treatment, four groups of patient's jaundice symptoms are all treated.Protect intestinal detoxifying micro pellets group, protect intestinal detoxicating soup group, the lactulose group is improved the jaundice symptom curative effect and all is better than matched group P＜0.05.Protect intestinal detoxifying micro pellets group, protect curative effect comparison no difference of science of statistics between intestinal detoxicating soup group, lactulose group group, P＞0.05.
After four groups of treatments are described, jaundice symptoms all obviously improve, but add on the basis of dialectical Chinese medicine compound with protect the intestinal detoxifying micro pellets, 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 intestinal detoxifying micro pellets group relatively △ P＜0.05, with clyster group comparison ▲ P＜0.05.
Upper table shows, has clear improvement before after treatment, four groups of fidgety irritability symptoms of patient are all treated.Protect intestinal detoxifying micro pellets group, protect intestinal detoxicating soup group and improve fidgety irritability symptom curative effect and be better than matched group, lactulose group (P＜0.05).Between matched group and lactulose group group, curative effect compares no difference of science of statistics (P＞0.05).Protect intestinal detoxifying micro pellets group and protect curative effect comparison no difference of science of statistics (P＞0.05) between intestinal detoxicating soup group group.
After four groups of treatments are described, fidgety irritability symptom is all obviously improved, 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 detoxifying micro pellets group after treatment, protect intestinal detoxicating soup group, lactulose group and matched group comparison, ☆ ☆ P＜0.05.
Upper table shows, has clear improvement before after treatment, four groups of patient's abdominal distention symptoms are all treated.Protect intestinal detoxifying micro pellets group, protect intestinal detoxicating soup group, the lactulose group improves abdominal distention symptom curative effect and all is better than matched group (P＜0.05).Protect intestinal detoxifying micro pellets group, protect curative effect comparison no difference of science of statistics (P＞0.05) between intestinal detoxicating soup group, lactulose group group.
After four groups of treatments are described, the abdominal distention symptoms are all obviously improved, but add on the basis of dialectical Chinese medicine compound with protect the intestinal detoxifying micro pellets, 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 detoxifying micro pellets group △ P＜0.05, and protect intestinal detoxicating soup group comparison ▲ P＜0.05.
Upper table shows, has clear improvement before after treatment, four groups of patient's bitter taste symptoms are all treated.Protect intestinal detoxifying micro pellets group, protect intestinal detoxicating soup group and improve the bitter taste curative effect and be better than matched group, lactulose group (P＜0.05).Between matched group and lactulose group group, curative effect compares no difference of science of statistics (P＞0.05).Protect intestinal detoxifying micro pellets group and protect curative effect comparison no difference of science of statistics (P＞0.05) between intestinal detoxicating soup group group.
After four groups of treatments are described, the bitter taste symptom is all obviously improved, but coordinates 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: with matched group ☆ ☆ P＜0.01, and protect intestinal detoxifying micro pellets group comparison △ P＜0.05 after treatment, and protect intestinal detoxicating soup group comparison ▲ P＜0.05.
Upper table shows, has clear improvement before after treatment, four groups of patient's stool abnormities are all treated.Protect intestinal detoxifying micro pellets group, protect intestinal detoxicating soup group and improve the stool abnormity curative effect and be better than matched group (P＜0.01), lactulose group (P＜0.05).Between matched group and lactulose group group, curative effect compares no difference of science of statistics, P＞0.05.Protect intestinal detoxifying micro pellets group and protect curative effect comparison no difference of science of statistics (P＞0.05) between intestinal detoxicating soup group group.
After four groups of treatments are described, stool abnormity all obviously improves, but coordinates 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: with matched group ☆ ☆ P＜0.01, and protect intestinal detoxifying micro pellets group comparison △ P＜0.05 after treatment, and protect intestinal detoxicating soup group comparison ▲ P＜0.05.
Upper table shows, has clear improvement before after treatment, four groups of patient's pain over the hypochondriac regions are all treated.Protect intestinal detoxifying micro pellets group, protect intestinal detoxicating soup group and improve pain over the hypochondriac region curative effect and be better than matched group, lactulose group, P＜0.01, P＜0.05.Between matched group and lactulose group group, curative effect compares no difference of science of statistics, P＞0.05.Protect intestinal detoxifying micro pellets group and protect curative effect comparison no difference of science of statistics between intestinal detoxicating soup group group, P＞0.05.
After four groups of treatments are described, the pain over the hypochondriac region is all obviously improved, but coordinates 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: with matched group ☆ P＜0.05, and protect intestinal detoxifying micro pellets group comparison △ P＜0.05 after treatment, and protect intestinal detoxicating soup group comparison ▲ P＜0.05
Upper table shows, has clear improvement before after treatment, four groups of weak symptoms of patient are all treated.Protect intestinal detoxifying micro pellets group and protect the weak curative effect of intestinal detoxicating soup group improvement and be better than matched group and lactulose group, P＜0.05.Between matched group and lactulose group group, curative effect compares no difference of science of statistics, P＞0.05.Protect intestinal detoxifying micro pellets group and protect curative effect comparison no difference of science of statistics between intestinal detoxicating soup group group, P＞0.05.
After four groups of treatments are described, weak symptom is all obviously improved, but coordinates 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 intestinal detoxifying micro pellets group relatively △ P＜0.05, and protect intestinal detoxicating soup group comparison ▲ P＜0.05.
Upper table shows, has clear improvement before after treatment, four groups of patient's poor appetite symptoms are all treated.Protect intestinal detoxifying micro pellets group, protect intestinal detoxicating soup group and improve curative effect and be better than matched group, lactulose group, P＜0.01, P＜0.05.Between matched group and lactulose group group, curative effect compares no difference of science of statistics, P＞0.05.Protect intestinal detoxifying micro pellets group and protect curative effect comparison no difference of science of statistics between intestinal detoxicating soup group group, P＞0.05.
After four groups of treatments are described, the poor appetite symptoms are all obviously improved, and can more effectively improve patient's poor appetite symptom but coordinate spleen invigorating to protect intestinal, eliminating damp, detoxifying, activating blood and removing stasis Method colon administration.
Claims (1)
1. one kind has the Chinese medicine preparation that protects intestinal detoxicating effect, it is characterized in that: made by following crude drug: 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; Preparation method is: each crude drug is mixed, add 4 times of water gagings, be heated to the rear slow fire boiling of water boiling 30 minutes, filter to get filtrate, and get final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201110382533 CN102362993B (en) | 2011-11-26 | 2011-11-26 | Chinese medicinal preparation with effects of protecting intestines and removing toxic materials, and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201110382533 CN102362993B (en) | 2011-11-26 | 2011-11-26 | Chinese medicinal preparation with effects of protecting intestines and removing toxic materials, and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102362993A CN102362993A (en) | 2012-02-29 |
| CN102362993B true CN102362993B (en) | 2013-06-05 |
Family
ID=45689609
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 201110382533 Active CN102362993B (en) | 2011-11-26 | 2011-11-26 | Chinese medicinal preparation with effects of protecting intestines and removing toxic materials, and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102362993B (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102901726B (en) * | 2012-09-14 | 2014-08-13 | 莫水晶 | Preparation and application of detection kit for blood bacterial endotoxin |
| CN103768177B (en) * | 2014-01-23 | 2016-08-24 | 青岛市海慈医疗集团 | A kind of externally-applied medicinal composition treating hepatopathy intestinal endotoxemia |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1430991A (en) * | 2003-02-09 | 2003-07-23 | 王辅民 | Medicine combination for treating chronic hepatitis B |
| CN101152501A (en) * | 2007-09-24 | 2008-04-02 | 梁平 | Traditional Chinese medicine for treating acute virus hepatitis |
| CN101757509A (en) * | 2009-11-04 | 2010-06-30 | 泰一和浦（北京）中医药研究院有限公司 | Traditional Chinese medicine composition for treating icterohepatitis and preparation method thereof |
| CN101757598A (en) * | 2009-11-05 | 2010-06-30 | 泰一和浦（北京）中医药研究院有限公司 | Traditional Chinese medicine composition for treating advanced malignant liver tumor symptoms and preparation method thereof |
-
2011
- 2011-11-26 CN CN 201110382533 patent/CN102362993B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1430991A (en) * | 2003-02-09 | 2003-07-23 | 王辅民 | Medicine combination for treating chronic hepatitis B |
| CN101152501A (en) * | 2007-09-24 | 2008-04-02 | 梁平 | Traditional Chinese medicine for treating acute virus hepatitis |
| CN101757509A (en) * | 2009-11-04 | 2010-06-30 | 泰一和浦（北京）中医药研究院有限公司 | Traditional Chinese medicine composition for treating icterohepatitis and preparation method thereof |
| CN101757598A (en) * | 2009-11-05 | 2010-06-30 | 泰一和浦（北京）中医药研究院有限公司 | Traditional Chinese medicine composition for treating advanced malignant liver tumor symptoms and preparation method thereof |
Non-Patent Citations (4)
| Title |
|---|
| ""重型肝炎与肠源性内毒素血症;白晓云等;《临床肝胆病杂志》;20081031;第24卷(第5期);390 * |
| "大黄解毒汤灌肠治疗慢性乙型病毒性肝炎肠源性内毒素血症45例";毛毛等;《陕西中医》;20100531;第31卷(第5期);515 * |
| 毛毛等."大黄解毒汤灌肠治疗慢性乙型病毒性肝炎肠源性内毒素血症45例".《陕西中医》.2010,第31卷(第5期),515. |
| 白晓云等.""重型肝炎与肠源性内毒素血症.《临床肝胆病杂志》.2008,第24卷(第5期),388-390. |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102362993A (en) | 2012-02-29 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN100548323C (en) | A kind of pharmaceutical composition of making by Herb Gynostemmae Pentaphylli, Radix Panacis Quinquefolii and the Radix Astragali | |
| CN111358839B (en) | Formula granules of polygonum capitatum and preparation method thereof | |
| CN1977889B (en) | Medicinal composition of astragalus, salvia miltrorrhiza and oxymatrine, and its preparing method | |
| CN102526427B (en) | Traditional Chinese medicinal composition for treating gastrointestinal diseases and quality inspection method | |
| CN102885928B (en) | Chinese medicinal injection for treating jaundice and preparation method thereof | |
| CN101357203B (en) | Preparation for treating cancer and carcinoma and preparation method thereof | |
| CN102362993B (en) | Chinese medicinal preparation with effects of protecting intestines and removing toxic materials, and preparation method thereof | |
| CN102920964B (en) | Traditional Chinese medicine preparation for curing cough | |
| CN101987124A (en) | Traditional Chinese medicine composition for treating dyspepsia and preparation method thereof | |
| CN103006773A (en) | Traditional Chinese granule for children for clearing heat | |
| CN1985873B (en) | Medicine composition of glycyrrhizic acid or its salt, ginseng and astragalus root | |
| CN101869675B (en) | Chinese medicinal composition granules for treating summer-heat damp cold and preparation method thereof | |
| CN100584345C (en) | Distillage of Ardisia chinensis Benth of possessing function of antivirus, extraction method and application | |
| CN100482266C (en) | Medical composite prepared by sarcandra and oldenlandia | |
| CN108452008A (en) | A kind of application including Common Leafflower Herb, rainbow conk, Radix Salviae Miltiorrhizae and the Chinese medicine composition of Asian puccoon in preparing the drug for inhibiting recurrence of PHC | |
| CN108452009A (en) | A kind of application including Common Leafflower Herb, rainbow conk, Radix Salviae Miltiorrhizae and the Chinese medicine composition of Asian puccoon in the drug for preparing treatment liver cancer | |
| CN1969937B (en) | Pharmaceutical composition for treating hepatitis | |
| CN102614248B (en) | Traditional Chinese herbal composite for treating stroke and chest obstruction | |
| CN102309705A (en) | Medicine for reducing serum uric acid, preparation method thereof and purpose thereof | |
| CN103041288B (en) | A kind of Chinese medicine composition and preparation technology treating diabetic fatty liver | |
| CN102349956B (en) | Compound extract for moisturizeing pathogenic dryness and relieving itching and preparation thereof | |
| CN101011543B (en) | Antineoplastic medicine composition | |
| CN101642492A (en) | Drug for treating chronic pelvic inflammatory disease and preparation method thereof | |
| CN101073611B (en) | Medicinal composition for preventing tumor | |
| CN1970001B (en) | Pharmaceutical composition comprising kurarinone, magnolia vine fruit and ginseng for treating hepatitis |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |