CN103110884A - Traditional Chinese medicine composition for treating chronic cholecystitis - Google Patents
Traditional Chinese medicine composition for treating chronic cholecystitis Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating chronic cholecystitis. The traditional Chinese medicine composition comprises the following traditional Chinese medicines: artemisia capillaries, rheum palmatum, white paeony roots, rhizoma corydalis, cortex magnoliae officinalis, fructus aurantii, bupleurum chinense, pericarpium citri reticulatae, fructus meliae toosendan, radix scutellariae and radix glycyrrhizae. Clinical tests show that the traditional Chinese medicine composition provided by the invention has exact effect on treating the chronic cholecystitis; and the effect is better than the prior art.
Description
Technical field
The present invention relates to treat the Chinese medicine composition of cholecystitis, be specifically related to a kind of Chinese medicine composition for the treatment of chronic cholecystitis.
Background technology
Chronic cholecystitis (chronic cholecystitis) means gallbladder chronic inflammation pathological changes, mostly is greatly chronic venous insufficiency, accounts for 85%-95%, and minority is non-calcareous cholecystitis, as the typhoid carrier.Primary disease can show effect delay and come also can chronic onset repeatedly by acute cholecystitis.
The clinical manifestation of chronic cholecystitis is without specificity, commonly right upper quadrant of the abdomen or precordial region dull pain, and glutted discomfort after food, belch can have nauseatingly after the feed greasy food, vomiting is occasionally arranged.The old people, can without clinical symptoms, claim silent gallbladder scorching.Primary disease mostly is greatly chronic onset, also can repeatedly be shown effect by acute cholecystitis.Clinically can be without characteristic symptom.
Chronic cholecystitis is common in China, women's sickness rate is high, and female and man's ratio are 2-3:1, the various complexity of its cause of disease, comprise the factors such as age, sex, race, dietary habit, obesity, heredity, biliary tract infection, cholestasis, mostly be the result of comprehensive factor effect.
Along with the raising of China's living standards of the people and the improvement of sanitary condition, national average life extended over past ten years, and the sickness rate of cholelithiasis increases day by day, and especially the big city is increased more obviously, accounts for according to statistics 70% of whole cholelithiasis.
Chronic cholecystitis belongs to " hypochondriac pain " category more in tcm clinical practice, think that its pathogenesis is depression of liver-QI, loses in catharsis, and gallbladder loses logical falling, stagnation of QI and blood may bring about pain; Incoordination between the liver and stomach, belch, indigestion and loss of appetite, gastral cavity abdominal distention is vexed.Present domestic chronic cholecystitis patient takes as the leading factor with chemicals, they also produce a series of untoward reaction in the treatment disease, for improving patients ' life quality, improving compatriots' drug safety, demand the medicine of the carrying out " treating both the principal and secondary aspects of a disease " of developing determined curative effect, having no adverse reaction urgently.
And the medicament composing prescription of following relevant biliary tract is arranged:
CN200910094934.5 discloses a kind of dachaihu decoction sanction side treatment biliary tract infection disease, and its prescription is: Radix Bupleuri, Radix Et Rhizoma Rhei, Fructus Aurantii Immaturus, Radix Scutellariae, process the Rhizoma Pinelliae, Radix Paeoniae, Cortex Magnoliae Officinalis, Rhizoma Chuanxiong, Herba Lysimachiae, Radix Curcumae, Rhizoma Corydalis, rhizoma sparganic, vinegar parch skin, Fructus Gardeniae.
CN200910142119.1 relates to a kind of Chinese medicine preparation for the treatment of cholelithiasis, and raw medicinal material and the composition by weight thereof chosen are respectively: 30 parts of Herba Artemisiae Scopariaes, 9 parts of Radix Scutellariaes, 9 parts of Fructus Aurantiis, 9 parts of Radix Bupleuri, 9 parts of Radix Curcumaes, 9 parts of Cortex Magnoliae Officinalis, 9 parts of Radix Et Rhizoma Rhei, 9 parts of the Radix Paeoniae Albas, 9 parts of Rhizoma Atractylodis, 15 parts of Herba Lysimachiaes, 3 parts of the Radix Aucklandiae.
CN200810051442.3 discloses a kind of pharmaceutical composition for the treatment of cholecystitis, belongs to the field of Chinese medicines.It is to be made by the crude drug of following weight portion: Radix Bupleuri 1500-1700 part, Radix Scutellariae 1000-1200 part, Radix Paeoniae Alba 1000-1200 part, Fructus Aurantii Immaturus 600-800 part, Radix Glycyrrhizae 600-800 part, Radix Et Rhizoma Rhei 1000-1200 part, Cortex Magnoliae Officinalis 750-950 part, Herba Artemisiae Scopariae 2300-2400 part.
Above-mentioned prescription is partial to diuretic row and is drenched, and namely is mainly used in the treatment of cholelithiasis, and for chronic cholecystitis, more biases toward the treatment of inflammation, pain.
The inventor finally obtains the present invention through for many years clinical experience.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition for the treatment of chronic cholecystitis.
The invention provides a kind of Chinese medicine composition for the treatment of chronic cholecystitis, contain following Chinese medicine: Herba Artemisiae Scopariae, Radix Et Rhizoma Rhei, the Radix Paeoniae Alba, Rhizoma Corydalis, Cortex Magnoliae Officinalis, Fructus Aurantii, Radix Bupleuri, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Scutellariae, Radix Glycyrrhizae.
Preferably, described Chinese medicine composition contains the Chinese medicine of following weight portion: Herba Artemisiae Scopariae 20-30 part, Radix Et Rhizoma Rhei 10-15 part, Radix Paeoniae Alba 10-15 part, Rhizoma Corydalis 10-15 part, Cortex Magnoliae Officinalis 10-20 part, Fructus Aurantii 10-20 part, Radix Bupleuri 10-20 part, Pericarpium Citri Reticulatae 10-20 part, Fructus Toosendan 10-20 part, Radix Scutellariae 10-15 part, Radix Glycyrrhizae 10-15 part.
Further preferred, described Chinese medicine composition contains the Chinese medicine of following weight portion: Herba Artemisiae Scopariae 25-30 part, Radix Et Rhizoma Rhei 14-15 part, Radix Paeoniae Alba 10-12 part, Rhizoma Corydalis 10-15 part, Cortex Magnoliae Officinalis 10-15 part, Fructus Aurantii 10-18 part, Radix Bupleuri 10-15 part, Pericarpium Citri Reticulatae 10-15 part, Fructus Toosendan 10-15 part, Radix Scutellariae 10-16 part, Radix Glycyrrhizae 10-15 part.
Further preferred, described Chinese medicine composition contains the Chinese medicine of following weight portion: Herba Artemisiae Scopariae 28-30 part, Radix Et Rhizoma Rhei 14-15 part, Radix Paeoniae Alba 10-11 part, Rhizoma Corydalis 14-15 part, Cortex Magnoliae Officinalis 10-13 part, Fructus Aurantii 12-15 part, Radix Bupleuri 10-12 part, Pericarpium Citri Reticulatae 10-12 part, Fructus Toosendan 10-12 part, Radix Scutellariae 15-16 part, Radix Glycyrrhizae 13-15 part.
Most preferably, described Chinese medicine composition contains the Chinese medicine of following weight portion: 30 parts of Herba Artemisiae Scopariae, 15 parts of Radix Et Rhizoma Rhei, 10 parts of the Radix Paeoniae Albas, 15 parts of Rhizoma Corydalis, 10 parts of Cortex Magnoliae Officinalis, 15 parts of Fructus Aurantiis, 10 parts of Radix Bupleuri, 10 parts of Pericarpium Citri Reticulataes, 10 parts of Fructus Toosendans, 15 parts of Radix Scutellariaes, 15 parts, Radix Glycyrrhizae.
In above-mentioned Chinese medicine composition:
Described weight portion can be the known unit of weights of field of medicaments such as μ g, mg, g, kg, can be also its multiple, as 1/10,1/100,10 times, 100 times etc.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and the method comprises the following steps: the Radix Paeoniae Alba, Rhizoma Corydalis, Cortex Magnoliae Officinalis, Fructus Aurantii, Radix Bupleuri, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Scutellariae and Radix Glycyrrhizae water extraction, Herba Artemisiae Scopariae, Radix Et Rhizoma Rhei alcohol extraction.
Concrete, the method comprises the following steps:
1) take each composition according to proportioning, standby;
2) Radix Paeoniae Alba, Rhizoma Corydalis, Cortex Magnoliae Officinalis, Fructus Aurantii, Radix Bupleuri, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Scutellariae and Radix Glycyrrhizae water reflux, extract, are 2-3 time, add the water that above-mentioned nine flavor Chinese medicine gross weight 8-16 doubly measure at every turn, extraction time is 1-3h, merge extractive liquid,, filter, being concentrated into the room temperature measuring relative density is 1.10-1.15, obtains water extract, standby;
3) with Herba Artemisiae Scopariae and Radix Et Rhizoma Rhei 60-85% alcohol reflux 2-3 time, the ethanol of at every turn doubly measuring with two flavor Chinese medicine gross weight 8-12, extraction time is 1-3h, merge extractive liquid, filters, and reclaims ethanol, concentrated solution to 35 a ℃ mensuration relative density is 1.05-1.10, obtains ethanol extract, and is standby;
4) combining step 3) described ethanol extract and step 2) described water extract, concentrated medicament relative density to the room temperature is 1.15-1.25, drying.
Preferably, said method comprising the steps of:
1) take each composition according to proportioning, standby;
2) Radix Paeoniae Alba, Rhizoma Corydalis, Cortex Magnoliae Officinalis, Fructus Aurantii, Radix Bupleuri, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Scutellariae and Radix Glycyrrhizae water reflux, extract, are 2-3 time, add the water that above-mentioned nine flavor Chinese medicine gross weight 10-16 doubly measure at every turn, extraction time is 1.5-3h, merge extractive liquid,, filter, being concentrated into the room temperature measuring relative density is 1.10-1.15, obtains water extract, standby;
3) with Herba Artemisiae Scopariae and Radix Et Rhizoma Rhei 70-85% alcohol reflux 2-3 time, the ethanol of at every turn doubly measuring with two flavor Chinese medicine gross weight 10-12, extraction time is 2-3h, merge extractive liquid, filters, and reclaims ethanol, concentrated solution to 35 a ℃ mensuration relative density is 1.05-1.10, obtains ethanol extract, and is standby;
4) combining step 3) described ethanol extract and step 2) described water extract, concentrated medicament relative density to the room temperature is 1.20, drying.
Also comprise remove impurity in said method, remove impurity can be adopted method commonly used, as centrifugal, filtration etc.
The present invention also provides the preparation that contains above-mentioned Chinese medicine composition, and said preparation is made separately by Chinese medicine composition or is comprised of Chinese medicine composition and pharmaceutically acceptable carrier.
Described preparation is solid preparation or liquid preparation, and described solid preparation is sheet, capsule, granule or pill, and described capsule is preferably microspheres capsule; Described liquid preparation is mixture, oral liquid or injection.
Described pharmaceutically acceptable carrier refers to the pharmaceutical carrier of pharmaceutical field routine, is selected from one or more in filler, binding agent, disintegrating agent, lubricant, suspending agent, wetting agent, solvent, surfactant or correctives.
Described filler is selected from starch, sucrose, lactose, mannitol, sorbitol, xylitol, microcrystalline Cellulose or glucose etc.;
Described binding agent is selected from cellulose derivative, water, alginate, starch, dextrin, gelatin or polyvinylpyrrolidone etc.;
Described disintegrating agent is selected from microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose or cross-linking sodium carboxymethyl cellulose;
Described lubricant is selected from stearic acid, Polyethylene Glycol, calcium carbonate, sodium bicarbonate, micropowder silica gel, Pulvis Talci or magnesium stearate;
Described suspending agent is selected from micropowder silica gel, Cera Flava, cellulose, solid polyethylene glycol;
Described wetting agent is selected from glycerol, tween 80, ethyoxyl castor oil hydrogenated or lecithin;
Described solvent is selected from ethanol, liquid polyethylene glycol, isopropyl alcohol, tween 80, glycerol, propylene glycol or vegetable oil, and described vegetable oil is selected from soybean oil, Oleum Ricini, Oleum Arachidis hypogaeae semen, mediation wet goods;
Described surfactant is selected from dodecylbenzene sodium sulfonate, stearic acid, Pluronic F68, the fatty acid Pyrusussuriensis is smooth or Polysorbate (tween) etc.;
Described correctives is selected from aspartame, Sucralose, essence, citric acid or saccharin sodium.
The present invention also provides the preparation method of above-mentioned preparation, and the method is the conventional method of Chinese medicine preparation.
The present invention also provides above-mentioned Chinese medicine composition or the application of its preparation in the medicine of preparation treatment chronic cholecystitis.
The Chinese medicine composition for the treatment of chronic cholecystitis provided by the invention has the following advantages:
1, the present invention is based on the achievement in research of China's Chinese medical theory and modern pharmacology, the prescription that sums up through clinical trial for many years, use through pharmacodynamic study, clinical practice treatment, be a kind of determined curative effect, have no side effect, make many patients avoid operation, can be used for the treatment of the Chinese medicine composition of chronic cholecystitis, wherein:
Herba Artemisiae Scopariae is bitter, be slightly cold, and returns spleen, stomach, liver, gallbladder meridian, can clearing away heat-damp and promoting diuresis, promoting the function of the gallbladder to alleviate jaundice, and " herbal classic " carries its " main air cold-damp pathogenic heat gas, accumulation of heat jaundice ";
The Radix Et Rhizoma Rhei bitter cold is rushed down and is fallen, and can let out clearly damp and hot.Radix Paeoniae Alba property is bitter, acid, sweet, is slightly cold, and controls the blood deficiency stagnation of liver-QI pain over the hypochondriac region;
The hot loose temperature of Rhizoma Corydalis is logical, is the key medicine of blood-activating and qi-promoting pain relieving, joins the strongly fragrant stagnation of QI distending pain over the hypochondrium of Radix Bupleuri treating the liver;
The loose temperature of the bitter dry suffering of Cortex Magnoliae Officinalis is logical, is longer than circulation of qi promoting, dampness, removing food stagnancy;
Fructus Aurantii property is bitter, hot, be slightly cold, and is used for the food stagnation card;
Radix Bupleuri is bitter, hot, be slightly cold, and returns liver, gallbladder meridian, the function dispersing the stagnated live-QI to relieve the stagnation of QI, and " herbal classic " said: " main trusted subordinate's the intestines and stomach stagnation of QI, diet gathers, and the cold and heat pathogen pushes away Chen Zhixin;
The Pericarpium Citri Reticulatae acrid, bitter, warm is regulated the flow of vital energy and is transferred, and is used for the distension and fullness in the abdomen due to stagnation of QI in spleen and stomach.Fructus Toosendan is bitter, cold, and promoting the circulation of QI to relieve pain are used for the stagnation of QI due to depression of the liver distending pain over the hypochondrium;
Radix Scutellariae is bitter, cold, and heat clearing and damp drying is used for hygropyrexia, dysentery, jaundice.
The flat sweet in the mouth of Radix Glycyrrhizae property has detoxifcation, invigorating the spleen and replenishing QI, emergency detoxifcation, the effect of mediation hundred medicines.
2, prior art CN200910142119.1 has disclosed a kind of Chinese medicine preparation for the treatment of cholelithiasis, and raw medicinal material and the composition by weight thereof chosen are respectively: 30 parts of Herba Artemisiae Scopariaes, 9 parts of Radix Scutellariaes, 9 parts of Fructus Aurantiis, 9 parts of Radix Bupleuri, 9 parts of Radix Curcumaes, 9 parts of Cortex Magnoliae Officinalis, 9 parts of Radix Et Rhizoma Rhei, 9 parts of the Radix Paeoniae Albas, 9 parts of Rhizoma Atractylodis, 15 parts of Herba Lysimachiaes, 3 parts of the Radix Aucklandiae.
The present invention distinguishes with it and is, has replaced Radix Curcumae wherein, Herba Lysimachiae, the Radix Aucklandiae with Rhizoma Corydalis, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Glycyrrhizae.
In prior art: Radix Curcumae has blood circulation-promoting functions, promoting blood circulation and stopping pain, promoting QI circulation for relieving depression, the removing heat from blood that clears away heart-fire, promoting the function of the gallbladder to alleviate jaundice effect; Herba Lysimachiae has heat-clearing and toxic substances removing, dissipating blood stasis for subsidence of swelling, the effect of dampness removing jaundice eliminating; The Radix Aucklandiae has QI regulating medicine; Qi-activating drug; The effect of drugs for dispelling internal cold.Be mainly used in treating cholelithiasis, and circulation of qi promoting, diuretic, calculus are partial in the treatment of cholelithiasis.
And Rhizoma Corydalis of the present invention is the key medicine of blood-activating and qi-promoting pain relieving, joins the strongly fragrant stagnation of QI distending pain over the hypochondrium of Radix Bupleuri treating the liver; During Pericarpium Citri Reticulatae is regulated the flow of vital energy and transferred, be used for the distension and fullness in the abdomen due to stagnation of QI in spleen and stomach.Fructus Toosendan is bitter, cold, and promoting the circulation of QI to relieve pain are used for the stagnation of QI due to depression of the liver distending pain over the hypochondrium, and Radix Glycyrrhizae has the coordinating the actions of various ingredients in a prescription effect; And full side's Chinese medicine is hardship, cold, pungent medicine, with Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription not only, solved the side effect bitter, cold, that pungent medicine injures one's stomach, but also invigorating the spleen and replenishing QI increases the absorption of medicine.Replaced Radix Curcumae, Herba Lysimachiae, the Radix Aucklandiae of prior art with these four kinds of compositions, more bias toward the treatment hypochondriac pain, and effect has been more excellent.
3, clinical trial shows, Chinese medicine composition provided by the invention is determined curative effect aspect chronic cholecystitis, and is better than prior art.
The specific embodiment
Following examples are used for explanation the present invention, but are not used for limiting the scope of the invention.
Spray drying of the present invention can adopt conventional method to carry out, and with reference to take parameter setting: hydrojet speed is as 3000ml/min, and intake air temperature is 150 ℃, and the air outlet temperature is 90 ℃ and carries out for example; Remove impurity, take centrifugal remove impurity as example, rotating speed can be 1.0*10
5Turn/min or 1.3*10
5Turn/min.But said method should not be construed as limiting the invention.
Embodiment 1: Chinese medicine composition
1, raw material of Chinese medicine: Herba Artemisiae Scopariae 30g, Radix Et Rhizoma Rhei 15g, Radix Paeoniae Alba 10g, Rhizoma Corydalis 15g, Cortex Magnoliae Officinalis 10g, Fructus Aurantii 15g, Radix Bupleuri 10g, Pericarpium Citri Reticulatae 10g, Fructus Toosendan 10g, Radix Scutellariae 15g, Radix Glycyrrhizae 15g.
2, preparation method:
1) after the Radix Paeoniae Alba, Rhizoma Corydalis, Cortex Magnoliae Officinalis, Fructus Aurantii, Radix Bupleuri, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Scutellariae and Radix Glycyrrhizae mix, add 15 times of water gagings, reflux, extract, 2h extracts 3 times altogether, filter, merging filtrate treats that filtrate is cooled to 65 ℃, takes the concentrating under reduced pressure medicinal liquid, it is 1.10 that concentrated solution is cooled to the room temperature measuring relative density, centrifugal, namely get water extract, standby;
2) Herba Artemisiae Scopariae and Radix Et Rhizoma Rhei are added approximately 10 times of amount 70% alcohol reflux 2h, extract altogether 3 times, filter merging filtrate, reclaim ethanol, merging filtrate treats that filtrate is cooled to 50 ℃, takes the concentrating under reduced pressure medicinal liquid, it is 1.05 that concentrated solution is cooled to 35 ℃ of mensuration relative densities, namely gets ethanol extract, standby;
3) combining step 1) and step 2) extract, room temperature to be down to, concentrating under reduced pressure again, during to room temperature, relative density is 1.20 extractum, is prepared into cream powder 30g, namely gets Chinese medicine composition, and is standby;
4) coacervation prepares microsphere: get water for injection 200g, add gelatin 60g, heating for dissolving adds cream powder mixing, under 18-22r/min stirs, pour in the mineral oil 600g that is heated to 55-60 ℃, stir 6min, be cooled to below 5 ℃ with cold water, be that gelling becomes gelatine microsphere, add dehydrant isopropyl alcohol 300g dehydration, stir 5min, separate microsphere, wash 3 times with isopropyl alcohol (5 ℃), after drying, get microsphere 1g, add 10% formaldehyde aqueous isopropanol 10ml, putting refrigerator placement 24h is cured, considered, and be drying to obtain, microspherulite diameter is at 50-30um.
3, capsule preparation
Select No. 1 capsule, carry out plastic packaging according to 1g microsphere/grain, make 1000 of capsules.
Embodiment 2: Chinese medicine composition
1, raw material of Chinese medicine: Herba Artemisiae Scopariae 25g, Radix Et Rhizoma Rhei 15g, Radix Paeoniae Alba 12g, Rhizoma Corydalis 13g, Cortex Magnoliae Officinalis 15g, Fructus Aurantii 18g, Radix Bupleuri 15g, Pericarpium Citri Reticulatae 15g, Fructus Toosendan 15g, Radix Scutellariae 13g, Radix Glycyrrhizae 15g.
2, preparation method:
1) after the Radix Paeoniae Alba, Rhizoma Corydalis, Cortex Magnoliae Officinalis, Fructus Aurantii, Radix Bupleuri, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Scutellariae and Radix Glycyrrhizae mix, add 12 times of water gagings, reflux, extract, 1.5h extracts 3 times altogether, filters, merging filtrate, treat that filtrate is cooled to 60 ℃, take the concentrating under reduced pressure medicinal liquid, it is 1.12 that concentrated solution is cooled to the room temperature measuring relative density, namely get water extract, standby;
2) Herba Artemisiae Scopariae and Radix Et Rhizoma Rhei are added approximately 10 times of amount 80% alcohol reflux 2h, extract altogether 2 times, filter merging filtrate, reclaim ethanol, merging filtrate treats that filtrate is cooled to 55 ℃, takes the concentrating under reduced pressure medicinal liquid, it is 1.08 that concentrated solution is cooled to 35 ℃ of mensuration relative densities, namely gets ethanol extract, standby;
3) combining step 1) and step 2) extract, room temperature to be down to, concentrating under reduced pressure again, during to room temperature, relative density is 1.20 extractum, is dried to cream powder 30g, namely gets Chinese medicine composition, and is standby;
4) capsule preparation
Cream powder 30g and 10% gelatinized corn starch of the present invention preparation are mixed and made into soft material, through 14 order nylon mesh granulations, are dried to moisture below 3% in 70 ℃, load No. 1 capsule, make 1000 of capsules.
Embodiment 3: Chinese medicine composition
1, raw material of Chinese medicine: Herba Artemisiae Scopariae 28g, Radix Et Rhizoma Rhei 14g, Radix Paeoniae Alba 11g, Rhizoma Corydalis 14g, Cortex Magnoliae Officinalis 13g, Fructus Aurantii 12g, Radix Bupleuri 13g, Pericarpium Citri Reticulatae 12g, Fructus Toosendan 12g, Radix Scutellariae 16g, Radix Glycyrrhizae 13g.
2, preparation method:
1) after the Radix Paeoniae Alba, Rhizoma Corydalis, Cortex Magnoliae Officinalis, Fructus Aurantii, Radix Bupleuri, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Scutellariae and Radix Glycyrrhizae mix, add 10 times of water gagings, reflux, extract, 1.5h extracts 2 times altogether, filters, merging filtrate, treat that filtrate is cooled to 62 ℃, take the concentrating under reduced pressure medicinal liquid, it is 1.15 that concentrated solution is cooled to the room temperature measuring relative density, namely get water extract, standby;
2) Herba Artemisiae Scopariae and Radix Et Rhizoma Rhei are added approximately 12 times of amount 75% alcohol reflux 2h, extract altogether 2 times, filter merging filtrate, reclaim ethanol, merging filtrate treats that filtrate is cooled to 55 ℃, takes the concentrating under reduced pressure medicinal liquid, it is 1.10 that concentrated solution is cooled to 35 ℃ of mensuration relative densities, namely gets ethanol extract, standby;
3) combining step 1) and step 2) extract, room temperature to be down to, concentrating under reduced pressure again, during to room temperature, relative density is 1.20 extractum, is prepared into cream powder 30g, namely gets Chinese medicine composition;
4) get extract powder 30g and mix with 80g starch, add 17% starch slurry mixing, cross 16 mesh sieves and granulate, 70 ℃ of dryings, dry granular adds magnesium stearate and starch 20g, crosses 12 mesh sieve granulate, and mixing directly is prepared into 1000 tablets of tablets.
Embodiment 4: Chinese medicine composition
1, raw material of Chinese medicine: Herba Artemisiae Scopariae 20g, Radix Et Rhizoma Rhei 15g, Radix Paeoniae Alba 15g, Rhizoma Corydalis 15g, Cortex Magnoliae Officinalis 20g, Fructus Aurantii 20g, Radix Bupleuri 10g, Pericarpium Citri Reticulatae 15g, Fructus Toosendan 15g, Radix Scutellariae 10g, Radix Glycyrrhizae 10g.
2, preparation method:
1) after the Radix Paeoniae Alba, Rhizoma Corydalis, Cortex Magnoliae Officinalis, Fructus Aurantii, Radix Bupleuri, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Scutellariae and Radix Glycyrrhizae mix, add 8 times of water gagings, reflux, extract, 2h extracts 3 times altogether, filter, merging filtrate treats that filtrate is cooled to 65 ℃, takes the concentrating under reduced pressure medicinal liquid, it is 1.10 that concentrated solution is cooled to the room temperature measuring relative density, centrifugal, namely get water extract, standby;
2) Herba Artemisiae Scopariae and Radix Et Rhizoma Rhei are added approximately 8 times of amount 60% alcohol reflux 2h, extract altogether 3 times, filter merging filtrate, reclaim ethanol, merging filtrate treats that filtrate is cooled to 50 ℃, takes the concentrating under reduced pressure medicinal liquid, concentrated solution is cooled to 35 ℃, and to measure relative densities be 1.05, centrifugal, namely get ethanol extract, standby;
3) combining step 1) and step 2) extracting solution, room temperature to be down to, concentrating under reduced pressure again, during to room temperature, relative density is 1.20 extractum, utilizes high speed centrifugation, is prepared into cream powder 30g, and is standby;
4) the described cream powder of step 3) 30g mixes in right amount with saccharin sodium, and mixture is granulated with the polyvidone isopropyl alcohol liquid, drying, and granulate, classification and get final product is divided into 1000 bags of granules.
Embodiment 5: Chinese medicine composition
1, raw material of Chinese medicine: Herba Artemisiae Scopariae 30g, Radix Et Rhizoma Rhei 15g, Radix Paeoniae Alba 10g, Rhizoma Corydalis 10g, Cortex Magnoliae Officinalis 10g, Fructus Aurantii 10g, Radix Bupleuri 15g, Pericarpium Citri Reticulatae 10g, Fructus Toosendan 15g, Radix Scutellariae 10g, Radix Glycyrrhizae 10g.
2, preparation method:
1) after the Radix Paeoniae Alba, Rhizoma Corydalis, Cortex Magnoliae Officinalis, Fructus Aurantii, Radix Bupleuri, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Scutellariae and Radix Glycyrrhizae mix, add 16 times of water gagings, reflux, extract, 1.5h extracts 2 times altogether, filters, merging filtrate, treat that filtrate is cooled to 65 ℃, take the concentrating under reduced pressure medicinal liquid, it is 1.13 that concentrated solution is cooled to the room temperature measuring relative density, namely get water extract, standby;
2) Herba Artemisiae Scopariae and Radix Et Rhizoma Rhei are added approximately 12 times of amount 70% alcohol reflux 3h, extract altogether 2 times, filter merging filtrate, reclaim ethanol, merging filtrate treats that filtrate is cooled to 50 ℃, takes the concentrating under reduced pressure medicinal liquid, it is 1.10 that concentrated solution is cooled to 35 ℃ of mensuration relative densities, namely gets ethanol extract, standby;
3) combining step 1) and step 2) extracting solution, room temperature to be down to, concentrating under reduced pressure again, during to room temperature, relative density is 1.20 extractum, is prepared into the cream powder, and is standby;
4) it is even that step 3) described cream powder 30g and 1% carmine lactose 15 grams are put in mortar lapping-in, then add gradually needed lactose by the equivalent mixing method of progressively increasing, and fully lapping-in, treat whole color and lusters evenly and get final product, 1000 parts of powders.
Comparative Examples: Chinese medicine composition
Composition with reference to CN200910142119.1 is specially:
1, raw material: 30 parts of Herba Artemisiae Scopariaes, 9 parts of Radix Scutellariaes, 9 parts of Fructus Aurantiis, 9 parts of Radix Bupleuri, 9 parts of Radix Curcumaes, 9 parts of Cortex Magnoliae Officinalis, 9 parts of Radix Et Rhizoma Rhei, 9 parts of the Radix Paeoniae Albas, 9 parts of Rhizoma Atractylodis, 15 parts of Herba Lysimachiaes, 3 parts of the Radix Aucklandiae.
2, preparation method: with embodiment 1.
Experimental example: clinical efficacy
1, case is selected: clinical volunteer selects all through being diagnosed as the chronic cholecystitis patient, and diagnostic criteria, inclusive criteria, exclusion standard and efficacy evaluation are as follows,
1.1 the diagnosis of Western medicine diagnose all cases is carried out with reference to Ministry of Public Health " new Chinese medicine guideline of clinical investigations " (2002).
1) continue upper right abdomen dull pain or sense of discomfort, or with right shoulder blade district pain.
2) have nauseating, sigh, the indigestion symptoms such as pantothenic acid, abdominal distention and scorching hot, the postemphasis of feed greasy food.
3) course of disease is long, and the course of disease is through having acute attack and alleviating characteristics alternately.
4) gallbladder area has mild tenderness or tunks pain.
5) crude the thickening of the visible gallbladder wall of B ultrasonic, gallbladder dwindles or is out of shape, or visible cholelithiasis.
6) the visible gallbladder of cholecystography dwindles or is out of shape, and gallbladder contraction function is bad, or the gallbladder development is thin, or visible cholelithiasis.
All tools each one of in 5,6 two, add the binomial person in the 1-4 item, namely diagnosable.
1.2B super diagnostic criteria
Phase I: gallbladder shape, size and blister cavities Non Apparent Abnormality, or gallbladder wall slightly thickens,, or calculus is arranged in gallbladder.
Second stage: gallbladder enlargement, cyst wall thicken＞0.3cm, and the lighter only shows the broadening of cyst wall echo, when heavier, occur the dark hypoecho layer therebetween.
Phase III: the gallbladder wall of proliferous type significantly thickens, and can reach 1.5cm, is medium or weak echo, and the mucosa chamber significantly dwindles, and mucous membrane surface is more complete.The gallbladder of atrophic type dwindles, and blister cavities narrows down, and can be full of calculus in it and show as " WES levies ".
1.3 Chinese medical discrimination
Liver qi stagnation type: pain in the right hypochondrium is take distending pain as main, and it is indefinite to walk to alter, and pain is every because feelings will increases, sensation of oppression over the chest with shortness of breath, and indigestion and loss of appetite lack of appetite, belch is done frequently, yellow fur, stringy and thready pulse.
The qi stagnation blood stasis type: hypochondriac pain is ached localized pain take twinge as main, or bitterly draws the shoulder back of the body, enters Night Watch very, feel sick, and belch, poor appetite, purplish tongue is dark, deep and hesitant pulse.
Liver gallbladder damp-heat type: the pain over the hypochondriac region, feeling of fullness, bitter taste, nausea and vomiting, asthenia, conjunctival congestion yellowish body, dark coloured urine dry stool, yellowish fur, wiry and frequent pulse.
The deficiecny of liver-YIN type: epigastrium dull pain, abdominal distention, indigestion and loss of appetite, shallow complexion, singultus, bitter taste, dysphoria with smothery sensation, have a dizzy spell in the heart, red tongue, few tongue, thready,weak and rapid pulse.
1.4 symptom point system
2, experiment grouping and Therapeutic Method
2.1 experiment grouping: include case 360 examples according to above-mentioned standard, adopt principle random, balanced, contrast, the 360 qualified formula persons of being subjected to of routine case are divided into each 30 examples for the treatment of 1-5 group, positive controls 30 examples at random, treat observation of curative effect between front and back and group, be 2 months the course for the treatment of.
Analysis of comparable between two groups: two groups of cases from sex, age, course of disease aspect relatively,
Treat 1 group of 30 example, male 13 examples wherein, female's 17 examples, maximum 63 years old minimum 21 years old, 42.3 ± 12.7 years old mean age, the course of disease is the shortest 1 year, and was the longest 15 years;
Treat 2 group of 30 example, male 14 examples wherein, female's 16 examples, maximum 60 years old minimum 23 years old, 43.3 ± 10.7 years old mean age, the course of disease is the shortest 1.5 years, and was the longest 16 years;
Treat 3 group of 30 example, male 12 examples wherein, female's 18 examples, maximum 62 years old minimum 22 years old, 42.1 ± 13.3 years old mean age, the course of disease is the shortest 2 years, and was the longest 14 years;
Treat 4 group of 30 example, male 13 examples wherein, female's 17 examples, maximum 61 years old minimum 24 years old, 43.5 ± 11.3 years old mean age, the course of disease is the shortest 1 year, and was the longest 15 years;
Treat 5 group of 30 example, male 12 examples wherein, female's 18 examples, maximum 62 years old minimum 20 years old, 43.1 ± 13.1 years old mean age, the course of disease is the shortest 1.5 years, and was the longest 16 years;
Positive controls 30 examples, male 14 examples wherein, female's 16 examples, maximum 62 years old minimum 19 years old, 43.38 ± 13.1 years old mean age, the course of disease is the shortest 1.5 years, and was the longest 16 years.
Epidemiological Analysis, treat front two groups of cases and comparing aspect sex, age by statistics, and the equal not statistically significant of its difference (P＞0.05) has comparability.
2.2 Therapeutic Method administration every day 1 time, 3 tablets/times (containing crude drug 0.465g), it is a course for the treatment of that the volunteer takes 2 months.
Two groups of Chinese and western drugses of the acute and chronic cholecystitis of other treatment of all stopping using during treatment.
3, observation index
3.1 safety is observed: general health check-up, blood, urine, just routine test, electrocardiogram, liver function, renal function and untoward reaction.
3.2 observation of curative effect: observe and recording medicine front and back clinical symptoms weekly, itemized record are waited and are levied the integration variation, notice that patient's Abdominal Signs changes, and carries out the doctor trained in Western medicine objective determination around the course for the treatment of.
3.3 efficacy assessment standard
3.3.1 total effects evaluation criteria
Recovery from illness: after medication, symptom, sign disappear, and integrated value reduces＞95%;
Produce effects: after medication, symptom, sign are obviously improved, and integrated value reduces＞30%;
Invalid: after medication, symptom, sign are without obvious improvement, or integrated value reduces＜30%;
Annotate: computing formula (nimodipine method) is: integration * 100% before therapeutic index=(integration before integration after treatment-treatment)/treatment.
3.3.2B super curative effect determinate standard
Recovery from illness: the wall thickness of gallbladder or bile duct wall, three of crude, entrant sounds recover normal;
Produce effects: above improvement more than 2 or 2;
Effectively: above improvement more than 1 or 1;
Invalid: above 3 all without improving.
3.3.3 statistical method: the measurement data data are used
The t check is adopted in expression, and enumeration data adopts X
2Check, P＜0.05 is for there being significant difference, and P＞0.05 is not for there is no significant difference.
4, interpretation of result
4.1 two groups of case total effectses relatively: see Table 1
Table 1: two groups of case total effectses are observed
| Group | The number of cases number | Recovery from illness number (%) | Produce effects number (%) | Invalid number (%) | Total effective rate |
| Treat 1 group | 30 | 27（90%） | 3（10%） | 0 | 100% |
| Treat 2 groups | 30 | 26（86.7%） | 3（10%） | 1（3.3%） | 96.7% |
| Treat 3 groups | 30 | 26（86.7%） | 4（3.3%） | 0 | 100% |
| Treat 4 groups | 30 | 24（80%） | 3（10%） | 3（10%） | 90% |
| Treat 5 groups | 30 | 25（83.3%） | 8（26.7%） | 1（3.3%） | 96.7% |
| Positive controls | 30 | 4（13.3%） | 14（46.7） | 12（40%） | 60% |
Table 1 result shows: contrast the Epidemiological Analysis by statistics of 1 group, between two groups, total effective rate is learned difference P that significance is arranged after processing＜0.05 by statistics.Illustrate that the treatment group curative effect obviously is better than matched group
4.2
Before and after two groups of treatments, gall bladder B mode ultrasound imaging image B ultrasonic iconography relatively: see Table 2
Table 2: before and after two groups of treatments, the gall bladder B mode ultrasound imaging iconography relatively
| Group | Number of cases | Recovery from illness | Significantly | Effectively | Invalid | Total significant figure (%) |
| Treat 1 group | 30 | 6 | 10 | 14 | 0 | 100 |
| Treat 2 groups | 30 | 7 | 7 | 13 | 3 | 90 |
| Treat 3 groups | 30 | 8 | 10 | 11 | 1 | 96.7 |
| Treat 4 groups | 30 | 5 | 6 | 14 | 5 | 83.3 |
| Treat 5 groups | 30 | 8 | 5 | 15 | 2 | 93.3 |
| Positive controls | 30 | 2 | 8 | 6 | 14 | 53.3 |
Table 2 result shows: the B ultrasonic demonstration of positive controls, and its total effective rate is 53.3%, and the total effective rate for the treatment of 1-3 group obviously is better than positive controls higher than 85%.
Result shows: Chinese medicine composition provided by the invention is determined curative effect aspect the treatment chronic cholecystitis, and is better than prior art.
8.3 evaluation with toxic and side effects is commented in the safety of medicine of the present invention:
Prescription of the present invention is not found any untoward reaction or toxic and side effects in clinical research observation is observed, on blood, urine, just routine, hepatic and renal function, electrocardiogram etc. all without affecting, can illustrate that in conjunction with modern pharmacological research this prescription is safe and reliable.
Although, above used general explanation, the specific embodiment and test, the present invention is described in detail, on basis of the present invention, can make some modifications or improvements it, and this will be apparent to those skilled in the art.Therefore, these modifications or improvements, all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (10)
1. a Chinese medicine composition for the treatment of chronic cholecystitis, is characterized in that, described Chinese medicine composition contains following Chinese medicine: Herba Artemisiae Scopariae, Radix Et Rhizoma Rhei, the Radix Paeoniae Alba, Rhizoma Corydalis, Cortex Magnoliae Officinalis, Fructus Aurantii, Radix Bupleuri, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Scutellariae, Radix Glycyrrhizae.
2. Chinese medicine composition according to claim 1, it is characterized in that, described Chinese medicine composition contains the Chinese medicine of following weight portion: Herba Artemisiae Scopariae 20-30 part, Radix Et Rhizoma Rhei 10-15 part, Radix Paeoniae Alba 10-15 part, Rhizoma Corydalis 10-15 part, Cortex Magnoliae Officinalis 10-20 part, Fructus Aurantii 10-20 part, Radix Bupleuri 10-20 part, Pericarpium Citri Reticulatae 10-20 part, Fructus Toosendan 10-20 part, Radix Scutellariae 10-15 part, Radix Glycyrrhizae 10-15 part.
3. Chinese medicine composition according to claim 1, it is characterized in that, described Chinese medicine composition contains the Chinese medicine of following weight portion: Herba Artemisiae Scopariae 25-30 part, Radix Et Rhizoma Rhei 14-15 part, Radix Paeoniae Alba 10-12 part, Rhizoma Corydalis 10-15 part, Cortex Magnoliae Officinalis 10-15 part, Fructus Aurantii 10-18 part, Radix Bupleuri 10-15 part, Pericarpium Citri Reticulatae 10-15 part, Fructus Toosendan 10-15 part, Radix Scutellariae 10-16 part, Radix Glycyrrhizae 10-15 part.
4. Chinese medicine composition according to claim 1, it is characterized in that, described Chinese medicine composition contains the Chinese medicine of following weight portion: Herba Artemisiae Scopariae 28-30 part, Radix Et Rhizoma Rhei 14-15 part, Radix Paeoniae Alba 10-11 part, Rhizoma Corydalis 14-15 part, Cortex Magnoliae Officinalis 10-13 part, Fructus Aurantii 12-15 part, Radix Bupleuri 10-12 part, Pericarpium Citri Reticulatae 10-12 part, Fructus Toosendan 10-12 part, Radix Scutellariae 15-16 part, Radix Glycyrrhizae 13-15 part.
5. Chinese medicine composition according to claim 1, it is characterized in that, described Chinese medicine composition contains the Chinese medicine of following weight portion: 30 parts of Herba Artemisiae Scopariae, 15 parts of Radix Et Rhizoma Rhei, 10 parts of the Radix Paeoniae Albas, 15 parts of Rhizoma Corydalis, 10 parts of Cortex Magnoliae Officinalis, 15 parts of Fructus Aurantiis, 10 parts of Radix Bupleuri, 10 parts of Pericarpium Citri Reticulataes, 10 parts of Fructus Toosendans, 15 parts of Radix Scutellariaes, 15 parts, Radix Glycyrrhizae.
6. method for preparing the described Chinese medicine composition of claim 1-5 any one, it is characterized in that, the method comprises the following steps: the Radix Paeoniae Alba, Rhizoma Corydalis, Cortex Magnoliae Officinalis, Fructus Aurantii, Radix Bupleuri, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Scutellariae and Radix Glycyrrhizae water extraction, Herba Artemisiae Scopariae, Radix Et Rhizoma Rhei alcohol extraction.
7. method according to claim 6, is characterized in that, the method comprises the following steps:
1) take each composition according to proportioning, standby;
2) Radix Paeoniae Alba, Rhizoma Corydalis, Cortex Magnoliae Officinalis, Fructus Aurantii, Radix Bupleuri, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Scutellariae and Radix Glycyrrhizae water reflux, extract, are 2-3 time, add the water that above-mentioned nine flavor Chinese medicine gross weight 8-16 doubly measure at every turn, extraction time is 1-3h, merge extractive liquid,, filter, being concentrated into the room temperature measuring relative density is 1.10-1.15, obtains water extract, standby;
3) with Herba Artemisiae Scopariae and Radix Et Rhizoma Rhei 60-85% alcohol reflux 2-3 time, the ethanol of at every turn doubly measuring with two flavor Chinese medicine gross weight 8-12, extraction time is 1-3h, merge extractive liquid, filters, and reclaims ethanol, concentrated solution to 35 a ℃ mensuration relative density is 1.05-1.10, obtains ethanol extract, and is standby;
4) combining step 3) described ethanol extract and step 2) described water extract, concentrated medicament relative density to the room temperature is 1.15-1.25, drying.
8. method according to claim 6, is characterized in that, said method comprising the steps of:
1) take each composition according to proportioning, standby;
2) Radix Paeoniae Alba, Rhizoma Corydalis, Cortex Magnoliae Officinalis, Fructus Aurantii, Radix Bupleuri, Pericarpium Citri Reticulatae, Fructus Toosendan, Radix Scutellariae and Radix Glycyrrhizae water reflux, extract, are 2-3 time, add the water that above-mentioned nine flavor Chinese medicine gross weight 10-16 doubly measure at every turn, extraction time is 1.5-3h, merge extractive liquid,, filter, being concentrated into the room temperature measuring relative density is 1.10-1.15, obtains water extract, standby;
3) with Herba Artemisiae Scopariae and Radix Et Rhizoma Rhei 70-85% alcohol reflux 2-3 time, the ethanol of at every turn doubly measuring with two flavor Chinese medicine gross weight 10-12, extraction time is 2-3h, merge extractive liquid, filters, and reclaims ethanol, concentrated solution to 35 a ℃ mensuration relative density is 1.05-1.10, obtains ethanol extract, and is standby;
4) combining step 3) described ethanol extract and step 2) described water extract, concentrated medicament relative density to the room temperature is 1.20, drying.
9. contain the preparation that right requires the described Chinese medicine composition of 1-5 any one, it is characterized in that, described preparation is made separately by Chinese medicine composition or is comprised of Chinese medicine composition and pharmaceutically acceptable carrier.
10. the application of the described Chinese medicine composition of claim 1-5 any one in the medicine of preparation treatment chronic cholecystitis.
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